Booming of Direct-to-Consumer Ads of Medicines Disquiets Critics

Drug company spending on direct-to-consumer advertising continues to skyrocket, even while criticisms against it have soared. Calling meant for a moratorium, rather than just restrictions, on this kind of marketing might be to be able, state the authors of a report in the Aug. 16 problem of the brand new England Journal of Medicine.”Direct-to-consumer marketing spending is increasing with regards to its talk about of total marketing spending budget, but it’s still a smaller share in accordance with promotion targeted at influencing prescribers,” stated study author Julie M. Donohue, an assistant professor of wellness policy and management at the University of Pittsburgh Graduate School of Public Health. The U. S. Meals and Drug Administration started permitting direct-to-consumer marketing of prescription medications on television 10 years ago. After that, spots of Dorothy Hamill and Sally Field peddling Vioxx and Boniva, respectively, cartoon character types illustrating the effects of the antidepressant Zoloft, and an array of similar promotions have grown to be commonplace on American Television displays and in other mass media. But so, too, has criticism of the practice. Skeptics state that direct-to-consumer marketing encourages overuse of medications and drives up drug spending. The controversy reached critical proportions when the arthritis drug Vioxx, probably the most heavily promoted medications ever, was withdrawn from the market in 2004 due to serious cardiovascular risks.”It has been 10 years because the FDA clarified its plan with respect to broadcast marketing and unleashed direct-to-consumer marketing on television, that was new,” Donohue said. “We wanted to see, in the wake of the Vioxx withdrawal and an elevated focus on the basic safety of drugs and a concentrate on medication costs in light of the implementation of the new Medicare drug benefit, what sector and the FDA were doing with respect to advertising.”For this evaluation, Donohue and her co-workers viewed pharmaceutical company shelling out for direct-to-consumer advertising and promotion to physicians in the last decade. Total pharmaceutical industry spending on promotion soared from $11.4 billion in 1996 to almost $30 billion in 2005. Throughout that time, spending on direct-to-consumer marketing increased by 330 percent, yet this type of advertising just produced up 14 percent of total promotional expenditures. These mass-media advertising blitzes generally start before a drug’s safety background has been established available on the market, the researchers said.”In most of heavily advertised medications, direct-to-consumer marketing starts within in regards to a 12 months of FDA authorization and typically well before the safety profile has been established,” Donohue said. The many heavily marketed medication in 2005 was that “little purple pill,” Nexium, a proton pump inhibitor heartburn medication, on which AstraZeneca spent $224 million. Next arrived the sleeping tablet Lunesta ($214 million), accompanied by the cholesterol-lowering statins Vytorin ($155 million) and Crestor ($144 million), after that Advair, a corticosteroid ($137 million). Viagra was 17th on the list, with $80 million spent in 2005.Eight of the very best 10 drug classes in terms of sales had at least one item that was promoted through DTC advertising. Producers of proton pump inhibitors, statins and erythropoietin medications (drugs such as for example Procrit, which increase reddish colored blood cell counts) spent 34 percent, 34 percent and 31 percent of their total marketing budget on direct-to-consumer advertising in 2005, respectively.”In nearly all top-selling classes, at least one drug is advertised to customers and in over fifty percent of the classes multiple medicines are advertising to customers, so that it really does perform a major function,” Donohue said. “DTC marketing is used for a small subset of drugs, whereas other forms of advertising like ‘detailing’ [person-to-person meetings] and free samples are used by manufacturers for virtually all branded products.”The antidepressants referred to as selective serotonin reuptake inhibitors (SSRIs), such as Celexa, Paxil, Prozac and Zoloft, led the field in promotional spending with an increase of than $1 billion spent in 2005. Next had been statins ($859 million), then proton pump inhibitors ($884 million).Simultaneously, Donohue stated, “The FDA’s monitoring of drug advertising has not kept speed with the volume of advertising of prescription drugs. The amount of warning letters going out to drug companies has decreased markedly [from 142 in 1997 to 21 in 2006], and the amount of FDA staff accountable for ads was relatively flat in recent years, in spite of spending increases.”It may be that the rules themselves are sufficient, but that enforcement powers aren’t.”My look at is that the advertising rules that are on the book at this point are adequate. Prescription drug ads are among the most heavily regulated advertisements if you look at all the consumer products,” Donohue said. “But the enforcement of the regulations needs to be there as well, and resources necessary for reviewing advertisements have to be sufficient.””And drug manufacturers do not have to have FDA authorization of advertisements before airing them, so an advertisement campaign can run its course prior to the FDA can review the advertisements,” she added. In response to the analysis, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), stated in a statement: “DTC advertising has been shown to play a key role in educating and empowering patients, improving patient understanding of disease and available treatments, and fostering strong relationships between individuals and their health-care providers. Unfortunately, the study published today in the New England Journal of Medication all but overlooks these essential contributions to patient wellness.””Surveys display that DTC marketing brings patients into their doctors’ offices and assists start essential doctor-patient conversations about conditions that may otherwise move undiagnosed or untreated. In fact, a national study by Prevention Magazine discovered that 29 million patients talked to their doctor for the very first time about a health condition after viewing a DTC ad. The survey also discovered that of the patients, many discuss behavioral and changes in lifestyle and over fifty percent get a recommendation for nonprescription or generic alternatives,” the declaration said. Dr. A. Indicate Fendrick, a professor of health management plan at the University of Michigan College of Public Health in Ann Arbor, said: “As the health-care consumerism movement encourages more data on cost and quality, it really is increasingly important to consider the source of information.””This study confirms that direct-to-consumer advertising of medicines is here now to stay and can contribute to the info overload confronted by the normal consumer. Individuals, clinicians and payers should interact to implement steps to maximize the positive facet of DTC advertising —
increased utilization of drugs in those most likely to benefit — while minimizing the safety problems and unnecessary expenditure of inappropriate use,” he said.