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Now we're back to me,

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and we're going to do a case.

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My general disclaimer
you've seen many times.

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Imagine that.

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So this is a post Covid a
clinical trial

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for those who are experiencing
a post-Covid syndrome.

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So breathe better.

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Eight is a new compound
meant to treat impaired lung

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function.

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Among those suffering from this
post,

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Covid syndrome, or PKS.

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The investigators are proposing
a multi-site, randomized,

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double blind, placebo
controlled trial among patients

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discharged from the hospital
but with lingering pulmonary

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symptoms.

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So these are folks who had Covid
bad enough to be hospitalized,

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are leaving the hospital
now, going back home

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but have lingering pulmonary
symptoms.

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The patients will be randomized
to receive

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or a placebo for 12 weeks, with
a one year

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follow up.

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All patients will receive the
same

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background current standard of
care.

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Right.

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So just to remind you all,
the idea here is that they're

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coming in

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to the hospital for this
clinical trial,

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that they are expected

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to have someone outside
who is taking care of their

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primary care.

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But if issues come up

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during the process of the study,

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that is standard of care
the hospital will provide for

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cover.

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The cost of that.

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So the trial is a collaboration

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between the NIH and Dameron
Biologics,

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a private company.

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As the Covid pandemic has
slowed.

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The study team is concerned

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about their ability
to meet their targeted

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enrollment goals.

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So the trial is currently
underway

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at four in-force

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in sites in four states.

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One of these sites is in state
X,

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and they have indicated
that they plan to exclude

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otherwise medically eligible
subjects

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who are currently uninsured,

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meaning
they have no health insurance

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coverage.

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The health system
of which they are a part.

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Bil standard of care expenses
to participant insurers.

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The health system has notified
the Pi

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that it will not cover these
expenses.

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For participants
who do not have health

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insurance.

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So here is your first question.

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Is it okay for the state
X site to limit enrollment in

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this way?

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And so the first question is
just a

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yes or no.

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Do you think it's okay.

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And we'll of course talk about,
you know

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further about some of the
issues.

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But just your gut response.

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Is it okay for the state to
limit

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enrollment of those of you who
said yes?

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Or can think of a reason why?

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Why did you say yes? Or if you
said no?

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Why do you think someone who
said

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yes might say yes?

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Great.

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So one would be to prevent
too many costs to participants,

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right?

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If the site isn't going to cover
it,

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that means that the participant
is going to have to cover that

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expense.

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Great.

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So someone said I was taking
this

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with a very narrow perspective.

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The question of like,
is it legal to do this? Yes.

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I think we could decide that
maybe it's legal to do that,

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but we're going to be talking
about

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whether it's ethically
appropriate.

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Let's see if
it's done during the protocol

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development

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and as agreed upon by all the
sites,

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then maybe

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that's okay.

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They may not be able to get
their follow

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up care needed.

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Right?

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That's a participant focused
concern.

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And because it's still improve
some access

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to participants.

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Great.

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Everyone should receive equal
offer,

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equal treatment or opportunity.

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So I guess we could take that
in two different ways.

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One, you could say that
that means that it would,

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it's okay for them to do this
if they spread the opportunity

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widely

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among those who remain
or sort of the opposite.

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It it perhaps unfairly excludes

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a number of people.

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And the next question

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was to put it into ethics terms,
which many of you had already

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done.

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And so I just want to highlight
a couple of those,

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you know,
folks talked about equal

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opportunity.

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And thinking about,

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whether it's fair,
is it fair to do it or not?

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I mean, just look.

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Oh, you know, promoting health
and safety of the subjects,

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right?

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By excluding them, we are
protecting them.

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And so now I'm going to go on

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to the question of of those.

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And so now I'm going to go on
to the question of,

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of those who said no.

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Other other reasons to say no.

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Say that a slightly different
way.

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Why shouldn't

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state X limit enrollment in this
way?

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Unfair exclusion of the
uninsured?

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Perhaps inequitable.

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It may be seen as discriminatory
against those who are uninsured.

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Yeah.

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Excluding them isn't equitable.

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The protocol should account for
this.

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And make sure that the
participants

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receive the same care that
others

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are receiving.

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Would limit scientific validity.
Yes.

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Thank you.

