CASE
Mr. G, a 24-year-old male, presented to his PA with concerns about mood. Recent physical examination findings indicated he is healthy. Mr. G reported occasionally feeling "down," but further questioning confirmed that the patient did not have a mood disorder. Mr. G told the PA that he recently saw several advertisements on television and in magazines about a new medication, described in the ads as being indicated for people with occasional mood swings. Mr. G said that he had done "quite a bit of Internet research" and that he would like to try the medication. The PA performed a complete psychiatric evaluation and noted that prescribing this medication was not indicated. The disappointed patient, commenting that he "really thinks this medication will help him feel better," left dissatisfied and said he would find a "doctor who will listen to me."
Patients are surrounded by a variety of visual, auditory, and other forms of product advertising. These products represent varied industries, including
service, diet, and more recently, pharmaceuticals. Legal and ethical concerns surround all forms of advertisement regardless of the product or the intended audience. These concerns are notably relevant in the setting of pharmaceutical products and carry the additional weight of clinical relevance.
The issue is particularly concerning with direct-to-consumer advertising (DTCA) of pharmaceuticals. Current popular media is crowded with numerous advertisements promoting medications for depression, insomnia, and other common ailments. The pervasiveness of these advertisements is not without possible consequence.
BIOETHICAL PRINCIPLES
DTCA intersects all four ethical principles. If DTCA misleads or manipulates a patient, concerns about patient autonomy, beneficence, and nonmaleficence converge. If inaccurate information about medication convinces a patient to pursue treatment that may not otherwise be needed or desired, the patient's decision-making autonomy is threatened. The situation created by DTCA limits the autonomy of clinicians as well. The pressures and practice demands may sway a clinician to prescribe medications without a clear indication. Furthermore, does the clinician have an ethical obligation to respect and act on a patient request that is based on DTCA exposure in order to preserve patient autonomy?
DTCA may result in a patient receiving medication he or she does not need. In this setting, the patient is more likely to experience harm as a result of unnecessary treatment than from not taking medication. This may challenge the "do no harm" principle of nonmaleficence, as well as the bioethical principle that obligates PAs and other medical providers to offer advice and treatment that will help the patient, known as beneficence.
Another bioethical concept is
distributive justice, which looks at how communities and societies allocate resources. Stanford University's Encyclopedia of Philosophy describes the most basic tenet of distributive justice: "the first relatively simple principle of distributive justice examined is strict egalitarianism, which advocates the allocation of equal material goods to all members of society."1 The concept is certainly complex and nuanced. Some argue that the concept in fact should not require strict equality in distribution of goods. In this case, the distributive justice issue can be used to evaluate if public health would be better served if the resources spent on DTCA were allocated for actual provision of care.
HISTORY OF DTCA
Understanding the issues surrounding DTCA is enhanced by an appreciation of their historical foundation. Before the 1980s, pharmaceutical advertising was not directed toward the consumer. Many professional organizations and pharmaceutical corporations agreed that DTCA was inappropriate. The early 1990s set the stage for changes in sentiment and practice. An economic recession and an increase in managed care plans resulted in a rising distrust of the medical establishment. Many felt the lack of pharmaceutical product advertising directed toward consumers limited the consumer's ability to acquire clinical decision-making knowledge. Social movements stemming from the HIV/AIDS and cancer communities erupted parallel to these events, stimulating greater involvement in health care among persons outside the traditional medical establishment.2
Pharmaceutical advertisers planned their expansion into the enormous market potential of television and radio. In 1997, the FDA granted the pharmaceutical industry a reprieve from including the full brief of summary in short television and radio advertising segments.2 This allowance lead to a significant increase in pharmaceutical advertising aimed at people outside the medical establishment. Total promotional spending for pharmaceuticals in 1996 was US $11.4 billion, and 8 years after the emergence of television/radio advertising, that sum neared US $30 billion.3 During this time, money spent specifically on DTCA burgeoned 330% and came to represent 14% of the entire industry's advertising budget. Unfortunate parallel events were a reduction in FDA staff who review pharmaceutical advertisements and an alteration in the way a regulatory letter could be presented to the industry.3