1 00:00:05,880 --> 00:00:08,120 WELCOME BACK TO DAY TWO OF THE 2 00:00:08,120 --> 00:00:08,800 PRACTICUM. 3 00:00:08,800 --> 00:00:10,440 WE HAVE A VERY FULL SCHEDULE 4 00:00:10,440 --> 00:00:12,480 TODAY AND GREAT SESSIONS ON 5 00:00:12,480 --> 00:00:15,240 RIGOR AND REPRODUCIBILITY FIRST 6 00:00:15,240 --> 00:00:16,120 THEN EFFICACY AND SAFETY AND 7 00:00:16,120 --> 00:00:17,680 THEN A FEW SPECIAL PRESENTATIONS 8 00:00:17,680 --> 00:00:20,760 AT THE END OF THE DAY. 9 00:00:20,760 --> 00:00:22,880 THANK YOU SO MUCH, YESTERDAY, 10 00:00:22,880 --> 00:00:24,360 FOR ALL YOUR GREAT QUESTIONS. 11 00:00:24,360 --> 00:00:25,320 PLEASE KEEP SUBMITTING THEM. 12 00:00:25,320 --> 00:00:27,200 THAT REALLY ADDS TO THE SUCCESS 13 00:00:27,200 --> 00:00:29,240 OF THIS PRACTICUM. 14 00:00:29,240 --> 00:00:30,800 JUST A REMINDER, PLEASE SUBMIT 15 00:00:30,800 --> 00:00:32,320 ALL TECHNICAL ISSUES, PROBLEMS 16 00:00:32,320 --> 00:00:34,800 YOU'RE HAVING IN WEBEX INTO THE 17 00:00:34,800 --> 00:00:37,120 CHAT BOX, AND PLEASE SUBMIT 18 00:00:37,120 --> 00:00:38,880 QUESTIONS FOR THE PRESENTER IN 19 00:00:38,880 --> 00:00:40,520 THE Q & A PANEL, AND DIRECT 20 00:00:40,520 --> 00:00:42,920 THOSE TO ALL PANELISTS. 21 00:00:42,920 --> 00:00:47,520 OUR FIRST SESSION TODAY IS RIGOR 22 00:00:47,520 --> 00:00:48,120 AND REPRODUCIBILITY IN DIETARY 23 00:00:48,120 --> 00:00:48,600 SUPPLEMENTS RESEARCH. 24 00:00:48,600 --> 00:00:52,000 IT IS MODERATED BY DR. SANEM 25 00:00:52,000 --> 00:00:52,360 HOSBAS COSKUN. 26 00:00:52,360 --> 00:00:54,120 SHE JOINED THE OFFICE OF DIETARY 27 00:00:54,120 --> 00:00:56,400 SUPPLEMENTS IN 2020 AS 28 00:00:56,400 --> 00:00:59,760 SCIENTIFIC CONSULTANT TO THE 29 00:00:59,760 --> 00:01:01,600 BIOCHEMIST WHO SUPPORTS THE 30 00:01:01,600 --> 00:01:03,600 ANALYTICAL METHODS AND REFERENCE 31 00:01:03,600 --> 00:01:04,040 MATERIALS PROGRAM. 32 00:01:04,040 --> 00:01:08,400 THANK YOU, SANEM. 33 00:01:08,400 --> 00:01:09,480 >> THANK YOU. 34 00:01:09,480 --> 00:01:11,080 WELCOME, EVERYONE, TO SESSION 35 00:01:11,080 --> 00:01:14,840 4 OF THE PRACTICUM, RIGOR AND 36 00:01:14,840 --> 00:01:15,360 REPRODUCIBILITY IN DIETARY 37 00:01:15,360 --> 00:01:16,200 SUPPLEMENTS RESEARCH. 38 00:01:16,200 --> 00:01:18,600 WE HAVE TWO SPEAKERS IN THIS 39 00:01:18,600 --> 00:01:20,120 SESSION AND THERE WILL BE TIME 40 00:01:20,120 --> 00:01:22,640 TO ANSWER YOUR QUESTIONS AFTER 41 00:01:22,640 --> 00:01:24,280 EACH PRESENTATION. 42 00:01:24,280 --> 00:01:26,480 OUR FIRST SPEAKER TODAY IS 43 00:01:26,480 --> 00:01:28,840 DR. ADAM KUSZAK. 44 00:01:28,840 --> 00:01:30,680 DR. KUSZAK JOINED THE ODS, 45 00:01:30,680 --> 00:01:32,840 OFFICE OF DIETARY SUPPLEMENTS, 46 00:01:32,840 --> 00:01:35,360 IN TWEB 14. 47 00:01:35,360 --> 00:01:36,640 2014. 48 00:01:36,640 --> 00:01:43,040 HE I WOULD LIKE TO WELCOME 49 00:01:43,040 --> 00:01:46,480 DR. KUSZAK WITH HIS TALK ON 50 00:01:46,480 --> 00:01:47,920 ANALYTICAL CHARACTERIZATION OF 51 00:01:47,920 --> 00:01:50,120 DIETARY SUPPLEMENTS: METHODS, 52 00:01:50,120 --> 00:01:51,800 STANDARDS AND QUALITY ASSURANCE. 53 00:01:51,800 --> 00:01:53,560 DR. KUSZAK? 54 00:01:53,560 --> 00:01:54,800 I'M ADAM KUSZAK AND IT IS MY 55 00:01:54,800 --> 00:01:57,440 PLEASURE TO PRESENT AT THIS ODS 56 00:01:57,440 --> 00:01:58,200 RESEARCH PRACTICUM. 57 00:01:58,200 --> 00:02:00,040 I'LL BE GOING OVER THE 58 00:02:00,040 --> 00:02:00,880 ANALYTICAL CHARACTERIZATION OF 59 00:02:00,880 --> 00:02:02,440 DIETARY SUPPLEMENTS, DESCRIBING 60 00:02:02,440 --> 00:02:03,520 ITS IMPORTANCE AND COVERING 61 00:02:03,520 --> 00:02:05,560 ASPECTS OF METHODS, STANDARDS 62 00:02:05,560 --> 00:02:08,720 AND QUALITY ASSURANCE. 63 00:02:08,720 --> 00:02:11,080 THE FUNDAMENTAL QUESTION FOR US 64 00:02:11,080 --> 00:02:13,440 TODAY ON QUALITY AND METHODS IS, 65 00:02:13,440 --> 00:02:15,520 HOW DO YOU KNOW EXACTLY WHAT YOU 66 00:02:15,520 --> 00:02:18,000 ARE MANUFACTURING, SELLING, 67 00:02:18,000 --> 00:02:20,000 CONSUMING, OR STUDYING? 68 00:02:20,000 --> 00:02:22,360 OUR OBJECTIVES FOR UNDERSTANDING 69 00:02:22,360 --> 00:02:23,480 DIETARY SUPPLEMENT 70 00:02:23,480 --> 00:02:25,080 CHARACTERIZATION ARE TO GO OVER 71 00:02:25,080 --> 00:02:27,640 THE CONCEPTS OF IDENTITY, 72 00:02:27,640 --> 00:02:29,840 PURITY, QUALITY, AND 73 00:02:29,840 --> 00:02:30,400 COMPOSITION. 74 00:02:30,400 --> 00:02:32,240 WE'LL DISCUSS AN OVERVIEW OF THE 75 00:02:32,240 --> 00:02:33,960 ANALYTICAL CHALLENGES AND NEEDS 76 00:02:33,960 --> 00:02:36,240 IN RESEARCH, AND WE'LL ALSO TALK 77 00:02:36,240 --> 00:02:38,560 ABOUT THE USE OF REFERENCE 78 00:02:38,560 --> 00:02:39,720 MATERIALS AND RELIABLE 79 00:02:39,720 --> 00:02:41,320 ANALYTICAL METHODS TO SUPPORT 80 00:02:41,320 --> 00:02:45,160 RIGOROUS RESEARCH AND TO SUPPORT 81 00:02:45,160 --> 00:02:47,600 ITS TRANSLATION TO IMPROVE 82 00:02:47,600 --> 00:02:50,200 PUBLIC HEALTH. 83 00:02:50,200 --> 00:02:51,760 NOW THE CORE ISSUE AND CHALLENGE 84 00:02:51,760 --> 00:02:53,880 IS THE FACT THAT BY DEFINITION, 85 00:02:53,880 --> 00:02:57,160 DIETARY SUPPLEMENTS CAN BE 86 00:02:57,160 --> 00:02:57,840 COMPLEX. 87 00:02:57,840 --> 00:02:58,920 WE'VE HEARD THE LEGISLATIVE 88 00:02:58,920 --> 00:02:59,920 DEFINITION OF DIETARY 89 00:02:59,920 --> 00:03:00,880 SUPPLEMENTS IN THE U.S., WHICH 90 00:03:00,880 --> 00:03:03,280 COVERS A LOT OF GROUND. 91 00:03:03,280 --> 00:03:05,280 VITAMIN, MINERALS, METABOLITES, 92 00:03:05,280 --> 00:03:07,880 PLANT MATERIAL, FUNGI, ET 93 00:03:07,880 --> 00:03:09,120 CETERA. 94 00:03:09,120 --> 00:03:11,040 AND OF COURSE SUPPLEMENTS CAN 95 00:03:11,040 --> 00:03:12,280 CONTAIN INGREDIENTS FROM EACH OF 96 00:03:12,280 --> 00:03:14,120 THESE CHEMICAL CATEGORIES, WHICH 97 00:03:14,120 --> 00:03:15,880 COMPLICATES ATTEMPTS TO 98 00:03:15,880 --> 00:03:16,720 ANALYTICALLY CHARACTERIZE THEIR 99 00:03:16,720 --> 00:03:18,160 COMPOSITION. 100 00:03:18,160 --> 00:03:19,680 AS DESCRIBED IN EARLIER TALKS IN 101 00:03:19,680 --> 00:03:22,960 OUR PROGRAM, THE INCLUSION OF 102 00:03:22,960 --> 00:03:24,000 BOTANICALS AS DIETARY 103 00:03:24,000 --> 00:03:25,200 SUPPLEMENTS CAN BRING ADDITIONAL 104 00:03:25,200 --> 00:03:26,960 LAYERS OF COMPLEXITY TO 105 00:03:26,960 --> 00:03:29,000 STANDARDIZATION AND QUALITY 106 00:03:29,000 --> 00:03:29,400 ASSURANCE. 107 00:03:29,400 --> 00:03:31,400 IN DEALING WITH A VARIETY OF 108 00:03:31,400 --> 00:03:34,080 FORMULATION MATRIX TYPES, 109 00:03:34,080 --> 00:03:35,960 TABLETS, LIQUIDS, GUMMIES, ET 110 00:03:35,960 --> 00:03:37,560 CETERA, THESE ALL CAN CREATE 111 00:03:37,560 --> 00:03:40,880 SIGNIFICANT ANALYTICAL 112 00:03:40,880 --> 00:03:42,640 CHALLENGES. 113 00:03:42,640 --> 00:03:44,000 FROM A COMMERCIAL POINT OF VIEW, 114 00:03:44,000 --> 00:03:46,880 AS WE'VE HEARD, IT IS THE 115 00:03:46,880 --> 00:03:47,480 DIETARY SUPPLEMENT HEALTH AND 116 00:03:47,480 --> 00:03:49,680 EDUCATION ACT OF 1994 WHICH 117 00:03:49,680 --> 00:03:50,880 ESTABLISHES HOW SUPPLEMENTS ARE 118 00:03:50,880 --> 00:03:53,520 REGULATED IN THE U.S. 119 00:03:53,520 --> 00:03:56,440 THE CODE OF FEDERAL REGULATIONS 120 00:03:56,440 --> 00:03:58,440 DESCRIBES THE DETAILS OF HOW FDA 121 00:03:58,440 --> 00:03:59,280 REGULATES SUPPLEMENT 122 00:03:59,280 --> 00:04:01,000 MANUFACTURERS, AND IT OUTLINES 123 00:04:01,000 --> 00:04:02,280 CURRENT GOOD MANUFACTURING 124 00:04:02,280 --> 00:04:04,400 PRACTICES THAT THEY MUST FOLLOW. 125 00:04:04,400 --> 00:04:08,000 IT IS THE MANUFACTURERS' 126 00:04:08,000 --> 00:04:09,120 RESPONSIBILITY TO ESTABLISH 127 00:04:09,120 --> 00:04:12,080 SPECIFICATIONS FOR THE IDENTITY, 128 00:04:12,080 --> 00:04:13,280 PURITY, COMPOSITION, AND 129 00:04:13,280 --> 00:04:15,360 STRENGTH OF THEIR PRODUCTS. 130 00:04:15,360 --> 00:04:17,800 AND BOTH INCOMING INGREDIENTS 131 00:04:17,800 --> 00:04:19,600 AND OUTGOING PRODUCTS ARE TO BE 132 00:04:19,600 --> 00:04:20,920 TESTED AGAINST THOSE 133 00:04:20,920 --> 00:04:22,600 SPECIFICATIONS. 134 00:04:22,600 --> 00:04:26,160 NOW IMPORTANTLY, REGULATORS AND 135 00:04:26,160 --> 00:04:27,560 REGULATIONS THAT DON'T MANDATE 136 00:04:27,560 --> 00:04:28,960 THAT A PARTICULAR METHOD OR 137 00:04:28,960 --> 00:04:31,440 TECHNOLOGY BE USED, BUT INSTEAD 138 00:04:31,440 --> 00:04:33,400 THEY STIPULATE THAT METHODS MUST 139 00:04:33,400 --> 00:04:35,800 BE FIT-FOR-PURPOSE AND 140 00:04:35,800 --> 00:04:38,680 SCIENTIFICALLY VALID. 141 00:04:38,680 --> 00:04:41,200 NOW ON THE SIDE OF BIOMEDICAL 142 00:04:41,200 --> 00:04:42,160 RESEARCH ON THE HEALTH EFFECTS 143 00:04:42,160 --> 00:04:44,680 OF DIETARY SUPPLEMENTS, 144 00:04:44,680 --> 00:04:46,880 ANALYTICAL CHARACTERIZATION OF 145 00:04:46,880 --> 00:04:48,000 EXPERIMENTAL MATERIALS IS 146 00:04:48,000 --> 00:04:49,680 ESSENTIAL FOR SUPPORTING 147 00:04:49,680 --> 00:04:51,560 RIGOROUS BASIC AND CLINICAL 148 00:04:51,560 --> 00:04:54,320 RESEARCH ON THE MECHANISMS OF 149 00:04:54,320 --> 00:04:56,800 ACTION, METABOLISM, SAFETY, AND 150 00:04:56,800 --> 00:04:58,600 HEALTH OUTCOMES OF DIETARY 151 00:04:58,600 --> 00:05:00,360 SUPPLEMENTS. 152 00:05:00,360 --> 00:05:01,960 AND OVERALL, A THOROUGH 153 00:05:01,960 --> 00:05:03,960 CHARACTERIZATION OF THE REAGENTS 154 00:05:03,960 --> 00:05:05,440 USED IN RESEARCH IS A CRITICAL 155 00:05:05,440 --> 00:05:09,120 COMPONENT OF BUILDING 156 00:05:09,120 --> 00:05:09,920 REPRODUCIBILITY, SUPPORTING 157 00:05:09,920 --> 00:05:11,520 COMPARABILITY, AND ULTIMATELY 158 00:05:11,520 --> 00:05:14,720 LENDING CREDIBILITY TO THE 159 00:05:14,720 --> 00:05:17,120 RESEARCH. 160 00:05:17,120 --> 00:05:18,880 THERE ARE MULTIPLE GUIDELINES 161 00:05:18,880 --> 00:05:21,120 FOR ACADEMIC LABS AND FUNDING 162 00:05:21,120 --> 00:05:22,520 CRITERIA THAT OUTLINE THE 163 00:05:22,520 --> 00:05:25,040 IMPORTANCE OF AUTHENTICATING AND 164 00:05:25,040 --> 00:05:26,120 THOROUGHLY CHARACTERIZING 165 00:05:26,120 --> 00:05:28,200 NATURAL PRODUCT REAGENTS. 166 00:05:28,200 --> 00:05:30,640 INCLUDING BOTANICAL-DERIVED 167 00:05:30,640 --> 00:05:31,960 REAGENTS THAT YOU OFTEN FIND IN 168 00:05:31,960 --> 00:05:32,920 DIETARY SUPPLEMENTS. 169 00:05:32,920 --> 00:05:34,160 SO HERE ARE SOME EXAMPLES FROM 170 00:05:34,160 --> 00:05:37,200 THE LITERATURE EMPHASIZING THE 171 00:05:37,200 --> 00:05:40,800 NEED FOR CLINICAL TRIALS TO 172 00:05:40,800 --> 00:05:42,400 SUFFICIENTLY DESCRIBE BOTANICAL 173 00:05:42,400 --> 00:05:44,480 AND DIETARY SUPPLEMENT RESEARCH 174 00:05:44,480 --> 00:05:44,840 REAGENTS. 175 00:05:44,840 --> 00:05:46,400 AS IT IS QUITE DIFFICULT, YOU 176 00:05:46,400 --> 00:05:48,680 CAN IMAGINE, IF NOT IMPOSSIBLE 177 00:05:48,680 --> 00:05:50,680 TO INTERPRET AND REPRODUCE A 178 00:05:50,680 --> 00:05:53,600 CLINICAL STUDY THAT DESCRIBES 179 00:05:53,600 --> 00:05:55,160 EXPERIMENTAL INTERVENTION AS 180 00:05:55,160 --> 00:05:56,480 SIMPLY ECHINACEA. 181 00:05:56,480 --> 00:05:59,040 WHAT IS NEEDED INSTEAD IS A 182 00:05:59,040 --> 00:06:00,520 CAREFUL ASSESSMENT OF THE 183 00:06:00,520 --> 00:06:05,200 REAGENT OR INTERVENTION'S 184 00:06:05,200 --> 00:06:06,840 AUTHENTICITY, ITS BIOACTIVE AND 185 00:06:06,840 --> 00:06:08,720 MARKER COMPOUNDS, AND A CHECK 186 00:06:08,720 --> 00:06:11,720 FOR POSSIBLE CONTAMINANTS. 187 00:06:11,720 --> 00:06:14,880 NIH ALSO HAS GUIDANCE STRESSING 188 00:06:14,880 --> 00:06:17,240 THE IMPORTANCE OF AUTHENTICATION 189 00:06:17,240 --> 00:06:18,560 AND BATCH TO BATCH 190 00:06:18,560 --> 00:06:23,040 REPRODUCIBILITY FOR RESEARCH 191 00:06:23,040 --> 00:06:23,960 MATERIALS, AS WELL AS 192 00:06:23,960 --> 00:06:24,680 QUANTIFICATION AND 193 00:06:24,680 --> 00:06:26,080 STANDARDIZATION OF BIOACTIVE 194 00:06:26,080 --> 00:06:30,280 COMPOUNDS USED IN RESEARCH. 195 00:06:30,280 --> 00:06:31,720 SO WHAT DO WE MEAN WHEN WE'RE 196 00:06:31,720 --> 00:06:32,720 TALKING ABOUT CHARACTERIZATION 197 00:06:32,720 --> 00:06:37,080 OF SUPPLEMENTS AND PRODUCT 198 00:06:37,080 --> 00:06:37,560 INTEGRITY? 199 00:06:37,560 --> 00:06:39,560 GENERALLY SPEAKING, A QUALITY 200 00:06:39,560 --> 00:06:41,640 PRODUCT HAS THE DESIRED 201 00:06:41,640 --> 00:06:42,320 INGREDIENTS, IT MEETS LABEL 202 00:06:42,320 --> 00:06:43,800 CLAIMS FOR THE AMOUNT PRESENT, 203 00:06:43,800 --> 00:06:46,720 AND IT IS FREE OF CONTAMINANTS. 204 00:06:46,720 --> 00:06:49,400 TO BE MORE TECHNICAL, PRODUCT 205 00:06:49,400 --> 00:06:51,240 INTEGRITY ENTAILS FOUR 206 00:06:51,240 --> 00:06:53,720 FUNDAMENTAL PARAMETERS: 207 00:06:53,720 --> 00:06:57,240 IDENTITY, PURITY, COMPOSITION, 208 00:06:57,240 --> 00:06:57,600 AND QUALITY. 209 00:06:57,600 --> 00:06:59,520 EACH OF THESE PARAMETERS BRINGS 210 00:06:59,520 --> 00:07:01,400 ITS OWN SET OF CHALLENGES, WHICH 211 00:07:01,400 --> 00:07:02,600 MANUFACTURERS AND RESEARCHERS 212 00:07:02,600 --> 00:07:05,200 NEED TO CONSIDER. 213 00:07:05,200 --> 00:07:06,840 AGAIN, THE QUESTION COMES DOWN 214 00:07:06,840 --> 00:07:08,720 TO, HOW DO YOU KNOW EXACTLY WHAT 215 00:07:08,720 --> 00:07:11,320 YOU ARE MAKING, SELLING, 216 00:07:11,320 --> 00:07:15,560 CONSUMING, OR STUDYING? 217 00:07:15,560 --> 00:07:17,840 SO LET'S START WITH ISSUES OF 218 00:07:17,840 --> 00:07:19,720 IDENTIFYING DIETARY INGREDIENTS 219 00:07:19,720 --> 00:07:21,040 AND SUPPLEMENT PRODUCTS. 220 00:07:21,040 --> 00:07:24,240 AND THE FIRST STEP IS NAMING. 221 00:07:24,240 --> 00:07:25,840 SO LET'S IMAGINE A SCENARIO 222 00:07:25,840 --> 00:07:28,040 WHERE YOU'RE LOOKING TO RESEARCH 223 00:07:28,040 --> 00:07:29,880 MECHANISMS OR CLINICAL EFFECTS 224 00:07:29,880 --> 00:07:32,200 OF COENZYME Q10. 225 00:07:32,200 --> 00:07:33,960 YOU GO TO A COMPANY'S CATALOG 226 00:07:33,960 --> 00:07:35,600 LOOKING TO PURCHASE REAGENTS, 227 00:07:35,600 --> 00:07:37,440 AND IT MAY BE OF NO SURPRISE 228 00:07:37,440 --> 00:07:39,120 THAT THERE CAN BE MANY DIFFERENT 229 00:07:39,120 --> 00:07:40,600 ACCEPTED NAMES FOR THE SAME 230 00:07:40,600 --> 00:07:44,000 CHEMICAL ENTITY. 231 00:07:44,000 --> 00:07:49,160 COQ10, EU UBIQUINONE, HOWEVERU 232 00:07:49,160 --> 00:07:50,280 NEED TO BE CAREFUL. 233 00:07:50,280 --> 00:07:55,240 YOU MIGHT CONSIDER USING 234 00:07:55,240 --> 00:07:59,120 ODIBINONE BUT THAT IS A 235 00:07:59,120 --> 00:08:00,040 SYNTHETICALLY DERIVED DRUG 236 00:08:00,040 --> 00:08:01,920 VERSION APPROVED AS A DRUG IN 237 00:08:01,920 --> 00:08:03,800 SOME REGULATORY ENTITIES. 238 00:08:03,800 --> 00:08:06,120 AND THAT DIFFERENCE IN CHEMICAL 239 00:08:06,120 --> 00:08:07,280 COMPOSITION MIGHT INFLUENCE THE 240 00:08:07,280 --> 00:08:15,520 RESULTS OF YOUR RESEARCH. 241 00:08:15,520 --> 00:08:16,800 BOTANICAL INGREDIENTS BRING 242 00:08:16,800 --> 00:08:18,840 THEIR OWN COMPLEXITIES IN NAMING 243 00:08:18,840 --> 00:08:22,400 WHICH MIGHT CREATE CONFUSION. 244 00:08:22,400 --> 00:08:26,000 THERE ARE UPWARDS OF 3,000 PLANT 245 00:08:26,000 --> 00:08:27,720 SPECIES SOLD IN COMMERCE AND 246 00:08:27,720 --> 00:08:31,120 NAMING DOES NOT ALWAYS EQUAL 247 00:08:31,120 --> 00:08:31,440 IDENTIFYING. 248 00:08:31,440 --> 00:08:35,440 LET'S TAKE A LOOK AT CURCUMIN 249 00:08:35,440 --> 00:08:36,080 INGREDIENTS. 250 00:08:36,080 --> 00:08:37,600 ACCEPTED COMMON NAMES MIGHT 251 00:08:37,600 --> 00:08:39,480 EQUATE ONE SPECIES TO A WHOLELY 252 00:08:39,480 --> 00:08:40,880 DIFFERENT SPECIES, SEEN HERE 253 00:08:40,880 --> 00:08:48,760 WITH DESCRIBING TURMERIC SIMILAR 254 00:08:48,760 --> 00:08:52,680 TO SAFFRON OR GINGER. 255 00:08:52,680 --> 00:08:54,720 IN THE CONTEXT OF HERBAL 256 00:08:54,720 --> 00:08:55,960 MEDICINES, THE USE OF 257 00:08:55,960 --> 00:08:57,400 TRADITIONAL AND REGIONAL NAMES 258 00:08:57,400 --> 00:08:59,240 IS ALSO AN IMPORTANT 259 00:08:59,240 --> 00:09:00,280 CONSIDERATION WHEN SOURCING 260 00:09:00,280 --> 00:09:03,320 INGREDIENTS. 261 00:09:03,320 --> 00:09:05,640 FURTHERMORE, IN TODAY'S GLOBAL 262 00:09:05,640 --> 00:09:07,640 SYSTEM OF SOURCING BOTANICAL 263 00:09:07,640 --> 00:09:09,120 INGREDIENTS WHERE MANUFACTURERS 264 00:09:09,120 --> 00:09:10,520 DO NOT NECESSARILY HAVE CONTROL 265 00:09:10,520 --> 00:09:14,080 OVER THEIR SUPPLY CHAIN, THERE 266 00:09:14,080 --> 00:09:16,600 ARE INSTANCES WHERE REGIONAL 267 00:09:16,600 --> 00:09:17,920 NAMES MAY CONFUSE 268 00:09:17,920 --> 00:09:18,320 IDENTIFICATION. 269 00:09:18,320 --> 00:09:20,200 HERE'S A TABLE OF SEVERAL 270 00:09:20,200 --> 00:09:20,960 UNRELATED PLANT SPECIES. 271 00:09:20,960 --> 00:09:28,480 THEY ARE ALL CLOAK ALL REFE 272 00:09:28,480 --> 00:09:30,600 TYPE OF GINSENG, BUT IMPORTANTLY 273 00:09:30,600 --> 00:09:32,440 THESE HAVE ALL BEEN FOUND TO BE 274 00:09:32,440 --> 00:09:35,160 IMPROPERLY SOLD AS JUST SIMPLY 275 00:09:35,160 --> 00:09:38,120 GINSENG, JUST CONFUSING THE 276 00:09:38,120 --> 00:09:40,560 INGREDIENT WITH PANEX GINSENG. 277 00:09:40,560 --> 00:09:42,760 MANY OF THESE NAMING ISSUES 278 00:09:42,760 --> 00:09:45,760 ARISE BECAUSE PLANT NAMES ARE 279 00:09:45,760 --> 00:09:47,200 OFTEN BASED ON MORPHOLOGICAL 280 00:09:47,200 --> 00:09:48,480 FEATURES, NOT THE CHEMICAL 281 00:09:48,480 --> 00:09:49,520 COMPOSITION OR GENETICS OF THE 282 00:09:49,520 --> 00:09:50,920 PLANT. 283 00:09:50,920 --> 00:09:53,080 ON THE ONE HAND, DISTINCT 284 00:09:53,080 --> 00:09:54,160 SPECIES HAVING SIMILAR NAMES CAN 285 00:09:54,160 --> 00:09:55,600 BE RATHER BENIGN. 286 00:09:55,600 --> 00:09:58,000 FOR EXAMPLE, GERMAN AND ROMAN 287 00:09:58,000 --> 00:10:01,760 CAM 288 00:10:01,760 --> 00:10:05,360 CHAMOMILE HAVE SIGNIFICANTLY 289 00:10:05,360 --> 00:10:07,520 DIFFERENT PHYTOCHEMICAL 290 00:10:07,520 --> 00:10:08,080 PROFILES. 291 00:10:08,080 --> 00:10:08,960 YOU MAY ALREADY BE FAMILIAR WITH 292 00:10:08,960 --> 00:10:13,160 THE CASE OF CHINESE STAR ANISE 293 00:10:13,160 --> 00:10:18,000 WHERE THE FRUIT OF THE CHINESE 294 00:10:18,000 --> 00:10:21,200 FORM HAS MEDICINAL USES BUT 295 00:10:21,200 --> 00:10:24,880 FRUIT FROM JAPANESE STAR ANISE 296 00:10:24,880 --> 00:10:27,720 AND THE FRUIT CONTAIN TOXIC 297 00:10:27,720 --> 00:10:29,040 CONSTITUENTS AND OBVIOUSLY WOULD 298 00:10:29,040 --> 00:10:30,440 NOT BE THE ONES TO USE FOR YOUR 299 00:10:30,440 --> 00:10:36,440 RESEARCH OR YOUR PRODUCT. 300 00:10:36,440 --> 00:10:37,760 AND OF COURSE IDENTIFICATION 301 00:10:37,760 --> 00:10:38,800 CHALLENGES INCREASE AS 302 00:10:38,800 --> 00:10:42,000 INGREDIENTS ARE INCREASINGLY 303 00:10:42,000 --> 00:10:42,680 PROCESSED. 304 00:10:42,680 --> 00:10:43,840 MANUFACTURERS AND RESEARCHERS 305 00:10:43,840 --> 00:10:44,920 ARE ROUTINELY FACED WITH THE 306 00:10:44,920 --> 00:10:47,040 QUESTION OF WHETHER A FINALLY 307 00:10:47,040 --> 00:10:48,720 GROUND POWDER OR A LIQUID 308 00:10:48,720 --> 00:10:51,480 EXTRACT IS THE DESIRED BOTANICAL 309 00:10:51,480 --> 00:10:51,800 INGREDIENT. 310 00:10:51,800 --> 00:10:54,400 FOR EXAMPLE, ARE ANY ONE OR ALL 311 00:10:54,400 --> 00:10:56,640 OF THESE PREPARATIONS ACTUALLY 312 00:10:56,640 --> 00:10:59,520 GOLDENSEAL? 313 00:10:59,520 --> 00:11:01,040 IN THESE SITUATION, 314 00:11:01,040 --> 00:11:01,640 CHARACTERIZATION EFFORTS MUST 315 00:11:01,640 --> 00:11:05,160 OFTEN TURN TO ANALYTICAL 316 00:11:05,160 --> 00:11:07,200 CHEMISTRY APPROACHES. 317 00:11:07,200 --> 00:11:10,280 NOW IN TERMS OF PURITY, FOR VICE 318 00:11:10,280 --> 00:11:12,720 MINES AND 319 00:11:12,720 --> 00:11:17,200 VITAMINS AND MINERALS, WHETHER 320 00:11:17,200 --> 00:11:19,000 THE INGREDIENTS ARE BIOACTIVE 321 00:11:19,000 --> 00:11:20,760 AND BIOAVAILABLE IN CERTAIN 322 00:11:20,760 --> 00:11:22,920 FORMS, OR BOTANICAL 323 00:11:22,920 --> 00:11:24,600 PREPARATIONS, PURITY ISSUES ALSO 324 00:11:24,600 --> 00:11:26,520 INCLUDE THE USE OF PROPER PLANT 325 00:11:26,520 --> 00:11:27,960 PARTS, THE ABSENCE OF 326 00:11:27,960 --> 00:11:29,680 POTENTIALLY HARMFUL MICROBES, 327 00:11:29,680 --> 00:11:33,720 PESTICIDES, TOXINS, AND 328 00:11:33,720 --> 00:11:35,440 UNDECLARED SYNTHETIC SUBSTANCES 329 00:11:35,440 --> 00:11:36,400 LIKE STIMULANTS HAVE BEEN FOUND 330 00:11:36,400 --> 00:11:38,840 TO BE A CONCERN IN CERTAIN TYPES 331 00:11:38,840 --> 00:11:46,880 OF PRODUCTS MARKETED AS SUCH. 332 00:11:46,880 --> 00:11:47,520 NOW A VERY IMPORTANT 333 00:11:47,520 --> 00:11:49,040 CONSIDERATION IS THAT BOTANICAL 334 00:11:49,040 --> 00:11:50,600 COMPOSITION IS INHERENTLY 335 00:11:50,600 --> 00:11:51,800 VARIABLE AND CHARACTERIZATION 336 00:11:51,800 --> 00:11:55,280 NEEDS TO TAKE THIS INTO ACCOUNT. 337 00:11:55,280 --> 00:11:57,600 THE PLANT PART, THE CLIMATE AND 338 00:11:57,600 --> 00:11:59,280 HARVESTING CONDITIONS AND 339 00:11:59,280 --> 00:12:00,520 GENETIC HYBRIDIZATION, THESE ALL 340 00:12:00,520 --> 00:12:03,360 CAN DRAMATICALLY ALTER A PLANT'S 341 00:12:03,360 --> 00:12:06,040 PHYTOCHEMICAL PROFILE. 342 00:12:06,040 --> 00:12:07,480 SIMILARLY, PROCESSING CONDITIONS 343 00:12:07,480 --> 00:12:08,560 CAN SIGNIFICANTLY AFFECT THE 344 00:12:08,560 --> 00:12:09,840 FINAL COMPOSITION OF 345 00:12:09,840 --> 00:12:11,520 PHYTOCHEMICALS IN A SUPPLEMENT 346 00:12:11,520 --> 00:12:15,240 PRODUCT OR RESEARCH REAGENT. 347 00:12:15,240 --> 00:12:16,440 AQUEOUS OR ALCOHOL EXTRACTION 348 00:12:16,440 --> 00:12:17,480 CAN YIELD VERY DIFFERENT 349 00:12:17,480 --> 00:12:19,280 MIXTURES OF BIOACTIVE COMPOUNDS. 350 00:12:19,280 --> 00:12:21,160 IN THE FORMULATION MATRIX CAN 351 00:12:21,160 --> 00:12:22,880 INFLUENCE THINGS LIKE 352 00:12:22,880 --> 00:12:24,240 DISINTEGRATION AND DISSOLUTION 353 00:12:24,240 --> 00:12:26,440 OF THE FORMULATION. 354 00:12:26,440 --> 00:12:28,120 AND, THEREFORE, ALTER ITS 355 00:12:28,120 --> 00:12:31,720 BIOAVAILABILITY. 356 00:12:31,720 --> 00:12:34,440 AS A CONSEQUENCE OF THESE 357 00:12:34,440 --> 00:12:36,480 FACTORS, MYRIAD CHEMICAL 358 00:12:36,480 --> 00:12:39,200 DIVERSITY AND VARIABILITY, IT 359 00:12:39,200 --> 00:12:40,400 CAN BE QUITE CHALLENGING TO 360 00:12:40,400 --> 00:12:41,920 MEASURE AND MAINTAIN CONSISTENCY 361 00:12:41,920 --> 00:12:43,120 IN FINISHED PRODUCTS. 362 00:12:43,120 --> 00:12:45,160 AGAIN, IT IS THE RESPONSIBILITY 363 00:12:45,160 --> 00:12:46,920 OF MANUFACTURERS TO SET 364 00:12:46,920 --> 00:12:47,800 SPECIFICATIONS FOR WHAT 365 00:12:47,800 --> 00:12:49,640 DETERMINES QUALITY. 366 00:12:49,640 --> 00:12:52,400 FOR EXAMPLE, SETTING MINIMUM AND 367 00:12:52,400 --> 00:12:54,240 MAXIMUM CONCENTRATIONS FOR 368 00:12:54,240 --> 00:12:56,400 ACTIVE OR MARKER COMPOUNDS, 369 00:12:56,400 --> 00:13:00,480 SETTING LIMITS ON UNDESIRABLE 370 00:13:00,480 --> 00:13:00,840 CONSTITUENTS. 371 00:13:00,840 --> 00:13:01,640 MANUFACTURERS MUST DEMONSTRATE 372 00:13:01,640 --> 00:13:04,240 THOSE QUALITY SPECIFICATIONS ARE 373 00:13:04,240 --> 00:13:08,440 BEING MET. 374 00:13:08,440 --> 00:13:09,880 WHEN IT COMES TO TESTING AGAINST 375 00:13:09,880 --> 00:13:13,200 THOSE SPECIFICATIONS, REMEMBER 376 00:13:13,200 --> 00:13:14,400 THAT REGULATIONS DO NOT MANDATE 377 00:13:14,400 --> 00:13:15,920 THE PARTICULAR METHOD OR 378 00:13:15,920 --> 00:13:16,920 TECHNOLOGY BE USED. 379 00:13:16,920 --> 00:13:18,240 RATHER, THEY STIPULATE THAT 380 00:13:18,240 --> 00:13:19,920 METHODS MUST BE FIT-FOR-PURPOSE 381 00:13:19,920 --> 00:13:25,000 AND SCIENTIFICALLY VALID. 382 00:13:25,000 --> 00:13:27,200 SO WHAT DOES FIT-FOR-PURPOSE 383 00:13:27,200 --> 00:13:27,400 MEAN? 384 00:13:27,400 --> 00:13:29,320 A FIT-FOR-PURPOSE METHOD IS ONE 385 00:13:29,320 --> 00:13:32,000 DEMONSTRATED TO BE SENSITIVE, 386 00:13:32,000 --> 00:13:33,640 ACCURATE, PRECISE, AND SPECIFIC 387 00:13:33,640 --> 00:13:37,400 FOR THE ANALYTE OF INTEREST. 388 00:13:37,400 --> 00:13:39,000 AND IT ALSO IS A METHOD THAT IS 389 00:13:39,000 --> 00:13:41,160 DEMONSTRATED TO BE RELIABLE AND 390 00:13:41,160 --> 00:13:41,480 REPRODUCIBLE. 391 00:13:41,480 --> 00:13:43,760 SO A NONSPECIFIC METHOD CAN HAVE 392 00:13:43,760 --> 00:13:45,520 ITS PLACE IN A LAB, BUT IT 393 00:13:45,520 --> 00:13:48,920 SHOULD NOT STABBED ALONE. 394 00:13:48,920 --> 00:13:50,400 IMAGINE THE ISSUE THAT CAN ARISE 395 00:13:50,400 --> 00:13:52,800 WHEN, FOR EXAMPLE, A COUNT ALL 396 00:13:52,800 --> 00:13:55,320 METHOD THAT MEASURES NITROGEN 397 00:13:55,320 --> 00:13:56,360 CONTENT AS A PROXY FOR PROTEIN 398 00:13:56,360 --> 00:13:58,200 IS USED AS A SOLE MEASUREMENT. 399 00:13:58,200 --> 00:13:59,760 IF THERE IS AN ADULT RANGE OF 400 00:13:59,760 --> 00:14:01,440 MOTION WITH NITROGEN HAD BEEN 401 00:14:01,440 --> 00:14:03,440 RICH MELAMINE OR UREA, THAT 402 00:14:03,440 --> 00:14:04,440 METHOD IS NOT GOING TO 403 00:14:04,440 --> 00:14:05,880 DISTINGUISH BETWEEN THE 404 00:14:05,880 --> 00:14:12,440 CONTAMINANT AND REAL PROTEIN. 405 00:14:12,440 --> 00:14:14,080 SO WHAT KINDS OF METHODS ARE 406 00:14:14,080 --> 00:14:14,640 NEEDED AND USED? 407 00:14:14,640 --> 00:14:17,600 HOW ARE REAGENTS, PRODUCTS, AND 408 00:14:17,600 --> 00:14:20,720 INGREDIENTS CHARACTERIZED? 409 00:14:20,720 --> 00:14:22,520 A WIDE ARRAY OF ANALYTICAL 410 00:14:22,520 --> 00:14:24,360 METHODS ARE EMPLOYED TO IDENTIFY 411 00:14:24,360 --> 00:14:25,480 AND QUANTIFY CHEMICAL 412 00:14:25,480 --> 00:14:29,080 CONSTITUENTS OF INTEREST. 413 00:14:29,080 --> 00:14:31,000 CHROMATOGRAPHY METHODS OR 414 00:14:31,000 --> 00:14:32,920 CHEMICAL SEPARATION, 415 00:14:32,920 --> 00:14:34,200 SPECTROSCOPY AND MASS SPEC 416 00:14:34,200 --> 00:14:35,760 APPROACHES TO MEASURE ANALYTES, 417 00:14:35,760 --> 00:14:37,760 HYBRID COMBINATIONS OF THESE AS 418 00:14:37,760 --> 00:14:40,440 WELL AS GENOMIC ANALYSES TO 419 00:14:40,440 --> 00:14:42,120 IDENTIFY NATURAL PRODUCT SOURCE 420 00:14:42,120 --> 00:14:45,520 MATERIALS. 421 00:14:45,520 --> 00:14:46,760 AND MULTIPLE TECHNIQUES ARE 422 00:14:46,760 --> 00:14:49,400 OFTEN COUPLED FOR MORE POWERFUL 423 00:14:49,400 --> 00:14:49,680 ANALYSES. 424 00:14:49,680 --> 00:14:52,320 FOR EXAMPLE, A CHROMATOGRAPHIC 425 00:14:52,320 --> 00:14:54,320 SEPARATION OF PHYTOCHEMICALS 426 00:14:54,320 --> 00:14:57,400 FOLLOWED BY A MASS SPEC ANALYSIS 427 00:14:57,400 --> 00:15:00,360 TO QUANTIFY INDIVIDUAL PEAKS. 428 00:15:00,360 --> 00:15:03,400 IN NEWER ANALYTICAL PARADIGMS, 429 00:15:03,400 --> 00:15:04,520 NON-TARGETED ANALYTICAL METHODS 430 00:15:04,520 --> 00:15:07,000 ARE BEING DEVELOPED WHICH CAN 431 00:15:07,000 --> 00:15:08,320 STATISTICALLY CLASSIFY SAMPLES 432 00:15:08,320 --> 00:15:10,800 BASED ON THEIR CHEMICAL OR 433 00:15:10,800 --> 00:15:14,160 METABALOME FIPGER PRINT. 434 00:15:14,160 --> 00:15:14,480 FINGERPRINT. 435 00:15:14,480 --> 00:15:17,440 A NEAR INFRARED SPECTROSCOPY 436 00:15:17,440 --> 00:15:19,240 DATA USED TO THEN MODEL WHETHER 437 00:15:19,240 --> 00:15:21,480 THOSE POWDERS WE SAW EARLIER ARE 438 00:15:21,480 --> 00:15:23,240 INDEED GOLDEN SEAL ROOT OR ONE 439 00:15:23,240 --> 00:15:27,080 OF THE COMMON ADULTERANTS. 440 00:15:27,080 --> 00:15:30,520 NOW YOU MAY BE AWARE FROM 441 00:15:30,520 --> 00:15:32,560 RESEARCH ARTICLES OR NEWS 442 00:15:32,560 --> 00:15:34,320 REPORTS ABOUT DNA-BASED 443 00:15:34,320 --> 00:15:35,360 ANALYTICAL METHODS BEING APPLIED 444 00:15:35,360 --> 00:15:37,840 TO DIETARY SUPPLEMENTS. 445 00:15:37,840 --> 00:15:39,560 WHILE GENETIC TECHNIQUES CAN BE 446 00:15:39,560 --> 00:15:41,680 A POWERFUL APPROACH, ONE MUST 447 00:15:41,680 --> 00:15:43,120 CAREFULLY CONSIDER WHEN IT IS 448 00:15:43,120 --> 00:15:45,640 FIT-FOR-PURPOSE. 449 00:15:45,640 --> 00:15:46,840 IMPORTANTLY, A DNA ANALYSIS, 450 00:15:46,840 --> 00:15:49,440 IT'S NOT GOING TO DIFFERENTIATE 451 00:15:49,440 --> 00:15:50,440 BETWEEN PLANT PARTS, IT'S NOT 452 00:15:50,440 --> 00:15:55,080 GOING TO TELL BUT ABOUT CHEMIL 453 00:15:55,080 --> 00:15:56,160 COMPOSITION. 454 00:15:56,160 --> 00:15:58,520 DATA ANALYSES CAN BE CONFOUNDED 455 00:15:58,520 --> 00:15:59,960 BY EXTENSIVE GENETIC 456 00:15:59,960 --> 00:16:00,800 HYBRIDIZATION THAT IS OBSERVED 457 00:16:00,800 --> 00:16:02,480 IN PLANTS, AND THE DNA 458 00:16:02,480 --> 00:16:04,760 AMPLIFICATION PRIMERS THAT ARE 459 00:16:04,760 --> 00:16:06,080 USED, THEY MAY HAVE POOR 460 00:16:06,080 --> 00:16:07,680 SELECTIVITY FOR DIFFERENTIATING 461 00:16:07,680 --> 00:16:09,000 BETWEEN DIFFERENT BUT CLOSELY 462 00:16:09,000 --> 00:16:11,400 RELATED SPECIES. 463 00:16:11,400 --> 00:16:13,720 NOW THAT ALL BEING SAID, 464 00:16:13,720 --> 00:16:15,840 INNOVATIVE NEXT GENERATION 465 00:16:15,840 --> 00:16:16,400 SEQUENCING APPROACHES ARE 466 00:16:16,400 --> 00:16:19,400 PROVING USEFUL AS COMPLEMENTARY 467 00:16:19,400 --> 00:16:21,160 APPROACH ALONG WITH CHEMICAL 468 00:16:21,160 --> 00:16:22,400 ANALYSES. 469 00:16:22,400 --> 00:16:24,160 AND SEQUENCE REFERENCE LIBRARIES 470 00:16:24,160 --> 00:16:25,240 LIKE THOSE AT THE FDA ARE 471 00:16:25,240 --> 00:16:27,280 BECOMING MORE AND MORE ROBUST IN 472 00:16:27,280 --> 00:16:29,000 THEIR CONTENT AND THEIR ABILITY 473 00:16:29,000 --> 00:16:34,520 TO DIFFERENTIATE PLANT SPECIES. 474 00:16:34,520 --> 00:16:35,840 SO NOW THAT WE HAVE SOME 475 00:16:35,840 --> 00:16:37,600 IMPORTANT CONCEPTS UNDER OUR 476 00:16:37,600 --> 00:16:40,200 BELTS, LET'S TAKE A LOOK AT A 477 00:16:40,200 --> 00:16:43,320 BRIEF EXAMPLE OF SUPPLEMENT 478 00:16:43,320 --> 00:16:45,200 CHARACTERIZATION. 479 00:16:45,200 --> 00:16:47,000 THE UNITED STATES PHARMACOMONO 480 00:16:47,000 --> 00:16:48,240 GRAPH IS ONE STANDARD RESOURCE 481 00:16:48,240 --> 00:16:50,160 THAT ESTABLISHES A DEFINITION OF 482 00:16:50,160 --> 00:16:54,040 WHAT CONSTITUTES QUALITY FOR 483 00:16:54,040 --> 00:16:55,280 GINKGO BILOBA LEAF INGREDIENTS. 484 00:16:55,280 --> 00:16:56,680 IT ESTABLISHES KEY CHEMICAL 485 00:16:56,680 --> 00:16:58,440 ANALYTES AND CONCENTRATION 486 00:16:58,440 --> 00:17:00,080 RANGES FOR BOTH DESIRABLE AND 487 00:17:00,080 --> 00:17:01,000 POTENTIALLY HARMFUL 488 00:17:01,000 --> 00:17:02,360 CONSTITUENTS. 489 00:17:02,360 --> 00:17:10,280 SUCH AS FLAVONOL GLYCOSIDES, AND 490 00:17:10,280 --> 00:17:11,080 GINKGOLIC ACIDS. 491 00:17:11,080 --> 00:17:12,560 A VARIETY OF ANALYTICAL METHODS 492 00:17:12,560 --> 00:17:14,600 CAN BE APPLIED TO A POWDERED 493 00:17:14,600 --> 00:17:15,880 LEAF SAMPLE TO ASCERTAIN WHETHER 494 00:17:15,880 --> 00:17:18,200 A MANUFACTURER'S SPECIFICATIONS 495 00:17:18,200 --> 00:17:19,200 FOR INGREDIENTS HAVE BEEN MET. 496 00:17:19,200 --> 00:17:22,200 YOU CAN SEE LIQUID 497 00:17:22,200 --> 00:17:23,080 CHROMATOGRAPHY SEPARATION AND 498 00:17:23,080 --> 00:17:27,040 MASS SPEC QUANTIFICATION OF 499 00:17:27,040 --> 00:17:31,800 FLAVONOIDS AND TERPENE LACK , 500 00:17:31,800 --> 00:17:33,680 THEY CAN ALSO BE DETECTED BY 501 00:17:33,680 --> 00:17:35,400 THIN LAYER CHROMATOGRAPHY AS 502 00:17:35,400 --> 00:17:35,600 WELL. 503 00:17:35,600 --> 00:17:37,600 IMPORTANT TO NOTE HERE, NO 504 00:17:37,600 --> 00:17:38,720 SINGLE ANALYSIS IS QUANTIFYING 505 00:17:38,720 --> 00:17:40,680 ALL OF THE IMPORTANT ANALYTES. 506 00:17:40,680 --> 00:17:42,720 YOU OFTEN NEED A NUMBER OF 507 00:17:42,720 --> 00:17:44,800 COMPLEMENTARY METHODS TO 508 00:17:44,800 --> 00:17:45,840 SUFFICIENTLY CHARACTERIZE 509 00:17:45,840 --> 00:17:46,720 DIETARY SUPPLEMENT INGREDIENTS 510 00:17:46,720 --> 00:17:50,480 AND PRODUCTS. 511 00:17:50,480 --> 00:17:52,000 NOW WHILE MANUFACTURERS ARE 512 00:17:52,000 --> 00:17:55,080 RESPONSIBLE FOR TESTING, THERE 513 00:17:55,080 --> 00:17:55,840 ARE MANY THIRD PARTY 514 00:17:55,840 --> 00:17:56,920 LABORATORIES AND CONTRACT 515 00:17:56,920 --> 00:18:00,880 RESEARCH ORGANIZATIONS WHO OFFER 516 00:18:00,880 --> 00:18:01,640 STANDARDIZATION AND ANALYTICAL 517 00:18:01,640 --> 00:18:03,600 SERVICES TO HELP COMPLY WITH 518 00:18:03,600 --> 00:18:06,680 REGULATIONS AND ENSURE PRODUCT 519 00:18:06,680 --> 00:18:06,880 QUALITY. 520 00:18:06,880 --> 00:18:08,560 THERE ARE ALSO VOLUNTARY 521 00:18:08,560 --> 00:18:09,240 INDEPENDENT CERTIFICATION 522 00:18:09,240 --> 00:18:11,400 PROGRAMS AVAILABLE TO 523 00:18:11,400 --> 00:18:11,840 MANUFACTURERS. 524 00:18:11,840 --> 00:18:13,720 FOR EXAMPLE, NSF INTERNATIONAL 525 00:18:13,720 --> 00:18:16,160 WILL TEST PRODUCTS TO VERIFY 526 00:18:16,160 --> 00:18:17,320 INGREDIENT CLAIMS AND ALSO 527 00:18:17,320 --> 00:18:18,920 ASSURE CONSUMERS THAT CERTAIN 528 00:18:18,920 --> 00:18:21,480 CONTAMINANTS ARE NOT PRESENT. 529 00:18:21,480 --> 00:18:24,080 THE USP CERTIFICATION PROGRAM 530 00:18:24,080 --> 00:18:25,800 PERFORMS SIMILAR TESTING AND IT 531 00:18:25,800 --> 00:18:27,520 ALSO AUDITS MANUFACTURERS FOR 532 00:18:27,520 --> 00:18:29,000 COMPLIANCE TO GOOD MANUFACTURING 533 00:18:29,000 --> 00:18:29,360 PRACTICES. 534 00:18:29,360 --> 00:18:32,160 SO THESE ARE LABELS, 535 00:18:32,160 --> 00:18:32,960 CERTIFICATION LABELS THAT YOU 536 00:18:32,960 --> 00:18:35,600 CAN FIND ON THE PRODUCTS' 537 00:18:35,600 --> 00:18:39,880 LABELING. 538 00:18:39,880 --> 00:18:41,400 THERE ARE ALSO EFFORTS AT 539 00:18:41,400 --> 00:18:43,080 CERTAIN FEDERAL AGENCIES TO 540 00:18:43,080 --> 00:18:44,360 SUPPORT AND ADVANCE SUPPLEMENT 541 00:18:44,360 --> 00:18:46,200 CHARACTERIZATION. 542 00:18:46,200 --> 00:18:47,480 NOVEL ANALYTICAL METHODS ARE 543 00:18:47,480 --> 00:18:49,480 BEING DEVELOPED BY SCIENTISTS AT 544 00:18:49,480 --> 00:18:51,560 USDA, SOME OF WHICH IS FUNDED BY 545 00:18:51,560 --> 00:18:53,160 THE NIH OFFICE OF DIETARY 546 00:18:53,160 --> 00:18:55,080 SUPPLEMENTS. 547 00:18:55,080 --> 00:18:56,400 FDA SCIENTISTS ARE ROUTINELY 548 00:18:56,400 --> 00:18:58,400 DEVELOPING NEW ANALYTICAL 549 00:18:58,400 --> 00:19:02,400 METHODOLOGY, OFTEN WITH A LEG 550 00:19:02,400 --> 00:19:05,040 REGULATORY FOCUS ON IDENTIFYING 551 00:19:05,040 --> 00:19:08,080 CONTAMINANTS AND ADULTERANTS. 552 00:19:08,080 --> 00:19:10,560 HERE AT NIH, THE PRODUCT 553 00:19:10,560 --> 00:19:11,680 INTEGRITY POLICY IS AN EFFORT TO 554 00:19:11,680 --> 00:19:13,760 ENSURE THAT FUNDED RESEARCH 555 00:19:13,760 --> 00:19:15,280 APPROPRIATELY CHARACTERIZES 556 00:19:15,280 --> 00:19:17,280 NATURAL PRODUCTS USED AS 557 00:19:17,280 --> 00:19:20,320 EXPERIMENTAL REAGENTS. 558 00:19:20,320 --> 00:19:21,800 AND THE NATIONAL TOXICOLOGY 559 00:19:21,800 --> 00:19:23,320 PROGRAM AT THE NATIONAL 560 00:19:23,320 --> 00:19:24,320 INSTITUTE OF ENVIRONMENTAL 561 00:19:24,320 --> 00:19:25,160 HEALTH SCIENCES, THEY HAVE A 562 00:19:25,160 --> 00:19:27,800 PROGRAM DEDICATED TO EVALUATING 563 00:19:27,800 --> 00:19:29,040 THE CHEMICAL COMPOSITION AND 564 00:19:29,040 --> 00:19:32,240 POSSIBLE TOXICITIES OF BOTANICAL 565 00:19:32,240 --> 00:19:37,360 DIETARY SUPPLEMENTS. 566 00:19:37,360 --> 00:19:38,840 AT THE OFFICE OF DIETARY 567 00:19:38,840 --> 00:19:42,680 SUPPLEMENTS, THE AN ANALYTICAL 568 00:19:42,680 --> 00:19:44,880 METHODS PROGRAM IS DISTINCTLY 569 00:19:44,880 --> 00:19:46,120 FOCUSED ON THE ISSUES OF 570 00:19:46,120 --> 00:19:51,320 RELIABLE CHARACTERIZATION. 571 00:19:51,320 --> 00:19:52,760 THEY SUPPORT EFFORTS IN METHOD 572 00:19:52,760 --> 00:19:53,760 DEVELOPMENT AND VALIDATION, 573 00:19:53,760 --> 00:19:55,120 REFERENCE MATERIAL PRODUCTION, 574 00:19:55,120 --> 00:19:59,520 AND LABORATORY QUALITY ASSURANCE 575 00:19:59,520 --> 00:19:59,800 EXERCISES. 576 00:19:59,800 --> 00:20:01,120 THESE ARE ALL DESIGNED TO WORK 577 00:20:01,120 --> 00:20:02,560 TOGETHER TO HELP SCIENTISTS 578 00:20:02,560 --> 00:20:03,440 BETTER ANSWER QUESTIONS THAT 579 00:20:03,440 --> 00:20:06,840 THEY HAVE ABOUT THEIR BOTANICAL 580 00:20:06,840 --> 00:20:10,000 PRODUCT OR RESEARCH SAMPLE, AND 581 00:20:10,000 --> 00:20:11,800 ULTIMATELY DRIVE TO ENHANCED 582 00:20:11,800 --> 00:20:13,200 FOUNDATION FOR RIGOROUS RESEARCH 583 00:20:13,200 --> 00:20:19,560 AND INDUSTRY ANALYSES. 584 00:20:19,560 --> 00:20:20,800 OVERALL, AMRM'S ROLE IS TO 585 00:20:20,800 --> 00:20:23,960 PROVIDE THE RESOURCES NECESSARY 586 00:20:23,960 --> 00:20:25,720 TO ADDRESS THE ANALYTICAL 587 00:20:25,720 --> 00:20:27,040 CHALLENGES WE'VE OUTLINED. 588 00:20:27,040 --> 00:20:28,320 THESE RESOURCES ARE INTENDED TO 589 00:20:28,320 --> 00:20:29,760 MEET THE NEEDS OF ALL 590 00:20:29,760 --> 00:20:31,400 STAKEHOLDER, HELPING THEM TO 591 00:20:31,400 --> 00:20:32,680 ASSESS QUALITY CONTROL TO ENSURE 592 00:20:32,680 --> 00:20:36,040 LABEL CLAIMS ARE BEING MET, TO 593 00:20:36,040 --> 00:20:39,320 DEVELOP STANDARDS AND TO COMPLY 594 00:20:39,320 --> 00:20:45,120 WITH AND ENFORCE REGULATIONS. 595 00:20:45,120 --> 00:20:46,840 SO NOW TO BRIEFLY DISCUSS THE 596 00:20:46,840 --> 00:20:51,000 DIFFERENT AMRM PROGRAM AREAS, O 597 00:20:51,000 --> 00:20:53,440 DS AMRM FUNDED DEVELOPMENT 598 00:20:53,440 --> 00:20:54,640 ACTIVITIES ARE PERFORMED BY 599 00:20:54,640 --> 00:20:55,280 FEDERAL PARTNERS. 600 00:20:55,280 --> 00:20:57,120 FOR EXAMPLE, THEY'VE DEVELOPED 601 00:20:57,120 --> 00:21:02,280 TARGETED AND NON-TARGETED 602 00:21:02,280 --> 00:21:04,920 APPROACHES, QUANTIFYING 603 00:21:04,920 --> 00:21:06,200 PHYTOSTEROLS IN SUPPLEMENTAL 604 00:21:06,200 --> 00:21:09,040 EXTRACT OR DIFFERENTIATING AN 605 00:21:09,040 --> 00:21:11,160 AUTHENTICATED BLACK KOHOSH ON 606 00:21:11,160 --> 00:21:15,200 RELATED SPECIES BASED ON 607 00:21:15,200 --> 00:21:17,760 PHYTOCHEMICAL PRO TILE FILES. 608 00:21:17,760 --> 00:21:19,640 IN ADDITION TO PROMOTING METHOD 609 00:21:19,640 --> 00:21:22,040 DEVELOPMENT, THEY ALSO SUPPORT 610 00:21:22,040 --> 00:21:24,360 STUDIES OF QUANTITATIVE CHEMICAL 611 00:21:24,360 --> 00:21:25,840 METHODS, WHERE A METHODS 612 00:21:25,840 --> 00:21:27,120 RELIABILITY AND ITS FITNESS FOR 613 00:21:27,120 --> 00:21:29,800 PURPOSE IS DEMONSTRATED THROUGH 614 00:21:29,800 --> 00:21:33,400 THE MEASUREMENT OF KEY 615 00:21:33,400 --> 00:21:34,920 PERFORMANCE PARAMETERS SUCH AS 616 00:21:34,920 --> 00:21:36,680 ITS PRECISION, LIMIT OF 617 00:21:36,680 --> 00:21:38,360 DETECTION, SPECIFICITY, 618 00:21:38,360 --> 00:21:44,360 REPRODUCIBILITY, ET CETERA. 619 00:21:44,360 --> 00:21:46,160 AMRM'S SUPPORT OF METHOD 620 00:21:46,160 --> 00:21:47,520 VALIDATION HAS BEEN ACCOMPLISHED 621 00:21:47,520 --> 00:21:48,960 THROUGH TWO MAIN APPROACHES. 622 00:21:48,960 --> 00:21:51,320 CURRENTLY ODS UTILIZES NIH GRANT 623 00:21:51,320 --> 00:21:52,280 FUNDING OPPORTUNITY 624 00:21:52,280 --> 00:21:54,720 ANNOUNCEMENTS TO SUPPORT 625 00:21:54,720 --> 00:21:56,040 RESEARCHERS IN THE PERFORMANCE 626 00:21:56,040 --> 00:21:58,240 OF VALIDATION STUDIES FOR THE 627 00:21:58,240 --> 00:22:02,680 ANALYTICAL METHODS THEY'VE 628 00:22:02,680 --> 00:22:02,920 DEVELOPED. 629 00:22:02,920 --> 00:22:03,400 SO THESE GRANT FUNDING 630 00:22:03,400 --> 00:22:05,160 OPPORTUNITIES ARE FOCUSED ON 631 00:22:05,160 --> 00:22:09,000 METHODS THAT QUANTIFY CHEMICAL 632 00:22:09,000 --> 00:22:10,720 CONSTITUENTS, THEIR METABOLITES, 633 00:22:10,720 --> 00:22:14,480 OR ADULTERANTS IN EITHER 634 00:22:14,480 --> 00:22:15,960 EXPERIMENTAL REAGENTS LIKE THE 635 00:22:15,960 --> 00:22:18,320 EXTRACTS, THE TABLETS, THE 636 00:22:18,320 --> 00:22:20,520 GUMMIES USED IN RESEARCH, OR 637 00:22:20,520 --> 00:22:22,120 CLINICAL SPECIMENS. 638 00:22:22,120 --> 00:22:24,920 PLASMA OR TISSUE SAMPLES 639 00:22:24,920 --> 00:22:26,520 COLLECTED AS PART OF RESEARCH TO 640 00:22:26,520 --> 00:22:28,800 DETERMINE MECHANISMS OF ACTION 641 00:22:28,800 --> 00:22:36,080 OR PHARMACOKINETIC STUDIES. 642 00:22:36,080 --> 00:22:37,440 SHOWN HERE ARE JUST A FEW OF THE 643 00:22:37,440 --> 00:22:38,520 PUBLICATIONS THAT HIGHLIGHT HOW 644 00:22:38,520 --> 00:22:41,280 THIS GRANT FUNDING ASPECT OF THE 645 00:22:41,280 --> 00:22:43,120 AMRM PROGRAM HELPS INVESTIGATORS 646 00:22:43,120 --> 00:22:45,320 DEMONSTRATE THE PERFORMANCE OF 647 00:22:45,320 --> 00:22:47,440 THEIR STATE OF THE ART METHODS, 648 00:22:47,440 --> 00:22:52,360 LOOKING AT NEW METHODS TO 649 00:22:52,360 --> 00:22:56,160 UNDERSTAND THE FLAVONOL LIPIDS 650 00:22:56,160 --> 00:22:59,200 FOUND IN EXTRACTS, COMPARING THE 651 00:22:59,200 --> 00:23:01,640 AVAILABILITY, THE INTAKE AND THE 652 00:23:01,640 --> 00:23:05,880 OUTPUT OF RED CLOVER ISOFLAVONES 653 00:23:05,880 --> 00:23:07,280 LOOKING AT THE AMOUNT IN THE 654 00:23:07,280 --> 00:23:09,200 SUPPLEMENT AND ALSO IN HUMAN 655 00:23:09,200 --> 00:23:09,400 SERUM. 656 00:23:09,400 --> 00:23:11,760 SO THIS TYPE OF METHOD 657 00:23:11,760 --> 00:23:16,120 VALIDATION ADDS CONFIDENCE TO 658 00:23:16,120 --> 00:23:16,920 BIOMEDICAL RESEARCH ON THE LINKS 659 00:23:16,920 --> 00:23:18,800 BETWEEN DIETARY INGREDIENTS, 660 00:23:18,800 --> 00:23:20,680 THEIR METABOLITES, MECHANISMS OF 661 00:23:20,680 --> 00:23:25,160 ACTION AND ULTIMATE HEALTH 662 00:23:25,160 --> 00:23:27,360 OUTCOME. 663 00:23:27,360 --> 00:23:28,800 HISTORICALLY, THE AMRM PROGRAM 664 00:23:28,800 --> 00:23:31,760 HAS ALSO SUPPORTED METHOD 665 00:23:31,760 --> 00:23:32,400 STANDARDIZATION EFFORTS THAT PRO 666 00:23:32,400 --> 00:23:35,840 PLOAT THE 667 00:23:35,840 --> 00:23:39,240 PROMOTE THE OFFICIAL ANALYSIS 668 00:23:39,240 --> 00:23:40,840 FOR DIETARY SUPPLEMENTS AND 669 00:23:40,840 --> 00:23:41,360 BOTANICALS. 670 00:23:41,360 --> 00:23:43,480 THESE OFFICIAL METHODS, FOR 671 00:23:43,480 --> 00:23:44,480 EXAMPLE, CHROMATOGRAPHIC 672 00:23:44,480 --> 00:23:47,800 SEPARATION OF NON-VOLATILE 673 00:23:47,800 --> 00:23:49,800 GINGER CONSTITUENTS IN PLANT 674 00:23:49,800 --> 00:23:53,280 PARTS, EXTRACTS AND SUPPLEMENT 675 00:23:53,280 --> 00:23:54,360 PRODUCTS THEE ARE ESTABLISHED BY 676 00:23:54,360 --> 00:23:55,320 THE STANDARD SETTING 677 00:23:55,320 --> 00:23:58,240 ORGANIZATION AOAC INTERNATIONAL. 678 00:23:58,240 --> 00:24:01,120 AND THE RESULTING OFFICIAL 679 00:24:01,120 --> 00:24:02,400 METHODS OF ANALYSIS AS WELL AS 680 00:24:02,400 --> 00:24:04,400 GUIDELINES FOR METHOD VALIDATION 681 00:24:04,400 --> 00:24:06,240 STUDIES, THESE ARE AVAILABLE TO 682 00:24:06,240 --> 00:24:09,640 MANUFACTURERS AND RESEARCHERS 683 00:24:09,640 --> 00:24:13,600 ALIKE. 684 00:24:13,600 --> 00:24:15,440 NOW WITH ALL THIS TALK OF METHOD 685 00:24:15,440 --> 00:24:18,240 DEVELOPMENT AND VALIDATION, HOW 686 00:24:18,240 --> 00:24:19,600 CAN RESEARCHERS KNOW THAT THEIR 687 00:24:19,600 --> 00:24:21,200 METHODS ARE GENERATING THE RIGHT 688 00:24:21,200 --> 00:24:25,200 ANSWERS FOR QUANTIFICATION OR 689 00:24:25,200 --> 00:24:25,960 IDENTIFICATION? 690 00:24:25,960 --> 00:24:26,960 THIS IS WHERE REFERENCE 691 00:24:26,960 --> 00:24:28,560 MATERIALS ARE VITAL FOR RESEARCH 692 00:24:28,560 --> 00:24:30,600 AND PRODUCT TESTING. 693 00:24:30,600 --> 00:24:32,800 REFERENCE MATERIALS ARE 694 00:24:32,800 --> 00:24:35,240 AUTHENTICATED HOMO GENIUS 695 00:24:35,240 --> 00:24:36,560 PREPARATIONS WITH WELL 696 00:24:36,560 --> 00:24:39,880 CHARACTERIZED COMPOSITION AND/OR 697 00:24:39,880 --> 00:24:41,000 PROPERTIES. 698 00:24:41,000 --> 00:24:42,560 FOR EXAMPLE, THESE REFERENCE 699 00:24:42,560 --> 00:24:44,680 MATERIALS FOR GINKGO BILOBA 700 00:24:44,680 --> 00:24:47,480 LEAVES HAVE CERTIFIED MEASURED 701 00:24:47,480 --> 00:24:50,680 VALUES FOR FLAVONOIDS AND TRACE 702 00:24:50,680 --> 00:24:52,960 HEAVY METALS. 703 00:24:52,960 --> 00:24:54,600 REFERENCE MATERIALS ARE USED TO 704 00:24:54,600 --> 00:24:56,360 VERIFY THE ACCURACY OF SPECIFIC 705 00:24:56,360 --> 00:24:57,680 MEASUREMENTS, AND TO SUPPORT THE 706 00:24:57,680 --> 00:25:00,000 DEVELOPMENT OF NEW MEASUREMENT 707 00:25:00,000 --> 00:25:04,880 METHODS. 708 00:25:04,880 --> 00:25:06,200 HERE'S AN EXAMPLE OF REFERENCE 709 00:25:06,200 --> 00:25:07,360 MATERIAL IN ACTION. 710 00:25:07,360 --> 00:25:08,520 AMRM CONTRACTED WITH A COMPANY 711 00:25:08,520 --> 00:25:11,520 TO PRODUCE A MIXTURE SOLUTION OF 712 00:25:11,520 --> 00:25:14,840 NINE KEY CONSTITUENTS OF KAVA 713 00:25:14,840 --> 00:25:15,320 KAVA. 714 00:25:15,320 --> 00:25:17,080 THIS MIXTURE WAS DEVELOPED TO 715 00:25:17,080 --> 00:25:22,680 HAVE KNOWN AMOUNTS OF SPECIFIC 716 00:25:22,680 --> 00:25:33,240 KAVALECTONES AND FLAHAVEKAVAINS. 717 00:25:34,280 --> 00:25:36,400 SO WE SEE HERE IN THESE 718 00:25:36,400 --> 00:25:37,720 CHROMATOGRAMS CONFIRMATION THAT 719 00:25:37,720 --> 00:25:42,600 A METHOD CAN SEPARATE FROM 720 00:25:42,600 --> 00:25:43,960 EXTRACT AND CAPSULE PREPARATION 721 00:25:43,960 --> 00:25:45,200 IN THE BLUE TRACES AND THAT 722 00:25:45,200 --> 00:25:47,800 THOSE SEPARATED AND IDENTIFIED 723 00:25:47,800 --> 00:25:49,840 PEAKS, THEY DO ALIGN WITH THE 724 00:25:49,840 --> 00:25:52,480 REFERENCE MATERIALS' CHEMICAL 725 00:25:52,480 --> 00:25:56,240 CONSTITUENTS IN THE RED TRACE. 726 00:25:56,240 --> 00:25:57,080 BECAUSE THE REFERENCE MATERIAL 727 00:25:57,080 --> 00:25:59,320 HAS A KNOWN COMPOSITION BY MASS, 728 00:25:59,320 --> 00:26:01,160 THE AMOUNT OF EACH CONSTITUENT 729 00:26:01,160 --> 00:26:04,240 IN THE KAVA INGREDIENT HERE AND 730 00:26:04,240 --> 00:26:05,960 ALSO IN THE CAPSULE PRODUCT CAN 731 00:26:05,960 --> 00:26:10,360 BE DETERMINED. 732 00:26:10,360 --> 00:26:11,720 IN THIS WAY, REFERENCE MATERIALS 733 00:26:11,720 --> 00:26:13,200 PROVIDE RESEARCHERS THE MEANS TO 734 00:26:13,200 --> 00:26:14,840 TEST, IMPROVE AND VALIDATE THEIR 735 00:26:14,840 --> 00:26:21,520 METHOD PERFORMANCE. 736 00:26:21,520 --> 00:26:25,080 THROUGH THE COLLABORATIVE WORK 737 00:26:25,080 --> 00:26:25,680 AT THE NATIONAL STANDARDS 738 00:26:25,680 --> 00:26:27,320 TECHNOLOGY, AMRM HAS ALSO MADE 739 00:26:27,320 --> 00:26:29,240 AVAILABLE OVER 30 METRICS-BASED 740 00:26:29,240 --> 00:26:29,960 REFERENCE MATERIALS FOR SOME OF 741 00:26:29,960 --> 00:26:32,160 THE MOST POPULAR BOTANICALS AND 742 00:26:32,160 --> 00:26:36,320 TIE TRI 743 00:26:36,320 --> 00:26:37,640 DIETARY SUPPLEMENTS. 744 00:26:37,640 --> 00:26:39,160 THE MATERIAL IS IN A FORM 745 00:26:39,160 --> 00:26:40,440 RELEVANT TO THE DIETARY 746 00:26:40,440 --> 00:26:41,840 SUPPLEMENT ANALYST. 747 00:26:41,840 --> 00:26:43,920 SUCH AS A GROUND ROOT, A 748 00:26:43,920 --> 00:26:46,360 MULTIVITAMIN AND MULTI-MINERAL 749 00:26:46,360 --> 00:26:48,520 TABLET, OR A FISH OIL EXTRACT. 750 00:26:48,520 --> 00:26:50,160 AS SHOWN HERE IS A SELECTION OF 751 00:26:50,160 --> 00:26:53,040 THE AVAILABLE MATERIALS WITH THE 752 00:26:53,040 --> 00:26:55,000 MEASURED ANALYTES INDICATED. 753 00:26:55,000 --> 00:26:58,640 AND MANY OF THESE SUCH AS GINKGO 754 00:26:58,640 --> 00:27:02,080 BILOBA, ST. JOHN'S WORT, GREEN 755 00:27:02,080 --> 00:27:03,040 TEA AND SOME OTHERS ARE 756 00:27:03,040 --> 00:27:03,960 AVAILABLE AS A SUITE OF 757 00:27:03,960 --> 00:27:06,280 MATERIALS COVERING POWDERS, 758 00:27:06,280 --> 00:27:10,920 EXTRACTS AND TABLET 759 00:27:10,920 --> 00:27:11,280 FORMULATIONS. 760 00:27:11,280 --> 00:27:13,360 FINALLY, AMRM ALSO FUNDS THE 761 00:27:13,360 --> 00:27:14,960 ADMINISTRATION OF LABORATORY 762 00:27:14,960 --> 00:27:16,560 QUALITY ASSURANCE PROGRAMS. 763 00:27:16,560 --> 00:27:20,840 THESE ARE VOLUNTARY PROGRAMS 764 00:27:20,840 --> 00:27:24,640 WHERE PARTICIPATING LABS MEASURE 765 00:27:24,640 --> 00:27:26,160 NUTRITION NAND AND COX CLOJ 766 00:27:26,160 --> 00:27:28,560 ELEMENTS, VITAMINS, FATTY ACIDS, 767 00:27:28,560 --> 00:27:30,040 CONTAMINANTS AND BOTANICAL 768 00:27:30,040 --> 00:27:32,000 MARKERS IN SAMPLES DISTRIBUTED 769 00:27:32,000 --> 00:27:33,600 BY NIST. 770 00:27:33,600 --> 00:27:34,560 PARTICIPATING LABS THEN REPORT 771 00:27:34,560 --> 00:27:36,760 BACK THE RESULTS, AND THESE 772 00:27:36,760 --> 00:27:38,280 EXERCISES ARE A MEANS FOR THE 773 00:27:38,280 --> 00:27:41,320 COMMUNITY OF LABS TO IDENTIFY 774 00:27:41,320 --> 00:27:42,920 ANALYTICAL PROBLEM AREAS, 775 00:27:42,920 --> 00:27:46,080 COMPARE THEIR METHODS, AND 776 00:27:46,080 --> 00:27:47,680 REDUCE ANY BIASES THAT THEY FIND 777 00:27:47,680 --> 00:27:51,760 IN THEIR MEASUREMENTS. 778 00:27:51,760 --> 00:27:55,800 SO AN EXAMPLE OF THAT HERE IS A 779 00:27:55,800 --> 00:27:57,400 QUALITY ASSURANCE PROGRAM 780 00:27:57,400 --> 00:28:00,480 EXERCISE WHERE PARTICIPANT LABS 781 00:28:00,480 --> 00:28:04,880 MEASURE FOR CUMINOIDS IN 782 00:28:04,880 --> 00:28:06,840 EXTRACTS AND WITH A CERTIFIED 783 00:28:06,840 --> 00:28:13,520 TRUE VALUE FOR ONE OF THE 784 00:28:13,520 --> 00:28:15,240 CURCUMINOIDS AND ALSO A TARGET 785 00:28:15,240 --> 00:28:16,160 ANALYTICAL RANGE IN BETWEEN THE 786 00:28:16,160 --> 00:28:16,720 ORANGE LINES. 787 00:28:16,720 --> 00:28:17,960 THE PARTICIPATING LABS WERE ABLE 788 00:28:17,960 --> 00:28:20,360 TO SEE IF THEIR RESULTS FELL IN 789 00:28:20,360 --> 00:28:24,960 THAT ACCEPTABLE RANGE OR NOT. 790 00:28:24,960 --> 00:28:25,800 THEY'RE THEREFORE ABLE TO 791 00:28:25,800 --> 00:28:26,800 DETERMINE IS THEIR PERFORMANCE 792 00:28:26,800 --> 00:28:28,480 WITH THEIR ANALYTICAL 793 00:28:28,480 --> 00:28:33,560 METHODOLOGY ACCEPTABLE. 794 00:28:33,560 --> 00:28:34,240 ALL RIGHT. 795 00:28:34,240 --> 00:28:35,400 WELL, WE'VE COVERED A LOT OF 796 00:28:35,400 --> 00:28:36,320 GROUND TODAY. 797 00:28:36,320 --> 00:28:38,440 THE MAIN TAKEAWAYS ARE THAT THE 798 00:28:38,440 --> 00:28:39,840 CHEMICAL COMPOSITION OF DIETARY 799 00:28:39,840 --> 00:28:43,880 SUPPLEMENTS CAN BE VERY COMPLEX. 800 00:28:43,880 --> 00:28:46,320 COMBINATIONS OF MULTIPLE VIED 801 00:28:46,320 --> 00:28:49,120 MINES, MINERALS, PROTEIN AND 802 00:28:49,120 --> 00:28:51,600 BOTANICAL INGREDIENTS MAKE 803 00:28:51,600 --> 00:28:52,440 CHEMICAL ANALYSIS QUITE 804 00:28:52,440 --> 00:28:54,960 CHALLENGING. 805 00:28:54,960 --> 00:28:56,760 FURTHER, THE FORMULATION CAN 806 00:28:56,760 --> 00:28:58,160 VARY FROM BATCH TO BATCH. 807 00:28:58,160 --> 00:29:01,080 HOWEVER, DESPITE THESE 808 00:29:01,080 --> 00:29:02,360 CHALLENGES, RELIABLE RESEARCH 809 00:29:02,360 --> 00:29:05,200 AND CONSISTENT PRODUCT QUALITY 810 00:29:05,200 --> 00:29:06,360 DEPENDS UPON THOROUGH 811 00:29:06,360 --> 00:29:07,040 CHARACTERIZATION OF THE 812 00:29:07,040 --> 00:29:08,960 SUPPLEMENTS USED IN CLINICAL 813 00:29:08,960 --> 00:29:09,840 INVESTIGATIONS OR SOLD ON THE 814 00:29:09,840 --> 00:29:11,360 MARKET. 815 00:29:11,360 --> 00:29:13,200 AND THERE ARE MULTIPLE FEDERAL 816 00:29:13,200 --> 00:29:15,320 AND INDUSTRY PROGRAMS THAT WORK 817 00:29:15,320 --> 00:29:16,880 TO SUPPORT THIS LEVEL OF 818 00:29:16,880 --> 00:29:18,240 CHARACTERIZATION AND PROMOTE 819 00:29:18,240 --> 00:29:22,440 RIGOROUS RESEARCH. 820 00:29:22,440 --> 00:29:23,680 THE PROGRAMS I DISCUSSED TODAY, 821 00:29:23,680 --> 00:29:24,720 THEY WOULDN'T BE POSSIBLE 822 00:29:24,720 --> 00:29:27,040 WITHOUT THE WORK OF MANY PEOPLE. 823 00:29:27,040 --> 00:29:29,440 MY COLLEAGUES AT ODS, AND THE 824 00:29:29,440 --> 00:29:32,760 TEAMS AT USDA, NIST, AND I ALSO 825 00:29:32,760 --> 00:29:36,120 MENTIONED SOME OF THE WORK AT 826 00:29:36,120 --> 00:29:37,840 SIRILIANT. 827 00:29:37,840 --> 00:29:38,960 SO THANK YOU VERY MUCH FOR YOUR 828 00:29:38,960 --> 00:29:39,280 ATTENTION. 829 00:29:39,280 --> 00:29:40,520 IT'S BEEN MY PLEASURE TO SPEAK 830 00:29:40,520 --> 00:29:41,560 WITH YOU TODAY. 831 00:29:41,560 --> 00:29:45,720 AND I WILL TRANSITION TO A Q & A 832 00:29:45,720 --> 00:29:47,280 SESSION. 833 00:29:47,280 --> 00:29:48,840 >>THANK YOU, DR. KUSZAK, FOR 834 00:29:48,840 --> 00:29:50,000 THIS VERY INFORMATIVE 835 00:29:50,000 --> 00:29:50,880 PRESENTATION. 836 00:29:50,880 --> 00:29:55,200 NOW WE HAVE LIKE 10 MINUTES FOR 837 00:29:55,200 --> 00:29:56,800 THE QUESTIONS AND YOU CAN SUBMIT 838 00:29:56,800 --> 00:29:59,520 THEM IN THE Q & A BOX. 839 00:29:59,520 --> 00:30:01,920 FOR THE Q & A SESSION, DR. JOE 840 00:30:01,920 --> 00:30:04,000 BEST IS WITH US WITH HIS 841 00:30:04,000 --> 00:30:04,640 EXTENSIVE KNOWLEDGE. 842 00:30:04,640 --> 00:30:06,560 HE IS THE ACTING DIRECTOR OF THE 843 00:30:06,560 --> 00:30:09,040 ODS AND THE FORMER DIRECTOR OF 844 00:30:09,040 --> 00:30:10,200 THE ANALYTICAL METHODS AND 845 00:30:10,200 --> 00:30:14,720 REFERENCE MATERIALS PROGRAM. 846 00:30:14,720 --> 00:30:15,480 SO WELCOME, JOE. 847 00:30:15,480 --> 00:30:17,360 >> THANK YOU. 848 00:30:17,360 --> 00:30:19,840 >> I WOULD LIKE TO START WITH A 849 00:30:19,840 --> 00:30:20,360 QUESTION. 850 00:30:20,360 --> 00:30:21,720 IF A LABORATORY WOULD LIKE TO 851 00:30:21,720 --> 00:30:22,760 USE A REFERENCE MATERIAL BUT 852 00:30:22,760 --> 00:30:25,240 DON'T HAVE THE SAME 853 00:30:25,240 --> 00:30:26,160 ANALYTICAL -- THAT HAS BEEN USED 854 00:30:26,160 --> 00:30:31,160 FOR THE DEVELOPMENT OF THE SRM, 855 00:30:31,160 --> 00:30:33,000 CAN THIS LAB HELP OUTCOMES BY 856 00:30:33,000 --> 00:30:34,000 USING THE REFERENCE MATERIAL 857 00:30:34,000 --> 00:30:36,200 WITHOUT ADAPTING THE SAME 858 00:30:36,200 --> 00:30:40,640 ANALYTICAL METHOD? 859 00:30:40,640 --> 00:30:42,040 >> ACTUALLY THE WHOLE POINT OF 860 00:30:42,040 --> 00:30:43,360 THESE REFERENCE MATERIALS IS 861 00:30:43,360 --> 00:30:46,480 THAT THEY ARE METHOD-AGNOSTIC. 862 00:30:46,480 --> 00:30:49,720 THE REASON THAT THEY'RE ANALYZED 863 00:30:49,720 --> 00:30:51,400 BY NIST WHEN THE REFERENCE 864 00:30:51,400 --> 00:30:53,840 MATERIALS ARE BEING DEVELOPED IS 865 00:30:53,840 --> 00:30:54,520 TO CHARACTERIZE A MATERIAL. 866 00:30:54,520 --> 00:30:55,360 THERE'S NOTHING THAT SAYS THAT 867 00:30:55,360 --> 00:31:00,240 YOU HAVE TO USE THE EXACT SAME 868 00:31:00,240 --> 00:31:00,560 TECHNOLOGY. 869 00:31:00,560 --> 00:31:02,200 THE GOAL IS TO GET THE SAME 870 00:31:02,200 --> 00:31:04,000 ANSWERS AS WERE PROVIDED IN THE 871 00:31:04,000 --> 00:31:05,680 CERTIFICATE OF ANALYSIS, AND YOU 872 00:31:05,680 --> 00:31:07,600 CAN USE WHATEVER METHOD YOU NEED 873 00:31:07,600 --> 00:31:11,840 TO DO THAT. 874 00:31:11,840 --> 00:31:13,680 SANEM, YOU'RE A PERSON WHO WORKS 875 00:31:13,680 --> 00:31:15,040 AT NIST, SO YOU CAN CHIME IN ON 876 00:31:15,040 --> 00:31:20,480 THIS AS WELL IF YOU WISH. 877 00:31:20,480 --> 00:31:22,480 IT'S JUST NOT ME. 878 00:31:22,480 --> 00:31:23,920 THERE'S TWO EXPERTS IN THIS 879 00:31:23,920 --> 00:31:24,480 SESSION. 880 00:31:24,480 --> 00:31:25,720 >> OKAY, THANK YOU. 881 00:31:25,720 --> 00:31:29,480 SO YEAH, I'M WORKING ON THIS, 882 00:31:29,480 --> 00:31:32,720 THIS IS EXACTLY HOW -- WHY WE 883 00:31:32,720 --> 00:31:36,240 ARE DOING THIS. 884 00:31:36,240 --> 00:31:38,080 ANY LABORATORY WANTS TO USE 885 00:31:38,080 --> 00:31:38,760 REFERENCE MATERIALS DOESN'T HAVE 886 00:31:38,760 --> 00:31:42,120 TO USE THE SAME EXACT METHOD. 887 00:31:42,120 --> 00:31:44,480 WHAT WE ARE DOING IS, WE ARE 888 00:31:44,480 --> 00:31:45,440 DEVELOPING ANALYTICAL METHODS, 889 00:31:45,440 --> 00:31:49,080 WE ARE TRYING TO WORK WITH THE 890 00:31:49,080 --> 00:31:51,280 BEST METHOD TO IDENTIFY THE 891 00:31:51,280 --> 00:31:52,640 COMPOUNDS, ACCURATE AMOUNTS, AND 892 00:31:52,640 --> 00:31:56,560 YOU CAN JUST USE YOUR OWN METHOD 893 00:31:56,560 --> 00:31:59,720 AND COMPARE THE REFERENCE 894 00:31:59,720 --> 00:32:00,720 MATERIALS WITH THE METHODS THAT 895 00:32:00,720 --> 00:32:02,440 YOU DEVELOPED YOURSELF. 896 00:32:02,440 --> 00:32:04,320 SO THANK YOU. 897 00:32:04,320 --> 00:32:06,280 I'M GOING TO FOLLOW WITH THE 898 00:32:06,280 --> 00:32:06,840 SECOND QUESTION. 899 00:32:06,840 --> 00:32:09,560 WHO SHOULD BE CONTACTED IF YOU 900 00:32:09,560 --> 00:32:12,240 WANT TO BE PART OF THE 901 00:32:12,240 --> 00:32:15,040 PARTICIPATION LABS IN ANALYZING 902 00:32:15,040 --> 00:32:16,840 STANDARD SAMPLES? 903 00:32:16,840 --> 00:32:19,640 >> WE WILL ADD THAT TO THE CHAT. 904 00:32:19,640 --> 00:32:22,520 WE'LL HAVE THE URL AND THE EMAIL 905 00:32:22,520 --> 00:32:25,640 CONTACT INFORMATION FOR THAT 906 00:32:25,640 --> 00:32:28,680 PROGRAM. 907 00:32:28,680 --> 00:32:30,440 SO IT'S NIST. 908 00:32:30,440 --> 00:32:34,520 THEY HAVE A FORMAL PROGRAM 909 00:32:34,520 --> 00:32:39,000 DIRECTOR THERE, I'M TRYING TO 910 00:32:39,000 --> 00:32:40,600 THINK OF THE CONTACT EMAIL. 911 00:32:40,600 --> 00:32:42,360 SANEM, YOU MAY KNOW THAT. 912 00:32:42,360 --> 00:32:49,560 >> CAROL LYNN IS COORDINATING SO 913 00:32:49,560 --> 00:32:51,760 WE CAN INCLUDE HER EMAIL LINK IN 914 00:32:51,760 --> 00:32:53,000 THE CHAT BOX SO YOU CAN FIND 915 00:32:53,000 --> 00:32:53,680 THOSE INFORMATION THERE. 916 00:32:53,680 --> 00:32:57,800 IS THERE A DATABASE FOR 917 00:32:57,800 --> 00:32:59,240 ANALYTICAL MATERIALS? 918 00:32:59,240 --> 00:33:01,160 >> THERE IS ONE. 919 00:33:01,160 --> 00:33:04,000 THERE IS ONE IN DEVELOPMENT, ODS 920 00:33:04,000 --> 00:33:06,920 IS PUTTING ONE TOGETHER IN 921 00:33:06,920 --> 00:33:11,960 CONJUNCTION WITH NIST, AND THE 922 00:33:11,960 --> 00:33:12,960 AOAC INTERNATIONAL, ADAM 923 00:33:12,960 --> 00:33:14,560 MENTIONED THAT EARLIER, HAS A 924 00:33:14,560 --> 00:33:15,760 TECHNICAL DIVISION ON REFERENCE 925 00:33:15,760 --> 00:33:16,160 MATERIALS. 926 00:33:16,160 --> 00:33:17,560 AND THEY ARE ALSO IN THE PROCESS 927 00:33:17,560 --> 00:33:20,440 OF DEVELOPING A REFERENCE 928 00:33:20,440 --> 00:33:21,240 MATERIAL LIST. 929 00:33:21,240 --> 00:33:23,920 I CAN'T GIVE YOU A TIMELINE WHEN 930 00:33:23,920 --> 00:33:27,440 THAT WILL BE AVAILABLE, BUT YOU 931 00:33:27,440 --> 00:33:32,400 CAN CONTACT EITHER ADAM OR 932 00:33:32,400 --> 00:33:33,600 MYSELF AND I WILL PROVIDE YOU 933 00:33:33,600 --> 00:33:36,280 THE INFORMATION TO KEEP TRACK. 934 00:33:36,280 --> 00:33:38,240 THERE'S ALSO A LIST OF MATERIALS 935 00:33:38,240 --> 00:33:39,680 ON THE ODS AMRM WEBSITE, I 936 00:33:39,680 --> 00:33:45,960 BELIEVE, BUT IT'S NOT A FULLY 937 00:33:45,960 --> 00:33:46,560 FUNCTIONAL SEARCHABLE DATABASE 938 00:33:46,560 --> 00:33:51,960 JUST YET. 939 00:33:51,960 --> 00:33:53,400 >> OKAY, NEXT QUESTION. 940 00:33:53,400 --> 00:33:57,800 CAN YOU DISCUSS WHAT 941 00:33:57,800 --> 00:33:58,280 CONSTITUTES -- CLINICAL 942 00:33:58,280 --> 00:33:59,400 FORMULATION THAT IS THE PLANT 943 00:33:59,400 --> 00:34:02,800 MATERIALS GOING TO -- GOING INTO 944 00:34:02,800 --> 00:34:04,640 MANUFACTURED PRODUCT IS LIKELY 945 00:34:04,640 --> 00:34:06,960 TO BE A COMPOSITION OF PLANTS OR 946 00:34:06,960 --> 00:34:09,160 PLANT PARTS, SO HOW DOES ONE 947 00:34:09,160 --> 00:34:10,880 KNOW WHEN SUFFICIENT SAMPLING 948 00:34:10,880 --> 00:34:12,560 HAS BEEN ACCOMPLISHED? 949 00:34:12,560 --> 00:34:15,720 >> THERE ARE ACTUALLY STANDARD 950 00:34:15,720 --> 00:34:18,520 PARADIGMS FOR SAMPLING PLANS FOR 951 00:34:18,520 --> 00:34:20,040 THIS SORT OF THING. 952 00:34:20,040 --> 00:34:24,320 FDA PROVIDES GUIDANCE BY 953 00:34:24,320 --> 00:34:26,800 ANALYTICAL METHOD VALIDATION. 954 00:34:26,800 --> 00:34:28,880 AND AOAC ALSO PROVIDES GUIDANCE. 955 00:34:28,880 --> 00:34:33,240 SO THERE'S THE AOAC VALIDATION 956 00:34:33,240 --> 00:34:35,360 PROTOCOLS THAT ARE IN APPENDIX K 957 00:34:35,360 --> 00:34:37,080 OF THE OFFICIAL METHODS OF 958 00:34:37,080 --> 00:34:40,040 ANALYSIS THAT PROVIDES THE 959 00:34:40,040 --> 00:34:42,360 TECHNIQUES FOR VALIDATING 960 00:34:42,360 --> 00:34:43,720 METHODS OR GENERAL APPROACHES TO 961 00:34:43,720 --> 00:34:45,880 VALIDATING METHODS. 962 00:34:45,880 --> 00:34:47,880 AND THE SAMPLING PLANS ARE ALL 963 00:34:47,880 --> 00:34:50,360 PART OF THAT METHODS 964 00:34:50,360 --> 00:34:54,240 DEVELOPMENT. 965 00:34:54,240 --> 00:34:55,720 AGAIN, IF YOU WRITE TO ADAM OR 966 00:34:55,720 --> 00:34:57,240 MYSELF, WE'D BE HAPPY TO SEND 967 00:34:57,240 --> 00:35:00,000 YOU THOSE RESOURCES. 968 00:35:00,000 --> 00:35:00,160 THE 969 00:35:00,160 --> 00:35:00,400 >> OKAY. 970 00:35:00,400 --> 00:35:03,440 THANK YOU, JOE. 971 00:35:03,440 --> 00:35:05,000 THERE ARE NO MORE QUESTIONS 972 00:35:05,000 --> 00:35:06,840 COMING UP. 973 00:35:06,840 --> 00:35:08,240 I THINK THE PRESENTATION WAS 974 00:35:08,240 --> 00:35:10,720 VERY INFORMATIVE AND YOUR 975 00:35:10,720 --> 00:35:13,400 QUESTIONS WERE VERY DETAILED, SO 976 00:35:13,400 --> 00:35:15,200 THANK YOU ALL. 977 00:35:15,200 --> 00:35:16,600 SO I'M GOING TO CONTINUE WITH 978 00:35:16,600 --> 00:35:21,800 OUR NEXT SPEAKER. 979 00:35:21,800 --> 00:35:27,680 THANK YOU. 980 00:35:27,680 --> 00:35:29,480 OUR NEXT SPEAKER IN THIS SESSION 981 00:35:29,480 --> 00:35:31,440 IS DR. BARBARA SORKIN. 982 00:35:31,440 --> 00:35:34,120 DR. BARBARA SORKIN JOINED ODS AS 983 00:35:34,120 --> 00:35:35,640 DIRECTOR OF THE BOTANICAL 984 00:35:35,640 --> 00:35:38,360 RESEARCH CENTERS PROGRAM IN 985 00:35:38,360 --> 00:35:38,560 2011. 986 00:35:38,560 --> 00:35:40,840 BEFORE MOVING TO ODS, DR. SORKIN 987 00:35:40,840 --> 00:35:43,280 WAS RESPONSIBLE FOR 988 00:35:43,280 --> 00:35:44,760 ADMINISTRATING EXTRAMURAL 989 00:35:44,760 --> 00:35:47,880 RESEARCH IN THE AREAS OF 990 00:35:47,880 --> 00:35:49,200 ANTIOXIDANTS, HEALTH AGING 991 00:35:49,200 --> 00:35:51,680 CANCER AND SLEEP AT NIH NATIONAL 992 00:35:51,680 --> 00:35:53,200 CENTER FOR COMPLEMENTARY AND 993 00:35:53,200 --> 00:35:55,040 INTEGRATIVE HEALTH. 994 00:35:55,040 --> 00:35:56,360 TODAY, DR. SORKIN WILL TALK 995 00:35:56,360 --> 00:35:58,200 ABOUT HOW CONCEPTS OF EFFICACY, 996 00:35:58,200 --> 00:36:00,040 SAFETY AND IDENTITY ARE 997 00:36:00,040 --> 00:36:03,000 ADDRESSED IN STUDYING BOTANICALS 998 00:36:03,000 --> 00:36:04,040 AND PLANT-DERIVED INGREED YEBTS. 999 00:36:04,040 --> 00:36:07,160 AND INGREDIENTS 1000 00:36:07,160 --> 00:36:11,000 AND SHE WILL PROVIDE AN OVERVIEW 1001 00:36:11,000 --> 00:36:11,880 OF THE NIH CENTERS FOR ADVANCING 1002 00:36:11,880 --> 00:36:12,600 RESEARCH ON BOTANICALS AND OTHER 1003 00:36:12,600 --> 00:36:13,120 NATURAL PRODUCTS, CARBON 1004 00:36:13,120 --> 00:36:13,360 PROGRAM. 1005 00:36:13,360 --> 00:36:15,160 I'D LIKE TO WELCOME DR. SORKIN 1006 00:36:15,160 --> 00:36:17,960 TO DISCUSS THE CHALLENGES IN 1007 00:36:17,960 --> 00:36:19,640 RESEARCH ON BOTANICAL DIETARY 1008 00:36:19,640 --> 00:36:20,520 SUPPLEMENTS. 1009 00:36:20,520 --> 00:36:22,400 WELCOME, DR. SORKIN. 1010 00:36:22,400 --> 00:36:24,480 THANK YOU ALL FOR YOUR INTEREST, 1011 00:36:24,480 --> 00:36:25,880 THANK YOU, SANEM, FOR YOUR HELP 1012 00:36:25,880 --> 00:36:32,680 AND FOR THE INTRODUCTION. 1013 00:36:32,680 --> 00:36:34,720 DR. KUSZAK [INAUDIBLE] I WANT TO 1014 00:36:34,720 --> 00:36:35,760 TELL YOU ABOUT TODAY. 