February 16, 2009
Neurontin whistleblower case reveals off-label promo
Two University of California San Francisco medical school professors who were unpaid consultants to plaintiffs in a Neurontin whistleblower marketing case reported in January that trial documents illuminated “marketing methods that may be widespread but remain unseen because companies are rarely prosecuted for illegal marketing.”
C. Seth Landefeld and Michael Steinman wrote in the New England Journal of Medicine that the Neurontin case “revealed the mechanisms of action of a comprehensive marketing campaign — its goals and strategies, tactics and programs, and the participation of particular physicians and institutions.”
The case was brought by biologist David Franklin, who was a Parke-Davis employee and was told at a medical liaison training session about FDA prohibitions against promoting off-label uses for drugs, but then reportedly was told by a company executive to sell Neurontin not for its indicated use as adjunctive therapy for partial complex seizures but for monotherapy for epilepsy and for pain management.
“We can't wait for [physicians] to ask, we need [to] get out there and tell them up front,” Franklin reportedly was told. “Dinner programs, CME 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 4,800 mg/day. I don't want to hear that safety crap, either, have you tried Neurontin every one of you should take just one to see there is nothing. It's a great drug.”
Shortly after that, Franklin left Parke-Davis and filed his whistleblower suit alleging that off-label Neurontin marketing constituted false claims designed to elicit federal payments. In 2004 the company agreed to plead guilty and to pay more than $430 million to resolve criminal charges and civil liabilities. A class action suit on behalf of private parties who paid for illegally marketed Neurontin is still active.
Three lessons learned from the case, Landefeld and Steinman said, are:
- Pharmaceutical marketing can be comprehensive, strategic, well-financed, disguised as education and research, influential, and very effective. Promotion of Neurontin was integrated in nearly every aspect of physicians' professional lives.
- Comprehensive Neurontin marketing involved many people and institutions that apparently failed to recognize the serious ethical and legal problems with their actions.
- The cases substantiate the emerging conviction that drastic action is essential to preserve medical science and practice's integrity and to justify public trust.