Documents Show Effort to Promote Unproven Drug

By MELODY PETERSEN

arketing executives at Warner-Lambert urged their superiors to let them promote the epilepsy drug Neurontin for an unapproved use rather than perform the clinical studies needed to prove the medicine was safe for such patients, according to a corporate memorandum unsealed on Friday in federal court.

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The six-page memorandum was filed in Federal District Court in Boston by Thomas M. 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.

In the memo, dated May 5, 1997, the marketing executives propose that Neurontin be promoted to treat pain in diabetic patients by creating education classes for doctors and sponsoring a symposium with the American Diabetes Association.

Mr. Greene also filed another memorandum with the court that details 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 memo, dated June 26, 1995, said that in the Northeast, doctors attending the dinners wrote 70 percent more prescriptions for Neurontin than doctors who did not attend.

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.

Pfizer, which acquired Warner-Lambert and its Parke-Davis division in 2000, says the lawsuit relates to activities that took place before the acquisition and that its employees do not promote drugs for unapproved uses. Pfizer has said that it is not aware of any credible evidence showing Warner-Lambert employees made false claims about the drug.

Pfizer has been fighting to prevent the release of hundreds of similar documents, which it says are confidential information. This summer, Judge Patti B. Saris ordered Pfizer to go through the documents and release any that did not include information that would put it at a competitive disadvantage.

Mr. Greene charged in a motion on Friday that Pfizer was selectively seeking to keep confidential the documents that were "the most damaging." To support his claim, he filed the two memos, which Pfizer had allowed to be released, along with other documents it had stamped confidential to show that all were similar. All the documents, he said, detailed how Warner-Lambert had marketed Neurontin.

"These documents tell a consistent story of the defendants' marketing strategy," Mr. Greene wrote, "hatched at the highest levels of Parke-Davis, to brazenly market Neurontin off-label."

Mr. Greene's client, Dr. David P. Franklin, worked for Warner-Lambert in 1996, and says that he resigned after finding that the company was involved in a nationwide marketing campaign that he thought was illegal and was endangering patients.

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.

Kathleen McDermott, a former assistant United States attorney who works at the law firm of Blank Rome Comisky & McCauley, said that it is not always clear that a company has broken the law by promoting a drug for an unapproved use through continuing medical education.

"There is a gray area of what is permissible," Ms. McDermott said.

What is more troublesome, she said, is when drug companies give doctors gifts or financial incentives that could be viewed as financial rewards for prescribing a drug.

"If these activities go beyond C.M.E. to big dinners and junkets, I would be concerned," Ms. McDermott said.