|Photo: Roger L Wollenberg|
U.S. Rep. John Dingell (D-Mich.)
Related Story:Drug Companies One Step Away From More Regulation
An Ad Age Editorial
Reports that Merck & Co. and Schering-Plough Corp. kept under wraps for more than a year findings that Vytorin does not deliver results it spent more than $100 million advertising to consumers is much more than a PR disaster for the drug's co-marketers. Coming on the heels of a New York Times story that Pfizer's $2 billion drug Lyrica treats a condition, fibromyalgia, that a lot of doctors don't think exists, the Vytorin news is fanning the flames of public mistrust for the $5 billion direct-to-consumer drug industry -- and the ad business in general.
"The pharmas are in big trouble in terms of credibility," said brand expert Rob Frankel, who runs his own consultancy at RobFrankel.com. "They're just above Congress and used-car salesmen."
Results may vary
The scientific study conducted among 720 patients with hereditary high cholesterol showed that Vytorin (a combination of two cholesterol drugs, Zetia and Zocor) did not reduce the build-up of fatty plaque in the arteries as promised in the companies' marketing.
The two-year study was completed in April 2006, but Merck and Schering didn't make it public until last week. The reasons they cited were complexity of the data and their own scientific concerns, which led them to do more research. In the interim, the drug was reaping billions in sales.
That's sparked U.S. Reps. John Dingell and Bart Stupak (both D-Mich.) to write a letter to the two drug companies and the Food and Drug Administration asking why "the massive advertisement campaign for Vytorin was allowed to continue" when "the study's results may have been available to Schering-Plough and Merck officials."
There's a lot at stake here beyond drawing more political heat to the drug business. Vytorin is one of the players in the lucrative $18 billion cholesterol-drug market that includes market leader Lipitor, from Pfizer, and AstraZeneca's Crestor. Vytorin notched $1.5 billion in sales through the first nine months of 2007 according to pharmaceutical research group IMS Health, and Zetia earned $1.3 billion in sales.
High recall rate
The drug makers spent $102 million to market Vytorin through the first nine months of last year, according TNS Media Intelligence, and $83 million on Zetia. The TV spots from DDB Worldwide for Vytorin are consistently among the most-recalled by viewers according to IAG Research.
Schering-Plough spokesman Lee Davies said the company is still evaluating the schedule of the advertising, but added that information on its future ad plans is proprietary.
Dr. Sidney Wolfe, director of the Health Research Group for Washington-based advocate Public Citizen, said he isn't surprised the ads continue to run. "There's a $20 billion market for cholesterol-lowering drugs, and companies will do whatever it takes to get as much of that market as they can, even if it means letting people continue to take prescription drugs that they know are not beneficial and that even may be harmful," he said. "What's much more likely is that the companies put their stockholders above their responsibility to public health."
Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Question of relevance
"Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold," Mr. Pitts said. "DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it."
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. "The industry should absolutely explain to the general population where drugs come from and how they're made," he said. "It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
Then again, it may be too late. "Frankly, I don't think it would do any good," said Alan Siegel, chairman-CEO of strategic branding consultancy Siegel & Gale, New York. "Their advertising is ubiquitous and there's a lot of backlash from people who feel they're being force-fed drugs. Now you have this issue with Vytorin, you have high drug prices. ... I don't think more advertising is going to solve their problems. Until they do something substantive in terms of pricing and being responsible with the advertising they already do, a brand campaign for the industry isn't going to do anything."
Spotlight may move to OTC drugsDrug marketers soon may have one more thing to worry about: Congress may tell the Food and Drug Administration to scrutinize ads for over-the-counter drugs.
Two legislative heavyweights, Sen. Ted Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) late last year proposed legislation that would expand the FDA's authority and its right to preview direct-to-consumer ads for drugs sold over the counter. They could try to pass the legislation this year.
While the FDA can quash unapproved ad claims for OTC drugs, the ads typically are reviewed by the Federal Trade Commission, which handles drug ads like any others, investigating complaints after ads run.
FDA supervision could force marketers to get prior approval before running ads and subject marketers to fines not only if the ads are untruthful but also if any potential side effects aren't displayed prominently enough.
People close to the situation say Mr. Kennedy, chairman of the Senate Committee on Health Education Labor and Pensions, and Mr. Waxman, chairman of the House Committee on Oversight and Government Reform, will hold hearings on the legislation this year, but in the shortened election-year session, it still isn't clear how far they will proceed beyond that.
Ad groups are worried. They have placed the issue as their No. 1 congressional concern for this year.
"When you get a Waxman or a Kennedy, you have to take it seriously," said Jeff Perlman, exec VP of the American Advertising Federation.
Dan Jaffe, exec VP of the Association of National Advertisers, said drugs are sold over the counter precisely because there isn't as much of a safety issue as for prescription products.
"The whole point of having two categories is not to treat apples and oranges the same," he said. "To treat over-the-counter drugs and prescription drugs as equally dangerous we think is misguided."
He said he is hopeful the bills won't get a vote but also cautious.
"The people who are pushing this have to be taken seriously," he said.
Dick O'Brien, exec VP of the American Association of Advertising Agencies, said there is concern that whatever happens this year in Congress, any steps forward could increase the likelihood the measure will pass if a Democratic administration takes office next year.
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