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Unfair exclusion without
insurance

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could be a large demographic
and may have other

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characteristics.

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By excluding them,
you may not then be able to

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generalize

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to the larger population.

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Right.

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Lots of good words here.

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Justice, unfair
exclusion, limiting scientific

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light, scientific validity,

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less representative.

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Yeah.

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So it it

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lots of good lots of good terms
here.

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Could impact generalizability.

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Discriminates
against those without insurance.

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Great. And so you've already.

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I'm really excited. Week six.

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You're already. I don't want to
ask.

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I don't have to ask you
to put these into the terms of

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someone,

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thinking about ethics.

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You're already putting them into
ethics

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terms, which is awesome.

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Okay, so what I want to do now
is just

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cover a couple of recover
a couple of the issues

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that we've already talked about
and then ask.

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So we've already,

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we've already talked about some
of these.

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So participants

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should be chosen based primarily
on the scientific objectives of

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the trial.

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So issues around
scientific validity right.

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If someone is medically eligible
according to the criteria.

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One could say that
excluding a particular group,

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based on

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what we might call a morally
irrelevant

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characteristic, would be
inappropriate.

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Participants should be chosen
in a way that reduces risks and

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enhances

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potential benefits
both to individuals and society.

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Right?

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So again, if the if the goal
here

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is to think about both
those who might be eligible,

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those who might benefit if
enrolled

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and those patients in the long
run

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who may benefit from the
contribution

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that these individuals make.

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We want to think about how well

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we identify Phi and consider the
risks.

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Reduce them as much as you can.

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And so one thing that all of
you,

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many of you noted is like,

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what is what does reduce risk
mean

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in this context?

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And it picks up a little on
what Joe was mentioning before,

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right?

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Including someone who is
uninsured

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may put them at financial risk.

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Right.

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So when someone is uninsured,
that means that they don't

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have health insurance, right?

200
00:09:02,075 --> 00:09:04,168
And for those of you who have
ever,

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00:09:04,168 --> 00:09:05,245
you know, visited

202
00:09:05,245 --> 00:09:09,249
an emergency room, for example,
when you have health insurance,

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00:09:10,250 --> 00:09:11,451
you know, you're going to pay

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some portion of that bill

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if you don't have health
insurance.

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00:09:17,390 --> 00:09:20,827
And and as a side note, right,
those rates are negotiated

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with the insurance companies,
large academic medical centers

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00:09:24,864 --> 00:09:28,034
or health systems
get discounts on that rate.

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00:09:28,802 --> 00:09:30,536
But if you're a regular old
person

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who does not have health
insurance,

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00:09:32,605 --> 00:09:37,177
you are paying the full amount
of the care provided.

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00:09:37,410 --> 00:09:40,057
So you may end up paying much
more

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00:09:40,057 --> 00:09:41,381
when you compare

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the two costs from someone who's
insured

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and someone who's not.

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That's a general injustice in
our system,

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00:09:49,889 --> 00:09:52,210
but enrolling someone where
there's

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00:09:52,210 --> 00:09:54,928
an expectation that there is
going to be

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00:09:54,928 --> 00:09:57,665
standard of care
and someone's going to have to

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00:09:57,665 --> 00:09:58,364
pay for it,

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00:09:58,665 --> 00:10:02,635
it's going to be out of pocket
for that participant.

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00:10:02,635 --> 00:10:05,949
So are we putting them at
financial risk

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00:10:05,949 --> 00:10:07,440
as including them

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00:10:08,007 --> 00:10:10,493
and then we need to balance that
along

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00:10:10,493 --> 00:10:12,912
with the physical, social,
emotional

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00:10:12,912 --> 00:10:15,619
risk of being in the study and
then what

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00:10:15,619 --> 00:10:17,717
the potential benefits are. So

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00:10:18,751 --> 00:10:20,253
maybe

229
00:10:20,253 --> 00:10:22,722
we would want to engage with the
person

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00:10:22,722 --> 00:10:26,226
in an informed consent
conversation about

231
00:10:27,760 --> 00:10:29,863
what might happen if they
enroll,

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what additional financial,

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00:10:33,500 --> 00:10:35,435
responsibilities they might
have.

