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And our topic today,

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international research ethics
specifically.

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I'm going to be offering
a brief introduction and then a

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more

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in-depth discussion of standards
of care.

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And while I am a faculty member
in the

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Clinical Center Department of
Bioethics,

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nonetheless,
none of the views that are

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expressed

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in this talk are anyone else's
but my own.

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I'm not representing my ass.

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That's not not even the
department itself.

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I'm just speaking for me here.

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So another note on terminology.

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I'm going to be using the term

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the terms low and middle income
countries

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and high income countries.

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Lmics and HIV Aids.

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But in using those terms,
I don't mean to imply that

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there's

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a hierarchy of countries
based on their economic status.

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There's more to well-being
than wealth, both at the

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individual

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and at the social levels.

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And I also don't mean to imply
the individual countries that

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fall within

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these designations
are just interchangeable with

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each other.

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Obviously,
there's a great deal of

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variation

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between countries at any income
level.

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Nonetheless, even acknowledging
that generalizations are never

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perfectly accurate.

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It is helpful to be able to
speak broadly,

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and these are

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the terms that match current
NIH terminology and program

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announcements.

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So those are going to be the
ones

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that I'm going to use in this
talk.

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Okay.

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So let's start off with the big
question.

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What are researchers and
sponsors

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ethical obligations
in international collaborative

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research.

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Specifically, what are
researchers

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and sponsors ethical obligations

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when it comes to research,
which is sponsored by

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institutions

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in high income countries

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and carried out in low and
middle

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income countries with limited
resources.

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I mean, of course,

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there's no principled reason
that an institution in a lower

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middle

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income country cannot sponsor
research

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to take place in a high income
country.

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But the reality of where current
money

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and resources are concentrated

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means that the vast majority
of international collaborations

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do rely on

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high income country funding to
conduct

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trials in low and middle income
countries.

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So it makes sense to ask about
the ethical considerations that

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arise

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in that kind of partnership.

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Specifically.

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Okay.

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In thinking through those
issues,

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it's helpful

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to take a step back
and think about the context.

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So what is that context first?

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There are cultural differences
that include different habits

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and systems of value and
meaning.

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For instance, moral, political
and

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economic understandings of human
activity

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that shape people's ideas
about what research should be

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conducted

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and how that research should be
conducted.

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These differences
can exist between the research

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team

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and the study population, but
importantly

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also within the research team
itself

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and also within the study
population,

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which is not a homogeneous

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okay.

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So there are also power
differentials,

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which are differences in the
ability

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to direct or influence

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the behavior of others
or courses of events.

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These kind of create
and include differences in the

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ability

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to negotiate collaborative
projects

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due to differences in

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funding,

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sorry, the differences in
funding,

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access to facilities, education,
and so on.

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Again, these can exist between
the research team and study

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population,

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but also within each of the
research team

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and study populations

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themselves.

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And finally,
they're also background

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injustices.

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These can include injustices
due to colonial history,

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to the current global order
and political failures at the

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local level.

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These injustices mean that

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there are cases where the
institutions

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and society do not function in a
way

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that allows study participants
and host

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communities to meet their basic
needs.

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For example, some host community
communities may not have access

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to sanitation, good quality
health care, or universal

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education.

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And as a result, people living
in those

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communities can be especially
vulnerable.

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Researchers and sponsors
typically have no personal

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responsibility
for these preexisting

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injustices.

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And their primary professional
responsibility is to conduct

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research.

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But nonetheless, background
injustices form part

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of the non-ideal conditions
under

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which they need to conduct their
studies,

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and attempting to address,
or at least attempting to not

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exploit

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or exacerbate those
vulnerabilities

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will place some obligations on
them.

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So what sort of challenges are
created

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by the context I've just
described?

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I list some out.

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For me,

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I list some out here.

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Got lost on my slides for a
second.

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My apologies. Okay.

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I list them out here.

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So start with,

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cultural differences and
informed consent.

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What should informed consent
looks like when cultural or

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social norms

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around decision making differ

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from what the standard view of
informed

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consent presumes?

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Like, for instance,
if those norms are less

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individualistic,

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or think about how those norms
might have,

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or think about how power
differentials

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might affect collaborative
partnership,

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how can researchers achieve
collaborative partnership?

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And there are big differences in
power

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between research teams and
research teams

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and communities in terms of
education,

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skills, funding and the like.

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How might they affect
independent review?

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How can the independence of
ethical review

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be ensured when research
projects

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could bring in, for example,

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enormous investments in research
or health

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infrastructure,

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prestigious collaboration and
other

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extremely scarce and important
goods?

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Or consider background
injustices

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in conditions

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where health needs can be very
different

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between the sponsoring and host
country.

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Must research always address
and attempt to directly correct

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the needs of the host country,
as opposed to the sponsoring

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country.

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Or in other words, does research

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need to be responsive
to the local health needs?

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In particular?

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Or could it be reasonable to
conduct

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research that provides other
benefits

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to host communities, for
instance, through

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investing in health
infrastructure?

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Even when the study question
itself

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is not directly relevant,

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related and important questions

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concerning appropriate standards
of care.

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What is the appropriate
standard of care in research

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when there are large differences
in the level of care that's

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provided

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in low and middle income
countries,

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in high income countries?

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Relatedly, what are

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researchers
and ancillary care obligations?

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Do researchers have an
obligation

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to address

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health problems of participants
that are unrelated to research?

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And if so, like when and which
kinds?

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Finally,
whether researchers to study

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obligations.

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Once the study is over to
researchers and

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or sponsors have an obligation
to continue

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to provide treatment for
participants

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or to make any of the proven
effective study interventions

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available to the wider
community.

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You'll note that on this slide,
some of this is highlighted in

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pink.

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That's because we're going
to be focusing on them in

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today's session.

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So I'm going to transition
tonight

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into examining

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what standard of care
researchers are ethically

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required

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to provide to study participants
in international collective

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research.

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I Joe, we'll talk to you shortly
about post-trial obligations,

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and you'll also hear later from
Da

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fiscal year about community
engagement,

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which can be helpful
with navigating background

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injustices,

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as I'll mention later,

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but is especially essential
in responding to cultural

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differences

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and power differentials, which
is why it's

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highlighted in both of those
categories.

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Okay, so that's our background.

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As I mentioned,

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I will be,

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sorry, I just realized it
takes several clicks to advance

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the slide.

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That's what's been going on on
my side.

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There's with the way it's
set up on the side.

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Okay. So.

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As I mentioned, I'm going to be
discussing

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standards of care.

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What sorts of ethical questions
does this raise

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and why is it an important
topic?

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It's quite helpful to start
by discussing a particular,

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very prominent controversy
that erupted about 20 years ago

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about standard of care
and international research,

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which will help clarify both
what's the issue and why it

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matters.

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So that controversy was over
short course AZT trials.

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And here's the context.

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When untreated, pregnant people
who live with HIV

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transmit
it to 15 to 45% of their

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newborns.

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AZT AZT

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is a particular type of
antiretroviral,

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and in the early 1990s,

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a placebo controlled trial
conducted in the United States

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showed that the so-called 076
regimen,

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which was named after the
clinical

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trial number of the trial,
reduced

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perinatal transmission to less
than 5%.

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This regimen involved oral
AZT in the second trimester

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IV, especially during delivery.

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Oral AZT for six weeks after
birth

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and volunteering for six months.

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While this quickly became

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the standard of care in the US
and other high income countries,

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it was not implementable
in many low and middle income

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countries,

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which were also the countries
suffering the greatest burden of

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HIV

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and the highest rates
of perinatal transmission.

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Long course AZT cost $800 for a
treatment,

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while the per person expenditure
per year in on health

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was less than $100 in most
pharmacies

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and less than 20 or $30 in many.

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There was also a lack of
personnel

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and infrastructure to implement

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such a complex and long term
regimen.

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Finally, bottle
feeding infants in settings

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without access to clean
water poses risks of serious

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infection and death.

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Okay, so

270
00:10:23,556 --> 00:10:27,360
against this backdrop,
I learned, in fact, a strategy

271
00:10:27,360 --> 00:10:29,279
to test simpler and cheaper
regimens

272
00:10:29,279 --> 00:10:31,197
against placebo or no
intervention.

273
00:10:32,132 --> 00:10:35,802
16 trials were conducted
in total, 15 against placebo

274
00:10:36,135 --> 00:10:39,138
and one against a 76 as an
active control.

275
00:10:40,173 --> 00:10:43,243
These were expected
to be less effective than a 76,

276
00:10:43,243 --> 00:10:45,154
but it was hoped they'd be
effective

277
00:10:45,154 --> 00:10:47,013
enough and cheap and simple
enough

278
00:10:47,480 --> 00:10:49,582
to be worth implementing in low
and middle

279
00:10:49,582 --> 00:10:50,483
income countries.

280
00:10:52,352 --> 00:10:53,286
So the decision

281
00:10:53,286 --> 00:10:56,289
to run these trials left
controversy

282
00:10:56,656 --> 00:10:59,151
with two high profile articles
in the New England Journal of

283
00:10:59,151 --> 00:10:59,526
Medicine

284
00:10:59,526 --> 00:11:02,695
criticizing
the medicine and unethical one.

285
00:11:02,695 --> 00:11:03,796
The first one you see here

286
00:11:03,796 --> 00:11:06,922
was written by Peter Lurie
and Sidney Wolfe from Public

287
00:11:06,922 --> 00:11:07,433
Citizen,

288
00:11:07,967 --> 00:11:10,858
a nonprofit consumer advocacy
organization

289
00:11:10,858 --> 00:11:12,372
founded in 1971 that,

290
00:11:12,739 --> 00:11:15,872
in its own words, champions
the public interest in the halls

291
00:11:15,872 --> 00:11:16,342
of power

292
00:11:16,809 --> 00:11:19,712
and defends democracy, resists
corporate power, and works

293
00:11:19,712 --> 00:11:21,857
to ensure the government works
for the

294
00:11:21,857 --> 00:11:23,550
people, not big corporations.

