Ethical Issues in Marketing within Pharmaceutical Industry - Term Paper Example

Introduction The United s pharmaceutical industry is the largest pharmaceutical industry in the world, reaping billions of dollars in profit. Part of its success and profitability in establishing itself as a major US industry is due in large part to the weight pharmaceutical companies give to marketing and advertising. According to a study conducted by Families USA these companies spent, on the average, 27 percent of their yearly expenditures on marketing and advertising (2002). As a pharmaceutical company, Pfizer is bound by the rules of the FDA to market Neurontin only for indications approved in their label. However, after its approval for distribution in 1993, Neurontin was aggressively marketed for a large number of off-label usage that were not only unapproved by the FDA, but were also suspected of negative effects such as suicide. Thus, given the important role pharmaceutical companies play in ensuring the well-being of a nation, and the dangerous effect off-label marketing can have on patients; this essay will argue that it is unethical, not to mention illegal, to market drugs for unproven uses on the basis of public health, especially if it is linked to harmful effects such as suicidal behavior. Discussion Off-Label Drug Usage Off-label drug usage is a common practice in the medical community. Defined as the use of medicines for "indication, dosage form, population, or other use parameter not mentioned in the approved labeling," it has been accepted, and even warranted, in some occasions, where it presents the best and sometimes even only course of possible treatment (qtd. in Kaufman 2004, 3). According to Steven Salbu, there are three forms of off-label activities - off-label use, of-label prescription, and off-label marketing (qtd. in Kaufman 2004, 5). While off-label use and prescription are readily accepted, off-label marketing for unapproved usage of drugs is another story. In this regard, pharmaceutical companies are restricted by the FDA to market and advertise drugs for off-label usage other than that approved in the label, with exception of distributing informational articles to physicians, provided that these articles are based on scientific studies from legitimate third parties (Kaufman 2004, 21). Despite these restrictions, pharmaceutical companies still embark on off-label marketing campaigns, taking advantage of the leeway provided by the FDA exceptions. The interest of pharmaceutical companies to market off-label usage of their products lies in their need as business entities to get these medicines out in the market as soon as possible without the long and expensive wait that FDA approval requires. One company that took advantage of this leeway to the point of fraudulently marketing their products is Pfizer in its efforts of promoting Neurontin. Neurontin: An Effective Marketing Strategy Neurontin is a legally approved drug indicated as an "adjunctive therapy" for the treatment of partial seizures and epilepsy (Pfizer Inc., 2005, 7). Hence, it is not to be used alone, but only as a secondary treatment "added to other antiepileptic drugs" in the event that the primary drugs are not successful (7). However, it was still aggressively marketed for non-approved uses in treating a wide range of ailments including: bipolar mental disorders, various pain disorders, Lou Gehrig's disease, attention deficit disorders, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a primary treatment for epilepsy (DOJ, 2004). In a whistleblower suit filed by Dr. David Franklin, evidence emerged that the off-label uses previously mentioned were marketed in an illegal and fraudulent manner in what has been known as "the most complete and well documented case of off-label promotion to ever come into public view" (Sweet 2003, 18). According to Franklin, the company implemented a "coordinated national effort to implement an off-label marketing plan" because first, conducting further clinical trials to prove its effectiveness for off-label uses are both too time consuming and expensive; and second, because seeking FDA approval for its off-label uses will cause Neurontin to lose profits against its generic competitors given that Neurontin's patent is about to expire (DOJ 2004; Kaufman 2004, 40). Furthermore, he adds that given the limited approved uses of the drug, the market size is simply too small to achieve the profits that the company expects in the production of Neurontin (Kaufman 2004, 40). Hence, Pfizer conducted a number of strategies to promote Neurontin's off-label uses including: (1) the use of sales representatives to act as medical liaisons by representing themselves falsely as independent scientific experts in providing one-on-one sales pitches to doctors about Neurontin's off-label uses; (2) encouraging these medical liaisons to make false claims about the drug's efficacy and the existence of scientific evidence to back up their claims; (3) conducting "consultant meetings" where doctors are invited to funded dinners and paid a fee for attending conferences; (4) sponsoring continued medical education of doctors who advocate the drug; (5) paying physicians to let sales representatives accompany them while they see patients; and (6) conducting numerous teleconferences, seminars, and talks disguised as independent events where doctors are "educated" about the off-label uses of Neurontin (Kaufman 2004, 40; Sweet 2003, 18; DOJ 2004; United States ex rel. Franklin v. Parke-Davis, 147). In addition, Pfizer also took advantaged