1015 00:36:35,760 --> 00:36:37,520 HE TALKED ABOUT CHARACTERIZATION 1016 00:36:37,520 --> 00:36:40,920 OF CHEMICALLY COMPLEX AND -- 1017 00:36:40,920 --> 00:36:42,080 VARIABLE DIETARY SUPPLEMENTS 1018 00:36:42,080 --> 00:36:44,080 LIKE BOTANICAL PRODUCTS, AND 1019 00:36:44,080 --> 00:36:46,400 WHAT I WANT TO DO IS BUILD ON 1020 00:36:46,400 --> 00:36:50,360 THAT FOUNDATION THAT HE PROVIDED 1021 00:36:50,360 --> 00:36:52,400 AND TALK -- DIVE WAY MORE INTO 1022 00:36:52,400 --> 00:36:54,040 HOW YOU FIGURE OUT WHETHER THE 1023 00:36:54,040 --> 00:36:55,320 CHEMISTRY OF THE PRODUCT THAT 1024 00:36:55,320 --> 00:36:57,640 YOU'RE LOOKING AT IS GOING TO 1025 00:36:57,640 --> 00:36:59,640 GIVE YOU THE BIOLOGICAL EFFECT 1026 00:36:59,640 --> 00:37:02,360 THAT YOU ARE HOPING TO HAVE. 1027 00:37:02,360 --> 00:37:03,960 SO THE QUESTION THAT I ALWAYS 1028 00:37:03,960 --> 00:37:08,760 GET FROM PEOPLE IS TELL US WHICH 1029 00:37:08,760 --> 00:37:11,720 PLANT, WHICH SUPPLEMENTS WILL 1030 00:37:11,720 --> 00:37:12,920 WORK FOR WHICH CONDITIONS. 1031 00:37:12,920 --> 00:37:14,920 AND AS YOU CAN SEE FROM THIS 1032 00:37:14,920 --> 00:37:16,560 GRAPHIC HERE, I AM GOING TO 1033 00:37:16,560 --> 00:37:25,040 TOUCH VERY BRIEFLY ON 1034 00:37:25,040 --> 00:37:29,080 [INAUDIBLE] BUT HOW DO WE AN SER 1035 00:37:29,080 --> 00:37:29,480 THIS QUESTION? 1036 00:37:29,480 --> 00:37:31,080 BEFORE WE TURN TO A ANSWER IT IN 1037 00:37:31,080 --> 00:37:32,360 MORE DEPTH, ADAM TALKED ABOUT 1038 00:37:32,360 --> 00:37:33,880 HOW WE CHARACTERIZE THE 1039 00:37:33,880 --> 00:37:34,800 CHEMISTRY BUT NOT WHAT I'M GOING 1040 00:37:34,800 --> 00:37:36,160 TO TALK ABOUT, WHICH IS HOW WE 1041 00:37:36,160 --> 00:37:37,880 CONNECT THE CHEMISTRY TO THE 1042 00:37:37,880 --> 00:37:39,400 BIOLOGICAL EFFECTS IN THE 1043 00:37:39,400 --> 00:37:40,480 CONSUMER. 1044 00:37:40,480 --> 00:37:41,520 BUT WHY IS THIS IMPORTANT? 1045 00:37:41,520 --> 00:37:45,120 BECAUSE IT IS CHALLENGING, GIVEN 1046 00:37:45,120 --> 00:37:46,720 THE CHEMICAL CHALLENGES ADAM WAS 1047 00:37:46,720 --> 00:37:48,040 TELLING YOU ABOUT. 1048 00:37:48,040 --> 00:37:49,600 ONE WAS THAT AS DR. BAILEY TOLD 1049 00:37:49,600 --> 00:37:52,360 YOU YET, A LOT OF PEOPLE USE 1050 00:37:52,360 --> 00:37:53,400 DIETARY SUPPLEMENTS. 1051 00:37:53,400 --> 00:37:55,240 NOW A SMALLER PERCENTAGE USE THE 1052 00:37:55,240 --> 00:37:57,000 ONES THAT ARE NOT VITAMINS OR 1053 00:37:57,000 --> 00:37:59,320 MINERALS LIKE BOTANICALS, BUT 1054 00:37:59,320 --> 00:38:01,680 THAT'S STILL AT A MINIMUM 5% OF 1055 00:38:01,680 --> 00:38:04,280 THE U.S. POPULATION WHICH IS 1056 00:38:04,280 --> 00:38:04,960 50 MILLION PEOPLE WHICH IS 1057 00:38:04,960 --> 00:38:07,080 GETTING TO BE REAL NUMBERS. 1058 00:38:07,080 --> 00:38:07,960 THE OTHER REASON I THINK IT'S 1059 00:38:07,960 --> 00:38:13,360 IMPORTANT TO STUDY THIS IS THAT 1060 00:38:13,360 --> 00:38:15,600 THE -- COMPLEXITY, CHEMICALLY 1061 00:38:15,600 --> 00:38:16,960 COMPLEX AS THESE DIETARY 1062 00:38:16,960 --> 00:38:18,040 SUPPLEMENTS MAY BE, AND I'M 1063 00:38:18,040 --> 00:38:19,040 GOING TO SHOW YOU SOME EXAMPLES 1064 00:38:19,040 --> 00:38:22,840 OF WHAT I MEAN BY THAT, COMPLEX 1065 00:38:22,840 --> 00:38:25,840 AS THEY MAY BE, THEY'RE STILL 1066 00:38:25,840 --> 00:38:27,560 SIMPLER TO TRACK HUMAN EXPOSURE 1067 00:38:27,560 --> 00:38:30,640 TO AND SIMPLER TO TRACK ONCE 1068 00:38:30,640 --> 00:38:31,960 THEY'RE INSIDE THE BODY BECAUSE 1069 00:38:31,960 --> 00:38:36,000 THEY DON'T HAVE A UBIQUITOUS 1070 00:38:36,000 --> 00:38:38,160 BACKGROUND LIKE FLAVONOID, FOR 1071 00:38:38,160 --> 00:38:39,520 EXAMPLE, WHICH ARE IN MANY OF 1072 00:38:39,520 --> 00:38:40,600 THE FOODS ONE HOPES YOU ARE 1073 00:38:40,600 --> 00:38:40,960 EATING. 1074 00:38:40,960 --> 00:38:42,320 AND THEN YOU CAN TAKE THE 1075 00:38:42,320 --> 00:38:46,680 METHODS THAT YOU DEVELOPED, 1076 00:38:46,680 --> 00:38:48,120 EASIER TO TRACK CASES, BRING 1077 00:38:48,120 --> 00:38:49,880 THEM TO UNDERSTANDING WHICH MAY 1078 00:38:49,880 --> 00:38:51,360 BE BENEFICIAL FOR WHAT AND WHY. 1079 00:38:51,360 --> 00:38:53,000 SO HERE'S THE ROAD MAP THAT I'M 1080 00:38:53,000 --> 00:38:56,400 HOPING TO TAKE YOU THROUGH 1081 00:38:56,400 --> 00:38:56,680 TODAY. 1082 00:38:56,680 --> 00:38:57,440 I'M GOING TO START BY TELLING 1083 00:38:57,440 --> 00:39:01,920 YOU A LITTLE BIT ABOUT THE 1084 00:39:01,920 --> 00:39:03,520 CONSORTIUM EVENTS -- AND OTHER 1085 00:39:03,520 --> 00:39:05,600 NATURAL PRODUCTS WHICH I 1086 00:39:05,600 --> 00:39:06,920 CODIRECT AND WE'RE GOING TO 1087 00:39:06,920 --> 00:39:08,280 SPEND A LOT OF TIME CONTINUING 1088 00:39:08,280 --> 00:39:09,880 TO FOCUS ON PRODUCT BUT MORE 1089 00:39:09,880 --> 00:39:10,640 FROM THE POINT OF VIEW, DOES IT 1090 00:39:10,640 --> 00:39:14,720 HAVE THE DESIRED -- DR. KUSZAK 1091 00:39:14,720 --> 00:39:17,680 TOLD YOU A LOT ABOUT LOOKING AT 1092 00:39:17,680 --> 00:39:18,520 SAFETY, WHAT'S THE RIGHT 1093 00:39:18,520 --> 00:39:19,960 CHEMISTRY AND HOW DO YOU FIGURE 1094 00:39:19,960 --> 00:39:21,000 THAT OUT. 1095 00:39:21,000 --> 00:39:22,960 SOME EXTENT IS THAT SORT OF A 1096 00:39:22,960 --> 00:39:25,440 CHICKEN AND EGG QUESTION, AS 1097 00:39:25,440 --> 00:39:27,320 YOU'RE NOT SEEING THE DESIRED 1098 00:39:27,320 --> 00:39:29,880 EFFECTS BECAUSE YOU'RE LOOKING 1099 00:39:29,880 --> 00:39:31,360 AT THE WRONG -- THE RIGHT 1100 00:39:31,360 --> 00:39:32,360 CHEMISTRY SO YOU'RE WORKING BACK 1101 00:39:32,360 --> 00:39:37,320 AND FORTH BETWEEN THOSE. 1102 00:39:37,320 --> 00:39:41,480 I'LL THEN TALK A LITTLE ABOUT 1103 00:39:41,480 --> 00:39:43,320 WHETHER WHAT'S IN THE 1104 00:39:43,320 --> 00:39:44,680 SUPPLEMENT, HOW DID IT GET TO -- 1105 00:39:44,680 --> 00:39:47,120 AND VERY LITTLE BIT ABOUT TIMING 1106 00:39:47,120 --> 00:39:48,320 AT CONSUMPTION. 1107 00:39:48,320 --> 00:39:49,320 OBVIOUSLY THAT'S REALLY 1108 00:39:49,320 --> 00:39:50,520 IMPORTANT, WHAT TIME OF DAY YOU 1109 00:39:50,520 --> 00:39:57,360 TAKE THINGS, WHETHER YOU TAKE IT 1110 00:39:57,360 --> 00:40:01,920 BEFORE, IF DO YOU TAKE IT EARO 1111 00:40:01,920 --> 00:40:03,560 PREVENT, FOR RECOVER AFTER YOU 1112 00:40:03,560 --> 00:40:04,800 ALREADY SEE SYMPTOMS, AND THEN 1113 00:40:04,800 --> 00:40:07,360 I'M GOING TO TAKE IT A BIT 1114 00:40:07,360 --> 00:40:08,480 BEYOND THE CHEMICAL COMPLEXITY 1115 00:40:08,480 --> 00:40:11,680 OF NATURAL PRODUCTS THAT ARE -- 1116 00:40:11,680 --> 00:40:13,600 FOR THIS 30 MINUTES AND TALK A 1117 00:40:13,600 --> 00:40:14,400 LITTLE ABOUT SOME OF THE 1118 00:40:14,400 --> 00:40:19,360 CHALLENGES OF TAKING STUDIES ON 1119 00:40:19,360 --> 00:40:20,360 CHEMICALLY COMPLEX INHERENTLY 1120 00:40:20,360 --> 00:40:21,640 VARIABLE SUPPLEMENTS THAT PEOPLE 1121 00:40:21,640 --> 00:40:23,360 HAVE VERY STRONG BELIEFS ABOUT 1122 00:40:23,360 --> 00:40:27,440 IN MANY CASES. 1123 00:40:27,440 --> 00:40:30,040 FROM TAKING ANIMAL MODELS LIKE 1124 00:40:30,040 --> 00:40:32,200 MICE AND GOING FROM THOSE TO 1125 00:40:32,200 --> 00:40:33,000 HUMANS AND SOME OF THE 1126 00:40:33,000 --> 00:40:33,920 CHALLENGES THAT I DON'T THINK 1127 00:40:33,920 --> 00:40:35,080 YOU'RE GOING TO HEAR ABOUT 1128 00:40:35,080 --> 00:40:39,840 ELSEWHERE TODAY OR TOMORROW. 1129 00:40:39,840 --> 00:40:40,320 HERE'S THE OUTLINE. 1130 00:40:40,320 --> 00:40:41,920 THIS IS ONE OF THE PAPERS THAT I 1131 00:40:41,920 --> 00:40:44,160 PUT IN MY REFERENCE LIST OR LIST 1132 00:40:44,160 --> 00:40:47,440 OF REFERENCES AND RESOURCES, THE 1133 00:40:47,440 --> 00:40:50,200 PAPER THAT I READ, MANY, MANY 1134 00:40:50,200 --> 00:40:52,560 AUTHORS, BEGINNING OF 2020, AND 1135 00:40:52,560 --> 00:40:53,680 MANY OF THE THINGS I'M GOING TO 1136 00:40:53,680 --> 00:40:55,960 TALK ABOUT TODAY ARE EXPANDED ON 1137 00:40:55,960 --> 00:40:57,000 IN THAT PAPER IF YOU'RE 1138 00:40:57,000 --> 00:41:03,760 INTERESTED. 1139 00:41:03,760 --> 00:41:05,160 CHEMICAL CONSTITUENTS IN THE 1140 00:41:05,160 --> 00:41:06,080 PRODUCT, WE KNOW HERE YOU'RE 1141 00:41:06,080 --> 00:41:10,400 LOOKING AT MULTIPLE CONSTITUENTS 1142 00:41:10,400 --> 00:41:11,200 AND POTENTIALLY MULTIPLE 1143 00:41:11,200 --> 00:41:12,000 DIFFERENT TARGETS IN THE 1144 00:41:12,000 --> 00:41:13,600 CONSUMER. 1145 00:41:13,600 --> 00:41:15,440 AND THAT IS, I THINK, AN PORP 1146 00:41:15,440 --> 00:41:16,720 POINT AND ONE OF THE VERY 1147 00:41:16,720 --> 00:41:19,200 IMPORTANT REASONS WHY IT'S NOT 1148 00:41:19,200 --> 00:41:20,480 SUFFICIENT TO LOOK AT A SINGLE 1149 00:41:20,480 --> 00:41:26,560 COMPOUND IN A BOTANICAL LIKE 1150 00:41:26,560 --> 00:41:27,720 CURCUMIN, FOR EXAMPLE, AND I'LL 1151 00:41:27,720 --> 00:41:29,920 TRY TO CONVINCE YOU THAT IS A 1152 00:41:29,920 --> 00:41:31,040 REALLY IMPORTANT THING TO DO AND 1153 00:41:31,040 --> 00:41:32,720 IMPORTANT FOREIGN UNDERSTANDING 1154 00:41:32,720 --> 00:41:33,560 BIOLOGICAL EFFECTS BECAUSE 1155 00:41:33,560 --> 00:41:35,760 OBVIOUSLY IF YOU HAVE MULTIPLE 1156 00:41:35,760 --> 00:41:38,760 COMPONENTS IN A PRODUCT, 1157 00:41:38,760 --> 00:41:40,720 MULTIPLE CELLULAR TARGETS IN THE 1158 00:41:40,720 --> 00:41:43,200 CONSUMER, DIFFERENT WAYS OF -- 1159 00:41:43,200 --> 00:41:44,200 DIFFERENT CHEMISTRIES, DIFFERENT 1160 00:41:44,200 --> 00:41:45,760 WAYS OF STANDARD USING THE 1161 00:41:45,760 --> 00:41:46,920 PRODUCT ARE GOING TO GIVE YOU 1162 00:41:46,920 --> 00:41:48,840 DIFFERENT OUTCOMES, AND SO 1163 00:41:48,840 --> 00:41:51,160 KNOWING WHICH CHEMISTRY HAS WHAT 1164 00:41:51,160 --> 00:41:52,440 OUTCOME IS GOING TO BE REALLY 1165 00:41:52,440 --> 00:41:53,600 IMPORTANT FOR COMPARING BETWEEN 1166 00:41:53,600 --> 00:41:55,240 DIFFERENT STUDY, DIFFERENT 1167 00:41:55,240 --> 00:41:58,520 OUTCOMES, DIFFERENT POPULATIONS, 1168 00:41:58,520 --> 00:41:59,960 PERHAPS, THAT POPULATIONS DIFFER 1169 00:41:59,960 --> 00:42:06,960 IN, FOR EXAMPLE, MICROBIOTA. 1170 00:42:06,960 --> 00:42:08,880 THE ODS WEBSITE HAS A NUMBER OF 1171 00:42:08,880 --> 00:42:09,560 PAGES ON THE CONSORTIUM. 1172 00:42:09,560 --> 00:42:13,600 YOU CAN FIND THEM AT THIS URL. 1173 00:42:13,600 --> 00:42:15,360 I AM NOT GOING TO TAKE YOU 1174 00:42:15,360 --> 00:42:17,080 THROUGH THE FIVE CURRENT 1175 00:42:17,080 --> 00:42:19,960 BOTANICAL -- FIVE CURRENT 1176 00:42:19,960 --> 00:42:21,480 CENTERS, RESEARCH CENTERS IN 1177 00:42:21,480 --> 00:42:22,760 DETAIL, BUT WHAT I AM GOING TO 1178 00:42:22,760 --> 00:42:24,640 DO IS, AS I GO THROUGH MY 1179 00:42:24,640 --> 00:42:26,640 DISCUSSION OF HOW YOU GET THE 1180 00:42:26,640 --> 00:42:31,000 RIGHT CHEMISTRY IN YOUR PRODUCT 1181 00:42:31,000 --> 00:42:32,560 FOR THE BIOLOGY, THE OUTCOME 1182 00:42:32,560 --> 00:42:36,920 THAT YOU'RE INTERESTED IN, HOW 1183 00:42:36,920 --> 00:42:37,800 YOU -- HOW THEY'VE CONTRIBUTED 1184 00:42:37,800 --> 00:42:40,880 TO THAT ARGUMENT, EXCITING WORK 1185 00:42:40,880 --> 00:42:41,800 THEY HAVE DONE. 1186 00:42:41,800 --> 00:42:42,600 THE ONE CENTER I'M NOT GOING TO 1187 00:42:42,600 --> 00:42:44,680 TALK ABOUT IS THE NATURAL 1188 00:42:44,680 --> 00:42:46,640 PRODUCTS MAGNETIC RESONANCE 1189 00:42:46,640 --> 00:42:46,920 DATABASE. 1190 00:42:46,920 --> 00:42:48,560 IF YOU ARE INTERESTED IN 1191 00:42:48,560 --> 00:42:55,280 CHEMISTRY OF NATURAL PRODUCTS, I 1192 00:42:55,280 --> 00:42:57,320 URGE YOU SO HAVE A LOOK AT IT 1193 00:42:57,320 --> 00:42:58,880 AND IF YOU GO TO THIS WEBPAGE 1194 00:42:58,880 --> 00:43:01,360 THAT WILL TAKE YOU TO THEIR 1195 00:43:01,360 --> 00:43:08,000 WEBSITE. 1196 00:43:08,000 --> 00:43:08,760 WE'VE TALKED ABOUT THE 1197 00:43:08,760 --> 00:43:09,920 CONSORTIUM. 1198 00:43:09,920 --> 00:43:12,200 LET'S TURN TO THE PRODUCT. 1199 00:43:12,200 --> 00:43:14,960 ADAM ALREADY TALKED TO YOU ABOUT 1200 00:43:14,960 --> 00:43:25,400 IT. URMERIC, CURCUMIN, AND 1201 00:43:27,640 --> 00:43:37,840 CURCUMINOIDS. 1202 00:43:43,560 --> 00:43:54,040 IN ADDITION TO CURCUMINNOIDS, -- 1203 00:44:02,760 --> 00:44:06,480 PEOPLE USUALLY THINK CURCUMIN OR 1204 00:44:06,480 --> 00:44:09,480 PERHAPS CURCUMINNOIDS BUT 1205 00:44:09,480 --> 00:44:10,560 DR. JANET FUNK AT UNIVERSITY OF 1206 00:44:10,560 --> 00:44:12,600 ARIZONA HAS SOME EVIDENCE THAT, 1207 00:44:12,600 --> 00:44:14,200 IN FACT, EXOIN THE OILS MAY ALSO 1208 00:44:14,200 --> 00:44:16,840 CONTRIBUTE TO SOME BIOLOGICAL 1209 00:44:16,840 --> 00:44:19,400 ACTIVITIES OF TURMERIC ROOT. 1210 00:44:19,400 --> 00:44:20,880 ARGUMENT ONE, THE IMPORTANCE OF 1211 00:44:20,880 --> 00:44:25,560 LOOKING AT THE WHOLE PLANT, NOT 1212 00:44:25,560 --> 00:44:29,160 JUST THE CHARACTERISTIC 1213 00:44:29,160 --> 00:44:30,440 BIOACTIVE COMPOUNDS IN IT. 1214 00:44:30,440 --> 00:44:32,280 HERE'S ANOTHER REASON THAT IT'S 1215 00:44:32,280 --> 00:44:33,840 IMPORTANT TO LOOK AT MULTIPLE 1216 00:44:33,840 --> 00:44:34,520 COMPOUNDS. 1217 00:44:34,520 --> 00:44:39,320 AGAIN, THIS WAS SOMETHING -- A 1218 00:44:39,320 --> 00:44:41,520 STORY AT THE BOTANICAL RESEARCH 1219 00:44:41,520 --> 00:44:43,560 CENTER AT UNIVERSITY OF ILLINOIS 1220 00:44:43,560 --> 00:44:45,440 AT CHICAGO, THERE WERE 20-SOME 1221 00:44:45,440 --> 00:44:47,080 CASES OF ACUTE NON-VIRAL 1222 00:44:47,080 --> 00:44:48,440 HEPATITIS REPORTED AROUND 1223 00:44:48,440 --> 00:44:53,880 EUROPE, ALL IN ASSOCIATION 1224 00:44:53,880 --> 00:44:55,200 WITH -- TURMERIC PRODUCTS. 1225 00:44:55,200 --> 00:44:59,360 NOW WHEN YOU ARE -- SIMPLY BY 1226 00:44:59,360 --> 00:45:01,800 THE PRESENCE OF CURCUMIN, GIVEN 1227 00:45:01,800 --> 00:45:03,280 THAT IT'S RELATIVELY INEXPENSIVE 1228 00:45:03,280 --> 00:45:05,880 TO SYNTHESIZE CURCUMIN BUT MORE 1229 00:45:05,880 --> 00:45:09,760 EXPENSIVE TO ISOLATE 1230 00:45:09,760 --> 00:45:12,480 CURCUMINNOIDS FROM TURMERIC 1231 00:45:12,480 --> 00:45:13,560 ROOTS, ONE THING THAT SOMETIMES 1232 00:45:13,560 --> 00:45:16,720 HAPPENS IS THAT PEOPLE WILL TAKE 1233 00:45:16,720 --> 00:45:19,240 POWDER AND COLOR IT THAT LOVELY 1234 00:45:19,240 --> 00:45:24,560 ORANGE COLOR OF TURMERIC ROOT 1235 00:45:24,560 --> 00:45:25,720 USING OTHER -- LIKE CHROMATE 1236 00:45:25,720 --> 00:45:27,640 WHICH WOULD NOT SHOW UP ON A 1237 00:45:27,640 --> 00:45:30,360 TYPICAL ANALYSIS FOR 1238 00:45:30,360 --> 00:45:31,560 CURCUMINOIDS BECAUSE IT WOULDN'T 1239 00:45:31,560 --> 00:45:32,800 BE SOLUBLE IN THE SOLVENT THAT 1240 00:45:32,800 --> 00:45:38,200 YOU WOULD USE. 1241 00:45:38,200 --> 00:45:41,240 SO THIS GROUP GOT CALLED IN AND 1242 00:45:41,240 --> 00:45:42,800 THEY ANALYZED SOME OF THE 1243 00:45:42,800 --> 00:45:45,480 BATCHES OF SO-CALLED TURMERIC 1244 00:45:45,480 --> 00:45:47,440 THAT WERE ASSOCIATED WITH THIS 1245 00:45:47,440 --> 00:45:50,200 ACUTE NON-VIRAL HEPATITIS. 1246 00:45:50,200 --> 00:45:52,480 THE BATCHES A AND B SHOWN HERE. 1247 00:45:52,480 --> 00:45:54,120 AND INDEED, COMPARING THEM TO 1248 00:45:54,120 --> 00:45:55,520 GENUINE ISOLATED CURCUMIN, YOU 1249 00:45:55,520 --> 00:45:58,680 CAN SEE THAT THIS HAD CURCUMIN 1250 00:45:58,680 --> 00:46:00,720 IN IT, BUT IF IT WERE REALLY 1251 00:46:00,720 --> 00:46:02,760 ISOLATED FROM TURMERIC ROOT, IT 1252 00:46:02,760 --> 00:46:04,600 WOULD ALSO CONTAIN AT LEAST 1253 00:46:04,600 --> 00:46:08,000 TRACE AMOUNTS OF THE OTHER 1254 00:46:08,000 --> 00:46:11,440 CURCUMINOIDS ISOLATED PROTON NMR 1255 00:46:11,440 --> 00:46:13,520 OF THOSE CURCUMINOIDS SHOWN AT 1256 00:46:13,520 --> 00:46:15,120 THE BOTTOM, AND YOU CAN SEE 1257 00:46:15,120 --> 00:46:17,160 THESE ARE ABSENT FROM THESE TWO 1258 00:46:17,160 --> 00:46:18,160 PRODUCTS INDICATING THEY ARE 1259 00:46:18,160 --> 00:46:19,440 INDEED SYNTHETIC PRODUCTS AND 1260 00:46:19,440 --> 00:46:20,840 THAT IN ALL LIKELIHOOD, THE 1261 00:46:20,840 --> 00:46:22,480 CAUSE OF THE ACUTE HEPATITIS IN 1262 00:46:22,480 --> 00:46:24,640 THE PEOPLE WHO USED THESE 1263 00:46:24,640 --> 00:46:26,040 PRODUCTS WAS PROBABLY FROM ONE 1264 00:46:26,040 --> 00:46:28,360 OF THOSE SOLVENTS USED TO 1265 00:46:28,360 --> 00:46:30,360 SYNTHESIZE THE PRODUCT THAT WAS 1266 00:46:30,360 --> 00:46:39,360 NOT SUFFICIENTLY REMOVED. 1267 00:46:39,360 --> 00:46:40,840 GIVEN THE AMOUNT OF TIME I'VE 1268 00:46:40,840 --> 00:46:44,840 SPENT TALKING ABOUT TURMERIC AND 1269 00:46:44,840 --> 00:46:45,440 CURCUMINOIDS, OBVIOUSLY THERE 1270 00:46:45,440 --> 00:46:47,080 ARE MANY, MANY DIFFERENT HEALTH 1271 00:46:47,080 --> 00:46:49,600 CLAIMS FOR THEM. 1272 00:46:49,600 --> 00:46:51,000 AND THIS WEBSITE, I'M NOT GOING 1273 00:46:51,000 --> 00:46:54,960 TO TELL YOU WHAT IT WAS, GIVEN 1274 00:46:54,960 --> 00:46:55,920 WHAT I'M ABOUT TO SAY ABOUT IT. 1275 00:46:55,920 --> 00:46:57,080 THEY DID POINT OUT THAT THERE 1276 00:46:57,080 --> 00:47:00,520 ARE CASES WHERE INTEREST ARE 1277 00:47:00,520 --> 00:47:01,480 PROBLEMS WITH TURMERIC 1278 00:47:01,480 --> 00:47:03,920 SUPPLEMENTS THAT ARE ON THE 1279 00:47:03,920 --> 00:47:04,920 MARKET. 1280 00:47:04,920 --> 00:47:06,920 ALTHOUGH OF COURSE NOT THEIRS. 1281 00:47:06,920 --> 00:47:10,920 THEY ALSO POINT TO A GREAT MANY 1282 00:47:10,920 --> 00:47:12,560 DIFFERENT HEALTH OUTCOMES 1283 00:47:12,560 --> 00:47:13,560 THAT -- I'M NOT SURE WHETHER 1284 00:47:13,560 --> 00:47:15,200 THEY'RE TALKING ABOUT TURMERIC 1285 00:47:15,200 --> 00:47:15,800 OR CURCUMIN. 1286 00:47:15,800 --> 00:47:20,320 THEY DO SEEM TO HAVE SOME 1287 00:47:20,320 --> 00:47:24,280 PROBLEMS WITH -- THAT IT'S NOT 1288 00:47:24,280 --> 00:47:28,280 BOTH, AND THEY ALSO -- THE OTHER 1289 00:47:28,280 --> 00:47:30,880 THING THAT YOU SEE A LOT OF WITH 1290 00:47:30,880 --> 00:47:32,400 CURCUMIN, TURMERIC, IS INTEREST 1291 00:47:32,400 --> 00:47:34,120 IN WHETHER IT CAN HELP TO 1292 00:47:34,120 --> 00:47:37,800 PROTECT YOU FROM COVID-19. 1293 00:47:37,800 --> 00:47:41,160 I SEARCHED PUBMED LAST WEEK AND 1294 00:47:41,160 --> 00:47:42,200 FOUND 200 PAPERS THAT INCLUDED 1295 00:47:42,200 --> 00:47:42,720 THESE TERMS. 1296 00:47:42,720 --> 00:47:48,440 SO A LOT OF INTEREST THERE. 1297 00:47:48,440 --> 00:47:51,920 NOW, WHY SO MUCH INTEREST IN 1298 00:47:51,920 --> 00:47:52,320 TURMERIC? 1299 00:47:52,320 --> 00:47:55,520 I WOULD ARGUE THAT CERTAINLY 1300 00:47:55,520 --> 00:47:58,200 IT'S TRADITIONALLY USED AS A 1301 00:47:58,200 --> 00:47:59,000 MEDICINAL, I'LL COME BACK TO 1302 00:47:59,000 --> 00:48:00,320 THAT IN A MOMENT, BUT THE OTHER 1303 00:48:00,320 --> 00:48:03,400 THING IS THAT IN MANY CELL-BASED 1304 00:48:03,400 --> 00:48:07,120 OR IN VITRO ASSAYS, CURCUMIN 1305 00:48:07,120 --> 00:48:08,920 GIVES A POSITIVE RESULT. 1306 00:48:08,920 --> 00:48:09,320 OKAY. 1307 00:48:09,320 --> 00:48:11,640 NOW I'M GOING TO TELL YOU ABOUT 1308 00:48:11,640 --> 00:48:13,800 THE BOTANICAL TRADITIONAL USE 1309 00:48:13,800 --> 00:48:17,280 BASIS HERE, AND MY CAVEAT ABOUT 1310 00:48:17,280 --> 00:48:20,920 BUILDING A NON-CLINICAL TRIAL OR 1311 00:48:20,920 --> 00:48:23,120 MODERN USE WHERE YOU GO TO YOUR 1312 00:48:23,120 --> 00:48:24,360 SUPERMARKET OR HEALTH FOOD STORE 1313 00:48:24,360 --> 00:48:26,200 AND YOU BUY A PLASTIC BOTTLE 1314 00:48:26,200 --> 00:48:34,880 WITH CAPSULES IN IT, CONTRASTING 1315 00:48:34,880 --> 00:48:37,760 THAT FROM TRADITIONAL USE, YOU 1316 00:48:37,760 --> 00:48:39,240 NEED TO BE REALLY CAREFUL. 1317 00:48:39,240 --> 00:48:41,520 IN TRADITIONAL USE, THE 1318 00:48:41,520 --> 00:48:42,320 DIAGNOSTIC SYSTEM IS PROBABLY 1319 00:48:42,320 --> 00:48:42,840 DIFFERENT. 1320 00:48:42,840 --> 00:48:48,000 THIS IS A IS A SCENE FROM THH 1321 00:48:48,000 --> 00:48:51,160 AMERICA RAIN FOREST AND MY 1322 00:48:51,160 --> 00:48:52,440 COLLEAGUE AT THE FOOD AND DRUG 1323 00:48:52,440 --> 00:48:52,800 ADMINISTRATION. 1324 00:48:52,800 --> 00:48:54,360 YOU CAN IMAGINE THAT THE WAY 1325 00:48:54,360 --> 00:48:56,680 THEY GROW THEIR PLANTS, THAT 1326 00:48:56,680 --> 00:49:00,640 THEY'RE USING PERHAPS 1327 00:49:00,640 --> 00:49:01,720 MEDICINALLY IN THE WAY THEY 1328 00:49:01,720 --> 00:49:04,560 HARVEST AND PREPARE THEM, THEIR 1329 00:49:04,560 --> 00:49:05,840 ENVIRONMENTAL CONTEXT, WHAT THEY 1330 00:49:05,840 --> 00:49:08,160 EAT, STRESS THAT THEY'RE UNDER, 1331 00:49:08,160 --> 00:49:15,400 ARE ALL VERY, VERY DIFFERENT 1332 00:49:15,400 --> 00:49:15,920 FROM MODERN AMERICA. 1333 00:49:15,920 --> 00:49:18,000 AND I THINK JOE IS PUTTING 1334 00:49:18,000 --> 00:49:18,640 REGULATORY INFORMATION IN THE 1335 00:49:18,640 --> 00:49:19,120 CHAT. 1336 00:49:19,120 --> 00:49:20,440 I CAN'T SEE THE CHAT, JOE, I 1337 00:49:20,440 --> 00:49:21,080 DON'T THINK. 1338 00:49:21,080 --> 00:49:27,400 CAN I SEE THE CHAT? 1339 00:49:27,400 --> 00:49:28,760 I DON'T THINK I CAN WHILE I'M 1340 00:49:28,760 --> 00:49:29,120 SHARING, JOE. 1341 00:49:29,120 --> 00:49:31,400 >> NO, THOSE ARE ANSWERS TO THE 1342 00:49:31,400 --> 00:49:32,440 QUESTIONS FROM ADAM'S THING. 1343 00:49:32,440 --> 00:49:34,360 SO YOU CAN IGNORE THOSE. 1344 00:49:34,360 --> 00:49:35,080 >> OKAY. 1345 00:49:35,080 --> 00:49:37,440 SORRY. 1346 00:49:37,440 --> 00:49:37,880 THANKS. 1347 00:49:37,880 --> 00:49:40,440 OKAY. 1348 00:49:40,440 --> 00:49:42,680 SO THERE MAY CERTAINLY BE 1349 00:49:42,680 --> 00:49:44,160 DIFFERENCES BETWEEN THE EFFECTS 1350 00:49:44,160 --> 00:49:47,360 YOU WOULD SEE IN YOURSELF BUYING 1351 00:49:47,360 --> 00:49:49,880 SOMETHING AT YOUR LOCAL 1352 00:49:49,880 --> 00:49:51,840 SUPPLEMENT STORE AND THE RESULTS 1353 00:49:51,840 --> 00:49:55,080 THAT THESE PEOPLE SEE PERHAPS 1354 00:49:55,080 --> 00:49:59,560 SOMETHING IN A VIRTUAL CONTEXT, 1355 00:49:59,560 --> 00:50:01,480 THEY'RE PREPARING THEM 1356 00:50:01,480 --> 00:50:03,600 DIFFERENTLY, DIFFERENT DIE TET 1357 00:50:03,600 --> 00:50:05,200 ETS, DIFFERENT GUT MICROBIOTA. 1358 00:50:05,200 --> 00:50:09,400 THE OTHER TYPICAL MODERN USE IS 1359 00:50:09,400 --> 00:50:19,920 BASED ON ARE -- IN VITRO ASSAYS. 1360 00:50:21,920 --> 00:50:24,960 CURCUMIN IS ONE OF A NUMBER OF 1361 00:50:24,960 --> 00:50:27,640 COMPOUNDS THAT DRS. BAIL AND 1362 00:50:27,640 --> 00:50:29,720 WALTERS HAVE DUBBED IN THIS 2014 1363 00:50:29,720 --> 00:50:32,000 NATURE PAPER, THE PAN ASSAY 1364 00:50:32,000 --> 00:50:35,400 INTERFERENCE COMPOUND. 1365 00:50:35,400 --> 00:50:37,800 THESE ARE COMPOUNDS THAT ARE IN 1366 00:50:37,800 --> 00:50:40,040 MANY CASES HIGHLY CHEMICALLY 1367 00:50:40,040 --> 00:50:41,760 REACTIVE, IN MANY CASES THEY CAN 1368 00:50:41,760 --> 00:50:44,000 DISRUPT CELL MEMBRANES. 1369 00:50:44,000 --> 00:50:44,720 AMONG THESE COMPOUNDS IN 1370 00:50:44,720 --> 00:50:54,280 ADDITION TO KIRK MIN, ARE 1371 00:50:54,280 --> 00:50:55,040 RESVERITROL -- FROM GREEN TEA, 1372 00:50:55,040 --> 00:50:56,680 ALL OF WHICH YOU PROBABLY HAVE 1373 00:50:56,680 --> 00:50:58,760 HEARD OF AND SEEN AS DIETARY 1374 00:50:58,760 --> 00:50:59,080 SUPPLEMENTS. 1375 00:50:59,080 --> 00:51:00,800 SO WHEN YOU SEE POSITIVES WITH 1376 00:51:00,800 --> 00:51:04,200 THESE THINGS IN CELL-BASED DRUG 1377 00:51:04,200 --> 00:51:06,240 IN VITRO ASSAYS, IT DOESN'T 1378 00:51:06,240 --> 00:51:07,160 NECESSARILY MEAN THEY WORK THE 1379 00:51:07,160 --> 00:51:08,800 WAY THAT ASSAY INDICATES. 1380 00:51:08,800 --> 00:51:13,400 THEY HAVE I'M NOT SAYING THO 1381 00:51:13,400 --> 00:51:14,240 BIOLOGICAL EFFECT, I'M SIMPLY 1382 00:51:14,240 --> 00:51:16,240 SAYING USING THOSE ASSAYS AS A 1383 00:51:16,240 --> 00:51:18,360 GUIDE TO HOW THEY -- MAY BE 1384 00:51:18,360 --> 00:51:20,080 DECEPTIVE. 1385 00:51:20,080 --> 00:51:23,120 THE FACT THAT THEY'RE SO 1386 00:51:23,120 --> 00:51:25,280 CHEMICALLY ACTIVE AND WORK ON 1387 00:51:25,280 --> 00:51:27,080 CELL MEMBRANES SUGGEST TO ME 1388 00:51:27,080 --> 00:51:30,080 THEY MAY HAVE MANY BIOLOGICAL 1389 00:51:30,080 --> 00:51:33,880 EFFECTS, THEY MAY BE VERY 1390 00:51:33,880 --> 00:51:35,040 CONTEXT-DEPENDENT AND IT'S HARD 1391 00:51:35,040 --> 00:51:37,360 TO UNDERSTAND AND HARD TO 1392 00:51:37,360 --> 00:51:42,720 CONTROL. 1393 00:51:42,720 --> 00:51:45,240 SOME OF THE PROBLEMS WITH HOW WE 1394 00:51:45,240 --> 00:51:47,880 THINK ABOUT -- PROBLEMS WITH HOW 1395 00:51:47,880 --> 00:51:50,040 YOU THINK ABOUT CHEMICAL 1396 00:51:50,040 --> 00:51:51,920 CONSTITUENTS OR PHYTOCHEMICALS 1397 00:51:51,920 --> 00:51:54,520 FROM THESE CHEMICALLY COMPLEX 1398 00:51:54,520 --> 00:51:56,600 SOURCES ACT ON HUMAN BIOLOGY OR 1399 00:51:56,600 --> 00:51:58,720 CONTROL ANIMAL BIOLOGY. 1400 00:51:58,720 --> 00:52:00,560 WHAT ARE SOME OF THE 1401 00:52:00,560 --> 00:52:01,400 SOLUTIONS -- FIRST LET'S TAKE A 1402 00:52:01,400 --> 00:52:03,000 LOOK AT REALLY EXPLAINING WHAT I 1403 00:52:03,000 --> 00:52:04,680 MEAN WHEN I SAY THESE ARE 1404 00:52:04,680 --> 00:52:05,800 CHEMICALLY COMPLEX. 1405 00:52:05,800 --> 00:52:09,760 BECAUSE SO FAR YOU'VE LOOKED AT 1406 00:52:09,760 --> 00:52:10,360 TWO CURCUMINNOIDS AND OTHER 1407 00:52:10,360 --> 00:52:10,800 COMPOUNDS. 1408 00:52:10,800 --> 00:52:13,960 HERE'S ANOTHER EXAMPLE FROM THE 1409 00:52:13,960 --> 00:52:15,520 FOLKS FROM THE UNIVERSITY OF 1410 00:52:15,520 --> 00:52:16,240 ILLINOIS-CHICAGO. 1411 00:52:16,240 --> 00:52:17,760 YOU'RE LOOKING AT ABOUT THESE 1412 00:52:17,760 --> 00:52:19,480 TWO DOZEN BARS ABOUT TWO DOZEN 1413 00:52:19,480 --> 00:52:23,640 DIFFERENT BATCHES OF ONE OF THE 1414 00:52:23,640 --> 00:52:25,120 PLANTS THEY STUDIED COMMONLY 1415 00:52:25,120 --> 00:52:29,200 USED AROUND MENOPAUSE. 1416 00:52:29,200 --> 00:52:30,320 EACH DIFFERENT COLOR, THERE ARE 1417 00:52:30,320 --> 00:52:32,160 SIX DIFFERENT COLORS IN THESE 1418 00:52:32,160 --> 00:52:34,720 BARS, REPRESENTS A STANDARDIZED 1419 00:52:34,720 --> 00:52:40,560 AMOUNT OF EACH OF THESE VERIFIED 1420 00:52:40,560 --> 00:52:42,160 BATCHES EXACTLY THE SAME WAY AND 1421 00:52:42,160 --> 00:52:43,640 ANALYZED IN EXACTLY THE SAME WAY 1422 00:52:43,640 --> 00:52:46,240 WITH THE AMOUNT OF THESE SIX 1423 00:52:46,240 --> 00:52:47,840 DIFFERENT COMPOUNDS QUANTIFIED 1424 00:52:47,840 --> 00:52:48,520 EXACTLY THE SAME WAY. 1425 00:52:48,520 --> 00:52:50,360 SO THESE ARE ALL COMPARABLE, 1426 00:52:50,360 --> 00:52:53,520 THESE ARE ALL SET TO 100% OF 1427 00:52:53,520 --> 00:52:54,240 THESE SIX COMPOUNDS AND WHAT YOU 1428 00:52:54,240 --> 00:52:58,520 CAN SEE IS THAT THE RATIOS OF 1429 00:52:58,520 --> 00:53:02,280 THE COMPOUNDS BASED ON 1430 00:53:02,280 --> 00:53:02,920 ESTROGENIC ACTIVITY ARE ALL OVER 1431 00:53:02,920 --> 00:53:03,320 THE PLACE. 1432 00:53:03,320 --> 00:53:07,080 SO IF ONLY ONE -- THEN YOU COULD 1433 00:53:07,080 --> 00:53:08,120 STANDARDIZE TO THE AMOUNT OF 1434 00:53:08,120 --> 00:53:10,480 THAT COMPOUND, BUT THAT IS 1435 00:53:10,480 --> 00:53:11,240 MULTIPLE OF THESE COMPOUNDS, 1436 00:53:11,240 --> 00:53:13,320 THAT IS TWO OR THREE OF THEM, 1437 00:53:13,320 --> 00:53:16,360 CONTRIBUTE TO THE ESTROGENIC 1438 00:53:16,360 --> 00:53:18,240 ACTIVITY OF IT. 1439 00:53:18,240 --> 00:53:21,680 YOU JUST KEEP YOUR PRODUCT 1440 00:53:21,680 --> 00:53:23,200 STANDARD TO HAVE CONSISTENT 1441 00:53:23,200 --> 00:53:24,200 BIOLOGICAL ACTIVITY, YOU WOULD 1442 00:53:24,200 --> 00:53:27,520 NEED TO BE MIXING BATCHES 1443 00:53:27,520 --> 00:53:27,840 PROBABLY. 1444 00:53:27,840 --> 00:53:29,600 BECAUSE THIS IS HOW INHERENTLY 1445 00:53:29,600 --> 00:53:37,640 VARIABLE THE PLANT ITSELF IS. 1446 00:53:37,640 --> 00:53:39,320 TURNING TO HOW CHEMICALLY 1447 00:53:39,320 --> 00:53:43,360 COMPLEX THESE ARE, THIS IS A 1448 00:53:43,360 --> 00:53:50,760 PAPER FROM A DECADE AGO A 1449 00:53:50,760 --> 00:53:53,520 TYPICAL EXTRACT OF ST. JOHN'S 1450 00:53:53,520 --> 00:53:55,160 WORT COMMONLY USED FOR MOON 1451 00:53:55,160 --> 00:53:55,720 MODULATION. 1452 00:53:55,720 --> 00:53:57,880 THERE ARE 10 DIFFERENT BULLETS 1453 00:53:57,880 --> 00:53:59,200 HERE BUT EACH CORRESPONDS TO A 1454 00:53:59,200 --> 00:54:02,480 WHOLE FAMILY OF DIFFERENT 1455 00:54:02,480 --> 00:54:05,680 COMPOUNDS. 1456 00:54:05,680 --> 00:54:07,120 CHEMICALLY UNASSIGNED EXOWNTDZ 1457 00:54:07,120 --> 00:54:08,560 EXOWNDZ AT THE BOTTOM WHICH MAKE 1458 00:54:08,560 --> 00:54:12,720 UP 30 TO 40% OF WHAT'S IN THE 1459 00:54:12,720 --> 00:54:16,320 MAP OF YOUR TYPICAL EXTRACT. 1460 00:54:16,320 --> 00:54:24,560 UP AT THE TOP, THOUGHT TO BE 1461 00:54:24,560 --> 00:54:28,040 RESPONSIBLE FOR THE MOON 1462 00:54:28,040 --> 00:54:29,800 MODULATING -- OF ST. JOHN'S 1463 00:54:29,800 --> 00:54:39,880 WORT. 1464 00:54:43,880 --> 00:54:45,480 WE ALSO ARE CURRENTLY PARTNERING 1465 00:54:45,480 --> 00:54:48,360 WITH NATIONAL INSTITUTE ON 1466 00:54:48,360 --> 00:54:50,480 AGING. 1467 00:54:50,480 --> 00:54:51,640 DR. WEBER AND HER COLLEAGUES 1468 00:54:51,640 --> 00:54:54,400 WANT TO TEST WHETHER AN EXTRACT 1469 00:54:54,400 --> 00:54:56,400 OF ST. JOHN'S WORT WOULD IMPROVE 1470 00:54:56,400 --> 00:55:03,880 ADHD IN YOUNG PEOPLE WHEN THEY 1471 00:55:03,880 --> 00:55:05,440 STARTED IT THEIR HYPOTHESIS WAS 1472 00:55:05,440 --> 00:55:08,800 THAT THAT WAS THE ACTIVE 1473 00:55:08,800 --> 00:55:16,120 COMPOUND. 1474 00:55:16,120 --> 00:55:18,480 THERE IS NO DIFFERENCE IN ADHD 1475 00:55:18,480 --> 00:55:19,920 SYMPTOMS BETWEEN THEIR PLACEBO 1476 00:55:19,920 --> 00:55:23,120 AND THEIR CONTROL GROUP. 1477 00:55:23,120 --> 00:55:26,680 DOES THAT MEAN THAT ST. JOHN'S 1478 00:55:26,680 --> 00:55:29,560 WORT DIDN'T WORK, OR, GIVEN WHAT 1479 00:55:29,560 --> 00:55:31,800 WAS IN THEIR PRODUCT AT THE END 1480 00:55:31,800 --> 00:55:36,840 OF THE TRIAL WHICH WAS ONLY 1481 00:55:36,840 --> 00:55:39,000 .13%, DOES THAT MEAN ST. JOHN'S 1482 00:55:39,000 --> 00:55:40,160 WORT WASN'T SUFFICIENTLY THERE 1483 00:55:40,160 --> 00:55:40,840 TO HAVE THE EFFECT? 1484 00:55:40,840 --> 00:55:42,440 HARD TO KNOW. 1485 00:55:42,440 --> 00:55:43,640 DON'T KNOW WHY THEY DIDN'T TEST 1486 00:55:43,640 --> 00:55:45,600 TO MAKE SURE IT WAS .3% AT THE 1487 00:55:45,600 --> 00:55:48,680 BEGINNING OF THE STUDY, AND THEN 1488 00:55:48,680 --> 00:55:52,080 MONITOR THE STABILITY. 1489 00:55:52,080 --> 00:55:53,720 SO STABILITY IS A HUGE ISSUE AND 1490 00:55:53,720 --> 00:55:54,720 IF YOU'RE DOING A CLINICAL 1491 00:55:54,720 --> 00:55:55,920 TRIAL, YOU ABSOLUTELY DON'T WANT 1492 00:55:55,920 --> 00:55:56,960 TO BE IN THIS SITUATION. 1493 00:55:56,960 --> 00:55:57,640 THE OTHER SITUATION YOU DON'T 1494 00:55:57,640 --> 00:55:59,280 WANT TO BE IN IS THAT BY THE 1495 00:55:59,280 --> 00:56:02,320 TIME THEY FINISH THIS TRIAL, THE 1496 00:56:02,320 --> 00:56:07,320 THINKING WAS MORE THAT IT WAS 1497 00:56:07,320 --> 00:56:10,200 THE HYPERFORIN WAS RESPONSIBLE, 1498 00:56:10,200 --> 00:56:12,760 BUT IT WOULDN'T HAVE BEEN ENOUGH 1499 00:56:12,760 --> 00:56:15,080 EITHER ACCORDING TO THAT 1500 00:56:15,080 --> 00:56:15,440 HYPOTHESIS. 1501 00:56:15,440 --> 00:56:17,400 IT'S A REALLY GOOD IDEA FROM 1502 00:56:17,400 --> 00:56:19,040 YOUR STARTING DATA WHAT CONTENT 1503 00:56:19,040 --> 00:56:21,440 YOU NEED AND AT WHAT LEVELS, AND 1504 00:56:21,440 --> 00:56:22,760 HOW STABLE THEY'RE LIKELY TO BE 1505 00:56:22,760 --> 00:56:25,160 AND MONITOR THAT, BECAUSE YOU 1506 00:56:25,160 --> 00:56:26,240 GET TO THE END OF THE CLINICAL 1507 00:56:26,240 --> 00:56:28,000 TRIAL AND YOU DON'T KNOW WHETHER 1508 00:56:28,000 --> 00:56:31,120 THE PROBLEM WITH WAS YOUR PRR 1509 00:56:31,120 --> 00:56:32,560 THAT THE PRODUCT JUST COULDN'T 1510 00:56:32,560 --> 00:56:36,160 WORK EVEN IF YOU HAD ENOUGH, 1511 00:56:36,160 --> 00:56:37,720 EVEN IF YOU'RE NOT PLANNING TO 1512 00:56:37,720 --> 00:56:38,360 REPEAT THAT STUDY. 1513 00:56:38,360 --> 00:56:39,760 HERE IS ANOTHER EXAMPLE THAT I 1514 00:56:39,760 --> 00:56:41,360 LIKE. 1515 00:56:41,360 --> 00:56:47,560 FROM OUR BOTANICAL CENTER IN 1516 00:56:47,560 --> 00:56:49,480 OREGON, CHEMICAL ENHANCING -- 1517 00:56:49,480 --> 00:56:50,680 AND AGING CENTER. 1518 00:56:50,680 --> 00:56:54,360 HERE THEY ARE LOOKING AT 1519 00:56:54,360 --> 00:57:04,920 COMPOUNDS IN CENTELLA ASIATICA, 1520 00:57:05,720 --> 00:57:07,000 TO IMPROVE MEMORY AND COGNITIVE 1521 00:57:07,000 --> 00:57:10,400 FUNCTION. 1522 00:57:10,400 --> 00:57:12,560 AND TRADITIONALLY, THE 1523 00:57:12,560 --> 00:57:13,840 TRITERPENES ARE THOUGHT TO BE 1524 00:57:13,840 --> 00:57:14,840 THE COMPOUNDS IMPORTANT FOR THAT 1525 00:57:14,840 --> 00:57:15,800 ACTIVITY. 1526 00:57:15,800 --> 00:57:19,040 THEY INCLUDE ASIATIC ACID, SHOWN 1527 00:57:19,040 --> 00:57:23,040 HERE AS AA, AND WHAT YOU'RE 1528 00:57:23,040 --> 00:57:25,840 LOOKING AT HERE IS IN THE YELLOW 1529 00:57:25,840 --> 00:57:27,240 BOXES, TRANSGENIC MICE 1530 00:57:27,240 --> 00:57:30,480 ENGINEERED TO HAVE AN AMYLOID 1531 00:57:30,480 --> 00:57:35,440 BETA GENE MUTATION THAT IS FOUND 1532 00:57:35,440 --> 00:57:37,840 IN HUMANS LINKED WITH 1533 00:57:37,840 --> 00:57:40,680 ALZHEIMER'S DISEASE, AND THE 1534 00:57:40,680 --> 00:57:42,760 AREA OF -- WHICH IS WHERE YOU 1535 00:57:42,760 --> 00:57:45,000 WOULD HAVE YOUR SYNAPSES IN THE 1536 00:57:45,000 --> 00:57:46,000 HIPPOCAMPUS, WHICH IS A PART OF 1537 00:57:46,000 --> 00:57:47,680 THE BRAIN ASSOCIATED WITH 1538 00:57:47,680 --> 00:57:50,240 MEMORY, ARE GREATER SO 1539 00:57:50,240 --> 00:57:52,760 PRESUMABLY BETTER MEMORY, IN THE 1540 00:57:52,760 --> 00:57:53,800 WILD TYPE MICE THEY'RE BEING 1541 00:57:53,800 --> 00:57:55,800 COMPARED TO THAN IN THE 1542 00:57:55,800 --> 00:57:57,840 TRANSGENIC MICE, AND IN THE 1543 00:57:57,840 --> 00:58:01,720 TRANSGENIC MICE THAT GET -- ACID 1544 00:58:01,720 --> 00:58:12,120 OR ITS -- THE WILD TYPE MICE. 1545 00:58:12,120 --> 00:58:13,520 THE PRINCIPAL INVESTIGATOR HAD 1546 00:58:13,520 --> 00:58:15,360 SHOWN EARLIER THAT THEY ALSO SAW 1547 00:58:15,360 --> 00:58:20,840 SOME ACTIVITY OF -- ACIDS IN 1548 00:58:20,840 --> 00:58:22,520 IMPROVING COGNITION AND MEMORY 1549 00:58:22,520 --> 00:58:24,120 IN OLDER MICE AND IN THESE MICE 1550 00:58:24,120 --> 00:58:28,360 THAT ARE ENGINEERED WITH THE 1551 00:58:28,360 --> 00:58:30,080 AMYLOID BETA MUTATION. 1552 00:58:30,080 --> 00:58:34,840 AND INDEED THEY ALSO SAW 1553 00:58:34,840 --> 00:58:41,160 IMPROVEMENT IN DENDRITIC 1554 00:58:41,160 --> 00:58:43,000 ARBORIZATION AREA. 1555 00:58:43,000 --> 00:58:48,200 INTERESTINGLY, A DIFFERENT -- 1556 00:58:48,200 --> 00:58:55,360 ACID HAS SIGNIFICANT EFFECT ON 1557 00:58:55,360 --> 00:59:00,240 THE NUMB WE NUMBER OF -- PEF 1558 00:59:00,240 --> 00:59:00,880 DENDRITE. 1559 00:59:00,880 --> 00:59:02,320 SO PERHAPS THE DENSITY OF 1560 00:59:02,320 --> 00:59:03,400 SYNAPTIC CONNECTIONS IN MEMORY. 1561 00:59:03,400 --> 00:59:04,760 SO THE IDEA HERE IS THAT 1562 00:59:04,760 --> 00:59:07,240 DIFFERENT CHEMICALS IN AN 1563 00:59:07,240 --> 00:59:08,680 ABSTRACT -- PLANT MAY CONTRIBUTE 1564 00:59:08,680 --> 00:59:10,200 TO DIFFERENT MECHANISMS OF 1565 00:59:10,200 --> 00:59:11,880 ACTION THAT ALL CONTRIBUTE TO 1566 00:59:11,880 --> 00:59:14,280 THE SAME OUTCOME, MAINLY, BETTER 1567 00:59:14,280 --> 00:59:18,920 MEMORY IN THE CONTEXT OF THIS 1568 00:59:18,920 --> 00:59:24,680 DEMENTIA-ASSOCIATED GENE DEFECT. 1569 00:59:24,680 --> 00:59:27,000 THAT IS CONSISTENT WITH 1570 00:59:27,000 --> 00:59:29,240 TRADITIONAL THINKING ABOUT HOW 1571 00:59:29,240 --> 00:59:30,760 BOTANICAL EXTRACTS WORK. 1572 00:59:30,760 --> 00:59:32,920 INDEED IN TRADITIONAL ASIAN 1573 00:59:32,920 --> 00:59:34,480 MEDICAL SYSTEMS OFTEN DIFFERENT 1574 00:59:34,480 --> 00:59:38,640 PLANTS ARE COMBINED. 1575 00:59:38,640 --> 00:59:41,200 FOR A GIVEN 1576 00:59:41,200 --> 00:59:42,080 PRESCRIPTION FOR A PATIENT. 1577 00:59:42,080 --> 00:59:44,080 HERE WE ARE SEEING THAT 1578 00:59:44,080 --> 00:59:45,160 DIFFERENT AND OFTEN IN 1579 00:59:45,160 --> 00:59:46,040 TRADITIONAL MEDICAL SYSTEMS 1580 00:59:46,040 --> 00:59:47,320 THERE'S A BELIEF THAT THE WHOLE 1581 00:59:47,320 --> 00:59:49,240 PLANT CAN BE BETTER THAN A 1582 00:59:49,240 --> 00:59:50,400 SINGLE ISOLATED CHEMICAL. 1583 00:59:50,400 --> 00:59:54,320 SO IT'S NOT JUST THAT THERE CAN 1584 00:59:54,320 --> 00:59:56,480 BE -- FOR ECONOMIC ADULTERATION 1585 00:59:56,480 --> 00:59:58,080 IF YOU FOCUS ON A SINGLE 1586 00:59:58,080 --> 00:59:59,640 CHEMICAL BUT ALSO THAT YOU MIGHT 1587 00:59:59,640 --> 01:00:01,000 GET BETTER -- WITH A MIBG TOUR 1588 01:00:01,000 --> 01:00:02,320 OF CHEMICALS FROM THE SAME 1589 01:00:02,320 --> 01:00:02,520 PLANT. 1590 01:00:02,520 --> 01:00:04,080 BUT THAT DOES MAKE IT HARDER TO 1591 01:00:04,080 --> 01:00:05,280 FIGURE OUT WHICH CHEMICALS TO 1592 01:00:05,280 --> 01:00:08,520 USE AND WHICH ONES DO WHAT. 1593 01:00:08,520 --> 01:00:09,680 I JUST WANTED TO GIVE YOU A 1594 01:00:09,680 --> 01:00:11,120 NUMBER OF OTHER REFERENCES WHERE 1595 01:00:11,120 --> 01:00:15,440 PEOPLE HAVE QUITE RIGOROUSLY 1596 01:00:15,440 --> 01:00:16,560 SHOWN CONTRIBUTION FROM MULTIPLE 1597 01:00:16,560 --> 01:00:19,360 CHEMICALS IN A SINGLE PLANT 1598 01:00:19,360 --> 01:00:21,120 ABSTRACT TO AN ACTIVITY OF 1599 01:00:21,120 --> 01:00:23,280 INTEREST, THIS ONE FROM 1600 01:00:23,280 --> 01:00:24,560 BOTANICAL CENTERS AT UNIVERSITY 1601 01:00:24,560 --> 01:00:27,480 OF ILLINOIS CHICAGO IN 1602 01:00:27,480 --> 01:00:29,600 COLLABORATION WITH ONE -- 1603 01:00:29,600 --> 01:00:31,360 LOOKING AT ABILITY TO MAINTAIN 1604 01:00:31,360 --> 01:00:34,920 BLOOD SUGAR LEVELS IN THE 1605 01:00:34,920 --> 01:00:38,200 CONTEXT OF -- AND SUGAR INTAKE 1606 01:00:38,200 --> 01:00:40,400 FOR ANTIMALARIAL THERAPY, WHERE 1607 01:00:40,400 --> 01:00:44,120 WHOLE PLANT -- THE SOURCE OF THE 1608 01:00:44,120 --> 01:00:45,240 WORLD HEALTH ORGANIZATION FRONT 1609 01:00:45,240 --> 01:00:48,600 LINE DRUG FOR MALARIA TREATMENT, 1610 01:00:48,600 --> 01:00:50,960 SHOULD BE USED IN COMBINATION 1611 01:00:50,960 --> 01:00:54,320 THERAPY FOR MALARIA. 1612 01:00:54,320 --> 01:00:55,720 SO THERE AGAIN PEOPLE USE 1613 01:00:55,720 --> 01:00:56,960 COMBINATIONS BUT THEY'RE USING 1614 01:00:56,960 --> 01:01:06,120 DRUG COMBINATIONS, BULL -- TE 1615 01:01:06,120 --> 01:01:09,640 PLANT CAN ACTUALLY BE MORE 1616 01:01:09,640 --> 01:01:13,360 EFFECTIVE AND ELICIT MORE 1617 01:01:13,360 --> 01:01:17,160 RESISTANCE BY THE -- THAN BY 1618 01:01:17,160 --> 01:01:21,280 USING -- OR ITS DERIVATIVE. 1619 01:01:21,280 --> 01:01:24,480 DR. CECH AND HER COLLEAGUES HAVE 1620 01:01:24,480 --> 01:01:33,120 SHOWN GOLDENSEAL AGAINST METH 1621 01:01:33,120 --> 01:01:34,120 METHICILLIN-RESISTANT 1622 01:01:34,120 --> 01:01:41,520 STAPHYLOCOCCUS US AUREUS -- AA 1623 01:01:41,520 --> 01:01:44,000 LOVELY PAPER IN 2019 WHERE THEY 1624 01:01:44,000 --> 01:01:45,400 TALK ABOUT METHODS, SO HERE YOU 1625 01:01:45,400 --> 01:01:46,520 START GETTING THE METHODS THAT 1626 01:01:46,520 --> 01:01:48,440 ALLOW YOU TO DO THIS, FINDING 1627 01:01:48,440 --> 01:01:51,320 EITHER SYNERGY OR ANTAGONISM IN 1628 01:01:51,320 --> 01:01:54,320 NATURAL PRODUCT EXTRACT. 1629 01:01:54,320 --> 01:01:56,880 AND NOW AN APPROACH TO ACTUALLY 1630 01:01:56,880 --> 01:01:57,960 DOING THIS SUFFICIENTLY, FINDING 1631 01:01:57,960 --> 01:02:00,280 WHICH CHEMICALS IN A CHEMICALLY 1632 01:02:00,280 --> 01:02:01,800 COMPLEX EXTRACT AS SHOWN HERE 1633 01:02:01,800 --> 01:02:03,280 CONTRIBUTE TO WHICH BIOLOGICAL 1634 01:02:03,280 --> 01:02:03,560 ACTIVITY. 1635 01:02:03,560 --> 01:02:12,800 THIS IS THE GOAL OF THE CARBON 1636 01:02:12,800 --> 01:02:14,040 CENTER, HIFAN CENTER. 1637 01:02:14,040 --> 01:02:15,880 AGAIN YOU CAN FIND OUT MORE 1638 01:02:15,880 --> 01:02:17,760 ABOUT THEM FROM THE ODS CARBON 1639 01:02:17,760 --> 01:02:19,040 WEBSITE VIA THEIR WEBSITE. 1640 01:02:19,040 --> 01:02:21,240 THE APPROACH THEY'RE TRYING TO 1641 01:02:21,240 --> 01:02:22,800 USE IS THAT YOU TAKE YOUR 1642 01:02:22,800 --> 01:02:23,960 CHEMICALLY COMPLEX NATURAL 1643 01:02:23,960 --> 01:02:28,680 PRODUCT, YOU FRAX ATE FRAC, 1644 01:02:28,680 --> 01:02:31,080 THEY HAVE REALLY DEVELOPED THE 1645 01:02:31,080 --> 01:02:34,840 METHOD OF USING MASS SPEC 1646 01:02:34,840 --> 01:02:39,760 ANALYSIS USING CHEMICALLY 1647 01:02:39,760 --> 01:02:41,160 COMPLEX -- AND ARE GOOD AND 1648 01:02:41,160 --> 01:02:42,760 FINDING OUT WHAT THE DIFFERENT 1649 01:02:42,760 --> 01:02:47,520 COMPOUNDS ARE IN THE MIXTURE. 1650 01:02:47,520 --> 01:02:49,000 AT THE SAME TIME, THEY ARE 1651 01:02:49,000 --> 01:02:52,200 TAKING THE SAME FRACTIONS THAT 1652 01:02:52,200 --> 01:02:53,520 THEY'RE ANALYZING CHEMICALLY AND 1653 01:02:53,520 --> 01:02:57,280 LOOKING AT THEIR EFFECTS ON CELL 1654 01:02:57,280 --> 01:03:00,000 PHENOTYPE AND GENE EXPRESSION IN 1655 01:03:00,000 --> 01:03:01,400 THE SAME CELLS. 1656 01:03:01,400 --> 01:03:03,720 THEY ORIGINALLY USED THIS METHOD 1657 01:03:03,720 --> 01:03:04,840 WITH CANCER CELLS BUT THEY CAN 1658 01:03:04,840 --> 01:03:06,760 NOW USE IT WITH IMMUNE CELLS SO 1659 01:03:06,760 --> 01:03:08,760 THIS IS STARTING TO GET VERY 1660 01:03:08,760 --> 01:03:09,400 INTERESTING. 1661 01:03:09,400 --> 01:03:11,800 OBVIOUSLY YOU CAN USE 21ST 1662 01:03:11,800 --> 01:03:13,320 CENTURY COMPUTATIONAL METHODS, 1663 01:03:13,320 --> 01:03:14,000 ISOLATE SPECIFIC COMPOUNDS THAT 1664 01:03:14,000 --> 01:03:16,120 YOU SEE IN ASSOCIATION WITH 1665 01:03:16,120 --> 01:03:17,560 CHANGES IN CELL PHENOTYPE OR 1666 01:03:17,560 --> 01:03:19,160 CHANGES IN GENE EXPRESSION THAT 1667 01:03:19,160 --> 01:03:21,520 THEY HAVE SHOWN IN SOME OF THEIR 1668 01:03:21,520 --> 01:03:25,800 PAPERS THAT IF YOU COMBINE TWO 1669 01:03:25,800 --> 01:03:27,760 DIFFERENT WAYS OF LOOKING AT 1670 01:03:27,760 --> 01:03:30,480 CHANGES IN CELLS, YOU GET 1671 01:03:30,480 --> 01:03:32,920 STRONGER AND MORE SPECIFIC 1672 01:03:32,920 --> 01:03:35,760 ABILITY TO PREDICT WHICH 1673 01:03:35,760 --> 01:03:38,280 COMPOUNDS ARE ACTING ON WHICH 1674 01:03:38,280 --> 01:03:41,440 CELLULAR SUBSTRATES TO GENERATE 1675 01:03:41,440 --> 01:03:43,400 POTENTIAL BIOLOGICAL EFFECT OF 1676 01:03:43,400 --> 01:03:47,720 INTEREST. 1677 01:03:47,720 --> 01:03:49,880 AND I THINK I HAVE SOME OF THEIR 1678 01:03:49,880 --> 01:03:52,760 PAPERS IN THE REFERENCE LIST. 1679 01:03:52,760 --> 01:03:54,160 WE'VE COVERED ALL OF THIS, LET'S 1680 01:03:54,160 --> 01:03:55,400 MOVE TO BIOLOGICAL AVAILABILITY 1681 01:03:55,400 --> 01:03:57,440 AND TIMING VERY BRIEFLY. 1682 01:03:57,440 --> 01:03:59,480 AND THEN HOW WE TAKE THIS FROM 1683 01:03:59,480 --> 01:04:03,160 THE CHEMISTRY AND THE CELLS INTO 1684 01:04:03,160 --> 01:04:05,520 HUMANS. 1685 01:04:05,520 --> 01:04:06,160 BIOLOGICAL AVAILABILITY, ADAM 1686 01:04:06,160 --> 01:04:07,600 MENTIONED THE IMPORTANCE OF 1687 01:04:07,600 --> 01:04:08,600 FORMULATION. 1688 01:04:08,600 --> 01:04:12,560 HERE'S AN EXAMPLE OF EGCG FROM 1689 01:04:12,560 --> 01:04:15,800 GREEN TEA, WITH COLLEAGUES, FROM 1690 01:04:15,800 --> 01:04:20,400 U.S. DEPARTMENT DEPARTMEN. 1691 01:04:20,400 --> 01:04:21,920 DR. KUSZAK IS A CO-AUTHOR ON IT. 1692 01:04:21,920 --> 01:04:23,560 THEY TOOK 11 DIFFERENT BATCHES 1693 01:04:23,560 --> 01:04:25,360 OF GREEN TEA CAPSULES AND THEY 1694 01:04:25,360 --> 01:04:27,960 TRIED TO SEE HOW WELL THOSE 1695 01:04:27,960 --> 01:04:31,800 DISSOLVED AND RELEASED THE ECGC, 1696 01:04:31,800 --> 01:04:33,600 WHICH IS OFTEN THOUGHT TO HAVE 1697 01:04:33,600 --> 01:04:39,320 BIOLOGICAL ACTIVITY THAT MAY BE 1698 01:04:39,320 --> 01:04:42,360 A FUNCTION OF ITS CHEMICAL 1699 01:04:42,360 --> 01:04:43,800 REACTIVITY AND ABILITY TO 1700 01:04:43,800 --> 01:04:47,080 INTERACT WITH CELL MEMBRANE, BUT 1701 01:04:47,080 --> 01:04:48,480 IT'S NOT GOING TO HAVE 1702 01:04:48,480 --> 01:04:49,680 BIOLOGICAL ACTIVITY IF IT 1703 01:04:49,680 --> 01:04:50,880 DOESN'T GET OUT OF THE CAPSULE 1704 01:04:50,880 --> 01:04:51,800 AND INTO THE CONSUMER. 1705 01:04:51,800 --> 01:04:53,320 THREE OF THESE BATCHES OF 1706 01:04:53,320 --> 01:04:55,800 CAPSULES, IN FACT, OVER TWO 1707 01:04:55,800 --> 01:04:59,080 HOURS AT 37 DEGREES NEVER DID 1708 01:04:59,080 --> 01:05:00,720 RELEASE MORE THAN ABOUT HALF OF 1709 01:05:00,720 --> 01:05:02,840 THE EGCG THAT WAS IN THEM. 1710 01:05:02,840 --> 01:05:04,480 SO IF YOU'RE THINKING ABOUT 1711 01:05:04,480 --> 01:05:06,440 CHEMICAL TRIALS, IF YOU'RE 1712 01:05:06,440 --> 01:05:07,760 LOOKING AT THE TRIAL THAT HAS 1713 01:05:07,760 --> 01:05:09,800 COME OUT NEGATIVE, YOU MAY WANT 1714 01:05:09,800 --> 01:05:13,200 TO THINK ABOUT WHETHER THE 1715 01:05:13,200 --> 01:05:14,560 CHEMISTRY THAT YOU NEED ACTUALLY 1716 01:05:14,560 --> 01:05:16,280 GOT OUT OF YOUR CAPSULE AS 1717 01:05:16,280 --> 01:05:16,880 FORMULATED. 1718 01:05:16,880 --> 01:05:19,680 VERY IMPORTANT. 1719 01:05:19,680 --> 01:05:21,240 AND THEN YOU DO WANT TO THINK 1720 01:05:21,240 --> 01:05:24,720 ABOUT HOW MUCH OF IT GETS TO 1721 01:05:24,720 --> 01:05:26,720 WHEREVER YOUR HIGH CONTENT ASSAY 1722 01:05:26,720 --> 01:05:29,680 SAYS IT NIEDZ NEEDS TO GO TOE 1723 01:05:29,680 --> 01:05:30,000 ACTIVE. 1724 01:05:30,000 --> 01:05:37,440 HERE WE'RE LOOKING AT CATACHIN 1725 01:05:37,440 --> 01:05:41,840 IN PARTICULAR, A GREAT 1726 01:05:41,840 --> 01:05:43,120 POLYPHENOL PRODUCT, IN 1727 01:05:43,120 --> 01:05:45,840 COLLABORATION WITH WHAT'S NOW A 1728 01:05:45,840 --> 01:05:48,960 CARBON CENTER AT MOUNT MOUNT. 1729 01:05:48,960 --> 01:05:52,800 THEY'RE LOOKING AT HOW MUCH OF 1730 01:05:52,800 --> 01:05:55,120 THE DIFFERENT PHENOLICS FROM THE 1731 01:05:55,120 --> 01:05:59,040 GREAT POLYPHENOL MIXTURE GETTINT 1732 01:05:59,040 --> 01:06:01,640 INTO THE PLASMA IN HUMANS, 1733 01:06:01,640 --> 01:06:03,280 LOOKING WITH PEOPLE AT EITHER 1734 01:06:03,280 --> 01:06:05,040 LOW OR HIGH BODY MASS INDICES. 1735 01:06:05,040 --> 01:06:07,160 YOU CAN SEE A LOT MORE GET IN TO 1736 01:06:07,160 --> 01:06:11,200 THE PLASMA OF PEOPLE WITH LOW 1737 01:06:11,200 --> 01:06:18,520 BMI, THE BEING TRIANGLE, BUTT 1738 01:06:18,520 --> 01:06:21,040 SEE IT AFTER ONE DAY, ONLY AFTER 1739 01:06:21,040 --> 01:06:21,360 11 DAYS. 1740 01:06:21,360 --> 01:06:22,800 SO THE IMPORTANT OF BACKGROUND 1741 01:06:22,800 --> 01:06:23,760 DIET AND HOW MUCH OF THESE 1742 01:06:23,760 --> 01:06:26,280 THINGS PEOPLE CAN ABSORB, AND 1743 01:06:26,280 --> 01:06:27,880 YOU CAN SEE HERE THAT IT VARIES 1744 01:06:27,880 --> 01:06:30,880 FOR DIFFERENT POLYPHENOLS, THE 1745 01:06:30,880 --> 01:06:33,520 CATACHIN I JUST SHOWED YOU GOT 1746 01:06:33,520 --> 01:06:38,160 FAIRLY SIMILAR RESULT FOR -- 1747 01:06:38,160 --> 01:06:39,360 CATACHIN AS YOU MIGHT EXPECT. 1748 01:06:39,360 --> 01:06:40,600 WE SEE SOME DIFFERENCES IN 1749 01:06:40,600 --> 01:06:42,360 TIMING PERHAPS. 1750 01:06:42,360 --> 01:06:44,440 AT LEAST AT 11 DAYS DOSING AS 1751 01:06:44,440 --> 01:06:48,080 WELL AS THE INCREASED 1752 01:06:48,080 --> 01:06:48,600 BIOAVAILABILITY. 1753 01:06:48,600 --> 01:06:50,720 SO THERE ARE IMPORTANT CHANGES, 1754 01:06:50,720 --> 01:06:52,960 IMPORTANT CONSUMER-RELATED 1755 01:06:52,960 --> 01:06:54,160 EFFECT ON BIOAVAILABILITY. 1756 01:06:54,160 --> 01:06:56,840 IT'S NOT JUST -- BUT HERE AS WE 1757 01:06:56,840 --> 01:06:58,680 START TO TALK ABOUT THE 1758 01:06:58,680 --> 01:07:04,680 INTERFACE WITH HUMANS, THEY CAN 1759 01:07:04,680 --> 01:07:06,280 BE VARIABLE DEPENDING ON THEIR 1760 01:07:06,280 --> 01:07:07,320 HISTORIES AS WELL AS, FOR 1761 01:07:07,320 --> 01:07:10,360 EXAMPLE, THEIR GUT MICROBIOTA. 1762 01:07:10,360 --> 01:07:12,960 SO MOUSE MODELS ARE GREAT, THEY 1763 01:07:12,960 --> 01:07:15,160 ALLOW YOU TO MAKE IMPORTANT 1764 01:07:15,160 --> 01:07:16,320 PREDICTIONS ABOUT WHAT'S GOING 1765 01:07:16,320 --> 01:07:17,920 ON BECAUSE THEY ARE SO 1766 01:07:17,920 --> 01:07:18,800 HOMOGENEOUS, AND IT'S REALLY 1767 01:07:18,800 --> 01:07:21,000 IMPORTANT TO REMEMBER MODELS ARE 1768 01:07:21,000 --> 01:07:24,240 USEFUL BUT THEY'RE ALWAYS -- YOU 1769 01:07:24,240 --> 01:07:25,640 NEED TO THINK ABOUT THE WAYS IN 1770 01:07:25,640 --> 01:07:27,320 WHICH YOUR MOUSE MODEL IS 1771 01:07:27,320 --> 01:07:33,480 DIFFERENT FROM HUMANS, PROBABLY 1772 01:07:33,480 --> 01:07:35,440 MOST UNDERSTANDING OF YOUR 1773 01:07:35,440 --> 01:07:37,520 PRODUCT ON, PRESUMABLY ARE GOING 1774 01:07:37,520 --> 01:07:38,880 TO ADJUST TEMPERATURE IN MOST 1775 01:07:38,880 --> 01:07:40,200 CASES TO MAKE THEM FEEL 1776 01:07:40,200 --> 01:07:40,800 COMFORTABLE. 1777 01:07:40,800 --> 01:07:42,440 THE MICE CAN'T DO THAT. 1778 01:07:42,440 --> 01:07:43,280 -- SUBJECT TO DIFFERENT KINDS 1779 01:07:43,280 --> 01:07:44,320 OF STRESSES. 1780 01:07:44,320 --> 01:07:46,000 THE MICE UNLIKE HUMANS THAT 1781 01:07:46,000 --> 01:07:48,280 REQUIRE VITAMIN C, THEY CAN MAKE 1782 01:07:48,280 --> 01:07:49,280 THEIR OWN. 1783 01:07:49,280 --> 01:07:50,600 THERE ARE DIFFERENCES IN THEIR 1784 01:07:50,600 --> 01:07:52,400 IMMUNE SYSTEMS, DIFFERENCES IN 1785 01:07:52,400 --> 01:07:54,720 THEIR GUT MICROBIOTA, ESPECIALLY 1786 01:07:54,720 --> 01:07:56,280 IF LIKE MOST MICE THAT YOU DO 1787 01:07:56,280 --> 01:08:01,520 RESEARCH IN, THERE ARE SPECIFIC 1788 01:08:01,520 --> 01:08:03,160 PATHOGEN-FREE MICE, VERY 1789 01:08:03,160 --> 01:08:04,920 DIFFERENT FROM THOSE OF WILD 1790 01:08:04,920 --> 01:08:06,280 TYPE MICE. 1791 01:08:06,280 --> 01:08:08,080 IN THAT PAPER I TOLD YOU ABOUT 1792 01:08:08,080 --> 01:08:10,520 EARLIER, THERE'S MORE ON THAT. 1793 01:08:10,520 --> 01:08:12,480 I KEEP TALKING ABOUT MICROBIOTA 1794 01:08:12,480 --> 01:08:15,440 SO JUST VERY QUICKLY, I KNOW I'M 1795 01:08:15,440 --> 01:08:18,040 RUNNING OUT OF TIME HERE, THIS 1796 01:08:18,040 --> 01:08:26,040 IS ANOTHER STUDY FROM THE EYE TN 1797 01:08:26,040 --> 01:08:27,040 SCHOOL OF MEDICINE IN SUPPORT OF 1798 01:08:27,040 --> 01:08:27,920 THEIR APPLICATION TO BECOME A 1799 01:08:27,920 --> 01:08:28,760 CENTER. 1800 01:08:28,760 --> 01:08:29,920 WHAT YOU'RE LOOKING AT HERE -- 1801 01:08:29,920 --> 01:08:31,920 AND THEY'RE INTERESTED IN THIS 1802 01:08:31,920 --> 01:08:33,920 GREAT PRODUCT TO IMPROVE 1803 01:08:33,920 --> 01:08:34,560 COGNITIVE FUNCTION IN THE 1804 01:08:34,560 --> 01:08:36,160 CONTEXT OF STRESS. 1805 01:08:36,160 --> 01:08:38,080 THIS IS AN EXPERIMENT IN MICE, 1806 01:08:38,080 --> 01:08:40,720 AND WHAT THEY'RE LOOKING AT IS 1807 01:08:40,720 --> 01:08:42,320 HOW MUCH TIME THE MOUSE SPENDS 1808 01:08:42,320 --> 01:08:43,760 IN DIFFERENT PARTS OF ITS CAGE 1809 01:08:43,760 --> 01:08:45,080 OR LOOKING DOWN ON ITS CAGE, 1810 01:08:45,080 --> 01:08:47,280 THERE'S A COMPARTMENT OVER HERE 1811 01:08:47,280 --> 01:08:53,200 THAT CAN CONTAIN A STRANGER 1812 01:08:53,200 --> 01:08:54,800 MOUSE, YOU CAN SEE IF THE MICE 1813 01:08:54,800 --> 01:08:56,240 HAVE NOT BEEN SUBJECT TO STRESS, 1814 01:08:56,240 --> 01:08:59,440 NO RSDS, NO SOCIAL STRESS, THEY 1815 01:08:59,440 --> 01:09:00,800 EXPLORE AROUND THAT COMPARTMENT 1816 01:09:00,800 --> 01:09:02,160 WHETHER THERE'S A MOUSE IN IT AS 1817 01:09:02,160 --> 01:09:04,240 SHOWN IN THE BOTTOM OR NOT, BUT 1818 01:09:04,240 --> 01:09:08,040 IF THEY'VE BEEN SUBJECT TO 1819 01:09:08,040 --> 01:09:11,440 STRESS, THE -- IF THERE'S NO 1820 01:09:11,440 --> 01:09:13,080 MOUSE IN IT, BUT IF THEY'VE HAD 1821 01:09:13,080 --> 01:09:14,280 BAD EXPERIENCES WITH STRANGER 1822 01:09:14,280 --> 01:09:16,600 MICE BEFORE, ONLY IF THEY'VE 1823 01:09:16,600 --> 01:09:22,800 TAKEN THIS POLLLY POLYPHENOL 1824 01:09:22,800 --> 01:09:24,320 SUPPLEMENT, IF THEY'VE BEEN FED 1825 01:09:24,320 --> 01:09:26,000 IT, DO THEY EXPLORE IF THERE'S A 1826 01:09:26,000 --> 01:09:26,560 NOVEL MOUSE THERE. 1827 01:09:26,560 --> 01:09:28,400 NOW WHAT HAPPENS IN THE CONTEXT 1828 01:09:28,400 --> 01:09:30,360 OF SLEEP DEPRIVATION STRESS AND 1829 01:09:30,360 --> 01:09:32,360 COGNITION WITH THIS SUPPLEMENT? 1830 01:09:32,360 --> 01:09:34,000 WHAT HAPPENS IS IF YOU -- AND 1831 01:09:34,000 --> 01:09:39,360 HERE WE'RE TESTING MEMORY OF THE 1832 01:09:39,360 --> 01:09:42,120 SHOCK, MICE FREEZE, IF YOU PUT 1833 01:09:42,120 --> 01:09:44,080 THEM BACK -- IF THEY'RE SLEEP 1834 01:09:44,080 --> 01:09:45,080 DEPRIVED, THEY SORT OF FORGET 1835 01:09:45,080 --> 01:09:46,040 WHAT HAPPENED THERE THE DAY 1836 01:09:46,040 --> 01:09:47,400 BEFORE, BUT THEY DON'T FORGET IF 1837 01:09:47,400 --> 01:09:50,520 YOU GIVE THEM THIS POLYPHENOL 1838 01:09:50,520 --> 01:09:51,040 SUPPLEMENT. 1839 01:09:51,040 --> 01:09:52,120 HOWEVER, MICE THAT HAVE BEEN 1840 01:09:52,120 --> 01:09:54,520 TREATED WITH ENOUGH ANTIBIOTIC 1841 01:09:54,520 --> 01:09:57,720 TO -- AT THEIR GUT MICROBIOTA 1842 01:09:57,720 --> 01:09:59,480 EVEN WITHOUT SLEEP DEPRIVATION 1843 01:09:59,480 --> 01:10:00,960 LIKE THE SLEEP DEPRIVED MICE 1844 01:10:00,960 --> 01:10:03,120 WITH NORMAL MICROBIOTA AND IN 1845 01:10:03,120 --> 01:10:06,800 THE CONTEXT OF SLEEP DEPRIVATION 1846 01:10:06,800 --> 01:10:11,280 AND KNOCKED OUT MICROBIOTA, THE 1847 01:10:11,280 --> 01:10:14,440 POLYPHENOLIC PREPARATIONS -- TO 1848 01:10:14,440 --> 01:10:15,320 BRING THEM BACK TO THE WILD 1849 01:10:15,320 --> 01:10:16,320 TYPE. 1850 01:10:16,320 --> 01:10:18,160 SO GUT MICROBIOTA IS SUPER 1851 01:10:18,160 --> 01:10:20,040 IMPORTANT, AND HUMANS MUCH MORE 1852 01:10:20,040 --> 01:10:20,880 VARIABLE THAN THEY'RE GOING TO 1853 01:10:20,880 --> 01:10:22,680 BE IN THE MICE. 1854 01:10:22,680 --> 01:10:27,920 SO I'VE TALKED ABOUT THE 1855 01:10:27,920 --> 01:10:28,960 IMPORTANCE OF THINKING ABOUT THE 1856 01:10:28,960 --> 01:10:30,560 CHEMISTRY OF THE PRODUCT, WHICH 1857 01:10:30,560 --> 01:10:33,520 CHEMICALS IN THE PRODUCT MAY ACT 1858 01:10:33,520 --> 01:10:35,880 ON WHICH SUBSTRATES AND THE 1859 01:10:35,880 --> 01:10:37,560 CONSUMER, AND I TALKED A LITTLE 1860 01:10:37,560 --> 01:10:41,800 BIT ABOUT VARIABILITY IN THE 1861 01:10:41,800 --> 01:10:42,160 CONSUMER. 1862 01:10:42,160 --> 01:10:44,240 ONE MORE THING I WANT TO TALK 1863 01:10:44,240 --> 01:10:46,600 ABOUT VERY BRIEFLY THAT'S 1864 01:10:46,600 --> 01:10:48,680 TYPICAL OF HUMANS BUT NOT OTHER 1865 01:10:48,680 --> 01:10:50,800 ANIMAL MODELS IS PLACEBO 1866 01:10:50,800 --> 01:10:51,960 RESPONSE. 1867 01:10:51,960 --> 01:10:52,600 SUPER IMPORTANT. 1868 01:10:52,600 --> 01:10:55,480 HERE LOOKING AT ST. JOHN'S WORT 1869 01:10:55,480 --> 01:10:57,920 AGAIN, COMPARING TO A POSITIVE 1870 01:10:57,920 --> 01:11:02,480 CONTROL ANTIDEPRESSANT IN A 1871 01:11:02,480 --> 01:11:03,440 DEPRESSION TRIAL FROM 20 YEARS 1872 01:11:03,440 --> 01:11:03,760 AGO. 1873 01:11:03,760 --> 01:11:06,280 JUST COMPARING ST. JOHN'S WORT 1874 01:11:06,280 --> 01:11:09,200 AND ANTIDEPRESSANT, LOOKS LIKE 1875 01:11:09,200 --> 01:11:10,640 IT'S JUST AS GOOD AS THE 1876 01:11:10,640 --> 01:11:12,400 POSITIVE CONTROL BUT BECAUSE THE 1877 01:11:12,400 --> 01:11:13,440 PLACEBO RESPONSE IN THIS TRIAL 1878 01:11:13,440 --> 01:11:17,160 WAS SO STRONG, THE TRIAL AS A 1879 01:11:17,160 --> 01:11:18,760 WHOLE WAS UNINFORMATIVE BECAUSE 1880 01:11:18,760 --> 01:11:20,520 NEITHER OF THE ANTIDEPRESSANT 1881 01:11:20,520 --> 01:11:22,360 NOR THE ST. JOHN'S WORT WERE AS 1882 01:11:22,360 --> 01:11:25,840 GOOD AS THE PLACEBO, ALLEVIATING 1883 01:11:25,840 --> 01:11:26,880 DEPRESSION IN THIS TRIAL. 1884 01:11:26,880 --> 01:11:32,320 SO I THINK TO CONTROL FOR AND 1885 01:11:32,320 --> 01:11:36,560 MINIMIZE THE INFORMATION 1886 01:11:36,560 --> 01:11:38,160 DEPLETING EFFECT OF PLACEBO 1887 01:11:38,160 --> 01:11:39,720 RESPONSE IN TRIALS, IT'S REALLY 1888 01:11:39,720 --> 01:11:41,120 IMPORTANT TO DO A NUMBER OF 1889 01:11:41,120 --> 01:11:41,360 THINGS. 1890 01:11:41,360 --> 01:11:46,320 THIS IS FROM A PAPER FROM 10 1891 01:11:46,320 --> 01:11:47,600 YEARS AGO LOOKING AT ECHINACEA 1892 01:11:47,600 --> 01:11:49,280 FOR THE COMMON COLD, AND WHAT 1893 01:11:49,280 --> 01:11:52,360 THEY FOUND, THEY DID A NO TELL 1894 01:11:52,360 --> 01:11:53,640 GROUP AND THEY FOUND THAT IN 1895 01:11:53,640 --> 01:11:55,280 PARTICIPANTS WHO GOT NO PILLS, 1896 01:11:55,280 --> 01:11:57,200 THEY ALL HAD LONGER AND MORE 1897 01:11:57,200 --> 01:11:58,680 SEVERE ILLNESSES THAN THOSE WHO 1898 01:11:58,680 --> 01:11:59,440 RECEIVED PILLS. 1899 01:11:59,440 --> 01:12:00,680 WHETHER THOSE PILLS WERE 1900 01:12:00,680 --> 01:12:05,320 ECHINACEA OR PLACEBO. 1901 01:12:05,320 --> 01:12:06,800 AND PEOPLE WHO AT BASELINE TOLD 1902 01:12:06,800 --> 01:12:08,600 THEM THEY EXPECTED THE ECHINACEA 1903 01:12:08,600 --> 01:12:10,600 WOULD HELP THEM HAVE SHORTER AND 1904 01:12:10,600 --> 01:12:15,120 LESS SEVERE COLDS REGARDLESS OF 1905 01:12:15,120 --> 01:12:16,920 WHETHER THEIR PILLS CONTAINED 1906 01:12:16,920 --> 01:12:18,000 ECHINACEA OR PLACEBO. 1907 01:12:18,000 --> 01:12:21,000 SO I THINK IT'S REALLY USEFUL IN 1908 01:12:21,000 --> 01:12:22,480 DOING CLINICAL TRIALS OF ANY 1909 01:12:22,480 --> 01:12:25,440 SORT TO ASK AT BASELINE WHAT 1910 01:12:25,440 --> 01:12:26,120 PARTICIPANTS' EXPECTATIONS ARE 1911 01:12:26,120 --> 01:12:27,440 AND THE OTHER THING THAT REALLY 1912 01:12:27,440 --> 01:12:28,960 HELPS IF YOU ASK AT THE END OF 1913 01:12:28,960 --> 01:12:30,240 THE TRIAL WHICH GROUP THEY THINK 1914 01:12:30,240 --> 01:12:32,880 THEY WERE ASSIGNED TO SO THEY 1915 01:12:32,880 --> 01:12:35,120 CAN TELL YOU WHETHER THEY -- SO 1916 01:12:35,120 --> 01:12:38,280 THAT YOU CAN FIND OUT WHETHER -- 1917 01:12:38,280 --> 01:12:39,720 BECAUSE IF YOUR BLINDING DIDN'T 1918 01:12:39,720 --> 01:12:41,760 WORK, YOUR TRIAL IS GOING TO BE 1919 01:12:41,760 --> 01:12:43,360 CONTAMINATED BY THEIR BASELINE 1920 01:12:43,360 --> 01:12:44,320 EXPECTATION. 1921 01:12:44,320 --> 01:12:46,600 REALLY NICE PAPER FROM HARVARD 1922 01:12:46,600 --> 01:12:47,880 MAGAZINE FROM 2013, IF YOU WANT 1923 01:12:47,880 --> 01:12:52,040 TO LEARN MORE ABOUT THE 1924 01:12:52,040 --> 01:12:53,280 FASCINATING COMPLEXITIES OF 1925 01:12:53,280 --> 01:12:55,200 PLACEBO EFFECT. 1926 01:12:55,200 --> 01:12:56,160 SO I'VE TOLD YOU SOME OF THE 1927 01:12:56,160 --> 01:12:59,040 THINGS THAT I THINK WE CAN DO TO 1928 01:12:59,040 --> 01:13:01,240 GET MORE REPLICABLE RESULTS 1929 01:13:01,240 --> 01:13:02,800 ADDED TO OUR CLINICAL TRIALS OF 1930 01:13:02,800 --> 01:13:06,680 NATURAL PRODUCTS TO MOVE FROM A 1931 01:13:06,680 --> 01:13:07,640 DIFFERENT RESULT EVERY TIME WE 1932 01:13:07,640 --> 01:13:09,400 DO A NEW TRIAL TO INFORMATION 1933 01:13:09,400 --> 01:13:10,800 THAT WE ACTUALLY FEEL 1934 01:13:10,800 --> 01:13:16,960 COMFORTABLE USING. 1935 01:13:16,960 --> 01:13:18,040 MORE THINGS HERE ABOUT THINGS TO 1936 01:13:18,040 --> 01:13:19,280 LOOK AT BEFORE YOU BELIEVE 1937 01:13:19,280 --> 01:13:20,160 WHAT'S IN THE LITERATURE AND USE 1938 01:13:20,160 --> 01:13:22,200 IT AND BUILD ON IT THAT I AM 1939 01:13:22,200 --> 01:13:23,600 RUNNING SHORT ON TIME, SO WITH 1940 01:13:23,600 --> 01:13:26,440 THAT PARTING WORD, I AM OPEN TO 1941 01:13:26,440 --> 01:13:32,400 YOUR QUESTIONS. 1942 01:13:32,400 --> 01:13:41,880 >> THANK YOU, DR. SOL SORKIN. 1943 01:13:41,880 --> 01:13:44,240 IS THERE ANYTHING IN PLACE FOR 1944 01:13:44,240 --> 01:13:46,760 NIH GRANTS USING DIETARY 1945 01:13:46,760 --> 01:13:48,040 SUPPLEMENTS THAT REALLY COVERS 1946 01:13:48,040 --> 01:13:49,920 ALL THE PRODUCT CHARACTERIZATION 1947 01:13:49,920 --> 01:13:52,200 ISSUES YOU BRING UP IN YOUR FINE 1948 01:13:52,200 --> 01:13:54,920 TALK? 1949 01:13:54,920 --> 01:13:56,600 >> THANKS FOR THAT GREAT 1950 01:13:56,600 --> 01:13:58,680 QUESTION, JOHANNA. 1951 01:13:58,680 --> 01:14:00,520 I'M NOT SURE WHAT YOU MEAN ABOUT 1952 01:14:00,520 --> 01:14:03,240 ALL OF THE CHARACTERIZATION 1953 01:14:03,240 --> 01:14:03,680 ISSUES. 1954 01:14:03,680 --> 01:14:06,360 I THINK ONE IS THE REASON THAT 1955 01:14:06,360 --> 01:14:08,880 WE FUND THAT THE OFFICE IN 1956 01:14:08,880 --> 01:14:11,680 COLLABORATION WITH NCCIH FUNDS 1957 01:14:11,680 --> 01:14:13,360 BOTANICAL RESEARCH CENTERS, IS 1958 01:14:13,360 --> 01:14:15,680 THAT THE CENTER FOR MATT ALLOWS 1959 01:14:15,680 --> 01:14:19,720 US TO BRING IN BOTH A RANGE OF 1960 01:14:19,720 --> 01:14:21,480 PEOPLE WITH DIFFERENT KINDS OF 1961 01:14:21,480 --> 01:14:23,640 PHYTOCHEMICAL EXPERTISE. 1962 01:14:23,640 --> 01:14:26,000 PEOPLE WITH COMPUTATIONAL 1963 01:14:26,000 --> 01:14:28,560 EXPERTISE, AS WELL AS PEOPLE 1964 01:14:28,560 --> 01:14:33,200 WITH CLINICAL EXPERTISE AND 1965 01:14:33,200 --> 01:14:35,640 EXPERTISE IN THE -- IN DIET, FOR 1966 01:14:35,640 --> 01:14:35,880 EXAMPLE. 1967 01:14:35,880 --> 01:14:37,720 SO IT ALLOWS US TO BRING 1968 01:14:37,720 --> 01:14:38,560 TOGETHER MANY DIFFERENT KINDS OF 1969 01:14:38,560 --> 01:14:40,560 EXPERTISE AND HAVE THEM WORKING 1970 01:14:40,560 --> 01:14:42,520 ON A DAY-TO-DAY BASIS BACK AND 1971 01:14:42,520 --> 01:14:43,960 FORTH SO THAT EACH EXPERTISE CAN 1972 01:14:43,960 --> 01:14:47,640 INFORM THE OTHER. 1973 01:14:47,640 --> 01:14:48,760 DOES THAT -- NOW THAT I HAVE 1974 01:14:48,760 --> 01:14:55,320 ACCESS TO THE CHAT AGAIN, OR DO 1975 01:14:55,320 --> 01:15:01,200 I -- THAT I'M NOT -- IN Q & A. 1976 01:15:01,200 --> 01:15:01,960 THAT DOESN'T ANSWER YOUR 1977 01:15:01,960 --> 01:15:03,040 QUESTION BUT CERTAINLY WE HAVE 1978 01:15:03,040 --> 01:15:04,600 THOSE -- AND WE ENCOURAGE OUR 1979 01:15:04,600 --> 01:15:06,200 CARBON CENTERS TO COLLABORATE 1980 01:15:06,200 --> 01:15:09,200 WITH EACH OTHER IF ONE CENTER 1981 01:15:09,200 --> 01:15:10,520 HAS EXPERTISE THAT ANOTHER COULD 1982 01:15:10,520 --> 01:15:10,800 USE. 1983 01:15:10,800 --> 01:15:12,480 WE DO TRY TO KEEP THEM TALKING 1984 01:15:12,480 --> 01:15:16,080 TO EACH OTHER AND AWARE OF EACH 1985 01:15:16,080 --> 01:15:17,160 OTHER'S CAPACITIES AND INTEREST 1986 01:15:17,160 --> 01:15:19,280 SO THAT THEY CAN COLLABORATE AND 1987 01:15:19,280 --> 01:15:21,600 I SHOWED YOU AT LEAST ONE PAPER 1988 01:15:21,600 --> 01:15:23,960 WHERE, IN FACT, ONE OF THOSE 1989 01:15:23,960 --> 01:15:25,040 COLLABORATIONS ARE SUCCESSFUL 1990 01:15:25,040 --> 01:15:26,880 AND PUBLISHED, AND WE'VE SEEN 1991 01:15:26,880 --> 01:15:31,640 THAT CAN REALLY ADD SYNERGY 1992 01:15:31,640 --> 01:15:32,920 WITHIN THE CARBON PROGRAM 1993 01:15:32,920 --> 01:15:34,920 ITSELF. 1994 01:15:34,920 --> 01:15:38,600 >> SO FROM JOHANNA, SH MEANS 1995 01:15:38,600 --> 01:15:42,400 EFFICACY AND ALSO EXPERTISE IN 1996 01:15:42,400 --> 01:15:43,280 PLACEBOS' EFFECTS, ET CETERA. 1997 01:15:43,280 --> 01:15:47,320 >> YES, YES, SO THAT'S WHAT THE 1998 01:15:47,320 --> 01:15:48,240 CENTER -- IT'S REALLY DIFFICULT 1999 01:15:48,240 --> 01:15:50,480 TO FUND ALL OF THAT IN A TYPICAL 2000 01:15:50,480 --> 01:15:51,320 NIH R01. 