Legal and Ethical Issues in Marketing and Product Safety - Essay Example

Legal and Ethical Issues in Marketing and Product Safety Legal and Ethical Issues in Marketing and Product Safety Ethics forms one of the most important aspects in any business. Ethical codes are the core of ensuring safety of any product and are supposed to be observed at all times. To ensure this, there are laws. Beltramini (2006) defines marketing ethics as the area of applies ethics that deals with the operations behind marketing. Product safety is of course always beside marketing ethics. Any organization or individual who partake in product advertising should market a safe product. To ensure that producers observe this, there are organizations that have the mandate to enforce these laws. This essay aims at mentioning issues that are behind marketing and production. The essay also gives research on the Food and Drug association and its duties in regulation. I also intend on giving my opinion on Direct- to-Consumer Marketing (DTC). By the end of the essay, I will show that DTC is (Lorence & Churchill 2007). Finally, I will give my opinion on various aspects of ethics in marketing such as utilitarianism deontology virtue ethics and ethics of care. Direct-to-Consumer Marketing Beltramini (2006) defines Direct-to-Consumer marketing as marketing targets consumer patients. Note that it is not directed towards health care providers. The DTC term is mainly used in medicine marketing. In the US, Food and Drug Administration (FDA) is in charge of DTC marketing. To target the consumers, DTC methods include television advertising, radio, print forms and even social media. There have been ethical and regulatory concerns about the DTC advertising. These concerns are specifically the extent to which prescribing of prescription drugs. Joseph et al (2005) argues that due to consumer needs, prescriptions may apply where not medically necessary. Since the 1940’s, western nations have banned the use of DTC marketing. However, the United States legalized the use of DTC after 1985. They imposed rules on the advertising methods. This included the inclusion of the risks in detail involved in use of the drug. This was meant to reduce the risk on the consumers wellbeing. Rufen was the first drug to advertise using DTC (Beltramini 2006). In 1997, the FDA imposed more relaxed rules on DTC marketing. The firms investments shot from $791 million to as high as $4.8 billion in DTC advertising. According to Friedman (2006), research shows for every $1 spent in advertising, there was a $4.20 increase in sales. In addition, due to increased marketing investments, healthcare costs rose by 9.6 percent annually from 2000 to 2004. As mentioned earlier, DTC marketing influences physicians’ prescriptions to patients. The FDA does not recognize the negative health implications of DTC marketing. Current regulations have failed to appease opposition to the practice. Wakeam (2009) argues that at a minimum, FDA should not allow product claims advertisements that persuade. Rather, they should be more informative. Most DTC advertisements are meant to increase sales. To achieve this, firms concentrate on being pleasant rather than being informative. DTC impacts and Policy Implications As mentioned earlier in the literature, the FDA new regulations led to an increase in pharmaceutical costs, which led to hiking in prices. A good example is the cholesterol reduction medication called Lipitor. With heavy marketing, Lipitor marked $1 billion in sales within the initial year of its launch (Wakeam 2009). Such a high growth in expenditure, lucrative returns and increased prevalence of the advertisements resulted in scrutiny of the patience by stakeholders including physicians and policy makers. I am engrossed interested in the impact of DTC marketing of pharmaceuticals on the doctor-patient relationship, demand and overall cost for prescription drugs and more particularly vulnerable populations. The question I determine to answer is: what is the implication of DTC pharmaceutical marketing? This analysis examines these issues from both patients and healthcare industry. Companies rely on the fundamental cover that physicians are in the best positions to consult on the medical implications of drugs. Lorence (2007) describes it as “a common law doctrine called the learned immediately rule (LIR)”that has existed since the late 1960’s. Then, pharmaceutical advertisements were targeted toward physicians (Lorence & Churchill 2007). How has this led to current issues in health care industry? Implications Researchers agree that DTC advertising has led to awareness of patients in common conditions and available treatments. This leads to results in patient empowerment and assertiveness. This enhances patient-physician communication and compliance with prescription (Joseph et al 2005). In contrast to that, opposition argues that DTC advertising lacks information about alternate therapies, costs and efficacy. They provide inappropriate in misleading information towards the targeted audience (Joseph et al 2005). Additionally, argument is that patients opt for advertised medicine rather than consult physicians (Friedman 2006). Lorence (2007) refers to it as a “quick-fix” approach, which may not be even the appropriate therapy. Vulnerable populations With an ever diversifying population, researchers