VIEWS: 47 PAGES: 4 CATEGORY: Medicine POSTED ON: 8/26/2010
Whilst improved regulation and education will address it to some degree, major reforms to payment systems for drug companies and doctors are also required. [...] all these systemic reforms can be put in place, the best policy option is to ban the promotion of drugs to doctors and the public.10 Other negative aspects of DTCA include concerns about the emotion stimulated through advertisements, as well as their questionable educational value.5 DTCA critics cite the economic and time costs these ads bring into the clinic, touching on the issue of distributive justice.
PA QUANDARIES KEVIN MICHAEL O’HARA, MMSc, PA-C Is banning direct-to-consumer advertising consistent with bioethical principles? ›CASE ous advertisements promoting medica- result of unnecessary treatment than Mr. G, a 24-year-old male, presented tions for depression, insomnia, and from not taking medication. This may to his PA with concerns about mood. other common ailments. The perva- challenge the “do no harm” principle Recent physical examination ﬁndings siveness of these advertisements is not of nonmaleﬁcence, as well as the indicated he is healthy. Mr. G reported without possible consequence. bioethical principle that obligates PAs occasionally feeling “down,” but fur- and other medical providers to offer ther questioning conﬁrmed that the ›BIOETHICAL PRINCIPLES advice and treatment that will help the patient did not have a mood disorder. DTCA intersects all four ethical prin- patient, known as beneﬁcence. Mr. G told the PA that he recently saw ciples. If DTCA misleads or manipu- Another bioethical concept is several advertisements on television lates a patient, concerns about patient distributive justice, which looks at and in magazines about a new medi- autonomy, beneﬁcence, and nonma- how communities and societies allo- cation, described in the ads as being leﬁcence converge. If inaccurate infor- cate resources. Stanford University’s indicated for people with occasional mation about medication convinces a Encyclopedia of Philosophy describes the mood swings. Mr. G said that he had patient to pursue treatment that may most basic tenet of distributive justice: done “quite a bit of Internet research” not otherwise be needed or desired, the “the ﬁrst relatively simple principle of and that he would like to try the medi- patient’s decision-making autonomy distributive justice examined is strict cation. The PA performed a complete is threatened. The situation created by egalitarianism, which advocates the psychiatric evaluation and noted that DTCA limits the autonomy of clinicians allocation of equal material goods to all prescribing this medication was not as well. The pressures and practice members of society.”1 The concept is indicated. The disappointed patient, demands may sway a clinician to pre- certainly complex and nuanced. Some commenting that he “really thinks this scribe medications without a clear indi- argue that the concept in fact should medication will help him feel better,” cation. Furthermore, does the clinician not require strict equality in distribution left dissatisﬁed and said he would ﬁnd have an ethical obligation to respect and of goods. In this case, the distributive a “doctor who will listen to me.” act on a patient request that is based on justice issue can be used to evaluate if Patients are surrounded by a vari- DTCA exposure in order to preserve public health would be better served if ety of visual, auditory, and other forms patient autonomy? the resources spent on DTCA were allo- of product advertising. These products DTCA may result in a patient cated for actual provision of care. represent varied industries, including receiving medication he or she does service, diet, and more recently, phar- not need. In this setting, the patient is ›HISTORY OF DTCA maceuticals. Legal and ethical concerns more likely to experience harm as a Understanding the issues surrounding surround all forms of advertisement re- DTCA is enhanced by an appreciation gardless of the product or the intended of their historical foundation. Before audience. These concerns are notably CONTACT US the 1980s, pharmaceutical advertising relevant in the setting of pharmaceuti- Do you have an ethical was not directed toward the consumer. cal products and carry the additional quandary? Many professional organizations and weight of clinical relevance. pharmaceutical corporations agreed This department addresses the real- The issue is particularly concerning world ethics concerns and problems that DTCA was inappropriate. The with direct-to-consumer advertising of PAs. These might include problems early 1990s set the stage for changes (DTCA) of pharmaceuticals. Current in practice that may