TY - JOUR
AU1 - Mitka, Mike
AB - In the half-dozen years since the US Food and Drug Administration (FDA) eased restrictions on direct-to-consumer (DTC) advertising of prescription drugs, the practice has proliferated—and so has the controversy surrounding it. Proponents have claimed DTC advertising educates the public to make more informed medical choices, while critics charge that aggressive marketing campaigns encourage patients to demand newer, more expensive, and sometimes inappropriate medications. Direct-to-consumer advertising of prescription drugs remains a controversial issue. (Photo credit: Brand X Pictures/Picture Quest) Preliminary findings released last month from a new FDA survey on the practice are unlikely to lessen the controversy. The agency says that the survey, which it conducted in 2002, found that many physicians are comfortable practicing in a world with DTC advertising of prescription drugs. "The results confirm that DTC advertising, when done correctly, can serve positive public health functions such as increasing patient awareness of diseases that can be treated, and prompting thoughtful discussions with physicians that result in needed treatments being prescribed—often, not the treatment in the DTC advertisement," the FDA stated in a "Talk Paper" summarizing the survey's findings, which is available at http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01189.html. "This study also demonstrated that most physicians view DTC advertisements as one of many factors that affect their practice and their interactions with patients, both positively and, in some respects, negatively." But critics of the study say the FDA is overly optimistic in its interpretation of the results, and question whether the study design permits drawing definitive conclusions from the data. Patient-physician interactions Patient-physician interactions Of the 500 physicians who filled out the survey (a response rate of 46%), 459 said they could recall their most recent interaction with a patient who initiated a discussion about a prescription drug seen advertised. Survey participants came from a random sample of 250 general practitioners and 250 specialists (in dermatology, allergy/pulmonology, endocrinology, and psychiatry) selected from the American Medical Association's (AMA) Physician Masterfile. Patient-physician interactions The survey's findings are available on-line at http://www.fda.gov/cder/ddmac/globalsummit2003/index.htm. Patient-physician interactions The researchers found that 41% of the physicians surveyed said that having a patient view an advertisement for a prescription drug had a beneficial effect on their interaction with that patient. Of the 187 physicians seeing a benefit, 53% said the ads allowed for a better discussion with patients and 42% said patients were more aware of treatments for a particular medical problem. Patient-physician interactions Still, 82 of the 459 physicians, (18%), said a patient seeing a DTC advertisement did create problems with the interaction. Of the 82 saying they had problems, 41% said that time was spent correcting misconceptions, 26% said the drug was not needed or the patient did not have the condition for which the drug is indicated, and 9% said the patient wanted a prescription rather than other treatment for the condition. Patient-physician interactions The positive findings cited by the FDA are at odds with the historically negative view of physicians on DTC advertising. Patient-physician interactions In 1984, for example, before the explosion of DTC advertising in the 1990s, the AMA conducted a survey of its members and found that 84% opposed the advertising of prescription drugs on television (JAMA. 1993;268:146,150). In 1997, the year the FDA issued guidelines that relaxed the requirements for DTC advertising on television and radio (a time when advertising prescription drugs in consumer magazines and newspapers was already increasingly common), a study published in the Journal of Family Practice found that 80% of surveyed members of the American Academy of Family Physicians believed that print DTC advertising was not a good idea and 84% expressed negative feelings about television and radio advertising (J Fam Pract. 1997;45:495-499). Patient pressures? Patient pressures? One frequently cited concern among physicians about advertising directly to consumers is that the practice will encourage patients to pressure physicians to prescribe specific drugs and interfere with the patient-physician relationship. Patient pressures? One of the unexpected findings from the FDA's study was that many of the physicians surveyed said patients exerted relatively little pressure as a result of DTC advertising. Patient pressures? When asked if a patient who had seen a DTC advertisement tried to influence the course of treatment in a way that would have been harmful to him or her, 91% of physicians said, "No." As for a perceived pressure to prescribe, 53% of physicians said they were "not at all pressured" while only 4% said they were "very pressured." And when a patient asked for a prescription, 41% of physicians said they were "not at all pressured" to prescribe that drug at that particular visit while 8% said they were "very pressured" to prescribe. Patient pressures? But those numbers don't jibe with clinical experience, said Sarah Walker, MD, president of the American College of Physicians-American Society of Internal Medicine. Walker, who practices internal medicine and rheumatology in Columbia, Mo, charges that DTC advertising is creating pressure on her to write scripts. Patient pressures? "My experience is that patients tend to believe deeply anything they read in a newspaper