CASE STUDY MERCK THE FDA AND THE VIOXX RECALL
American Journal of Public Health Vol. It appears that the arguments against direct-to-consumer far outweigh arguments for. The huge market share and profits that go with such position propelled Merck to overlook essential findings that would have revealed the heart attack risks associated with Vioxx at research and development stages. As opposed to the normal two-year review period for other companies, it took only six months for FDA to review Vioxx for Merck made possible by a special relationship and money inducement. Literature Review Dissertation chapter: The belief through trials in Merck was that while Vioxx provides guarantee against stomach damage, there is no increased risk to the heart. Related Essays Pharmaceutical Industry and E.
Direct-to Consumer Advertising Direct-to-consumer advertising of pharmaceutical drugs which involves direct promotion of prescription drugs to patients and physicians has continued to generate a lot of controversies with regard to its impact on the public health and on the relationships that exist between doctors and their patients. The COX-2 medication was effective for treatment of arthritis and other pains without users being exposed to stomach damage by naproxen. 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 possibility that the knowledge gap would exist is very high especially among the less privileged members of the society. The legal implications of the recall and the effect of an enactment of a law by the Congress to prevent the use of DTC method of advertising will also be examined. As opposed to the normal two-year review period for other companies, it took only six months for FDA to review Vioxx for Merck made possible by a special relationship and money inducement. Food and Drug Administration FDA paved the way for intensification of such mode of advertising by the pharmaceutical companies.
Merck Ag Pharmaceutical Industry and E.
Related Essays Pharmaceutical Industry and E. Excluding patients with high risk of heart problem, the study gave some patients high doses of Vioxx and precluded them from taking aspirin. Want to get a price estimate for your Essay?
COX-2 inhibitors are the newest form of nonsteroidal anti-inflammatory drugs NSAIDs and Vioxx, as one of them, was developed to overcome the stomach irritation and gastric bleeding associated with older 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 relaxation of the rule governing the direct-to-consumer DTC advertising in by the U. The legal implications of the recall and the effect of an enactment of a law by the Congress to prevent the use of DTC method of advertising will also be examined. This case obviously calls for more and stricter regulations by strengthening the operations of FDA.
Case Study: Merck & Company: the Vioxx Recall
The outcome was that even though Vioxx patients showed less stomach damage, there is more blood clot problems than drugs in the naproxen group with five times higher risk of heart attack. The Ethical Considerations Clearly, the objective to regain and maintain leadership position in the pharmaceutical industry was paramount to Merck than getting a safe product to the market. This was the case particularly in the aggressive marketing of Vioxx which evidently was discovered to be dangerous to the consumers but which the company ignored as will be expatiated later in this paper.
It appears that the arguments against direct-to-consumer far outweigh arguments for. The relaxed rule led to widespread use of television to advertise prescription drugs with commensurate big spending by the drug ffda Beauchamp et al, The antagonists argue further that the huge amount of money that pharmaceutical companies expend on DTC advertising could make prescription drugs more expensive to the consumers.
How to cite this page Choose cite format: In a situation whereby FDA as the regulator is on the pay of the pharmaceutical industry, it can be expected that the rules and the procedures would be compromised.
The antagonists of DTC advertising however, are of the opinion that the advertising cannot provide enough or detailed information that will enable the consumers to make appropriate drug choices Sullivan, American Journal of Public Health Vol.
Merck, the FDA, and the Vioxx Recall by melinda harkless on Prezi
InMerck wanted to prove whether Vioxx can reduce colon polyps. Marketing and advertising do not discriminate between segments of the society. The possibility that the knowledge gap would exist is very high especially among the less privileged members of the society. DTC advertisings offer a lot of information such that would require assistance from professionals to be properly evaluated by the consumer in order to make good choices.
The belief through trials in Merck was that while Vioxx provides guarantee against stomach damage, there is no increased risk to the heart. Conclusion The case of Merck and its Vioxx recall has proved that pharmaceutical manufacturing companies need to strongly take into consideration the overall interest of public good.
The quest for make bigger profits and control the painkiller drug market seem to becloud their sense of judgments. Surprisingly, Merck would ignore the recommendation only to be forced to include a warning label that highlight the fewer stomach problems but to expressly include a msrck about possibly more heart attacks and strokes Beauchamp et al, A pharmaceutical company should have no control over the information that is jerck about its products because patients rely on the expertise of the physicians to make the best choice for them.
Case Study: Merck & Company: the Vioxx Recall | Free Essays –
The purpose of this paper is to make an exposition of issues that the recall case entailed including the ethical issues that were involved, and the propriety of DTC advertising method. Ethical Theory and Business.
To give effect and credibility to the study, it was controlled and it compared Vioxx with a placebo rather than another drug. We will write a custom essay sample on Case Study: Upper Saddle River, NJ: But the market for it was insignificant.
Reference Beauchamp et al, These include the competitiveness of very high magnitude that existed in the pharmaceutical industry in the s and the dilemma that Merck faced as a result of a number of its patents that were due to expire. As opposed to the normal two-year review period for other companies, it ghe only six months for FDA to review Vioxx for Merck made possible by a special relationship and money inducement.
Pearson Prentice Hall Green, R.