be inconspicuous, in sentiment and practice. An eco- popular media is crowded with numer- problems related to systems of care, nomic recession and an increase in problems related to the process of care, managed care plans resulted in a rising and preventive ethics. distrust of the medical establishment. Kevin O’Hara practices in internal and HIV Please e-mail your ethics question to Many felt the lack of pharmaceutical medicine in New York, New York, and is a gradu- email@example.com. We will product advertising directed toward ate student with the Department of Sociomedical consider it for discussion in a future Sciences at Columbia University, also in New consumers limited the consumer’s installment of PA Quandaries ability to acquire clinical decision- York. He has indicated no relationships to dis- close relating to the content of this article. making knowledge. Social movements 54 JAAPA • AUGUST 2010 • 23(8) • www.jaapa.com PA QUANDARIES stemming from the HIV/AIDS and around people.” This type of anxiety that can be treated.2 High volumes of cancer communities erupted parallel is often part of a normal life course advertisements that show these types of to these events, stimulating greater and does not necessarily reﬂect pathol- conditions in a distressing or negative involvement in health care among ogy. People viewing the advertisement way can change how a person views his persons outside the traditional medical may identify with the actors’ por- or her own experience with these condi- establishment.2 trayal, thereby expanding the scope tions. This may threaten a patient’s abil- Pharmaceutical advertisers planned of medicine to include stressful social ity to make an informed decision and their expansion into the enormous mar- situations. suggests other educational sources are ket potential of television and radio. Medicalization arises on at least three needed to preserve patient autonomy. In 1997, the FDA granted the phar- levels: conceptual, interactional, and maceutical industry a reprieve from institutional.4 Each level has a presence ›IS DTCA PROVIDING NEEDED including the full brief of summary in in the relationship between DTCA and INFORMATION? short television and radio advertising medicalization. For example, the pres- In 2005, the Journal of Bioethical Inquiry segments.2 This allowance lead to a sures that can push PAs to prescribe, featured two papers that looked at the signiﬁcant increase in pharmaceutical such as increasingly busy schedules and issue of DTCA from opposing per- advertising aimed at people outside the the economics of clinical practice, are spectives. Both sides of the argument medical establishment. Total promo- ampliﬁed when patient requests stem regarding the allowance of DTCA pres- tional spending for pharmaceuticals from DTCA and, in turn, engender ent interesting theories as to why their in 1996 was US $11.4 billion, and 8 medicalization at the interactional level. position best represents the health and years after the emergence of television/ By conceding to patient prescription welfare of our society.6 radio advertising, that sum neared US demands, clinicians may be afﬁrming DTCA supporters cite an increased understanding of disease and treat- ment options as a positive attribute.7,8 “Common human experiences, such as They also attempt to demonstrate several mechanisms through which baldness, menstruation, and stress, have been increased patient involvement can turned into diseases that can be treated.” bring about improved health out- comes, including better medication adherence.8,9 Support for DTCA is $30 billion.3 During this time, money the presence of an illness that requires summarized as, “Those who sup- spent speciﬁcally on DTCA burgeoned treatment, thereby validating the pur- port DTCA counter-argue that the 330% and came to represent 14% of pose of DTCA. This can pose a viola- ads are in principle no different to the entire industry’s advertising bud- tion of beneﬁcence and nonmaleﬁcence. other forms of advertising, that they get. Unfortunate parallel events were A hallmark of ethical clinical practice inform the population, and reassure a reduction in FDA staff who review is maintaining patient autonomy. This individuals they are not alone with pharmaceutical advertisements and an affords the patient the possibility of their problem and that help is avail- alteration in the way a regulatory letter making medical decisions that ﬁt his able. They are also said to encourage could be presented to the industry.3 or her personal wishes, taking into people to initiate discussions with account the many facets of a patient’s their doctor.”6 ›THE ROLE OF life (culture, economy, and logistics). From the opposite perspective, a MEDICALIZATION Autonomy