2001 01:15:51,320 --> 01:15:54,120 YOU CAN GET SOME GOOD PIECES OF 2002 01:15:54,120 --> 01:15:56,080 THAT, AND NCCIH, FOR EXAMPLE, 2003 01:15:56,080 --> 01:15:58,880 FUNDS SOME LOVELY WORK ON 2004 01:15:58,880 --> 01:16:00,120 CHEMICAL CHARACTERIZATION AS IT 2005 01:16:00,120 --> 01:16:01,240 RELATES TO BIOLOGY, BUT IT'S 2006 01:16:01,240 --> 01:16:03,440 REALLY HARD TO GET THE BREADTH 2007 01:16:03,440 --> 01:16:06,160 THAT YOU CAN GET WITH A CENTER 2008 01:16:06,160 --> 01:16:09,120 APPROACH WITHOUT THAT KIND OF 2009 01:16:09,120 --> 01:16:12,000 FUNDING THAT ALLOWS YOU TO BRING 2010 01:16:12,000 --> 01:16:16,240 IN THAT LARGE A TEAM UNDER 2011 01:16:16,240 --> 01:16:17,200 PRINCIPAL INVESTIGATORS WITH 2012 01:16:17,200 --> 01:16:18,200 DIFFERENT EXPERTISE. 2013 01:16:18,200 --> 01:16:20,720 AND OF COURSE THE CENTER FOR 2014 01:16:20,720 --> 01:16:26,440 MATT ALSO ALLOWS YOU TO GIVE THE 2015 01:16:26,440 --> 01:16:28,360 POSTDOCTORAL FELLOWS AND OTHER 2016 01:16:28,360 --> 01:16:30,640 STUDENTS FROM THE CENTERS THAT 2017 01:16:30,640 --> 01:16:31,600 TRANS DISCIPLINARY EXPERIENCE 2018 01:16:31,600 --> 01:16:32,840 AND LEARN HOW TO WORK THAT WAY. 2019 01:16:32,840 --> 01:16:34,520 BECAUSE SOMETIMES IT'S HARD TO 2020 01:16:34,520 --> 01:16:37,640 COMMUNICATE ACROSS DIFFERENT 2021 01:16:37,640 --> 01:16:37,920 EXPERTISE. 2022 01:16:37,920 --> 01:16:39,000 >> THANK YOU. 2023 01:16:39,000 --> 01:16:40,840 ANOTHER QUESTION. 2024 01:16:40,840 --> 01:16:42,960 RECENTLY, MANY PRODUCTS THAT ARE 2025 01:16:42,960 --> 01:16:46,040 NOT VERY BIOAVAILABLE ALONE HAVE 2026 01:16:46,040 --> 01:16:48,240 ADDED BLACK PEPPER EXTRACT TO 2027 01:16:48,240 --> 01:16:50,440 INCREASE BIOAVAILABILITY OF THE 2028 01:16:50,440 --> 01:16:51,600 PRINCIPAL AGENT. 2029 01:16:51,600 --> 01:16:52,720 HOW EFFICIENT IS THIS 2030 01:16:52,720 --> 01:16:53,040 COMBINATION? 2031 01:16:53,040 --> 01:16:54,160 DO YOU HAVE ANY COMMENTS ON 2032 01:16:54,160 --> 01:16:56,560 THIS? 2033 01:16:56,560 --> 01:16:58,040 >> LET ME REPEAT THE QUESTION TO 2034 01:16:58,040 --> 01:16:59,440 MAKE SURE I UNDERSTAND. 2035 01:16:59,440 --> 01:17:01,560 THE QUESTION IS ABOUT ADDING 2036 01:17:01,560 --> 01:17:03,360 CAPSAICIN OR PEPPER TO OTHER -- 2037 01:17:03,360 --> 01:17:06,320 >> BLACK PEPPER, BUT 2038 01:17:06,320 --> 01:17:07,720 SPECIFICALLY WITH CURCUMIN 2039 01:17:07,720 --> 01:17:08,960 BECAUSE IT'S USUALLY USED FOR 2040 01:17:08,960 --> 01:17:11,480 THAT. 2041 01:17:11,480 --> 01:17:14,960 >> I KNOW THAT IS A COMMON 2042 01:17:14,960 --> 01:17:17,440 PRACTICE, ALSO USING 2043 01:17:17,440 --> 01:17:19,520 NANOCURCUMIN, MAKING IT INTO 2044 01:17:19,520 --> 01:17:20,080 NANOPARTICLES. 2045 01:17:20,080 --> 01:17:25,680 AND I CAN'T SAY THAT I'VE REALLY 2046 01:17:25,680 --> 01:17:28,440 SEEN DATA ON HOW THAT AFFECTS 2047 01:17:28,440 --> 01:17:28,800 BIOAVAILABILITY. 2048 01:17:28,800 --> 01:17:30,240 THAT MIGHT BE AN INTERESTING 2049 01:17:30,240 --> 01:17:31,560 STUDY TO DO IF IT HASN'T BEEN 2050 01:17:31,560 --> 01:17:33,360 DONE, BUT I HAVE NOT SEARCHED 2051 01:17:33,360 --> 01:17:35,360 RECENTLY TO SEE WHETHER THERE 2052 01:17:35,360 --> 01:17:37,440 ARE DATA THAT, IN FACT, SHOW 2053 01:17:37,440 --> 01:17:39,120 INCREASED BIOAVAILABILITY. 2054 01:17:39,120 --> 01:17:41,520 CERTAINLY I, TOO, HAVE HEARD 2055 01:17:41,520 --> 01:17:43,600 THAT THE PEPPER INCREASES THE 2056 01:17:43,600 --> 01:17:44,520 BIOAVAILABILITY AND THAT THAT'S 2057 01:17:44,520 --> 01:17:49,600 WHY TRADITIONALLY YOU USE -- YOU 2058 01:17:49,600 --> 01:17:51,120 INCLUDE IT WHEN YOU'RE MAKING A 2059 01:17:51,120 --> 01:17:51,320 CURRY. 2060 01:17:51,320 --> 01:17:54,320 >> THANK YOU. 2061 01:17:54,320 --> 01:17:56,400 AS WE'VE LEARNED FROM COVID IN 2062 01:17:56,400 --> 01:17:58,280 CHINA AND COMBINATIONS OF 2063 01:17:58,280 --> 01:18:00,360 BOTANICALS IN TERMS OF HOW TO DO 2064 01:18:00,360 --> 01:18:01,760 CLINICAL STUDIES. 2065 01:18:01,760 --> 01:18:04,200 TRADITIONAL MEDICINE OFTEN USES 2066 01:18:04,200 --> 01:18:08,880 COMBINATIONS IN PATIENT 2067 01:18:08,880 --> 01:18:10,520 CENTER -- THE STUDY 2068 01:18:10,520 --> 01:18:10,960 APPROPRIATELY. 2069 01:18:10,960 --> 01:18:14,000 >> I THINK THAT THERE'S A GOOD 2070 01:18:14,000 --> 01:18:14,560 POINT THERE, THAT'S AN 2071 01:18:14,560 --> 01:18:16,640 INTERESTING QUESTION. 2072 01:18:16,640 --> 01:18:19,520 I DON'T SEE WHY YOU COULD NOT 2073 01:18:19,520 --> 01:18:21,640 TAKE TWO DIFFERENT EXTRACTS AND 2074 01:18:21,640 --> 01:18:23,560 CHARACTERIZE THEIR POTENTIAL 2075 01:18:23,560 --> 01:18:32,240 BIOLOGICAL ACTIVITY AS OUR HIFAN 2076 01:18:32,240 --> 01:18:33,200 CENTER IS DOING. 2077 01:18:33,200 --> 01:18:34,760 IT TESTS YOUR CHEMICAL 2078 01:18:34,760 --> 01:18:37,280 COMPLEXITY SOMEWHAT AND THEY ARE 2079 01:18:37,280 --> 01:18:38,400 JUST PIONEERING THIS METHOD, 2080 01:18:38,400 --> 01:18:41,320 THIS APPROACH, BUT CERTAINLY 2081 01:18:41,320 --> 01:18:44,960 THERE'S NO REASON WHY IT 2082 01:18:44,960 --> 01:18:47,480 COULDN'T BE EXTENDED TO MIXTURES 2083 01:18:47,480 --> 01:18:48,320 OF BOTANICALS. 2084 01:18:48,320 --> 01:18:50,400 WE ARE FINDING THAT EVEN WITHIN 2085 01:18:50,400 --> 01:18:52,360 A SINGLE BOTANICAL, THERE ARE 2086 01:18:52,360 --> 01:18:55,080 CHEMICAL CONSTITUENTS THAT HAVE 2087 01:18:55,080 --> 01:18:55,840 DIFFERENT ACTIVITIES OR APPEAR 2088 01:18:55,840 --> 01:18:59,400 TO HAVE DIFFERENT ACTIVITIES IN 2089 01:18:59,400 --> 01:19:06,920 ANIMAL MODELS AND IN VITRO. 2090 01:19:06,920 --> 01:19:08,640 AND MY TEMPTATION IS ALWAYS TO 2091 01:19:08,640 --> 01:19:11,760 BE REDUCTIONIST AND TO START 2092 01:19:11,760 --> 01:19:12,720 THERE BECAUSE YOU WANT TO SEE 2093 01:19:12,720 --> 01:19:14,160 WHETHER YOUR METHODS ACTUALLY 2094 01:19:14,160 --> 01:19:22,840 WORK AND ARE REP -- BUT ABSOLY 2095 01:19:22,840 --> 01:19:23,920 MULTIPLE BOTANICALS COULD GIVE 2096 01:19:23,920 --> 01:19:25,440 YOU MORE BIOLOGICAL ACTIVITIES 2097 01:19:25,440 --> 01:19:26,760 THAT COULD CONTRIBUTE TO AN 2098 01:19:26,760 --> 01:19:27,320 OUTCOME. 2099 01:19:27,320 --> 01:19:30,520 I DO THINK THAT WE ARE GOING TO 2100 01:19:30,520 --> 01:19:32,320 SEE OVER THE NEXT YEAR OR SO 2101 01:19:32,320 --> 01:19:35,120 WITH ALL THE FOCUS ON RESEARCH 2102 01:19:35,120 --> 01:19:37,760 ON BOTANICALS AND OTHER -- AND 2103 01:19:37,760 --> 01:19:43,880 DRUGS, AND THAT MAY BE USED TO 2104 01:19:43,880 --> 01:19:45,320 REDUCE ILLNESS FROM COVID, THAT 2105 01:19:45,320 --> 01:19:50,200 WE WILL SEE THINGS, MY GUESS IS 2106 01:19:50,200 --> 01:19:50,960 FROM BOTANICALS AS WELL AS FROM 2107 01:19:50,960 --> 01:19:52,520 MORE TRADITIONAL DRUG-BASED 2108 01:19:52,520 --> 01:19:53,600 APPROACHES. 2109 01:19:53,600 --> 01:19:54,760 >> THANK YOU. 2110 01:19:54,760 --> 01:19:57,160 SO I HAVE A QUESTION RELATED 2111 01:19:57,160 --> 01:19:59,360 WITH THE PLANTS FOR THEIR 2112 01:19:59,360 --> 01:20:00,120 TRADITIONAL USE THAT YOU 2113 01:20:00,120 --> 01:20:04,240 MENTIONED IN YOUR PRESENTATION 2114 01:20:04,240 --> 01:20:05,120 THAT COULD BE DIFFERENT FROM THE 2115 01:20:05,120 --> 01:20:06,480 PLANTS THAT ARE USED IN MODERN 2116 01:20:06,480 --> 01:20:06,960 TIMES. 2117 01:20:06,960 --> 01:20:08,680 SO IN SOME COUNTRIES AROUND THE 2118 01:20:08,680 --> 01:20:12,280 WORLD, SOME REGULATIONS DEPEND 2119 01:20:12,280 --> 01:20:13,600 ON THE LONG TERM USAGE OF 2120 01:20:13,600 --> 01:20:15,720 TRADITIONAL MEDICINE. 2121 01:20:15,720 --> 01:20:17,480 CAN WE -- COUNT ON THEIR LONG 2122 01:20:17,480 --> 01:20:19,280 TERM USAGE FOR THEIR SAFETY? 2123 01:20:19,280 --> 01:20:20,000 DO YOU HAVE ANY COMMENTS ON 2124 01:20:20,000 --> 01:20:22,520 THAT? 2125 01:20:22,520 --> 01:20:24,200 >> SO ARE THERE DIFFERENCES IN 2126 01:20:24,200 --> 01:20:27,840 SAFETY BETWEEN LONG TERM USAGE 2127 01:20:27,840 --> 01:20:28,800 AND ACHIEVEMENTS? 2128 01:20:28,800 --> 01:20:30,720 >> SO IF A PLANT EXTRACT HAS 2129 01:20:30,720 --> 01:20:34,160 BEEN USED FOR SEVERAL YEARS, 2130 01:20:34,160 --> 01:20:38,840 MORE THAN 15 YEARS, IT CAN BE 2131 01:20:38,840 --> 01:20:40,560 LIKE ACCEPTED AS SAFE IN SOME 2132 01:20:40,560 --> 01:20:42,920 COUNTRIES FOR THE REGULATIONS OF 2133 01:20:42,920 --> 01:20:43,520 THESE COMPOUNDS. 2134 01:20:43,520 --> 01:20:44,640 DO YOU HAVE ANY COMMENTS ON 2135 01:20:44,640 --> 01:20:49,320 THIS? 2136 01:20:49,320 --> 01:20:53,000 >> I AM --IO 2137 01:20:53,000 --> 01:20:54,800 INSTITUTES OF HEALTH DOES 2138 01:20:54,800 --> 01:20:56,200 RESEARCH ON MANY THINGS AND WE 2139 01:20:56,200 --> 01:20:57,560 HOPE IT IS USEFUL TO OUR 2140 01:20:57,560 --> 01:20:59,520 COLLEAGUES AT THE FOOD AND DRUG 2141 01:20:59,520 --> 01:21:00,320 ADMINISTRATION THAT ARE 2142 01:21:00,320 --> 01:21:01,520 RESPONSIBLE FOR THE REGULATIONS, 2143 01:21:01,520 --> 01:21:02,880 BUT I THINK I'M GOING TO STAY 2144 01:21:02,880 --> 01:21:04,760 WITHIN MY UNIT AND NOT COMMENT 2145 01:21:04,760 --> 01:21:05,320 ON REGULATION. 2146 01:21:05,320 --> 01:21:07,640 >> OKAY. 2147 01:21:07,640 --> 01:21:13,720 IS THERE ANY ONLINE RESOURCE 2148 01:21:13,720 --> 01:21:16,960 FOR -- AND HERBAL DIETARY -- 2149 01:21:16,960 --> 01:21:18,800 >> YES, THERE ARE A NUMBER OF 2150 01:21:18,800 --> 01:21:20,560 RESOURCES. 2151 01:21:20,560 --> 01:21:22,440 ONE THAT IMMEDIATELY COMES TO 2152 01:21:22,440 --> 01:21:26,480 MIND IS OUR COLLEAGUES AT NCCIH, 2153 01:21:26,480 --> 01:21:30,920 AND I THINK THIS WAS MENTIONED 2154 01:21:30,920 --> 01:21:33,760 YESTERDAY, THE CENTER ON 2155 01:21:33,760 --> 01:21:35,520 HERB-DRUG INTERACTIONS BASED AT 2156 01:21:35,520 --> 01:21:40,120 UNIVERSITY OF WASHINGTON. 2157 01:21:40,120 --> 01:21:41,560 UNDER DR. -- THE PRINCIPAL 2158 01:21:41,560 --> 01:21:46,720 INVESTIGATOR IS OR WAS DR. MARY 2159 01:21:46,720 --> 01:21:47,160 PAINE. 2160 01:21:47,160 --> 01:21:52,600 BUT THERE ARE ALSO -- THERE IS 2161 01:21:52,600 --> 01:21:53,640 DATABASES THAT HAVE SOME 2162 01:21:53,640 --> 01:21:55,440 INFORMATION ON HERB-DRUG 2163 01:21:55,440 --> 01:21:56,720 INTERACTION. 2164 01:21:56,720 --> 01:21:58,880 THE CENTER AT THE NCCIH FUNDED 2165 01:21:58,880 --> 01:22:01,880 OR DRUG INTERACTION CENTER IS 2166 01:22:01,880 --> 01:22:03,920 WORKING MUCH MORE SYSTEMATICALLY 2167 01:22:03,920 --> 01:22:05,240 AND CONDUCTING SOME CLINICAL 2168 01:22:05,240 --> 01:22:08,120 TRIALS TO ACTUAL LITTLE VERIFY 2169 01:22:08,120 --> 01:22:09,520 THESE INTERACTIONS. 2170 01:22:09,520 --> 01:22:11,560 MOST OF THE ONES YOU'LL FIND IN 2171 01:22:11,560 --> 01:22:13,840 THE ONLINE DATABASES ARE BASED 2172 01:22:13,840 --> 01:22:18,400 ON IN VITRO ASSAYS ON ADMISSION 2173 01:22:18,400 --> 01:22:20,720 OF CYTOCHROME P450, FOR EXAMPLE, 2174 01:22:20,720 --> 01:22:26,440 OR ON ANECDOTAL REPORTS OF 2175 01:22:26,440 --> 01:22:27,080 INTERACTIONS. 2176 01:22:27,080 --> 01:22:27,920 FOR OBVIOUS REASON, THERE'S NOT 2177 01:22:27,920 --> 01:22:29,560 BEEN A LOT OF RESEARCH LOOKING 2178 01:22:29,560 --> 01:22:30,920 FOR POTENTIAL ADVERSE 2179 01:22:30,920 --> 01:22:33,400 INTERACTIONS OF BOTANICALS AND 2180 01:22:33,400 --> 01:22:35,520 DRUGS IN HUMANS, BUT THEY TRYING 2181 01:22:35,520 --> 01:22:39,280 TO BE MORE SYSTEMATIC ABOUT 2182 01:22:39,280 --> 01:22:41,480 THAT. 2183 01:22:41,480 --> 01:22:42,680 THE UNIVERSITY OF 2184 01:22:42,680 --> 01:22:44,120 ILLINOIS-CHICAGO HAS TWO STUDIES 2185 01:22:44,120 --> 01:22:51,600 LOOKING FOR POTENTIAL FOR DRUG 2186 01:22:51,600 --> 01:22:52,320 INTERACTIONS. 2187 01:22:52,320 --> 01:22:58,600 I DON'T REMEMBER WHETHER THEY 2188 01:22:58,600 --> 01:23:00,520 REPORTED ON COHOSH. 2189 01:23:00,520 --> 01:23:01,360 >> THANK YOU SO MUCH. 2190 01:23:01,360 --> 01:23:03,040 I CAN'T SEE ANY MORE QUESTIONS 2191 01:23:03,040 --> 01:23:06,480 COMING UP, SO I WOULD LIKE TO 2192 01:23:06,480 --> 01:23:09,640 THANK ALL OUR SPEAKER, 2193 01:23:09,640 --> 01:23:11,720 DR. KUSZAK, DR. SORKIN AND 2194 01:23:11,720 --> 01:23:14,200 DR. BETZ FOR JOINING US FOR THE 2195 01:23:14,200 --> 01:23:14,440 SESSION. 2196 01:23:14,440 --> 01:23:18,200 THANK YOU, I'LL LEAVE TO 2197 01:23:18,200 --> 01:23:18,520 DR. GAHCHE. 2198 01:23:18,520 --> 01:23:19,680 >> THANK YOU. 2199 01:23:19,680 --> 01:23:20,000 OKAY. 2200 01:23:20,000 --> 01:23:21,520 THAT WAS GREAT. 2201 01:23:21,520 --> 01:23:22,560 WE'RE GOING TO TAKE A LITTLE 2202 01:23:22,560 --> 01:23:23,680 BREAK 2203 01:23:23,680 --> 01:23:26,280 THIS IS SESSION 5, DR. LAVERNE 2204 01:23:26,280 --> 01:23:26,880 BROWN WILL MODERATE. 2205 01:23:26,880 --> 01:23:30,440 DR. BROWN IS PROGRAM DIRECTOR AT 2206 01:23:30,440 --> 01:23:32,080 OFFICE OF DIETARY SUPPLEMENTS, 2207 01:23:32,080 --> 01:23:33,760 INTERESTED IN RESEARCH THAT 2208 01:23:33,760 --> 01:23:35,720 EXPLORES IMPACT OF DIETARY 2209 01:23:35,720 --> 01:23:38,080 SUPPLEMENT USE ON RESILIENCE AND 2210 01:23:38,080 --> 01:23:39,720 HEALTH IN DIVERSE POPULATIONS. 2211 01:23:39,720 --> 01:23:41,320 SHE WILL BE GIVING A 2212 01:23:41,320 --> 01:23:44,360 PRESENTATION LATER TODAY AT 2213 01:23:44,360 --> 01:23:45,800 3:15, RESILIENCE RESEARCH AT 2214 01:23:45,800 --> 01:23:45,960 NIH. 2215 01:23:45,960 --> 01:23:48,600 PLEASE STICK AROUND FOR THAT. 2216 01:23:48,600 --> 01:47:48,760 THANK YOU, DR. BROWN. 2217 01:47:48,760 --> 01:47:51,800 WE WILL INVITE DR. HOWARD SESSO 2218 01:47:51,800 --> 01:47:54,120 TO THE PODIUM, VIRTUAL PODIUM. 2219 01:47:54,120 --> 01:47:55,680 DR. SESSO IS ASSOCIATE 2220 01:47:55,680 --> 01:47:56,920 EPIDEMIOLOGIST AT DIVISION OF 2221 01:47:56,920 --> 01:47:57,440 PREVENTIVE MEDICINE AND AGING AT 2222 01:47:57,440 --> 01:47:59,600 BRIGHAM AND YOUNG WOMEN'S 2223 01:47:59,600 --> 01:48:00,960 HOSPITAL, ASSOCIATE PROFESSOR OF 2224 01:48:00,960 --> 01:48:03,000 MEDICINE AT HARVARD MEDICAL 2225 01:48:03,000 --> 01:48:04,800 SCHOOL, ASSOCIATE PROFESSOR IN 2226 01:48:04,800 --> 01:48:08,080 EPIDEMIOLOGY AT HARVARD T H CHAN 2227 01:48:08,080 --> 01:48:10,720 SCHOOL OF PUBLIC HEALTH, LEADS 2228 01:48:10,720 --> 01:48:12,720 DESIGN METHODOLOGY AND CONDUCT 2229 01:48:12,720 --> 01:48:17,520 OF RANDOMIZED CLINICAL TRIALS IN 2230 01:48:17,520 --> 01:48:19,760 EPIDEMIOLOGIC STUDIES FOCUSING 2231 01:48:19,760 --> 01:48:21,120 ON VITAMIN AND MINERAL 2232 01:48:21,120 --> 01:48:22,200 SUPPLEMENTS AND LIFESTYLE 2233 01:48:22,200 --> 01:48:24,640 FACTORS IN PREVENTION OF 2234 01:48:24,640 --> 01:48:25,720 CARDIOVASCULAR DISEASE, 2235 01:48:25,720 --> 01:48:27,760 HYPERTENSION, OBESITY, CANCER, 2236 01:48:27,760 --> 01:48:29,440 AND OTHER AGING-RELATED 2237 01:48:29,440 --> 01:48:30,240 OUTCOMES. 2238 01:48:30,240 --> 01:48:32,440 TODAY DR. SESSO'S PRESENTATION 2239 01:48:32,440 --> 01:48:34,000 IS EFFICACY AND EFFECTIVENESS, 2240 01:48:34,000 --> 01:48:36,400 LINES OF EVIDENCE IN SUPPLEMENT 2241 01:48:36,400 --> 01:48:36,680 RESEARCH. 2242 01:48:36,680 --> 01:48:42,520 TAKE IT AWAY, DR. SESSO. 2243 01:48:42,520 --> 01:48:45,120 2244 01:48:45,120 --> 01:48:46,280 >> NECESSARY PART OF THE 2245 01:48:46,280 --> 01:48:46,760 PROCESS. 2246 01:48:46,760 --> 01:48:48,320 CAN EVERYONE HEAR ME? 2247 01:48:48,320 --> 01:48:51,960 AND I'LL SWITCH TO FULL SCREEN 2248 01:48:51,960 --> 01:48:52,360 MODE. 2249 01:48:52,360 --> 01:48:54,720 >> COMING THROUGH CLEARLY. 2250 01:48:54,720 --> 01:48:55,520 >> GREAT. 2251 01:48:55,520 --> 01:48:56,480 SO APPRECIATE EVERYONE'S 2252 01:48:56,480 --> 01:48:57,400 FLEXIBILITY, WHETHER IN PERSON 2253 01:48:57,400 --> 01:48:59,800 OR VIRTUAL. 2254 01:48:59,800 --> 01:49:01,200 THESE THINGS HAPPEN. 2255 01:49:01,200 --> 01:49:02,000 NEVERTHELESS WHAT I'M HERE TO 2256 01:49:02,000 --> 01:49:04,560 SPEAK ABOUT FOR THE NEXT HALF 2257 01:49:04,560 --> 01:49:10,480 HOUR OR SO IS ISSUE OF EFFICACY 2258 01:49:10,480 --> 01:49:12,080 AND/OR EFFECTIVENESS ESPECIALLY 2259 01:49:12,080 --> 01:49:14,200 IN CONTEXT OF DIETARY SUPPLEMENT 2260 01:49:14,200 --> 01:49:14,760 RESEARCH. 2261 01:49:14,760 --> 01:49:17,280 WHERE I'M COMING FROM, BY 2262 01:49:17,280 --> 01:49:27,560 TRAINING BOTH AN 2263 01:49:28,240 --> 01:49:29,960 EPIDEMIOLOGIST AND TRIALIST. 2264 01:49:29,960 --> 01:49:34,560 WE COME IN FROM DIFFERENT ANGLES 2265 01:49:34,560 --> 01:49:36,240 RESEARCHING DIETARY SUPPLEMENTS, 2266 01:49:36,240 --> 01:49:39,600 BUT JUST AS A DISCLOSURE MY 2267 01:49:39,600 --> 01:49:40,760 INTEREST IN DIET HAS GONE FAR 2268 01:49:40,760 --> 01:49:42,880 BACK IN TIME, THIS IS FROM FOUR 2269 01:49:42,880 --> 01:49:43,800 DECADES AGO. 2270 01:49:43,800 --> 01:49:47,120 I REALIZED QUICKLY I WAS MUCH 2271 01:49:47,120 --> 01:49:49,000 LESS OF AN ARTIST, MORE 2272 01:49:49,000 --> 01:49:50,520 INTERESTED IN ROLES OF DIET AND 2273 01:49:50,520 --> 01:49:51,320 NUTRITION. 2274 01:49:51,320 --> 01:49:58,920 WHAT I LOVE ABOUT THIS PRACTICE. 2275 01:49:58,920 --> 01:49:59,680 WE'RE BRINGING EXPERTS FROM 2276 01:49:59,680 --> 01:50:02,520 DIFFERENT ANGLES IN THE 2277 01:50:02,520 --> 01:50:03,440 DISCUSSION, IMPORTANT HOW WE 2278 01:50:03,440 --> 01:50:05,600 APPROACH RESEARCH, THIS IS WHERE 2279 01:50:05,600 --> 01:50:12,160 THE ODS HAS BEEN A HUGE 2280 01:50:12,160 --> 01:50:13,840 SUPPORTER OF UNDERSTANDING THE 2281 01:50:13,840 --> 01:50:15,440 INTERDISCIPLINARY ASPECTS, NO 2282 01:50:15,440 --> 01:50:16,840 DIFFERENT THAN THE CONTEXT OF 2283 01:50:16,840 --> 01:50:18,880 CLINICAL TRIALS AND EFFICACY AND 2284 01:50:18,880 --> 01:50:22,520 EFFECTIVENESS, UNDERSTANDING 2285 01:50:22,520 --> 01:50:24,480 WHAT EACH REPRESENTS. 2286 01:50:24,480 --> 01:50:28,560 SO, FOR STARTERS, I JUST WANT TO 2287 01:50:28,560 --> 01:50:32,560 START WITH A BROAD CONCEPT. 2288 01:50:32,560 --> 01:50:37,880 IT'S WHAT I CONSIDER TO BE 2289 01:50:37,880 --> 01:50:38,800 TERMED DIETARY REDUCTIONISM THAT 2290 01:50:38,800 --> 01:50:39,520 TAKES PLACE IN THE UNITED STATES 2291 01:50:39,520 --> 01:50:41,320 AND AROUND THE WORLD. 2292 01:50:41,320 --> 01:50:43,360 TYPICALLY WHEN WE THINK OF 2293 01:50:43,360 --> 01:50:44,240 NUTRITION AND NUTRITIONAL 2294 01:50:44,240 --> 01:50:46,480 EPIDEMIOLOGY WE'VE IDENTIFIED 2295 01:50:46,480 --> 01:50:47,600 FOODS, DIETARY PATTERNS, 2296 01:50:47,600 --> 01:50:48,680 SPECIFIC NUTRIENTS, AND SOME OF 2297 01:50:48,680 --> 01:50:51,080 THESE AT LEAST IN THE 2298 01:50:51,080 --> 01:50:52,120 OBSERVATIONAL STUDIES THROUGH 2299 01:50:52,120 --> 01:50:54,280 EPIDEMIOLOGY HAVE BEEN SHOWN TO 2300 01:50:54,280 --> 01:50:55,720 FOLKSILY REDUCE MAJOR MORBIDITY 2301 01:50:55,720 --> 01:50:59,120 AND MORTALITY AND DIFFERENT 2302 01:50:59,120 --> 01:51:00,320 BIOMARKER CHANGES. 2303 01:51:00,320 --> 01:51:02,960 WE BELIEVE THESE BENEFITS ARE 2304 01:51:02,960 --> 01:51:07,920 DRIVEN BY SPECIFIC VITAMINS, 2305 01:51:07,920 --> 01:51:12,560 MINERALS, NUTRIENTS, BIOACTIVE 2306 01:51:12,560 --> 01:51:14,480 OR HERBAL COMPONENTS BUT DIETARY 2307 01:51:14,480 --> 01:51:15,000 SUPPLEMENTS, WHETHER A 2308 01:51:15,000 --> 01:51:19,800 PARTICULAR ONE CAN CAPTURE 2309 01:51:19,800 --> 01:51:21,040 BENEFITS IN FOODS TO 2310 01:51:21,040 --> 01:51:22,040 MEANINGFULLY IMPROVE HEALTH. 2311 01:51:22,040 --> 01:51:25,920 WHAT WE ALSO KNOW IS THAT THE 2312 01:51:25,920 --> 01:51:27,840 STUDIES COME OUT AND DIETARY 2313 01:51:27,840 --> 01:51:30,800 SUPPLEMENT USE OFTEN INCREASES 2314 01:51:30,800 --> 01:51:32,160 MARKEDLY BEFORE SOME DEFINITIVE 2315 01:51:32,160 --> 01:51:33,160 RANDOMIZED CLINICAL TRIAL IS 2316 01:51:33,160 --> 01:51:37,880 GOING TO GET PUBLISHED THAT 2317 01:51:37,880 --> 01:51:41,080 DEMONSTRATES TO SOME EXTENT 2318 01:51:41,080 --> 01:51:42,720 EITHER EFFICACY OR 2319 01:51:42,720 --> 01:51:43,320 EFFECTIVENESS. 2320 01:51:43,320 --> 01:51:45,760 I'M JUST USING A STRAWBERRY HAS 2321 01:51:45,760 --> 01:51:46,480 AN EXAMPLE. 2322 01:51:46,480 --> 01:51:48,000 A CHALLENGE IS WE LOOK AT A 2323 01:51:48,000 --> 01:51:50,040 STRAWBERRY, IS IT THE FOOD, IS 2324 01:51:50,040 --> 01:51:51,440 IT THE FOOD MATRIX, SOMEBODY 2325 01:51:51,440 --> 01:51:54,440 ABOUT THE STRAWBERRY THAT HAS 2326 01:51:54,440 --> 01:51:57,280 FIBER, VITAMIN C, OTHER 2327 01:51:57,280 --> 01:51:57,520 NUTRIENTS? 2328 01:51:57,520 --> 01:51:59,200 IS IT THE STRAWBERRY IN 2329 01:51:59,200 --> 01:52:00,560 COMBINATION WITH OTHER FOODS? 2330 01:52:00,560 --> 01:52:02,560 IS IT ABOUT DIETARY PATTERN? 2331 01:52:02,560 --> 01:52:07,560 OR IS IT A FUNCTION SIMPLY OF 2332 01:52:07,560 --> 01:52:08,040 NON-DIETARY FACTORS, 2333 01:52:08,040 --> 01:52:13,640 CONFOUNDING, USUALLY THE BANE OF 2334 01:52:13,640 --> 01:52:14,480 AN EPIDEMIOLOGIST'S EXISTENCE OR 2335 01:52:14,480 --> 01:52:17,680 ONE OR MORE NUTRIENT WHERE WE 2336 01:52:17,680 --> 01:52:19,040 THINK ABOUT SUPPLEMENTS ON THE 2337 01:52:19,040 --> 01:52:21,760 BASIS OF SPECIFIC NUTRIENTS OR 2338 01:52:21,760 --> 01:52:23,640 FOOD-BASED SUPPLEMENTS DEVELOPED 2339 01:52:23,640 --> 01:52:25,080 AS WELL. 2340 01:52:25,080 --> 01:52:26,600 WHEN WE'RE THINKING ABOUT 2341 01:52:26,600 --> 01:52:28,280 CONCEPTS OF EFFICACY OR 2342 01:52:28,280 --> 01:52:29,800 EFFECTIVENESS WHICH I'LL 2343 01:52:29,800 --> 01:52:31,560 INTRODUCE IN A MOMENT, IN THE 2344 01:52:31,560 --> 01:52:33,240 CONTEXT OF DIETARY SUPPLEMENTS 2345 01:52:33,240 --> 01:52:35,360 WE AT LEAST TRADITIONALLY THINK 2346 01:52:35,360 --> 01:52:37,480 OF THIS HIERARCHY OF DESIGN OF 2347 01:52:37,480 --> 01:52:39,520 STUDIES THAT PUT US IN THE 2348 01:52:39,520 --> 01:52:42,840 POSITION OF BEING MORE VALID. 2349 01:52:42,840 --> 01:52:44,760 NOW, THE MECHANISTIC STUDIES IN 2350 01:52:44,760 --> 01:52:45,760 FOOD SCIENCE ARE KEY FOUNDATION 2351 01:52:45,760 --> 01:52:47,280 UPON WHICH ALL THESE OTHER 2352 01:52:47,280 --> 01:52:48,280 STUDIES ARE DONE. 2353 01:52:48,280 --> 01:52:50,200 THAT TAKES NOTHING AWAY FROM THE 2354 01:52:50,200 --> 01:52:51,000 IMPORTANCE OF THOSE. 2355 01:52:51,000 --> 01:52:53,200 THOSE SHAPE THE WAIT WE APPROACH 2356 01:52:53,200 --> 01:52:54,840 THE OBSERVATIONAL STUDIES AND 2357 01:52:54,840 --> 01:52:55,520 CLINICAL TRIALS. 2358 01:52:55,520 --> 01:52:57,640 AT THE SAME TIME I WOULD SUBMIT 2359 01:52:57,640 --> 01:52:59,000 TO YOU JUST BECAUSE THE CLINICAL 2360 01:52:59,000 --> 01:53:00,640 TRIAL IS VERY LONG AND LARGE, 2361 01:53:00,640 --> 01:53:02,080 THAT DOESN'T -- IF IT'S DONE 2362 01:53:02,080 --> 01:53:03,920 POORLY THAT DOESN'T GIVE IT THAT 2363 01:53:03,920 --> 01:53:07,240 MUCH WEIGHT RELATIVE TO A COHORT 2364 01:53:07,240 --> 01:53:09,320 STUDY DONE QUITE WELL. 2365 01:53:09,320 --> 01:53:11,200 SO, IT'S NOT JUST THE STUDY 2366 01:53:11,200 --> 01:53:13,400 DESIGN BUT ALSO HOW WELL -- THE 2367 01:53:13,400 --> 01:53:18,200 QUALITY OF THE STUDY THAT 2368 01:53:18,200 --> 01:53:24,760 MATTERS TOO. 2369 01:53:24,760 --> 01:53:28,760 SO, WHEN WE THINK ABOUT THE 2370 01:53:28,760 --> 01:53:30,600 CONCEPTS OF EFFICACY VERSUS -- 2371 01:53:30,600 --> 01:53:32,880 OR EFFECTIVENESS, YOU HAVE TO 2372 01:53:32,880 --> 01:53:34,240 REMEMBER THAT CLINICAL TRIALS 2373 01:53:34,240 --> 01:53:35,440 ESPECIALLY WHEN -- SO THE DANGER 2374 01:53:35,440 --> 01:53:37,080 HERE IS WE THINK ABOUT CONTEXT 2375 01:53:37,080 --> 01:53:38,520 OF DIETARY SUPPLEMENTS WE MIGHT 2376 01:53:38,520 --> 01:53:41,080 VIEW IT ONE WAY, MORE BROADLY 2377 01:53:41,080 --> 01:53:44,440 WHEN WE THINK ABOUT 2378 01:53:44,440 --> 01:53:45,400 PHARMACOLOGIC INTERVENTIONS, 2379 01:53:45,400 --> 01:53:45,920 STATINS, ANTI-HYPERTENSIVE 2380 01:53:45,920 --> 01:53:47,400 MEDICATIONS AS THOSE ARE BEING 2381 01:53:47,400 --> 01:53:49,040 DEVELOPED WE'RE TRYING TO 2382 01:53:49,040 --> 01:53:50,800 DESCRIBE THE RESULTS OF A 2383 01:53:50,800 --> 01:53:52,920 CLINICAL TRIAL FOR THAT 2384 01:53:52,920 --> 01:53:55,400 INTERVENTION, WHAT WE DEEM IDEAL 2385 01:53:55,400 --> 01:53:58,760 OR REAL WORLD SITUATIONS, 2386 01:53:58,760 --> 01:53:59,000 EITHER/OR. 2387 01:53:59,000 --> 01:54:01,400 EFFICACY REFLECTS WHETHER OR NOT 2388 01:54:01,400 --> 01:54:02,960 A TREATMENT INCLUDING DIETARY 2389 01:54:02,960 --> 01:54:05,040 SUPPLEMENTS MIGHT WORK UNDER 2390 01:54:05,040 --> 01:54:05,840 IDEAL CIRCUMSTANCES. 2391 01:54:05,840 --> 01:54:10,360 AS YOU'LL SEE THIS HAS THE 2392 01:54:10,360 --> 01:54:19,680 HIGHEST DEGREE OF INTERNAL -- -- 2393 01:54:19,680 --> 01:54:20,600 INTERNAL VALIDITY, WORKING IN 2394 01:54:20,600 --> 01:54:21,640 IDEAL CIRCUMSTANCES BUT WHAT 2395 01:54:21,640 --> 01:54:23,320 ABOUT ACTUAL PRACTICE WHAT 2396 01:54:23,320 --> 01:54:25,120 HAPPENS? 2397 01:54:25,120 --> 01:54:30,080 WHAT AFFECTS ARE THINGS LIKE 2398 01:54:30,080 --> 01:54:31,840 COMPLIANCE, WHO ARE PATIENTS, 2399 01:54:31,840 --> 01:54:32,720 HOW PRACTICAL, SIDE EFFECTS, 2400 01:54:32,720 --> 01:54:33,840 WHAT ARE COSTS? WITH 2401 01:54:33,840 --> 01:54:36,120 EFFECTIVENESS YOU START TO GET 2402 01:54:36,120 --> 01:54:36,760 MORE OF A REAL WORLD 2403 01:54:36,760 --> 01:54:38,280 INTERPRETATION OF YOUR CLINICAL 2404 01:54:38,280 --> 01:54:39,440 TRIAL OR STUDY OF THE DIETARY 2405 01:54:39,440 --> 01:54:42,080 SUPPLEMENT, AND THAT HELPS TO 2406 01:54:42,080 --> 01:54:43,000 INCREASE YOUR GENERALIZABILITY 2407 01:54:43,000 --> 01:54:45,880 BUT COMES AT A COST OF THE 2408 01:54:45,880 --> 01:54:46,960 INTERNAL VALIDITY, AS YOU'LL 2409 01:54:46,960 --> 01:54:47,120 SEE. 2410 01:54:47,120 --> 01:54:49,200 LET'S LOOK AT THIS IN MORE 2411 01:54:49,200 --> 01:54:49,520 DETAIL. 2412 01:54:49,520 --> 01:54:52,080 SO, AGAIN, FOR THIS QUESTION OF 2413 01:54:52,080 --> 01:54:54,360 WHAT IS AN EFFICACY TRIAL, WHAT 2414 01:54:54,360 --> 01:54:55,160 IS EFFICACY, THIS ASKS THE 2415 01:54:55,160 --> 01:54:59,080 QUESTION WHETHER OR NOT A 2416 01:54:59,080 --> 01:55:00,960 TREATMENT, AKA DIETARY 2417 01:55:00,960 --> 01:55:01,640 SUPPLEMENT, WHATEVER YOU'RE 2418 01:55:01,640 --> 01:55:04,400 TESTING, CAN HELP UNDER IDEAL 2419 01:55:04,400 --> 01:55:05,200 CIRCUMSTANCES. 2420 01:55:05,200 --> 01:55:06,440 NOW, TRIALS, CLINICAL TRIALS 2421 01:55:06,440 --> 01:55:08,440 THAT ARE DEEMED OR TREATED AS 2422 01:55:08,440 --> 01:55:09,640 EFFICACY TRIALS, HAVE SPECIFIC 2423 01:55:09,640 --> 01:55:11,360 CHARACTERISTICS THAT ARE 2424 01:55:11,360 --> 01:55:13,240 IMPORTANT TO CONSIDER. 2425 01:55:13,240 --> 01:55:15,440 FIRST, THINK ABOUT IT, RIGHT? 2426 01:55:15,440 --> 01:55:17,760 I'VE BEEN RANDOMIZED INTO A 2427 01:55:17,760 --> 01:55:20,880 TRIAL, AND I'VE BEEN ASSIGNED TO 2428 01:55:20,880 --> 01:55:21,760 TAKE A DIETARY SUPPLEMENT, I'M 2429 01:55:21,760 --> 01:55:22,720 TOLD TOE TAKE IT. 2430 01:55:22,720 --> 01:55:25,320 I DON'T KNOW WHAT IT IS, MAYBE, 2431 01:55:25,320 --> 01:55:26,120 DEPENDING ON THE BLINDING. 2432 01:55:26,120 --> 01:55:27,520 I HAVE TO ACCEPT THAT 2433 01:55:27,520 --> 01:55:29,800 INTERVENTION IS OFFERED. 2434 01:55:29,800 --> 01:55:31,440 THAT'S HOW I'M TREATED. 2435 01:55:31,440 --> 01:55:33,040 I FOLLOW THE INSTRUCTIONS TO THE 2436 01:55:33,040 --> 01:55:33,560 TRIAL FAITHFULLY. 2437 01:55:33,560 --> 01:55:35,680 I HAVE TO HOPEFULLY GET THE BEST 2438 01:55:35,680 --> 01:55:36,560 POSSIBLE CARE AND HOPEFULLY NOT 2439 01:55:36,560 --> 01:55:37,800 HAVE TO CARE FOR ANY OTHER 2440 01:55:37,800 --> 01:55:39,600 CONDITIONS OR DISEASES OR SIDE 2441 01:55:39,600 --> 01:55:40,840 EFFECTS THAT MIGHT EMERGE. 2442 01:55:40,840 --> 01:55:42,280 AND MOST TRIALS ARE DESIGNED 2443 01:55:42,280 --> 01:55:43,160 THIS WAY, RIGHT? 2444 01:55:43,160 --> 01:55:47,480 SEWS, IF WE'RE GOING TO TEST THE 2445 01:55:47,480 --> 01:55:54,960 ROLE OF A LYCOPENE SUPPLEMENT ON 2446 01:55:54,960 --> 01:55:56,320 PSA LEVELS WE HOPE THEY TAKE AT 2447 01:55:56,320 --> 01:55:58,160 THIS TIME AS ASKED, AND THOSE 2448 01:55:58,160 --> 01:55:59,840 GIVEN PLACEBO WOULD TAKE IT AS 2449 01:55:59,840 --> 01:56:02,120 WE'VE ASKED THEM TO, THROUGHOUT 2450 01:56:02,120 --> 01:56:04,640 THE STUDY, SO WE CAN ANALYZE 2451 01:56:04,640 --> 01:56:06,160 DATA APPROPRIATELY FOR OUTCOME. 2452 01:56:06,160 --> 01:56:07,880 WHEN WE ANALYZED THESE DATA FOR 2453 01:56:07,880 --> 01:56:10,240 EFFICACY, IN A CLINICAL TRIAL, 2454 01:56:10,240 --> 01:56:12,280 THESE ARE CALLED INTENTION TO 2455 01:56:12,280 --> 01:56:13,880 TREAT ANALYSES. 2456 01:56:13,880 --> 01:56:15,400 AND THE BEAUTY OF A CLINICAL 2457 01:56:15,400 --> 01:56:16,360 TRIAL INHERENTLY, NO MATTER HOW 2458 01:56:16,360 --> 01:56:18,960 SMALL OR LARGE IT MIGHT BE, IS 2459 01:56:18,960 --> 01:56:20,720 THROUGH THE POWER OF 2460 01:56:20,720 --> 01:56:22,760 RANDOMIZATION, AND THROUGH AN 2461 01:56:22,760 --> 01:56:24,720 INTENTION TO TREAT ANALYSIS, 2462 01:56:24,720 --> 01:56:27,120 WHERE YOU'RE BASICALLY ASSUMING 2463 01:56:27,120 --> 01:56:29,200 ONCE RANDOMIZED ALWAYS ANALYZED. 2464 01:56:29,200 --> 01:56:30,080 IT ELIMINATES CONFOUNDING WHICH 2465 01:56:30,080 --> 01:56:35,480 AS I SAID BEFORE IS REALLY WHAT 2466 01:56:35,480 --> 01:56:37,720 DOGS OBSERVATIONAL STUDIES. 2467 01:56:37,720 --> 01:56:38,160 SO, THAT'S THE PERFECT 2468 01:56:38,160 --> 01:56:38,440 SITUATION. 2469 01:56:38,440 --> 01:56:40,200 ON THE OTHER HAND, WE HAVE THIS 2470 01:56:40,200 --> 01:56:42,800 ISSUE OF EFFECTIVENESS. 2471 01:56:42,800 --> 01:56:44,280 EFFECTIVENESS ALSO GIVES 2472 01:56:44,280 --> 01:56:44,600 INFORMATION. 2473 01:56:44,600 --> 01:56:46,320 THIS TELLS US WHETHER A DIETARY 2474 01:56:46,320 --> 01:56:48,000 SUPPLEMENT MIGHT HELP UNDER 2475 01:56:48,000 --> 01:56:51,640 ORDINARY OR REAL WORLD 2476 01:56:51,640 --> 01:56:52,080 CIRCUMSTANCES. 2477 01:56:52,080 --> 01:56:53,240 HERE, NOW WE'RE TRYING TO 2478 01:56:53,240 --> 01:56:55,200 INCORPORATE WHAT REALLY HAPPENS 2479 01:56:55,200 --> 01:56:56,720 IN PRACTICE. 2480 01:56:56,720 --> 01:56:57,680 IT'S THE USUAL ELEMENTS OF 2481 01:56:57,680 --> 01:56:59,960 PATIENT CARE OR WHAT HAPPENS 2482 01:56:59,960 --> 01:57:00,680 WHEN YOU ASK SOMEONE TO TAKE 2483 01:57:00,680 --> 01:57:02,320 SOMETHING IF YOU'RE SEEING THEM 2484 01:57:02,320 --> 01:57:04,920 IN THE DOCTOR'S OFFICE, OR IN 2485 01:57:04,920 --> 01:57:06,480 SOME OTHER SITUATION, AND WHAT 2486 01:57:06,480 --> 01:57:09,000 THEY ACTUALLY DO WHEN THEY 2487 01:57:09,000 --> 01:57:09,480 LEAVE. 2488 01:57:09,480 --> 01:57:12,040 SO, SUBJECTS MIGHT NOT TAKE WHAT 2489 01:57:12,040 --> 01:57:16,880 YOU'RE ASSIGNING THEM TO TAKE 2490 01:57:16,880 --> 01:57:18,200 BASED ON RANDOMIZATION, MIGHT 2491 01:57:18,200 --> 01:57:19,800 DROP OUT, MIGHT FIND WAYS TO 2492 01:57:19,800 --> 01:57:21,320 TAKE TREATMENT THEY WEREN'T 2493 01:57:21,320 --> 01:57:25,440 ASSIGNED, THINK THEY ARE TAKING 2494 01:57:25,440 --> 01:57:27,840 A PLACEBO AND WILL FIND A WAY TO 2495 01:57:27,840 --> 01:57:29,840 TAKE A VITAMIN OR HERBAL 2496 01:57:29,840 --> 01:57:31,640 SUPPLEMENT AND IT ACCOUNTS FOR 2497 01:57:31,640 --> 01:57:33,440 THE FACT ALL DOCTORS AND 2498 01:57:33,440 --> 01:57:34,520 FACILITIES AND TREATMENT 2499 01:57:34,520 --> 01:57:35,560 CENTERS, THERE'S VARIATION. 2500 01:57:35,560 --> 01:57:38,640 HOW DOCTORS TREAT PATIENTS WILL 2501 01:57:38,640 --> 01:57:40,360 VARY. 2502 01:57:40,360 --> 01:57:41,120 WHAT'S NICE ABOUT EFFECTIVENESS 2503 01:57:41,120 --> 01:57:42,480 TRIAL THIS DESCRIBES THE RESULT 2504 01:57:42,480 --> 01:57:48,000 MIDDLE -- MOST EXPERIENCE WOULD 2505 01:57:48,000 --> 01:57:48,720 EXPERIENCE THEM, COMPLIANCE 2506 01:57:48,720 --> 01:57:50,280 BASED MORE BROADLY FOR 2507 01:57:50,280 --> 01:57:51,040 EFFECTIVENESS TRIALS OR DEEMED 2508 01:57:51,040 --> 01:57:55,640 AS YOU'LL SEE IN A MOMENT PER 2509 01:57:55,640 --> 01:57:56,920 PROTOCOL OR AS-TREATED. 2510 01:57:56,920 --> 01:57:58,840 WHILE THIS DOES HELP TO ADDRESS 2511 01:57:58,840 --> 01:58:00,360 THE QUESTION OF WHAT A DIETARY 2512 01:58:00,360 --> 01:58:03,080 SUPPLEMENT MIGHT DO IN THE REAL 2513 01:58:03,080 --> 01:58:04,160 WORLD, IT DOES INTRODUCE 2514 01:58:04,160 --> 01:58:06,440 CONFOUNDING WHICH IS WHY WE 2515 01:58:06,440 --> 01:58:07,360 TYPICALLY DO RANDOMIZED TRIALS 2516 01:58:07,360 --> 01:58:08,520 IN THE FIRST PLACE. 2517 01:58:08,520 --> 01:58:09,760 SO YOU GAIN MORE CREDIBILITY AS 2518 01:58:09,760 --> 01:58:11,800 FAR AS HOW YOU CAN INTERPRET 2519 01:58:11,800 --> 01:58:13,920 THOSE DATA, DIRECTLY TO YOUR 2520 01:58:13,920 --> 01:58:15,880 INTERVENTION, BUT AT THE EXPENSE 2521 01:58:15,880 --> 01:58:18,760 OF POTENTIAL CONFOUNDING THAT'S 2522 01:58:18,760 --> 01:58:19,440 BEEN INTRODUCED. 2523 01:58:19,440 --> 01:58:22,160 JUST A LITTLE BIT MORE ON 2524 01:58:22,160 --> 01:58:22,800 APPROACHES TO ANALYZE CLINICAL 2525 01:58:22,800 --> 01:58:24,720 TRIALS TO DIETARY SUPPLEMENTS, 2526 01:58:24,720 --> 01:58:27,600 INTENTION TO TREAT ANALYSES 2527 01:58:27,600 --> 01:58:28,640 MEASURES EFFECT OF ASSIGNING 2528 01:58:28,640 --> 01:58:30,840 PARTICIPANTS TO A PARTICULAR 2529 01:58:30,840 --> 01:58:33,200 TREATMENT OTHER SUPPLEMENT, 2530 01:58:33,200 --> 01:58:34,520 INCLUDES ALL RANDOMIZED 2531 01:58:34,520 --> 01:58:37,360 PARTICIPANTS, INCORPORATION THE 2532 01:58:37,360 --> 01:58:39,440 FOLLOW-UP TIME THAT USUALLY 2533 01:58:39,440 --> 01:58:40,800 LEANS TO AN ENDPOINT, INCIDENT 2534 01:58:40,800 --> 01:58:41,640 OUTCOME, CHANGE IN BIOMARKER, 2535 01:58:41,640 --> 01:58:43,440 BUT THE IDEA IS TREATMENT 2536 01:58:43,440 --> 01:58:44,920 ASSIGNMENT NEVER CHANGES. 2537 01:58:44,920 --> 01:58:46,120 THAT'S THE KEY COMPONENT. 2538 01:58:46,120 --> 01:58:48,720 IF I'VE BEEN ASSIGNED TO 2539 01:58:48,720 --> 01:58:50,000 PLACEBO, I'M ALWAYS ANALYZED AS 2540 01:58:50,000 --> 01:58:52,440 IF I'M TAKING PLACEBO, EVEN IF I 2541 01:58:52,440 --> 01:58:52,640 DON'T. 2542 01:58:52,640 --> 01:58:56,520 ON THE OTHER HAND, 2543 01:58:56,520 --> 01:58:57,400 COMPLIANCE-BASED ANALYSIS 2544 01:58:57,400 --> 01:58:58,360 ESTIMATES EFFECTIVE RECEIVING A 2545 01:58:58,360 --> 01:58:59,760 TREATMENT, NOT WHAT I WAS 2546 01:58:59,760 --> 01:59:02,080 ASSIGNED THROUGH A FLIP OF A 2547 01:59:02,080 --> 01:59:03,120 COIN BUT WHETHER BASED ON WHAT I 2548 01:59:03,120 --> 01:59:05,240 RECEIVED AND WHAT I DID. 2549 01:59:05,240 --> 01:59:07,440 THERE'S TWO TYPES OF 2550 01:59:07,440 --> 01:59:08,960 COMPLIANCE-BASED ANALYSES. 2551 01:59:08,960 --> 01:59:11,040 ONE IS PER PROTOCOL ANALYSIS, 2552 01:59:11,040 --> 01:59:12,440 THIS MEANS THAT BASED ON THE 2553 01:59:12,440 --> 01:59:14,120 PROTOCOL YOU'VE WRITTEN UP FOR 2554 01:59:14,120 --> 01:59:15,880 YOUR STUDY, YOU'RE ONLY GOING TO 2555 01:59:15,880 --> 01:59:18,080 ANALYZE THE DATA FROM 2556 01:59:18,080 --> 01:59:20,080 PARTICIPANTS WHO FOLLOWED THAT 2557 01:59:20,080 --> 01:59:20,560 PROTOCOL. 2558 01:59:20,560 --> 01:59:24,960 EVERY CON STARTS -- EVERYONE 2559 01:59:24,960 --> 01:59:26,840 STARTS WITH WHAT YOU'RE 2560 01:59:26,840 --> 01:59:29,000 RANDOMIZED TOO BUT AS THEY 2561 01:59:29,000 --> 01:59:30,320 BECOME NON-COMPLIANT DURING THE 2562 01:59:30,320 --> 01:59:32,400 STUDY YOU EXCLUDE ANY DATA AFTER 2563 01:59:32,400 --> 01:59:34,160 THEY HAVE BECOME NON-COMPLIANT. 2564 01:59:34,160 --> 01:59:36,760 IF I'M TAKING A SUPPLEMENT, FOR 2565 01:59:36,760 --> 01:59:39,240 WHATEVER I STOP, MAYBE MY 2566 01:59:39,240 --> 01:59:40,360 STOMACH IS UPSET, REACTING IN 2567 01:59:40,360 --> 01:59:41,920 SOME WAY, THE DAY I STOP TAKING 2568 01:59:41,920 --> 01:59:44,080 THE PILLS IS THE DAY THAT I NO 2569 01:59:44,080 --> 01:59:47,720 LONGER CONTRIBUTE DATA IN A PER 2570 01:59:47,720 --> 01:59:49,240 PROTOCOL ANALYSIS. 2571 01:59:49,240 --> 01:59:50,960 SIMILARLY, IN AN AS-TREATED 2572 01:59:50,960 --> 01:59:53,360 ANALYSIS, ANOTHER TYPE OF 2573 01:59:53,360 --> 01:59:56,160 COMPLIANT BASED ANALYSIS THIS IS 2574 01:59:56,160 --> 01:59:56,480 MORE FLEXIBLE. 2575 01:59:56,480 --> 01:59:57,960 THIS ANALYZES DATA FOR 2576 01:59:57,960 --> 01:59:59,720 PARTICIPANTS BASED ON TREATMENTS 2577 01:59:59,720 --> 02:00:01,720 THEY TAKE WITHOUT REGARD TO 2578 02:00:01,720 --> 02:00:02,840 RANDOMIZED TREATMENT ASSIGNMENT. 2579 02:00:02,840 --> 02:00:04,600 IF YOU TAKE ME AS AN EXAMPLE 2580 02:00:04,600 --> 02:00:06,360 AGAIN I MIGHT INITIALLY BE 2581 02:00:06,360 --> 02:00:08,560 RANDOMIZED TO TAKE A PARTICULAR 2582 02:00:08,560 --> 02:00:10,040 DIETARY SUPPLEMENT, SO I AM 2583 02:00:10,040 --> 02:00:14,280 BEING ANALYZED AS IF I WAS -- TO 2584 02:00:14,280 --> 02:00:16,640 WHAT I WAS RANDOMIZED BUT IF YOU 2585 02:00:16,640 --> 02:00:18,320 STOP TAKING IT AND DECIDE TO 2586 02:00:18,320 --> 02:00:19,960 STAY OFF, IT'S LIKE A TIME 2587 02:00:19,960 --> 02:00:21,080 VARYING ANALYSIS, WHERE THE 2588 02:00:21,080 --> 02:00:22,960 MOMENT I STOP AND THEN I SWITCH 2589 02:00:22,960 --> 02:00:25,440 TO PLACEBO, NO TREATMENT AT ALL, 2590 02:00:25,440 --> 02:00:26,720 I'M STILL BEING FOLLOWED. 2591 02:00:26,720 --> 02:00:29,080 THE CHALLENGE AGAIN WITH THESE 2592 02:00:29,080 --> 02:00:30,880 COMPLIANCE BASED ANALYSES IT 2593 02:00:30,880 --> 02:00:32,840 INTRODUCES CONFOUNDING, THE 2594 02:00:32,840 --> 02:00:34,120 REASONS PEOPLE STOP TAKING 2595 02:00:34,120 --> 02:00:35,480 DIETARY SUPPLEMENT OR PLACEBO OR 2596 02:00:35,480 --> 02:00:37,400 WHATEVER YOU'RE TESTING COULD BE 2597 02:00:37,400 --> 02:00:38,600 RELATED TO PARTICULAR FACTORS 2598 02:00:38,600 --> 02:00:39,920 THAT WE DON'T NECESSARILY KNOW 2599 02:00:39,920 --> 02:00:42,440 OR CAN MEASURE VERY EASILY. 2600 02:00:42,440 --> 02:00:43,840 AND THE CHALLENGE THAT WE HAVE 2601 02:00:43,840 --> 02:00:45,840 IN CLINICAL TRIALS WHEN WE THINK 2602 02:00:45,840 --> 02:00:47,480 ABOUT EFFICACY AND EFFECTIVENESS 2603 02:00:47,480 --> 02:00:50,320 IS TO UNDERSTAND WHICH ONE IS 2604 02:00:50,320 --> 02:00:51,640 RIGHT, HOW DO YOU DECIDE, AND 2605 02:00:51,640 --> 02:00:54,120 WE'LL DIVE INTO THAT WITH 2606 02:00:54,120 --> 02:00:56,000 EXAMPLES TOWARD THE END. 2607 02:00:56,000 --> 02:00:59,880 SO, THIS DIFFERENCE WE SEE 2608 02:00:59,880 --> 02:01:01,320 BETWEEN EFFICACY AND 2609 02:01:01,320 --> 02:01:01,840 EFFECTIVENESS IS THE 2610 02:01:01,840 --> 02:01:04,000 IMPLEMENTATION GAP. 2611 02:01:04,000 --> 02:01:05,880 IT'S A GAP BETWEEN IDEAL CARE 2612 02:01:05,880 --> 02:01:07,080 AND ACTUAL TYPICAL CARE YOU 2613 02:01:07,080 --> 02:01:08,720 MIGHT HAVE FOR A PATIENT. 2614 02:01:08,720 --> 02:01:10,400 AND IT'S IMPORTANT TO CONSIDER 2615 02:01:10,400 --> 02:01:13,200 THIS GAP FOR NOT JUST DIETARY 2616 02:01:13,200 --> 02:01:14,400 SUPPLEMENTS BUT COMPARING 2617 02:01:14,400 --> 02:01:15,320 AGAINST DIFFERENT INTERVENTIONS. 2618 02:01:15,320 --> 02:01:17,920 HOW WE MIGHT INTERPRET IT IN 2619 02:01:17,920 --> 02:01:20,520 NUTRITION AND FOOD AND DIETARY 2620 02:01:20,520 --> 02:01:22,760 SUPPLEMENTS MIGHT DIFFER VERSUS 2621 02:01:22,760 --> 02:01:23,600 SOME NOVEL NEW DRUG. 2622 02:01:23,600 --> 02:01:28,200 BUT IT'S IMPORTANT TO NOTE THAT 2623 02:01:28,200 --> 02:01:28,920 EFFICACY TRIALS TYPICALLY 2624 02:01:28,920 --> 02:01:30,880 PRECEDE EFFECTIVENESS TRIALS. 2625 02:01:30,880 --> 02:01:33,320 IF A SUPPLEMENT UNDER BEST 2626 02:01:33,320 --> 02:01:35,440 CIRCUMSTANCES, MOST CONTROL 2627 02:01:35,440 --> 02:01:37,360 DOESN'T IMPACT YOUR OUTCOME, 2628 02:01:37,360 --> 02:01:37,960 EFFECTIVENESS MIGHT BE UNLIKELY 2629 02:01:37,960 --> 02:01:38,960 UNDER ORDINARY CIRCUMSTANCES. 2630 02:01:38,960 --> 02:01:40,360 IF HE EFFECTIVENESS TRIAL WERE 2631 02:01:40,360 --> 02:01:42,800 DONE FIRST AND SHOWED NO EFFECT 2632 02:01:42,800 --> 02:01:44,560 THAT RESULT MIGHT HAVE BEEN 2633 02:01:44,560 --> 02:01:45,400 BECAUSE SUPPLEMENT MIGHT HAVE 2634 02:01:45,400 --> 02:01:47,920 NOT WORKED OR WAS EFFECTIVE BUT 2635 02:01:47,920 --> 02:01:49,440 THERE WERE LIMITATIONS THAT 2636 02:01:49,440 --> 02:01:50,200 MIGHT HAVE MITIGATED EFFECTS IN 2637 02:01:50,200 --> 02:01:51,040 THE FIRST PLACE. 2638 02:01:51,040 --> 02:01:54,040 IT'S A TRICKY BALANCE BETWEEN 2639 02:01:54,040 --> 02:01:54,800 THE TWO. 2640 02:01:54,800 --> 02:01:55,480 WHAT NICE ABOUT DIETARY 2641 02:01:55,480 --> 02:01:58,080 SUPPLEMENTS THEY ARE NICELY 2642 02:01:58,080 --> 02:01:59,440 SUITED TO EVALUATE EFFICACY. 2643 02:01:59,440 --> 02:02:01,680 TYPICALLY, NOT ALL THE TIME, YOU 2644 02:02:01,680 --> 02:02:03,680 CAN USE PLACEBO CONTROL. 2645 02:02:03,680 --> 02:02:04,760 YOU HAVE A SIMPLE INTERVENTION 2646 02:02:04,760 --> 02:02:05,360 FOR DIETARY SUPPLEMENT. 2647 02:02:05,360 --> 02:02:07,720 AS YOU CAN IMAGINE IF IT'S A 2648 02:02:07,720 --> 02:02:10,680 DIETARY PATTERN, LOW FAT DIET 2649 02:02:10,680 --> 02:02:12,600 OTHER MEDITERRANEAN DIET, IT'S 2650 02:02:12,600 --> 02:02:15,160 MUCH HARDER TO REALLY TEASE OUT 2651 02:02:15,160 --> 02:02:16,200 AND HAVE CLEAR DISTINCTIONS 2652 02:02:16,200 --> 02:02:18,560 BETWEEN YOUR INTERVENTION GROUP 2653 02:02:18,560 --> 02:02:20,160 AND PLACEBO GROUP. 2654 02:02:20,160 --> 02:02:22,320 WHAT'S NICE ABOUT DIETARY 2655 02:02:22,320 --> 02:02:24,120 SUPPLEMENTS THESE ISSUES OF 2656 02:02:24,120 --> 02:02:25,880 EFFICACY CAN BE APPLIED TO LARGE 2657 02:02:25,880 --> 02:02:27,640 AND SMALL SCALE CLINICAL TRIALS 2658 02:02:27,640 --> 02:02:29,080 BUT IT'S DIFFICULT TO ACHIEVE 2659 02:02:29,080 --> 02:02:29,960 IDEAL EFFICACY. 2660 02:02:29,960 --> 02:02:32,640 ESPECIALLY WHEN THE TRIALS ARE 2661 02:02:32,640 --> 02:02:35,320 LONGER, LARGER, MORE 2662 02:02:35,320 --> 02:02:37,880 COMPLICATED, SIDE EFFECTS. 2663 02:02:37,880 --> 02:02:40,160 WE CAN'T EXPECT EVERY 2664 02:02:40,160 --> 02:02:43,120 INTERVENTION TO HAVE 100% 2665 02:02:43,120 --> 02:02:44,600 COMPLIANCE OR FOR LONGER TRIALS 2666 02:02:44,600 --> 02:02:46,760 CAN'T EXPECT FOLLOW-UP TO BE 2667 02:02:46,760 --> 02:02:47,760 100% EITHER. 2668 02:02:47,760 --> 02:02:51,760 THERE'S A SLIPPERY SLOPE BETWEEN 2669 02:02:51,760 --> 02:02:53,640 EFFICACY AND EFFECTIVENESS, THIS 2670 02:02:53,640 --> 02:02:54,640 IMPLEMENTATION GAP. 2671 02:02:54,640 --> 02:02:57,840 THE OTHER FACTOR IS IMPACT OF 2672 02:02:57,840 --> 02:02:58,440 GENERALIZABILITY. 2673 02:02:58,440 --> 02:03:00,960 THIS IS AN EXAMPLE FROM A TRIAL 2674 02:03:00,960 --> 02:03:04,840 I HELPED OVERSEE OVER WHO 2675 02:03:04,840 --> 02:03:05,840 DECADES, PHYSICIAN HEALTH STUDY, 2676 02:03:05,840 --> 02:03:06,480 UNDERSTANDING IT'S NOT JUST WHO 2677 02:03:06,480 --> 02:03:08,560 IS IN THE TRIAL FOR LOOKING AT 2678 02:03:08,560 --> 02:03:10,440 THE ISSUES OF EFFICACY AND 2679 02:03:10,440 --> 02:03:11,640 EFFECTIVENESS, BUT YOU CAN'T 2680 02:03:11,640 --> 02:03:13,720 FORGET THE ISSUE OF 2681 02:03:13,720 --> 02:03:15,400 GENERALIZABILITY FOR WHO ENROLLS 2682 02:03:15,400 --> 02:03:19,760 INTO A TRIAL. 2683 02:03:19,760 --> 02:03:21,160 THIS EXAMPLE, THIS RANDOMIZED 2684 02:03:21,160 --> 02:03:22,160 22,000 MALE PHYSICIANS. 2685 02:03:22,160 --> 02:03:24,000 WE STARTED WITH HALF A MILLION 2686 02:03:24,000 --> 02:03:25,840 QUESTIONNAIRES THAT WENT OUT TO 2687 02:03:25,840 --> 02:03:27,000 RESPONDENTS, SOME RESPOND, SOME 2688 02:03:27,000 --> 02:03:27,560 DON'T. 2689 02:03:27,560 --> 02:03:29,960 SOME PEOPLE ARE WILLING TO 2690 02:03:29,960 --> 02:03:31,960 ENROLL, SOME PEOPLE DON'T. 2691 02:03:31,960 --> 02:03:33,520 ULTIMATELY PEOPLE ARE ELIGIBLE 2692 02:03:33,520 --> 02:03:35,960 OR INELIGIBLE. 2693 02:03:35,960 --> 02:03:37,360 WE ULTIMATELY RANDOMIZED PEOPLE. 2694 02:03:37,360 --> 02:03:39,240 THIS IS TYPICAL FOR ANY STUDY, 2695 02:03:39,240 --> 02:03:41,720 LARGE OR SMALL. 2696 02:03:41,720 --> 02:03:44,280 BUT EVEN FOR SOMETHING AS SIMPLE 2697 02:03:44,280 --> 02:03:46,040 AND SUBTLE AS WHAT DIFFERENCES 2698 02:03:46,040 --> 02:03:50,960 ARE, I LIKE TO JOKE WITH 2699 02:03:50,960 --> 02:03:52,120 COLLEAGUES AND PARTICIPANTS, 2700 02:03:52,120 --> 02:03:54,520 GENTLY, THAT JUST BEING WILLING 2701 02:03:54,520 --> 02:03:56,200 TO RESPOND TO AN INVITATION TO 2702 02:03:56,200 --> 02:03:58,440 BE IN A TRIAL, BEING WILLING, AS 2703 02:03:58,440 --> 02:03:59,920 YOU SEE, THESE BARS GET LOWER 2704 02:03:59,920 --> 02:04:02,080 AND LOWER, AND THAT REFLECTS THE 2705 02:04:02,080 --> 02:04:04,040 FACT THE MORTALITY RATES FOR 2706 02:04:04,040 --> 02:04:06,440 THOSE WHO ARE ULTIMATELY 2707 02:04:06,440 --> 02:04:08,200 RANDOMIZED INTO A TRIAL ARE 2708 02:04:08,200 --> 02:04:09,480 BETTER, A LOT BETTER, MUCH LOWER 2709 02:04:09,480 --> 02:04:11,280 HERE THAN YOU SEE FOR TOTAL 2710 02:04:11,280 --> 02:04:12,160 CARDIOVASCULAR AND CANCER 2711 02:04:12,160 --> 02:04:13,240 MORTALITY, VERSUS THOSE WHO 2712 02:04:13,240 --> 02:04:16,120 NEVER RESPONDED IN THE FIRST 2713 02:04:16,120 --> 02:04:16,480 PLACE. 2714 02:04:16,480 --> 02:04:18,040 SO, WHILE EFFICACY AND 2715 02:04:18,040 --> 02:04:19,080 EFFECTIVENESS ARE EXTREMELY 2716 02:04:19,080 --> 02:04:22,200 IMPORTANT, DON'T DISCOUNT THE 2717 02:04:22,200 --> 02:04:23,560 ROLE OF GENERALIZABILITY AND WHO 2718 02:04:23,560 --> 02:04:25,560 YOU RECRUIT INTO A STUDY, LARGE 2719 02:04:25,560 --> 02:04:27,840 OR SMALL. 2720 02:04:27,840 --> 02:04:29,240 I'M GOING TO PIVOT. 2721 02:04:29,240 --> 02:04:30,920 ONE THING THAT'S WORTH NOTING IS 2722 02:04:30,920 --> 02:04:34,160 WHEN WE LOOK AT THE U.S. 2723 02:04:34,160 --> 02:04:35,920 PREVENTIVE SERVICES TASK FORCE 2724 02:04:35,920 --> 02:04:39,680 AND GUIDELINES THEY SET FORTH 2725 02:04:39,680 --> 02:04:42,360 NOW ABOUT 8 YEARS AGO ON 2726 02:04:42,360 --> 02:04:44,080 SUPPLEMENT USE FOR PREVENTING AT 2727 02:04:44,080 --> 02:04:46,760 LEAST CARDIOVASCULAR DISEASE AND 2728 02:04:46,760 --> 02:04:47,480 CANCER, LARGELY EQUIVOCAL 2729 02:04:47,480 --> 02:04:49,480 STATEMENTS THAT CAME OUT OF 2730 02:04:49,480 --> 02:04:50,200 THIS. 2731 02:04:50,200 --> 02:04:51,480 THERE ARE UPDATED GUIDELINES 2732 02:04:51,480 --> 02:04:54,440 FORTHCOMING LATER THIS YEAR I 2733 02:04:54,440 --> 02:04:58,480 BELIEVE, BUT IT DOES RACE THE 2734 02:04:58,480 --> 02:04:59,160 QUESTION OF OVERRELIANCE ON 2735 02:04:59,160 --> 02:05:01,280 CLINICAL TRIALS 2736 02:05:01,280 --> 02:05:01,960 WHAT ABOUT OBSERVATIONAL 2737 02:05:01,960 --> 02:05:04,280 STUDIES? YOU CAN HAVE A LOUSY 2738 02:05:04,280 --> 02:05:06,360 POORLY DESIGNED CLINICAL TRIAL 2739 02:05:06,360 --> 02:05:07,120 VERSUS A WELL-DESIGNED 2740 02:05:07,120 --> 02:05:08,960 OBSERVATIONAL STUDY. 2741 02:05:08,960 --> 02:05:12,040 SO WHY CAN'T A WELL-CONDUCTED 2742 02:05:12,040 --> 02:05:13,440 OBSERVATIONAL STUDY POTENTIALLY 2743 02:05:13,440 --> 02:05:15,200 DEMONSTRATE EFFICACY? 2744 02:05:15,200 --> 02:05:17,840 JUST BECAUSE A COHORT STUDY IS 2745 02:05:17,840 --> 02:05:19,640 LARGER, THAT DOESN'T NECESSARILY 2746 02:05:19,640 --> 02:05:20,400 CONSTITUTED EFFECTIVENESS 2747 02:05:20,400 --> 02:05:22,520 BECAUSE OF THE ISSUE OF 2748 02:05:22,520 --> 02:05:23,000 CONFOUNDING. 2749 02:05:23,000 --> 02:05:27,040 CONFOUNDING GETS IN THE WAY OF 2750 02:05:27,040 --> 02:05:28,560 DETERMINING WHETHER THERE'S 2751 02:05:28,560 --> 02:05:32,240 TRULY A SUPPLEMENT MIGHT BE 2752 02:05:32,240 --> 02:05:32,560 EFFICACIOUS. 2753 02:05:32,560 --> 02:05:35,880 WE KNOW FROM LOTS OF STUDIES, 2754 02:05:35,880 --> 02:05:38,080 YOU HEARD ABOUT THIS IN THE 2755 02:05:38,080 --> 02:05:38,920 PRESENTATIONS, THAT THOSE TAKING 2756 02:05:38,920 --> 02:05:40,680 DIETARY SUPPLEMENTS DO TEND TO 2757 02:05:40,680 --> 02:05:43,720 BE ON AVERAGE OLDER, TEND TO BE 2758 02:05:43,720 --> 02:05:45,200 WOMEN, TEND TO HAVE MEANS TO 2759 02:05:45,200 --> 02:05:45,800 PURCHASE DIETARY SUPPLEMENTS. 2760 02:05:45,800 --> 02:05:48,680 AND THEY HAVE A HEALTHIER DIET, 2761 02:05:48,680 --> 02:05:50,360 EXERCISE MORE, CONVERSELY TEND 2762 02:05:50,360 --> 02:05:51,880 TO BE DIAGNOSED WITH CHRONIC 2763 02:05:51,880 --> 02:05:52,280 CONDITIONS. 2764 02:05:52,280 --> 02:05:54,840 A LOT OF TIMES PEOPLE SAY I WAS 2765 02:05:54,840 --> 02:05:56,680 TOLD I HAVE HIGH BLOOD PRESSURE 2766 02:05:56,680 --> 02:05:57,840 AND I WANTED TO THINK ABOUT WHAT 2767 02:05:57,840 --> 02:05:59,720 I SHOULD TAKE TO ADDRESS THAT. 2768 02:05:59,720 --> 02:06:01,320 MAYBE THINGS I CAN TAKE AHEAD OF 2769 02:06:01,320 --> 02:06:03,960 PERHAPS SOME OF THE 2770 02:06:03,960 --> 02:06:06,400 PHARMACOLOGIC INTERVENTIONS. 2771 02:06:06,400 --> 02:06:07,520 AND JUST AS EXAMPLE, THIS IS, 2772 02:06:07,520 --> 02:06:11,200 AGAIN, AN EXAMPLE OF DATA FROM 2773 02:06:11,200 --> 02:06:12,400 THE PHYSICIANS' HEALTH STUDY. 2774 02:06:12,400 --> 02:06:15,120 WHEN WE COMPARED PEOPLE USING 2775 02:06:15,120 --> 02:06:16,680 ONLY MULTI-VITAMINS TO THOSE 2776 02:06:16,680 --> 02:06:18,560 USING BOTH MULTI-VITAMINS AND 2777 02:06:18,560 --> 02:06:20,640 OTHER TYPES OF VITAMIN AND 2778 02:06:20,640 --> 02:06:22,320 MINERAL SUPPLEMENTS COMPARED 2779 02:06:22,320 --> 02:06:25,440 WITH THE THIRDS COLUMN ON THE 2780 02:06:25,440 --> 02:06:27,880 RIGHT, OTHER SUPPLEMENTS BESIDES 2781 02:06:27,880 --> 02:06:28,800 A MULTI-VITAMIN INTERESTING 2782 02:06:28,800 --> 02:06:29,520 PATTERNS EMERGE. 2783 02:06:29,520 --> 02:06:34,000 WE SEE WITH AGE PEOPLE ARE MORE 2784 02:06:34,000 --> 02:06:35,720 LIKELY TO TAKE SUPPLEMENTS, 2785 02:06:35,720 --> 02:06:37,800 PEOPLE WHO ARE HEAVIER HAVE 2786 02:06:37,800 --> 02:06:40,760 HIGHER BMI, ARE LESS LIKELY TO 2787 02:06:40,760 --> 02:06:43,600 TAKE SUPPLEMENTS. 2788 02:06:43,600 --> 02:06:44,400 SMOKING STATUS, VIGOROUS 2789 02:06:44,400 --> 02:06:47,960 EXERCISE, ASPIRIN USE, ALL 2790 02:06:47,960 --> 02:06:48,440 THESE. 2791 02:06:48,440 --> 02:06:50,040 IF YOU'RE CONSUMING FRUITS AND 2792 02:06:50,040 --> 02:06:53,040 VEGETABLES YOU'RE MORE LIKELY TO 2793 02:06:53,040 --> 02:06:54,320 BE TAKING SUPPLEMENTS ON 2794 02:06:54,320 --> 02:06:54,600 AVERAGE. 2795 02:06:54,600 --> 02:06:58,160 THINKING ABOUT WHO IS USING IT, 2796 02:06:58,160 --> 02:07:00,280 THE ISSUE OF GENERALIZABILITY IS 2797 02:07:00,280 --> 02:07:00,880 AN IMPORTANT COMPONENT THAT 2798 02:07:00,880 --> 02:07:02,520 SHOULD BE INCORPORATED INTO THE 2799 02:07:02,520 --> 02:07:04,360 ISSUES OF EFFICACY AND 2800 02:07:04,360 --> 02:07:06,160 EFFECTIVENESS WHEN THINKING 2801 02:07:06,160 --> 02:07:08,120 ABOUT DIETARY SUPPLEMENTS AND 2802 02:07:08,120 --> 02:07:11,320 RESEARCH YOU'RE READING OR ARE 2803 02:07:11,320 --> 02:07:12,240 INVOLVED IN. 2804 02:07:12,240 --> 02:07:13,080 JUST AS ANOTHER EXAMPLE, 2805 02:07:13,080 --> 02:07:16,560 SOMETHING THAT COMES OUT ALL THE 2806 02:07:16,560 --> 02:07:19,480 TIME, WITHOUT TRYING TO BE 2807 02:07:19,480 --> 02:07:21,120 CRITICAL, THERE ARE LOTS OF MET 2808 02:07:21,120 --> 02:07:23,240 A ANALYSES PUBLISHED SEEMS LIKE 2809 02:07:23,240 --> 02:07:25,720 EVERY OTHER WEEK THAT ARE TAKING 2810 02:07:25,720 --> 02:07:27,080 OBSERVATIONAL STUDIES AND 2811 02:07:27,080 --> 02:07:33,640 COMBINING THOSE DATA TOGETHER TO 2812 02:07:33,640 --> 02:07:35,080 ADDRESS SPECIFIC QUESTIONS. 2813 02:07:35,080 --> 02:07:36,800 THE BEAUTY IS IT HELPS BY 2814 02:07:36,800 --> 02:07:38,640 PULLING DATA TOGETHER, HELPS TO 2815 02:07:38,640 --> 02:07:41,360 GIVE A MORE PRECISE ANSWER TO A 2816 02:07:41,360 --> 02:07:45,400 QUESTION THAT OTHERWISE MIGHT 2817 02:07:45,400 --> 02:07:46,240 HAVE UNCERTAIN. 2818 02:07:46,240 --> 02:07:48,280 THIS IS LOOKING AT RELATIONSHIP 2819 02:07:48,280 --> 02:07:58,480 BETWEEN CIRCULATING LEVELS, NOT 2820 02:07:58,480 --> 02:07:59,400 DIETARY SUPPLEMENTS BUT 2821 02:07:59,400 --> 02:08:01,560 CIRCULATING HYDROXY D, RELATED 2822 02:08:01,560 --> 02:08:04,840 TO VITAMIN D. 2823 02:08:04,840 --> 02:08:13,760 THE BEAUTY OF THE META-ANALYSIS, 2824 02:08:13,760 --> 02:08:20,440 EVERY UNIT INCREASE, ONE 2825 02:08:20,440 --> 02:08:21,840 STANDARD DEVIATION DECREASE YOU 2826 02:08:21,840 --> 02:08:24,400 HAVE A BETTER CHANCE OF 2827 02:08:24,400 --> 02:08:31,000 DEVELOPING CVD. 2828 02:08:31,000 --> 02:08:33,640 THIS DOESN'T GET YOU CLOSER. 2829 02:08:33,640 --> 02:08:34,560 BECAUSE THERE'S CONFOUNDING THAT 2830 02:08:34,560 --> 02:08:36,440 GETS IN THE WAY UNDERSTANDING 2831 02:08:36,440 --> 02:08:37,640 WHETHER THERE'S EFFICACY THAT'S 2832 02:08:37,640 --> 02:08:41,560 COMING INTO PLAY, CAN WE MAKE 2833 02:08:41,560 --> 02:08:44,120 THAT LINKAGE ON A CAUSAL BASIS. 2834 02:08:44,120 --> 02:08:47,360 I'D LIKE TO WALK YOU THROUGH THE 2835 02:08:47,360 --> 02:08:49,520 WAY WE THINK THROUGH TYPICAL 2836 02:08:49,520 --> 02:08:50,880 DIETARY SUPPLEMENT TRIALS. 2837 02:08:50,880 --> 02:08:53,400 I SAY TYPICAL IN A BROAD SENSE 2838 02:08:53,400 --> 02:08:54,000 OF THE TERM. 2839 02:08:54,000 --> 02:08:56,600 A LOT OF THE TRIALS DONE, YOU 2840 02:08:56,600 --> 02:08:58,360 MIGHT HAVE, SAY, FOUR, EIGHT, 16 2841 02:08:58,360 --> 02:09:00,120 WEEKS OF TREATMENT AND 2842 02:09:00,120 --> 02:09:02,400 FOLLOW-UP, MIGHT TEST AND 2843 02:09:02,400 --> 02:09:05,440 HOPEFULLY RANDOMIZED DOUBLE 2844 02:09:05,440 --> 02:09:06,640 BLIND PERHAPS PLACEBO CONTROLLED 2845 02:09:06,640 --> 02:09:09,800 TRIAL TESTING, AND THIS EXAMPLE 2846 02:09:09,800 --> 02:09:11,440 MIGHT BE A SEVERAL DOZEN MEN AND 2847 02:09:11,440 --> 02:09:15,920 WOMEN COMING IN WITH ELEVATE 2848 02:09:15,920 --> 02:09:18,440 BLOOD PRESSURED AND YOU'RE 2849 02:09:18,440 --> 02:09:19,840 INTERESTED IN BRACHIAL ARTERY 2850 02:09:19,840 --> 02:09:22,240 STIFFNESS, BIOMARKER ALSO. 2851 02:09:22,240 --> 02:09:23,400 WHAT ABOUT TRIALS LIKE THIS? 2852 02:09:23,400 --> 02:09:25,560 DOES IT HAVE TO APPLY TO 2853 02:09:25,560 --> 02:09:26,960 CLINICAL OUTCOMES? 2854 02:09:26,960 --> 02:09:28,280 NO, NOT NECESSARILY. 2855 02:09:28,280 --> 02:09:31,800 CAN THIS TRIAL ON ITS OWN GET 2856 02:09:31,800 --> 02:09:32,480 US THERE? 2857 02:09:32,480 --> 02:09:34,320 THE ONE THING THAT'S ALWAYS 2858 02:09:34,320 --> 02:09:35,680 IMPORTANT, AGAIN, WHEN WE THINK 2859 02:09:35,680 --> 02:09:36,640 ABOUT, AGAIN, WHETHER IT'S A 2860 02:09:36,640 --> 02:09:38,440 SMALL TRIAL OR LARGE TRIAL, TO 2861 02:09:38,440 --> 02:09:41,240 WHAT EXTENT WE CAN DRAW 2862 02:09:41,240 --> 02:09:42,040 CONCLUSIONS FROM THESE 2863 02:09:42,040 --> 02:09:44,000 RELATIVELY SMALL OR SHORTER 2864 02:09:44,000 --> 02:09:44,880 TRIALS OF DIETARY SUPPLEMENTS IS 2865 02:09:44,880 --> 02:09:46,800 IT STILL A FUNCTION OF HOW GOOD 2866 02:09:46,800 --> 02:09:49,000 THAT METHODOLOGY IS, QUALITY OF 2867 02:09:49,000 --> 02:09:50,120 STUDY MATTERS. 2868 02:09:50,120 --> 02:09:51,240 IT'S ALSO EQUALLY IMPORTANT TO 2869 02:09:51,240 --> 02:09:53,040 UNDERSTAND THERE'S A CLEAR 2870 02:09:53,040 --> 02:09:54,640 MECHANISM OF EFFECT BEING 2871 02:09:54,640 --> 02:09:59,360 DEMONSTRATED WHETHER FOR A 2872 02:09:59,360 --> 02:10:00,960 BIOMARKER OR CLINICAL MEASURE OR 2873 02:10:00,960 --> 02:10:02,360 CLINICAL ENDPOINT. 2874 02:10:02,360 --> 02:10:03,720 EVEN CLINICAL ENDPOINTS CAN BE 2875 02:10:03,720 --> 02:10:05,560 MESSY WITH THE WAY THEY ARE 2876 02:10:05,560 --> 02:10:06,360 CAPTURED OR CONFIRMED. 2877 02:10:06,360 --> 02:10:09,320 OF COURSE IN A SMALLER STUDY YOU 2878 02:10:09,320 --> 02:10:10,960 HAVE CONCERNS OF REPRODUCIBILITY 2879 02:10:10,960 --> 02:10:13,040 BUT THAT CAN BE DETERMINED, 2880 02:10:13,040 --> 02:10:14,920 THAT'S WHERE THE META-ANALYSES 2881 02:10:14,920 --> 02:10:17,040 CAN COME INTO PLAY. 2882 02:10:17,040 --> 02:10:19,480 LACK OF HARD CLINICAL OUTCOMES 2883 02:10:19,480 --> 02:10:21,240 DOES LIMIT THE WAY YOU CAN 2884 02:10:21,240 --> 02:10:23,920 INTERPRET, JUST BECAUSE A 2885 02:10:23,920 --> 02:10:25,240 PARTICULAR SUPPLEMENT MIGHT 2886 02:10:25,240 --> 02:10:26,560 LOWER BLOOD PRESSURE WE DON'T 2887 02:10:26,560 --> 02:10:28,720 KNOW NECESSARILY WHETHER THAT 2888 02:10:28,720 --> 02:10:30,920 EXTENDS TO REDUCING RISK OF 2889 02:10:30,920 --> 02:10:31,960 STROKE OR OTHER VASCULAR 2890 02:10:31,960 --> 02:10:34,320 OUTCOMES THAT MIGHT BE A 2891 02:10:34,320 --> 02:10:35,480 SEQUELAE OF THOSE REDUCTIONS, 2892 02:10:35,480 --> 02:10:37,360 HOPEFULLY IN BLOOD PRESSURE. 2893 02:10:37,360 --> 02:10:39,240 AGAIN, THE ISSUE OF 2894 02:10:39,240 --> 02:10:39,880 GENERALIZABILITY SHOULD ALWAYS 2895 02:10:39,880 --> 02:10:50,320 BE FACTORED INTO PLAY TOO. 2896 02:10:53,240 --> 02:10:55,840 THIS IS LOOKING AT MAGNESIUM AND 2897 02:10:55,840 --> 02:10:56,480 SYSTOLIC BLOOD PRESSURE, THERE'S 2898 02:10:56,480 --> 02:10:58,440 A LOT OF NOISE PERHAPS, RIGHT? 2899 02:10:58,440 --> 02:11:04,640 YOU HAVE SOME EFFECTS THAT SOME 2900 02:11:04,640 --> 02:11:05,360 MAGNESIUM SUPPLEMENTS MIGHT 2901 02:11:05,360 --> 02:11:07,040 INCREASE, SOME MIGHT DECREASE. 2902 02:11:07,040 --> 02:11:08,680 THIS SHOWED YOU COMBINE DATA 2903 02:11:08,680 --> 02:11:10,400 TOGETHER, THERE'S A SUGGESTION 2904 02:11:10,400 --> 02:11:13,360 OF A MODEST BUT PERHAPS MODEST 2905 02:11:13,360 --> 02:11:14,000 AND SIGNIFICANT REDUCTION IN 2906 02:11:14,000 --> 02:11:14,800 SYSTOLIC BLOOD PRESSURE. 2907 02:11:14,800 --> 02:11:17,240 BUT THIS IS THE CHALLENGE, 2908 02:11:17,240 --> 02:11:18,240 AGAIN, OF TAKING THE SMALLER 2909 02:11:18,240 --> 02:11:21,680 TRIALS AND ADDING THEM UP INTO A 2910 02:11:21,680 --> 02:11:22,360 SINGLE UNIT MEASURE, SUMMARY 2911 02:11:22,360 --> 02:11:24,640 MEASURE YOU WILL GET IN A 2912 02:11:24,640 --> 02:11:25,080 META-ANALYSIS. 2913 02:11:25,080 --> 02:11:26,720 AND JUST BY WAY OF NOTE, SOME OF 2914 02:11:26,720 --> 02:11:28,680 YOU MAY BE AWARE. 2915 02:11:28,680 --> 02:11:33,000 EARLIER THIS YEAR THERE WAS A 2916 02:11:33,000 --> 02:11:34,160 QUALIFIED HEALTH CLAIM 2917 02:11:34,160 --> 02:11:34,920 APPLICATION FOR MAGNESIUM AND 2918 02:11:34,920 --> 02:11:38,440 BLOOD PRESSURE THAT WAS APPROVED 2919 02:11:38,440 --> 02:11:41,920 BY THE FDA, THE LANGUAGE IS 2920 02:11:41,920 --> 02:11:42,920 QUITE CONSERVATIVE AND NOT 2921 02:11:42,920 --> 02:11:44,760 EXACTLY SWEEPING IN TERMS OF 2922 02:11:44,760 --> 02:11:46,200 SUPPORT BUT THESE ARE THE TYPES 2923 02:11:46,200 --> 02:11:48,160 OF QUESTIONS THAT COME UP WHEN 2924 02:11:48,160 --> 02:11:48,960 YOU'RE THINKING ABOUT HEALTH 2925 02:11:48,960 --> 02:11:50,080 CLAIMS AS WELL. 2926 02:11:50,080 --> 02:11:52,840 HOW DO WE PUT THESE SMALLER 2927 02:11:52,840 --> 02:11:54,440 TRIALS TOGETHER TO HELP 2928 02:11:54,440 --> 02:11:56,800 FORMULATE WHETHER THERE IS OR IS 2929 02:11:56,800 --> 02:12:02,040 NOT AN ARGUMENT THAT CAN BE MADE 2930 02:12:02,040 --> 02:12:03,720 FOR POTENTIAL EFFICACY OR 2931 02:12:03,720 --> 02:12:05,720 EFFECTIVENESS, NOT JUST FOR 2932 02:12:05,720 --> 02:12:06,320 MAGNESIUM SUPPLEMENTATION AND 2933 02:12:06,320 --> 02:12:07,840 BLOOD PRESSURE BUT EXTENDS TO 2934 02:12:07,840 --> 02:12:09,280 MANY OTHER PRODUCTS WITHIN THE 2935 02:12:09,280 --> 02:12:11,400 STATION. 2936 02:12:11,400 --> 02:12:13,960 IT'S AN IMPORTANT QUESTION. 2937 02:12:13,960 --> 02:12:16,360 I'LL DO ANOTHER PIVOT TO WALK 2938 02:12:16,360 --> 02:12:17,160 THROUGH SOME EXAMPLES OF A FEW 2939 02:12:17,160 --> 02:12:19,160 CLINICAL TRIALS AND HOW WE 2940 02:12:19,160 --> 02:12:22,000 APPROACH THEM AND QUESTIONS OF 2941 02:12:22,000 --> 02:12:23,240 EFFICACY AND EFFECTIVENESS. 2942 02:12:23,240 --> 02:12:25,360 AND FOR THE FIRST EXAMPLE, AS 2943 02:12:25,360 --> 02:12:31,280 I'VE MENTIONED BEFORE, THE 2944 02:12:31,280 --> 02:12:34,360 PHYSICIANS' HEALTH STUDY II 2945 02:12:34,360 --> 02:12:35,680 COMPLETED A WHILE BACK, 2946 02:12:35,680 --> 02:12:43,360 MAIL-BASED, 15,000 U.S. MALE 2947 02:12:43,360 --> 02:12:45,360 PHYSICIANS, THIS WAS MALE-BASED. 2948 02:12:45,360 --> 02:12:49,240 11 YEARS OF FOLLOW-UP. 2949 02:12:49,240 --> 02:12:51,000 LONG TRIAL, PRIMARY ENDPOINTS 2950 02:12:51,000 --> 02:12:52,760 CARDIOVASCULAR EVENTS, CANCER, 2951 02:12:52,760 --> 02:12:54,160 FOCUSED ON CLINICAL OUTCOMES 2952 02:12:54,160 --> 02:12:55,440 WITH SEVERAL INDIVIDUAL 2953 02:12:55,440 --> 02:12:57,040 CARDIOVASCULAR AND SITE-SPECIFIC 2954 02:12:57,040 --> 02:12:57,640 CANCER ENDPOINTS FOR SECONDARY 2955 02:12:57,640 --> 02:13:00,280 OUTCOMES ALONG WITH EYE DISEASE 2956 02:13:00,280 --> 02:13:01,160 AND COGNITIVE FUNCTION. 2957 02:13:01,160 --> 02:13:03,960 ONE ISSUE YOU THINK ABOUT IN THE 2958 02:13:03,960 --> 02:13:05,240 CONTEXT OF EFFICACY VERSUS 2959 02:13:05,240 --> 02:13:06,480 EFFECTIVENESS IS ISSUE OF 2960 02:13:06,480 --> 02:13:06,960 COMPLIANCE. 2961 02:13:06,960 --> 02:13:10,320 IF WE LOOK AT RESULTS FOR THE 2962 02:13:10,320 --> 02:13:10,840 RANDOMIZED MULTI-VITAMIN 2963 02:13:10,840 --> 02:13:12,240 COMPONENT, AT FOUR YEARS 2964 02:13:12,240 --> 02:13:13,960 COMPLIANCE WAS 77%. 2965 02:13:13,960 --> 02:13:14,680 AT EIGHT YEARS 72%. 2966 02:13:14,680 --> 02:13:18,160 AND BY THE END OF THE TRIAL, 11 2967 02:13:18,160 --> 02:13:19,160 YEARS, 67%. 2968 02:13:19,160 --> 02:13:20,880 NOW, I WOULD ARGUE I'M BIASED AS 2969 02:13:20,880 --> 02:13:23,840 ONE OF THE CO-P.I.s OF THE 2970 02:13:23,840 --> 02:13:25,000 PROJECT THAT COMPLIANCE WAS 2971 02:13:25,000 --> 02:13:26,600 PRETTY GOOD FOR THE MALE 2972 02:13:26,600 --> 02:13:28,360 PHYSICIAN PARTICIPANTS TO TAKE 2973 02:13:28,360 --> 02:13:30,360 THESE PILLS AS ASKED FOR AS LONG 2974 02:13:30,360 --> 02:13:33,400 AS THEY HAVE, IT'S NOT 100% BUT 2975 02:13:33,400 --> 02:13:34,240 WAS QUITE GOOD. 2976 02:13:34,240 --> 02:13:35,680 HOWEVER, RAISES THE QUESTION OF 2977 02:13:35,680 --> 02:13:37,680 WHEN WE ANALYZE OUR DATA HOW ARE 2978 02:13:37,680 --> 02:13:40,200 WE ANALYZING AND HOW DO WE 2979 02:13:40,200 --> 02:13:41,080 INTERPRET THAT? 2980 02:13:41,080 --> 02:13:43,280 WHAT YOU HEAR IS CLASSIC -- YOU 2981 02:13:43,280 --> 02:13:45,120 SEE THE CLASSIC INTENTION TO 2982 02:13:45,120 --> 02:13:46,000 TREAT ANALYSIS. 2983 02:13:46,000 --> 02:13:47,280 I'M NOT GOING TO WALK THROUGH 2984 02:13:47,280 --> 02:13:48,480 ALL RESULTS FOR PURPOSES OF TIME 2985 02:13:48,480 --> 02:13:51,240 BUT THE IDEA HERE IS THAT 2986 02:13:51,240 --> 02:13:55,080 TRADITIONALLY AT LEAST FOR THE 2987 02:13:55,080 --> 02:13:57,520 LARGER SCALE LONGER TERM TRIALS 2988 02:13:57,520 --> 02:13:59,600 DONE WITH DIETARY SUPPLEMENTS 2989 02:13:59,600 --> 02:14:01,840 WE'VE ALWAYS RELIED ON INTENTION 2990 02:14:01,840 --> 02:14:03,040 TO TREAT ANALYSES. 2991 02:14:03,040 --> 02:14:05,440 I THINK A LOT IS STEEPED IN THE 2992 02:14:05,440 --> 02:14:07,240 CLASSIC THOUGHT PROCESS OF ARE 2993 02:14:07,240 --> 02:14:08,200 WE DOING A PHARMACOLOGIC 2994 02:14:08,200 --> 02:14:10,360 INTERVENTION OR IS THIS A DIE 2995 02:14:10,360 --> 02:14:14,840 TEAR -- DIETARY INTERVENTION 2996 02:14:14,840 --> 02:14:16,520 AND YOU CAN MAKE MERITS ON BOTH 2997 02:14:16,520 --> 02:14:18,880 SIDES. 