The 076 Dilemma
    First Fruits

Initial Results from the First Round of Research.

Less than four years later, the first results of the research initiative were made public. On February 18, 1998, the CDC released the findings of a placebo-controlled study, also based in Thailand, that indicated that a regimen of AZT, administered orally during the last four weeks of pregnancy as well as during labor, reduced the mother-to-infant transmission rate by fifty percent.

While not quite as effective as the 076 regimen, these were nonetheless impressive results, and the cost of achieving them was dramatically lower: an estimated $80 per course of treatment, or about one-tenth the price of 076.

The following year, the results of even more pared-down courses of treatment were announced. A preliminary report of a large placebo-controlled study conducted in three African nations showed that treatment with anti-viral drugs begun at the time of delivery and continued for one week for both mother and infant cut the transmission rate by 37 percent at six weeks after birth. A second, even shorter course of treatment, however--anti-viral drugs administered only during labor and delivery--yielded a transmission rate no different from the placebo group.

The results of the Thai study and, later, the African study (known as the PETRA trials) were hailed by international health officials as potentially offering pregnant women in poorer countries their first realistic hope of an intervention that would help protect their babies from HIV infection. Not only were the short-course regimens cheaper, they were simpler to administer, requiring fewer oral doses and no intravenous injections.

"The data, though preliminary," said Dr. Joseph Saba, the UNAIDS official who managed the PETRA trials, "mean we can save a lot of children using several strategies, whichever makes sense for the women, their doctors or the community in which they live."

But although there was general agreement that the study results were promising, there was sharp, often bitter, disagreement as to the cost, in human terms, of the clinical trials.

While the studies were still in progress, a heated debate arose over the manner in which they were conducted. However valid their purpose, critics said, the trials were unethical: clinicians were knowingly putting lives at unnecessary risk in pursuit of their research goals.



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