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00:10:35,435 --> 00:10:37,991
What's required by the study is
that

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00:10:37,991 --> 00:10:40,974
this particular baseline care be
covered.

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00:10:41,474 --> 00:10:45,109
And so maybe they want to make a
decision

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00:10:45,109 --> 00:10:47,680
to enroll despite that risk.

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Is it appropriate for us, quote
unquote,

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00:10:50,664 --> 00:10:51,484
or for the

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00:10:52,785 --> 00:10:55,588
clinical study team to make

241
00:10:55,588 --> 00:10:58,958
that decision on behalf of the
individual?

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00:10:59,959 --> 00:11:02,521
And then lastly,
as it relates to fair

243
00:11:02,521 --> 00:11:03,329
participant

244
00:11:03,329 --> 00:11:06,003
selection, again, we've talked
about this,

245
00:11:06,003 --> 00:11:08,167
the importance of sort of
sharing

246
00:11:08,167 --> 00:11:10,854
the risks of burdens
and potential benefits of

247
00:11:10,854 --> 00:11:11,671
participation

248
00:11:12,105 --> 00:11:17,176
across all individuals
and societal groups as possible.

249
00:11:17,176 --> 00:11:22,148
So we worry about both exclusion
and inclusion.

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00:11:22,582 --> 00:11:26,772
Inclusion as it means someone
has an opportunity or a

251
00:11:26,772 --> 00:11:27,720
possibility

252
00:11:27,720 --> 00:11:30,186
of benefiting and exclusion in
terms

253
00:11:30,186 --> 00:11:32,926
of whether or not that
particular group

254
00:11:33,326 --> 00:11:36,771
is taking on
too much of the burden of the

255
00:11:36,771 --> 00:11:37,263
trial

256
00:11:37,263 --> 00:11:41,025
and or won't benefit
as a result of their

257
00:11:41,025 --> 00:11:42,402
participation,

258
00:11:42,402 --> 00:11:45,112
or the group from which they
come

259
00:11:45,112 --> 00:11:47,740
is less likely to benefit from,

260
00:11:48,908 --> 00:11:50,910
the findings of the study.

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00:11:50,910 --> 00:11:53,138
We'll talk more about that next
week

262
00:11:53,138 --> 00:11:54,314
when we transition

263
00:11:54,314 --> 00:11:57,317
to international issues.

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00:11:58,384 --> 00:12:01,821
So, Jill mentioned undue
inducement.

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00:12:01,821 --> 00:12:05,992
And so one might be concerned
that

266
00:12:06,593 --> 00:12:10,063
if the person who isn't insured

267
00:12:10,463 --> 00:12:13,499
and wants to enroll at one of
the sites

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00:12:13,499 --> 00:12:15,602
where the standard of care

269
00:12:15,602 --> 00:12:18,705
will be covered, if, let me say
that

270
00:12:18,705 --> 00:12:21,774
a different way at the other
three sites,

271
00:12:21,774 --> 00:12:25,477
they plan to enroll uninsured
participants

272
00:12:25,477 --> 00:12:27,680
and the sites will cover

273
00:12:27,680 --> 00:12:31,784
the standard of care costs
for those participants.

274
00:12:31,784 --> 00:12:34,127
So the participants in those
other

275
00:12:34,127 --> 00:12:34,954
three sites

276
00:12:34,954 --> 00:12:37,957
will not be at financial risk.

277
00:12:38,191 --> 00:12:42,962
This other site wants to exclude
anyone who's uninsured

278
00:12:43,229 --> 00:12:46,232
because they don't
want to cover that cost.

279
00:12:46,799 --> 00:12:50,169
And so the one worry
might be for the folks

280
00:12:50,169 --> 00:12:54,540
who are in those other sites of
is providing

281
00:12:55,008 --> 00:12:57,215
covering standard of care for
the period

282
00:12:57,215 --> 00:12:59,312
of this trial, which is up to a
year.

283
00:12:59,812 --> 00:13:02,578
Is that somehow an undue
inducement

284
00:13:02,578 --> 00:13:04,317
for those individuals

285
00:13:04,317 --> 00:13:09,397
and I would argue that it's it's
likely not, that it's relatively

286
00:13:09,397 --> 00:13:10,023
modest.

