Pfizer Faulted-1996 Clinical Trials In Nigeria: Unapproved Drug Tested On Kids_WashPost

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 secret report (obtained by The Post through a whistleblower) stated that:
"Pfizer never obtained authorization from the Nigerian government to give the unproven drug [Trovan] to nearly 100 children and infants."

According to the report, "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."

At the time of the experiment, Doctors Without Borders was dispensing approved antibiotics at the hospital; parents were not informed their children were given an experimental antibiotic rather than an approved drug; and the report determined that Pfizer later “concocted and backdated” an approval letter from a Nigerian ethics committee.

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."

Until now, a group of 30 Nigerian parents, represented by a U.S. law firm, Milberg Weiss Bershad & Schulman, failed 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."’
This 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. The Nigerian report state that Pfizer: “violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.”

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=335

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
veracare@ahrp.org <mailto:veracare@ahrp.org>  
 
http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.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.story?coll=bal-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.                             xxxxx cut xxxxx