E-drug: Helsinki declaration debate (cont)
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The question with regard to proposed changes in the Helsinki
Declaration is *what is the question?* Debating possible answers
without first identifying the question can never lead to 'The
Answer'. And while it is going on, vested interests will fill the
void with 'Their Answer' and that will be the one that generates the
highest returns to investors.
First, the shibboleth of so-called "informed consent" should be
destroyed. Can a person ever consent to be harmed? If this is
ethically possible, when can an illiterate person who can't read
about the issues, who has never used a phone, who has no electricity
or water, and who cannot get enough to eat, give "informed consent"?
I submit that it is patently wrong to base human experimentation on
the informed consent of illiterate people in deprived societies.
They cannot be held to have consented to permit harm to themselves
and, even if they can be cajoled into doing so, their consent cannot
be informed if they do not understand all relevant issues--including
issues surrounding this ethical controversy. The very fact that this
controversy is taking place proves the impossibility of informed
consent. If we, who are fantastically better informed, can't agree
whether particular kinds of experiments are 'ethical', how can a
Ugandan villager understand enough to give informed consent to
becoming a subject?
Second, assuming that consent cannot exist, by what right can
experiments, nevertheless, be carried out where such experiment may
harm participants? Who is entitled to harm whom? History is littered
with the corpses of the powerless whose end was necessary to the
advance of the powerful. *We* need new drugs. Someone must take
risks. But *We* are not willing to take them. The poor and
illiterate are available. But since they don't really understand,
they cannot be said to be truly willing. Yet we are willing to use
them anyway. Why? Because we need the drugs and poor Africans who
struggle to stay alive and have no clue about the issues we discuss
are simply available to serve as experimental subjects. They have no
interests groups to protect them and their governments can hardly be
concerned about such esoteric subjects as ethics. In many cases, in
fact, the governments
are inimical to their own people; so much less should they be expected to
look after their needs. That's why we go there to do what we could
not do in the US and other developed countries. We will experiment
on the poor because we can; not because we have any right. Erecting
scientific or ethical justifications for this only insults science
and ethics. It is what it is even if we are unwilling to call it
what it is. History will one day judge the use of unwitting poor
people for human experiments as it has judged so many other of man's
oppressions of men.
Third, in the US, regulatory agencies have cozy relationships with the
companies they regulate. FDA policy is substantially affected by the US
pharmaceutical industry. Putting aside the so-called "scientific
questions" for a moment, it should be recognized that the FDA's
interest is limited to the interests of the United States, its people
and its industries. The FDA should be expected to act based upon its
duties and responsibilities to the US and, when those conflict with
the interests of other countries and peoples, the FDA should not be
expected to put non-US interests ahead of US interests. If human
experimentation is in the interests of the US, the FDA should be
expected support it. If they believe this requires the use of
placebos, the FDA should be expected to support that too. While the
people at the FDA are probably perfectly well meaning people, they
should not be expected to be looking out for the interests of
Africans as they do Americans. And if Americans' interests are
better served by doing things that are against the interests of
others, the FDA should be expected to do resolve doubts in favor of
American interests. The FDA should not be viewed as a disinterested
scientist seeking the answer to an ethical dilemma but, rather, it
should be viewed as an agent of US interests.
So what is the question? The question is simple and has been set forth by
most of the world's religious and ethical leaders throughout history
*Should we do to another what we would not have done to us?*
We all know the answer. It is inbuilt into our hearts and minds. It is
there because it is bedrock morality. All societies base their laws on it.
But sometimes morality becomes inconvenient so we conjure up 'issues'
so that, while we debate them, we can do what we know is wrong.
Debating issues creates the impression that what we do may not be so
wrong as we thought because there are other points of view. And we
sometimes forget that most other views represent unspoken of
interests and influences. In the end, it is wrong for we rich people
in the developed world to use the poor people in the developing world
to develop new drugs that will benefit us (does anyone think these
drugs will be available to poor Africans after they have FDA
approval?). Period. If it's wrong, we shouldn't do it. If the
need is compelling enough to experiment on Africans, then it is
compelling enough to experiment on Americans and Europeans. To say
otherwise is an open admission that we are willing to do to Africans
what we would not do to ourselves. That is the logic of conquest
--"the progress of our people requires the oppression of other
peoples". This logic always disguises itself in lofty ideals and
justifications. In this case, for example, the *ideal* is to serve
the health needs of the world (in truth, only the world that can
afford the drugs being developed). The *justification* is that it is
OK to do less to protect others than we would do to protect ourselves
so long as we observe the local standard of care (if you have been to
the developing world, you know there is no standard of care in many
places).
Finally, a case in point. Recently, the Wall Street Journal covered
a story (also covered in Durban) about the collapse of the share
price of Columbia Laboratories, Inc. ( http://www.columbialabs.com/
)
The price collapsed because their human trials on 990 HIV *negative*
prostitutes in Africa and Thailand failed to show that their spermicide
reduced incidence of HIV infection. In fact, it showed the opposite.
Controls received placebos (lucky for them). Little note is made of
the 100 subjects on both sides who were HIV infected during the
trial--eventually they will die. Most will leave behind orphans.
Presumably, testing the spermicide against a control required that
neither use condoms while the subjects were given to believe that the
spermicide provided some protection (belief that this was true is why
the company ran the trial). Did they give "informed consent"? To
say that they gave informed consent requires that following to be
true (among other things)
1. They all knew that the purpose of the experiment was to determine
how many of them would become infected with a universally fatal
disease and that each was at a high risk of becoming infected (it is
reported that 10% did).
2. They were told not to use condoms since using condoms would
affect the infection rates and put the study results in doubt.
3. They were told that some would get a placebo and would,
therefore, would have no protection.
4. They were told that the spermicide might not work and that it could
actually increase the risk of those using it.
5. That each and every subject understood all of the above and,
nevertheless, consented to participate.
Meanwhile, if the results were poor, the economic consequences for
Columbia Laboratories would be devastating as turned out to be the
case. When results showed that the users of the spermicide had a
higher infection rate, the company's stock price fell by more than
50% and the investors started class action lawsuits against the
company which are still pending. So the company had powerful
incentives to cut corners and do what it took to make the study
succeed. One wonders if they took great care to fully inform each of
these nearly 1,000 women of everything they needed to know to give
informed consent. Or were they maybe informed in groups with limited
opportunity to ask questions? And one wonders why the women
participated; what is in it for a woman to agree to risk infection so
that a drug company can drive up is stock price? What were they
really told? How was their so-called informed consent obtained? Or
was it obtained at all? Has anyone investigated? How effective are
the regulators who had control over the
study? What incentives might they have been operating under?
In the end, 100 women will die and leave hundreds more children
without a mother. That fact seems to be dismissed with the view that
they were
prostitutes and would have been infected anyway. Not necessarily true.
More died because they *did* use the spermicide. Those poor souls
would have been better off left alone. But suppose some effort was
made to supply condoms. If an effort to supply condoms is presumed
to be useless, then a great many AIDS relief projects are wasting
their time. Suppose that just one life would have been saved. Would
that be enough to show what's wrong here? How about two? How many
would it take? Who should decide whose life should be risked and how
many lost lives is too many? Presently, vested interests decide.
And they would like to be free of the restraints of the Helsinki
Declaration.
Scott D. Hillstrom, Esq.
Cry for the World Foundation
New Zealand
scott.hillstrom@analyticorp.co.nz
+1.651.452.6003 (Mob) +1.612.802.2367
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