Thursday, August 31, 2006

 

Bad Pharma

Before pharma-giant Glaxosmithkline (GSK) was sued by the state of New York in June 2004, over two million children and adolescents in the United States were popping Paxil to treat their depression. Doctors comfortably prescribed the drug because published clinical trials – while showing mixed effects on children – did not reveal anything overwhelmingly negative. It was the best information they had, and it turned out to be completely misleading.

In the lawsuit, New York attorney general Eliot Spitzer argued that GSK had only published one of the five Paxil trials it ran. While the published test revealed mixed results, the four unpublished ones showed no benefits from the drug, and in fact suggested Paxil increased the risk of suicide. An internal gsk memo told the company to manage the release of the data effectively, “to minimize any potential negative commercial impact.”

That big pharma can tamper with the solid medical knowledge our doctors rely on is a terrifying wakeup call for patients – and it’s a story all too common, says Richard Smith, former head of the British Medical Journal. In an article in the Public Library of Science online journal, he said pharmaceutical companies routinely manipulate results to ensure favorable results, then get their trials published in the major medical journals to boost sales. Most of our information may be skewed, writes Smith, since industry sponsors two-thirds to three-quarters of trials found in the four major medical journals – Annals of Internal Medicine, Journal of the American Medical Association, The Lancet, and the New England Journal of Medicine.

The examples from recent years drive home the fact that profit – rather than our health – motivates the actions of pharmaceutical companies. That explains why drug salesmen with quotas to meet encourage doctors to prescribe Paxil to children (American sales: $2.6 billion in 2002), why drugs like Vioxx can stay on the market despite being known to increase heart attack and stroke (worldwide sales: $2.5 billion for Merck in 2003), and why drugs like Neurontin can be forcefully marketed to cure everything else alongside the epilepsy it is designed to treat (worldwide sales: $2.3 billion in 2002). US pharmaceutical companies spend about $6,000-7,000 per doctor on direct marketing alone, offering everything from mugs and pens to gourmet meals and luxury trips.

But while big pharma steps up the pressure, those on the front lines are drawing a line in the sand. The grassroots medical group No Free Lunch has had hundreds of American medical professionals sign on to its anti-marketing pledge. Forced by Spitzer’s lawsuit, GSK revealed all of its negative studies on Paxil and formed its own registry to display all of the clinical trials it has sponsored and will sponsor. And after facing up to their complicity in the drug-info sham, medical journals are changing the way they do business. In an article in Newsweek, Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine reiterates a call for an international registry of clinical trials – which would make all trial data available to the public, good or bad – and says that 11 major US medical journals have agreed not to publish any studies unless the trial is published in a similar public database. It’s voluntary, but it’s a step on the way to protecting our most precious resource – our health.

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