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18. Direct-to-Consumer Advertising: Status Quo and Suggestions to Enhance the Delivery of Independent Medication Information
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18 Direct-to-Consumer Advertising Status Quo and Suggestions to Enhance the Delivery of Independent Medication Information Wolf-Dieter Ludwig and Gisela Schott Abstract Direct-to-consumer advertising (DTCA) of prescription drugs has become a focus of public policy concern and academic research. Through it, pharmaceutical companies influence major parts of the health system, including the drug trials upon which DTCA is based. Advocates emphasize its potential in educating the public about health conditions and treatment options, but evidence supporting this argument is sparse. Critics highlight potential risks, such as encouraging the use of new drugs with unknown safety profiles—a view supported by some data. The literature is analyzed to characterize the data on approved drugs currently available on the market. Arguments for and against DTCA are given and an outline is presented of the current regulatory system in the United States, New Zealand, Canada, and Germany. Thereafter, appropriate ways of informing patients are discussed. Neither the central regulatory system in the United States nor the voluntary selfregulations in New Zealand and Canada have been able to ensure compliance with standards of acceptable advertising practice for DTCA. Therefore, the ban on DTCA in Europe is justified and should be maintained. To communicate the benefit-risk ratios of drugs to patients, evidence-based, independent, and neutral information is necessary and must be supported. Introduction Pharmaceutical companies and providers of medical devices use DTCA to promote medications and medical devices to the public through many media forms—newspapers, magazines, billboards, television, radio, and the Internet (Wilkes et al. 2000). Additional forms (e.g., patient brochures and videos) are 296 W.-D. Ludwig and G. Schott often made available in doctor’s offices or designed to be given to patients by medical professionals or patient groups. DTCA is just one example of the marketing and public relation efforts by drug companies to promote brand-name prescription drugs. More subtle forms of direct and indirect drug promotion, however, also take place, such as “disease awareness advertising” (i.e., bringing attention to a particular disease or “help-seeking” promotional campaigns run without naming a specific drug). This type of advertising encourages consumers to seek the advice of their health care practitioner about a diagnosis, a new treatment, or the prevention of a disease or condition. Reference is often provided to an outside source for further information, one that names individual branded products or specific programs. Other examples include articles placed in journals and newspapers as well as the financial support of patients’ organizations. Doctors and other health care professionals are also target audiences of marketing and public relation efforts. Activities such as advertising in medical journals, the placement and promotion of favorable studies in medical journals , the visits of sales representatives to doctors, reprints, the provision of free drug samples to doctors to pass on to patients, gifts for doctors, and subsidized “educational” events and conferences are commonplace and have been, from the industry’s perspective, very successful. For prescription drugs, DTCA methods differ from all other advertising in two main ways: First, consumers (i.e., patients) must consult a physician for a prescription before obtaining the product. Second, DTCA of prescription drugs is regulated, as is the advertising of other products deemed to have potentially harmful effects on human health. Currently, DTCA of prescription drugs is legal in only two industrialized countries: the United States and New Zealand. In Canada, it is prohibited. However, due to proximity, a considerable portion of the population is exposed to DTCA via the U.S. media. The collective experiences from these countries will serve as a basis to evaluate the situation in Europe (in particular, Germany) where DTCA is also prohibited, but where there is recurrent pressure to have it introduced. To inform the discussion of communicating accurate drug information to the public, we analyze data on approved drugs currently available on the market and highlight arguments for and against DTCA. The current regulatory system of DTCA in the United States, Canada, and New Zealand is outlined and recommendations made to inform patients effectively. Drug Information Available at Market Authorization: Rhetoric and Reality The development of effective medicines has contributed significantly to the welfare of patients, especially over the last fifty years. Medicines can offer [54.152.5.73] Project MUSE (2024-03-28 18:16 GMT) Direct-to-Consumer Advertising 297 enormous health benefits if treatment choices are made rationally; that is, when they are the appropriate...