Wednesday, August 7, 2019
Relationships with Government Regulators and Policymakers Essay Example for Free
Relationships with Government Regulators and Policymakers Essay No, I did not believe that Merck acted in a socially responsible and ethical manner with regard to Vioxx. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults and painful menstrual cycle and Merck was one of the worldââ¬â¢s leading pharmaceutical firms. Corporate social responsibility means that a corporation should act in a way that enhances society and its inhabitants and be held accountable for any of its actions that affect people, their communities, and their environment. I didnââ¬â¢t believe Merck acted in a socially responsible and ethical manner with regard to Vioxx is because Merck had long enjoyed a reputation as one of the most ethical and socially responsible of the major drug companies. Drug development and testing Merck was renowned for its research labs, which had a decades-long record of achievement, turning out one innovation after another, including drugs for cholesterol, hypertension, tuberculosis and other. In product development and testing, scientists know Vioxx there are serious health risks and the drug may have side effects such as cardiovascular complications but scientists think that the lives that could have potentially been and now know that the effects of the medication can improve then change and it can minimize the harmful side effects. During the development and testing phase for Vioxx has many issues regarding the safety of the drug were questioned due to the many cases of heart attacks and strokes resulting from the medication but also have people think heart attacks and strokes were common and they had multiple causes, including genetic predisposition, smoking, obesity and a sedentary lifestyles. Marketing and advertising This was new in the pharmaceutical industry as it was the first time the FDA were allowed to advertise to consumers and the advertising technique of Vioxx that was used was thru direct-to-consumer. Merck used an Olympic figure skater as the primary character within their commercials and telling viewers that she would ââ¬Å"not let arthritis stop me.â⬠The drug companies defended DTC ads, saying they informed consumers of newly available therapies and encouraged people to seek medical treatment so consumers then would request this medication, making doctors feel obliged to prescribe. Drug company focused most of their marketing efforts on prescribing physicians and as a result of this fiasco, implications for big pharmaceutical firms like Merck are clear, they have take more time to conduct more clinical studies and assess the health risks associated with the drugs even if it means a delay in the entry of the drug into the market. Relationships with government regulators and policymakers Vioxx were regulated by Food and Drug Administration (FDA) and work of FDA is whether or not to approve a new drug. Some evidence suggested that the morale of FDA staff charged with evaluating the safety of new medicine had been hurt by relentless pressure to bring drugs to market quickly. The government and policymakers received large sums of money from the development company during the advertising phase and market introduction. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically and FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market. Handling of the recall Merck announced a voluntary worldwide withdrawal of Vioxx. From the published evidence of Vioxx is crystal clear risk of heart attack, as early as in the late 1990s, the company should be aware of risk awareness and the companys internal documents confirmed the the companys awareness of the risks. Yet Merck continued not only to sell the drug, but to market it heavily and as a first line choice, not merely for those thought to be at higher risk of stomach bleeding. Merck decisions and judgments of certain problems with Vioxxs launch can be faulted. They are either ignored or dismissed early signs of an increased risk of heart attack, whether it is in their own research and other post, trying to get to market faster. This proved to be deadly further studies in line with the concerns, and lead ultimately to lead to another wrong decision to recall the drug from the market and Merck would have hoped for, instead they lost the market of customers who would still have taken Vioxx in spite of the risks.
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