Direct-to-consumer advertising of prescription drugs and medical devices is not new in the United States, though its prevalence continues to increase. Proponents say the ads are educational and provide patients with helpful information, whereas critics contend they are coercive, designed to sell rather than educate, and lead health care providers to prescribe medications they otherwise might not. Studies examining the effects of direct-to-consumer advertising on practice, prescribing, patient benefit, and health care expenditures have reached mixed conclusions.
"Direct-to-consumer advertising has both negative and positive consequences and empirical studies have demonstrated both," explains Meredith B. Rosenthal, PhD, an associate professor of health economics and policy at the Harvard School of Public Health. "Clearly it increases spending, but [it] also [increases] access to worthwhile treatments. There are also public health issues to worry about-is it generating wasteful spending? Are the messages misleading and causing patients to demand and sometimes get inappropriate treatment?"
In the 1990s drug manufacturers began running television "reminder" ads that included the product's name but, under Food and Drug Administration (FDA) rules, could not say what the product was for or how effective it was. In August 1997, the FDA started allowing companies to direct product-claim advertisements, which do state the product's indications and effectiveness, at consumers over the airwaves, and by 2001 the amount spent on direct-to-consumer advertising rose dramatically, from $1.3 billion in 1997 to nearly $3 billion, according to a study published in the August 16 issue of the New England Journal of Medicine by Donohue and colleagues. By 2005 pharmaceutical companies were spending $4.2 billion on advertising to the public.
"That is not necessarily a good thing," says Maryann Napoli, associate director of the Center for Medical Consumers in New York. "The industry says that their ads are educational and yet they seem to only be advertising the most expensive drugs and not cheaper generics."
Napoli also points out that so-called lifestyle drugs (those dealing with, for example, impotence or menopause) are heavily advertised, conveying a message that the natural problems of life can all be treated with medication. "They are telling us that there is a pill for every ill, and some of us feel that they are creating illnesses, such as redefining menopause as a hormone deficiency disease."
Advertising directed at the public isn't the main concern of Harvard's Rosenthal, however. "I worry much more about marketing to doctors and the inappropriate behavior it can engender [as opposed to] marketing to patients."
It's unclear how much direct-to-consumer advertising affects practice. In 2003 the FDA conducted a survey of 500 physicians to assess the impact of direct-to-consumer advertising. According to preliminary results available at http://www.fda.gov/cder/ddmac/globalsummit2003, 3% of the physicians said it affected their patients and practice "very positively," 37% said "somewhat positively," 5% said "very negatively," and 27% said "somewhat negatively." The remainder, 28%, said it had no effect.
A survey of orthopedic surgeons by Bozic and colleagues, published in the May issue of Clinical Orthopaedics and Related Research, that evaluated the influence of direct-to-consumer advertising on orthopedic surgeons and their practices reported that surgeons and patients view direct-to-consumer advertising quite differently. While 84% of surgeons reported that the benefits patients exposed to advertising expected from a specific treatment were unrealistic, only 37% of patients considered some of these advertisements misleading. Fifty-seven percent of patients believed they were more aware of new technologies, devices, or surgical options because of advertisements, whereas 77% of surgeons felt that the ads confused or misinformed patients about appropriate treatments. Patients who reported being exposed to advertising about hip or knee arthroplasty were more likely to ask for a specific brand of implant or type of surgery. The majority of the surgeons also believed that the advertisements did not adequately educate patients on possible risks and complications associated with various treatments and implants.
A November 2006 report from the Government Accountability Office, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising, found that, according to consumer surveys, 2% to 7% of patients who requested a drug that they saw advertised ultimately received a prescription for it. A survey of physicians published online by Weissman and colleagues in April 2004 in Health Affairs revealed that, of 643 physicians who had at least one visit with a patient in the previous week or month who asked about a drug she or he had seen advertised, 39% of those visits resulted in a prescription for the drug. Forty-six percent of the physicians who had written those prescriptions said that the drug was the most effective treatment for the patient's condition, 48% said other agents were equally effective but they wanted to accommodate the patient's request, and 5% reported that other options, including nonpharmaceutical ones, might have been more effective, but they prescribed the drug to comply with the patient's wishes. On the whole, the physicians surveyed had mixed feelings about the effects of direct-to-consumer advertising on their patients and practice, with 40% considering it positive, 30% negative, and 30% neutral.
Many consumer advocates and health care professionals believe that direct-to-consumer advertising should be prohibited or, at the very least, more closely regulated. In testimony before the Senate Special Committee on Aging in 2005, Peter Lurie, MD, deputy director of Public Citizen's Health Research Group, called direct-to-consumer advertising "nothing less than an end-run around the doctor-patient relationship-an attempt to turn patients into the agents of pharmaceutical companies as they pressure physicians for medications they may not need."
Peter Mansfield, a lecturer in general practice at the University of Adelaide in Australia and founder and director of Healthy Skepticism, a group that seeks to minimize the harm that can result from misleading drug ads, contends, "As with promotions targeting health professionals, direct-to-consumer advertising often overstates benefits or understates risks. This causes harm directly from inappropriate drug use and indirectly because money is wasted that could be better spent elsewhere."
Mansfield says health care professionals should balance respecting patients' preferences with helping them achieve the best outcomes. "When direct-to-consumer advertising distorts a patient's preferences, we can't do our job properly."
Currently, the only other industrialized country that permits direct-to-consumer advertising is New Zealand, although it is moving toward banning the practice. The pharmaceutical industry has been lobbying to overturn bans in other countries, a move that Mansfield strongly opposes.
"Governments have a responsibility to act in the best interests of their citizens by banning direct-to-consumer advertising," he says. "All of the claimed benefits of direct-to-consumer advertising can be gained more effectively and more cheaply with less adverse consequences in other ways, including publicly funded drug information services and health promotion campaigns."
The Donohue study notes that direct-to-consumer advertising of a new drug usually begins within a year of its approval. However, the industry's trade group, the Pharmaceutical Research and Manufacturers of America, and the Institute of Medicine both recommend that direct-to-consumer advertising be delayed until a drug's safety is established and professionals are educated on its proper use.
Roxanne Nelson, BSN, RN