Ethical Issues in The Case of Compassionate Use Release of an Unapproved Drug

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The Case study is based on Chimerix, a biotechnology company that is based in North Carolina; the company’s CEO is Kenneth Moch. The company is fully dedicated to coming up with antiviral medication. While working to ensure its first medication is approved, Chimerix is faced with a dilemma. It all started in early 2014 when a seven-year boy, Josh Hardy suffering from kidney cancer and in the past underwent bone marrow stem cell transplant requested to have the unapproved drug following his doctor’s advice at St.Jude Children Research Hospital. Soon after going through the transplant, Josh developed a deadly respiratory virus. Josh’s doctor at the hospital knew of an unproven medication developed by the company and advised that the family talk to the company for a compassionate use release of the uncertified medication (Kingson 80). Since was in its process of request for approval from the Food and Drug Administration (FDA), it declined the request.

            The whole issue took the worse for Chimerix when the social media was involved. Following the world’s compassion for children, the entire social media platform took into stage to persuade the company to provide the drug to the ailing boy. Josh’s support from the media was overwhelming, and the company understood and sympathized with the situation but still decline to issue the drug. Because Kenneth Moch was then the company’s CEO, Hardy’s supporters blamed him for not providing the boy with the experimental drug. He receives thousands of phone calls and emails some of which were death threats forcing him to relocate his family. The paper will address five major areas which include; ethical issues in the case, stakeholders involved, stakeholders involved in addressing the ethical issues, ethical theories, and principles and the plan of action for Chimerix Company.

Ethical issues arising

An ethical issue is a situation requiring an individual or an institution to choose between several options that should be assessed as either ethical or unethical. Business ethics requires that organizations apply professional ethics in their day to day operations; this involves examining ethical problems that can occur in a particular business environment. Any action that is taken by a business affects different stakeholders in one way or the other. From the case study, there are different ethical issues that rose; they include replacing Kenneth Moch and issuing the compassionate use release of an unapproved drug.

            Increased pressure from the social media, the company accepted to commence a clinical trial for brincidofovir a drug that Josh’s doctor requested. This was despite not getting an approval from FDA, in most cases compassionate use release is used outside clinical trials and before that the research ethics committee should approve it. This was not followed by the company, the chances of survival for the boy was minimal hence the company should not have taken such a move. Their decision could have negatively affected Josh who is the patient and his family too; the negative outcome could be due to the fact that Josh was not regularly being monitored hence interfering with the progress with FDA.

            Another ethical issue replacing Kenneth Moch, the company’s CEO shortly after Hardy when through the medication trials. The company’s management claimed that the CEO resigned which is not the truth, the CEO’s decision was for the good of the company, this is because the issue was already everywhere and any decision not to issue the boy the unapproved drug could negatively tarnish the reputation of the company. Since the drug was of benefit to the patient, Chimerix greatly benefited out of it but not the CEO. Much’s replacement wasn’t justified because the case of compassionate use release has several unpredicted outcomes.

            Failing to have informed consent from the boy is unethical, the company did not directly involve and know the consent of the boy even if he was a minor (Devettere 49). He too has a right to know anything concerning his health, and so was the treatment trial. Even if parents can sometimes decide for a minor, professionalism requires that the minor’s views be taken. The above ethical issues affect different individuals as discussed in the next section.

Stakeholder Analysis

A stakeholder refers to an entity that is directly or indirectly affected by any action that an institution or organization takes. The company or an organization has an ethical role towards these units. In a healthcare institution, some stakeholders including employees, physicians, patients, competitors, companies and even the general public are affected. These stakeholders have concerns, needs, desires, power and even benefits. In this particular case, the individuals involved were the focus. In the case stakeholders were Kenneth Moch, Josh Hardy, Chimerix and other biotech firms. These entities have a motive, agenda or need as to whether to release brincidofovir or not. The losses and benefits of these entities rely on whether the drug in question is issued or not.

