Healthy Skepticism Library item: 7453

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Publication type: news

Petersen M.
Court Papers Suggest Scale Of Drug's Use
New York Times 2003 May 30
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9502E6DD1630F933A05756C0A9659C8B63

Full text:

Documents released yesterday in the case of a drug company whistle-blower shed light on how extensively doctors were involved in promoting unapproved uses of a Warner-Lambert drug, Neurontin.

Warner-Lambert paid dozens of doctors tens of thousands of dollars each to speak to other physicians about how Neurontin, an epilepsy drug, could be prescribed for more than a dozen other medical uses that had not been approved by the Food and Drug Administration. The top speaker for Neurontin, Dr. B. J. Wilder, a former professor of neurology at the University of Florida, received more than $300,000 for speeches given from 1994 to 1997, according to a court filing. Six other doctors, including some from top medical schools, received more than $100,000 each.

Other doctors were paid to write reports on how Neurontin worked for a handful of their patients, the court papers said. Still others were paid to prescribe Neurontin in doses far exceeding the approved levels as part of a clinical trial that Warner-Lambert created to market the medicine, according to the court papers, which are new documents filed in the lawsuit by the whistle-blower. The papers are backed up by hundreds of pages of corporate documents and memos recently filed with the court.

The whistle-blower, Dr. David P. Franklin, a former Warner-Lambert employee, contends that the company’s marketing tactics, which have helped make Neurontin a top-selling medicine, with more than $2 billion in revenue, were illegal. He says that federal and state governments paid hundreds of millions of dollars for Neurontin as doctors prescribed the drug to Medicaid patients for various conditions including pain, bipolar disorder and restless-leg syndrome.

It is illegal for a drug company to market a medicine for uses the F.D.A. has not approved, but doctors can prescribe a drug in any manner that they think is best for their patients.

Lawyers for Dr. Franklin argued that the company relied on the doctors to market Neurontin for unapproved uses because it was illegal for the company to do so. The speaking program, which also included paying doctors to listen to the speeches at hotels and resorts, was called peer selling, according to the documents.

Also this week, prosecutors filed a brief supporting Dr. Franklin. The United States attorney in Boston, Michael J. Sullivan, asserted in the brief that his lawyers had ‘‘presented evidence of an illegal off-label marketing scheme that is rife with false statements and fraudulent conduct.’‘

For example, Mr. Sullivan said, Warner-Lambert had invited doctors to continuing medical education classes that the company said would provide unbiased information about Neurontin. In fact, Mr. Sullivan said, some of these classes were ‘‘a massive promotion’‘ in how Neurontin could be used to relieve pain and were planned by Warner-Lambert employees.

Mr. Sullivan’s brief, filed on Tuesday, was significant. Even though prosecutors have said in court that they are conducting both a civil and a criminal investigation into the accusations, the federal government has not formally entered the case as a plaintiff. Mr. Sullivan filed the brief after Pfizer, which acquired Warner-Lambert in 2000, asked the court to throw out the case, arguing that Dr. Franklin had not proved that the company violated the law.

A spokesman for Pfizer, Andy McCormick, said yesterday that the lawsuit dealt with events that occurred about four years before Pfizer acquired Warner-Lambert. He said Pfizer had helped to write and develop a code of ethics that was adopted by large pharmaceutical companies last year. ‘‘We strive to adhere to the highest ethical standards,’‘ he added.

Corporate documents made public in the case yesterday state that a Warner-Lambert strategy was to focus on respected doctors in the major teaching hospitals who would serve as ‘‘Neurontin champions.’‘

One of those was Dr. Steven C. Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston. Dr. Schachter received $71,477 from May 1994 to September 1997 to speak about Neurontin to other doctors, according to the court papers.

At a meeting Warner-Lambert sponsored for physicians at the Ritz-Carlton Hotel in Boston in 1996, Dr. Schachter said that ‘‘pain specialists are finding that low dosages of Neurontin are effective’‘ — a statement that lawyers for Dr. Franklin called misleading.

Paul Cirel, a lawyer for Dr. Schachter, declined yesterday to comment.

Another doctor, Ilo Leppik, a professor at the University of Minnesota, received $49,250 to speak about Neurontin. According to the court papers, Warner-Lambert also paid $303,764 to publish Dr. Leppik’s textbook on epilepsy.

Dr. Leppik said yesterday that in his speeches he had talked only about how Neurontin could be used in epilepsy. He said his textbook mentioned not just Neurontin, but also all other epilepsy medicines.

‘‘I’m an academic,’‘ Dr. Leppik said. ‘‘I’m not a marketer. I’m proud of that book. I don’t think of it as a marketing vehicle at all.’‘

Dr. Wilder, who received the most money for speaking about Neurontin, could not be reached yesterday. His wife, Eve Wilder, said that Warner-Lambert had never told her husband what to say. ‘‘He had total freedom on all the education programs he put on,’‘ Mrs. Wilder said.

Warner-Lambert tracked doctors’ prescriptions to see if the numbers increased after the doctors attended Neurontin meetings or after they were hired to speak about the drug.

For example, Dr. Joseph De Mayo, a Connecticut physician, wrote 58 prescriptions for Neurontin for unapproved uses like gastric ulcer, osteoarthritis and backache in the 14 months after he attended a meeting at the Ritz-Carlton in Atlanta where other doctors had spoken about Neurontin, according to court documents. In the year before that meeting, Dr. De Mayo did not write any Neurontin prescriptions for Medicaid patients, the papers said.

After the meeting, Dr. De Mayo also became a Warner-Lambert speaker and was paid more than $1,000, according to the papers.

Dr. De Mayo said yesterday he had not seen the lawsuit and could not comment.

In 2000, 88 percent of Neurontin sales were for uses not approved by the F.D.A., according to the lawsuit. Until last year, Neurontin was approved only for use in epilepsy as an add-on medicine when the patient’s primary drug did not work. Last year, the F.D.A. approved Neurontin for use in pain suffered by patients with shingles.

Dr. Franklin has said that Warner-Lambert also told its sales representatives to promote Neurontin to doctors for unapproved uses.

Until now, that accusation has largely rested on the testimony of the whistle-blower, who visited doctors as a Warner-Lambert medical liaison. The newly filed court papers, however, give details from Scott-Levin, a health industry consulting firm in Newtown, Pa., that Warner-Lambert hired to track what its sales representatives were saying to doctors.

According to computer records from Scott-Levin, almost half of the 503 doctors surveyed from October 1995 to December 1998 said they had received marketing appeals from the company’s sales representatives on unapproved uses. And of those doctors, about half told Scott-Levin that they intended to increase their prescribing of Neurontin, the court documents say.

Dr. Franklin is represented by Greene & Hoffman, a law firm in Boston.