Suicide Risk of Neurontin Kept Hidden for Years

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By Evelyn Pringle (about the author) Page 4 of 6 page(s)

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According to Mr Franklin, the company gave financial incentives to hundreds of doctors by inviting them to dinners, sports outings, and weekend trips to resorts where fellow-physicians were paid to speak about the use of Neurontin for unapproved indications.

The company founded a speakers' bureau, as a method of making large payments to physicians who gave presentations and court documents show doctors were paid to listen to speeches that took place on a "Bus to Yankee Stadium," a "World Yacht Cruise," and the "Braves Stadium."

During one trip in 1996, Parke-Davis paid for 18 doctors and their spouses to stay in Atlanta for 5 days to attend the Summer Olympics. The company paid for their meals, use of a resort, and travel to the games while the agenda for the seminar listed only 10.5 hours of business meetings, including one devoted to off-label uses for Neurontin.

The DOJ determined that the company kept track of how well these marketing efforts paid off. For instance, in a memo dated June 26, 1995, a marketing executive reported that doctors who attended dinners and listened to speeches from other physicians, wrote 70% more off-label prescriptions than doctors who did not attend.

Documents show that the company intentionally hired influential doctors from major teaching hospitals to speak at these events. For instance, Dr Steven Schachter, a professor at Harvard Medical School, received $71,477 between May 1994 and September 1997, and Dr B J Wilder, a former professor at the University of Florida, was paid more than $300,000, and other doctors received more than $100,000 each.

The company also paid to disseminate papers and articles on off-label uses throughout the medical literature so that doctors would find themselves bombarded with information about the many uses for Neurontin, made to look like independent scientific papers.

For some uses, like monotherapy, the research was used to support an attempt to obtain FDA approval. But in other cases, the company's goal was to disseminate the information as widely as possible to increase off-label prescribing for conditions like pain and bipolar disorder, without ever trying to obtain approval.

To carry out this part of the scheme, Warner-Lambert hired two marketing firms to write the articles and then found doctors willing to sign on as authors. According to Mr Franklin, the PR firms were paid $12,000 per article and the doctors were paid $1,000.

The DOJ found more than twenty 20 articles published in various medical journals that were fully paid for by Parke-Davis. Critics say this tactic still affects off-label prescribing today. According to Mr Braslow, "since 1999, the types of off-label are most likely weighted in the precise areas where the drug maker focused its illegal marketing efforts: bipolar disorder, peripheral neuropathy, migraine, depression, etc."

"Because physicians were inundated with false information for years," Mr. Pogust says, "they continue to prescribe it for off-label uses for which there is no reliable scientific support."

Parke-Davis also infiltrated the continuing education arena where doctors were misled into believing that seminars on the off-label uses for Neurontin were independent educational programs, when they actually were marketing events set up by Park-Davis.

For example, prosecutors found an undisclosed relationship with a firm known as Physicians World where Parke-Davis employees transferred to the firm to run the company's speakers bureau.

At the same time, the DOJ discovered that in a division of Physicians World, known as Professional Post-Graduate Services, which purported to be an independent education provider presenting programs on anticonvulsants for pain to thousands of US doctors, Parke-Davis employees actually planned and developed the programs.

According to the DOJ, in late 1995, the company took the position that medical liaisons could discuss off-label issues with doctors, so long as the doctor asked a question about the topic first. Because physicians believed medical liaisons were persons with a scientific background and not employed to sell Neurontin, they were often able to gain access to doctors that the sales representatives could not.

For example, Mr Franklin was trained to increase the rate of prescriptions of Neurontin as monotherapy, and one of the ways he was able to gain access to doctors was by fraudulently presenting himself as a neurology specialist conducting research on epilepsy and the actions of anticonvulsant drugs.

Company records reveal an extensive pattern of misuse of medical liaisons. A January 31, 1996, memo describes a goal to "utilize the medical liaison group to target the Neurontin, Pain & Psychiatric market."

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