Re: Pfizer accused of illegal Trovan testing on children


Yukon King wrote:


Panel Faults Pfizer in '96 Clinical Trial In Nigeria
Unapproved Drug Tested on Children

By Joe Stephens
Washington Post Staff Writer
Sunday, May 7, 2006; Page A01

(cont'd).

Panel Faults Pfizer in '96 Clinical Trial In Nigeria
A New York City attorney for the families of the children, Elaine Kusel
of Milberg Weiss Bershad & Schulman, said her firm had spent years
looking for the report, of which they believed there were only three
copies. They tracked one to a Nigerian government safe, but it was
reported stolen, she said. Another copy was reported to have been held
by an official who died.

"It sounds like a mystery novel here, like John le Carré," Kusel said.


The Infectious Diseases Hospital in Kano, Nigeria, was treating
meningitis patients in 1996 when Pfizer administered the experimental
drug Trovan to children.


The current Nigerian health minister, Eyitayo Lambo, did not respond to
calls and e-mail messages from a reporter. Dora Akunyili, director of
the Nigerian drug control agency, said she did not know why the report
remained confidential but added that her agency had independently
concluded that "these people did not have authority to conduct the
trial."

Executives at Pfizer, the world's biggest drug company, said they had
not seen the report. After reviewing a copy, they responded in a
two-page statement:

"The Nigerian government has neither contacted Pfizer about any of the
committee's findings nor are we aware that the committee has approved a
final report. Therefore it would be inappropriate for the company to
respond to specific points in the document.

"However, as we have stated repeatedly over the past several years,
Pfizer conducted this trial with the full knowledge of the Nigerian
government and in a responsible way consistent with Nigerian law and
Pfizer's abiding commitment to patient safety."

Pfizer said it had previously tested the drug in thousands of patients
and found it effective. Local nurses explained the experiment to
Nigerian parents, it added, and obtained their "verbal" consent. The
company said that Trovan demonstrated the highest survival rate of any
treatment at the hospital.

"Trovan unquestionably saved lives, and Pfizer strongly disagrees with
any suggestion that the company conducted its study in an unethical
manner," the statement said.

At the time of the Nigerian experiment, Pfizer was developing Trovan
for release in the United States, where it was expected to gross up to
$1 billion a year.

The FDA never approved Trovan for use in treating American children.
After being cleared for adult use in 1997, the drug quickly became one
of the most prescribed antibiotics in the United States. But Trovan was
later associated with reports of liver damage and deaths, leading the
FDA to severely restrict its use in 1999. European regulators banned
the drug.

After The Post published its report, Nigeria's health minister at the
time, Tim Menakaya, appointed a blue-ribbon panel of medical experts to
look into Pfizer's actions, saying, "Let me assure you that my ministry
will take all necessary steps to obtain details of this incident and
make them known to the general public." The committee collected
hundreds of documents and interviewed at least 26 people.

Pfizer had told authorities that a Nigerian doctor directed the
experiment. The committee, however, found that researchers from
Pfizer's U.S. office controlled the trial, and the inexperienced Kano
doctor, Abdulhamid Isa Dutse, was the principal investigator "only by
name."

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