Editorial Note: The marketing of pharmaceuticals avails of something given to no other area of marketing – the product is made available on prescription-only. In this post Johanna Ryan, from RxISK’s Community Advisory Board, spells out the risks this gives rise to. This is a theme that has come up often and one we will return to.
Direct to consumers?
If you live in the USA, I don’t have to tell you about Direct-to-Consumer Advertising of prescription drugs. You’ve seen the TV spots all the time, introducing some disease that sounds awfully serious but whose symptoms are broad enough that you start wondering if you should “Ask Your Doctor.”
Then you hear about the wonder drug that is helping sufferers Get Their Lives Back. Happy couples stroll hand-in-hand through meadows or romp with their adorable children … while a polite voiceover tells you about vague but ominous side effects, from strokes and cancer to “certain fungal infections.” (And of course, those alarming “erections lasting more than four hours” which have become a staple of TV comedy thanks to DTC ads for Viagra and Cialis.)
Many of us suspect the drug’s advantages are being oversold and its risks artfully downplayed. But we also assume there must be at least one thing restraining all that hype: If patients run to the doctor asking for the drug, and suffer harm as a result, won’t that rosy TV ad be playing for a jury somewhere soon? Surely they can sue the drug company!
Actually, no, they can’t. An earlier column on this blog told the story of Cynthia DiBartolo, who developed head and neck cancer after treating her psoriasis with Humira, a widely advertised biologic drug made by AbbVie Corp. If you don’t live in the USA, you may be amazed by this sample ad for Humira aimed at women with psoriasis.
Ms. DiBartolo faces an uphill fight for justice because of something called the “Learned Intermediary Doctrine,” which holds that AbbVie’s only responsibility is to inform the doctor of all the relevant risks – not the patient. No matter how aggressively a drugmaker advertises, they can still leave the doctor holding the bag for their failure to warn the patient. In recent years the Texas Supreme Court upheld this doctrine even in the case of a woman who watched a drug-company video at the clinic where she got her first IV infusion of the drug (Centocor, Inc. v. Hamilton, 55 Tex. Sup. J. 774). And in Illinois, a man whose doctor sent him to a patient-education class taught by a drug-company nurse was not allowed to sue the company for its failure to warn him of the risk of blindness (Hernandez v. Schering Corp., 958 N.E.2d 447).
Given the odds consumers face, perhaps these ads ought to come with their own set of warnings. Here’s my proposal for a “Devil’s Disclaimer” to run with American DTC advertising: 
THE DEVIL’S DISCLAIMER FOR DIRECT-TO-CONSUMER ADVERTISEMENTS IN U.S.A.
If you should experience any adverse effects from this medication, please note the following legal disclaimer:
Don’t Come Crying To Us. Legally Speaking, It’s Not Our Problem.
It’s true, we have used this ad to approach you about your personal medical problems while you were innocently leafing through a movie-star magazine or surfing the Net. We seem quite warm and friendly. And we have supplied you with a long list of possible side effects and contraindications, via the small print or the mellifluous voice-over. (Not that you know what a contraindication is, you poor sucker.)
However, we do not and never will have a Relationship with you. So, it’s been nice getting to know you – but no commitments, baby.
It’s not just us saying that either. The courts of just about every state in the nation are backing us up on this. So don’t go muttering about your father the police chief or your sister the lawyer. They can’t help.
Specifically, if you want to get all technical, we have no FIDUCIARY relationship with you. That’s the kind of relationship where we’d be expected to look out for your welfare, with the same degree of care that a reasonable person would devote to their own affairs. That’s up to your doctor.
All we’re obliged to do is give your doctor all the appropriate warnings, and let him sort it out for you. He’s the one that’s supposed to care, according to the courts. (Yeah, that guy – the one you just picked off the insurance company list. You can’t remember his name, and he can’t remember yours. But we’ve been snuggling up to him since he was in med school.) He’s in charge of digesting all that information, and thinking hard about how it applies to little ol’ you. And he’s the one we think you should sue if things go wrong. Let us know how that goes for you, okay? LOL.
And what if we don’t tell him everything? What if we’re manipulating what he sees in his doctor journals and his continuing-ed seminars, just like we do with that celebrity magazine you were skimming? Oh, don’t worry. The FDA will make sure we do the right thing. (We know, because nowadays we pay the bulk of their salaries. Betcha didn’t know that.) And if the FDA doesn’t catch us, then we’ll definitely pay some kind of fine in nine or ten years. That’ll keep us in line for sure! ROFL.
So don’t come around whining that we promised you this, we promised you that. To quote that old country song, Here’s A Quarter, Call Someone Who Cares.
Or as we like to say: Ask Your Doctor.
<<Insert name of drug company>>
 Here is the actual disclaimer posted on one of AbbVie’s websites:
“The content on this site has been created solely for U.S. residents. It is intended for informational purposes only and should not be used to replace a discussion with a health care professional. All decisions regarding patient care must be handled by a health care professional, and be made based on the unique needs of each patient.”