2998 02:14:18,880 --> 02:14:22,360 THESE ARE NOT PHARMACOLOGIC 2999 02:14:22,360 --> 02:14:23,480 INTERVENTIONS BUT THE DESIGN IS 3000 02:14:23,480 --> 02:14:26,360 SIMILAR TO WHAT IT MILD BE IF IT 3001 02:14:26,360 --> 02:14:32,200 WERE -- MIGHT BE A BLOOD 3002 02:14:32,200 --> 02:14:34,360 PRESSURE DRUG WE WERE TESTING. 3003 02:14:34,360 --> 02:14:37,040 FOR MAJOR CARDIOVASCULAR EVENTS, 3004 02:14:37,040 --> 02:14:41,680 ONE PRIMARY OUTCOMES, RATIO OF 3005 02:14:41,680 --> 02:14:42,400 1.01, NO EFFECT. 3006 02:14:42,400 --> 02:14:47,320 SECONDARY, KNOCK -- NOTHING IS 3007 02:14:47,320 --> 02:14:48,680 GOING ON BUT THIS WAS AN 3008 02:14:48,680 --> 02:14:52,480 INTENTION TO TREAT ANNUAL -- 3009 02:14:52,480 --> 02:14:52,960 ANALYSIS. 3010 02:14:52,960 --> 02:14:54,000 COMPLIANCE WAS REASONABLE, DID 3011 02:14:54,000 --> 02:14:57,720 NOT COMPEL US AT THE TIME TO 3012 02:14:57,720 --> 02:14:58,480 CONSIDER WHAT THE 3013 02:14:58,480 --> 02:14:59,520 COMPLIANCE-BASED ANALYSES MIGHT 3014 02:14:59,520 --> 02:15:00,480 LOOK LIKE. 3015 02:15:00,480 --> 02:15:02,360 NOW, WHEN WE ALSO LOOKED AT 3016 02:15:02,360 --> 02:15:04,720 OTHER PRIMARY OUTCOME FOR TOTAL 3017 02:15:04,720 --> 02:15:08,440 CANCER, HERE WE DID SEE A 3018 02:15:08,440 --> 02:15:09,880 SUGGESTION, BORDERLINE 3019 02:15:09,880 --> 02:15:14,440 SIGNIFICANT SUGGESTION, THAT 3020 02:15:14,440 --> 02:15:15,360 THOSE RANDOMIZED TO 3021 02:15:15,360 --> 02:15:17,120 MULTI-VITAMIN HAD 8% REDUCTION 3022 02:15:17,120 --> 02:15:18,280 VERSUS PLACEBO, AND 3023 02:15:18,280 --> 02:15:19,680 SITE-SPECIFIC CANCERS IN THE 3024 02:15:19,680 --> 02:15:20,320 RIGHT DIRECTION FOR OLDER MEN, 3025 02:15:20,320 --> 02:15:25,120 SEEMED TO BE A STRONGER EFFECT, 3026 02:15:25,120 --> 02:15:26,160 POTENTIALLY INTERACTION WITH AGE 3027 02:15:26,160 --> 02:15:30,520 WAS NOT SIGNIFICANT BUT WITH 3028 02:15:30,520 --> 02:15:32,240 INTENTION TO TREAT ANALYSIS, OUR 3029 02:15:32,240 --> 02:15:35,160 BELIEF WAS WE DON'T WORRY ABOUT 3030 02:15:35,160 --> 02:15:36,160 COMPLIANCE-BASED BECAUSE WE HANG 3031 02:15:36,160 --> 02:15:38,000 OUR HAT FOR CLINICAL OUTCOMES 3032 02:15:38,000 --> 02:15:40,000 WITH INTENTION TO TREAT 3033 02:15:40,000 --> 02:15:41,120 ANALYSES. 3034 02:15:41,120 --> 02:15:43,400 WE TREAT AS IF THIS IS EFFICACY. 3035 02:15:43,400 --> 02:15:45,120 ONCE RANDOMIZED TO A 3036 02:15:45,120 --> 02:15:47,160 MULTI-VITAMIN, THAT'S HOW YOU'RE 3037 02:15:47,160 --> 02:15:47,560 ALWAYS ANALYZED. 3038 02:15:47,560 --> 02:15:51,280 REGARDLESS OF WHAT HAPPENS. 3039 02:15:51,280 --> 02:15:53,240 SO FOR THE ONE-THIRD OR SO OF 3040 02:15:53,240 --> 02:15:54,360 PARTICIPANTS THAT STOPPED TAKING 3041 02:15:54,360 --> 02:15:55,920 THE MULTI-VITAMIN BY THE END OF 3042 02:15:55,920 --> 02:15:58,280 TRIAL WE'RE STILL ANALYZING AS 3043 02:15:58,280 --> 02:16:01,080 IF THEY WERE STILL TAKING THE 3044 02:16:01,080 --> 02:16:02,800 MULTI-VITAMIN EVEN THOUGH THEY 3045 02:16:02,800 --> 02:16:03,320 WEREN'T. 3046 02:16:03,320 --> 02:16:05,640 THERE'S A LITTLE BIT OF PARITY 3047 02:16:05,640 --> 02:16:06,760 THAT GETS INTRODUCED. 3048 02:16:06,760 --> 02:16:09,800 IT ANSWERS A FEW QUESTIONS AND 3049 02:16:09,800 --> 02:16:13,720 CREATES NEW QUESTIONS LIKE ANY 3050 02:16:13,720 --> 02:16:14,960 GOOD TRIAL. 3051 02:16:14,960 --> 02:16:19,760 SUBSEQUENTLY, WE PUBLISHED 3052 02:16:19,760 --> 02:16:25,680 RESULTS A FOLLOW-UP TRIAL, A 3053 02:16:25,680 --> 02:16:26,600 COCO SUPPLEMENT CALLED COSMOS, 3054 02:16:26,600 --> 02:16:35,960 21,000 OLDER U.S. MEN AND WOMEN, 3055 02:16:35,960 --> 02:16:37,560 TAKING COCOA FLAVANOL, PRIMARY 3056 02:16:37,560 --> 02:16:39,760 OUTCOMES FOR PURPOSES OF 3057 02:16:39,760 --> 02:16:42,400 EFFICACY AND EFFECTIVENESS MAJOR 3058 02:16:42,400 --> 02:16:43,960 CARDIOVASCULAR EVENTS AND TOTAL 3059 02:16:43,960 --> 02:16:45,520 INVASIVE CANCER. 3060 02:16:45,520 --> 02:16:47,960 JUST ON THE TOPIC OF COMPLIANCE, 3061 02:16:47,960 --> 02:16:50,400 AN IMPORTANT CONSIDERATION WHEN 3062 02:16:50,400 --> 02:16:52,920 THINKING ABOUT THE DISTINCTION 3063 02:16:52,920 --> 02:16:53,680 BETWEEN EFFICACY AND 3064 02:16:53,680 --> 02:16:54,640 EFFECTIVENESS, ONE GREAT THING 3065 02:16:54,640 --> 02:17:02,280 ABOUT THE TRIAL DESIGN, WHETHER 3066 02:17:02,280 --> 02:17:05,320 YOU'RE USING THESE CALENDAR 3067 02:17:05,320 --> 02:17:08,600 PACKS, ALL TOOLED TO INCREASE 3068 02:17:08,600 --> 02:17:09,480 COMPLIANCE. 3069 02:17:09,480 --> 02:17:11,560 WE WANT TO MAKE SURE THAT OUR 3070 02:17:11,560 --> 02:17:12,960 ANALYSES, WHETHER INTENTION TO 3071 02:17:12,960 --> 02:17:14,560 TREAT OR OTHERWISE, ARE GOING TO 3072 02:17:14,560 --> 02:17:16,160 REFLECT HOPEFULLY WHAT WE THINK 3073 02:17:16,160 --> 02:17:17,760 IS EFFICACY, AND OR 3074 02:17:17,760 --> 02:17:18,840 EFFECTIVENESS AS YOU'LL SEE. 3075 02:17:18,840 --> 02:17:21,320 AND IN FACT IF WE JUST FOCUS 3076 02:17:21,320 --> 02:17:22,840 EVEN ON THE MULTI-VITAMIN PART 3077 02:17:22,840 --> 02:17:27,000 OF THIS CHART ON THE RIGHT WE 3078 02:17:27,000 --> 02:17:29,640 SEE FIRST OF ALL OUR COMPLIANCE 3079 02:17:29,640 --> 02:17:32,040 WAS QUITE HIGH DEPENDING ON HOW 3080 02:17:32,040 --> 02:17:33,680 YOU DEFINED IT. 3081 02:17:33,680 --> 02:17:36,080 BY THE END WE HAD 80% TAKING 3082 02:17:36,080 --> 02:17:37,040 EITHER OR BOTH INTERVENTIONS. 3083 02:17:37,040 --> 02:17:40,360 AND AT THE SAME TIME IF YOU 3084 02:17:40,360 --> 02:17:42,320 DEFINE TOTAL COMPLIANCE ON BASIS 3085 02:17:42,320 --> 02:17:43,640 OF NOT TAKING OUT OF STUDY 3086 02:17:43,640 --> 02:17:45,360 PILLS, YOU CAN IMAGINE A LOT OF 3087 02:17:45,360 --> 02:17:47,240 PEOPLE RANDOMIZED TO TAKE 3088 02:17:47,240 --> 02:17:48,000 MULTI-VITAMIN DURING THE TRIAL 3089 02:17:48,000 --> 02:17:49,880 SAID, OH, I THINK I SHOULD BE, 3090 02:17:49,880 --> 02:17:52,080 I'M NOT SURE IF I AM. 3091 02:17:52,080 --> 02:17:54,200 AND THAT REFLECTS SLIGHTLY LOWER 3092 02:17:54,200 --> 02:17:55,880 TOTAL COMPLIANCE THAT YOU SEE AT 3093 02:17:55,880 --> 02:17:58,760 THE BOTTOM AT 24 AND 36 MONTHS. 3094 02:17:58,760 --> 02:18:01,240 BUT NEVERTHELESS WHAT WE DID FOR 3095 02:18:01,240 --> 02:18:03,520 COSMOS, A DEPARTURE THAN WHAT 3096 02:18:03,520 --> 02:18:05,120 WE'VE USUALLY DONE LOOK AT 3097 02:18:05,120 --> 02:18:06,440 RESULTS TWO WAYS. 3098 02:18:06,440 --> 02:18:08,480 WHAT I'M PRESENTING IS FIRST FOR 3099 02:18:08,480 --> 02:18:10,520 RESULTS OF MULTI-VITAMIN, ON 3100 02:18:10,520 --> 02:18:11,840 PRIMARY ENDPOINT OF TOTAL 3101 02:18:11,840 --> 02:18:13,960 INVASIVE CANCER, WHAT I WOULD 3102 02:18:13,960 --> 02:18:15,720 DEEM TRADITIONAL OR TYPICAL 3103 02:18:15,720 --> 02:18:20,160 INTENTION TO TREAT ANALYSES. 3104 02:18:20,160 --> 02:18:21,760 HOW YOU'RE RANDOMIZED IS HOW 3105 02:18:21,760 --> 02:18:24,480 YOU'RE GOING TO BE ANALYZED. 3106 02:18:24,480 --> 02:18:28,240 FOR THE MULTI-VITAMIN INVASIVE 3107 02:18:28,240 --> 02:18:31,160 CANCER OVERALL NO EFFECT. 3108 02:18:31,160 --> 02:18:33,560 PROMISING EFFECT IN PHYSICIANS 3109 02:18:33,560 --> 02:18:36,240 HEALTH STUDY II DID NOT 3110 02:18:36,240 --> 02:18:38,280 REPLICATE IN COSMOS, EXTENDED TO 3111 02:18:38,280 --> 02:18:43,760 SECONDARY OUTCOMES EXCEPT FOR 3112 02:18:43,760 --> 02:18:44,920 INVASIVE LUNG CANCER, INTRIGUING 3113 02:18:44,920 --> 02:18:48,120 38% REDUCTION FOR THOSE TAKING 3114 02:18:48,120 --> 02:18:50,400 MULTI-VITAMIN VERSUS PLACEBO. 3115 02:18:50,400 --> 02:18:51,680 THIS ASSUMES THAT WHEN YOU'RE 3116 02:18:51,680 --> 02:18:53,320 RANDOMIZED INTO THE TRIAL THAT'S 3117 02:18:53,320 --> 02:18:54,800 HOW YOUR ANALYZED. 3118 02:18:54,800 --> 02:18:57,520 WE ALSO WERE CURIOUS TO SEE WHAT 3119 02:18:57,520 --> 02:19:02,680 IF WE DID COMPLIANCE-BASED 3120 02:19:02,680 --> 02:19:04,880 ANALYSES, PER PROTOCOL ANALYSES. 3121 02:19:04,880 --> 02:19:07,040 THE RESULTS ARE BASICALLY THE 3122 02:19:07,040 --> 02:19:07,840 SAME. 3123 02:19:07,840 --> 02:19:09,480 I'LL FLIP-FLOP AND GO BACK FOR A 3124 02:19:09,480 --> 02:19:10,120 MOMENT. 3125 02:19:10,120 --> 02:19:14,600 PRIMARY OUTCOME OF TOTAL 3126 02:19:14,600 --> 02:19:15,680 INVASIVE CANCER, .97. 3127 02:19:15,680 --> 02:19:22,200 WHEN WE GO TO PROTOCOL ANALYSES, 3128 02:19:22,200 --> 02:19:22,880 STILL .97. 3129 02:19:22,880 --> 02:19:24,400 I'LL FLIP ONE MORE TIME. 3130 02:19:24,400 --> 02:19:26,400 YOU'LL NOTICE FOR THE INTENTION 3131 02:19:26,400 --> 02:19:27,720 TO TREAT ANALYSES, INCORPORATING 3132 02:19:27,720 --> 02:19:30,240 ALL OF THE DATA, WE HAVE MORE 3133 02:19:30,240 --> 02:19:32,000 THAN A THOUSAND PEOPLE WHO 3134 02:19:32,000 --> 02:19:32,800 DEVELOPED INVASIVE CANCER OVER 3135 02:19:32,800 --> 02:19:37,040 THE COURSE OF THE STUDY. 3136 02:19:37,040 --> 02:19:38,040 BECAUSE IN THE PER-PROTOCOL 3137 02:19:38,040 --> 02:19:39,200 ANALYSIS ONCE YOU BECOME 3138 02:19:39,200 --> 02:19:40,760 NON-COMPLIANCE WE STOP YOU FROM 3139 02:19:40,760 --> 02:19:42,040 BEING FOLLOWED UP ANYMORE, THE 3140 02:19:42,040 --> 02:19:43,360 NUMBER OF EVENTS HAS GONE DOWN. 3141 02:19:43,360 --> 02:19:47,280 ONE OF THE OTHER CONSIDERATIONS 3142 02:19:47,280 --> 02:19:49,200 FOR A PER-PROTOCOL ANALYSIS, 3143 02:19:49,200 --> 02:19:50,520 YOUR ENDPOINT COUNTS WILL BE 3144 02:19:50,520 --> 02:19:52,200 LESS BECAUSE WE'RE EXCLUDING YOU 3145 02:19:52,200 --> 02:19:53,520 ONCE YOU BECOME NON-COMPLIANT. 3146 02:19:53,520 --> 02:19:56,840 NOT ONLY ARE YOU INTRODUCING A 3147 02:19:56,840 --> 02:19:58,760 LITTLE BIT OF CONFOUNDING BUT 3148 02:19:58,760 --> 02:20:01,320 YOU'RE ALSO -- YOUR STUDY POWER 3149 02:20:01,320 --> 02:20:02,800 IS IMPACTED AS WELL. 3150 02:20:02,800 --> 02:20:05,120 WE FEEL IT'S IMPORTANT TO 3151 02:20:05,120 --> 02:20:07,200 COMPARE AN CONTRAST RESULTS, FOR 3152 02:20:07,200 --> 02:20:07,960 THE MULTI-VITAMIN IN COSMOS 3153 02:20:07,960 --> 02:20:08,720 REGARDLESS OF WHETHER YOU'RE 3154 02:20:08,720 --> 02:20:12,240 LOOKING AT FROM THE PERSPECTIVE 3155 02:20:12,240 --> 02:20:14,840 OF EFFICACY OR EFFECTIVENESS FOR 3156 02:20:14,840 --> 02:20:16,840 TOTAL INVASIVE CANCER THERE'S 3157 02:20:16,840 --> 02:20:17,480 SIMILAR LACK OF EFFECT. 3158 02:20:17,480 --> 02:20:21,720 ON THE OTHER HAND FOR OUR COCOA 3159 02:20:21,720 --> 02:20:24,040 FLAVANOL INTERVENTION PRIMARY 3160 02:20:24,040 --> 02:20:25,040 OUTCOME WAS, TOTAL 3161 02:20:25,040 --> 02:20:28,360 CARDIOVASCULAR EVENTS, INTENTION 3162 02:20:28,360 --> 02:20:31,160 TO TREAT ANALYSIS WE SAW NO 3163 02:20:31,160 --> 02:20:32,160 SIGNIFICANT REDUCTION IN TOTAL 3164 02:20:32,160 --> 02:20:33,440 CARDIOVASCULAR DISEASE BUT THERE 3165 02:20:33,440 --> 02:20:38,360 WAS AT LEAST A SUGGESTION, 3166 02:20:38,360 --> 02:20:40,320 PROMISING SIGNAL, A ALBEIT NOT 3167 02:20:40,320 --> 02:20:43,200 SIGNIFICANT, 10% REDUCTION FOR 3168 02:20:43,200 --> 02:20:44,560 THOSE TAKING THE COCOA EXTRACT 3169 02:20:44,560 --> 02:20:46,640 VERSUS PLACEBO, FOR THE COSMOS 3170 02:20:46,640 --> 02:20:50,920 TRIAL WE LOOK ALONG EACH 3171 02:20:50,920 --> 02:20:51,920 INDIVIDUAL RATIO, GENERAL 3172 02:20:51,920 --> 02:20:53,120 PATTERNS ARE POINTING IN THE 3173 02:20:53,120 --> 02:20:54,640 RIGHT DIRECTION. 3174 02:20:54,640 --> 02:20:56,240 WE WERE EQUALLY CURIOUS IF WE 3175 02:20:56,240 --> 02:20:59,520 LOOK AT THIS, FROM THE INTENTION 3176 02:20:59,520 --> 02:21:03,280 TO TREAT PERSPECTIVE, WHAT IF WE 3177 02:21:03,280 --> 02:21:05,040 LOOK FROM COMPLIANCE PERSPECTIVE 3178 02:21:05,040 --> 02:21:06,720 AND INCLUDE THOSE TAKING THE 3179 02:21:06,720 --> 02:21:08,080 COCOA EXTRACT CARING AGAINST 3180 02:21:08,080 --> 02:21:11,760 THOSE ONLY TAKING THE PLACEBO 3181 02:21:11,760 --> 02:21:12,520 WITH NO NOISE INTRODUCED? 3182 02:21:12,520 --> 02:21:17,000 SURE ENOUGH WHEN WE DO THE 3183 02:21:17,000 --> 02:21:18,400 PER-PROTOCOL ANALYSIS NUMBER OF 3184 02:21:18,400 --> 02:21:21,560 EVENTS GO DOWN, FEWER EVENTS, 3185 02:21:21,560 --> 02:21:23,680 YET THE STRENGTH OF THE EFFECT 3186 02:21:23,680 --> 02:21:28,280 NOT STATISTICALLY SIGNIFICANT IN 3187 02:21:28,280 --> 02:21:30,720 OUR INTENTION-TO-TREAT ANALYSES 3188 02:21:30,720 --> 02:21:37,320 BECAME STATISTICALLY 3189 02:21:37,320 --> 02:21:41,640 SIGNIFICANT, NOW 15% REDUCTION. 3190 02:21:41,640 --> 02:21:43,600 THERE WAS STRENGTHENING OF 3191 02:21:43,600 --> 02:21:44,760 EFFECT FOR SECONDARY OUTCOMES 3192 02:21:44,760 --> 02:21:47,200 RAISING THE QUESTION WHICH IS 3193 02:21:47,200 --> 02:21:48,840 RIGHT? 3194 02:21:48,840 --> 02:21:52,280 WHAT WE DECIDED I THINK THE BEST 3195 02:21:52,280 --> 02:21:53,360 WAY TO GO, DEPENDING ON YOUR 3196 02:21:53,360 --> 02:21:55,280 TRIAL AND DESIGN FOR YOUR 3197 02:21:55,280 --> 02:21:56,440 DIETARY SUPPLEMENT I WOULD 3198 02:21:56,440 --> 02:21:58,960 RATHER SEE MORE ANALYSES 3199 02:21:58,960 --> 02:22:02,080 PRESENTING BOTH SETS OF ANALYSES 3200 02:22:02,080 --> 02:22:04,840 TO MORE FULLY REFLECT WHAT WORKS 3201 02:22:04,840 --> 02:22:08,040 FOR DIETARY SUPPLEMENT, UNDER 3202 02:22:08,040 --> 02:22:11,360 EITHER IDEAL CIRCUMSTANCES OR 3203 02:22:11,360 --> 02:22:12,120 USUAL CIRCUMSTANCES. 3204 02:22:12,120 --> 02:22:14,320 SO JUST A FEW OTHER QUICK 3205 02:22:14,320 --> 02:22:14,560 THOUGHTS. 3206 02:22:14,560 --> 02:22:16,800 I THINK ANY TYPE OF TRIAL YOU 3207 02:22:16,800 --> 02:22:18,400 DO, WHETHER LARGE SCALE, SMALL 3208 02:22:18,400 --> 02:22:20,760 SCALE, IT'S ALWAYS HARD TO 3209 02:22:20,760 --> 02:22:21,480 DECLARE EFFICACY. 3210 02:22:21,480 --> 02:22:22,280 I THINK THAT'S AN IMPORTANT 3211 02:22:22,280 --> 02:22:23,800 THING TO REMEMBER. 3212 02:22:23,800 --> 02:22:25,320 EFFICACY IS IDEAL, RIGHT? 3213 02:22:25,320 --> 02:22:26,960 YOU'VE GOT A PERFECTLY DESIGNED 3214 02:22:26,960 --> 02:22:29,440 STUDY, NO ISSUES WITH FOLLOW-UP 3215 02:22:29,440 --> 02:22:31,640 COMPLIANCE, ET CETERA. 3216 02:22:31,640 --> 02:22:32,920 REGARDLESS, NO MATTER RESULTS 3217 02:22:32,920 --> 02:22:34,760 YOU'RE IN A CATCH-22. 3218 02:22:34,760 --> 02:22:36,080 IF YOU GET RESULTS PEOPLE THINK 3219 02:22:36,080 --> 02:22:37,320 THEY WANT TO HEAR THEY WILL 3220 02:22:37,320 --> 02:22:39,520 PRE-CLAIM YOU DID EVERYTHING 3221 02:22:39,520 --> 02:22:39,720 RIGHT. 3222 02:22:39,720 --> 02:22:41,320 TESTED THE RIGHT SUPPLEMENT, 3223 02:22:41,320 --> 02:22:44,320 REMOVED CONFOUNDING, MAYBE IT 3224 02:22:44,320 --> 02:22:45,320 WAS INTENTION-TO-TREAT, HAD THE 3225 02:22:45,320 --> 02:22:46,800 RIGHT ENDPOINTS BUT STILL ASK 3226 02:22:46,800 --> 02:22:47,840 YOURSELF WHAT ANALYSES DO WE 3227 02:22:47,840 --> 02:22:48,200 CONSIDER? 3228 02:22:48,200 --> 02:22:50,560 DID YOU INCORPORATE ALL THESE 3229 02:22:50,560 --> 02:22:51,000 ANALYSES? 3230 02:22:51,000 --> 02:22:51,800 NO DIFFERENTLY THAN A RESULT 3231 02:22:51,800 --> 02:22:53,400 PEOPLE DON'T LIKE OR AGREE WITH, 3232 02:22:53,400 --> 02:22:55,360 THEY WILL SAY HIGHLIGHTS THE 3233 02:22:55,360 --> 02:22:59,840 TRIALS AND WEAKNESSES AND 3234 02:22:59,840 --> 02:23:02,440 EPISTUDIES DON'T CONNECT WELL, 3235 02:23:02,440 --> 02:23:06,320 WRONG SUPPLEMENT, WRONG PATIENT 3236 02:23:06,320 --> 02:23:07,000 POPULATION, GENERALIZABILITY IS 3237 02:23:07,000 --> 02:23:07,480 AN ISSUE. 3238 02:23:07,480 --> 02:23:08,680 YOU CAN'T WIN. 3239 02:23:08,680 --> 02:23:13,240 IT'S IMPORTANT TO CONSIDER 3240 02:23:13,240 --> 02:23:14,120 INTENTION-TO-TREAT AND 3241 02:23:14,120 --> 02:23:16,160 INTENTION-BASED ANALYSIS. 3242 02:23:16,160 --> 02:23:16,920 LOOKING FORWARD SHORT-TERM 3243 02:23:16,920 --> 02:23:17,840 TRIALS WILL CONTINUE BUT WE WANT 3244 02:23:17,840 --> 02:23:20,720 TO THINK ABOUT IT BOTH IN TERMS 3245 02:23:20,720 --> 02:23:21,800 OF EFFICACY AND EFFECTIVENESS. 3246 02:23:21,800 --> 02:23:23,760 IT STARTS WITH A WELL-DESIGNED 3247 02:23:23,760 --> 02:23:25,400 CLINICAL TRIAL. 3248 02:23:25,400 --> 02:23:27,440 I CAN'T EMPHASIZE THAT ENOUGH. 3249 02:23:27,440 --> 02:23:29,400 YES, RESULTS MATTER, BUT IF IT'S 3250 02:23:29,400 --> 02:23:32,320 NOT A WELL-DESIGNED TRIAL IT'S 3251 02:23:32,320 --> 02:23:34,760 GARBAGE IN, GARBAGE OUT. 3252 02:23:34,760 --> 02:23:37,000 SELECT YOUR SUPPLEMENTS 3253 02:23:37,000 --> 02:23:37,800 CAREFULLY, CONSIDER MULTIPLE 3254 02:23:37,800 --> 02:23:38,760 DOSES, DIFFERENT FORMULATIONS, 3255 02:23:38,760 --> 02:23:39,680 HAVE THE RIGHT POPULATION 3256 02:23:39,680 --> 02:23:40,320 REPRESENTED. 3257 02:23:40,320 --> 02:23:41,480 AND MORE AND MORE NO MATTER HOW 3258 02:23:41,480 --> 02:23:44,520 SHORT OR LONG THE TRIAL IS IT'S 3259 02:23:44,520 --> 02:23:45,360 IMPORTANT TO CONSIDER TRIALS 3260 02:23:45,360 --> 02:23:46,480 WHERE YOU MIGHT HAVE I WOULD SAY 3261 02:23:46,480 --> 02:23:50,240 DOESN'T HAVE TO BE A HARD 3262 02:23:50,240 --> 02:23:52,520 CLINICAL OUTCOME LIKE 3263 02:23:52,520 --> 02:23:53,560 CARDIOVASCULAR DISEASE BUT 3264 02:23:53,560 --> 02:23:55,960 PRIMARY ENDPOINT, THINK THE 3265 02:23:55,960 --> 02:23:58,200 ABOUT MECHANISMS OF EFFECT THAT 3266 02:23:58,200 --> 02:23:58,920 UNDERLIE OUTCOMES YOU'RE 3267 02:23:58,920 --> 02:23:59,200 TESTING. 3268 02:23:59,200 --> 02:24:00,800 IT'S IMPORTANT TO THINK ABOUT 3269 02:24:00,800 --> 02:24:01,440 THAT. 3270 02:24:01,440 --> 02:24:02,200 IT REQUIRES THOUGHTFUL 3271 02:24:02,200 --> 02:24:05,440 COLLABORATION ACROSS MANY 3272 02:24:05,440 --> 02:24:05,720 SECTORS. 3273 02:24:05,720 --> 02:24:07,040 GOVERNMENT, INDUSTRY, ACADEMIA. 3274 02:24:07,040 --> 02:24:08,840 SO WITH THAT, THANK YOU FOR YOUR 3275 02:24:08,840 --> 02:24:11,040 ATTENTION, I'D BE HAPPY TO TAKE 3276 02:24:11,040 --> 02:24:13,440 QUESTIONS YOU MIGHT HAVE. 3277 02:24:13,440 --> 02:24:15,160 >> THANK YOU, DR. SESSO. 3278 02:24:15,160 --> 02:24:17,360 LET'S JUMP INTO THE QUESTIONS. 3279 02:24:17,360 --> 02:24:19,240 YOU HAVE A FEW. 3280 02:24:19,240 --> 02:24:21,640 NOT A LOT OF TIME. 3281 02:24:21,640 --> 02:24:24,120 FIRST QUESTION, IS CONFOUNDING 3282 02:24:24,120 --> 02:24:26,760 ELIMINATED IN SECONDARY OR 3283 02:24:26,760 --> 02:24:28,360 STRATIFIED ANALYSES IN EFFICACY 3284 02:24:28,360 --> 02:24:28,840 TRIALS? 3285 02:24:28,840 --> 02:24:31,600 >> YEAH, SO THAT'S A GOOD 3286 02:24:31,600 --> 02:24:31,920 QUESTION. 3287 02:24:31,920 --> 02:24:33,200 IF YOU'RE ANALYZING THE DATA AS 3288 02:24:33,200 --> 02:24:35,280 IF IT WERE INTENTION TO TREAT, 3289 02:24:35,280 --> 02:24:37,840 THEN IF YOU'RE LOOKING AT 3290 02:24:37,840 --> 02:24:40,080 SUBGROUP ANALYSES, AND THOSE 3291 02:24:40,080 --> 02:24:41,640 OUGHT TO BE PRE-SELECTED BEFORE 3292 02:24:41,640 --> 02:24:46,480 YOU DO YOUR STUDY INSTEAD OF 3293 02:24:46,480 --> 02:24:48,840 POST HOC, SUBGROUP ANALYSES 3294 02:24:48,840 --> 02:24:50,080 WOULD STILL BE APPROPRIATE IN 3295 02:24:50,080 --> 02:24:51,440 THE CONTEXT OF EFFICACY. 3296 02:24:51,440 --> 02:24:54,640 HOWEVER, IF YOU'RE DOING 3297 02:24:54,640 --> 02:24:55,720 PER-PROTOCOL ANALYSES YOU HAVE 3298 02:24:55,720 --> 02:24:58,360 TO BE MINDFUL -- AS-TREAT 3299 02:24:58,360 --> 02:25:02,760 ANALYSES YOU DO LOSE THAT 3300 02:25:02,760 --> 02:25:03,000 ABILITY. 3301 02:25:03,000 --> 02:25:06,240 >> ANOTHER QUESTION, HOW ABOUT 3302 02:25:06,240 --> 02:25:07,640 USING CLUSTER RANDOMIZED 3303 02:25:07,640 --> 02:25:10,800 PLATFORM TRIALS LIKE RECOVERY 3304 02:25:10,800 --> 02:25:11,160 AND SOLIDARITY? 3305 02:25:11,160 --> 02:25:13,040 A LOT OF WHAT YOU TALKED ABOUT 3306 02:25:13,040 --> 02:25:20,040 APPLIES TO DRUGS AS WELL, ALSO 3307 02:25:20,040 --> 02:25:24,160 BAYESIAN ANALYSES VERSUS 3308 02:25:24,160 --> 02:25:25,120 FREQUENT -- LET'S SEE WHAT YOU 3309 02:25:25,120 --> 02:25:26,480 CAN MAKE OF THAT. 3310 02:25:26,480 --> 02:25:29,040 >> THERE'S A BUNCH OF QUESTIONS 3311 02:25:29,040 --> 02:25:34,160 IN THAT, VALID POINTS RAISED BY 3312 02:25:34,160 --> 02:25:34,760 MR. CARTER, THAT THE -- SO MY 3313 02:25:34,760 --> 02:25:37,000 VIEW, I THINK WE NEED TO BE -- I 3314 02:25:37,000 --> 02:25:39,000 THINK THE POINT HERE IS AN 3315 02:25:39,000 --> 02:25:41,400 IMPORTANT ONE WE NEED TO BE NOR 3316 02:25:41,400 --> 02:25:42,880 INNOVATIVE WITH THE WAY WE 3317 02:25:42,880 --> 02:25:44,640 APPROACH THE DESIGN OF TRIALS, 3318 02:25:44,640 --> 02:25:46,120 NOT JUST FOR DIETARY SUPPLEMENTS 3319 02:25:46,120 --> 02:25:47,880 BUT FOR DRUG TRIALS TOO. 3320 02:25:47,880 --> 02:25:49,760 THERE ARE METHODS, WHETHER 3321 02:25:49,760 --> 02:25:53,440 IT'S -- SO THE BAYESIAN ANALYSES 3322 02:25:53,440 --> 02:25:54,680 AND FREQUENCY APPROACHES ARE ONE 3323 02:25:54,680 --> 02:25:56,080 WAY BUT IT STILL DOESN'T TAKE 3324 02:25:56,080 --> 02:25:57,920 AWAY FROM THE BASIC TENETS OF 3325 02:25:57,920 --> 02:25:59,400 CLINICAL TRIALS WHICH APPLY TO 3326 02:25:59,400 --> 02:25:59,840 DIETARY SUPPLEMENTS. 3327 02:25:59,840 --> 02:26:02,760 AT THE END OF THE DAY YOU NEED A 3328 02:26:02,760 --> 02:26:03,840 WELL-DESIGNED TRIAL REGARDLESS 3329 02:26:03,840 --> 02:26:08,040 OF METHODOLOGY IN WHICH YOU WANT 3330 02:26:08,040 --> 02:26:09,480 TO MAXIMIZE COMPLIANCE, MINIMIZE 3331 02:26:09,480 --> 02:26:10,560 LOSS TO FOLLOW-UP, CAPTURE THOSE 3332 02:26:10,560 --> 02:26:12,920 THINGS WELL SO YOU CAN 3333 02:26:12,920 --> 02:26:14,640 QUANTITATE IT, AND THEN AT THE 3334 02:26:14,640 --> 02:26:17,280 SAME TIME APPROACH THE ANALYSES 3335 02:26:17,280 --> 02:26:18,840 FROM DIFFERENT PERSPECTIVES TO 3336 02:26:18,840 --> 02:26:19,800 GIVE THE READER AND RESEARCH 3337 02:26:19,800 --> 02:26:21,560 COMMUNITY I THINK A MORE 3338 02:26:21,560 --> 02:26:27,280 COMPLETE PICTURE AS TO ROLE OF 3339 02:26:27,280 --> 02:26:28,280 DIET IS, WHAT THE DIETARY 3340 02:26:28,280 --> 02:26:29,960 SUPPLEMENT MIGHT BE ON A 3341 02:26:29,960 --> 02:26:31,840 PARTICULAR OUTCOME YOU'RE 3342 02:26:31,840 --> 02:26:32,320 TESTING. 3343 02:26:32,320 --> 02:26:33,760 >> THE NUTRITIONAL GENOMICS 3344 02:26:33,760 --> 02:26:39,520 TESTING FOR SNPs SEEMS TO 3345 02:26:39,520 --> 02:26:41,840 INDIVIDUALITY, INFLUENCED BY 3346 02:26:41,840 --> 02:26:44,760 ENVIRONMENTAL FACTORS AND 3347 02:26:44,760 --> 02:26:45,000 INTAKE. 3348 02:26:45,000 --> 02:26:47,440 DOES THIS MAKE META-ANALYSIS 3349 02:26:47,440 --> 02:26:47,920 INVALID FOR INDIVIDUAL 3350 02:26:47,920 --> 02:26:48,600 SUPPLEMENT EFFICACY? 3351 02:26:48,600 --> 02:26:49,360 >> GREAT QUESTION. 3352 02:26:49,360 --> 02:26:51,240 THIS IS ONE OF THE CHALLENGES 3353 02:26:51,240 --> 02:26:54,640 THAT WE HAVE WITH NUTRITION 3354 02:26:54,640 --> 02:26:56,240 RESEARCH MORE BROADLY, WHETHER 3355 02:26:56,240 --> 02:26:57,960 DIETARY SUPPLEMENTS, FOODS, 3356 02:26:57,960 --> 02:27:00,240 FUNCTIONAL FOODS OR DIETARY 3357 02:27:00,240 --> 02:27:02,360 PATTERNS FOR THAT MATTER, WE 3358 02:27:02,360 --> 02:27:03,720 KNOW NEUTRIGENOMICS OR HOWEVER 3359 02:27:03,720 --> 02:27:07,240 YOU WANT TO TERM IT, WE KNOW 3360 02:27:07,240 --> 02:27:08,840 INDIVIDUAL RESPONSES TO WHETHER 3361 02:27:08,840 --> 02:27:10,360 IT BE DIETARY SUPPLEMENTS, 3362 02:27:10,360 --> 02:27:12,080 WHETHER IT BE FUNCTIONAL FOODS, 3363 02:27:12,080 --> 02:27:14,120 OR WHETHER THEY BE DIETARY 3364 02:27:14,120 --> 02:27:14,760 PATTERNS DIFFERS. 3365 02:27:14,760 --> 02:27:18,080 SO THERE'S ALWAYS GOING TO BE 3366 02:27:18,080 --> 02:27:19,240 ENVIRONMENTAL FACTORS AND/OR 3367 02:27:19,240 --> 02:27:21,400 GENOMIC COMPONENTS THAT ARE 3368 02:27:21,400 --> 02:27:22,600 GOING TO DETERMINE WHETHER I 3369 02:27:22,600 --> 02:27:25,040 MIGHT RESPOND DIFFERENTLY TO A 3370 02:27:25,040 --> 02:27:26,280 MAGNESIUM SUPPLEMENT THAN DR. 3371 02:27:26,280 --> 02:27:27,000 BROWN MIGHT. 3372 02:27:27,000 --> 02:27:28,400 AND SO THE DANGER OF THIS OF 3373 02:27:28,400 --> 02:27:31,080 COURSE IS THAT A STUDY HAS TO BE 3374 02:27:31,080 --> 02:27:31,880 BIG ENOUGH AND DESIGNED 3375 02:27:31,880 --> 02:27:33,480 APPROPRIATELY ENOUGH TO TEASE 3376 02:27:33,480 --> 02:27:34,560 THOSE THINGS OUT. 3377 02:27:34,560 --> 02:27:36,640 SMALLER TRIALS, UNLESS YOU HAVE 3378 02:27:36,640 --> 02:27:39,520 A HYPOTHESIS FOR A SPECIFIC SNP 3379 02:27:39,520 --> 02:27:40,720 THAT YOU BELIEVE MIGHT MAKE ME 3380 02:27:40,720 --> 02:27:46,160 MORE OR LESS RESPONSIVE TO A 3381 02:27:46,160 --> 02:27:47,360 PARTICULAR SUPPLEMENT OR HAVE 3382 02:27:47,360 --> 02:27:48,560 SERUM LEVELS OF A BIOMARKER 3383 02:27:48,560 --> 02:27:49,240 CHANGE, THOSE ARE IMPORTANT BUT 3384 02:27:49,240 --> 02:27:50,520 YOU HAVE TO BE CAREFUL NOT TO 3385 02:27:50,520 --> 02:27:52,200 LET THAT BOG DOWN THE BASIC 3386 02:27:52,200 --> 02:27:53,520 QUESTION OF A DESIGNED TRIAL IN 3387 02:27:53,520 --> 02:27:56,240 THE FIRST PLACE TO ADDRESS THE 3388 02:27:56,240 --> 02:27:57,520 QUESTION OF EITHER EFFICACY OR 3389 02:27:57,520 --> 02:27:58,800 EFFECTIVENESS IN THE FIRST 3390 02:27:58,800 --> 02:28:00,120 PLACE. 3391 02:28:00,120 --> 02:28:03,040 IT'S AN IMPORTANT CONSIDERATION. 3392 02:28:03,040 --> 02:28:05,080 >> THANK YOU. 3393 02:28:05,080 --> 02:28:06,680 ANOTHER ONE, HOW MANY BLOOD 3394 02:28:06,680 --> 02:28:10,160 PRESSURE DRUG TRIALS GO ON FOR 3395 02:28:10,160 --> 02:28:16,080 11 YEARS? 3396 02:28:16,080 --> 02:28:17,360 >> NOT TOO MANY. 3397 02:28:17,360 --> 02:28:19,480 THE TRIAL I WAS ALLUDING TO WAS 3398 02:28:19,480 --> 02:28:20,400 A DIETARY SUPPLEMENT SUPPLEMENT 3399 02:28:20,400 --> 02:28:24,240 TRIAL OF A FEW SUPPLEMENTS, TWO 3400 02:28:24,240 --> 02:28:26,760 BY TWO BY TWO FACTORIAL TRIAL, 3401 02:28:26,760 --> 02:28:28,000 YOU CAN IMAGINE THE CALENDAR 3402 02:28:28,000 --> 02:28:30,600 PATH, THIS IS ONE FROM THE 3403 02:28:30,600 --> 02:28:32,240 COSMOS TRIAL, THIS HAD A LOT OF 3404 02:28:32,240 --> 02:28:33,960 PILLS IN IT BUT FOR DIETARY 3405 02:28:33,960 --> 02:28:39,560 SUPPLEMENT TRIALS ESPECIALLY FOR 3406 02:28:39,560 --> 02:28:41,800 CLINICAL OUTCOMES, NOT AS MUCH 3407 02:28:41,800 --> 02:28:42,880 FOR CARDIOVASCULAR, UP TO FIVE 3408 02:28:42,880 --> 02:28:47,280 YEARS OF FOLLOW-UP IS ENOUGH BUT 3409 02:28:47,280 --> 02:28:48,120 FOR CHEMOPREVENTION TRIALS, 3410 02:28:48,120 --> 02:28:49,800 ESPECIALLY FOR NUTRITION AND 3411 02:28:49,800 --> 02:28:52,280 CANCER, IT TAKES TIME FOR 3412 02:28:52,280 --> 02:28:54,600 EFFECTS TO EMERGE. 3413 02:28:54,600 --> 02:28:56,080 COLORECTAL CANCER, WITH 3414 02:28:56,080 --> 02:28:57,000 DIFFERENT NUTRITIONAL 3415 02:28:57,000 --> 02:28:57,760 INTERVENTIONS, EVEN AFTER 3416 02:28:57,760 --> 02:28:58,720 INTERVENTION STOPS IT'S 3417 02:28:58,720 --> 02:29:00,240 IMPORTANT FOR THE FOLLOW-UP TO 3418 02:29:00,240 --> 02:29:06,200 CONTINUE BECAUSE THERE'S ISSUES 3419 02:29:06,200 --> 02:29:06,480 OF LATENCY. 3420 02:29:06,480 --> 02:29:07,840 IT'S HARD TO DO. 3421 02:29:07,840 --> 02:29:10,040 BUT IT'S IMPORTANT TO HAVE 3422 02:29:10,040 --> 02:29:11,480 SUFFICIENT FOLLOW-UP TO TEASE 3423 02:29:11,480 --> 02:29:12,360 OUT THOSE EFFECTS. 3424 02:29:12,360 --> 02:29:13,160 >> THANK YOU. 3425 02:29:13,160 --> 02:29:17,160 I THINK WE DO HAVE TIME FOR ONE 3426 02:29:17,160 --> 02:29:20,320 MORE QUESTION. 3427 02:29:20,320 --> 02:29:23,520 MAYBE TWO MORE. 3428 02:29:23,520 --> 02:29:25,360 SUGGESTED COMBINES OBSERVATIONAL 3429 02:29:25,360 --> 02:29:26,920 STUDIES WITH RANDOMIZED CLINICAL 3430 02:29:26,920 --> 02:29:28,760 TRIALS, COULD YOU ELABORATE ON 3431 02:29:28,760 --> 02:29:29,880 THIS TYPE OF ANALYSIS? 3432 02:29:29,880 --> 02:29:31,520 >> YEAH, I APPRECIATE DR. 3433 02:29:31,520 --> 02:29:32,080 DWYER'S QUESTION. 3434 02:29:32,080 --> 02:29:34,280 I'VE HEARD THIS QUESTION A LOT. 3435 02:29:34,280 --> 02:29:39,720 I TAKE APPEARSALLY, IT 3436 02:29:39,720 --> 02:29:40,640 INTRODUCES DANGERS. 3437 02:29:40,640 --> 02:29:44,000 THE BEAUTY OF A CLINICAL TRIAL 3438 02:29:44,000 --> 02:29:45,880 DONE AS INTENTION, WHERE YOU CAN 3439 02:29:45,880 --> 02:29:46,920 ELIMINATE CONFOUNDING, NOT JUST 3440 02:29:46,920 --> 02:29:48,680 FOR WHAT YOU CAN MEASURE BUT YOU 3441 02:29:48,680 --> 02:29:49,600 CAN'T MEASURE. 3442 02:29:49,600 --> 02:29:53,120 OR NEW RISK FACTORS THAT HAVE 3443 02:29:53,120 --> 02:29:55,480 NOT YET EMERGED, IT BOILS DOWN 3444 02:29:55,480 --> 02:29:57,800 TO A SIMPLE TWO BY TWO TABLE, 3445 02:29:57,800 --> 02:29:59,880 TAKE A SUPPLEMENT, OR YOU DON'T, 3446 02:29:59,880 --> 02:30:03,400 WHATEVER THE CONTROL. 3447 02:30:03,400 --> 02:30:04,520 YOU HAVE AN OUTCOME. 3448 02:30:04,520 --> 02:30:06,640 OR YOU DON'T. 3449 02:30:06,640 --> 02:30:07,920 OBSERVATIONAL DATA WELL 3450 02:30:07,920 --> 02:30:09,680 CONDUCTED OBSERVATIONAL STUDY 3451 02:30:09,680 --> 02:30:10,040 CARRIES WEIGHT. 3452 02:30:10,040 --> 02:30:11,520 THERE'S ALSO WAYS TO TAKE 3453 02:30:11,520 --> 02:30:13,240 OBSERVATIONAL DATA THROUGH 3454 02:30:13,240 --> 02:30:15,640 MARGINAL STRUCTURAL MODELING AND 3455 02:30:15,640 --> 02:30:16,600 OTHER TECHNIQUES OUT THERE THAT 3456 02:30:16,600 --> 02:30:18,520 YOU CAN START TO APPROXIMATE 3457 02:30:18,520 --> 02:30:20,880 WHAT THE TRIAL RESULT MIGHT LOOK 3458 02:30:20,880 --> 02:30:22,160 LIKE FOR AN OBSERVATIONAL STUDY 3459 02:30:22,160 --> 02:30:29,800 BUT THAT BEING SAID I WOULD NOT 3460 02:30:29,800 --> 02:30:38,320 PUT THOSE TOGETHER PERSONALLY. 3461 02:30:38,320 --> 02:30:42,800 >> FOR DOCTORAL STUDENTS, DO YOU 3462 02:30:42,800 --> 02:30:43,560 HAVE SUGGESTIONS FOR STUDENTS, 3463 02:30:43,560 --> 02:30:44,440 WHAT ARE THINGS WE NEED TO BE 3464 02:30:44,440 --> 02:30:45,360 CAREFUL ABOUT? 3465 02:30:45,360 --> 02:30:47,400 >> IT'S A GREAT QUESTION. 3466 02:30:47,400 --> 02:30:50,080 I THINK THE SIMPLE ANSWER IS 3467 02:30:50,080 --> 02:30:50,480 TWO-FOLD. 3468 02:30:50,480 --> 02:31:01,120 ONE IS KNOW YOUR DATASET. 3469 02:31:01,120 --> 02:31:03,240 IT'S UNFAIR TO ASSUME ONLY 3470 02:31:03,240 --> 02:31:05,200 CLINICAL TRIALS ARE GOOD. 3471 02:31:05,200 --> 02:31:06,920 YOU HEARD ABOUT NHANES, THESE 3472 02:31:06,920 --> 02:31:07,960 ARE WONDERFUL RESOURCES WE ALL 3473 02:31:07,960 --> 02:31:08,920 OUGHT TO TAKE ADVANTAGE OF. 3474 02:31:08,920 --> 02:31:10,920 AT THE SAME TIME IT'S IMPORTANT 3475 02:31:10,920 --> 02:31:12,600 TO UNDERSTAND NOT JUST THE 3476 02:31:12,600 --> 02:31:15,160 NATURE OF THE OBSERVATIONAL 3477 02:31:15,160 --> 02:31:16,720 STUDY AND WHO IT RECOMMENDS BUT 3478 02:31:16,720 --> 02:31:18,160 HOW DATA WERE COLLECTED AS WELL 3479 02:31:18,160 --> 02:31:20,280 AS OUTCOMES AND QUESTIONS THAT 3480 02:31:20,280 --> 02:31:21,400 YOU'RE ASKING. 3481 02:31:21,400 --> 02:31:22,840 APPRECIATING THE ROLES OF BIAS 3482 02:31:22,840 --> 02:31:25,040 AND ERROR IN CONFOUNDING, HOW 3483 02:31:25,040 --> 02:31:27,600 THIS ROLLS INTO HOW YOU ANALYZE 3484 02:31:27,600 --> 02:31:30,440 DATA AND INTERPRET IT. 3485 02:31:30,440 --> 02:31:32,800 AT THE SAME TIME WHEN YOU'RE 3486 02:31:32,800 --> 02:31:35,040 DOING SECONDARY ANALYSES OF 3487 02:31:35,040 --> 02:31:36,920 EXISTING COHORTS EMBRACE THE 3488 02:31:36,920 --> 02:31:37,360 OPPORTUNITY. 3489 02:31:37,360 --> 02:31:40,320 KNOW WHAT YOUR LIMITATIONS ARE. 3490 02:31:40,320 --> 02:31:46,320 DON'T OVERINTERPRET YOUR 3491 02:31:46,320 --> 02:31:48,400 RESULTS, DON'T UNDERESTIMATE 3492 02:31:48,400 --> 02:31:50,120 WHAT RESULTS MEAN. 3493 02:31:50,120 --> 02:31:58,160 EMBRACE THE OPPORTUNITY. 3494 02:31:58,160 --> 02:31:59,080 >> THANK YOU. 3495 02:31:59,080 --> 02:32:00,120 >> MY PLEASURE. 3496 02:32:00,120 --> 02:32:01,360 IF ANYONE HAS QUESTIONS, DON'T 3497 02:32:01,360 --> 02:32:04,240 HESITATE TO REACH OUT TO ME, IF 3498 02:32:04,240 --> 02:32:04,720 YOU HAVE QUESTIONS ABOUT 3499 02:32:04,720 --> 02:32:05,720 RESEARCH AND DIETARY SUPPLEMENTS 3500 02:32:05,720 --> 02:32:15,760 IN GENERAL. 3501 02:32:15,760 --> 02:32:17,160 THANK YOU. 3502 02:32:17,160 --> 02:32:18,960 >> BACK TO DR. HARDY, IF SHE'S 3503 02:32:18,960 --> 02:32:19,640 READY. 3504 02:32:19,640 --> 02:32:21,880 DR. HARDY, ARE YOU READY? 3505 02:32:21,880 --> 02:32:24,640 I DON'T SEE DR. HARDY. 3506 02:32:24,640 --> 02:32:26,200 >> I'M HERE. 3507 02:32:26,200 --> 02:32:26,480 >> GREAT. 3508 02:32:26,480 --> 02:32:28,360 DR. HARDY WILL TAKE THE PODIUM 3509 02:32:28,360 --> 02:32:30,600 AND PRESENT ON THE CONCEPT OF 3510 02:32:30,600 --> 02:32:32,680 SAFETY, ITS MEASUREMENT, AND 3511 02:32:32,680 --> 02:32:33,360 REPORTING. 3512 02:32:33,360 --> 02:32:43,600 TAKE IT AWAY. 3513 02:32:45,960 --> 02:32:48,360 >> THANK YOU. 3514 02:32:48,360 --> 02:32:56,080 3515 02:32:56,080 --> 02:33:06,360 >> NOW WE DO. 3516 02:33:06,680 --> 02:33:07,040 >> OKAY. 3517 02:33:07,040 --> 02:33:09,640 LET ME GO BACK TO THE BEGINNING. 3518 02:33:09,640 --> 02:33:11,320 AGAIN, THIS IS AN ADVERSE EVENT, 3519 02:33:11,320 --> 02:33:13,320 SO WE'RE GOING TO HAVE TO THINK 3520 02:33:13,320 --> 02:33:15,920 ABOUT THIS AS THE SAFETY OF NOT 3521 02:33:15,920 --> 02:33:18,360 SIGNING ON FOR YOUR THING AN 3522 02:33:18,360 --> 02:33:19,560 HOUR EARLY. 3523 02:33:19,560 --> 02:33:20,680 THANK YOU, EVERYBODY. 3524 02:33:20,680 --> 02:33:23,360 I'M VERY GRATEFUL TO BE HERE AND 3525 02:33:23,360 --> 02:33:24,280 GRATEFUL TO OFFICE OF DIETARY 3526 02:33:24,280 --> 02:33:24,600 SUPPLEMENTS. 3527 02:33:24,600 --> 02:33:26,760 I WANT TO START THINKING ABOUT 3528 02:33:26,760 --> 02:33:29,120 THE CONCEPT OF SAFETY WITH YOU. 3529 02:33:29,120 --> 02:33:31,560 THIS IS USUALLY DISCUSSED AS AN 3530 02:33:31,560 --> 02:33:33,000 ON/OFF SWITCH. 3531 02:33:33,000 --> 02:33:34,640 I THINK IT'S REALLY -- WE HAVE 3532 02:33:34,640 --> 02:33:37,680 TO THINK BIT AS A MORE NUANCED 3533 02:33:37,680 --> 02:33:43,120 CONCEPT, AND AS DR. SESSO TALKED 3534 02:33:43,120 --> 02:33:44,320 ABOUT WHERE IS YOUR INFORMATION 3535 02:33:44,320 --> 02:33:47,080 COMING FROM AND WHAT DOES THAT 3536 02:33:47,080 --> 02:33:47,280 MEAN? 3537 02:33:47,280 --> 02:33:50,240 I TRAINED FIRST AS A CLINICIAN 3538 02:33:50,240 --> 02:33:52,760 SO I'M REALLY GOVERNING MYSELF 3539 02:33:52,760 --> 02:33:53,760 AND MY PRACTICE AND ANALYSIS AND 3540 02:33:53,760 --> 02:33:59,160 HOW I LOOK AT THINGS BY FIRST DO 3541 02:33:59,160 --> 02:34:01,200 NO HARM, BUT IS SAFETY ONLY THE 3542 02:34:01,200 --> 02:34:03,400 ABSENCE OF HARM OR IS THERE 3543 02:34:03,400 --> 02:34:05,200 SOMEBODY MORE PRO-ACTIVE WILL 3544 02:34:05,200 --> 02:34:06,160 SAFETY WE WOULD THINK ABOUT? 3545 02:34:06,160 --> 02:34:08,840 I THINK YOU CAN MAKE A CASE FOR 3546 02:34:08,840 --> 02:34:10,480 THE PRO-ACTIVE PUBLIC HEALTH 3547 02:34:10,480 --> 02:34:12,040 ISSUES OF SAFETY AT THE VERY 3548 02:34:12,040 --> 02:34:14,120 LEAST. 3549 02:34:14,120 --> 02:34:15,960 THIS IS WHAT THE ANALYSIS LOOKS 3550 02:34:15,960 --> 02:34:18,480 LIKE, THINKING ABOUT RISK, 3551 02:34:18,480 --> 02:34:19,600 RELATED TO SAFETY, VERSUS 3552 02:34:19,600 --> 02:34:19,840 BENEFIT. 3553 02:34:19,840 --> 02:34:24,520 CAN YOU PUT PATIENT CHOICE ON 3554 02:34:24,520 --> 02:34:28,200 TOP OF THAT, CAUSALITY, OR 3555 02:34:28,200 --> 02:34:29,200 POPULATION ISSUES, AND THEN 3556 02:34:29,200 --> 02:34:30,840 DECIDE OFTEN GIVEN THE AMOUNT OF 3557 02:34:30,840 --> 02:34:32,400 BENEFIT HOW MUCH RISK YOU'RE 3558 02:34:32,400 --> 02:34:34,760 WILLING TO ACCEPT. 3559 02:34:34,760 --> 02:34:39,160 SO, SAFETY IS OFTEN NOT AN 3560 02:34:39,160 --> 02:34:40,320 ABSOLUTE -- DISCUSSED IN 3561 02:34:40,320 --> 02:34:41,200 ABSOLUTE TERMS. 3562 02:34:41,200 --> 02:34:42,400 THERE ARE MULTIPLE SOURCES OF 3563 02:34:42,400 --> 02:34:43,200 SAFETY INFORMATION. 3564 02:34:43,200 --> 02:34:45,480 EACH OF THEM ARE USEFUL BUT EACH 3565 02:34:45,480 --> 02:34:50,240 OF THEM ARE LIMITED. 3566 02:34:50,240 --> 02:34:53,920 IN THE DIETARY SUPPLEMENT REALM 3567 02:34:53,920 --> 02:34:55,480 FOR HERBAL MEDICINE PEOPLE GO 3568 02:34:55,480 --> 02:34:56,680 STRAIGHT TO HISTORICAL USE IN 3569 02:34:56,680 --> 02:34:58,680 HUMANS, USED FOR THOUSANDS OF 3570 02:34:58,680 --> 02:35:01,320 YEARS, THEREFORE IT'S SAFE. 3571 02:35:01,320 --> 02:35:03,640 WE'LL LOOK AT THAT MORE CLOSELY 3572 02:35:03,640 --> 02:35:07,320 BECAUSE THERE'S SIGNIFICANT 3573 02:35:07,320 --> 02:35:07,960 LIMITATIONS. 3574 02:35:07,960 --> 02:35:09,080 PHARMACOLOGICAL AND MECHANISTIC 3575 02:35:09,080 --> 02:35:11,160 ACTIVITY IS USEFUL, IT MIGHT 3576 02:35:11,160 --> 02:35:13,440 SUPPORT YOU TO THINK ABOUT WHERE 3577 02:35:13,440 --> 02:35:15,520 THE SITUATION MIGHT BE OF HIGHER 3578 02:35:15,520 --> 02:35:22,160 RISK OR MIGHT BE BIOLOGICAL 3579 02:35:22,160 --> 02:35:22,880 PLAUSIBILITY. 3580 02:35:22,880 --> 02:35:24,120 IN SILICO ANALYSIS WHEN WE CAN'T 3581 02:35:24,120 --> 02:35:25,880 TEST THINKS IN VITRO OR IN VIVO 3582 02:35:25,880 --> 02:35:31,760 WHICH WE PREFER TO LOOK AT 3583 02:35:31,760 --> 02:35:33,400 SOMETHING, HERB-DRUG ANALYSIS IS 3584 02:35:33,400 --> 02:35:33,640 CLASSIC. 3585 02:35:33,640 --> 02:35:35,800 IN SILICO MAY GIVE US A HINT 3586 02:35:35,800 --> 02:35:41,280 BECAUSE WE FOUND OFTEN LOOKING 3587 02:35:41,280 --> 02:35:42,320 AT THIS STUFF SPECIFICALLY FROM 3588 02:35:42,320 --> 02:35:44,680 CELL SCREENING OR SOMETHING LIKE 3589 02:35:44,680 --> 02:35:46,040 THAT ISN'T ALWAYS PREDICTIVE, 3590 02:35:46,040 --> 02:35:49,440 NEITHER IS ANIMAL DATA OFTEN 3591 02:35:49,440 --> 02:35:51,560 PREDICTIVE OR ISOLATED SIP 3592 02:35:51,560 --> 02:35:52,280 ANALYSIS PREDICTIVE OF WHAT'S 3593 02:35:52,280 --> 02:35:53,760 GOING TO HAPPEN WHEN WE LOOK AT 3594 02:35:53,760 --> 02:35:57,280 A HUMAN WHO TAKES IT AS A FULL 3595 02:35:57,280 --> 02:35:58,480 PHARMACOLOGICAL STUDY. 3596 02:35:58,480 --> 02:36:00,000 OBSERVATIONAL DATA WE'VE HEARD 3597 02:36:00,000 --> 02:36:03,200 FROM DR. SESSO ABOUT THAT 3598 02:36:03,200 --> 02:36:03,760 ALREADY. 3599 02:36:03,760 --> 02:36:04,720 PHARMACOVIGILANCE IS VOLUNTARY 3600 02:36:04,720 --> 02:36:07,520 FOR THE PUBLIC, AND MANDATED FOR 3601 02:36:07,520 --> 02:36:11,560 REPORTERS, BUT IT'S WOEFULLY 3602 02:36:11,560 --> 02:36:11,880 UNDERREPORTED. 3603 02:36:11,880 --> 02:36:14,200 WE SEE A LOT OF DECISIONS MADE 3604 02:36:14,200 --> 02:36:24,720 BASED AROUND ADVERSE EVENTS AND 3605 02:36:25,240 --> 02:36:26,480 THIS HAS LIMITATIONS. 3606 02:36:26,480 --> 02:36:28,280 TRADITIONAL USE VARIES FOR 3607 02:36:28,280 --> 02:36:29,920 MODERN USE, WHAT LIMITS ABILITY 3608 02:36:29,920 --> 02:36:31,240 TO USE TRADITIONAL SAFETY. 3609 02:36:31,240 --> 02:36:34,520 SO, IF WE SAY WE WANT TO TAKE A 3610 02:36:34,520 --> 02:36:36,120 CERTAIN HERB FOR CARDIOVASCULAR 3611 02:36:36,120 --> 02:36:38,640 DISEASE, AND WE'RE THINKING 3612 02:36:38,640 --> 02:36:39,840 ABOUT CHOLESTEROL LOWERING, OR 3613 02:36:39,840 --> 02:36:42,560 BLOOD PRESSURE MEASUREMENT, IN A 3614 02:36:42,560 --> 02:36:47,000 TRADITIONAL SYSTEM THIS KIND OF 3615 02:36:47,000 --> 02:36:48,760 DIAGNOSTIC USE IS NOT REALLY 3616 02:36:48,760 --> 02:36:51,240 PRESENT IN THAT TRADITIONAL USE. 3617 02:36:51,240 --> 02:36:59,840 LIKEWISE, HERBS MAY BE MODIFIED, 3618 02:36:59,840 --> 02:37:06,040 GINKO HAS BEEN MODIFIED, IT'S A 3619 02:37:06,040 --> 02:37:08,200 PROPERTY STRUCTURED TO TAKE OUT 3620 02:37:08,200 --> 02:37:09,320 CERTAIN ADVERSE CONSTITUENTS, 3621 02:37:09,320 --> 02:37:10,840 BLEND IN THINGS THAT ARE THOUGHT 3622 02:37:10,840 --> 02:37:12,400 TO BE THE ACTIVE CONSTITUENTS, 3623 02:37:12,400 --> 02:37:14,560 AND SO THE PRODUCT THAT WE USE 3624 02:37:14,560 --> 02:37:16,800 AS A MODERN PHYTO MEDICINE, 3625 02:37:16,800 --> 02:37:19,600 GINGKO, HAS VERY LITTLE USE I 3626 02:37:19,600 --> 02:37:22,360 SUBMIT TO THE TRADITIONAL 3627 02:37:22,360 --> 02:37:26,400 CHINESE USE, SO WHEN DISEASES 3628 02:37:26,400 --> 02:37:28,280 AREN'T SAME, PATIENT POPULATIONS 3629 02:37:28,280 --> 02:37:30,240 AREN'T THE SAME YOU HAVE TROUBLE 3630 02:37:30,240 --> 02:37:33,480 INTEGRATING THIS, WE KNOW THAT 3631 02:37:33,480 --> 02:37:35,080 FOR ACUTE TOXICITY DATA 3632 02:37:35,080 --> 02:37:37,320 TRADITIONAL USE CAN BE HELPFUL. 3633 02:37:37,320 --> 02:37:39,200 THINGS THAT ARE TRADITIONALLY 3634 02:37:39,200 --> 02:37:42,120 TOXIC BUT GET THE LABEL OF 3635 02:37:42,120 --> 02:37:43,160 POISONS BECOME HISTORICALLY 3636 02:37:43,160 --> 02:37:45,320 IMPORTANT AS AGENTS OF 3637 02:37:45,320 --> 02:37:47,080 GOVERNMENTAL CHANGE IN A 3638 02:37:47,080 --> 02:37:48,320 DIFFERENT KIND OF SOCIETY, LET'S 3639 02:37:48,320 --> 02:37:48,760 SAY. 3640 02:37:48,760 --> 02:37:59,320 BUT WE DO HAVE SOME PRECEDENT IN 3641 02:37:59,320 --> 02:38:01,400 GOVERNMENTAL AGENCIES, LARGER 3642 02:38:01,400 --> 02:38:02,480 REGULATORY SCHEMA. 3643 02:38:02,480 --> 02:38:06,040 SO WHEN WE LOOK AT THIS DIETARY 3644 02:38:06,040 --> 02:38:07,320 SUPPLEMENT FOR SAFETY WE'RE 3645 02:38:07,320 --> 02:38:10,480 BALANCING BETWEEN TWO BASIC 3646 02:38:10,480 --> 02:38:11,000 THINGS. 3647 02:38:11,000 --> 02:38:13,640 WE'RE LOOKING AT SORT OF THE 3648 02:38:13,640 --> 02:38:15,640 ISSUE OF PATIENT AND CONSUMER 3649 02:38:15,640 --> 02:38:18,640 ISSUES, THINGS ABOUT THE 3650 02:38:18,640 --> 02:38:20,680 INDIVIDUAL PERSON, OR CONTEXT OF 3651 02:38:20,680 --> 02:38:22,320 USE, VERSES RELIABILITY OF THE 3652 02:38:22,320 --> 02:38:26,320 PRODUCT, QUALITY OF THE PRODUCT, 3653 02:38:26,320 --> 02:38:33,040 AND THOSE TWO INTERACTIONS OFTEN 3654 02:38:33,040 --> 02:38:33,960 RAISE SAFETY ISSUES. 3655 02:38:33,960 --> 02:38:36,280 WHEN WE'RE THINKING ABOUT SAFETY 3656 02:38:36,280 --> 02:38:38,040 ISSUES FOR THE PATIENT, WE'RE 3657 02:38:38,040 --> 02:38:40,920 LOOKING AT STAGE OF LIFE, VERY 3658 02:38:40,920 --> 02:38:41,960 YOUNG PEOPLE, VERY OLD PEOPLE, 3659 02:38:41,960 --> 02:38:44,840 IF THEY HAVE A MEDICAL CONDITION 3660 02:38:44,840 --> 02:38:45,520 OF HYPERTENSION WHICH 3661 02:38:45,520 --> 02:38:46,960 PREDISPOSES TO THE ADVERSE EVENT 3662 02:38:46,960 --> 02:38:48,760 WE'RE INTERESTED IN LET'S SAY 3663 02:38:48,760 --> 02:38:50,320 STROKE, THEN FINDING A STROKE IN 3664 02:38:50,320 --> 02:38:53,160 A PERSON WHO TOOK A DIETARY 3665 02:38:53,160 --> 02:38:56,760 SUPPLEMENT BUT HAS OTHER RISK 3666 02:38:56,760 --> 02:39:00,160 FACTORS BECOMES A LESS CLEAN 3667 02:39:00,160 --> 02:39:01,680 INDICATION OF NON-SAFETY OF THAT 3668 02:39:01,680 --> 02:39:04,000 PRODUCT, LET'S SAY. 3669 02:39:04,000 --> 02:39:05,720 AND THEN WHAT YOUR STATE OF 3670 02:39:05,720 --> 02:39:08,120 HYDRATION IS, STATE OF EXERTION, 3671 02:39:08,120 --> 02:39:10,520 AND ANY OTHER MEDICATION 3672 02:39:10,520 --> 02:39:11,640 SUPPLEMENTS, ET CETERA, ALL 3673 02:39:11,640 --> 02:39:14,480 PATIENT ISSUES RELEVANT AND CAN 3674 02:39:14,480 --> 02:39:18,280 BE SIGNIFICANTLY OF AN ISSUE. 3675 02:39:18,280 --> 02:39:22,840 WE HAD GUIDANCE IN THE PAST FROM 3676 02:39:22,840 --> 02:39:24,680 OUR WONDERFUL COLLEAGUE NORM WHO 3677 02:39:24,680 --> 02:39:28,360 IS NO LONGER WITH IS, HIS ADAGE 3678 02:39:28,360 --> 02:39:31,480 IF WHAT'S IN THE BOTTLE IS ON 3679 02:39:31,480 --> 02:39:32,360 THE LABEL, IF THEY ARE 3680 02:39:32,360 --> 02:39:35,440 CONCURRENT, IF THE PRODUCT HAS 3681 02:39:35,440 --> 02:39:37,080 BEEN PREPARED PROPERLY, SAFETY 3682 02:39:37,080 --> 02:39:39,880 IS NOT A COMMON EVENT, RARELY 3683 02:39:39,880 --> 02:39:40,560 ENCOUNTERED. 3684 02:39:40,560 --> 02:39:42,760 TOXICITY IS RARELY ENCOUNTERED. 3685 02:39:42,760 --> 02:39:45,080 LET'S LOOK AT WHY THAT'S SO. 3686 02:39:45,080 --> 02:39:46,320 THERE ARE DIFFERENT ISSUES ABOUT 3687 02:39:46,320 --> 02:39:47,360 QUALITY CONTROL THAT AFFECT 3688 02:39:47,360 --> 02:39:50,320 DIRECTLY ON SAFETY. 3689 02:39:50,320 --> 02:39:51,280 SOMETHING'S MISLABELED, IF IT'S 3690 02:39:51,280 --> 02:39:52,400 NOT -- IF PRODUCT IN THE BOTTLE 3691 02:39:52,400 --> 02:39:54,120 IS NOT WHAT THE LABEL SAYS IT 3692 02:39:54,120 --> 02:39:57,040 IS, IF THE PRODUCT'S BEEN 3693 02:39:57,040 --> 02:39:58,600 SUBSTITUTED OR MISIDENTIFIED, OR 3694 02:39:58,600 --> 02:40:00,960 IF IT'S THE RIGHT AGENT BUT 3695 02:40:00,960 --> 02:40:05,480 THERE'S TOXIC CONSTITUENTS 3696 02:40:05,480 --> 02:40:06,680 EITHER OVERCONCENTRATED OR NOT 3697 02:40:06,680 --> 02:40:07,760 ACCOUNTED FOR. 3698 02:40:07,760 --> 02:40:10,360 FOR EXAMPLE, IF YOU HAVE A 3699 02:40:10,360 --> 02:40:12,520 PRODUCT THAT'S TRADITIONALLY 3700 02:40:12,520 --> 02:40:15,240 USED AS A WATER-BASED HERBAL TEA 3701 02:40:15,240 --> 02:40:17,480 THAT'S TAKEN AS A WEAK 3702 02:40:17,480 --> 02:40:19,680 CONCOCTION, IN SMALL AMOUNTS, 3703 02:40:19,680 --> 02:40:22,280 YOU THEN EXTRACT THAT HERB WITH 3704 02:40:22,280 --> 02:40:26,920 AN ALCOHOL WATER EXTRACT, THE 3705 02:40:26,920 --> 02:40:30,120 CHANCE OF SEQUESTERING TOXIC 3706 02:40:30,120 --> 02:40:40,480 CONSTITUENTS IS GOOD. 3707 02:40:41,600 --> 02:40:42,680 IN ETHNIC PHARMACOPEIA PRODUCTS, 3708 02:40:42,680 --> 02:40:43,440 CONTAMINANTS HAPPEN ALL THE 3709 02:40:43,440 --> 02:40:46,760 TIME, IN THE WATER, MATERIAL, IF 3710 02:40:46,760 --> 02:40:53,920 WE MAKE OYSTER -- CALCIUM WITH 3711 02:40:53,920 --> 02:40:55,360 OYSTER SHELLS, CAN BE 3712 02:40:55,360 --> 02:40:57,680 CONTAMINATED BY LEAD. 3713 02:40:57,680 --> 02:40:58,680 IMPROPERLY MADE SUPPLEMENT WHEN 3714 02:40:58,680 --> 02:41:00,440 TOO MUCH OF THE OTHERWISE SAFE 3715 02:41:00,440 --> 02:41:01,920 INGREDIENT IS ADDED, WE SAW WITH 3716 02:41:01,920 --> 02:41:10,160 A THAT SELENIUM TOXICITY EVENT. 3717 02:41:10,160 --> 02:41:12,240 HOW IS MODERN REGULATION? 3718 02:41:12,240 --> 02:41:14,960 THIS IS THE PURVIEW OF THE 3719 02:41:14,960 --> 02:41:16,200 OFFICE OF FDA. 3720 02:41:16,200 --> 02:41:18,120 AND THERE ARE REGULATIONS ABOUT 3721 02:41:18,120 --> 02:41:21,000 HOW PLANTS ARE GROWN, COLLECTED, 3722 02:41:21,000 --> 02:41:21,920 HOW INGREDIENT IS HANDLED, WHAT 3723 02:41:21,920 --> 02:41:25,640 HAPPENS TO IT IN THE SUPPLY 3724 02:41:25,640 --> 02:41:29,440 CHAIN, AND THOSE ARE ALL 3725 02:41:29,440 --> 02:41:30,080 NECESSARY CONSTITUENTS THAT HAVE 3726 02:41:30,080 --> 02:41:32,640 SIGNIFICANT REGULATIONS ATTACHED 3727 02:41:32,640 --> 02:41:34,720 TO THEM NOW. 3728 02:41:34,720 --> 02:41:37,720 THE BETTER COMPANIES, MORE 3729 02:41:37,720 --> 02:41:38,600 RIGOROUS ABOUT UNDERSTANDING 3730 02:41:38,600 --> 02:41:42,560 THEIR MATERIALS REALLY GO ABOVE 3731 02:41:42,560 --> 02:41:44,600 AND BEYOND THESE REGULATIONS. 3732 02:41:44,600 --> 02:41:46,280 ONE OF THE ISSUES NOT 3733 02:41:46,280 --> 02:41:50,360 NECESSARILY TOXICITY BUT CAN 3734 02:41:50,360 --> 02:41:51,240 MAKE THIS COMPLICATED WITH 3735 02:41:51,240 --> 02:41:52,680 HERBAL PRODUCTS, THEY ARE 3736 02:41:52,680 --> 02:41:53,040 VARIABLE. 3737 02:41:53,040 --> 02:41:54,120 NOT INHERENTLY A BAD THING. 3738 02:41:54,120 --> 02:41:55,000 IT HAPPENS WHEN YOU GROW 3739 02:41:55,000 --> 02:41:55,560 SOMETHING. 3740 02:41:55,560 --> 02:41:56,960 YOU ARE JUST HAVE TO DRINK A 3741 02:41:56,960 --> 02:42:00,040 BOTTLE OF WINE AND YOU CAN GET A 3742 02:42:00,040 --> 02:42:02,960 WHITE WINE OR RED WINE OR 3743 02:42:02,960 --> 02:42:04,280 CHAMPAGNE, BASICALLY THE SAME 3744 02:42:04,280 --> 02:42:06,000 PLANT BUT THE WAY IT'S HANDLED 3745 02:42:06,000 --> 02:42:08,120 MAKES A DIFFERENCE. 3746 02:42:08,120 --> 02:42:10,280 THE WAY IT'S GROWN MAKES A 3747 02:42:10,280 --> 02:42:10,720 DIFFERENCE. 3748 02:42:10,720 --> 02:42:13,720 THAT SHOWS UP IN HERBAL PRODUCTS 3749 02:42:13,720 --> 02:42:14,960 AS WELL. 3750 02:42:14,960 --> 02:42:18,320 AND IT MAKES THIS ISSUE A BIT 3751 02:42:18,320 --> 02:42:19,720 MORE COMPLICATED. 3752 02:42:19,720 --> 02:42:21,240 VARIABILITY CAN MAKE IT 3753 02:42:21,240 --> 02:42:23,120 DIFFICULT, MAY CONTRIBUTE TO 3754 02:42:23,120 --> 02:42:25,320 TOXICITY DEPENDING ON ISSUES 3755 02:42:25,320 --> 02:42:26,560 THAT ARE THE NATURE OF THE 3756 02:42:26,560 --> 02:42:28,160 PLANT, WHERE IT'S GROWN. 3757 02:42:28,160 --> 02:42:30,440 AND WE ALSO LABEL UNEXPECTED 3758 02:42:30,440 --> 02:42:32,080 VARIABILITY BECAUSE WE KNOW 3759 02:42:32,080 --> 02:42:34,360 RTAIN AMOUNT OF VARIABILITY IS 3760 02:42:34,360 --> 02:42:35,520 TOLERATED, EXPECTED, WE ALL THAT 3761 02:42:35,520 --> 02:42:41,640 ADULT ADULTERATION, IF WE SEE 3762 02:42:41,640 --> 02:42:46,000 CHEAP TO BUY AND PUT BACK INTO 3763 02:42:46,000 --> 02:42:51,160 THE PRODUCT, ASCORBIC'S ACID, 3764 02:42:51,160 --> 02:42:54,200 FOR EXAMPLE, THE PRODUCT HAS 3765 02:42:54,200 --> 02:42:56,240 BEEN ARTIFICIALLY ENHANCED OR 3766 02:42:56,240 --> 02:42:56,560 ADULTERATED. 3767 02:42:56,560 --> 02:42:58,800 CONTAMINATION IS DIFFERENT THAN 3768 02:42:58,800 --> 02:42:59,640 ADULTERATION. 3769 02:42:59,640 --> 02:43:02,120 THIS IS AN EXAMPLE LOOKING AT 3770 02:43:02,120 --> 02:43:04,440 PRODUCTS BOUGHT OFF THE SHELF IN 3771 02:43:04,440 --> 02:43:06,840 BOSTON, LOOKING FOR HEAVY 3772 02:43:06,840 --> 02:43:08,240 METALS. 3773 02:43:08,240 --> 02:43:08,640 IT'S COMPLICATED. 3774 02:43:08,640 --> 02:43:19,160 IN THE ETHNOBOTANY OF PRODUCTS, 3775 02:43:25,280 --> 02:43:31,200 HEAVY METALS WOULD BE INCLUDED, 3776 02:43:31,200 --> 02:43:32,440 HANDLED BY PRECIPITATING AND 3777 02:43:32,440 --> 02:43:33,840 RESUSPENDING, ET CETERA. 3778 02:43:33,840 --> 02:43:38,240 SO, TO FIND THESE IN HERE IN 3779 02:43:38,240 --> 02:43:39,320 SMALL AMOUNTS MAY MIGHT OR MAY 3780 02:43:39,320 --> 02:43:41,080 NOT BE PART OF THE NATURE OF 3781 02:43:41,080 --> 02:43:42,520 THESE MATERIALS BUT WHAT WAS 3782 02:43:42,520 --> 02:43:46,040 FOUND WAS REALLY QUITE ALARMING 3783 02:43:46,040 --> 02:43:48,600 BECAUSE OF THE 70 PRODUCTS 3784 02:43:48,600 --> 02:43:49,880 IDENTIFIED AND ANALYZEDs, 14 3785 02:43:49,880 --> 02:43:50,840 BOUGHT OFF THE SHELF AVAILABLE 3786 02:43:50,840 --> 02:43:56,920 TO THE GENERAL SHELF HAD AT 3787 02:43:56,920 --> 02:43:59,400 LEAST ONE HEAVY METAL IN EXCESS, 3788 02:43:59,400 --> 02:44:02,840 THE RANGE WAS BROAD. 3789 02:44:02,840 --> 02:44:03,400 AND QUITE VARIABLE. 3790 02:44:03,400 --> 02:44:07,920 WHAT WAS SO -- ANOTHER FORM OF 3791 02:44:07,920 --> 02:44:11,200 CONTAMINATION IS IF THE PLANT 3792 02:44:11,200 --> 02:44:12,120 THAT'S USED IS MISIDENTIFIED, 3793 02:44:12,120 --> 02:44:16,280 THIS IS AN EXAMPLE OF A TOXIC 3794 02:44:16,280 --> 02:44:18,800 SUBSTITUTION, LOOKING FOR THIS 3795 02:44:18,800 --> 02:44:22,960 PLANT, PLANTAIN, BROAD LEAVES, 3796 02:44:22,960 --> 02:44:26,360 THIS IS THE INFLUORESCENCE, 3797 02:44:26,360 --> 02:44:27,680 IDENTIFYING IN THE WILD SHOULD 3798 02:44:27,680 --> 02:44:32,400 BE A STRAIGHT FORWARD EVENT. 3799 02:44:32,400 --> 02:44:36,560 BUT IF YOU JUST HAVE THE FLOWER, 3800 02:44:36,560 --> 02:44:40,160 A MISTAKE WAS MADE. 3801 02:44:40,160 --> 02:44:41,560 A RELATIVE OF FOXGLOVE WHERE THE 3802 02:44:41,560 --> 02:44:43,760 LEAF LOOKED LIKE THE PLANTAIN 3803 02:44:43,760 --> 02:44:46,480 WAS COLLECTED DURING A TIME WHEN 3804 02:44:46,480 --> 02:44:52,960 NO FLOWERS INFLUORESCENCE WAS 3805 02:44:52,960 --> 02:44:54,720 PRESENT, THE MISTAKE WAS MADE. 3806 02:44:54,720 --> 02:44:57,360 THIS IS AN EXAMPLE OF 3807 02:44:57,360 --> 02:44:59,040 UNINTENTIONAL ADULTERATION WITH 3808 02:44:59,040 --> 02:44:59,920 SIGNIFICANT CONSEQUENCES. 3809 02:44:59,920 --> 02:45:02,800 THIS IS A DIFFERENT EXAMPLE, 3810 02:45:02,800 --> 02:45:04,040 BLACK COHOSH, STARTING FROM THE 3811 02:45:04,040 --> 02:45:08,800 POINT OF VIEW OF KNOWN PROBLEM, 3812 02:45:08,800 --> 02:45:10,760 ADVERSE EVENTS, A CLUSTER FOUND 3813 02:45:10,760 --> 02:45:12,360 OF ADVERSE EVENTS SUBMITTED TO 3814 02:45:12,360 --> 02:45:15,080 THE NATURAL HEALTH PRODUCT 3815 02:45:15,080 --> 02:45:16,200 DIRECTORY OF CANADA. 3816 02:45:16,200 --> 02:45:18,960 WE WERE ASKED TO LOOK AT THIS 3817 02:45:18,960 --> 02:45:19,200 SERIES. 3818 02:45:19,200 --> 02:45:21,240 THE FIRST THING THAT THOSE OF US 3819 02:45:21,240 --> 02:45:22,880 WHO HAVE HAD EXPERIENCE FIRST 3820 02:45:22,880 --> 02:45:25,080 THING WE DID WAS FIND A BOTTLE 3821 02:45:25,080 --> 02:45:27,120 OF THE STUFF THAT ALLEGEDLY 3822 02:45:27,120 --> 02:45:28,360 CAUSED THE PROBLEM AND FIND OUT 3823 02:45:28,360 --> 02:45:30,320 WHAT'S IN THE BOTTLE. 3824 02:45:30,320 --> 02:45:33,360 AGAIN, THAT'S THE GUIDANCE OF 3825 02:45:33,360 --> 02:45:34,200 DR. FARNSWORTH, MAKE SURE WHAT'S 3826 02:45:34,200 --> 02:45:36,160 IN THE BOTTLE IS WHAT YOU THINK 3827 02:45:36,160 --> 02:45:36,720 YOU'VE GOT. 3828 02:45:36,720 --> 02:45:39,320 TURNED OUT THAT WASN'T THE CASE. 3829 02:45:39,320 --> 02:45:45,000 THESE PRODUCTS WERE ADULTERATED 3830 02:45:45,000 --> 02:45:47,880 WITH A DIFFERENT SPECIES, A 3831 02:45:47,880 --> 02:45:51,800 SEDATIVE FROM CANADA, WITH 3832 02:45:51,800 --> 02:45:52,640 DIFFERENT CONSTITUENT BASE, 3833 02:45:52,640 --> 02:45:53,880 DIFFERENT PHYTOCHEMICAL BASE 3834 02:45:53,880 --> 02:45:56,520 THAN THE NORTH AMERICAN BLACK 3835 02:45:56,520 --> 02:45:57,640 COHOSH, AND BECAUSE NORTH 3836 02:45:57,640 --> 02:45:59,200 AMERICAN BLACK COHOSH CAN BE 3837 02:45:59,200 --> 02:46:01,520 QUITE EXPENSIVE THIS WAS AN 3838 02:46:01,520 --> 02:46:05,560 ECONOMIC ADULTERATION, ONCE 3839 02:46:05,560 --> 02:46:07,280 ASSUMES IT WAS INTENTIONAL. 3840 02:46:07,280 --> 02:46:10,200 NOW A LOT OF ATTENTION PUT ON 3841 02:46:10,200 --> 02:46:14,040 ADVERSE EVENTS, 3842 02:46:14,040 --> 02:46:14,680 ATTENTION-GETTING THINGS, 3843 02:46:14,680 --> 02:46:21,240 TAINTED PRODUCTS SOLD, A 3844 02:46:21,240 --> 02:46:23,280 PITCHER DIED AFTER INGESTING 3845 02:46:23,280 --> 02:46:24,760 EFED RIN COMPOUND. 3846 02:46:24,760 --> 02:46:27,160 THEY ROUSE UP A LOT OF PUBLIC 3847 02:46:27,160 --> 02:46:31,200 FEELING SO THE ISSUE IS HOW TO 3848 02:46:31,200 --> 02:46:33,040 WEIGHT SAFETY ISSUES 3849 02:46:33,040 --> 02:46:34,520 APPROPRIATELY. 3850 02:46:34,520 --> 02:46:37,160 SO, HERE IS HOW ADVERSE EVENTS 3851 02:46:37,160 --> 02:46:37,640 CAN HAPPEN. 3852 02:46:37,640 --> 02:46:41,360 THERE'S A LOT OF THINGS I'VE 3853 02:46:41,360 --> 02:46:43,000 ALREADY TOLD YOU, ADULTERATION, 3854 02:46:43,000 --> 02:46:44,680 INHERENT TOXICITY. 3855 02:46:44,680 --> 02:46:45,240 PHARMACOLOGIC EFFECTS OF AN 3856 02:46:45,240 --> 02:46:46,200 INDIVIDUAL PRODUCT, FOR EXAMPLE, 3857 02:46:46,200 --> 02:46:49,680 IF IT'S SOMETHING THAT LOWERS 3858 02:46:49,680 --> 02:46:50,560 BLOOD SUGAR IN A SENSITIVE 3859 02:46:50,560 --> 02:46:52,640 INDIVIDUAL, YOU COULD HAVE A 3860 02:46:52,640 --> 02:46:54,440 SIGNIFICANT LOWERING OF BLOOD 3861 02:46:54,440 --> 02:46:55,840 PRESSURE, ISSUE OF INTERACTIONS 3862 02:46:55,840 --> 02:47:00,160 IS POSSIBLE, I THINK 3863 02:47:00,160 --> 02:47:02,080 OVEREXAGGERATED, AND BILL GURLEY 3864 02:47:02,080 --> 02:47:03,440 WILL GIVE YOU A DISCUSSION OF 3865 02:47:03,440 --> 02:47:05,240 THAT TODAY. 3866 02:47:05,240 --> 02:47:07,200 ABUSE AND MISUSE, YOU HAVE 3867 02:47:07,200 --> 02:47:08,520 PEOPLE USING THESE THINGS, DON'T 3868 02:47:08,520 --> 02:47:09,720 ALWAYS MAKE SENSIBLE CHOICES. 3869 02:47:09,720 --> 02:47:14,200 AND THEN AS ALWAYS THERE ARE 3870 02:47:14,200 --> 02:47:16,960 THINGS WE CALL IDIOSYNCRATIC 3871 02:47:16,960 --> 02:47:19,520 REACTIONS, SOME MAY BE EXPLAINED 3872 02:47:19,520 --> 02:47:21,800 BY THE ISSUE OF THE INDIVIDUAL 3873 02:47:21,800 --> 02:47:24,440 GENOMICS WE'RE BEGINNING TO GET 3874 02:47:24,440 --> 02:47:25,600 A HANDLE ON. 3875 02:47:25,600 --> 02:47:28,240 ADVERSE EVENTS ARE HARD TO FIND 3876 02:47:28,240 --> 02:47:28,760 REPORTS OF. 3877 02:47:28,760 --> 02:47:30,960 AND THERE ARE TWO SYSTEMS. 3878 02:47:30,960 --> 02:47:32,240 THERE'S GOVERNMENTAL SYSTEM BUT 3879 02:47:32,240 --> 02:47:35,520 WE ALSO AS A SCHOLAR LOOK BACK 3880 02:47:35,520 --> 02:47:35,800 AT PubMed. 3881 02:47:35,800 --> 02:47:38,320 THERE'S OFTEN MORE TIME TO 3882 02:47:38,320 --> 02:47:39,560 ANALYZE THESE EVENTS, REPORT 3883 02:47:39,560 --> 02:47:40,840 THEM MORE COMPLETELY, SO WE WANT 3884 02:47:40,840 --> 02:47:43,720 TO SEE CAN WE FIND THESE EVENTS 3885 02:47:43,720 --> 02:47:44,840 IN PubMed. 3886 02:47:44,840 --> 02:47:48,640 MeSH TERMS, A WAY THAT DATA IS 3887 02:47:48,640 --> 02:47:50,840 FOUND IN PubMed, AND OTHER 3888 02:47:50,840 --> 02:47:53,240 ACADEMIC TYPES OF SEARCHING 3889 02:47:53,240 --> 02:47:55,000 SYSTEMS, THEY ARE VERY -- 3890 02:47:55,000 --> 02:47:56,440 SENSITIVITY IS VERY POOR. 3891 02:47:56,440 --> 02:47:59,400 IF YOU SAY ADVERSE, YOU DON'T 3892 02:47:59,400 --> 02:48:01,160 GET MUCH. 3893 02:48:01,160 --> 02:48:02,280 ADVERSE EFFECTS, 86% BUT DON'T 3894 02:48:02,280 --> 02:48:03,880 ALWAYS GET WHAT YOU'RE LOOKING 3895 02:48:03,880 --> 02:48:04,040 FOR. 3896 02:48:04,040 --> 02:48:05,960 THAT CONTAINS A LOT OF THINGS 3897 02:48:05,960 --> 02:48:07,440 THAT AREN'T EXACTLY THE ISSUE 3898 02:48:07,440 --> 02:48:09,960 THAT YOU'RE LOOKING FOR. 3899 02:48:09,960 --> 02:48:11,440 COMPLICATIONS GIVES YOU A CHUNK, 3900 02:48:11,440 --> 02:48:13,520 POISONING GIVES YOU A CHUNK. 3901 02:48:13,520 --> 02:48:15,320 IF YOU ADD FOUR TERMS TOGETHER 3902 02:48:15,320 --> 02:48:16,200 YOU OFTEN GET EVERYTHING WHICH 3903 02:48:16,200 --> 02:48:18,560 YOU THEN HAVE TO SORT THROUGH TO 3904 02:48:18,560 --> 02:48:22,200 FIND THE RELEVANT DATA FOR WHAT 3905 02:48:22,200 --> 02:48:25,120 YOU'RE INTERESTED IN. 3906 02:48:25,120 --> 02:48:25,320 OKAY. 3907 02:48:25,320 --> 02:48:28,320 SO, NOW, FIRST OF ALL WE SHOULD 3908 02:48:28,320 --> 02:48:34,800 BE CLEAR, MINOR EVENTS HAPPEN A 3909 02:48:34,800 --> 02:48:35,440 LOT, SELF-LIMITING, OFTEN DON'T 3910 02:48:35,440 --> 02:48:39,040 STOP USE OF A PRODUCT, DRUG OR 3911 02:48:39,040 --> 02:48:39,920 SUPPLEMENT ESPECIALLY IF THE 3912 02:48:39,920 --> 02:48:44,240 PERSON IS COMMITTED TO USE. 3913 02:48:44,240 --> 02:48:46,640 ADVERSE EVENTS RESULT IN SERIOUS 3914 02:48:46,640 --> 02:48:48,120 OUTCOME THAT OFTEN REQUIRES 3915 02:48:48,120 --> 02:48:50,760 MEDICAL ATTENTION, IF IT'S 3916 02:48:50,760 --> 02:48:56,720 ULTIMATE, IT'S DEATH. 3917 02:48:56,720 --> 02:48:57,960 CAN REQUIRE A VISIT TO THE 3918 02:48:57,960 --> 02:49:00,560 EMERGENCY ROOM, MAY OR MAY NOT 3919 02:49:00,560 --> 02:49:02,240 IN RESULT IN HOSPITALIZATION. 3920 02:49:02,240 --> 02:49:05,680 BIRTH DEFECTS ARE DIFFICULT TO 3921 02:49:05,680 --> 02:49:06,040 PROVE. 3922 02:49:06,040 --> 02:49:08,080 BUT IT'S BASICALLY AN IMPORTANT 3923 02:49:08,080 --> 02:49:10,640 MEDICAL EVENT THAT REQUIRES 3924 02:49:10,640 --> 02:49:12,080 MEDICAL OR SURGICAL INTERVENTION 3925 02:49:12,080 --> 02:49:14,000 TO PREVENT A SERIOUS OUTCOME IF 3926 02:49:14,000 --> 02:49:14,920 ONE HASN'T ALREADY OCCURRED. 3927 02:49:14,920 --> 02:49:17,320 FOR THE PURPOSE OF REPORTING 3928 02:49:17,320 --> 02:49:20,000 EVENTS, THE PATIENT ALSO GETS TO 3929 02:49:20,000 --> 02:49:22,200 DECIDE FOR THEMSELVES WHAT'S A 3930 02:49:22,200 --> 02:49:23,760 SERIOUS OUTCOME, MAY BE 3931 02:49:23,760 --> 02:49:24,800 DIFFERENT THAN OUR SERIOUS 3932 02:49:24,800 --> 02:49:25,280 MEDICAL INTERVENTION. 3933 02:49:25,280 --> 02:49:27,560 IN FACT I'LL TELL YOU ABOUT THAT 3934 02:49:27,560 --> 02:49:28,880 WHEN HE LOOK AT ADVERSE EVENT 3935 02:49:28,880 --> 02:49:31,080 DATA BIT LATER ON. 3936 02:49:31,080 --> 02:49:33,120 THERE'S A LOT OF UNCERTAINTY AND 3937 02:49:33,120 --> 02:49:34,960 VARIABILITY IN THIS REPORTED 3938 02:49:34,960 --> 02:49:37,000 INFORMATION, MISSING INFORMATION 3939 02:49:37,000 --> 02:49:39,200 IS VERY, VERY COMMON. 3940 02:49:39,200 --> 02:49:42,560 WE OFTEN DON'T KNOW THE PRODUCT, 3941 02:49:42,560 --> 02:49:44,760 WHICH IS BAD, BECAUSE ONLY 50% 3942 02:49:44,760 --> 02:49:45,720 OF DIETARY SUPPLEMENTS SOLD IN 3943 02:49:45,720 --> 02:49:47,560 THE UNITED STATES ARE SOLD AS 3944 02:49:47,560 --> 02:49:48,880 SINGLE AGENT PRODUCTS. 3945 02:49:48,880 --> 02:49:51,240 MANY OF THEM ARE MULTIPLE 3946 02:49:51,240 --> 02:49:53,920 FORMULAS, AND THEREFORE YOU 3947 02:49:53,920 --> 02:49:56,760 CAN'T ATTRIBUTE RISK SOLELY TO 3948 02:49:56,760 --> 02:49:59,280 ONE ENTITY IF IT'S IN A 3949 02:49:59,280 --> 02:50:00,040 MULTIPLE-ENTITY PRODUCT. 3950 02:50:00,040 --> 02:50:02,760 AGAIN, WE HAVE ALL THIS 3951 02:50:02,760 --> 02:50:04,080 VARIABILITY WITH PATIENTS AND 3952 02:50:04,080 --> 02:50:05,600 POPULATIONS AND CONDITIONS OF 3953 02:50:05,600 --> 02:50:07,320 USE, WHICH WITHOUT ADEQUATE 3954 02:50:07,320 --> 02:50:09,040 REPORTING MAKE IT VERY DIFFICULT 3955 02:50:09,040 --> 02:50:11,840 FOR US TO PUT ADVERSE EVENT IN 3956 02:50:11,840 --> 02:50:12,600 CONTEXT. 3957 02:50:12,600 --> 02:50:16,440 HAPPILY, AS DR. SESSO TOLD US, A 3958 02:50:16,440 --> 02:50:17,720 WELL-DESIGNED CLINICAL TRIAL 3959 02:50:17,720 --> 02:50:21,000 WHICH ELIMINATES A LOT OF 3960 02:50:21,000 --> 02:50:21,880 VARIABILITY AND SOURCES OF 3961 02:50:21,880 --> 02:50:24,640 EFFECT THAT WE DO OR DON'T KNOW 3962 02:50:24,640 --> 02:50:27,040 ABOUT AS HE SAID CAN BE GOOD 3963 02:50:27,040 --> 02:50:28,680 PLACES TO SELECT ADVERSE EVENT 3964 02:50:28,680 --> 02:50:29,360 DATA. 3965 02:50:29,360 --> 02:50:33,280 A LOT OF STUDIES DO REPORT SIDE 3966 02:50:33,280 --> 02:50:35,240 EFFECTS OR ADVERSE EFFECTS IN 3967 02:50:35,240 --> 02:50:38,200 THE PROCESS OF DESIGNING AND 3968 02:50:38,200 --> 02:50:39,400 REPORTING A TRIAL, BUT, AGAIN, 3969 02:50:39,400 --> 02:50:42,560 CAUSALITY CAN STILL BE AN ISSUE, 3970 02:50:42,560 --> 02:50:45,240 AND IN AS YOU ASK THE QUESTION 3971 02:50:45,240 --> 02:50:47,040 AFFECTS WHAT YOU GET. 3972 02:50:47,040 --> 02:50:50,000 SO IF YOU JUST SAY ANY PROBLEMS, 3973 02:50:50,000 --> 02:50:52,520 AND THAT MAY BE TOO CASUAL, IF 3974 02:50:52,520 --> 02:50:54,160 YOU SPECIFICALLY ASK FOR ISSUES 3975 02:50:54,160 --> 02:50:56,280 YOU'RE INTERESTED IN, YOU MAY 3976 02:50:56,280 --> 02:50:57,920 GET OVERREPORTING OF THOSE 3977 02:50:57,920 --> 02:50:59,520 ISSUES, AND LESS REPORTING OF 3978 02:50:59,520 --> 02:51:00,720 ISSUES THAT YOU DON'T 3979 02:51:00,720 --> 02:51:02,400 PARTICULARLY KNOW ABOUT, ET 3980 02:51:02,400 --> 02:51:02,720 CETERA. 3981 02:51:02,720 --> 02:51:04,200 AND THE ISSUE ALWAYS NEEDS TO BE 3982 02:51:04,200 --> 02:51:06,200 MAKE SURE YOU KNOW WHAT YOUR 3983 02:51:06,200 --> 02:51:07,720 MATERIAL IS, EITHER THE 3984 02:51:07,720 --> 02:51:11,160 OFFENDING MATERIAL OR MATERIAL 3985 02:51:11,160 --> 02:51:15,800 YOU'RE STUDDING IN A CLINICAL 3986 02:51:15,800 --> 02:51:16,880 TRIAL. 3987 02:51:16,880 --> 02:51:19,200 THIS IS A BIT TRICKY, IT'S NOT 3988 02:51:19,200 --> 02:51:21,440 THE SAME AS INTAKE LIMIT 3989 02:51:21,440 --> 02:51:22,240 ANALYSIS IN TOXICOLOGY. 