To further discredit HIVNET 012 and support her argument that anti-HIV drugs are deadly, Farber also tells the story of Joyce Ann Hafford, an HIV-positive, pregnant mother in Tennessee, who in 2003 entered another drug trial called PACTG 1022, designed to test anti-HIV drugs on pregnant women. While taking nevirapine in combination with other drugs, and for a longer time than the HIVNET 012 subjects did, Hafford developed terrible symptoms, including rashes, nausea, pain, and breathing trouble. She died soon after giving birth, probably from drug toxicity. Farber asserts that the trial was unethical, that nevirapine is unacceptably dangerous and useless, and that Hafford “never had AIDS, or anything even on the diagnostic scale of AIDS.” She implies that Hafford was probably not even HIV positive.
The clinical trial in which Joyce Ann Hafford enrolled did find nevirapine to have greater-than-expected toxicity when used in combination with other drugs in a particular regimen. These results were reported and published and led to a revision in Federal Drug Administration guidelines for the drug’s use. Hafford’s death, in which nevirapine was almost certainly a contributing cause, was a tragedy. It does not follow, however, that the risks of nevirapine will always outweigh the benefits, or that the drug is never a good treatment. HIV is a potentially fatal virus, and some of the treatments capable of holding it in check have dangerous side effects (as is also true of some anticancer regimens, such as chemotherapy). It should also be noted that Farber’s claim that Hafford did not have AIDS or was not HIV positive is not substantiated.
Farber’s treatment of HIVNET 012 is equally cavalier. She writes, “Although HIVNET was designed to be a randomized, placebo-controlled, double-blind, Phase III trial of 1,500 mother/infant pairs, it wound up being a no-placebo, neither double- nor even single-blind Phase II trial of 626 mother/infant pairs.” She implies that this degradation in standards occurred because the Ugandans were corrupted by “the lucrative promise of AIDS drug research” and is scandalized that the results of the study were “received rapturously.” She concludes, “With the results of the study now published in The Lancet, Boehringer [a German pharmaceutical company]…pressed for FDA approval to have nevira-pine licensed for use in preventing the transmission of HIV in pregnancy.”
By implication, therefore, HIVNET led to the death of Joyce Ann Hafford.
Most of these claims are false or misleading. HIVNET 012 was, in fact, a randomized, single-blind phase III trial – that is, a trial primarily designed to study the efficacy of a new drug (in this case, nevirapine), where patients randomly receive either the new drug or the standard treatment for a disease (here, AZT). It was not double blind, because the drug administration procedures were different in the two arms of the trial; but while phase III trials are, ideally, double blind, the FDA does not absolutely require them to be. Similarly, placebos, while desirable, are not strictly necessary to yield scientifically valid trial results. In the case of HIVNET 012, hospital clinicians resisted giving patients placebos, allowing AZT to stand in their place for purposes of control: they wanted to provide treatments to sick people.