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- ↵*Reprint requests and correspondence:
Anthony N. DeMaria, MD, MACC, Editor-in-Chief, Journal of the American College of Cardiology, 3655 Nobel Drive, Suite 400, San Diego, California 92122, USA.
A startling change has occurred in the way medical products and services are promoted to the public since I completed house staff training. At that time it was unheard of for prescription drugs or medical procedures to be advertised to lay consumers. Rather, marketing and education efforts were directed almost exclusively to physicians. As we enter 2003, direct-to-consumer (DTC) advertising has been in place for years and is growing steadily. Recently, the issue of DTC promotion by pharmaceutical companies has been colored by similar advertising to the public by physicians and hospitals, and by new government rules addressing the interaction of pharmaceutical companies with health care professionals. Such advertising remains controversial and stirs strong emotions in many quarters.
Currently, DTC advertising is permitted only in the U.S. and New Zealand. The first DTC advertisement of a prescription drug appeared in Reader’s Digestin 1981. In 1985 the Food and Drug Administration (FDA) permitted DTC promotion providing it contained fair balance and full disclosure. Although such standards could readily be met in printed publications, albeit often in the fine print, they were difficult to achieve in an image media such as television. The watershed for video advertising came in 1997 when the FDA decided that it was not necessary for specific information regarding a drug, such as indications and side effects, to be in the promotion if sources, such as telephone numbers and Internet sites, were provided from which this information could be obtained.
Since 1997 there has been a tremendous growth in DTC advertising of brand name prescription drugs. Spending for DTC advertising has increased from $600 million in 1996 to approximately $2.5 billion in the current year, and has been projected to grow to $7.5 billion in the future. Although most promotions target non–life-threatening disorders, such as baldness or allergies, the full spectrum of disease entities has been considered. Currently, it is virtually impossible to watch television for even a short interval and not see a commercial for a prescription drug.
The support for DTC advertising must, of course, be drawn from some source, such as promotion to physicians. In fact, Woloshin et al. (1)reported in the Lancetin 2001 that in the preceding year pharmaceutical companies had spent $685 million on advertisements in newspapers and lay magazines, compared to $473 million in medical journals. Given the much smaller financial base of medical journals than the lay press, this poses an issue of some concern to the traditional vehicle used to transmit new research discoveriesand other educational material. However, it must be recognized that DTC advertising still represents only a small part of industrial expenditures for promotion. Data from Rosenthal et al. (2)in the New England Journal of Medicinefound that DTC advertising accounts for only 15% of money spent on drug promotion by industry, and is highly concentrated in a subgroup of products.
The DTC advertisements are generally received favorably by the public. People have reported that they feel that an advertisement in the lay media conveys increased credibility upon the product and its claims. In fact, many individuals believe that a drug must be completely safe to be advertised in a public venue such as television. Thus, far from being viewed as unbalanced or self serving, drug advertisements seem to imply a degree of efficacy and safety for the product in the mind of the public.
It is clear that DTC advertising would not continue to flourish if it were not successful. Although it is difficult to measure the effect of DTC upon sales, some evidence can be drawn from the available data. One national survey indicated that two-thirds of Americans reported seeing at least one advertisement for a prescription drug. Ten percent of the surveyed individuals requested the drug from their physician, a request which was honored approximately 70% of the time. Another study found that approximately 80% of cardiologists indicated that patients had requested a specific prescription drug. The National Institute for Healthcare Management reported that spending on prescription drugs increased by $20.8 billion from 1999 to 2000, and nearly 48% of the increase was the result of sales of the 50 drugs with the largest advertising budgets. The exact increase due to advertising is, of course, uncertain.
The proponents of DTC advertising cite an impressive list of potential benefits that may accrue from these promotions. They point out that such promotion can teach patients to recognize disease, encourage them to take responsibility for their own health, and motivate them to seek needed medical attention. Used properly, it is posited that DTC can prompt an informed discussion between patients and their physicians. Of importance, DTC represents one approach to avoid the well-documented under-utilization of drugs of proven efficacy, including beta-blockers and angiotensin-converting enzyme inhibitors. Finally, advocates indicate that promotion to the public is protected by the right to free speech, and that the information provided is already widely available in lay publications and on the Internet.
