CRUCIAL DATA IGNORED IN JUSTIFYING PLACEBO STUDIES

U.S. Double Standard on HIV Research

CRUCIAL DATA IGNORED IN JUSTIFYING PLACEBO STUDIES

In an article in the September 18 New England Journalof Medicine, two Public Citizen Health Research Group physicians attack the U.S.Government for funding unethical HIV experiments in some of the world’s poorest countriesand assert that safer alternative research methods have been largely ignored.

The Sounding Board article, “Unethical Trials of Interventions to ReducePerinatal Transmission of the Human Immunodeficiency Virus in Developing Countries”,addresses 15 studies conducted on HIV-positive pregnant women in Cote d’Ivoire, Uganda,Tanzania, South Africa, Malawi, Thailand, Ethiopia, Burkina Faso, Zimbabwe, Kenya and theDominican Republic in which some women are not given AZT even though the drug has beenproved to reduce transmission of HIV from mother to infant by two-thirds. Nine of the 15studies are funded by the U.S. Government, through the National Institutes of Health (NIH)and the Centers for Disease Control and Prevention (CDC), although such experiments wouldnever be tolerated if attempted in the U.S. Indeed, both studies being conducted in theU.S. provide AZT or similar drugs for all women.

The article presents a previously unpublished analysis of data from the 1994placebo-controlled study which established the standard AZT treatment for reducingmother-to-infant HIV transmission. This analysis suggests that shorter regimens of AZTtreatment may be as effective as longer ones. This makes it very likely that the shorterregimens are more effective than a placebo, undermining any ethical basis for the trials.”Those who gave the go-ahead for the unethical placebo trials appear to have missedor ignored these vital data. These findings undermine the rationale for continuing theselethal experiments,” said Dr. Sidney Wolfe, co-author of the article and Director ofPublic Citizen’s Health Research Group.

“These studies, despite the fact that most are being funded by Westerngovernments, deny women access to the kind of effective treatment that has been availablefor several years in developed countries. Comparing the shorter regimen to nothing (aplacebo) is the wrong comparison and needlessly places patients’ lives at risk. Instead,the shorter regimens should be compared with a treatment similar to the AZT regimenalready proved effective,” said Dr. Peter Lurie of Public Citizen’s Health ResearchGroup, co-author of the article.

Some of those defending the placebo studies suggest that experiments should only meetthe standard of care offered in the developing countries. The article strongly rejectsthis double standard: “Residents of impoverished, postcolonial countries, themajority of whom are people of color, must be protected from potential exploitation inresearch. Otherwise, the abominable state of health care in these countries can be used tojustify studies that could never pass ethical muster in the sponsoring country,” itsays.

The NIH and CDC have responded to Public Citizen’s complaint by saying that “ourdecision to support these trials rest (sic) heavily on local support and approval.”Yet an internal CDC memo dated January 27, 1995 states that “Despite detaileddiscussions … justifying the use of placebo, it has become evident that some of theIvoirian physicians working at [the CDC research project in Cote d’Ivoire], several of ourimportant Ivoirian collaborators, and a number of international researchers involved in[perinatal HIV transmission], do not feel comfortable with the use of placebo.” Ifdeveloping countries’ scientists did support the trials, it may be because they wereoffered the wrong choice: given a choice between a placebo-controlled trial and no trialat all, it is not surprising that some opted for the placebo-controlled trial, said Lurie.

The authors urge that future studies should adhere to a single international ethicalstandard that does not discriminate between patients’ countries of residence.”Tragically, for the hundreds of infants who have needlessly contracted HIV infectionin the perinatal-transmission studies that have already been completed, any suchprotection will have come too late,” the article concludes.