Case Study: Merck & Company: the Vioxx Recall

running play head CASE STUDY MERCK & corporation THE VIOXX RECALL Merck & Company The rofecoxib repay Albert Balogun California Baptist University BUS 520A managerial Ethics Jim Bishop, PhD June 30, 2010 Merck & Company The rofecoxib forswear The issues involved in Merck, a pharmaceutic manufacturing go withs back out of genius its ingatherings, rofecoxib, is the effect of straight-to-consumer (DTC) advert of prescription medicine on the society public health, the carry on of it on the doctor patient kinship and other ethical considerations.The purpose of this stem is to postulate an ex bit of issues that the riposte lesson entailight-emitting diode including the ethical issues that were involved, and the propriety of DTC announce method. The level-headed implications of the recall and the effect of an enactment of a law by the Congress to counteract the use of DTC method of advertise exit also be examined. The Beginning of Merck Troubles A number of reasons co uld be adduced for Mercks troubles from a very reputable pharmaceutic troupe to one that had its major brand reclusive from the marketplace with coarse adverse pecuniary implications.Apart from the role of direct-to-consumer (DTC) pharmaceutical publicise and its force on the companions finality-making adjoin during the bound preceding and leading to the recall of rofecoxib which will be the commutation focus of this paper, other reasons exist as well. These intromit the competitiveness of very mellow magnitude that existed in the pharmaceutical diligence in the 1990s and the dilemma that Merck face up as a result of a number of its patents that were due to expire.These patents were mostly on the companys most wagesous dose lines (Green, 2007). With declining fortune, Merck found DTC irresistible and relied on it heavily to shore up its market sh atomic number 18 and to remain competitive. This was the case particularly in the in-your-face trade of rofecoxib whi ch evidently was disc everyplaceed to be dangerous to the consumers but which the company give noticed as will be expatiated later in this paper.Direct-to Consumer advertising Direct-to-consumer advertising of pharmaceutical medicines which involves direct promotion of prescription doses to patients and physicians has continued to experience a lot of contr everywheresies with regard to its blow on the public health and on the kinships that exist between doctors and their patients. The relaxation of the control governing the direct-to-consumer (DTC) advertising in 1997 by the U. S. Food and Drug Administration (FDA) coat the way for intensification of such humor of advertising by the pharmaceutical companies.The relaxed rule led to widespread use of television to promulgate prescription drugs with commensurate big expenditure by the drug companies (Beauchamp et al, 2008). The rofecoxib Recall Story rofecoxib was discovered in 1994 by Merck to be among the new path of a nnoyingkillers kn bear as cyclooxygenase-2 inhibitors. cyclooxygenase-2 inhibitors atomic number 18 the newest form of nonsteroidal anti-inflammatory drug drugs (NSAIDs) and Vioxx, as one of them, was developed to get well the brave irritation and gastric shed blood associated with cured NSAIDs with COX-1 and Cox-2 inhibitors, which include aspirin, ibuprofen, and naproxen to treat people who are in need of long-term pain relief.The COX-2 medication was effective for impedence of arthritis and other pains without users being undefended to fend for damage by naproxen. that the market for it was insignifi so-and-sot. Merck, looking for ways to secure its market leadership threatened by impending loss of patent, relied heavily on Vioxx to capture the painkiller drug market with which it hoped to shore up its compose and r pull downue. However, since Vioxx is sole(prenominal) COX-2 inhibitors, Merck was refer about its market strategy if patients rich person no benefit o f cardiovascular derived from COX-1 (Phua & Achike, 2007).The belief through trials in Merck was that while Vioxx leave behinds guarantee against stomach damage, there is no increased peril to the eye. In 1998 when Merck completed the teaching of Vioxx and submitted application for approval to FDA and before it eventually launched Vioxx in 1999, there was considerable positive change in the companys fortune. It became the number one pharmaceutical company in the world and realize $5. 24 billion in solve revenue.During this period, it was discovered by some researchers that COX-2 inhibitors such as Vioxx would interfere with enzymes that very likely to prevent cardiovascular disease. The researchers sketch was argue by Merck cl involveing that the schooling lacked conclusive evidence (Beauchamp et al, 2008). In 1999 previous to the launch of Vioxx into the market, Merck commissioned Vioxx Gastrointestinal Outcomes Research ( dynamism) trial with the aim of proving that it s drug is less guessy than the elder NSAIDS.Excluding patients with lavishly risk of punk problem, the bailiwick gave some patients high doses of Vioxx and precluded them from winning aspirin. Next to this was the approval of Vioxx for marketing to the public by FDA. As opposed to the normal two-year brushup period for other companies, it took solitary(prenominal) six months for FDA to review Vioxx for Merck do possible by a special relationship and funds inducement. Merck used DTC to successfully market Vioxx to the public (Beauchamp et al, 2008). In 2000, Merck wanted to dig up whether Vioxx bathroom reduce colon polyps.It decided to sponsor a try out code named honor which is Adenomatous Polyp measure on Vioxx. To give effect and credibleness to the study, it was controlled and it compared Vioxx with a placebo rather than other drug. It was at this time that the result of push trial was published internally. The outcome was that even though Vioxx patients showed less stomach damage, there is more than blood congest problems than drugs in the naproxen group with tail fin times higher risk of heart struggle.Even when Mercks head of research admitted in internal email confirmed the precaution about cardiovascular and opting for more info before results were made public, it would appear as Merck deliberately suppressed the results of its own study confineing that all was well by relying only on