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Issue 129 Item 15 Neurontin Illegaly Promoted for Off Label Use in Diabetic Pati

May 6, 2002
 

Executives promote drug to treat pain in diabetic patients, rather than perform the clinical studies needed to prove the medicine was safe for such patients. Marketing executives at Warner-Lambert urged superiors to let them promote the epilepsy drug Neurontin for an unapproved use, The New York Times reported in its online edition on Tuesday, citing court documents.

A memorandum, filed in Federal District Court in Boston, showed executives proposed using other means to promote the drug to treat pain in diabetic patients, rather than perform the clinical studies needed to prove the medicine was safe for such patients, the newspaper reported.

According to the six-page memo, dated May 5, 1997, Warner-Lambert marketing executives suggested creating education classes for doctors and sponsoring a symposium with the American Diabetes Association to promote the drug as a pain killer, the Times said.

The memo was filed by Thomas Greene, a lawyer for a whistle-blower who accused Warner-Lambert of promoting Neurontin to doctors in the late 1990’s for more than a dozen conditions it was never approved to treat, the paper said.

Greene also filed another memorandum, dated 1995, with the court detailing how Warner-Lambert tracked prescriptions written by doctors after they attended dinner meetings paid for by the drug company at which Neurontin was discussed, the paper said.

The memo showed that in the Northeast, doctors attending the dinners wrote 70 percent more prescriptions for Neurontin than doctors who did not attend, the Times reported. At issue in the case is tens of millions of dollars that taxpayers paid for Neurontin prescriptions written for Medicaid patients who had conditions the drug was not approved to treat.

Mr. Franklin says that company gave financial incentives to hundreds of doctors to prescribe Neurontin for unapproved uses ranging from bipolar disorder to a myriad of pain syndromes, by inviting them to dinners and weekend trips to resorts. He asserts that Warner-Lambert also paid doctors to speak about Neurontin and to prescribe Neurontin to patients who were enrolled in the company’s clinical trials.

The United States attorney’s office in Boston is conducting criminal and civil investigations into the marketing of Neurontin. In addition, 47 states have joined to pursue their own criminal and civil investigations.

Pfizer said in 2000 that more than 78 percent of Neurontin prescriptions were written for unapproved uses. This year, sales of the drug are expected to exceed $2 billion. Pfizer says it is cooperating with investigators and cannot comment in more detail due to the pending litigation.

Under federal law, doctors can prescribe drugs in any way they believe will best help patients. But it is illegal for a drug maker to promote a medicine for conditions that are not approved by the Food and Drug Administration, which requires detailed clinical trials showing its safety and effectiveness.

In the 1997 memo, Warner-Lambert executives recommended against doing studies needed to get Neurontin approved to treat diabetic patients because of the short time that they expected the company to be able to sell the drug exclusively. The executives expected the drug’s patent to expire in 2000, which would allow companies to make low-priced generic versions.

The executives recommended that Neurontin be promoted for the unapproved condition through educational courses.