of the leeway provided by the FDA for off-label marketing where they hire ghostwriters to write numerous articles regarding Neurontin's off-label uses and pay doctors to sign their names under these articles and publish them in medical journals to give it the character of an independent scientific study (Sweet 2003, 18). Reports even show that aside from luxury trips including tickets to the Olympics, a doctor received $308,000 to advertise Neurontin in conferences (United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d at 46). As a result of Pfizer's well-organized marketing scheme, Neurontin reached a "blockbuster drug status" such that it reached annual sales of more than $1 billion in the United States alone (Lenzer 2004, 328:1217). In 2003, it was estimated that 90 percent of the drug's total worldwide sales were for off-label prescriptions, such that its profits worldwide reached $2.7billion (Lenzer 2004, 328:1217). Thus, there is no question that the off-label marketing scheme Pfizer conducted for Neurontin was extremely effective. Neurontin: Risks and Consequences According to the advocates of Neurontin, off-label use of the drug is not necessarily dangerous given that it is a benign drug (Lenzer 2004, 328:1217). However, despite such statements, evidence of negative consequences from off-label use of the drug exists, the most severe of which is linked to suicidal behavior. In a correspondence between Dr. Russell Katz of the FDA and Finkelstein and Partners Law Firm regarding Neurontin, Andrew Finkelstein notes: During the clinical trials, Parke-Davis reported Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty two participants reporting depression so severe it required pharmacologic intervention. (Finkelstein 2005) He continues that among the seventy eight participants who reported depression, nineteen never experienced them before the clinical trials. Links to suicidal behavior is further strengthened in a report by the Alliance for Human Research Protection where it was found that two thousand Americans who never attempted suicide before taking Neurontin were hospitalized after a suicide attempt, and an additional 160 Americans, without any suicidal tendency, committed suicide while using the drug (qtd. in Hasslberger 2004). Furthermore, Dr. Matthew Keats of the Eastern Virginia Medical School states that in May 2002, a 16 year old being treated for bipolar disorder, which is among the off-label uses identified for Neurontin, committed suicide while under medication of the drug (Lenzer 2004, 328:1217). Aside from links to suicidal behavior, sedation, dizziness, fatigue, unsteadiness, nausea and terror were also identified as possible side effects that can result from using the drug (Pfizer Inc. 2005, 18). In addition, children aged three to twelve, were found to have viral infection, somnolence, and hostility while under medication (Pfizer Inc. 2005, 22). In addition to these side effects, patients being treated with Neurontin for its off-label uses were also endangered by taking them off other drugs that were proven to be effective, depriving them of proper medical treatment (Lenzer 2004, 328:1217). Hence, had these physicians been aware of the lack of scientific evidence regarding Neurontin's claims, they would have prescribed other more effective drugs. Lastly, the nation's Medicaid program was also harmed by doctors who prescribe Neurontin for Medicaid patients claiming reimbursements for sales of the drug even though it is ineligible. According to the DOJ, Neurontin reimbursements jumped from $287,000 in 1994 to $43.2 million in 2002, which is believed to be directly caused by Pfizer's illegal marketing strategy (DOJ 2004). As a result of the insurmountable risk Pfizer placed on the population and the damages they caused in the well-being of patients due to their illegal marketing activities, Pfizer has agreed to plead guilty over two counts of violations on the Food, Drug, & Cosmetic Act, admitting criminal and civil liabilities and paying a financial settlement amounting to $430 million (DOJ 2004). However, despite the large financial settlement, Pfizer's actions requires a more severe punishment given the number of lives it destroyed, and the amount of suffering that it caused many. Ethical Considerations The aforementioned illegal marketing practices of Pfizer elicit several ethical concerns. First, as legitimate companies concerned with increasing their profitability, pharmaceutical companies have a greater responsibility to the public as a whole - they have the moral obligation to ensure that they produce medicine that will not only effectively help patients, but also that these products do not impact a population's well-being in a negative way. Hence, in the midst of the pharmaceutical industry is an ethical dilemma to balance public health and well-being on one hand and ensure profitability of their business on the other. This ethical dilemma is illustrative of the conditions surrounding Pfizer's marketing of their FDA approved drug - Neurontin. Second, according to Packer and Parke, trust is a crucial component within the ethical framework surrounding the pharmaceutical industry (2004, 774). This trust is implied in the relationship between doctor and patient, doctor and the industry, and industry and the society. However, Pfizer violated this trust through their fraudulent marketing practices. First, it violated the trust physicians gave pharmaceutical companies in giving them the correct information regarding their drugs, and proper drugs that will not harm their