DRUG ADS: PRESCRIPTION FOR CONTROVERSY : Pharmaceutical Firms Bypass Doctors to Aim Pitch Directly at Consumers

“Special Update for Doctors,” shouted the full-page newspaper advertisements for a new drug that eases the sneezes of hay fever.

But don’t be mistaken. The drug maker didn’t spend $400,000 advertising in 25 big-city newspapers just to reach the nation’s medical fraternity. The real targets were the estimated 42 million Americans who suffer from hay fever and allergies, the people who routinely buy Contac, Sudafed, Allerest and dozens of other non-prescription remedies readily available at their neighborhood drugstores.

However, this ad wasn’t for any of those drugs. This was an ad for Tavist-1--a new drug available only by prescription. And when Sandoz Pharmaceuticals launched the first-ever national campaign to tout a prescription drug by name last September, it turned out to be a prescription for controversy.

For years, the drug companies and the nation’s doctors have had a distinctly close and closed relationship when it comes to marketing prescription drugs. Pharmaceutical houses have filled the medical journals with their ads. They have deployed office-to-office sales forces numbering well into the thousands. And they have showered doctors with reams of literature and countless free samples--all in the hope that the physicians will prescribe these drugs when they fill out their Rx forms.

The Tavist ad, with its huge type and plain, everyday language, showed how easily that relationship could be circumvented with a direct pitch aimed straight at the consumer. And the ads quickly rekindled a new round of debate over the ethics and effects of direct advertising of name-brand prescription drugs in the mass media.

“The pros and cons of medicine are so complex that they should be left to the folks who have the experience and knowledge to handle it,” says Dr. Eric Cohen, a Milwaukee kidney specialist and a leading opponent within the medical fraternity of prescription drug advertising. “We cannot expect lay people to make complex judgments in the area of prescription medicines.”

Robert Portman, president of a New Jersey medical products advertising agency, disagrees. Physicians and hospitals now advertise openly and regularly to attract patients. Insurance plans market their services, not just to employers but directly to their workers. So, why not advertise medicines to the people who will ultimately swallow them?

“There’s a very different type of consumer these days. The consumer’s health-care IQ has increased,” Portman says.

“The public wants more health-care information; that’s without dispute,” concedes Dr. Donald Bennett, director of drugs and toxicology for the American Medical Assn. “The question is whether these ads can supply that information in a fair and balanced way.”

The U.S. Food and Drug Administration, which regulates drug marketing, allows drug companies to advertise prescription medicines to a consumer audience. However, the agency imposes an important restriction: These ads must include a laundry list of warnings and advisories, a condition that the Tavist ad met in the tiniest of type. Still, the requirement has traditionally served as an effective barrier, particularly on network television.

Hot Issue in Congress

In the past two months, a coalition of 52 advertising agencies, media concerns and drug companies, brought together by the CBS network, has started a campaign to loosen the FDA regulations. The move did not escape detection.

Recently, three powerful congressional leaders wrote to all three national television networks urging them to reconsider their positions. Although the letter contained no open threats, Rep. Henry A. Waxman (D-Los Angeles), the chairman of an important health subcommittee and one of the signers of the letter, tersely observes that Congress can quiet the debate once and for all with an outright ban on all prescription drug advertising aimed at consumers.

“This is as hot an issue in Congress as any, including Social Security,” says Donald Evers, director of marketing communications at CBS and a leader of the advertising forces. And much of the hoopla, Evers acknowledges, has precious little to do with health care.

“There are some major economic issues at play here,” he says.

Revenue-hungry television networks, which have already made fortunes airing ads for over-the-counter headache and cold remedies, see prescription drugs as a vast, untapped source of new ad dollars. Drug companies, battered by the rise of generic medicines and skyrocketing development costs, are increasingly anxious to wring as many sales as possible out of their drugs before patents expire and generic copycats are allowed on the market.

Although a new drug typically receives a 17-year patent, at least a third of that time can be consumed getting FDA approvals to enter the market. Then it can take another four years for a drug to reach its full sales potential, leaving its maker considerably less than 10 years to cash in on the product.

Opposition to prescription drug advertising comes from an unlikely combination of groups: the American Assn. of Retired Persons, some congressional heavyweights and a highly incensed American Medical Assn. They argue that advertising can lead to increased health-care costs, more confusion among consumers about medicines and unhealthy pressure on the traditional doctor-knows-best relationship between physician and patient.

Despite the complaints and the continuing government roadblocks to effective mass advertising of brand-name prescription drugs on television, many believe that the direction has been set and that the advertising forces will eventually win.

“It’s an evolutionary process,” says Joseph Davis, president of Medicus Consumer Communications, which has created several ad campaigns for prescription drugs. “We’re in the crawl stage now.”

The issue has moved a fair distance rather rapidly.

Until the early 1980s, drug companies and their advertising agencies seemed largely content to market their prescription drugs in medical journals and through their vast networks of office-to-office salespeople. Consumer advertising was generally viewed as costly and unnecessary.

FDA Assessment Urged

And even those drug companies that were interested in testing the value of such ads were unwilling to upset the status quo and jeopardize their relationship with the FDA, which also controls the approval of a drug company’s lifeblood: its new drugs.

The climate changed in early 1982 when Arthur Hull Hayes, then the FDA’s commissioner, suggested in a speech to the Pharmaceutical Advertising Council that they explore the potential of consumer advertising. With the gates opened for them, the council members and their clients were off and running.

