Neurontin

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Neurontin was approved by the U.S. Food and Drug Administration in December 1993 solely for "supplemental anti-seizure use by epilepsy patients". [1]

In May 2004 Warner-Lambert pleaded guilty and paid over $430 million to settle criminal charges over the promotion of the drug for unapproved uses. [1]

"Warner-Lambert’s strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig's Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug)," the Department of Justice stated at the time of the settlement of the case. [1]

In October 2008, internal emails and documents from Pfizer (which purchased Warner-Lambert in 2000) concerning Neurontin were released in the U.S. District Court for the District of Massachusetts. The documents suggest that Pfizer sought to boost the "off label" sales of Neurontin by manipulating the scientific record about the drug. Specifically, Pfizer failed to release or changed the conclusions of several studies that showed no beneficial effect for a number of such "off label" uses of Neurontin. The documents were made public as part of expert reports filed by plaintiffs' lawyers in a national class action lawsuit brought against Pfizer on behalf of consumers and "third party payors" (health plans, union benefit funds, self-insured employers, etc.). The Pfizer documents are available on the website of Prescription Access Litigation.

According to the internal emails, after one study showed Neurontin didn't lessen diabetic nerve pain, a marketer suggested "delaying the publication for as long as possible." One researcher emailed that she was told "not to publish anything that damages Neurontin's marketing success." Pfizer also failed to publish results that Neurontin didn't ease post-operative nerve pain. Lastly, after the drug was shown to have no effect on bipolar disorder, a Pfizer consultant writing up the study excluded 16 patients and changed how other patients were characterized, thus "turning a failure into a success." [2]

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References

  1. 1.0 1.1 1.2 U.S. Department of Justice, "Warner-Lambert To Pay $430 million to resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion", Media Release, May 13, 2004.
  2. Keith J. Winstein, "Suit Alleges Pfizer Spun Unfavorable Drug Studies," Wall Street Journal, October 8, 2008.

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