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Alice Dreger, thank you for being ready. These are jointly authored by Susan (indiscernible)
Mary Butler McClain college, Wesley college, Massachusetts.
the Professor is unable to join us today. I expect you're familiar with her book including
the award winning book Tuskegee health services and the sexually transmitted disease study
in Guatemala. Because of time limits we present orally only
a portion of our written analysis. OHRP was right in its findings on the support
study. As stated in the letter we signed with 43
colleagues to the New England journal. Quote informed consent documents that were
used were seriously inadequate unquote. Using the phrase standard of care whether
in clinical care or clinical research does not exempt a physician from clearly explaining
risk before obtaining consent. Here as so many times in the history of American
medical research, the consent process failed. Now we would note successful pressure put
on OHRP to pull back represents a frightening dangerous precedent.
Yet that is what is new here. Not the essential kind of research, nor unfortunately
the failure to obtain formed consent. A as the story ends we can tell you nothing
is magically different about the technologically advanced multi-center clinical trials like
the support study that makes them exempt from codes and regulations already devised.
Existing OHRP regulations are absolutely adequate for the management of trials involving commonly
used medical interventions as well as for trials like support.
We are not in a newer era ethically speaking. We are here to have the same conversation
we have been having for generations about failure to obtain appropriate informed consent.
It's a conversation worth having but we should not pretend it is new.
Almost 50 years ago in 1966 Henry beecher published his famous review in New England
journal called ethics and clinical research which showed ethical problems within American
medical research appeared endemic. Given problems with risk disclosure informed
consent process we -- redoing study finds many problematic studies including the support
study. This is exactly why we need OHRP enforcement
to stand and why we continue to meet external eyes on research trials.
Features analysis suggested that the etiology of the problem late in the skewed professional
milieu today become more problematic. Though individual medical researchers are
motivated by desire to preserve health and save lives, what rewarded in medical research
system is ever more scholarly production not new ethical behavior.
In today's academic climate researchers who are ethically meticulous find them effectively
punished through delays, lower enrollment and compete.
To allow the ethics problems to keep happening may promote ethical short cuts and missteps.
If ethical short cuts and missteps go unpunished, OHRP failed findings of wrong doing what external
is there other than fear of (inaudible). Make no mistake, we are enthusiastically in
favor of good research on premature baby bus research that has potential to benefit the
whole of society can not be done at expense of the rights of vulnerable individual whose
are used as subjects and in this case the rights of their parents as well.
Claim the move toward more evidence based medicine or learned healthcare system in which
essentially every patient becomes a subject requires a system where the line between patient
and research subject becomes blurry. We object to this idea strongly and warn this
type of reasoning has been used again as way for researchers to justify poorly consented
risky research on unsuspecting subjects who thought they were just patients.
We're not saying the support study is akin to Tuskegee study and discourage using that
as met metaphor we understand the study understood to be a standard of care research because
the researchers thought the men in the study were not going to get adequate treatment for
syphilis anyway. But the road to better informed evidence based
medicine never be paved with the body of informed subjects.
We cannot allow physicians to slip into a mode where they fail to remain vividly conscious
of difference between patients and subjects. As beecher understand well intention red searchers
people at the top of their field have been responsible for ethical mischief in medical
research. Ethical mistakes happen not because researchers
become Nazis by evil state or greedy research by big Pharma or ego maniacs.
Ethical problems happen because of intrinsic and extrinsic pressures on American medical
researchers to produce science. Until they realize the road to hell is paved
with good intention, until they truly believe good people can unthinkingly do bad things
in every day work we will continue to see the same mistakes happening.
We will continue to ritualistically meet this to express shock failing to see the irony
of how a cathartic event of possible scandal and punishment keeps the same dangerous system
in place. Until we see how we created an environment
that fosters ethical mistakes and openly resists enforcement when mistakes are found the same
problems with keep arising. We make the following recommendations and
conclusions. The case of support should not be used to
discuss research on interventions commonly understood as standard of care, several experimental
interventions would have to be called clinically peculiar if not non-existent.
Standard of care in clinical medicine or research does not exempt a physician or researcher
from discussion of risk with patients an subjects as part of the consent process.
