Interesting read about big pharma



http://www.spiked-online.com/index.p...e/article/924/

Pfizer Clinical Trial Foreshadowed 'The Constant Gardener'
By Brandon Keim May 30, 2007

Details of the clinical trial that prompted the Nigerian lawsuit against Pfizer are eerily similar to The Constant Gardener, a John le Carré novel-based 2005 film about one couple's fight against a transnational drug company's exploitation of poor Kenyans. The parallel has been widely noted, most eloquently by former New England Journal of Medicine editor Marcia Angell, who reviewed the film in the New York Review of Books.

"The story is based on the premise that a pharmaceutical company would be so threatened by disclosures of its activities that it would have someone killed," wrote Angell. "In fact, many of the practices that so horrified le Carré's heroine are fairly standard and generally well known and accepted."

She goes on to discuss Pfizer's trial in Kano, then suffering from an epidemic of bacterial meningitis at the same time as Pfizer was seeking FDA approval for a new meningitis drug. Hoping to show that the drug, Trovan, was as effective for children in pill form as traditionally-used fast-acting intravenous antibiotics, Pfizer's doctors gave Trovan to 200 children. A control group received the antibiotic. After two weeks, an equal number had died, suggesting that the new drug worked as well as the old one. Pfizer then asked the FDA to approve Trovan for children with meningitis.

Those are the bare outlines of what happened. But critics such as Médecins Sans Frontières, the Nobel Prize– winning international medical relief organization, charge that this was exactly the sort of study that would not have been permitted in the United States. To these critics, it was unethical to test an experimental drug orally in the midst of an epidemic. The usual treatment for meningitis in such urgent conditions would be intravenous antibiotics. In fact, the Pfizer doctor who organized the study told The Washington Post that antibiotics "would never be used like that in the United States. The standard is IV therapy." It was also charged that there had not been adequate preliminary research into how Trovan is absorbed and metabolized by children or how effective it is against meningitis.

Furthermore, to lessen the pain of injections, the dose of intravenous ceftriaxone given for comparison was much smaller than originally planned. But if the dose of the comparison drug were inadequate, that would make Trovan look better than if it were compared with a full dose of ceftriaxone. Pfizer maintained that the smaller dose was still more than sufficient, but the medical director of Hoffmann-La Roche, the manufacturer of ceftriaxone, was quoted as saying, "A high dose is essential."

The Body Hunters [New York Review of Books]