287
00:13:10,023 --> 00:13:12,416
And when we talk about undue
inducement

288
00:13:12,416 --> 00:13:14,994
and, and, and Jill mentioned
this before,

289
00:13:14,994 --> 00:13:17,021
sometimes we think about it in
the,

290
00:13:17,021 --> 00:13:18,064
in the setting of

291
00:13:18,631 --> 00:13:21,768
if you're talking about people
who have a condition,

292
00:13:21,768 --> 00:13:26,873
these folks are all at high
risk of having long Covid

293
00:13:28,574 --> 00:13:31,088
when there is a potential
benefit

294
00:13:31,088 --> 00:13:32,612
for the individuals

295
00:13:32,612 --> 00:13:36,883
who enroll, maybe that's enough
as a potential benefit.

296
00:13:36,883 --> 00:13:40,707
And we don't traditionally
then pay them for their

297
00:13:40,707 --> 00:13:41,854
participation.

298
00:13:42,355 --> 00:13:44,663
But in this case, there is going
to be

299
00:13:44,663 --> 00:13:47,093
for those who are in those other
sites,

300
00:13:47,660 --> 00:13:51,097
some financial benefit
in covering the standard

301
00:13:51,097 --> 00:13:54,373
of care procedures
that they otherwise wouldn't

302
00:13:54,373 --> 00:13:55,001
receive.

303
00:13:55,001 --> 00:13:57,365
Right, because they are
uninsured

304
00:13:57,365 --> 00:13:59,372
or they are at risk of long

305
00:13:59,372 --> 00:14:01,675
Covid,
they are going to be out in the

306
00:14:01,675 --> 00:14:02,341
community.

307
00:14:02,341 --> 00:14:05,344
Maybe there's something that,

308
00:14:05,344 --> 00:14:08,281
is of undue inducement for them.

309
00:14:08,281 --> 00:14:11,284
But in the context of a trial

310
00:14:11,284 --> 00:14:14,287
for people who may benefit,

311
00:14:14,620 --> 00:14:16,789
we think about undue inducement

312
00:14:16,789 --> 00:14:19,792
as a concern.

313
00:14:20,426 --> 00:14:23,029
But from my perspective,

314
00:14:23,029 --> 00:14:25,486
and we've talked a little about
this

315
00:14:25,486 --> 00:14:26,032
before,

316
00:14:26,299 --> 00:14:29,435
undue inducement sort of kicks
in

317
00:14:29,435 --> 00:14:33,506
when the benefit
that the person may receive,

318
00:14:33,506 --> 00:14:37,457
and in this case,
it's a potential benefit from

319
00:14:37,457 --> 00:14:37,877
the,

320
00:14:38,945 --> 00:14:40,179
compound

321
00:14:40,179 --> 00:14:43,950
and some financial benefit
of having standard of care

322
00:14:44,550 --> 00:14:49,088
available overwhelms their
concerns

323
00:14:49,088 --> 00:14:51,649
about the risk of the
intervention

324
00:14:51,649 --> 00:14:54,060
that they may be randomized to.

325
00:14:54,694 --> 00:14:57,363
So another way to say that is
that

326
00:14:57,363 --> 00:15:00,348
because the coverage of the
standard of

327
00:15:00,348 --> 00:15:02,568
care is so valuable to them,

328
00:15:03,236 --> 00:15:05,135
it would swamp their ability to
make

329
00:15:05,135 --> 00:15:07,140
an informed decision about
enrollment

330
00:15:07,140 --> 00:15:10,209
because they're going to
underestimate

331
00:15:10,209 --> 00:15:13,312
or diminish the potential risk
for them.

332
00:15:13,312 --> 00:15:17,850
And from my perspective,
I don't think that providing

333
00:15:17,850 --> 00:15:20,084
standard of coverage for
standard of care

334
00:15:20,084 --> 00:15:22,155
for those other folks is
problematic.

335
00:15:22,989 --> 00:15:25,251
And you guys brought this up
categorically

336
00:15:25,251 --> 00:15:27,460
excluding uninsured patients
would be a,

337
00:15:28,127 --> 00:15:30,234
I think, a disproportionate
response

338
00:15:30,234 --> 00:15:31,931
to undue inducement concerns

339
00:15:32,298 --> 00:15:35,568
and would likely violate
that principle above,

340
00:15:35,968 --> 00:15:38,366
that we talked about
in terms of fair participant

341
00:15:38,366 --> 00:15:38,905
selection.

