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Suit: Neurontin Marketed Illegally for Bipolar Disorder

Also, Studies Say Neurontin Not Effective for BP

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Updated May 15, 2012

A lawsuit filed in June of 2002 claims that pharmaceutical company Parke-Davis illegally marketed its anticonvulsant medication Neurontin (generic name: gabapentin) to doctors for uses unapproved by the US Food and Drug Administration. Documents filed in Franklin v. Parke-Davis and unsealed over the last several months allege that the company deliberately formed a plan to persuade doctors to prescribe Neurontin for bipolar disorder, diabetic neuropathy, migraine, panic disorder and other conditions - all in the name of profit.

The lawsuit alleges that Parke-Davis paid for small, inexpensive clinical studies and paid to have the "successful" ones - that is, those showing results favorable for selling purposes - written up for medical journals. Then, according to National Public Radio, salesmen were told to "whisper 'Neurontin for bipolar disorder,' 'Neurontin for migraine,' 'Neurontin for everything,' " into doctors' ears. Physicians were also paid to attend lavish functions and hear Neurontin's virtues extolled, and were sometimes rewarded for writing certain levels of Neurontin prescriptions.

Unsealed documents in the case indicate that Parke-Davis undertook this strategy for two reasons:

  1. Neurontin was approved only for add-on use in epilepsy, and only up to 1800 mg dosage. There are about 2 million people in the US with epilepsy - a relatively small market.
  2. To have obtained FDA approval for other uses of Neurontin would have been expensive and time-consuming, with approval possibly not coming until the patent ran out - at which time generics would become available and the profits would drain away.
According to NPR's Snigdha Prakash, in 2001 $1.8 billion worth of Neurontin was sold in the United States, and a staggering 80 percent of that was for unapproved uses.

Dr. Paul Keck, in a September 2002 article "Clinical Management of Bipolar Disorder," reported that "In 2 studies, a placebo-controlled crossover monotherapy trial and a placebo-controlled, parallel-group, adjunctive treatment trial, gabapentin-treated patients did not display significantly greater improvement in manic symptoms than patients receiving placebo."

One such study was paid for by Parke-Davis and concluded: "The findings of this study did not demonstrate that gabapentin is an effective adjunctive treatment when administered to outpatients with bipolar disorder."

Dr. Gary Sachs, director of the Harvard Bipolar Research Program at Massachusetts General Hospital in Boston, helped design and conduct such a study for Parke-Davis. He said on NPR's "All Things Considered" program: "Yes, patients get better on Neurontin, but they get better at an even more impressive rate if they don't get Neurontin." He called the results "shocking," saying the patients did better with sugar pills than on Neurontin. However, Parke-Davis withheld the results of that study until 2000 - about when the patent on Neurontin ran out.

Parke-Davis was acquired in 2000 when Pfizer, Inc. bought its parent company, Warner-Lambert. Pfizer has consistently declined to comment on the pending litigation except to say that the alleged actions took place before the year 2000, and that Pfizer does not engage in off-label marketing. However, Neurontin continues to be prescribed and sold for mostly unapproved uses such as bipolar disorder - because doctors were told it worked, and have not been told it doesn't work.

What Does This Mean For You?

If you are taking Neurontin or gabapentin, we suggest you make an appointment to discuss this with your prescribing doctor and/or therapist. No one has said Neurontin is absolutely useless in treating bipolar disorder. You and your mental healthcare providers need to evaluate your progress and make the decision that is right for you.

Update 5/16/04: Pfizer Settles Felony Case

Warner-Lambert, a division of Pfizer and Parke-Davis's parent, has "admitted that it aggressively marketed [Neuronton] by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal" and will pay $430 million dollars in penalties, reports Bernadette Tansey in the May 14, 2004 San Francisco Chronicle. Pfizer, in its press release [no longer online], emphasized that "[t]he underlying allegations and related investigations originated in 1996, well before Pfizer’s acquisition of Warner-Lambert in 2000."

References:

Neurontin Lawsuit, National Public Radio, June 18, 2002.

Neurontin, National Public Radio, Oct. 29, 2002.

Court Files Yield New Information in Suit Against Drugmaker, National Public Radio, Nov. 2, 2002.

The Selling of Neurontin, National Public Radio, Jan. 16, 2003.

An open label study of gabapentin in the treatment of acute mania

Gabapentin: a review of published experience in the treatment of bipolar disorder and other psychiatric conditions

Gabapentin in bipolar disorder: a placebo-controlled trial of adjunctive therapy.

Clinical Management of Bipolar Disorder

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