295
00:11:25,451 --> 00:11:27,259
The other was written by Marcia
Angel,

296
00:11:27,259 --> 00:11:28,021
the New England

297
00:11:28,021 --> 00:11:30,290
Journal of the Journal of
Medicine

298
00:11:30,290 --> 00:11:31,624
editor at the time.

299
00:11:33,226 --> 00:11:34,919
The journal also ran a response
piece

300
00:11:34,919 --> 00:11:36,796
defending the trials from Harold
Varmus,

301
00:11:37,096 --> 00:11:39,394
who was NIH director, and David
Satcher,

302
00:11:39,394 --> 00:11:40,600
who was CDC director

303
00:11:40,967 --> 00:11:43,970
and who had funded the placebo
controlled studies.

304
00:11:45,872 --> 00:11:47,640
In this exchange,

305
00:11:47,640 --> 00:11:49,642
the key claim that critics of
the Salk

306
00:11:49,642 --> 00:11:50,643
course trials made

307
00:11:50,910 --> 00:11:53,580
was that they were unethical
because they did not provide

308
00:11:53,580 --> 00:11:55,349
the control group with the
global

309
00:11:55,349 --> 00:11:56,583
best standard of care,

310
00:11:56,583 --> 00:11:59,586
which at the time
would have been the 076 regimen.

311
00:12:00,219 --> 00:12:01,888
But while I think that providing
the global

312
00:12:01,888 --> 00:12:04,891
best standard of care is
required,

313
00:12:04,891 --> 00:12:07,860
they offer several reasons.

314
00:12:07,860 --> 00:12:10,552
Okay,
so first, researchers have an

315
00:12:10,552 --> 00:12:11,397
obligation

316
00:12:11,397 --> 00:12:13,130
of beneficence, which requires
them

317
00:12:13,130 --> 00:12:14,467
to avoid preventable harm.

318
00:12:15,535 --> 00:12:16,769
As they point out,

319
00:12:16,769 --> 00:12:18,788
giving given a control group of
seven six

320
00:12:18,788 --> 00:12:19,772
rather than placebo

321
00:12:20,039 --> 00:12:22,790
would result in fewer
perinatal transmissions and

322
00:12:22,790 --> 00:12:23,576
fewer deaths.

323
00:12:25,044 --> 00:12:27,480
So, of course, fewer
transmissions

324
00:12:27,480 --> 00:12:30,483
and fewer deaths are good
things.

325
00:12:31,517 --> 00:12:35,521
So they also have an obligation
to avoid treating participants

326
00:12:35,521 --> 00:12:37,955
merely as a means
to answering their scientific

327
00:12:37,955 --> 00:12:38,524
questions.

328
00:12:39,525 --> 00:12:42,895
Now it's it's less clear
what's meant by this,

329
00:12:42,895 --> 00:12:46,178
since the authors don't explain
and philosophers don't actually

330
00:12:46,178 --> 00:12:46,699
all agree

331
00:12:46,699 --> 00:12:49,702
on, what it means to treat
someone as a mere means.

332
00:12:50,570 --> 00:12:52,372
Since it's not clear,
I'm not going to focus on it

333
00:12:52,372 --> 00:12:55,375
now, but I will come back to it
and address it at the end,

334
00:12:56,142 --> 00:12:56,976
okay?

335
00:12:56,976 --> 00:13:00,113
They also have an obligation
to treat participants equally

336
00:13:00,113 --> 00:13:03,223
and relatedly,
to adhere to universal ethical

337
00:13:03,223 --> 00:13:03,983
standards.

338
00:13:05,284 --> 00:13:06,753
So they say that

339
00:13:06,753 --> 00:13:09,600
given that an act of control
would have been required for a

340
00:13:09,600 --> 00:13:09,889
short

341
00:13:09,889 --> 00:13:12,748
course AZT trial in a high
income country

342
00:13:12,748 --> 00:13:14,560
where 0761 standard care,

343
00:13:15,228 --> 00:13:17,038
the same standard should apply
in the low

344
00:13:17,038 --> 00:13:18,231
and middle income country.

345
00:13:18,931 --> 00:13:20,495
Otherwise, pregnant people and
infants

346
00:13:20,495 --> 00:13:21,934
in low and middle income
countries

347
00:13:22,235 --> 00:13:25,238
are being treated equally,
which is morally wrong.

348
00:13:29,942 --> 00:13:32,445
Is that true?

349
00:13:32,445 --> 00:13:35,448
So it is true

350
00:13:35,648 --> 00:13:38,851
that requiring active controls
in high income countries,

351
00:13:38,851 --> 00:13:40,733
and that low and middle income
countries

352
00:13:40,733 --> 00:13:42,755
would involve treating people
differently?

353
00:13:43,690 --> 00:13:45,356
But does being treated
differently

354
00:13:45,356 --> 00:13:46,826
mean being treated unequally?

355
00:13:47,260 --> 00:13:50,263
And does it imply
violating universal standards?

356
00:13:51,364 --> 00:13:54,014
As philosophers will tell you,
these questions can be pretty

357
00:13:54,014 --> 00:13:54,367
tricky.

358
00:13:55,101 --> 00:13:58,471
So here's just a quick sort of
cute.

359
00:13:58,805 --> 00:14:00,728
Some might even say facile
argument

360
00:14:00,728 --> 00:14:02,542
that treating people differently

361
00:14:02,775 --> 00:14:04,840
doesn't necessarily mean
treating them

362
00:14:04,840 --> 00:14:07,013
unequally in a morally
problematic way.

363
00:14:07,914 --> 00:14:11,217
So my mom received a cesarean
section.

364
00:14:11,851 --> 00:14:14,487
Difficult labor. Sorry, mom. My
fault.

365
00:14:15,521 --> 00:14:17,457
My dad never did.

366
00:14:17,457 --> 00:14:20,159
So doctors treated them
differently.

367
00:14:20,159 --> 00:14:22,095
Does that mean
they were treated unequally?

368
00:14:22,095 --> 00:14:24,263
And was that unequal treatment
wrong?

369
00:14:24,263 --> 00:14:25,765
Well, of course not.

370
00:14:25,765 --> 00:14:29,068
My mom had a difficult labor
and needed a C-section.

371
00:14:29,402 --> 00:14:32,205
My dad was never pregnant. He
didn't.

372
00:14:32,205 --> 00:14:35,475
So they were treated
equally in a moral sense.

373
00:14:35,475 --> 00:14:37,268
Both were able to access the
medical care

374
00:14:37,268 --> 00:14:38,711
that they needed in their lives.

375
00:14:39,178 --> 00:14:40,946
But they were also treated
differently

376
00:14:40,946 --> 00:14:42,248
because that was different.

377
00:14:42,248 --> 00:14:45,218
Care for each of them.

378
00:14:45,218 --> 00:14:47,220
So the top line point here

379
00:14:47,220 --> 00:14:49,178
is just that moral equality
requires

380
00:14:49,178 --> 00:14:51,190
that we not treat people
differently

381
00:14:51,457 --> 00:14:54,250
on the basis of morally
irrelevant differences between

382
00:14:54,250 --> 00:14:54,560
them.

383
00:14:54,961 --> 00:14:57,877
For instance,
treating one person from a

384
00:14:57,877 --> 00:14:58,898
favored race,

385
00:14:58,898 --> 00:15:01,901
religion, or gender better than
another.

386
00:15:02,668 --> 00:15:04,382
But it does allow for treating
people

387
00:15:04,382 --> 00:15:04,937
differently

388
00:15:04,937 --> 00:15:08,107
when there are relevant
differences between them.

389
00:15:09,242 --> 00:15:12,178
So the important question here

390
00:15:12,178 --> 00:15:13,989
is just whether, for the
purposes

391
00:15:13,989 --> 00:15:14,647
of deciding

392
00:15:14,647 --> 00:15:16,549
whether to offer the seven six
regimen

393
00:15:16,549 --> 00:15:17,650
as an act of control,

394
00:15:18,251 --> 00:15:19,970
the fact that it's locally
available

395
00:15:19,970 --> 00:15:20,686
in some places

396
00:15:20,686 --> 00:15:22,983
and not in others is a morally
relevant

397
00:15:22,983 --> 00:15:23,689
difference.

398
00:15:23,689 --> 00:15:24,824
Is it or is it not?

399
00:15:24,824 --> 00:15:27,827
That's what we need to
investigate.

400
00:15:28,828 --> 00:15:30,613
Now, in saying the equal
treatment

401
00:15:30,613 --> 00:15:32,031
requires offering under 76

402
00:15:32,031 --> 00:15:34,200
as an act of control
everywhere in the world

403
00:15:34,200 --> 00:15:36,803
whose officials were asserting
that local availability.

404
00:15:36,803 --> 00:15:38,037
It's not a relative difference.

405
00:15:38,037 --> 00:15:40,239
It's an irrelevant difference.

406
00:15:40,239 --> 00:15:43,009
But what justifies that claim?

407
00:15:43,009 --> 00:15:44,881
They lean heavily on the
Declaration

408
00:15:44,881 --> 00:15:46,546
of Helsinki to substantiate it.

409
00:15:48,147 --> 00:15:50,283
So the Declaration of Helsinki
is a World

410
00:15:50,283 --> 00:15:53,286
Medical Association statement
putting forth

411
00:15:53,286 --> 00:15:55,058
ethical principles for medical
research

412
00:15:55,058 --> 00:15:56,422
involving human participants.

