Via ProPublica’s Charles Ornstein, I learned of a disturbing decision from the Court of Appeals for the Second Circuit. In an insane ruling, two of judges determined that a drug rep promoting “off-label” uses for a drug was exercising his freedom of speech. Let’s stroll to the back of a typical doctor’s office to see how this plays out.
Of all the ways pharmaceutical companies market drugs, two are especially distasteful (i.e. annoying, immoral, and dangerous). The first is direct-to-consumer advertising (“Having chest pain? Take Brand A aspirin! Oh, and call 911!) The other is the practice of drug company marketers (drug reps) visiting doctors’ offices.
In both cases, people whose job it is to sell a product are doing their best to get patients asking for a drug and doctors prescribing it. The drug companies argue that they are providing a necessary service: educating doctors about new drugs, the obvious fallacy being that their incentive isn’t to “educate” but to inculcate. One of the ways this practice has been regulated historically is by telling drug reps they can only promote the drug for uses approved by the FDA.
So, for example, if NewSuperDrug has been shown to improve hair growth, and that’s what the FDA has approved it for, a drug rep cannot (except perhaps in the Second Circuit) also say, “By the way, it’s also great for blood pressure. Give it a try.”
Here’s where it gets sticky. It may be true that the drug is good for blood pressure. A doctor may choose to prescribe it for that. But when it comes to marketing, the manufacturers have to stick to what they proved to the FDA (except perhaps in the Second Circuit).
This is bad—really bad. First of all, doctors shouldn’t be getting their information from drug reps. It’s hard enough parsing through the literature, with its publication biases, decline effect, and drug company shenanigans—hard, but not impossible. What’s not so hard is finding appropriate non-corporate-sponsored Continuing Medical Education (CME) credits. Conferences, websites, medical associations all give docs access to information, information less biased than that from the people who stand to benefit from your prescribing habits.
Drug reps are, by reputation, young, attractive, and sociable. They also tend to want to feed you. Many medical centers, especially the ones that participate in medical education, have banned drug reps. But doctors offices often let them in. (Full disclosure: we let them in, but don’t let them bring lunches. Certain drugs, like ALL asthma drugs, aren’t available as generics, and we need the samples.)
It’s hard for a doc like me to see how free speech enters into limiting what these folks can say. The obvious analogies (theater, fire, etc.) aren’t even needed. We regulate advertisers all the time, for example, prosecuting certain types of deception. Bait-and-switch advertising isn’t OK and we don’t see limiting it as an onerous imposition on free speech.
Drugs are pretty damned complicated and important. Telling drug companies they can’t promote their drugs except for the uses they managed to get approved is actually a good thing. Allowing them to say whatever they want gives them license to increase their sales by convincing busy doctors to prescribe for off-label uses that may or may not be OK. Yes, docs like me are supposed to know the difference, but studies have clearly shown that we are influenced by drug reps, whether we think so or not.
My advice: docs shouldn’t talk to drug reps. Cut of their access, and the companies will have to find other ways to promote their products. But since we can’t and probably shouldn’t prevent drug companies from marketing their products to doctors, we have to make it clear that this isn’t a free speech issue, but a safety and public health issue.
My guess would be that the current Supreme Court, where this case may end up, will think it’s just fine for drug reps to say whatever they want, so it’s time for doctors to stop listening.
(By the way, the answer to the question posed in the title of this post: they can both say whatever they want about their product, at least in the Second Circuit.)