Suicide Risk of Neurontin Kept Hidden for Years

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"Objective to conduct twice weekly Pain Teleconferences moderated by key Neuro Consultants," the memo states. "Goals 250 Physician participants quarterly."

One of the most alarming sales tactics identified during the DOJ's investigation was that sales representatives were allowed to review patient records, suggest an increase in Neurontin dosage, and "shadow" doctors while they examined patients, in exchange for paying the doctor a few hundred dollars a day.

According to the DOJ, at various times Parke-Davis made a conscious decision to not seek approval for a new use because it would have required solid proof from clinical trials that could not be provided.

Documents show that Parke-Davis even went to the trouble of determining how much could be made off Neurontin for a new approved use, compared to sales from marketing the drug off-label for the same use.

For example, a May 19, 1995, Marketing Assessment forecast potential revenue from Neurontin for bipolar without approval at $6 million in 1997, rising to $36 million in 1999. On the other hand, with approval, forecasted sales were almost $12 million in 1997, to over $80 million in 2002, but the company still decided not to seek approval for bipolar.

The DOJ found that similar projections were made for other uses including various types of pain but again, after evaluating the potential sales with and without approval, Parke-Davis decided to market Neurontin off-label instead of seeking approval.

The company also kept track of doctor's prescribing habits for Neurontin's competitors. In October of 1995, Parke-Davis determined that two competing epilepsy drugs, Tegretol and Depakote, had total sales of 18-27% for bipolar disorder, and up to 9% for pain, while at the time, only 1-2% of sales for Neurontin were for pain and bipolar.

The company continued to market the drug for bipolar even after studies showed it was ineffective for that use. The DOJ's sentencing Memorandum states: "One of the psychiatric uses for which Neurontin was promoted ... bipolar disorder, was particularly troubling because the Company had very weak evidence of Neurontin's efficacy in treating this condition."

"Indeed," the prosecutor wrote, "in one study ... the placebo was as effective or more effective than was Neurontin."

Yet with full knowledge of this study, medical liaisons told psychiatrists that early results from clinical trials indicated a 90% response rate for bipolar. Likewise, they told pediatricians that Neurontin was effective for children with attention deficit disorder, when no data other than occasional anecdotal evidence supported that claim.

And although no studies existed to prove that Neurontin was even as effective as inexpensive pain killers already on the market, medical liaisons told doctors that clinical trials demonstrated that Neurontin was highly effective in treating various pain syndromes and reported once again that a 90% response rate was found in the treatment of pain.

The DOJ also reports that the company continued to promote Neurontin for monotherapy even after the FDA refused to approve it. Parke-Davis sought approval in September 1996, but because one of the 2 clinical trials submitted with the application showed no demonstrable monotherapy efficacy, the application was denied.

Nonetheless, the DOJ produced evidence showing that Parke-Davis continued to promote Neurontin for monotherapy through at least 2000, without ever mentioning the rejected application, and that at one 1998 event, Parke-Davis went so far as to state that Neurontin is "now approved as monotherapy for seizures."

When caught red-handed promoting drugs for unapproved uses, drug makers always feign ignorance of the high rate of off-label prescribing. However in this instance, company documents show that Warner-Lambert regularly obtained detailed information on the number of prescriptions written for Neurontin and what indication they were written for.

Neurontin sales did finally drop to $182 million in the first quarter of 2005, but as a result of new generic competition on the market, according to USA Today on April 20, 2005.

Persons seeking information about Neurontin representation can contact the Pogust & Braslow law firm at 610-941-4204, or http://www.pogustbraslow.com/

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