First there was Risk-Free DTC (see “DTC without the Risk“). Now there is Risk-First DTC!

Before I get into that, there’s a related story I’d like to review about how risk is communicated in the US vs. the UK.

Just when I thought the UK can do no wrong when it comes to regulating prescription drugs, I learn that its regulatory agency — the Medicines and Healthcare products Regulatory Agency (MHRA) — may be doing a worse job than the FDA warning citizens about emerging drug risks (see article here).

The issue of reporting drug risks in the US will be the subject of a Pharma Marketing Talk podcast this Thursday (see “An Innovative System for Communicating Drug Risks to Patients“).

“The concern is that, after such high-profile controversies as Vioxx and Avandia, the UK watchdog lacks initiative in encouraging doctors to file adverse event reports and most of its budget is earmarked for reviewing drugs (if this sounds familiar to American ears, well…),” says Ed Silverman over at Pharmalot.

The example cited in the article involves Avandia, which, after review by the FDA, will soon carry a black box warning that it could cause cardiovascular problems.

In the UK, on the other hand, “the only response of our drug watchdog,” claims the article, “has been to say that leaflets that come with the drug already contain warnings about heart problems.”

On the surface, this sounds that the US FDA is more proactive than the UK drug agency. But only if the FDA-required “black box” warning really is an effective warning system.

The black box certainly is not seen by consumers. I mean, when was the last time you got the package insert (official FDA drug label) when you picked up your prescription?

Yes, physicians see it, if THEY read the label. But if physicians in the UK read their Avandia label, they would get the same information as US physicians.

Besides, what with aggressive detailing of physicians by Avandia salespeople, I am sure the black box is a mere pea under the extra-firm sales mattress — hardly noticeable to the rank and file physician!

What’s needed is Direct-to-Consumer drug warnings.

This is more important, IMHO, than warnings issued to physicians who may. let us say, have certain conflicts of interest that may unduly influence their prescribing habits.

It’s interesting that Patrick Clinton, Editor of Pharmaceutical Executive Magazine, picked up on this topic in a recent editorial entitled “What Do You Say?” “I’m thinking of how companies and FDA should react to what we might as well call the ‘Vioxx [or Avandia] moment’,” says Patrick. “What should we say, what should we do, when the Vioxx moment comes to call?”

Here’s his answer:

“I wouldn’t want to see us go to the Canadian system of “pull it from the market first and ask questions later.” But the current system is obviously not aggressive enough. I suspect the answer will include both a standard format for reporting safety signals to the public—one that assesses the validity of the evidence and provides a realistic estimate of how long it will take to get more—and perhaps even some sort of informed-consent procedure. That would be a burden to physicians, patients, and pharma alike. It would certainly frighten some patients out of taking their drugs and some doctors out of prescribing them. But that may turn out to be the price of trust.

The execution may prove difficult, but the goal is simplicity itself. No patient should ever be able to say of a risky drug, ‘You knew, and you didn’t tell me.’ For everyone’s sake, that must be utterly nonnegotiable.”

In other words, TELL THE PATIENT!

Rule: If Black Box, No DTC
It’s interesting to note that whenever FDA slaps a “black box” warning on a drug label, that’s usually the end of direct-to-consumer communication (aka, advertising). The drug company goes dark on the subject of its drug as far as the public is concerned.

The FDA was going to launch a website where consumers could find emerging drug risk information, but it nixed that idea in the bud (see “Drug Safety – A Mere Asterisk to the FDA“).

Risk-First DTC
There was one notable exception to the “If Black Box, No DTC” rule of thumb: the recent 150-second Celebrex DTC TV ad (see “The New Celebrex TV Ad: What Did You Learn?” and “Celebrex Ad: Let’s Dive Deeper“).

Although this ad has been criticised for mentioning “death” several times, an article in PE Magazine suggested that this “risk-first DTC” appears to be a new tactic — “to persuade the public about a drug’s usefulness … acknowledging the negative allows the product to gain credibility, mitigates resistance and counterarguing, and permits information that would normally ‘hit a brick wall’ to be viewed in a credible context.”

Sigh! In other words, communicating risk to consumers in DTC is really a tactic to overcome resistance and get to the core benefit message.