413
00:15:57,356 --> 00:15:59,662
It was originally formulated
in the wake of medical

414
00:15:59,662 --> 00:16:00,159
atrocities

415
00:16:00,159 --> 00:16:03,963
during the Second World War,
and was first published in 1964.

416
00:16:05,198 --> 00:16:07,010
It's been controversial and
subject

417
00:16:07,010 --> 00:16:08,201
to multiple revisions,

418
00:16:08,401 --> 00:16:11,404
many of which did address
standard of care, specifically.

419
00:16:11,871 --> 00:16:14,707
So what I quoted here is the
1996 version

420
00:16:14,707 --> 00:16:17,710
that was getting referenced
in this debate.

421
00:16:18,644 --> 00:16:21,948
It states in any medical study,
every patient,

422
00:16:22,515 --> 00:16:24,659
including those of a control
group,

423
00:16:24,659 --> 00:16:26,252
if any, should be assured

424
00:16:26,252 --> 00:16:29,222
of the best proven diagnostic
and therapeutic method.

425
00:16:31,057 --> 00:16:34,227
Note that this actually implies
that it

426
00:16:34,227 --> 00:16:36,401
or may imply that it would be
wonderful

427
00:16:36,401 --> 00:16:38,798
to test short course AZT, even
against 076

428
00:16:38,798 --> 00:16:41,997
as an active control, as short
course was expected to be

429
00:16:41,997 --> 00:16:42,568
inferior,

430
00:16:42,869 --> 00:16:44,597
and hence it wouldn't be the
case

431
00:16:44,597 --> 00:16:46,639
even in a trial with an active
control

432
00:16:46,873 --> 00:16:50,596
that every patient was getting
the best proven therapeutic

433
00:16:50,596 --> 00:16:51,110
method.

434
00:16:51,911 --> 00:16:54,280
And indeed, some commenters
did in fact argue for that.

435
00:16:54,280 --> 00:16:55,681
You just can't touch short
course at all,

436
00:16:55,681 --> 00:16:57,103
because we should be getting
everyone

437
00:16:57,103 --> 00:16:58,217
long course in all contexts.

438
00:17:00,052 --> 00:17:01,687
The bracketing at issue.

439
00:17:01,687 --> 00:17:04,490
This declaration does support
the more limited claim

440
00:17:04,490 --> 00:17:07,426
that local availability
is not a relevant difference,

441
00:17:07,426 --> 00:17:09,918
as it appears to assert
a universal ethical principle

442
00:17:09,918 --> 00:17:10,529
which states

443
00:17:10,730 --> 00:17:12,982
the best proven care must be
offered

444
00:17:12,982 --> 00:17:13,733
everywhere.

445
00:17:14,433 --> 00:17:16,302
Okay,

446
00:17:16,302 --> 00:17:18,871
as mentioned, this element
of the Declaration of Helsinki

447
00:17:18,871 --> 00:17:20,873
has been controversial.

448
00:17:20,873 --> 00:17:23,843
Are still, the current stance
from 2024

449
00:17:23,843 --> 00:17:26,665
is not substantially updated
from the last tradition, and

450
00:17:26,665 --> 00:17:26,913
it's

451
00:17:26,913 --> 00:17:29,882
only slightly more permissive
than the 1996 version.

452
00:17:31,217 --> 00:17:32,785
Per the updates,

453
00:17:32,785 --> 00:17:34,445
it is permissible for
researchers

454
00:17:34,445 --> 00:17:36,055
to offer some participants less

455
00:17:36,055 --> 00:17:38,040
than the global best standard of
care

456
00:17:38,040 --> 00:17:40,293
only when there's no proven
intervention,

457
00:17:41,127 --> 00:17:44,130
or there are compelling
methodological reasons

458
00:17:44,130 --> 00:17:47,133
for using less
than the global standard of care

459
00:17:47,133 --> 00:17:49,210
and providing less than global
best poses

460
00:17:49,210 --> 00:17:51,337
no risk of serious and
irreversible harm.

461
00:17:52,872 --> 00:17:55,167
Even with
that requirement, the document

462
00:17:55,167 --> 00:17:55,741
also says

463
00:17:55,741 --> 00:17:58,437
extreme care must be taken
to avoid the abuse of this

464
00:17:58,437 --> 00:17:58,844
option.

465
00:18:00,513 --> 00:18:03,082
So the Declaration of Helsinki
is generally

466
00:18:03,082 --> 00:18:04,554
opposed to the placebo controls,
where

467
00:18:04,554 --> 00:18:05,484
active control controls

468
00:18:05,484 --> 00:18:07,386
exists, and endorses trials
which offer

469
00:18:07,386 --> 00:18:09,288
some participants less than the
global

470
00:18:09,288 --> 00:18:11,841
best standard of care
only under quite select

471
00:18:11,841 --> 00:18:12,692
circumstances.

472
00:18:14,527 --> 00:18:17,163
Okay, so it says these things

473
00:18:17,163 --> 00:18:19,298
and also the claim that research

474
00:18:19,298 --> 00:18:22,301
should generally and to compare
against some standard of care,

475
00:18:22,702 --> 00:18:25,439
even if not the global best,
does have plausible reasons

476
00:18:25,439 --> 00:18:26,172
supporting it.

477
00:18:26,973 --> 00:18:29,549
It's often socially valuable
to know how a new intervention

478
00:18:29,549 --> 00:18:29,942
performs

479
00:18:29,942 --> 00:18:32,211
against what's already
available,

480
00:18:32,211 --> 00:18:35,081
and offering standard care,
rather than placebo,

481
00:18:35,081 --> 00:18:37,112
can help minimize risk to
participants,

482
00:18:37,112 --> 00:18:39,352
as it does increase the number
who receive

483
00:18:39,352 --> 00:18:40,419
effective interventions.

484
00:18:42,722 --> 00:18:44,223
But as we will

485
00:18:44,223 --> 00:18:47,193
see, there are also some
challenges.

486
00:18:47,493 --> 00:18:49,747
One I'll just note is that the
requirement

487
00:18:49,747 --> 00:18:51,464
that deviations from the global

488
00:18:51,464 --> 00:18:53,798
best must pose
no risk of serious and

489
00:18:53,798 --> 00:18:54,934
irreversible harm

490
00:18:55,501 --> 00:18:58,337
is a version of a minimal risk
requirement,

491
00:18:58,337 --> 00:18:59,802
but in this case, it's being
applied

492
00:18:59,802 --> 00:19:01,307
to trials enrolling competent
adults

493
00:19:01,307 --> 00:19:04,377
rather than, as is typical,
being applied to trials

494
00:19:04,377 --> 00:19:07,313
in which participants
cannot consent for themselves.

495
00:19:07,313 --> 00:19:08,481
So like that's curious.

496
00:19:08,481 --> 00:19:10,916
And that could use an
explanation.

497
00:19:10,916 --> 00:19:12,653
But rather than dwell on that
future,

498
00:19:12,653 --> 00:19:13,919
I'm going to focus instead

499
00:19:13,919 --> 00:19:16,678
focus on the challenges
involved in determining what

500
00:19:16,678 --> 00:19:17,156
baseline

501
00:19:17,156 --> 00:19:20,159
researchers should be comparing
against as the standard of care.

502
00:19:23,729 --> 00:19:25,581
Okay, so the organizing question
here

503
00:19:25,581 --> 00:19:27,033
is whether it is permissible

504
00:19:27,033 --> 00:19:30,036
to provide less than the global
best standard of care.

505
00:19:30,469 --> 00:19:32,838
You know, the critics
we've just summarized said no

506
00:19:32,838 --> 00:19:34,612
and leaned heavily on the
Declaration

507
00:19:34,612 --> 00:19:36,242
of Helsinki in making their
case.

508
00:19:36,909 --> 00:19:39,038
But I'm going to give some
reasons

509
00:19:39,038 --> 00:19:40,980
to think yes, and also discuss

510
00:19:40,980 --> 00:19:44,399
some potential alternatives to
the global test as the relevant

511
00:19:44,399 --> 00:19:44,950
standard.

512
00:19:47,553 --> 00:19:50,556
Okay, here's the first proposal.

513
00:19:50,823 --> 00:19:52,525
The baseline that researchers
can compare

514
00:19:52,525 --> 00:19:55,528
against is what participants
otherwise would have gotten,

515
00:19:55,861 --> 00:19:59,212
which can also be referred to
as the de facto standard of

516
00:19:59,212 --> 00:19:59,565
care.

517
00:20:01,100 --> 00:20:03,286
After all,
if everyone who participates in

518
00:20:03,286 --> 00:20:03,702
a trial

519
00:20:03,702 --> 00:20:05,542
gets at least as good as what
they would

520
00:20:05,542 --> 00:20:07,106
have gotten outside of the
trial,

521
00:20:07,940 --> 00:20:09,854
possibly some people get
something

522
00:20:09,854 --> 00:20:10,643
that's better

523
00:20:10,643 --> 00:20:12,333
than some people were made
better off,

524
00:20:12,333 --> 00:20:13,712
and nobody was made worse off.

525
00:20:14,613 --> 00:20:18,451
So on this view, there's no loss
to participants from trials

526
00:20:18,451 --> 00:20:20,283
taking place under those
conditions,

527
00:20:20,283 --> 00:20:21,454
and perhaps some gain,

528
00:20:22,855 --> 00:20:24,690
of course, in some places.

529
00:20:24,690 --> 00:20:26,598
What participants are able to
get outside

530
00:20:26,598 --> 00:20:27,993
of the trial is not very much

531
00:20:28,427 --> 00:20:31,430
as was true in the short
course AZT trials,

532
00:20:32,131 --> 00:20:34,031
but for this view, the
consequence

533
00:20:34,031 --> 00:20:36,435
of not getting very much outside
the trial

534
00:20:36,735 --> 00:20:39,460
is that researchers
also don't need to offer that

535
00:20:39,460 --> 00:20:39,739
much

536
00:20:39,972 --> 00:20:42,508
in order to get participants
a better deal than what they

537
00:20:42,508 --> 00:20:42,775
would

538
00:20:42,775 --> 00:20:43,576
have otherwise gotten.

