May 25, 2006 at 17:01:18

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Neurontin Deal - Slap On The Hand To Pfizer

By Evelyn Pringle (about the author)     Page 6 of 12 page(s)

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Parke-Davis paid key “thought leaders” well who could be counted on to deliver a strongly favorable message on off-label use. At least 20 of these doctors, the DOJ said, were paid more than $50,000 over time for speaking on the company's behalf. In fact, some received in excess of $250,000.

Corporate documents show, the DOJ says, that the company focused its attention on recruiting doctors from major teaching hospitals to serve as "Neurontin champions."

For example, documents show that Dr Steven Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston received $71,477 between May 1994 and September 1997, and a Dr B.J. Wilder, a former professor of neurology at the University of Florida, was paid more than $300,000 for speeches given between 1994 and 1997. Six other doctors, including some from top medical schools, the DOJ said, received more than $100, 000 each.

The most common forums for speakers were consultant and advisory board meetings, where doctors were gathered to listen to a presentation. Parke-Davis justified holding these meetings, because it entered into pro forma consultant agreements with the physician attendees and doctors were paid anywhere from $250-$2,500 to serve as consultants or advisers.

In one 6-month period alone, the DOJ said, Park-Davis held over 50 meetings and despite being called “consultant” meetings, the actual objective was to provide off-label information to the doctors rather than to receive information from the consultants.

During its investigation, the DOJ discovered that doctors were misled into believing that educational programs they attended were independent programs when they were actually led by the drug maker. For example, prosecutors found a Ward-Lambert relationship with a company known as Physicians World where Warner-Lambert employees transferred to Physicians World to run the company's speakers bureau.

At the same time, a division of Physicians World, known as Professional Post-Graduate Services, purported to be an independent education provider for a program on anticonvulsants for pain, when in fact, Ward-Lambert staff planned and developed the program and thousands of US doctors took the classes.

This program was provided to thousands of doctors all around the country and in each
instance, the materials stated that they were created in compliance with ACCME guidelines, which prohibited content control by Parke-Davis as a condition of accreditation, and required disclosure of all financial affiliations.

The materials did not disclose the relationship between Physicians World and Parke-Davis, and did not disclose the financial links between Parke-Davis and each of the faculty members, all of whom were paid consultants, the DOJ said.

For instance, one physician was a regular Neurontin speaker who had received payments of more than $10,000 and yet by the listing of each faculty member, there was an asterisk indicating “no significant financial or other affiliation reported."

"This evidence," the US attorney said, "demonstrates that Parke-Davis knew that these events were unlawful promotional activities."

Another method of promoting face-to-face was the preceptorship, or “shadowing.” This involved paying a doctor to allow a sales rep to follow the doctor through the course of a day seeing patients. In one example, a sales rep did a preceptorship with a neurologist and after they saw a teenage patient, the doctor and the sales rep discussed treatment options.

The sales rep advised the doctor to increase the Neurontin dose and at the same time, taper the patient off other epilepsy medication to reduce side effects, thus resulting in Neurontin being used for monotherapy. According to the sales rep, as recorded in a voice mail sent in to the company obtained by the DOJ: “I really felt I made a difference. I saw the actual prescription generated in front of me... and I certainly felt that me being there, I had some influence on that medical decision.”

Another patient seen was a 65 year old veteran who suffered neuralgia with pain in his limbs. The patient developed blurred vision while on Neurontin; and the sales rep told the doctor that such side effects are mild and transient and so the doctor kept the patient on the drug. In the sales rep's own words: “I felt like I influenced that particular situation. So again, another prescription was generated for us. Overall, the day went, you know, very well. And we had the immediate impact of two prescriptions written.”

The DOJ said the drug maker decided not to seek an expanded use for Neurontin with the FDA because it would have required solid proof from clinical trials so instead, the company boosted sales through promotional strategies, even for conditions where studies had indicated that Neurontin was not effective.

In his sentencing Memorandum the US Attorney noted: "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."

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