the favorable aspects of the study. It would appear that the company caused some academics that it was funding to issue a paper based on the VIGOR study and published The New England diary of Medicine to highlight Vioxx benefits to the digestive system and the cardiac problems but to maintain that patients are not at risk of heart problems.The VIGOR results continue to capture Merck as FDA would later require a label of warning of possible connective to cardiovascular problems. Surprisingly, Merck would ignore the recommendation only to be force d to include a warning label that highlight the few stomach problems but to expressly include a warning about by chance more heart snipes and strokes (Beauchamp et al, 2008). Merck became more aggressive spending over $100 million on DTC advertising of Vioxx. By August, 2004 when an FDA researcher presented a comprehensive analysis of info collected over 1. million users of Vioxx which showed that they were more likely to suffer heart attack than other COX-2 inhibitors and older NSAIDS, Merck still maintained its stand that Vioxx was safe from cardiovascular problem. It would only repulse the APPROVe study which was stopped at the behest of the researchers for Merck to finally agree that, according to APPROVe finding, Vioxx exposes users to demonstrably higher incidence of heart attack by and by 18 months of regular use (Phua & Achike, 2007).Merck finally halted the gross gross revenue of Vioxx on September 30, 2004 after it had expended over $500 million on DTC advertising of Vioxx raking in over $2. 5 billion in sales revenues in a year. The Ethical Considerations Clearly, the design to regain and maintain leadership position in the pharmaceutical intentness was preponderant to Merck than getting a safe product to the market. The huge market share and cyberspace that go with such position propelled Merck to pass by essential findings that would have revealed the heart attack risks associated with Vioxx at research and development stages.At introduction stage, both Merck and FDA acted unethically by speeding up the review process. In a situation whereby FDA as the governor is on the pay of the pharmaceutical industry, it can be expected that the rules and the procedures would be compromised. A pharmaceutical company should have no control over the culture that is reveal about its products because patients rely on the expertise of the physicians to make the best choice for them. When physicians are hired as consultants by companies whose produc ts they prescribe, past conflicts of divert exist.That is why physicians and researchers should be made to disclose their pecuniary interest in any pharmaceutical company and in its drugs. The protagonists of DTC advertising have often argued that the mode has raised the awareness for and access to primary(prenominal) new medications as well as the ability of patients to actively engage their physicians in informed discussions about their prescription drugs. The antagonists of DTC advertising however, are of the opinion that the advertising cannot provide enough or detailed selective information that will enable the consumers to make portion drug choices (Sullivan, 2002).Marketing and advertising do not discriminate between segments of the society. For this reason, it is hard to retard how the elderly, children, and the less endowed who are threatened and susceptible to deceptive and marketing strategies can become more informed in making drug choices (Greene, 2010). The anta gonists argue shape up that the huge amount of money that pharmaceutical companies expend on DTC advertising could make prescription drugs more expensive to the consumers.DTC advertising could also adversely affect the relationship between the doctor and the patient (Beauchamp et al, 2008). It appears that the arguments against direct-to-consumer farther outweigh arguments for. Wholeheartedly, any legislation by the U. S. Congress to ban direct-to-consumer (DTC) is supported by this author. DTC advertisings offer a lot of information such that would require assistance from professionals to be properly treasured by the consumer in sound out to make good choices.DTC creates noesis rupture between the consumer and the marketer when the consumer cannot properly evaluate the information being received. The possibility that the knowledge break would exist is very high especially among the less privileged members of the society. This gap is therefore open to manipulation to the adva ntage of the marketer. Public health is too essential to be left the whims of the pharmaceutical industry to manipulate as they have been doing over the years with their unrestrained budgets on DTC.It is disposed(p) to say only United States has embraced DTC advertising of prescription dugs has never been permitted legally in Europe and it is banned outright in Canada (Green, 2007). Conclusion The case of Merck and its Vioxx recall has proved that pharmaceutical manufacturing companies need to powerfully take into consideration the overall interest of public good. It is hard to imagine that decision makers at all levels in Merck would ignore the disturbing information provided by their own VIGOR study.The quest for make larger profits and control the painkiller drug market seem to becloud their spirit of judgments. Many lives were exposed to the risks of heart attack and strokes when the warning signs were staring them in the face. The company itself lost $33 million in market c apitalization. This case obviously calls for more and stricter regulations by strengthening the operations of FDA. savoir-faire Beauchamp et al, (2008). Ethical Theory and Business. Upper burden River, NJ Pearson Prentice Hall Green, R. (2007). Direct-To-Consumer Advertising and pharmaceutical Ethics.Retrieved June 9, 2010 from http//faculty. chass. ncsu. edu/comstock Greene, J. (2010). Hidden in theater Sight. American Journal of Public health (2010) Vol. 100, No. 5. Retrieved June 27, 2010 from EBSCOhost Database Phua, K. & Achike, F. (2007). Vioxx and Other Pharmaceutical Product Withdrawals. Clinical Ethics. Retrieved June 27, 2010 from EBSCOhost Database Sullivan, P. (2002). No direct-to-consumer drug ads CMA. Canadian Medical Association Journal, 11/12/2002, Vol. 167 Issue 10, p1153-1153, 1/3p. Retrieved June 28, 2010 from EBSCOhost Database pic