or national magazine, and the fact that it's a drug ad designed specifically to increase the usage of a particular drug doesn't enter their minds," she said. "Quite often, I feel pressured to prescribe a certain drug. Then I need to explain to them why it may not be the best treatment option, or that they may be on a medication that does not need to change." Questions on methods Questions on methods Barbara Mintzes, a critic of the role of DTC advertising can play in the patient-physician relationship (BMJ. 2002;324:279-279), shares Walker's skepticism regarding the survey's findings. Mintzes, a graduate researcher with the Centre for Health Services and Policy Research at the University of British Columbia in Vancouver, said that she was surprised by the positive spin that the FDA put on the survey results, in light of the study's limitations. Questions on methods Mintzes noted that the survey asked physicians to base their responses on a recent specific encounter with a patient. "While this would help minimize recall bias, the survey is still an uncontrolled case series that does not allow one to collect data on the direction DTC ads are pushing the patient-physician encounter," Mintzes said. Questions on methods While DTC advertising is perhaps the most visible facet of marketing efforts by drug companies, it is just one portion of an explosion in pharmaceutical promotional advertising. In 2000, the industry spent $15.7 billion on promotion, with $2.5 billion spent on DTC advertising, $4 billion on office-based promotions, and $8 billion on free samples. In 2001, overall promotional spending jumped to $19.1 billion, with $2.7 billion on DTC advertising, $4.8 billion on office-based promotions, and $10.5 billion on free samples, according to IMS, a Plymouth Meeting, Pa-based company offering economic information and analysis to the pharmaceutical industry. Questions on methods Sidney Wolfe, MD, director of the Public Citizen's Health Research Group, a consumer advocacy group in the health care arena and a vocal critic of DTC advertising (N Engl J Med. 2001;346:524-526), suggests that the positive findings in the FDA survey may be the result of multifaceted marketing efforts by the pharmaceutical industry to change physicians' perceptions. Questions on methods With the "huge number of free samples given away by the companies" coupled with patients asking about a drug because they saw it in an advertisement, "it becomes pretty easy for the physician to say ‘Hey, I have free samples,' and then hand them out," said Wolfe. But the effects of such promotional efforts may ultimately mean that "the patient gets socked with long-term bills, in either cash or insurance premiums, for drugs that may not be any better than cheaper alternatives," he said. Questions on methods The FDA's numbers imply that DTC advertising is having the effect desired by drug manufacturers. In the survey, 211 of 359 physicians (59%) said a patient had asked them to prescribe a specific brand name drug. And of those 211 physicians, 57% prescribed the brand name drug requested. Is Vigilance Delayed Vigilance Denied? Is Vigilance Delayed Vigilance Denied? How vigilant a watchdog is the Food and Drug Administration (FDA) in ensuring that direct-to-consumer advertising of prescription drugs is not misleading? In a recent report, the US General Accounting Office (GAO) said that while the FDA's oversight is "generally effective" at halting misleading advertising, a change implemented early last year by the Department of Health and Human Services (HHS) has "adversely affected the FDA's ability to enforce compliance with its regulations." Is Vigilance Delayed Vigilance Denied? When the FDA finds a DTC advertisement that is misleading, the agency sends a regulatory letter to the pharmaceutical manufacturer, instructing the company to halt the ad. In the past, the GAO said, the FDA usually issued a regulatory letter within several days of identifying a misleading advertisement. But on January 31, 2002, the HHS required the FDA's Office of the Chief Counsel to review all regulatory letters prior to dissemination to pharmaceutical manufacturers. Is Vigilance Delayed Vigilance Denied? The effect has been to substantially increase the time between the FDA's discovery of a misleading advertisement and the issuing of a regulatory letter. Such delays have reached 78 days, which means that an ad's "life cycle" could be completed before the manufacturer faced any request to stop its use, the GAO said. Is Vigilance Delayed Vigilance Denied? The GAO, which compiled its report at the request of certain members of Congress, said, "To ensure that FDA's enforcement actions are timely, we recommend that HHS reduce the amount of time for internal review of draft regulatory letters." Is Vigilance Delayed Vigilance Denied? HHS has defended the legal review in its comments on the report, saying that its purpose is "to ensure that such letters rest on a solid legal foundation, are credible, and will promote compliance." The agency also said it had established a goal of issuing regulatory letters within 15 working days of review at the Office of the Chief Counsel. Is Vigilance Delayed Vigilance Denied? The GAO report, "FDA Oversight of Direct-to-Consumer Advertising Has Limitations," is available on the Internet at http://www.gao.gov/new.items/d03177.pdf.
TI - Survey Suggesting That Prescription Drug Ads Help Public Is Met With Skepticism
JF - JAMA
DO - 10.1001/jama.289.7.827
DA - 2003-02-19
UR - https://www.deepdyve.com/lp/american-medical-association/survey-suggesting-that-prescription-drug-ads-help-public-is-met-with-Dr0piT96pu
SP - 827
EP - 828
VL - 289
IS - 7
DP - DeepDyve
ER -