FLIPNeurontin Settlement
I want you out there every day selling Neurontin . Look this isn't just me, it
comes down from Morris Plains that Neurontin is more profitable . . . . we know
Neurontin's not growing adjunctive therapy, beside that is not where the money
is. Pain management now that's money . Monotherapy, that's money. We don't
want to share these patients with everybody, we want them on Neurontin only.
We want their whole drug budget, not a quarter, not half, the whole thing . . . . We
can't wait for them to ask, we need to get out there and tell them up front . . . 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 until they
have 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 on just to see there is
nothing, it's a great drug.
Quote from John Ford, Park-Davis executive speaking to marketing managers
Background on Neurontin® Lawsuit
In December of 1993, Parke-Davis, then a subdivision of Warner-Lambert, received approval for its drug Neurontin® (gabapentin) by the Food and Drug Administration (FDA). The original FDA approval stipulated that Neurontin® could be used in conjunction with another drug to control epileptic seizures. Since 2002 Neurontin® has been approved by the FDA to control residual pain after shingles. In 1996 the manufacturer hired Dr. David Franklin, a microbiologist and former fellow at Harvard Medical School, as a medical liaison, an expert field scientist to answer prescriber questions. Soon after Dr. Franklin started the job he had tremendous qualms about what he was doing. Franklin says “he became part of a broad mission to deceive, even entice doctors to prescribe drugs to patients whether it was scientifically justified or not.” One of things Dr. Franklin was hired to do was to push the off-label uses of the drug Neurontin®. Prescribers may prescribe an off-label use for a medication if it is good medical practice to do so. However, manufacturers are prohibited from marketing medications for off-label uses.
Dr. Franklin filed a federal qui tam, or whistleblower lawsuit against Pfizer, which had acquired Warner-Lambert and its Parke-Davis division in 2000, charging the company with violations of the False Claims Act. Profits for sales of Neurontin® were increasing from $97.5 million in 1995 to $2.5 billion in 2003. Further, Warner-Lambert reported in 2000 that up to 78% of the prescriptions for Neurontin® were for off-label purposes. The U.S. Attorney’s office in Boston intervened, brought more charges under FDA criminal statutes. This private/public charge on pharmaceutical industry giant Pfizer forced a settlement in the amount of $430 million, the second largest settlement of its kind. While Direct-to-Consumer advertising is rampant, what is more hidden is the industry tactics to influence the prescribing practices of doctors. In this case, we are given a glimpse into the $20 billion spent annually on marketing and promotion by the pharmaceutical industry.
Relevant Articles
Narrative Review: The Promotion of Gabapentin: An Analysis of Industry Documents
Drug Maker to Pay $430 Million in Fines, Civil Damages
Whistleblower David Franklin's Affidavit
NPR Story:Pfizer to Pay $430 Million Fine over Illegal Marketing
UCSF Drug Industry Document Archive
Off-Label Marketing Stirs an Legal Hornet's Nest