OHRP and HHS should require extraordinary proof before accepting any claim that today's
forms of research require revised regulations, or new interpretations of regulation.
Existing regulation is adequate and shouldn't be weakened in name of promoting science and
patient care. Vigorous enforcement of existing regulation
is needed and should be supported. The political pressure from NIH and researchers
forced OHRP to back off actions suggesting existing regulations at this political moment
result in weakened protections for subjects. Parent whose agree to enroll children in support
study should be informed of OHRP findings. The support trial should be understood to
be another classic case of failure of informed consent by well intentioned eager researchers
on greater good driven by problematic system. We should acknowledge the system is set up
more to foster than prevent these kinds of ethical failures enforce.
In cases of wrong doing and active wards for meticulous behavior is critical to producing
ethical behavior. We do not think any bureaucratic system can
prevent more cases like this from happening. The only real protection involves a combination
of extreme humility, constant attention of uninvolved, and genuinely willingness on part
of academic researchers and administrators to lose in the research game --
Time up is up. Thank you.
Ethics first. Thank you.
Panel, NIH.
Thank you very much for your comments. You argue that support study shouldn't be
used as a center point for discussing informed consent for standard of care research.
I think you would agree it's important to continue to do research on what is now the
standard of care in order to improve that so that we have a better understanding of
optimal intervention versus less optimal intervention. So if you don't believe support study should
be used as a centerpiece for discussing the standard of care do you agree we have a need
to talk about what are those issues for participants and researchers as we seek to improve standard
of care through additional research? Be interested in talking more about that blurry
line between patient participant and how we make it distinct.
I believe we should encourage as many patients as possible to be research participants and
actively involved as participants. So I would be interested in a little bit more
-- Thank you for your question.
I support and encourage research on interventions that are commonly used in the clinic.
We all know that historically speaking medicine has not been evidence based, evidence based
medicine is a new phenomenon. What goes on in clinical care obstetrics is
an example I have written about personally what is happening is not based on good evidence.
Absolutely we need those studies. I would shy away from calling this standard
of care research because I think that phrase ends up making people think that somehow what
you're doing doesn't add risk. I would prefer to think of it as interventions
from commonly -- studies on commonly used interventions.
Certainly we can do that and manage to explain to parents or subjects in other cases, that
when you go into a randomized system, it ceases to be the case your physician is individualizing
care for you. Maybe the case the individual care is not
evidence based, is attempting to visualize your care as soon as you go into a randomized
system that ceases.
OHRP.
Thank you for your comments. If I can pick up on what Dr. Hudson was talking
about. If we imagine many of the other commentators
are giving this -- these examples. There might be scenario which is we're comparing
two things that actually we don't have any supposition in terms of differences between
them and perhaps you think there might be situations in which we basically these are
in fact minimal risk studies because there's a much bigger picture in terms of scenarios
that are very, very different than the fact pattern that started this discussion.
An example from my life, I use a cream for my rosacea.
I would love to be in a randomized trial that tested this and told me what I'm doing to
my body whether it's safe or effective. We lack that in all sorts of places so research
is very important but we shouldn't into the system we think because it's used in clinic
there's little risk and we don't have to have the consent discussion.
One good thing is the kinds of consent discussions ought to be happening in clinical care and
not could be forced in discussion virtue of adding research into the mix.
The research to informed conSent might improve to informed consent in clinical care.
FDA.
For reasons the fact you study it means there might be a difference otherwise you wouldn't
study it and there's no purpose in it. I guess I thought standard of care was used
to explain why it's reasonable to study this treatment, a lot of people believe anytime,
et cetera, et cetera. What you're saying, standard of care doesn't
mean there's important differences and this illustrates that.
There were two potentially important differences looked for, eye disease and lung disease and
survival. So whether it be gold standard of care to
support the idea these are wide used is the remedy to make sure that you do say what you're
looking for and what the down side and upside might be.
Existing regulation say to do that. They tell you to tell people the purpose of
the research tell you to tell them risks you're interested in so reasonable to follow existing
regulations.
Thank you very much.
Thank you.