incorporates knowledge of rationale for a total ban of DTCA is The impact of DTCA on American the issues surrounding a medical deci- described this way: Drug promotion culture is complex. More speciﬁcally, sion and the capacity to thoughtfully should be evaluated according to its DTCA has contributed to increasing evaluate them. Advocates of DTCA impact on health, access to information, medicalization, a term that refers suggest that DTCA can provide some informed consent, and wealth. Drug to labeling more and more human of this knowledge. Opponents challenge promotion currently does more harm experience and behavior as a medi- the value of this education and feel it than good to each of these objectives cal problem or illness for which the produces more emotional sentiment because it is usually misleading. This is medical profession has treatment.4 As than enlightenment.5 a systemic problem. Whilst improved DTCA creates excitement and inter- The pervasiveness of advertising and regulation and education will address est, the media increase medicalization the emotive storylines it carries make it to some degree, major reforms to through further reporting/coverage. people identify with the products and payment systems for drug companies For example, many advertisements for conditions. Common human experienc- and doctors are also required. Until all anxiolytics describe anxiety disorders es, such as baldness, menstruation, and these systemic reforms can be put in as an “anxious feeling” or “nerves stress, have been turned into diseases place, the best policy option is to ban 56 JAAPA • AUGUST 2010 • 23(8) • www.jaapa.com JAAPA needs the promotion of drugs to doctors and manuscripts! the public.10 Other negative aspects of DTCA include concerns about the emotion Case of the Month Heidi Menga, PA-C Interested in being stimulated through advertisements, as as showing a thin left subdural hemor- rhage with meningeal enhancement and diffuse left hemispheric edema causing in men, lung cancer accounts for 28% of all cancer deaths, with SCLC encompassing 18% of those deaths.2 published in the premier well as their questionable educational mass effect on the ventricle and midline Dissemination to regional lymph nodes shift. Most signiﬁcant was that the soft (limited-stage) or distant metastasis be- journal for physician tissue involvement extended from the yond the hemithorax (extensive-stage) occiput to the parietal and temporal to the brain, liver, bone, or pleura is regions on the left scalp. A brain MRI often present at diagnosis. Brain metas- with contrast demonstrated an apparent tasis is found in approximately 10% of diffuse left-sided subdural hematoma patients at the time of initial diagnosis.3 value.5 DTCA critics cite the economic with edema and a hypodense left tem- SCLC responds well to chemother- poral region and conﬁrmed the left- apy, but tumors often recur as they assistants? We’re FIGURE 1 scalp soft tissue involvement (Figure 1). become resistant to the drugs. In Soft tissue involvement seen on axial MRI extensive-stage tumors, the response ›WHAT IS YOUR DIAGNOSIS? rate is 65% to 85%; 1% to 5% of patients • Subdural hematoma with achieve a complete response. With treat- ›CASE cephalohematoma ment, the median life expectancy of a and time costs these ads bring into A 61-year-old man presented to the emergency department (ED) in January 2008 complaining of a tender • Undifferentiated small cell carcinoma • Lymphoma ›DISCUSSION patient with extensive-stage disease is 9 months; the 2-year survival rate is less than 3%.1 Treatment administration looking for PA authors bump on the back of his head. He for more than 6 months has not been denied any recent trauma but reported The patient underwent subtotal resection found to improve survival.3 Radiation watering of the left eye and ringing in of the scalp tumor. Pathology conﬁrmed therapy is important for palliation of the clinic, touching on the issue of dis- the left ear. CT of his head was sig- the tumor to be an undifferentiated small symptoms. Patients with extensive-stage niﬁcant for an old right basal ganglia cell cancer. Despite a normal-appearing disease survive longer when two or lacunar infarct, but there were no acute chest radiograph, the patient underwent more drugs are used, compared with ﬁndings. He was discharged with a CT of his chest along with positron single-agent therapy or low-dose regi- diagnosis of conjunctivitis. emission tomography (PET). Both scans mens. Commonly used agents include to write for these In March 2008, the man returned conﬁrmed a malignant left upper-lobe cyclophosphami
Pages to are hidden for
"Is banning direct-to-consumer advertising consistent with bioethical principles?"Please download to view full document