MERCK THE FDA AND THE VIOXX RECALL CASE STUDY SUMMARY

At introduction stage, both Merck and FDA acted unethically by speeding up the review process. Ethical Theory and Business. That is why physicians and researchers should be made to disclose their pecuniary interest in any pharmaceutical company and in its drugs. Many lives were exposed to the risks of heart attack and strokes when the warning signs were staring them in the face. The relaxed rule led to widespread use of television to advertise prescription drugs with commensurate big spending by the drug companies Beauchamp et al, Nor is it a primary information source.

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. It is hard to imagine that decision makers at all levels in Merck would ignore the disturbing information provided by their own VIGOR study. BECG click on the button below, and select the case from the list of available cases: Case Study Volumes Collection. It is not intended to illustrate either effective or ineffective handling of a management situation.

The Recall of Vioxx|Business Ethics|Case Study|Case Studies

Click Fecall Delivery Details: Reference Beauchamp et al, 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.

Ever since its launch, medical experts had raised doubts ccase the cardiovascular risks associated with Vioxx’s usage. At introduction stage, both Merck and FDA acted unethically by speeding up the review process. Merck, looking for ways to entrench 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 profile and revenue.

Next to this was the approval of Vioxx for marketing to the public by FDA. The protagonists of DTC advertising have often argued that the mode has raised the awareness for and access to important new medications as well as the ability of patients to actively engage their physicians in informed discussions about their prescription drugs. DTC advertisings offer a lot of information such that would require assistance from professionals to be properly evaluated by the consumer in th to make good choices.

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The Recall of Vioxx

DTC creates knowledge gap between the consumer and the marketer when the consumer cannot properly evaluate the information being received.

Reacting to the withdrawal of Vioxx, Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research said, “We have been concerned and aware of the potential for cardiovascular effects for the last few years, and this is not a total surprise” Literature Review Dissertation chapter: 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.

Excluding patients with high risk of heart problem, the study gave some patients high doses of Vioxx and precluded them from taking aspirin. Public health is too important 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. By August, when an FDA researcher presented a comprehensive analysis of data collected over 1.

When physicians are hired as consultants by companies whose products they prescribe, then conflicts of interest exist.

merck the fda and the vioxx recall case study summary

The relaxed rule led to widespread use of television to advertise prescription drugs with commensurate big spending by the drug companies Beauchamp et al, studg It is not intended to illustrate either effective or ineffective handling of a management situation. To give effect and credibility to the study, it was controlled and it compared Vioxx with a placebo rather than another drug.

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This case obviously calls for more and stricter regulations by strengthening the operations of FDA.

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. BECG click on the button below, and select the case from the list of available cases: The belief through trials in Merck was that while Vioxx yhe guarantee against stomach damage, there is no increased risk to the heart.

Case Study: Merck & Company: the Vioxx Recall

Wayne Ray, Epidemiologist, Vanderbilt University. It appears that the arguments against direct-to-consumer far outweigh arguments for. Ethical Theory and Business.

merck the fda and the vioxx recall case study summary

Congress to ban direct-to-consumer DTC is supported by this author. ,erck 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.

Get custom essay sample written according to your requirements Urgent 3h delivery guaranteed Order Now. Related Essays Pharmaceutical Industry and E. Home Essays Case Study: 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.

The relaxation of the rule governing the direct-to-consumer DTC advertising in by the U.