The Constant Gardner: Pfizer Faulted-1996

[Guest guest]

SSRI-Research@

Sun, 7 May 2006 20:55:31 -0400

[sSRI-Research] The Constant Gardner: Pfizer Faulted-1996

 

 

 

Clinical Trials In Nigeria: Unapproved Drug Tested On Kids_WashPost

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

For those who thought the film, The Constant Gardner, based on the

book by John LeCarre, overstated the criminal conduct engaged in by

pharmaceutical companies, a front page report by Joe Stephens of The

Washington Post (below) should disabuse them of their innocence.

 

The Post reveals that a secret report by a Nigerian government panel

of medical experts, determined that Pfizer Pharmaceuticals violated

international law when it conducted an unethical drug experiment,

testing the lethal antibiotic, Trovan, on 100 critically ill Nigerian

children in 1996. The report found that Pfizer had failed to obtain

permission to conduct the experiment, failed to inform parents,

withheld life-saving available antibiotics-in order to test its

experimental drug-and " concocted and backdated " an approval letter

from a Nigerian ethics committee.

 

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. "

 

The Post reports: " 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 antibiotic for three

days as her condition deteriorated. She died without receiving any

other antibiotic. "

 

Congressman Tom Lantos of the International Relations Committee, said:

" 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. "

 

A group of 30 Nigerian parents, represented by a U.S. law firm,

Milberg Weiss Bershad & Schulman, had tried to obtain justice in a

U.S. court. They were rebuffed by a federal court that inconceivably

denied it had jurisdiction over a U.S. company that is required by

U.S. law to comply with federal research regulations here and abroad.

 

The Post reports: " 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. " '

 

The report has been concealed for five years-a demonstration that

pharmaceutical company giants like Pfizer can buy silence and burry

their crimes. Indeed, a report in the Baltimore Sun (excerpt below)

reveals that industry wide corruption has cost pharmaceutical

companies $3.5 billion in fines since 2001. The evidence was brought

to public light by whistleblowers who are protected under the False

Claims Act of 1863.

 

The Pfizer-Nigeria case-with its international ramifications--should

move Congress to put legal brakes on the despicable activities engaged

in by U.S. pharmaceutical companies-both in the U.S. and offshore.

 

In 2005, Constitutional lawyer, John Whitehead, of the Rutherford

Institute, put such unethical experiments in their appropriate context:

 

" Inevitably, when we hear about humans being experimented on, our

minds turn to the Auschwitz concentration camp and the infamous Nazi

Angel of Death, Josef Mengele. Seen as immoral and scientifically

dubious, Mengele's work included placing human beings in pressure

chambers, freezing them to death, testing drugs on them and castrating

them. He also injected children with lethal germs, removed their

organs and limbs and performed sex change operations on them.

 

His primary interest was twins. The Nuremberg Code, created as a

reaction to the horrors of Mengele's work, provided directives for

human experimentation to protect the experimental subject from even

remote possibilities of injury, disability, or death. Above all else,

the Code stressed that it is necessary to obtain voluntary, informed

consent from the patient.

 

Despite the existence of this code and subsequent medical ethics

codes, Mengele's legacy lives on. This time, the culprit is none other

than the United States government through its involvement in numerous

questionable and immoral human research programs. Lest you think that

the scientific community and government agencies would not carry out

immoral experiments on humans, particularly children, think again. "

 

See: Mengele's Legacy Lives On: Inhumane Experiments on Children in

America by John W. Whitehead 4/18/2005

http://www.rutherford.org/articles_db/commentary.asp?record_id=35

 

A companion Infomail will deal with FDA's proposed Guidelines to

vaccine manufacturers that would give manufacturers the green light to

exploit children as test subjects in HIV vaccine experiments.

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare <veracare

 

 

--

 

http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601

338.html

 

THE WASHINGTON POST

 

Panel Faults Pfizer in '96 Clinical Trial In Nigeria

Unapproved Drug Tested on Children

 

By Joe Stephens

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

safety concerns.

 

The report concludes that Pfizer never obtained authorization from the

Nigerian government to give the unproven drug to nearly 100 children and

infants. 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

testing. The news was met in Nigeria with street demonstrations, lawsuits

and demands for reform.

