The vioxx recall merck and fda essay

This information was revealed at a very early stage of development. In addition, all government regulators and policymakers in the field of pharmaceutical industries also should bear in mind that they have a huge responsibility in protecting the public against any harmful and risky drugs, so that they will not go easy on the companies that do not abide the law.

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. Many lives were exposed to the risks of heart attack and strokes when the warning signs were staring them in the face.

Merck Research suggested that some scientists had been worried about cardiovascular risks and VIGOR found that Vioxx was easier on the stomach but caused five times as many heart attacks in the study group, this concerned the FDA and it required Merck to add an additional warning language to its label.

Merck, the FDA, and the Vioxx Recall Case

During production process, there were serious safety concerns raised by a number of studies, which Merck failed to consider and thus contributed to its unethical behavior.

Food and Drug Administration FDA paved the way for intensification of such mode of advertising by the pharmaceutical companies.

Many doctors expressed their concerns regarding the use of direct-to-consumer marketing strategy suggesting that it created an impression that all drugs are safe, which in reality is never the case. Vioxx was the 9th drug taken off the market in 7 years.

It destroys trust between the firm and its customers in all forms of communication Ferell et al Inthe FDA for the first time allowed drug companies to advertise directly to consumers. Merck should have held their product to a higher standard than their competitors and fully research all potential possibilities of why cardiovascular events occurred before the drug was put on the market.

To seize the opportunities, Merck then employed tens of thousands of sales representatives; mostly attractive young men and women. Merck used an advertising technique called direct-to-consumer, which was new in the pharmaceutical industry as it was the first time they were allowed to advertise to consumers.

In 9 MarchDr. Why or why not. There are various ways to do so. Historically, drug companies focused most of their marketing efforts on prescribing physicians. Merck should have considered what could have been potentially happened and the medication should have been changed in order to minimize the harmful side effects.

Studies the company should have been aware of include: 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.

By lobbying, Merck and other drug companies consistently donate large sums of money to political parties, and this benefits them in terms of influence they had over some superiors, even at the FDA. The study concluded that Vioxx carried an increased risk of such cardiovascular events.

However, the company cannot completely exonerate itself from the legal blame considering the fact that at the time, many staff members working for FDA were under pressure to accelerate entry of prescription drugs into the market. Section 5 From an ethical and legal dimension, recall was an act of corporate social responsibility.

They should ensure that pharmaceutical companies do not interfere with the healthcare system such as limited DTC so that doctors can prescribe the correct medications for their patients not what medication their patients saw on a commercial.

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.

Recall also amounted to admission that Vioxx really caused heart attacks, which led to lawsuits further affecting reputation and profitability of the firm.

With declining fortune, Merck found DTC irresistible and relied on it heavily to shore up its market share and to remain competitive. It is pertinent 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, Yes, Merck did not act socially and in ethical manner before, but if they do get back to do what they were used to do; of course, without all those illegal and immoral behavior, comeback sure to follow.

Actually, some of the staff working for the agency aired their concerns that FDA was not assessing the safety of drugs satisfactorily.

Merck, the FDA, and the Vioxx Recall Essay Sample

Though the company complied eventually, its failure to comply with the legislation without questioning raises major ethical issues. The evidence that there is a problem is the fact that the company had to pull the drug from the market and that the Justice Department opened a criminal investigation against Merck.

COX-2, on the other hand, contributed to pain and inflammation.

Merck, the FDA, and the Vioxx Recall Essay Sample

Other drugs such as Advil suppressed both enzymes which is why some users had stomach irritation. When studies became public of Vioxx users being twice as susceptible to heart attacks, the president of Merck Research Lab, Dr. The ad did not provide safety information to consumer, which would have enabled them to make the right decision.

Though Merck consistently irresponsible socially and ethically in the way they dealt with the Vioxx situation, the handling of Vioxx recall from the pharmaceutical market seems to be managed appropriately and in a professional manner by Merck. Merck Vioxx Recall Essay.

Merck, the FDA, and the VIOXX Recall MBA D4C2 Ethics & Leadership in a Global Environment April 22, Merck and Vioxx Recall Did Merck act in social and ethical manner? InMerck was ranked fourth in sales among pharmaceutical companies. Merck had released the drug Vioxx, for treating.

Case Study; MERCK, the FDA, and the VIOXX RECALL Inthe pharmaceutical giant Merck faced major challenges. Vioxx, the company’s once best-selling prescription painkiller, had been pulled off the market in September after Merck realized it increased the risk of heart attacks and strokes.

Merck, the FDA, and the VIOXX Recall MBA Ethics and Leadership in a Global Environment MBA 15 November Merck, the FDA, and the VIOXX Recall InMerck started a clinical trial called VIGOR, checking the effectiveness of VIOXX in patients with gastrointestinal problems, and in this trial they noted for the first.

Merck, the Fda, and the Vioxx Recall Essay Merck, the FDA, and the VIOXX Recall MBA Ethics and Leadership in a Global Environment MBA 15 November Merck, the FDA, and the VIOXX Recall InMerck started a. The Central Problem In the Merck, the FDA, and the Vioxx Recall case study, the question as to whether or not Merck conducted itself in a socially responsible and ethical manner with regard to Vioxx is the central problem we will examine in this case.

The vioxx recall merck and fda essay
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Merck, the FDA, and the Vioxx Recall | Essay Example