Healthy Skepticism Library item: 15398

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Publication type: news

Stephens J.
Pfizer Reaches Settlement In Nigerian Drug-Trial Case
The Washington Post 2009 Apr 4
http://www.washingtonpost.com/wp-dyn/content/article/2009/04/03/AR2009040301877.html

Full text:

Pfizer has reached a broad agreement to pay millions of dollars to Nigeria’s Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic.

The details remain private, but sources close to the negotiations said the total payments — including those to the children, their families, the government and the government’s attorneys — would be about $75 million under the current settlement terms. Other details, including how the money will be distributed, are to be worked out within weeks.

Nigerian authorities say Pfizer’s infamous trial of the antibiotic Trovan killed 11 children and disabled scores more. The world’s largest drug company says the deaths and injuries were the result of meningitis.

“It is a good, solid agreement,” Aliyu Umar, attorney general for Kano state, said of the settlement, declining to discuss its size. “I wouldn’t call it a victory as such. When you negotiate and reach an amicable agreement, it means both parties need to give and take.”

Nigerian lawyers close to the negotiations, held over the past year in Nigeria, London and Dubai, told The Washington Post that Pfizer set a number of conditions, specifics of which remain undisclosed.

In 2007, Nigeria’s federal government and the state of Kano filed four civil and criminal actions against Pfizer and 10 individuals, including former Pfizer chief executive William C. Steere Jr. The actions sought $9 billion in restitution and damages, and included 31 criminal counts, including homicide.

“We have made good progress in the negotiations,” Pfizer said in a formal statement issued yesterday from its corporate headquarters in New York. “There are still several important issues that need to be resolved before a final agreement can be reached.”

An attorney for the Nigerian government who spoke on the condition of anonymity said a sticking point in recent negotiations was Pfizer’s request that authorities absolve the company of wrongdoing.

Pfizer defended its drug trial in a 2007 statement, saying it was conducted safely, legally and “with the full knowledge of the Nigerian government.” The company said Trovan demonstrated the highest survival rate of any treatment at the field hospital.

The case has been watched closely by medical ethicists as well as legal experts; it represents a rare instance in which the developing world’s anger at multinational corporations has boiled over into criminal charges.

Details of the drug trial were first made public more than eight years ago in a Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter. Researchers also gave children substandard doses of a comparison antibiotic, the articles added.

The articles sparked street demonstrations and demands for reform in Nigeria. The nation’s health minister appointed experts to investigate, but their final report was suppressed.

Five years later, in May 2006, The Post obtained and published the Health Ministry’s report, which concluded that Pfizer had violated Nigerian and international law.

Pfizer’s experiment was “an illegal trial of an unregistered drug,” the Nigerian panel concluded, and a “clear case of exploitation of the ignorant.”

The disclosure of the commission’s findings set in motion the criminal investigation. “The people in the federal Justice Ministry had no idea about this,” said Babatunde Irukera, an attorney for the ministry. “People in government at that point said, ‘Oh my God, we have to deal with this.’ “

Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.