Fwd: Suits Saying Pfizer Experimented on Nigerian Children Are Revived

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe exploitation of disadvantaged children--including babies--in drug andvaccine trials--without legal informed consent--is a moral travesty.The U.S. Court of Appeals for the 2nd Circuit in New York has overruled alower-court judge and allowed the (close to a decade old) case againstPfizer by Nigerian parents, to move forward in US courts.This ruling occurs nine years after Joe Stephens of The Washington postbrought to light the findings of a year long investigation of a morallyindefensible experiment in which Pfizer exploited a 1996 meningitis epidemicto test its "new, untested and unproven" antibiotic, Trovan, on 200 childrenwithout parental consent.Eleven children died in the experiment and others whose children sufferedbrain damage as a result. The parents have persevered all these years intheir effort to obtain just compensation.Trovan was never approved for use by American children. The FDA approved itfor adults in 1998 but later severely restricted its use after reports ofliver 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 unapproveddrug 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 settlementnegotiations there.Another case involving the exploitation of children in foster care testedAIDS drugs and vaccines without legal consent -- in some cases without theapproval of an institutional review board, in other instances in defiance ofIRB disapproval--is stymied by the refusal of the NYS Department of Healthto make the children's medical clinical trial records accessible to the VeraInstitute of Justice which was commissioned by the NYC Administration forChildren's Services. See "THE EXPERIENCES OF NEW YORK CITY FOSTER CHILDRENIN HIV/AIDS CLINICAL TRIALS, January 2009, Full Report:http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdf; Executive Summary:http://www.vera.org/publication_pdf/clinicaltrials-execsum.pdfBackground information Re: Pfizer-Nigerian ExperimentMay 7, 2006: Joe Stephens. Panel Faults Pfizer in '96 Clinical Trial InNigeria Unapproved Drug Tested on Children Washington Post,  A01http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338_pf.htmlJan. 10, 2008: Pharmalot reported: "A federal High Court in Abuja yesterdayissued a warrant of arrest for eight former directors of a pharmaceuticalgiant, Pfizer Specialties Ltd, AllAfrica.com reports. Those affected weredirectors who were on the board of the subsidiary when a controversialTrovan clinical trial took place in Kano in which over 200 persons, mostlychildren, died allegedly as a result of the unapproved trial."http://www.pharmalot.com/2008/01/nigeria-seeks-arrests-in-pfizer-trovan-case/~~~~~~~~Background information Re: NYC Foster children:March 2004: AHRP complaint: http://www.ahrp.org/ahrpspMay 5, 2004: The Associated Press report, "Researchers Tested AIDS Drugs onChildren"by John Solomon, http://www.ahrp.org/infomail/05/05/04.phpFeb. 2006: OHRP letter at:http://www.hhs.gov/ohrp/detrm_letrs/YR06/feb06a.pdfContact: Vera Hassner Sharavveracare212-595-8974http://www.washingtonpost.com/wp-dyn/content/article/2009/01/30/AR2009013003432_pf.htmlWashington PostSuits Saying Pfizer Experimented on Nigerian Children Are RevivedBy Joe StephensSaturday, January 31, 2009; A07A federal appeals court on Friday revived two lawsuits brought againstPfizer by Nigerian families who say the giant drugmaker used their childrenin an illegal test of an experimental antibiotic.The U.S. Court of Appeals for the 2nd Circuit in New York ruled that thesuits, dismissed earlier by a lower-court judge who said they should havebeen brought in Nigeria, can now go forward in the U.S. courts. Lawyers saidthe ruling could set a precedent affecting other American companies accusedof wrongdoing overseas.The lawsuits seek unspecified damages on behalf of the families, who sayPfizer violated international law by testing the drug, known as Trovan, onperilously ill children without their knowledge. Eleven children died duringthe 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 thefamilies. "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 theruling in New York has no direct effect on the Nigerian actions, lawyers inthe case said it could complicate long-running settlement negotiationsthere.Pfizer issued a statement dismissing the court action as "only a proceduralruling.""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 appellateproceedings. 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 theNigerian government and the consent of the participants' parents orguardians. The trial violated no international or Nigerian laws, the companysaid.The experiment came to light in December 2000, when The Washington Postpublished a lengthy examination of the trial. It found that Pfizer carriedout the experiment on 200 children at a makeshift epidemic camp in theNigerian town of Kano. The articles reported that Pfizer had no signedconsent forms for the children and relied on a falsified ethics approvalletter to defend the design of the experiment.Trovan was never approved for use by American children. The Food and DrugAdministration approved it for adults in 1998 but later severely restrictedits use after reports of liver failure. The European Union banned the drugin 1999.FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. 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