342
00:15:40,306 --> 00:15:40,907
So I want

343
00:15:40,907 --> 00:15:44,744
to end with sort of a more meta
question

344
00:15:44,744 --> 00:15:47,747
in thinking about clinical
trials

345
00:15:47,747 --> 00:15:50,917
and the ethics of clinical
trials.

346
00:15:50,917 --> 00:15:53,319
My last question is

347
00:15:53,319 --> 00:15:56,088
if we're thinking about

348
00:15:56,088 --> 00:15:59,091
fairness right.

349
00:15:59,992 --> 00:16:00,893
Is it

350
00:16:00,893 --> 00:16:04,129
so again, just to remind you,
we have three sites that are

351
00:16:04,129 --> 00:16:04,463
going

352
00:16:04,463 --> 00:16:06,490
to enroll people who are
uninsured

353
00:16:06,490 --> 00:16:08,935
or regardless of their uninsured
status,

354
00:16:09,335 --> 00:16:12,338
and another site
who wants to exclude them.

355
00:16:13,739 --> 00:16:18,177
Now, is that fair to other
participants?

356
00:16:19,111 --> 00:16:19,779
Right.

357
00:16:19,779 --> 00:16:22,782
So another way to think about
that is if,

358
00:16:24,016 --> 00:16:26,519
covering that cost

359
00:16:26,519 --> 00:16:30,356
for those who have insurance or
charging

360
00:16:30,356 --> 00:16:33,359
insurance is covering the cost

361
00:16:33,359 --> 00:16:36,529
for those who are uninsured,
unfair

362
00:16:36,529 --> 00:16:39,532
to the larger participant
population

363
00:16:40,233 --> 00:16:43,135
and or is covering it at one
site

364
00:16:43,135 --> 00:16:45,805
unfair to the other sites?

365
00:16:45,805 --> 00:16:49,609
And I mentioned these
just in the sense that you

366
00:16:49,876 --> 00:16:52,106
you know, generally when we're
thinking

367
00:16:52,106 --> 00:16:54,280
about the conduct of clinical
trials,

368
00:16:54,747 --> 00:16:55,815
we're thinking,

369
00:16:55,815 --> 00:16:58,651
you know, about the clinical
trial itself.

370
00:16:58,651 --> 00:17:02,489
We're thinking about the risk to
participants, the benefits to

371
00:17:02,489 --> 00:17:03,356
participants,

372
00:17:04,557 --> 00:17:05,258
making sure

373
00:17:05,258 --> 00:17:07,452
that's balanced, considering
informed

374
00:17:07,452 --> 00:17:09,528
consent, increasing the
likelihood

375
00:17:09,528 --> 00:17:12,531
that people will understand,

376
00:17:14,133 --> 00:17:15,468
Sometimes we have to

377
00:17:15,468 --> 00:17:18,504
look at how the trial itself is

378
00:17:18,504 --> 00:17:22,608
being designed and how different
sites

379
00:17:22,608 --> 00:17:26,045
or different policies
or different criteria

380
00:17:26,579 --> 00:17:29,582
might.

381
00:17:30,216 --> 00:17:33,052
Invite.

382
00:17:33,052 --> 00:17:36,055
Disparities or,

383
00:17:36,622 --> 00:17:40,293
inequalities among sites
and or participants.

384
00:17:40,293 --> 00:17:43,726
And should it be a goal
that everyone is doing the same

385
00:17:43,726 --> 00:17:44,163
thing?

386
00:17:44,163 --> 00:17:47,690
Is that a
a reason, a thing for us to

387
00:17:47,690 --> 00:17:48,834
think about

388
00:17:48,834 --> 00:17:51,871
when we're evaluating a clinical
trial?

389
00:17:51,871 --> 00:17:54,874
I don't I don't think so.

