Do you believe that Merck acted in a socially responsible and ethical manner about Vioxx
I believe the actions of Merck were not ethically or morally appropriate because he his company was aware of the fact that the drugs were unsafe before being approved by the FDA 1999. Prior to FDA’s rigorous testing and approval, Merck had already learnt that Vioxx increases the chances of developing a stroke or hear attack in 1998. The case points out that he knew quite well the possible cardiovascular consequences like heart failure that patients would develop in case the drug was launched in the market. Hence, Merck’s actions concerning Vioxx were unethical because the lacked utilitarianism ethics. Utilitarianism refers to the virtue grounded on utility, and it argues that action must be geared towards the benefit of the larger number of individuals.
Merck also acted in an immoral manner in not considering how launching Vioxx in the market would affect stakeholders including Merck, the public, users of the product and shareholders. The actions are based on pure self-interest for the business in securing profits than realizing the ethics of consequentialism. The consequentialist theory holds that Merck should have understood the benefits and harms to various stakeholders and opted so a decision that is of greater good for the greater amount of people. This implies Merck realised the various problems from the start of the product such as the trials in arthritis proving to be highly challenging and experiencing difficulties in requiring the controlled safety studies before the drug’s approval.
Either, Merck failed to act in accordance with virtue ethics as it requires him to demonstrate a character of integrity and looks to moral communities to aid determine ethical issues and guide ethical actions. For instance, in 2004, the company called for a meeting with FDA to stop the long-term research on Vioxx on patients who are prone to colon polyps. Merck informed the FDA that this study would remove Vioxx from the market voluntarily. They presented data, which indicates greater risks of strokes and cardiovascular diseases as from the 18th month in comparison to the placebo samples. As such, Merck saw that this drug was much a health risk to people who use it and the key issue here is that he was clearly aware of the problems from the very start but proceeded until he launched the drug on the market.
What should Merck have done differently?
I believe Merck should have approached this issue differently. They would have issued a press release acknowledging the potential risks to the particular target audience and confirming that the company was working with key stakeholders to lessen the risk before administering Vioxx therapy. Besides, they could have included in the drug’s package insert and fair balance to show that Vioxx has been contraindicated in high MI risk patients. This means Merck would need additional education and work for the sales department to communicate patient profiles with MI risk thus reduce potential income to profit the majority affected in this scenario. Utilitarianism suggests that Merck should continue marketing the Vioxx though with a revised package insert to determine the high-risk sub group as a contraindication. Further, Merck’s press statement should alert the public regarding the situation and advise the public that he is ethically dedicated to the safety of all patients. This would establish his reputable image while building trust with the HCPs, stakeholders, and patients. Though it would cut revenue in the short term, both the public and the company would profit in the long term.
What is the best way for the society to protect consumers of prescription medicines?
Physicians assume a critical part in health promotion, notably helping patients develop informed, responsible self-medication. Physicians recommend interventions for common health issues, recurrent and chronic illnesses. They are the main providers of primary healthcare among them the use of prescription and non-prescription medications. Physicians assume a key role in patient education concerning responsible self-medication such as when to pursue medication, how to track effects and when to stop medication. Therefore, they are charged with the responsibility of guiding patients regarding the use of prescription medicines and self-medication competencies such as the desired results of self-medication drugs.
The pharmaceutical sector ensures patient safety regarding prescription drugs by vigorously monitoring health outcomes. Then it reports to the FDA all evidence of potential side effects of negative impacts observed in some patients after the drug is introduced in the market. Besides the pharm sector, government regulators are also important in promoting patient safety. For instance, regulators such as the National Drug Control (NDC) and Food and Drug Administration (FDA) try to educate patients about the proper use and possible risks of drugs. These agencies are charged with the responsibility of ensuring the efficacy and safety of the drugs available to the general public.
On the other hand, policy makers are launching actions and measures to combat medication shortages. For instance, they are developing procedures and policies to ensure the use and accuracy of information in the current drug shortages information pool. Moreover, the use the existing drug shortage database to conduct periodic analyses which help identify risk aspects for possible shortages early. For instance, DFA’s strategic plan stipulates a rule that requires companies such as Merck to notify them promptly of possible disruptions to the supply of medically vital drugs.
Though consumers are expected to count on the health system to keep them safe, there are often steps they can embrace to look out for their safety. Despite being prescribed by the physician, consumers must find out what drugs they are taking and the purpose of the drug. Instead of simply letting the physician write and send you a prescription, consumers must ask the name and purpose of the drug. Such practices serve as a check in cases of confusion regarding the drug name.
How the present system should be changed to protect patients
The FDA could improve the current system of assessing effectiveness on drug safety by creating multiple clinical trials over a sporadic duration to identify if the drug is utterly safe to launch onto the market. I believe the best way would be for FDA to initiate a new strategy in the criteria for deciding whether a drug is safe for users. I would recommend that the FDA hold various test runs over 3-years duration after the creation of a drug. This process should conduct tests on patients from diverse demographic domains, which would serve them a winder of time to observe whether there are any new signs in the patients. By improving the present process sin this manner, the FDA would determine whether to accept or reject the product for further reviews and research. Such a process would prevent prospective harmful drug products from entering the market and harming thousands of individuals.