E-DRUG: US/NBAC Suggests Rules For Foreign Drug Tests
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[crossposted from Pharm-Policy with thanks. WB]
http://washingtonpost.com/wp-dyn/articles/A24814-2001Apr30.html
Panel Suggests Rules For Foreign Drug Tests
A presidential panel has recommended creating a range of safeguards to
prevent U.S. drug companies and government researchers from unethically
testing experimental medicines on residents of developing countries.
The National Bioethics Advisory Commission yesterday issued a 140-page
report calling, in part, for rules barring researchers from testing new
pharmaceuticals on impoverished communities unless their residents would
benefit if the drugs proved safe and effective. Such rules might mean that
American researchers could not test an expensive heart drug in a rural Third
World village if its residents could not afford to purchase the medicine
once it was brought to market in the United States.
In the words of the report: "No population . . . should be the focus of
research unless some of the potential benefits of the research will accrue
to that group after the trial."
The bioethics panel -- composed of ethicists, legal scholars, patient
advocates and pharmaceutical industry representatives -- submitted the
report to President Bush after an 18-month study. None of the
recommendations is binding.
The report also follows an 11-month Washington Post investigation into
ethical issues surrounding medical research conducted in the developing
world. The series of articles, "The Body Hunters," documented risky and
exploitative medical research that U.S. companies and institutions carried
out in poor countries that had scant hope of benefiting from new drugs or
medical breakthroughs. Some research described in the series was carried out
on adults and children who said they had no idea what experimental drugs
they were taking and who said they had not been warned of potential risks.
The articles generated complaints on Capitol Hill and sparked concern at
the Department of Health and Human Services. HHS announced creation of a new
office to oversee U.S.-funded medical research on foreign patients and to
address the ethical problems caused by experimentation on Third World
populations.
The bioethics commission report addressed a broad swath of private and
government research in the developing world. The commission had struggled
with many of the issues, crafting and then rejecting language far more
restrictive than the final version in the report released yesterday.
Some ethicists attacked the final wording as weak and ineffective. "In
every relevant portion, the report creates a loophole that might be
exploited by an unethical researcher," charged Peter Lurie, deputy director
of Public Citizen's Health Research Group, a Washington advocacy
organization.
Among the report's recommendations:
� Research proposals should be reviewed and approved in advance by ethics
review panels in both the United States and in the host countries. However,
the report recommended that this requirement for review in the United States
be waived if "the host country or host institution has in place a system of
equivalent substantive ethical protections."
� U.S. researchers overseas should not use placebos or a dummy comparison
treatment if there is an established, effective treatment for the malady
being studied, even if that treatment is not routinely available in the host
country.
If patients in the comparison group are not provided with an effective
treatment, the researchers should justify their actions to an ethics review
committee, the report said.
� Members of the community on which a new medicine will be tested should be
consulted by researchers as they design their medical experiment, and those
community representatives should ensure that the research is "responsive" to
the community's needs -- not just the needs of the United States and of the
experiment's sponsor.
� Researchers should obtain voluntary, informed consent from all
participants in medical research abroad. Where custom requires, researchers
also should obtain permission from community leaders and from a patient's
family. But in no case, the report said, should a male or husband's consent
supplant that of a female participant.
� In areas lacking adequate health care, researchers should "make
reasonable, good-faith efforts" to ensure that participants receive "needed
experimental interventions that have proven effective." Research proposals
submitted to ethics review committees should explain how new treatments that
prove effective will be made available to "some or all" residents of the
host country.
<em>Staff writer Mary Pat Flaherty contributed to this report.</em>
Paul Davis
pdavis@critpath.org
Health GAP Coalition
ACT UP Philadelphia
+1.215.731.1844 ACT UP tel.
+1.215.731.1845 fax
+1.215 474.6886 direct