Pfizer Tampered With Neurontin Studies, Lawsuit Claims

By Anna Boyd
15:08, October 8th 2008
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Pfizer Tampered With Neurontin Studies, Lawsuit Claims

Another page is written these days in the scandal around pharmaceutical companies paying good money in order to hide eventual bad results of their drug trials and promote the drugs although they proved inefficient. This time the scandal builds around world’s largest pharmaceutical company, Pfizer Inc., and its anti-seizure drug Neurontin.

The company appears to have suppressed a large European study suggesting that Neurontin was ineffective for chronic nerve pain, and it privately strategized about how to silence a British researcher who wanted to bring everything out in the open, according to internal Pfizer documents submitted in a lawsuit against the company. The documents were submitted to the US District Court in Boston and were made available on its website.

During the same time, the company launched in a public campaign promoting positive findings of a smaller Neurontin study it had published in a major medical journal. The campaign turned the drug into one of the fastest-growing blockbuster drugs worldwide. Overall, it generated more than $2 billion a year in US sales before a generic competitor entered the market in 2004. The same year, Pfizer agreed to pay $430 million and plead guilty to criminal charges for illegally marketing Neurontin for unapproved uses such as migraines and pain.

In response to these accusations, Pfizer released a statement denying the charges. “Study results are reported by Pfizer in an objective, accurate, balanced, and complete manner, with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study or the country in which the study was conducted,” the statement read.

On the other hand, Dr. Kay Dickersin of the Johns Hopkins Bllomberg School of Public Health, one of the experts reviewing the documents, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.”

This is not the first time a drug company does questionable things in order to promote their drugs even though they are ineffective and pose patients’ lives in danger. A report appeared in the August 19 issue of the Annals of Internal Medicine revealed that a 1999 clinical trial (called ADVANTAGE or Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) of Merck & Co.’s Vioxx, was done in fact to support a marketing campaign before the drug’s launch.

Many researchers believe that such behavior, which raises ethical and scientific questions, is not singular when it comes to drug companies and their way of promoting their new recipes. An editorial in the Journal of the American Medical Association suggested the ENHANCE study of Vytorin was also done for marketing purposes, but the authors cited only circumstantial evidence for the allegation.

Merck reported in the first place that Vioxx was “well tolerated,” but internal company documents revealed that patients given the drug in one trial had been more than four times as likely to die as those given a placebo, and 2.5 times as likely to die in a second trial. The two trials resulted in 34 deaths among about 1,000 patients given Vioxx and 12 deaths among a similar number given a placebo.

Vioxx generated sales of $2.5 billion a year before the arthritis and chronic pain pill was withdrawn from US drugstores almost four years ago, when a Merck study showed that long-term users had twice the risk of heart attack and stroke.



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