# \[e-drug\] Pfizer drug trial in Nigeria being investigated **URL:** \ **Category:** e-drug\ **Created:** [January 16, 2001, 5:30am UTC](https://talk.edrugplus.org/t/e-drug-pfizer-drug-trial-in-nigeria-being-investigated/10069 "2001-01-16T05:30:52Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![myhr](https://avatars.discourse-cdn.com/v4/letter/m/f07891/32.png) [@myhr](https://talk.edrugplus.org/u/myhr)\ **Post date:** [January 16, 2001, 5:30am UTC](https://talk.edrugplus.org/t/e-drug-pfizer-drug-trial-in-nigeria-being-investigated/10069/1 "2001-01-16T05:30:52Z")
E-drug: Pfizer drug trial in Nigeria being investigated --------------------------------------------- Reprinted under the fair use doctrine of international copyright law: [http://www4.law.cornell.edu/uscode/17/107.html](http://www4.law.cornell.edu/uscode/17/107.html) Lancet, 357, 9250, 13 January 2001 Nigerian government investigates Pfizer drug trial allegations The Nigerian government has ordered an inquiry into a clinical trial by Pfizer in which the pharmaceutical company's researchers allegedly tested an "unapproved" meningitis drug, trovafloxacin, on patients from Kano in north Nigeria. The government's decision followed the alleged disappearance of medical records of more than 300 children from the Aminu Kano Teaching Hospital where the trial took place during a meningitis epidemic in 1996. Many of the missing records are believed to be of patients who received the drug. The case was raised by The Washington Post last month and sparked widespread anger in Nigeria. According to the article, 11 children assigned the drug died and 200 became deaf, blind, or lame. However, a spokesperson for Pfizer, Robin Kate, told The Lancet that "the trial saved 189 lives". According to Kate, 200 children were included in the open-label trial--100 children were given cephtriaxone and the rest were given trovafloxacin. Kate agreed that six children died after cephtriaxone treatment and five children died after trovafloxacin treatment. As condemnation rages over the trial, Nigeria's Health Minister, Tim Menakaya, vowed that Pfizer would pay compensation if found guilty. Menakaya has set up a ministerial commission to investigate the allegations, which is scheduled to report in 3 weeks. The commission includes the Director of Food and Drugs, Reuben Omotayo, director of special projects at the Health Ministry, Abdusalami Nasidi, and a director from the National Agency for Food and Drug Administration and Control (NAFDAC), which is at the centre of the controversy. Last week, Menakaya said the panel was looking at whether Pfizer was given permission by NAFDAC, and whether Pfizer followed international ethical standards while doing the trial. Pfizer says the trial was done strictly in line with ethical standards set by Nigeria's Ministry of Health and the ethics review committee at the hospital. Abdulhammed Isah-Dutse, chairman of the medical advisory committee at the hospital, endorses Pfizer's claim. Despite great concern shown by ethicists in the recent past over ethical violations in trials involving human beings in developing countries, to date, "no comprehensive survey has been undertaken that would support a firm judgment on how often [such] questionable practices occur, nor on trends, says Daniel Wikler, a senior staff ethicist from the WHO, Geneva, Switzerland. "There exists no monitoring authority for collaborative research across borders. All regulation is national, though authorities in some countries can and do scrutinise research practices abroad when the results are submitted in support of an application for licensing." Universal compliance is in the long-term interest of all sponsors of research, continues Wikler. "Only by strengthening national capacities for drug regulation and ethical review and oversight can these norms be enforced on a global scale. As numerous research initiatives by WHO and other agencies have demonstrated, it is perfectly feasible to conduct research in developing countries that complies with the highest ethical and scientific standards", says Wikler. Khabir Ahmad Kirsten Myhr, MScPharm, MPH Bygd�y alle 58B 0265 Oslo, Norway Tel.: +47 22 56 05 85 myhr@online.no -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.