A major drug distributor used “deception and misinformation” to promote the unapproved, “off label” use of an epilepsy drug, two researchers from the University of California-San Francisco claim.
What’s more, they claim the practice is widespread in the pharmaceutical industry, while other sources say the side effects of off-label prescriptions can be deadly.
Writing in the New England Journal of Medicine, the UCSF researchers say their review of a 1995 lawsuit against Parke-Davis revealed a “systematic” marketing campaign by the company to promote Neurontin, approved by the Food and Drug Administration to treat epilepsy, for unapproved conditions such as pain, migraines and bipolar disorder.
The company, now owned by Pfizer, pleaded guilty in 2004, and paid over $430 million in fines for trying to suppress publication of unfavorable peer-reviewed research, allowing sales reps to pitch “off label” uses to doctors, and providing gifts and financial compensation to doctors to attend presentations about Neurontin.
The researchers say the extensive marketing and influence campaign was “disguised” as educational programming for researchers, and amounted to a manipulation of the medical establishment that pushed Neurontin sales from $93 million to $3 billion in a decade.
Off-label uses can have risks. Following reports of increased suicidal behavior from patients using gabapentin, the generic name of Neurontin, the FDA reviewed nearly 200 clinical trials, and found roughly twice the risk of suicide in patients using anti-epileptic drugs.
Although a new federal drug-labeling requirement warns of such risks, the impacts of off-label marketing persists — and even crosses borders.
In Canada, an off-label prescription of gabapentin has led to a new lawsuit targeting Pfizer by a woman who was given the drug to treat nerve pain, and subsequently was repeatedly hospitalized for suicidal behavior.
According to the Ottawa Citizen, of the 423 million prescriptions filled last year in Canada, about one-fourth were written for off-label uses.
Gabapentin is prescribed off-label for everything from hot flashes for post-menopausal women to attention deficit disorders in children, while drugs approved for diabetes, depression, psychotic behavior or cardiac health are used as off-label answers for hard-to-treat conditions like insomnia, obesity and headaches.
Experts suggest tougher restrictions on off-label marketing, requiring informed consent from patients, conducting more independent peer-reviewed drug trials, and the creation of new, national-scale research and regulation programs.
“UCSF VA researchers call drug company deceptions typical”
University of California-San Francisco, January 15, 2009
“Widespread off-label drug prescription raises safety concerns”
Ottawa Citizen, January 1, 2009
“The Impact of Antiepileptic Drugs on Suicide Risk”
Medscape, January 26, 2009