Item #7: Are reports of PACTG 1022 Sinister?

The conclusion of the PACTG 1022 study team was published in the journal JAIDS in July of 2004. “The study was suspended,” the authors reported, “because of greater than expected toxicity and changes in nevirapine prescribing information.” They reported that within the nevirapine group, “one subject developed fulminant hepatic liver failure and died, and another developed Stevens-Johnson syndrome.” Stevens-Johnson syndrome is skin necrolysis—a severe toxic reaction that is similar to internal third-degree burns, in which the skin detaches from the body. Another paper, entitled “Toxicity with Continuous Nevirapine in Pregnancy: Results from PACTG 1022,” puts the results in charts, with artful graphics. A small illustration of Hafford's liver floats in a box, with what looks like a jagged gash running through it. Four of the women in the nevirapine group developed hepatic toxicity.
As Terri Schiavo lay in her fourteenth year of a persistent vegetative state, and the nation erupted into a classically American moral opera over the sanctity of life, Joyce Ann Hafford's story made only a fleeting appearance—accompanied by a photo of her holding a red rose in an article that was also written by the AP's John Solomon. But soon a chorus of condemnation was turned against those who were sensationalizing Hafford's death and the growing HIVNET controversy to condemn nevirapine, which had been branded by the AIDS industry as a “life-saving” drug and a “very important tool” to combat HIV in the Third World.

Farber reports on the publication of PACTG 1022 as if it is something sinister.

In fact, its publication was standard scientific procedure. Furthermore, that nevirapine toxicity was reported in the paper is an indication of honestly conducted science that is inconsistent with Farber’s implications of some sort of cover-up. There is no logical comparison with the Schiavo case; Farber's analogy is bizarre and hard to understand.

This appears to be more a critique of Farber’s writing style than anything else. It is a fairly straightforward description of the publication that admitted that there were serious consequences for several people in a US-based trial of Nevirapine. It is interesting to contrast the lack of interest over the Hafford death versus the highly publicized Terry Schiavo death watch. It may be possible to argue that the legal issues in the Schiavo case made it particularly compelling (as opposed to just Schadenfreude), but it is also possible to argue that Hafford should be seen as an icon for the many people who die in clinical trials. And it is true that the serious reactions of all six UK men in a recent clinical trial did get widespread press attention (see, for example, news.bbc.co.uk/1/hi/england/london/4807042.stm), so perhaps more attention is being drawn to this important issue.