Table of ContentsEthical IssuesStakeholder AnalysisStakeholder Involvement in Resolving Ethical IssuesEthical Theories and PrinciplesAction PlanThe Case Analyzes Poor Ethical Judgments Made by a Small Business biotechnology company, Chimerix and its CEO (CEO), Kenneth Moch, regarding the decision to withhold an experimental drug from Josh Hardy, a 7-year-old cancer patient, to treat his potentially deadly respiratory virus. When the Hardys were informed by Josh's doctor that Chimerix was developing an unapproved experimental drug that could help treat Josh's respiratory virus, Josh's parents immediately contacted Chimerix, asking if Chimerix would release the drug for compassionate care to their son. After the Hardy family was turned away twice by Chimerix, Chimerix and its CEO, Kenneth Moch, faced an outcry on social media because they had not granted the Hardy family's request for Josh gets the experimental treatment (Chen, 2015).Say no to plagiarism. . Get a tailor-made essay on “Why Violent Video Games Should Not Be Banned”? Get an original essay Due to repetitive demands and social media uproar, Chimerix CEO and Kenneth Moch finally reached a compromise. On April 9, Chimerix collaborated with the Food and Drug Administration (FDA) and launched a clinical trial for the drug, brincidofovir, followed by the enrollment of Josh as the first candidate to receive the drug. However, because brincidofovir has not been approved safely by the FDA, but only for compassionate use, i.e. expanded access, Moch was skeptical about marketing brincidofovir as a drug. compassionate use because the company wanted to protect its reputation. Not to mention, Chimerix was also skeptical about marketing the drug for compassionate use, as it could complicate Chimerix's efforts to gain FDA approval and ultimately make the drug widely available. As a result, Moch was faced with the potentially life-threatening decision of whether Chimerix should market the drug for compassionate use. After weeks of advocacy with back-to-back campaigns, Josh received the medication, which significantly improved his respiratory virus. (Chen, 2015). In turn, Moch was fired as CEO. This case also analyzes the ethical issues that emerged throughout the case.Ethical IssuesSome ethical issues arose when Moch was considering the decision of whether or not to give brincidofovir to Josh as a compassionate use medication. The first ethical issue in this case arose when Hardy's family publicly announced that Chimerix and Moch had refused to distribute brincidofovir to their son for compassionate use. The Hardy family's poor ethical actions caused chaos between Chimerix and the media, leaving Moch with the burden of making a difficult decision: choosing between his job or saving a life. Additionally, due to the social media uproar, Moch was heavily influenced to make the decision to market brincidofovir as a compassionate use drug while the drug was under review. Although Chimerix is ​​a biotechnology company specializing in the formulation of drugs to treat the sick, To avoid medical negligence, it is the responsibility of the company to ensure that the drug is effective and safe to consume before it is not widely available. On the other hand, the second ethical problem that arose in the case isthe one where Moch rejected the Hardy family's request to provide brincidofovir to Josh as a compassionate use drug. Moch's decision was unethical because he failed to uphold the company's moral obligation to focus on the well-being of the individual by manufacturing medicines and bringing them to market. provision of 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 authorized for treatment, life of the patient is not threatened and Chimerix is ​​not held responsible for medical negligence. Moch's decision was also unethical because Chimerix had already distributed brincidofivir for compassionate use to 430 other patients in a program partly funded by the government. So, it also emerged that Moch did not agree to release brincidofovir for compassionate use, because this time Chimerix's compassionate use program was not going to be partly funded by the government. Moch worked for Chimerix as CEO, Moch had back-to-back meetings with executives of other small companies on compassionate use issues (Chen, 2015). Not to mention, Moch consulted with 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 Moch making the decision whether to release brincidofovir for compassionate use based on what Chimerix had encountered in the past, he used unethical reasoning that stemmed from challenges faced by other companies of biotechnology with compassionate use medicines. Stakeholder Analysis Chimerix and Moch's poor decision-making affected Josh and the company had many ethical duties to fulfill towards various stakeholders. There are several stakeholders in this matter, including: shareholders, employees, the federal agency (Food and Drug Administration) (FDA), patient advocates, the community, non-profit organizations (NPOs), the biotechnology industry and future generations. Shareholders, such as Chimerix, board members, Kenneth Moch (CEO), and investors, are directly related to the company and have several expectations. Chimerix, Moch and employees want to protect the company from any fatal incidents and hope to commercialize any drugs developed on the 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 comply to the moral obligation to ensure the well-being of individuals, which in this case can be accomplished by marketing medicines for humanitarian purposes. 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 the board members are the primary stakeholders because they hold the power to influence Chimerix's decisions, actions and policies. For example, one of theDecisions made by Chimerix and board members was to replace CEO Moch with another person. Kenneth Moch is a stakeholder because he is affected by the ethical decisions implemented by Chimerix board members and the unethical actions of the Hardy family and the community (media). Chimerix board members, Moch, and employees are more concerned about benefiting from the drugs produced by the company and want to successfully complete the clinical trial and submit the safety and efficacy data that would enable brincidofovir to be available on the market for health care. providers and patients around the world. 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, biological products, and medical devices. Therefore, the FDA has the authority to regulate the approval of brincidofovir. , which would then allow Chimerix to make brincidofovir widely available. FDA Affects Chimerixcar, Without FDA approval of brincidofovir, Chimerix would only be able to market brincidofovir as a compassionate use drug, which would eliminate any accrued revenue for Chimerix and eliminate the company's liability protection in the event of medical negligence. Josh Hardy and his family, patient advocates and the community are also parties in this case. They do not have legal or economic power, but they do have the power of moral persuasion. They are all affected by Chimerix and Moch's decision and actions. 