 

Pfizer contended that its researchers traveled to Kano with a purely

philanthropic motive, to help fight the epidemic, which ultimately killed

more than 15,000 Africans. The committee rejected that explanation,

pointing

out that Pfizer physicians completed their trial and left while " the

epidemic was still raging. "

 

The panel said an oral form of Trovan, the Pfizer drug used in the

test, had

apparently never been given to children with meningitis. There are no

records 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

directed

to issue " an unreserved apology to the government and people of Nigeria. "

The company should also pay an unspecified amount of restitution, the

report

said. The panel recommended that Nigeria enact reforms to prevent a

recurrence.

 

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

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 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. "

 

Publications listed Dutse as the lead author of articles on Trovan,

but the

committee found that depiction " did not sufficiently reflect his role. "

Dutse indicated he was kept in the dark about the experiment's results and

said he 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

" naive 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

ethics 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

months 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, that

Pfizer

thought proper procedure had been followed at the time of the clinical

study. "

 

The former director of Nigeria's version of the FDA said the agency

had been

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 antibiotic for three days as her condition deteriorated. She

died without receiving any other antibiotic.

 

Last week, Rep. Tom Lantos of California, the senior Democrat on the

International Relations Committee, described the report's findings as

" absolutely 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 one his

committee approved in 2001 that did not make it out of the House. " There

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 that

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.

 

© 2006 The Washington Post Company

 

--

 

http://www.baltimoresun.com/news/nationworld/bal-te.drugs07may07,0,5731781.s

tory?coll=ºl-home-headlines

 

THE BALTIMORE SUN

 

Improper sales of medicines targeted

Drug firms have paid fines of $3.5 billion since 2001 for wrongful

promotions

 

By Jonathan D. Rockoff

May 7, 2006

 

WASHINGTON -- A Civil War-era law designed to root out fraudulent Army

contracts has been quietly employed by whistleblowers and federal

prosecutors in recent years as a powerful tool for cracking down on

pharmaceutical companies wrongly promoting their drugs.

 

Companies prosecuted under the federal False Claims Act have paid nearly

$3.5 billion in penalties since 2001 for giving doctors televisions,

selling

them drugs at undisclosed discounts and taking other improper steps to

encourage sales.

 

Such intensive drug marketing campaigns have led doctors to give patients

drugs they don't need, sometimes with dangerous results, according to

watchdog groups and academics.

 

Industry lawyers and consultants say the risk of hefty fines has become as

potent as the threat of congressional action in prompting pharmaceutical

companies to reform their sales practices, especially after studies

linking

painkillers and anti-depressants to deaths and suicides.

 

To avoid prosecution under the act, drug companies are hiring compliance

officers, re-training sales staff and creating hot lines so employees can

alert them of wrongdoing. Concern is so heightened, said one lawyer, that

companies interested in acquiring competitors first investigate employee

firings and grievances that could result in a whistleblower's filing a

false

claim complaint.

 

" There's no facet of pharmaceutical company activities that has not been

affected, " said William A. Sarraille, another lawyer representing drug

manufacturers, who has defended six cases.

 

Federal law permits companies to promote drugs only for uses approved

by the

Food and Drug Administration. For decades, that agency, almost

exclusively,

policed advertising. When it found " off-label " -- not FDA-approved --

promotions or misleading marketing, it sent a warning letter.

Occasionally,

companies signed a consent degree, but they did not face fines.

 

Then in 1991 prosecutors began looking into claims that Genentech had

marketed the growth hormone Protropin by suggesting that doctors prescribe

it to healthy children who did not suffer from a hormone deficiency, an

unapproved use. While doctors and patients are free to depart from FDA

guidelines for drug use, companies cannot promote off-label prescriptions.

 

Prosecutors alleged improper marketing under the False Claims Act --- an

obscure federal law that had been on the books for more than 100 years --

and Genentech paid $50 million in 1999 to settle the case.

 

Lincoln backed law

The False Claims Act, passed in 1863 with the strong support of President

Abraham Lincoln, was enacted to prevent arms manufacturers from sending to

the Union Army crates stuffed with sawdust instead of guns. The act was

strengthened in 1986, after criticism that the Pentagon had paid

exorbitant

prices for toilet seats and hammers.

 

Until Genentech, the law had been applied only to military

procurement. But

federal prosecutors realized that they could use it also for

pharmaceutical

companies that marketed drugs to patients for unapproved purposes and had

been reimbursed for the medicine by a federal program, such as

Medicare and

Medicaid.