390
00:17:54,874 --> 00:17:58,678
I'll say from my experience
of being on many IRBs,

391
00:17:59,912 --> 00:18:02,014
I'm not sure,

392
00:18:02,014 --> 00:18:04,857
that the average institutional
review

393
00:18:04,857 --> 00:18:05,318
board

394
00:18:05,318 --> 00:18:08,921
thinks as much as they should
in some cases,

395
00:18:09,789 --> 00:18:13,388
about whether or not some of
these arrangements are fair or

396
00:18:13,388 --> 00:18:13,693
not.

397
00:18:14,427 --> 00:18:18,364
And so I'm wondering,
I'd like to just open the,

398
00:18:19,031 --> 00:18:22,401
discussion of what do you what
do

399
00:18:23,703 --> 00:18:25,605
is whether or

400
00:18:25,605 --> 00:18:29,809
not to include participants
who are uninsured,

401
00:18:31,644 --> 00:18:34,547
should we say, in a system

402
00:18:34,547 --> 00:18:39,642
that is already unfair,
that it would be inappropriate

403
00:18:39,642 --> 00:18:40,586
to always

404
00:18:40,586 --> 00:18:43,689
or considered to exclude people
who are uninsured?

405
00:18:44,256 --> 00:18:48,160
Or do we say, well, given that
our system

406
00:18:48,160 --> 00:18:52,198
is by definition unfair,
we shouldn't doubly

407
00:18:53,499 --> 00:18:56,068
place a burden on those who are
uninsured

408
00:18:56,068 --> 00:18:59,562
and therefore should make sure
that we include them as often as

409
00:18:59,562 --> 00:19:00,006
we can.

410
00:19:00,773 --> 00:19:02,999
Does anybody have any sort of
opinion

411
00:19:02,999 --> 00:19:04,443
or thoughts about that?

412
00:19:05,845 --> 00:19:08,748
And I'll mention that this is a
relatively

413
00:19:08,748 --> 00:19:12,700
this is a unique issue for us,
you know, in the United States

414
00:19:12,700 --> 00:19:13,219
in that

415
00:19:14,253 --> 00:19:17,156
it's not the case that everybody
has access to health care.

416
00:19:17,156 --> 00:19:19,184
Another way of saying that would
be

417
00:19:19,184 --> 00:19:20,459
we don't have to have

418
00:19:20,459 --> 00:19:24,163
this conversation in other
settings where

419
00:19:25,231 --> 00:19:29,201
basic health care is provided to
everyone.

420
00:19:29,201 --> 00:19:29,468
Right?

421
00:19:29,468 --> 00:19:32,389
It's sort of one way to address
the ethical concern is to say,

422
00:19:32,389 --> 00:19:32,672
well,

423
00:19:33,239 --> 00:19:35,808
let's just make sure everybody's
insured.

424
00:19:35,808 --> 00:19:37,276
We can't do that.

425
00:19:37,276 --> 00:19:40,846
So then we have to
sort of manage, is it okay?

426
00:19:40,846 --> 00:19:43,382
Should we always include
or should we exclude?

427
00:19:43,382 --> 00:19:46,352
And what were the justifications
for that? Be.

428
00:19:48,487 --> 00:19:49,622
Yeah, I guess I could,

429
00:19:49,622 --> 00:19:52,939
I could see maybe an argument
for excluding the uninsured,

430
00:19:52,939 --> 00:19:53,225
like

431
00:19:54,326 --> 00:19:56,996
if the costs of including them
were made

432
00:19:56,996 --> 00:20:01,167
for externalized specifically
on to the insured participants,

433
00:20:01,167 --> 00:20:04,403
like if they received less
compensation

434
00:20:04,403 --> 00:20:07,473
because more money had to,

435
00:20:07,473 --> 00:20:09,442
be given to pay,

436
00:20:09,442 --> 00:20:12,445
for the care of the uninsured.

437
00:20:12,712 --> 00:20:15,848
But even then, it just seems
like the

438
00:20:15,848 --> 00:20:18,250
the other side of just of that
is just like

439
00:20:18,250 --> 00:20:20,729
you have to exclude a bunch of
uninsured

440
00:20:20,729 --> 00:20:22,154
possible participants,

441
00:20:22,154 --> 00:20:24,101
and that just seems like to be
sort

442
00:20:24,101 --> 00:20:26,325
of an overriding right issue
like that.

443
00:20:26,325 --> 00:20:28,439
It seems particularly
indiscriminate,

444
00:20:28,439 --> 00:20:29,695
discriminatory to me.