539
00:20:45,578 --> 00:20:46,178
So this

540
00:20:46,178 --> 00:20:48,812
view denies that what is locally
available is an irrelevant

541
00:20:48,812 --> 00:20:49,348
difference.

542
00:20:50,082 --> 00:20:51,848
Instead, it maintains that what
is locally

543
00:20:51,848 --> 00:20:53,319
available is irrelevant
difference

544
00:20:53,886 --> 00:20:56,222
because in areas
where the global best standard

545
00:20:56,222 --> 00:20:58,719
is available, offering
less than that can harm

546
00:20:58,719 --> 00:20:59,425
participants

547
00:20:59,425 --> 00:21:01,441
by preventing them from
receiving it,

548
00:21:01,441 --> 00:21:02,695
since they would have.

549
00:21:03,662 --> 00:21:05,418
But in areas where very little
is

550
00:21:05,418 --> 00:21:07,600
available, offering less than
the global

551
00:21:07,600 --> 00:21:09,784
best may not harm anyone as they
weren't

552
00:21:09,784 --> 00:21:11,804
going to get the global best
anyway.

553
00:21:13,038 --> 00:21:14,811
This view maintains that this
difference,

554
00:21:14,811 --> 00:21:16,108
namely the difference between

555
00:21:16,108 --> 00:21:19,453
whether you might be harming
people or not, is not morally

556
00:21:19,453 --> 00:21:20,146
irrelevant.

557
00:21:21,747 --> 00:21:24,817
Okay.

558
00:21:24,817 --> 00:21:27,887
But while this view has a simple
and compelling argument

559
00:21:27,887 --> 00:21:30,652
in its favor, it's
also subject to powerful

560
00:21:30,652 --> 00:21:31,423
criticisms.

561
00:21:32,458 --> 00:21:35,127
The most serious is that the de
facto

562
00:21:35,127 --> 00:21:38,297
standard of care can be
unacceptable.

563
00:21:38,297 --> 00:21:41,388
It is, as in this quote,
just a description of what

564
00:21:41,388 --> 00:21:41,934
happens,

565
00:21:42,334 --> 00:21:45,137
even as what happens
is highly morally objectionable.

566
00:21:46,438 --> 00:21:46,772
So there

567
00:21:46,772 --> 00:21:48,380
may be cases where treatment is
known

568
00:21:48,380 --> 00:21:50,075
to be effective in a given
population.

569
00:21:50,576 --> 00:21:52,511
It's cheap and feasible to
implement.

570
00:21:52,511 --> 00:21:55,648
And so it really should be
widely available,

571
00:21:55,648 --> 00:21:57,249
but it just isn't.

572
00:21:57,249 --> 00:21:58,993
For instance, basic childhood
vaccines

573
00:21:58,993 --> 00:22:00,553
might be the kind of
intervention

574
00:22:00,953 --> 00:22:03,722
where that could be true.

575
00:22:03,722 --> 00:22:07,526
The point is even more forceful
when we consider limitations

576
00:22:07,526 --> 00:22:09,424
on available care that are
grounded

577
00:22:09,424 --> 00:22:10,996
in extreme social injustice.

578
00:22:12,598 --> 00:22:14,233
For instance, while there are
many, many,

579
00:22:14,233 --> 00:22:17,236
many things wrong with Tuskegee,

580
00:22:17,670 --> 00:22:20,839
one was that it withheld
syphilis treatments even once,

581
00:22:20,839 --> 00:22:22,284
once were developed that were
safe,

582
00:22:22,284 --> 00:22:23,976
highly effective, and easy to
implement.

583
00:22:24,310 --> 00:22:26,912
Penicillin.

584
00:22:26,912 --> 00:22:29,242
The no loss view apparently
suggests

585
00:22:29,242 --> 00:22:31,183
that this could be acceptable

586
00:22:31,717 --> 00:22:33,146
if it were known that
participants

587
00:22:33,146 --> 00:22:33,986
would not be tested

588
00:22:33,986 --> 00:22:36,689
or treated for syphilis
outside of the trial,

589
00:22:36,689 --> 00:22:38,963
even if the reasons
they wouldn't be tested or

590
00:22:38,963 --> 00:22:39,358
treated

591
00:22:39,358 --> 00:22:41,263
are injustice in the form of
extreme

592
00:22:41,263 --> 00:22:42,428
racial discrimination

593
00:22:42,428 --> 00:22:43,963
and economic marginalization.

594
00:22:45,631 --> 00:22:47,967
But many people
believe it would be a form of

595
00:22:47,967 --> 00:22:48,434
wrongful

596
00:22:48,434 --> 00:22:50,925
compounding of this injustice to
allow,

597
00:22:50,925 --> 00:22:53,672
as the no last few apparently
does, for it

598
00:22:53,672 --> 00:22:55,912
to be used to justify offering
less

599
00:22:55,912 --> 00:22:57,576
care to these individuals

600
00:22:57,576 --> 00:22:59,445
than would be offered to other
individuals

601
00:22:59,445 --> 00:23:00,512
who have better options

602
00:23:00,512 --> 00:23:03,515
outside of a trial.

603
00:23:07,152 --> 00:23:08,254
Okay,

604
00:23:08,254 --> 00:23:11,257
so a second proposal addresses
that problem

605
00:23:11,724 --> 00:23:13,576
by maintaining that baseline
research

606
00:23:13,576 --> 00:23:14,727
as you compare against

607
00:23:15,060 --> 00:23:17,863
should be what participants
should receive

608
00:23:17,863 --> 00:23:18,998
rather than what

609
00:23:19,231 --> 00:23:21,777
they actually
would receive outside of the

610
00:23:21,777 --> 00:23:22,201
trial.

611
00:23:22,968 --> 00:23:25,289
This is the discovery or by
rights

612
00:23:25,289 --> 00:23:25,971
standard,

613
00:23:26,171 --> 00:23:28,535
as opposed to the de facto or by
fact

614
00:23:28,535 --> 00:23:29,174
standard.

615
00:23:30,843 --> 00:23:34,107
Those two standards come apart
when the actually existing

616
00:23:34,107 --> 00:23:34,680
situation

617
00:23:34,680 --> 00:23:37,644
violates someone's legal,
and more likely, their moral

618
00:23:37,644 --> 00:23:38,083
rights,

619
00:23:38,751 --> 00:23:41,247
as for instance,
when extreme racial

620
00:23:41,247 --> 00:23:42,288
discrimination

621
00:23:42,588 --> 00:23:46,416
and economic marginalization
meant that many black men in the

622
00:23:46,416 --> 00:23:46,792
South

623
00:23:46,792 --> 00:23:49,623
were not going to be diagnosed
or treated, was treated for

624
00:23:49,623 --> 00:23:50,062
syphilis

625
00:23:50,763 --> 00:23:52,860
despite testing and treatment
being cheap and easily

626
00:23:52,860 --> 00:23:53,465
implementable.

627
00:23:54,566 --> 00:23:56,368
So in those kinds of cases,

628
00:23:56,368 --> 00:23:58,187
the appropriate local care view
maintains

629
00:23:58,187 --> 00:24:00,005
that we should not identify the
standard

630
00:24:00,005 --> 00:24:02,274
of care with white individuals
or actually getting,

631
00:24:02,274 --> 00:24:04,677
but instead
with what they should be

632
00:24:04,677 --> 00:24:05,277
getting.

633
00:24:05,911 --> 00:24:07,908
This view, like the no last
view,

634
00:24:07,908 --> 00:24:10,449
also denies that where research
conducted

635
00:24:10,449 --> 00:24:13,166
is an irrelevant feature
when it comes to the standard of

636
00:24:13,166 --> 00:24:13,452
care,

637
00:24:14,386 --> 00:24:17,289
but it says that it's relevant
not because it affects

638
00:24:17,289 --> 00:24:20,292
what people actually
are getting outside of trials,

639
00:24:20,726 --> 00:24:23,175
but because it affects
what people should get outside

640
00:24:23,175 --> 00:24:23,729
of a trial.

641
00:24:24,830 --> 00:24:26,535
It's reasonable for different
areas

642
00:24:26,535 --> 00:24:27,900
to adopt different tertiary

643
00:24:27,900 --> 00:24:29,935
standards of care
based on their populations

644
00:24:29,935 --> 00:24:34,218
needs, their resources,
their priorities for instance,

645
00:24:34,218 --> 00:24:34,773
health

646
00:24:34,773 --> 00:24:37,776
against other socially valuable
improvements and projects.

647
00:24:39,378 --> 00:24:42,848
It can be at least can be
reasonable

648
00:24:43,349 --> 00:24:45,349
for more resource constrained
contexts

649
00:24:45,349 --> 00:24:46,719
to prioritize and decline

650
00:24:46,719 --> 00:24:48,754
to offer the most expensive
health

651
00:24:48,754 --> 00:24:51,090
interventions, including some of
those

652
00:24:51,090 --> 00:24:52,358
that are among the global best

653
00:24:53,525 --> 00:24:55,861
per the local appropriate care
of you.

654
00:24:55,861 --> 00:24:57,457
Whether the global best is
something

655
00:24:57,457 --> 00:24:58,831
that should be offered locally

656
00:24:59,198 --> 00:25:02,201
is the morally relevant
difference.

