IndexEthical issuesStakeholder analysisStakeholder involvement in solving ethical issuesEthical theories and principlesAction planThe case analyzes the poor ethical judgments made by a small biotechnology company, Chimerix , and its CEO, Kenneth Moch, regarding the decision to withhold an experimental drug from a 7-year-old cancer patient, Josh Hardy, to treat his life-threatening respiratory virus. When the Hardys are informed by Josh's doctor that Chimerix is ​​developing an unapproved experimental drug that could help treat Josh's respiratory virus, Josh's parents immediately contact Chimerix, asking if Chimerix would release the drug for compassionate care for their son . After the Hardy family was proven wrong twice by Chimerix, Chimerix and CEO, Kenneth Moch, faced an uproar on social media because they did not comply with the Hardy family's request for Josh to receive the experimental treatment ( Chen, 2015). Say no to plagiarism. Get a tailor-made essay on "Why Violent Video Games Shouldn't Be Banned"? Get an Original Essay Due to repetitive requests and social media turmoil, Chimerix CEO and Kenneth Moch have finally compromised. On April 9, Chimerix partnered with the Food and Drug Administration (FDA) and began a clinical trial for the drug, brincidofovir, followed by enrolling Josh as the first candidate to receive the drug. However, because brincidofovir was not safely approved by the FDA but was instead only approved by the FDA for compassionate use, i.e. expanded access, Moch was skeptical about releasing brincidofovir as a compassionate use drug because the company wanted to protect its reputation . Not to mention, Chimerix was also skeptical about releasing the drug for compassionate use because that could complicate Chimerix's efforts to gain FDA approval and ultimately make the drug widely available. Therefore, Moch was faced with the life-threatening decision of whether Chimerix should release the drug for compassionate use. After weeks of support with consecutive campaigns, Josh received the drug, which significantly improved his respiratory virus. (Chen, 2015). In turn, Moch was fired as CEO. This case also analyzes the ethical issues that arose during the case. Ethical Issues There were some ethical issues that arose as Moch pondered the decision whether to release brincidofovir to Josh as a compassionate use drug. The first ethical issue that arose in the case was when Hardy's family announced publicly that Chimerix and Moch had refused to release brincidofovir to their son for compassionate use. The Hardy family's poor ethical actions have caused chaos between Chimerix and the media, leaving Moch with the burden of making the difficult decision of choosing between his job or saving a life. Additionally, due to the social media uproar, Moch was heavily influenced to make the decision to release brincidofovir as a compassionate use drug while the drug was under review. Although Chimerix is ​​a biotechnology company that specializes in formulating drugs to treat sick people, To avoid any medical malpractice, it is the company's responsibility to ensure that the drug is effective and safe to consume before it becomes widely available. In contrast, the second ethical issue that arose in the case was when Moch denied the Hardy family's request to release brincidofovir to Josh as a compassionate use drug. Moch's decision is notwas unethical because it failed to meet the company's moral obligation to focus on the well-being of the individual by producing drugs and making them available to desperately ill patients. Instead, he chose to focus on the FDA approval process, to ensure that the approval process was not delayed, so that when brincidofovir was released for treatment, the patient's life would not be threatened and Chimerix would not be was held liable for medical negligence. Moch's decision was also unethical because Chimerix had previously released brincidofivir for compassionate use to 430 other patients in a partially government-funded program. Therefore, it also emerged that Moch did not agree to release brincidofovir for compassionate use because this time the Chimerix compassionate use program would not be partially funded by the government. The final ethical issue that arose in the case is, while Moch worked for Chimerix as CEO, Moch had consecutive meetings with CEOs of other small companies about issues related to compassionate use (Chen, 2015). Not to mention, Moch consulted a working group of ethicists at New York University Langone Medical Center, who were studying the challenges of compassionate use (Chen, 2015). This was unethical because there was a conflict of interest between Chimerix and the other drug manufacturers. Instead of making the decision whether to release brincidofovir for compassionate use based on what Chimerix had encountered in the past, Moch used unethical reasoning derived from challenges other biotech companies have encountered with compassionate use drugs. Stakeholder Analysis Chimerix and Moch's poor decision making influenced Josh and the company had many ethical duties to fulfill to various stakeholders. There are several stakeholders in the case, including: shareholders, employees, the Food and Drug Administration (FDA), patient advocates, the community, non-profit organizations (NPOs), the healthcare industry biotechnology and future generations. Shareholders, such as Chimerix, board members, Kenneth Moch (CEO), and investors are directly connected to the company and have different expectations. Chimerix, Moch and the employees are interested in protecting the company from any fatalities and expect to bring all developed drugs to market as a source of revenue. They have the voting power and economic power to make ethical decisions that benefit the company. In contrast, stakeholders