E-drug: American research without a requirement for American IRB review (cont)
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Hello Scott, and fellow e-druggers: I would like to reply, but more
importantly, I would like to make a point. The issue of which
country should be charged with providing IRB services for clinical
research is a fundamental question, which, more appropriately, should
be which country is in a better position to oversee and protect the
interests of its population, the U.S., Great Britain, or the country
in which the clinical research is taking place?
Take five Americans and five [respective country] representatives,
attach the charge of IRB to them, and you tell me, which group is
going to make a better review of the information on the clinical
research that will be carried out on their populace? Both groups
will receive the same information, right? Now, maybe it's necessary
to provide additional information to a group that is in a developing
country, but in my personal opinion, I don't think that's necessary.
There are resources available worldwide that will provide the
necessary information for you, or me, or anyone to make decisions
that are in the best interest of the populace that looks to us to
protect their interests.
Where we get into trouble, is when the IRB doesn't do the job they're
charged with. How many IRB's actively participate in the clinical
research taking place? None! is a pretty good guess. How many
IRB's insist that the multi-site clinical trial protocols be carried
out in strict accordance with Good Manufacturing Practices [GMP]
standards. None! And, that's not a guess, but a clear and
well-known fact. And this is the point.
Give the countries that are participants in clinical research the
power and realization that they can, in fact, insist on an active
role in the clinical research, and combine that with the capability
to insist on the clinical research being carried out in strict
accordance with GMP standards, and you now have the research data
available that is both reliable and accurate. Hell, you and I could
make the right decisions if we had accurate and reliable data in
front of us.
So, maybe the issue isn't hiding behind a weak, impotent,
malpractice-oriented IRB institution from the U.S., but rather, just
when are we going to stop the pharmaceutical juggernaut and insist on
GMP standards for clinical research? By the way, if we did shift to
such a policy, the industry would actually increase their profits,
lengthen their patent exclusivity in the marketplace, and, we'd pay
less for the medications so desperately needed.
Thanks for this opportunity, and HAPPY HOLIDAYS. Tom
Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2044 Plumas Street Reno, NV 89509-3708
Phone: 775-829-1799
admin@worldccr.org http://worldccr.org
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