Suicide Risk of Neurontin Kept Hidden for Years

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"These prescriptions for pain," Mr Pogust notes, "are still being written, as a direct result of past illegal promotional activities."

"Likewise," he points out, "the off-label prescriptions of Neurontin for bipolar disorder, attention deficit disorder, and depression are also without any scientific evidence supporting such uses."

The off-label scheme was first revealed by whistleblower, David Franklin, a former Park-Davis employee who worked as a medical liaison, in a lawsuit against Warner-Lambert and its Parke-Davis division filed under the federal False Claims Act.

By Mr Franklin's estimates, as much as 90% of prescriptions for Neurontin were written off-label as a result of the illegal scheme which prosecutors claim dates back to1995. To back up his allegations, Mr Franklin offered a voicemail he saved from his boss that stated:

I want you out there every day selling Neurontin... holding their hand, whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don't want to see a single patient coming off Neurontin before they've been up to at least 4,800 milligrams a day.

His boss concluded by stating: "I don't want to hear that safety crap either. It's a great drug"

As a whistleblower in a case to recover federal funds, Mr Franklin was entitled to a percentage of the settlement and received $24.6 million

The Drug Industry Document Archive (DIDA), created by the Center for Knowledge Management at the University of California San Francisco Library in collaboration with faculty members, contains roughly 1,000 documents drawn primarily from the case titled, United States ex rel David Franklin vs Parke-Davis, Division of Warner-Lambert, which describe all the specific details on the Neutontin off-label marketing scheme.

In settling the charges, Pfizer pleaded guilty only to conduct occurring before August 21, 1996, even though the DOJ determined that illegal activities had occurred much later, making it possible for Pfizer to continue to participate in federally funded health care programs despite a health care fraud law that went into effect on August 21, 1996, that would have required its exclusion from public programs.

Pfizer escaped the severe penalties, that many critics say would have sent a clear message to companies engaging in such conduct to knock it off or risk losing the most treasured customer base of all public health care programs, even though Warner-Lambert had been convicted of a felony in 1995, for failing to report failures concerning other drugs, which meant the new charges were second offenses "punishable as felonies without regard to proof of intent to defraud or mislead."

Initially, Neurontin was approved only to treat epilepsy in combination with another drug, and at a maximum 1800 mg daily dose. But the DOJ found the drug was being promoted for a multitude of pain uses, psychiatric conditions such as bipolar disorder and anxiety, social phobia, and general mood stabilization, as well as certain unapproved uses within epilepsy treatment. According to the DOJ, the list of unapproved uses became so long that company employees called it the "snake oil" list.

Over all, the DOJ listed the potential harm caused by the illegal scheme as: (1) public health care programs paid more in reimbursement; (2) consumers paid for ineffective, experimental use and may have been improperly medicated; (3) patient's unnecessary exposure to adverse side effects; and (4) improper medication may have resulted where Neurontin was not as effective as another approved drug.

The DOJ listed six tactics involved in carrying out the off-label scheme as: (1) Detailing by sales representatives; (2) Use of Medical Liaisons; (3) Preceptorships; (4) Consultant meetings, speakers bureaus and advisory boards; (5) Series of teleconferences to disseminate off-label uses; and (6) Control of Purportedly Independent Medical Education.

Another element of the overall scheme to increase profits was to convince doctors to prescribe Neurontin at substantially higher doses than the maximum approved dose.

The DOJ produced evidence to show that Parke-Davis had arranged hundreds of teleconferences, meetings, and educational seminars, in addition to the detailing of individual doctors by sales representatives, to promote the off-label use of Neurontin.

In 1996, a Parke-Davis sales representative created a document that said sales representatives could ask doctors if they ever used other antiepileptic drugs for painful neuropathies and then mention that approximately 35% of all Neurontin use is non-seizure. This same document, entitled "Neurontin Can Do/Can't Do," also stated that sales representatives could present lunch programs on Neurontin and pain.

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