Sunday, August 14, 2005

Pfizer DTC Pledge: ED is Litmus Test

Pfizer recently announced changes to its direct-to-consumer (DTC) advertising of prescription drugs (see "Pfizer Announces Improvements to Consumer Advertising for Prescription Medicines"). The Pfizer pledge promises improvements before the end of 2005 and is not limited to new products. You may wish to compare this with the Bristol-Myers Squibb "DTC Communications Code" (see "New DTC Principles Emerging"), which applies to newly launched drugs. Pfizer's new rules are consistent with PhRMA's DTC guidelines (see "PhRMA Finalizes DTC Principles"), which were released on August 2, 2005.

I comment below on just a few of Pfizer's pledges that I think are noteworthy, need some more clarification, or fall short. I also anticipate how these rules may (or should) be applied to future erectile dysfuntion (ED)/Viagra ads. These ads will be the litmus test of Pfizer's new commitment to making improvements to its consumer advertisements..


A 6-month "DTC Moratorium"

While the PhRMA guidelines recommend that DTC ads be delayed for a period until physicians are adequately informed about bew drugs, the Pfizer pledge specifies a 6-month moratorium (BMS specified one year, Senator Frist suggested 2 years).

However, I am not sure exactly when this 6-month period is supposed to start. Pfizer pledges to:

Educate physicians about new prescription medicines prior to beginning product TV and print advertising so that doctors can be well-informed about a new medicine before patients start conversations about it. The length of time used for physician education will be no less than six months and will vary depending on the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and health care providers' knowledge of the condition being treated.
This has been interpreted as "a pledge not to advertise new drugs directly to the public for at least six months after they enter the market" (FDLI SmartBrief, an industry news service). Other news outlets also interpret this pledge as a moratorium beginning AFTER drug approval. But as I pointed out before regarding the PhRMA guidelines, the wording does not strictly say "after FDA approval" and Pfizer could comply with this pledge by educating physicians about a new drug months or even years BEFORE it is approved. It is perfectly legal for them to do so using third parties (e.g., CME providers) as long as the drug tradename is not used. Drug companies ALREADY support this physician education about "new treatments" coming down the pike PRIOR to the actual launch of the product.

Another hint is the use of the word "educate", which the industry now separates from branded detailing. That is, when they say "educate," it often means non-branded "continuing medical education" carried out by their professional services people rather than sales reps.


However, since no one else is interpreting it this way, I'll just go with the flow, read between the lines, and assume that Pfizer means that this physician "education" will happen AFTER the drug is approved. It would be good if Pfizer added the words "after launch" or "after approval" so that we don't have to read between the lines!


Disease Awareness and Compliance Focus

The second Pfizer pledge that I find unique and interesting is the promise to "invest a meaningful amount -- on par with what it spends on a branded advertisement campaign" to create non-branded ads such as disease-awareness ads and compliance ads. This only applies in 2006, however. Anyway, it's better than nothing.


According to TNS Media Intelligence data quoted in the Wall Street Journal article "
Pfizer to Promote Health Awareness," Pfizer spent more on DTC advertising in 2004 ($667,815,000) than any other pharma company. If this budget is split between branded and non-branded DTC in 2006, then Pfizer will be making a substantial contribution -- at least a quarter of a billion dollars -- to its disease awareness and compliance effort.
NOTE: These numbers may vary. Pfizer is clearly cutting back its DTC spending. For the first 5 months of 2005, Pfizer spent only $187,985,000 on DTC. At that rate it will end up spending only $451,164,000 in 2005, about 35% less than it spent in 2004. If that rate of decline were to continue into 2006, Pfizer would only spend about $300,000,000 on DTC in 2006 ($150,000,000 for non-branded DTC). However, you have to factor in that much of the decline in ad spending in 2005 may be due to the fact that Pfizer agreed not to advertise Celebrex or Bextra.
It's Good to be the King!
Even though non-branded ads will benefit competitors with drugs that treat the same conditions as Pfizer's drugs, most of the benefit would go to the market leader -- i.e., Pfizer. As pointed out by the WSJ: "Pfizer has leading drugs in many disease categories, such as Lipitor for cholesterol, that would stand to gain a larger share of any increase in prescriptions prompted by increased disease awareness."


ED is the Key

The litmus test for all these promised changes in DTC advertising is how the new rules are applied in the erectile dysfunction (ED) market.


I eagerly await Pfizer's disease awareness ads in this category. Will there be illustrative animations such as the ones we often see explaining overactive bladder?


The Viagra.com Web site has a very good video explanation of ED. While it does not include an animation, it's a pretty good explanation of what ED is and how Viagra works. (Levitra.com may have more information, but it's not animated; Cialis.com has text only.)


Of course, now we will see ED drug ads only during appropriate shows -- Pfizer says " all [ED] TV ads will be aired during programs that have more than 90 percent adult viewership."


I'd like to see a list of those shows, which I suspect are few and far between. I can think of only 3 shows that qualify: reruns of "Sex and the City," BassMasters, and the senior PGA golf tournament. Definitely out of the mix will be sports shows like baseball and football - right?


Use of Celebrity Spokespersons

In its announcement, Pfizer specifically called attention to its "Why Live With Depression" campaign that featured actress Lorraine Bracco (Tony Soprano's psychiatrist in the HBO series "The Sopranos") as a model for what it plans for its new disease awareness emphasis. Clearly, the new rules do not put a stop to this practice, which was criticized when Dorothy Hamill was used to promote Vioxx.


I noted above that Pfizer, according to its own rules, should not be running Viagra ads during the World Series or Super Bowl or any other sport event (other than perhaps the senior PGA tournament) -- because kids watch these programs. However, nothing in Pfizer's pledge will prevent it from promoting Viagra
at sports events such as Nascar races. Nor will the new rules prevent the use of sports celebrities as spokespersons.

Senator Frist, in his statement about DTC advertising (see "
Deconstructing Frist on DTC"), has frowned upon these practices. So it may behoove Pfizer to tread carefully using the sports connection. How about replacing the branded Mark Martin Viagra race car with an unbranded ED car? Yeah, that'll work!

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