445
00:20:29,695 --> 00:20:34,213
So that, yeah, I think it would
make more sense to just have

446
00:20:34,213 --> 00:20:35,267
like, ideally

447
00:20:35,801 --> 00:20:38,838
there's some sort of institution
that can, at least in this case,

448
00:20:40,606 --> 00:20:40,973
you know,

449
00:20:40,973 --> 00:20:43,789
subsidize and pay for that
uninsured

450
00:20:43,789 --> 00:20:45,744
medical care and I guess

451
00:20:45,744 --> 00:20:47,589
even more ideally, that we would
just have

452
00:20:47,589 --> 00:20:49,215
a sort of different insurance
regime

453
00:20:49,215 --> 00:20:51,077
where it's not private in such a
way

454
00:20:51,077 --> 00:20:52,785
where some people are uninsured.

455
00:20:53,252 --> 00:20:53,853
Yeah.

456
00:20:53,853 --> 00:20:57,356
So I'll mention and this is, so,

457
00:20:59,458 --> 00:21:00,493
from the perspective

458
00:21:00,493 --> 00:21:03,496
of an academic medical center,

459
00:21:03,929 --> 00:21:06,932
when I was at Hopkins,
the School of Medicine

460
00:21:07,266 --> 00:21:10,102
would not routinely

461
00:21:10,102 --> 00:21:13,205
exclude individuals
based on their insurance status.

462
00:21:13,539 --> 00:21:17,141
What they would do is once
someone is identified as

463
00:21:17,141 --> 00:21:17,777
eligible

464
00:21:17,777 --> 00:21:20,913
and insurance was highlighted
as a concern,

465
00:21:21,547 --> 00:21:24,518
they would basically send the
person

466
00:21:24,518 --> 00:21:26,252
to the social worker

467
00:21:26,252 --> 00:21:28,287
who is in charge of making sure

468
00:21:28,287 --> 00:21:30,052
that they're receiving all the
benefits

469
00:21:30,052 --> 00:21:31,590
that they're eligible for,
right?

470
00:21:31,590 --> 00:21:35,060
So someone who's never enrolled
in Medicaid

471
00:21:35,060 --> 00:21:36,989
or lives in a state like
Maryland,

472
00:21:36,989 --> 00:21:39,031
where there are safety net
programs

473
00:21:39,031 --> 00:21:42,501
that individuals can apply for
to get their health care

474
00:21:42,501 --> 00:21:43,068
insured.

475
00:21:43,068 --> 00:21:46,172
So that's I think that's one
way.

476
00:21:46,172 --> 00:21:48,107
I mean,
it doesn't eliminate the

477
00:21:48,107 --> 00:21:49,074
problem, right?

478
00:21:49,074 --> 00:21:51,705
There may be some individuals,
right,

479
00:21:51,705 --> 00:21:52,344
who just

480
00:21:53,145 --> 00:21:56,615
are not eligible for they make
too much

481
00:21:56,615 --> 00:21:59,320
or they're male or they're not
pregnant

482
00:21:59,320 --> 00:22:01,053
or all sorts of reasons.

483
00:22:01,320 --> 00:22:05,191
They may not qualify
for any of the public benefits

484
00:22:05,191 --> 00:22:09,461
available to them that they
they will be uninsured.

485
00:22:09,461 --> 00:22:10,196
They. Right.

486
00:22:10,196 --> 00:22:11,163
They don't have a job.

487
00:22:11,163 --> 00:22:14,266
Most people get insurance
through their jobs.

488
00:22:14,266 --> 00:22:18,771
So that's a way of at least
trying to close that gap.

489
00:22:20,072 --> 00:22:23,108
And the other thing,

490
00:22:23,108 --> 00:22:26,008
to think about,
I mean, my, my, the most

491
00:22:26,008 --> 00:22:27,313
experience I have

492
00:22:27,313 --> 00:22:31,083
as it relates
to inclusion of individual roles

493
00:22:31,083 --> 00:22:34,809
who are uninsured is,
you know, earlier in the HIV

494
00:22:34,809 --> 00:22:35,554
epidemic,

495
00:22:36,288 --> 00:22:41,360
where there were trials
that were open back

496
00:22:41,360 --> 00:22:44,125
then, you were randomized to a
placebo

497
00:22:44,125 --> 00:22:45,798
or an active compound.