3990 02:51:22,240 --> 02:51:27,240 IT'S NOT THE SAME THING AS 3991 02:51:27,240 --> 02:51:28,240 TOXICOLOGY ASSESSMENT. 3992 02:51:28,240 --> 02:51:29,440 YOU CAN GET A WELL ROUNDED 3993 02:51:29,440 --> 02:51:32,320 PICTURE OF WHAT THIS IS. 3994 02:51:32,320 --> 02:51:33,560 IT'S INFORMED BY PHARMACOLOGY. 3995 02:51:33,560 --> 02:51:35,320 WHAT KIND OF TIME FRAME WOULD BE 3996 02:51:35,320 --> 02:51:37,520 APPROPRIATE TO SEE AN ADVERSE 3997 02:51:37,520 --> 02:51:38,560 EVENT, WOULD BE BASED ON 3998 02:51:38,560 --> 02:51:40,920 PHARMACOLOGY OF THE MATERIAL 3999 02:51:40,920 --> 02:51:45,640 THAT'S BEING TAKEN. 4000 02:51:45,640 --> 02:51:47,680 IF ADVERSE EVENT IS TOO QUICKLY, 4001 02:51:47,680 --> 02:51:49,400 OR SEPARATED IN TIME, THE EVENT 4002 02:51:49,400 --> 02:51:51,520 HAS LESS OF A LIKELIHOOD OF 4003 02:51:51,520 --> 02:51:55,680 BEING A CLEAR DEMONSTRATION OF 4004 02:51:55,680 --> 02:51:56,240 TOXICITY. 4005 02:51:56,240 --> 02:51:57,560 TOXICOLOGY ALSO EXPOSURE, ET 4006 02:51:57,560 --> 02:51:58,000 CETERA. 4007 02:51:58,000 --> 02:52:00,480 THE THINGS THAT MAKE THIS 4008 02:52:00,480 --> 02:52:02,360 ANALYSIS IMPORTANT IS IF YOU CAN 4009 02:52:02,360 --> 02:52:07,520 TIE THEM BACK TO CAUSALITY, AND 4010 02:52:07,520 --> 02:52:07,840 THAT'S TRICKY. 4011 02:52:07,840 --> 02:52:11,920 SO RANDOMIZED CONTROLLED TRIALS 4012 02:52:11,920 --> 02:52:12,720 YOU CAN ATTRIBUTE CAUSALITY, 4013 02:52:12,720 --> 02:52:14,760 SUCCESSFULLY RANDOMIZED TRIAL 4014 02:52:14,760 --> 02:52:15,600 ANYTHING THAT HAPPENS IN THE 4015 02:52:15,600 --> 02:52:17,640 GROUP THAT GOT THE MATERIAL 4016 02:52:17,640 --> 02:52:19,800 VERSUS PLACEBO GROUP OR CONTROL 4017 02:52:19,800 --> 02:52:21,600 GROUP THAT DIDN'T GET THE 4018 02:52:21,600 --> 02:52:23,680 MATERIAL AS A BROAD STATEMENT IF 4019 02:52:23,680 --> 02:52:24,680 YOU'VE DONE YOUR RANDOMIZATION 4020 02:52:24,680 --> 02:52:27,000 PROPERLY AND HAVE SHOWN A 4021 02:52:27,000 --> 02:52:30,040 DIFFERENCE IN OUTCOME THAT 4022 02:52:30,040 --> 02:52:31,560 OUTCOME COULD BE CALLED -- COULD 4023 02:52:31,560 --> 02:52:34,240 BE ATTRIBUTED TO MATERIAL TAKEN. 4024 02:52:34,240 --> 02:52:35,720 THE COHORT DEPENDING HOW 4025 02:52:35,720 --> 02:52:42,080 STRUCTURED MIGHT BE ABLE TO 4026 02:52:42,080 --> 02:52:42,880 ATTRIBUTE CAUSALITY. 4027 02:52:42,880 --> 02:52:45,080 CASE SERIES OR LARGE NUMBERS, 4028 02:52:45,080 --> 02:52:46,160 UNABLE TO ATTRIBUTE CAUSALITY 4029 02:52:46,160 --> 02:52:48,960 UNLESS THE PATIENT IS 4030 02:52:48,960 --> 02:52:49,560 RECHALLENGED. 4031 02:52:49,560 --> 02:52:52,000 NOW, THIS IS A TRICKY PIECE OF 4032 02:52:52,000 --> 02:52:53,440 BUSINESS BECAUSE LET'S SAY YOU 4033 02:52:53,440 --> 02:52:56,720 TOOK SOMETHING AND HAVE SERIOUS 4034 02:52:56,720 --> 02:52:57,680 MEDICAL ADVERSE EVENT, CERTAINLY 4035 02:52:57,680 --> 02:52:59,480 IF YOU DIED THAT ABILITY TO 4036 02:52:59,480 --> 02:53:02,240 RECHALLENGE THAT IS NOT 4037 02:53:02,240 --> 02:53:02,480 POSSIBLE. 4038 02:53:02,480 --> 02:53:04,200 AND SO DECHALLENGING, TAKE THE 4039 02:53:04,200 --> 02:53:05,200 MATERIAL AWAY, ADVERSE EVENT 4040 02:53:05,200 --> 02:53:06,360 GOES AWAY. 4041 02:53:06,360 --> 02:53:09,320 WELL, IF IT'S A HARD ENDPOINT 4042 02:53:09,320 --> 02:53:11,160 ADVERSE EVENT LIKE STROKE, THE 4043 02:53:11,160 --> 02:53:12,600 STROKE ISN'T GOING AWAY BUT YOU 4044 02:53:12,600 --> 02:53:15,080 MIGHT SEE RESOLUTION OF SYMPTOMS 4045 02:53:15,080 --> 02:53:20,440 FOR ANXIETY, BLOOD PRESSURE, 4046 02:53:20,440 --> 02:53:21,680 TACHYCARDIA, ET CETERA, YOU CAN 4047 02:53:21,680 --> 02:53:26,200 SEE ADVERSE EVENT GO AWAY, TAKE 4048 02:53:26,200 --> 02:53:28,320 THE MEDICATION AWAY. 4049 02:53:28,320 --> 02:53:29,600 TAKE THE CAUSATIVE AGENT AWAY, 4050 02:53:29,600 --> 02:53:32,960 AND RETURN IF YOU'RE 4051 02:53:32,960 --> 02:53:33,520 RECHALLENGES. 4052 02:53:33,520 --> 02:53:35,120 I'VE SEEN THAT IN AN INTEGRATIVE 4053 02:53:35,120 --> 02:53:38,920 ONCOLOGY CASE, WHERE A PATIENT 4054 02:53:38,920 --> 02:53:41,480 WAS GIVEN A BIOLOGICAL RESPONSE 4055 02:53:41,480 --> 02:53:42,880 MODIFIER DRUG ON THEIR CANCER, 4056 02:53:42,880 --> 02:53:45,080 WERE HAVING A CERTAIN EFFECT, 4057 02:53:45,080 --> 02:53:47,520 STARTED DRINKING GREEN TEA, 4058 02:53:47,520 --> 02:53:49,240 EFFECT REDUCED ON TUMOR, STOPPED 4059 02:53:49,240 --> 02:53:50,880 THE GREEN TEA, TUMOR RESPONSE 4060 02:53:50,880 --> 02:53:54,640 CAME BACK TO NORMAL, READDED 4061 02:53:54,640 --> 02:53:59,800 GREEN TEE AND REPLICATED SAME 4062 02:53:59,800 --> 02:54:01,800 RESPONSE, THAT'S SUCCESSFUL 4063 02:54:01,800 --> 02:54:03,080 DECHALLENGE/RECHALLENGE BUT MOST 4064 02:54:03,080 --> 02:54:04,520 PEOPLE WON'T RISK SERIOUS 4065 02:54:04,520 --> 02:54:04,840 ADVERSE EVENT. 4066 02:54:04,840 --> 02:54:08,280 AND THERE ARE LOTS OF OTHER 4067 02:54:08,280 --> 02:54:10,000 KINDS OF STUDIES BUT NONE ON THE 4068 02:54:10,000 --> 02:54:11,440 FACE AS A SINGLE ENTITY, A PIECE 4069 02:54:11,440 --> 02:54:16,120 OF DATA WOULD BE ABLE TO 4070 02:54:16,120 --> 02:54:18,720 ATTRIBUTE CAUSALITY. 4071 02:54:18,720 --> 02:54:21,720 NOW, CLINICAL STUDIES HAVE THE 4072 02:54:21,720 --> 02:54:23,720 STRONGEST ABILITY TO GIVE US A 4073 02:54:23,720 --> 02:54:25,640 SENSE OF ADVERSE EVENT, ALSO 4074 02:54:25,640 --> 02:54:27,160 HAVE LIMITATIONS. 4075 02:54:27,160 --> 02:54:28,920 THEY ARE USUALLY NOT LARGE 4076 02:54:28,920 --> 02:54:31,680 ENOUGH TO SHOW US RARE EVENTS. 4077 02:54:31,680 --> 02:54:33,240 SO, LOOK AT THIS. 4078 02:54:33,240 --> 02:54:34,520 IF AN EVENT HAPPENS ONE TIME IN 4079 02:54:34,520 --> 02:54:37,600 A THOUSAND THE RULE OF THUMB IS 4080 02:54:37,600 --> 02:54:38,560 YOU NEED TO ENROLL THREE TIMES 4081 02:54:38,560 --> 02:54:40,840 OF THE NUMBER OF PREVALENCE OF 4082 02:54:40,840 --> 02:54:42,560 EVENT TO BE ABLE TO CLEARLY SAY 4083 02:54:42,560 --> 02:54:44,600 THAT YOU SHOULD SEE IT OR NOT 4084 02:54:44,600 --> 02:54:45,360 SEE IT. 4085 02:54:45,360 --> 02:54:47,800 SO IF SOMETHING HAPPENS ONCE IN 4086 02:54:47,800 --> 02:54:49,320 A THOUSAND, WHICH ON PUBLIC 4087 02:54:49,320 --> 02:54:52,360 HEALTH LEVELS IS NOT ALL THAT 4088 02:54:52,360 --> 02:54:55,480 UNUSUAL, YOU NEED A TRIAL WITH 4089 02:54:55,480 --> 02:54:57,400 THREE THOUSAND SUBJECTS AT 4090 02:54:57,400 --> 02:54:57,640 MINIMUM. 4091 02:54:57,640 --> 02:55:00,040 WE DON'T USUALLY SEE THAT IN 4092 02:55:00,040 --> 02:55:00,680 RANDOMIZED CONTROLLED TRIAL, 4093 02:55:00,680 --> 02:55:04,280 CERTAIN CERTAINLY NOT FOR WHAT 4094 02:55:04,280 --> 02:55:05,200 YEAR LOOKING AT. 4095 02:55:05,200 --> 02:55:06,720 ALSO IT TAKES A LONG TIME TO 4096 02:55:06,720 --> 02:55:08,320 SHOW ADVERSE EVENT. 4097 02:55:08,320 --> 02:55:09,440 IT'S A SELECTIVE POPULATION. 4098 02:55:09,440 --> 02:55:11,920 YOU DON'T GET ALL COMERS. 4099 02:55:11,920 --> 02:55:14,200 PEOPLE WHO MIGHT HAVE ISSUES 4100 02:55:14,200 --> 02:55:16,240 THAT WOULD MAKE THEM MORE LIKELY 4101 02:55:16,240 --> 02:55:18,680 TO HAVE AN ADVERSE EVENT MIGHT 4102 02:55:18,680 --> 02:55:20,520 NOT SHOW UP. 4103 02:55:20,520 --> 02:55:22,040 OBJECTS SERVERS AND SUBJECTS 4104 02:55:22,040 --> 02:55:22,920 OFTEN UNDERREPORT. 4105 02:55:22,920 --> 02:55:25,400 METHOD OF ASKING THE QUESTION AS 4106 02:55:25,400 --> 02:55:27,640 WE SAID EARLIER COULD BIAS 4107 02:55:27,640 --> 02:55:29,360 REPORTING, AND VERY FEW TRIALS 4108 02:55:29,360 --> 02:55:30,800 ARE RUN IN SAFETY STUDIES BUT 4109 02:55:30,800 --> 02:55:36,440 ONES THAT WILL CAN BE INCREDIBLY 4110 02:55:36,440 --> 02:55:37,080 USEFUL. 4111 02:55:37,080 --> 02:55:37,280 OKAY. 4112 02:55:37,280 --> 02:55:39,920 NOW, WE TALKED ABOUT THESE 4113 02:55:39,920 --> 02:55:40,440 ADVERSE EVENT LIMITATIONS 4114 02:55:40,440 --> 02:55:40,800 BEFORE. 4115 02:55:40,800 --> 02:55:42,520 JUST THEY ARE THERE AGAIN SO YOU 4116 02:55:42,520 --> 02:55:43,320 CAN SEE THEM. 4117 02:55:43,320 --> 02:55:45,880 AND JUST AS AN ADDITIONAL PIECE 4118 02:55:45,880 --> 02:55:49,040 OF REMINDER THIS MAY BE THE ONLY 4119 02:55:49,040 --> 02:55:51,040 WAY POST MARKET REPORTING MAY BE 4120 02:55:51,040 --> 02:55:55,880 THE ONLY WAY TO ACTUALLY FIND 4121 02:55:55,880 --> 02:55:57,080 UNEXPECTED RARE BUT SERIOUS 4122 02:55:57,080 --> 02:55:58,240 ADVERSE EVENTS, WE'VE SEEN THAT 4123 02:55:58,240 --> 02:56:01,600 WITH DRUGS AS WELL AS 4124 02:56:01,600 --> 02:56:03,320 POTENTIALLY DIETARY SUPPLEMENTS. 4125 02:56:03,320 --> 02:56:04,160 ONE ISSUE THAT'S PARTICULARLY 4126 02:56:04,160 --> 02:56:06,720 STICKY WHEN TRYING TO ATTRIBUTE 4127 02:56:06,720 --> 02:56:08,520 CAUSALITY TO ADVERSE EVENT OR 4128 02:56:08,520 --> 02:56:10,160 CLUSTER OF ADVERSE EVENTS IS 4129 02:56:10,160 --> 02:56:11,440 ELIMINATION OF OTHER CAUSAL 4130 02:56:11,440 --> 02:56:11,800 FACTORS. 4131 02:56:11,800 --> 02:56:14,640 THE MORE THAT YOU CAN ELIMINATE 4132 02:56:14,640 --> 02:56:17,400 OTHER CAUSAL FACTORS AND HAVE 4133 02:56:17,400 --> 02:56:18,520 CONCORDANCE IN OTHER REPORTED 4134 02:56:18,520 --> 02:56:21,400 THINGS LIKE THE RIGHT 4135 02:56:21,400 --> 02:56:22,240 PHARMACOLOGY, EXPOSURE IS 4136 02:56:22,240 --> 02:56:24,040 CORRECT, YOU KNOW THE PERSON 4137 02:56:24,040 --> 02:56:25,280 BOUGHT AND HAD THE MATERIAL 4138 02:56:25,280 --> 02:56:26,880 YOU'RE INTERESTED IN THEIR HAND, 4139 02:56:26,880 --> 02:56:29,680 YOU SAW THE BOTTLE, ET CETERA. 4140 02:56:29,680 --> 02:56:31,800 THIS IS MUCH TRICKIER BECAUSE 4141 02:56:31,800 --> 02:56:37,200 THIS IS LARGELY A CLINICAL 4142 02:56:37,200 --> 02:56:37,480 DECISION. 4143 02:56:37,480 --> 02:56:38,560 YOU TRY TO TAKE AWAY ANY 4144 02:56:38,560 --> 02:56:39,720 CONDITIONS THAT MIGHT HAVE 4145 02:56:39,720 --> 02:56:40,760 CORRECTED TO THE OUTCOME YOU'RE 4146 02:56:40,760 --> 02:56:41,960 LOOKING AT. 4147 02:56:41,960 --> 02:56:43,040 IF YOU'RE LOOKING AT A 4148 02:56:43,040 --> 02:56:45,720 CARDIOVASCULAR EVENT YOU WANT TO 4149 02:56:45,720 --> 02:56:50,080 RULE OUT HYPERTENSION, HIGH 4150 02:56:50,080 --> 02:56:53,320 CHOLESTEROL, REALLY ADVERSE 4151 02:56:53,320 --> 02:56:57,040 FAMILY HISTORY, SHORT T2 4152 02:56:57,040 --> 02:56:57,880 INTERVAL. 4153 02:56:57,880 --> 02:57:00,120 MOST CLINICAL TRIALS ARE NOT -- 4154 02:57:00,120 --> 02:57:02,760 MOST ADVERSE EVENTS REPORTS, 4155 02:57:02,760 --> 02:57:04,880 EXCUSE ME, ARE NOT INVESTIGATED 4156 02:57:04,880 --> 02:57:07,720 ENOUGH, NOT EXPLICIT OR COMPLETE 4157 02:57:07,720 --> 02:57:08,880 ENOUGH TO MAKE THIS ASSESSMENT, 4158 02:57:08,880 --> 02:57:11,000 AND I CAN SAY THIS WITH SOME 4159 02:57:11,000 --> 02:57:12,440 DEGREE OF AUTHORITY BECAUSE I 4160 02:57:12,440 --> 02:57:15,680 READ ALL THE ADVERSE EVENT 4161 02:57:15,680 --> 02:57:20,080 REPORTS, WHEN WE DID OUR -- WE 4162 02:57:20,080 --> 02:57:22,440 DID THE ADVERSE EVENT ANALYSIS 4163 02:57:22,440 --> 02:57:27,800 FOR EPHEDRA. 4164 02:57:27,800 --> 02:57:28,480 WITH FDA INVESTIGATING IN 4165 02:57:28,480 --> 02:57:32,640 DEMENTIA A -- DEPTH, THERE WAS 4166 02:57:32,640 --> 02:57:34,960 NOT ENOUGH DATA TO MAKE A 4167 02:57:34,960 --> 02:57:35,680 CLEAR-CUT ASSESSMENT. 4168 02:57:35,680 --> 02:57:37,600 HERE IS A LOOK AT SAFETY STUDIES 4169 02:57:37,600 --> 02:57:42,840 SO YOU CAN SEE THEY EXIST. 4170 02:57:42,840 --> 02:57:44,000 THIS IS EPHEDRA CASE ANALYSIS 4171 02:57:44,000 --> 02:57:46,760 FROM WHAT I WAS SPEAKING ABOUT. 4172 02:57:46,760 --> 02:57:50,600 WE TOOK RANDOMIZED CONTROLLED 4173 02:57:50,600 --> 02:57:52,200 STYLES USING EPHEDRA, 4174 02:57:52,200 --> 02:58:00,080 EPHEDRA-CONTAINING PRODUCTS, DID 4175 02:58:00,080 --> 02:58:02,640 EPHEDRA AND EPHEDRINE, TWO 4176 02:58:02,640 --> 02:58:03,120 REVIEWERS, CHECKING FOR 4177 02:58:03,120 --> 02:58:05,280 ANALYSIS, PUT THEM IN CATEGORIES 4178 02:58:05,280 --> 02:58:07,680 WHERE THEY WERE THOUGHT TO BE 4179 02:58:07,680 --> 02:58:12,560 SENTINEL EVENTS THAT WE COULDN'T 4180 02:58:12,560 --> 02:58:13,280 OTHERWISE EXPLAIN, POSSIBLE 4181 02:58:13,280 --> 02:58:14,880 SENTINEL EVENTS WITH OTHER 4182 02:58:14,880 --> 02:58:16,920 CAUSAL FACTORS BUT THERE WAS A 4183 02:58:16,920 --> 02:58:20,520 CLUSTER OF THESE CASE, SEPARATED 4184 02:58:20,520 --> 02:58:22,600 BY AGE, SEPARATED BY THE CAUSE. 4185 02:58:22,600 --> 02:58:25,720 I WILL SAY IN OUR DEATH ANALYSIS 4186 02:58:25,720 --> 02:58:26,800 WE WERE INCREDIBLY STRICT, THERE 4187 02:58:26,800 --> 02:58:28,640 HAD TO HAVE BEEN AN AUTOPSY 4188 02:58:28,640 --> 02:58:31,560 AFTER THE EVENT FOR US TO EVEN 4189 02:58:31,560 --> 02:58:33,080 CONSIDER THIS AS A SENTINEL 4190 02:58:33,080 --> 02:58:34,440 EVENT, FOR EXAMPLE. 4191 02:58:34,440 --> 02:58:36,440 AND YOU CAN SEE HERE THAT IF WE 4192 02:58:36,440 --> 02:58:39,880 GO DOWN IN THE YOUNG AGE GROUP, 4193 02:58:39,880 --> 02:58:45,080 WE ACTUALLY HAVE EVENTS THAT 4194 02:58:45,080 --> 02:58:47,760 WERE OCCURRING IN VERY YOUNG 4195 02:58:47,760 --> 02:58:50,200 PATIENTS WITHOUT OTHER POSSIBLE 4196 02:58:50,200 --> 02:58:50,920 SENTINEL EVENTS. 4197 02:58:50,920 --> 02:58:52,720 THAT WAS VERY COMMON. 4198 02:58:52,720 --> 02:58:54,880 THE POSSIBLE SENTINEL EVENTS 4199 02:58:54,880 --> 02:58:56,320 OCCURRED WHEN THE PATIENTS 4200 02:58:56,320 --> 02:58:56,920 CHANGED THEIR EXTERNAL 4201 02:58:56,920 --> 02:58:58,160 ENVIRONMENT TO MAKE IT MORE 4202 02:58:58,160 --> 02:59:01,400 LIKELY TO HAVE CAUSED THE 4203 02:59:01,400 --> 02:59:01,800 OUTCOME. 4204 02:59:01,800 --> 02:59:03,840 HEAT STROKE, CARDIOVASCULAR 4205 02:59:03,840 --> 02:59:04,640 COLLAPSE, DEATH. 4206 02:59:04,640 --> 02:59:06,400 SO, THIS REQUIRED A GREAT DEAL 4207 02:59:06,400 --> 02:59:10,240 OF EFFORTS TO FIND THE DATA AND 4208 02:59:10,240 --> 02:59:12,880 ANNUAL IT. 4209 02:59:12,880 --> 02:59:13,960 NOW, LOOKING AT THE CLINICAL 4210 02:59:13,960 --> 02:59:15,840 TRIALS WE HAD A DIFFERENT KIND 4211 02:59:15,840 --> 02:59:17,680 OF ADVERSE EVENT DATA TO LOOK 4212 02:59:17,680 --> 02:59:17,880 AT. 4213 02:59:17,880 --> 02:59:21,920 THIS IS DATA THAT WE FOUND IN 4214 02:59:21,920 --> 02:59:24,160 LOOKING AT CLINICAL TRIALS, 4215 02:59:24,160 --> 02:59:25,120 TOLERABILITY SECTION, ADVERSE 4216 02:59:25,120 --> 02:59:26,680 EVENT REPORTED, WE HAD A NUMBER 4217 02:59:26,680 --> 02:59:29,200 OF STUDIES THAT REPORTED THESE 4218 02:59:29,200 --> 02:59:29,960 EVENTS. 4219 02:59:29,960 --> 02:59:32,440 YOU CAN SEE THE ONES I'VE 4220 02:59:32,440 --> 02:59:36,400 HIGHLIGHTED IN PINK ODDS RATIO 4221 02:59:36,400 --> 02:59:40,240 GREATER THAN 1 TO SUGGEST 4222 02:59:40,240 --> 02:59:44,480 DIFFERENCE BETWEEN PLACEBO AND 4223 02:59:44,480 --> 02:59:46,480 INTERVENTION WAS STATISTICALLY 4224 02:59:46,480 --> 02:59:50,480 SIGNIFICANT AND COULD BE 4225 02:59:50,480 --> 02:59:58,920 ATTRIBUTED TO EFFECTS. 4226 02:59:58,920 --> 03:00:07,400 TAKING EPHEDRA, JITTERY AND 4227 03:00:07,400 --> 03:00:09,440 NERVOUS INSIDE LOOKED CAUSAL. 4228 03:00:09,440 --> 03:00:11,480 EPHEDRA WAS NOT OFTEN GIVEN AS 4229 03:00:11,480 --> 03:00:16,440 SINGLE ENTITY, IT WAS IN 4230 03:00:16,440 --> 03:00:17,960 COMBINATION WITH OTHER PRODUCTS 4231 03:00:17,960 --> 03:00:25,080 WHICH COULD HAVE AFFECTED 4232 03:00:25,080 --> 03:00:28,640 ADVERSE EFFECT PROFILE BUT 4233 03:00:28,640 --> 03:00:32,360 EPHEDRA WAS A CAUSAL AGENT IF 4234 03:00:32,360 --> 03:00:33,560 NOT THE CAUSAL AGENT. 4235 03:00:33,560 --> 03:00:36,280 I WANTED TO TALK ABOUT THIS, AN 4236 03:00:36,280 --> 03:00:39,080 OPEN LABEL STUDY FOR 12 MONTHS, 4237 03:00:39,080 --> 03:00:41,200 LOOKED AT POST MENOPAUSAL 4238 03:00:41,200 --> 03:00:46,040 SYMPTOMATIC WOMEN, TAKING A 4239 03:00:46,040 --> 03:00:47,520 WELL-CHARACTERIZED GERMAN BLACK 4240 03:00:47,520 --> 03:00:49,360 COHOSH EXTRACT, DOSE IS THERE. 4241 03:00:49,360 --> 03:00:50,600 AND THIS WAS TO LOOK TO SEE, 4242 03:00:50,600 --> 03:00:54,160 THERE'S A LOT OF CONFUSION IN 4243 03:00:54,160 --> 03:00:58,560 LITERATURE ABOUT WHETHER BLACK 4244 03:00:58,560 --> 03:01:08,720 COHOSH WAS A PHYTOESTROGEN, A 4245 03:01:08,720 --> 03:01:10,760 PATIENT POPULATION WITH BREAST 4246 03:01:10,760 --> 03:01:12,160 CANCER THAT WAS ESTROGEN 4247 03:01:12,160 --> 03:01:14,120 SENSITIVE, DESIGNED TO LOOK AND 4248 03:01:14,120 --> 03:01:17,240 SEE IF YOU COULD SEE ESTROGEN 4249 03:01:17,240 --> 03:01:18,920 EFFECT, WHETHER THAT WAS OR 4250 03:01:18,920 --> 03:01:21,040 WASN'T AN ADVERSE EVENT, LIKE 4251 03:01:21,040 --> 03:01:23,840 BLEEDING, FOR EXAMPLE, COULD YOU 4252 03:01:23,840 --> 03:01:28,000 SEE AN ESTROGEN EFFECT, IT WAS 4253 03:01:28,000 --> 03:01:34,080 LOOKED AT ENDOMETRIAL SAFETY. 4254 03:01:34,080 --> 03:01:36,720 A VERY DETAILED STUDY. 4255 03:01:36,720 --> 03:01:39,920 WOMEN WITHOUT ADVERSE PATHOLOGY 4256 03:01:39,920 --> 03:01:46,600 AGREED TO HAVE A BIOPSY IF THEY 4257 03:01:46,600 --> 03:01:48,520 ARE ENDOMETRIAL LINING 4258 03:01:48,520 --> 03:01:49,760 THICKENED, AND DENSE BREASTS ARE 4259 03:01:49,760 --> 03:01:51,400 AT HIGHER RISK FOR DEVELOPING 4260 03:01:51,400 --> 03:01:53,120 BREAST CANCER, LIVER FUNCTION 4261 03:01:53,120 --> 03:01:55,320 TEST, ET CETERA, LIPIDS, BONE, 4262 03:01:55,320 --> 03:01:55,840 ET CETERA. 4263 03:01:55,840 --> 03:01:57,400 I WON'T SHOW ALL THE DATA FROM 4264 03:01:57,400 --> 03:02:06,560 THIS TRIAL BECAUSE OF TIME BUT 4265 03:02:06,560 --> 03:02:07,800 ISOFORMS SHOW HIGHER EFFECT AT 4266 03:02:07,800 --> 03:02:14,160 BEGINNING, GREAT NUMBER OF 4267 03:02:14,160 --> 03:02:15,600 PATIENTS, THAT THE SAFETY, 4268 03:02:15,600 --> 03:02:17,560 DISTRIBUTION WAS HIGH EFFECT 4269 03:02:17,560 --> 03:02:19,880 HERE, LOW EFFECT HERE, 4270 03:02:19,880 --> 03:02:22,200 DISTRIBUTION DID FAVOR POST 4271 03:02:22,200 --> 03:02:24,760 MENOPAUSAL WOMEN WITH LOW 4272 03:02:24,760 --> 03:02:27,320 EFFECT, ONCE GIVEN MATERIAL 4273 03:02:27,320 --> 03:02:32,440 AFTER VISIT 7, MAJORITY SHOWED 4274 03:02:32,440 --> 03:02:35,360 LOWER EFFECT, AGAIN THE BIOPSY 4275 03:02:35,360 --> 03:02:40,440 AGAIN SHOWED THAT AS WELL. 4276 03:02:40,440 --> 03:02:47,920 THIS IS LOOKING AT THE SAFETY 4277 03:02:47,920 --> 03:02:50,360 DATA FOR REGULAR MONITORED 4278 03:02:50,360 --> 03:02:50,960 LABORATORY VALUES. 4279 03:02:50,960 --> 03:02:53,280 A SLIGHT INCREASE IN CHOLESTEROL 4280 03:02:53,280 --> 03:02:54,600 BUT PROBABLY NOT CLINICALLY 4281 03:02:54,600 --> 03:02:56,520 SIGNIFICANT. 4282 03:02:56,520 --> 03:02:58,520 THE ISSUE OF LIVER FUNCTION TEST 4283 03:02:58,520 --> 03:02:59,680 WAS HIGHLY RELEVANT BECAUSE 4284 03:02:59,680 --> 03:03:02,640 THERE HAD BEEN CASE REPORTS OF 4285 03:03:02,640 --> 03:03:04,240 ADVERSE REPORTS OF LIVER 4286 03:03:04,240 --> 03:03:07,080 DIFFICULTY CAN BLACK COHOSH. 4287 03:03:07,080 --> 03:03:09,640 I SHOWED THAT REPORTS, GIVEN TO 4288 03:03:09,640 --> 03:03:11,480 THE NATURAL HEALTH PRODUCT DRUG 4289 03:03:11,480 --> 03:03:13,400 OF CANADA, WHAT WOULD THIS LOOK 4290 03:03:13,400 --> 03:03:16,920 LIKE AT A YEAR, EVIDENCE OF 4291 03:03:16,920 --> 03:03:20,160 SIGNIFICANT DISTURBANCE IN LIVER 4292 03:03:20,160 --> 03:03:20,400 FUNCTION? 4293 03:03:20,400 --> 03:03:21,320 THERE WAS SLIGHT ELEVATIONS 4294 03:03:21,320 --> 03:03:22,800 TAKEN IN THIS GROUP. 4295 03:03:22,800 --> 03:03:25,120 A FAIRLY LARGE GROUP OF WOMEN SO 4296 03:03:25,120 --> 03:03:26,960 THINGS COULD BE STATISTICALLY 4297 03:03:26,960 --> 03:03:28,000 SIGNIFICANT WITHOUT BEING 4298 03:03:28,000 --> 03:03:29,400 CLINICALLY SIGNIFICANT. 4299 03:03:29,400 --> 03:03:34,160 INCREASES WERE SMALL AND I WENT 4300 03:03:34,160 --> 03:03:35,640 BACK AND ASKED THE STUDY AUTHORS 4301 03:03:35,640 --> 03:03:39,080 TO GIVE ME THEIR FULL DATA AND 4302 03:03:39,080 --> 03:03:40,400 LOOKED AT EACH INDIVIDUAL 4303 03:03:40,400 --> 03:03:43,200 PATIENT DATA, NONE OF THESE 4304 03:03:43,200 --> 03:03:43,920 ELEVATIONS WERE SUSTAINED. 4305 03:03:43,920 --> 03:03:51,400 SO THIS DID NOT SHOW EVIDENCE 4306 03:03:51,400 --> 03:03:52,560 EVIDENCE OF SUSTAINED LIVER 4307 03:03:52,560 --> 03:03:54,520 FUNCTION STAGE. 4308 03:03:54,520 --> 03:03:58,280 MANDATORY REPORTING STARTED IN 4309 03:03:58,280 --> 03:04:01,160 DECEMBER 2007 FOR HERBAL AND 4310 03:04:01,160 --> 03:04:02,800 OVER THE COUNTER PRODUCTS, 4311 03:04:02,800 --> 03:04:05,080 ANYTHING REPORTED BY PATIENTS 4312 03:04:05,080 --> 03:04:06,040 DEEMED A SERIOUS ADVERSE EVENT 4313 03:04:06,040 --> 03:04:08,080 HAS TO BE REPORTED. 4314 03:04:08,080 --> 03:04:09,000 MANY PEOPLE JUST REPORTED 4315 03:04:09,000 --> 03:04:10,400 EVERYTHING, SO AS NOT TO BE 4316 03:04:10,400 --> 03:04:15,880 CAUGHT IN THE ISSUE WHETHER IT 4317 03:04:15,880 --> 03:04:20,320 IS OR ISN'T A SIGNIFICANT EVENT. 4318 03:04:20,320 --> 03:04:24,960 NOW, I DID ANALYSIS WITH THE 4319 03:04:24,960 --> 03:04:27,680 AMERICAN HERBAL PRODUCTS 4320 03:04:27,680 --> 03:04:28,720 ASSOCIATION, MERLE ZIMMERMAN 4321 03:04:28,720 --> 03:04:29,720 WILL PRESENT TOMORROW, MY 4322 03:04:29,720 --> 03:04:36,360 PARTNER IN DOING THIS DATA 4323 03:04:36,360 --> 03:04:42,200 ANALYSIS. 4324 03:04:42,200 --> 03:04:45,640 MANDATORY REPORTERS WERE 4325 03:04:45,640 --> 03:04:56,360 REPORTED, MUCH SMALLER, LIMITS . 4326 03:05:00,800 --> 03:05:07,240 BUT ONE THING, WE DID FIND ONE 4327 03:05:07,240 --> 03:05:08,800 DETECTED, THAT ALSO DETECTED BY 4328 03:05:08,800 --> 03:05:11,040 THE FDA, ACTED ON WHEN A BODY 4329 03:05:11,040 --> 03:05:14,040 BUILDING SUPPLEMENT WAS TAKEN 4330 03:05:14,040 --> 03:05:18,840 OFF THE MARKET. 4331 03:05:18,840 --> 03:05:22,640 SO, THE PILLS WERE TOO LARGE, 4332 03:05:22,640 --> 03:05:24,520 THAT GAVE AN INTERESTING VIEW ON 4333 03:05:24,520 --> 03:05:28,840 THE DIFFERENCE BETWEEN WHAT WE 4334 03:05:28,840 --> 03:05:29,880 AND THE PATIENT CONSIDER 4335 03:05:29,880 --> 03:05:31,400 ADVERSE. 4336 03:05:31,400 --> 03:05:33,400 THERE WAS A SIGNAL, SENTINEL 4337 03:05:33,400 --> 03:05:35,960 EVENT, NO OTHER APPARENT CAUSE, 4338 03:05:35,960 --> 03:05:37,560 LIKELY CAUSE, CLUSTER OF 4339 03:05:37,560 --> 03:05:39,480 SENTINEL EVENTS IS A SIGNAL. 4340 03:05:39,480 --> 03:05:41,360 RISK ASSESSMENT NEEDS TO BE 4341 03:05:41,360 --> 03:05:43,040 DONE, USUALLY BY A FEDERAL 4342 03:05:43,040 --> 03:05:45,200 AGENCY OR PUBLIC HEALTH AGENCY, 4343 03:05:45,200 --> 03:05:47,160 TO DECIDE WHETHER THIS MATERIAL 4344 03:05:47,160 --> 03:05:50,440 IS RISKY ENOUGH THAT IT SHOULD 4345 03:05:50,440 --> 03:05:52,680 BE TAKEN -- ACCESS BY THE PUBLIC 4346 03:05:52,680 --> 03:05:56,800 TO THIS MATERIAL SHOULD BE 4347 03:05:56,800 --> 03:05:57,360 LIMITED. 4348 03:05:57,360 --> 03:06:01,520 AND AGAIN ANALYSIS WITH 4349 03:06:01,520 --> 03:06:03,840 POTENTIAL SIGNALS IS LIKELY, IS 4350 03:06:03,840 --> 03:06:06,240 THERE EVIDENCE FOR MECHANISM, 4351 03:06:06,240 --> 03:06:07,440 ANALYSIS OF PROPER MATERIAL, IS 4352 03:06:07,440 --> 03:06:09,160 THE CLUSTER LARGE ENOUGH AND 4353 03:06:09,160 --> 03:06:10,960 DIFFERENT ENOUGH FROM BACKGROUND 4354 03:06:10,960 --> 03:06:14,400 REPORTING TO ADD A DEGREE OF 4355 03:06:14,400 --> 03:06:15,680 SURGERY TO TAKING ACTION ON 4356 03:06:15,680 --> 03:06:16,000 THAT. 4357 03:06:16,000 --> 03:06:18,280 SO THANK YOU VERY MUCH. 4358 03:06:18,280 --> 03:06:20,440 I WILL STOP MY SHARING AND 4359 03:06:20,440 --> 03:06:25,560 ANSWER QUESTIONS. 4360 03:06:25,560 --> 03:06:27,280 >> THANK YOU, DR. HARDY. 4361 03:06:27,280 --> 03:06:30,120 THERE'S ALREADY ONE QUESTION IN 4362 03:06:30,120 --> 03:06:33,320 THE CHAT. 4363 03:06:33,320 --> 03:06:37,360 FROM GEORGE CARTER, DIFFERENCE 4364 03:06:37,360 --> 03:06:39,120 BETWEEN (INDISCERNIBLE) GROWING 4365 03:06:39,120 --> 03:06:39,520 CONDITIONS. 4366 03:06:39,520 --> 03:06:40,080 >> REPEAT THAT AGAIN. 4367 03:06:40,080 --> 03:06:44,120 >> IT SAYS, I DON'T KNOW IF I'M 4368 03:06:44,120 --> 03:06:45,360 PRONOUNCING IT CORRECTLY, 4369 03:06:45,360 --> 03:06:46,520 DIFFERENCE BETWEEN 4370 03:06:46,520 --> 03:06:47,400 (INDISCERNIBLE) VERSUS HIGH 4371 03:06:47,400 --> 03:06:52,360 CHROMIUM OR LIGHT FROM GROWING 4372 03:06:52,360 --> 03:06:52,800 CONDITIONS. 4373 03:06:52,800 --> 03:06:53,440 >> SO, I DON'T QUITE UNDERSTAND 4374 03:06:53,440 --> 03:06:56,720 THE QUESTION BUT I CAN COMMENT 4375 03:06:56,720 --> 03:06:59,480 ABOUT THE ISSUE OF GROWING 4376 03:06:59,480 --> 03:07:00,240 CONDITIONS. 4377 03:07:00,240 --> 03:07:03,280 YOU DO THEN -- PLANTS CAN HAVE 4378 03:07:03,280 --> 03:07:05,280 DIFFERENT VARIANTS, DIFFERENT -- 4379 03:07:05,280 --> 03:07:07,520 CAN BE GENETICALLY DIFFERENT, IN 4380 03:07:07,520 --> 03:07:08,320 THE SAME CLONE, AND THEREFORE 4381 03:07:08,320 --> 03:07:11,520 THE RESULTS WOULD BE EXPECTED TO 4382 03:07:11,520 --> 03:07:13,800 BE SIMILAR BASED ON SIMILAR 4383 03:07:13,800 --> 03:07:14,560 ENVIRONMENT AFFECTING SIMILAR 4384 03:07:14,560 --> 03:07:20,640 SETS . 4385 03:07:20,640 --> 03:07:23,760 ALL THE PRODUCTS ARE SECONDARY 4386 03:07:23,760 --> 03:07:26,760 METABOLITES OF THE PLANT'S 4387 03:07:26,760 --> 03:07:27,800 METABOLISM WHICH IT MAKES FOR 4388 03:07:27,800 --> 03:07:28,560 ITS OWN USE. 4389 03:07:28,560 --> 03:07:30,000 IF I UNDERSTOOD THE QUESTION 4390 03:07:30,000 --> 03:07:32,160 THAT MIGHT GET CLOSE TO IT, IF 4391 03:07:32,160 --> 03:07:40,920 NOT, GEORGE COULD ASK IT AGAIN. 4392 03:07:40,920 --> 03:07:42,840 >> GEORGE HAS ELABORATED. 4393 03:07:42,840 --> 03:07:44,400 PREPARATION OF HEAVY METALS. 4394 03:07:44,400 --> 03:07:46,400 >> OH YES. 4395 03:07:46,400 --> 03:07:46,720 ABSOLUTELY. 4396 03:07:46,720 --> 03:07:47,680 ABSOLUTELY. 4397 03:07:47,680 --> 03:07:49,080 AND THIS WE SEE NOT JUST IN 4398 03:07:49,080 --> 03:07:52,480 MEDICINAL PLANTS BUT IN FOOD 4399 03:07:52,480 --> 03:07:54,120 PLANTS, WE COULD ASK DR. SESSO. 4400 03:07:54,120 --> 03:07:56,040 THE WATER THAT YOU GROW RICE IN 4401 03:07:56,040 --> 03:07:58,320 AFFECTS HOW MUCH ARSENIC IS IN 4402 03:07:58,320 --> 03:07:58,960 RICE. 4403 03:07:58,960 --> 03:08:00,760 THAT'S A COMMON CONTAMINANT TO 4404 03:08:00,760 --> 03:08:02,960 FIND IN RICE. 4405 03:08:02,960 --> 03:08:04,920 IT'S NEVER A MATTER OF NO EXPOSE 4406 03:08:04,920 --> 03:08:08,480 WHY YOU BUT MINIMAL EXPOSURE. 4407 03:08:08,480 --> 03:08:11,440 I WAS ASSOCIATE DIRECTOR OF 4408 03:08:11,440 --> 03:08:13,680 BOTANICAL RESEARCH GROUP AT 4409 03:08:13,680 --> 03:08:14,720 UCLA, SOURCING PLANT MATERIALS 4410 03:08:14,720 --> 03:08:16,320 IN CHINA, THE FIRST THING WE DID 4411 03:08:16,320 --> 03:08:18,320 TO VALIDATE OUR MATERIALS WAS TO 4412 03:08:18,320 --> 03:08:19,880 DO A HEAVY METAL SCREEN. 4413 03:08:19,880 --> 03:08:23,040 IF THE FIELD THAT WE GOT OUR 4414 03:08:23,040 --> 03:08:24,560 PLANTS FROM SHOWED EVIDENCE OF 4415 03:08:24,560 --> 03:08:28,520 HEAVY METAL WE WENT TO A 4416 03:08:28,520 --> 03:08:30,480 DIFFERENT COLLECTING SITE 4417 03:08:30,480 --> 03:08:32,440 BECAUSE THAT INVALIDATED THE 4418 03:08:32,440 --> 03:08:32,720 MATERIAL. 4419 03:08:32,720 --> 03:08:34,080 YOU MIGHT HAVE TOXICITY YOU'RE 4420 03:08:34,080 --> 03:08:35,120 ATTRIBUTING TO THE PLANT WHEN IT 4421 03:08:35,120 --> 03:08:42,880 MIGHT BE A RESULT OF HEAVY MET 4422 03:08:42,880 --> 03:08:44,680 METALS, AND EXTRACTION 4423 03:08:44,680 --> 03:08:45,720 TECHNIQUES COULD ENHANCE OR 4424 03:08:45,720 --> 03:08:48,560 INCREASE. 4425 03:08:48,560 --> 03:08:51,720 POLLUTION IS A PROBLEM, CERTAIN 4426 03:08:51,720 --> 03:08:52,840 GROWING GROUNDS NOW BECOME 4427 03:08:52,840 --> 03:08:55,440 INTOLERABLE BECAUSE OF CLIMATE 4428 03:08:55,440 --> 03:08:56,640 CHANGE OR INHOSPITABLE BUT 4429 03:08:56,640 --> 03:08:58,360 POLLUTION PUTS TOXINS INTO THE 4430 03:08:58,360 --> 03:09:00,480 WATER AND SOIL WHICH IS 4431 03:09:00,480 --> 03:09:02,720 SEQUESTERED IN PLANTS, OR LIKE 4432 03:09:02,720 --> 03:09:07,760 IN THE CASE OF CALCIUM SOURCES 4433 03:09:07,760 --> 03:09:10,800 IF THE CALCIUM SOURCE OYSTER 4434 03:09:10,800 --> 03:09:13,280 SHELL GROWS IN POLLUTED WATER 4435 03:09:13,280 --> 03:09:17,360 SEQUESTERS HEAVY METAL CAN BE 4436 03:09:17,360 --> 03:09:18,120 PASSED ALONG THE CHAIN OF 4437 03:09:18,120 --> 03:09:20,160 DEVELOPMENT IN A PRODUCT FOR 4438 03:09:20,160 --> 03:09:21,320 HUMANS TO TAKE. 4439 03:09:21,320 --> 03:09:24,840 >> AND A NOD TO TRADITIONAL 4440 03:09:24,840 --> 03:09:26,600 MEDICINE PREPARATION, 4441 03:09:26,600 --> 03:09:27,920 TRADITIONAL PREPARATION, HE'S 4442 03:09:27,920 --> 03:09:29,440 STATING IF PREPARED CORRECTLY 4443 03:09:29,440 --> 03:09:33,440 ACCORDING TO SOME DATA FROM 4444 03:09:33,440 --> 03:09:36,160 COLLEAGUE IT DOES NOT INDUCE 4445 03:09:36,160 --> 03:09:37,080 TOXICITY. 4446 03:09:37,080 --> 03:09:43,240 >> I'VE HEARD THAT BEFORE WITH 4447 03:09:43,240 --> 03:09:45,480 SHANGMI, CHINESE PLANTS IN 4448 03:09:45,480 --> 03:09:50,000 PARTICULAR, I ALLUDED TO THAT 4449 03:09:50,000 --> 03:09:52,080 WITH AYUREDIC PREPARATION, IN 4450 03:09:52,080 --> 03:09:54,080 PREPARATION AS DESCRIBED THEY 4451 03:09:54,080 --> 03:09:55,920 ASSERT THAT MEANS HEAVY METALS 4452 03:09:55,920 --> 03:09:58,320 ARE NOT AVAILABLE TO BE 4453 03:09:58,320 --> 03:09:59,560 METABOLICALLY ACTIVE, THEREFORE 4454 03:09:59,560 --> 03:10:00,960 AREN'T TOXIC. 4455 03:10:00,960 --> 03:10:02,880 BUT THERE'S A LOT OF SLIP 4456 03:10:02,880 --> 03:10:05,520 BETWEEN CUP AND LIP, AS WE SAY. 4457 03:10:05,520 --> 03:10:07,640 I THINK HE'S RIGHT. 4458 03:10:07,640 --> 03:10:08,520 SOMETIMES TRADITIONAL MEDICINE 4459 03:10:08,520 --> 03:10:09,320 PREPARATIONS BECAUSE THEY ARE SO 4460 03:10:09,320 --> 03:10:10,360 FAMILIAR WITH THE PLANT AND 4461 03:10:10,360 --> 03:10:12,480 AGAIN I GO BACK TO CHAPPARAL 4462 03:10:12,480 --> 03:10:16,400 ISSUE, I HAD A NATIVE AMERICAN 4463 03:10:16,400 --> 03:10:17,640 CHIEFTAIN GIVE THIS MATERIAL TO 4464 03:10:17,640 --> 03:10:21,040 A WHOM BEING TREATED BUT GAVE -- 4465 03:10:21,040 --> 03:10:23,480 WOMAN BEING TREATED IN CUP FORM, 4466 03:10:23,480 --> 03:10:27,040 WE AGREED ON LIMITATION OF 4467 03:10:27,040 --> 03:10:28,200 AMOUNT AND HOW WEAK THE TEA 4468 03:10:28,200 --> 03:10:30,200 WOULD BE, WERE ABLE TO REDUCE 4469 03:10:30,200 --> 03:10:37,000 RISK BUT STILL ALLOW HER TO 4470 03:10:37,000 --> 03:10:38,160 PARTICIPATE WITH TRADITIONAL 4471 03:10:38,160 --> 03:10:38,760 MEDICINE TRADITIONS. 4472 03:10:38,760 --> 03:10:39,680 EVERY BIT OF INFORMATION IS 4473 03:10:39,680 --> 03:10:48,440 GOOD, YOU HAVE TO PUT IT IN 4474 03:10:48,440 --> 03:10:48,840 CONTEXT. 4475 03:10:48,840 --> 03:10:50,080 >> THANK YOU, WE'RE BACK ON 4476 03:10:50,080 --> 03:10:50,400 SCHEDULE. 4477 03:10:50,400 --> 03:10:51,080 >> MY APOLOGIES FOR WHATEVER 4478 03:10:51,080 --> 03:10:51,800 HAPPENED. 4479 03:10:51,800 --> 03:10:58,040 THANK YOU FOR YOUR FLEXIBILITY 4480 03:10:58,040 --> 03:11:01,560 AND KUDOS TO DR. SESSO. 4481 03:11:01,560 --> 03:11:03,400 >> THANK YOU. 4482 03:11:03,400 --> 03:11:07,720 WE'RE READY FOR DR. BILL 4483 03:11:07,720 --> 03:11:08,720 GURLEY'S PRESENTATION. 4484 03:11:08,720 --> 03:11:11,480 PRINCIPAL SCIENTIST, DIRECTOR OF 4485 03:11:11,480 --> 03:11:12,160 CLINICAL RESEARCH FACILITY 4486 03:11:12,160 --> 03:11:13,760 NATIONAL CENTER FOR NATURAL 4487 03:11:13,760 --> 03:11:14,800 PRODUCTS RESEARCH, MISSISSIPPI 4488 03:11:14,800 --> 03:11:16,280 SCHOOL OF PHARMACY, MEMBER OF 4489 03:11:16,280 --> 03:11:18,440 THE AMERICAN ASSOCIATION OF 4490 03:11:18,440 --> 03:11:19,400 PHARMACEUTICAL SCIENTISTS, 4491 03:11:19,400 --> 03:11:23,040 AMERICAN SOCIETY OF CLINICAL 4492 03:11:23,040 --> 03:11:23,760 PHARMACOLOGY AND THERAPEUTICS, 4493 03:11:23,760 --> 03:11:28,080 USP EXPERT PANEL ON DIETARY 4494 03:11:28,080 --> 03:11:28,400 SUPPLEMENTS. 4495 03:11:28,400 --> 03:11:30,120 RESEARCH INTERESTS INCLUDE 4496 03:11:30,120 --> 03:11:35,960 MECHANISM ALSO OF HERB-DRUG 4497 03:11:35,960 --> 03:11:38,480 INTERACTION, PHYTOCHEMICAL 4498 03:11:38,480 --> 03:11:40,680 MODULATION OF HUMAN DRUG 4499 03:11:40,680 --> 03:11:46,000 METABOLIZING ENZYMES AND DRUG 4500 03:11:46,000 --> 03:11:47,760 TRANSPORT PROTEINS, 4501 03:11:47,760 --> 03:11:48,600 PHARMACOKINETICS, USE IN SPECIAL 4502 03:11:48,600 --> 03:11:50,000 POPULATIONS, PRESENTATION FOR 4503 03:11:50,000 --> 03:11:52,160 TODAY IS "INTERACTIONS BETWEEN 4504 03:11:52,160 --> 03:11:53,400 SUPPLEMENTS AND DRUGS." 4505 03:11:53,400 --> 03:11:56,080 TAKE IT AWAY, DR. GURLEY. 4506 03:11:56,080 --> 03:11:57,920 >> THANK YOU, LAVERNE. 4507 03:11:57,920 --> 03:12:00,600 IT'S A PLEASURE TO SPEAK AT THE 4508 03:12:00,600 --> 03:12:03,000 OFFICE OF DIETARY SUPPLEMENTS 4509 03:12:03,000 --> 03:12:04,600 RESEARCH PRACTICUM AGAIN. 4510 03:12:04,600 --> 03:12:07,080 I'VE BEEN DOING THIS FOR QUITE 4511 03:12:07,080 --> 03:12:09,960 SOME TIME. 4512 03:12:09,960 --> 03:12:17,280 I'M GOING TO CUT TO THE CHASE. 4513 03:12:17,280 --> 03:12:25,480 LET ME SHARE THINGS WITH YOU AND 4514 03:12:25,480 --> 03:12:26,760 MAKE SURE THINGS ARE SQUARED 4515 03:12:26,760 --> 03:12:27,120 AWAY. 4516 03:12:27,120 --> 03:12:31,040 CAN YOU SEE MY SLIDES OKAY? 4517 03:12:31,040 --> 03:12:31,160 4518 03:12:31,160 --> 03:12:32,120 >> LOOKS GREAT. 4519 03:12:32,120 --> 03:12:35,480 >> VERY GOOD. 4520 03:12:35,480 --> 03:12:37,280 I WANTED TO -- WE'RE SLAVES TO 4521 03:12:37,280 --> 03:12:39,360 TECHNOLOGY, I WANTED TO MAKE 4522 03:12:39,360 --> 03:12:39,880 SURE. 4523 03:12:39,880 --> 03:12:44,000 SO I'M GOING TO CUT STRAIGHT TO 4524 03:12:44,000 --> 03:12:45,720 THE CHASE AND LET EVERYBODY KNOW 4525 03:12:45,720 --> 03:12:47,160 I THINK WHAT WE ALREADY KNOW, 4526 03:12:47,160 --> 03:12:49,640 PLANTS HAVE BEEN A SOURCE OF 4527 03:12:49,640 --> 03:12:52,680 DRUGS SINCE TIME IMMEMORIAL BUT 4528 03:12:52,680 --> 03:12:53,720 THE ISSUE OF HERB-DRUG 4529 03:12:53,720 --> 03:12:55,960 INTERACTION CAME TO THE 4530 03:12:55,960 --> 03:12:59,560 FOREFRONT AFTER THE SECOND WORLD 4531 03:12:59,560 --> 03:13:03,520 WAR WHEN MOVING TO PURIFIED 4532 03:13:03,520 --> 03:13:05,480 SYNTHETIC COMPOUNDS. 4533 03:13:05,480 --> 03:13:06,960 IT'S OBVIOUS PHYTOCHEMICALS HAVE 4534 03:13:06,960 --> 03:13:08,880 BEEN RECOGNIZED FOR ABILITY TO 4535 03:13:08,880 --> 03:13:09,600 MODULATE THE ACTIVITY OF 4536 03:13:09,600 --> 03:13:13,080 CONVENTIONAL DRUGS FOR MANY 4537 03:13:13,080 --> 03:13:13,520 DECADES. 4538 03:13:13,520 --> 03:13:15,120 INTERACTION IS DESCRIBED AS 4539 03:13:15,120 --> 03:13:18,120 ABILITY OF PHYTOCHEMICALS 4540 03:13:18,120 --> 03:13:24,160 PRESENT IN CRUCIFEROUS 4541 03:13:24,160 --> 03:13:27,240 VEGETABLES, TO MODULATE ENZYMES 4542 03:13:27,240 --> 03:13:28,040 AND AFFECT PHARMACOKINETICS, 4543 03:13:28,040 --> 03:13:30,920 THAT WAS IT FOR A LONG TIME. 4544 03:13:30,920 --> 03:13:34,320 THEN CONCERN FOR HERB-DRUG 4545 03:13:34,320 --> 03:13:35,840 INTERACTION WAS MINIMAL UNTIL 4546 03:13:35,840 --> 03:13:41,760 1991, THAT YEAR GREAT FRUIT 4547 03:13:41,760 --> 03:13:46,440 JUICE WAS FOUND TO INCREASE ORAL 4548 03:13:46,440 --> 03:13:48,600 ABSORPTION OF DRUGS AND THE ACT 4549 03:13:48,600 --> 03:13:51,960 WAS PASSED AND PLETHORA OF 4550 03:13:51,960 --> 03:13:52,960 UNIQUE PHYTOCHEMICALS BECAME 4551 03:13:52,960 --> 03:13:53,680 AVAILABLE FOR CONSUMPTION IN THE 4552 03:13:53,680 --> 03:13:56,640 UNITED STATES IN THE FORM OF 4553 03:13:56,640 --> 03:13:59,080 BOTANICAL DIETARY SUPPLEMENTS. 4554 03:13:59,080 --> 03:14:04,200 NOW, SEVERAL FACTORS CAN 4555 03:14:04,200 --> 03:14:04,840 CONTRIBUTE TO HERB-DRUG 4556 03:14:04,840 --> 03:14:06,160 INTERACTIONS, THE MORE ONE IS 4557 03:14:06,160 --> 03:14:09,000 EXPOSED TO THE GREATER THE 4558 03:14:09,000 --> 03:14:10,680 INTERACTION RISK. 4559 03:14:10,680 --> 03:14:13,480 SUPPLEMENTS ARE COMPLEX MIXTURES 4560 03:14:13,480 --> 03:14:20,720 OF MULTIPLE PHYTOCHEMICALS. 4561 03:14:20,720 --> 03:14:23,760 MULTI-INGREDIENTS ARE 4562 03:14:23,760 --> 03:14:24,720 COMPLICATED. 4563 03:14:24,720 --> 03:14:27,840 THEY ARE ACTUALLY POWDERED PLANT 4564 03:14:27,840 --> 03:14:29,560 MATERIAL THAT'S EXTRACTED WITH 4565 03:14:29,560 --> 03:14:32,480 AQUEOUS OR NON-AQUEOUS SOLVENTS 4566 03:14:32,480 --> 03:14:35,760 AND TRIED TO CONCENTRATE 4567 03:14:35,760 --> 03:14:37,720 PHYTOCHEMICALS. 4568 03:14:37,720 --> 03:14:46,520 THE DRIED EXTRACTS INCREASE 4569 03:14:46,520 --> 03:14:47,720 PHYTOCHEMICAL EXPOSURE. 4570 03:14:47,720 --> 03:14:53,960 WE KNOW VERY LITTLE, LET ALONE 4571 03:14:53,960 --> 03:14:56,640 COMPLEX MIXTURES. 4572 03:14:56,640 --> 03:15:04,400 PANAX GINSENG IS GOOD EXAMPLE. 4573 03:15:04,400 --> 03:15:05,360 500 PHYTOCHEMICALS HAVE BEEN 4574 03:15:05,360 --> 03:15:05,720 IDENTIFIED. 4575 03:15:05,720 --> 03:15:08,000 YOU CAN GET A PICTURE OF JUST 4576 03:15:08,000 --> 03:15:11,200 HOW COMPLICATED THE SITUATION 4577 03:15:11,200 --> 03:15:14,240 CAN GET. 4578 03:15:14,240 --> 03:15:15,360 NOW, TO ILLUSTRATE COMPLEXITY 4579 03:15:15,360 --> 03:15:18,240 THERE'S A PARTIAL LISTING OF 4580 03:15:18,240 --> 03:15:20,760 SOME OF THE KNOWN PHYTO 4581 03:15:20,760 --> 03:15:22,520 CONSTITUENTS IN ST. JOHN'S WART 4582 03:15:22,520 --> 03:15:23,880 EXTRACT. 4583 03:15:23,880 --> 03:15:29,080 ON THE RIGHT FLAVANOIDS AND 4584 03:15:29,080 --> 03:15:31,160 ESSENTIAL OILS ARE FOUND IN MANY 4585 03:15:31,160 --> 03:15:31,400 PLANTS. 4586 03:15:31,400 --> 03:15:33,600 THOSE ON THE RIGHT ARE MORE 4587 03:15:33,600 --> 03:15:38,000 SPECIFIC TO ST. JOHN'S WORT. 4588 03:15:38,000 --> 03:15:42,880 I'VE GOT ONE HIGHLIGHTED IN RED, 4589 03:15:42,880 --> 03:15:44,640 HYPERFORIN, PLAYING AN IMPORTANT 4590 03:15:44,640 --> 03:15:46,000 ROLE IN INTERACTIONS, AS WE'LL 4591 03:15:46,000 --> 03:15:48,480 SEE LATER IN THE TALK. 4592 03:15:48,480 --> 03:15:50,360 SEVERAL SURVEYS HINT AT OTHER 4593 03:15:50,360 --> 03:15:53,160 FACTORS THAT CAN CONTRIBUTE TO 4594 03:15:53,160 --> 03:15:56,480 THE RISK OF HERB-DRUG 4595 03:15:56,480 --> 03:15:58,680 INTERACTION, FROM 30 TO 60% OF 4596 03:15:58,680 --> 03:16:01,000 HOSPITAL PATIENTS USE THE 4597 03:16:01,000 --> 03:16:01,960 BOTANICAL DIETARY SUPPLEMENTS ON 4598 03:16:01,960 --> 03:16:04,720 A REGULAR BASIS. 4599 03:16:04,720 --> 03:16:06,320 SURVEYS INDICATE BETWEEN 25 AND 4600 03:16:06,320 --> 03:16:10,360 30% OF PRESCRIPTION DRUG USER 4601 03:16:10,360 --> 03:16:12,240 INGEST SUPPLEMENTS WITH 4602 03:16:12,240 --> 03:16:14,680 PRESCRIPTION MEDICATIONS. 4603 03:16:14,680 --> 03:16:16,520 ONE STATISTIC THAT HELD STEADY, 4604 03:16:16,520 --> 03:16:19,200 LESS THAN 40% OF PATIENTS REVEAL 4605 03:16:19,200 --> 03:16:20,680 THE FACT THAT THEY INGEST 4606 03:16:20,680 --> 03:16:22,880 SUPPLEMENT TO HEALTH CARE 4607 03:16:22,880 --> 03:16:23,160 PROVIDER. 4608 03:16:23,160 --> 03:16:25,200 SO EVEN IF PATIENTS DID REVEAL 4609 03:16:25,200 --> 03:16:28,400 THEIR SUPPLEMENT USAGE TO HEALTH 4610 03:16:28,400 --> 03:16:31,080 CARE PROVIDERS, SADLY NURSES AND 4611 03:16:31,080 --> 03:16:33,720 PHARMACIESES AND PHYSICIANS KNOW 4612 03:16:33,720 --> 03:16:36,440 VERY LITTLE ABOUT SUPPLEMENTS TO 4613 03:16:36,440 --> 03:16:38,000 BEGIN WITH. 4614 03:16:38,000 --> 03:16:40,920 HOW DO YOU INITIALLY RECOGNIZE 4615 03:16:40,920 --> 03:16:43,360 POTENTIAL HERB-DRUG INTERACTION? 4616 03:16:43,360 --> 03:16:43,880 OFTENTIMES CASE REPORTS 4617 03:16:43,880 --> 03:16:45,160 APPEARING IN THE PEER REVIEWED 4618 03:16:45,160 --> 03:16:47,040 MEDICAL LITERATURE ARE GOOD 4619 03:16:47,040 --> 03:16:48,040 INDICATORS ESPECIALLY IF THERE'S 4620 03:16:48,040 --> 03:16:49,200 SEVERAL CASE REPORTS THAT 4621 03:16:49,200 --> 03:16:51,560 DESCRIBE THE SAME TYPE OF 4622 03:16:51,560 --> 03:16:52,000 INTERACTION. 4623 03:16:52,000 --> 03:16:53,400 THAT CASE REPORT CANNOT 4624 03:16:53,400 --> 03:16:55,920 ESTABLISH CAUSATION BUT THEY CAN 4625 03:16:55,920 --> 03:16:58,160 HELP GENERATE HYPOTHESES FOR 4626 03:16:58,160 --> 03:17:00,600 POSSIBLE MECHANISMS OF ACTION. 4627 03:17:00,600 --> 03:17:02,120 NOW, ADVERSE EVENT REPORTS ARE 4628 03:17:02,120 --> 03:17:03,760 QUITE HELPFUL ESPECIALLY THOSE 4629 03:17:03,760 --> 03:17:06,080 REPORTED THROUGH THE FDA 4630 03:17:06,080 --> 03:17:07,440 MEDWATCH PROGRAM, AS WELL AS 4631 03:17:07,440 --> 03:17:09,600 CENTER FOR FOOD SAFETY AND 4632 03:17:09,600 --> 03:17:10,800 APPLIED NUTRITION'S ADVERSE 4633 03:17:10,800 --> 03:17:12,160 EVENT REPORTING DATABASE AS WELL 4634 03:17:12,160 --> 03:17:15,760 AS REPORTS THAT ARE SUBMITTED TO 4635 03:17:15,760 --> 03:17:17,680 STATE AND REGIONAL POISON 4636 03:17:17,680 --> 03:17:18,680 CONTROL CENTERS. 4637 03:17:18,680 --> 03:17:20,400 SCIENTIFIC LITERATURE IS ALSO 4638 03:17:20,400 --> 03:17:23,240 AWASH IN IN VITRO STUDIES AIMED 4639 03:17:23,240 --> 03:17:24,720 AT PREDICTING HERB OF HERB-DRUG 4640 03:17:24,720 --> 03:17:26,000 INTERACTIONS, AND THE REASON 4641 03:17:26,000 --> 03:17:28,840 THESE ARE USED IS BECAUSE THEY 4642 03:17:28,840 --> 03:17:30,400 ARE COST EFFECTIVE. 4643 03:17:30,400 --> 03:17:33,360 MANY IN VITRO STUDIES EXPOSE THE 4644 03:17:33,360 --> 03:17:35,760 WHOLE MECHANISM IS THAT THESE 4645 03:17:35,760 --> 03:17:41,600 STUDIES EXPOSE PURIFIED DRUG 4646 03:17:41,600 --> 03:17:43,600 METABOLIZING ENZYMES OR CELL 4647 03:17:43,600 --> 03:17:49,560 LINES, OR EVEN HUMAN LIVER CELLS 4648 03:17:49,560 --> 03:17:53,840 THAT EXPOSE CONCENTRATED 4649 03:17:53,840 --> 03:17:55,640 SOLUTIONS, IF HIGH ENOUGH YOU'LL 4650 03:17:55,640 --> 03:17:57,320 OBSERVE EFFECT. 4651 03:17:57,320 --> 03:17:58,400 OFTENTIMES THEY RARELY TRANSLATE 4652 03:17:58,400 --> 03:18:01,800 TO THE IN VIVO CONDITION. 4653 03:18:01,800 --> 03:18:09,200 SO THE GOLD STAND ARD IS 4654 03:18:09,200 --> 03:18:11,000 PROSPECTIVE CLINICAL STUDIES IN 4655 03:18:11,000 --> 03:18:13,080 HUMAN BEINGS. 4656 03:18:13,080 --> 03:18:14,480 RATE LIMITING ASPECTS HOWEVER IS 4657 03:18:14,480 --> 03:18:16,680 EXPENSE AND THEY CAN BE QUITE 4658 03:18:16,680 --> 03:18:17,120 EXPENSIVE. 4659 03:18:17,120 --> 03:18:19,880 OUR GROUP HAS BEEN CONDUCTING 4660 03:18:19,880 --> 03:18:22,280 SUCH STUDIES FOR 25 YEARS, SO 4661 03:18:22,280 --> 03:18:24,760 I'M GOING TO SHARE A FEW 4662 03:18:24,760 --> 03:18:26,400 EXAMPLES FROM OUR EXPERIENCE IN 4663 03:18:26,400 --> 03:18:27,720 THIS PARTICULAR PRESENTATION TO 4664 03:18:27,720 --> 03:18:29,760 ILLUSTRATE EXACTLY WHAT IT IS 4665 03:18:29,760 --> 03:18:35,440 WE'RE TALKING ABOUT TIMES OF 4666 03:18:35,440 --> 03:18:36,000 HERB-DRUG INTERACTIONS. 4667 03:18:36,000 --> 03:18:40,080 THERE ARE TWO CATEGORIES, FIRST 4668 03:18:40,080 --> 03:18:41,720 IS PHARMACODYNAMIC. 4669 03:18:41,720 --> 03:18:43,080 THE PHARMACODYNAMIC INTERACTION 4670 03:18:43,080 --> 03:18:46,800 ARISES WHEN THE BOTANICAL HAS 4671 03:18:46,800 --> 03:18:50,280 PHARMACOLOGICAL PROPERTIES, 4672 03:18:50,280 --> 03:18:53,160 EITHER SIMILAR TO OR HAS 4673 03:18:53,160 --> 03:18:55,720 PHARMACOLOGICAL PRODUCTS THE 4674 03:18:55,720 --> 03:18:58,040 OPPOSITE OF CONVENTIONAL 4675 03:18:58,040 --> 03:18:59,440 MEDICATION. 4676 03:18:59,440 --> 03:19:01,560 BOTANICAL MIGHT COMPOUND OR 4677 03:19:01,560 --> 03:19:03,240 EXACERBATE THE ACTIVITY OF 4678 03:19:03,240 --> 03:19:05,240 CONVENTIONAL OR MIGHT COUNTERACT 4679 03:19:05,240 --> 03:19:08,720 THE EFFECTS OF THAT MEDICATION. 4680 03:19:08,720 --> 03:19:18,680 FOR THE SAKE OF TIME I'LL 4681 03:19:18,680 --> 03:19:21,040 ILLUSTRATE THE EPHEDRA-FREE 4682 03:19:21,040 --> 03:19:22,520 SUPPLEMENTS. 4683 03:19:22,520 --> 03:19:28,800 I'LL TOUCH TO THOSE AGAIN. 4684 03:19:28,800 --> 03:19:35,600 THE EPHEDRA-FREE ARE A NICE 4685 03:19:35,600 --> 03:19:36,960 EXAMPLE OF PHARMACODYNAMIC 4686 03:19:36,960 --> 03:19:38,120 HERB-DRUG INTERACTION. 4687 03:19:38,120 --> 03:19:42,160 MANY OF YOU MAY REMEMBER THE 4688 03:19:42,160 --> 03:19:44,120 SUPPLEMENTS THAT CAUSED QUITE A 4689 03:19:44,120 --> 03:19:46,800 STIR FROM 1994 UNTIL REMOVAL 4690 03:19:46,800 --> 03:19:48,280 FROM THE MARKET IN 2004. 4691 03:19:48,280 --> 03:19:52,880 THIS WAS A PERIOD I CALL EPHEDRA 4692 03:19:52,880 --> 03:19:55,320 WARS, BECAUSE I WAS A TESTED 4693 03:19:55,320 --> 03:19:57,440 VETERAN IN THAT CONFLICT. 4694 03:19:57,440 --> 03:19:59,400 BASICALLY THE SUPPLEMENTS WERE 4695 03:19:59,400 --> 03:20:00,760 MULTI-INGREDIENT FORMULATIONS 4696 03:20:00,760 --> 03:20:09,000 CONTAINING NATURAL SOURCES OF 4697 03:20:09,000 --> 03:20:11,680 ALLOYS BUT ALSO CONTAINED OTHER 4698 03:20:11,680 --> 03:20:12,280 NATURAL STIMULANTS, PRIMARILY 4699 03:20:12,280 --> 03:20:14,680 CAFFEINE, A HOST OF OTHERS WE'LL 4700 03:20:14,680 --> 03:20:15,840 TALK ABOUT SHORTLY. 4701 03:20:15,840 --> 03:20:17,360 THREE OF THE MOST POPULAR 4702 03:20:17,360 --> 03:20:18,800 PRODUCTS ARE SHOWN HERE, BACK IN 4703 03:20:18,800 --> 03:20:21,880 THE DAY. 4704 03:20:21,880 --> 03:20:26,920 SO RIPPED FUEL, METABO LIFE AND 4705 03:20:26,920 --> 03:20:28,080 XENADRIN SWAYED THE MARKET, 4706 03:20:28,080 --> 03:20:33,720 MARKETED AS WEIGHT LOSS AIDS, 4707 03:20:33,720 --> 03:20:34,480 ENERGY BOOSTERS, EXERCISE 4708 03:20:34,480 --> 03:20:35,560 PERFORMANCE ENHANCERS. 4709 03:20:35,560 --> 03:20:37,480 PRIOR TO THESE PRODUCTS COMING 4710 03:20:37,480 --> 03:20:45,000 ON THE MARKET, IN THE LATE 4711 03:20:45,000 --> 03:20:45,680 1980s SYNTHETIC COMBINATIONS 4712 03:20:45,680 --> 03:20:47,000 OF THESE DRUGS HAVE COME ON THE 4713 03:20:47,000 --> 03:20:49,080 MARKET AND HAD SHOWN TO PRODUCE 4714 03:20:49,080 --> 03:20:50,840 SERIOUS ADVERSE HEALTH EFFECTS 4715 03:20:50,840 --> 03:20:52,880 LIKE HEART ATTACKS, STROKES, 4716 03:20:52,880 --> 03:20:55,920 SEIZURES, PSYCHOTIC EVENTS. 4717 03:20:55,920 --> 03:20:57,960 SO, NOT SURPRISINGLY, THESE 4718 03:20:57,960 --> 03:20:59,600 NATURAL ALTERNATIVES WERE ALSO 4719 03:20:59,600 --> 03:21:03,280 LINKED TO SOME OF THE SAME TYPES 4720 03:21:03,280 --> 03:21:04,480 OF ADVERSE EVENTS. 4721 03:21:04,480 --> 03:21:08,880 SALES, AS YOU SEE WITH THE 4722 03:21:08,880 --> 03:21:10,760 GRAPH, SALES PEAKED AROUND 2001, 4723 03:21:10,760 --> 03:21:12,640 EXCEEDED OVER A BILLION DOLLARS 4724 03:21:12,640 --> 03:21:13,720 IN SALES PER YEAR. 4725 03:21:13,720 --> 03:21:18,840 AND MUCH OF THOSE SALES WERE 4726 03:21:18,840 --> 03:21:20,320 ATTRIBUTED TO METABO-LIFE. 4727 03:21:20,320 --> 03:21:22,240 DEATHS OF SEVERAL COLLEGE AND 4728 03:21:22,240 --> 03:21:24,200 PROFESSIONAL ATHLETES AS WELL AS 4729 03:21:24,200 --> 03:21:26,200 MANY NON-ATHLETES WERE LINKED TO 4730 03:21:26,200 --> 03:21:28,080 THESE PRODUCTS. 4731 03:21:28,080 --> 03:21:29,840 AND ACCORDINGLY THERE WAS A 4732 03:21:29,840 --> 03:21:31,480 RESULTANT MEDIA FRENZY AND 4733 03:21:31,480 --> 03:21:32,640 LITIGATIONS AIMED AT THESE 4734 03:21:32,640 --> 03:21:35,080 PRODUCTS, INCLUDING THOSE BY THE 4735 03:21:35,080 --> 03:21:36,560 FDA CAUSED THE EPHEDRA SALES TO 4736 03:21:36,560 --> 03:21:38,880 PLUMMET AS YOU CAN SEE WITH THE 4737 03:21:38,880 --> 03:21:42,960 ORANGE CURVE IF YOU FOLLOW FROM 4738 03:21:42,960 --> 03:21:45,440 1998 UNTIL 2000, PEAKED AND 4739 03:21:45,440 --> 03:21:46,560 DROPPED PRECIPITOUSLY. 4740 03:21:46,560 --> 03:21:47,880 SO, THE COMPANIES, THEY SOLVED 4741 03:21:47,880 --> 03:21:49,440 THAT PROBLEM BY TAKING THE 4742 03:21:49,440 --> 03:21:53,520 EPHEDRA OUT OF THE FORMULATIONS. 4743 03:21:53,520 --> 03:21:55,320 AND QUICKLY EPHEDRA-FREE 4744 03:21:55,320 --> 03:21:56,640 PRODUCTS SURFACED THEIR 4745 03:21:56,640 --> 03:21:57,840 PROBLEMATIC PREDECESSORS. 4746 03:21:57,840 --> 03:22:03,800 NOW THE QUESTION IS, OR WAS, ARE 4747 03:22:03,800 --> 03:22:07,080 THESE PRODUCTS ANY SAFER? 4748 03:22:07,080 --> 03:22:08,520 SO TODAY NATURAL CAFFEINE 4749 03:22:08,520 --> 03:22:11,160 SOURCES ARE THE MOST FREQUENTLY 4750 03:22:11,160 --> 03:22:13,360 USED SUBSTITUTES FOR EPHEDRA. 4751 03:22:13,360 --> 03:22:16,800 THIS INCLUDES PLANT SOURCES FOR 4752 03:22:16,800 --> 03:22:19,840 CAFFEINE LIKE QUARINA, GREEN 4753 03:22:19,840 --> 03:22:26,400 TEA, COLA NUT, YERBA MATTE AND 4754 03:22:26,400 --> 03:22:33,240 SYNTHETIC CAFFEINE, CAN CONTAIN 4755 03:22:33,240 --> 03:22:35,760 3 TO 6 CUPS OR MORE, ARE THEY 4756 03:22:35,760 --> 03:22:36,680 ANY SAFER? 4757 03:22:36,680 --> 03:22:38,480 AND WHEN HIGH DOSE CAFFEINE 4758 03:22:38,480 --> 03:22:48,640 SOURCES ARE COMBINED WITH OTHER 4759 03:22:48,640 --> 03:22:50,160 NATURAL STIMULANTS, AND OTHER 4760 03:22:50,160 --> 03:22:55,320 NATURAL STIMULANTS, ARE THEY ANY 4761 03:22:55,320 --> 03:23:00,600 SAFER THAN THEIR 4762 03:23:00,600 --> 03:23:02,040 EPHEDRA-CONTAINING PREDECESSORS? 4763 03:23:02,040 --> 03:23:04,800 CASE REPORTS BEGAN APPEARING 4764 03:23:04,800 --> 03:23:07,280 DOCUMENTS ADVERSE EVENTS EERILY 4765 03:23:07,280 --> 03:23:08,280 SIMILAR TO THE 4766 03:23:08,280 --> 03:23:11,120 EPHEDRA-CONTAINING PRODUCTS. 4767 03:23:11,120 --> 03:23:14,000 AND SO CLEARLY, THIS DIDN'T BODE 4768 03:23:14,000 --> 03:23:14,920 WELL FOR THE EPHEDRA 4769 03:23:14,920 --> 03:23:17,760 SUPPLEMENTS, SAME TYPES OF STUFF 4770 03:23:17,760 --> 03:23:20,600 WE WERE SEEING WITH EPHEDRA WERE 4771 03:23:20,600 --> 03:23:24,400 BEING LINKED WITH EPHEDRA-FREE 4772 03:23:24,400 --> 03:23:25,120 SUPPLEMENTS. 4773 03:23:25,120 --> 03:23:27,040 SO, SINCE THAT WAS -- WE WERE 4774 03:23:27,040 --> 03:23:28,640 INTIMATELY INVOLVED IN EPHEDRA 4775 03:23:28,640 --> 03:23:33,480 WARS, WE DECIDED TO TAKE PART IN 4776 03:23:33,480 --> 03:23:35,760 THE EPHEDRA-FREE WARS. 4777 03:23:35,760 --> 03:23:38,000 IN 2012 CONDUCTED A SMALL 4778 03:23:38,000 --> 03:23:40,640 CLINICAL TRIAL LOOKING AT THREE 4779 03:23:40,640 --> 03:23:42,480 POPULAR EPHEDRA-FREE PRODUCTS AS 4780 03:23:42,480 --> 03:23:45,960 WELL AS COMMON INGREDIENT IN ALL 4781 03:23:45,960 --> 03:23:47,120 OF THEM, GUARANA, A NATURAL 4782 03:23:47,120 --> 03:23:48,160 SOURCE OF CAFFEINE. 4783 03:23:48,160 --> 03:23:53,400 SO YOU CAN SEE UNDER THE 4784 03:23:53,400 --> 03:23:55,640 PRODUCTS IN YELLOW, UNDER EACH 4785 03:23:55,640 --> 03:23:56,800 TRADE NAME IS LIST OF 4786 03:23:56,800 --> 03:23:58,440 INGREDIENTS IN THE PRODUCT. 4787 03:23:58,440 --> 03:24:05,120 YOU CAN SEE ALL MULTI-INGREDIENT 4788 03:24:05,120 --> 03:24:06,760 PRODUCTS WITH EXCEPTION OF 4789 03:24:06,760 --> 03:24:09,080 GUARANA, A MAIN STAY. 4790 03:24:09,080 --> 03:24:10,440 YOU'LL NOTICE THERE'S NUMBERS 4791 03:24:10,440 --> 03:24:11,520 HIGHLIGHTED IN RED. 4792 03:24:11,520 --> 03:24:12,880 FIRST NUMBER IS AMOUNT OF 4793 03:24:12,880 --> 03:24:15,680 CAFFEINE THAT WOULD HAVE BEEN IN 4794 03:24:15,680 --> 03:24:17,000 AN INDIVIDUAL DOSAGE FORM. 4795 03:24:17,000 --> 03:24:18,960 AND THEN NEXT NUMBER IS AMOUNT 4796 03:24:18,960 --> 03:24:20,840 OF CAFFEINE THAT AN INDIVIDUAL 4797 03:24:20,840 --> 03:24:22,880 WOULD HAVE CONSUMED IF THEY 4798 03:24:22,880 --> 03:24:24,000 FOLLOWED THE LABEL DIRECTIONS. 4799 03:24:24,000 --> 03:24:30,360 AND SO YOU CAN SEE THAT THE 4800 03:24:30,360 --> 03:24:32,880 CAFFEINE DOSES WENT FROM HALF A 4801 03:24:32,880 --> 03:24:37,040 GRAM TO ALMOST OVER A GRAM OF 4802 03:24:37,040 --> 03:24:39,040 CAFFEINE PER DAY, AND DEPENDING 4803 03:24:39,040 --> 03:24:40,000 UPON YOUR INDIVIDUAL 4804 03:24:40,000 --> 03:24:43,480 SENSITIVITY, A GRAM OF CAFFEINE 4805 03:24:43,480 --> 03:24:44,800 CAN HAVE SIGNIFICANT 4806 03:24:44,800 --> 03:24:45,800 PHARMACOLOGICAL EFFECTS. 4807 03:24:45,800 --> 03:24:48,680 SO BASICALLY WE TOOK 12 HEALTHY 4808 03:24:48,680 --> 03:24:51,480 MALE VOLUNTEERS, RANDOMIZED TO 4809 03:24:51,480 --> 03:24:54,440 TAKE EACH OF THESE PRODUCTS, 4810 03:24:54,440 --> 03:24:57,720 RANDOMIZED FOR SEQUENCE, ACTIVE 4811 03:24:57,720 --> 03:24:59,120 PHASES, IN BETWEEN EACH ACTIVE 4812 03:24:59,120 --> 03:25:02,400 PHASE THERE WAS A WASH OUT 4813 03:25:02,400 --> 03:25:03,000 PHASE. 4814 03:25:03,000 --> 03:25:06,280 TWO CAPSULES THREE TIMES A DAY 4815 03:25:06,280 --> 03:25:09,640 FOR THREE DAYS, WE MONITORED 4816 03:25:09,640 --> 03:25:12,240 SUBJECTS FOR BLOOD PRESSURE, 4817 03:25:12,240 --> 03:25:17,240 HEART RATE, EKG ACTIVITY USING A 4818 03:25:17,240 --> 03:25:18,160 HOLTER MONITOR. 4819 03:25:18,160 --> 03:25:20,600 AND SO NOT TOO SURPRISINGLY 4820 03:25:20,600 --> 03:25:22,240 DURING THE ACTIVE PHASES OF THE 4821 03:25:22,240 --> 03:25:23,560 STUDY WE SAW SIGNIFICANT 4822 03:25:23,560 --> 03:25:28,480 INCREASES IN SYSTOLIC AND 4823 03:25:28,480 --> 03:25:33,880 DIASTOLIC BLOOD PRESSURE, HEART 4824 03:25:33,880 --> 03:25:35,520 RATE, AND MORE ABNORMAL EKGs 4825 03:25:35,520 --> 03:25:38,360 THAN IN WASHOUT PHASE. 4826 03:25:38,360 --> 03:25:41,000 WE ASKED OURSELVES SIGNIFICANT 4827 03:25:41,000 --> 03:25:43,200 NAUSEA AND VOMITING, WITH THIS 4828 03:25:43,200 --> 03:25:46,200 MUCH CAFFEINE, INSOMNIA AND 4829 03:25:46,200 --> 03:25:49,040 ANXIETY WERE COMMON SIDE EFFECTS 4830 03:25:49,040 --> 03:25:49,200 TOO. 4831 03:25:49,200 --> 03:25:50,720 WE WERE NOT TOO SURPRISED BY THE 4832 03:25:50,720 --> 03:25:53,440 FACT THAT WE SAW SOME INSOMNIA, 4833 03:25:53,440 --> 03:25:54,880 CHANGES IN HEART RATE, BLOOD 4834 03:25:54,880 --> 03:25:56,480 PRESSURE, BECAUSE IN THE 4835 03:25:56,480 --> 03:25:59,120 CAFFEINE DOSE IS HIGH BUT ALSO 4836 03:25:59,120 --> 03:25:59,800 COMPLEXITY OF FORMULATIONS 4837 03:25:59,800 --> 03:26:01,560 PROBABLY CONTRIBUTED TO EFFECTS 4838 03:26:01,560 --> 03:26:02,640 AS WELL. 4839 03:26:02,640 --> 03:26:05,680 ONE OF THE THINGS WE ANALYZED 4840 03:26:05,680 --> 03:26:07,280 FOR CAFFEINE CONTENT, WE FOUND 4841 03:26:07,280 --> 03:26:08,720 TWO PRODUCTS RAN US OUT OF THE 4842 03:26:08,720 --> 03:26:11,080 LAB BECAUSE THEY SMELLED SO BAD, 4843 03:26:11,080 --> 03:26:12,720 MY TECHNICIANS SAID I THINK WE 4844 03:26:12,720 --> 03:26:14,600 MAY HAVE A BACTERIAL 4845 03:26:14,600 --> 03:26:15,040 CONTAMINATION. 4846 03:26:15,040 --> 03:26:16,640 SURE ENOUGH WE SENT THE PRODUCTS 4847 03:26:16,640 --> 03:26:19,520 DOWN TO THE NATIONAL CENTER FOR 4848 03:26:19,520 --> 03:26:20,640 TOXICOLOGIC RESEARCH AND TWO 4849 03:26:20,640 --> 03:26:23,040 PRODUCTS CAME BACK AS BEING 4850 03:26:23,040 --> 03:26:25,680 HEAVILY CONTAMINATED WITH 4851 03:26:25,680 --> 03:26:27,960 BACILLUS SPECIES, ONE WAS 4852 03:26:27,960 --> 03:26:29,200 BACILLUS SIRIUS, WELL RECOGNIZED 4853 03:26:29,200 --> 03:26:30,880 HUMAN PATHOGEN. 4854 03:26:30,880 --> 03:26:34,560 I FELT BAD ABOUT EXPOSED MY 4855 03:26:34,560 --> 03:26:37,000 SUBJECTS TO THESE CONTAMINATED 4856 03:26:37,000 --> 03:26:37,720 PRODUCTS, CERTAINLY COULD 4857 03:26:37,720 --> 03:26:40,640 ATTRIBUTE TO NAUSEA AND 4858 03:26:40,640 --> 03:26:40,960 VOMITING. 4859 03:26:40,960 --> 03:26:42,920 HEY, THERE WAS NO LISTING FOR, 4860 03:26:42,920 --> 03:26:45,360 AS YOU CAN NOTICE ON LIST OF 4861 03:26:45,360 --> 03:26:47,880 INGREDIENTS, NO LIST LABEL CLAIM 4862 03:26:47,880 --> 03:26:48,760 FOR BACILLUS SPECIES. 4863 03:26:48,760 --> 03:26:53,320 BOTTOM LINE IS EVEN THOUGH THESE 4864 03:26:53,320 --> 03:26:54,440 PRODUCTS MAY BE EPHEDRA FREE 4865 03:26:54,440 --> 03:26:56,400 THEY ARE NOT NECESSARILY TROUBLE 4866 03:26:56,400 --> 03:26:57,600 FREE. 4867 03:26:57,600 --> 03:26:58,880 WITH REGARDS TO CARDIOVASCULAR 4868 03:26:58,880 --> 03:27:00,120 EFFECT, NEXT POINT, IF AN 4869 03:27:00,120 --> 03:27:01,200 INDIVIDUAL IS TAKING SOME OF 4870 03:27:01,200 --> 03:27:04,200 THESE PRODUCTS PRIMARILY TO LOSE 4871 03:27:04,200 --> 03:27:07,720 WEIGHT OR WHATEVER AND YOU'RE ON 4872 03:27:07,720 --> 03:27:09,400 AN ANTI-HYPERTENSIVE MEDICATION 4873 03:27:09,400 --> 03:27:10,720 DON'T BE SURPRISED IF YOUR 4874 03:27:10,720 --> 03:27:11,720 MEDICATION DOESN'T WORK VERY 4875 03:27:11,720 --> 03:27:16,400 WELL AND YOUR BLOOD PRESSURE IS 4876 03:27:16,400 --> 03:27:18,880 NOT CONTROLLED WELL. 4877 03:27:18,880 --> 03:27:21,200 PRE-WORKOUT SUPPLEMENTS ARE 4878 03:27:21,200 --> 03:27:22,160 POPULAR TODAY, IT'S SURPRISING 4879 03:27:22,160 --> 03:27:28,400 HOW MANY YOUNG ATHLETES WITH 4880 03:27:28,400 --> 03:27:31,560 TAKING ADHD MEDICATIONS 4881 03:27:31,560 --> 03:27:32,240 CONCOMITANTLY. 4882 03:27:32,240 --> 03:27:34,800 THIS PRODUCT HERE CALLED STIM 4883 03:27:34,800 --> 03:27:36,320 LORD IS A PRE-WORKOUT 4884 03:27:36,320 --> 03:27:36,840 SUPPLEMENT. 4885 03:27:36,840 --> 03:27:38,200 YOU NOTICE I'VE GOT SOME 4886 03:27:38,200 --> 03:27:39,200 INGREDIENTS HIGHLIGHTED IN 4887 03:27:39,200 --> 03:27:39,480 YELLOW. 4888 03:27:39,480 --> 03:27:42,440 THESE ARE ALL CAFFEINE SOURCES. 4889 03:27:42,440 --> 03:27:45,120 ALSO SOURCES OF OTHER 4890 03:27:45,120 --> 03:27:46,120 STIMULANTS. 4891 03:27:46,120 --> 03:27:49,840 AND THE COMPOUND IN RED OCCURS 4892 03:27:49,840 --> 03:27:53,200 IN CERTAIN PLANTS, IT'S AN OLD 4893 03:27:53,200 --> 03:28:00,160 DRUG, ONCE USED AS A MAINSTAY TO 4894 03:28:00,160 --> 03:28:03,040 TREAT ASTHMA AND PULMONARY 4895 03:28:03,040 --> 03:28:05,160 DISEASE, THE NARROW THERAPEUTIC 4896 03:28:05,160 --> 03:28:06,960 INDEX, IT DOESN'T TAKE MUCH TO 4897 03:28:06,960 --> 03:28:07,360 BECOME TOXIC. 4898 03:28:07,360 --> 03:28:12,600 IF YOU HAVE AN INDIVIDUAL YOUNG 4899 03:28:12,600 --> 03:28:17,560 ATHLETES TAKING ADHD MED LIKE 4900 03:28:17,560 --> 03:28:19,800 AMPHETAMINE, EXERCISING IN A HOT 4901 03:28:19,800 --> 03:28:20,720 HUMID ENVIRONMENT DON'T BE 4902 03:28:20,720 --> 03:28:22,520 SURPRISED IF YOU EXPERIENCE 4903 03:28:22,520 --> 03:28:27,760 UNTOWARD CARDIOVASCULAR EFFECT. 4904 03:28:27,760 --> 03:28:31,600 SOMEONE IS OVERWEIGHT, ALSO ON 4905 03:28:31,600 --> 03:28:32,400 HYPERTENSIVE MEDS, BLOOD 4906 03:28:32,400 --> 03:28:34,120 PRESSURE WON'T BE WELL 4907 03:28:34,120 --> 03:28:35,440 CONTROLLED. 4908 03:28:35,440 --> 03:28:42,080 PRODUCTS LIKE THIS ARE BASICALLY 4909 03:28:42,080 --> 03:28:42,640 PHARMACODYNAMIC HERB-DRUG 4910 03:28:42,640 --> 03:28:44,920 INTERACTIONS WAITING TO HAPPEN. 4911 03:28:44,920 --> 03:28:46,280 YOU MAY RECOGNIZE PABLO ESCOBAR, 4912 03:28:46,280 --> 03:28:49,200 THAT GIVES YOU AN IDEA HOW THE 4913 03:28:49,200 --> 03:28:50,080 MARKETERS OF SOME PRODUCTS, YOU 4914 03:28:50,080 --> 03:28:53,800 KNOW, HOW THEY THINK ABOUT THIS. 4915 03:28:53,800 --> 03:28:57,560 THAT SPEAKS VOLUMES ABOUT THE 4916 03:28:57,560 --> 03:28:57,800 PRODUCTS. 4917 03:28:57,800 --> 03:29:00,600 I WANTS TO SHIFT GEARS AND TALK 4918 03:29:00,600 --> 03:29:06,600 ABOUT THE NEXT MAJOR CATEGORY 4919 03:29:06,600 --> 03:29:09,640 WITH PHARMACOKINETIC MECHANISM. 4920 03:29:09,640 --> 03:29:13,760 THE HERB-DRUG, BOTANICAL ALTERS 4921 03:29:13,760 --> 03:29:15,040 ABSORPTION, DISTRIBUTION, 4922 03:29:15,040 --> 03:29:17,440 METABOLISM, AND/OR EXCRETION OF 4923 03:29:17,440 --> 03:29:18,880 A CO-ADMINISTERED MEDICATION. 4924 03:29:18,880 --> 03:29:21,760 THIS USUALLY COMES ABOUT THROUGH 4925 03:29:21,760 --> 03:29:22,720 PHYTO CHEMICAL MODULATION OF 4926 03:29:22,720 --> 03:29:25,320 ENZYMES FOUND IN THE SMALL 4927 03:29:25,320 --> 03:29:27,120 INTESTINE AND LIVER. 4928 03:29:27,120 --> 03:29:37,680 AND THESE ARE PRIMARILY ENZYMES, 4929 03:29:39,240 --> 03:29:39,920 TRANSFERATIONS, SULFATASE 4930 03:29:39,920 --> 03:29:44,400 A HOSE OF -- HOST OF ENZYMES 4931 03:29:44,400 --> 03:29:45,640 THAT CAN BE AFFECTED AND CAN BE 4932 03:29:45,640 --> 03:29:56,120 THE RESULT OF PHYTOCHEMICAL 4933 03:29:58,480 --> 03:30:08,040 MODULATION, FOUND IN THE 4934 03:30:08,040 --> 03:30:11,080 BLOOD-BRAIN BARRIER. 4935 03:30:11,080 --> 03:30:15,800 AN EFFLUX PUMP PREVENTS DRUGS 4936 03:30:15,800 --> 03:30:16,440 FROM GETTING INTO CELLS, ON THE 4937 03:30:16,440 --> 03:30:19,800 OTHER HAND YOU CAN HAVE UPTAKE 4938 03:30:19,800 --> 03:30:20,680 TRANSPORTERS, PROTEINS THAT 4939 03:30:20,680 --> 03:30:21,880 LITERALLY PULL DRUGS OR 4940 03:30:21,880 --> 03:30:23,680 TRANSPORT DRUGS INTO CELLS. 4941 03:30:23,680 --> 03:30:25,240 YOU CAN HAVE DEPENDING ON THE 4942 03:30:25,240 --> 03:30:29,200 TYPE OF TRANSPORTER CAN WORK AT 4943 03:30:29,200 --> 03:30:29,800 CROSS-PURPOSES. 4944 03:30:29,800 --> 03:30:36,360 NOW, ENZYMES THAT ARE MOST 4945 03:30:36,360 --> 03:30:38,760 INVOLVED ARE CYTOKINE P450s, 4946 03:30:38,760 --> 03:30:39,440 THIS ILLUSTRATES THE ENZYMES 4947 03:30:39,440 --> 03:30:41,640 PRESENT IN THE LIVER AND SMALL 4948 03:30:41,640 --> 03:30:42,000 INTESTINE. 4949 03:30:42,000 --> 03:30:46,680 OF THESE THE MOST IMPORTANT IS 4950 03:30:46,680 --> 03:30:48,440 WHAT'S CALLED CYP 3A4, IT'S 4951 03:30:48,440 --> 03:30:50,760 INVOLVED IN METABOLISM OF ALMOST 4952 03:30:50,760 --> 03:30:52,360 HALF OF ALL CONVENTIONAL 4953 03:30:52,360 --> 03:30:53,680 MEDICATIONS TO SOME EXTEND. 4954 03:30:53,680 --> 03:30:56,400 SECOND MOST IMPORTANT ONE IS CYP 4955 03:30:56,400 --> 03:31:02,680 2D 6, 20% OF DRUG METABOLISM, 4956 03:31:02,680 --> 03:31:05,040 AND THEN SEVERAL OTHERS KIND OF 4957 03:31:05,040 --> 03:31:07,800 ROUND OUT THE LIST. 4958 03:31:07,800 --> 03:31:11,440 THIS PARTICULAR CARTOON 4959 03:31:11,440 --> 03:31:13,360 DEMONSTRATES SPECTRUM OF 4960 03:31:13,360 --> 03:31:13,920 POSSIBLE PHARMACOKINETIC 4961 03:31:13,920 --> 03:31:14,400 HERB-DRUG INTERACTION. 4962 03:31:14,400 --> 03:31:17,400 AT THE TOP WE SEE THIS RED 4963 03:31:17,400 --> 03:31:24,240 CIRCLE WHICH IS A DOSE 4964 03:31:24,240 --> 03:31:26,280 FEDODAPINE, IN THE SMALL 4965 03:31:26,280 --> 03:31:29,280 INTESTINE IT'S EXPOSED TO 4966 03:31:29,280 --> 03:31:32,200 ENZYMES, NAMELY CYP 384, THAT 4967 03:31:32,200 --> 03:31:33,680 METABOLIZES SUCH THAT ONLY ABOUT 4968 03:31:33,680 --> 03:31:37,680 30% OF THE ORIGINAL DOSE REACHES 4969 03:31:37,680 --> 03:31:38,560 PORTAL CIRCULATION UNCHANGED, 4970 03:31:38,560 --> 03:31:41,520 AND THEN GOES TO THE LIVER, 4971 03:31:41,520 --> 03:31:46,080 EXPOSED TO EVEN MORE CYTOCHROME 4972 03:31:46,080 --> 03:31:48,880 P450 METABOLISM, 15% OF ORIGINAL 4973 03:31:48,880 --> 03:31:50,400 DOSE REACHS THE SYSTEMIC 4974 03:31:50,400 --> 03:31:52,000 CIRCULATION, WHERE IT CAN THEN 4975 03:31:52,000 --> 03:31:53,440 ACT ON CALCIUM CHANNELS IN THE 4976 03:31:53,440 --> 03:31:58,000 HEART TO LOWER BLOOD PRESSURE. 