Pharma will be faced with numerous challenges in 2006 according to experts who have responded to the 2006 Pharma Trend Survey hosted by Pharma Marketing News. The most visible challenge — i.e., the one that can affect the industry’s image the most if not handled correctly — is direct-to-consumer (DTC) advertising, which has become “a poster child for the industry and its marketing activities,” according to Pharma Marketing Roundtable member Harry Sweeney.

A large majority (68%) of respondents to the survey feel that there will be an increase in regulations of DTC by FDA in 2006 as opposed to 11% who feel there will not be any increase. [You can take the survey and add your views on trends for 2006.]

“Obviously Vioxx accelerated [FDA’s] concerns [about risk],” said Vince DeChellis, another member of the Roundtable. “The FDA is going to be pretty antsy trying to deal with public opinion, especially with additional lawsuits that will be enjoined in the upcoming months and years ahead, not to mention mid-term elections this year.”

Most experts I have spoken with believe that if the FDA comes out with new regulations, these will most likely focus on the communication of risk in consumer drug ads.

The industry, of course, has its own views on how risk should be communicated. Some industry proponents, for example, contend that risk should be presented in absolute terms rather that relative terms (see Marketing Acceptable Risk). Study data presented at a recent FDA public hearing suggest that consumers presented with drug risk information as an absolute risk were willing to accept a higher level of risk to achieve therapeutic benefit than those who were presented information as relative risk. That is, if I told you that your chances of getting a heart attack was 5 times higher if you took Vioxx than if you took Aleve, you would be less inclined to accept that risk than if I told you that your absolute risk was 0.25% under Vioxx vs. 0.05% under Aleve. Neither of the latter two numbers are big enough to worry about, but a 5-times increase just sounds bad.

I believe that risk communications to consumers should be in terms of relative risk, not absolute risk. This fits with industry rhetoric about “choice” as in more drugs that treat the same condition give consumers a better choice. To make an informed choice, it’s best to compare one drug to another and relative risk is the way to go. That’s how I buy computers and other stuff — by side-by-side comparison of features (risk is just another feature of a drug).

However risk is communicated, pharma’s marketing messages and PR need to be better aligned with regard to drug risk. If all drugs have risks as the industry PR says, then all drug ads should adequately convey that risk. FDA needs to provide the ground rules for how this should be done, otherwise we will end up with a crazy quilt and consumers will be even more confused.

Another misalignment between marketing and PR has been around the issue of the educational merit of DTC ads. Some pharma executives (e.g., Pfizer’s CEO Harry McKinnell) go so far as calling consumer ads “direct to consumer education.” Readers of this blog know that’s a bit too far for me!

ED Category: The Good Poster Boy?
To achieve better alignment with what the industry says in its PR, therefore, DTC ads must become more educational and also better at communicating risk. Oddly enough, the therapeutic category that is leading the way is the erectile dysfunction (ED) category, which has been the “bad” poster boy for the drug industry for years and exemplified everything that was wrong with DTC.

New ED ads, however, feature a real doctor talking about risks associated with taking ED drugs and other ED ads are unbranded and talk about the risk factors for developing ED Schering-Plough and GSK, marketers of Levitra, are running ads that talk about high blood pressure, high cholesterol, and diabetes as risk factors. The ads direct viewers to a Web site where they can get a Men’s Facts Kit. (I sent for mine, but haven’t received it yet.)

[BTW, SP/GSK’s unbranded ads break a rule in drug advertising that says that such ads benefit the market leader — Viagra in this case — more than the product sponsoring the unbranded ad. In this case, however, a rising tide floats all ships. Sales in the ED market have not been up to the industry’s expectations (see “Why are ED Sales Falling?” and “ED Sales Limp“) and any increase will be welcome. Levitra may still be number 3 in its share of the pie, but the pie will be bigger if the new ads work.]

With these new campaigns, the ED category may become the “good” poster boy for the industry. I hope so. The whole world — at least the world that matters most to pharma (i.e., the US consumer) — is watching!