 

" Health care spending was high. There was concern about fraud and abuse

issues. Pricing was becoming more complex, " said Wayne Pines, a former FDA

associate commissioner who now consults for the pharmaceutical

industry and

who is writing a book about false claims prosecutions. " All those were the

variables that led to the enforcement. "

 

Since the Genentech case, prosecutors have used the law in 15 cases

involving such major companies as AstraZeneca, Bayer, GlaxoSmithKline,

Schering-Plough and Pfizer. Those cases were settled, and another 150 are

pending, according to Taxpayers Against Fraud, a nonprofit group that

assists whistleblowers and tracks False Claims Act litigation.

 

One reason the law has been effective is its reward to tipsters, who can

receive 15 percent to 30 percent of the penalties against a company. A

formal complaint is typically kept under seal while prosecutors decide

whether to take the case. The litigation sometimes includes criminal

charges

under other federal laws. It usually takes 38 months for a case to go from

complaint to settlement, according to Taxpayers Against Fraud, and the

average award to whistleblowers is $120,000.

 

A Baltimore woman, Sandra Boucher, was among several whistleblowers who

tipped off prosecutors in what turned out to be one of the largest

settlements. Last year, Serono Laboratories of Rockland, Mass., agreed to

pay $704 million to resolve charges that it had illegally marketed the

drug

Serostim to patients who didn't need it. Boucher, who was a sales

representative, declined through her lawyer to comment.

 

At $21,000 for a course of medication, Serostim aimed to reverse the

profound weight loss often experienced by AIDS patients. But the

development

of other treatments soon limited the AIDS wasting. Prosecutors said Serono

tried to spur sales anyway, offering doctors free trips to a medical

conference in Cannes, France, in exchange for writing more

prescriptions for

the drug. The company also allegedly gave doctors a device designed to

show

patients were losing body mass and needed the drug, though the FDA never

approved use of the device for that purpose. From 1997 to 2004,

prosecutors

said, Medicaid paid more than $600 million in claims for Serostim.

 

Incentives

 

Given the potential for such large sums from federal programs, attempts to

cheat the government are inevitable, lawyers for whistleblowers say. But

without the financial incentives for whistleblowers, they say, the

government would be unlikely to unearth such fraud. " A regulator

sitting in

an office in Washington isn't going to know that a sales rep sitting in a

doctor's office is going to offer a trip to Cannes, " said J. Stephen

Simms,

a Baltimore lawyer who represented Boucher. Simms said he has 50

whistleblower cases under seal.

 

Lawyers who represent drug companies say oversight is better left to

the FDA

because it understands the industry and the practice of medicine. And

prosecutors' legal premise -- that marketing a drug for off-label use can

defraud the government -- might not even stand up in court, the

lawyers add,

although drug companies have chosen to settle cases rather than risk

losing

lucrative government reimbursement for their drugs.

 

" Everyone wants to kick around [pharmaceutical companies] these days, and

you don't really want to go through a trial about your marketing

activities,

even if you think they are appropriate, " added John Kamp, executive

director

of the Coalition for Healthcare Communication, a group of trade

associations.

 

Prosecutors, Kamp says, have unfairly criminalized activities that federal

drug regulators and courts had permitted. Doctors often prescribe drugs

off-label, and if the physicians inquire about such uses,

manufacturers can

legally provide copies of journal articles and other information. But Kamp

says some prosecutors have used such information exchanges against

companies.

 

The industry has asked the Department of Justice to reconsider the

prosecution tactics, Kamp says. Meanwhile, conservatives have reportedly

lobbied Congress to cut whistleblower awards. The Washington Legal

Foundation, a pro-business group, has also stepped in, filing briefs in a

few false claims cases defending drug manufacturers and seeking to reduce

whistleblower awards. It has also urged the Justice Department to involve

the FDA more in deciding when to prosecute.

 

" The FDA, in general, gets it, " said Richard Samp, the foundation's chief

counsel. " But the FDA is very much out of the loop in many of these

criminal

prosecutions. "

 

Patrick L. Meehan, a U.S. attorney in Pennsylvania, says whether or

not the

FDA condoned the practices, the companies broke the law. " If that's

the way

things work, then it's wrong, " he said.

 

As a condition of the settlements, prosecutors require drug companies to

institute programs to prevent further improper marketing. When it

agreed in

2001 to pay $875 million to settle charges -- the largest penalty so

far --

TAP Pharmaceutical Products also pledged to reform its promotional

practices.