In contrast to the above, in a recent survey by Lipsky et al. (3)in the Journal of Family Practice, most physicians were ambivalent or negative about DTC advertising. A number of concerns have been expressed regarding promotion of prescription drugs to the public. There is concern that such commercials may “medicalize” trivial complaints, such as a runny nose or occasional fatigue, or imply that drugs are the answer to every symptom. Advertisements may certainly increase the demand for pharmaceuticals, appropriately or inappropriately, placing the physician in the difficult position of risking patient alienation if the request is denied. Filling prescriptions for unnecessary or marginally indicated drugs, which are often the newest and most expensive agents, has the potential to produce a large increase in health care expenses. Of great concern is the potential of DTC commercials to undermine the credibility of the physician, and to imply that they are not providing adequate care, particularly if drug requests are denied. Finally, a potential worry exists that the promotions are not fully balanced, and that the actual efficacy and side effects of the drugs are not presented in detail. In fact, severe side effects of new pharmacologic agents are often not identified until post-marketing surveillance (e.g., troglitazone), so that use of these drugs rather than older agents of proven value may expose patients to increased risk.
The concerns regarding DTC advertising might be more than offset by potential benefits, if they indeed exist. However, no data are available regarding the ability of promoting prescription drugs to the public to produce favorable effects. There is neither evidence that DTC advertising increases application of beneficial therapy, nor that it enhances outcomes or reduces morbidity. Accordingly, it is understandable that some parties question whether considerable expense is being incurred for no benefit. In fact, in 2001 the United Kingdom Consumers Association, a prominent consumer group, opined that DTC advertising had led to increased drug bills, distorted prescribing behavior, and misinformation for patients.
It is interesting, if not ironic, that the increase in DTC advertising in the last five years has been somewhat paralleled by similar marketing efforts by physicians and hospitals. Physicians increasingly advertise services directly to the public, while hospitals tout programs in services, such as cardiac disease and cancer, as well as favorable performance statistics. This trend is perhaps expressed to the greatest extent by imaging centers that screen for early detection of disease. In fact, even medical journals participate in this process by providing press releases on selected reports from each issue, often when the ultimate value of the new data is completely speculative. It would seem reasonable that the same demand for balance, completeness, and proof of benefit be required of advertising by health care professionals as is required of pharmaceutical companies.
Another issue related to DTC advertising is the interaction of the pharmaceutical industry with physicians and other health care professionals involved in the provision of drugs to patients. As this paper is submitted for press, the Office of the Inspector General, Janet Rehnquist, has just released new rules proscribing the offer of financial incentives or other tangible benefits by pharmaceutical companies provided to physicians, pharmacists, or others who managed drug benefits. Such incentives were said to include educational conferences and research grants to doctors and hospitals. Given the importance that industrial support has assumed in post-graduate education and clinical research in contemporary medicine, the new rules could have profound consequences that could ultimately impact patient care.
The basis for the new rules was said to be concerned about industry marketing practices that could improperly drive up Medicare and Medicaid costs. The notice of the rules will be posted in the Federal Registerfor comment by more knowledgeable people than myself. However, as an initial impression, it seems to be somewhat contradictory for the FDA to foster DTC marketing while the Office of the Inspector General undertakes action that may inhibit research to define the optimal use of new drugs, and transmission of this information to physicians charged with the care of patients.
Many essays and editorials have previously addressed the topic of the DTC advertising of prescription drugs. The potential benefits and hazards of DTC advertising have been well delineated. The debate regarding DTC advertising continues, and is often spirited. The one thing that appears certain is that a pressing need exists to define the benefits, if any, produced by DTC advertising. Such studies should also assess any pitfalls, such as increased adverse drug effects or deterioration of the physician-patient relationship. Physicians and industry representatives should collaborate in defining the best method to increase clinical application of therapies which have proven to be of benefit and the best technique to introduce newly discovered agents. Similar studies are warranted with regard to marketing by physicians and other health care providers. As evidence-based physicians, it is only when we have accurate data regarding the value of marketing prescription drugs and medical services directly to the public that we can optimize the process, or call for its limitation or termination.
↵* Editor-in-Chief, Journal of the American College of Cardiology
- American College of Cardiology Foundation