Life Imitating Art Imitating Life

The Constant Gardener, a 2005 film adaptation of the similarly named novel, has become a pop culture referent for what many believe to be the pharmaceutical industry's entrenched greed and duplicity - particularly in regards to outsourcing clinical trials. But, fiction may no longer be needed to make this point.

Nigeria recently filed suit against Pfizer for the questionable clinical trials it ran on hundreds of Nigerian children during the country's 1996 meningitis epidemic. At the center of this scandal is Trovan, an antibiotic that was then under development by Pfizer. Meningitis is typically treated intravenously with antibiotics. What makes Trovan unique - and profitable - is that it is administered orally.

When meningitis broke out in Kano, a northern Nigerian city, Pfizer quickly obtained local and federal consent to test the drug within the affected population. Two hundred children were enrolled in the study; half were given Trovan, the other half antibiotic injections. After two weeks, an equal number of children died in each group, grounding Pfizer's claim that Trovan is just as effective as the traditional therapy and propelling its application for FDA approval.

Pfizer's behavior has been heavily criticized over the past decade; Doctors Without Borders, the international medical relief agency, argues that this is the exact type of clinical trial that would not be allowed in the United States. They may have a point. Running a clinical trial in the middle of an epidemic is ethically dubious at best, particularly when a known treatment is available. To drive this point home a bit further, Trovan was not being tested for possibly improving outcomes - only for possibly improving convenience, e.g. oral vs. intravenous administration. This is not insignificant; convenience can translate into improved accessibility which can save many lives. The issue, however, is whether these types of considerations should be tested in the midst of a deadly outbreak.

Even more questionable is the fact that the Trovan comparison group given antibiotic injections received smaller-than-normal dosages. Some think that less than altruistic motivations may have been behind this. Smaller dosages may have led these injections to be less effective than standard treatments, making it easier for Pfizer to claim that Trovan is statistically equivalent to traditional therapies.

Pfizer denies these claims. Hopefully, a fairly litigated suit will unearth what really happened.