such as Josh and his family, patient advocates, the community (general public and media), and non-profit organizations (NPOs) expect biotech companies to meet the moral obligation to care about well-being of individuals, which in this case can be achieved by releasing drugs for compassionate use. Josh and other seriously ill patients have the power of moral persuasion, which can be very effective with the support of activists and nonprofit organizations. The most powerful stakeholders, in this case, are Chimerix, the board members, Kenneth Moch (CEO), and the employees. Chimerix and its board members are primary stakeholders because they hold the power to influence Chimerix's decisions, actions and policies. For example, one of the decisions made by Chimerix and board members was to replace CEO Moch with another individual. Kenneth Moch is a stakeholder because he is affected by the ethical decisions implemented by Chimerix board members and the unethical actions raised by the Hardy family and the community (media). Chimerix board members, Moch, and employeesthey are more concerned about benefiting from the drugs produced by the company and want to successfully complete the clinical trial and present the safety and efficacy data that would allow brincidofovir to become commercially available to healthcare providers and patients worldwide. The federal agency known as the Food and Drug Administration (FDA), is another powerful stakeholder in this case. One of the responsibilities of the Food and Drug Administration (FDA) is to protect the public health by ensuring the safety, effectiveness, and security of human drugs, biologics, and medical devices. Therefore, the FDA has the power to regulate the approval of brincidofovir, which would then allow Chimerix to make brincidofovir widely available. FDA hits Chimerix because, without FDA approval of brincidofovir, Chimerix would be able to release brincidofovir only as a compassionate use drug, which would eliminate any accrued revenue for Chimerix and eliminate the company's protection from medical malpractice liability . Josh Hardy and his family, patient advocates and the community are also involved in this case. They have no legal or economic power, however they have the power of moral suasion. They are all affected by the decisions and actions of Chimerix and Moch. Josh needs the experimental drug, brincidofovir, to treat his respiratory virus. The Hardy family wishes to influence Chimerix and Moch to release brincidofovir to Josh for compassionate care. Patient advocates and the community (the media and the general public) are concerned as to why Chimerix will not release brincidofovir to Josh for compassionate care. In this case, non-profit organizations are powerful stakeholders. Although they do not hold legal power and have less legitimacy than shareholders because they are more distant from the company, they do have the power of moral suasion. Most nonprofit organizations, such as the nonprofit advocacy group for children with cancer, Kids v Cancer, help publicize campaigns for children who are desperately ill. The executive director of Kids v Cancer, Nancy Goodman, believed that Chimerix CEO Kenneth Moch was unethical to deprive Josh of brincidofovir (Chen 2015). She and the patient advocates of Kids v Cancer had a strong desire to help sick patients by any means necessary. The biotechnology industry is one of the stakeholders in this case. After witnessing the chaos Chimerix had gone through with the decision on whether or not to release an experimental drug for compassionate use, other biotech companies decided to implement a future plan in case they faced the same predicament that Chimerix and Moch had experimented with the Hardy. family. While Chimerix's experience has not directly affected the biotechnology industry, its experience has intimidated other biotech companies by illustrating how they could potentially be affected in the future. Future generations are stakeholders in this case. Future generations are affected by Chimerix and the FDA's decisions on whether to approve the experimental drug, brincidofovir, for compassionate use. If the FDA approves the drug, allowing Chimerix to release it for compassionate use, and Josh's respiratory virus is cured, then future generations who may encounter Josh's respiratory virus will have access to brincidofovir. So, future generations will have a cure for this disease. Stakeholder involvement in resolving ethical issues Stakeholders who could be helpful in resolving the ethical issues raised in the case are:shareholders (Chimerix and Kenneth Moch) and the federal agency (the Food and Drug Administration (FDA)). Chimerix has the economic and legal power to resolve ethical issues. Moch is the company's CEO, which means he has the power to authorize decisions for Chimerix, such as FDA clinical trial approval. Although Moch was publicly criticized and subjected to great pressure, Moch resolved the ethical issue by initiating the FDA clinical trial, so that Josh's respiratory virus could be cured and he could have a chance to survive. Unfortunately, after granting Josh, his family and the community their wish to release brincidofovir for compassionate use, he lost his job as CEO of Chimerix. On the other hand, the FDA also has the legal power to resolve ethical issues. It is because of the FDA that Chimerix and Moth refused to release brincidofovir as a compassionate use drug. The FDA has the authority to regulate the approval of brincidofovir. If the FDA were more involved in the administration of brincidofovir, Chimerix and Moch would not have to face the burden of making the life-threatening decision whether they should release brincidofovir as a compassionate use drug. The FDA could speed up the approval process, and Chimerix and Moch could