have focused their research in vulnerable populations. These include women, minorities, senior citizens and low income earners. Joseph et al (2005) have based their research on the impact of DTC advertising on different income levels. The research estimates that income earners of $80,000 consult a physician less that those who earn lower. Low income earners do not prefer generic drugs. They, therefore, prefer to consult physicians on the advertised drugs. In addition, senior citizens, having claimed to be aware of DTC advertising (77%), a majority of them (57%) prefer to consult physicians on the drugs (Joseph et al). There is literature available on the impact of gender. Research shows that women are more likely to consult a physician than the male gender (Lorence 2007). However, the Joseph et al (2005) research does not find any difference in gender behavior towards DTC. The gender research literature is limited and, therefore, calls for more research on the same. Physicians Since the 1960’s, pharmaceutical advertising has been focused on the physicians who will in turn prescribe the medicine to the patients. Since the relaxation of the DTC rules, advertising is directed towards the consumer patients. While, patients do advocate for DTC advertising, physicians have resulted to researching information about the drug (Joseph et al 2005). In contrast to the patients’ preferences, physicians are against the DTC advertisement strategy. According to Lorence (2007) research, 53 percent of physicians are against claiming that it leads to patients asking for incorrect medication and prescriptions. 66 percent of the physicians’ claims that it includes preferences for brand name while generic are sufficient. 60-65% of physicians in the United States wants DTC advertisement to reduce or eradicated completely. Despite this, most physicians prescribed requested drugs to the patients despite them being against the prescription. Friedman & Gould, (2006) report that between 1991 and 2001, there was an increased prescription of psychotropic medication in adolescent patients. This of course increased in 1999 rapidly when the FDA imposed the relaxed rules. Moreover, only 20.9 percent of the patience accompanied the prescriptions with a mental health diagnosis. This seems to be very inappropriate the patients’ health. Beltramini (2006) opines that faced with a choice of comparable medication physicians will likely defer the patients preference. In 80 percent of the cases, physicians prescribe the drug the patients requested. 80 percent of investigated physicians report having received requested medications. 23.5 percent of them report changing method due to increased numbers of requests. Among the polled physicians, only 50 percent feel that the prescription was best for the patient. 5 percent of them report having prescribed the drug to appease the patient. According to Wakeam (2009) research 53 percent of the patients discuss the non-drug therapies who ask about an advertised drug. This increases to 77 percent in diabetes to 84 percent for overweight patients and 92 percent for those with hypercholesterolemia. Despite the preference of 60-65 percent of the US physicians for the eradication of the DTC advertisement, their behavior does not reflect since the still prescribe the requested drug (Joseph et al 2005). Options and Opinion From a personal perspective, I am not for the DTC advertising method. The council of Royal Pharmaceutical Society of Great Britain has its stand on the issue. In 2001, the society argued that the information about the prescribed medicine is likely to increase. However, DTC is likely not the best way to give adequate information. Moreover, DTC carries the risk of exposing consumer patients to adverse effects of new drugs. The society argued that if DTC is successful, it may affect the physician-patient relationship, distort public health priorities and disrupt cost controls managed by the National Health Service (Lorence 2007). Many of the countries prohibit the use of DTC marketing for similar reasons. Only the US and New Zealand allow it. The US government has proved that it has been unable to regulate the pharmaceutical industry. Good examples include the warning letter issued to Bayer Healthcare Pharmaceutical Inc and the Perez v Wyeth Laboratories Inc. Despite the opponents of the DTC marketing strategy, posing arguments against it, it is highly unlikely that the government will impose a ban the use of DTC due to the vast resources and influence the pharmaceutical industry possesses. The FDA should revise the guidelines imposed on pharmaceutical marketing. They should eliminate product claim categories which promote specified products by name for the treatment and management of specific conditions. Both opponents and proponents of the DTC advertising would agree that it is possible for patients to find out about new therapies and medication, which suit their conditions without persuasion through direct advertising. However, if both parties were to agree to this, the producers are likely to encounter lower profits. I do not put my complete faith in businessmen, which is what these producers are. This is because they are likely not to pay attention to the negative effects of their drugs. The government ought to stop such advertising and come up with more ways which are safer and more reassuring. As