            Chimerix is one of the stakeholders in the case; this is because the issue discussed here revolves around it. The firm is in its early stages, and the drug that they hope will be its first source of income is in the limelight. Chimerix has an interest in making money out of the drug and stop depending on investors and well-wishers. The company’s main objective is to issue the population with antiviral drug to save lives, but the risk of releasing the drug for compassionate use is that the FDA will stop the approval process if the outcome is negative. Having said this, the company’s concern is not only that they will not benefit from the treatment , but that the other patients in need of the medication will not seek it due to the unfortunate incident involving Josh Hardy, and the fact that the boy was not monitored in a facility at it is in trials. The company has not decent income of its own; this means that issuing the medication as a compassionate use release will be an expense with no financial coverage. On the other hand, if the company was to issue the drug and it works, the high demand by the patients and the doctors will make the funding difficult.

            Kenneth Moch is the other stakeholder. He is the CEO of the company; Kenneth is in a compromising situation because he represents the image of the company and all the decision making depend on him. Much’s concern is more of an ethical issue. If he takes a position not to issue the drug, he will be risking the life of the boy; on the other hand, not issuing it might save the many lives with the treatment later on. The whole thing puts his job at a compromising position; this is because his job is at the center of it all. If the general public has a negative view of the company, Moch is the scapegoat, and on the other hand, if he makes up his mind to issue the drug and the outcome is negative, Chimerix is stopped on the treatment, and he is dismissed. Kenneth is also concern that the company might not benefit from the release of the drug and having no products to sell to produce income and to compensate for the treatment, Moch had no option but to refute the request although he had the power to approve the request.

            Josh Hardy and his family are the other stakeholders in the case, what faces them are irreversibly lost. Josh’s health was worsening, and he was finally going to die. The only hope that the family had was on the unapproved drug; they had hope that the drug could heal their boy. The boy’s need, in this case, was a chance. The family knew that their son would die having not treatment and they were not ready to let it be their son’s fate. The shocking social media report fully benefited Hardy’s family. The support for the boy was the driving force for the company to find a way to administer the drug to the boy. Josh would be a great beneficiary in the case; this is because he gets to live a healthy life.

            Biotech companies are also stakeholders in the case. The companies have desires, benefits and concerns as far the case is concern. The firms are much concern of the impact of social media and its influence on their operations. By Hardy’s family resorting to making use of the social media to get medical assistance for their dying son, the firms feared that the issue would be precedent causing an epidemic when drug is involved. Following the power and the influence the media has, the firms could easily tarnish their reputations something the companies were concern with. The firms stand to benefit if the medication becomes successful, they can also gain from publicity that comes with no costs at all. More individuals will be willing to undergo trails hence making medicine cherished rather than being feared.

Stakeholders Involved in Solving the Ethical Issues

The stakeholders responsible for solving the ethical issues include biotech firms and Kenneth Moch. These stakeholders have a lot to lose and comprehend the inner workings, and the ethical issues faced. For instance, Kenneth has lived the situation and has been affected by its outcome. Moch patience makes him remain focus on the common good regardless of how much his moral and ethical standards being challenged. His experience, focus, and skills are important in establishing a notable decision. 

            The Biotech companies are important because they could fall victim just like Chimerix. The firms contribute to the development of the industry’s standard as a whole. The firms’ position as far as the replacement of Moch is concern is that the CEO made the right decision when he says no to the compassionate use release with the situation his company was (Devettere 37). If the firms harmoniously work together, they can come up with rules to address such cases when it occurs. Their wide knowledge of the operations of an organization and its ethical understandings will serve as industrial security. Its proposals on having persons in place to come up with a program for compassionate use treatment release, this is a clear indication that they fully understand ethical situations, and require an advocate for circumstance under which a compassionate use is requested. The reason why they are important is that they fell being discriminated by the media and need to have good relations with the public.

Ethical Theories and Principles

There exists several ethical principles which can be used to address ethical issues arising  from the case study, they include; “Employees shall put forth honest effort in the performance of their duties”, “Public service is a public trust, requiring employees to place loyalty to the Constitution, the laws and ethical principles above private gain”, “Employees shall not hold financial interests that conflict with the conscientious performance of duty”, and “Employees shall not use public office for private gain,”( Kingson 20). The first ethical principle to be used in this case is “Employees shall not use public office for private gain,” Kenneth in the case acted selflessly, he didn’t use the office he was for his gain. This can be illustrated by him convincing the FDA to the media and approve the drug to enable Hardy in the trail. The principle enables Moch to stop the cries from the media and to obtain several subjects for information on the drug in question; this further played a role in the company’s effort to get approval from FDA.