4977 03:31:58,000 --> 03:32:06,880 NOW, AN N SAID ON THE LEFT, THE 4978 03:32:06,880 --> 03:32:08,560 GREEN CIRCLE RECOMMENDS 4979 03:32:08,560 --> 03:32:12,120 GRAPEFRUIT JUICE THAT CONTAINS 4980 03:32:12,120 --> 03:32:16,280 AN INHIBITOR OF CYP 384 IN THE 4981 03:32:16,280 --> 03:32:17,480 GUT. 4982 03:32:17,480 --> 03:32:22,120 IF FELODAPINE IS TAKEN WITH 4983 03:32:22,120 --> 03:32:22,840 GREAT FRUIT JUICE, 4984 03:32:22,840 --> 03:32:24,000 BIOAVAILABILITY CAN BE INCREASED 4985 03:32:24,000 --> 03:32:26,480 TO AS MUCH AS 45%, VIRTUALLY 4986 03:32:26,480 --> 03:32:28,440 TRIPLING OF THE DOSE, AND SO 4987 03:32:28,440 --> 03:32:34,520 THAT CAN LEAD TO SIGNIFICANT 4988 03:32:34,520 --> 03:32:36,200 HYPOTENSION DUE TO GRAPEFRUIT 4989 03:32:36,200 --> 03:32:45,040 JUICE EFFECT ON INHIBITING 4990 03:32:45,040 --> 03:32:45,920 METABOLISM OF FELODAPINE. 4991 03:32:45,920 --> 03:32:47,960 IT MIGHT RENDER A DRUG MORE 4992 03:32:47,960 --> 03:32:49,080 TOXIC, IN THIS CASE. 4993 03:32:49,080 --> 03:32:54,840 ON THE OTHER HAND, IF WE HAVE A 4994 03:32:54,840 --> 03:32:57,400 PHYTOCHEMICAL THAT INDUCES 4995 03:32:57,400 --> 03:33:00,560 EXPRESSION OF DRUG METABOLIZING 4996 03:33:00,560 --> 03:33:05,400 ENZYMES IN GUT OR LIFE 4997 03:33:05,400 --> 03:33:07,520 BIOAVAILABILITY OF FELODAPINE 4998 03:33:07,520 --> 03:33:10,280 MIGHT BE REDUCED TO SAY 5%, TO 4999 03:33:10,280 --> 03:33:13,560 THE POINT THAT IT RENDERS THE 5000 03:33:13,560 --> 03:33:14,160 DRUG INEFFECTIVE. 5001 03:33:14,160 --> 03:33:16,040 SO THOSE ARE POSSIBILITIES, YOU 5002 03:33:16,040 --> 03:33:23,800 COULD HAVE IN TERMS OF TOXICITY. 5003 03:33:23,800 --> 03:33:27,080 LET'S LOOK AT THIS INDUCTION OR 5004 03:33:27,080 --> 03:33:31,160 INHIBITION ON STEADY STATE BLOOD 5005 03:33:31,160 --> 03:33:31,400 LEVELS. 5006 03:33:31,400 --> 03:33:33,760 SO, WE ADMINISTER DRUGS AT DOSES 5007 03:33:33,760 --> 03:33:35,480 AND DOSING INTERVALS TO ACHIEVE 5008 03:33:35,480 --> 03:33:37,720 STEADY STATE BLOOD LEVEL THAT 5009 03:33:37,720 --> 03:33:39,480 FALLS WITHIN A DESIRED 5010 03:33:39,480 --> 03:33:41,760 THERAPEUTIC RANGE. 5011 03:33:41,760 --> 03:33:44,280 DOTTED LINE HERE DEPICTS 5012 03:33:44,280 --> 03:33:46,160 THERAPEUTIC RANGE BOUNDED BY 5013 03:33:46,160 --> 03:33:47,760 THEORETICAL MAXIMUM SAFE 5014 03:33:47,760 --> 03:33:49,640 CONCENTRATION AND MINIMUM 5015 03:33:49,640 --> 03:33:50,160 EFFECTIVE CONCENTRATION. 5016 03:33:50,160 --> 03:33:53,480 IT'S THE ACTIVITY OF THESE 5017 03:33:53,480 --> 03:33:54,720 VARIOUS ENZYMES AND TRANSPORTERS 5018 03:33:54,720 --> 03:33:56,760 THAT DICTATE WHETHER THE STEADY 5019 03:33:56,760 --> 03:33:58,320 STATE BLOOD LEVELS WILL FALL 5020 03:33:58,320 --> 03:34:01,240 WITHIN OR OUTSIDE OF THIS 5021 03:34:01,240 --> 03:34:01,640 THERAPEUTIC RANGE. 5022 03:34:01,640 --> 03:34:07,160 SO THE YELLOW LINE DEPICTS IDEAL 5023 03:34:07,160 --> 03:34:07,520 DOSING SCHEDULE. 5024 03:34:07,520 --> 03:34:11,080 GREEN LINE DEPICTS WHAT HAPPENS 5025 03:34:11,080 --> 03:34:14,840 WHEN THE ENZYMES OR EFFLUX 5026 03:34:14,840 --> 03:34:16,480 TRANSPORTERS ARE INDUCED. 5027 03:34:16,480 --> 03:34:19,080 LESS DRUG GETS ABSORBED, WHAT 5028 03:34:19,080 --> 03:34:20,080 DOES GET ABSORBED GETS 5029 03:34:20,080 --> 03:34:21,760 METABOLIZED QUICKLY, THEREFORE 5030 03:34:21,760 --> 03:34:22,400 THE HALF-LIFE IS MUCH SHORTER 5031 03:34:22,400 --> 03:34:24,920 AND LESS OF THE DRUG 5032 03:34:24,920 --> 03:34:25,240 ACCUMULATES. 5033 03:34:25,240 --> 03:34:26,880 AND IT RENDERS THE DOSING 5034 03:34:26,880 --> 03:34:28,160 REGIMEN IN EFFECTIVE. 5035 03:34:28,160 --> 03:34:31,360 YOU CAN SEE BELOW MINIMUM 5036 03:34:31,360 --> 03:34:32,040 EFFECTIVE CONCENTRATION. 5037 03:34:32,040 --> 03:34:37,000 PURPLE LINE ON THE OTHER HAND 5038 03:34:37,000 --> 03:34:39,640 DEPICTS WHATS WHEN ENZYMES OR 5039 03:34:39,640 --> 03:34:41,520 TRANSPORTSERS ARE INHIBITS, MORE 5040 03:34:41,520 --> 03:34:44,280 DRUG GETS ABSORBED, IT'S NOT AS 5041 03:34:44,280 --> 03:34:45,440 METABOLIZED AS READILY, 5042 03:34:45,440 --> 03:34:48,200 HALF-LIFE GETS LONGER, MORE DRUG 5043 03:34:48,200 --> 03:34:49,080 ACCUMULATES. 5044 03:34:49,080 --> 03:34:51,080 THERE BY EXCEEDING MAXIMUM SAFE 5045 03:34:51,080 --> 03:34:52,280 CONCENTRATION AND POSSIBLY 5046 03:34:52,280 --> 03:34:55,000 INDUCING TOXICITY. 5047 03:34:55,000 --> 03:34:57,320 THIS IS THE SPECTRUM OF 5048 03:34:57,320 --> 03:35:03,080 HERB-DRUG INTERACTION 5049 03:35:03,080 --> 03:35:04,360 POSSIBILITY WITH PHARMACOKINETIC 5050 03:35:04,360 --> 03:35:04,600 MECHANISM. 5051 03:35:04,600 --> 03:35:05,840 LET'S LOOK AT EXAMPLES. 5052 03:35:05,840 --> 03:35:10,080 YOU ALREADY KNOW THIS BUT THE 5053 03:35:10,080 --> 03:35:10,880 MOST PROBLEMATIC BOTANICAL WITH 5054 03:35:10,880 --> 03:35:13,200 REGARD TO NUMBER OF CLINICALLY 5055 03:35:13,200 --> 03:35:16,960 RELEVANT INTERACTIONS IS ST. 5056 03:35:16,960 --> 03:35:19,120 JOHN'S WART USED TO RELIEF MILD 5057 03:35:19,120 --> 03:35:20,840 TO MODERATE DEPRESSION. 5058 03:35:20,840 --> 03:35:22,680 EFFICACY IS QUITE GOOD, IF YOU 5059 03:35:22,680 --> 03:35:24,040 HAVE HIGH QUALITY ST. JOHN'S 5060 03:35:24,040 --> 03:35:25,000 WORT BEING USED. 5061 03:35:25,000 --> 03:35:33,880 IN FACT ST. JOHN'S WORT AHERE'S 5062 03:35:33,880 --> 03:35:37,520 APPEARS TO BE BETTER, BUT 5063 03:35:37,520 --> 03:35:43,080 CARRIES A RISK BECAUSE IT CAN 5064 03:35:43,080 --> 03:35:44,520 RENDER MOST MEDICATIONS 5065 03:35:44,520 --> 03:35:45,240 INEFFECTIVE. 5066 03:35:45,240 --> 03:35:49,480 WHAT IT DOES IS INDUCES 5067 03:35:49,480 --> 03:35:55,720 EXPRESSION OF SEVERAL KEY P450 5068 03:35:55,720 --> 03:35:57,240 ENZYMES, AND MY GROUP IN THE 5069 03:35:57,240 --> 03:36:02,160 LATE 1990s WAS THE FIRST TO 5070 03:36:02,160 --> 03:36:05,400 IDENTIFY PENCHANT FOR INDUCING 5071 03:36:05,400 --> 03:36:10,480 CYP 3A4 IN HUMANS. 5072 03:36:10,480 --> 03:36:15,680 WE'RE CONDUCTING A CLINICAL 5073 03:36:15,680 --> 03:36:16,320 ASSESSMENT, ABILITY TO MODERATE 5074 03:36:16,320 --> 03:36:18,400 ACTIVITY, IT WAS AMONG THE FIRST 5075 03:36:18,400 --> 03:36:19,600 WE EVALUATED. 5076 03:36:19,600 --> 03:36:20,800 WHAT THESE TWO SLIDES 5077 03:36:20,800 --> 03:36:29,480 DEMONSTRATE IS WHAT HAPPENS TO 5078 03:36:29,480 --> 03:36:35,200 CYP 3 A 4 ACTIVITY, BLUE BARS 5079 03:36:35,200 --> 03:36:38,640 ARE PHENOTYPE BEFORE AND AFTER A 5080 03:36:38,640 --> 03:36:38,920 COURSE. 5081 03:36:38,920 --> 03:36:40,640 RED CIRCLE IS MEAN VALUES. 5082 03:36:40,640 --> 03:36:45,440 IN BOTH YOUNG AND ELDERLY 5083 03:36:45,440 --> 03:36:47,160 COHORTS ACTIVITY WAS INCREASED 5084 03:36:47,160 --> 03:36:49,200 BY APPROXIMATELY 100%, YOU MIGHT 5085 03:36:49,200 --> 03:36:51,640 SAY THAT'S ALL WELL AND GOOD, 5086 03:36:51,640 --> 03:36:56,880 BUT IS THAT EFFECT CLINICAL 5087 03:36:56,880 --> 03:36:57,160 RELEVANT? 5088 03:36:57,160 --> 03:36:58,080 WELL, LET'S FIND OUT. 5089 03:36:58,080 --> 03:37:04,080 ABOUT TWO WEEKS AFTER I 5090 03:37:04,080 --> 03:37:04,720 GENERATED THAT DATA 5091 03:37:04,720 --> 03:37:07,880 AGAIN DATA IN THE PREVIOUS SLIDE 5092 03:37:07,880 --> 03:37:09,840 I GOT A PHONE CALL FROM THE 5093 03:37:09,840 --> 03:37:11,120 CHIEF TRANSPLANT SURGERY AT MY 5094 03:37:11,120 --> 03:37:13,520 PREVIOUS INSTITUTION, UNIVERSITY 5095 03:37:13,520 --> 03:37:15,960 OF ARKANSAS FOR MEDICAL 5096 03:37:15,960 --> 03:37:16,960 SCIENCES. 5097 03:37:16,960 --> 03:37:17,960 AND THE TRANSPLANT SURGEON WHO 5098 03:37:17,960 --> 03:37:20,360 WAS A GOOD FRIEND CALLS ME AND 5099 03:37:20,360 --> 03:37:24,960 SAYS, I KNOW YOU WORK WITH THAT 5100 03:37:24,960 --> 03:37:29,880 HERBAL CRAP, HE USED A HARSHER 5101 03:37:29,880 --> 03:37:32,040 EXPLETIVE, SAME NUMBER OF 5102 03:37:32,040 --> 03:37:32,840 LETTERS. 5103 03:37:32,840 --> 03:37:36,280 HE ASKED IF ST. JOHN'S WART 5104 03:37:36,280 --> 03:37:37,120 WOULD INTERFERE WITH 5105 03:37:37,120 --> 03:37:37,880 CYCLOSPORIN. 5106 03:37:37,880 --> 03:37:40,000 I SAID DO YOU HAVE TRANSPLANT 5107 03:37:40,000 --> 03:37:41,840 PATIENTS TAKING ST. JOHN'S WORT 5108 03:37:41,840 --> 03:37:43,720 WITH CYCLOSPORIN? 5109 03:37:43,720 --> 03:37:44,280 YEAH, WE DO. 5110 03:37:44,280 --> 03:37:46,400 I SAID I'LL BET THE CYCLOSPORIN 5111 03:37:46,400 --> 03:37:47,920 LEVELS ARE REALLY LOW, AREN'T 5112 03:37:47,920 --> 03:37:48,200 THEY? 5113 03:37:48,200 --> 03:37:51,600 THERE WAS A LONG PAUSE ON THE 5114 03:37:51,600 --> 03:37:52,040 PHONE. 5115 03:37:52,040 --> 03:37:54,360 HE'S LIKE, YEAH, HOW DID YOU 5116 03:37:54,360 --> 03:37:55,520 KNOW THAT? 5117 03:37:55,520 --> 03:38:01,720 SO WHAT THIS FIGURE DEPICTS IS 5118 03:38:01,720 --> 03:38:06,400 CYCLOSPORIN TROUGH CONCENTRATION 5119 03:38:06,400 --> 03:38:10,120 PROFILE IN 28-YEAR-OLD WHITE 5120 03:38:10,120 --> 03:38:15,280 FEMALE FIVE YEARS POST 5121 03:38:15,280 --> 03:38:16,240 TRANSPLANT. 5122 03:38:16,240 --> 03:38:17,440 IT REVOLUTIONIZED SOLID ORGAN 5123 03:38:17,440 --> 03:38:23,160 TRANSPLANT BUT HAS A NARROW 5124 03:38:23,160 --> 03:38:25,360 THERAPEUTIC INDEX, SUBSTRATE FOR 5125 03:38:25,360 --> 03:38:26,960 CYP 3A4, YOU CAN REJECT YOUR 5126 03:38:26,960 --> 03:38:29,600 KIDNEY IF LEVELS ARE TOO LOW, IF 5127 03:38:29,600 --> 03:38:32,600 TOO HIGH CAN BE TOXIC. 5128 03:38:32,600 --> 03:38:34,760 LEVELS HAVE TO BE CLOSELY 5129 03:38:34,760 --> 03:38:35,280 MONITORED. 5130 03:38:35,280 --> 03:38:37,200 FOR A LONG TIME THIS PARTICULAR 5131 03:38:37,200 --> 03:38:38,440 INDIVIDUAL THINGS WERE JUST 5132 03:38:38,440 --> 03:38:39,560 FINE. 5133 03:38:39,560 --> 03:38:41,440 AROUND CHRISTMAS TIME OF 1999 5134 03:38:41,440 --> 03:38:43,520 HER LEVELS STARTED TO PLUMMET. 5135 03:38:43,520 --> 03:38:45,800 IN ORDER TO ADJUST, THE DOSE WAS 5136 03:38:45,800 --> 03:38:46,960 ALMOST DOUBLED, FROM 100 5137 03:38:46,960 --> 03:38:49,920 MILLIGRAMS TWICE A DAY TO 175 5138 03:38:49,920 --> 03:38:51,520 MILLIGRAMS TWICE A DAY. 5139 03:38:51,520 --> 03:38:55,760 EVEN AFTER THAT DOUBLING OF THE 5140 03:38:55,760 --> 03:38:59,760 DOSE LEVELS KEPT GOING DOWN, 5141 03:38:59,760 --> 03:39:00,400 DOWN, DOWN, EVERYBODY WAS 5142 03:39:00,400 --> 03:39:05,240 STARTING TO GET IN A BIT OF 5143 03:39:05,240 --> 03:39:06,320 CONCERN, THE TRANSPLANT TIME, 5144 03:39:06,320 --> 03:39:07,920 SHOWING SIGNS OF ACUTE 5145 03:39:07,920 --> 03:39:08,800 REJECTION. 5146 03:39:08,800 --> 03:39:10,120 SHE WAS BEING COMPLIANT AND 5147 03:39:10,120 --> 03:39:12,560 WASN'T TAKING ANY OTHER 5148 03:39:12,560 --> 03:39:13,120 MEDICATIONS. 5149 03:39:13,120 --> 03:39:15,680 AND SO IT JUST SO HAPPENED AN 5150 03:39:15,680 --> 03:39:17,280 OFFHAND COMMENT SHE MENTIONED TO 5151 03:39:17,280 --> 03:39:20,400 THE DIETITIAN ON THE TEAM, I'VE 5152 03:39:20,400 --> 03:39:22,520 BEEN FEELING DEPRESSED, HAVE 5153 03:39:22,520 --> 03:39:23,520 BEEN TAKING ST. JOHN'S WORT, 5154 03:39:23,520 --> 03:39:25,000 THAT'S ABOUT THE ONLY THING I 5155 03:39:25,000 --> 03:39:26,480 CAN RECALL THAT MIGHT BE 5156 03:39:26,480 --> 03:39:26,720 DIFFERENT. 5157 03:39:26,720 --> 03:39:30,480 THAT'S WHAT PROMPTED THE PHONE 5158 03:39:30,480 --> 03:39:30,960 CALL. 5159 03:39:30,960 --> 03:39:34,640 SO, ONCE THEY GOT HER OFF ST. 5160 03:39:34,640 --> 03:39:36,400 JOHN'S WORT THE EFFECT WENT 5161 03:39:36,400 --> 03:39:39,600 AWAY, BUT WITH HIGH DOSES OF 5162 03:39:39,600 --> 03:39:40,760 CYCLOSPORIN, LEVELS STARTED TO 5163 03:39:40,760 --> 03:39:43,000 SKYROCKET, THERE WAS A RISK OF 5164 03:39:43,000 --> 03:39:44,040 KIDNEY DAMAGE. 5165 03:39:44,040 --> 03:39:46,200 THEY REDUCED HER DOSE, GOT HER 5166 03:39:46,200 --> 03:39:48,560 LEVELS BACK UNDER CONTROL, BUT 5167 03:39:48,560 --> 03:39:50,480 UNFORTUNATELY HERE ACUTE 5168 03:39:50,480 --> 03:39:51,720 REJECTION, DEVOLVED INTO CHRONIC 5169 03:39:51,720 --> 03:39:52,600 REJECTION, SHE LOST THE GRAFT 5170 03:39:52,600 --> 03:39:56,160 AND HAD TO GO BACK ON DIALYSIS, 5171 03:39:56,160 --> 03:39:59,960 BACK ON THE TRANS TRANSPLANT 5172 03:39:59,960 --> 03:40:02,000 LIST, ONE OF FOUR CASES IN OUR 5173 03:40:02,000 --> 03:40:04,760 TRANSPLANT CENTER AT ABOUT THAT 5174 03:40:04,760 --> 03:40:04,960 TIME. 5175 03:40:04,960 --> 03:40:07,080 SO, SOON AFTER WE PUBLISHED OUR 5176 03:40:07,080 --> 03:40:08,280 RESULTS, TRANSPLANT CENTERS 5177 03:40:08,280 --> 03:40:10,560 AROUND THE WORLD BEGAN 5178 03:40:10,560 --> 03:40:13,000 DESCRIBING CASES OF REJECTION IN 5179 03:40:13,000 --> 03:40:17,720 HEART, LIVER, KIDNEY TRANSPLANT 5180 03:40:17,720 --> 03:40:22,240 RECIPIENTS, TAKING ST. JOHN'S 5181 03:40:22,240 --> 03:40:24,160 WART, SO THE INTERACTION WAS 5182 03:40:24,160 --> 03:40:25,600 EXTREMELY CLINICALLY RELEVANT. 5183 03:40:25,600 --> 03:40:29,320 THE REASON IT'S SO PROBLEMATIC 5184 03:40:29,320 --> 03:40:32,080 IT INDUCES THE EXPRESSION OF 5185 03:40:32,080 --> 03:40:34,880 SEVERAL KEY CYTOCHROME P450 5186 03:40:34,880 --> 03:40:39,720 ENZYMES AND EFFLUX TRANSPORTERS. 5187 03:40:39,720 --> 03:40:42,640 PRIMARILY P-GLYCOPROTEIN. 5188 03:40:42,640 --> 03:40:45,280 TOGETHER WHEN INDUCED, THEY 5189 03:40:45,280 --> 03:40:47,160 MARKEDLY REDUCE BIOAVAILABILITY 5190 03:40:47,160 --> 03:40:50,200 OF MANY ORALLY ADMINISTERED 5191 03:40:50,200 --> 03:40:50,480 MEDICATIONS. 5192 03:40:50,480 --> 03:40:55,080 IT SO HAPPENS A UNIQUE CHEMICAL 5193 03:40:55,080 --> 03:40:58,880 IN ST. JOHN'S WART IS THE 5194 03:40:58,880 --> 03:41:01,120 CULPRIT, WE POINTED OUT 5195 03:41:01,120 --> 03:41:04,000 HYPERFORIN EARLIER, IT BINDS TO 5196 03:41:04,000 --> 03:41:07,000 HUMAN PXR, AND WE WON'T GET INTO 5197 03:41:07,000 --> 03:41:09,520 THAT, BUT NEVERTHELESS WHAT IT 5198 03:41:09,520 --> 03:41:10,720 DOES WHEN IT'S ACTIVATED, IT 5199 03:41:10,720 --> 03:41:13,120 TURNS ON THE GENES FOR THESE 5200 03:41:13,120 --> 03:41:14,560 VARIOUS ENZYMES AND TRANSPORTERS 5201 03:41:14,560 --> 03:41:15,960 AND CAUSES THEM TO BE 5202 03:41:15,960 --> 03:41:20,520 OVEREXPRESSED IN THE GUT AND 5203 03:41:20,520 --> 03:41:23,680 LIVER. 5204 03:41:23,680 --> 03:41:34,240 IN FACT, HYPERFORIN IS THE MOST 5205 03:41:38,920 --> 03:41:42,720 POTENT LIGAND. 5206 03:41:42,720 --> 03:41:44,400 BUT HYPERFORIN RUNS CIRCLES IN 5207 03:41:44,400 --> 03:41:45,840 TERMS OF POTENCY. 5208 03:41:45,840 --> 03:41:51,800 WHAT MAKES IT SO PROBLEMATIC, 5209 03:41:51,800 --> 03:41:53,440 TOGETHER CYP3A4 ARE RESPONSIBLE 5210 03:41:53,440 --> 03:42:03,880 IN HALF OF CONVENTIONAL 5211 03:42:10,920 --> 03:42:11,120 MEDICATIONS. 5212 03:42:11,120 --> 03:42:18,200 HYPERICIN IS EASY TO MEASURE BUT 5213 03:42:18,200 --> 03:42:21,720 DOESN'T AFFECT P450, IT TOLD YOU 5214 03:42:21,720 --> 03:42:24,400 NOTHING ABOUT THE HYPERFORIN 5215 03:42:24,400 --> 03:42:25,800 CONTENT. 5216 03:42:25,800 --> 03:42:27,640 TODAY MOST SUPPLEMENTS ARE 5217 03:42:27,640 --> 03:42:29,240 STANDARDIZED TO HYPERFORIN, 5218 03:42:29,240 --> 03:42:30,840 THERE'S A WARNING ABOUT 5219 03:42:30,840 --> 03:42:32,600 POTENTIAL DRUG INTERACTIONS ON 5220 03:42:32,600 --> 03:42:35,680 THE LABEL, BUT TO GO FURTHER, I 5221 03:42:35,680 --> 03:42:38,320 WANT TO ILLUSTRATE WHY 5222 03:42:38,320 --> 03:42:40,680 STANDARDIZING TO ONE 5223 03:42:40,680 --> 03:42:41,800 PHYTOCHEMICAL COMPOUND DOESN'T 5224 03:42:41,800 --> 03:42:45,560 TELL MUCH ABOUT THE CONTENT OF 5225 03:42:45,560 --> 03:42:46,320 THE OTHERS. 5226 03:42:46,320 --> 03:42:49,040 WE'VE ANALYZED CONSENT OF SIX 5227 03:42:49,040 --> 03:42:55,360 BRANDS OF SAINT JOHN'S WORTH, 5228 03:42:55,360 --> 03:42:56,800 STANDARDIZED TO HYPERICIN, THE 5229 03:42:56,800 --> 03:42:59,400 CONTENT IS CONSISTENT ACROSS ALL 5230 03:42:59,400 --> 03:43:01,560 THE BRANDS, BUT LOOK AT THE 5231 03:43:01,560 --> 03:43:02,600 HYPERFORIN INNED MEL. 5232 03:43:02,600 --> 03:43:08,800 IT'S ALL -- IN THE MIDDLE, IT'S 5233 03:43:08,800 --> 03:43:11,080 ALL OVER THE MAP, WHEN THE 5234 03:43:11,080 --> 03:43:12,280 CONTENT GETS ABOVE 7 MILLIGRAMS 5235 03:43:12,280 --> 03:43:20,560 PER GRAM YOU HAVE SIGNIFICANT IN 5236 03:43:20,560 --> 03:43:21,960 INDUCTION OF P450. 5237 03:43:21,960 --> 03:43:23,640 PRODUCT A IS TWO LOTS OF THE 5238 03:43:23,640 --> 03:43:24,760 SAME BRAND. 5239 03:43:24,760 --> 03:43:26,480 THE CONTENT BETWEEN LOTS DIFFERS 5240 03:43:26,480 --> 03:43:29,160 BY ALMOST A FACTOR OF FOUR, SO 5241 03:43:29,160 --> 03:43:30,320 CLEARLY ONE LOT IS GOING TO POSE 5242 03:43:30,320 --> 03:43:34,520 GREAT GREATER RISK, AND SUCH 5243 03:43:34,520 --> 03:43:36,440 DISCREPANCIES ARE NOT ALL THAT 5244 03:43:36,440 --> 03:43:39,080 UNCOMMON WHEN IT COMES TO 5245 03:43:39,080 --> 03:43:40,440 DIETARY SUPPLEMENT WORLD, 5246 03:43:40,440 --> 03:43:41,000 REGARDLESS OF BOTANICAL. 5247 03:43:41,000 --> 03:43:44,960 NOT AS BAD AS IT USED TO BE BUT 5248 03:43:44,960 --> 03:43:48,840 YOU SEE A LOT OF VARIABILITY 5249 03:43:48,840 --> 03:43:50,920 SOMETIMES BETWEEN LOTS TO LOT. 5250 03:43:50,920 --> 03:43:52,600 ALL RIGHT. 5251 03:43:52,600 --> 03:43:56,760 SO TO SUMMARIZE IT INDUCES HOST 5252 03:43:56,760 --> 03:43:58,240 OF P450 ENZYMES AND EFFLUX 5253 03:43:58,240 --> 03:43:58,800 TRANSPORTERS. 5254 03:43:58,800 --> 03:44:00,120 HERE ARE A FEW OF THE DRUGS 5255 03:44:00,120 --> 03:44:02,760 KNOWN TO BE ADVERSELY AFFECTED 5256 03:44:02,760 --> 03:44:09,000 BY ST. JOHN'S WORT, WE SAW 5257 03:44:09,000 --> 03:44:14,240 CYCLOSPORIN, AFFECTS DRUGS LIKE 5258 03:44:14,240 --> 03:44:24,720 DIGOXIN, WARFARIN AND CANCER 5259 03:44:24,720 --> 03:44:25,680 CHEMOTHERAPEUTIC, AND MIRACLE 5260 03:44:25,680 --> 03:44:30,760 BABIES WITH WOMEN TAKING ORAL 5261 03:44:30,760 --> 03:44:32,760 CONTRACEPTIVES, IF YOU ARE 5262 03:44:32,760 --> 03:44:34,640 TAKING IT WITH ST. JOHN'S WORT 5263 03:44:34,640 --> 03:44:37,200 YOU DON'T HAVE GOOD 5264 03:44:37,200 --> 03:44:37,560 CONTRACEPTION. 5265 03:44:37,560 --> 03:44:39,280 IN SHORT, THE CONSEQUENCES ARE 5266 03:44:39,280 --> 03:44:43,040 NUMEROUS, AS ST. JOHN'S WART 5267 03:44:43,040 --> 03:44:46,400 RENDERS MOST MEDICATIONS 5268 03:44:46,400 --> 03:44:47,520 INEFFECTIVE. 5269 03:44:47,520 --> 03:44:49,920 SHIFTING GEARS TO THE OPPOSITE 5270 03:44:49,920 --> 03:44:55,440 EFFECT IN TERMS OF CYTOKINE P450 5271 03:44:55,440 --> 03:45:00,680 ENZYMES, GOLDENSEAL, TO WARD OFF 5272 03:45:00,680 --> 03:45:02,640 COLDS AND LOWER BLOOD GLUCOSE 5273 03:45:02,640 --> 03:45:03,720 AND MASK URINE DRUG SCREEN 5274 03:45:03,720 --> 03:45:04,040 RESULTS. 5275 03:45:04,040 --> 03:45:06,760 IF YOU PLAN ON USING GOLDENSEAL 5276 03:45:06,760 --> 03:45:08,520 TO MASK A URINE DRUG SCREEN YOU 5277 03:45:08,520 --> 03:45:11,560 BETTER KNOW HOW DRUG OF ABUSE IS 5278 03:45:11,560 --> 03:45:12,960 METABOLIZED, IT CAN MAKE CERTAIN 5279 03:45:12,960 --> 03:45:18,240 ONES EASIER TO DETECT. 5280 03:45:18,240 --> 03:45:21,640 I WON'T TELL WHICH ONES. 5281 03:45:21,640 --> 03:45:24,800 EFFICACY IS DEBATABLE BUT ITS 5282 03:45:24,800 --> 03:45:31,400 HERB-DRUG INTERACTION POTENTIAL 5283 03:45:31,400 --> 03:45:35,400 IS HIGH BECAUSE IT INHIBITS 5284 03:45:35,400 --> 03:45:37,760 ACTIVITIES MANY P450 ENZYMES. 5285 03:45:37,760 --> 03:45:44,600 WE CAN SEE 30-DAY ON CYP3A4 IN 5286 03:45:44,600 --> 03:45:46,200 HEALTHY VOLUNTEERS, THE ACTIVITY 5287 03:45:46,200 --> 03:45:49,200 OF BOTH ENZYMES WAS REDUCED BY 5288 03:45:49,200 --> 03:45:50,600 40%, CLINICAL RELEVANT OUTCOME. 5289 03:45:50,600 --> 03:45:53,120 JUST THIS PAST YEAR OUR FINDINGS 5290 03:45:53,120 --> 03:45:55,280 WERE BORNE OUT BY CLINICAL 5291 03:45:55,280 --> 03:45:58,800 STUDIES BY A COLLEAGUE, DR. MARY 5292 03:45:58,800 --> 03:46:03,920 PAINE, CURRENT DIRECTOR OF 5293 03:46:03,920 --> 03:46:08,120 NCCIH-SPONSORED CENTER FOR 5294 03:46:08,120 --> 03:46:08,520 NATURAL PRODUCT-DRUG 5295 03:46:08,520 --> 03:46:13,000 INTERACTIONS, IT'S NICE TO HAVE 5296 03:46:13,000 --> 03:46:14,080 YOUR RESEARCH INDEPENDENTLY 5297 03:46:14,080 --> 03:46:14,960 VERIFIED. 5298 03:46:14,960 --> 03:46:16,880 SO WHAT MAKES GOLDENSEAL 5299 03:46:16,880 --> 03:46:19,520 PROBLEMATIC IS THAT THE 5300 03:46:19,520 --> 03:46:20,800 INHIBITORY EFFECTS ARE CLINICAL 5301 03:46:20,800 --> 03:46:25,640 RELEVANT AND THESE TWO ENZYMES, 5302 03:46:25,640 --> 03:46:27,400 IT PRIMARILY EFFECTS ARE 5303 03:46:27,400 --> 03:46:29,080 RESPONSIBLE FOR METABOLISM OF 5304 03:46:29,080 --> 03:46:32,280 75% OF ALL MEDICATIONS, IT'S 5305 03:46:32,280 --> 03:46:40,600 CLINICAL RELEVANT OUTCOME. 5306 03:46:40,600 --> 03:46:51,000 AND THE RESPONSIBLE ARE 5307 03:46:55,280 --> 03:46:55,960 ALKALOIDS 5308 03:46:55,960 --> 03:46:57,640 MECHANISM BASED OR TIME 5309 03:46:57,640 --> 03:46:58,640 DEPENDENT, EFFECT IS PRONOUNCED 5310 03:46:58,640 --> 03:47:01,560 AND TAKES SEVERAL DAYS FOR THE 5311 03:47:01,560 --> 03:47:04,640 ENZYME ACTIVITY TO RECOVER ONCE 5312 03:47:04,640 --> 03:47:05,280 GOLDENSEAL HAS BEEN STOPPED. 5313 03:47:05,280 --> 03:47:10,960 SO WHEN YOU HAVE A 5314 03:47:10,960 --> 03:47:12,120 MECHANISM-BASED INHIBITION, 5315 03:47:12,120 --> 03:47:18,440 TIME-DEPEND OR IRREVERSE ABLE, 5316 03:47:18,440 --> 03:47:21,000 IT'S MORE PROBLEMATIC THAN 5317 03:47:21,000 --> 03:47:23,480 STANDARD REVERSIBLE INHIBITION. 5318 03:47:23,480 --> 03:47:28,080 HERE ARE STRUCTURES THAT ARE THE 5319 03:47:28,080 --> 03:47:31,440 CULPRITS IN GOLDENSEAL. 5320 03:47:31,440 --> 03:47:39,880 THE BROKEN CIRCLE OF THE 5321 03:47:39,880 --> 03:47:43,320 MOLECULE HIGHLIGHTS A MOIETY, 5322 03:47:43,320 --> 03:47:45,520 INTERACTS CAN P450 ENZYME, 5323 03:47:45,520 --> 03:47:49,040 METABOLIZED BINDS TO ENZYME AND 5324 03:47:49,040 --> 03:47:53,000 SHUTS IT DOWN, COMPLETELY LOCKS 5325 03:47:53,000 --> 03:47:53,680 UP THE ENZYME. 5326 03:47:53,680 --> 03:47:57,640 AND SO A WHOLE HOST OF PLANTS 5327 03:47:57,640 --> 03:47:59,880 BESIDES GOLDENSEAL PRODUCE PHYTO 5328 03:47:59,880 --> 03:48:01,080 CHEMICALS WITH THESE MOIETIES, 5329 03:48:01,080 --> 03:48:03,160 AND THE REASON THEY DO THAT IS 5330 03:48:03,160 --> 03:48:05,640 BECAUSE THEY ARE ACTUALLY PRETTY 5331 03:48:05,640 --> 03:48:06,600 DECENT INSECTICIDES. 5332 03:48:06,600 --> 03:48:10,720 SO, PLANTS ARE MOTHER NATURE'S 5333 03:48:10,720 --> 03:48:12,320 QUINTESSENTIAL ORGANIC CHEMISTS. 5334 03:48:12,320 --> 03:48:13,840 WHEN BUGS START NIBBLING ON THEM 5335 03:48:13,840 --> 03:48:17,360 IN ORDER TO GET RID OF THE 5336 03:48:17,360 --> 03:48:20,040 INSECTS THEY MAKE SOME 5337 03:48:20,040 --> 03:48:21,320 INTERESTING PHYTOCHEMICALS THAT 5338 03:48:21,320 --> 03:48:24,600 CAN BE HAZARDOUS TO THE INSECT 5339 03:48:24,600 --> 03:48:28,040 BUT IN OUR CASE WHEN A HUMAN 5340 03:48:28,040 --> 03:48:30,280 BEING INGESTS THESE THEY CAN 5341 03:48:30,280 --> 03:48:37,440 HAVE OTHER INTERESTING EFFECTS, 5342 03:48:37,440 --> 03:48:39,120 LIKE INHIBITING P450. 5343 03:48:39,120 --> 03:48:49,440 PIPER IS ANOTHER PLANT THAT 5344 03:48:49,440 --> 03:48:51,720 CONTAINS THESE MOIETIES, 5345 03:48:51,720 --> 03:48:54,280 PIPERANINES, WE CONSUME BLACK 5346 03:48:54,280 --> 03:48:57,880 PEPPER, ON A DAILY BASIS, I'M A 5347 03:48:57,880 --> 03:49:00,120 HUGE BLACK PEPPER AFICIONADO, 5348 03:49:00,120 --> 03:49:03,200 BUT THE QUANTITY PRESENT IN 5349 03:49:03,200 --> 03:49:06,360 BLACK PEPPER IS NOT ENOUGH TO 5350 03:49:06,360 --> 03:49:07,440 CAUSE HERB-DRUG INTERACTION IN 5351 03:49:07,440 --> 03:49:07,800 FOOD. 5352 03:49:07,800 --> 03:49:10,400 NOT AT ALL. 5353 03:49:10,400 --> 03:49:11,080 CONCENTRATED BLACK PEPPER 5354 03:49:11,080 --> 03:49:15,040 EXTRACT HOWEVER IS FORMULATED IN 5355 03:49:15,040 --> 03:49:15,520 MANY MULTI-INGREDIENT 5356 03:49:15,520 --> 03:49:21,160 SUPPLEMENTS, AND THE REASON THEY 5357 03:49:21,160 --> 03:49:23,520 ADD BLACK PEPPER EXTRACT IS THAT 5358 03:49:23,520 --> 03:49:25,320 BY INHIBITING THESE ENZYMES IN 5359 03:49:25,320 --> 03:49:28,840 THE GUT AND LIVER, YOU CAN 5360 03:49:28,840 --> 03:49:30,200 IMPROVE BIOAVAILABILITY OF OTHER 5361 03:49:30,200 --> 03:49:33,960 PHYTOCHEMICALS THAT MIGHT 5362 03:49:33,960 --> 03:49:44,440 NORMALLY UNDERGO EXTENSIVE 5363 03:49:55,440 --> 03:49:57,120 PRE-SYSTEMIC METABOLISM. 5364 03:49:57,120 --> 03:50:00,920 THE OPEN CIRCLES ARE LEVELS 5365 03:50:00,920 --> 03:50:05,400 BEFORE, CLOSED CIRCLES ARE 5366 03:50:05,400 --> 03:50:08,600 CONCENTRATIONS AFTER COURSE OF 5367 03:50:08,600 --> 03:50:09,080 PIPERINE. 5368 03:50:09,080 --> 03:50:11,000 BECAUSE IT HAS A NARROW 5369 03:50:11,000 --> 03:50:12,600 THERAPEUTIC WINDOW AND NASTY 5370 03:50:12,600 --> 03:50:19,400 SIDE EFFECT PROFILE, YOU CAN SEE 5371 03:50:19,400 --> 03:50:28,680 PIPARINE INCREASES BLOOD LEVELS 5372 03:50:28,680 --> 03:50:29,040 OF NEVIRAPINE. 5373 03:50:29,040 --> 03:50:32,520 I WANTED TO ILLUSTRATE THIS 5374 03:50:32,520 --> 03:50:34,120 EFFECT ON NEVIRAPINE. 5375 03:50:34,120 --> 03:50:40,760 ANOTHER EMERGING BOTANICAL FOUND 5376 03:50:40,760 --> 03:50:51,040 IN MANY SUPPLEMENTS IS HOST TO A 5377 03:50:51,040 --> 03:50:55,560 NUMBER OF PHYTOCHEMICALS, 5378 03:50:55,560 --> 03:50:58,320 SCISANDRA, AND POSES ARE RISK 5379 03:50:58,320 --> 03:51:03,320 FOR INTERACTION, ON THE 5380 03:51:03,320 --> 03:51:08,600 IMMUNOSUPPRESSIVE DRUG TAKEN 5381 03:51:08,600 --> 03:51:10,120 OVER FOR CYCLOSPORIN, 5382 03:51:10,120 --> 03:51:11,840 IMMUNOSUPPRESSANT USED FOR SOLID 5383 03:51:11,840 --> 03:51:13,440 ORGAN TRANSPLANT RECIPIENTS TO 5384 03:51:13,440 --> 03:51:16,200 KEEP THEM FROM REJECTING THE 5385 03:51:16,200 --> 03:51:17,360 ORGAN, HAS A NARROW THERAPEUTIC 5386 03:51:17,360 --> 03:51:27,120 INDEX, SO YOU CAN SEE IF TAKEN 5387 03:51:27,120 --> 03:51:30,840 WITH SCISANDRA, BLOOD LEVELS ARE 5388 03:51:30,840 --> 03:51:31,400 MARKEDLY INCREASED. 5389 03:51:31,400 --> 03:51:35,560 HERE AGAIN WE HAVE AN EXAMPLE OF 5390 03:51:35,560 --> 03:51:37,880 A CLINICAL RELEVANT HERB-DRUG 5391 03:51:37,880 --> 03:51:42,880 INTERACTION CAUSED BY A 5392 03:51:42,880 --> 03:51:43,640 PHYTOCHEMICAL THAT INHIBITS 5393 03:51:43,640 --> 03:51:46,800 METABOLISM, INHIBIT ACTIVITY OF 5394 03:51:46,800 --> 03:51:50,680 DRUG METABOLIZING ENZYMES. 5395 03:51:50,680 --> 03:51:51,840 ONE FINAL EXAMPLE INVOLVES GREEN 5396 03:51:51,840 --> 03:51:52,000 TEA. 5397 03:51:52,000 --> 03:51:55,280 IN THE FIGURE TO THE LEFT, GREEN 5398 03:51:55,280 --> 03:52:01,640 TEA WHEN TAKEN CONCOMITANTLY 5399 03:52:01,640 --> 03:52:02,920 WITH ANTI-HYPERTENSIVE DRUG 5400 03:52:02,920 --> 03:52:04,880 NADOLOL INCREASES 5401 03:52:04,880 --> 03:52:05,240 CONCENTRATIONS. 5402 03:52:05,240 --> 03:52:09,320 YOU MIGHT THINK, IT LOOKS LIKE 5403 03:52:09,320 --> 03:52:11,520 GREEN TEA IS INDUCING 5404 03:52:11,520 --> 03:52:12,160 METABOLISM. 5405 03:52:12,160 --> 03:52:13,600 IT IS NOT METABOLIZED. 5406 03:52:13,600 --> 03:52:13,960 OKAY. 5407 03:52:13,960 --> 03:52:20,120 SO WHAT'S GOING ON HERE? 5408 03:52:20,120 --> 03:52:22,920 NOT ONLY DOES IT REDUCE BLOOD 5409 03:52:22,920 --> 03:52:26,960 LEVELS WILL YOU AFFECTS 5410 03:52:26,960 --> 03:52:28,520 NADOLOL'S ANTI-HYPERTENSIVE 5411 03:52:28,520 --> 03:52:29,560 ACTIVITY AND PRECLUDES 5412 03:52:29,560 --> 03:52:32,000 APPEARANCE IN URINE, ON THE 5413 03:52:32,000 --> 03:52:33,240 RIGHT-HAND SIDE. 5414 03:52:33,240 --> 03:52:35,840 WHAT'S GOING ON? 5415 03:52:35,840 --> 03:52:37,560 WELL, WHAT'S HAPPENING IS THAT A 5416 03:52:37,560 --> 03:52:41,000 GROUP OF CHEMICALS IN GREEN TEA, 5417 03:52:41,000 --> 03:52:50,160 YOU MAY HAVE HEARD OF EGCG, ONE 5418 03:52:50,160 --> 03:52:52,080 OF THE MORE PREVALENT 5419 03:52:52,080 --> 03:52:55,960 PHYTOCHEMICALS, WHAT THEY DO IS 5420 03:52:55,960 --> 03:52:56,800 INHIBIT SPECIFIC UPTAKE 5421 03:52:56,800 --> 03:52:57,760 TRANSPORTERS IN THE GUT. 5422 03:52:57,760 --> 03:53:02,680 AND SO THESE ARE UPTAKE 5423 03:53:02,680 --> 03:53:05,160 TRANSPORTERS LIKE OATP, ORGANIC 5424 03:53:05,160 --> 03:53:08,600 ANTI-ION TRANSPORTING 5425 03:53:08,600 --> 03:53:09,360 POLYPEPTIDE. 5426 03:53:09,360 --> 03:53:14,280 SO, BECAUSE NADOLOL USES UPTAKE 5427 03:53:14,280 --> 03:53:22,240 TRANSPORTERS TO BE ABSORBED, 5428 03:53:22,240 --> 03:53:23,760 INOF RENDERS THE DRUG LESS 5429 03:53:23,760 --> 03:53:24,960 EFFECTIVE. 5430 03:53:24,960 --> 03:53:25,680 THIS INTERACTION IS QUITE 5431 03:53:25,680 --> 03:53:28,160 IMPORTANT GIVEN GREEN TEA IS ONE 5432 03:53:28,160 --> 03:53:30,080 OF THE MOST POPULAR BEVERAGES, 5433 03:53:30,080 --> 03:53:33,240 PRESENT IN A HOST OF WEIGHT LOSS 5434 03:53:33,240 --> 03:53:33,840 SUPPLEMENTS. 5435 03:53:33,840 --> 03:53:36,480 FROM THE PREVIOUS EXAMPLES, ONE 5436 03:53:36,480 --> 03:53:38,440 MIGHT THINK ALL BOTANICALS POSE 5437 03:53:38,440 --> 03:53:41,440 A SERIOUS RISK BUT THAT'S NOT 5438 03:53:41,440 --> 03:53:44,280 THE CASE. 5439 03:53:44,280 --> 03:53:44,720 MANY POPULAR BOTANICAL 5440 03:53:44,720 --> 03:53:46,480 SUPPLEMENTS POSE LITTLE TO NO 5441 03:53:46,480 --> 03:53:48,680 RISK FOR CLINICAL RELEVANT 5442 03:53:48,680 --> 03:53:50,560 INTERACTIONS, HOWEVER THE VAST 5443 03:53:50,560 --> 03:53:53,000 MAJORITY OF OF HAVEN'T BEEN 5444 03:53:53,000 --> 03:53:54,360 STUDIED ADEQUATELY IN CLINICAL 5445 03:53:54,360 --> 03:53:54,600 SETTING. 5446 03:53:54,600 --> 03:53:55,960 THERE ARE SEVERAL REASONS WHY 5447 03:53:55,960 --> 03:53:58,000 THIS IS THE CASE. 5448 03:53:58,000 --> 03:54:00,360 AND ONE EXPLANATION INVOLVES 5449 03:54:00,360 --> 03:54:01,960 POOR DOSAGE FORM PERFORMANCE DUE 5450 03:54:01,960 --> 03:54:09,720 TO POOR WATER SOLUBILITY, IF IT 5451 03:54:09,720 --> 03:54:10,880 CAN'T GO INTO SOLUTION IN. 5452 03:54:10,880 --> 03:54:14,040 GOOD 5453 03:54:14,040 --> 03:54:18,040 THE-- IN THE G.I. TRACT IT CAN'T 5454 03:54:18,040 --> 03:54:20,080 BE ABSORBED. 5455 03:54:20,080 --> 03:54:21,080 MANY UNDERGO EXTENSIVE 5456 03:54:21,080 --> 03:54:31,560 PRE-SYSTEM SYSTEM METABOLISM. 5457 03:54:37,920 --> 03:54:43,680 THE PLANT MIGHT NOT HAVE ANY 5458 03:54:43,680 --> 03:54:54,240 PHYTOCHEMICALS THAT CAN CAUSE AN 5459 03:54:55,840 --> 03:54:56,080 INTERACTION. 5460 03:54:56,080 --> 03:55:02,360 TO CONCLUDE, MANY POPULAR 5461 03:55:02,360 --> 03:55:05,000 BOTANICALS APPEAR TO POSE NO 5462 03:55:05,000 --> 03:55:06,760 RISK WE HAVEN'T EVALUATED IN A 5463 03:55:06,760 --> 03:55:08,120 CLINICAL SETTING. 5464 03:55:08,120 --> 03:55:10,000 IF YOU'RE NOT SURE ABOUT RISK 5465 03:55:10,000 --> 03:55:11,440 FOR A PARTICULAR BOTANICAL MY 5466 03:55:11,440 --> 03:55:13,840 ADVICE IS JUST TO AVOID TAKING 5467 03:55:13,840 --> 03:55:15,640 THEM CONCURRENTLY WITH YOUR 5468 03:55:15,640 --> 03:55:16,800 CONVENTIONAL MEDICATIONS. 5469 03:55:16,800 --> 03:55:20,760 SO WITH THAT, I WILL END AND BE 5470 03:55:20,760 --> 03:55:22,480 HAPPY TO ANSWER ANY QIONS 5471 03:55:22,480 --> 03:55:23,360 YOU MIGHT HAVE. 5472 03:55:23,360 --> 03:55:29,200 SO I WILL SEE IF WE CAN GET BACK 5473 03:55:29,200 --> 03:55:29,600 TO THE -- 5474 03:55:29,600 --> 03:55:32,120 >> THANK YOU VERY MUCH. 5475 03:55:32,120 --> 03:55:34,120 WE DO HAVE A FEW QUESTIONS IN 5476 03:55:34,120 --> 03:55:35,040 THE CHAT. 5477 03:55:35,040 --> 03:55:38,760 SINCE WE'RE UP AGAINST THE BREAK 5478 03:55:38,760 --> 03:55:39,640 WE'VE BEEN GIVEN PERMISSION TO 5479 03:55:39,640 --> 03:55:41,360 GO A LITTLE BIT OVER. 5480 03:55:41,360 --> 03:55:45,000 HERE IS A QUESTION. 5481 03:55:45,000 --> 03:55:47,120 IN YOUR STUDIES WHY DID YOUR 5482 03:55:47,120 --> 03:55:50,640 GROUP USE ONLY MALE SUBJECTS, NO 5483 03:55:50,640 --> 03:55:51,040 FEMALES? 5484 03:55:51,040 --> 03:55:52,520 >> THAT'S JUST ONE OF THOSE 5485 03:55:52,520 --> 03:55:52,920 THINGS. 5486 03:55:52,920 --> 03:55:55,200 WE TRY TO GET FEMALES BUT THEY 5487 03:55:55,200 --> 03:55:57,280 JUST DIDN'T SHOW UP AND WE 5488 03:55:57,280 --> 03:56:00,320 COULDN'T WAIT FOR FOREVER. 5489 03:56:00,320 --> 03:56:01,880 SO THERE YOU GO. 5490 03:56:01,880 --> 03:56:04,320 THAT'S JUST A PRACTICAL ASPECT 5491 03:56:04,320 --> 03:56:06,720 OF DOING CLINICAL TRIALS 5492 03:56:06,720 --> 03:56:07,160 SOMETIMES. 5493 03:56:07,160 --> 03:56:12,240 NOW, WRITE -- IDEALLY WOULD 5494 03:56:12,240 --> 03:56:13,720 HAVE LIKED FEMALES BUT THAT'S 5495 03:56:13,720 --> 03:56:16,200 THE WAY IT CAME OUT. 5496 03:56:16,200 --> 03:56:18,040 WE WENT WITH IT. 5497 03:56:18,040 --> 03:56:19,960 >> DR. DWYER HAS A QUESTION, A 5498 03:56:19,960 --> 03:56:21,200 COMMENT AND QUESTION. 5499 03:56:21,200 --> 03:56:23,760 SHE'S ALWAYS WONDERED WHY DURING 5500 03:56:23,760 --> 03:56:26,840 THE EPHEDRA YEARS NOBODY DID A 5501 03:56:26,840 --> 03:56:29,880 SMALL CLINICAL TRIAL ON THE 5502 03:56:29,880 --> 03:56:31,800 EPHEDRA-FREE PRODUCTS EXCEPT YOU 5503 03:56:31,800 --> 03:56:35,000 DID IN 2012. 5504 03:56:35,000 --> 03:56:35,320 >> YES. 5505 03:56:35,320 --> 03:56:38,560 >> WHY DO YOU THINK THAT WAS THE 5506 03:56:38,560 --> 03:56:39,400 CASE? 5507 03:56:39,400 --> 03:56:42,960 >> YOU KNOW, I'M NOT REALLY 5508 03:56:42,960 --> 03:56:43,360 SURE. 5509 03:56:43,360 --> 03:56:45,400 I MEAN, IN FACT WHEN THAT PAPER 5510 03:56:45,400 --> 03:56:47,200 WAS PUBLISHED IN CLINICAL 5511 03:56:47,200 --> 03:56:48,160 PHARMACOLOGY AND THERAPEUTICS IN 5512 03:56:48,160 --> 03:56:50,280 2012, THERE WAS AN EDITORIAL 5513 03:56:50,280 --> 03:56:52,280 ASSOCIATED WITH IT. 5514 03:56:52,280 --> 03:56:54,760 PEOPLE WERE ASKING WHY IS THIS 5515 03:56:54,760 --> 03:56:56,040 RESEARCH EVEN NECESSARY, BUT 5516 03:56:56,040 --> 03:56:59,960 WHEN THE REASON IT'S NECESSARY 5517 03:56:59,960 --> 03:57:01,560 IS BECAUSE PEOPLE JUST DIDN'T 5518 03:57:01,560 --> 03:57:03,040 REALIZE HOW PROBLEMATIC THESE 5519 03:57:03,040 --> 03:57:08,040 THINGS COULD BE, SO THEY JUST 5520 03:57:08,040 --> 03:57:12,520 ASSUMED THAT TAKING EPHEDRA OUT 5521 03:57:12,520 --> 03:57:13,520 OF THE EPHEDRA-CONTAINING 5522 03:57:13,520 --> 03:57:14,200 SUPPLEMENTS WAS THE SOLUTION, 5523 03:57:14,200 --> 03:57:16,120 BUT THAT WASN'T THE CASE. 5524 03:57:16,120 --> 03:57:17,200 I'VE BEEN A PROPONENT IT WAS 5525 03:57:17,200 --> 03:57:19,120 NEVER THE PROBLEM, IT WAS THE 5526 03:57:19,120 --> 03:57:25,320 MILIEU THAT WAS THE ISSUE. 5527 03:57:25,320 --> 03:57:28,280 AND SO I'LL BE HONEST WITH YOU 5528 03:57:28,280 --> 03:57:29,920 AGAIN, ANOTHER REASON PEOPLE 5529 03:57:29,920 --> 03:57:31,480 HAVEN'T DONE IT, IT'S HARD TO 5530 03:57:31,480 --> 03:57:34,200 GET FUNDING, YOU'RE NOT GOING TO 5531 03:57:34,200 --> 03:57:35,560 GET DIETARY SUPPLEMENT INDUSTRY 5532 03:57:35,560 --> 03:57:36,720 TO FUND IT. 5533 03:57:36,720 --> 03:57:40,200 AND SO WE JUST DECIDED TO FOOT 5534 03:57:40,200 --> 03:57:42,080 OUR OWN BILL AND DO THAT BECAUSE 5535 03:57:42,080 --> 03:57:44,120 WE THOUGHT IT WAS NECESSARY, 5536 03:57:44,120 --> 03:57:46,320 NEEDED TO BE DONE. 5537 03:57:46,320 --> 03:57:51,960 AND IT ILLUSTRATES A HOST OF 5538 03:57:51,960 --> 03:57:52,880 POINTS. 5539 03:57:52,880 --> 03:57:54,480 THERE ARE PHARMACODYNAMIC 5540 03:57:54,480 --> 03:57:56,600 INTERACTIONS, ALSO ILLUSTRATED 5541 03:57:56,600 --> 03:57:59,840 PROBLEMS WHEN YOU COMBINE 5542 03:57:59,840 --> 03:58:00,600 MULTIPLE STIMULANTS, ALSO 5543 03:58:00,600 --> 03:58:03,600 ILLUSTRATED THE WHOLE ISSUE OF 5544 03:58:03,600 --> 03:58:05,120 CONTAMINATION ISSUE THAT DR. 5545 03:58:05,120 --> 03:58:08,760 HARDY BROUGHT UP TOO. 5546 03:58:08,760 --> 03:58:10,360 THE STUDY WAS HIGHLY CITED, I 5547 03:58:10,360 --> 03:58:12,760 DON'T KNOW IF IT'S THE BE-ALL, 5548 03:58:12,760 --> 03:58:14,160 END-ALL, AND THERE MAY BE OTHER 5549 03:58:14,160 --> 03:58:16,920 STUDIES OUT THERE SINCE, BUT 5550 03:58:16,920 --> 03:58:18,280 I'VE NOT SEEN THEM. 5551 03:58:18,280 --> 03:58:22,080 THAT'S MY TAKE ON IT. 5552 03:58:22,080 --> 03:58:27,000 >> WE HAVE A QUESTION FROM MARY 5553 03:58:27,000 --> 03:58:28,120 LEE, WONDERING ABOUT 5554 03:58:28,120 --> 03:58:30,400 VERIFICATIONS OF THE COMPONENTS 5555 03:58:30,400 --> 03:58:31,240 OR INGREDIENTS IN SUPPLEMENTS 5556 03:58:31,240 --> 03:58:34,080 YOU'RE TESTING IN YOUR STUDIES. 5557 03:58:34,080 --> 03:58:37,440 >> WE ALWAYS HAVE OUR PRODUCTS 5558 03:58:37,440 --> 03:58:40,920 INDEPENDENTLY VERIFIED FOR 5559 03:58:40,920 --> 03:58:43,000 PHYTOCHEMICAL CONTENT, SINCE DAY 5560 03:58:43,000 --> 03:58:43,880 1. 5561 03:58:43,880 --> 03:58:45,200 WE WOULD SEND OUR PRODUCTS, THE 5562 03:58:45,200 --> 03:58:47,440 ONES WE WERE GOING TO UTILIZE 5563 03:58:47,440 --> 03:58:49,560 FOR CLINICAL STUDY, WOULD SEND 5564 03:58:49,560 --> 03:58:50,720 THEM TO UNIVERSITY OF 5565 03:58:50,720 --> 03:58:52,160 MISSISSIPPI AT THE NATIONAL 5566 03:58:52,160 --> 03:58:54,040 CENTER FOR NATURAL PRODUCTS 5567 03:58:54,040 --> 03:58:57,960 RESEARCH, AND HAVE THEM WELL 5568 03:58:57,960 --> 03:58:58,720 CHARACTERIZED AND THAT WAS WHEN 5569 03:58:58,720 --> 03:59:00,080 I WAS AT THE UNIVERSITY OF 5570 03:59:00,080 --> 03:59:01,040 ARKANSAS. 5571 03:59:01,040 --> 03:59:03,160 NOW I'M AT THE NATIONAL CENTER 5572 03:59:03,160 --> 03:59:03,840 FOR NATURAL PRODUCTS RESEARCH, 5573 03:59:03,840 --> 03:59:05,880 AND SO FOR ANYBODY THAT DOES ANY 5574 03:59:05,880 --> 03:59:07,800 TYPE OF CLINICAL RESEARCH, 5575 03:59:07,800 --> 03:59:11,160 WHETHER IT'S EFFICACY STUDIES OR 5576 03:59:11,160 --> 03:59:12,760 WHETHER IT'S SAFETY OR HERB-DRUG 5577 03:59:12,760 --> 03:59:16,000 INTERACTION STUDIES YOU JUST 5578 03:59:16,000 --> 03:59:17,400 CAN'T TAKE -- YOU JUST CAN'T 5579 03:59:17,400 --> 03:59:19,440 TAKE -- A LOT OF PEOPLE TAKE FOR 5580 03:59:19,440 --> 03:59:21,960 GRANTED THAT LABEL CLAIM 5581 03:59:21,960 --> 03:59:22,680 ACTUALLY REPRESENTS WHAT'S IN 5582 03:59:22,680 --> 03:59:23,840 THE PRODUCT. 5583 03:59:23,840 --> 03:59:24,800 YOU CAN'T ASSUME THAT. 5584 03:59:24,800 --> 03:59:31,280 YOU HAVE TO HAVE IT 5585 03:59:31,280 --> 03:59:32,320 INDEPENDENTLY VERIFIED, 5586 03:59:32,320 --> 03:59:33,600 SURPRISED HOW OFTEN THE LABEL 5587 03:59:33,600 --> 03:59:34,240 CLAIM DOESN'T REPRESENT WHAT'S 5588 03:59:34,240 --> 03:59:34,880 IN THE PRODUCT. 5589 03:59:34,880 --> 03:59:36,520 WE'VE BEEN DOING THAT FOR MANY 5590 03:59:36,520 --> 03:59:41,560 YEARS, AND IF YOU DON'T DO THAT, 5591 03:59:41,560 --> 03:59:44,040 YOU NEED TO FIND ANOTHER AREA OF 5592 03:59:44,040 --> 03:59:45,440 RESEARCH TO GET INTO. 5593 03:59:45,440 --> 03:59:47,080 >> WE HAVE TWO QUESTIONS BUT 5594 03:59:47,080 --> 03:59:50,120 THEY ARE ALONG THE SAME LINES SO 5595 03:59:50,120 --> 03:59:55,240 WE'LL WRAP IT AFTER THESE 5596 03:59:55,240 --> 03:59:55,760 QUESTIONS. 5597 03:59:55,760 --> 03:59:59,280 THE QUESTION IS INSTEAD OF 5598 03:59:59,280 --> 04:00:04,560 LOOKING AT THE PHARMACOKINETIC 5599 04:00:04,560 --> 04:00:08,160 OR PHARMACODYNAMIC EFFECTS, DRUG 5600 04:00:08,160 --> 04:00:10,760 INTERACTION, THESE BOTANICALS 5601 04:00:10,760 --> 04:00:14,200 HAVE ON THE DRUGS, AS PROBLEMS, 5602 04:00:14,200 --> 04:00:15,800 HAS ANYBODY CONSIDERED THEM AS 5603 04:00:15,800 --> 04:00:18,080 POTENTIAL BENEFITS? 5604 04:00:18,080 --> 04:00:18,480 >> SURE. 5605 04:00:18,480 --> 04:00:23,040 OF COURSE, IN FACT THE CLASSIC 5606 04:00:23,040 --> 04:00:25,320 EXAMPLE WITH GRAPEFRUIT JUICE, 5607 04:00:25,320 --> 04:00:27,840 PEOPLE WOULD GIVE IT WITH 5608 04:00:27,840 --> 04:00:28,960 CERTAIN MEDICATIONS TO IMPROVE 5609 04:00:28,960 --> 04:00:29,480 BIOAVAILABILITY. 5610 04:00:29,480 --> 04:00:31,160 HAVE YOU TO BE CAREFUL WHICH 5611 04:00:31,160 --> 04:00:41,720 DRUGS AND PHYTOCHEMICALS YOU'RE 5612 04:00:43,400 --> 04:00:45,200 ADMIXING, AS LONG AS YOU 5613 04:00:45,200 --> 04:00:46,400 UNDERSTAND THE BOTANICAL YOU'RE 5614 04:00:46,400 --> 04:00:51,960 DEALING WITH AS WELL AS THE 5615 04:00:51,960 --> 04:00:53,520 PHARMACOLOGY OF BOTH 5616 04:00:53,520 --> 04:00:55,800 PHYTOCHEMICAL AND CONVENTIONAL 5617 04:00:55,800 --> 04:00:56,800 MEDICATION YOU'RE COMBINING, 5618 04:00:56,800 --> 04:01:00,360 DOESN'T MEAN THERE ARE HORRIBLE 5619 04:01:00,360 --> 04:01:00,600 THINGS. 5620 04:01:00,600 --> 04:01:03,040 THEY CAN BE USED ADVANTAGEOUSLY, 5621 04:01:03,040 --> 04:01:04,680 IN THE PROPER CONTEXT AND MAKE 5622 04:01:04,680 --> 04:01:07,520 SURE THINGS ARE MONITORED 5623 04:01:07,520 --> 04:01:08,720 PROPERLY. 5624 04:01:08,720 --> 04:01:13,760 THAT'S ALL. 5625 04:01:13,760 --> 04:01:15,560 >> THANK YOU, DR. GURLEY. 5626 04:01:15,560 --> 04:01:17,440 I'LL GIVE THE PLATFORM TO JAIME 5627 04:01:17,440 --> 04:01:18,840 TO TAKE US TO THE BREAK. 5628 04:01:18,840 --> 04:01:20,000 >> THANK YOU, DR. BROWN. 5629 04:01:20,000 --> 04:01:22,200 WE LOOK FORWARD TO SEEING YOU 5630 04:01:22,200 --> 04:01:27,640 NEXT SESSION AT 3:15, TALKING 5631 04:01:27,640 --> 04:01:31,720 ABOUT RESILIENCE STUDIES AT NIH 5632 04:01:31,720 --> 04:01:34,680 AND WE HAVE DR. HAGGERTY TALKING 5633 04:01:34,680 --> 04:01:36,000 ABOUT NIH SUPPORT FOR RESEARCH 5634 04:01:36,000 --> 04:01:38,560 AND TRAINING ON NUTRITION AND 5635 04:01:38,560 --> 04:01:40,520 DIETARY SUPPLEMENTS. 5636 04:01:40,520 --> 04:01:42,320 TWO GREAT PRESENTATIONS, WE'LL 5637 04:01:42,320 --> 04:01:43,200 BE STARTING THEN AT 3:15. 5638 04:01:43,200 --> 04:01:47,200 THANK YOU. 5639 04:01:47,200 --> 04:01:49,680 >>THIS IS SESSION 6, MODERATED 5640 04:01:49,680 --> 04:01:52,360 BY DR. BECKY COSTELLO, WITH THE 5641 04:01:52,360 --> 04:01:54,640 OFFICE ALMOST SINCE ITS 5642 04:01:54,640 --> 04:01:59,280 INCEPTION SINCE 1999. 5643 04:01:59,280 --> 04:02:01,440 THANK YOU, BECKY. 5644 04:02:01,440 --> 04:02:01,760 >> WELCOME. 5645 04:02:01,760 --> 04:02:08,000 THIS IS SESSION 6, SPECIAL 5646 04:02:08,000 --> 04:02:08,600 TOPICS. 5647 04:02:08,600 --> 04:02:10,960 THIS AFTERNOON'S SESSION WE'LL 5648 04:02:10,960 --> 04:02:15,000 HEAR FROM DR. BROWN AND DR. 5649 04:02:15,000 --> 04:02:16,680 HAGGERTY, INTRODUCING YOU TO 5650 04:02:16,680 --> 04:02:18,840 SOME ADDITIONAL PROGRAMS HERE AT 5651 04:02:18,840 --> 04:02:21,720 THE ODS, AND DESCRIBE HOW THEIR 5652 04:02:21,720 --> 04:02:22,800 PROGRAMS ARE CARRYING OUT THE 5653 04:02:22,800 --> 04:02:26,520 MISSION OF THE OFFERS OF DIETARY 5654 04:02:26,520 --> 04:02:27,040 SUPPLEMENTS. 5655 04:02:27,040 --> 04:02:30,640 OUR FIRST SPEAKER WILL BE DR. 5656 04:02:30,640 --> 04:02:34,720 BROWN, AND TO REMIND YOU BEFORE 5657 04:02:34,720 --> 04:02:38,720 I INTRODUCE HER TO USE THE Q&A 5658 04:02:38,720 --> 04:02:45,280 BOX FOR YOUR QUESTIONS, CHAT BOX 5659 04:02:45,280 --> 04:02:48,280 FOR TECHNICAL ISSUES. 5660 04:02:48,280 --> 04:02:54,200 DR. BROWN IS AT THE ODS 5661 04:02:54,200 --> 04:02:55,040 EXPLORING IMPACT OF DIETARY 5662 04:02:55,040 --> 04:02:58,760 SUPPLEMENT IS UP USE ON 5663 04:02:58,760 --> 04:03:01,880 RESILIENCE AND HEALTH IN DIVERSE 5664 04:03:01,880 --> 04:03:07,480 POPULATIONS, TRAINING IN ORGANIC 5665 04:03:07,480 --> 04:03:09,560 AND NATURAL PRODUCTS CHEMISTRY. 5666 04:03:09,560 --> 04:03:19,160 I WILL LET DR. BROWN BEGIN HER . 5667 04:03:19,160 --> 04:03:20,760 THANK YOU. 5668 04:03:20,760 --> 04:03:23,120 >> IT'S MY PLEASURE TO JOIN YOU 5669 04:03:23,120 --> 04:03:27,680 FOR THE 2022 OFFICE OF DIETARY 5670 04:03:27,680 --> 04:03:29,040 SUPPLEMENT PRACTICUM, I'M A 5671 04:03:29,040 --> 04:03:30,120 PROGRAM DIRECTOR AT THE OFFICE 5672 04:03:30,120 --> 04:03:35,360 OF DIETARY SUPPLEMENTS, FOUNDER 5673 04:03:35,360 --> 04:03:37,240 OF THE RESILIENCE WORKING GROUP. 5674 04:03:37,240 --> 04:03:42,680 THE PRESENTATION WILL FOCUS ON 5675 04:03:42,680 --> 04:03:44,520 PROCESS TO HARMONIZE RESEARCH 5676 04:03:44,520 --> 04:03:47,600 ACROSS MULTIPLE NIH INSTITUTES, 5677 04:03:47,600 --> 04:03:53,440 CENTERS, OFFICE, AS WELL AS 5678 04:03:53,440 --> 04:03:55,680 DOMAINS. 5679 04:03:55,680 --> 04:03:57,960 I WILL DISCUSS BEST PRACTICES IN 5680 04:03:57,960 --> 04:04:05,960 A DESIGN OF RESEARCH STUDY. 5681 04:04:05,960 --> 04:04:08,520 WHY RESILIENCE RESEARCH? 5682 04:04:08,520 --> 04:04:11,640 AS YOU KNOW, SUPPLEMENTS ARE NOT 5683 04:04:11,640 --> 04:04:13,240 INTENDED TO TREAT, CURE, 5684 04:04:13,240 --> 04:04:15,760 MITIGATE, OR PREVENT ANY 5685 04:04:15,760 --> 04:04:16,240 DISEASE. 5686 04:04:16,240 --> 04:04:19,720 WHILE DIETARY SUPPLEMENT LABELS 5687 04:04:19,720 --> 04:04:21,800 USUALLY DO NOT MAKE CLAIMS, THEY 5688 04:04:21,800 --> 04:04:28,600 DO CLAIM TO ENHANCE OR 5689 04:04:28,600 --> 04:04:30,360 STRENGTHEN RESILIENCE. 5690 04:04:30,360 --> 04:04:31,480 SHOWN ARE EXAMPLES, OBTAINED 5691 04:04:31,480 --> 04:04:36,920 FROM THE OFFICE OF DIETARY 5692 04:04:36,920 --> 04:04:38,600 SUPPLEMENT LABEL DATABASE. 5693 04:04:38,600 --> 04:04:40,640 NOTICE THAT THE WORD RESILIENT 5694 04:04:40,640 --> 04:04:42,480 OR SIMILAR TERMS ARE FREQUENTLY 5695 04:04:42,480 --> 04:04:44,680 USED IN NAMES OR CLAIMS 5696 04:04:44,680 --> 04:04:47,840 STATEMENTS OF DIETARY SUPPLEMENT 5697 04:04:47,840 --> 04:04:48,760 PRODUCTS. 5698 04:04:48,760 --> 04:04:50,720 HOW BEST TO ADDRESS KNOWLEDGE 5699 04:04:50,720 --> 04:04:52,720 GAPS ENTERTAINING TO BENEFITS OF 5700 04:04:52,720 --> 04:04:58,520 PRODUCT SUCH AS THESE? 5701 04:04:58,520 --> 04:05:00,360 INCREASED RIGOR AND 5702 04:05:00,360 --> 04:05:01,400 HARMONIZATION OF DATA. 5703 04:05:01,400 --> 04:05:06,080 AND THE OFFICE OF DIETARY 5704 04:05:06,080 --> 04:05:08,920 SUPPLEMENTS IS SUITED TO TAKE ON 5705 04:05:08,920 --> 04:05:15,880 THIS ROLE, COORDINATION AND 5706 04:05:15,880 --> 04:05:17,520 HARMONIZATION ACROSS NIH. 5707 04:05:17,520 --> 04:05:18,200 RESILIENCE RESEARCH STUDIES 5708 04:05:18,200 --> 04:05:20,720 RELEVANT TO TYPE OF SCIENCE WE 5709 04:05:20,720 --> 04:05:24,760 DO HERE AT NIH IS NOT A NEW 5710 04:05:24,760 --> 04:05:28,960 CONCEPT. 5711 04:05:28,960 --> 04:05:31,320 IN FACT, APPLIES TO BIOMEDICAL 5712 04:05:31,320 --> 04:05:35,840 SCIENCES DATING BACK TO THE 5713 04:05:35,840 --> 04:05:39,680 1800s, THERE HAS BEEN 5714 04:05:39,680 --> 04:05:41,360 SIGNIFICANT UPTICK IN RECENT 5715 04:05:41,360 --> 04:05:45,880 YEARS AS EVIDENCED BY THIS 5716 04:05:45,880 --> 04:05:48,800 PubMed SEARCH SHOWING 42,000 5717 04:05:48,800 --> 04:05:51,200 FULL TEXT ARTICLES BETWEEN 2012 5718 04:05:51,200 --> 04:05:55,400 AND 2022 HAVING THE TERM 5719 04:05:55,400 --> 04:06:04,880 RESILIENCE IN THE TITLE. 5720 04:06:04,880 --> 04:06:06,320 BROADER SEARCH GAVE 1.6 MILLION 5721 04:06:06,320 --> 04:06:07,560 RESULTS WITH THE TERM RESILIENCE 5722 04:06:07,560 --> 04:06:08,840 IN THE TITLE. 5723 04:06:08,840 --> 04:06:10,520 WHAT'S EVEN MORE INTERESTING 5724 04:06:10,520 --> 04:06:11,800 ABOUT THESE SEARCH RESULTS IS 5725 04:06:11,800 --> 04:06:16,960 THE FACT THE TOP FEW MANUSCRIPTS 5726 04:06:16,960 --> 04:06:24,440 ARE FOCUSED ON DEFINING 5727 04:06:24,440 --> 04:06:28,640 RESILIENCE, AND THEY HAVE A 5728 04:06:28,640 --> 04:06:30,840 CUMULATIVE TOTAL OF 3,000 5729 04:06:30,840 --> 04:06:31,120 CITATIONS. 5730 04:06:31,120 --> 04:06:32,880 CLEARLY THERE'S AN IMPORTANT GAP 5731 04:06:32,880 --> 04:06:34,120 THAT NEEDS ADDRESSING, AND 5732 04:06:34,120 --> 04:06:36,000 SCIENTISTS ARE EAGER FOR 5733 04:06:36,000 --> 04:06:36,760 SOLUTIONS. 5734 04:06:36,760 --> 04:06:38,160 I'D LIKE TO SUGGEST ONE SOLUTION 5735 04:06:38,160 --> 04:06:42,600 COULD BE THE DEVELOPMENT OF AN 5736 04:06:42,600 --> 04:06:44,200 OPERATIONALIZED DEFINITION OF 5737 04:06:44,200 --> 04:06:46,600 RESILIENCE OR SCIENTIFIC 5738 04:06:46,600 --> 04:06:49,520 RESEARCH. 5739 04:06:49,520 --> 04:06:50,880 IN 2019 THE RESEARCH WORKING 5740 04:06:50,880 --> 04:06:52,520 GROUP WAS ESTABLISHED TO 5741 04:06:52,520 --> 04:06:56,080 CONTRIBUTE TO DEVELOPMENT OF 5742 04:06:56,080 --> 04:06:58,160 OPERATIONALIZED DEFINITION OF 5743 04:06:58,160 --> 04:06:58,880 RESILIENCE. 5744 04:06:58,880 --> 04:07:00,520 UPON CONVENING MEMBERS AGREED 5745 04:07:00,520 --> 04:07:02,640 SCIENCE OF RESILIENCE ALIGNS 5746 04:07:02,640 --> 04:07:04,480 WITH MISSION OF NIH, SEEK 5747 04:07:04,480 --> 04:07:05,920 FUNDAMENTAL KNOWLEDGE ABOUT 5748 04:07:05,920 --> 04:07:08,040 NATURE AND BEHAVIOR OF LIVING 5749 04:07:08,040 --> 04:07:10,320 SYSTEMS AND APPLICATION OF THAT 5750 04:07:10,320 --> 04:07:12,280 KNOWLEDGE TO ENHANCE HEALTH, 5751 04:07:12,280 --> 04:07:14,160 LENGTHEN LIFE, REDUCE ILLNESS 5752 04:07:14,160 --> 04:07:15,800 AND DISABILITY. 5753 04:07:15,800 --> 04:07:19,800 IN FACT, NIH FUNDED RESILIENCE 5754 04:07:19,800 --> 04:07:21,200 RESEARCH STUDIES WERE EVIDENT 5755 04:07:21,200 --> 04:07:26,640 ACROSS INSTITUTES, CENTERS, AND 5756 04:07:26,640 --> 04:07:28,040 OFFICES, SPANNING MULTIPLE 5757 04:07:28,040 --> 04:07:32,840 DOMAINS INCLUDING INDIVIDUALS 5758 04:07:32,840 --> 04:07:38,520 SUCH AS MOLECULAR, PHYSIOLOGIC 5759 04:07:38,520 --> 04:07:41,040 AND PSYCHOSOCIAL, BEHAVIOR, 5760 04:07:41,040 --> 04:07:43,400 COMMUNITY, ENVIRONMENTAL 5761 04:07:43,400 --> 04:07:43,720 RESILIENCE. 5762 04:07:43,720 --> 04:07:44,560 FINALLY THE FOUNDATION OF THE 5763 04:07:44,560 --> 04:07:48,400 GROUP WAS BUILT ON A NOTION THAT 5764 04:07:48,400 --> 04:07:50,080 UNDERSTANDING OF RESILIENCE 5765 04:07:50,080 --> 04:07:52,320 WITHIN CONTEXT OF HUMAN HEALTH 5766 04:07:52,320 --> 04:07:56,160 AND BIOMEDICAL SCIENCES MIGHT 5767 04:07:56,160 --> 04:07:58,800 PROVIDE INSIGHT TOWARD 5768 04:07:58,800 --> 04:08:04,280 IMPROVEMENT OF HEALTH AND 5769 04:08:04,280 --> 04:08:06,240 MAINTENANCE WITH COMPLEMENTING 5770 04:08:06,240 --> 04:08:06,560 PERSPECTIVES. 5771 04:08:06,560 --> 04:08:09,840 REALIZING OPPORTUNITY TO HELP 5772 04:08:09,840 --> 04:08:10,840 ADVANCE SCIENCE, TRANS-NIH 5773 04:08:10,840 --> 04:08:14,120 RESILIENCE WORKING GROUP HOSTED 5774 04:08:14,120 --> 04:08:17,920 A FORUM TO DEVELOP NIH-WIDE 5775 04:08:17,920 --> 04:08:19,280 OPERATIONAL DEFINITION OF 5776 04:08:19,280 --> 04:08:20,800 RESILIENCE, PARTICIPANTS 5777 04:08:20,800 --> 04:08:22,880 INCLUDED REPRESENTATIVES FROM 5778 04:08:22,880 --> 04:08:23,800 NATIONAL CANCER INSTITUTE, 5779 04:08:23,800 --> 04:08:25,520 NATIONAL HEART, LUNG AND BLOOD 5780 04:08:25,520 --> 04:08:27,920 INSTITUTE,NA NAT INSTITUTE ON 5781 04:08:27,920 --> 04:08:29,120 AGING, NATIONAL INSTITUTE ON 5782 04:08:29,120 --> 04:08:31,040 MINORITY HEALTH AND HEALTH 5783 04:08:31,040 --> 04:08:33,320 DISPARITIES, NATIONAL INSTITUTE 5784 04:08:33,320 --> 04:08:35,360 ON NURSING RESEARCH, NATIONAL 5785 04:08:35,360 --> 04:08:37,120 CENTER FOR COMPLEMENTARY AND 5786 04:08:37,120 --> 04:08:38,760 INTEGRATIVE HEALTH, OFFICE OF 5787 04:08:38,760 --> 04:08:40,800 BEHAVIOR AND SOCIAL SCIENCES 5788 04:08:40,800 --> 04:08:42,560 RESEARCH, NATIONAL INSTITUTE ON 5789 04:08:42,560 --> 04:08:47,800 MENTAL HEALTH, OF COURSE THE 5790 04:08:47,800 --> 04:08:51,160 OFFICE OF DIETARY SUPPLEMENTS. 5791 04:08:51,160 --> 04:08:52,720 FOLLOWING PRESENTATIONS OF 5792 04:08:52,720 --> 04:08:56,680 EXAMPLES OF RESILIENCE RESEARCH 5793 04:08:56,680 --> 04:09:02,040 TWO BREAKOUT SESSIONS AND SERIES 5794 04:09:02,040 --> 04:09:03,600 OF DELIBERATIONS, PARTICIPANTS 5795 04:09:03,600 --> 04:09:05,520 SUGGESTED CRITERIA FOR 5796 04:09:05,520 --> 04:09:08,840 CONSIDERATION OF NIH-WIDE 5797 04:09:08,840 --> 04:09:09,760 DEFINITION OF RESILIENCE. 5798 04:09:09,760 --> 04:09:16,560 THOSE CRITERIA WERE BROAD ENOUGH 5799 04:09:16,560 --> 04:09:18,040 TO ENCOMPASS ALL THE HEALTH 5800 04:09:18,040 --> 04:09:19,320 DISEASE OUTCOMES, RANGE OF 5801 04:09:19,320 --> 04:09:21,240 STRESSORS AND CHALLENGES DUE TO 5802 04:09:21,240 --> 04:09:23,960 NORMAL PHYSIOLOGIC PROCESSES 5803 04:09:23,960 --> 04:09:26,680 SUCH AS AGING, NUMBER TWO 5804 04:09:26,680 --> 04:09:27,840 DEFINITION SHOULD ENSURE 5805 04:09:27,840 --> 04:09:30,480 APPLICABILITY AT THE POPULATION 5806 04:09:30,480 --> 04:09:33,840 LEVEL, INDIVIDUAL BIOLOGICAL 5807 04:09:33,840 --> 04:09:35,120 LEVEL, PSYCHOLOGICAL LEVEL. 5808 04:09:35,120 --> 04:09:37,440 NUMBER THREE, NIH WIDE 5809 04:09:37,440 --> 04:09:41,960 DEFINITION SHOULD ALIGN WITH THE 5810 04:09:41,960 --> 04:09:43,280 MISSION OF THE NIH. 5811 04:09:43,280 --> 04:09:45,080 WITH THESE CRITERIA AND 5812 04:09:45,080 --> 04:09:49,320 ACKNOWLEDGMENT OF KEY RESILIENCE 5813 04:09:49,320 --> 04:09:50,880 CONSENTS UTILIZED IN LITERATURE, 5814 04:09:50,880 --> 04:09:54,120 NIH DEFINITION OF RESILIENCE WAS 5815 04:09:54,120 --> 04:09:55,080 DEVELOPED. 5816 04:09:55,080 --> 04:09:56,960 IT STATES RESILIENCE CAN BE 5817 04:09:56,960 --> 04:10:00,680 DEFINED AS SYSTEM'S CAPACITY TO 5818 04:10:00,680 --> 04:10:02,040 RESIST, RECOVER, RECOVER BETTER, 5819 04:10:02,040 --> 04:10:06,760 GROW, OR ADAPT IN RESPONSE TO A 5820 04:10:06,760 --> 04:10:08,400 CHALLENGE OR STRESSOR. 5821 04:10:08,400 --> 04:10:12,680 THEN TO FULLY CAPTURE THE 5822 04:10:12,680 --> 04:10:19,040 FUNCTIONAL ASPECT, TRANS-NIH 5823 04:10:19,040 --> 04:10:20,600 RESILIENCE DEVELOPED A GRAPHIC, 5824 04:10:20,600 --> 04:10:22,920 OVER TIME A SYSTEM'S RESPONSE TO 5825 04:10:22,920 --> 04:10:28,080 CHALLENGE MIGHT SHOW VARYING 5826 04:10:28,080 --> 04:10:36,400 DEGREES OF REACTION THAT 5827 04:10:36,400 --> 04:10:37,160 FLUBBING FLUCTUATE, GRAPHIC 5828 04:10:37,160 --> 04:10:38,920 SHOWS A SYSTEM CAN BE 5829 04:10:38,920 --> 04:10:41,280 REPRESENTED BY VARIOUS DEMAINS, 5830 04:10:41,280 --> 04:10:43,400 FACTORS OR PROCESSES THAT IMPACT 5831 04:10:43,400 --> 04:10:46,240 HUMAN HEALTH, INCLUDING BUT NOT 5832 04:10:46,240 --> 04:10:48,040 LIMITED TO ENVIRONMENTAL OR 5833 04:10:48,040 --> 04:10:52,240 COMMUNITY FACTORS, AS WELL AS 5834 04:10:52,240 --> 04:10:57,440 INDIVIDUAL PSYCHOLOGICAL, 5835 04:10:57,440 --> 04:10:59,320 PHYSIOLOGICAL, MOLECULAR 5836 04:10:59,320 --> 04:11:00,520 CAPACITY. 5837 04:11:00,520 --> 04:11:01,480 IT PROVIDES EXAMPLES OF REACTION 5838 04:11:01,480 --> 04:11:03,520 TO STRESSOR. 5839 04:11:03,520 --> 04:11:04,720 FOR EXAMPLE, WHEN A SYSTEM IS 5840 04:11:04,720 --> 04:11:08,080 EXPOSED TO A CHALLENGE OR 5841 04:11:08,080 --> 04:11:10,920 STRESSOR RESULTS IN NO 5842 04:11:10,920 --> 04:11:13,880 DISRUPTION, SYSTEM RESPONDED BY 5843 04:11:13,880 --> 04:11:17,080 RESISTING THE CHALLENGE. 5844 04:11:17,080 --> 04:11:17,840 RESISTING THE STRESSOR. 5845 04:11:17,840 --> 04:11:21,040 IF THE SYSTEM IS INITIALLY 5846 04:11:21,040 --> 04:11:23,360 DISTURBED AND THEN RECOVERS, BUT 5847 04:11:23,360 --> 04:11:24,960 RECOVER STATE IS IMPROVEMENT 5848 04:11:24,960 --> 04:11:26,680 COMPARED WITH BASELINE THE 5849 04:11:26,680 --> 04:11:29,360 SYSTEM SHOWED GROWTH OR 5850 04:11:29,360 --> 04:11:30,560 RECOVERED BETTER. 5851 04:11:30,560 --> 04:11:34,200 HOWEVER, IF A SYSTEM SHOWS 5852 04:11:34,200 --> 04:11:34,840 UNANTICIPATED CHANGES THAT 5853 04:11:34,840 --> 04:11:40,640 INFLUENCE SYSTEM'S ABILITY TO 5854 04:11:40,640 --> 04:11:43,120 THRIVE, EXPERIENCE CAN BE 5855 04:11:43,120 --> 04:11:45,200 CHARACTERIZED AS ADAPTIVE 5856 04:11:45,200 --> 04:11:45,560 RESPONSE. 5857 04:11:45,560 --> 04:11:48,800 AND IF A SYSTEM SHOWS INITIAL 5858 04:11:48,800 --> 04:11:51,080 DISRUPTION THAT IS ULTIMATELY 5859 04:11:51,080 --> 04:11:52,760 RESTORED TO BASELINE STATUS, 5860 04:11:52,760 --> 04:11:55,440 SYSTEM'S RESPONSE IS 5861 04:11:55,440 --> 04:11:58,080 CHARACTERIZED AS RECOVERY. 5862 04:11:58,080 --> 04:12:00,680 EACH ARE RELEVANT TO THE 5863 04:12:00,680 --> 04:12:02,200 RESILIENCE OUTCOMES. 5864 04:12:02,200 --> 04:12:08,760 ON THE OTHER HAND, REACTIONS NOT 5865 04:12:08,760 --> 04:12:09,760 CONSISTENT RESILIENCE OUTCOMES 5866 04:12:09,760 --> 04:12:14,640 OCCUR WHEN IT RESULTS IN A 5867 04:12:14,640 --> 04:12:15,640 WORSENED CONDITION, 5868 04:12:15,640 --> 04:12:22,560 CHARACTERIZED AS DIMINISHED OR 5869 04:12:22,560 --> 04:12:24,400 MALADAPTIVE RESPONSE. 5870 04:12:24,400 --> 04:12:25,520 IF IT FAILS TO RECOVER, IT IS 5871 04:12:25,520 --> 04:12:30,880 LOST OR HAS COLLAPSE. 5872 04:12:30,880 --> 04:12:33,160 THE GOAL IS NOT TO SUGGEST ONE 5873 04:12:33,160 --> 04:12:37,960 FRAMEWORK IS PREFERRED OVER THE 5874 04:12:37,960 --> 04:12:38,400 OTHER. 5875 04:12:38,400 --> 04:12:39,480 RESILIENCE, RISK REDUCTION, 5876 04:12:39,480 --> 04:12:40,920 PREVENTION AND EVEN DISEASE 5877 04:12:40,920 --> 04:12:43,480 TREATMENT ARE ALL BENEFICIAL 5878 04:12:43,480 --> 04:12:45,560 FRAMEWORKS FOR WHICH THE DESIGN 5879 04:12:45,560 --> 04:12:46,560 STUDIES OR ASK QUESTIONS OF THE 5880 04:12:46,560 --> 04:12:47,040 DATA. 5881 04:12:47,040 --> 04:12:48,560 EACH OF THE FRAMEWORKS MIGHT 5882 04:12:48,560 --> 04:12:52,600 LEAD TO IMPROVE HEALTH OUTCOMES. 5883 04:12:52,600 --> 04:12:54,920 I'M SUGGESTING A NICE BALANCE 5884 04:12:54,920 --> 04:12:56,960 REPRESENTING EACH OF THE 5885 04:12:56,960 --> 04:12:57,560 FRAMEWORKS IN THE LITERATURE 5886 04:12:57,560 --> 04:12:59,160 WHICH I DON'T THINK IS CURRENTLY 5887 04:12:59,160 --> 04:13:04,760 THE CASE FOR RESILIENCE 5888 04:13:04,760 --> 04:13:07,080 FRAMEWORKS, BUT IF THERE WERE A 5889 04:13:07,080 --> 04:13:07,800 NICE BALANCE INCLUDING 5890 04:13:07,800 --> 04:13:10,520 RESILIENCE FRAMEWORKS, IT MIGHT 5891 04:13:10,520 --> 04:13:13,520 OPEN OUR EYES TO QUESTIONS AND 5892 04:13:13,520 --> 04:13:17,480 KNOWLEDGE GAPS CURRENTLY 5893 04:13:17,480 --> 04:13:18,880 OVERLOOKED OR UNDERAPPRECIATED. 5894 04:13:18,880 --> 04:13:21,160 LET'S CONSIDER AS EXAMPLE THE 5895 04:13:21,160 --> 04:13:24,600 STATUS OF POPULATION 5896 04:13:24,600 --> 04:13:27,040 DISTRIBUTION DATA SHOWN HERE. 5897 04:13:27,040 --> 04:13:29,760 WE SEE FROM DATA THAT IN 5898 04:13:29,760 --> 04:13:39,320 POPULATION D, THE LEVELS RANGE 5899 04:13:39,320 --> 04:13:45,640 FROM 10 TO 80 NANOGRAMS PER MIL. 5900 04:13:45,640 --> 04:13:48,320 TAKE A LOOK AT POPULATION A 5901 04:13:48,320 --> 04:13:48,960 CURVE. 5902 04:13:48,960 --> 04:13:52,560 THE NUTRIENT X STATUS LEVELS IN 5903 04:13:52,560 --> 04:13:56,800 POPULATION A RANGE FROM 2 5904 04:13:56,800 --> 04:13:59,160 NANOGRAMS TO 40 NANOGRAMS PER 5905 04:13:59,160 --> 04:14:02,640 MIL, AND MEAN STATUS LEFT IN 5906 04:14:02,640 --> 04:14:04,520 POPULATION A IS ABOUT 15 5907 04:14:04,520 --> 04:14:06,440 NANOGRAMS PER MIL. 5908 04:14:06,440 --> 04:14:09,040 NOW, DEPENDING UPON YOUR 5909 04:14:09,040 --> 04:14:11,160 PERSPECTIVE, OR LENS BY WHICH 5910 04:14:11,160 --> 04:14:12,800 YOU VIEW THIS DATA YOUR IDEAS ON 5911 04:14:12,800 --> 04:14:15,320 HOW BEST TO RESPOND TO THE DATA 5912 04:14:15,320 --> 04:14:17,520 OR YOUR APPROACH TO TREATMENT 5913 04:14:17,520 --> 04:14:20,520 PARADIGM OR THOUGHTS ON HOW BEST 5914 04:14:20,520 --> 04:14:21,320 TO ADDRESS POTENTIAL KNOWLEDGE 5915 04:14:21,320 --> 04:14:26,680 GAPS COULD ALL BE VERY 5916 04:14:26,680 --> 04:14:27,040 DIFFERENT. 5917 04:14:27,040 --> 04:14:28,440 FOR EXAMPLE, YOU COULD LOOK AT 5918 04:14:28,440 --> 04:14:31,360 THIS DATA AND SAY, HMM, LET'S 5919 04:14:31,360 --> 04:14:33,520 DEVELOP A DRUG OR SUPPLEMENT TO 5920 04:14:33,520 --> 04:14:36,040 MAKE LEVELS OF NUTRIENT X IN 5921 04:14:36,040 --> 04:14:37,840 POPULATIONS A, B,C LOOK MORE 5922 04:14:37,840 --> 04:14:41,800 LIKE THOSE IN POPULATION D. 5923 04:14:41,800 --> 04:14:43,080 OR DEPENDENTING UPON YOUR 5924 04:14:43,080 --> 04:14:46,000 PERSPECTIVE YOU COULD LOOK AT 5925 04:14:46,000 --> 04:14:48,680 THIS DATA AND THINK LET'S 5926 04:14:48,680 --> 04:14:50,800 IDENTIFY FACTORS THAT ALLOW OR 5927 04:14:50,800 --> 04:14:54,320 CAUSE POPULATIONS A, B, C, TO BE 5928 04:14:54,320 --> 04:14:56,800 AT GREATER RISK FOR HAVING LOWER 5929 04:14:56,800 --> 04:14:57,720 LEVELS OF NUTRIENT X. 5930 04:14:57,720 --> 04:15:00,280 PERHAPS YOU LOOK AT THIS DATA 5931 04:15:00,280 --> 04:15:02,680 AND THINK, LET'S DEVELOP 5932 04:15:02,680 --> 04:15:04,320 POLICIES TO PREVENT POPULATIONS 5933 04:15:04,320 --> 04:15:06,920 A, B, AND C FROM EXPOSURE TO 5934 04:15:06,920 --> 04:15:08,360 THOSE RISK FACTORS THAT MIGHT 5935 04:15:08,360 --> 04:15:13,640 LEAD TO LOWER LEVELS OF NUTRIENT 5936 04:15:13,640 --> 04:15:13,920 X. 5937 04:15:13,920 --> 04:15:17,720 MAYBE YOU LOOK AND SAY LET'S 5938 04:15:17,720 --> 04:15:20,600 STUDY SUCCESS STORIES IN 5939 04:15:20,600 --> 04:15:22,040 POPULATION A AND IDENTIFY 5940 04:15:22,040 --> 04:15:22,840 PROTECTIVE FACTORS ASSOCIATED 5941 04:15:22,840 --> 04:15:29,920 WITH LOWER LEVELS OF NUTRIENT X. 5942 04:15:29,920 --> 04:15:32,480 PERHAPS YOU'LL LOOK AND SAY 5943 04:15:32,480 --> 04:15:33,320 LET'S IDENTIFY POTENTIAL 5944 04:15:33,320 --> 04:15:34,720 BENEFITS ASSOCIATED WITH HAVING 5945 04:15:34,720 --> 04:15:44,440 LOWER LEVELS OF NUTRIENT X IN 5946 04:15:44,440 --> 04:15:48,680 POPULATION A. 5947 04:15:48,680 --> 04:15:49,480 EACH IS IMPORTANT. 5948 04:15:49,480 --> 04:15:52,240 HOWEVER, I'D LIKE TO SUGGEST THE 5949 04:15:52,240 --> 04:16:00,120 LOWER TWO PERSPECTIVES WHICH 5950 04:16:00,120 --> 04:16:01,640 WERE DESIGNED OTHER CONSIDERED 5951 04:16:01,640 --> 04:16:04,240 IN RESILIENCE ARE APPLIED LESS 5952 04:16:04,240 --> 04:16:04,480 OFTEN. 5953 04:16:04,480 --> 04:16:08,720 IN OTHER WORDS, PERSPECTIVE OR 5954 04:16:08,720 --> 04:16:09,840 FRAMEWORK CAN DETERMINE NOT ONLY 5955 04:16:09,840 --> 04:16:11,160 TYPES OF QUESTIONS THAT ARE 5956 04:16:11,160 --> 04:16:13,680 ASKED IN YOUR STUDY BUT CAN ALSO 5957 04:16:13,680 --> 04:16:16,880 DETERMINE HOW YOU RESPOND TO THE 5958 04:16:16,880 --> 04:16:17,480 DATA. 5959 04:16:17,480 --> 04:16:19,880 FOR EXAMPLE, IF YOUR STUDY IS 5960 04:16:19,880 --> 04:16:22,480 DESIGNED WITHIN THE RISK 5961 04:16:22,480 --> 04:16:23,480 REDUCTION OR PREVENTION 5962 04:16:23,480 --> 04:16:26,280 FRAMEWORK, IT'S LIKELY YOUR 5963 04:16:26,280 --> 04:16:27,280 STUDY IS FOCUSED ON 5964 04:16:27,280 --> 04:16:30,160 UNDERSTANDING RISK FACTORS, 5965 04:16:30,160 --> 04:16:30,360 RIGHT? 5966 04:16:30,360 --> 04:16:31,280 UNDERSTANDING OR IDENTIFYING 5967 04:16:31,280 --> 04:16:33,480 THOSE FACTORS THAT ARE 5968 04:16:33,480 --> 04:16:35,720 ASSOCIATED WITH INCREASED 5969 04:16:35,720 --> 04:16:38,240 LIKELIHOOD OF ADVERSE OUTCOMES. 5970 04:16:38,240 --> 04:16:40,440 BUT IF YOUR STUDY IS DESIGNED IN 5971 04:16:40,440 --> 04:16:42,480 RESILIENCE FRAMEWORK IT'S LIKELY 5972 04:16:42,480 --> 04:16:44,680 THAT THE FOCUS IS TO BETTER 5973 04:16:44,680 --> 04:16:46,120 UNDERSTAND THE PROTECTIVE 5974 04:16:46,120 --> 04:16:48,680 FACTORS, OR TO IDENTIFY THOSE 5975 04:16:48,680 --> 04:16:51,040 FACTORS THAT ARE ASSOCIATED WITH 5976 04:16:51,040 --> 04:16:55,000 POSITIVE RESPONSE UPON EXPOSURE 5977 04:16:55,000 --> 04:16:55,600 TO ADVERSITY, STRESSES, 5978 04:16:55,600 --> 04:16:58,120 CHALLENGES. 5979 04:16:58,120 --> 04:16:59,560 RISK REDUCTION AND PREVENTION 5980 04:16:59,560 --> 04:17:03,640 OPINION BASED FRAMEWORKS TEND TO 5981 04:17:03,640 --> 04:17:08,120 EMPHASIZE OR PLACE EMPHASIS ON 5982 04:17:08,120 --> 04:17:10,360 EXPOSING VULNERABILITIES, 5983 04:17:10,360 --> 04:17:11,800 WHEREASES ARE FRAMEWORKS PLACE 5984 04:17:11,800 --> 04:17:13,040 EMPHASIS ON UTILIZATION OF 5985 04:17:13,040 --> 04:17:17,800 ASSETS OR STRENGTH IN A SYSTEM. 