History refresh: AZT and ethics

A professor pointed me to this online history and ethics lesson from the Harvard Kennedy School’s Program on Ethical Issues in International Research: The Debate Over Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations. It’s surprisingly readable, and the issues debated are surprisingly current.

In 1994, researchers in the US and France announced stunning news of a rare victory in the battle against the AIDS pandemic. Studies conducted in both countries had shown conclusively that a regimen of the drug AZT, administered prenatally to HIV-positive pregnant women and then to their babies after birth, reduced the rate of mother-to-infant transmission of HIV by fully two-thirds. The results of the clinical trials constituted “one of the most dramatic discoveries of the AIDS epidemic,” the New York Times declared, and one of the most heartening as well.

The new regimen–known by its study name, AIDS Clinical Trials Group (ACTG) 076 or, often, simply “076”–offered the epidemic’s most vulnerable targets, newborns, their best hope thus far of a healthy childhood and a normal life span. The number of infants who might benefit from this research was significant: according to World Health Organization (WHO) figures, as many as five to ten million children born between 1990-2000 would be infected with HIV. In the mid-1990s, it was estimated that HIV-infected infants were being born at the rate of 1,000 a day worldwide.

So impressive were the findings of ACTG 076–and so substantial the difference in the transmission rate between subjects given AZT and those given a placebo (eight percent versus 25 percent)–that the clinical trials, which were still ongoing, were stopped early, and all participants in the studies were treated with AZT. In June 1994, after reviewing the study results, the US Public Health Service recommended that the 076 regimen be administered to HIV-infected pregnant women in the US as standard treatment to prevent transmission of the virus.

But while 076 was hailed as a major breakthrough, the celebration was somewhat muted. For a variety of reasons, the new treatment regimen would not likely reach those who most desperately needed it: pregnant women in the developing nations of the world and, most particularly, sub-Saharan Africa, where AIDS was wreaking devastation on a scale unimagined in the West.

I think one reason why graduate school can be so overwhelming is that you’re trying to learn the basic technical skills of a field or subfield, and also playing catch-up on everything that’s been written on your field, ever. True, some of it’s outdated, and there are reviews that bring you up to speed on questions that are basically settled. But there’s a lot of history that gets lost in the shuttle, and it’s easy to forget that something was once controversial. Something as universally agreed upon today as using antiretrovirals to prevent mother-to-child transmission of HIV was once the subject of massive, heart-wrenching debate. I tend to wax pessimistic and think we’re doomed to repeat the mistakes of the past regardless of whether we know our history, because we either can’t agree on what the mistakes of the past were, or because past conflicts represent unavoidable differences of opinion, certainty, and power. But getting a quick refresher on the history of a is valuable because it puts current debates in perspective.

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02 2011

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