Monday, May 08, 2006

Pfizer Imitating Art or Vice Versa?

Sometimes "life imitates art" completely by happenstance as when Mandy Patinkin -- the actor that plays a doctor in some Crestor TV ads -- was saved by the Heimlich maneuver in a NYC restaurant. It so happens that he also stars in a movie called "Choking Man" whose "primary plot concern is the trauma, both literal and metaphorical, of tracheal blockage" (New Yorker Magazine, May 8, 2006). In that movie, a customer in a restaurant owned by Patinkin's character chokes on a fish bone and is saved by a dishwasher using the Heimlich maneuver after everyone else does the wrong thing. In real life, Patinkin's family also tried to help him by doing the wrong maneuvers until someone did the right thing and saved his life.

When I first saw the movie "Constant Gardener" I thought it was another unfair casting of the pharmaceutical industry as villain -- murderous villain at that -- and although good art, not a very believable portrayal of real life. But then I read the Washington Post story yesterday about a report by a panel of Nigerian medical experts that "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" (see "
Panel Faults Pfizer in '96 Clinical Trial In Nigeria. Unapproved Drug Tested on Children").
"The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug [Trovan] 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."
The movie is based on a book by the same name written by John le Carre -- the famous author of several spy novels.
"The Constant Gardener does offer something new. Le Carre's earlier novels painted a bleak picture of the abuses and corruptions and betrayals of power; here that is augmented with a hard look at a specific issue -- the abuse of power by pharmaceutical companies. The integration of this into the plot is occasionally awkward but mostly effective, touching on the testing of defective drugs in Third World countries, the corruption of governments and corporations, and the twisting of scientific research agendas." (A book review by Danny Yee)
The Nigerian panel report, which remained unreleased for 5 years, "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."

Pfizer says that "local nurses explained the experiment to Nigerian parents and obtained their 'verbal' consent."

"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 [Nigerian] committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while 'the epidemic was still raging.' "
Pfizer was testing Trovan in Africa before it was approved for use in the US. According to the Post story: "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." The pharma industry has long been accused of testing unsafe drugs in poor countries before they are approved.

The Smoking Letter

What lends credence to the report's accusations is the fact that a letter "purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee" was a fake, written by the lead investigator AFTER the experiment, backdated to a week before the trial began. It turns out that the hospital had no ethics committee at that time.

"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."
Pfizer now admits that the letter was "incorrect" and "regrets" that it was written.

There are many intriguing plot elements here that could be the basis of a book and movie like "Constant Gardener." I notice, however, that this book -- as well as the book "The Karasik Conspiracy" (see "
Celsius 3014: Ketek, Drug Safety, & Bioterrorism") -- cast pharmaceutical executives as murderous conspirators. In the movie, the deaths of the children are covered up by secretly disposing of the bodies. The heroine is also murdered by pharmaceutical company hired thugs because she is learning too much about these cover-ups.

In real life, children did die, but the deaths didn't need to be hidden in a garbage dump. They only had to be explained away statistically:

"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."
Life is complicated with shades of gray and arguments pro and con. Art, on the other hand, is simple with just black and white. Outright murder and lies are easily understood devices that convey the message in art. In life, things are not that simple. That's why prosecutors have a hard time convicting executives of complicated financial crimes and opt instead to catch them lying about it.

Meanwhile the Nigerian report continues to be suppressed. "A report like this does not get suppressed without someone high up being involved," said Elaine Kusel a New York City attorney for the families of the Nigerian children. In the movie, diplomats and executives at the highest levels were involved in the coverup. Pfizer, which gains by the report's unofficial status, said "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."


This real life story imitates art in other ways -- the head of the Nigerian panel has received "unspecified death threats." This is where it becomes closer to art and easy to understand.

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