657
00:25:02,701 --> 00:25:03,902
Okay,

658
00:25:03,902 --> 00:25:07,139
of course, applying
any of you like this requires

659
00:25:07,373 --> 00:25:08,841
some method of determining

660
00:25:08,841 --> 00:25:09,775
what people should be

661
00:25:09,775 --> 00:25:11,201
getting outside of research, if
that's

662
00:25:11,201 --> 00:25:12,778
what we're going to be comparing
against.

663
00:25:13,612 --> 00:25:15,547
And that's very difficult.

664
00:25:15,547 --> 00:25:17,602
So I'll briefly sketch some
suggestions

665
00:25:17,602 --> 00:25:18,550
for how to do it,

666
00:25:19,051 --> 00:25:21,293
aiming mostly
just to demonstrate the

667
00:25:21,293 --> 00:25:22,020
complexity.

668
00:25:23,122 --> 00:25:26,597
Okay, so first
the Nuffield Council proposed

669
00:25:26,597 --> 00:25:26,992
that

670
00:25:27,359 --> 00:25:29,728
that minimum standard of care
should be

671
00:25:29,728 --> 00:25:32,094
whatever a country endeavors to
provide

672
00:25:32,094 --> 00:25:33,065
nationally e.g.

673
00:25:33,065 --> 00:25:35,093
what is made available in the
formulary

674
00:25:35,093 --> 00:25:36,602
of the public health system.

675
00:25:37,770 --> 00:25:39,805
In many circumstances, they
maintain

676
00:25:39,805 --> 00:25:42,596
it will be appropriate to offer
an even higher level of care

677
00:25:42,596 --> 00:25:43,108
than that.

678
00:25:43,909 --> 00:25:47,670
And exceptionally,
it may be okay to offer a lower

679
00:25:47,670 --> 00:25:48,046
one.

680
00:25:48,781 --> 00:25:51,383
But nonetheless,
what the nation commits itself

681
00:25:51,383 --> 00:25:54,686
to providing is the relevant
standard to compare against.

682
00:25:56,221 --> 00:25:59,124
Okay, so that's one proposal.

683
00:25:59,124 --> 00:26:00,793
It's also UNAids in a report

684
00:26:00,793 --> 00:26:03,740
from 2000, offers
a somewhat more demanding

685
00:26:03,740 --> 00:26:04,563
conception,

686
00:26:05,030 --> 00:26:06,938
saying that the ideal is to
provide

687
00:26:06,938 --> 00:26:08,300
the best proven therapy.

688
00:26:08,600 --> 00:26:10,202
So that's the ideal.

689
00:26:10,202 --> 00:26:12,353
But at minimum, researchers must
offer

690
00:26:12,353 --> 00:26:13,372
the highest level

691
00:26:13,372 --> 00:26:16,375
of care attainable in a country.

692
00:26:16,608 --> 00:26:18,229
And that's going to depend on
facts

693
00:26:18,229 --> 00:26:19,711
about the sponsor and the host,

694
00:26:19,711 --> 00:26:21,282
the availability of
infrastructure

695
00:26:21,282 --> 00:26:22,714
to provide care and treatment,

696
00:26:23,115 --> 00:26:24,933
the potential duration and
sustainability

697
00:26:24,933 --> 00:26:26,618
of the care and treatment, and
so on.

698
00:26:28,053 --> 00:26:30,368
Both this
and the Nuffield suggestion,

699
00:26:30,368 --> 00:26:30,856
though,

700
00:26:30,856 --> 00:26:33,859
do suffer from a problem
similar to the no loss sphere.

701
00:26:35,694 --> 00:26:37,985
Which is that
it may be that what a nation

702
00:26:37,985 --> 00:26:38,530
endeavors

703
00:26:38,530 --> 00:26:41,494
to supply, or the highest level
of that is

704
00:26:41,494 --> 00:26:42,835
in fact available,

705
00:26:43,702 --> 00:26:46,142
are poor for
what are just actually bad

706
00:26:46,142 --> 00:26:46,705
reasons.

707
00:26:47,072 --> 00:26:49,508
So a nation might lack political

708
00:26:49,508 --> 00:26:52,744
will to supply things
that it really could and should,

709
00:26:54,580 --> 00:26:55,981
and then

710
00:26:55,981 --> 00:26:58,445
that would not be something
that the nation endeavor to

711
00:26:58,445 --> 00:26:59,117
provide itself

712
00:26:59,117 --> 00:27:01,753
or a level of care attainable,
but arguably is something

713
00:27:01,753 --> 00:27:04,756
that should still be provided
regardless.

714
00:27:05,624 --> 00:27:09,528
So another UNAids report from
2021 offers

715
00:27:09,528 --> 00:27:11,560
a more explicitly normative
justification

716
00:27:11,560 --> 00:27:12,898
to help with this problem.

717
00:27:13,632 --> 00:27:15,619
This one recommends that
researchers adopt

718
00:27:15,619 --> 00:27:17,369
the standards recommended by
W.H.O..

719
00:27:18,237 --> 00:27:19,862
Those standards are based on
available

720
00:27:19,862 --> 00:27:21,573
evidence using a transparent
framework,

721
00:27:21,940 --> 00:27:24,576
and take into account values
and preferences of end users

722
00:27:24,576 --> 00:27:26,869
and providers,
as well as equity costs and

723
00:27:26,869 --> 00:27:27,579
feasibility.

724
00:27:28,914 --> 00:27:31,216
So in this case,
even if some countries lack

725
00:27:31,216 --> 00:27:34,041
the political will
to supply an intervention, if

726
00:27:34,041 --> 00:27:34,453
W.H.O.

727
00:27:34,453 --> 00:27:37,567
had recommended it, researchers
would be obligated to supply the

728
00:27:37,567 --> 00:27:37,956
trials.

729
00:27:39,191 --> 00:27:41,944
A practical difficulty
with this suggestion, though, is

730
00:27:41,944 --> 00:27:42,194
that

731
00:27:42,194 --> 00:27:44,037
global standards don't always
reflect

732
00:27:44,037 --> 00:27:45,931
local differences, and it may be
hard

733
00:27:45,931 --> 00:27:49,131
to distinguish whether countries
departing from recommendations

734
00:27:49,131 --> 00:27:49,334
due

735
00:27:49,334 --> 00:27:52,471
to sort of political failures,
as suggested above,

736
00:27:53,071 --> 00:27:55,129
or whether it's actually
a reasonable decision based on

737
00:27:55,129 --> 00:27:55,541
the unique

738
00:27:55,541 --> 00:27:58,074
features
and challenges of that specific

739
00:27:58,074 --> 00:27:58,644
country.

740
00:27:58,644 --> 00:28:00,679
After all, as I pointed out
at the beginning,

741
00:28:00,679 --> 00:28:02,207
countries are very
heterogeneous,

742
00:28:02,207 --> 00:28:03,782
and even when recommendations
are

743
00:28:03,782 --> 00:28:06,535
specifically targeted at home, I
see this

744
00:28:06,535 --> 00:28:09,154
clinic might be importantly
different.

745
00:28:11,423 --> 00:28:14,126
Okay, so a final proposal,

746
00:28:14,126 --> 00:28:16,662
this one from a colleague,
which I also like.

747
00:28:16,662 --> 00:28:19,702
Is that a fair priority
setting process on the path to

748
00:28:19,702 --> 00:28:20,265
universal

749
00:28:20,265 --> 00:28:22,982
health coverage should be
what defines local, appropriate

750
00:28:22,982 --> 00:28:23,268
care.

751
00:28:26,772 --> 00:28:27,506
This thought takes

752
00:28:27,506 --> 00:28:30,031
as a starting point
that universal health care is a

753
00:28:30,031 --> 00:28:30,576
good goal,

754
00:28:30,576 --> 00:28:32,109
and that any universal health
care

755
00:28:32,109 --> 00:28:33,912
system will need to make
determinations

756
00:28:34,279 --> 00:28:38,183
regarding what it covers,
and also that making

757
00:28:38,183 --> 00:28:41,124
this determinations
will require some kind of fair

758
00:28:41,124 --> 00:28:41,653
process.

759
00:28:43,355 --> 00:28:44,897
So ideally, all around the
world,

760
00:28:44,897 --> 00:28:46,858
there will eventually be
universal health

761
00:28:46,858 --> 00:28:48,590
care and along with it,
independent,

762
00:28:48,590 --> 00:28:50,128
fair priority setting processes

763
00:28:50,462 --> 00:28:52,598
aimed at determining
what services should be included

764
00:28:52,598 --> 00:28:55,567
in that country's
basic health care package.

765
00:28:55,567 --> 00:28:57,192
This standard from the health
system could

766
00:28:57,192 --> 00:28:58,236
then be used as a standard

767
00:28:58,236 --> 00:28:59,137
of care and research.

768
00:29:00,172 --> 00:29:01,406
Of course, we don't live in the
future.

769
00:29:01,406 --> 00:29:02,207
We live in the now.

770
00:29:02,207 --> 00:29:04,276
And not all countries actually
do have

771
00:29:04,276 --> 00:29:06,345
universal health care or any
priority

772
00:29:06,345 --> 00:29:09,459
setting process, let alone
a fair and transparent one like

773
00:29:09,459 --> 00:29:09,781
this.

774
00:29:10,849 --> 00:29:13,477
Nonetheless,
even more such a process doesn't

775
00:29:13,477 --> 00:29:13,885
exist.

776
00:29:13,885 --> 00:29:17,222
We can still use it
as a hypothetical ideal, which

777
00:29:17,222 --> 00:29:18,023
can help us

778
00:29:18,023 --> 00:29:19,471
think about what standard of
care

779
00:29:19,471 --> 00:29:21,226
there should be in different
countries.

780
00:29:21,893 --> 00:29:23,328
What are the sorts of
interventions

781
00:29:23,328 --> 00:29:24,229
that universal health

782
00:29:24,229 --> 00:29:27,232
care in that country should
cover?

