DIRECT-TO-CONSUMER ADS ARE ECONOMICALLY "JUSTIFIED" ONLY FOR "VERY FEW" Rx DRUGS TO TREAT LARGE, UNMEDICATED PATIENT POPULATIONS, LIFETIME CABLE TV PRESIDENT SAYS

Direct-to-consumer advertising is economically justified only for those Rx drugs that have a large, unmedicated patient population, Lifetime Cable Network Medical Television President Tom Rockwell, MD, maintained at a June 17 session of the Natl. Assn. of Pharmaceutical Mfrs. semi-annual meeting and educational conference. To warrant launching a national media campaign to consumers, an Rx product must have a large "untapped" market, Rockwell asserted. After drugs with potential for abuse are eliminated, in accordance with advertising guidelines voluntarily adopted by Lifetime and CBS, the number of Rx drugs that "justify paying that kind of an investment" is "probably in the range of 20-30% -- and only because there is a legitimate untapped market for those drugs out there," he said. Consequently, "very few" drugs "have an honest market that's big enough to generate enough revenues to pay the cost of a national media campaign," Rockwell maintained, noting that 30-second network television ads can cost up to $200,000. "In reality, only a small fraction of Rx drugs have any economic basis for direct-to-consumer advertising," he said. "For that reason," the network executive continued, "the number of problems that people anticipate are grossly overblown." Generally, "the benefits to society from free dissemination of information, which advertising can and will support, outweigh the hazards." To the extent that advertising is dissemination of information, it can only help the public use drugs properly, Rockwell contended. For example, "fewer than one-third of the hypertensives in the U.S. are appropriately medicated," he said. In addition, "close to 8 million of the women in the U.S. taking oral contraceptives are taking formulations that, in the opinion of both the industry and the medical community, are obsolete: they have excessively high amounts of progestogen and estrogen, and they pose a hazard to the women who are taking them." Furthermore, he continued, the medical literature on patient compliance indicates "that only a small fraction, only a minority of Rxs are taken as intended." Consequently, Rockwell maintained, "we are mis-medicated; we are mal-medicated -- taking the inappropriate product very often; and in some cases we are overmedicated, particularly with regard to tranquilizers." There is "vast evidence that the current chain of dissemination of product information -- from manufacturers and from doctors to patients -- is simply failing to perform," he said, adding: "I therefore suggest to you that there is very good reason to believe that there is a widespread need for dissemination of information. I would suggest that it is virtually impossible for the medical profession to disseminate this information." Former FDA lawyer Michael Peskoe (N.Y. firm Bass & Ullman) maintained that guidelines are needed to codify agency policy on direct-to-consumer ads for Rx drugs. "Guidelines or some sort of guidance" is "necessary," Peskoe said. 'I don't think we should have to live with" a case-by-case, "we'll know it when we see it" approach to regulation. He noted that Merrell Dow has run direct-to-consumer ads for two Rx drugs -- Nicorette and Seldane -- but that neither ad mentions the product name. "How can we say the regulations are working . . . when they result in a product advertisement that does not permit the name of product to be mentioned in the advertisement but still permits the product to be advertised?" Peskoe asked rhetorically. "If the policy were such that it didn't want the advertisement to be run, it wouldn't permit it to be run. If it wanted such advertisements to be run, it certainly should permit the name of the product.