eliminate brincidofovir's release as a compassionate-use drug and instead make it widely available to providers and patients. Not to mention, if Chimerix is ​​able to release a drug that has been safely approved by the FDA, not only will the patient be able to be treated with a safe and effective drug, but Chimerix will be able to accrue revenue from the drug . Overall, this would be a win-win situation. Ethical Theories and Principles Ethical theories and principles offer guidelines to help people make ethical decisions, especially leaders who often encounter obstacles and conflicts of interest. In the case, there are several ethical theories and principles that can be used to resolve the ethical issues presented during the case. Teleological theories could be used by Chimerix and Moch to resolve ethical issues. Instead of focusing on the actions taken, teleological theories focus on the consequences that arise from the actions, such as Moch being publicly criticized for refusing to release brincidofovir to Josh for compassionate care. Even though brincidofovir was being tested, the employees and Moch knew of the legality of the drug that could be used to treat Josh's respiratory virus, because not only had Chimerix developed drugs to treat seriously ill patients, but Chimerix had previously released brincidofovir for compassionate use. to treat other patients. Using teleological theory would be helpful for Chimerix and Moch to resolve the ethical question of deciding whether to work with the FDA to release brincidofovir as a compassionate use drug because it would give Chimerix and Moch a better perspective of the consequences. Whether they released brincidofovir for compassionate use, the ratio of Josh Hardy surviving or dying is 50/50. Similarly, the principle of utilitarianism could also be used for Chimerix and Moch to resolve ethical issues. This principle focuses on producing the greatest good for the greatest number of people. In essence, this principle will force Chimerix and Moch to engage in utilitarian thinking and think about the overall well-being of the individual. Furthermore, this principle will provide Chimerix and Moch with a broader perspective of the outcomes and consequences that arise from the ethical decision. For example, if brincidofoviris released to treat Josh for compassionate use and the drug treats his respiratory virus, Chimerix and Moch will be influenced to move forward with FDA approval because they will be informed that brincidofovir will produce the greatest good for the greatest number of people. The deontological principle (Kant's categorical imperative) would also be appropriate to resolve the ethical issues that arise in this case. This principle revolves around the fact that a duty is an obligation. Moch's job was to protect Chimerix and his family. Additionally, his job was to ensure that FDA approval for the experimental drug brincidofovir was not delayed. Furthermore, the principle of rights would be appropriate to resolve the ethical issues of the case. The principle of rights focuses on the moral and legal rights of the individual, which should be honored and respected. Stakeholders such as the Hardy family, patient advocates, the community and NPOs can express their morality and argue that Josh has the right to life and should be privileged to receive brincidofovir for compassionate use. Moral rights are meaningful and justifiable rights, which do not depend on a legal system to be valid but should instead be formed on moral reasoning, while legal rights are rights proposed by government authorities. Chimerix is ​​a biotechnology company that formulates drugs, such as brincidofovir, to help treat sick people. This theory will present Chimerix and Moch with a broader perception of why the company should make the ethical decision to release brincidofovir to Josh for compassionate use based on moral reasoning versus legal reasoning. The principle of justice could also be used as a similar approach in resolving the ethical issues presented in the case, as interested parties could argue that it is unfair for Chimerix to have released brincidofovir for compassionate use to the other 430 patients but refuse to give Josh the same opportunity . Aretaic Theory (virtue ethics theory) includes servant leadership, which is also an approach that could be used to resolve ethical issues. This approach focuses on serving the individual first. Chimerix and Moch were so focused on trying to complete the criteria for the FDA approval process that they rejected the idea, and the purpose of developing brincidofovir was to help treat patients efficiently and effectively. Instead of Chimerix and Moch waiting for brincidofovir to be released to the market to help treat sick patients, Chimerix should listen and empathize with stakeholders to help treat patients who are now seriously and desperately ill, like Josh who he is seriously ill with a respiratory virus. Furthermore, the golden rule is the most significant approach that can be used to resolve the ethical questions that are presented during the case. In essence, the golden rules mean treating others as you would like to be treated. Chimerix and Moch could use the golden rule as a reminder of how they would like to be treated as a company and as individuals as opposed to how they treat stakeholders affected by their unethical actions. Chimerix and Moch could use this principle to develop an action plan that will remedy the effects of their actions and to ensure that the stakeholders involved are treated with the same respect with which Chimerix and Moch would like to be treated as a company and as an individual. Action PlanAfter further analyzing the theories and ethical principles presented above, there are several actions that could be used by Chimerix. The first.