A year later, however, as efforts to produce these ads gathered momentum, Hull backtracked and asked for an indefinite moratorium on prescription drug ads until the FDA fully assessed the issue.

When the moratorium was lifted in late 1986, nothing had changed at the FDA. “Basically, our regulations make advertising of (prescription) drugs on television impossible from a cost standpoint,” says Kenneth Feather, acting director of the FDA division of drug advertising and labeling. “And no one in the agency is unhappy with that.”

But there are plenty of people outside the agency who are unhappy and complain that the FDA’s posture denies consumers much needed health-care information.

“Maybe the FDA’s position was legitimate 15 years ago, but not now,” Portman says. “The consumer is an active participant in health-care decisions.”

Still, the questions remain: Do consumers need to be bombarded with yet more advertising that can drive up the price of medicine? Can consumers sort out conflicting drug claims? Can complicated material be distilled to 30- and 60-second video snippets? And, finally, do mass media drug ads really bring all that much benefit to the drug makers?

Physicians, who have been among the most outspoken opponents of the ads, repeatedly argue that consumers are ill-equipped to understand the complexities of medicinal treatments and that ads would serve up more confusion more than enlightenment. In a 1984 survey, the AMA found that 84% of its membership opposed such ads.

Among the reasons most often cited are the failure of the ads to deliver balanced information and a concern that they could lead to undue pressure on doctors to prescribe certain drugs.

Bennett, the AMA’s drugs and toxicology director, acknowledges that some physician resistance also stems from a fear that their professional status is undermined when patients know too much or know just enough to challenge their authority. “Some doctors become terribly threatened by what they don’t know and having a patient bring it to their attention,” he says.

Surfeit of Information?

Nancy L. Buc, a former FDA attorney and now a Washington lawyer, contends that advertising is a potent education tool that can help consumers understand health issues. And even if consumers don’t understand everything, as advertising opponents argue, Buc says that just getting consumers to think about a particular health problem is a major “plus.”

“Television advertising reaches people who don’t have the perfect middle-class relationship with a physician,” she says.

Still, most opponents claim that ad campaigns, which can easily cost millions of dollars, are unnecessary given the large volume of health information readily available in newspapers, magazines and on television.

Dr. Phillip Lee, a federal health official in the Johnson Administration and the author of “Pills, Profits and Politics,” says advertising will increase drug prices and ultimately harm consumers, particularly the elderly who are more prone to illness. Further, Lee argues that advertising drugs by name will lead to increased prescriptions for the more costly brand-name drugs and undermine the progress that has been made on behalf of their less expensive generic substitutes.

But Alison Masson, an economist with the Federal Trade Commission and an outspoken proponent of direct-to-consumer drug marketing, argues that the strategy can lead to lower drug prices for consumers as pharmaceutical houses are forced to distinguish their products in the open market. “To keep market share, companies sometimes shave their prices,” Masson notes.

Most drug company executives have publicly shied away from the latest round of debate, preferring instead to let network executives, ad agency owners and others lead the fight.

Some observers attribute the posture to fears of antagonizing the FDA and potentially jeopardizing the progress of their drug research and development. Still others note that drug companies have little to gain from angering physicians who are responsible for prescribing the drugs, whether or not they are advertised.

“Remember, the drug companies’ customers are still physicians, and they need to be responsive to physicians’ concerns,” Buc says.

However, pharmaceutical executives say the reason for their low profile is that a mass-media ad campaign is hardly suited to every drug. In fact, drug companies say consumer-oriented ads are ideal only for new, breakthrough drugs aimed at a common disease because these offer the largest potential for big sales.

“The vast majority of drugs have very limited appeal,” notes Thomas Beckett, executive director of marketing and communications at the Merck & Co. pharmaceutical house. “And most drug companies have limited advertising resources.”

Perhaps the best example of how consumer advertising can work without causing a controversy was the series of ads created for Seldane, a hay fever drug available only through prescription.

‘Important Advances’

The FDA’s position on consumer ads posed a potential problem for Merrell Dow Pharmaceuticals, which introduced Seldane in mid-1985.

According to Kirk Schueler, the company’s marketing director, initial research showed that only one out of three allergy sufferers consults a physician about his hay fever problems. In fact, the vast majority of hay fever patients said they did not associate their physician with a potential solution to their problem.

In September, 1985, just in time for the autumn hay fever season, Merrell Dow introduced a series of radio, television and print ads urging allergy victims to ask their doctor about “important advances in hay fever treatments.” The name of this “advance” was neither mentioned nor described, a deliberate omission that allowed the ad to escape FDA requirements to include the appropriate warnings.

Even without a name, the multimillion-dollar campaign was an immediate hit. In 1987, Seldane posted sales of $160 million and was one of the pharmaceutical industry’s 20 top-selling drugs, a phenomenal performance for such a new medicine.

Although Schueler says Merrell Dow believes in consumer education, he acknowledges that the company would not have been as committed to the ad campaign if Seldane had not been the only new hay fever drug at that time that physicians were likely to tell their patients about.

Drug and advertising executives predict that the next big drug campaign will be created for the new cholesterol-fighting agents that have been hitting the market in recent months. In fact, industry insiders say they have been anxiously waiting for Merck to unveil its advertising strategy for Mevicor, its relatively new cholesterol-lowering drug. At Merck, Beckett says only that the company is currently working on a cholesterol campaign.

“You are going to see a lot of ads for new drugs in the future. . . . Drug companies are more anxious now,” says ad man Joe Davis, who created the Seldane campaign. “If we turn patients on to a drug early, then we can build up the total business.”