A Peek Behind the Foreign Drug Trial Curtain

From the ‘truth is as strange as fiction’ department, comes this story of a foreign drug trial gone wrong. Looks like the subject of multinational pharmaceutical companies farming their clinical trials out to research facilities in foreign countries is going to be a hot topic for awhile.

the passages below are from Jim Edwards’ Pharma blog at BNET

The U.S. Supreme Court’s decision to send the Pfizer(PFE) Trovan case to trialthreatens 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…

…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…

much more via … Could Blow The Lid Off Foreign Drug Trials


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