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News release: NationalOctober 9, 2005 Contact: Kaiser Permanente Beverly Hayon, 510-271-6437 Kaiser Permanente Study Confirms Direct to Consumer Advertising Influences Physician Prescribing Oakland, CA--One of the first studies to analyze whether direct-to-consumer (DTC) advertising of drugs actually influences the prescribing practices of physicians appears in the October issue of Medical Care Research and Review. In 2001, researchers from Kaiser Permanente and UCLA surveyed 3,000 Kaiser Permanente patients. The patients were first asked if they had seen ads for the COX-2 inhibitor drugs, Celebrex or Vioxx. Patients who had seen the ads were then asked whether they had asked their physicians about the drugs. Prescription data was then analyzed to see if the patients actually were prescribed the COX-2 inhibitor drugs, whether the prescription was consistent with clinical protocols which called for reserving COX-2 inhibitors for patients at increased risk of gastrointestinal bleeding. This is the primary group thought to obtain benefit of the drugs compared to older non-steroidal anti-inflammatory drugs (NSAIDS). Results of the analysis show patients not at increased risk of gastrointestinal bleeding who saw the ads and asked their physician about the advertised drugs were 4 times more likely to be prescribed a COX-2 inhibitor than similar patients who did not see the ads. According to lead author, Michele Spence, PhD, manager, pharmacy outcomes at Kaiser Permanente, "This study shows just how much patients are influenced by DTC advertising, and how they, in turn, can influence their physicians. Much more study is needed, but this is a good start at understanding what influences patients and physicians." The study also found that some patients may benefit from DTC advertising - those who are among the population that clinical evidence shows stand to benefit from the advertised drugs. Dr. Spence added, "Our findings raise questions regarding trade-offs. The potential benefits of DTC advertising might be offset by the overuse of new drugs before they have a demonstrated record of safety and effectiveness." Since this study was conducted, serious questions have been raised about the safety of the COX-2 inhibitor drugs. A landmark study conducted jointly by Kaiser Permanente and the Food and Drug Administration and published in the Lancet showed significantly increased risk of cardiovascular events among patients taking high doses of COX-2 inhibitor drugs. Two of these drugs, Vioxx and Bextra, were subsequently removed from market. However, while the drugs were available Kaiser Permanente made significant progress in keeping the number of COX-2 inhibitor prescriptions low compared to all NSAIDS by carefully monitoring for safety and appropriateness. The results are that COX-2 inhibitor prescriptions account for less than 1 percent of the market share of all NSAIDS within Kaiser Permanente, compared to about 25 percent market share in the community at large. (At the time of the study, before both Vioxx and Bextra were removed from the market, COX-2 inhibitors represented approximately 5% of NSAID use among Kaiser Permanente patients compared to about 45% in the rest of the population.) "This remarkable study, in fact, almost certainly understates the problem," stated Sharon Levine, MD, associate executive director of The Permanente Medical Group in Northern California. "The investigators found that even in Kaiser Permanente, widely acknowledged for highly effective drug use management programs, and for robust efforts to arm clinicians with independent and unbiased information about the health value and clinical effectiveness of prescription drugs, direct to consumer advertising can have a measurable impact on use. If Kaiser Permanente clinicians' low overall use of COX-2 inhibitors was increased as a result of DTC advertising, it is very likely the approximately ten-fold higher rate of use in the community (as a percentage of overall NSAID use) would in some significant part have been driven by DTC-induced demand." In 2003, $166 million was spent on COX-2 advertising, with total sales of $4.43 billion. Total spending on DTC is now around $4.1 billion. This study was a collaborative project involving Kaiser Permanente's Pharmacy Outcomes Research Group and the UCLA School of Public Health. It was funded by the California HealthCare Foundation. An abstract of the study can be found at http://mcr.sagepub.com/cgi/content/abstract/62/5/544 Kaiser Permanente is America's leading integrated health plan. Founded in 1945, it is a nonprofit, group practice prepayment program with headquarters in Oakland, California. Kaiser Permanente serves the health care needs of 8.3 million members in 9 states and the District of Columbia. Today it encompasses the not-for-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the for-profit Permanente Medical Groups. Nationwide, Kaiser Permanente includes approximately 142,000 technical, administrative and clerical employees and caregivers, and more than 12,000 physicians representing all specialties. #####
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