783
00:29:27,432 --> 00:29:29,968
Whatever those are,
those are the interventions

784
00:29:29,968 --> 00:29:32,971
which participants in research
should also be entitled to.

785
00:29:34,806 --> 00:29:36,375
Okay.

786
00:29:36,375 --> 00:29:38,243
Let's apply the specific
appropriate

787
00:29:38,243 --> 00:29:41,246
care of you to AZT trials

788
00:29:41,680 --> 00:29:44,379
since again, few like us, let
alone

789
00:29:44,379 --> 00:29:45,150
HIV Aids,

790
00:29:45,150 --> 00:29:46,658
had fair priority setting
processes

791
00:29:46,658 --> 00:29:48,253
for health care coverage in the
90s.

792
00:29:48,620 --> 00:29:50,565
We can't ask about what the
actual results

793
00:29:50,565 --> 00:29:51,723
of those processes were.

794
00:29:52,491 --> 00:29:55,494
Still, we can imagine
what they might have covered.

795
00:29:55,494 --> 00:29:58,386
And really, given the basic fact
that the

796
00:29:58,386 --> 00:30:01,066
oh 76 regimen cost $800 per
treatment

797
00:30:01,466 --> 00:30:04,624
when the per person
per year budgets were often less

798
00:30:04,624 --> 00:30:05,170
than 100

799
00:30:05,170 --> 00:30:07,472
or even less than 20 or $30,

800
00:30:07,472 --> 00:30:10,170
makes it reasonable to expect
that a fair priority setting

801
00:30:10,170 --> 00:30:10,542
process

802
00:30:10,909 --> 00:30:12,934
would not have selected 076 for
provision

803
00:30:12,934 --> 00:30:14,613
through a national health
system.

804
00:30:15,881 --> 00:30:18,116
So on this view, 76

805
00:30:18,116 --> 00:30:20,153
would not count as part of
appropriate

806
00:30:20,153 --> 00:30:21,653
local care in those places,

807
00:30:22,020 --> 00:30:23,958
and it wouldn't be wrong to test
short

808
00:30:23,958 --> 00:30:25,590
course against short course AZT

809
00:30:25,590 --> 00:30:28,593
against placebo in those places.

810
00:30:29,461 --> 00:30:32,564
Okay.

811
00:30:32,564 --> 00:30:35,250
You've seen that there are ways
of understanding a standard of

812
00:30:35,250 --> 00:30:35,467
care

813
00:30:35,467 --> 00:30:37,238
that's different from the global
test

814
00:30:37,238 --> 00:30:39,104
and also plausibly is morally
relevant

815
00:30:39,504 --> 00:30:41,074
because it matters whether
participants

816
00:30:41,074 --> 00:30:42,240
would or would not be harmed

817
00:30:42,240 --> 00:30:43,542
on the de facto standard.

818
00:30:43,542 --> 00:30:45,177
And it matters whether
participants

819
00:30:45,177 --> 00:30:46,578
are not deprived of something

820
00:30:46,578 --> 00:30:49,581
they should be getting
on the jury standard.

821
00:30:50,215 --> 00:30:52,334
But considering the other
objection,

822
00:30:52,334 --> 00:30:54,453
this objection just maintains
that,

823
00:30:54,786 --> 00:30:56,988
look, even if local appropriate
care

824
00:30:56,988 --> 00:30:59,191
weren't to include an
intervention,

825
00:30:59,891 --> 00:31:01,456
if that intervention really does
work

826
00:31:01,456 --> 00:31:02,894
and researchers could provide
it,

827
00:31:03,829 --> 00:31:05,897
they need some justification not
to.

828
00:31:07,199 --> 00:31:08,722
After
all, why not provide the best

829
00:31:08,722 --> 00:31:09,201
treatment?

830
00:31:09,201 --> 00:31:10,969
And wouldn't that just prevent
more harm?

831
00:31:10,969 --> 00:31:12,804
And isn't that a good thing?

832
00:31:12,804 --> 00:31:15,071
Again, coming back
to the obligations of

833
00:31:15,071 --> 00:31:15,807
beneficence.

834
00:31:17,342 --> 00:31:19,945
So the answer

835
00:31:19,945 --> 00:31:22,217
which defenders of the short
course

836
00:31:22,217 --> 00:31:24,750
trials leaned on is that not
providing

837
00:31:24,750 --> 00:31:27,091
the best treatments is sometimes
necessary

838
00:31:27,091 --> 00:31:29,154
for doing socially valuable
science.

839
00:31:30,722 --> 00:31:32,386
In particular, testing against
less

840
00:31:32,386 --> 00:31:34,192
than the global best can be
essential

841
00:31:34,593 --> 00:31:37,662
for the ability of researchers
to answer the questions

842
00:31:37,662 --> 00:31:40,665
most pressing to local
communities.

843
00:31:41,900 --> 00:31:44,283
Setting this rationale
and adding it on as another

844
00:31:44,283 --> 00:31:44,903
requirement,

845
00:31:45,137 --> 00:31:48,140
we get the view.

846
00:31:48,840 --> 00:31:51,877
That testing against less than
the global

847
00:31:51,877 --> 00:31:54,913
best is permissible

848
00:31:54,913 --> 00:31:57,549
when it doesn't undercut
the local standard of care,

849
00:31:57,549 --> 00:31:59,149
and it's also scientifically
necessary

850
00:31:59,149 --> 00:32:00,285
to test against the lesser

851
00:32:00,285 --> 00:32:02,137
standard in order to conduct
research

852
00:32:02,137 --> 00:32:04,289
which is responsive to local
health needs.

853
00:32:07,592 --> 00:32:10,562
So again,

854
00:32:10,562 --> 00:32:13,030
this is something that defenders
of the short course trials

855
00:32:13,030 --> 00:32:13,532
emphasized.

856
00:32:13,899 --> 00:32:16,376
The point of the whole trial
was to gain knowledge that would

857
00:32:16,376 --> 00:32:16,701
be most

858
00:32:16,701 --> 00:32:19,115
useful in the lmics,
where they were being

859
00:32:19,115 --> 00:32:19,805
contracted.

860
00:32:20,472 --> 00:32:22,908
So Varmus and Satcher
say the most compelling reasons

861
00:32:22,908 --> 00:32:24,525
to use a placebo controlled
study

862
00:32:24,525 --> 00:32:26,044
is that it provides definitive

863
00:32:26,044 --> 00:32:27,905
answers to questions about the
safety

864
00:32:27,905 --> 00:32:29,414
and value of the intervention

865
00:32:29,848 --> 00:32:31,683
and the setting
in which the study is performed.

866
00:32:31,683 --> 00:32:32,551
And these are.

867
00:32:32,551 --> 00:32:35,453
These answers are the point
of the research without clear

868
00:32:35,453 --> 00:32:39,100
and firm answers to whether
and if so, how well an

869
00:32:39,100 --> 00:32:40,559
intervention works.

870
00:32:40,559 --> 00:32:42,155
It is impossible for a country
to make

871
00:32:42,155 --> 00:32:43,962
a sound judgment about the
appropriateness

872
00:32:44,296 --> 00:32:47,399
and financial feasibility
of offering that intervention.

873
00:32:50,769 --> 00:32:53,705
So the act,

874
00:32:53,705 --> 00:32:57,242
of course, trials, in addition
to not undercutting appropriate

875
00:32:57,242 --> 00:32:59,766
local care, seem
to meet this responsiveness

876
00:32:59,766 --> 00:33:00,512
requirement.

877
00:33:01,246 --> 00:33:03,061
The point was to develop
knowledge

878
00:33:03,061 --> 00:33:04,983
of a regimen that would be
feasible

879
00:33:04,983 --> 00:33:08,415
to implement in Olympics,
and testing costs against

880
00:33:08,415 --> 00:33:08,954
placebo

881
00:33:08,954 --> 00:33:12,791
helped answer for policymakers
how much better it was then.

882
00:33:12,791 --> 00:33:13,225
Nothing.

883
00:33:15,594 --> 00:33:17,095
Which in turn could tell them

884
00:33:17,095 --> 00:33:18,908
whether it was worth investing
scarce

885
00:33:18,908 --> 00:33:20,232
resources in providing it.

886
00:33:21,666 --> 00:33:24,669
Furthermore, in this case,

887
00:33:26,972 --> 00:33:28,288
Furthermore, in this case, the
placebo

888
00:33:28,288 --> 00:33:29,674
control was particularly
scientifically

889
00:33:29,674 --> 00:33:32,677
important given the variability
in perinatal transmission rates

890
00:33:32,911 --> 00:33:34,518
and the fact that enabled the
trials

891
00:33:34,518 --> 00:33:36,214
to be conducted at a manageable
size.

892
00:33:40,552 --> 00:33:43,555
Okay, this yes.

893
00:33:43,989 --> 00:33:45,490
Okay.

894
00:33:45,490 --> 00:33:48,126
How do critics of the trials
respond to the point

895
00:33:48,126 --> 00:33:50,962
that they were responding
to important local health needs,

896
00:33:50,962 --> 00:33:53,614
and it was necessary
to test against placebo to do

897
00:33:53,614 --> 00:33:53,932
this?

898
00:33:53,932 --> 00:33:55,667
Do they say that these important
healthy

899
00:33:55,667 --> 00:33:56,968
is simply cannot ever be met,

900
00:33:57,235 --> 00:33:59,448
because the research necessary
to do

901
00:33:59,448 --> 00:34:00,739
so is unethical? No.

902
00:34:01,473 --> 00:34:03,184
Instead, they say that these
needs

903
00:34:03,184 --> 00:34:04,442
should be in other ways.

