Item #36: Was Indinavir Approved Without a Clinical Trial?

Anti-HIV drugs such as Crixivan were approved in as little as six weeks, and cast as a triumph of AIDS activism. This pattern of jettisoning standard experimental controls has continued up to the present

Immediately after making the above statement, Farber creates the same impression about indinavir. Though she does not explicitly state it was not tested, readers are left with this impression.

The FDA based its registration of this medicine on two controlled trials.61

According to a March 8, 1996 FDA press release [1] Indinavir (aka Crixivan) was approved after “The committee primarily discussed two controlled clinical trials…[that] involved a total of 490 patients and studied one group receiving indinavir alone, another group receiving the drug in combination with AZT, and a third group treated with just AZT. The committee also discussed the data from a small study that evaluated indinavir in combination with two nucleoside analogues, AZT and 3TC.”
These trials were extremely short term (6 months) and measured only surrogate markers: “Patients’ CD4 cell counts…and viral load…were monitored to determine the drug’s effectiveness for 24 weeks of study. Clinical data presented at the advisory committee meeting indicated that patients in the indinavir-only and combination therapy arms experienced a marked increase in their CD4 levels and had a marked decrease in their viral load.”
Without proving that Indinavir was better than nothing (a placebo), without long term safety data, and without any proof that the drug would reduce disease and extend life the FDA noted that “Based on this data, the committee recommended that indinavir be granted accelerated approval”.

1. FDA Panel Recommends Approval of Third Protease Inhibitor. FDA. 1996 Mar 8.