The good news arrived in mid-February, when the U.S. Centers for Disease Control and Prevention announced the stunningly successful results of its study to reduce the transfer of the AIDS virus from mothers to their babies.
By administering a shortened, experimental version of a successful American AZT regimen to the expecting women, the researchers’ results showed a 50 percent decline in newborns infected with the virus.
But the results have been tainted by methods of the study itself, said Ruth Faden, director of the Johns Hopkins University Bioethics institute. He spoke to a group of 40 University administrators, students and professors Monday at the Basic Sciences and Biomedical Engineering Building.
A national controversy has sprung up surrounding the study’s use of placebos, non-medicated treatments given as medicine.
Women participating in the study and 14 others like it throughout Asia and Africa were given placebos, a practice that is illegal and considered unethical in the United States if proven treatments are available.
The debate split America’s scientific community, some comparing the study with the infamous Tuskegee syphilis study. During that incident, African-American men were denied access to a penicillin treatments during a government study in the 1940s.
Others argue the HIV studies generated crystal clear results, and did not compromise the health of participants.
Either way, international scientists must develop new ethical guidelines for research as their clinical trials expand abroad, Faden told the crowd.
“Research ethics as we have understood them until now are truly inadequate to the challenge of research in the developing world,” she said.
Strong criteria for the new field of research are needed to judge between assistance and exploitation, she added. Without consistent guidelines, widespread exploitation of the Third World is inevitable, Faden said.
“We risk seeing a wholesale transfer of biomedical research to the developing world,” she said. “Poor nations will become the clinical laboratories of the world.”
“Drugs that only patients of wealthy nations will receive will be tested on the backs of the poorest of the poor.”
The University follows federal regulations and guidelines, said Moira Keane, director of research subject protection programs.
“But not all the script is written because science is progressing very rapidly,” Keane said. “Not all of the ethical decisions can be anticipated.”
The Tuskegee analysis is an apt description, Keane said.
“The rights and the welfare of a disfranchised group were ultimately exploited in the interests of perusing a scientific question,” she said. “And that is, in fact, at the heart of this controversy.”
For Kathryn Chaloner, professor of statistics, the topic hit close to home. Her work with the international Community Program for Clinical Research in AIDS drew her to Faden’s morning lecture.
“We are constantly confronted with these same issues: about whether something is ethical, and what to use as a control,” Chaloner said.