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CHP research presented at FDA hearing by Heather Woolwine Public Relations One group feels the need for more restrictions. Some want nothing to change. Still others want it stopped altogether.   Without a doubt, consumer-directed advertising for pharmaceutical products remains a hot topic in American media and for policy-makers in the federal government.   Dr. David Bradford During the last week of October, research led by David Bradford, Ph.D., MUSC Center for Health Economic and Policy Studies director, was presented as evidence related to this controversial topic at a public hearing held by the U.S. Food and Drug Administration (FDA) in Washington, D.C.   “There was a real mix of industry, academic and special interest representatives at the hearing, all focused on the content of the advertisements, how risks and benefits of the drug were communicated to consumers and other related issues,” Bradford said. “The work that we’re doing here at the center, and the evidence we presented at the meeting, looks at how the commercials affect patient health instead.”   With nothing on this particular topic in research literature, Bradford and his colleagues hypothesized that these commercials would affect patients’ behavior when it comes to seeking out drug therapies.   Two studies funded by the federal government provided insight into two classes of drugs, the advertisements that boast them, and how those advertisements affect patient outcomes. “We were interested in using clinical data and advertising data to determine if an increased amount of exposures to this kind of advertisement led to better patient outcomes,” Bradford said.   The studies focused on two drug classes, statins and Cox-2 inhibitors. Bradford chose to present the information pertaining to Cox-2s during the hearing because these drugs (Vioxx and Celebrex) are meant to alleviate pain and were in the media recently.   With the help of an extensive, nationwide medical records database (Practice Partner Research Network) compiled throughout the last decade by Steve Ornstein, M.D., Family Medicine; Bradford pinpointed patients with a diagnosis of arthritis. From there, patients living in areas with a high concentration of advertisements for Vioxx and Celebrex were noted on the amount of time it took between their initial diagnoses of arthritis and when they began taking this class of drugs.   Things became a little tricky once it was established that there were issues for patients with cardiovascular problems taking these drugs, with a widely reported link to heart attacks.   This would seem like a setback, but instead, it became an opportunity.   “With learning more about the side effects for certain patients, we separated patients into good candidates for this class and bad candidates for this class of drugs,” Bradford said. “Good candidates had gastrointestinal problems (drugs decrease stomach irritation) and bad candidates were those with cardiovascular disease. You would expect that overall, increased advertising would shorten the amount of time between diagnosis and beginning the medication.   “Prior to 2001, that was the case. However, after 2001, bad candidates who were in areas with more advertisements waited longer to approach their physicians about using the drugs and good candidates saw their physicians the same as before. As recommended by physicians, patients with heart disease tried other means and therapies first, before taking the risk of using these drugs.”   What Bradford’s study showed was that the claim that consumer-directed drug advertising does not carry useful information and endangers patients was unfounded. In addition, it seemed that careful consumer-directed advertisements could positively affect patient outcomes. By viewing the advertisements, study participants went to see their physicians, which is not necessarily a bad thing.   “A 15- or 30-second commercial provided real information to patients and seemed to help match patients and therapies,” Bradford said. “It is potentially an efficient way to get treatment information into the hands of patients.”   Bradford professed his belief in the “leave it as it is” philosophy for consumer-directed drug advertising regulation, and in MUSC’s commitment to health economics and policy oriented research. “As director of this center, I want to affect the world and its health, as does MUSC,” Bradford said. “MUSC and the College of Health Professions Department of Health Administration and Policy employ one of the largest concentrations of health economists in the Southeast. Our method of bringing together health economic expertise and clinical issues that need to be addressed make us a unique voice in important policy questions.”   Friday, Dec. 9, 2005 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to petersnd@musc.edu or catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Community Press at 849-1778.