• by Erik Sass  @eriksass1, January 31, 2007

The controversy over direct-to-consumer drug advertising is heating up, pitting pharmaceutical manufacturers and advertisers against doctors and academics demanding more regulation. The conflict comes at a crucial juncture for the pharmaceutical industry, as drug behemoths face serious financial challenges.

Any regulation will also have a huge impact on the ad industry; the DTC market rakes in $4.5 billion annually.

The pro-regulation side fired two shots this week in the Annals of Family Medicine, a relatively new peer-reviewed medical journal devoted to general practice produced by six respected family medicine associations.

The first volley came from Dominick L. Frosch, whose research team at UCLA claims to have demonstrated that DTC TV ads persuade Americans they're sicker than they actually are--and in greater need of medication.

Frosch, an assistant professor of general internal medicine and health services research at the David Geffen School of Medicine at UCLA, examined 38 TV ads for drugs for various ailments, including high blood pressure, cholesterol, depression and insomnia.

His UCLA research team determined that the TV ads had "virtually no educational value." They avoided descriptions of symptoms and treatment alternatives, relying mostly on emotional appeals. Frosch concluded by recommending that the government consider a ban on direct-to-consumer TV advertising.

The UCLA study was accompanied in the January-February edition of the Annals of Family Medicine by an editorial by Dr. David Kessler, the former commissioner of the Food and Drug Administration, titled "Direct-to-Consumer Advertising: Is It Too Late to Manage the Risks?"

Taking the same tack as Frosch, Kessler wrote: "No matter how much the industry claims its advertising provides public-health benefits, the amount spent promoting drugs for conditions of varying severity begs the question of whether the industry truly is acting for the public benefit."

To support this assertion, Kessler noted the results of a 2002 survey of primary care and specialty physicians by the FDA, which found that "41% of all physicians said they believed their patients were confused about a drug's efficacy because of DTC ads; 22% of primary-care physicians and 13% of specialists said they felt "somewhat" or "very" pressured to prescribe a drug when a patient requested it."

The ANA's Executive Vice President Dan Jaffe yesterday blasted Kessler for painting a simplistic picture of pharmaceutical advertising based on out-of-date information. Jaffe also wrote on his blog that Kessler downplayed the informational benefits of pharmaceutical advertising.

"DTC ads are not intended to be an encyclopedia with all possible information about a product," Jaffe noted. "The primary role of DTC advertising is to encourage consumers to discuss health issues with their doctor."

In this regard, drug ads are achieving substantial success, Jaffe insisted, citing a study by Harvard Medical School and the Harvard Business School which found that among a study group of 3,000 patients, "35% discussed a DTC ad during an appointment with their doctor, and of that population, 25% received a new diagnosis." According to Jaffe, "approximately 43% of the new diagnoses were for "high priority" conditions, such as hypertension, diabetes, depression and high cholesterol"--real conditions that can't be confused with psychosomatic or imagined illnesses suggested to the patient by drug advertising.

Jaffe argues that DTC ads play a crucial role in getting people to go to doctors, including groups that have less contact with them on average: "That's why the National Medical Association (NMA), the largest group of African-American doctors in the country, has stated there should be more DTC advertising, not less."

The drug giants would agree. In the fourth quarter of 2006, Merck, the third-largest U.S. pharmaceutical company, saw profits decline 58% in comparison to the same period in 2005. On a year-over-year basis, Bristol-Myers Squibb Co. saw net sales decline 16% in the fourth quarter to $4.2 billion. Pfizer saw net profits drop 12% in the fourth quarter, and must also contend with waning demand for Lipitor, an anti-cholesterol drug. Torcetrapib, a new anti-cholesterol drug from Pfizer, was recently nixed because of safety concerns.

Finally, Jaffe noted that the source material for the UCLA survey used ads from 2004--produced before the industry adopted new voluntary "PhRMA" standards on Jan. 1, 2006.