5986 04:17:17,800 --> 04:17:19,920 RISK REDUCTION AND PREVENTION 5987 04:17:19,920 --> 04:17:22,320 FRAMEWORKS TEND TO HAVE 5988 04:17:22,320 --> 04:17:25,320 INTERVENTIONS THAT TEND TOWARDS 5989 04:17:25,320 --> 04:17:28,640 PREVENTING OR REDUCING RISK. 5990 04:17:28,640 --> 04:17:30,880 RESILIENCE FRAMEWORKS HAVE 5991 04:17:30,880 --> 04:17:32,600 INTERVENTIONS THAT TEND TOWARDS 5992 04:17:32,600 --> 04:17:33,520 EMPOWERING OR STRENGTHENING TO 5993 04:17:33,520 --> 04:17:43,160 BETTER RESPOND TO THOSE RISKS OR 5994 04:17:43,160 --> 04:17:47,320 STRESSORS OR CHALLENGES. 5995 04:17:47,320 --> 04:17:49,080 IF YOU'RE DESIGNING A STUDY IT'S 5996 04:17:49,080 --> 04:17:52,000 LIKELY IT WILL BE DESIGNED TO 5997 04:17:52,000 --> 04:17:54,640 TARGET OR MANIPULATE RISK OR 5998 04:17:54,640 --> 04:17:55,800 VULNERABILITIES. 5999 04:17:55,800 --> 04:17:58,160 ON THE OTHER HAND, IF YOUR STUDY 6000 04:17:58,160 --> 04:18:00,680 IS DESIGNED TO INVESTIGATE 6001 04:18:00,680 --> 04:18:02,760 PROTECTION FACTORS, OR 6002 04:18:02,760 --> 04:18:04,080 RESILIENCE OUTCOMES, YOUR STUDY 6003 04:18:04,080 --> 04:18:08,960 WILL BE DESIGNED TO FOCUS ON THE 6004 04:18:08,960 --> 04:18:09,960 SYSTEM, MORE SPECIFICALLY 6005 04:18:09,960 --> 04:18:11,840 RESILIENCE-BASED STUDIES WILL BE 6006 04:18:11,840 --> 04:18:13,760 DESIGNED TO STRENGTHEN A 6007 04:18:13,760 --> 04:18:17,240 SYSTEM'S RESPONSE TO THE RISK. 6008 04:18:17,240 --> 04:18:21,360 HOW CAN YOU APPLY THE RESILIENCE 6009 04:18:21,360 --> 04:18:24,720 FRAMEWORK TO THE DESIGN OF YOUR 6010 04:18:24,720 --> 04:18:28,000 NEXT RESILIENCE STUDY? 6011 04:18:28,000 --> 04:18:28,600 YOU CAN CONSIDER FIRST WHETHER 6012 04:18:28,600 --> 04:18:31,520 OR NOT ONE OF THE FOLLOWING KEY 6013 04:18:31,520 --> 04:18:33,880 TERMS OR SIMILAR TERMS ARE ISSUE 6014 04:18:33,880 --> 04:18:34,560 REPLACEABLE IN DESCRIBING YOUR 6015 04:18:34,560 --> 04:18:35,320 STUDY DESIGN. 6016 04:18:35,320 --> 04:18:38,880 FOR EXAMPLE, DO YOU HAVE TERMS 6017 04:18:38,880 --> 04:18:40,600 LIKE RESILIENCE? 6018 04:18:40,600 --> 04:18:41,920 OR RESTORATION? 6019 04:18:41,920 --> 04:18:43,200 OR ADAPTIVE RESPONSE? 6020 04:18:43,200 --> 04:18:46,120 OR PROTECTIVE FACTORS IN YOUR 6021 04:18:46,120 --> 04:18:46,560 STUDY? 6022 04:18:46,560 --> 04:18:48,280 NOW, OF COURSE, INCLUSION OF 6023 04:18:48,280 --> 04:18:51,000 THESE TERMS ALONE IN YOUR STUDY 6024 04:18:51,000 --> 04:18:52,560 DESIGN IS NOT SUFFICIENT. 6025 04:18:52,560 --> 04:18:55,320 YOU SHOULD ALSO ASK YOURSELF, 6026 04:18:55,320 --> 04:18:57,320 DOES THE RESEARCH DESIGN INCLUDE 6027 04:18:57,320 --> 04:18:59,040 STRESSOR OR CHALLENGE? 6028 04:18:59,040 --> 04:19:01,400 THE LITERATURE SUPPORTS THE 6029 04:19:01,400 --> 04:19:03,160 NOTION WE CANNOT PERCEIVE 6030 04:19:03,160 --> 04:19:05,440 RESILIENCE OR MEASURE RESILIENCE 6031 04:19:05,440 --> 04:19:06,840 UNLESS THE SYSTEM IS EXPOSED 6032 04:19:06,840 --> 04:19:10,040 FIRST TO A STRESSOR OR 6033 04:19:10,040 --> 04:19:10,520 CHALLENGE. 6034 04:19:10,520 --> 04:19:12,680 SO ANY STUDY DESIGN TO ADVANCE 6035 04:19:12,680 --> 04:19:14,480 SCIENCE OF RESILIENCE SHOULD 6036 04:19:14,480 --> 04:19:16,120 HAVE WELL CHARACTERIZED DETAILS 6037 04:19:16,120 --> 04:19:18,440 DESCRIBING MAGNITUDE OF THE 6038 04:19:18,440 --> 04:19:19,120 STRESSOR, TIMING OF THE 6039 04:19:19,120 --> 04:19:23,600 STRESSOR, IS IT AN ACUTE OR 6040 04:19:23,600 --> 04:19:25,000 CHRONIC STRESSOR, WHAT LIFE 6041 04:19:25,000 --> 04:19:27,080 STAGE OR CYCLE DOES THE STRESSOR 6042 04:19:27,080 --> 04:19:27,640 IMPACT THE SYSTEM? 6043 04:19:27,640 --> 04:19:29,600 ALL OF THESE ARE FEATURES THAT 6044 04:19:29,600 --> 04:19:33,800 SHOULD BE CONSIDERED IN YOUR 6045 04:19:33,800 --> 04:19:34,800 RESILIENCE STUDY DESIGN. 6046 04:19:34,800 --> 04:19:39,040 YOU SHOULD ASK YOURSELF DO THE 6047 04:19:39,040 --> 04:19:40,280 MEASUREMENTS AND/OR OUTCOMES 6048 04:19:40,280 --> 04:19:42,320 TARGET HEALTH MAINTENANCE 6049 04:19:42,320 --> 04:19:43,080 SURVIVORSHIP OR PROTECTIVE 6050 04:19:43,080 --> 04:19:44,400 PATHWAYS OR ANOTHER WAY TO THINK 6051 04:19:44,400 --> 04:19:46,920 ABOUT IT, DO YOUR METRICS 6052 04:19:46,920 --> 04:19:49,640 CAPTURE CHANGE THAT STRENGTHENS 6053 04:19:49,640 --> 04:19:51,320 THE SYSTEM TOWARDS RESISTANCE, 6054 04:19:51,320 --> 04:19:52,200 ADAPTIVE RESPONSE, GROWTH, 6055 04:19:52,200 --> 04:19:54,080 RECOVERY FROM A STRESS OR 6056 04:19:54,080 --> 04:19:54,320 CHALLENGE? 6057 04:19:54,320 --> 04:20:00,000 IN OTHER WORDS, DO THE METRICS 6058 04:20:00,000 --> 04:20:01,760 CAPTURE CHANGE TOWARD A MORE 6059 04:20:01,760 --> 04:20:03,200 POSITIVE RESPONSE WHEN EXPOSED 6060 04:20:03,200 --> 04:20:04,360 TO A STRESSOR? 6061 04:20:04,360 --> 04:20:07,080 YOU SHOULD ALSO ASK, IS THERE AN 6062 04:20:07,080 --> 04:20:09,200 INTERVENTION OR PROTECTIVE 6063 04:20:09,200 --> 04:20:11,040 FACTOR IDENTIFIED OR SOUGHT FOR 6064 04:20:11,040 --> 04:20:13,040 DISCOVERY IN YOUR STUDY? 6065 04:20:13,040 --> 04:20:15,520 IF AN INTERVENTION IS 6066 04:20:15,520 --> 04:20:16,440 IDENTIFIED, DOES THE 6067 04:20:16,440 --> 04:20:19,680 INTERVENTION TRAIN THE SYSTEM TO 6068 04:20:19,680 --> 04:20:20,680 REACT DIFFERENTLY OR MORE 6069 04:20:20,680 --> 04:20:25,960 POSITIVELY TOWARDS THE STRESSOR 6070 04:20:25,960 --> 04:20:28,240 OR CHALLENGE? 6071 04:20:28,240 --> 04:20:29,920 ASK YOURSELF DOES THE 6072 04:20:29,920 --> 04:20:30,480 INTERVENTION HAVE MULTIPLE 6073 04:20:30,480 --> 04:20:35,360 DIVERSE EFFECTS WITHIN A SYSTEM 6074 04:20:35,360 --> 04:20:39,200 OR ACROSS SYSTEMS, DOES IT SHOW 6075 04:20:39,200 --> 04:20:42,680 POTENTIAL TO STRENGTHEN THE 6076 04:20:42,680 --> 04:20:43,400 SYSTEM, VIA MULTIPLE PATHWAYS 6077 04:20:43,400 --> 04:20:45,280 THAT ARE DISTINCT FROM TARGETED 6078 04:20:45,280 --> 04:20:46,760 APPROACH THAT IS DESIGNED TO 6079 04:20:46,760 --> 04:20:51,080 MITIGATE SOME RISK OR DISEASE 6080 04:20:51,080 --> 04:20:51,480 PATHWAY? 6081 04:20:51,480 --> 04:20:57,240 LET'S CONSIDER A FEW EXAMPLES. 6082 04:20:57,240 --> 04:20:59,200 SHOWN IS A HANDFUL OF EXAMPLES 6083 04:20:59,200 --> 04:21:00,960 OF RESEARCH STUDIES THAT WERE 6084 04:21:00,960 --> 04:21:05,160 CO-FUNDED BY THE OFFICE DIETARY 6085 04:21:05,160 --> 04:21:06,120 SUPPLEMENTS BETWEEN 2018 AND 6086 04:21:06,120 --> 04:21:06,440 2020. 6087 04:21:06,440 --> 04:21:08,600 NOTICE THE WIDE RANGE OF SYSTEMS 6088 04:21:08,600 --> 04:21:11,480 INVESTIGATED IN THIS LIST OF 6089 04:21:11,480 --> 04:21:14,000 EXAMPLES, YOU HAVE PHYSIOLOGIC 6090 04:21:14,000 --> 04:21:16,040 NEUROVASCULAR, BIOLOGICAL AND 6091 04:21:16,040 --> 04:21:17,640 BEHAVIOR SYSTEMS. 6092 04:21:17,640 --> 04:21:18,920 IN EACH STUDY SYSTEMS ARE 6093 04:21:18,920 --> 04:21:22,280 EXPOSED TO A CHALLENGE OR 6094 04:21:22,280 --> 04:21:23,000 STRESSORS. 6095 04:21:23,000 --> 04:21:24,680 MEASUREMENTS TARGET HEALTH 6096 04:21:24,680 --> 04:21:26,360 MAINTENANCE OR POTENTIAL 6097 04:21:26,360 --> 04:21:27,600 PROTECTIVE PATHWAYS, AND 6098 04:21:27,600 --> 04:21:32,320 INTERVENTIONS IN THIS CASE ALL 6099 04:21:32,320 --> 04:21:35,280 ARE DIETARY SUPPLEMENTS BELIEVED 6100 04:21:35,280 --> 04:21:39,640 TO HAVE DIVERSE EFFECTS ACROSS 6101 04:21:39,640 --> 04:21:41,160 MULTIPLE SYSTEMS. 6102 04:21:41,160 --> 04:21:42,800 HERE'S AN EXCERPT OF A STUDY 6103 04:21:42,800 --> 04:21:46,200 THAT WAS CO-FUNDED BY THE OFFICE 6104 04:21:46,200 --> 04:21:48,000 OF DIETARY SUPPLEMENTS. 6105 04:21:48,000 --> 04:21:51,000 I MODIFIED THE TITLE SLIGHTLY TO 6106 04:21:51,000 --> 04:21:52,560 PROTECT THE INVESTIGATORS AND 6107 04:21:52,560 --> 04:21:53,760 RESEARCH INTEGRITY. 6108 04:21:53,760 --> 04:21:56,720 THIS IS STUDY WHICH I'VE TITLED 6109 04:21:56,720 --> 04:21:58,680 MECHANISMS AND ACTIVE COMPOUNDS 6110 04:21:58,680 --> 04:22:02,920 IN BOTANICAL WATER EXTRACT, BWE, 6111 04:22:02,920 --> 04:22:07,120 SERVES AS GOOD EXAMPLE OF 6112 04:22:07,120 --> 04:22:07,840 RESILIENCE STUDIES ADDRESSING 6113 04:22:07,840 --> 04:22:08,840 KEY CRITERIA. 6114 04:22:08,840 --> 04:22:10,480 FOR EXAMPLE, ONE OR MORE OF THE 6115 04:22:10,480 --> 04:22:16,680 KEY WORD TERMS, IN THIS CASE 6116 04:22:16,680 --> 04:22:18,600 ENHANCE OR REVERSE ARE 6117 04:22:18,600 --> 04:22:21,360 IRREPLACEABLE IN DESCRIBING THE 6118 04:22:21,360 --> 04:22:22,200 STUDY DESIGN. 6119 04:22:22,200 --> 04:22:24,840 ALSO, WE SEE THE INVESTIGATORS 6120 04:22:24,840 --> 04:22:27,960 USE AN AGED MICE MODEL WITH HIGH 6121 04:22:27,960 --> 04:22:29,400 BETA AMYLOID PLAQUE BURDEN IN 6122 04:22:29,400 --> 04:22:31,520 THE STUDY DESIGN. 6123 04:22:31,520 --> 04:22:33,480 THIS MODEL OF ALZHEIMER'S 6124 04:22:33,480 --> 04:22:36,200 DISEASE SERVES AS STRESSOR OR 6125 04:22:36,200 --> 04:22:38,360 CHALLENGE IN THIS STUDY. 6126 04:22:38,360 --> 04:22:40,520 AND THEN WHEN CONSIDERING 6127 04:22:40,520 --> 04:22:42,600 WHETHER MEASUREMENTS OR OUTCOMES 6128 04:22:42,600 --> 04:22:44,680 TARGET HEALTH MAINTENANCE, 6129 04:22:44,680 --> 04:22:45,400 SURVIVORSHIP OR PROTECTIVE 6130 04:22:45,400 --> 04:22:47,760 PATHWAYS WE SEE THE 6131 04:22:47,760 --> 04:22:49,800 INVESTIGATORS USE BOTH TARGETED 6132 04:22:49,800 --> 04:22:51,640 AND UNBIASED APPROACHES TO 6133 04:22:51,640 --> 04:22:56,040 EXPLORE THE INTERVENTION OR 6134 04:22:56,040 --> 04:22:58,560 BWEs PROTECTIVE EFFECTS 6135 04:22:58,560 --> 04:23:03,680 AGAINST MECHANISMS OF BETA 6136 04:23:03,680 --> 04:23:04,240 AMYLOID PLAQUE TOXICITY AND 6137 04:23:04,240 --> 04:23:05,680 WHETHER OR NOT MEASURES CAPTURE 6138 04:23:05,680 --> 04:23:08,520 CHANGE TO STRENGTHEN TOWARDS A 6139 04:23:08,520 --> 04:23:10,640 POSITIVE RESPONSE UPON EXPOSURE 6140 04:23:10,640 --> 04:23:12,600 TO STRESSOR, WE SEE THE 6141 04:23:12,600 --> 04:23:16,120 INVESTIGATORS HAVE SHOWN THAT 6142 04:23:16,120 --> 04:23:19,720 THE INTERVENTION BWE CAN 6143 04:23:19,720 --> 04:23:21,440 ATTENUATE BETA AMYLOID 6144 04:23:21,440 --> 04:23:23,720 NEUROTOXICITY WITHOUT ALTERING 6145 04:23:23,720 --> 04:23:27,040 ITS FORMATION OR DEPOSITION. 6146 04:23:27,040 --> 04:23:28,200 IN OTHER WORDS, DESPITE 6147 04:23:28,200 --> 04:23:32,200 CONTINUED EXPOSURE TO THE 6148 04:23:32,200 --> 04:23:33,920 STRESSOR, THE INTERVENTION 6149 04:23:33,920 --> 04:23:36,400 APPEARS TO STRENGTHEN SYSTEM 6150 04:23:36,400 --> 04:23:39,320 TOWARD ABILITY TO RESIS 6151 04:23:39,320 --> 04:23:40,240 PERTURBATION FROM STRESSOR. 6152 04:23:40,240 --> 04:23:42,920 THEN WE ASK, IS THERE AN 6153 04:23:42,920 --> 04:23:44,360 INTERVENTION OR PROTECTIVE 6154 04:23:44,360 --> 04:23:45,080 FACTOR IDENTIFIED? 6155 04:23:45,080 --> 04:23:48,320 JUST IN THIS STUDY WE HAVE 6156 04:23:48,320 --> 04:23:49,080 INDICATED INTERVENTION IS 6157 04:23:49,080 --> 04:23:52,160 BOTANICAL WATER EXTRACT OR BWE, 6158 04:23:52,160 --> 04:23:54,360 BUT THEN WE ASK DOES THE 6159 04:23:54,360 --> 04:23:57,120 INTERVENTION TRAIN THE SYSTEM TO 6160 04:23:57,120 --> 04:23:58,960 REACT DIFFERENTLY OR MORE 6161 04:23:58,960 --> 04:24:01,800 POSITIVELY TOWARDS STRESSOR OR 6162 04:24:01,800 --> 04:24:02,040 CHALLENGE? 6163 04:24:02,040 --> 04:24:03,200 WE SEE HERE THAT THE 6164 04:24:03,200 --> 04:24:06,840 INTERVENTION IS ABLE TO REVERSE 6165 04:24:06,840 --> 04:24:09,880 LEARNING DEFICITS THAT ARE 6166 04:24:09,880 --> 04:24:13,040 CAUSED BY HIGH BETA AMYLOID 6167 04:24:13,040 --> 04:24:14,800 PLAQUE BURDEN WITHOUT ALTERING 6168 04:24:14,800 --> 04:24:19,720 THE BRAIN BETA AMYLOID PLAQUE 6169 04:24:19,720 --> 04:24:22,000 LEVELS SUGGESTING DESPITE 6170 04:24:22,000 --> 04:24:23,760 CONTINUED EXPOSURE TO STRESSOR, 6171 04:24:23,760 --> 04:24:26,960 WITHOUT ALTERING THE HIGH LEVELS 6172 04:24:26,960 --> 04:24:27,800 OF THE STRESSOR, THE 6173 04:24:27,800 --> 04:24:30,480 INTERVENTION IN THIS CASE IS 6174 04:24:30,480 --> 04:24:32,960 ABLE TO REVERSE THE LEARNING 6175 04:24:32,960 --> 04:24:36,680 DEFICITS, REVERSE THE NEGATIVE 6176 04:24:36,680 --> 04:24:36,920 IMPACT. 6177 04:24:36,920 --> 04:24:39,800 THEN WE ASK OURSELVES, DOES THE 6178 04:24:39,800 --> 04:24:40,680 INTERVENTION HAVE MULTIPLE 6179 04:24:40,680 --> 04:24:42,880 DIVERSE EFFECTS WITHIN A SYSTEM 6180 04:24:42,880 --> 04:24:43,920 OR ACROSS MULTIPLE SYSTEMS. 6181 04:24:43,920 --> 04:24:46,560 WE SEE HERE THAT THE 6182 04:24:46,560 --> 04:24:48,280 INVESTIGATORS HAVE INDICATED 6183 04:24:48,280 --> 04:24:51,240 THAT THEIR STUDY WILL FOCUS ON 6184 04:24:51,240 --> 04:24:53,520 NEURONAL HEALTH AND COGNITION IN 6185 04:24:53,520 --> 04:24:56,280 GENERAL, AND THE STUDY DESIGN IS 6186 04:24:56,280 --> 04:24:59,160 NOT LIMITED TO THOSE IMPACTS OR 6187 04:24:59,160 --> 04:25:02,960 EFFECTS ASSOCIATED SOLELY WITH 6188 04:25:02,960 --> 04:25:04,680 THE BETA AMYLOID TOXICITY. 6189 04:25:04,680 --> 04:25:09,840 THEY ALSO HYPOTHESIZE THE BETA 6190 04:25:09,840 --> 04:25:18,040 AMYLOID MODULATING EFFECTS ARE 6191 04:25:18,040 --> 04:25:18,920 MEDIATED BY NON-TRITERPENE 6192 04:25:18,920 --> 04:25:23,360 COMPOUNDS RELEVANT TO NEURONAL 6193 04:25:23,360 --> 04:25:23,880 HEALTH. 6194 04:25:23,880 --> 04:25:26,760 I'VE WALKED YOU THROUGH ONE 6195 04:25:26,760 --> 04:25:27,000 EXAMPLE. 6196 04:25:27,000 --> 04:25:29,200 I'VE OFFERED A FEW QUESTIONS TO 6197 04:25:29,200 --> 04:25:31,560 CONSIDER WHEN REPORTING ON OR 6198 04:25:31,560 --> 04:25:32,360 DESIGNING YOUR NEXT RESILIENCE 6199 04:25:32,360 --> 04:25:36,080 STUDY BUT REALLY THE KEY TO 6200 04:25:36,080 --> 04:25:36,640 UTILIZING THE RESILIENCE 6201 04:25:36,640 --> 04:25:37,760 FRAMEWORK IS HAVING A CLEAR 6202 04:25:37,760 --> 04:25:38,600 UNDERSTANDING WHAT RESILIENCE IS 6203 04:25:38,600 --> 04:25:44,760 AND WHAT IT IS NOT. 6204 04:25:44,760 --> 04:25:46,400 RESILIENCE IS ABOUT STRENGTHEN 6205 04:25:46,400 --> 04:25:46,840 THE SYSTEM. 6206 04:25:46,840 --> 04:25:50,560 IT IS NOT ABOUT MITIGATING THE 6207 04:25:50,560 --> 04:25:50,960 RISK. 6208 04:25:50,960 --> 04:25:53,480 RESILIENCE IS ABOUT LEARNING OR 6209 04:25:53,480 --> 04:25:54,880 BUILDING RESPONSE DIVERSITY, IT 6210 04:25:54,880 --> 04:25:56,680 IS NOT ABOUT MAINTAINING PERFECT 6211 04:25:56,680 --> 04:25:59,560 CONTROL OF THE STRESSORS OR 6212 04:25:59,560 --> 04:26:02,600 SYSTEM FOR THAT MATTER. 6213 04:26:02,600 --> 04:26:03,880 RESILIENCE IS ABOUT 6214 04:26:03,880 --> 04:26:06,440 ACKNOWLEDGING SOME EXPOSURE TO 6215 04:26:06,440 --> 04:26:09,760 SOCIAL, ENVIRONMENTAL, AND 6216 04:26:09,760 --> 04:26:10,600 BIOLOGICAL STRESSORS ARE 6217 04:26:10,600 --> 04:26:11,200 EXPECTED. 6218 04:26:11,200 --> 04:26:14,000 IT MAY EVEN STRENGTHEN THE 6219 04:26:14,000 --> 04:26:14,440 SYSTEM. 6220 04:26:14,440 --> 04:26:20,240 RESILIENCE IS NOT ABOUT 6221 04:26:20,240 --> 04:26:22,280 AVOIDANCE OF ALL CHALLENGES. 6222 04:26:22,280 --> 04:26:24,080 WITH THAT I'D LIKE TO CLOSE BUT 6223 04:26:24,080 --> 04:26:26,680 IN CLOSING I'D LIKE TO FIRST 6224 04:26:26,680 --> 04:26:29,200 ACKNOWLEDGE A FEW OF THE 6225 04:26:29,200 --> 04:26:32,120 DETERMINED BRAVE INDIVIDUALS 6226 04:26:32,120 --> 04:26:33,560 WHOSE FULL DATE OF DELIBERATION, 6227 04:26:33,560 --> 04:26:36,000 ONE DAY BEFORE WE WERE IN 6228 04:26:36,000 --> 04:26:38,080 ISOLATION DUE A PANDEMIC, THOSE 6229 04:26:38,080 --> 04:26:40,440 DELIBERATIONS LED TO THE 6230 04:26:40,440 --> 04:26:47,920 DEVELOPMENT OF OUR RESILIENCE 6231 04:26:47,920 --> 04:26:49,840 DEFINITION AND CONCEPTUAL MODEL. 6232 04:26:49,840 --> 04:26:51,160 PLEASE SHARE YOUR FEEDBACK. 6233 04:26:51,160 --> 04:26:53,360 TELL US ABOUT YOUR NEXT 6234 04:26:53,360 --> 04:26:55,120 RESILIENCE STUDY DESIGN. 6235 04:26:55,120 --> 04:27:01,120 YOU CAN E-MAIL US AT TRANS-NIH 6236 04:27:01,120 --> 04:27:02,320 RESILIENCE PROGRAM@OD.NIH.GOV OR 6237 04:27:02,320 --> 04:27:04,520 IF YOU WOULD LIKE MORE 6238 04:27:04,520 --> 04:27:06,080 INFORMATION ABOUT SOME 6239 04:27:06,080 --> 04:27:08,520 ACTIVITIES OF THE TRANSNIH 6240 04:27:08,520 --> 04:27:10,560 WORKING GROUP REVIEW OUR WEB 6241 04:27:10,560 --> 04:27:12,360 PAGE ON THE ODS WEBSITE. 6242 04:27:12,360 --> 04:27:14,080 THANK YOU FOR YOUR INTEREST IN 6243 04:27:14,080 --> 04:27:17,040 OUR EFFORTS TO ADVANCE THE 6244 04:27:17,040 --> 04:27:17,760 SCIENCE OF RESILIENCE. 6245 04:27:17,760 --> 04:27:28,240 ENJOY THE REST OF YOUR DAY. 6246 04:27:31,320 --> 04:27:32,640 >> THANK YOU VERY MUCH, DR. 6247 04:27:32,640 --> 04:27:33,200 BROWN. 6248 04:27:33,200 --> 04:27:36,480 THAT WAS A WONDERFUL OVERVIEW OF 6249 04:27:36,480 --> 04:27:38,120 THE RESISTANCE PROGRAM. 6250 04:27:38,120 --> 04:27:41,640 AND WHILE WE'RE WAITING FOR SOME 6251 04:27:41,640 --> 04:27:45,720 QUESTIONS TO COME IN THE Q&A 6252 04:27:45,720 --> 04:27:53,040 BOX, LET ME ASK YOU, CAN A STUDY 6253 04:27:53,040 --> 04:27:56,760 THAT'S INITIALLY DESIGNED TO 6254 04:27:56,760 --> 04:27:58,040 LOOK AT PREVENTION ALSO 6255 04:27:58,040 --> 04:27:59,040 INCORPORATE RESILIENCE FEATURES 6256 04:27:59,040 --> 04:28:02,640 WITHIN IT? 6257 04:28:02,640 --> 04:28:04,360 SO COULD YOU LOOK AT BOTH SIDES 6258 04:28:04,360 --> 04:28:06,560 OF THE COIN IN THE SAME STUDY 6259 04:28:06,560 --> 04:28:09,200 DESIGN? 6260 04:28:09,200 --> 04:28:09,920 >> OF COURSE. 6261 04:28:09,920 --> 04:28:11,720 IN FACT I THINK IN SOME WAYS 6262 04:28:11,720 --> 04:28:14,840 THAT'S WHAT WE'RE HOPING FOR, 6263 04:28:14,840 --> 04:28:15,400 RIGHT? 6264 04:28:15,400 --> 04:28:16,360 WE'RE HOPING THAT THE STUDIES 6265 04:28:16,360 --> 04:28:19,560 THAT ARE OUT THERE NOW CAN 6266 04:28:19,560 --> 04:28:21,360 CONSIDER MULTIPLE PERSPECTIVES. 6267 04:28:21,360 --> 04:28:23,880 WE LOOK AT DATA THAT HAS BEEN 6268 04:28:23,880 --> 04:28:25,960 CONTRIBUTED TO THE STUDIES THAT 6269 04:28:25,960 --> 04:28:27,120 HAVE ALREADY BEEN CONDUCTED, 6270 04:28:27,120 --> 04:28:29,000 MAYBE WE GO BACK AND CONSIDER 6271 04:28:29,000 --> 04:28:31,240 THAT DATA WITH DIFFERENT 6272 04:28:31,240 --> 04:28:31,840 QUESTIONS. 6273 04:28:31,840 --> 04:28:33,000 MAYBE THOSE QUESTIONS WILL COME 6274 04:28:33,000 --> 04:28:36,560 FROM A DIFFERENT PERSPECTIVE OR 6275 04:28:36,560 --> 04:28:38,120 DIFFERENT LENS. 6276 04:28:38,120 --> 04:28:42,720 AND SO MOST DEFINITELY ANY STUDY 6277 04:28:42,720 --> 04:28:45,960 CAN BE VIEWED FROM WHICH EVER 6278 04:28:45,960 --> 04:28:47,000 PERSPECTIVE, RIGHT? 6279 04:28:47,000 --> 04:28:50,080 AND ALL WE'RE SUGGESTING IS THAT 6280 04:28:50,080 --> 04:28:52,960 DEPENDING UPON YOUR PERSPECTIVE 6281 04:28:52,960 --> 04:28:54,800 YOUR NEXT STEP OR HOW YOU DECIDE 6282 04:28:54,800 --> 04:28:59,200 TO TREAT A GROUP OF INDIVIDUALS 6283 04:28:59,200 --> 04:29:01,640 OR HOW YOU INTERPRETED DATA ARE 6284 04:29:01,640 --> 04:29:03,160 ALL DEPENDENT UPON THE LENS BY 6285 04:29:03,160 --> 04:29:06,440 WHICH YOU'RE LOOKING AT DATA. 6286 04:29:06,440 --> 04:29:11,040 SO, YOU KNOW, THERE'S NO WAY 6287 04:29:11,040 --> 04:29:12,920 THAT ONE PARTICULAR FRAMEWORK 6288 04:29:12,920 --> 04:29:14,840 SHOULD BE PREFERRED OR THAT WE 6289 04:29:14,840 --> 04:29:16,320 SHOULD EVEN STOP AT ONE 6290 04:29:16,320 --> 04:29:18,400 PARTICULAR FRAMEWORK WHEN WE'RE 6291 04:29:18,400 --> 04:29:20,600 LOOKING AT THESE STUDIES OR 6292 04:29:20,600 --> 04:29:21,160 DATA. 6293 04:29:21,160 --> 04:29:22,080 >> GREAT. 6294 04:29:22,080 --> 04:29:23,040 GREAT. 6295 04:29:23,040 --> 04:29:25,440 MAYBE YOU COULD GIVE US AN IDEA 6296 04:29:25,440 --> 04:29:28,400 OF THE LENS OF SOME OF THE OTHER 6297 04:29:28,400 --> 04:29:31,000 I.C.s THAT ARE PARTICIPATING 6298 04:29:31,000 --> 04:29:32,680 IN THE RESILIENCE PROGRAM. 6299 04:29:32,680 --> 04:29:34,160 FOR EXAMPLE, MAYBE THE INSTITUTE 6300 04:29:34,160 --> 04:29:35,760 OF AGING, DO THEY HAVE A LITTLE 6301 04:29:35,760 --> 04:29:38,480 BIT DIFFERENT LENS OF LOOKING AT 6302 04:29:38,480 --> 04:29:42,040 RESILIENCE THAN THE ODS MIGHT 6303 04:29:42,040 --> 04:29:43,040 HAVE? 6304 04:29:43,040 --> 04:29:45,520 >> IT'S INTERESTING THAT WITH 6305 04:29:45,520 --> 04:29:46,640 THAT QUESTION, I MIGHT ARGUE 6306 04:29:46,640 --> 04:29:49,160 YOU'RE COMING FROM A DIFFERENT 6307 04:29:49,160 --> 04:29:52,640 PERSPECTIVE F . 6308 04:29:52,640 --> 04:29:53,760 IF I LOOK FOR DIFFERENCES, I'M 6309 04:29:53,760 --> 04:29:54,720 GOING TO INDIAN FOO IT. 6310 04:29:54,720 --> 04:29:56,400 IF I LOOK FOR SIMILARITIES, I 6311 04:29:56,400 --> 04:29:58,160 CAN FIND THAT TOO. 6312 04:29:58,160 --> 04:29:59,320 TWO I NOTICE IS THAT THERE ARE 6313 04:29:59,320 --> 04:30:09,840 QUITE A BIT OF SIMILARITIES HOW 6314 04:30:11,640 --> 04:30:12,640 INSTITUTES AND CENTERS APPLY 6315 04:30:12,640 --> 04:30:13,760 RESILIENCE BUT OUTSIDE THE NIH 6316 04:30:13,760 --> 04:30:14,640 AS WELL. 6317 04:30:14,640 --> 04:30:17,240 WE'VE SEEN FROM ANOTHER GROUP I 6318 04:30:17,240 --> 04:30:23,680 WORK WITH, WE'VE SEEN HOW 6319 04:30:23,680 --> 04:30:24,680 SIMILARITIES ACROSS FEDERAL 6320 04:30:24,680 --> 04:30:26,480 AGENCIES, EVEN IF DO YOU A 6321 04:30:26,480 --> 04:30:27,880 GOOGLE SEARCH, HOW RESILIENCE IS 6322 04:30:27,880 --> 04:30:28,760 DEFINED IN GOOGLE, OF COURSE 6323 04:30:28,760 --> 04:30:31,160 YOU'RE GOING TO SEE SOME 6324 04:30:31,160 --> 04:30:34,000 DIFFERENCE IN THE TEXT BUT IF 6325 04:30:34,000 --> 04:30:37,720 YOU THINK ABOUT WHAT IT MEANS TO 6326 04:30:37,720 --> 04:30:39,560 MEASURE RESILIENCE GIVEN THOSE 6327 04:30:39,560 --> 04:30:41,000 DEFINITIONS AND WHAT THOSE 6328 04:30:41,000 --> 04:30:43,080 DEFINITIONS ARE TRYING TO 6329 04:30:43,080 --> 04:30:44,680 APPLIER THERE FAR MORE 6330 04:30:44,680 --> 04:30:45,640 SIMILARITIES THAN DIFFERENCES. 6331 04:30:45,640 --> 04:30:47,640 >> THAT'S GOOD TO KNOW. 6332 04:30:47,640 --> 04:30:50,720 WE HAVE A QUESTION IN THE BOX 6333 04:30:50,720 --> 04:30:51,120 HERE. 6334 04:30:51,120 --> 04:30:54,040 THERE'S AN INTEREST IN 6335 04:30:54,040 --> 04:30:55,120 OPTIMIZING HEALTH THROUGH 6336 04:30:55,120 --> 04:30:57,760 DIETARY SUPPLEMENTS WHAT ROLE 6337 04:30:57,760 --> 04:31:01,240 DOES RESILIENCY PLAY IN 6338 04:31:01,240 --> 04:31:01,840 OPTIMIZING HEALTH? 6339 04:31:01,840 --> 04:31:05,320 >> AGAIN, RESILIENCE IS A 6340 04:31:05,320 --> 04:31:05,600 FRAMEWORK. 6341 04:31:05,600 --> 04:31:06,600 UP TO THIS DATE I DON'T KNOW 6342 04:31:06,600 --> 04:31:09,880 WHAT YOU FEEL BUT I KNOW THAT 6343 04:31:09,880 --> 04:31:11,640 WHENEVER I LOOK AT SOME BENEFITS 6344 04:31:11,640 --> 04:31:13,800 OR TRY TO UNDERSTAND BENEFITS OR 6345 04:31:13,800 --> 04:31:15,960 RISK OF A DIETARY SUPPLEMENT, 6346 04:31:15,960 --> 04:31:17,720 THERE'S ALWAYS THIS LINE THAT 6347 04:31:17,720 --> 04:31:20,240 SAYS MORE INFORMATION IS NEEDED. 6348 04:31:20,240 --> 04:31:22,880 MORE STUDIES ARE NEEDED. 6349 04:31:22,880 --> 04:31:28,080 AND WHAT I SUGGEST, MAYBE WE'RE 6350 04:31:28,080 --> 04:31:29,720 JUST APPROACHING DIETARY 6351 04:31:29,720 --> 04:31:31,840 SUPPLEMENT OR STUDY OF DIETARY 6352 04:31:31,840 --> 04:31:33,560 SUPPLEMENTS, MAYBE WE CAN 6353 04:31:33,560 --> 04:31:35,160 CONSIDER APPROACHING FROM A 6354 04:31:35,160 --> 04:31:41,560 DIFFERENT LENS, MAYBE FROM A 6355 04:31:41,560 --> 04:31:43,320 RESILIENCE FRAMEWORK, MAYBE IF 6356 04:31:43,320 --> 04:31:49,760 WE CAN HAVE THE BALANCE OF 6357 04:31:49,760 --> 04:31:55,040 DISEASE PERSPECTIVE OR 6358 04:31:55,040 --> 04:31:57,440 PREVENTION PERSPECTIVE, MAYBE WE 6359 04:31:57,440 --> 04:31:58,560 CAN COMMENT DEFINITIVE RESULTS, 6360 04:31:58,560 --> 04:31:59,280 BETTER INTERPRETATIONS OF DATA 6361 04:31:59,280 --> 04:32:01,720 THAT COULD LEAD US TO UNDERSTAND 6362 04:32:01,720 --> 04:32:04,280 ARE THERE TRULY BENEFITS OF SOME 6363 04:32:04,280 --> 04:32:05,120 OF THESE DIETARY SUPPLEMENTS, SO 6364 04:32:05,120 --> 04:32:09,200 THE GOAL HERE IS NOT TO SUGGEST 6365 04:32:09,200 --> 04:32:15,000 THAT THIS ONE INTERVENTION IS 6366 04:32:15,000 --> 04:32:21,760 MORE RESILIENT OR ONE POPULATION 6367 04:32:21,760 --> 04:32:24,000 IS MORE RESILIENT BUT DEPENDING 6368 04:32:24,000 --> 04:32:25,440 UPON YOUR PERSPECTIVE, WHAT YOU 6369 04:32:25,440 --> 04:32:28,320 LOOK FOR, YOU'LL FIND. 6370 04:32:28,320 --> 04:32:30,440 IF YOU'RE LOOKING FOR 6371 04:32:30,440 --> 04:32:31,160 RESILIENCE, OR PROTECTIVE 6372 04:32:31,160 --> 04:32:34,320 FACTORS, YOU CAN FIND THEM, 6373 04:32:34,320 --> 04:32:35,480 RIGHT? 6374 04:32:35,480 --> 04:32:36,960 WHAT I SUGGEST IS LOOKING -- 6375 04:32:36,960 --> 04:32:40,480 WE'VE BEEN FOCUSING MORE OFTEN 6376 04:32:40,480 --> 04:32:42,720 THAN NOT ON THE RISK OR THE 6377 04:32:42,720 --> 04:32:43,920 DISEASE PATHWAYS, SO OF COURSE 6378 04:32:43,920 --> 04:32:46,440 THAT'S WHAT WE'VE BEEN FINDING. 6379 04:32:46,440 --> 04:32:49,680 >> AND I THINK WE CAN DO ONE 6380 04:32:49,680 --> 04:32:52,200 LAST QUESTION HERE. 6381 04:32:52,200 --> 04:32:54,200 CAN YOU PROVIDE SOME EXAMPLES OF 6382 04:32:54,200 --> 04:32:57,920 PHYSIOLOGICAL AND MENTAL 6383 04:32:57,920 --> 04:33:00,680 STRESSORS APPLIED TO A STUDY 6384 04:33:00,680 --> 04:33:05,120 DESIGN TO CAPTURE RESILIENCE? 6385 04:33:05,120 --> 04:33:05,680 >> SO, OKAY. 6386 04:33:05,680 --> 04:33:07,840 SO, WE THINK THE WAY WE APPROACH 6387 04:33:07,840 --> 04:33:11,240 IT, AGAIN, IS JUST A FRAMEWORK. 6388 04:33:11,240 --> 04:33:13,400 WE UNDERSTAND THAT WE ACCEPT THE 6389 04:33:13,400 --> 04:33:15,160 FACT AND ACKNOWLEDGE THE FACT 6390 04:33:15,160 --> 04:33:18,560 WE'RE ALWAYS EXPOSED TO 6391 04:33:18,560 --> 04:33:21,960 STRESSORS, RIGHT? 6392 04:33:21,960 --> 04:33:25,360 SO, MENTAL STRESSOR COULD BE -- 6393 04:33:25,360 --> 04:33:25,520 HMM. 6394 04:33:25,520 --> 04:33:27,560 THERE ARE SO MANY OF THEM. 6395 04:33:27,560 --> 04:33:33,560 I DON'T KNOW, IT COULD BE 6396 04:33:33,560 --> 04:33:33,920 (INDISCERNIBLE). 6397 04:33:33,920 --> 04:33:34,720 >> THANK YOU, BECKY. 6398 04:33:34,720 --> 04:33:37,200 YOU KNOW, YOU CAN COME UP WITH 6399 04:33:37,200 --> 04:33:41,880 ANY TYPE OF STRESSOR, YOU NAME 6400 04:33:41,880 --> 04:33:42,200 IT. 6401 04:33:42,200 --> 04:33:44,000 IF IT'S SOMETHING THAT DISRUPTS 6402 04:33:44,000 --> 04:33:45,640 THE SYSTEM OR DISTURBS THE 6403 04:33:45,640 --> 04:33:48,680 SYSTEM, THEN WE CAN CONSIDER IT 6404 04:33:48,680 --> 04:33:49,320 A STRESSOR. 6405 04:33:49,320 --> 04:33:52,160 IN FACT, EVEN IF IT DOESN'T 6406 04:33:52,160 --> 04:33:56,240 DISRUPT ONE SYSTEM BUT DOES 6407 04:33:56,240 --> 04:33:59,440 DISRUPT A SECOND SYSTEM, WE 6408 04:33:59,440 --> 04:34:02,160 COULD CONSIDER THAT A STRESSOR, 6409 04:34:02,160 --> 04:34:06,040 FROM ANY DOMAIN, FROM THE MENTAL 6410 04:34:06,040 --> 04:34:07,720 HEALTH DOMAIN, PHYSIOLOGIC 6411 04:34:07,720 --> 04:34:09,520 DOMAIN, AND IT'S ALL, AGAIN -- 6412 04:34:09,520 --> 04:34:14,120 LET ME TAKE, FOR EXAMPLE, THE 6413 04:34:14,120 --> 04:34:15,600 PHYSIOLOGIC DOMAIN. 6414 04:34:15,600 --> 04:34:20,120 I'VE SEEN FOR INSTANCE EXERCISE. 6415 04:34:20,120 --> 04:34:22,840 EXERCISE HAS BEEN APPLIED AS 6416 04:34:22,840 --> 04:34:26,280 BOTH A STRESSOR IN SOME OF THESE 6417 04:34:26,280 --> 04:34:29,160 RESILIENCE STUDIES AS WELL AS AN 6418 04:34:29,160 --> 04:34:32,560 INTERVENTION OR POTENTIAL 6419 04:34:32,560 --> 04:34:37,640 PROTECTIVE FACTOR. 6420 04:34:37,640 --> 04:34:39,640 BUT NONETHELESS WE STILL 6421 04:34:39,640 --> 04:34:40,280 CONSIDER THOSE THINGS RESILIENCE 6422 04:34:40,280 --> 04:34:41,920 STUDIES BECAUSE OF THE TYPE OF 6423 04:34:41,920 --> 04:34:43,120 QUESTIONS THEY WERE ASKING, AND 6424 04:34:43,120 --> 04:34:46,720 BECAUSE OF THE LENS BY WHICH 6425 04:34:46,720 --> 04:34:48,640 THEY APPROACH THE STUDY. 6426 04:34:48,640 --> 04:34:49,000 >> GREAT. 6427 04:34:49,000 --> 04:34:49,200 GREAT. 6428 04:34:49,200 --> 04:34:51,360 WELL, THANK YOU SO MUCH FOR YOUR 6429 04:34:51,360 --> 04:34:52,120 PRESENTATION TODAY. 6430 04:34:52,120 --> 04:34:53,680 I'M SURE IT GIVES EVERYBODY A 6431 04:34:53,680 --> 04:34:57,000 LOT OF FOOD FOR THOUGHT ON A NEW 6432 04:34:57,000 --> 04:34:57,560 PARADIGM. 6433 04:34:57,560 --> 04:35:00,720 AND THEY CAN CONTACT YOU WITH 6434 04:35:00,720 --> 04:35:02,280 YOUR INFORMATION. 6435 04:35:02,280 --> 04:35:02,800 >> GREAT. 6436 04:35:02,800 --> 04:35:06,720 THANK YOU, BECKY. 6437 04:35:06,720 --> 04:35:11,280 >> THANK YOU. 6438 04:35:11,280 --> 04:35:13,080 AND NOW OUR NEXT SPEAKER, OUR 6439 04:35:13,080 --> 04:35:16,920 LAST SPEAKER FOR THE SESSION 6440 04:35:16,920 --> 04:35:19,040 TODAY, DR. PATRICIA HAGGERTY. 6441 04:35:19,040 --> 04:35:20,880 SHE'S CURRENTLY THE DIRECTOR OF 6442 04:35:20,880 --> 04:35:23,520 GRANTS AND EXTRAMURAL ACTIVITIES 6443 04:35:23,520 --> 04:35:27,640 AT THE OFFICE OF DIETARY 6444 04:35:27,640 --> 04:35:29,840 SUPPLEMENTS, IN THIS CAPACITY 6445 04:35:29,840 --> 04:35:32,680 ENGAGES OTHER NIH INSTITUTES AND 6446 04:35:32,680 --> 04:35:34,560 CENTERS TO FACILITATE FUNDING OF 6447 04:35:34,560 --> 04:35:37,680 GRANTS OF HIGH RELEVANCE TO THE 6448 04:35:37,680 --> 04:35:38,320 ODS MISSION. 6449 04:35:38,320 --> 04:35:39,960 AND GOALS. 6450 04:35:39,960 --> 04:35:41,600 DR. HAGGERTY'S ACADEMIC TRAINING 6451 04:35:41,600 --> 04:35:43,560 IS IN HUMAN NUTRITION AND SHE 6452 04:35:43,560 --> 04:35:47,600 HAS WORKED AND TRAVELED 6453 04:35:47,600 --> 04:35:49,000 EXTENSIVELY GLOBAL NUTRITION 6454 04:35:49,000 --> 04:35:49,240 PROGRAMS. 6455 04:35:49,240 --> 04:35:51,600 I'M GOING TO TURN THE FLOOR OVER 6456 04:35:51,600 --> 04:35:54,280 TO DR. HAGGERTY NOW. 6457 04:35:54,280 --> 04:35:56,080 >> THANK YOU, BECKY. 6458 04:35:56,080 --> 04:36:00,680 CAN YOU HEAR ME ALL RIGHT? 6459 04:36:00,680 --> 04:36:01,440 6460 04:36:01,440 --> 04:36:02,040 >> OKAY. 6461 04:36:02,040 --> 04:36:03,280 >> YES, CAN YOU HEAR ME? 6462 04:36:03,280 --> 04:36:06,280 >> YES, WE CAN HEAR YOU. 6463 04:36:06,280 --> 04:36:07,760 >> OKAY, GREAT. 6464 04:36:07,760 --> 04:36:10,040 >> YEAH, VERY CLEAR. 6465 04:36:10,040 --> 04:36:20,520 >> I'LL SHARE MY SCREEN. 6466 04:36:20,960 --> 04:36:21,080 OKAY. 6467 04:36:21,080 --> 04:36:26,280 I'M GOING TO -- 6468 04:36:26,280 --> 04:36:26,480 OKAY. 6469 04:36:26,480 --> 04:36:28,400 CAN YOU SEE FULL SCREEN 6470 04:36:28,400 --> 04:36:29,440 PRESENTATION MODE? 6471 04:36:29,440 --> 04:36:32,520 >> THAT LOOKS GREAT. 6472 04:36:32,520 --> 04:36:32,920 >> OKAY, GREAT. 6473 04:36:32,920 --> 04:36:33,880 THANK YOU. 6474 04:36:33,880 --> 04:36:35,320 GOOD AFTERNOON, EVERYONE. 6475 04:36:35,320 --> 04:36:37,360 I'M VERY HAPPY TO BE HERE. 6476 04:36:37,360 --> 04:36:38,760 THIS IS THE FUN PART. 6477 04:36:38,760 --> 04:36:43,320 THIS IS WHAT YOU ALL HAVE BEEN 6478 04:36:43,320 --> 04:36:44,080 WAITING FOR. 6479 04:36:44,080 --> 04:36:45,400 NUTS AND BOLTS OF WHAT NEEDS TO 6480 04:36:45,400 --> 04:36:49,120 BE DONE, WHAT YOU NEED TO KNOW, 6481 04:36:49,120 --> 04:36:52,560 HOW YOU DO IT, TO GET FUNDED 6482 04:36:52,560 --> 04:36:55,240 THROUGH THE NIH EXTRAMURAL 6483 04:36:55,240 --> 04:37:00,680 RESEARCH SYSTEM. 6484 04:37:00,680 --> 04:37:02,160 I HOPE YOU STAY AWAKE FOR THIS 6485 04:37:02,160 --> 04:37:05,080 ONE BECAUSE THIS HAS A LOT OF 6486 04:37:05,080 --> 04:37:06,440 GOOD INFORMATION FOR YOU. 6487 04:37:06,440 --> 04:37:12,000 I DO WANT TO FIRST OF ALL SAY 6488 04:37:12,000 --> 04:37:14,120 THAT IN DISCLOSURE THIS 6489 04:37:14,120 --> 04:37:16,040 PRESENTATION HAS BEEN GIVEN IN 6490 04:37:16,040 --> 04:37:23,600 PREVIOUS YEARS BY MY GOOD FRIEND 6491 04:37:23,600 --> 04:37:27,760 AND COLLEAGUE, DR. ( 6492 04:37:27,760 --> 04:37:29,800 INDISCERNIBLE) STILL WITH THE 6493 04:37:29,800 --> 04:37:31,400 ODS, RETIRED CONTRACTOR, MOST OF 6494 04:37:31,400 --> 04:37:33,200 THIS IS IS FROM HER 6495 04:37:33,200 --> 04:37:33,680 PRESENTATION. 6496 04:37:33,680 --> 04:37:36,440 I'M NOT GOING TO GIVE IT WITH 6497 04:37:36,440 --> 04:37:40,840 THE SAME WIT AND CHARM BUT 6498 04:37:40,840 --> 04:37:42,920 HOPEFULLY I CAN REMAIN TRUE TO 6499 04:37:42,920 --> 04:37:44,360 THE CONTENT. 6500 04:37:44,360 --> 04:37:46,720 THE PRESENTATION IS GOING TO 6501 04:37:46,720 --> 04:37:48,120 LOOK AT THE EXTRAMURAL SYSTEM AT 6502 04:37:48,120 --> 04:37:50,200 NIH, I'M GOING TO TALK ABOUT 6503 04:37:50,200 --> 04:37:54,360 THAT AND THE TOPICS FALL INTO 6504 04:37:54,360 --> 04:37:56,120 THREE MAIN BUCKETS. 6505 04:37:56,120 --> 04:38:00,080 FIRST, AN OVERVIEW OF THE NIH 6506 04:38:00,080 --> 04:38:01,440 AGENCY. 6507 04:38:01,440 --> 04:38:06,000 THEN WE'LL TALK ABOUT THE 6508 04:38:06,000 --> 04:38:06,560 SUPPORT OF NUTRITION 6509 04:38:06,560 --> 04:38:07,600 [AUDIO DISTORTION] 6510 04:38:07,600 --> 04:38:09,960 AND THEN FINALLY ABOUT HOW YOU 6511 04:38:09,960 --> 04:38:13,120 AS A RESEARCHER ARE LIKELY TO BE 6512 04:38:13,120 --> 04:38:20,560 INTERACTING WITH THE NIH 6513 04:38:20,560 --> 04:38:22,360 EXTRAMURAL SYSTEM. 6514 04:38:22,360 --> 04:38:25,160 SO, WHERE DOES THE NIH FIT IN 6515 04:38:25,160 --> 04:38:28,400 THE ENTIRE FEDERAL GOVERNMENT 6516 04:38:28,400 --> 04:38:28,640 SYSTEM? 6517 04:38:28,640 --> 04:38:30,000 ABBY WOULD SAY THIS IS YOUR 6518 04:38:30,000 --> 04:38:33,000 LESSON IN CIVICS. 6519 04:38:33,000 --> 04:38:34,880 THE NIH IS -- I'LL TURN MY LASER 6520 04:38:34,880 --> 04:38:35,440 ON HERE. 6521 04:38:35,440 --> 04:38:40,640 THE NIH IN THE MIDDLE IS A 6522 04:38:40,640 --> 04:38:41,960 SUBAGENCY OF THE DEPARTMENT OF 6523 04:38:41,960 --> 04:38:44,560 HEALTH AND HUMAN SERVICES, OR 6524 04:38:44,560 --> 04:38:44,920 DHHS. 6525 04:38:44,920 --> 04:38:47,120 WE ALL WORK UNDER THE AUTHORITY 6526 04:38:47,120 --> 04:38:51,560 OF THE PUBLIC HEALTH SERVICES 6527 04:38:51,560 --> 04:38:51,840 ACT. 6528 04:38:51,840 --> 04:38:54,840 AND THE JARGON TECHNICALLY IS 6529 04:38:54,840 --> 04:38:56,360 DHHS IS THE DEPARTMENT AND NIH 6530 04:38:56,360 --> 04:39:02,000 IS ONE OF THE AGENCIES IN THE 6531 04:39:02,000 --> 04:39:02,280 DEPARTMENT. 6532 04:39:02,280 --> 04:39:05,440 WITHIN THE DEPARTMENT WE HAVE 6533 04:39:05,440 --> 04:39:08,680 SISTER AGENCIES THAT YOU 6534 04:39:08,680 --> 04:39:10,640 CERTAINLY HEARD ABOUT, 6535 04:39:10,640 --> 04:39:11,160 ESPECIALLY THE CENTERS FOR 6536 04:39:11,160 --> 04:39:13,280 DISEASE CONTROL AND PREVENTION, 6537 04:39:13,280 --> 04:39:14,280 AND FOOD AND DRUG 6538 04:39:14,280 --> 04:39:14,680 ADMINISTRATION. 6539 04:39:14,680 --> 04:39:16,480 THERE ARE A NUMBER OF OTHER 6540 04:39:16,480 --> 04:39:17,720 AGENCIES WITHIN THE DEPARTMENT, 6541 04:39:17,720 --> 04:39:20,040 MOST OF THEM SOMEWHAT SMALLER. 6542 04:39:20,040 --> 04:39:22,720 BUT WE WORK CLOSELY WITH ALL OF 6543 04:39:22,720 --> 04:39:27,560 THESE OTHER AGENCIES, EACH ONE 6544 04:39:27,560 --> 04:39:28,560 HAS A SPECIALTY. 6545 04:39:28,560 --> 04:39:31,720 WE TRY TO AVOID OVERLAP AS WELL 6546 04:39:31,720 --> 04:39:34,680 AS COORDINATE PROGRAMS, AND 6547 04:39:34,680 --> 04:39:36,240 BASICALLY WE AIM FOR EFFICIENCY 6548 04:39:36,240 --> 04:39:40,200 AND GOOD STEWARDSHIP OF THE 6549 04:39:40,200 --> 04:39:40,840 PUBLIC'S DOLLAR. 6550 04:39:40,840 --> 04:39:43,640 SO A LITTLE BIT AT HIGH LEVEL 6551 04:39:43,640 --> 04:39:46,120 ABOUT THE NATIONAL INSTITUTES OF 6552 04:39:46,120 --> 04:39:47,680 HEALTH, OR NIH. 6553 04:39:47,680 --> 04:39:52,360 THE NIH HAS AN ARRAY OF 6554 04:39:52,360 --> 04:39:52,760 ACTIVITIES. 6555 04:39:52,760 --> 04:39:55,720 I'LL TALK A LOT ABOUT JARGON 6556 04:39:55,720 --> 04:39:55,960 TODAY. 6557 04:39:55,960 --> 04:39:56,880 HOPEFULLY SOME WILL BECOME 6558 04:39:56,880 --> 04:40:00,520 CLEARER TO YOU BY THE END OF 6559 04:40:00,520 --> 04:40:01,920 THIS PRESENTATION. 6560 04:40:01,920 --> 04:40:05,280 SO, NIH HAS A MAIN CAMPUS, MUCH 6561 04:40:05,280 --> 04:40:09,800 LIKE A UNIVERSITY CAMPUS OR 6562 04:40:09,800 --> 04:40:12,120 ACADEMIC RESEARCH CENTER CAMPUS 6563 04:40:12,120 --> 04:40:13,920 WITH LABORATORIES, AND CLINICAL 6564 04:40:13,920 --> 04:40:15,400 RESEARCH CENTER. 6565 04:40:15,400 --> 04:40:18,880 THE CLINICAL RESEARCH CENTER IS 6566 04:40:18,880 --> 04:40:21,000 ALSO THE NIH HOSPITAL, WHICH IS 6567 04:40:21,000 --> 04:40:22,000 PROBABLY THE BIGGEST BUILDING 6568 04:40:22,000 --> 04:40:24,640 I'VE EVER SEEN IN MY LIFE. 6569 04:40:24,640 --> 04:40:29,040 IT IS HUGE, BUT IT'S ALSO 6570 04:40:29,040 --> 04:40:29,720 RENOWNED. 6571 04:40:29,720 --> 04:40:32,400 THE NIH HAS SEVERAL SATELLITE 6572 04:40:32,400 --> 04:40:34,320 CENTERS, BOTH HERE IN THE D.C. 6573 04:40:34,320 --> 04:40:41,840 AREA AS WELL AS ELSEWHERE IN THE 6574 04:40:41,840 --> 04:40:42,000 U.S. 6575 04:40:42,000 --> 04:40:44,880 NIH CONDUCTS RESEARCH IN ITS OWN 6576 04:40:44,880 --> 04:40:48,960 LABORATORIES, AND THIS IS CALLED 6577 04:40:48,960 --> 04:40:49,800 INTRAMURAL PROGRAM. 6578 04:40:49,800 --> 04:40:54,640 INTRAMURAL FOR WITHIN THE WALLS. 6579 04:40:54,640 --> 04:40:56,480 NIH ALSO SUPPORTS RESEARCH 6580 04:40:56,480 --> 04:40:57,960 CONDUCTED BY NON-FEDERAL 6581 04:40:57,960 --> 04:41:01,400 SCIENTISTS AT ACADEMIC RESEARCH 6582 04:41:01,400 --> 04:41:03,120 INSTITUTIONS, RESEARCH 6583 04:41:03,120 --> 04:41:04,080 HOSPITALS, INDEPENDENT RESEARCH 6584 04:41:04,080 --> 04:41:04,560 ORGANIZATIONS. 6585 04:41:04,560 --> 04:41:06,720 AND THIS IS CALLED THE 6586 04:41:06,720 --> 04:41:10,640 EXTRAMURAL PROGRAM, OR OUTSIDE 6587 04:41:10,640 --> 04:41:11,600 THE WALLS. 6588 04:41:11,600 --> 04:41:14,120 NIH SUPPORTS TRAINING OF 6589 04:41:14,120 --> 04:41:15,920 RESEARCHERS, EITHER DIRECTLY, 6590 04:41:15,920 --> 04:41:16,960 THROUGH TRAINING PROGRAMS, SUCH 6591 04:41:16,960 --> 04:41:19,640 AS WHAT WE'RE DOING RIGHT NOW, 6592 04:41:19,640 --> 04:41:21,680 SABBATICALS, AND OTHER TRAINING 6593 04:41:21,680 --> 04:41:24,000 PROGRAMS ON CAMPUS, AS WELL AS 6594 04:41:24,000 --> 04:41:26,840 INDIRECTLY THROUGH THE SUPPORT 6595 04:41:26,840 --> 04:41:29,480 OF TRAINING GRANTS. 6596 04:41:29,480 --> 04:41:31,040 NIH ALSO FOSTERS COMMUNICATION 6597 04:41:31,040 --> 04:41:33,680 OF HEALTH INFORMATION AND 6598 04:41:33,680 --> 04:41:36,360 RESEARCH FINDINGS TO THE PUBLIC. 6599 04:41:36,360 --> 04:41:40,400 IT DEVELOPS SCIENCE BASE FOR 6600 04:41:40,400 --> 04:41:41,160 TRANSLATING BASIC RESEARCH, 6601 04:41:41,160 --> 04:41:43,080 BASIC SCIENCE RESEARCH FINDINGS 6602 04:41:43,080 --> 04:41:45,480 INTO CLINICAL GUIDELINES AND 6603 04:41:45,480 --> 04:41:47,600 COMMUNITY PROGRAMS. 6604 04:41:47,600 --> 04:41:49,920 AS FOR THE BUDGET, HOW MANY OF 6605 04:41:49,920 --> 04:41:53,240 YOU KNOW WHAT THE CURRENT NIH 6606 04:41:53,240 --> 04:41:53,880 BUDGET IS? 6607 04:41:53,880 --> 04:41:54,640 WRITE IT DOWN. 6608 04:41:54,640 --> 04:41:56,320 I'M GOING TO TELL YOU. 6609 04:41:56,320 --> 04:41:57,080 IT'S AN HONOR SYSTEM. 6610 04:41:57,080 --> 04:42:02,200 SEE IF YOU GET IT RIGHT. 6611 04:42:02,200 --> 04:42:06,080 FISCAL YEAR 2022, CONGRESS 6612 04:42:06,080 --> 04:42:10,560 INCREASED NIH'S BASE BY $2,000, 6613 04:42:10,560 --> 04:42:12,680 $2 BILLION -- $2 BILLION, 6614 04:42:12,680 --> 04:42:16,320 RECURRENT BUDGET IS $45 BILLION, 6615 04:42:16,320 --> 04:42:18,720 BILLION WITH A B, A LOT OF 6616 04:42:18,720 --> 04:42:18,920 MONEY. 6617 04:42:18,920 --> 04:42:20,480 THE AGENCY THAT CONGRESS ALMOST 6618 04:42:20,480 --> 04:42:22,160 ALWAYS LIKES, BOTH SIDES OF THE 6619 04:42:22,160 --> 04:42:24,520 AISLE, SO WE'RE FORTUNATE TO BE 6620 04:42:24,520 --> 04:42:26,480 IN THAT POSITION. 6621 04:42:26,480 --> 04:42:29,840 ABOUT 10% OF THE BUDGET COVERS 6622 04:42:29,840 --> 04:42:32,320 OVERHEAD, INCLUDES MAINTENANCE 6623 04:42:32,320 --> 04:42:33,800 OF THE BUILDINGS, FACILITIES, 6624 04:42:33,800 --> 04:42:36,840 PAYS SALARIES OF THE EMPLOYEES 6625 04:42:36,840 --> 04:42:39,520 THAT WORK WITHIN, PROVIDES OUR 6626 04:42:39,520 --> 04:42:42,000 SUPPLIES AND MATERIALS AND SO 6627 04:42:42,000 --> 04:42:42,240 ON. 6628 04:42:42,240 --> 04:42:45,200 BUT 10% OF IT COVERS THE 6629 04:42:45,200 --> 04:42:46,320 INTRAMURAL PROGRAM, RESEARCH 6630 04:42:46,320 --> 04:42:49,040 DONE BY THE INTRAMURAL 6631 04:42:49,040 --> 04:42:49,360 SCIENTISTS. 6632 04:42:49,360 --> 04:42:52,320 AND BELIEVE IT OR NOT 80% OR 6633 04:42:52,320 --> 04:42:55,600 MORE OF THE BUDGET ACTUALLY GOES 6634 04:42:55,600 --> 04:42:57,040 OUT THE DOOR. 6635 04:42:57,040 --> 04:43:01,000 THEN 80% OF THE BUDGET IS USED 6636 04:43:01,000 --> 04:43:03,840 TO SUPPORT BIOMEDICAL RESEARCH 6637 04:43:03,840 --> 04:43:05,880 CONDUCTED OUTSIDE OF THE NIH, IN 6638 04:43:05,880 --> 04:43:07,640 THOSE ACADEMIC RESEARCH CENTERS, 6639 04:43:07,640 --> 04:43:13,920 HOSPITALS, AND INDEPENDENT 6640 04:43:13,920 --> 04:43:14,920 RESEARCH ORGANIZATIONS. 6641 04:43:14,920 --> 04:43:18,880 NOW, AT THE NIH, IT'S A VERY BIG 6642 04:43:18,880 --> 04:43:23,000 PLACE, THERE ARE FIRST OF ALL 6643 04:43:23,000 --> 04:43:24,120 THE URL HERE WILL GIVE YOU THE 6644 04:43:24,120 --> 04:43:27,640 LIST OF ALL OF THE INSTITUTES 6645 04:43:27,640 --> 04:43:31,440 AND CENTERS THAT COMPRISE THE 6646 04:43:31,440 --> 04:43:32,680 NIH. 6647 04:43:32,680 --> 04:43:34,560 THERE ARE 28 INSTITUTES, 6648 04:43:34,560 --> 04:43:38,840 CENTERS, AND OFFICES. 6649 04:43:38,840 --> 04:43:40,040 JARGON ALERT, INSTITUTES AND 6650 04:43:40,040 --> 04:43:42,000 CENTERS WE OFTEN CALL I.C.s. 6651 04:43:42,000 --> 04:43:47,560 YOU HEAR THE TERM I.C.s. 6652 04:43:47,560 --> 04:43:48,880 WE'RE TALKING ABOUT INSTITUTES 6653 04:43:48,880 --> 04:43:49,880 AND CENTERS. 6654 04:43:49,880 --> 04:43:51,040 WE HAVE OFFICES WHICH I'LL 6655 04:43:51,040 --> 04:43:51,920 DESCRIBE LATER. 6656 04:43:51,920 --> 04:43:55,760 SOMETIMES WE SAY I.C.Os, WE'RE 6657 04:43:55,760 --> 04:43:57,200 TALKING ABOUT INSTITUTE CENTERS 6658 04:43:57,200 --> 04:43:59,120 AND OFFICES. 6659 04:43:59,120 --> 04:44:01,560 THERE ARE THREE SERVICE UNITS 6660 04:44:01,560 --> 04:44:02,240 INCLUDING THE CLINICAL CENTER, 6661 04:44:02,240 --> 04:44:05,040 THAT IS THE HOSPITAL I 6662 04:44:05,040 --> 04:44:05,800 MENTIONED. 6663 04:44:05,800 --> 04:44:06,920 THE CENTER FOR INFORMATION 6664 04:44:06,920 --> 04:44:12,560 TECHNOLOGY, THEY TAKE CARE OF 6665 04:44:12,560 --> 04:44:15,480 ALL COMPUTER, DIGITAL, DATABASE 6666 04:44:15,480 --> 04:44:22,920 NEEDS, AS WELL AS PRIVACY AND SO 6667 04:44:22,920 --> 04:44:24,320 ON AND SECURITY. 6668 04:44:24,320 --> 04:44:27,400 CENTER FOR SCIENTIFIC REVIEW OR 6669 04:44:27,400 --> 04:44:30,680 CSR, AND THAT CENTER IS 6670 04:44:30,680 --> 04:44:33,320 RESPONSIBLE FOR CONDUCTING THE 6671 04:44:33,320 --> 04:44:34,760 MAJORITY OF THE PEER REVIEW 6672 04:44:34,760 --> 04:44:38,520 MEETINGS FOR THE GRANT 6673 04:44:38,520 --> 04:44:39,640 APPLICATIONS. 6674 04:44:39,640 --> 04:44:43,480 WE HAVE WITHIN THE NIH OFFICE OF 6675 04:44:43,480 --> 04:44:50,880 THE DIRECTOR THERE ARE A NUMBER 6676 04:44:50,880 --> 04:44:51,720 OF NUTRITION-RELEVANT OFFICES. 6677 04:44:51,720 --> 04:44:56,120 THE NIH OFFICE OF DIRECTOR HAS 6678 04:44:56,120 --> 04:44:57,400 A HUGE BUNCH OF OFFICES. 6679 04:44:57,400 --> 04:45:01,880 MOST OF THEM ARE UNDER AN 6680 04:45:01,880 --> 04:45:04,360 UMBRELLA DIVISION CALLED DPCPSI, 6681 04:45:04,360 --> 04:45:06,320 AND THAT STANDS FOR DIVISION OF 6682 04:45:06,320 --> 04:45:07,040 PROGRAM COORDINATION PLANNING 6683 04:45:07,040 --> 04:45:10,040 AND STRATEGIC INITIATIVE. 6684 04:45:10,040 --> 04:45:11,040 I KNEW THAT. 6685 04:45:11,040 --> 04:45:13,200 WITHIN THE UMBRELLA OF DPCPSI, 6686 04:45:13,200 --> 04:45:16,560 THERE ARE ABOUT 12 OR 13 6687 04:45:16,560 --> 04:45:18,200 OFFICES, AND ONES ON THE SLIDE 6688 04:45:18,200 --> 04:45:20,840 I'VE LISTED ARE THE ONES THAT 6689 04:45:20,840 --> 04:45:25,720 HAVE SOME RELEVANCE OR OVERLAP 6690 04:45:25,720 --> 04:45:31,160 OR INTEGRATION WITH NUTRITION 6691 04:45:31,160 --> 04:45:35,600 AND DIETARY SUPPLEMENT RESEARCH. 6692 04:45:35,600 --> 04:45:36,360 6693 04:45:36,360 --> 04:45:39,800 I ALSO SHOULD MENTION THAT THEY 6694 04:45:39,800 --> 04:45:44,200 TEND TO HAVE SPECIALTY AREAS OR 6695 04:45:44,200 --> 04:45:45,560 TRANS-NIH FUNCTIONS OR OTHER 6696 04:45:45,560 --> 04:45:46,840 NICHE KINDS OF FUNCTIONS, I WILL 6697 04:45:46,840 --> 04:45:50,600 COME BACK TO SOME OF THOSE 6698 04:45:50,600 --> 04:45:52,920 LATER. 6699 04:45:52,920 --> 04:45:55,320 SO LET'S START WITH INFORMATION 6700 04:45:55,320 --> 04:45:58,880 ABOUT THE NIH OFFICE OF 6701 04:45:58,880 --> 04:46:00,000 NUTRITION RESEARCH, ONR. 6702 04:46:00,000 --> 04:46:00,840 AGAIN, THE WEBSITE OF THIS 6703 04:46:00,840 --> 04:46:05,480 OFFICE IS AT THE TOP OF THE 6704 04:46:05,480 --> 04:46:05,680 SLIDE. 6705 04:46:05,680 --> 04:46:07,240 I HAVE TAKEN SOME OF THE 6706 04:46:07,240 --> 04:46:08,960 LANGUAGE DIRECTLY FROM THEIR 6707 04:46:08,960 --> 04:46:10,960 WEBSITE AS WELL AS ON THE 6708 04:46:10,960 --> 04:46:13,080 PICTURES, BECAUSE THEY DESCRIBE 6709 04:46:13,080 --> 04:46:15,320 THE OFFICEES THE B 6710 04:46:15,320 --> 04:46:16,680 PRIMARILY, THE OFFICE OF 6711 04:46:16,680 --> 04:46:21,000 NUTRITION RESEARCH HAS A 6712 04:46:21,000 --> 04:46:22,840 COORDINATION FUNCTION. 6713 04:46:22,840 --> 04:46:26,280 SO, THE OFFICE COORDINATES 6714 04:46:26,280 --> 04:46:28,080 NUTRITION RESEARCH NOT ONLY 6715 04:46:28,080 --> 04:46:32,600 ACROSS THE NIH ICOS BUT ALSO 6716 04:46:32,600 --> 04:46:34,720 ACROSS OTHER HHS AGENCIES, 6717 04:46:34,720 --> 04:46:37,600 INCLUDING THE FDA AND CDC, AND 6718 04:46:37,600 --> 04:46:41,120 EVEN OTHER DEPARTMENTS SUCH AS 6719 04:46:41,120 --> 04:46:43,080 DEFENSE AND AGRICULTURE. 6720 04:46:43,080 --> 04:46:45,920 I WOULD SAY THAT PROBABLY THE 6721 04:46:45,920 --> 04:46:49,840 BIGGEST, THE MOST PRIMARY ROLE, 6722 04:46:49,840 --> 04:46:53,280 IS THE IMPLEMENTATION, 6723 04:46:53,280 --> 04:46:55,560 COORDINATION AND IMPLEMENTATION, 6724 04:46:55,560 --> 04:46:59,720 OF THE STRATEGIC PLAN FOR NIH 6725 04:46:59,720 --> 04:47:01,840 NUTRITION RESEARCH. 6726 04:47:01,840 --> 04:47:04,520 I BELIEVE THAT THE DEVELOPMENT 6727 04:47:04,520 --> 04:47:08,840 OF THE STRATEGIC PLAN IS A GREAT 6728 04:47:08,840 --> 04:47:09,840 ACCOMPLISHMENT OF THIS OFFICE 6729 04:47:09,840 --> 04:47:11,960 BECAUSE NIH HAS NEVER HAD A 6730 04:47:11,960 --> 04:47:15,280 STRATEGIC PLAN FOR NUTRITION 6731 04:47:15,280 --> 04:47:15,960 RESEARCH BEFORE. 6732 04:47:15,960 --> 04:47:18,400 SO, IT IS A WONDERFUL 6733 04:47:18,400 --> 04:47:20,000 ACCOMPLISHMENT AND WE ARE 6734 04:47:20,000 --> 04:47:20,880 FOLLOWING THAT STRATEGIC PLAN 6735 04:47:20,880 --> 04:47:26,920 NOW TO THE BEST OF OUR ABILITY. 6736 04:47:26,920 --> 04:47:28,040 ONR ALSO IDENTIFIES RESEARCH 6737 04:47:28,040 --> 04:47:29,160 PROJECTS THAT DESERVE EXPANDED 6738 04:47:29,160 --> 04:47:39,720 EFFORT AND SUPPORT BY THE ICOS. 6739 04:47:40,200 --> 04:47:40,720 DEVELOPS, LEADS, MANAGES 6740 04:47:40,720 --> 04:47:41,480 TRANS-NIH NUTRITION PROJECTS 6741 04:47:41,480 --> 04:47:45,720 WITH THE ICOS. 6742 04:47:45,720 --> 04:47:47,880 YOU'VE HEARD OF THE DEVELOPMENT 6743 04:47:47,880 --> 04:47:52,480 OF THE NUTRITION FOR PRECISION 6744 04:47:52,480 --> 04:47:53,680 HEALTH INITIATIVE. 6745 04:47:53,680 --> 04:47:55,600 NOW THAT IS MANAGED BY THE 6746 04:47:55,600 --> 04:47:56,760 OFFICE OF THE COMMON FUND, 6747 04:47:56,760 --> 04:47:59,160 THERE'S ALSO INTEGRATED INTO THE 6748 04:47:59,160 --> 04:48:02,080 NIH "ALL OF US" RESEARCH 6749 04:48:02,080 --> 04:48:02,680 PROGRAM. 6750 04:48:02,680 --> 04:48:04,200 BUT THE DEVELOP RELATIVE 6751 04:48:04,200 --> 04:48:07,480 HUMIDITY OF THE NUTRITION 6752 04:48:07,480 --> 04:48:08,560 PRECISION HEALTH WAS INDEED 6753 04:48:08,560 --> 04:48:12,120 ORIGINATED FROM THE OFFICE OF 6754 04:48:12,120 --> 04:48:13,360 NUTRITION RESEARCH. 6755 04:48:13,360 --> 04:48:16,280 THE OFFICE ALSO REPRESENTS THE 6756 04:48:16,280 --> 04:48:17,560 NIH ACROSS THE FEDERAL 6757 04:48:17,560 --> 04:48:18,400 GOVERNMENT, ON COMMITTEES 6758 04:48:18,400 --> 04:48:22,000 RELEVANT TO NUTRITION AND 6759 04:48:22,000 --> 04:48:24,160 NUTRITION RESEARCH, LAST BUT NOT 6760 04:48:24,160 --> 04:48:25,600 LEAST ADVISES THE NIH LEADERSHIP 6761 04:48:25,600 --> 04:48:33,040 AND OTHER KEY OFFICIALS ON 6762 04:48:33,040 --> 04:48:33,640 NUTRITION-RELATED MATTERS. 6763 04:48:33,640 --> 04:48:37,480 I WANT TO SHOW YOU A LITTLE BIT 6764 04:48:37,480 --> 04:48:42,360 OF DATA ABOUT THE NIH NUTRITION 6765 04:48:42,360 --> 04:48:43,280 RESEARCH PORTFOLIO. 6766 04:48:43,280 --> 04:48:47,640 THE GRAPH HERE, TWO GRAPHS HERE, 6767 04:48:47,640 --> 04:48:50,680 REPRESENT THE NIH NUTRITION 6768 04:48:50,680 --> 04:48:55,400 RESEARCH PORTFOLIO FROM FISCAL 6769 04:48:55,400 --> 04:48:56,800 YEAR 2008 THROUGH 2020. 6770 04:48:56,800 --> 04:49:01,440 THIS ANALYSIS WAS DONE BY THE 6771 04:49:01,440 --> 04:49:04,040 OFFICE OF PORTFOLIO ANALYSES. 6772 04:49:04,040 --> 04:49:08,240 ON THE LEFT YOU SEE IT SHOWS ON 6773 04:49:08,240 --> 04:49:11,280 THE HORIZONTAL AXIS ALL OF THE 6774 04:49:11,280 --> 04:49:14,000 NIH ICOS, AND ON THE VERTICAL 6775 04:49:14,000 --> 04:49:18,360 AXIS IS THE AMOUNT OF DOLLARS 6776 04:49:18,360 --> 04:49:22,000 INVESTED IN BILLIONS, THAT'S THE 6777 04:49:22,000 --> 04:49:23,520 INVESTMENT IN NUTRITION 6778 04:49:23,520 --> 04:49:24,400 RESEARCH, SPECIFICALLY IN TYPE I 6779 04:49:24,400 --> 04:49:25,160 AND TYPE II AWARDS. 6780 04:49:25,160 --> 04:49:27,880 I WILL GET INTO THOSE 6781 04:49:27,880 --> 04:49:28,960 DEFINITIONS LATER BUT BASICALLY 6782 04:49:28,960 --> 04:49:33,320 FOR NOW THOSE ARE NEW AND 6783 04:49:33,320 --> 04:49:36,440 RENEWAL RESEARCH PROJECTS, AND 6784 04:49:36,440 --> 04:49:39,120 THIS IS THE LEVEL OF -- SHOWS 6785 04:49:39,120 --> 04:49:44,760 INVESTMENT LEVEL OF ALL OF THE 6786 04:49:44,760 --> 04:49:44,960 ICOS. 6787 04:49:44,960 --> 04:49:50,400 ON THE RIGHT IT HAS THE SAME 6788 04:49:50,400 --> 04:49:51,800 HORIZONTAL AXIS, VERTICAL AXIS 6789 04:49:51,800 --> 04:49:54,960 IS NUMBER OF AWARDS, MAXIMUM UP 6790 04:49:54,960 --> 04:49:56,320 HERE IS 4,000. 6791 04:49:56,320 --> 04:50:01,680 IT IS SMALL BUT I'LL READ 6792 04:50:01,680 --> 04:50:03,320 RELEVANT DATA. 6793 04:50:03,320 --> 04:50:05,920 SO THE LARGEST NUTRITION 6794 04:50:05,920 --> 04:50:12,160 PORTFOLIOS IN TERMS OF DOLLARS 6795 04:50:12,160 --> 04:50:13,960 ARE IN THE ORDER (INDISCERNIBLE) 6796 04:50:13,960 --> 04:50:16,960 NATIONAL INSTITUTE THE DIABETES 6797 04:50:16,960 --> 04:50:23,440 AND DIGESTIVE AND KIDNEY 6798 04:50:23,440 --> 04:50:26,200 DISEASE, NIDDK, AT $2.1 BILLION 6799 04:50:26,200 --> 04:50:33,360 OVER THAT FIVE-YEAR -- OVER 6800 04:50:33,360 --> 04:50:38,400 THAT, SORRY, 12- YEAR PERIOD 6801 04:50:38,400 --> 04:50:40,880 FOLLOWED BY NHLBI AT 6802 04:50:40,880 --> 04:50:45,280 $0.8 BILLION, FOLLOWED BY NCI, 6803 04:50:45,280 --> 04:50:47,240 CANCER, $0.5 BILLION, FOLLOWED 6804 04:50:47,240 --> 04:50:53,480 BY NATIONAL INSTITUTES OF AGING, 6805 04:50:53,480 --> 04:50:57,160 $0.5 BILLION, AND THEN THE 6806 04:50:57,160 --> 04:51:02,320 NICHD, CHILD HEALTH AND 6807 04:51:02,320 --> 04:51:02,880 DEVELOPMENT, $0.4 BILLION. 6808 04:51:02,880 --> 04:51:06,080 IN TERMS OF NUMBER OF AWARDS, 6809 04:51:06,080 --> 04:51:12,640 PATTERN IS PRETTY MUCH THE SAME. 6810 04:51:12,640 --> 04:51:14,880 AND THAT IS THAT -- MY LASER IS 6811 04:51:14,880 --> 04:51:16,920 HAVING A MIND OF ITS OWN HERE. 6812 04:51:16,920 --> 04:51:21,240 I'M GOING TO TURN IT OFF. 6813 04:51:21,240 --> 04:51:25,360 SORRY. 6814 04:51:25,360 --> 04:51:25,680 THERE WE GO. 6815 04:51:25,680 --> 04:51:28,040 IN TERMS OF NUMBER OF AWARDS, 6816 04:51:28,040 --> 04:51:33,800 FOR THE SAME PERIOD, THE ICOS 6817 04:51:33,800 --> 04:51:37,400 WITH THE MOST AWARDS WERE NIDDK, 6818 04:51:37,400 --> 04:51:41,520 DIABETES AND DIGESTIVE AND 6819 04:51:41,520 --> 04:51:46,040 KIDNEY DISEASE, AT ALMOST 4,000, 6820 04:51:46,040 --> 04:51:50,720 NHLBI CLOSE TO 1400 AWARDS, 6821 04:51:50,720 --> 04:51:52,480 CANCER CLOSE TO 1300 AWARDS, 6822 04:51:52,480 --> 04:51:56,920 CHILD HEALTH HAD CLOSE TO 900 6823 04:51:56,920 --> 04:52:00,120 AWARDS, AND NATIONAL INSTITUTE 6824 04:52:00,120 --> 04:52:07,440 OF AGING HAD APPROXIMATELY 850 6825 04:52:07,440 --> 04:52:07,680 AWARDS. 6826 04:52:07,680 --> 04:52:10,120 SO, NUTRITION IN MANY WAYS IS A 6827 04:52:10,120 --> 04:52:14,160 VERY SUBSTANTIAL PART OF THE NIH 6828 04:52:14,160 --> 04:52:14,400 PORTFOLIO. 6829 04:52:14,400 --> 04:52:15,960 THIS IS ONE MORE DATA SLIDE. 6830 04:52:15,960 --> 04:52:18,640 THIS IS A FUN ONE. 6831 04:52:18,640 --> 04:52:22,360 THIS SLIDE ALSO DONE BY THE 6832 04:52:22,360 --> 04:52:26,000 OFFICE OF PORTFOLIO ANALYSIS 6833 04:52:26,000 --> 04:52:28,960 SHOWS THE DOLLAR INVESTMENT AND 6834 04:52:28,960 --> 04:52:32,120 NUMBER OF AWARDS. 6835 04:52:32,120 --> 04:52:37,920 IN TERMS OF TOPIC AREAS, THIS IS 6836 04:52:37,920 --> 04:52:38,880 A CLUSTER ANALYSIS. 6837 04:52:38,880 --> 04:52:41,640 THE SCALE FOR THE DOLLARS IS 6838 04:52:41,640 --> 04:52:43,920 OVER HERE. 6839 04:52:43,920 --> 04:52:46,040 THE MORE RED INDICATES HIGHER 6840 04:52:46,040 --> 04:52:47,200 DOLLAR INVESTMENT. 6841 04:52:47,200 --> 04:52:49,080 THE CIRCLES, SIZE OF THE 6842 04:52:49,080 --> 04:52:50,400 CIRCLES, REPRESENTS THE NUMBER 6843 04:52:50,400 --> 04:52:51,400 OF AWARDS. 6844 04:52:51,400 --> 04:52:52,440 SO AS THE CIRCLES GET LARGE 6845 04:52:52,440 --> 04:53:03,000 ISSUE -- LARGER, THE NUMBER OF 6846 04:53:03,880 --> 04:53:05,520 AWARDS GET LARGER. 6847 04:53:05,520 --> 04:53:11,760 I THINK I GOT RID OF THAT LASER. 6848 04:53:11,760 --> 04:53:15,120 THE LARGEST CLUSTERS IN TERMS OF 6849 04:53:15,120 --> 04:53:18,280 DOLLAR INVESTMENTS WERE OBESITY 6850 04:53:18,280 --> 04:53:18,760 PREVENTION. 6851 04:53:18,760 --> 04:53:22,880 I GOT IT UNDER CONTROL. 6852 04:53:22,880 --> 04:53:24,440 OBESITY PREVENTION, FOLLOWED BY 6853 04:53:24,440 --> 04:53:28,480 BMI ACTIVITY AND CARDIOVASCULAR 6854 04:53:28,480 --> 04:53:29,600 DISEASE. 6855 04:53:29,600 --> 04:53:32,440 FOLLOWED BY METABOLIC 6856 04:53:32,440 --> 04:53:33,640 MECHANISMS, FOLLOWED BY TYPE 2 6857 04:53:33,640 --> 04:53:34,040 DIABETES. 6858 04:53:34,040 --> 04:53:37,560 AND THE NUMBER OF AWARDS FOLLOWS 6859 04:53:37,560 --> 04:53:39,880 A SIMILAR PATTERN, THE LARGEST 6860 04:53:39,880 --> 04:53:44,120 NUMBER OF AWARDS IN THE AREA OF 6861 04:53:44,120 --> 04:53:46,120 OBESITY PREVENTION, AND 6862 04:53:46,120 --> 04:53:48,000 METABOLIC MECHANISMS, AND THEN 6863 04:53:48,000 --> 04:53:49,360 BMI ACTIVITY AND CARDIOVASCULAR 6864 04:53:49,360 --> 04:53:49,880 DISEASE. 6865 04:53:49,880 --> 04:53:52,960 I DON'T THINK IT'S TOO MUCH OF A 6866 04:53:52,960 --> 04:53:55,960 SURPRISE TO THIS AUDIENCE. 6867 04:53:55,960 --> 04:53:58,400 BUT IT DOES SERVE TO REMIND US 6868 04:53:58,400 --> 04:54:00,040 THAT OBESITY RESEARCH IS STILL A 6869 04:54:00,040 --> 04:54:05,600 VERY LARGE PORTION OF THE NIH 6870 04:54:05,600 --> 04:54:08,160 NUTRITION RESEARCH PORTFOLIO. 6871 04:54:08,160 --> 04:54:09,640 FOR YOUR INFORMATION, OBESITY 6872 04:54:09,640 --> 04:54:13,080 RESEARCH IS CARRIED OUT, 6873 04:54:13,080 --> 04:54:16,360 COORDINATED BY THE NIH OBESITY 6874 04:54:16,360 --> 04:54:17,920 RESEARCH TASK FORCE. 6875 04:54:17,920 --> 04:54:22,720 THEY HAVE A WEB PAGE, AND THAT 6876 04:54:22,720 --> 04:54:23,920 IS OBESITYRESEARCH.NIH.GOV. 6877 04:54:23,920 --> 04:54:29,640 YOU CAN LEARN MORE ABOUT THAT. 6878 04:54:29,640 --> 04:54:30,360 OKAY. 6879 04:54:30,360 --> 04:54:33,000 SO WHAT ABOUT THE ODS? 6880 04:54:33,000 --> 04:54:36,400 NOW, THE TOP OF THE SLIDE HAS 6881 04:54:36,400 --> 04:54:40,640 OUR URL FOR OUR WEBSITE. 6882 04:54:40,640 --> 04:54:42,440 ODS IS AN OFFICE, AND IT 6883 04:54:42,440 --> 04:54:44,200 SPONSORS AND SUPPORTS MANY 6884 04:54:44,200 --> 04:54:46,880 DIETARY SUPPLEMENT RESEARCH AND 6885 04:54:46,880 --> 04:54:48,280 RESEARCH-RELATED ACTIVITIES 6886 04:54:48,280 --> 04:54:49,960 COVERING NOT ONLY THE NUTRITION 6887 04:54:49,960 --> 04:54:53,600 SIDE BUT ALSO THE BOTANICAL 6888 04:54:53,600 --> 04:54:54,520 SIDE. 6889 04:54:54,520 --> 04:54:56,280 THIS SLIDE IS FROM THE LANDING 6890 04:54:56,280 --> 04:54:58,920 PAGE, PART OF THE LANDING PAGE 6891 04:54:58,920 --> 04:55:00,400 OF OUR WEBSITE. 6892 04:55:00,400 --> 04:55:03,880 I TOOK A SNIP OF THE LANDING 6893 04:55:03,880 --> 04:55:04,080 PAGE. 6894 04:55:04,080 --> 04:55:07,520 I LIKE THIS PART BECAUSE YOU 6895 04:55:07,520 --> 04:55:10,000 CAN -- YOU CAN CLICK ON ANY ONE 6896 04:55:10,000 --> 04:55:11,840 OF THESE IMAGES, IT WILL TAKE 6897 04:55:11,840 --> 04:55:15,440 YOU TO A DEEPER DISCUSSION OF 6898 04:55:15,440 --> 04:55:16,680 THE INDIVIDUAL PROGRAMS, WHAT'S 6899 04:55:16,680 --> 04:55:18,120 BEEN FUNDED, WHAT THE RESEARCH 6900 04:55:18,120 --> 04:55:22,080 IS, WHAT'S THE TOPICS ARE, AND 6901 04:55:22,080 --> 04:55:22,400 SO ON. 6902 04:55:22,400 --> 04:55:27,320 I ENCOURAGE YOU TO GO TO THIS 6903 04:55:27,320 --> 04:55:28,400 WEBSITE, ONE OF THE BEST 6904 04:55:28,400 --> 04:55:30,640 WEBSITES AT THE NIH. 6905 04:55:30,640 --> 04:55:31,960 I SAY THAT WITH CONFIDENCE 6906 04:55:31,960 --> 04:55:33,280 BECAUSE I'M BEEN AT THE NIH FOR 6907 04:55:33,280 --> 04:55:36,560 20 YEARS AND HAVE SEEN A LOT OF 6908 04:55:36,560 --> 04:55:36,880 WEBSITES. 6909 04:55:36,880 --> 04:55:42,760 IT IS A MILE WIDE AND SEVERAL 6910 04:55:42,760 --> 04:55:43,560 MILES DEEP. 6911 04:55:43,560 --> 04:55:45,080 NOW, IF YOU AGAIN, WHEN YOU 6912 04:55:45,080 --> 04:55:47,880 CLICK ON THESE AREAS, YOU'RE 6913 04:55:47,880 --> 04:55:51,320 ALSO GOING TO SEE THAT A 6914 04:55:51,320 --> 04:55:53,440 SUBSTANTIAL PART OF OUR SUPPORT 6915 04:55:53,440 --> 04:55:56,120 IS NOT EXTRAMURAL BUT IN 6916 04:55:56,120 --> 04:55:58,200 ADDITION TO EXTRAMURAL IT IS 6917 04:55:58,200 --> 04:55:59,360 SOME INTERAGENCY AGREEMENTS, 6918 04:55:59,360 --> 04:56:02,920 SOME RESEARCH CONTRACTS, EVEN 6919 04:56:02,920 --> 04:56:03,760 SOME INTRAMURAL RESEARCH 6920 04:56:03,760 --> 04:56:04,120 PROGRAMS. 6921 04:56:04,120 --> 04:56:07,440 I WANT TO POINT OUT THE PROGRAM 6922 04:56:07,440 --> 04:56:10,320 IN THE BOTTOM RIGHT CORNER, 6923 04:56:10,320 --> 04:56:11,000 EDUCATION AND TRAINING. 6924 04:56:11,000 --> 04:56:12,680 IF YOU CLICK ON THAT, YOU'RE 6925 04:56:12,680 --> 04:56:15,400 GOING TO BE TAKEN TO A SECTION 6926 04:56:15,400 --> 04:56:19,720 THAT TELLS YOU MORE ABOUT SOME 6927 04:56:19,720 --> 04:56:20,680 NON-EXTRAMURAL PROGRAMS 6928 04:56:20,680 --> 04:56:23,360 INCLUDING THE ODS SEMINAR 6929 04:56:23,360 --> 04:56:26,680 SERIES, WHICH IS AN EXCELLENT 6930 04:56:26,680 --> 04:56:28,480 SERIES THAT RUNS APPROXIMATELY 6931 04:56:28,480 --> 04:56:31,320 THE ACADEMIC YEAR, AS WELL AS 6932 04:56:31,320 --> 04:56:32,360 THIS PRACTICUM THAT WE'RE IN 6933 04:56:32,360 --> 04:56:37,960 RIGHT NOW, AS WELL AS ODS 6934 04:56:37,960 --> 04:56:39,320 RESEARCH SCHOLARS PROGRAM. 6935 04:56:39,320 --> 04:56:41,360 THE LATTER, WHICH I MENTIONED TO 6936 04:56:41,360 --> 04:56:45,840 YOU A COUPLE OF ADDITIONAL 6937 04:56:45,840 --> 04:56:51,640 POINTS RESEARCH SCHOLARS PROGRAM 6938 04:56:51,640 --> 04:56:53,280 PROVIDES SUPPORT TO EARLY CAREER 6939 04:56:53,280 --> 04:56:55,680 SCIENTISTS WITH MENTORS IN THE 6940 04:56:55,680 --> 04:56:57,480 INTRAMURAL LABS WHO WISH TO DO 6941 04:56:57,480 --> 04:57:03,080 RESEARCH ON DIETARY SUPPLEMENTS. 6942 04:57:03,080 --> 04:57:05,800 ODS PROVIDES ONE-YEAR SUPPORT, 6943 04:57:05,800 --> 04:57:07,520 $100,000, AN APPLICATION PROCESS 6944 04:57:07,520 --> 04:57:12,560 IS INVOLVED AND INTERNAL 6945 04:57:12,560 --> 04:57:13,600 EVALUATION IS CONDUCTED. 6946 04:57:13,600 --> 04:57:20,560 IF YOU'RE INTERESTED REACH UP ON 6947 04:57:20,560 --> 04:57:22,800 THE-- REACH OUT AND CONTACT ME 6948 04:57:22,800 --> 04:57:24,360 FOR DETAILS. 6949 04:57:24,360 --> 04:57:25,920 YESTERDAY YOU HEARD ABOUT DAD 6950 04:57:25,920 --> 04:57:32,080 BASE, TODAY ABOUT THE CARBON AND 6951 04:57:32,080 --> 04:57:33,960 BOTANICAL PROGRAM, YOU JUST 6952 04:57:33,960 --> 04:57:36,040 HEARD ABOUT THE RESILIENCE 6953 04:57:36,040 --> 04:57:38,320 PROGRAM, AND NOW I'M GOING TO 6954 04:57:38,320 --> 04:57:41,360 TAKE YOU TO THE WORLD OF GRANTS 6955 04:57:41,360 --> 04:57:49,320 AND FUNDING AND TALK ABOUT 6956 04:57:49,320 --> 04:57:51,000 EXTRAMURAL GRANTS. 6957 04:57:51,000 --> 04:57:53,320 SO THIS IS THE PAGE FROM OUR 6958 04:57:53,320 --> 04:57:55,880 WEBSITE THAT DEALS WITH GRANTS 6959 04:57:55,880 --> 04:57:58,240 AND FUNDING OPPORTUNITIES. 6960 04:57:58,240 --> 04:58:01,600 THE URL IS HERE, YOUR 6961 04:58:01,600 --> 04:58:02,120 INFORMATION. 6962 04:58:02,120 --> 04:58:04,400 I WANT TO CALL YOUR ATTENTION TO 6963 04:58:04,400 --> 04:58:06,240 THREE HIGH LEVEL POINTS THAT YOU 6964 04:58:06,240 --> 04:58:07,880 SHOULD BEAR IN MIND. 6965 04:58:07,880 --> 04:58:11,840 FIRST OF ALL, AS AN OFFICE, LIKE 6966 04:58:11,840 --> 04:58:15,680 OTHER O.D. OFFICE, ODS IS NOT A 6967 04:58:15,680 --> 04:58:19,120 PRIMARY FUNDER OF EXTRAMURAL 6968 04:58:19,120 --> 04:58:19,360 GRANTS. 6969 04:58:19,360 --> 04:58:20,600 SO, WE DON'T HAVE GRANT-MAKING 6970 04:58:20,600 --> 04:58:23,960 AUTHORITY IN THE SAME WAY THAT 6971 04:58:23,960 --> 04:58:27,000 NIH RESEARCH INSTITUTES DO. 6972 04:58:27,000 --> 04:58:29,000 SO, WE CANNOT AWARD OR 6973 04:58:29,000 --> 04:58:31,640 ADMINISTER GRANTS THE SAME WAY 6974 04:58:31,640 --> 04:58:31,880 THEY CAN. 6975 04:58:31,880 --> 04:58:33,120 HOWEVER, THERE ARE TWO OTHER 6976 04:58:33,120 --> 04:58:37,200 WAYS THAT WE DO OR CAN AND WE DO 6977 04:58:37,200 --> 04:58:41,040 SUPPORT EXTRAMURAL GRANTS. 6978 04:58:41,040 --> 04:58:43,000 ONE IS THROUGH CO-FUNDING. 6979 04:58:43,000 --> 04:58:44,600 SO WE CAN CO-FUND GRANTS 6980 04:58:44,600 --> 04:58:47,840 ASSIGNED TO OTHER NIH 6981 04:58:47,840 --> 04:58:49,320 INSTITUTES. 6982 04:58:49,320 --> 04:58:51,720 WHAT DOES CO-FUNDING MEAN? 6983 04:58:51,720 --> 04:58:54,840 JUST AS THE TERM SUGGESTS, IT IS 6984 04:58:54,840 --> 04:58:58,160 A SHARING OF COSTS OF A 6985 04:58:58,160 --> 04:59:00,160 COMPETING RESEARCH PROJECT. 6986 04:59:00,160 --> 04:59:04,040 SO CO-FUND IS A FINANCIAL 6987 04:59:04,040 --> 04:59:06,640 AGREEMENT BETWEEN TWO OR MORE 6988 04:59:06,640 --> 04:59:07,320 ICOS. 6989 04:59:07,320 --> 04:59:11,960 IT IS AGREEMENT BETWEEN THE 6990 04:59:11,960 --> 04:59:13,520 ICOS, AFTER THE APPLICATION HAS 6991 04:59:13,520 --> 04:59:17,640 COME IN THE DOOR, AND HAS GONE 6992 04:59:17,640 --> 04:59:19,920 THROUGH PEER REVIEW, BUT BEFORE 6993 04:59:19,920 --> 04:59:21,320 THE PROJECT IS FUNDED. 