munich

A furious exchange between researchers at Johns Hopkins University (JHU) and public health advocates, carried out in letters to the Secretary of Health and Human Services (HHS), has fanned the flames of a growing controversy around the ethics of US government-sponsored trials seeking to prevent perinatal AIDS transmission in developing countries.

At issue is whether it is any longer justified to use placebo in these trials when an expensive but effective therapy has been found and is routinely used in women in industrialized countries.

On 23 October, Public Citizen, a Washington-based advocacy group, wrote to Donna Shalala, the HHS secretary, pointing out that researchers at the JHU School of Public Health in Baltimore, Maryland, had “tentatively” dropped plans for a placebo arm in an NIH-funded trial set to begin in Ethiopia as soon as February.

The trial, involving some 900 women, had originally proposed comparing short, less expensive regimens of an anti-AIDS drug, zidovudine (AZT), in pregnant women, against women given a placebo. The JHU researchers, Neal Halsey and Andrea Ruff, say that they have made “contingency plans” to modify the trial design by dropping the placebo arm “if other studies document the effectiveness of a practical short course regimen [of AZT] in a developing country”.

The doctors at Public Citizen, Peter Lurie and Sidney Wolfe, jumped on this as evidence that the JHU researchers are “acknowledging that it is possible to conduct a scientifically valid and useful study without the use of a placebo arm”. They demanded in their letter that Shalala immediately order US government-sponsored researchers “to stop any arm of their studies in which women are denied access to antiretroviral drugs, and to provide at least short-term AZT for all women now getting a placebo.”

The next day, the JHU researchers shot back a letter of their own to Shalala. “Our changes are not being made to accommodate any outside groups,” they said. Rather it was in response to information expected early in 1998 from other United Nations and US-supported trials.

They accused Public Citizen of spreading “mistruths and distortions” in press releases and said Wolfe and Lurie “have deliberately misrepresented our position and actions in an attempt to undermine the ongoing trials” of AZT in developing countries. Wolfe, in turn, accused Ruff and Halsey of “cheap justifications of what they are doing.”

A spokesman for Shalala, said on Saturday that Shalala would have no immediate response to the letters. But, he added “we’re keenly aware of the ethical implications of these experiments and we are always looking at new information.”