[Ip-health] Panel Faults Pfizer in '96 Clinical Trial In Nigeria,Unapproved Drug Tested on Children

[Jordan]

--
[ Picked text/plain from multipart/alternative ]
One intriguing question that has dominated the the AIDS debate in recent ye=
ars is that of drug quality.  What is the difference between what Pfizer is=
 alleged to have done in Nigeria with that of the Indian-made ARV's that ha=
ve been administered en masse to Africa and Asia by both NGOs and Governmen=
ts, yet were later removed from the market out of safety concerns?

  Jordan

Joana Ramos <joaninha@comcast.net> wrote:
  http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050=
601338.html

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; A01
A panel of Nigerian medical experts has concluded that Pfizer Inc. violated
international law during a 1996 epidemic by testing an unapproved drug on
children with brain infections at a field hospital.
That finding is detailed in a lengthy Nigerian government report that has
remained unreleased for five years, despite inquiries from the children's
attorneys and from the media. The Washington Post recently obtained a copy =
of the
confidential report, which is attracting congressional interest. It was
provided by a source who asked to remain anonymous because of personal safe=
ty
concerns.
The report concludes that Pfizer never obtained authorization from the
Nigerian government to give the unproven drug to nearly 100 children and in=
fants.
Pfizer selected the patients at a field hospital in the city of Kano, where
the children had been taken to be treated for an often deadly strain of
meningitis. At the time, Doctors Without Borders was dispensing approved
antibiotics at the hospital.
Pfizer's experiment was "an illegal trial of an unregistered drug," the
Nigerian panel concluded, and a "clear case of exploitation of the ignorant=
."
The test came to public attention in December 2000, when The Post published
the results of a year-long investigation into overseas pharmaceutical testi=
ng.
The news was met in Nigeria with street demonstrations, lawsuits and demand=
s
for reform.
Pfizer contended that its researchers traveled to Kano with a purely
philanthropic motive, to help fight the epidemic, which ultimately killed m=
ore than
15,000 Africans. The committee rejected that explanation, pointing out that
Pfizer physicians completed their trial and left while "the epidemic was st=
ill
raging."
The panel said an oral form of Trovan, the Pfizer drug used in the test, ha=
d
apparently never been given to children with meningitis. There are no recor=
ds
documenting that Pfizer told the children or their parents that they were
part of an experiment, it said. An approval letter from a Nigerian ethics
committee, which Pfizer used to justify its actions had been concocted and
backdated by the company's lead researcher in Kano, the report said.
The panel concluded that the experiment violated Nigerian law, the
international Declaration of Helsinki that governs ethical medical research=
 and the
U.N. Convention on the Rights of the Child.
Five children died after being treated with the experimental antibiotic and
others showed signs of arthritis, although there is no evidence the drug
played a part. Six children died while taking a comparison drug.
The panel recommended that Pfizer be "sanctioned appropriately" and directe=
d
to issue "an unreserved apology to the government and people of Nigeria." T=
he
company should also pay an unspecified amount of restitution, the report
said. The panel recommended that Nigeria enact reforms to prevent a recurre=
nce.
Aspects of the affair remain mysterious, such as why the report remains
confidential. The head of the investigative panel, Abdulsalami Nasidi, said=
 in a
brief telephone conversation from Nigeria, "I don't really know myself" why
the report was never released.
"I did my job as a civil servant," said Nasidi, who is quoted in the report
as saying he has been the target of unspecified death threats.
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 track=
ed
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 Carr=E9," Kusel said.
The current Nigerian health minister, Eyitayo Lambo, did not respond to cal=
ls
and e-mail messages from a reporter. Dora Akunyili, director of the Nigeria=
n
drug control agency, said she did not know why the report remained
confidential but added that her agency had independently concluded that "th=
ese 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 fin=
al
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 paren=
ts,
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," th=
e
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 billi=
on 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 mos=
t
prescribed antibiotics in the United States. But Trovan was later associate=
d
with reports of liver damage and deaths, leading the FDA to severely restri=
ct
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 t=
he
general public." The committee collected hundreds of documents and intervie=
wed
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 Dut=
se,
was the principal investigator "only by name."
Publications listed Dutse as the lead author of articles on Trovan, but the
committee found that depiction "did not sufficiently reflect his role." Dut=
se
indicated he was kept in the dark about the experiment's results and said h=
e
did not see at least one publication until the committee showed it to him.
"He was shocked that Pfizer could publish such data without showing him or
intimating him with details," the report said, concluding that Dutse was "n=
aive
and exploited."
The report quoted Dutse as saying that Pfizer's motive was far from
philanthropic.
"I have trusted people and am disappointed," Dutse told the committee. "I
regret this whole exercise, I wonder why on earth I did this."
Dutse admitted that he created a letter after the experiment purporting to
show that the test had been approved in advance by a Nigerian hospital's et=
hics
committee. He then backdated the letter to March 28, 1996 -- a week before
Pfizer's experiment began.
Pfizer used the letter as a key justification for the trial in discussions
with reporters and submitted it to the FDA. U.S. regulations require the
sponsors of foreign medical research seeking FDA approval to show that the =
tests
have been reviewed in advance by an ethics committee.
The Post previously reported that the hospital had no ethics committee in
March 1996 and that the letterhead stationery used was not created until mo=
nths
after the experiment's conclusion.
In a statement last week, Pfizer said that after that article appeared, the
company investigated and found that the letter was "incorrect."
"Obviously this should not have occurred and the company very much regrets
that it did," the statement said. "It is important to point out, though, th=
at
Pfizer thought proper procedure had been followed at the time of the clinic=
al
study."
The former director of Nigeria's version of the FDA said the agency had bee=
n
unaware of the experiment. He told the panel that he "viewed the conduct of
the trial by Pfizer as an act of deception and misuse of privilege."
The report said the treatment of two children during the experiment
represented unspecified "serious deviations" from the trial's protocol and =
concluded
that those deviations compromised their care. One was a 10-year-old girl
identified only as Patient No. 0069, who was given the experimental antibio=
tic
for three days as her condition deteriorated. She died without receiving an=
y
other antibiotic.
Last week, Rep. Tom Lantos of California, the senior Democrat on the
International Relations Committee, described the report's findings as "abso=
lutely
appalling" and called on Pfizer to open its records.
"I think it borders on the criminal that the large pharmaceutical companies=
,
both here and in Europe, are using these poor, illiterate and uninformed
people as guinea pigs," Lantos said.
Lantos said he expected to introduce a bill requiring U.S. researchers to
give regulators details of tests they plan in developing countries.
"It's the only ethical thing to do," Lantos said. The bill is similar to on=
e
his committee approved in 2001 that did not make it out of the House. "Ther=
e
should be a lot of bipartisan support for it. This outrages people."
The report's findings also breathe new life into a lawsuit against Pfizer,
according to Kusel, who represents 30 Nigerian families. "It's great news, =
I'm
very excited," she said when told of the committee's conclusions.
The families sued Pfizer in federal court in New York in 2001, alleging tha=
t
the company had exposed the children to "cruel, inhuman and degrading
treatment."
A U.S. judge dismissed the suit last summer, saying U.S. courts lacked
jurisdiction. Kusel is appealing.
"A report like this does not get suppressed without someone high up being
involved," she said.
=A9 2006 The Washington Post Company




--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA 98115
206-229-2420
http://ramoslink.info/

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