Prescription Drug Advertisement
Between 2009 and 2010, the total expense on pharmaceutical promotions of drugs was over $200 million, making up approximately 50 percent of pharmaceutical spending. The bulk of the promotions involves direct to customer promotions in which pharmaceutical manufacturers engage directly with the customers in the promotion of their products and to entice the customers to accept their prescription. The controversy surrounding the use of the mass media to promote pharmaceutical products is surrounded in controversy with many country split on the need for legislations on the issue. The main underlying concern is the role of consumers in health decisions that may seem inappropriate of engaging in self diagnosis or over the counter drugs influenced by heavy influence from the advertisements. The continued changes currently visible in the role of pharmaceuticals in drug promotions open controversy surrounding the ethics of the industry as regards self diagnosis. The author volunteered as an Assist in a pharmacy in which he observed and noted behavioral characteristics of customers on over the counter drugs, inquiries, and general customer perception on purchase of drugs. The author helped in answering questions, stock keeping, filling of forms, restocking supplies, and observing general customer response to self prescription while buying drugs. This article looks into the drug advertisement in the United States and its ethical implications in terms of health and the well-being of consumers.
Direct marketing and promotion of pharmaceutical products entail the promotional activities involving consumer diagnostics, medical services, and financial services (Kesselheim 2011). However, the prescription of drug advertisement and marketing has gained more prominence in which consumers are influenced to embrace and purchase developed products. In the United States, the Food Drug Administration has the mandate of regulating drug advertisement with several states having no policy or legislation on the same. While many states such as Virginia have their own laws regulating the advertisement of drugs directly to consumers, many states are yet to make a positive attempt towards regulating the industry in terms of controlling and putting measures on promotions and advertisements. The major concern on drug advertisement is self diagnosis and the riskiest aspect of wrong dosage and poor application or use of the drugs. On the other hand, a poor relationship between the consumer and the pharmaceutical company may be affected negatively due to the aspect of self administration of these products. It thus exposes the ethical concern of drug advertisement aimed at patients surpassing the major role of health specialists and physicians. Although the Food and Drug Administration has regulations on the issues, it does not point to the influence that the promotions may arouse or influence in the patients or consumers (Dorn 2009).
Serious laws and legislation on direct drug advertisement to consumers included the 2002 requirement by the Secretary of Health and Services putting a legislation that requires all advertisements and letters be approved by the FDA before issuance. Later in 2005, Pharmaceutical Research and Manufacturers of the United States produced its own guidelines concerning direct advertisement to consumers with the intent of stopping Congress from enacting a law barring or touching on direct consumer regulation. In 2015, a ban on device advertisement directed to consumers was put in place by the American Medical Association. The argument behind the ban entailed the notion of self prescription in which patients do not seek for professional care, but rely on promotional commercial broadcast to make health decisions (Kesselheim 2012). In 2016, a bill was put before congress that sought to do away with tax breaks involving companies producing drugs and advertising directly to consumers. On the same note, a representative urged for a specified period moratorium on promotions of new consented drugs. However, the ban received criticism from the manufacturers stating that drug promotion aimed at empowering consumers to make the right choice involving their health and well-being (Masood 2009).
Patient’s exposure to unreliable and misleading advertisement and information on a specific drug is another major concern for lawmakers. Often and many a time, patients or the public has little information entailing health complications. However, pharmaceutical companies only emphasize on the purchase of the drugs to boost their revenue and sales with little concern as pertains to the ethical implication of the said drug. It thus means that the menace has been perpetuated by the economic reasoning of pharmaceutical companies seeking to improve on their sales and boost their revenue. On the other hand, patients with little or no means to afford medical care or fiancés to cover their treatments may easily be influenced by over the counter drugs motivated by a popular advertisement. The urge to by-pass a professional physician or health care specialist is high, especially in a situation in which the patient has little means to afford Medicare.