            The other principle is “Public service is a public trust, requiring employees to place loyalty to the Constitution, the laws and ethical principles above private gain” (Devettere 67). Moch went against the principle by being willing to let the boy die for the sake of the company’s success. Here, life was more important than anything, by doing this he made the public to lack trust towards the company. Instead of being loyal to the constitution and the ethical principles, he chooses to b loyal to his bosses who later dismissed him. The ethical principle if well applied in the case could stop Moch being replaced by the management.

            “Employees shall put forth honest effort in the performance of their duties,” this is another principle that can be used to address the ethical issues addressed in the paper. Moch did not apply this principle, that is why he did not when ahead and have informed consent from the patient, he was only concern on getting approval for the company. He could have put a genuine effort in his undertaking now that the company had already displayed the outcome from its previous trial and hence making it possible for the compassionate release to be approved to benefit the patients including Hardy.

            The last appropriate principle for this case is “Employees shall not hold financial interests that conflict with the conscientious performance of duty” (Devettere 41). Following the outcries from the social media in support of Hardy, Moch still ignored the request for the medication; he was much concern about the costs the company will incur as a result of the medication. He was putting the company’s finance interest before the general good of the public. This can be seen by the criticism he received by failing to release the medication. Moch should have acted promptly to allow the Hardy have drug since he was in need of. Moch and the company violated the theory of justice which requires that individuals are treated fairly to have a good relationship with the community (Caroline). They did not give justice to the patients seeking medication in the facility; they were concern on making income out of it. It lacked compensation strategy in case of any damage caused by the drug during the trials.

The Plan of Action

The whole scenario was a nightmare to the company, the contributing factor to this was inadequate preparation. Going forward, Chimerix should have a plan to take care of the backlash and to come up with a standard. The plan is as follows. First, when dealing with patients with similar medical condition as Hardy, a qualified physician must be the one managing the company. This will ensure that there is no interaction between the company and the patients seeking the medication. There will be no confusion as to whether the case is business or personal. For instance, if a physician is thinking of having a drug as compassionate use, it will be simple; he or she will have to make an application which will be completed by the doctor’s office and not the company’s management office. The content of the document must include a clause that should be filled by the patients’ family, preventing the company’s obligation and require one on one monitoring of the issue for collection of information and the wellbeing of the patient. Once the application is through, the researchers would review it of the compassionate use clause and determine whether it should be approved. After the outcome is given, the application filled up and preserved for security. The other condition for the plan would be that the medication to have been taken through clinical trial and the outcome produced be positive. In case a clinical trial is done, a request to the medication released for purposes of compassionate use, FDA should approve it (Kingson 16). This will enable the FDA to be aware that the company had no intention of administering the medication before receiving and analyzing the results. This acts to limit unfortunate incident such as this one from happening. There is need for a committee of socialites be developed. The company should have designated employees to deal with social media acceptance and community relations. These employees would act as the ears and the eyes of the company, making sure that they take note of what the public think of the company and to review the needs of the population. The last step of the plan is to have a mission statement stating our intentions towards Chimerix. One disadvantage of the plan is that it takes much time to implement it.

            Overall, I think life sometimes becomes a business. When one is employed, he or she gains a lot from the growth of the company employing him or her but gradually losing ethical background. Risk is an important aspect of life, although most people fear taking risks, it is worth taking. This explains why Moch denied releasing the unapproved drug for use but ethically it was wrong. There is no life that is better than the other one; it is good to address what one can now because no one knows of what will happen in future.

Works Cited

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Caroline Chen .The CEO Who Saved a Life and Lost His Job, 2015. Retrieved on 19th

October 2016:

Devettere, Raymond J. Practical Decision Making in Health Care Ethics: Cases and Concepts. Washington, D.C: Georgetown University Press, 2010.

Kingson, Eric R. Lessons from Joan: Living and Loving with Cancer, a Husband's Story. Syracuse, N.Y: Syracuse University Press, 2005.

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October 24, 2023

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