E-drug: American research without a requirement for American IRB review (cont)
---------------------------------------------
In reply to Tom Poe of The World Center For Clinical Research who
suggests that authorities in developing countries can be relied upon
to protect subjects in drug trials and research rather than requiring
U.S. based independent ethical review committees.
People in extreme poverty in the developing world die because they do
not have money enough for water, food, medicine and other
necessities. Life saving drugs are often diverted from hospitals and
clinics and sold for private profit by the very people who are
responsible to provide them to patients who sometimes die without
them. The newspapers are daily jammed with stories of corruption,
payoffs, murder and uprisings. The situation is getting worse. The
idea that the authorities in such places will effectively safeguard
subjects in research and trials is unrealistic in the extreme.
I am a businessman, commercial lawyer, and active investor and no
stranger to free markets. But unregulated free markets have a long
and dark history of oppressing the poor for the benefit of the rich
(e.g. slavery, colonialism, etc.). Whether by communism or
capitalism, history has been the same: Those with wealth and power
sap the life from those without it. And always it is to gain still
more wealth and power.
There's big money in new drugs. But, because rich countries do a
better job of protecting their people, valuable research and trials
cannot be conducted in them as easily and cheaply as they can be
conducted in the developing world. The very reason that companies do
research and trials in the developing world is why U.S. based ethical
review is essential: It's
dangerous. The attempt to eliminate the U.S. based ethical review
requirement is an attempt to avoid the protections that the U.S.
provides to American subjects. If those protections are not needed,
they should be
dropped. If they are, they should be accorded to even more vulnerable
subjects in developing countries.
Any argument that developing countries generally will provide sufficient
safeguards is not only wrong but disingenuous. The only people who
believe it are those who benefit by convincing others to believe it.
To use
political parlance, it's 'spin'. That may be OK in politics. But not when
the lives of the world's most poor and vulnerable hang in the balance.
Finally, following is a message just in from Kenya which describes
how well the authorities in Kitali provide water to the people there.
It seems
unlikely that countries that cannot deliver water to their people will
effectively protect them in research and trials.
"It has become apparent that the City Water Company will not be
operating reliably in time to meet this crisis, we are not sure when
it will become operable again. It is an issue of corruption, failing
outdated equipment, failure of payment of bills by users, the power
rationing that forced them to use diesel generator fuel which is
twice as expensive as power, and back debts to the power company of
over 20 million shillings. Pretty bleak. The immediate need is for
water now through mid-March, when the rains come again."
Scott D. Hillstrom, J.D.
scott.hillstrom@analyticorp.co.nz
Cry for the World Foundation
+(651) 452-6003; Mobile +(612) 730-5884; Fax (312) 803-0175
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.