Charanet al. (2011), maintains that social influence in which common knowledge from amongst the public may also play a role in influencing a patient to seek for the advertised drugs instead of involving a professional in their health issues. To a patient is sounds easy and saving time, getting a self prescribed drug due to heavy influence from an advertisement instead of seeking for full medical diagnosis. Other social factors that have perpetuated the practice involve peer influence in which consumers have taken up the role of professional physicians and caregivers. Many consumers often seek for advice and diagnosis tips from their fellow friends and relatives. Due to the heavy influence of advertisement and the media in promoting drugs, many individuals tend to have information which in most cases is unprofessional. The majority of individuals spread and dispense this information to fellow friends who easily buy into their ideas spreading the influence and practice of relying on advertising drugs and over the counter self prescription (Mullard, 2012).
The fundamental issue of concern is the controversy of the part, consumers play in health care decisions, the involvement of patients/consumers taking part in self diagnosis, and the ethical implications of the practice. However, concernsare raised about the possibility of promoting dangerous drugs. According to Kesselheim(2011), although reforms within the health department has ensured that patients have the right to information pertaining to a particular treatment and sales decisions. Concerns have also been raised about the possibility of pharmaceutical manufactures involvement in such legislation as attempts to promote and influence the commercials and advertisement of drugs directly to consumers. For example, the policies enacted and passed by pharmaceutical manufacturers do not trace the changes in the promotions together with the development of direct drug advertisement to consumers.
Initially, in 1900, the pharmaceutical manufacturers focused their advertisement and promotions at physicians, medical practitioners, specialists, and health care givers. According to Charanet al., (2011), due to economic and weak government guidelines on the same, pharmaceutical manufacturers took advantage of the weak link and started to reach out to consumers directly oblivious of the ethical concerns of the practice. It remains unclear, the role of Food and Drug Administration, in allowing the expansion of the practice with Congress silent on the issue. Passed legislations are often too weak and pharmaceutical manufacturers have often found a way around the weak legislations perpetuated by the their strong invisible financial control of some of the lawmakers (Mullard, 2012).
Ahistorical look at the direct sale advertisement of drugs to consumers rose from the agitation of consumer and patient rights that gave individuals more responsibility on their health expenditures for example, the consumer-directed health arrangements. These plans encouraged shared prescription and decision making involving health professionals and consumers. The practice and freedom gave consumers the opportunity to take first hand responsibility of their health with the freedom to seek for health advice and help from a person or institution of choice. While it remained a matter of choice, a loophole had been created in which pharmaceutical company’s saw an opportunity to exploit and avail their products directly to the consumers. Direct involvement of the consumers, thus ensured that their products moved and sold faster than previously in which they only relied on specialists and health care professionals. By engaging directly with the consumers, sales increased, thus increasing revenue and profits. As the practice evolved over time, many in the Medi-care industry looked down upon the ethical implications of the direct promotions and advertisement.Pharmaceutical manufacturers have worked around the clock to protect their interest and ethical implications of the practice of passing guidelines that only seek to control measures of the advertisement and not curbing the practice or limiting the advertisement to a particular segment.
While many consumers do not or are not keen on the ethical implications of the advertisement, legislators, stakeholders within the medical industry have turned a blind eye to the practice. However, some argue that direct involvement with the consumers enables consumers to take responsibility of their health while at the same time improve communication with their medical physicians (Charan et al., 2011). While the American College of Physician called for the enactment of good practices that promoted and focused on the interest of the consumer, pharmaceutical manufacturers got an opportunity to directly engage with consumers a move that has continued to raise concern on the negative implications of the practice.
Challenges in Enforcing FDA Laws on Direct Drug Advertisement
Although FDA has all the authority and power to enforce and act on the practice and companies going against its regulations, the bodies authority and influence has weakened over the years. According to research actions taken against pharmaceutical companies has reduced significantly pointing to a decline in the body’s oversight role. The table below shows the trends in FDA’s enforcement of advertisement between 1997 and 2006. From the statistics, it is evident that the regulatory body has lost its mandate and oversight role either willingly or due to a number of of socio-political forces beyond its ability. For example, a key factor that has seen the drop include the increased number of pharmaceutical companies while the number of FDA staff has remained constant over the years. In 2009, FDA only had a staff of 59 employees mandated to review materials from pharmaceutical companies involved in direct advertisement. Additionally, FDA has grumbled with low funding a fact that has weakened its ability to reach out to all manufacturing facilities and advertisement letters. For example, in 2010, FDA had to struggle with over 15000 DTC promotional papers, a clear sign of a weakened agency. While the pharmaceutical industry has continuously grown and expanded in manufacturing and their outreach capability, FDA has remained a weak oversight body, understaffed and unable to keep up with its responsibilities. For example, in 2012, the manufacture’s budget alone was nearly three times that of FDA, a fact that shows the disparity and logistical challenges in carrying out an oversight role.
