"I think it borders on the criminal that the large pharmaceutical companies, both here and in Europe, are using these poor, illiterate and uninformed people as guinea pigs."
Congressman Tom Lantos of the International Relations Committee
Pfizer Faulted-1996 Clinical Trials In Nigeria: Unapproved Drug Tested On Kids_WashPos
Tuesday, 09 May 2006
"The Washington Post reveals that a shocking secret investigative report by a Nigerian government panel of medical experts concluded that Pfizer Pharmaceuticals conducted an unethical drug experiment in Nigeria in 1996.
For those who thought the film, The Constant Gardner, based on the book by John LeCarre, overstated the criminal conduct engaged in by pharmaceutical companies, a front page report by Joe Stephens of The Washington Post (below) should disabuse them of their innocence.
The secret report (obtained by The Post through a whistleblower) stated that:
"Pfizer never obtained authorization from the Nigerian government to give the unproven drug [Trovan] to nearly 100 children and infants."
According to the report, "five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evidence the drug played a part. Six children died while taking a comparison drug."
At the time of the experiment, Doctors Without Borders was dispensing approved antibiotics at the hospital; parents were not informed their children were given an experimental antibiotic rather than an approved drug; and the report determined that Pfizer later “concocted and backdated” an approval letter from a Nigerian ethics committee.
The Post reports: “The report said the treatment of two children during the experiment represented unspecified "serious deviations" from the trial's protocol and concluded that those deviations compromised their care. One was a 10-year-old girl identified only as Patient No. 0069, who was given the experimental antibiotic for three days as her condition deteriorated. She died without receiving any other antibiotic.”
Congressman Tom Lantos of the International Relations Committee, said: "I think it borders on the criminal that the large pharmaceutical companies, both here and in Europe, are using these poor, illiterate and uninformed people as guinea pigs."
Until now, a group of 30 Nigerian parents, represented by a U.S. law firm, Milberg Weiss Bershad & Schulman, failed to obtain justice in a U.S. court. They were rebuffed by a federal court that inconceivably denied it had jurisdiction over a U.S. company that is required by U.S. law to comply with federal research regulations here and abroad.
The Post reports: “Pfizer had told authorities that a Nigerian doctor directed the experiment. The committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the principal investigator "only by name."’
This report has been concealed for five years—a demonstration that pharmaceutical company giants like Pfizer can buy silence and burry their crimes. Indeed, a report in the Baltimore Sun (excerpt below) reveals that industry wide corruption has cost pharmaceutical companies $3.5 billion in fines since 2001. The evidence was brought to public light by whistleblowers who are protected under the False Claims Act of 1863.
The Pfizer-Nigeria case—with its international ramifications--should move Congress to put legal brakes on the despicable activities engaged in by U.S. pharmaceutical companies—both in the U.S. and offshore. The Nigerian report state that Pfizer: “violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.”
In 2005, Constitutional lawyer, John Whitehead, of the Rutherford Institute, put such unethical experiments in their appropriate context:
“Inevitably, when we hear about humans being experimented on, our minds turn to the Auschwitz concentration camp and the infamous Nazi Angel of Death, Josef Mengele. Seen as immoral and scientifically dubious, Mengele’s work included placing human beings in pressure chambers, freezing them to death, testing drugs on them and castrating them. He also injected children with lethal germs, removed their organs and limbs and performed sex change operations on them. His primary interest was twins. The Nuremberg Code, created as a reaction to the horrors of Mengele’s work, provided directives for human experimentation to protect the experimental subject from even remote possibilities of injury, disability, or death. Above all else, the Code stressed that it is necessary to obtain voluntary, informed consent from the patient.
Despite the existence of this code and subsequent medical ethics codes, Mengele’s legacy lives on. This time, the culprit is none other than the United States government through its involvement in numerous questionable and immoral human research programs. Lest you think that the scientific community and government agencies would not carry out immoral experiments on humans, particularly children, think again.”"
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