498
00:22:46,098 --> 00:22:48,453
You know, as time went by, there
would be

499
00:22:48,453 --> 00:22:50,636
many fewer placebo controlled
trials,

500
00:22:50,636 --> 00:22:53,672
but still trials that tested the
standard

501
00:22:53,672 --> 00:22:56,642
towards the, the new novel
thing.

502
00:22:57,176 --> 00:23:00,512
That group by demographically,

503
00:23:01,413 --> 00:23:03,749
were much less likely to be
insured

504
00:23:03,749 --> 00:23:08,053
than the average person
in terms of their ability

505
00:23:08,053 --> 00:23:11,290
to qualify for disability on
Medicare,

506
00:23:11,290 --> 00:23:14,126
their ability to hold down a
job, etc..

507
00:23:14,126 --> 00:23:17,576
So, you know, a blanket
exclusion of,

508
00:23:17,576 --> 00:23:20,466
of excluding those individuals

509
00:23:20,466 --> 00:23:22,794
meant that they would basically
be

510
00:23:22,794 --> 00:23:25,671
without health care for a period
of time,

511
00:23:27,006 --> 00:23:27,973
or if they would

512
00:23:27,973 --> 00:23:30,298
extend the time with which they
didn't

513
00:23:30,298 --> 00:23:32,011
have access to health care.

514
00:23:32,278 --> 00:23:34,905
So really saw this as an
opportunity

515
00:23:34,905 --> 00:23:36,949
to have stable health care,

516
00:23:36,949 --> 00:23:40,486
which again, ethically I find
problematic.

517
00:23:40,486 --> 00:23:42,813
But I'm not going to say and
therefore

518
00:23:42,813 --> 00:23:45,324
we should exclude them because
if that's

519
00:23:45,324 --> 00:23:48,162
the only way to have access to
stable

520
00:23:48,162 --> 00:23:51,230
health care, there's a trade off
there.

521
00:23:51,230 --> 00:23:51,664
Right.

522
00:23:51,664 --> 00:23:56,101
And, my inclination is to say,
if that's the only way

523
00:23:56,101 --> 00:23:58,470
you're going to have access,
this seems like a,

524
00:23:58,470 --> 00:24:00,731
you know, given the background
conditions,

525
00:24:00,731 --> 00:24:02,508
given the contextual conditions,

526
00:24:02,975 --> 00:24:05,798
it seems, you know, not only
reasonable

527
00:24:05,798 --> 00:24:06,812
but important

528
00:24:06,812 --> 00:24:10,416
to facilitate enrollment
in clinical trials.

529
00:24:10,416 --> 00:24:13,485
And on the first day of class,
I think Christine showed,

530
00:24:14,353 --> 00:24:16,555
there was sort of a series of,

531
00:24:16,555 --> 00:24:18,770
I can't remember the term she
used for

532
00:24:18,770 --> 00:24:20,926
er, as I think of clinical
research.

533
00:24:20,926 --> 00:24:24,263
And one of those eras was the
early,

534
00:24:25,297 --> 00:24:27,066
advocacy for HIV

535
00:24:27,066 --> 00:24:30,970
and the signs that many would
hold peer

536
00:24:30,970 --> 00:24:34,373
at the NIH and FDA is,
you know, clinical trials is

537
00:24:34,373 --> 00:24:35,240
health care.

538
00:24:35,474 --> 00:24:35,808
Right?

539
00:24:35,808 --> 00:24:37,762
And some people said, well, you
know,

540
00:24:37,762 --> 00:24:39,611
that shouldn't be the case,
right?

541
00:24:39,611 --> 00:24:42,175
Like, kind of you shouldn't
think of clinical trials as

542
00:24:42,175 --> 00:24:42,781
health care.

543
00:24:42,781 --> 00:24:44,783
That's a therapeutic
misconception.

544
00:24:44,783 --> 00:24:47,537
But for them, it was literal in
the sense

545
00:24:47,537 --> 00:24:50,022
of having access to a clinical
trial

546
00:24:50,022 --> 00:24:54,560
means that I might have access
to sustainable health care.