Also Appearing in This Week’s JAMA
EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, SEPTEMBER 11, 2012
Study Analyzes Changes in Pharmaceutical Advertising Following Shift to OTC Status
“The U.S. Food and Drug Administration (FDA) regulates prescription drug advertising, including requirements to provide consumers with a ‘fair balance’ of risks and benefits. When prescription drugs switch to over-the-counter (OTC) status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC). Unlike the FDA, the FTC holds drug advertisements to the same standards as any consumer product: it applies a ‘reasonable consumer’ standard of truthfulness and nondeception that does not require any balancing of potential benefits and harms. Such a shift may be associated with changes in content,” writes Jeremy A. Greene, M.D., Ph.D., of Brigham and Women’s Hospital, Boston, and colleagues.
As reported in a Research Letter, the authors analyzed all print and broadcast advertisements from 4 commonly used prescription drugs that were the subject of extensive direct-to-consumer advertising (DTCA) promotion before and after OTC shift: loratidine (OTC in 2002), omeprazole (in 2004), orlistat (in 2007), and cetirizine (in 2008). Television and print materials spanning 24 months before and 6 months following OTC shift for each drug were obtained from an advertising database, and ads were stratified by whether they appeared in print or television, and coded for descriptive characteristics, presentation of health benefits, and potential health harms.
The researchers found that after the OTC switch, 62 of 64 (97 percent) advertisements described benefits of medications compared with 57 of 69 (83 percent) during the prescription only period. “The difference was not statistically significant for individual drugs. Differences existed in the presentation of potential harms during the prescription-only period in 48 of 69 advertisements (70 percent) vs. 7 of 64 (11 percent) after OTC shift. With the exception of print advertisements for orlistat, no post-switch advertisements mentioned contraindications or adverse effects. Print and broadcast advertisements after OTC switch were less likely to mention drugs’ generic names (33 of 64 [52 percent] vs. 65 of 69 [94 percent]).”
(JAMA. 2012;308:973-975. Available pre-embargo to the media at http://media.jamanetwork.com)
Viewpoints in This Week’s JAMA
The Attending Physician on the Wards – Finding a New Homeostasis
Robert M. Wachter, M.D., of the University of California, San Francisco, and Abraham Verghese, M.D., M.A.C.P., of Stanford University, Stanford, Calif., examine the changes that have taken place in recent years regarding attending physicians, including the reasons for the marked shift in demographics (such as from older to younger attendings), consider its effects on education and clinical care, and suggest interventions that may help improve the experience of trainees as well as attendings.
“Although some challenges will be more easily addressed by junior attendings and others by senior ones, the goals are the same. All attendings will need encouragement and wisdom to take a step back, keeping a measured distance that allows house staff to achieve and demonstrate competency while still ensuring patient safety. It is time that programs, trainees, and attendings take vigorous action to balance all these competing imperatives and establish a ‘new normal.’”
(JAMA. 2012;308:977-978. Available pre-embargo to the media at http://media.jamanetwork.com)
Engaging Physicians and Leveraging Professionalism – A Key to Success for Quality Measurement and Improvement
Patrick H. Conway, M.D., M.Sc., of the Centers for Medicare & Medicaid Services, Baltimore, and Cincinnati Children’s Hospital Medical Center, and Christine K. Cassel, M.D., M.Sc., of the American Board of Internal Medicine, Philadelphia, discuss the topic of quality measurement and improvement, including the implementation of Maintenance of Certification, which includes assessment of physician performance. Also, the authors examine initiatives by the Centers for Medicare & Medicaid Services on this topic.
(JAMA. 2012;308:979-980. Available pre-embargo to the media at http://media.jamanetwork.com)
Surgical vs. Lifestyle Treatment for Type 2 Diabetes
David S. Ludwig, M.D., Ph.D., of Boston Children’s Hospital, and colleagues write that “recent clinical trials have reported that substantially more weight loss and greater likelihood of diabetes remission occur following bariatric surgery compared with medical therapy, leading to calls for earlier consideration of surgery in the treatment of this obesity-related metabolic disease. Although these studies demonstrate the lack of efficacy of conventional practices, they do not prove the inherent superiority of surgery to lifestyle change.”
In this Viewpoint, the authors consider the limitations of published research and highlight the need for clinical trials with improved design.
“Before bariatric surgery becomes a mainstay for obesity-related complications, additional research is needed to compare the efficacy and safety of these procedures with that of truly intensive lifestyle intervention, not just standard practice. Design issues warranting consideration include the need for standardization of treatment, statistical methods (e.g., superiority vs. noninferiority trial), and generalizability. Because drug and device manufacturers would not profit from, and therefore have little incentive to sponsor, lifestyle intervention, the federal government should consider funding this research as a high priority.”
(JAMA. 2012;308:981-982. Available pre-embargo to the media at http://media.jamanetwork.com)
Changing Eating Habits for the Medical Profession
Lenard I. Lesser, M.D., M.S.H.S., of the Palo Alto Medical Foundation Research Institute, Palo Alto, Calif., and colleagues write that health professionals spend a great deal of time at meetings. “Grand rounds, noon seminars, research meetings, and medical conferences are part of the life of a health professional. At many of these activities, food is available. Although some members of the health professional community have called for changes to the food environment in the community in which they live, they have paid less attention to the quality of food served at hospitals, physician offices, and at conferences.”
The authors examine steps that the medical profession can take to improve eating habits.
“The medical profession was influential in reducing smoking in the United States; it has the capacity to encourage food-system change within its own institutions. This would likely reduce caloric consumption of health professionals, promote the health of physicians, and could also cause a ripple effect in local food economies.”
(JAMA. 2012;308:983-984. Available pre-embargo to the media at http://media.jamanetwork.com)
Editor’s Note: Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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