Item #6: Comparing Clinical Trial PACTG 1022 to HIVNET 012

On August 8, 2003, Jonathan Fishbein, who had recently taken a job as the director of the Office for Policy in Clinical Research Operations at DAIDS, wrote an email to his boss, DAIDS director Ed Tramont, alerting him that “there was a fulminant liver failure resulting in death” in a DAIDS trial and that it looked like “nevirapine was the likely culprit.” He said that the FDA was being informed. He was referring to Joyce Ann Hafford. Tramont emailed him hack, “Ouch. Not much we can do about dumb docs!”
This email exchange came to light in December 2004, when AP reporter John Solomon broke the story that Fishbein was seeking whistle-blower protection, in part because he had refused to sign off on the reprimand of an NIH officer who had sent the FDA a safety report concerning the DAIDS trial that launched the worldwide use of nevirapine for pregnant women. The study was called HIVNET 012, and it began in Uganda in 1997.

Farber switches from a discussion of PACTG 1022 to HIVNET 012 and omits to explain a critical distinction.

Here Farber misleads in a way that is repeated throughout the remainder of the article. She confuses the short-course nevirapine-only regimen used to reduce MTCT with chronic treatment using nevirapine as one component of a combination of ARVs. Not a single life-threatening event related to short-course nevirapine has been recorded in mother or child in tens of thousands of such uses around the world. The nevirapine toxicity found in PACTG 1022 was in chronic treatment.

In our opinion Farber quite neatly moves from a discussion of the trial that resulted in the death of one American woman to the Uganda trial of the same drug. Writing style is somewhat a matter of opinion, but the fact that both trials had serious problems with adverse events, and both involved the same drug, Nevirapine, surely is connection enough to allow them to both belong in the same magazine article.