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 general public) are wondering why Chimerix will not provide Josh with brincidofovir for compassionate care. Nonprofits are powerful players in this matter. Even if they do not hold legal power and have less legitimacy than shareholders because they are further removed from the company, they have the power of moral persuasion. Most nonprofit organizations, such as the children's cancer advocacy group Kids v Cancer, help publicize campaigns for desperately ill children. 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 at Kids v Cancer had a strong desire to help sick patients by any means necessary. The biotechnology industry is a stakeholder in this matter. After witnessing the chaos that Chimerix experienced with the decision of whether to market an experimental compassionate use drug, other biotech companies decided that they should implement a future plan in case they encountered the same situation difficult that Chimerix and Moch had experienced with the Hardy. family. Although Chimerix's experiment did not directly affect the biotechnology industry, its experience intimidated other biotechnology companies by illustrating how they could potentially be affected in the future. Future generations are stakeholders in this matter. Future generations are affected by Chimerix and the FDA's decisions about whether they will approve theinvestigational drug, brincidofovir, for compassionate use. If the FDA approves the drug, allowing Chimerix to market it for compassionate use, and Josh's respiratory virus is cured, then future generations who may encounter the same respiratory virus as Josh will have access to brincidofovir. Thus, future generations will have a cure for this disease. Stakeholder Involvement in Resolving Ethical Issues Stakeholders who would be helpful in resolving the ethical issues that emerged in this case are: the 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, meaning he has the authority to authorize decisions regarding Chimerix such as its FDA clinical trial approval. Although Moch was publicly criticized and put under intense pressure, Moch resolved the ethical issue by initiating the FDA clinical trial, so that Josh's respiratory virus would be treated and he could have a chance to survive. Unfortunately, after telling Josh, his family, and the community about their desire to release brincidofovir for compassionate use, he lost his position as CEO of Chimerix. On the other hand, the FDA also has the legal authority to resolve ethical issues. It was because of the FDA that Chimerix and Moth refused to market brincidofovir as a compassionate use drug. The FDA has the authority to regulate the approval of brincidofovir. If the FDA became more involved in the administration of brincidofovir, Chimerix and Moch would not have to face the burden of making a potentially life-threatening decision about whether to administer brincidofovir. compassionate use. The FDA could expedite the approval process and Chimerix and Moch could eliminate the release of brincidofovir as a compassionate use drug and make it widely available to providers and patients. Not to mention, if Chimerix is ​​able to bring a drug to market 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 also be able to accrue revenue from the drug. Overall, it would be a win-win situation for everyone. Ethical Theories and Principles Ethical theories and principles provide guidelines to help people make ethical decisions, especially leaders who often encounter obstacles and conflicts of interest. In this case, several ethical theories and principles can be used to resolve the ethical issues presented throughout 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 follow, such as Moch being publicly criticized for refusing to provide Josh with brincidofovir for compassionate care. Even though brincidofovir was being tested, the employees and Moch knew the drug could be used to treat Josh's respiratory virus, because not only had Chimerix developed drugs to treat critically ill patients, but Chimerix had already marketed brincidofovir for compassionate purposes. to treat other patients. Using teleological theory would be helpful for Chimerix and Moch in resolving the ethical issue of deciding whether or not to collaborate with the FDA to release brincidofovir as a compassionate use drug, because itwould give Chimerix and Moch a better perspective of the consequences. Whether they released brincidofovir for compassionate purposes, Josh Hardy's survival or death ratio is 50/50. Similarly, the principle of utilitarianism could also be used by Chimerix and Moch to solve ethical problems. This principle aims to produce the greatest good for the greatest number of people. Essentially, this principle will force Chimerix and Moch to engage in utilitarian thinking and think about the overall well-being of the individual. Additionally, 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 brincidofovir is released to treat Josh for compassionate use and the drug cures his respiratory virus, Chimerix and Moch will have an incentive to seek 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 presented in this case. This principle revolves around the fact that a duty is an obligation. Moch's duty was to protect Chimerix and his family. Additionally, his duty was to ensure that FDA approval of the experimental drug brincidofovir was not delayed. Furthermore, the principle of rights would be appropriate to resolve the ethical questions in this case. The principle of rights focuses on an individual's moral and legal rights, which must be honored and respected. Stakeholders such as the Hardy family, patient advocates, the community, and non-profits can express their morality and assert that Josh has the right to life and should have the privilege of receiving brincidofovir for compassionate purposes. Moral rights are important, justifiable rights that do not depend on a legal system to be valid but rather must be based on moral reasoning, whereas 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 sense of why the company should make the ethical decision to distribute brincidofovir to Josh for compassionate use, based on moral versus legal reasoning. The principle of justice could also be used as a similar approach to resolving the ethical issues presented in the case, as stakeholders could argue that it is unfair for Chimerix to have distributed brincidofovir for compassionate use to the other 430 patients, but refuse to give it to Josh. the same opportunity. Aretaic theory (virtue ethics theory) includes servant leadership, which is also an approach that could be used to solve ethical problems. This approach focuses first on serving the individual. Chimerix and Moch were so focused on trying to complete the criteria for the FDA approval process that they rejected the idea and the goal of developing brincidofovir was to help treat sick people effectively and efficiently. Instead of Chimerix and Moch waiting for brincidofovir to come to market to help treat sick patients, Chimerix should listen and empathize with stakeholders to help treat patients who are currently seriously and desperately ill, like Josh who is seriously ill with a respiratory virus. Furthermore, the Golden Rule is the most important approach that can be used to resolve questions..