Drug Ads -- Without Harmful Side Effects

As Vioxx shows, pitching medicines directly to consumers has serious drawbacks. Here are some innovative ways to get info out -- safely

By Amy Tsao

In the years that arthritis pain drug Vioxx was on the market, starting in 1998, Merck (MRK ) spent $100 million annually on ads that appeared on TV and in newspapers and magazines. The drug's rise was so spectacular, in part, because of the highly effective consumer marketing that built it into a $2.5 billion dollar revenue source for Merck before its withdrawal on Sept. 29.

Writes cardiovascular expert Eric Topol, who's chairman of the department of cardiovascular medicine at The Cleveland Clinic, in the Oct. 21, 2004, issue of the New England Journal of Medicine: "Had the company not valued sales over safety, a suitable trial could have been initiated rapidly at the cost of Merck's direct-to-consumer advertising campaign."

Vioxx is one among many blockbuster drugs to benefit from the Pandora's Box of direct-to-consumer (DTC) advertising that was opened in 1997 when the Food & Drug Administration loosened regulations on how pharmaceutical companies can advertise to a general audience. Since then, drugs that were originally meant to treat specific medical problems have become used in far broader populations.


  "Vioxx is a great illustration of what concerns many physicians," says Jerry Avorn, associate professor of medicine at Harvard Medical School and author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. "The ads distorted the medical marketplace by encouraging the use of an option that's more expensive and less cost-effective that older options."

Despite the renewed criticism of DTC advertising as a result of the Vioxx fiasco, the industry has done little self-reflection so far. Instead, Pfizer (PFE ), which makes Vioxx competitor Celebrex, has boosted its spending to fill the void. And pharmaceutical analysts expect advertising for blockbuster drugs to continue unfettered. "I don't buy the idea that the ads educate," Avorn says. "What they do is educate patients to demand more."

Like it or not, drug advertising to the masses is here to stay in the U.S. But the practice doesn't have to be as deleterious as it has been. Ultimately, the goal is to make "doctors and patients smarter buyers of drugs," says Avorn. He and others have some novel proposals on how to get the benefits of DTC ads -- without the harmful side effects:

Set up a third-party reviewer.

The FDA will now intervene with drug companies if an ad poses a clear risk to public health. Unfortunately, with the agency so continually understaffed, the rules are hardly enforced. A separate watchdog authority comprising a combination of experts among physicians, scientific organizations, and the media could be established to identify misleading ads and levy fines upon irresponsible campaigns, says Michael Montagne, professor of social medicine at Massachusetts College of Pharmacy.

Limit the kinds of ads that can run.

Another approach would have the FDA allow marketing only for completely novel products. "There would be no DTC ads for the sixth or seventh in the class," says Montagne. The first-of-a-kind drug to market (i.e. Pfizer's Viagra for impotence) would benefit most in this framework, but it would also reduce the amount ads with the express purpose of switching patients to competitors' drug (i.e. newcomers to impotence like Bayer's (BAY ) Levitra and Eli Lilly's (LLY ) Cialis).

Dr. Arnold S. Relman, former editor-in-chief of the New England Journal of Medicine vehemently opposes DTC marketing. "There is really no valid socially acceptable justification for pharmaceutical companies advertising drugs to consumers," Relman says. Though he does concede that "institutional" advertising in which companies "put their name before the public" to instill consumers' trust in drugmakers could have a place.

Add new drugs to formularies only after they're proven.

Massachusetts General Hospital came up with a novel idea 18 months ago. It waits at least six months before adding a newly approved drug to its list of approved treatments, what the industry calls a formulary. The thinking is that doing this will prevent doctors and patients from getting caught up in the hype that fuels sales of a newly approved drug. "In that six-month period when use is exploding, you can also see what adverse events come out," says Montagne.

Increase "counterdetailing."

One way to offset the effects of so much advertising would be to take a page from one of the Big Pharma's own tried-and-true methods. A "detailman" in industry parlance is one of the pharmaceutical business' most effective foot soldiers. These salespeople visit doctors door-to-door, bringing free drug samples (and probably free lunch and other handsome carrots) and a sales pitch about the product. This marketing tactic has become, for many doctors who are increasingly swamped with patients and paperwork, a primary source of information about new treatments.

Avorn, in a demonstration project funded by the National Institutes of Health, helped pioneer a practice called "counterdetailing" in the 1980s, in which a nonindustry set of detailmen were sent to doctors' offices to counter the drug company sales rep's come-ons.

"We would advocate for drugs that met criteria for evidence-based medicine," Avorn says. Doctors welcomed the clear and unbiased information, which looks every bit as polished as industry advertising but doesn't hawk any particular product, says Avorn.

Counterdetailing has reemerged in the last few years, says Avorn, who heads a successful effort at Boston's Brigham & Women's Hospital. The health systems of Pennsylvania and Kentucky will launch their own programs in the coming months, and large HMOs have also heavily invested in similar plans. "It's becoming a fairly widespread approach," says Avorn, who adds that such programs have been shown to save $2 for every dollar spent on the program.

Boost consumer education.

This part is tricky. Educating the public to adopt healthier behavior or take their medicine as they're meant to is notoriously difficult. But according to some observers, the general public does seem to suspect that so much advertising for drugs isn't benefiting them. "They're getting much more skeptical," says Avorn. "The novelty has worn off, and they're sick of them."

If people like Montagne and Avorn have their way, industry will be just one of many sources of information available to both patients and doctors. "We're starting to get more voices out there," Avorn says. Another promising development: Consumers Union, the nonprofit publisher behind Consumer Reports, is in the midst of setting up a program to help patients shop for prescription drugs more wisely.

All of these initiatives add up to the beginnings of an effective counterbalance to the drug industry's unrelenting marketing efforts. It's about time.

Tsao is a reporter for BusinessWeek Online in New York

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