Some experts are worried that the recent COX-2 FDA advisory committee vote to ban direct-to-consumer (DTC) advertising of COX-2 drugs is a harbinger of stricter DTC regulation by the FDA across the board.

Every few years it seems the FDA is motivated to come up with new regulations for DTC advertising. In February 2004, for example, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. This included guidance concerning the acceptable alternatives to the lengthy, detailed, and technically-written brief summary of risk information for consumer-directed print advertisements for prescription drugs. The industry breathed easier after seeing the guidances issued because they expected much worse (see “FDA Draft Guidance for Print DTCA: Less than Feared“).

Do pharma marketers have more to fear this time around?

The Vioxx debacle is seen by many as a turning point for DTC advertising (see, for example, an article in Sunday’s San Francisco Chronicle “HARD SELL: HOW MARKETING DRIVES THE PHARMACEUTICAL INDUSTRY: The side effects of drug promotion“). Several members of Congress and industry critics are calling for FDA reform. Even most pharmaceutical marketing executives agree that some kind of reform is necessary (see the latest results of a Pharma Marketing News poll summarized in the article “Does the FDA Need to be Overhauled?“). Who knows, reforms may lead to new FDA powers to limit or ban DTC.

Defenders of DTC laissez-faire posit that many beneficial and powerful drugs (e.g., statins that treat high cholesterol, cancer drugs, and anti-depressants) have serious side effects, yet they are allowed to be advertised. If FDA restricts one category of drugs, what’s to stop them from restricting all? It’s the classic slippery slope argument.

The “better solution,” some experts say, is to “explain risk in DTC ads in an understandable way using realistic odds of occurrence.” (I should mention that these “experts” are not unbiased but have substantial financial interests in the continuance of DTC as is; in fact, they would rather see more DTC, not less.)

Let me argue against this solution. At least let me suggest that it is not the only better solution (there may be others) and that it may not be a solution at all!

There are Other Solutions
First, there are other solutions such as the one I suggested about banning DTC advertising of newly-approved drugs until the risks are better known through required post-approval surveillance (see “How the FDA Can Fix DTC“).

When Vioxx came on the market and was heavily advertised to the public, its risks were not known (or the risks were covered up by Merck, see “Who Should Pay for Merck’s Obstructionism?“). So the ads had no risk to communicate even as thousands of people taking Vioxx may have been dying from side effects.

As reported in the SF Chronicle article cited above: “The way it used to be, if a drug got approval, its use would increase gradually over time,” said Kessler, who is dean of the UCSF School of Medicine. Thus, when unexpected side effects surfaced, he said, relatively few people had been exposed to the risk.

In recent years, though, new medicines explode into widespread use before they build up a safety track record, said Kessler, who prevented the widespread use of drug commercials on television when he was FDA commissioner. “Many more people are going to be exposed. That’s the nightmare.”

Banning DTC — even in the limited fashion that I suggest — is probably not something the FDA can do. It can make it very hard to do DTC and put pressure on drug companies to voluntarily stop DTC advertising (as it did with Pfizer). But it would take additional authority for the FDA to actually ban DTC.

AN ASIDE: I note with interest an opinion piece (“Dose of caution for new cures“) by Michael Castleman, a San Francisco medical journalist, who suggested a “probationary drug approval” scheme similar to the reform I suggested back in January (“How the FDA Can Fix DTC“). “The FDA could institute two-tier approval,” says Castleman. “Initially, new drugs could be granted probationary approval, meaning that they look safe and effective based on studies involving a few thousand users. But final approval would have to wait for, say, five years. That’s enough time for a clearer cost-benefit picture to emerge. Currently, nearly all drug recalls take place within five years of approval.”

Given the limited patent life of new drugs, five years without advertising is a long time. My scheme calls for extending the patent life of drugs to make up for this lost time and to give drug companies an incentive to support the post-approval surveillance studies that will be necessary to determine risks, if any.

Communicating Risk in DTC is Not a Solution
My second criticism of the communicate risk solution is that communicating risk in a 30-second or 1-minute TV ad is a tricky proposition at best (see “Can Drug Ads Communicate Risk?” and “Numbers, Math and Communicating Risk“).

In the current conservative, so-called “ownership” political environment, we consumers are being asked to assume more and more risk while the government is being phased out of the consumer-protection business. However, I don’t think consumers are ready to go it alone to determine their drug side effect risk profile. The information they need can’t be easily communicated in an unbiased fashion and even if it could, consumers are not mathematically trained to evaluate the risk.

I tested this out on subscribers to Pharma Marketing News, the vast majority of whom are college-educated pharmaceutical experts. I asked them to take a Clinical Trials Brain Teaser, which was based upon a recent article published in the press (I won’t reveal the source because I want you to try the math).

So far, out of a dozen responses, none got the mathematically correct answer and only 2 (17%) were close (but no cigar)! If these people cannot calculate risk, how can you expect your mom to do it?

Of course, you do not have to be a math whiz to determine if the risk of a drug is worth the benefit to you. But who should you depend upon to communicate risk to you — mathematically or not? Should it be DTC advertisers who have a financial interest in the success of the drug? Should it be the FDA with its ties to the drug industry? Should it be your physician? I would vote for the latter, but with the caveat that the physician not be beholden to the drug company selling the product. But that’s a sub-topic of another post (see “FDA Advisory Panels: Elephants in the Room“).