Bob Erlich of DTC Perspectives magazine said in a recent newsletter:

“Drug makers … need to be totally upfront about risk, educating consumers in understandable language on the odds of a serious side effect. Most consumers understand drugs have side effects, but need to know that serious side effects can occur and at what frequency.” (DTC in Perspective, January 28, 2005).

Presumably this would be done through Direct-to-Consumer Advertising (DTCA) on TV and in magazines.

In a recent New England Journal article entitled “To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs” (N ENGL J MED 352:4, January 27, 2005) the author — Ernst B. Berndt, Ph.D. — said “As an instrument promoting public health, direct-to-consumer advertising has considerable potential. But industry needs to respond to consumers and physicians, who seek more balanced communication of risks and benefits.

Less is More?

Indeed, on February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. The draft guidance “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements” encourages manufacturers to use clearer, less cluttered formats for presenting risk information and encourages them to focus their risk disclosures on the most important and the most common risks and to do so in language easily understood by the average consumer. (See “FDA Draft Guidance for Print DTCA: Less than Feared“, Pharma Marketing News, Vol 3, #2).

Ads Can’t Educate About Statistics

Is it really possible to convey adequate risk information in a 30- or 60-second DTC ad on TV?

I think not.

Take the COX-2 drug situation, for example. I find the risk information to be (1) confusing and (2) inconclusive. And that’s after reading lengthy analyses such as in Public Citizen’s “Petition to remove the Cox-2 Inhibitors Celecoxib (CELEBREX) and Valdecoxib (BEXTRA) From the Market.”

Let’s see. One study showed a statistically significant “four-fold increase” in the risk of having a myocardial infarction in patients taking rofecoxib compared with those taking naproxen. Another study showed a “two-fold” increase (3.5% vs. 1.9%).

“Four-fold” and “two-fold” sound like huge differences, but the actual numbers for both cases are VERY SMALL (e.g., 0.4% vs. 0.1%). This is a big difference for society as a whole, but it’s an insignificant risk for me whether it be 0.1% or 0.4%.

Look at it this way. Suppose I wanted to get to grandma’s house quickly and I had two different routes. One route was very long and difficult, but there was only a 1 in a thousand chance of me getting eaten by the wolf. The other route was short and easy but there is a 4 in thousand chance of getting eaten by the wolf. I’m only going to grandma’s this one time to satisfy my mom. So, what the hell, I’ll take the easy route and take the higher risk. It’s not likely that I’ll be eaten in any event.

I don’t know if this is a good analogy, but my point is that any discussion of risk needs to be weighed against benefits and that kind of discussion cannot be accomplished via DTC advertising.

Even if DTC could adequately communicate risks and benefits, not all the risks associated with a drug are apparent or revealed when the drug is launched as the Vioxx example shows. Perhaps, as in the case of Vioxx, only when long-term use data are available will risks become apparent. By then it is too late — the cow has already left the barn! Also, risks may be revealed only when millions of people have taken the drug in real-life situations as opposed to the artificial parameters of a clinical trial.

Keep in mind that DTC advertising is most intense when a new drug is launched and less so as the drug nears patent expiration. If you don’t know the risk, how can you communicate it?

Don’t Fix DTC, Solve the Problem

All this brings me back to how this problem should be solved rather than how DTC should be “fixed.” In the recent post How the FDA Can Fix DTC, I suggest that DTC advertising — at least the type of ad that mentions the drug by name — be banned during and immediately after the launch phase of a drug and until the drug company can come up with post-marketing surveillance data. This data should reveal any risks. At that point, DTC ads could convey accurate risk information.

Even so, the ads won’t be able to educate consumers about risks vs. benefits as some people would like them to do. Again, I am talking about those ads you see on TV.

So, what’s a better idea?

Not enough effort or money, in my opinion, is spent to foster the synergy between DTC broadcast and print ads and the Internet. DTC ads focus on what may be a giant step for many people – go see your doctor. They don’t emphasize enough an intermediate step – i.e., go to a website to learn more about the condition, the treatment options and the risks.

The FDA has urged that DTC broadcast ads refer viewers to an 800 number, website, or print ad to find more information. Print ads can include the full prescribing information and you can get brochures by calling the 800 number (although you might have to wait a long time; see article “Beyond DTC: Consumer Relationship Satisfaction“), but only the Web can offer in-depth education, interactivity, and personalization. This, not repetition of 30-second TV ads, is what’s needed to truly educate consumers.