6994 04:59:21,320 --> 04:59:23,760 SO THAT'S IMPORTANT. 6995 04:59:23,760 --> 04:59:25,680 THE CO-FUND IS AN AGREEMENT 6996 04:59:25,680 --> 04:59:31,000 BETWEEN TWO OR MORE ICOS, TO 6997 04:59:31,000 --> 04:59:33,600 SHARE THE COST OF A RESEARCH 6998 04:59:33,600 --> 04:59:34,200 PROJECT, AFTER THAT APPLICATION 6999 04:59:34,200 --> 04:59:36,200 HAS BEEN RECEIVED, GONE THROUGH 7000 04:59:36,200 --> 04:59:37,800 PEER REVIEW, BUT BEFORE ANY 7001 04:59:37,800 --> 04:59:43,520 FUNDING DECISION HAS BEEN MADE. 7002 04:59:43,520 --> 04:59:46,560 ODS CO-FUNDS NEW AND RENEWAL 7003 04:59:46,560 --> 04:59:50,520 GRANT WITH PARTNER ICOS. 7004 04:59:50,520 --> 04:59:53,360 NOW, THE APPLICANT HAS NO ROLE. 7005 04:59:53,360 --> 04:59:54,920 THIS IS AN INTERNAL 7006 04:59:54,920 --> 04:59:56,120 BEHIND-THE-SCENES PROCESS, THE 7007 04:59:56,120 --> 04:59:58,040 APPLICANT CANNOT ARRANGE A 7008 04:59:58,040 --> 04:59:59,960 CO-FUND AGREEMENT BETWEEN 7009 04:59:59,960 --> 05:00:00,240 INSTITUTES. 7010 05:00:00,240 --> 05:00:04,440 THE CO-FUND IS MADE, YOU KNOW, 7011 05:00:04,440 --> 05:00:12,720 WITH CERTAIN REQUIREMENTS, 7012 05:00:12,720 --> 05:00:13,800 ACONDITIONS GIVEN, MET BY THE 7013 05:00:13,800 --> 05:00:14,080 PROGRAM. 7014 05:00:14,080 --> 05:00:15,920 THE PROJECT MUST HAVE RELEVANCE 7015 05:00:15,920 --> 05:00:18,480 TO OUR MISSION AND TO ONE OR 7016 05:00:18,480 --> 05:00:23,200 MORE OF OUR STRATEGIC 7017 05:00:23,200 --> 05:00:24,240 OBJECTIVES. 7018 05:00:24,240 --> 05:00:25,200 OFTEN, ODS PARTICIPATE IN 7019 05:00:25,200 --> 05:00:27,760 DEVELOPMENT OF THE FUNDING 7020 05:00:27,760 --> 05:00:30,480 INITIATIVE THAT AN APPLICATION 7021 05:00:30,480 --> 05:00:32,520 HAS RESPONDED TO. 7022 05:00:32,520 --> 05:00:36,760 AND IN FACT WE HAVE INTEREST IN 7023 05:00:36,760 --> 05:00:38,400 MANY TRANS-NIH INITIATIVES AND 7024 05:00:38,400 --> 05:00:42,360 THAT OPENS UP A NUMBER OF 7025 05:00:42,360 --> 05:00:43,240 POSSIBILITIES FOR CO-FUNDING. 7026 05:00:43,240 --> 05:00:48,400 SO THE OTHER WAY WE SUPPORT 7027 05:00:48,400 --> 05:00:50,440 GRANTS THROUGH ADMINISTRATIVE 7028 05:00:50,440 --> 05:00:51,040 SUPPLEMENTS. 7029 05:00:51,040 --> 05:00:56,120 SO ODS CAN FOUND ADMINISTRATIVE 7030 05:00:56,120 --> 05:00:58,720 SUPPLEMENTS TO EXISTING GRANTS. 7031 05:00:58,720 --> 05:01:02,320 THE PROJECT THAT'S ALREADY 7032 05:01:02,320 --> 05:01:04,280 EXISTING, ALREADY FUNDED, THIS 7033 05:01:04,280 --> 05:01:05,960 IS ADMINISTRATIVE SUPPLEMENTS 7034 05:01:05,960 --> 05:01:07,400 ESSENTIALLY ADD-ONS, TO THE 7035 05:01:07,400 --> 05:01:08,880 EXISTING PROJECT. 7036 05:01:08,880 --> 05:01:12,600 SO, IN THIS CASE, FOR ODS, 7037 05:01:12,600 --> 05:01:14,000 SUPPORT AND ADMINISTRATIVE 7038 05:01:14,000 --> 05:01:16,400 SUPPLEMENT, WITH ADDITION OF A 7039 05:01:16,400 --> 05:01:17,600 DIETARY SUPPLEMENT RESEARCH 7040 05:01:17,600 --> 05:01:19,440 COMPONENT, AND MAY BE A NEW 7041 05:01:19,440 --> 05:01:22,720 SPECIFIC AIM BUT USUALLY IT'S 7042 05:01:22,720 --> 05:01:22,920 NOT. 7043 05:01:22,920 --> 05:01:26,920 COULD BE JUST SOME ADDITIONAL 7044 05:01:26,920 --> 05:01:27,480 COMPONENT. 7045 05:01:27,480 --> 05:01:30,520 AS LONG AS IT IS WITHIN THE 7046 05:01:30,520 --> 05:01:34,120 SCOPE OF THE ORIGINAL PARENT 7047 05:01:34,120 --> 05:01:34,440 GRANT. 7048 05:01:34,440 --> 05:01:37,520 NOW, WE HEARD YESTERDAY THE 7049 05:01:37,520 --> 05:01:38,280 DEFINITION OF DIETARY SUPPLEMENT 7050 05:01:38,280 --> 05:01:40,840 RESEARCH BUT I'M GOING TO REMIND 7051 05:01:40,840 --> 05:01:42,040 YOU AGAIN ANYWAY BECAUSE THERE'S 7052 05:01:42,040 --> 05:01:44,600 A LOT OF TALKS THAT HAVE 7053 05:01:44,600 --> 05:01:47,440 OCCURRED IN BETWEEN THEN. 7054 05:01:47,440 --> 05:01:49,200 SO, DIETARY SUPPLEMENT RESEARCH 7055 05:01:49,200 --> 05:01:53,000 INCLUDES RESEARCH ON VITAMINS, 7056 05:01:53,000 --> 05:01:54,240 MINERALS, HERBS, OTHER 7057 05:01:54,240 --> 05:01:56,160 BOTANICALS, AMINO ACIDS, OTHER 7058 05:01:56,160 --> 05:01:57,720 DIETARY SUPPLEMENT OR BIOACTIVE 7059 05:01:57,720 --> 05:02:02,800 SUBSTANCES, AS WELL AS EXTRACTS, 7060 05:02:02,800 --> 05:02:03,720 CONCENTRATES, METABOLITES, 7061 05:02:03,720 --> 05:02:06,480 CONSTITUENTS THAT ARE AVAILABLE 7062 05:02:06,480 --> 05:02:07,120 WITHOUT PRESCRIPTION, THAT ARE 7063 05:02:07,120 --> 05:02:10,520 INTENDED TO BE TAKEN BY MOUTH, 7064 05:02:10,520 --> 05:02:12,760 CONSUMED, IN ADDITION TO REGULAR 7065 05:02:12,760 --> 05:02:17,040 DIET, TO PROMOTE HEALTH AND 7066 05:02:17,040 --> 05:02:17,520 PREVENT DISEASE. 7067 05:02:17,520 --> 05:02:21,040 ON THE RIGHT SIDE OF THE SLIDE 7068 05:02:21,040 --> 05:02:24,640 HERE IS A PICTURE FROM THE WEB 7069 05:02:24,640 --> 05:02:29,280 PAGE, AND I HAVE CIRCLED IN RED 7070 05:02:29,280 --> 05:02:30,800 SOME COMPONENT, SOME PARTS OF 7071 05:02:30,800 --> 05:02:34,040 THIS THAT I STRONGLY URGE YOU TO 7072 05:02:34,040 --> 05:02:40,240 GO TO AND READ FOR MORE 7073 05:02:40,240 --> 05:02:40,680 INFORMATION. 7074 05:02:40,680 --> 05:02:41,720 HERE ODS RESEARCH PORTFOLIO, 7075 05:02:41,720 --> 05:02:43,320 CLICK ON THIS, YOU'LL BE TAKEN 7076 05:02:43,320 --> 05:02:46,600 TO A LIST OF ALL OF THE 7077 05:02:46,600 --> 05:02:52,560 EXTRAMURAL GRANTS THAT ODS HAS 7078 05:02:52,560 --> 05:02:55,360 FUNDED, IN THE PAST MANY FISCAL 7079 05:02:55,360 --> 05:02:56,880 YEARS SO YOU WILL GET A FLAVOR 7080 05:02:56,880 --> 05:02:59,960 OF THE TYPES OF PROJECTS THAT WE 7081 05:02:59,960 --> 05:03:00,240 FUND. 7082 05:03:00,240 --> 05:03:03,160 HERE IF YOU CLICK ON THIS, 7083 05:03:03,160 --> 05:03:06,840 YOU'LL BE TAKEN TO AN 7084 05:03:06,840 --> 05:03:08,560 ANNOUNCEMENT FOR FUNDING 7085 05:03:08,560 --> 05:03:11,200 OPPORTUNITY FOR ADMINISTRATIVE 7086 05:03:11,200 --> 05:03:12,560 SUPPLEMENTS FOR RESEARCH ON 7087 05:03:12,560 --> 05:03:14,720 DIETARY SUPPLEMENTS, THE NUMBER 7088 05:03:14,720 --> 05:03:21,480 HAPPENS TO BE PA 20-227, IT IS 7089 05:03:21,480 --> 05:03:23,040 CURRENTLY ACTIVE. 7090 05:03:23,040 --> 05:03:23,760 HERE, PRODUCT INTEGRITY 7091 05:03:23,760 --> 05:03:24,840 INFORMATION, CLICK ON THIS 7092 05:03:24,840 --> 05:03:28,560 SECTION, IT'S GOING TO TAKE YOU 7093 05:03:28,560 --> 05:03:30,560 TO MORE INFORMATION, MORE 7094 05:03:30,560 --> 05:03:32,960 IN-DEPTH INFORMATION, DETAIL AND 7095 05:03:32,960 --> 05:03:36,720 RESOURCES ABOUT WHAT I MEANS TO 7096 05:03:36,720 --> 05:03:37,400 PROVIDE PRODUCT INTEGRITY 7097 05:03:37,400 --> 05:03:39,560 INFORMATION, AND THIS IS 7098 05:03:39,560 --> 05:03:44,280 IMPORTANT IF YOUR RESEARCH 7099 05:03:44,280 --> 05:03:46,080 PROJECT INVOLVES TESTING A 7100 05:03:46,080 --> 05:03:48,120 DIETARY SUPPLEMENT OR 7101 05:03:48,120 --> 05:03:49,560 INTERVENING WITH A NEW DIETARY 7102 05:03:49,560 --> 05:03:49,880 SUPPLEMENT. 7103 05:03:49,880 --> 05:03:53,920 YOU WILL NEED TO PROVIDE THAT 7104 05:03:53,920 --> 05:03:56,040 INFORMATION IN YOUR APPLICATION. 7105 05:03:56,040 --> 05:03:58,360 IN THIS SECTION, THIS IS ALL 7106 05:03:58,360 --> 05:04:02,040 ABOUT ODS FUNDING OF GRANTS AND 7107 05:04:02,040 --> 05:04:02,600 ADMINISTRATIVE SUPPLEMENTS. 7108 05:04:02,600 --> 05:04:04,320 AND THE FREQUENTLY ASKED 7109 05:04:04,320 --> 05:04:06,320 QUESTIONS AND ANSWERS WHICH IS 7110 05:04:06,320 --> 05:04:09,360 VERY USEFUL. 7111 05:04:09,360 --> 05:04:13,360 AND THIS SECTION HERE IS ABOUT 7112 05:04:13,360 --> 05:04:14,880 ADMINISTRATIVE SUPPLEMENTS FOR 7113 05:04:14,880 --> 05:04:16,480 VALIDATION STUDIES OF ANALYTICAL 7114 05:04:16,480 --> 05:04:18,000 METHODS, WHICH TIES TO THE 7115 05:04:18,000 --> 05:04:21,680 PROGRAM THAT DR. KUZAK WAS 7116 05:04:21,680 --> 05:04:23,640 TALKING ABOUT EARLIER. 7117 05:04:23,640 --> 05:04:25,480 THIS PARTICULAR ANNOUNCEMENT HAS 7118 05:04:25,480 --> 05:04:28,800 JUST EXPIRED, BUT WE ARE 7119 05:04:28,800 --> 05:04:30,040 CURRENTLY WORKING TO REISSUE IT. 7120 05:04:30,040 --> 05:04:33,320 AND IT WILL BE REISSUED IN TIME 7121 05:04:33,320 --> 05:04:36,400 FOR THE NEXT RECEIPT DATE, WHICH 7122 05:04:36,400 --> 05:04:37,480 IS OCTOBER 15. 7123 05:04:37,480 --> 05:04:39,040 SO LAST BUT NOT LEAST ON THE 7124 05:04:39,040 --> 05:04:44,120 RIGHT SIDE OF THE PAGE, UNDER 7125 05:04:44,120 --> 05:04:48,560 ANNOUNCEMENTS, IS A LIST WITH 7126 05:04:48,560 --> 05:04:50,200 LINKS TO ACTIVE FUNDING 7127 05:04:50,200 --> 05:04:51,200 ANNOUNCEMENTS OUT THERE 7128 05:04:51,200 --> 05:04:54,720 AVAILABLE TO YOU. 7129 05:04:54,720 --> 05:04:58,120 OKAY. 7130 05:04:58,120 --> 05:04:58,640 OOPS. 7131 05:04:58,640 --> 05:04:59,920 GO BACK. 7132 05:04:59,920 --> 05:05:02,160 THERE WE GO. 7133 05:05:02,160 --> 05:05:06,840 SO, NOW I WANT TO TALK A LITTLE 7134 05:05:06,840 --> 05:05:09,760 BIT MORE ABOUT THE NIH 7135 05:05:09,760 --> 05:05:11,360 EXTRAMURAL SYSTEMS, REALLY THE 7136 05:05:11,360 --> 05:05:13,920 MACHINERY OF THE EXTRAMURAL 7137 05:05:13,920 --> 05:05:14,600 PROGRAM. 7138 05:05:14,600 --> 05:05:17,280 I ENCOURAGE YOU TO VISIT THE 7139 05:05:17,280 --> 05:05:21,120 WEBSITE, THE OFFICE OF 7140 05:05:21,120 --> 05:05:22,240 EXTRAMURAL RESEARCH, HERE'S URL. 7141 05:05:22,240 --> 05:05:26,680 PLENTY OF INFORMATION BEHIND 7142 05:05:26,680 --> 05:05:27,560 THAT URL. 7143 05:05:27,560 --> 05:05:30,440 A VERY HIGH LEVEL, IF YOU'RE 7144 05:05:30,440 --> 05:05:34,560 ENTERING INTO THIS WORLD, YOU 7145 05:05:34,560 --> 05:05:39,040 SHOULD UNDERSTAND THAT THERE ARE 7146 05:05:39,040 --> 05:05:41,840 ORGANIZATIONAL COMPONENTS AND 7147 05:05:41,840 --> 05:05:46,040 FUNCTIONS OF THOSE COMPONENTS. 7148 05:05:46,040 --> 05:05:47,280 THE ORGANIZATIONAL COMPONENTS 7149 05:05:47,280 --> 05:05:49,200 WITHIN -- ARE WITHIN EACH I.C. 7150 05:05:49,200 --> 05:05:54,720 AND CONSIST OF PROGRAM OFFICES, 7151 05:05:54,720 --> 05:05:58,200 PROGRAM OFFICES ARE DIVISIONS, 7152 05:05:58,200 --> 05:06:01,240 OR BRANCHES, THAT HAVE SPECIFIC 7153 05:06:01,240 --> 05:06:04,040 SCIENTIFIC FOCUS OR PRIORITY. 7154 05:06:04,040 --> 05:06:05,480 THERE ARE ALSO MANAGEMENT 7155 05:06:05,480 --> 05:06:06,360 OFFICES, INCLUDING BRANCH 7156 05:06:06,360 --> 05:06:10,040 MANAGEMENTS, USUALLY A BUDGET 7157 05:06:10,040 --> 05:06:11,160 OFFICE, AND ACQUISITION OFFICE, 7158 05:06:11,160 --> 05:06:15,880 NOT ALWAYS WITH SOME SMALLER 7159 05:06:15,880 --> 05:06:18,040 I.C.s, BUT ACQUISITIONS WILL 7160 05:06:18,040 --> 05:06:19,640 BE OVERSEEING RESEARCH 7161 05:06:19,640 --> 05:06:20,080 CONTRACTS. 7162 05:06:20,080 --> 05:06:22,040 AND THEN MANY OF THE INSTITUTES 7163 05:06:22,040 --> 05:06:24,600 HAVE THEIR OWN PEER REVIEW 7164 05:06:24,600 --> 05:06:25,160 UNITS. 7165 05:06:25,160 --> 05:06:28,000 AND THEN YOU HAVE PROGRAM 7166 05:06:28,000 --> 05:06:28,280 OFFICIALS. 7167 05:06:28,280 --> 05:06:30,280 SO THESE ARE THE PEOPLE WITHIN 7168 05:06:30,280 --> 05:06:33,080 THE OFFICES THAT YOU WILL LIKELY 7169 05:06:33,080 --> 05:06:34,880 BE INTERACTING WITH, AND THEY 7170 05:06:34,880 --> 05:06:37,080 HAVE A NUMBER OF DUTIES AND 7171 05:06:37,080 --> 05:06:39,520 FUNCTIONS TOO LONG TO LIST HERE. 7172 05:06:39,520 --> 05:06:42,960 BUT IN GENERAL PROVIDE GUIDANCE 7173 05:06:42,960 --> 05:06:44,760 TO APPLICANTS AND AWARDEES, THEY 7174 05:06:44,760 --> 05:06:46,280 DEVELOP AND MANAGE PORTFOLIOS 7175 05:06:46,280 --> 05:06:51,360 AND THEY MONITOR THE AWARDS OF 7176 05:06:51,360 --> 05:06:52,440 THE BRANCH WITHIN THEIR 7177 05:06:52,440 --> 05:06:57,040 PORTFOLIOS. 7178 05:06:57,040 --> 05:07:01,680 ALL OF THESE COMPONENTS HAVE 7179 05:07:01,680 --> 05:07:03,960 CHARTERED RESPONSIBILITIES THAT 7180 05:07:03,960 --> 05:07:06,680 REVOLVE AROUND THE MISSION AREAS 7181 05:07:06,680 --> 05:07:07,440 OF THEIR INDIVIDUAL -- 7182 05:07:07,440 --> 05:07:08,520 SCIENTIFIC MISSION AREAS AROUND 7183 05:07:08,520 --> 05:07:11,520 THEIR INDIVIDUAL I.C.s. 7184 05:07:11,520 --> 05:07:13,360 THEY ALL PROVIDE GUIDANCE AND 7185 05:07:13,360 --> 05:07:15,160 SERVICE, SERVICES TO THE 7186 05:07:15,160 --> 05:07:18,560 APPLICANTS AND AWARDEES. 7187 05:07:18,560 --> 05:07:21,480 THEY PROVIDE SCIENTIFIC FISCAL 7188 05:07:21,480 --> 05:07:22,760 ETHICAL AND LEGAL OVERSIGHT, 7189 05:07:22,760 --> 05:07:25,000 POLICIES AND COMPLIANCE, 7190 05:07:25,000 --> 05:07:26,280 RECOMMEND FUNDING, IN 7191 05:07:26,280 --> 05:07:30,360 COORDINATION WITH OVERSIGHT 7192 05:07:30,360 --> 05:07:30,760 COMMITTEES. 7193 05:07:30,760 --> 05:07:33,800 AND PORTFOLIOS ARE DEVELOPED 7194 05:07:33,800 --> 05:07:36,560 THROUGH WORKSHOPS, CONFERENCES, 7195 05:07:36,560 --> 05:07:43,040 AND RESEARCH SOLICITATIONS, 7196 05:07:43,040 --> 05:07:45,800 THERE ARE PROGRAMS DESIGNED TO 7197 05:07:45,800 --> 05:07:48,960 DEVELOP INDIVIDUAL AND INSTITUTE 7198 05:07:48,960 --> 05:07:49,560 RESEARCH CAPACITY FOR 7199 05:07:49,560 --> 05:07:52,680 CONSTITUENTS THROUGH TRAINING 7200 05:07:52,680 --> 05:07:56,160 AND INFRASTRUCTURE SUPPORT. 7201 05:07:56,160 --> 05:07:57,200 OKAY. 7202 05:07:57,200 --> 05:08:02,040 NOW, WHAT ARE THE NIH 7203 05:08:02,040 --> 05:08:02,760 MECHANISMS? 7204 05:08:02,760 --> 05:08:04,560 MORE JARGON, ALERT, ALERT! 7205 05:08:04,560 --> 05:08:07,080 MECHANISMS, THIS IS A TERM YOU 7206 05:08:07,080 --> 05:08:08,120 HEAR A LOT. 7207 05:08:08,120 --> 05:08:14,520 IT IS AN UMBRELLA TERM. 7208 05:08:14,520 --> 05:08:20,080 AND IT REFERS TO THE WAY THE NIH 7209 05:08:20,080 --> 05:08:23,760 SUPPORTS GRANTS. 7210 05:08:23,760 --> 05:08:26,080 AND THE NIH DISTINGUISHES GRANTS 7211 05:08:26,080 --> 05:08:27,960 BY VARIOUS CHARACTERISTICS, SUCH 7212 05:08:27,960 --> 05:08:30,680 AS THE PURPOSE, TYPE OF THE 7213 05:08:30,680 --> 05:08:34,880 RECIPIENT, THE AMOUNT OF MONEY 7214 05:08:34,880 --> 05:08:36,120 AVAILABLE, OTHER 7215 05:08:36,120 --> 05:08:36,480 CHARACTERISTICS. 7216 05:08:36,480 --> 05:08:37,640 THE MAIN FUNDING MECHANISM THAT 7217 05:08:37,640 --> 05:08:42,640 YOU'VE LIKE LIKELY HEARD OF 7218 05:08:42,640 --> 05:08:44,240 GRANTS, COOPERATIVE AGREEMENTS, 7219 05:08:44,240 --> 05:08:44,480 CONTRACTS. 7220 05:08:44,480 --> 05:08:45,720 THERE ARE OTHERS, BUT MAIN ONES 7221 05:08:45,720 --> 05:08:46,320 ARE THESE. 7222 05:08:46,320 --> 05:08:49,560 AND THE ONCE WE'RE GOING TO 7223 05:08:49,560 --> 05:08:51,280 FOCUS ON IN -- ONES WE'RE GOING 7224 05:08:51,280 --> 05:08:52,680 TO FOCUS ON IN THIS PRESENTATION 7225 05:08:52,680 --> 05:08:53,560 ARE GRANTS. 7226 05:08:53,560 --> 05:08:55,360 ONE WAY THAT THE NIH 7227 05:08:55,360 --> 05:08:57,160 DIFFERENTIATES THIS WIDE VARIETY 7228 05:08:57,160 --> 05:09:00,000 OF RESEARCH PROGRAMS IS THROUGH 7229 05:09:00,000 --> 05:09:02,240 ACTIVITY CODES. 7230 05:09:02,240 --> 05:09:04,200 ACTIVITY CODES ARE THREE 7231 05:09:04,200 --> 05:09:05,760 CHARACTER CODES THAT INDICATE 7232 05:09:05,760 --> 05:09:08,960 THE CATEGORY AND SPECIFIC FORM 7233 05:09:08,960 --> 05:09:11,520 OF SUPPORT. 7234 05:09:11,520 --> 05:09:12,480 FOR EXAMPLE, R01, U01. 7235 05:09:12,480 --> 05:09:15,080 FOR A FULL LIST OF THOSE 7236 05:09:15,080 --> 05:09:17,680 ACTIVITY CODES, HERE'S THE URL. 7237 05:09:17,680 --> 05:09:20,320 AGAIN, I ENCOURAGE YOU TO GO TO 7238 05:09:20,320 --> 05:09:21,760 THAT WEBSITE, YOU KNOW, IF 7239 05:09:21,760 --> 05:09:23,960 YOU'RE BEGINNING TO ENTER THIS 7240 05:09:23,960 --> 05:09:25,520 WORLD AND SEEKING SUPPORT. 7241 05:09:25,520 --> 05:09:28,600 HOPING TO MAKE THIS A CAREER. 7242 05:09:28,600 --> 05:09:32,200 I DO WANT TO POINT OUT TO YOU 7243 05:09:32,200 --> 05:09:34,840 THOUGH THAT NIH I.C.s MAY VARY 7244 05:09:34,840 --> 05:09:37,800 IN THE WAY THEY USE SPECIFIC 7245 05:09:37,800 --> 05:09:40,960 ACTIVITY CODES, A COUPLE 7246 05:09:40,960 --> 05:09:43,080 EXAMPLES ARE R21 AND R56, THEY 7247 05:09:43,080 --> 05:09:44,320 ARE USED SLIGHTLY DIFFERENTLY 7248 05:09:44,320 --> 05:09:48,360 AMONGST THE I.C.s. 7249 05:09:48,360 --> 05:09:50,520 AND THEN NOT ALL I.C. ACCEPTS 7250 05:09:50,520 --> 05:09:51,680 APPLICATION FOR ALL ACTIVITY 7251 05:09:51,680 --> 05:09:52,240 CODES. 7252 05:09:52,240 --> 05:09:56,920 THAT WOULD BE TOO MUCH. 7253 05:09:56,920 --> 05:10:01,200 IN TERMS OF GRANT TYPES, WE 7254 05:10:01,200 --> 05:10:04,160 HAVE -- THESE ARE CATEGORIES, 7255 05:10:04,160 --> 05:10:04,520 RIGHT? 7256 05:10:04,520 --> 05:10:07,520 GRANT TYPES AGAIN IS A KIND OF 7257 05:10:07,520 --> 05:10:08,400 UMBRELLA TERM. 7258 05:10:08,400 --> 05:10:12,160 BUT THE SAKE OF THIS DISCUSSION, 7259 05:10:12,160 --> 05:10:16,000 ONE WAY TO CHARACTERIZE GRANT 7260 05:10:16,000 --> 05:10:18,440 TYPES IS THROUGH CATEGORIES. 7261 05:10:18,440 --> 05:10:22,080 ACTUALLY BUDGET CATEGORIES. 7262 05:10:22,080 --> 05:10:26,720 ONE CATEGORY IS RESEARCH PROJECT 7263 05:10:26,720 --> 05:10:33,160 GRANTS, AND THAT ARE SUCH THINGS 7264 05:10:33,160 --> 05:10:36,120 AS R01, R21, R03, LARGE CENTER 7265 05:10:36,120 --> 05:10:38,600 GRANTS BEGIN WITH P ACTIVITY 7266 05:10:38,600 --> 05:10:39,720 CODES SOMETIMES USED. 7267 05:10:39,720 --> 05:10:42,080 THERE ARE TRAINING MECHANISMS, 7268 05:10:42,080 --> 05:10:45,280 MOST OF THESE BEGIN WITH 7269 05:10:45,280 --> 05:10:48,040 ACTIVITY CODES F, T, OR Ks. 7270 05:10:48,040 --> 05:10:50,840 SMALL BUSINESS AND TECHNOLOGY 7271 05:10:50,840 --> 05:10:53,080 TRANSFER AWARDS, SBIR, STTR, AND 7272 05:10:53,080 --> 05:10:54,440 THERE'S RESEARCH RESOURCES AND 7273 05:10:54,440 --> 05:10:55,520 INFRASTRUCTURE AWARDS, THERE ARE 7274 05:10:55,520 --> 05:10:58,200 OTHER CATEGORIES BUT THOSE ARE 7275 05:10:58,200 --> 05:10:59,720 THE MOST COMMON THAT YOU'LL RUN 7276 05:10:59,720 --> 05:11:00,280 INTO. 7277 05:11:00,280 --> 05:11:01,880 AGAIN, THIS IS A URL THAT WILL 7278 05:11:01,880 --> 05:11:04,680 TAKE YOU TO A LIST OF THESE 7279 05:11:04,680 --> 05:11:05,720 DIFFERENT GRANT TYPES. 7280 05:11:05,720 --> 05:11:07,880 BY FAR AND LARGE THE ONE THAT IS 7281 05:11:07,880 --> 05:11:11,680 MOST WELL KNOWN IS THE R01 7282 05:11:11,680 --> 05:11:15,320 RESEARCH PROJECT GRANT. 7283 05:11:15,320 --> 05:11:16,880 THAT IS I BELIEVE STILL 7284 05:11:16,880 --> 05:11:19,480 CONSIDERED TO BE THE GOLD 7285 05:11:19,480 --> 05:11:24,080 STANDARD OF NIH RESEARCH 7286 05:11:24,080 --> 05:11:24,320 SUPPORT. 7287 05:11:24,320 --> 05:11:26,760 IT IS I THINK A PREVAILING 7288 05:11:26,760 --> 05:11:31,080 BELIEF THAT ONCE YOU HAVE AN R01 7289 05:11:31,080 --> 05:11:34,080 YOU ARE ON YOUR WAY BECAUSE IT'S 7290 05:11:34,080 --> 05:11:36,200 A BIG -- QUITE A BIG 7291 05:11:36,200 --> 05:11:42,560 ACCOMPLISHMENT TO GET THAT FIRST 7292 05:11:42,560 --> 05:11:43,560 R01. 7293 05:11:43,560 --> 05:11:44,280 OKAY. 7294 05:11:44,280 --> 05:11:46,800 AND I ADDED THIS SLIDE BECAUSE I 7295 05:11:46,800 --> 05:11:51,560 THINK IT IS IMPORTANT, AND I'M 7296 05:11:51,560 --> 05:11:54,600 OFTEN SURPRISED AT HOW MANY 7297 05:11:54,600 --> 05:11:56,280 PEOPLE DON'T KNOW WHAT 7298 05:11:56,280 --> 05:11:58,880 APPLICATION TYPES ARE. 7299 05:11:58,880 --> 05:12:00,840 NOW, THIS IS JARGON THAT'S NOT 7300 05:12:00,840 --> 05:12:04,440 FOR THE FAINT HEARTED. 7301 05:12:04,440 --> 05:12:05,080 ALERT. 7302 05:12:05,080 --> 05:12:06,920 THIS IS ALSO SOME JARGON THAT'S 7303 05:12:06,920 --> 05:12:08,520 PROBABLY MORE IMPORTANT TO KNOW 7304 05:12:08,520 --> 05:12:12,360 ONCE YOU HAVE RECEIVED AN NIH 7305 05:12:12,360 --> 05:12:13,040 AWARD. 7306 05:12:13,040 --> 05:12:14,600 FOR EXAMPLE, IF YOU'RE READING 7307 05:12:14,600 --> 05:12:17,160 UP ON NIH POLICY NOTICES, OR 7308 05:12:17,160 --> 05:12:20,160 YOU'RE ON AN I.C. WEBSITE, AND 7309 05:12:20,160 --> 05:12:21,960 READING A PAGE, YOU MIGHT BE 7310 05:12:21,960 --> 05:12:23,680 LOOKING UP PAY LINES OR MAY BE 7311 05:12:23,680 --> 05:12:26,200 SPEAKING TO A PROGRAM OFFICIAL, 7312 05:12:26,200 --> 05:12:27,760 THESE ARE -- I'VE LISTED A FEW 7313 05:12:27,760 --> 05:12:28,400 OF THE TYPES. 7314 05:12:28,400 --> 05:12:29,000 THERE ARE OTHERS. 7315 05:12:29,000 --> 05:12:32,480 BUT THESE ARE THE MOST IMPORTANT 7316 05:12:32,480 --> 05:12:34,080 ONES. 7317 05:12:34,080 --> 05:12:36,120 A TYPE 1 MEANS THAT THIS IS A 7318 05:12:36,120 --> 05:12:38,680 NEW RESEARCH PROJECT THAT HAS 7319 05:12:38,680 --> 05:12:40,160 NEVER HAD PRIOR NIH FUNDING. 7320 05:12:40,160 --> 05:12:43,680 IT IS COMPETING, IT HAS TO GO 7321 05:12:43,680 --> 05:12:44,440 THROUGH PEER REVIEW. 7322 05:12:44,440 --> 05:12:47,680 TYPE 2 IS A RENEWAL. 7323 05:12:47,680 --> 05:12:50,280 SO, IT HAD -- THIS IS A RESEARCH 7324 05:12:50,280 --> 05:12:53,400 PROJECT WITH PRIOR FUNDING, THAT 7325 05:12:53,400 --> 05:12:54,400 FUNDING ENDED. 7326 05:12:54,400 --> 05:12:56,720 NOW THE APPLICATION IS COMING 7327 05:12:56,720 --> 05:12:57,400 IN. 7328 05:12:57,400 --> 05:13:00,360 IT IS COMPETING APPLICATION FOR 7329 05:13:00,360 --> 05:13:01,640 CONTINUATION OF SUPPORT. 7330 05:13:01,640 --> 05:13:04,160 AND EASY EXAMPLE IS AN R01 7331 05:13:04,160 --> 05:13:05,720 FUNDED FOR FIVE YEARS, COMES TO 7332 05:13:05,720 --> 05:13:08,840 THE END OF THAT FIVE YEARS, AND 7333 05:13:08,840 --> 05:13:11,680 NOW THE P.I. SUBMITS A ANOTHER 7334 05:13:11,680 --> 05:13:12,440 COMPETING APPLICATION FOR 7335 05:13:12,440 --> 05:13:15,760 ANOTHER FIVE YEARS OF SUPPORT. 7336 05:13:15,760 --> 05:13:17,480 YEARS SIX THROUGH TEN. 7337 05:13:17,480 --> 05:13:19,520 THAT'S TYPE 2. 7338 05:13:19,520 --> 05:13:21,360 A DATA SLIDES I SHOWED TYPE 2 7339 05:13:21,360 --> 05:13:24,760 AND TYPE 2 ON THE SLIDE. 7340 05:13:24,760 --> 05:13:28,440 TYPE 3 IS A SUPPLEMENT TO AN 7341 05:13:28,440 --> 05:13:30,320 EXISTING GRANT. 7342 05:13:30,320 --> 05:13:33,000 AND TO MAKE THINGS REALLY 7343 05:13:33,000 --> 05:13:37,240 INTERESTING, NIH HAS BOTH 7344 05:13:37,240 --> 05:13:39,520 COMPETITIVE AND NON-COMPETITIVE 7345 05:13:39,520 --> 05:13:41,680 ADMINISTRATIVE -- COMPETITIVE 7346 05:13:41,680 --> 05:13:41,960 SUPPLEMENTS. 7347 05:13:41,960 --> 05:13:42,920 ADMINISTRATIVE SUPPLEMENTS ARE 7348 05:13:42,920 --> 05:13:45,800 NON-COMPETITIVE BY DEFINITION. 7349 05:13:45,800 --> 05:13:51,360 A COMPETITIVE SUPPLEMENT MUST GO 7350 05:13:51,360 --> 05:13:52,040 THROUGH PEER REVIEW. 7351 05:13:52,040 --> 05:13:54,160 TYPE 5 IS A NON-COMPETING 7352 05:13:54,160 --> 05:13:55,320 CONTINUATION, THIS IS AN EASY 7353 05:13:55,320 --> 05:13:56,120 ONE. 7354 05:13:56,120 --> 05:13:57,800 THIS IS THE OUTYEAR. 7355 05:13:57,800 --> 05:14:00,480 YOU GET YOUR R01, YEAR 1 IS 7356 05:14:00,480 --> 05:14:02,120 COMPETING YEAR, HAS TO GO 7357 05:14:02,120 --> 05:14:03,200 THROUGH PEER REVIEW, YEARS 2, 3, 7358 05:14:03,200 --> 05:14:05,080 4 AND 5 DON'T HAVE TO GO THROUGH 7359 05:14:05,080 --> 05:14:07,440 PEER REVIEW EACH OF THOSE YEARS. 7360 05:14:07,440 --> 05:14:09,440 THOSE ARE THE OUTYEARS, EACH 7361 05:14:09,440 --> 05:14:10,040 CALLED TYPE 5s. 7362 05:14:10,040 --> 05:14:12,800 AGAIN FOR A LIST OF APPLICATION 7363 05:14:12,800 --> 05:14:16,080 TYPES, HERE IS THE URL. 7364 05:14:16,080 --> 05:14:17,440 7365 05:14:17,440 --> 05:14:17,880 OKAY. 7366 05:14:17,880 --> 05:14:22,520 SO, WHAT IS A FUNDING 7367 05:14:22,520 --> 05:14:23,280 OPPORTUNITY ANNOUNCEMENT? 7368 05:14:23,280 --> 05:14:25,760 IT IS, I QUOTE, A PUBLICLY 7369 05:14:25,760 --> 05:14:28,080 AVAILABLE DOCUMENT IN WHICH THE 7370 05:14:28,080 --> 05:14:30,360 FEDERAL AGENCY MAKES KNOWN ITS 7371 05:14:30,360 --> 05:14:32,360 INTENTIONS TO AWARD, USUALLY AS 7372 05:14:32,360 --> 05:14:35,000 A RESULT OF COMPETITION FOR 7373 05:14:35,000 --> 05:14:39,720 FUNDS, THAT'S STRAIGHT FROM THE 7374 05:14:39,720 --> 05:14:40,440 NIH GRANTS MANUAL. 7375 05:14:40,440 --> 05:14:45,480 WE CALL THEM FOAs, FUNDING 7376 05:14:45,480 --> 05:14:46,840 OPPORTUNITY ANNOUNCEMENTS. 7377 05:14:46,840 --> 05:14:48,480 FOA IS THE ACRONYM. 7378 05:14:48,480 --> 05:14:51,000 NIH FOAs PRIMARILY FALL INTO 7379 05:14:51,000 --> 05:14:54,440 THE CATEGORIES OF PROGRAM 7380 05:14:54,440 --> 05:14:56,800 ANNOUNCEMENTS, REQUESTS FOR 7381 05:14:56,800 --> 05:15:00,160 APPLICATIONS, PARENT 7382 05:15:00,160 --> 05:15:00,800 ANNOUNCEMENT. 7383 05:15:00,800 --> 05:15:01,520 PROGRAM ANNOUNCEMENTS ARE 7384 05:15:01,520 --> 05:15:04,760 ANNOUNCEMENTS OF A NEW OR 7385 05:15:04,760 --> 05:15:05,840 ONGOING EXTRAMURAL ACTIVITY, 7386 05:15:05,840 --> 05:15:07,840 PROGRAM, MAY SERVE AS REMINDER 7387 05:15:07,840 --> 05:15:10,000 OF CONTINUING INTEREST IN 7388 05:15:10,000 --> 05:15:12,240 RESEARCH AREA, OR DESCRIBE 7389 05:15:12,240 --> 05:15:14,600 MODIFICATION OF AN ACTIVITY OR 7390 05:15:14,600 --> 05:15:19,840 PROGRAM, USUALLY ALWAYS INVITE 7391 05:15:19,840 --> 05:15:20,760 APPLICATIONS. 7392 05:15:20,760 --> 05:15:22,840 RFA SOLICITS GRANT OR 7393 05:15:22,840 --> 05:15:24,600 COOPERATIVE AGREEMENT 7394 05:15:24,600 --> 05:15:26,160 APPLICATIONS IN A WELL-DEFINED 7395 05:15:26,160 --> 05:15:30,560 SCIENTIFIC AREA TO ACCOMPLISH 7396 05:15:30,560 --> 05:15:32,960 SPECIFIC PROGRAM OBJECTIVES. 7397 05:15:32,960 --> 05:15:35,640 AND A PARENT ANNOUNCEMENT, VERY 7398 05:15:35,640 --> 05:15:40,440 GENERIC, THESE ARE OMNIBUS OR 7399 05:15:40,440 --> 05:15:42,200 PARENT ANNOUNCEMENTS PROVIDED TO 7400 05:15:42,200 --> 05:15:43,360 APPLICANTS BECAUSE EVERY 7401 05:15:43,360 --> 05:15:48,640 APPLICATION MUST BE SUBMITTED 7402 05:15:48,640 --> 05:15:51,400 ELECTRONICALLY UNDER SOME FOA, 7403 05:15:51,400 --> 05:15:56,000 UNDER THE GUISE OR UMBRELLA OF 7404 05:15:56,000 --> 05:15:57,200 AN ANNOUNCEMENT. 7405 05:15:57,200 --> 05:15:59,800 AND THE PROJECT SUBMITTED UNDER 7406 05:15:59,800 --> 05:16:00,880 PARENT ANNOUNCEMENTS ARE NOT 7407 05:16:00,880 --> 05:16:04,240 TARGETED TO ANY SPECIFIC 7408 05:16:04,240 --> 05:16:06,680 INITIATIVE BUT THEY ARE FUNNELED 7409 05:16:06,680 --> 05:16:09,160 TO THE CORRECT -- MOST FITTING 7410 05:16:09,160 --> 05:16:11,920 INSTITUTES ONCE THEY COME IN THE 7411 05:16:11,920 --> 05:16:12,960 DOOR. 7412 05:16:12,960 --> 05:16:17,040 REQUEST FOR PROPOSALS, RFPs, 7413 05:16:17,040 --> 05:16:18,000 SOLICITATIONS FOR CONTRACTS, 7414 05:16:18,000 --> 05:16:18,400 RESEARCH CONTRACTS. 7415 05:16:18,400 --> 05:16:19,760 WE'RE NOT GOING TO TALK ABOUT 7416 05:16:19,760 --> 05:16:22,040 THOSE TODAY BECAUSE THEY ARE 7417 05:16:22,040 --> 05:16:23,600 VERY, VERY DIFFERENT. 7418 05:16:23,600 --> 05:16:32,520 THEY ARE NOT AS FREQUENT. 7419 05:16:32,520 --> 05:16:36,680 SO, NIH ALSO HAS AN EXTENSIVE 7420 05:16:36,680 --> 05:16:39,240 TRAINING AND CAREER DEVELOPMENT 7421 05:16:39,240 --> 05:16:39,560 PROGRAM. 7422 05:16:39,560 --> 05:16:42,360 THIS IS FROM THE WEBSITE FOR 7423 05:16:42,360 --> 05:16:44,080 TRAINING AND CAREER DEVELOPMENT. 7424 05:16:44,080 --> 05:16:46,000 AGAIN, THE URL IS HERE. 7425 05:16:46,000 --> 05:16:47,840 I LOVE THIS WEBSITE. 7426 05:16:47,840 --> 05:16:49,240 IT IS EXTREMELY THOROUGH, IT'S 7427 05:16:49,240 --> 05:16:52,600 BEEN HERE FOR A LONG TIME. 7428 05:16:52,600 --> 05:16:54,920 THEY REALLY BUILT IT UP AND MADE 7429 05:16:54,920 --> 05:16:57,240 IT A BEAUTIFUL WEBSITE. 7430 05:16:57,240 --> 05:17:02,040 IT'S EASY TO USE. 7431 05:17:02,040 --> 05:17:02,480 VERY COMPREHENSIVE. 7432 05:17:02,480 --> 05:17:09,480 AT THE TOP YOU HAVE THE 7433 05:17:09,480 --> 05:17:10,160 TRAJECTORY, GENERIC TRAJECTORY 7434 05:17:10,160 --> 05:17:11,120 OF RESEARCH CAREER. 7435 05:17:11,120 --> 05:17:12,400 CLICK ON ANY BOX, IT WILL TAKE 7436 05:17:12,400 --> 05:17:15,960 YOU TO MORE INFORMATION ABOUT 7437 05:17:15,960 --> 05:17:19,200 THAT STAGE OF THE RESEARCH 7438 05:17:19,200 --> 05:17:19,920 CAREER. 7439 05:17:19,920 --> 05:17:27,240 MOST OF THE TRAINING AND CAREER 7440 05:17:27,240 --> 05:17:28,520 DEVELOPMENT GRANTS FALL INTO 7441 05:17:28,520 --> 05:17:31,320 THREE GROUPS, ONE IS THE 7442 05:17:31,320 --> 05:17:32,320 INSTITUTIONAL AND INDIVIDUAL 7443 05:17:32,320 --> 05:17:33,720 TRAINING GRANTS, THEY BEGIN WITH 7444 05:17:33,720 --> 05:17:36,920 Ts FOR THE MOST PART. 7445 05:17:36,920 --> 05:17:38,240 ANOTHER GROUP ARE THE INDIVIDUAL 7446 05:17:38,240 --> 05:17:39,920 FELLOWSHIPS WHICH BEGIN WITH 7447 05:17:39,920 --> 05:17:40,080 Fs. 7448 05:17:40,080 --> 05:17:43,280 AND THEN THE OTHER GROUP IS 7449 05:17:43,280 --> 05:17:44,840 CAREER DEVELOPMENT AWARDS WHICH 7450 05:17:44,840 --> 05:17:51,360 BEGIN WITH Ks FOR THE MOST 7451 05:17:51,360 --> 05:17:51,840 PART. 7452 05:17:51,840 --> 05:17:54,520 THE MIDDLE OF THE PAGE YOU SEE 7453 05:17:54,520 --> 05:17:54,840 KIOSKS. 7454 05:17:54,840 --> 05:17:56,560 WHEN YOU'RE ON THE SITE, IF YOU 7455 05:17:56,560 --> 05:18:01,040 CLICK ON ANY OF THESE KIOSKS IT 7456 05:18:01,040 --> 05:18:02,640 WILL TAKE YOU TO MUCH MORE 7457 05:18:02,640 --> 05:18:05,880 INFORMATION ABOUT EACH OF THOSE 7458 05:18:05,880 --> 05:18:08,760 AREAS. 7459 05:18:08,760 --> 05:18:10,320 IN THE CAREER DEVELOPMENT KIOSK 7460 05:18:10,320 --> 05:18:14,440 YOU'LL SEE 15 DIFFERENT TYPES OF 7461 05:18:14,440 --> 05:18:15,760 K GRANTS. 7462 05:18:15,760 --> 05:18:21,560 RESEARCH TRAINING KIOSK THERE'S 7463 05:18:21,560 --> 05:18:23,960 SEVEN DIFFERENT TYPES OF 7464 05:18:23,960 --> 05:18:24,360 PROGRAMS. 7465 05:18:24,360 --> 05:18:26,160 IN THE FELLOWSHIP KIOSK THERE 7466 05:18:26,160 --> 05:18:29,680 ARE ALSO SEVEN DIFFERENT TYPES 7467 05:18:29,680 --> 05:18:33,120 OF FELLOWSHIPS, FELLOWSHIP 7468 05:18:33,120 --> 05:18:35,960 GRANTS. 7469 05:18:35,960 --> 05:18:38,200 THE OTHER TRAINING-RELATED 7470 05:18:38,200 --> 05:18:44,840 KIOSK, DP 2, DP 5, R35, LRP LOAN 7471 05:18:44,840 --> 05:18:45,960 REPAYMENT PROGRAM AND 7472 05:18:45,960 --> 05:18:47,280 ADMINISTRATIVE SUPPLEMENTS TO 7473 05:18:47,280 --> 05:18:48,320 PROMOTE DIVERSITY AND 7474 05:18:48,320 --> 05:18:53,400 HEALTH-RELATED RESEARCH AND 7475 05:18:53,400 --> 05:18:56,040 REENTRY INTO THE BIOMEDICAL WORK 7476 05:18:56,040 --> 05:18:57,440 FORCE FOR THOSE WITH 7477 05:18:57,440 --> 05:19:00,000 INTERRUPTIONS IN THEIR CAREERS. 7478 05:19:00,000 --> 05:19:05,640 NOT ALL I.C.s HAVE ALL OF 7479 05:19:05,640 --> 05:19:06,720 THESE GRANT MECHANISMS TO OFFER. 7480 05:19:06,720 --> 05:19:10,000 THAT WOULD BE TOO MUCH. 7481 05:19:10,000 --> 05:19:11,520 BUT ON THE WEBSITE THERE'S A 7482 05:19:11,520 --> 05:19:14,280 VERY NICE LINK THAT WILL TAKE 7483 05:19:14,280 --> 05:19:15,480 YOU TO A TABLE, THAT TABLE WILL 7484 05:19:15,480 --> 05:19:17,560 TAKE YOU TO EACH OF THE I.C.s, 7485 05:19:17,560 --> 05:19:19,880 WHICH EVER ONE YOU'RE INTERESTED 7486 05:19:19,880 --> 05:19:23,240 IN, TO THEIR TRAINING PAGE WHERE 7487 05:19:23,240 --> 05:19:27,000 THEY WILL DESCRIBE THE TRAINING 7488 05:19:27,000 --> 05:19:28,000 PROGRAMS THEY OFFER. 7489 05:19:28,000 --> 05:19:31,520 I ALSO SHOULD POINT OUT THIS 7490 05:19:31,520 --> 05:19:32,520 ONE, EXTRAMURAL DIVERSITY KIOSK, 7491 05:19:32,520 --> 05:19:34,480 CLICK ON THAT KIOSK AND IT 7492 05:19:34,480 --> 05:19:36,720 BRINGS YOU ALMOST TO AN ENTIRELY 7493 05:19:36,720 --> 05:19:38,880 NEW WEBSITE, IT SEEMS. 7494 05:19:38,880 --> 05:19:44,040 IT'S VERY EXTENSIVE. 7495 05:19:44,040 --> 05:19:46,080 THIS KIOSK COVERS ALL OF THE -- 7496 05:19:46,080 --> 05:19:49,560 IT'S A WEALTH OF INFORMATION 7497 05:19:49,560 --> 05:19:51,800 ABOUT HOW NIH PROMOTES 7498 05:19:51,800 --> 05:19:53,280 SCIENTIFIC -- DIVERSE SCIENTIFIC 7499 05:19:53,280 --> 05:19:56,040 RESEARCH WORKFORCE AND DOES 7500 05:19:56,040 --> 05:19:59,800 INCLUDE FUNDING OPPORTUNITIES AS 7501 05:19:59,800 --> 05:20:00,240 WELL. 7502 05:20:00,240 --> 05:20:00,760 OKAY. 7503 05:20:00,760 --> 05:20:03,840 NOW, WE'RE GOING TO TALK ABOUT 7504 05:20:03,840 --> 05:20:06,400 HOW YOU INTERACT WITH THIS 7505 05:20:06,400 --> 05:20:07,960 SYSTEM AND THE PEOPLE. 7506 05:20:07,960 --> 05:20:15,680 HOW CAN I IDENTIFY TOPICS, 7507 05:20:15,680 --> 05:20:17,480 FUNDING MECHANISMS, FUNDING 7508 05:20:17,480 --> 05:20:18,120 OPPORTUNITIES? 7509 05:20:18,120 --> 05:20:20,080 YOU NEED TO BECOME FAMILIAR WITH 7510 05:20:20,080 --> 05:20:22,160 NIH-WIDE AND I.C. WEBSITES. 7511 05:20:22,160 --> 05:20:25,520 I KNOW IT SOUNDS TRITE BUT IT IS 7512 05:20:25,520 --> 05:20:26,720 REALLY TRUE. 7513 05:20:26,720 --> 05:20:29,360 IT IS SO HELPFUL AND SO MUCH 7514 05:20:29,360 --> 05:20:30,880 MORE PRODUCTIVE IF YOU'RE DONE 7515 05:20:30,880 --> 05:20:32,360 YOUR HOMEWORK BY LOOKING THROUGH 7516 05:20:32,360 --> 05:20:33,160 SOME OF THESE WEBSITES, THAT'S 7517 05:20:33,160 --> 05:20:35,840 THE REASON I GAVE YOU SO MANY 7518 05:20:35,840 --> 05:20:38,040 URLs IN THE PREVIOUS SLIDES. 7519 05:20:38,040 --> 05:20:40,000 BEFORE YOU CONTACT A PROGRAM 7520 05:20:40,000 --> 05:20:40,800 OFFICIAL. 7521 05:20:40,800 --> 05:20:43,720 BECAUSE YOU'LL BE INFORMED. 7522 05:20:43,720 --> 05:20:44,400 SOMEWHAT INFORMED. 7523 05:20:44,400 --> 05:20:46,760 ALSO, BECOME FAMILIAR WITH THE 7524 05:20:46,760 --> 05:20:48,440 NIH GUIDE FOR GRANTS AND 7525 05:20:48,440 --> 05:20:50,840 CONTRACTS, AND I'LL SHOW YOU 7526 05:20:50,840 --> 05:20:53,080 MORE IN JUST A MINUTE. 7527 05:20:53,080 --> 05:20:56,360 WHEN YOU ATTEND SCIENTIFIC 7528 05:20:56,360 --> 05:20:58,920 MEETINGS, CORNER AN NIH 7529 05:20:58,920 --> 05:20:59,320 OFFICIAL. 7530 05:20:59,320 --> 05:21:01,160 NIH PROGRAM OFFICIALS LOVE TO 7531 05:21:01,160 --> 05:21:01,920 ANSWER QUESTIONS. 7532 05:21:01,920 --> 05:21:06,760 LOVE TO FEEL LIKE THEY ARE 7533 05:21:06,760 --> 05:21:07,560 HELPING YOU. 7534 05:21:07,560 --> 05:21:09,440 CONTACT AN OFFICIAL FOR GUIDANCE 7535 05:21:09,440 --> 05:21:10,800 ON WHETHER CERTAIN FUNDING 7536 05:21:10,800 --> 05:21:12,600 MECHANISMS ARE SUITABLE FOR YOU 7537 05:21:12,600 --> 05:21:14,800 OR WHAT FUNDING ANNOUNCEMENTS 7538 05:21:14,800 --> 05:21:17,240 ARE OUT THERE. 7539 05:21:17,240 --> 05:21:19,960 SCIENTIFIC TOPIC THAT YOU HAVE 7540 05:21:19,960 --> 05:21:22,000 AND ARE DEVELOPING, TYPE OF 7541 05:21:22,000 --> 05:21:24,520 PROJECT, ALSO TO ASK ABOUT 7542 05:21:24,520 --> 05:21:26,080 WHAT'S AVAILABLE FOR YOUR CAREER 7543 05:21:26,080 --> 05:21:29,720 STAGE AND YOUR PRIOR RESEARCH 7544 05:21:29,720 --> 05:21:30,040 EXPERIENCE. 7545 05:21:30,040 --> 05:21:34,720 THERE ARE MANY GOOD PROGRAMS AND 7546 05:21:34,720 --> 05:21:36,400 POLICIES AVAILABLE FOR 7547 05:21:36,400 --> 05:21:39,960 EARLY-STAGE INVESTIGATORS, THAT 7548 05:21:39,960 --> 05:21:41,360 PROVIDE VERY ADVANTAGEOUS 7549 05:21:41,360 --> 05:21:46,960 CLIMATES FOR YOUR APPLICATION. 7550 05:21:46,960 --> 05:21:50,600 AND DO FOLLOW UP. 7551 05:21:50,600 --> 05:21:52,560 >> DR. HAGGERTY, WE'RE AT TIME. 7552 05:21:52,560 --> 05:21:55,400 A FEW MORE MINUTES TO WRAP UP. 7553 05:21:55,400 --> 05:21:55,960 >> SURE. 7554 05:21:55,960 --> 05:21:59,320 I'M GOING TO JUST SKIP THAT ONE. 7555 05:21:59,320 --> 05:22:00,280 AND SHOW YOU THE GUIDE. 7556 05:22:00,280 --> 05:22:05,920 THIS IS A PAGE FROM THE NIH 7557 05:22:05,920 --> 05:22:06,120 GUIDE. 7558 05:22:06,120 --> 05:22:11,160 THAT IS WHERE YOU WILL FIND 7559 05:22:11,160 --> 05:22:15,520 PROGRAM ANNOUNCEMENTS. 7560 05:22:15,520 --> 05:22:17,760 [AUDIO DISTORTION] 7561 05:22:17,760 --> 05:22:23,200 IN THE MIDDLE YOU CAN PUT A 7562 05:22:23,200 --> 05:22:23,600 SEARCH TERM IN. 7563 05:22:23,600 --> 05:22:32,040 [AUDIO DISTORTION] 7564 05:22:32,040 --> 05:22:36,160 7565 05:22:36,160 --> 05:22:37,240 7566 05:22:37,240 --> 05:22:39,280 THIS IS RECENT. 7567 05:22:39,280 --> 05:22:42,080 >> WE'RE GETTING SOME FEEDBACK 7568 05:22:42,080 --> 05:22:44,920 WITH YOUR MICROPHONE. 7569 05:22:44,920 --> 05:22:45,320 >> IS THAT BETTER? 7570 05:22:45,320 --> 05:22:49,760 >> YES, MUCH BETTER. 7571 05:22:49,760 --> 05:22:50,240 >> OKAY. 7572 05:22:50,240 --> 05:22:51,680 SO THAT'S WHAT YOU'LL SEE. 7573 05:22:51,680 --> 05:22:55,480 I ENCOURAGE YOU NOT TO LIMIT 7574 05:22:55,480 --> 05:22:58,320 YOURSELF TO THE WORD 7575 05:22:58,320 --> 05:22:59,040 "NUTRITION." 7576 05:22:59,040 --> 05:23:00,040 HOW CAN I IDENTIFY? 7577 05:23:00,040 --> 05:23:02,960 AGAIN, MORE ON THIS TOPIC, NIH 7578 05:23:02,960 --> 05:23:05,040 REPORTER IS ANOTHER BEAUTIFUL 7579 05:23:05,040 --> 05:23:06,280 WEBSITE. 7580 05:23:06,280 --> 05:23:07,880 I THINK IT'S PROBABLY THE BEST 7581 05:23:07,880 --> 05:23:11,280 RESOURCE THAT THE NIH HAS. 7582 05:23:11,280 --> 05:23:14,480 IN ADDITION TO REPORTER, YOU 7583 05:23:14,480 --> 05:23:18,160 ALSO HAVE CLINICALTRIALS.GOV, A 7584 05:23:18,160 --> 05:23:19,560 WORLDWIDE DATABASE, PRIVATELY 7585 05:23:19,560 --> 05:23:20,720 AND PUBLICLY FUNDED CLINICAL 7586 05:23:20,720 --> 05:23:22,480 TRIALS STUDIES AND REGISTRATION 7587 05:23:22,480 --> 05:23:24,640 IS REQUIRED NOW BEFORE JOURNALS 7588 05:23:24,640 --> 05:23:27,000 WILL PUBLISH YOUR PAPERS. 7589 05:23:27,000 --> 05:23:29,520 I'M PUTTING THIS IN HERE BECAUSE 7590 05:23:29,520 --> 05:23:31,480 I JUST FOUND OUT, I RECENTLY 7591 05:23:31,480 --> 05:23:33,200 JUST LEARNED THAT THE FEDERAL 7592 05:23:33,200 --> 05:23:36,760 REPORTER, WHICH SOME OF YOU KNOW 7593 05:23:36,760 --> 05:23:39,280 ABOUT, HAS BEEN PUT TO SLEEP. 7594 05:23:39,280 --> 05:23:42,680 AND IS NOW REPLACED BY ANOTHER 7595 05:23:42,680 --> 05:23:47,920 SITE CALLED U.S. SPENDING, 7596 05:23:47,920 --> 05:23:51,440 USSPENDING.GOV, THERE FOR YOUR 7597 05:23:51,440 --> 05:23:52,160 INFORMATION. 7598 05:23:52,160 --> 05:23:55,960 AND THE NIH REPORTER IS A 7599 05:23:55,960 --> 05:23:59,440 WONDERFUL RESOURCE, HERE IS THE 7600 05:23:59,440 --> 05:23:59,680 WEBSITE. 7601 05:23:59,680 --> 05:24:01,400 THIS IS ACTUALLY THE MODERNIZED 7602 05:24:01,400 --> 05:24:03,520 VERSION OF THE REPORTER WEBSITE. 7603 05:24:03,520 --> 05:24:06,480 IT WAS JUST RELEASED TO THE 7604 05:24:06,480 --> 05:24:07,840 PUBLIC IN OCTOBER OF 2020. 7605 05:24:07,840 --> 05:24:11,240 IT HAS A GUIDED TOUR FOR YOU UP 7606 05:24:11,240 --> 05:24:11,440 HERE. 7607 05:24:11,440 --> 05:24:14,920 IT ALSO HAS A QUICK SEARCH BAR. 7608 05:24:14,920 --> 05:24:18,760 YOU CAN PUT IN A TERM LIKE A 7609 05:24:18,760 --> 05:24:21,120 P.I. NAME, OR A PROJECT NUMBER, 7610 05:24:21,120 --> 05:24:23,240 OR A FISCAL YEAR. 7611 05:24:23,240 --> 05:24:24,360 I WOULD NOT ENCOURAGE YOU TO 7612 05:24:24,360 --> 05:24:27,600 JUST PUT IN A FISCAL YEAR 7613 05:24:27,600 --> 05:24:29,120 BECAUSE YOU'LL GET A LONG LIST 7614 05:24:29,120 --> 05:24:31,120 BUT WILL PULL UP EVERYTHING 7615 05:24:31,120 --> 05:24:32,760 FUNDED BASED ON YOUR SEARCH 7616 05:24:32,760 --> 05:24:33,720 TERM. 7617 05:24:33,720 --> 05:24:38,440 THE REPORTER, NIH REPORTER, IS A 7618 05:24:38,440 --> 05:24:39,480 DATABASE THAT CONTAINS FUNDED -- 7619 05:24:39,480 --> 05:24:40,800 INFORMATION ON FUND RESEARCH 7620 05:24:40,800 --> 05:24:42,240 PROJECTS, DOES NOT CONTAIN 7621 05:24:42,240 --> 05:24:45,000 INFORMATION ON APPLICATIONS THAT 7622 05:24:45,000 --> 05:24:47,480 WERE NOT FUNDED. 7623 05:24:47,480 --> 05:24:50,080 IN REPORTER YOU CAN DO MANY 7624 05:24:50,080 --> 05:24:50,960 DIFFERENT THINGS. 7625 05:24:50,960 --> 05:24:54,920 YOU CAN USE AN ADVANCED SEARCH 7626 05:24:54,920 --> 05:24:56,480 FEATURE WHICH HAS MULTIPLE 7627 05:24:56,480 --> 05:24:58,320 DIFFERENT FILTERS, THAT YOU CAN 7628 05:24:58,320 --> 05:25:03,040 SET TO NARROW DOWN THE SEARCH 7629 05:25:03,040 --> 05:25:05,280 THAT YOU WANT TO FIND FUNDED 7630 05:25:05,280 --> 05:25:07,280 RESEARCH THAT IS GOING TO INFORM 7631 05:25:07,280 --> 05:25:08,800 WHAT YOU ARE TRYING TO DO. 7632 05:25:08,800 --> 05:25:13,320 AND IT ALSO HAS A VERY COOL 7633 05:25:13,320 --> 05:25:17,160 TOOL, I'M GOING TO MENTION THE 7634 05:25:17,160 --> 05:25:18,840 MATCHMAKER, FOR ONE. 7635 05:25:18,840 --> 05:25:23,120 MATCHMAKER IS A NEW FUNCTION IN 7636 05:25:23,120 --> 05:25:23,400 REPORTER. 7637 05:25:23,400 --> 05:25:25,800 AND THIS IS -- YOU CAN ENTER 7638 05:25:25,800 --> 05:25:28,800 ANYTHING HERE, ENTER UP TO 7639 05:25:28,800 --> 05:25:37,760 15,000 CHARACTERS, CAN YOU ENTER 7640 05:25:37,760 --> 05:25:39,040 EXTRACTS, MATCHMAKER WILL 7641 05:25:39,040 --> 05:25:39,880 RETURN SIMILAR PROJECTS 7642 05:25:39,880 --> 05:25:41,040 ASSOCIATED WITH THOSE PROJECTS. 7643 05:25:41,040 --> 05:25:45,560 SO THIS IS ONE WAY TO FIND 7644 05:25:45,560 --> 05:25:47,640 PROGRAM OFFICIALS THAT ARE 7645 05:25:47,640 --> 05:25:50,280 MATCHED TO YOUR AREA OF SCIENCE. 7646 05:25:50,280 --> 05:25:52,240 I WOULD ENCOURAGE YOU TO PLAY 7647 05:25:52,240 --> 05:25:54,520 WITH THIS, TRY IT OUT. 7648 05:25:54,520 --> 05:25:57,480 YOU CAN ALSO LOOK AT THE ONR AND 7649 05:25:57,480 --> 05:25:59,040 ODS WEBSITES. 7650 05:25:59,040 --> 05:26:01,320 WE HAVE VARIOUS COMMITTEES, 7651 05:26:01,320 --> 05:26:02,800 WORKING GROUPS, WITH LISTS OF 7652 05:26:02,800 --> 05:26:06,240 MEMBERS AND YOU CAN FIND I.C. 7653 05:26:06,240 --> 05:26:07,440 REPRESENTATIVES ON THOSE LISTS. 7654 05:26:07,440 --> 05:26:09,960 AND LAST BUT NOT LEAST OF COURSE 7655 05:26:09,960 --> 05:26:12,040 LOOK AT THE INDIVIDUAL I.C. 7656 05:26:12,040 --> 05:26:18,200 WEBSITES AS I MENTIONED BEFORE. 7657 05:26:18,200 --> 05:26:21,040 SO, IN CLOSING, LAST SLIDE IS 7658 05:26:21,040 --> 05:26:21,240 THIS. 7659 05:26:21,240 --> 05:26:27,080 THERE ARE A NUMBER OF EXCELLENT 7660 05:26:27,080 --> 05:26:27,840 GRANTSMANSHIP WEBSITES DEVELOPED 7661 05:26:27,840 --> 05:26:29,480 BY NIAID. 7662 05:26:29,480 --> 05:26:30,800 AND THIS WAS IN HERE LAST YEAR 7663 05:26:30,800 --> 05:26:33,200 BEFORE I WAS HERE AT ODS, SO 7664 05:26:33,200 --> 05:26:37,160 IT'S NOT JUST BECAUSE I WAS AT 7665 05:26:37,160 --> 05:26:38,720 NIAID FOR 13 YEARS, IT'S IN 7666 05:26:38,720 --> 05:26:38,920 HERE. 7667 05:26:38,920 --> 05:26:43,800 ALL OF THE I.C.s LIKE TO USE 7668 05:26:43,800 --> 05:26:45,240 NIAID'S WEBSITE, PARTICULARLY 7669 05:26:45,240 --> 05:26:47,480 THESE RESOURCES. 7670 05:26:47,480 --> 05:26:49,840 THEY HAVE EXCELLENT SECTIONS FOR 7671 05:26:49,840 --> 05:26:52,640 GRANTS, GRANTS PROCESS, AND 7672 05:26:52,640 --> 05:26:56,440 APPLICATION STRATEGIES, FOR SBIR 7673 05:26:56,440 --> 05:26:58,080 AND STTR PROGRAMS, APPLICATIONS, 7674 05:26:58,080 --> 05:26:58,480 STRATEGIES. 7675 05:26:58,480 --> 05:27:02,280 THEY EVEN HAVE SOME SIMPLE 7676 05:27:02,280 --> 05:27:04,720 APPLICATIONS AND SUMMARY 7677 05:27:04,720 --> 05:27:05,880 STATEMENTS THAT SOME P.I.s 7678 05:27:05,880 --> 05:27:08,880 WERE WILLING TO HAVE POSTED ON 7679 05:27:08,880 --> 05:27:11,760 THE WEBSITE FOR OTHERS TO LEARN 7680 05:27:11,760 --> 05:27:12,360 FROM. 7681 05:27:12,360 --> 05:27:14,160 SO, WITH THAT, I WILL CLOSE AND 7682 05:27:14,160 --> 05:27:18,840 THANK YOU FOR YOUR ATTENTION . 7683 05:27:18,840 --> 05:27:20,320 IF I HAVE ANY QUESTIONS PLEASE 7684 05:27:20,320 --> 05:27:22,400 FOLLOW UP, CALL ME OR E-MAIL. 7685 05:27:22,400 --> 05:27:25,840 GLAD TO HELP YOU. 7686 05:27:25,840 --> 05:27:26,080 THANKS. 7687 05:27:26,080 --> 05:27:28,440 >> THANK YOU SO MUCH, DR. 7688 05:27:28,440 --> 05:27:28,800 HAGGERTY. 7689 05:27:28,800 --> 05:27:31,240 THAT'S A WEALTH OF INFORMATION 7690 05:27:31,240 --> 05:27:35,200 AND WEBSITES FOR US TO GO BACK 7691 05:27:35,200 --> 05:27:35,680 TO. 7692 05:27:35,680 --> 05:27:36,880 I'LL CHECK WITH THE CHAIRMAN 7693 05:27:36,880 --> 05:27:38,600 HERE TO SEE IF WE HAVE SOME TIME 7694 05:27:38,600 --> 05:27:39,760 FOR QUESTIONS OR IF SHE WANTS TO 7695 05:27:39,760 --> 05:27:42,280 CLOSE UP ON THE THE SESSION. 7696 05:27:42,280 --> 05:27:45,800 >> NO, LET'S DO A FEW QUESTIONS. 7697 05:27:45,800 --> 05:27:46,320 >> OKAY. 7698 05:27:46,320 --> 05:27:49,560 GREAT. 7699 05:27:49,560 --> 05:27:52,800 7700 05:27:52,800 --> 05:27:55,200 SO, THIS IS ONE OF THE 7701 05:27:55,200 --> 05:27:55,960 CHALLENGES IN DIETARY 7702 05:27:55,960 --> 05:27:57,800 SUPPLEMENTS SPACE, LACK OF 7703 05:27:57,800 --> 05:28:00,240 QUALITY RESEARCH STUDIES ON 7704 05:28:00,240 --> 05:28:02,640 MARKETED PRODUCTS. 7705 05:28:02,640 --> 05:28:05,720 ARE THERE RFPs SPECIFIC FOR 7706 05:28:05,720 --> 05:28:06,560 INDUSTRY IN ADDITION TO SBIRs 7707 05:28:06,560 --> 05:28:10,680 TO HELP SUPPORT FUNDING OF 7708 05:28:10,680 --> 05:28:13,720 RESEARCH ON DIETARY SUPPLEMENTS? 7709 05:28:13,720 --> 05:28:17,280 SO ASKING SPECIFICALLY ABOUT 7710 05:28:17,280 --> 05:28:20,480 RFPs WITH INDUSTRY. 7711 05:28:20,480 --> 05:28:25,560 >> SO, I DON'T HAVE A LOT OF 7712 05:28:25,560 --> 05:28:28,200 FAMILIARITY WITH RFPs. 7713 05:28:28,200 --> 05:28:31,640 I MENTIONED THOSE ARE FOR 7714 05:28:31,640 --> 05:28:35,840 CONTRACTS, SOLICITATIONS, THE 7715 05:28:35,840 --> 05:28:37,160 QUESTION IS SPECIFIC TO 7716 05:28:37,160 --> 05:28:38,600 INDUSTRY, PERHAPS JOE, IF HE'S 7717 05:28:38,600 --> 05:28:42,440 ON THE LINE, MIGHT HAVE SOME 7718 05:28:42,440 --> 05:28:45,280 INSIGHTS ABOUT THAT. 7719 05:28:45,280 --> 05:28:47,320 BUT OFF THE TOP OF MY HEAD, YOU 7720 05:28:47,320 --> 05:28:49,360 KNOW, I JUST -- I DON'T KNOW. 7721 05:28:49,360 --> 05:28:52,720 I WOULD SAY TO THE PERSON WHO 7722 05:28:52,720 --> 05:28:58,720 ASKED, GO TO THE SITE WHERE IT 7723 05:28:58,720 --> 05:29:03,240 USED TO BE FEDBIZOPS WHERE THEY 7724 05:29:03,240 --> 05:29:04,440 HAVE RFPs LISTED AND ENTER 7725 05:29:04,440 --> 05:29:05,240 SEARCH TERMS. 7726 05:29:05,240 --> 05:29:07,680 THAT'S NOT A GREAT ANSWER BUT 7727 05:29:07,680 --> 05:29:10,120 THAT'S THE BEST I HAVE. 7728 05:29:10,120 --> 05:29:11,040 >> YEAH, THIS IS JOE. 7729 05:29:11,040 --> 05:29:13,760 I'LL WEIGH IN A LITTLE BIT. 7730 05:29:13,760 --> 05:29:15,960 THERE ARE SOME SPECIFIC GRANTS 7731 05:29:15,960 --> 05:29:18,240 THAT ARE ACTUALLY CONGRESSIONAL 7732 05:29:18,240 --> 05:29:21,000 SET-ASIDES, NOT JUST FOR NIH BUT 7733 05:29:21,000 --> 05:29:23,280 ACROSS THE FEDERAL GOVERNMENT 7734 05:29:23,280 --> 05:29:26,480 THAT ARE SBIR, SMALL BUSINESS 7735 05:29:26,480 --> 05:29:30,240 INNOVATION RESEARCH, OR STTR, 7736 05:29:30,240 --> 05:29:31,400 THOSE ARE TECHNOLOGY RESEARCH 7737 05:29:31,400 --> 05:29:31,640 GRANTS. 7738 05:29:31,640 --> 05:29:35,040 THOSE ARE TYPICALLY FUNDED IN 7739 05:29:35,040 --> 05:29:37,880 TWO PHASES, ONE IS TO HELP 7740 05:29:37,880 --> 05:29:41,640 DEVELOP THE SCIENCE FOR THE 7741 05:29:41,640 --> 05:29:43,400 CREATION, BASIC SCIENCE CREATION 7742 05:29:43,400 --> 05:29:44,800 OF COMMERCIAL PRODUCT, AND 7743 05:29:44,800 --> 05:29:48,320 SECOND PHASE I BELIEVE IS 7744 05:29:48,320 --> 05:29:50,640 REVIEWED FOR BUSINESS PLAN, TO 7745 05:29:50,640 --> 05:29:57,720 TAKE, TO COMMERCIALIZE THE NEW 7746 05:29:57,720 --> 05:29:58,000 TECHNOLOGY. 7747 05:29:58,000 --> 05:29:59,000 THOSE ARE PEER REVIEWED THE SAME 7748 05:29:59,000 --> 05:29:59,560 AS ANY OTHER GRANT. 7749 05:29:59,560 --> 05:30:03,440 I DON'T KNOW IF YOU CALL THOSE 7750 05:30:03,440 --> 05:30:06,560 RFAs. 7751 05:30:06,560 --> 05:30:11,400 THERE'S A STANDING RFA IN THE 7752 05:30:11,400 --> 05:30:13,640 GRANTS.GOV WEBSITE WHERE YOU CAN 7753 05:30:13,640 --> 05:30:15,040 FIND -- I'M SORRY, NIH GRANTS 7754 05:30:15,040 --> 05:30:19,040 WEBSITE, WHERE YOU CAN FIND 7755 05:30:19,040 --> 05:30:20,520 INFORMATION ABOUT THE STANDING 7756 05:30:20,520 --> 05:30:23,880 RFA FOR THESE BUSINESS GRANTS. 7757 05:30:23,880 --> 05:30:26,520 SOME PLACES, THE GRANTS ARE VERY 7758 05:30:26,520 --> 05:30:27,120 COMPETITIVE. 7759 05:30:27,120 --> 05:30:31,120 SOME PLACES NOT SO MUCH. 7760 05:30:31,120 --> 05:30:35,120 SO NSF, NIST, FDA, I SAID, 7761 05:30:35,120 --> 05:30:37,640 EPA, NIH, ARE ALL REQUIRED TO 7762 05:30:37,640 --> 05:30:41,240 SUPPORT THESE PROGRAMS, THESE 7763 05:30:41,240 --> 05:30:42,640 GRANT PROGRAMS FOR BUSINESS. 7764 05:30:42,640 --> 05:30:45,560 SOME PLACES GET FEWER OF THESE 7765 05:30:45,560 --> 05:30:46,360 APPLICATIONS THAN OTHERS. 7766 05:30:46,360 --> 05:30:47,680 AND SO THEY WILL BE LESS 7767 05:30:47,680 --> 05:30:48,040 COMPETITIVE. 7768 05:30:48,040 --> 05:30:49,280 I CAN'T TELL YOU WHICH ONES 7769 05:30:49,280 --> 05:30:51,640 THOSE WOULD BE. 7770 05:30:51,640 --> 05:30:52,440 SORRY. 7771 05:30:52,440 --> 05:30:53,600 I DON'T HAVE THAT DEPTH OF 7772 05:30:53,600 --> 05:30:53,960 KNOWLEDGE. 7773 05:30:53,960 --> 05:30:55,480 BUT THEY ARE INDUSTRY SPECIFIC 7774 05:30:55,480 --> 05:31:01,440 AND THE IDEA IS TO DEVELOP 7775 05:31:01,440 --> 05:31:03,000 COMMERCIALIZABLE PRODUCTS FROM 7776 05:31:03,000 --> 05:31:03,920 THE GOVERNMENT RESEARCH 7777 05:31:03,920 --> 05:31:07,400 ENTERPRISE. 7778 05:31:07,400 --> 05:31:09,560 >> THANKS, JOE. 7779 05:31:09,560 --> 05:31:13,960 YEAH, AND SO THE -- FOR GRANTS 7780 05:31:13,960 --> 05:31:18,600 THERE ARE THE OMNIBUS 7781 05:31:18,600 --> 05:31:23,040 SOLICITATIONS FOR SMALL BUSINESS 7782 05:31:23,040 --> 05:31:25,560 AND SBIR AND STTR PROGRAM,S CAN 7783 05:31:25,560 --> 05:31:27,080 GO TO THE SMALL BUSINESS 7784 05:31:27,080 --> 05:31:28,840 ADMINISTRATION WEBSITE TO FIND 7785 05:31:28,840 --> 05:31:32,240 THOSE BUT NIH HAS A LOT OF 7786 05:31:32,240 --> 05:31:32,880 THOSE. 7787 05:31:32,880 --> 05:31:34,080 I UNDERSTOOD THE QUESTION TO 7788 05:31:34,080 --> 05:31:38,320 SORT OF ALSO BE ASKED ABOUT 7789 05:31:38,320 --> 05:31:40,240 RFPs OR CONTRACTS. 7790 05:31:40,240 --> 05:31:45,040 THERE ARE SUCH THINGS. 7791 05:31:45,040 --> 05:31:47,200 I KNOW NIAID HAS SOME BUSINESS 7792 05:31:47,200 --> 05:31:49,680 CONTRACT SOLICITATIONS SO I 7793 05:31:49,680 --> 05:31:53,440 WOULD ENCOURAGE YOU TO GO TO THE 7794 05:31:53,440 --> 05:31:56,040 I.C.s THAT DO HAVE -- MOST OF 7795 05:31:56,040 --> 05:31:58,960 THE I.C.s HAVE SMALL BUSINESS 7796 05:31:58,960 --> 05:32:01,240 COMPONENTS, SMALL BUSINESS 7797 05:32:01,240 --> 05:32:04,280 PROGRAMS, AND THEN CONTACT THE 7798 05:32:04,280 --> 05:32:05,800 PEOPLE WITHIN THOSE PROGRAMS TO 7799 05:32:05,800 --> 05:32:08,120 ASK THAT KIND OF A QUESTION. 7800 05:32:08,120 --> 05:32:11,920 NIAID DOES HAVE BOTH GRANT AND 7801 05:32:11,920 --> 05:32:13,080 CONTRACT SMALL BUSINESS 7802 05:32:13,080 --> 05:32:13,400 SOLICITATIONS. 7803 05:32:13,400 --> 05:32:14,360 I DON'T KNOW AS MUCH ABOUT THE 7804 05:32:14,360 --> 05:32:17,440 OTHER I.C.s. 7805 05:32:17,440 --> 05:32:19,360 I KNOW THAT NICHD, CHILD HEALTH 7806 05:32:19,360 --> 05:32:20,720 HAS SMALL BUSINESS SECTION, BUT 7807 05:32:20,720 --> 05:32:26,760 NOT TOO MUCH DETAIL ABOUT IT. 7808 05:32:26,760 --> 05:32:27,040 >> OKAY. 7809 05:32:27,040 --> 05:32:27,240 GOOD. 7810 05:32:27,240 --> 05:32:28,320 NEXT QUESTION, QUITE A FEW 7811 05:32:28,320 --> 05:32:30,840 COMPANIES ARE WILLING TO PROVIDE 7812 05:32:30,840 --> 05:32:33,680 OR DONATE RESEARCH MATERIAL FOR 7813 05:32:33,680 --> 05:32:35,400 PRE-CLINICAL AND CLINICAL 7814 05:32:35,400 --> 05:32:36,280 STUDIES. 7815 05:32:36,280 --> 05:32:39,480 DOES ODS PROVIDE A DATABASE OR 7816 05:32:39,480 --> 05:32:43,400 INFORMATION OF SUCH COMPANIES 7817 05:32:43,400 --> 05:32:45,120 AND MATERIALS THEY PROVIDE, 7818 05:32:45,120 --> 05:32:46,520 OBVIOUSLY SOME DONATIONS COULD 7819 05:32:46,520 --> 05:32:57,040 HELP OFFSET COST OF RESEARCH. 7820 05:32:58,040 --> 05:33:00,600 7821 05:33:00,600 --> 05:33:01,280 7822 05:33:01,280 --> 05:33:04,320 >> AGAIN, I'M GOING TO MAYBE 7823 05:33:04,320 --> 05:33:11,400 DEFER TO ADAM, IF HE'S ON THE 7824 05:33:11,400 --> 05:33:11,680 LINE. 7825 05:33:11,680 --> 05:33:14,520 IN TERMS OF DONATION OF RESEARCH 7826 05:33:14,520 --> 05:33:17,520 MATERIAL FOR PRE-CLINICAL AND 7827 05:33:17,520 --> 05:33:18,720 CLINICAL STUDIES, I DON'T 7828 05:33:18,720 --> 05:33:24,800 BELIEVE ODS HAS THAT KIND OF 7829 05:33:24,800 --> 05:33:25,440 FUNCTION. 7830 05:33:25,440 --> 05:33:28,000 OR DATABASE. 7831 05:33:28,000 --> 05:33:28,880 SOMEONE CAN CORRECT ME IF I'M 7832 05:33:28,880 --> 05:33:30,280 WRONG BUT I DON'T THINK THAT'S 7833 05:33:30,280 --> 05:33:31,720 ONE OF OUR DATABASES. 7834 05:33:31,720 --> 05:33:36,000 >> THAT WOULD PROBABLY BE LEFT 7835 05:33:36,000 --> 05:33:36,800 UP TO INDIVIDUAL INVESTIGATE 7836 05:33:36,800 --> 05:33:41,520 COURT -- INVESTIGATORS TO SEEK 7837 05:33:41,520 --> 05:33:42,720 THEIR OWN RESEARCH THEY DO. 7838 05:33:42,720 --> 05:33:44,640 ANOTHER QUESTION YOU TOUCHED ON, 7839 05:33:44,640 --> 05:33:49,480 ARE THERE CURRENT -- ANY CURRENT 7840 05:33:49,480 --> 05:33:52,760 R01s, R21s, OR RFAs 7841 05:33:52,760 --> 05:34:00,240 SPECIFICALLY TARGETED FOR 7842 05:34:00,240 --> 05:34:01,080 DIETARY SUPPLEMENT RESEARCH? 7843 05:34:01,080 --> 05:34:05,200 >> SO, I WOULD -- THAT'S A 7844 05:34:05,200 --> 05:34:08,040 LITTLE BIT OF A TRICKY QUESTION. 7845 05:34:08,040 --> 05:34:10,120 I WOULD ENCOURAGE YOU TO GO TO 7846 05:34:10,120 --> 05:34:13,480 THE NIH GUIDE WITH THOSE KEY 7847 05:34:13,480 --> 05:34:15,920 WORDS, DIETARY SUPPLEMENT, IN 7848 05:34:15,920 --> 05:34:19,840 YOUR SEARCH TERMS. 7849 05:34:19,840 --> 05:34:21,720 AND USE THE ADVANCED SEARCH 7850 05:34:21,720 --> 05:34:25,600 TERM, USE THE ADVANCED SEARCH 7851 05:34:25,600 --> 05:34:30,160 FEATURE WHICH WILL SEARCH NOT 7852 05:34:30,160 --> 05:34:33,760 ONLY THE TITLE BUT ALSO THE 7853 05:34:33,760 --> 05:34:37,440 ABSTRACT AND THE SPECIFIC AIMS 7854 05:34:37,440 --> 05:34:40,600 OF THE INITIATIVE OR FUNDING 7855 05:34:40,600 --> 05:34:42,240 OPPORTUNITY. 7856 05:34:42,240 --> 05:34:46,040 OF TO PULL UP ANY. 7857 05:34:46,040 --> 05:34:47,600 ODS HAS THE FUNDING 7858 05:34:47,600 --> 05:34:49,640 ANNOUNCEMENTS THAT I MENTIONED, 7859 05:34:49,640 --> 05:34:56,920 ONE IS FOR ADMINISTRATIVE 7860 05:34:56,920 --> 05:35:00,360 SUPPLEMENTS, FOR RESEARCH ON AN 7861 05:35:00,360 --> 05:35:01,720 EXISTING PARENT GRANT. 7862 05:35:01,720 --> 05:35:05,280 AS I SAID, WE CO-FUND GRANTS, SO 7863 05:35:05,280 --> 05:35:12,280 OTHER I.C.s ARE THE PRIMARY 7864 05:35:12,280 --> 05:35:15,040 ADMINISTERS OF THOSE GRANTS, AND 7865 05:35:15,040 --> 05:35:18,600 DIETARY SUPPLEMENTS MAY BE 7866 05:35:18,600 --> 05:35:21,280 RELATED TO TOPIC OF THOSE 7867 05:35:21,280 --> 05:35:24,600 INITIATIVES THE OTHER I.C.s 7868 05:35:24,600 --> 05:35:28,440 SPONSOR, BUT ODS DOESN'T HAVE A 7869 05:35:28,440 --> 05:35:30,240 PRIMARY INITIATIVE OUT THERE, 7870 05:35:30,240 --> 05:35:30,920 JUST ON THAT. 7871 05:35:30,920 --> 05:35:34,040 AGAIN, IT'S SUCH A BIG QUESTION 7872 05:35:34,040 --> 05:35:39,400 THAT IT'S A LITTLE BIT HARD TO 7873 05:35:39,400 --> 05:35:39,640 ANSWER. 7874 05:35:39,640 --> 05:35:43,560 MANY NUTRITION STUDIES AND 7875 05:35:43,560 --> 05:35:47,600 INITIATIVES WILL HAVE RELEVANCE 7876 05:35:47,600 --> 05:35:49,040 TO DIETARY SUPPLEMENTS. 7877 05:35:49,040 --> 05:35:50,280 THERE ARE INITIATIVES IN 7878 05:35:50,280 --> 05:35:56,240 DEVELOPMENT OR OUT THERE ON FOOD 7879 05:35:56,240 --> 05:35:59,520 AND NUTRITION SECURITY, ABOUT 7880 05:35:59,520 --> 05:36:01,520 MATERNAL MORTALITY, AND 7881 05:36:01,520 --> 05:36:02,720 CHARACTERISTICS INVOLVED IN 7882 05:36:02,720 --> 05:36:04,360 THAT. 7883 05:36:04,360 --> 05:36:05,720 THERE'S MANY DIFFERENT 7884 05:36:05,720 --> 05:36:07,560 INITIATIVES THAT TOUCH ON 7885 05:36:07,560 --> 05:36:09,560 NUTRITION AND DIETARY INTAKE, 7886 05:36:09,560 --> 05:36:09,760 RIGHT? 7887 05:36:09,760 --> 05:36:14,400 BUT -- AND SO THERE'S A 7888 05:36:14,400 --> 05:36:15,240 PERIPHERAL POTENTIAL 7889 05:36:15,240 --> 05:36:15,920 RELATIONSHIP BETWEEN DIETARY 7890 05:36:15,920 --> 05:36:17,760 SUPPLEMENTS AND FOR THOSE WE 7891 05:36:17,760 --> 05:36:20,000 SOMETIMES RECEIVE -- WE 7892 05:36:20,000 --> 05:36:21,120 SOMETIMES CO-FUND. 7893 05:36:21,120 --> 05:36:24,000 BUT MY BEST ADVICE WOULD BE GO 7894 05:36:24,000 --> 05:36:26,400 TO THE NIH GUIDE AND DO A SEARCH 7895 05:36:26,400 --> 05:36:29,440 WITH THOSE KEY WORD TERMS. 7896 05:36:29,440 --> 05:36:29,720 >> GREAT. 7897 05:36:29,720 --> 05:36:30,280 THANK YOU. 7898 05:36:30,280 --> 05:36:33,600 I'LL TAKE THE PREROGATIVE FOR 7899 05:36:33,600 --> 05:36:35,120 THE LAST QUESTION. 7900 05:36:35,120 --> 05:36:41,160 YOU SHOWED US THAT THE NIH 7901 05:36:41,160 --> 05:36:43,440 NUTRITION PORTFOLIO IS LARGELY 7902 05:36:43,440 --> 05:36:45,200 PREDOMINANTLY FOCUSED ON OBESITY 7903 05:36:45,200 --> 05:36:46,160 RESEARCH. 7904 05:36:46,160 --> 05:36:48,200 SO, FOR THE ODS, DIETARY 7905 05:36:48,200 --> 05:36:50,120 SUPPLEMENT SUPPLEMENT RESRCH, 7906 05:36:50,120 --> 05:36:53,000 OTHER THAN OUR BOTANICAL CENTERS 7907 05:36:53,000 --> 05:36:55,920 PROGRAM OR CARBON PROGRAM, DOES 7908 05:36:55,920 --> 05:36:58,320 ODS HAVE A SPECIFIC FOCUS FOR 7909 05:36:58,320 --> 05:37:01,680 THE GRANT PORTFOLIO OR WHAT WE 7910 05:37:01,680 --> 05:37:11,520 FUND? 7911 05:37:11,520 --> 05:37:12,840 >> SO, I'M TRYING TO FIND THAT 7912 05:37:12,840 --> 05:37:14,560 QUESTION IN THE Q&A, BECKY. 7913 05:37:14,560 --> 05:37:15,760 I THOUGHT YOU WERE GOING TO SAY 7914 05:37:15,760 --> 05:37:18,480 YOU WERE GOING TO ANSWER IT. 7915 05:37:18,480 --> 05:37:22,560 >> OH, NO, I'M ASKING IT. 7916 05:37:22,560 --> 05:37:24,600 >> SO, THE QUESTION AGAIN, 7917 05:37:24,600 --> 05:37:27,000 SUMMARIZE FOR ME PLEASE. 7918 05:37:27,000 --> 05:37:29,120 >> OTHER THAN THE BOTANICAL 7919 05:37:29,120 --> 05:37:31,960 RESEARCH CENTERS, CARBON 7920 05:37:31,960 --> 05:37:34,640 PROGRAM, WHAT DOES THE ODS 7921 05:37:34,640 --> 05:37:37,160 PORTFOLIO LOOK LIKE GENERALLY? 7922 05:37:37,160 --> 05:37:43,080 DO WE FUND, YOU KNOW, VITAMINS, 7923 05:37:43,080 --> 05:37:43,680 MINERALS, AMINO ACIDS? 7924 05:37:43,680 --> 05:37:48,360 >> ALL OF THE ABOVE. 7925 05:37:48,360 --> 05:37:50,960 WE FUND A WIDE VARIETY OF 7926 05:37:50,960 --> 05:37:53,800 RESEARCH PROJECTS THAT HAVE 7927 05:37:53,800 --> 05:37:54,800 RELEVANCE TO DIETARY SUPPLEMENT 7928 05:37:54,800 --> 05:37:57,360 RESEARCH, AND I PUT THE 7929 05:37:57,360 --> 05:37:58,040 DEFINITION, I MENTIONED 7930 05:37:58,040 --> 05:37:59,880 DEFINITION OF DIETARY SUPPLEMENT 7931 05:37:59,880 --> 05:38:02,800 RESEARCH, ONE OF THE SLIDES. 7932 05:38:02,800 --> 05:38:07,080 SO, JUST FOR THAT REASON, TO 7933 05:38:07,080 --> 05:38:09,040 SHOW HOW WIDE, YEAH, HOW MANY 7934 05:38:09,040 --> 05:38:12,640 DIFFERENT TYPES OF TERMS ARE 7935 05:38:12,640 --> 05:38:15,880 ENCOMPASSED IN THAT. 7936 05:38:15,880 --> 05:38:17,680 WE HAVE -- I THINK THE 7937 05:38:17,680 --> 05:38:25,520 QUESTIONER IS ASKING IF WE HAVE 7938 05:38:25,520 --> 05:38:27,560 SPECIFIC IDENTIFIED RESEARCH 7939 05:38:27,560 --> 05:38:29,320 PRIORITIES FOR NON-MANDATED 7940 05:38:29,320 --> 05:38:32,360 PROGRAMS, SO THE GRANTS PROGRAMS 7941 05:38:32,360 --> 05:38:33,640 THAT ARE COMPLETELY INVESTIGATOR 7942 05:38:33,640 --> 05:38:36,240 INITIATED, AND I WOULD SAY WE DO 7943 05:38:36,240 --> 05:38:43,280 NOT, AT THE MOMENT. 7944 05:38:43,280 --> 05:38:47,920 BUT WE DO TEND TO -- WE ARE 7945 05:38:47,920 --> 05:38:48,920 SUPPORTIVE OF OTHER NUTRITION 7946 05:38:48,920 --> 05:38:50,520 RESEARCH, PRIORITIES OF OTHER 7947 05:38:50,520 --> 05:38:57,520 PARTS OF THE NIH, LIKE THE ONR, 7948 05:38:57,520 --> 05:39:00,200 OFFICE OF DIETARY DISEASE 7949 05:39:00,200 --> 05:39:02,400 PREVENTION HAS MANY INITIATIVES 7950 05:39:02,400 --> 05:39:03,200 THAT RELATE TO DIETARY 7951 05:39:03,200 --> 05:39:05,800 SUPPLEMENT RESEARCH. 7952 05:39:05,800 --> 05:39:08,400 SO WE'RE PRETTY BROADLY BASED. 7953 05:39:08,400 --> 05:39:09,640 I WOULD ENCOURAGE THE INDIVIDUAL 7954 05:39:09,640 --> 05:39:12,280 TO GO TO THE GRANTS AND FUNDING 7955 05:39:12,280 --> 05:39:15,080 WEB PAGE I SHOWED AND CLICK ON 7956 05:39:15,080 --> 05:39:16,160 ODS RESEARCH PROJECTS TO SEE A 7957 05:39:16,160 --> 05:39:18,320 LIST OF WHAT WE HAVE FUNDED IN 7958 05:39:18,320 --> 05:39:19,240 THE PAST. 7959 05:39:19,240 --> 05:39:22,440 IT'S ALL OF THE ABOVE. 7960 05:39:22,440 --> 05:39:23,840 BOTANICALS, MINERALS, VITAMINS, 7961 05:39:23,840 --> 05:39:26,120 ALL THE MICRONUTRIENTS AS WELL 7962 05:39:26,120 --> 05:39:28,760 AS CONSTITUENTS OF THOSE WHICH 7963 05:39:28,760 --> 05:39:31,280 OFTEN ARE THE FOCUS OF THE BASIC 7964 05:39:31,280 --> 05:39:33,880 SCIENCE RESEARCH WE SUPPORT. 7965 05:39:33,880 --> 05:39:35,600 WE SUPPORT BASIC SCIENCE, 7966 05:39:35,600 --> 05:39:38,840 CLINICAL SCIENCE, TRANSLATIONAL, 7967 05:39:38,840 --> 05:39:39,840 THE WHOLE GAMUT. 7968 05:39:39,840 --> 05:39:40,160 >> GREAT. 7969 05:39:40,160 --> 05:39:43,200 THANK YOU SO MUCH. 7970 05:39:43,200 --> 05:39:44,160 WONDERFUL PRESENTATION. 7971 05:39:44,160 --> 05:39:49,200 AND I THANK ALL THE ATTENDEES 7972 05:39:49,200 --> 05:39:53,720 FOR QUESTIONS AND RETURN THE 7973 05:39:53,720 --> 05:39:54,640 FLOOR TO DR. GHACHE. 7974 05:39:54,640 --> 05:39:55,960 >> THIS CONCLUDES THE SECOND DAY 7975 05:39:55,960 --> 05:39:57,080 OF THE PRACTICUM. 7976 05:39:57,080 --> 05:40:00,040 A BIG THANKS TO MODERATORS AND 7977 05:40:00,040 --> 05:40:00,560 SPEAKERS. 7978 05:40:00,560 --> 05:40:03,240 TOMORROW WE'RE GOING TO CONTINUE 7979 05:40:03,240 --> 05:40:05,440 OUR SESSION 6, AND DR. COSTELLO 7980 05:40:05,440 --> 05:40:07,400 WILL STILL BE MODERATED. 7981 05:40:07,400 --> 05:40:08,720 WE HAVE A PRESENTATION ON 7982 05:40:08,720 --> 05:40:10,800 DIETARY SUPPLEMENT USE IN THE 7983 05:40:10,800 --> 05:40:12,920 MILITARY AND DIETARY SUPPLEMENTS 7984 05:40:12,920 --> 05:40:14,320 AND IMMUNITY, LESSONS LEARNED 7985 05:40:14,320 --> 05:40:16,440 FROM COVID-19, SO TWO REALLY 7986 05:40:16,440 --> 05:40:18,400 INTERESTING TALKS. 7987 05:40:18,400 --> 05:40:20,080 WE HAVE A SPECIAL SESSION, 7988 05:40:20,080 --> 05:40:21,640 DIFFERENT THAN WHAT WE HAVE SO 7989 05:40:21,640 --> 05:40:22,760 FAR. 7990 05:40:22,760 --> 05:40:26,560 WE'LL HAVE SHORT PRESENTATIONS 7991 05:40:26,560 --> 05:40:30,080 FOLLOWED BY SEVERAL PANEL 7992 05:40:30,080 --> 05:40:31,920 DISCUSSIONS, WITH FOLKS FROM 7993 05:40:31,920 --> 05:40:33,960 DIETARY SUPPLEMENT TRADE GROUPS, 7994 05:40:33,960 --> 05:40:37,600 CONSUMER ADVOCACY GROUP, SOMEONE 7995 05:40:37,600 --> 05:40:38,320 FROM THE MEDIA. 7996 05:40:38,320 --> 05:40:44,200 SO THEY ARE GOING TO TALK ABOUT 7997 05:40:44,200 --> 05:40:45,920 DIFFERENT TOPICS RELATED TO 7998 05:40:45,920 --> 05:40:47,000 DIETARY SUPPLEMENTS. 7999 05:40:47,000 --> 05:40:48,640 WE'LL START AT 11:00 EASTERN 8000 05:40:48,640 --> 05:40:48,840 TIME. 8001 05:40:48,840 --> 05:40:50,240 PLEASE HAVE A GREAT EVENING. 8002 05:40:50,240 --> 05:40:52,560 THANK YOU ALL FOR ATTENDING. 8003 05:40:52,560 --> 05:40:53,440 AND SUBMITTING GREAT QUESTIONS. 8004 05:40:53,440 --> 05:40:55,680 AND PLEASE KEEP THAT UP FOR 8005 05:40:55,680 --> 05:40:55,960 TOMORROW. 8006 05:40:55,960 --> 00:00:00,000 THANK YOU.