Dead Children, An Unapproved Drug, A Silenced Whistleblower, And A Secret Report

The Washington Post revealed during the weekend that a panel of Nigerian medical experts has concluded that Pfizer Inc. violated the international Declaration of Helsinki that governs ethical medical research; the U.N. Convention on the Rights of the Child; and Nigerian law, during a 1996 epidemic by testing an unapproved drug on children with brain infections.

That finding is described in a Nigerian government report that has remained secret for five years, despite inquiries from the children's attorneys and from the media. The Washington Post apparently obtained a copy of the confidential report from a person who asked to remain anonymous because of personal safety concerns.

According to the report, Doctors Without Borders was dispensing approved antibiotics at the hospital and "Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants."

During Pfizer's experiment, "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."

If true, these accusations are shocking. But what may be more shocking are some of the things we still don't know.

First, Pfizer apparently told authorities that a Nigerian doctor directed the experiment. The investigative committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and an inexperienced local doctor, Abdulhamid Isa Dutse, was the principal investigator "only by name." So why did Pfizer claim the local doctor was responsible for tests of Pfizer's new billion-dollar drug?

Second, Pfizer's publications listed Dutse as the lead author of articles on Trovan. Dutse, however, 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. How can someone be a lead author of a publication and data he hasn't seen?

Third, "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 then used this letter as 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. Not until last week did Pfizer in a statement say that after the first article appeared, the company investigated and found that the letter was "incorrect." This begs the question, did Pfizer knowingly use a fake letter to mislead the media and the FDA?

Attorney Elaine Kusel

Fourth, "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, according to the Post. Indeed it does. Who could benefit from this report never seeing the light of day? There is really only one entity that would benefit from this--Pfizer. So the fourth question is, did Pfizer have anything to do with the fact that the report vanished for five years? Who was paid off, and by whom?

Fifth, Pfizer claims that "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. There is only one tiny weeny issue here that makes Pfizer look not so good. "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." We should note that the difference between the FDA and European regulators is that the FDA is partly funded by the drug companies. So the only independent regulators have completely forbidden use of this drug. And the fifth question is, did Pfizer know about the liver toxicity when they gave the drug to African children?

Sixth, Pfizer did allegedly know they had a problem. And this is something the Washington Post failed to write about. But a New York Times article from year 2000 did bring up the fact that even Pfizer's own researchers protested. According to a separate lawsuit, "Dr. Juan Walterspiel, a Pfizer infectious disease specialist assigned to the Trovan test, repeatedly told Pfizer management that the company was violating international law, federal regulations and medical ethics standards." And what did Pfizer do? "Dr. Walterspiel was subsequently dismissed." According to an overseas article Pfizer later settled with Walterspiel, which presumable is one reason we haven't heard from him lately. And this begs the next question: What did Pfizer really know and who within Pfizer fired Walterspiel, later agreed to settle with him, and why?

Seventh, another overseas article about the scandal in Africa, describes how Pfizer chartered a plane, and Pfizer researcher Scott Hopkins claims that "people in Nigeria were desperate, willing to let anyone come and do anything." The article goes on to describe how "Pfizer's team, with only one person who could speak the local language, took over part of the hospital and Doctors Without Borders were pushed to the side. Pfizer got the best beds and the best personnel. They paid better. Patients immediately arrive. Parents want to help their children with the deadly disease meningitis. But instead of receiving approved and safe drugs they become participants in an experiment. Many claim they weren't told anything about this. They were treated like guinea pigs, unknowingly. The children were separated from their parents, and soon several children died."

The children died using a drug which European regulators later banned from the market, and the parents claimed they didn't know their children participated in an experiment.

Sadly, in the pharmaceutical industry history keeps repeating itself. I can't help but note the similarities in this case with my own experience.

In January 2003, I sent an e-mail to Pfizer warning about illegal marketing of growth hormone. The response was simple; you're fired.

Later, after I filed a lawsuit against Pharmacia and Pfizer based on the illegal marketing to children and adults (which Pfizer admitted in a letter to the FDA had taken place) I received a letter from Pfizer's General Counsel. Only the letter arrived almost a week after my lawsuit was filed and almost two weeks after it was dated, which immediately made me suspect that it was backdated. Two years later, when Pfizer tried to get my lawsuit dismissed, I learned that it was very important to Pfizer that it appeared as if I had received this letter before I filed my lawsuit.

In December 2005 I was fired by Pfizer, just like Dr. Walterspiel. Many of the documents related to this case are available here.

But in the end, these stories are not about whistleblowers, ruined careers or backdated letters.

They are about sick children who get drugs they probably shouldn't have received and companies pushing the limits in the name of profits.

In short, these stories are about lives vs. dollars. And the almighty dollar always wins.

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