U.S. Doing Unethical Experiments In Third World, Says Med Journal

A blistering editorial in the mid-September edition of the New England Journal of Medicine compared ongoing experiments in Asia, Africa and the Caribbean with the notorious Tuskegee study, a government-funded project in which poor African-American men with syphilis were studied over four decades without being provided treatment.

The editor of the Journal of Medicine editorial, Dr. Marcia Angell, wrote that ongoing HIV research in the Third World was similar to the Tuskegee scandal.

"The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work," Angell declared. "It seems as if we have not come very far from Tuskegee after all."

The White House Thursday rejected her analogy, calling it "unfortunate and untrue." Spokesman Mike McCurry said the Clinton administration "is very confident that the ethical review of these experiments has been done with a high sense of moral purpose, and that the ultimate objective...is to protect millions of children."

The specific focus of the Journal's editorial was a series of experiments in 15 countries on the use of the anti-AIDS drug AZT in preventing the transmission of the human immunodeficiency virus (HIV) from pregnant women to their infants. The U.S. government funded nine of the studies of more than 12,000 women through its National Institute of Health (NIH) and the Centers for Disease Control and Prevention (CDC).

The 15 countries included in the study Cote d'Ivoire, Uganda, Tanzania, South Africa, Malawi, Thailand, Ethiopia, Burkina Faso, Zimbabwe, Kenya and the Dominican Republic.

In these experiments, the women were divided into control groups, one of which received a placebo -- a medication which is known to have no effect on their condition but which is administered to compare the effectiveness of the medication being tested.

Other groups were given varying dosages of AZT, a very expensive medication which is known to reduce the transmission of HIV to infants by as much as two-thirds. Extended use of AZT is now considered standard treatment in the United States.

The Health Research Group of the consumer association 'Public Citizen', which first raised the issue earlier this year, charged that about 1,000 children born to the placebo group will contract HIV and probably die, and that the doctors who conducted the experiment violated their ethical obligation to these women by denying them AZT.

Their charges were endorsed by Angell in her article. The basic ethical principle at stake, she wrote, is: "when effective treatment exists, a placebo may not be used. Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo."

This principle was codified in the Declaration of Helsinki of the World Health Organisation (WHO) in 1964 when it decreed that "in any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method."

Defenders of the current research argue that the "best" method is simply not available in most of the developing world because of the great costs involved.

"The '076' (AZT-based) regimen, which is the standard of care in the developed world, is not feasible for poorer nations," according to a joint statement released by the NIH and the CDC. "This is the fundamental fact which brought about the international call (by WHO) for research on alternative approaches."

"Developing nations are seeking a lower-cost and less intensive intervention ...to help prevent mother-to-infant HIV transmission," the two institutes argued, noting that the placebo control was chosen by poor countries themselves because "it is the only approach that can be expected to produce a sufficiently clear response, in a reasonable time period, to the questions that must be answered: is the intervention safe and effective, and is it feasible in the developing world?"

"People are doing these studies in poor countries because they can get away with it there," countered Dr. Stephen Bezruchka of the international health programme of the University of Washington in Seattle. "They are not acceptable here."

Critics of the experiments agree that researchers could address the ethical problem by providing longer and shorter AZT treatment to different groups, particularly in light of evidence dating back to 1994 when these studies began.

More than one million children throughout the world have been infected with HIV through mother-to-infant transmission and WHO projections say a total of five to 10 million children -- the vast majority in poor countries - will become infected in this decade.

What also concerns Angell is that the HIV research is being defended in much the same way as the Tuskegee study in which the subjects were denied the best known treatment for syphilis. Supporters of the study argued that the subjects probably would not have been treated anyway and that the study was important for medical knowledge.