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Patients have been victimized by Pfizer's unethical efforts to persuade doctors to prescribe the epilepsy drug Neurontin for "off-label" uses.
It's not easy nowadays to claim the trophy for Most Despicable Corporation Activity, given the competition, but Pfizer is a leading contender. The world's largest pharmaceutical company, Pfizer pleaded guilty to misleading doctors and patients on the number of diseases that could be effectively treated by its epilepsy drug Neurontin. While Pfizer has agreed to pay a $430-million fine, that is a trivial amount compared to the company's ill-gotten gains on the drug.
Pfizer points out that the illegal promotion occurred before the company acquired Warner-Lambert, the maker of the drug. While that is the case, Neurontin is still one of the most popular drugs, with annual sales of $2.7-billion, and the bulk of that is for what is called "off label" use - to treat ailments other than epilepsy, the use approved by the Food and Drug Administration. Neurontin is commonly prescribed for migraine headaches, attention deficit disorder, restless leg syndrome and even bipolar disorder, for which the drug is no more effective than a placebo, yet Pfizer issued no warning in its news release about the settlement.
So, many patients face significant drug costs without the prospect of real improvement. Particularly disappointing is the fact that doctors participated in the scam. A drug company is not allowed by law to promote off-label drug use, although doctors can prescribe a drug for other conditions. That decision should be based on unassailable scientific evidence, of course, but some doctors accepted free trips to conferences at which Neurontin was promoted for ailments other than epilepsy, and some even allowed a sales representative to accompany them into examination rooms to promote the drug to patients.
Dr. David Franklin was one such "adviser," and the practice so disgusted him that he quit his job and filed a whistleblower lawsuit that led to the guilty plea and fine against Pfizer. He says off-label drug use is still rampant.
Drug companies continue to hire ad agencies to do clinical trials, pay experts to put their names on ghostwritten studies and hire physicians as consultants to influence other doctors in drug choice, according to the New York Times. The scandal is probably far from over. Over the past year, at least seven drug companies have been investigated for promoting off-label drug use, the Wall Street Journal reported.
Neurontin is commonly prescribed for migraine headaches, attention deficit disorder, restless leg syndrome and even bipolar disorder.
One of the reasons the practice is so rampant is that the FDA has backed down from aggressive enforcement of the law. That atmosphere may change with the court victory against Pfizer. One thing motivating the government is cost - with Medicaid payments for off-label use of Neurontin alone running to millions of dollars. "Every taxpayer in the country has been paying for these prescriptions for minimal benefit to a huge majority of patients," said Thomas Greene, the plaintiff's lawyer in the Pfizer case.
Considering the staggering amounts of money to be made by the pharmaceutical industry, however, the message may not get through until drug executives in fancy suits and shiny shoes face prison sentences.