904
00:34:05,143 --> 00:34:07,412
For instance, Laurie and Wolfe
argue

905
00:34:07,412 --> 00:34:10,382
we shouldn't aim to develop
inferior regimens for illnesses.

906
00:34:11,149 --> 00:34:13,985
We should aim to develop
equivalent ones.

907
00:34:15,620 --> 00:34:18,456
So here they are saying

908
00:34:18,456 --> 00:34:20,184
the researchers conducting the
placebo

909
00:34:20,184 --> 00:34:22,093
controlled trials assert that
such trials

910
00:34:22,093 --> 00:34:24,231
represent the only appropriate
research

911
00:34:24,231 --> 00:34:25,163
design, implying

912
00:34:25,163 --> 00:34:26,704
that the answer to the question
is this

913
00:34:26,704 --> 00:34:28,166
sort of regimen better than
nothing?

914
00:34:28,800 --> 00:34:31,303
We take the more optimistic view
that, given the findings

915
00:34:31,303 --> 00:34:33,490
of A-76 and other clinical
information,

916
00:34:33,490 --> 00:34:35,173
researchers are quite capable

917
00:34:35,173 --> 00:34:38,276
of designing a sort of regimen
that's approximately as

918
00:34:38,276 --> 00:34:39,311
effective as 076.

919
00:34:40,111 --> 00:34:41,246
The proposal

920
00:34:41,246 --> 00:34:42,956
for the Harvard study in
Thailand states

921
00:34:42,956 --> 00:34:44,282
the research question clearly.

922
00:34:44,783 --> 00:34:48,153
Can we reduce the duration
of the prophylactic?

923
00:34:49,020 --> 00:34:51,923
This is another name for AZT,
by the way, in the brackets

924
00:34:51,923 --> 00:34:53,679
treatment without increasing the
risk

925
00:34:53,679 --> 00:34:55,293
of perinatal transmission of
HIV.

926
00:34:55,627 --> 00:34:58,852
That is, without compromising
the demonstrated efficacy of

927
00:34:58,852 --> 00:34:59,130
076.

928
00:35:00,332 --> 00:35:02,291
We believe that such equivalency
studies

929
00:35:02,291 --> 00:35:04,202
of alternative antiretroviral
regimens

930
00:35:04,536 --> 00:35:06,218
will provide even more useful
results

931
00:35:06,218 --> 00:35:07,672
than placebo controlled trials,

932
00:35:08,039 --> 00:35:10,152
without the deaths of hundreds
of newborns

933
00:35:10,152 --> 00:35:11,209
that are inevitable.

934
00:35:11,643 --> 00:35:12,844
If placebo groups are used.

935
00:35:15,213 --> 00:35:18,183
In a similar,

936
00:35:20,051 --> 00:35:22,687
in a similar yet different vein.

937
00:35:22,687 --> 00:35:24,435
Others argue that instead of
developed

938
00:35:24,435 --> 00:35:26,091
aiming to develop inferior
regimens

939
00:35:26,091 --> 00:35:27,862
for areas where resource
scarcity

940
00:35:27,862 --> 00:35:29,794
complicates provision of the
global

941
00:35:29,794 --> 00:35:32,649
best care, research
should target those inequalities

942
00:35:32,649 --> 00:35:33,198
in cells,

943
00:35:33,632 --> 00:35:35,425
for instance, lowering drug
prices

944
00:35:35,425 --> 00:35:37,535
for existing drugs so that
unaffordable

945
00:35:37,535 --> 00:35:39,925
drugs become more affordable,
or building health

946
00:35:39,925 --> 00:35:40,672
infrastructure

947
00:35:40,672 --> 00:35:43,742
so that impracticable regimens
become practicable.

948
00:35:45,210 --> 00:35:46,811
So here's

949
00:35:46,811 --> 00:35:49,581
Rochelle Blank arguing as much,
saying

950
00:35:49,581 --> 00:35:51,339
wanting to develop a treatment
regime

951
00:35:51,339 --> 00:35:52,717
that is easier to administer

952
00:35:52,717 --> 00:35:55,400
in the developing world
context is not a scientific

953
00:35:55,400 --> 00:35:55,820
reason.

954
00:35:55,820 --> 00:35:57,889
It is an economic reason.

955
00:35:57,889 --> 00:35:59,843
If we really want to improve
medical care

956
00:35:59,843 --> 00:36:00,892
for the world's poor,

957
00:36:01,192 --> 00:36:02,931
perhaps we should spend more
time thinking

958
00:36:02,931 --> 00:36:04,629
about ensuring access to
existing drugs,

959
00:36:05,130 --> 00:36:07,804
as opposed to using this
as a rationale for developing

960
00:36:07,804 --> 00:36:08,299
new ones.

961
00:36:10,535 --> 00:36:11,403
Okay, so what can be said

962
00:36:11,403 --> 00:36:14,406
in response to these critiques?

963
00:36:14,406 --> 00:36:16,553
Of course, we should agree
immediately

964
00:36:16,553 --> 00:36:17,909
that it's a great thing

965
00:36:17,909 --> 00:36:19,644
to develop interventions for
illnesses

966
00:36:19,644 --> 00:36:21,346
there as good or better than
those

967
00:36:21,346 --> 00:36:22,647
in high income countries,

968
00:36:22,947 --> 00:36:25,683
and also that researchers
should try to conduct research

969
00:36:25,683 --> 00:36:27,852
which can ameliorate
the underlying inequalities

970
00:36:27,852 --> 00:36:30,505
that drive differences
in standard of care around the

971
00:36:30,505 --> 00:36:30,855
world.

972
00:36:32,157 --> 00:36:34,278
But the problem is that these
suggestions

973
00:36:34,278 --> 00:36:35,727
just might not be feasible.

974
00:36:36,628 --> 00:36:38,614
It's difficult to make simpler
or cheaper

975
00:36:38,614 --> 00:36:40,165
and equally good interventions.

976
00:36:40,165 --> 00:36:43,201
Otherwise, we would do it all
the time.

977
00:36:43,201 --> 00:36:45,246
If you could just ask for that
and get it,

978
00:36:45,246 --> 00:36:46,171
it would be great.

979
00:36:48,239 --> 00:36:49,714
And demonstrating
non-inferiority

980
00:36:49,714 --> 00:36:50,875
against an active control

981
00:36:50,875 --> 00:36:53,878
does typically require larger
and more expensive trials.

982
00:36:55,380 --> 00:36:57,782
And it is, if anything, even
harder

983
00:36:57,782 --> 00:36:59,459
to intervene on incorrect
resource

984
00:36:59,459 --> 00:37:01,086
inequalities and social systems.

985
00:37:01,953 --> 00:37:05,023
That research is important
and will hopefully be fruitful.

986
00:37:05,023 --> 00:37:07,759
I don't think anyone could,
with a straight face,

987
00:37:07,759 --> 00:37:10,862
maintain that the results
are just around the corner,

988
00:37:10,862 --> 00:37:13,049
so we're not going to be able to
respond

989
00:37:13,049 --> 00:37:14,799
to local health needs, at least

990
00:37:14,799 --> 00:37:17,221
in the short and medium term,
effectively,

991
00:37:17,221 --> 00:37:19,471
by using these strategies
exclusively.

992
00:37:21,673 --> 00:37:23,842
In fact, Surface Act was found
to reduce

993
00:37:23,842 --> 00:37:25,494
perinatal transmission by about
half,

994
00:37:25,494 --> 00:37:26,878
which was worse than the other

995
00:37:26,878 --> 00:37:29,856
seven six regimen,
but substantially better than

996
00:37:29,856 --> 00:37:30,415
nothing.

997
00:37:30,849 --> 00:37:32,484
And many babies were prevented

998
00:37:32,484 --> 00:37:35,093
from carrying HIV through
the administration of short

999
00:37:35,093 --> 00:37:35,487
course,

1000
00:37:36,254 --> 00:37:39,157
insisting that development,
insisting that instead of

1001
00:37:39,157 --> 00:37:39,924
developing it

1002
00:37:39,924 --> 00:37:41,893
through testing against placebo,

1003
00:37:41,893 --> 00:37:43,379
we should have waited for much
more

1004
00:37:43,379 --> 00:37:45,163
difficult and far off research
to finish.

1005
00:37:45,663 --> 00:37:47,801
We'd be saying
that those babies in the here

1006
00:37:47,801 --> 00:37:48,433
and now need

1007
00:37:48,433 --> 00:37:51,391
to go unprotected, and so we
should avoid,

1008
00:37:51,391 --> 00:37:52,871
in cases like these,

1009
00:37:53,204 --> 00:37:56,207
making the perfect the enemy of
the good.

1010
00:37:57,175 --> 00:37:59,043
Okay,

1011
00:37:59,043 --> 00:38:01,235
so we should work to improve
health

1012
00:38:01,235 --> 00:38:03,114
and like in a number of ways,

1013
00:38:03,414 --> 00:38:04,913
but developing new
interventions,

1014
00:38:04,913 --> 00:38:06,184
including second test ones,

1015
00:38:06,184 --> 00:38:08,751
can be an important way
of doing that. In the short

1016
00:38:08,751 --> 00:38:09,053
term.

1017
00:38:09,053 --> 00:38:11,656
And different efforts can't go
in tandem.

1018
00:38:11,656 --> 00:38:13,424
We can research better
interventions,

1019
00:38:13,424 --> 00:38:15,193
health system improvements, and
also

1020
00:38:15,627 --> 00:38:17,262
feasible interventions that
could make

1021
00:38:17,262 --> 00:38:18,897
a big difference in the here and
now.

1022
00:38:20,732 --> 00:38:22,901
Okay,

1023
00:38:22,901 --> 00:38:24,135
wrapping things up

1024
00:38:24,135 --> 00:38:27,138
or transitioning into that.

