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African Traditional Herbal Research ClinicVolume 1, Issue 12 NEWSLETTER December 2006FEATURED ARTICLESPfizer Faulted over Drug Trials in NigeriaReport cites use of unproven drug on African children in mid ’90sBy Joe Stephens, The Washington PostMay 7, 2006A panel of Nigerian medical experts has concluded thatPfizer Inc. violated international law during a 1996epidemic by testing an unapproved drug on children withbrain infections at a field hospital.That finding is detailed in a lengthy Nigerian governmentreport that has remained unreleased for five years, despiteinquiries from the children's attorneys and from themedia. The Washington Post recently obtained a copy ofthe confidential report, which is attracting congressionalinterest. It was provided by a source who asked to remainanonymous because of personal safety concerns.The report concludes that Pfizer never obtainedauthorization from the Nigerian government to give theunproven drug to nearly 100 children and infants. Pfizerselected the patients at a field hospital in the city of Kano,where the children had been taken to be treated for anoften deadly strain of meningitis. At the time, DoctorsWithout Borders was dispensing approved antibiotics atthe hospital.Accused of ‘exploitating the ignorant’Pfizer's experiment was "an illegal trial of an unregistereddrug," the Nigerian panel concluded, and a "clear case ofexploitation of the ignorant."The test came to public attention in December 2000,when The Post published the results of a year-longinvestigation into overseas pharmaceutical testing. Thenews was met in Nigeria with street demonstrations,lawsuits and demands for reform.Pfizer contended that its researchers traveled to Kanowith a purely philanthropic motive, to help fight theepidemic, which ultimately killed more than 15,000Africans. The committee rejected that explanation,pointing out that Pfizer physicians completed their trialand left while "the epidemic was still raging."The panel said an oral form of Trovan, the Pfizer drugused in the test, had apparently never been given tochildren with meningitis. There are no records indicatingthat Pfizer told the children or their parents that they werepart of an experiment. An approval letter from a Nigerianethics committee, which Pfizer used to justify its actions,actually was a falsified document that had beenconcocted and backdated by the company's leadresearcher in Kano, the report said.The panel concluded that the experiment violatedNigerian law, the international Declaration of Helsinkithat governs ethical medical research and the U.N.Convention on the Rights of the Child.Five children died after being treated with theexperimental antibiotic and others contracted arthritis,although there is no evidence the drug played a part. Sixchildren died while taking a comparison drug.Demand for sanctionsThe panel recommended that Pfizer be "sanctionedappropriately" and directed to issue "an unreservedapology to the government and people of Nigeria." Thecompany should also pay an unspecified amount ofrestitution, the report said. The panel recommended thatNigeria enact reforms to prevent a recurrence.Aspects of the affair remain mysterious, such as why thereport remains confidential. The head of the investigativepanel, Abdulsalami Nasidi, said in a brief telephoneconversation from Nigeria, "I don't really know myself"why the report was never released. an official who died."I did my job as a civil servant," said Nasidi, who isquoted in the report as saying he has been the target ofunspecified death threats.A New York City attorney for the families of thechildren, Elaine Kusel of Milberg Weiss Bershad&Schulman, said her firm had spent years looking for theContinued on page 8-6- Traditional African Clinic December 2006
Continued from page 7 – Pfizer Faulted over Drug Trials inNigeriareport, of which they believed there were only threecopies. They tracked one to a Nigerian government safe,but it was reported stolen, she said. Another copy wasreported to have been held by an official who died."It sounds like a mystery novel here, like John le Carré,"Kusel said.The current Nigerian health minister, Eyitayo Lambo, didnot respond to calls and e-mail messages from a reporter.Dora Akunyili, director of the Nigerian drug controlagency, said she did not know why the report remainedconfidential but added that her agency had independentlyconcluded that "these people did not have authority toconduct the trial."Pfizer responds to chargesExecutives at Pfizer, the world's biggest drug company,said they had not seen the report. After reviewing a copy,they responded in a two-page statement:"The Nigerian government has neither contacted Pfizerabout any of the committee's findings nor are we awarethat the committee has approved a final report. Thereforeit would be inappropriate for the company to respond tospecific points in the document."However, as we have stated repeatedly over the pastseveral years, Pfizer conducted this trial with the fullknowledge of the Nigerian government and in aresponsible way consistent with Nigerian law and Pfizer'sabiding commitment to patient safety."Pfizer said it had previously tested the drug in thousandsof patients and found it effective. Local nurses explainedthe experiment to Nigerian parents, it added, and obtainedtheir "verbal" consent. The company said that Trovandemonstrated the highest survival rate of any treatment atthe hospital."Trovan unquestionably saved lives, and Pfizer stronglydisagrees with any suggestion that the companyconducted its study in an unethical manner," thestatement said.At the time of the Nigerian experiment, Pfizer wasdeveloping Trovan for release in the United States, whereit was expected to gross up to $1 billion a year.The FDA never approved Trovan for use in treatingAmerican children. After being cleared for adult use in1997, the drug quickly became one of the most prescribedantibiotics in the United States. But Trovan was laterassociated with reports of liver damage and deaths,leading the FDA to severely restrict its use in 1999.European regulators banned the drug.Oversight of trial questionedAfter The Post published its report, Nigeria's healthminister at the time, Tim Menakaya, appointed a blueribbonpanel of medical experts to look into Pfizer'sactions, saying, "Let me assure you that my ministry willtake all necessary steps to obtain details of this incidentand make them known to the general public." Thecommittee collected hundreds of documents andinterviewed at least 26 people.Pfizer had told authorities that a local Nigerian doctordirected the experiment. The committee, however, foundthat researchers from Pfizer's U.S. office controlled thetrial, and the inexperienced Kano doctor, Abdulhamid IsaDutse, was the principal investigator "only by name."Publications listed Dutse as the lead author of articles onTrovan, but the committee found that depiction "did notsufficiently reflect his role." Dutse indicated he was keptin the dark about the experiment's results and said he didnot see at least one publication until the committeeshowed it to him."He was shocked that Pfizer could publish such datawithout showing him [the data] or intimating him withdetails," the report said, concluding that Dutse was "naiveand exploited."The report quoted Dutse as saying that Pfizer's motivewas far from philanthropic."I have trusted people and am disappointed," Dutse toldthe committee. "I regret this whole exercise, I wonderwhy on Earth I did this."Back-dated letter of approvalDutse admitted that he created a letter after theexperiment purporting to show that the test had beenapproved in advance by a Nigerian hospital's ethicscommittee. He then backdated the letter to March 28,1996 -- a week before Pfizer's experiment began.Pfizer used the letter as a key justification for the trial indiscussions with reporters and submitted it to the FDA.U.S. regulations require the sponsors of foreign medicalresearch seeking FDA approval to show that the testshave been reviewed in advance by an ethics committee.The Post previously reported that the hospital had noethics committee in March 1996 and that the letterheadstationery used was not created until months after theexperiment's conclusion.In a statement last week, Pfizer said that after that articleappeared, the company investigated and found that theletter was "incorrect."Continued on page 10-7- Traditional African Clinic December 2006
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