Ethical Dilemma Faced by Pfizer - Assignment Example

This paper tends to analyze an ethical dilemma faced by a famous New York based pharmaceutical company Pfizer via application of ethical decision making and review factors that contributed to the alleged unethical conduct in order to seek a plausible conclusion for management. Serious questions were hoisted by the Pfizer’s case, and they remain unreciprocated by the company at least. Introduction Given the hazards and outlay of developing a new drug, pharmaceutical companies will jump at opportunities to diminish them. The drug development process is time-consuming, dicey and costly. It can take 10 years and cost of $500 million to develop a new drug. 80 to 90 percent of drug candidates fall short in clinical testing. Pharmaceutical companies rely upon a handful of successes to pay for their failures. Joe Stephens (2000) points out that Pfizer had been developing an antibiotic, Trovan that was proving to be handy in treating a wide range of bacterial infections. Wall Street analysts were predicting that Trovan could be a runaway success, one of a handful of drugs competent of generating sales of more than $1 billion a year. However, management decision to introduce drug hastily to market without conclusive research proved disastrous and present an interesting study from an ethical standpoint. Application of ethical decision making model This paper tends to apply Treviño and Nelson's (1990) eight step ethical decision making model in this case study. Gathering Facts In 1996, Pfizer was pushing to submit data on Trovan’s efficacy to the Food and Drug Administration (FDA) for review. An approving review would allow Pfizer to sell the drug in the United States, the world’s largest market both for adults and children. But it was having trouble finding sufficient number of sick children in the United States to test the drug on. Then in early 1996, an emerging epidemic of bacterial meningitis in Kano, Nigeria presented Pfizer a quick way to test the drug on a large number of sick children. Desperate for help, Nigerian authorities had given the go ahead for Pfizer to give the drug to children. Pfizer treated 198 children. The protocol called for half the patients to get Trovan and half to get a comparison antibiotic already approved for the treatment of children. Trovan seemed to be about as effective and safe as the already approved antibiotic. Data was subsequently submitted to FDA. Queries were soon heaved about the nature of Pfizer’s experiment. Accusations incriminated that the Pfizer’s team kept children on Trovan even after they failed to respond to the drug. The result was that some children died who might have been saved otherwise. Inquiries were also made about the safety of oral formulation of Trovan, which some doctors feared might lead to arthritis in children. Fifteen children who took Trovan showed signs of joint pain. Ethical issues Is it ethical to test an experiment drug on children in a crisis setting in the developing world, where the overall standard of health care is so much lower than in the developed world and proper protocols might not be followed? Did Pfizer behave unethically by rushing to take advantage of an epidemic in Nigeria to test an experimental drug on children? Was regard given to patient consent in the rush to establish a trial? And did doctors keep patient on Trovan too long, when they should have switched them on other medication? This whole scenario presented ethical dilemma to Pfizer top management. They had a big opportunity to cash in a new drug but on the other hand they had responsibility to community as well. Choice of making money at expense of social responsibility prevailed and experimentation on kids without a valid consent for material gains proved to be a business blunder. Impact on stakeholders This has to be done by getting into the shoes of stakeholders. Employees, shareholders and leadership were the internal stakeholders. Users, public and Nigerian government were external stakeholders. Management was eager to show progress in terms of introducing drug to market and revenue generation. Management failed to assess threat they were likely to pose to lives of millions in case of hasty research. Public and users were expecting an effective safe drug with no side effects from the company. Nigerian government failed to fulfill its obligations to its people by ignoring procedures/protocols and allowing company to proceed with a hasty research. This invariably resulted in loss of lives due to an incomplete researched drug placement in market. Identification of consequences Management failed to identify consequences. In case of failure/ineffective drug, likely litigation and awards of damages were totally ignored. Procedures and protocols were ignored. Then there were questions about consent. The FDA required that patient or parent consent be given before patients are enrolled in clinical trials. In the rush to get the trials established in Nigeria, Pfizer’s did not follow proper procedures, and that many parents of the infected children did not know that their children were participating in a trial for experimental drug. Many of the parents were illiterate, and could not read consent forms and had to rely upon the inadequate translation of the Nigerian nursing staff. Trovan was approved by the FDA for use in adults in 1997, but it was never approved for use in children. It was launched in 1998, and by 1999 there were reports that up to 140 patients in Europe had suffered liver damage after taking Trovan. The FDA subsequently restricted the use of Trovan to those cases where the benefits of treatment overweighed the risk of liver damage. European regulators banned sales of the drugs. Scott Hensley (2004) points out that, in 2003, two dozen Nigerian families sued Pfizer in a federal court in New York and claimed that their children either died or were injured because Pfizer did not adequately inform them of the risks and alternatives for treatment with Trovan. Management adopted consequentialist approach where the morality of decision is determined by its consequences. Thomas Donaldson (1989) believes that moral worth of actions is primarily assessed by their consequences. Management was so much consumed with revenue generation that they failed to analyze the harms and benefits of their actions on the stakeholders. Obligations This step needs to encompass the obligations of both management of the company and the government of Nigeria. Management obligation arises from the mere fact that it is the user money that eventually shapes company’s review. Hence, management is morally obligated not to take decisions resulting in hasty production of drug without proper and conclusive tests. Management failed to fulfill its obligations towards customers. Character and integrity Management should know its moral obligations, duties and responsibilities. Top management should display sound character and integrity. This eventually wins customer’s confidence and good business. In this particular case leadership did not exhibit integrity requisite for sound decision making. A manager should be convinced of his decision and should have the integrity to question an unethical practice. He should have the character to voice his concerns on an unethical move motivated solely for profit. Thinking creatively about potential options Management failed to create more options and got cornered by very limited choice of options. The deontologist philosophical approach should have been followed in this case because it not only caters rights of individuals but also it gives paramount importance to consequences of a decision with respect to rights of all the stakeholders as suggested by Charles Hills (2002). Here management failed to anticipate likely outcomes due to absence of a proper review system of their decisions and calculation of impact of their decisions. Research should not have been hurried as results affect lives of people. Management should have carried research in America and should have taken their time on analysis of data for sake of potential customers. Checking guts Empathy is an important consideration but should not be the only consideration. A manager needs to take decisions ensuring not only to good will of the company but also the well being of clientage. Bad decisions hamper not only the reputation of company but also hamper the revenue of the company. A good manger should have the guts to say no to a decision which is unethical. Ethical dilemmas are adequately dealt in business places where code of ethics is clearly stated and known to its stakeholders. Had Pfizer management focus been on ethical decision making ensuring conclusive research based drug production, there would have been a life saving drug in market not only winning the trust of clients but also bringing huge revenue to the company. References Joe Stephens. (2000, December 17). Where profits and lives hang in balance. Washington Post, p. A1. Scott Hensley. (2004, October 13). Court revives suit against Pfizer on Nigeria study. The Wall Street Journal, p. B4. Treviño, L.K. & Nelson, K. A. (2007). Managing Business Ethics. Hoboken, NJ: John Wiley & Sons, Inc. Thomas Donaldson, (1989). Ethics of international business law. Oxford: Oxford University Charles Hill, (2002). International Business: Ethics in business. Washington, DC: McGraw-Hill. Read More