Drug companies' quest for speedy results has led to a boom in trials based in developing countries, where ethical standards may be lax and the impoverished sick abundant. According to the U.S. Department of Health and Human Services Inspector General's office, the number of researchers based outside the United States seeking new drug approvals has increased 16-fold over the last decade. In this article, a 1996 Pfizer trial in Nigeria—the subject of a controversial class-action suit—illustrates the dangers.
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References
1.
KarimQ. AbdoolInformed consent for HIV testing in a South African hospital: Is it truly informed and truly voluntary?Am. J. Public Health88(4): 637–640, 1998.
2.
AngellM.The ethics of clinical research in the Third World. N. Engl. J. Med., September 18, 1997, pp. 847–849.
3.
Bastian, H., of the Cochrane Collaboration Consumer Network. Gains and losses for rights of consumer and research participants. BMJ, December 15, 2001, p. 7.
4.
GuayL.Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet, September 4, 1999 (see also critical letters in the following issue).
5.
LurieP.WolfeS.Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N. Engl. J. Med.337(12): 853–856, 1997.
6.
National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Vol. II. May 2001.
7.
PecoulB.Access to essential drugs in poor countries: A lost battle?JAMA281(4), 1999.
8.
Pfizer. Correspondence with the Washington Post on Clinical Trials Series. www.pfizer.com.
9.
Public Citizen. Comments on the Draft Health and Human Services Inspector General's Report. Washington, D.C., July 5, 2001.
10.
Public Citizen. Request to the Department of Health and Human Services to Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome in Latin America Unless It Is Redesigned to Treat All Patients. Washington, D.C., February 22, 2001.
11.
StephensJ.Where profits and lives hang in balance: Finding an abundance of subjects and lack of oversight abroad, big drug companies test offshore to speed products to market. Washington Post, December 17, 2000, p. A1.
12.
U.S. Department of Health and Human Services, Office of Inspector General. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Washington, D.C., September 2001.
13.
VarmusH.SatcherD.Ethical complexities of conducting research in developing countries. N. Engl. J. Med., October 2, 1997.
14.
VickersA.Do certain countries produce only positive results? A systematic review of controlled trials. Control. Clin. Trials19(2): 159–166, 1998.
15.
World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Ferney, France, 1964; 5th revision, 2000.
