posted 11/06/02
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.
Source: Diabetes In Control Dot Com.
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