ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com
Court Rules Nigerian Case Against Pfizer Can Move Forward In US
The exploitation of disadvantaged children--including babies--in drug and vaccine trials--without legal informed consent--is a moral travesty.
The U.S. Court of Appeals for the 2nd Circuit in New York has overruled a lower-court judge and allowed the (close to a decade old) case against Pfizer by Nigerian parents, to move forward in US courts.
This ruling occurs nine years after Joe Stephens of The Washington post brought to light the findings of a year long investigation of a morally indefensible experiment in which Pfizer exploited a 1996 meningitis epidemic to test its "new, untested and unproven" antibiotic, Trovan, on 200 children without parental consent.
Eleven children died in the experiment and others whose children suffered brain damage as a result. The parents have persevered all these years in their effort to obtain just compensation.
Trovan was never approved for use by American children. The FDA 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.
In Nigeria, Pfizer is the target of criminal and civil legal actions.
Authorities are seeking damages of more than $8 billion.
In 2006, a panel of Nigerian medical experts concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital.
While the ruling in New York has no direct effect on the Nigerian actions, lawyers in the case said it could complicate long-running settlement negotiations there.
Another case involving the exploitation of children in foster care tested AIDS drugs and vaccines without legal consent -- in some cases without the approval of an institutional review board, in other instances in defiance of IRB disapproval--is stymied by the refusal of the NYS Department of Health to make the children's medical clinical trial records accessible to the Vera Institute of Justice which was commissioned by the NYC Administration for Children's Services. See "THE EXPERIENCES OF NEW YORK CITY FOSTER CHILDREN IN HIV/AIDS CLINICAL TRIALS, January 2009, Full Report, Executive Summary
Background information Re: Pfizer-Nigerian Experiment
May 7, 2006: Joe Stephens. Panel Faults Pfizer in '96 Clinical Trial In Nigeria Unapproved Drug Tested on Children
Washington Post, A01
Jan. 10, 2008, Pharmalot reported: "A federal High Court in Abuja yesterday issued a warrant of arrest for eight former directors of a pharmaceutical giant, Pfizer Specialties Ltd, AllAfrica.com reports. Those affected were directors who were on the board of the subsidiary when a controversial
Trovan clinical trial took place in Kano in which over 200 persons, mostly children, died allegedly as a result of the unapproved trial."
Background information Re: NYC Forster children:
March 2004, AHRP complaint:
May 5, 2004: The Associated Press report, Researchers Tested AIDS Drugs on Children
by John Solomon
Feb. 2006: OHRP letter
Contact: Vera Hassner Sharav
Suits Saying Pfizer Experimented on Nigerian Children Are Revived
By Joe Stephens
Saturday, January 31, 2009; A07
A federal appeals court on Friday revived two lawsuits brought against Pfizer by Nigerian families who say the giant drugmaker used their children in an illegal test of an experimental antibiotic.
The U.S. Court of Appeals for the 2nd Circuit in New York ruled that the suits, dismissed earlier by a lower-court judge who said they should have been brought in Nigeria, can now go forward in the U.S. courts. Lawyers said the ruling could set a precedent affecting other American companies accused of wrongdoing overseas.
The lawsuits seek unspecified damages on behalf of the families, who say Pfizer violated international law by testing the drug, known as Trovan, on perilously ill children without their knowledge. Eleven children died during the 1996 clinical trial, carried out during a record meningitis epidemic. Other children developed brain damage and crippling arthritis.
"This is a home run for us," said Richard P. Altschuler, an attorney for the families. "The judges are making a statement. They are telling companies, 'If you go overseas, justice will come back to the United States.' "
Pfizer also is the target of criminal and civil legal actions in Nigeria, where authorities are seeking damages of more than $8 billion. While the ruling in New York has no direct effect on the Nigerian actions, lawyers in the case said it could complicate long-running settlement negotiations there.
Pfizer issued a statement dismissing the court action as "only a procedural ruling." "It is not a determination on their merits," the statement said. "Indeed, the strong dissent by one of the judges may be grounds for further appellate proceedings. Pfizer remains confident that it will prevail in these cases, and is weighing its options on how to best respond to this decision."
Pfizer said the clinical study was conducted with the approval of the Nigerian government and the consent of the participants' parents or guardians. The trial violated no international or Nigerian laws, the company said.
The experiment came to light in December 2000, when The Washington Post published a lengthy examination of the trial. It found that Pfizer carried out the experiment on 200 children at a makeshift epidemic camp in the Nigerian town of Kano. The articles reported that Pfizer had no signed consent forms for the children and relied on a falsified ethics approval letter to defend the design of the experiment.
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.