patients. Second, within the doctor-patient relationship, doctors unknowingly provided improper medical treatment to their patients who entrusted them with their well-being. Third, Pfizer also violated the trust society gave them in supplying drugs that are beneficial to their well-being, instead of being harmful. Third, by giving doctors incentives and gifts, Pfizer took advantage of doctor's abilities to make prescriptions by making them indebted to Pfizer, forcing them to use their products in return. Doctors should be initially responsible to their patients before anyone else. However, by virtue of these gifts, it became difficult for doctors to fulfill this responsibility, sacrificing patient's well-being for profits. Last, as the case illustrated, pharmaceutical companies can abuse their ability to market off-label drug usage and reap negative consequences. While this may call for the need to regulate these companies further and restrict their ability to distribute published articles regarding off-label claims, it does not solve the need of some doctors to receive legitimate scientific information regarding off-label uses of drugs that can help them in treating their patients. Thus, problems arise in determining the extent and manner that these promotional activities must be regulated. Keeping Safe Given the dangers entailed in the off-label use of drugs, it is important for consumers to take precaution in ensuring that they do not fall victims to fraudulent activities such as that conducted by Pfizer. Since it is evident that doctors themselves, despite their knowledge in the medical field, can be fooled by these practices, it is up to the consumers to ensure that they are protected. In this respect, the most important precaution one can take is to stay informed and be vigilant about taking drugs for its off-label usage. However, it should be noted that being too skeptical to the point of avoiding all off-label uses of drugs may be just as harmful as taking the drugs to treat the wrong ailments. Thus, what is important is to ensure that proper information is made available to be certain that the best decision is made. Practical steps that can be taken to stay properly informed is to check where information about off-label drug usage came from, find out who is giving out the information, and cross-check if other independent studies corroborates such claims. In addition, consumers must also make sure that they know their rights regarding receiving medical treatment and that they report violations of these rights to the proper authorities such as the FDA to punish illegal activities and prevent them from happening again in the future. Lastly, consumers and patients must also remember that despite what their doctors say, they still make the final decision, such that they have the right to reject a certain treatment in favor of another or go to a different doctor to get a second opinion. Critique and Summary As the case illustrated ethical issues in marketing within the pharmaceutical industry is a big problem. The extent of this problem is based on the fact that medicine is a crucial key to a population's health. Hence, without the proper medicine and the correct information on how to use such medicine effectively a nation's well-being may be endangered. In this respect, Pfizer obviously placed the nations' well-being in danger by fraudulently marketing off-label uses of Neurontin without the making doctors and patients alike to think that there is sufficient scientific evidence to support their claims and ignoring evidence on the contrary. By exposing the doctors to fabricated and exaggerated evidence, they were made to believe these fraudulent claims and by virtue of their autonomy in their practice, convince patients to use them without the correct information regarding its effects. The fact that such practices are commonplace in the industry should be a cause of alarm not only for the consumers who use these drugs but also for physicians and policymakers alike. In this respect, physicians must practice greater ethical standards by ensuring that they avoid situations where they might be placed in danger of violating their patient's trust; while policymakers must re-evaluate laws to regulate these practices more effectively. Consumers and patients in return must also be more aware by educating themselves about the possible dangers of taking medication to ensure that they do not fall victims to illegal marketing strategies of pharmaceutical companies. References Families USA Foundation. Profiting From Pain: Where Do Prescription Drug Dollars Go Families USA Publication No. 02-105. Washington, DC: Families USA, 2002. Kaufman, Robert. The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues. Harvard Law School. 27 April 2004. 1 November 2005 . Pfizer, Inc. Important Product Information. Neurontin Homepage. 2005. 31 October 2005 . Department of Justice. Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion. 13 May 2004. 31 October 2005 . Sweet, Melissa. "Gabapentin Documents Raise Concerns About Off-label Promotion and Prescribing." Australian Prescriber 26.1 (2003): 18-19. Lenzer, Jeanne. "Pfizer Pleads Guilty, But Drug Sales Continue to Soar." BMJ International Journal 328 (2004): 1217. United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d at 46. Finkelstein, Andrew. Correspondence regarding Neurontin. 21 March 2005. 28 October 2005 . Packer, Samuel and Parke, David. "Ethical Concerns in Industry Support of Continuing Medical Education: The Con Side." Archives of Ophthalmology 122 (2004): 773-776. Read More