Calls and Campaigns For Banning The DTCPA
In addition to medical practitioners and the medical body, many calls and campaigns have been called to curtail direct consumer advertisement. While courts have occasionally passed a ruling that drug advertisement and promotions are a way of commercial speech stating that banning the adverts is a form of violating the First Amendment and the protection of the freedom of speech. The Central Hudson test, developed by the court, in place till today, was placed to help determine whether a ban on such promotions was permissible (Masood 2009). The test has formed the cornerstone of most judgement relating to a direct drug advertisement, a concept that has often placed medical scholars at loggerheads with the courts. However, critics of the practice argue that improved regulation would help and satisfy the Central Hudson test. Other measures proposed include saying no to drug ads, a legislation fronted by Jerrrold Nadler first introduced in the house in 2002 and reintroduced in 2011. The act aimed at amending the Internal Revenue Code that would in effect avert pharmaceutical manufacturers from arguing that direct drug advertisement is a form of tax deductions. Although support for the legislation has been on going, little has been achieved towards enacting and enforcing the proposal.
Support for the Direct Advertisement and Sales
Despite the numerous calls for curtailing the practice, proponents of the ads argue that targeting consumers informs, teaches, and gives power to patients allowing them to take charge of their health and well-being (Dorn 2009). On the other hand, proponents argue that patients engage better with physicians when they too have prior information on their well-being. For instance, the internet has formed an important source of medical information. A large number of patients first seek for information from the internet before seeking for treatment or diagnosis from their medical physicians. A survey of 6000 adults indicated that 49 percent of patients first seek for information from the internet before consulting their doctors. Only a paltry 11 percent first seek the advice and diagnosis of their doctors (Dorn 2009). Proponents argue that online advertisement is a way in which patients are informed, educated, and empowered on health issues, warning, and topics especially on topics such as drug purchase. Additionally, direct advertisement increases dialogue with health care professionals while at the same time helping improve the relationship with the medical practitioners. Proponents further argue that direct advertisement helps promote patient compliance I which the drug advertisement helps improve a patient’s medical prescription and condition (Othman et al., 2009). On the other hand, proponents maintain that the advertisements reduce underdiagnosis and mistreatment of a patient’s health condition.
Conclusion
Despite the controversy around direct drug advertisement to consumers, the practice is long from coming to an end. With the strongest pharmaceutical manufacturers controlling much of the Medicare and health facilities, the consumers and patients have little to do other that learn the best from the advertisement. On the other hand, despite the fact that Congress has the ability to control and pass legislations that can control the practice, it is unable due to direct and indirect prevailing circumstances in addition to the historical background of the practice.
References
Charan, J., Yadav, P., Saxena, D.&Kantharia, N. D. (2011). Drug advertisements published in Indian Medical Journals: Are they ethical?. Journal of Pharmacy and Bioallied Sciences, 3(3), 403.
Dorn, S. D., Farley, J. F., Hansen, R. A., Shah, N. D.& Sandler, R. S. (2009). Direct-to-consumer and physician promotion of tegaserod correlated with physician visits, diagnoses, and prescriptions. Gastroenterology, 137(2), 518-524.
Kesselheim, A. S. (2011). Off-label drug use and promotion: balancing public health goals and commercial speech. American journal of law & medicine, 37(2-3), 225-257.
Kesselheim, A. S., Wang, B., Studdert, D. M.&Avorn, J. (2012). Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures. PLoS Med, 9(8), e1001280.
Masood, I., Ibrahim, M., Hassali, M. A.& Ahmed, M. (2009). Evolution of marketing techniques, adoption in pharmaceutical industry and related issues: a review. J Clin Diagnostic Res, 3, 1942-52.
Mullard, A. (2012). 2011 FDA drug approvals. Nature Reviews Drug Discovery, 11(2), 91-94.
Othman, N., Vitry, A.&Roughead, E. E. (2009). Quality of pharmaceutical advertisements in medical journals: a systematic review. PloS one, 4(7), e6350.