What's It Going to Take to Lock Up Drug Company Execs?

"Laws are like cobwebs, which may catch small flies, but let wasps and hornets break through." - Jonathan Swift

After reading "The Neurontin Legacy -- Marketing through Misinformation and Manipulation" in the January 8, 2009 issue of the New England Journal of Medicine, one may conclude that (1) America's prisons would be put to better use incarcerating drug company executives instead of pot smokers, and (2) society may need a return of public scorn via the pillory for those doctors who are essentially drug-company shills.

Drug-company corruption of American medicine is of course not news. What is news is that such corruption has become so egregious, so transparent, and so embarrassing that the New England Journal of Medicine, perhaps the most influential American medical journal, is now stating that "drastic action is essential to preserve the integrity of medical science and practice and to justify public trust."

Neurontin was approved by the Food and Drug Administration (FDA) in 1993 in doses of up to 1800 mg per day as adjunctive therapy for partial complex seizures. How did U.S. annual sales of Neurontin increase from $98 million in 1995 to nearly $3 billion in 2004? The answer is "off-label" marketing, in which Neurontin manufacturer Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000) marketed Neurontin to doctors for uses not approved by the FDA (because doctors can legally prescribe drugs for uses not approved by the FDA).

While aggressive off-label marketing to doctors is standard among drug companies, it is routinely kept quiet. But thanks to a Parke-Davis whistle blower, we have first-hand evidence of off-label marketing -- and how the Neurontin financial bonanza was created.

In 1996, David Franklin, a young biologist, took a sales representative position for Parke-Davis. But shortly after beginning the job, Franklin grew concerned that he was participating in the illegal marketing of Neurontin. Franklin reports that a Parke-Davis executive informed him and his fellow sales reps:

"I want you out there every day selling Neurontin. . . .We all know Neurontin's not growing for adjunctive therapy, besides that's not where the money is. Pain management, now that's money. Monotherapy [for epilepsy], that's money. . . . We can't wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME [continuing medical education] programs, consultantships all work great but don't forget the one-on-one. That's where we need to be, holding their hand and 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 4800 mg/day. I don't want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it's a great drug."

Franklin left Parke-Davis and filed suit (ultimately, United States of America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis Division of Warner-Lambert Company) alleging that off-label marketing of Neurontin constituted false claims designed to elicit payments from the federal government. In 2004, Warner-Lambert resolved criminal charges and civil liabilities by agreeing to plead guilty and pay $430 million -- less than 15 percent of the $3 billion the drug company had grossed on Neurontin in 2004.