Medicine: Excess Marks the Spot

The FDA blows the whistle on abuses in new-drug ads

Every year scores of new drugs are launched on the American market. Most of them are variations on an existing medicine; the greatest distinction of the newcomer usually is a catchier name. Of the 96 drugs approved last year, only three were judged by the FDA to represent important therapeutic gains. As a result, to push their sometimes unneeded new products, drug companies pour their energy and money into advertising and promotion. Last year $215 million worth of advertisements were placed in the 150 leading medical journals, and that represents only the smallest part of the typical drug promotion campaign. Hundreds of millions more go into snazzy exhibits at medical meetings, glossy brochures presented to doctors by company “detail men,” and “educational” videotapes for physicians.

The number of new-drug approvals has been rising. So much so, says Lloyd Millstein, acting director of the FDA’s drug advertising and labeling division, that there has been “a general increase in the level of advertising and competition in the marketplace.” The overheated atmosphere has led to marketing tactics that the FDA finds worrisome. Among them: the advertisement of drugs before they are approved, the promotion of prescription drugs not only to doctors but also to consumers, the increasing use of comparative ads in which the deficiencies of competing brands are cited, and a growing tendency to make promotional claims that, according to Millstein, fall “outside the limits of good advertising.”

The latest example of such excess was the promotion of nifedipine, a heart medication marketed by Pfizer Inc. under the brand name Procardia. Introduced with a splashy campaign after approval in January, the drug racked up $17 million in sales in twelve weeks, vastly outselling verapamil, a similar product marketed by the Searle and Knoll pharmaceutical companies. Late last month the FDA blew the whistle. In a ten-page letter issued to Pfizer, the agency complained that the Procardia campaign was “false and misleading in its overall message,” and that by misrepresenting important warnings, it “increases the risk of serious adverse reactions to patients.” Procardia is a valuable treatment for chest pain (angina) caused by coronary-artery spasms, but according to the FDA letter, it was being promoted as a “first-line” treatment for all types of angina, despite the fact that Pfizer’s own research indicated other drugs were as good if not more useful in most cases. The agency also took issue with Pfizer brochures comparing Procardia with verapamil. The comparisons, said the FDA, “emphasized only the advantages of Procardia by making carefully worded positive statements about nifedipine and then remaining silent regarding any similar actions of verapamil.”

To correct the abuses, the FDA ordered Pfizer to revise its promotional material, send letters to all physicians who might have received the original literature and publish “remedial advertisements” in two issues of each publication carrying the objectionable ads. Last week Pfizer informed the FDA that it has begun to make those amends. In addition, says company Vice President Dr. Sheldon Gilgore, “we’ve decided to stay out of comparative advertising for now.”

The Procardia letter is not the only example of an FDA corrective attack on drug-advertising practices. Last June the agency ordered Eli Lilly and Co. to revise the press kit it had prepared on Oraflex, an arthritis medication. The kit contained releases implying that the drug could retard the course of arthritis, a claim based on inconclusive animal studies. Lilly had taken the bold course of promoting its product directly to the consumer, and the misleading claim was trumpeted in newspapers and on television. The result was an enormous demand: more than $6 million in sales for Oraflex in the first month. Ironically, the big demand may have resulted in the drug’s downfall. Oraflex was withdrawn from the market last month after it was linked to eleven deaths, mostly among patients who were poor candidates for the drug. If it had been promoted less zealously, perhaps fewer of these patients would have urged their doctors to prescribe it. Predicts Industry Watcher Michael Smith of Pharmaceutical Data Services, Inc.: “The fallout from Oraflex is that companies will become more circumspect.”

The FDA hopes so. Agency Commissioner Arthur Hull Hayes has already indicated that he will more closely monitor promotional statements made in press kits and at scientific conferences, especially for the huge heart and arthritis markets, where the rewards for overstatement are most tempting. In addition, the agency has issued guidelines to control the growing practice of advertising drugs before they are approved. Henceforth, such ads may not make any claims about the safety or efficacy of a product, and if a drug is named, the ad cannot detail its uses. Ciba-Geigy met these requirements by not naming the antidepressant drug Ludiomil in its teaser preapproval ads; one FDA official, however, has informally criticized preapproval drug ads by five other companies. Says Hayes: “We at the FDA have an obligation to work with those who have the power of the pen and the advertising buck to see that the right stuff gets out.”