Monday, January 14, 2013
Off-label drugs and free speech
The Food and Drug Administration (FDA) has ruled that pharmaceutical companies cannot promote drugs for purposes other than the reasons for which the drug was approved. Physicians are free to do such off-label prescribing, however the drug companies cannot suggest in any way that physicians and other prescribers do so.
Companies have to do expensive studies to show that a medication is both safe and effective. How the FDA approves the drug is based on the research the company did. For example, Neurontin (gabapentin) is approved for certain kinds of seizures, post-herpetic neuralgia and neuropathic pain. In 2004, Warner-Lambert paid $430 million in a court case brought by the government for off-label use. The pharmaceutical company sales representatives had, promoted it for conditions including bipolar mental disorder, Amyotrophic Lateral Sclerosis, attention deficit disorder, migraine, and other conditions.
Some of those claims were true, and the company later received the nerve pain indications that it didn't originally have. Physicians may rightly prescribe the medication without it having an indication because they have reasons to believe it may work based on the pharmacology or published studies. The pharmaceutical company may just not have been able to get it approved yet, or if it's not a common problem, they may decide that financially it's not worth the cost of getting an indication.
When a physician prescribes a medication, there is usually no direct economic benefit to them, and whether they are right or wrong, they will prescribe a medicine because they think it will benefit the patient. That's not necessarily true of pharmaceutical companies, though. They have a direct economic incentive to sell as much of their product as possible, and their sales reps are often compensated on how many prescriptions the doctors they call on write. So although many of the reps are ethical, economic pressures are a strong incentive to get them to push for off-label uses. Multi-million dollar settlements help hold those pressures in check.
Recently a three-judge panel of the Second Circuit Court of Appeals, in a case involving pharmaceutical sales rep Alfred Caronia, ruled that the FDA regulations violated the First Amendment's guarantee of free speech. In an editorial, the Wall Street Journal sided with the court, saying that, "health regulation is by nature health coercion."
The Wall Street may smack down anything at all related to the Affordable Care Act (ObamaCare), but I think they are wrong. I'm not a lawyer, and much less a constitutional one, but I think of free speech in a different way. I don't think selling a product is free speech. Selling an idea is. If you are not allowed to put up a sign touting you believe or don't believe in God, for example, then your right to express your opinion is being abridged. If, however, you put up a sign saying the price of gasoline at your station, that's not stating what you believe in, that's just advertising.
Granted, some cases might be fuzzy and I would err on the side of free speech, but sales reps talking about their medications are usually just advertising. In fact the FDA does allow companies to support off-label use, but it's strictly limited (done by a physician in response to questions, etc.).
The Supreme Court acted in a similar manner in 2010 when they removed some limitations to political causes, allowing unlimited donations. This led to over a billion dollars donated in the last presidential cycle. It was done in the name of free speech, but because they could blanket the airwaves with ads, I'd argue those with less money basically lost some of their free speech to rich donors.
A lot of taxpayer money is spent on prescription medications. Busy physicians don't have time to fact check everything pharmaceutical sales reps tell them. Allowing reps to say whatever they want, in the name of free speech, is not good for anyone's health, other than perhaps that of the pharmaceutical companies.
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington. This post originally appeared on his blog, World's Best Site.
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