Statement: Pfizer Falsely Claims MSF Involvement in the Company's Unethical 1996 Drug Trials in Nigeria

Among the US government diplomatic cables recently published by the
Wikileaks website were details of a meeting between an official from the
pharmaceutical company, Pfizer, and US Embassy officials in Nigeria in
April 2009.

At the time of the meeting, Pfizer was in the midst of a legal battle
with Nigerian government officials regarding a medically unethical
antibiotic clinical trial in children. The clinical trial took place in
Kano State in 1996 during a massive meningitis outbreak.

Pfizer carried out the trial of the oral antibiotic trovafloxacin,
branded Trovan, even though there had not been any previous medical
evidence that it could be effective against meningitis. The Pfizer
researchers conducted the trial in Kano State Hospital, where a Doctors
Without Borders/Medecins Sans Frontieres (MSF) was treating children
using a preferred and clinically approved antibiotic regimen for
bacterial meningitis.

A US$75 million settlement with the State of Kano was reached July 30,
2009. Other cases are still pending before the US courts and the
Nigerian federal government continues to pursue legal claims against
Pfizer.

It is against this backdrop that Pfizer falsely accused MSF in the US
diplomatic cables of using Trovan. Documented evidence has shown that
these accusations are patently false. MSF did not, at any time,
administer Trovan to patients. Litigation connected to this case and
comprehensive investigative reports on the matter suggest that Pfizer's
attempts to rewrite history are intended to deflect responsibility for
the company's actions.

MSF was not working in the same part of the hospital in Kano State as
Pfizer clinical researchers, and MSF staff had no connection to Pfizer.
When MSF staff became aware of what Pfizer was doing, they were appalled
at the practices of the company's team. MSF personnel on the ground
communicated their concerns to both Pfizer and the local authorities.

"It was not a time for a drug trial," says Jean Herve Bradol, former
president of MSF France, to whom the Kano teams were reporting at the
time. "They were panicking in the hospital, overrun by critically ill
patients. The team were shocked that Pfizer continued the so-called
scientific work in the middle of hell."

Pfizer officials have made no attempt to clear the record as of yet and
retract these unsubstantiated claims against MSF. A handful of internet
reports have adopted the version of events proffered by the Pfizer
official.

An exhaustive Washington Post investigation, drawing on extensive
background information and interviews provided by MSF staff, published
on December 17, 2000, makes clear the distinction between Pfizer's
activities and the work of MSF during the meningitis outbreak:

"Behind a gate besieged by suffering crowds stood two very different
clinics. A humanitarian charity, Doctors Without Borders, had erected a
treatment center solely in an effort to save lives. Researchers for
Pfizer Inc., a huge American drug company, had set up a second center.
They were using Nigeria's meningitis epidemic to conduct experiments on
children with what Pfizer believed was a promising new antibiotic--a drug
not yet approved in the United States."

The article later triggered the various legal proceeding taken by the victims and Nigerian authorities against Pfizer.

With proven treatments at hand, Pfizer instead chose to carry out tests
for an unproven drug on children whose lives hung in the balance. "The
situation...called for using treatment protocols known to be effective
rather than carrying out clinical trials on a new antibiotic, with
uncertain results," said Dr. Bradol.
Pfizer's researchers put at risk not only the children in Kano but also
other clinical trials done under the proper circumstances that could
have a positive impact on sick people in the developing world. Pfizer
never intended to sell Trovan at an accessible price in Africa if it had
been approved.

Further Reading:

The Washington Post: Where Profits and Lives Hang in the Balance

The Guardian: As Doctors Fought to Save Lives, Pfizer Flew in a Drug Trail Team

Interview with Dr. Jean Herve Bradol: Ethical Research Needed on Diseases

Interview with Philippe Guerin of Epicentre: Strict Rules Govern the Conduct of Clinical Trials in Africa