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'Dangerously flawed' AIDS research criticized


'It's Tuskegee Part II,' consumer group alleges

April 22, 1997
Web posted at: 7:41 p.m. EDT (2341 GMT)

WASHINGTON (CNN) -- A consumer group claimed that unethical AIDS research by the United States has caused the deaths of about 1,000 children overseas.

Public Citizen, a consumer group affiliated with Ralph Nader, accused the government of deliberately denying AIDS-infected patients access to AZT, a drug that reduces the transmission of AIDS. The group's claims are based on federal documents it obtained on the research.

"It's Tuskegee part two," Public Citizen's Director Dr. Sidney Wolfe said, in reference to the notorious experiment involving African-American patients in Alabama. From 1932 to 1972 about 400 poor black men were used as guinea pigs as scientists studied the effects of syphilis when left untreated.

"It's certainly as bad as anything that has occurred since World War II in terms of the violations of the basics of medical ethics," Public Citizen's Dr. Peter Lurie added.

U.S. defends research


But a U.S. disease researcher defended the research, saying that it is not feasible or scientifically proper to give AZT to all patients involved with the research.

Dr. Phillip Nieburg, an AIDS researcher for the Centers for Disease Control, said AZT is unavailable and unaffordable for use in developing countries.

The cost of treating a single pregnant woman at delivery is $800. Nieburg also says the host countries in which CDC has operated were willing partners in the research.

Nieburg stressed the importance from a scientific point of view of comparing new treatments with the existing "standard of care" in a particular country. In developing countries, AZT is not the standard of care.

"In the countries that we're talking about, the health care expenditure is about $10 per person per year, and so it's really important to make sure that what we're looking for as a potential outgrowth of this is something that is really relevant and affordable," Helene Gayle of the CDC said.

'Double standard'

But Public Citizen claims that is unethical because some of the women in the AIDS research trials are being denied access to AZT; instead, they were given placebos. The experiments focus on the transmission of the AIDS virus from pregnant women to their unborn babies

The government insists a placebo comparison is the only way to prove potential new therapies are better than no treatment.

But Lurie said, "It is a clear-cut double standard, and for these babies it will be lethal. We are demanding today that the federal government provide AZT or similar drugs to all of the women in these studies."

At issue are nine studies being conducted in African, Asian and Caribbean nations and underwritten by the National Institutes of Health or the Centers for Disease Control and Prevention. About 9,000 women are involved in the research.

Studies conducted in the U.S. have clearly demonstrated AZT reduces the transmission rate of HIV from mother to unborn child by two-thirds.

Public Citizen says similar studies involving U.S. women offer effective anti-HIV therapy to all participants.

Wolfe called the experiments "horribly...dangerously flawed" and said his organization had asked federal officials how such experiments could have gotten through the ethical review boards.

Public Citizen also noted six European studies of anti-HIV drugs were ethically flawed and could result in the deaths of 500 more infants whose mothers were involved in the research.


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