Healthy Skepticism Library item: 14666

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Perlroth N.
Pfizer's Nigerian Nightmare
Forbes.com 2008 Aug 8
http://www.forbes.com/business/forbes/2008/1208/066.html?feed=rss_business

Abstract:

After years of legal maneuvering, Pfizer may soon face its Nigerian guinea pigs in court.

Full text:

What if a drug company experimenting on critically ill children doesn’t get the proper parental consent, 11 of those children die and a whistleblower is fired?

Those are the charges leveled against Pfizer in a legal battle that has dragged on for the past seven years in Manhattan federal court and in Nigeria, where the government is seeking $8.5 billion in restitution and damages—and jail terms for various Pfizer officials, including former chief executive William Steere.

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Things may come to a head soon. A federal appeals court is expected to rule on whether the children’s parents can go after Pfizer in New York. Meanwhile, to avoid what’s shaping up to be an ugly court battle, Pfizer is said to have offered to settle with the Nigerian government for $150 million, plus money to modernize and equip a Nigerian infectious disease hospital.

Pfizer says the children died from the disease, not from the drug trial, won’t confirm a possible settlement, and says it’s “proud” of its role during the 1996 epidemic, an ugly trifecta of meningitis, cholera and measles. Twelve thousand Nigerians died from meningitis alone, many of them children.

What really happened at a remote sub-Saharan hospital in Kano, Nigeria may never be known. But interviews with Pfizer employees, parents of some of the victims, Food & Drug Administration officials, court filings and other legal documents provide an unsettling look at the pitfalls of doing hurried drug trials in Third World countries.

That’s happening more often these days. Under pressure to reduce research costs and win fast-track approvals, drug companies do 43% of their clinical trials abroad, up from 14% ten years ago. The Tufts Center for the Study of Drug Development says that number will rise to 65% within three years.

Roll the tape back to the spring of 1996. Outside the cluster of cinder block structures that make up Kano’s Infectious Diseases Hospital, hundreds of sick children are lined up, awaiting treatment from Doctors Without Borders, the nonprofit group, which has set up a tent on hospital grounds.