1025
00:38:27,138 --> 00:38:30,328
So in this talk so far,
we looked at three potential

1026
00:38:30,328 --> 00:38:30,942
standards

1027
00:38:30,942 --> 00:38:32,549
for defining the care that
researchers

1028
00:38:32,549 --> 00:38:33,945
out of their trial participants.

1029
00:38:34,646 --> 00:38:38,068
The de facto standard
or in their last view, the jury

1030
00:38:38,068 --> 00:38:38,650
standard

1031
00:38:38,650 --> 00:38:40,329
for local appropriate care
review

1032
00:38:40,329 --> 00:38:41,653
and the global best view,

1033
00:38:42,420 --> 00:38:45,851
notably the Tertiary Standard
and Local Appropriate Care of

1034
00:38:45,851 --> 00:38:46,491
you, admit

1035
00:38:46,491 --> 00:38:48,777
of many different possible
specifications

1036
00:38:48,777 --> 00:38:50,395
depending on what you think.

1037
00:38:50,662 --> 00:38:53,131
Locally appropriate care is.

1038
00:38:53,131 --> 00:38:54,883
Along the lines of those
proposals,

1039
00:38:54,883 --> 00:38:56,134
I was canvasing earlier.

1040
00:38:57,235 --> 00:39:00,383
We also added on one refinement
responsiveness to local health

1041
00:39:00,383 --> 00:39:00,738
needs.

1042
00:39:01,472 --> 00:39:03,912
And then what I'm going to offer
you

1043
00:39:03,912 --> 00:39:05,877
now is a limited conclusion,

1044
00:39:06,911 --> 00:39:09,414
which is that

1045
00:39:09,414 --> 00:39:10,648
the local appropriate care

1046
00:39:10,648 --> 00:39:12,681
review, together with the
responsiveness

1047
00:39:12,681 --> 00:39:13,952
requirement, is superior

1048
00:39:13,952 --> 00:39:16,428
to the view that the global test
is always

1049
00:39:16,428 --> 00:39:18,256
the required standard of care.

1050
00:39:20,625 --> 00:39:22,351
So here, just for reference, is
the view

1051
00:39:22,351 --> 00:39:23,127
I'm referring to.

1052
00:39:23,127 --> 00:39:24,818
Again, it says contrary to
global

1053
00:39:24,818 --> 00:39:26,764
best view, it's sometimes
permissible

1054
00:39:26,764 --> 00:39:30,001
to provide less than the global
best standard, specifically,

1055
00:39:30,602 --> 00:39:33,605
when participants still receive
the appropriate local standard

1056
00:39:33,838 --> 00:39:35,418
and offering that instead of the
global

1057
00:39:35,418 --> 00:39:36,674
best, it's also scientifically

1058
00:39:36,674 --> 00:39:39,188
necessary
to respond to local health

1059
00:39:39,188 --> 00:39:39,677
needs.

1060
00:39:40,044 --> 00:39:42,947
Also, though I haven't discussed
it prior,

1061
00:39:42,947 --> 00:39:44,701
you know that it is actually
responsive

1062
00:39:44,701 --> 00:39:46,050
and provides appropriate care

1063
00:39:46,050 --> 00:39:47,569
is something
that ideally should be ensured

1064
00:39:47,569 --> 00:39:47,852
through

1065
00:39:47,852 --> 00:39:49,888
meaningful engagement
with local communities.

1066
00:39:49,888 --> 00:39:51,456
And I am adding that on.

1067
00:39:51,456 --> 00:39:53,191
Yeah.

1068
00:39:53,191 --> 00:39:54,959
Okay.

1069
00:39:54,959 --> 00:39:58,263
So often earlier at the reasons
for embracing the global best

1070
00:39:59,597 --> 00:40:01,348
with respect to treating people
equally

1071
00:40:01,348 --> 00:40:03,234
and applying universal ethical
standards,

1072
00:40:03,835 --> 00:40:04,369
the appropriate

1073
00:40:04,369 --> 00:40:06,255
local care view with the
responsiveness

1074
00:40:06,255 --> 00:40:07,705
requirement arguably does so.

1075
00:40:08,339 --> 00:40:10,708
The equal treatment
and the universal standard

1076
00:40:10,708 --> 00:40:12,441
is that everyone in clinical
research

1077
00:40:12,441 --> 00:40:13,144
should receive

1078
00:40:13,144 --> 00:40:15,179
at least locally appropriate
care,

1079
00:40:15,179 --> 00:40:17,497
and that if they're receiving
less than the global best, this

1080
00:40:17,497 --> 00:40:17,915
is because

1081
00:40:17,915 --> 00:40:20,798
it is scientifically necessary
to respond to local health

1082
00:40:20,798 --> 00:40:21,152
needs.

1083
00:40:23,254 --> 00:40:24,806
Insistence on local appropriate
care

1084
00:40:24,806 --> 00:40:26,357
also avoids much of the
preventable

1085
00:40:26,357 --> 00:40:29,282
harm that allowing de facto
standards of care to prevail

1086
00:40:29,282 --> 00:40:29,961
might allow.

1087
00:40:31,162 --> 00:40:33,095
Granted, it still does allow
more harm

1088
00:40:33,095 --> 00:40:34,265
to befall participants

1089
00:40:34,465 --> 00:40:37,435
than insisting on the global
best standard would,

1090
00:40:37,435 --> 00:40:39,537
because it will allow, for
instance,

1091
00:40:39,537 --> 00:40:40,471
placebo groups.

1092
00:40:40,471 --> 00:40:42,616
When there is a global best
intervention

1093
00:40:42,616 --> 00:40:43,474
that does work.

1094
00:40:44,709 --> 00:40:47,100
Nonetheless,
although it does allow more of

1095
00:40:47,100 --> 00:40:47,712
that harm,

1096
00:40:48,079 --> 00:40:51,182
it does also prevent more harm
to populations

1097
00:40:51,182 --> 00:40:53,618
through enabling the answering
of what we've been arguing

1098
00:40:53,618 --> 00:40:56,621
are extremely important
research questions.

1099
00:40:57,155 --> 00:40:59,502
So overall, I would say it does
better

1100
00:40:59,502 --> 00:41:01,726
on the standard of preventing
harm.

1101
00:41:01,726 --> 00:41:04,729
It prevents more harm.

1102
00:41:05,463 --> 00:41:06,264
Nor does it treat

1103
00:41:06,264 --> 00:41:09,701
participants merely as a means,
at least not on a rating.

1104
00:41:09,701 --> 00:41:10,968
That makes much sense to me.

1105
00:41:10,968 --> 00:41:12,969
As I mentioned at the beginning,
it's

1106
00:41:12,969 --> 00:41:15,239
often quite obscure what this
term means.

1107
00:41:15,506 --> 00:41:17,639
People
don't agree on a simple

1108
00:41:17,639 --> 00:41:18,776
definition, but

1109
00:41:19,744 --> 00:41:21,679
it's important here that

1110
00:41:21,679 --> 00:41:24,682
the reason that the global best
is being

1111
00:41:24,949 --> 00:41:28,986
withheld is to respond to local
health needs that participants

1112
00:41:28,986 --> 00:41:32,090
presumably also care about
and want to see corrected,

1113
00:41:32,090 --> 00:41:33,801
and also that they have
meaningful

1114
00:41:33,801 --> 00:41:35,159
opportunity to participate

1115
00:41:35,460 --> 00:41:38,429
in the governance of those
decisions

1116
00:41:38,429 --> 00:41:41,432
through meaningful community
engagement.

1117
00:41:41,766 --> 00:41:44,702
So under those conditions, it's
hard to see them

1118
00:41:44,702 --> 00:41:47,672
being used merely as a means.

1119
00:41:48,840 --> 00:41:50,608
Okay.

1120
00:41:50,608 --> 00:41:53,144
And at the same time,

1121
00:41:53,144 --> 00:41:56,372
that responsive research
is able to accommodate these

1122
00:41:56,372 --> 00:41:56,981
concerns.

1123
00:41:57,915 --> 00:42:01,001
It's also allows for researchers
to answer questions that, in the

1124
00:42:01,001 --> 00:42:01,285
short

1125
00:42:01,285 --> 00:42:03,697
medium term, maybe the only
realistic way,

1126
00:42:03,697 --> 00:42:05,189
as we have, of preventing

1127
00:42:05,690 --> 00:42:07,477
large amounts of suffering and
death,

1128
00:42:07,477 --> 00:42:09,360
where the global best for you
doesn't.

1129
00:42:09,827 --> 00:42:14,265
So my own view anyhow,
and I'm going to repeat

1130
00:42:14,265 --> 00:42:17,301
for the umpteenth time, it's
mine.

1131
00:42:17,301 --> 00:42:20,238
And it's not NIH
is it's not the department's.

1132
00:42:20,238 --> 00:42:21,639
I'm not speaking for anyone
else.

1133
00:42:23,408 --> 00:42:25,850
My view is that working
through this controversy over

1134
00:42:25,850 --> 00:42:26,310
standards

1135
00:42:26,310 --> 00:42:28,430
of care reveals that there are
just better

1136
00:42:28,430 --> 00:42:30,348
alternatives to the global best
view.

1137
00:42:30,681 --> 00:42:32,473
And this, in particular strikes
me

1138
00:42:32,473 --> 00:42:33,684
as a promising option.

1139
00:42:34,152 --> 00:42:37,504
Of course, I'm happy to hear
if you disagree with me in the

1140
00:42:37,504 --> 00:42:37,789
Q&A.

1141
00:42:38,523 --> 00:42:41,292
Finally, the last slide.

1142
00:42:41,292 --> 00:42:44,233
We have some meetings for those
interested

1143
00:42:44,233 --> 00:42:46,264
in following up more deeply.