Pfizer Neurontin Studies Altered, Suppressed to Boost Sales

A lawsuit against Pfizer Inc. claims the drug maker delayed the release and altered the conclusions of <"">Neurontin studies that did not support expanded use of the epilepsy drug.  Pfizer is just the latest drug maker accused of manipulating research in this way for marketing purposes.  Earlier this year, a Vioxx lawsuit accused Merck & Co. of omitting findings on cardiovascular problems and death rates in studies it funded.

Documents detailing the allegedly-manipulated Neurontin studies were released in a federal lawsuit filed by heath insurers and consumers who want refunds for the money they spent on the drug.  They are claiming that Pfizer fraudulently marketed Neurontin.  The plaintiffs’ petition to have their Neurontin suits consolidated in a class action was rejected by the court last year, but they are trying again.
According to The Wall Street Journal,  Pfizer’s Warner-Lambert unit pled guilty in 2004 to felony charges that it promoted Neurontin for uses not approved by the Food and Drug Administration, including bipolar disorder and chronic nerve pain. The FDA originally approved the drug to treat epilepsy, and in 2002  it was approved to treat one type of pain related to shingles.  Pfizer paid $430 million to resolve the charges and reimburse state Medicaid programs for or off-label uses of Neurontin.  At the time, Pfizer said that after it acquired in Warner-Lambert in 2000, it  made sure no illegal marketing was being conducted.

But according to documents and emails released in the Neurontin lawsuit in the U.S. District Court in Boston, marketers at Pfizer continued to manipulate studies in order to boost the drug’s sales.  The studies in question found no beneficial effect from Neurontin for the treatment of conditions other than epilepsy.

According to one 2000 email sent after the company acquired Warner-Lambert, a Pfizer executive suggested that the company delay releasing a European study that showed Neurontin was of little help in treating diabetic nerve pain.  “I think we can limit the potential downsides of the … study by delaying the publication for as long as possible,” wrote Michael Rowbothan, then Neurontin’s marketing team leader. He added that “it will be more important to how WE write up the study.”

In another email, Pfizer’s scientific manager on that study wrote she had been instructed “that we should take care not to publish anything that damages Neurontin’s marketing success.

In 2002, Neurontin’s senior marketing manager, Angela Crespo, wrote an email to an outside firm hired to write-up the European study results: “We are not interested at all in having this paper published because it is negative!!”

According to The Wall Street Journal, Pfizer’s write up of the European Neurontin study was ultimately rejected by two medical journals.  Court documents show that some of the journals’ reviewers thought the articles presented the findings in a too-favorable light.

In the end, no journal ever published that Neurontin study.  But Pfizer did eventually summarize its results in a review published in 2003 in the journal Clinical Therapeutics.  However, that same review did not make mention of a second Scandinavian study that found Neurontin was no better than a placebo in treating post-operative nerve pain.

The court documents also show that a five-year Spanish study completed in 2004 that investigated Neurontin as a possible treatment for bipolar disorder was altered.  Researchers on the study originally found that Neurontin patients did no better than those on a placebo.  But by the time it was published in 2006, the study’s conclusions had been changed to claim that the results indicated a benefit from Neurontin.

According to the Journal, prior to publication, the lead researcher on the Spanish study had modified the scale used to assess how severely patients exhibited bipolar bipolar disorder.  While that change helped boost Neurontin’s score in the study, it was never disclosed by the researchers.  Making a change like that is considered improper by most scientists, especially when it is not disclosed.

The lead attorney in the Neurontin lawsuits told The Wall Street Journal that Pfizer’s manipulation and of the Neurontin studies created the illusion of Neurontin’s efficacy in the scientific record” that encouraged doctors to use the drug even when it wasn’t effective.

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