E-drug: Pfizer drug trial in Nigeria being investigated
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Reprinted under the fair use doctrine of international copyright law:
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
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