posited in the literature, the method has adverse effects even on physicians, whom we believe are the "watchers" that protect us from the few harmful drugs. We should be able count on them. Compounding Pharmacies Compounding is the process of manufacturing drugs for specific patients with particular needs (Wakeam 2009). To do this, pharmacists combine various ingredients to come up with the drugs. In October 2012, the headlines were filled with news of a meningitis outbreak. Investigations proved it was caused by the use of a compounded injectable medicine manufactured by a pharmaceutical company in Massachusetts. Compounding pharmaceutical companies have existed for a long time, yet we do not mention them frequently. The term compounding pharmacies is used to any company that is involved in the compounding of drugs. The Food and Drugs Administration is responsible for the regulation of compounded medication. However, state plays the major role in the regulation of the medication. Some of the issues that arise are, it is not clear which is compounded drug meets the state standard (Wakeam 2009). Definitions on the following are clear: wholesale, specialty and hospital based pharmacies. There should be a clear and definite definition of how often companies are inspected. There should also be clarification on who will take action when regulations are broken. Some people have also raised concerns on how often companies are inspected and whether inspection records are public records (Lorence 2007). According to (Wakeam 2009), some vials of injection medication are in higher than they are supposed to be and some do have preservatives. These pose a higher risk to patients. The FDA should have the mandate over the compounding pharmacies since they are part of the pharmaceutical.I believe it is not complicated for the FDA to implement regulations on the companies. I do not apprehend why there should be complains why there should be complains of any irregularities and the FDA not taking the appropriate action, perhaps due to the high influence that the industry has. However, if the FDA has the power, then it should be able to execute the mandates without questions. They should also be in agood position to work with state governments. PharmaCare in Colberia Analysis According to (Wakeam 2009), the PharmaCare violated several ethics with both its workers and its consumer targets. There were accusations that the company does not offer a good working environment for the employees. Even with this knowledge, the company has declined to take any action to improve their condition. The company has also been accused of selling harmful drugs to consumers. The same drugs have been associated with cardiac complications. From these facts, the company has clearly violated marketing ethics. The company has damaged its reputation and lost public trust (Lorence & Churchill 2007). Based on the Utilitarianism theory of ethics, which states that good ethical conduct involves causing maximum happiness and minimum suffering, PharmaCare did not have good ethical conduct. Workers in a bad environment are not happy workers. From the deontology perspective, ethical behavior involves one to follow rules. Not causing harm to the public is a fundamental rule in any marketing campaign. PharmaCare did not observe this rule. Based on virtue ethics, ethical standards depend on the company’s position. Virtue ethics mainly involve the benefit of the company. Since the company seemed to profit from the sale of drugs, then based on this theory, the company was ethical. From the ethics of care perspective, PharmaCare did not follow ethical standards. The theory states that one should take into consideration theimpact of their actions on others. The company did not consider the negative effects of their actions on the targeted marking neither on their employees (Wakeam 2009). PhamaCare and how it protects its intellectual property Intellectual property refers to the intellectual invention that holds a patent right. The PharmaCare Company uses voluntary licenses to protect its intellectual property. It was awarded this license to distribute drugs in various countries. Pharmaceutical companies continue to break the law. An example is the GlaxoSmithKline Company was accused of hiding clinical studies. They even went to the level of threatening anyone who discovered that their drug meant to treat diabetes cause cardiac arrest. I believe that these laws can be controlled, and governments should not have problems in executing the necessary measures. References Beltramini, R.F. (2006). Consumer believability of information in direct-to-consumer (DTC) advertising of prescription drugs. Journal of Business Ethics, 63, 333-343. Friedman, M., & Gould, J. (2006). Physicians’ attitudes toward direct-to-consumer prescription drug marketing. Journal of Medical Marketing, 7(1), 33-44. Joseph, M., Stone, G., Haper, J., Stockwell, E., Johnson, K., & Huckaby, J. (2005). The effect of manufacturer-to-consumer prescription drug advertisements: An exploratory investigation. Journal of Medical Marketing, 5(3), 233-244. Lorence, D., & Churchill, R. (2007). A study of the web as DTC drug marketing agent. Journal of Medical Systems, 31, 551-556. Wakeam, E. (2009). Price check! An analysis of direct-to-consumer pharmaceutical marketing. Academic Medicine, 84(2), 234-235. Read More