CASE STUDY MERCK THE FDA AND THE VIOXX RECALL

With declining fortune, Merck found DTC irresistible and relied on it heavily to shore up its market share and to remain competitive. The relaxed rule led to widespread use of television to advertise prescription drugs with commensurate big spending by the drug companies Beauchamp et al, Ethical Theory and Business. It appears that the arguments against direct-to-consumer far outweigh arguments for. The belief through trials in Merck was that while Vioxx provides guarantee against stomach damage, there is no increased risk to the heart. The possibility that the knowledge gap would exist is very high especially among the less privileged members of the society. American Journal of Public Health Vol.

How to cite this page Choose cite format: 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. In , Merck wanted to prove whether Vioxx can reduce colon polyps. The belief through trials in Merck was that while Vioxx provides guarantee against stomach damage, there is no increased risk to the heart. 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 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.

Case Study: Merck & Company: the Vioxx Recall

But the market for it was insignificant. 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 vikxx which it hoped to shore ths its profile and revenue.

Next to this was the approval of Vioxx for marketing to the public by FDA. Reference Beauchamp et al, 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 warning about possibly more heart attacks and strokes Beauchamp et al, 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.

  ANGLIA RUSKIN DISSERTATION DECLARATION

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, The protagonists of DTC advertising have often argued that the mode has raised the awareness for and access to important new recaol as well as the ability of patients to actively engage their physicians in informed discussions about their prescription drugs.

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The Ethical Considerations Clearly, the objective to regain and maintain leadership fdaa in the pharmaceutical industry was paramount to Merck than getting a safe product to the market. 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.

Many lives were exposed to the risks of heart attack and strokes when the warning signs were staring them in the face. Congress to ban direct-to-consumer DTC is supported by this author. 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.

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.

Case Study: Merck & Company: the Vioxx Recall | Free Essays –

Public health is too important to be recal the whims of the pharmaceutical industry to manipulate as they have been doing over the years with their unrestrained budgets on DTC. DTC creates knowledge gap between the consumer and the marketer when the consumer cannot properly evaluate the information being received. The quest for make bigger profits and control the painkiller drug market seem to becloud their sense of judgments. That is why physicians and researchers should be made to disclose their pecuniary interest in any pharmaceutical company and in its drugs.

The belief through trials in Merck was that while Vioxx provides guarantee against stomach damage, there is no increased risk to the heart.

case study merck the fda and the vioxx recall

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. This gap is therefore open to manipulation to the advantage of the marketer. Home Essays Case Stury Retrieved May 22,from https: COX-2 inhibitors are the newest form of nonsteroidal anti-inflammatory drugs NSAIDs and Vioxx, vvioxx 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.

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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. Want to get a price estimate for your Essay?

case study merck the fda and the vioxx recall

We will write a custom essay sample on Case Study: Excluding patients with high risk of heart problem, the study gave some patients high doses of Vioxx and precluded them from taking aspirin. The relaxed rule led to widespread use of television to advertise prescription drugs with commensurate big spending by the drug companies Beauchamp et al, For this reason, it is hard to see how the elderly, children, and the less endowed who are vulnerable and susceptible to deceptive and marketing strategies can become more informed in making drug choices Greene, This case obviously calls for more and stricter regulations by strengthening the operations of FDA.

Retrieved June 9, from http: At introduction stage, both Merck and FDA acted unethically by speeding up the review process.

The outcome was that even though Vioxx patients showed stufy stomach damage, there is more blood clot problems than drugs in the naproxen group with five times higher risk of heart attack. 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.

It is hard to imagine that decision makers at all levels in Merck would ignore the disturbing information provided by their own VIGOR study.