IRB review (cont)
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E-drug: NBAC: American research without a requirement for American
IRB review (cont)
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Peter,
I have copied below and attached [attachments don't work. BS] the
letter I am submitting to the National Bioethical Advisory Commission
per your suggestion. It would be interesting to organize some class
litigation against abusive companies. What about Columbia?
Scott Hillstrom
607 MARQUETTE AVE.
SUITE 400
MINNEAPOLIS, MN
612-730-5884
scott.hillstrom@analyticorp.co.nz
U.S. National Bioethics Advisory Commission
6705 Rockledge Drive
Suite 700
Bethesda, MD 20892-7979
Fax: (301) 480-6900
Gentlemen:
December 3, 2000
It is a sad testimony against our society that American companies are
conducting research and clinical trials using human subjects in the
developing world but aren't applying the same safeguards that would be
required in the U.S. using American subjects. Now it is proposed that what
safeguards exist be diminished by elimination of the requirement that U.S.
independent ethics review committees approve clinical trials in developing
countries. The Cry For the World Foundation strongly opposes the proposed
change and any other reduction in U. S. based independent ethical review
requirements for research and trials in the developing world.
In truth, there can be no ethical justification for rich people exposing
poor uneducated people to risks that rich people are not willing to take
themselves. It is especially unethical when the poor stand to gain little
or nothing by taking the risk. Rich people have, through the centuries,
erected whatever shibboleth conscience required to justify the imposition of
the costs of their gains on the poor who do not enjoy them. For the ancient
Romans, the sheer power to do it was all the justification needed to exact
from whole peoples the fruit of their labor. In the old American South,
Biblical justifications were necessary for a religious people--thus, even
the author of the Declaration of Independence slept with a clear conscience
in a comfortable bed purchased by the sweat of people who were made to live
like beasts of burden. Today, we assert the necessity that science and
medicine advance to justify the imposition of risks on the poor and
powerless so that we will be safer and healthier. How easily we perceive
the error of other people past while being utterly blind to our own here and
now. The truth is, that we do what serves our self-interest and adapt our
ethical standards to abide what we do.
Columbia Laboratories' recent South African trial of Nonoxynol 9 is a case
in point. This trial of an HIV virucide used 700 (presumably uninfected)
prostitutes. Obviously, such a trial requires that subjects engage in
unprotected sex. Admonitions that they use condoms can only cloak the true
intent that they not be used since actually using them would frustrate the
purpose of the trial - the trial requires deliberate exposure to HIV. It was
justified on the theory that the research is needed to help the world
(meaning those who can buy medicine) and the women gave informed
consent - how can an illiterate person who does not understand what a
microbe is, give
informed consent to undertake this lethal risk? In the end, many women
acquired a lethal infection and, worse, the infection rate in the
experimental group exceeded the control. Some subjects of this trial will
die. Some of their children will die. Supporters of such trials quickly
observe that not all will die because they were in the trial; some would
have died anyway. After all, it is said, they are prostitutes. But perhaps
just one might not have died had they not participated; or perhaps two, or
three. How many deaths does it take to be 'unethical'?
Trials like this and worse occur routinely in the developing world even with
the oversight of U.S. independent ethics review committees. When these
committees are no longer required, some companies who stand to make a
billion dollars on their next block-buster drug will be encouraged take even
more license with the health and lives of the world�s poor and illiterate.
And they will have the revised NBAC's report on the ethics of international
research to rely upon. The National Bioethics Advisory Commission will be
cited as authority for what we would all agree are unethical actions.
George Orwell will smile knowingly from the grave.
The developing world cannot provide even basic healthcare to its people and,
sometimes, cannot even feed its children. The notion that desperately poor
countries and corrupt officials will turn blind eyes to millions of dollars
in 'research' funds because the research is not ethical is ludicrous.
Companies do trials because successful trials are necessary to sell drugs
and get results for their shareholders. There is a lot of money at stake.
Even conscientious companies operate under extreme conflicts of interest
when running trials. For the same reason we regulate them in U.S. trials
they need to be regulated elsewhere. It would reckless and immoral for the
United States to delegate to other countries the necessity of regulating
American companies developing drugs for the American market when those
countries lack effective regulation of their own.
If the requirement that trials be approved by U.S. independent advisory
committees has historically been based on ethical needs, it cannot be argued
that eliminating them will better serve those needs. Please do not approve
the change.
Respectfully,
Scott D. Hillstrom, J.D., President
CC. Peter Lurie, MD, MPH
Scott D. Hillstrom, J.D.
scott.hillstrom@analyticorp.co.nz
+(651) 452-6003; Mobile +(612) 730-5884; Fax (312) 803-0175
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