Pfizer Case Over Test That Killed 11 Kids Could Blow the Lid Off Foreign Drug Trials

The U.S. Supreme Court's decision to send the Pfizer (PFE) Trovan case to trial threatens to do the one thing the pharmaceutical industry most wishes won't happen: Reveal to Americans exactly how foreign drug trials are unregulated, sometimes dangerous and often unreliable.

The seemingly endless Trovan case involves Pfizer's test of a meningitis drug on 200 children in Kano, Nigeria, in 1996. Pfizer failed to get proper consent for the trial. Eleven kids died and the drug was eventually nixed because it was too dangerous. The events may have inspired the book and film, The Constant Gardener. Pfizer has attempted to do the right thing in recent years by settling the case for $75 million, but it's been stymied by local bureaucracy and corruption.

One friend-of-the-court brief filed in support of Pfizer was from the Washington Legal Foundation. Why might this conservative legal think tank have a sudden interest in the intricacies of the Alien Tort Statute (the law at stake in the Supreme Court appeal)? All will be revealed ...

The case coincides with an investigation of the FDA's lack of supervision of drug trials on foreigners conducted by the Office of the Inspector General. It found that the FDA looks at only 1 percent of trials conducted outside the U.S. The trial data are then used to convince the FDA to approve medicines which are taken by Americans.

Other disconcerting facts about the U.S. drug industry's use of foreign resources include:

• The FDA only has two people inspecting drug factories in all of China.
• Trials done in Russia and other Eastern hemisphere countries often can't be replicated back in the U.S. One analyst has suggested that foreign clinicians have "uncertain credibility."
• The New England Journal of Medicine suggested last year that foreign drug trials could hurt U.S. patients because foreign test subjects may have different genetic or environmental responses to drugs. The journal also noted that foreign trials were plagued by ethical dilemmas, as they often recruit poor, uneducated patients who lack other healthcare alternatives.

Some of that mess was hinted at in the Second Circuit Court of Appeal's decision on the case. It turns out that a Pfizer doctor may be a whistleblower in the case, who balked at the Trovan trials when his coworkers began faking their paperwork:

At the time, Pfizer also claimed to have secured approval from an IDH [Nigeria's Infectious Disease Hospital] ethics committee. Appellants allege, however, that the March 1996 approval letter was backdated by Nigerian officials working at the government hospital well after the experiments had taken place and that at the time the letter was purportedly written, the IDH had no ethics committee. Appellants also contend that the experiments were condemned by doctors, including one on Pfizer's staff at the time of the Kano trial.

A Nigerian physician who was the principal investigator for the test allegedly admitted that his office created the backdated approval letter when the FDA conducted an audit of the experiment in 1997.

Related:

• Lesson from an Alzheimer-Drug Failure: Beware Russian Clinical Trial Data
• Why Pfizer Is Emerging as the Good Guy in Drug Tests That Killed 11 Children
• India to Regulate Clinical Drug Trials by Foreign Companies
• NEJM: Foreign Drug Trials Could Hurt U.S. Patients
• FDA Has Only 2 Inspectors Watching Drug Factories in China
• PhRMA's New Clinical Trial Guidelines Leave Plenty of Room for Maneuver
• Body Count Linked to GSK Vaccine Trial Rises