PSYCHOTROPIC DRUG ADS MOST OFTEN MISLEADING IN UCLA ADVERTISING STUDY, HRG SAYS

PSYCHOTROPIC DRUG ADS MOST OFTEN MISLEADING IN UCLA ADVERTISING STUDY, HRG SAYS at a July 30 press conference. Public Citizen's Health Research Group called the conference to discuss its review of a recent study of prescriptior drug advertisements conducted by researchers at the University of California at Los Angeles. Findings from that study were published in the June 1 issue of the Annals of Internal Medicine ("The Pink Sheet" June 1, p. 3). Partially funded by the HHS Office of the Inspector General, the UCLA study reviewed 109 ads for 62 drugs manufactured by 27 companies. Of the 109 ads, the reviewers determined that 19 should have been rejected and 47 deserved "at the least -- major revisions." However, HRG said, "neither the Inspector General nor the authors of the study would say which [specific] ads received this harsh criticism." In a same-day letter to Sen. Kennedy (D- Mass.), HRG said it "obtained from the Inspector General the names of these 62 drugs, the names of their manufacturers, and expert reviewer criticism of the advertisements -- none of which has been previously disclosed." HRG found that of 18 ads for three classes of psychotropic drugs (tranquilizers and sleeping pills, anti-psychotic drugs and anti-depressive drugs), 15 were deemed "to merit rejection or major revision" by a majority of reviewers. Among the psychotropic drug advertisements "that would have been rejected by expert reviewers," according to HRG, were ads for Sandoz' Pamelor (nortriptyline), Lilly's Prozac (fluoxetine), and SmithKline Beecham's Thorazine (chlorpromazine). In addition, 75% of ads for birth control pills and asthma drugs reviewed at UCLA would have been rejected or revised by the reviewers, as would 55% of ulcer drug ads, 50% of pain/arthritis drug ads and 40% of cardiovascular drug ads, HRG said. "Advertisements for cardiovascular drugs were significantly less likely to be misleading than ads for psychotropic drugs," HRG noted. "One reason may be that there are more reliable methods to measure the effectiveness of cardiovascular drugs than there are for psychotropic drugs and thus less room for misleading advertisements." Of the 27 companies with ads reviewed in the study, HRG singled out SmithKline Beecham in its letter to Kennedy for "the gold medal for poor advertising." HRG said that "of the 12 SmithKline Beecham advertisements considered in the study, all 12 were found deserving of rejection or major revision by a majority of reviewers." SmithKline Beecham ads that the study reviewers said should have been rejected included promotions for Amoxil (amoxicillin), Fastin (phentermine), an anti-obesity drug, and Thorazine. Two ads for the anti-ulcer drug Tagamet (cimetidine) were among the remaining nine advertisements considered in need of "major revisions," according to the HRG review. SmithKline Beecham responded that all SB advertisements are subject to a "rigorous internal approval standard" to assure that they are accurate and "meet all regulatory standards." The company also noted that the Annals article has been attacked by a "variety of experts," including Editor-in-Chief Emeritus of the New England Journal of Medicine Arnold Relman, MD, who dismissed the UCLA report as "silly." The HRG letter to Kennedy concludes that a Canadian-style independent review board to approve advertisements before distribution should be formed and funded by fees charged to pharmaceutical companies for each advertisement submitted. HRG also urged Kennedy to support the Integrity in Prescription Drug Advertising Act of 1992 (HR 5485), introduced June 24 by Rep. Stark (D-Calif.) ("The Pink Sheet" June 29, In Brief). Stark's bill would revoke the tax exempt status of medical organizations "if their medical journals continue to publish unreviewed ads," HRG explained, and its passage would "signal a new, safer era of prescription drug advertising in the United States." Predating the HRG announcement, Kennedy and 12 other senators responded to the IG report in a July 21 letter to FDA Commissioner Kessler. The letter asks "that the FDA act quickly and decisively to ensure that prescription drug advertisements...meet the regulatory standards for quality and integrity as established by the agency." Kennedy and his colleagues stated that the study "reinforces the need for FDA to enforce its own guidelines" regarding advertising integrity, suggesting that "the agency may need to determine whether it should strengthen its own standards to ensure that the advertisements have an educational value for the health professionals that read them." At this time Kennedy has not indicated that he will support the Stark bill. In an editorial accompanying the UCLA study, Annals editors Robert Fletcher, MD, and Suzanne Fletcher, MD, also called for the establishment in the U.S. of a large, "multidisciplinary review body" similar to Canada's Pharmaceutical Advertising Advisory Board ("The Pink Sheet" June 1, p. 5). FDA Commissioner Kessler published an editorial in the same edition, stressing the "adverse consequences" that can arise from misleading advertisements. However, a May 29 "Talk Paper" issued by FDA pointed out that the study was based on 1990 advertisements, "and the results do not reflect stepped-up FDA attention to this matter and recent increased cooperation by the pharmaceutical industry."