Government Sides With Whistleblower in Drug Maker Lawsuit

The federal government is siding with a whistleblower who is suing Pfizer and a subsidiary, accusing them of illegally marketing the epilepsy drug Neurontin and offering lavish kickbacks to doctors. The case concerns "off-label" uses of Neurontin -- prescribing the drug for uses that the FDA has not officially approved.

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The federal government is siding with a whistleblower who is suing Pfizer and a subsidiary, accusing them of illegally marketing the epilepsy drug Neurontin and offering lavish kickbacks to doctors. U.S. Attorney Michael Sullivan filed a “statement of interest” Friday in Dr. David Franklin’s lawsuit, arguing against the company’s motion to have the lawsuit thrown out. The case concerns “off-label” uses of Neurontin — prescribing the drug for uses that the FDA has not officially approved. Federal law allows doctors to prescribe drugs in any way they believe will best help patients, but forbids companies from promoting drugs for conditions that are not approved by the FDA, which requires clinical trials showing a drug’s safety and effectiveness. Franklin, who worked for Warner-Lambert, the former parent company of Pfizer subsidiary Parke-Davis, claims in his lawsuit filed in 1996 that the company gave financial incentives to hundreds of doctors to prescribe Neurontin for non-approved uses. Internal company memos outline plans for promoting the drug for bipolar disorder, social phobias, panic disorder, and neuropathic pain in journals and medical conferences, rather than seeking FDA approval. In Friday’s filing, Sullivan said Franklin had documented the company’s kickback schemes for physicians who prescribe Neurontin for off-label uses, such as a 1996 meeting in Atlanta where doctors were given tickets to the Olympics, meals, and use of a spa. He also says doctors were given a three-day trip to Palm Beach, Fla., cash payments and yacht trips, and were afterward tracked by Parke-Davis to see if the perks had an impact on their prescriptions. Another 1997 junket to Puerto Rico offered cash, meals and airfare. “(The U.S.) has a keen interest in the development of the law in this area and in the correct application of that law in this case and similar cases pending in several courts,” Sullivan wrote. Messages left for two Pfizer spokesmen were not immediately returned. In the past, Pfizer — which merged with Warner-Lambert and its Parke-Davis division three years ago — has said the lawsuit relates to activities that took place before the acquisition and that its employees do not promote drugs for non-approved uses. Christina Sterling, a spokeswoman for the U.S. Attorney’s Office, wouldn’t comment. Copyright 2003 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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