-Caveat Lector- Children Used as Guinea Pigs By U.S. Company By Toye Olori LAGOS, Jan 9 (IPS) - A recent report by a U.S. newspaper that a major international pharmaceutical company carried out unapproved tests of a risky drug on Nigerian children which led to tragic consequences, has put the company on a firing line in Nigeria. The report, by the Washington Post, said Pfizer, the American pharmaceutical company, in 1996 carried out the clinical test that led to the death of 11 Nigerian children and the deformation of 200 others. The drug, ''Trovan Floxacin'', was developed for the treatment of meningcocal meningitis, a form of Cerebro-Spinal Meningitis (CSM) which ravages part of northern Nigeria during the hot season. Nigeria has two weather conditions - dry season and rainy season. Unconfirmed reports say Pfizer did not obtain the approval of the Food and Drug Administration, the agency which regulates pharmaceutical products in the United States, before embarking on on the test. ''The action of Pfizer is most detestable,'' says Peter Ebigbo of ChildRights Africa, a Network for the Prevention and Protection against Child Abuse and Rights. ''Our leaders must not allow Nigerians to be used as guinea pigs by any company to make money. We must now begin to claim back our rights. My organisation will look into it and come up with an appropriate statement on the issue,'' says Ebigbo. Medical experts in Nigeria believe there was gross abuse of professional ethics as internationally accepted standards seemed to have either been poorly enforced or completely ignored. They argued that the patients and their families were not adequately educated on the parameters of the test and its possible consequences. In its first official reaction, contained in a statement released in Lagos over the weekend, Pfizer maintained that approval was received from all appropriate agencies before trial was carried out for its test on CSM patients at the Infectious Disease Hospital in Kano. The statement, signed by the Pharmaceutical Division Director and Medical Director of Pfizer Specialities, Lere Baale and Segun Dogunro respectively, expressed shock at the report which they described as lopsided. ''It is unimaginable that a company like ours would be involved in a clinical trial without the approval of the appropriate agencies. Indeed relevant agencies and government bodies were fully involved in our drive to save lives during the crisis,'' the statement said. It added that only 90 CSM patients were treated with Trovan during the trial while another 97 were treated with the company's Cefiriaxone which is the gold standard for the CSM treatment even in the United States. But, Sadiq Wali, Chief Medical Director of the Aminu Kano Teaching Hospital (AKTH), has denied that the hospital's medical ethics committee gave approval to Pfizer to use the drug at the Infectious Diseases Hospital in Kano. He says for any pharmaceutical company to get approval to test any drug, it must get the approval of a local ethics committee in the community made up of senior medical personnel and members of the community where the test would be carried out. ''Pfizer did not do that. I am not sure if they had the consent of the people used as guinea pigs, because that means informed consent in medical parlance. Such consent has to do with the patients being told the good as well as the side effects of the drugs to be administered'', he says. The Kano State government has instituted a probe into the matter. While inaugurating a three-man team mandated to investigate the issue, Commissioner for Health, Dr. Mansur Kabir, said the ministry was appalled by the news reports on the trial of the CSM drug. He warned that anybody indicted by the committee expected to submit its report within a week, would be made to face the full wrath of the law no matter his position in the society. Getting proper records would, however, not be easy. Reports from Kano say the medical records of 350 CSM patients, who were treated between April and June 1996, had disappeared from the hospital. So far, the growing public pressure appears to be forcing the government to take action against the company. A Ministry of Health memorandum on award of contracts for the supply of CSM vaccines this year shows that 11 pharmaceutical companies would supply 33 million doses of the vaccine valued at 9 million dollars, but Pfizer's name was conspicuously missing from the list. <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance—not soap-boxing—please! 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