Public Citizen Attacks Study

The public interest group Public Citizen condemned a Harvard School of Public Health (SPH) study as unethical on Tuesday.

The SPH project, headed by SPH Assistant Professor Wafaie W. Fawzi, was one of 16 HIV studies abroad examined by Public Citizen, 15 of which were found to be unethical.

The only study to meet Public Citizen's standards was also conducted by an SPH researcher, Marc J. Lallemant, a visiting professor at SPH.

Each of the studies monitored the effects of different drug treatments on mother-to-child transmissions of HIV, the virus that causes AIDS.

The studies were conducted in Africa, Asia and Latin America. Peter Lurie, a research associate at Public Citizen's health research group, charged that the researchers took advantage of the regions' lax health standards.

"Instead of seeing the abominable state of health care as something they can rectify, they are exploiting the inadequate health care of those countries to conduct studies that they would never do in the U.S.," Lurie said.

Public Citizen, which was founded in 1971 by Ralph Nader, condemned the studies because they did not provide HIV-infected mothers with AZT, a drug that reduces the possibility of mother-to-child transmission by two-thirds, according to Wilbert C. Jordan '66, director of the AIDS program at King-Drew Medical Center in Los Angeles.

Jordan signed a letter that Public Citizen sent Tuesday to Donna Shalala, U.S. secretary of Health and Human Services. The 18 page document requests an investigation into how these federally-funded studies were approved.

"The question is whether the government is going to admit they made a mistake or whether they will try to justify their action," Jordan said. "If they do try and justify it, then on what basis?"

The group's letter to Shalala said that 18 such studies were funded worldwide, and that the two conducted in the U.S. met Public Citizen's ethical standards, while 15 of the 16 conducted on foreign soil did not.

Lurie said that Fawzi's study, based in Tanzania, provided some experimental drug therapy for the infected women but withheld AZT for the duration of the project.

"You get stuff but no one has proven that the stuff is any good," he said.

Public Citizen rejects any study that does not provide all subjects with AZT.

"We don't object to research," Lurie said. "We do object to studies of these kinds with placebos. That's unethical as far as we're concerned."

Lurie praised Lallemant, who conducted his research in Thailand, for providing all mothers in his project with AZT.

"Lallemant's work shows that it is possible to do ethical research in developing countries," Lurie said.

Neither Lallemant nor Fawzi could be reached last night for comment

Jordan signed a letter that Public Citizen sent Tuesday to Donna Shalala, U.S. secretary of Health and Human Services. The 18 page document requests an investigation into how these federally-funded studies were approved.

"The question is whether the government is going to admit they made a mistake or whether they will try to justify their action," Jordan said. "If they do try and justify it, then on what basis?"

The group's letter to Shalala said that 18 such studies were funded worldwide, and that the two conducted in the U.S. met Public Citizen's ethical standards, while 15 of the 16 conducted on foreign soil did not.

Lurie said that Fawzi's study, based in Tanzania, provided some experimental drug therapy for the infected women but withheld AZT for the duration of the project.

"You get stuff but no one has proven that the stuff is any good," he said.

Public Citizen rejects any study that does not provide all subjects with AZT.

"We don't object to research," Lurie said. "We do object to studies of these kinds with placebos. That's unethical as far as we're concerned."

Lurie praised Lallemant, who conducted his research in Thailand, for providing all mothers in his project with AZT.

"Lallemant's work shows that it is possible to do ethical research in developing countries," Lurie said.

Neither Lallemant nor Fawzi could be reached last night for comment