Pharma Biz Cops to $5 Billion Drug Problem

The pharmaceutical industry is finally acknowledging that it needs a new marketing prescription after a perfect storm of waning patience in Congress, incredulousness from the medical community and growing angst among a skeptical public.

It's all led the $5 billion direct-to-consumer ad business to concede it has a drug problem.

"In a number of states across the country, there is backlash building against [pharmaceutical] sales and marketing," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America.

"This isn't five years ago. There are new challenges with respect to safety, to sales and marketing, to a wide range of issues.

We represent some very smart people that recognize the world doesn't stand still." Though Mr. Johnson declined to offer details, he said the industry trade group will examine how it brings medications to market.

"We've engaged our companies in looking at sales and marketing practices," he said. "We're also reaching out to patients, hospitals, doctors, health-care providers and others to get their input on how to address some of their concerns with respect to current marketing practices." But he stopped short of calling PhRMA's move a task force or committee.

"I'm not going to get into that, whether it's a task force or this or that. These are all internal discussions," Mr. Johnson said, also declining to comment on whether there is a goal or time frame involved.

Vytorin dilemmaThe move follows a difficult two weeks for the industry, as a recently released study on cholesterol drug Vytorin found that while it is safe and does reduce the amount of LDL, or bad, cholesterol, it does not accomplish what its marketing also promises: to reduce the buildup of fatty plaque in the arteries.

Merck & Co. and Schering-Plough Corp., which co-market Vytorin, pulled TV ads for the drug last week -- well after the study, which was completed in April 2006.

The drug makers did not release the findings until Jan. 14 of this year and continued to market Vytorin. (The Food and Drug Administration on Jan. 25 issued an Early Communication about a continuing review of Vytorin, stating that the agency will conduct a review of Merck and Schering Plough's recent trial once it receives the final study results.) Clearly it was the last thing needed by an industry already suffering from a deteriorating public trust among consumers.

A poll by the New York Institute of Technology and Gallup & Robinson found that 34% of adults aged 18 to 26 agreed with the statement: "I trust pharmaceutical companies less than I used to," and when asked to agree or disagree with the statement "Prescription-medication advertising makes people want products they don't need," 49% agreed.

But when asked to agree or disagree with "Pharmaceutical manufacturers should not advertise their products to consumers," some 40% disagreed.

Cynics wonder if this isn't the same halfhearted path PhRMA traveled in August 2005, when it issued its DTC ad guidelines, a 15-point code of conduct that shied away from mandates on the most serious issues, including a one- or two-year moratorium on advertising drugs newly approved by the Food and Drug Administration. "Self-regulation is going to be a dead end," said Robert Weissman, managing director of advocacy group Commercial Alert.

"It has been and it will be." Agency responsibilityThere is also a growing sentiment that the ad-agency community has some responsibility here as well.

A request to speak to American Association of Advertising Agencies President O. Burtch Drake was referred to John Kamp, executive director of the Coalition for Healthcare Communication, whose member organizations include the 4A's, the American Advertising Federation and the Association of National Advertisers. Mr. Kamp insisted that "DTC works. It isn't going away.

" But when asked if it should be incumbent upon agencies to be more diligent, especially in pharma advertising, he said, "Sure. If agencies are worried about their own reputation and pay attention to the veracity of their own ads and their clients' ads, yes, they should have some responsibility.

" But in this instance, Omnicom Group's DDB Worldwide, the creative agency of record for Vytorin, did not have access to the Vytorin study at any point between its completion in 2006 and its release earlier this month, according to Schering spokesman Lee Davies. DDB referred all requests for comment to its client.

"Even if DDB had the [Vytorin] study, the ability to understand that trial on the consumer side [of advertising] is almost nil. People at consumer agencies don't have the required backgrounds and, frankly, there isn't a desire to know," said one health-care-agency executive, who asked not to be identified.

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