DTC without the Risk

The Coalition for Healthcare Communication (CHC) -- comprised of major advertising, marketing and PR organizations, including the American Association of Advertising Agencies, the Association of National Advertisers, and the Public Relations Society of America -- filed a Citizen Petition with the Food and Drug Administration today asking the FDA to formulate new rules governing consumer advertising of prescription drugs (see "Coalition for Healthcare Communication Seeks New Prescription Drug Advertising Rules").

The proposal calls for the elimination of specific risk information in print and broadcast DTC (direct to consumer) advertising. You know, things like erections lasting 4 hours or longer and sleep binge eating; great material for comedians but a royal pain in the ass for advertisers.

It is very difficult, if not impossible, to communicate risk in the current DTC format -- mostly 60-second TV ads (see "Can Drug Ads Communicate Risk?"). The problem has led many influential stakeholders -- including Senator Frist (see "Deconstructing Frist on DTC") -- to call for a ban or moratorium on DTC. In fact, PhRMA -- the drug industry's trade association in the US -- suggests "companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign" (see "PhRMA Finalizes DTC Principles"). Not a call for a moratorium exactly, but a tacit recognition of the problem.

Instead of eliminating DTC or grappling with how to communicate risk, the CHC simply wishes to do away completely with the necessity to communicate risk in DTC -- including print and Internet DTC! And they call themselves communicators!

CHC's argument goes something like this:

1. Consumers are too dumb to weigh all the risks vs. benefits [CHC doesn't use that derogatory term. Their petition uses the more PC phrase "consumers with different educational and economic backgrounds"]
2. Only prescribers -- "learned intermediaries" -- can do this
3. DTC ads are effective at getting consumers to visit their doctors and ask about treatment and not effective as an educational tool
4. DTC ads, therefore, should not mention specific risks, just say that there are risks and direct consumers to discuss these risks with their physicians.

QED.

Here's what the CHC envisions the risk statement in a DTC ad to look like:

"Like all drugs, [drug name] has both benefits and risks. [Drug name] is only available by prescription, and your doctor can explain how [drug name] is likely to affect you. Be sure to tell your doctor about all of your medical conditions, and about any other medications you are taking, because this information could affect whether you should take [drug name]. Remember, only your doctor can decide if [drug name] is best for you."

The onus is plainly on the physician. This is the "learned intermediary" doctrine, which has seen better days (ie, starting in 1951 when Congress required FDA to identify drugs requiring a prescription to be filled by a doctor rather than bought over the counter). "Under this rubric," says CHC, "courts recognized that drug manufacturers owe duties of specific side effect disclosure to practitioners, rather than patients, and that practitioners must take responsibility for understanding those risks, relating them to the clinical situation of the patient, and counseling the patient appropriately."

There is one problem -- OK, maybe a few problems -- with the learned intermediary doctrine: how learned is the intermediary? The "duty" of the manufacturer to inform doctors of drug risks has been under scrutiny lately in VIOXX trials and other news that brings into question whether or not drug companies are being completely transparent about risks in communications to physicians (see, for example, "Merck's Hand in the Cookie Jar").

CHC itself cited a New Jersey Supreme Court view that stated physicians play a "much diminished role as an evaluator and decisionmaker" with respect to prescription drugs and that manufacturers using DTC must take responsibility for comprehensive risk disclosure to patients. The CHC's petition effectively retorts: "Not in my backyard (ie, DTC advertising) you don't!"

Another small criticism of the learned intermediary doctrine: it seems a bit quaint in this day when patients have access to the same information as physicians and often surpass them in the knowledge of medications (of course, I am not talking about those "different" patients). Besides, patients are now being asked to make more decisions about their own healthcare -- like how to spend their insurance dollar (heard of "consumer-directed healthcare" anyone?)

According to the CHC, "the patient is the decision-maker only with respect to whether a practitioner should be approached." How atavistic can you get?

The CHC cites a couple of dangers of including specific risk information in DTC:

1. "Patients may conclude innocently, but wrongly, that an FDA-endorsed brief summary tells them all they need to know about the risks of taking a particular drug, and
2. "they may purchase the drug without a prescription or meaningful diagnosis from 'bargain' web sites, or other non-US sources, thus endangering their health."

Point (1) goes under the "patients are dumb" heading. Funny thing -- a couple of paragraphs up in the CHC's petition, they say that OTC drugs (over the counter drugs; do not require a prescription) may be used safely by patients without medical guidance. Keep in mind that OTC drugs used to be Rx drugs. The side effects don't magically disappear when a drug is switched to OTC, but suddenly, consumers are smart enough to weigh the risks against the benefits of the drug without a physician to help them!

Point (2) is the Internet and Canadian Pharmacy Bogeyman scare tactic, which is often used by the drug industry (see, for example, "PhRMA's Terrorist Plot"). I won't say any more about that.

Obviously, I could go on all day about this. I prefer, however, to open this up to your comments: Take the Online Survey Now! Your responses are confidential and you may remain anonymous. You can view the de-identified results as soon as you complete the survey. Thanks!