ocuments 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,
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
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
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
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