# \[e-drug\] Drug company sued over research trial in Nigeria **URL:** \ **Category:** e-drug\ **Created:** [September 10, 2001, 7:15pm UTC](https://talk.edrugplus.org/t/e-drug-drug-company-sued-over-research-trial-in-nigeria/12378 "2001-09-10T19:15:58Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![e-drug2](https://avatars.discourse-cdn.com/v4/letter/e/8dc957/32.png) [@e-drug2](https://talk.edrugplus.org/u/e-drug2)\ **Post date:** [September 10, 2001, 7:15pm UTC](https://talk.edrugplus.org/t/e-drug-drug-company-sued-over-research-trial-in-nigeria/12378/1 "2001-09-10T19:15:58Z")
E-drug: Drug company sued over research trial in Nigeria ------------------------------------------------------------------------- [This clinical trial was discussed on E-drug some time ago. Pfizer has now been sued. Copied as fair use. KM] Lancet 2001; 358: 815 (8 September 2001) Drug company sued over research trial in Nigeria A group of Nigerian families has taken legal action against the pharmaceutical company, Pfizer. The lawsuit, which was filed in a US court on Aug 29, claims that the families' children were entered into a trial of Pfizer's Trovan (trovafloxacin) for bacterial meningitis in 1996 without informed consent. The families accuse the US-based drug company of violating "international law, federal regulations and medical ethics, in its zeal to carry out its test". Pfizer gave the children a "new, untested and unproven drug without first obtaining their informed consent, or explaining to the children or their parents that the proposed treatment was experimental and that they were free to refuse it and instead choose the safe, effective treatment for bacterial meningitis offered at the same site, free of charge, by a charitable medical group", according to the lawsuit. Responding to the suit, Pfizer maintained that the Trovan trial had been approved by the Nigerian government and that consent of the families of participants had been obtained. The study "was an important clinical investigation, and Pfizer is proud of the way the study was conducted, in the midst of a deadly meningococcal meningitis epidemic", a statement said. The statement added: "The study was well conceived, well executed and saved lives". "We stand by our statement", Pfizer's Bob Huber told The Lancet. In 1996, when Nigeria's Kano city was in the grip of concurrent epidemics of meningitis, cholera, and measles, Pfizer sent researchers to the Infectious Disease Hospital in Kano to test Trovan. In Kano, the non-governmental organisation, M�decins Sans Fronti�res (MSF) was using chloramphenicol to treat people with meningitis. The lawsuit contends that Pfizer assigned 100 children Trovan and 100 controls a lower than recommended dose of ceftriaxone. "Pfizer took the opportunity presented by the chaos caused by the civil and medical crises in Kano to accomplish what the company could not do elsewhere--to quickly conduct on young children a test of the potentially dangerous antibiotic Trovan", stated the lawsuit. "This [the launch of Pfizer's trial] created a great deal of friction between MSF and Pfizer", says MSF's Jean-Michel Piedagnel, who as a member of the MSF mission to Nigeria in 1996 witnessed part of Pfizer's operations during the outbreak. "The introduction of a new treatment protocol by Pfizer created serious problems for health workers managing the cases in the ward. Therefore we asked Nigeria's ministry of health to intervene", he said. To diffuse the situation, the ministry gave a separate ward to Pfizer, he added. Pfizer said: "the fatality rates in the Kano study, approximately 6% for both Trovan and ceftriaxone, were lower than published results for other forms of treatment in this epidemic." But, the suit alleges that the deaths and injuries among controls were the result of a lower than recommended dose of ceftriaxone. The case was raised by the Washington Post last year and sparked widespread anger in Nigeria and abroad. According to ethicist Arthur Caplan (Center for Bioethics, University of Pennsylvania, PA, USA) the Trovan case represents yet another in a growing list of controversial experiments involving western pharmaceutical companies doing research in very poor nations. "Given that the twin protections of informed consent and [intitutional review board] review are under attack as inadequate for protecting the interests of subjects in the developed world, it is very unlikely that these protections, or weaker versions of them, will suffice in the underdeveloped world", he argued. He added that inadequate attention had been paid to the moral duties incumbent on those doing research in poor nations and warned that until remedial measures are taken, more and more Trovan-type cases could be expected to be brought. The Trovan trial supports the veracity of the international concerns that developing countries will merely be used as test areas for medical treatments designed for developed countries, adds Charles Weijer (Dalhousie University, Halifax Nova Scotia, Canada). International law, he said, requires that research done in developing countries be reviewed by both host and sponsor country, as well as upholding requirements for informed consent. "The comparison of Trovan to a low dose of ceftriaxone violates the central requirement of the Declaration of Helsinki by knowingly exposing children in need of treatment to inferior therapy", Weijer added. The new Declaration of Helsinki (2000) specifically requires that "the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods". Weijer called on the international community to guard against the exploitation of developing countries, and ensure that all research participants receive equal protection. "The pharmaceutical industry has, as illustrated in this case, demonstrated its willingness to exploit the vulnerable." Khabir Ahmad -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. 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