The CEO Who Saved a Life and Lost His Job

The case analyzes the poor ethical judgments made by a small biotechnology company, Chimerix and its Chief Executive Officer (CEO), Kenneth Moch, regarding the decision to withhold an experimental medication from a 7-year-old cancer patient, Josh Hardy, to treat his life-threatening respiratory virus. When the Hardy’s are informed by Josh’s doctor that Chimerix is developing an experimental, unapproved drug that may help treat Josh’s respiratory virus, Josh’s parents immediately contacted Chimerix, requesting if Chimerix would release the drug for compassionate care for their son. After the Hardy family was denied twice by Chimerix, Chimerix and CEO, Kenneth Moch, were faced with a social media uproar because they did not grant the Hardy family’s request for Josh to receive the experimental treatment (Chen, 2015).

Due to the repetitive requests and the social media uproar, Chimerix’s CEO and Kenneth Moch finally compromised. On April 9th, Chimerix collaborated with the Food and Drug Administration (FDA) and initiated a clinical trial for the drug, brincidofovir, followed by enrolling Josh as the first candidate to receive the drug. However, because brincidofovir was not securely approved by the FDA but instead was only approved by the FDA for compassionate use, aka: expanded access, Moch was skeptical to release brincidofovir as a compassionate-use drug because the company wanted to protect its reputation. Not to mention, Chimerix was also skeptical of releasing the drug for compassionate-use because it could complicate Chimerix’s efforts to secure the FDA approval and to ultimately make the drug widely available. Hence, Moch faced the life-threatening decision whether Chimerix should release the drug for compassionate use. After weeks of advocating with consecutive campaigns, Josh received the drug, which dramatically improved his respiratory virus. (Chen, 2015). In turn, Moch was terminated as CEO. This case also analyzes the ethical issues that emerged throughout the case.

Ethical Issues

There are some ethical issues that emerged as Moch contemplated on the decision of whether to release brincidofovir to Josh as a compassionate-use drug. The first ethical issue that arose in the case is when Hardy’s family publically announced that Chimerix and Moch refused to release brincidofovir to their son for compassionate-use. The poor ethical actions of the Hardy family caused chaos between Chimerix and the media, leaving a burden on Moch to make a difficult decision to choose between his job or to save a life. Furthermore, due to the social media uproar, Moch was forcefully influenced to make the decision of releasing brincidofovir as a compassionate-use drug while the drug was under examination.

Although Chimerix is a biotechnology company that specializes in formulating drugs to treat the ill, to prevent any medical negligence, it is the company’s responsibility to ensure that the drug is effective and safe to consume before a drug becomes widely available. In contrast, the second ethical issue that arose in the case is when Moch denied the Hardy family’s request to release brincidofovir to Josh as a compassionate-use drug. Moch’s decision was unethical because he failed to comply with the company’s moral obligation, of focusing on the welfare of the individual by manufacturing drugs and making them available for patients that are desperately ill. Instead, he chose to focus on the FDA approval process, to ensure 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 held accountable for medical negligence. Moch’s decision was also unethical because Chimerix had previously released brincidofivir for compassionate-use to 430 other patients in a program that was partly funded by the government. Thus, it also appeared that Moch did not agree to release brincidofovir for compassionate-use because this time, the Chimerix’s compassionate-use program was not going to be partly funded by the government.

The last ethical issue that arose in the case is, while Moch was working for Chimerix as CEO, Moch had consecutive meetings with chief executives of other small companies about compassionate-use issues (Chen, 2015). Not to mention, Moch consulted for a working group of ethicists at New York University’s Langone Medical Center, that was 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 of whether to release brincidofovir for compassionate-use based on what Chimerix had encountered in the past, he used unethical reasonings that derived from the challenges that other biotechnology companies encountered with compassionate-use drugs.

Stakeholder Analysis

Chimerix’s and Moch’s poor decision-making affected Josh and the company had many ethical duties to fulfill for various stakeholders. There are several stakeholders in the case which include: stockholders, employees, the federal agency (the Food and Drug Administration) (FDA), patient advocates, the community, non-profit organizations (NPOs), the biotechnology industry, and future generations. Stockholders, such as Chimerix, the board members, Kenneth Moch (CEO), and the investors, are directly related to the company and have several expectations. Chimerix, Moch, and the employees are interested in protecting the company from any fatal incidents and expect to release all the drugs that are developed into the market for a source of revenue. They have the voting power and economic power to make ethical decisions to benefit the company.

In contrast, stakeholders such like Josh and his family, patient advocates, the community (general public and the media), and non-profit organizations (NPOs) expect for biotechnology companies to comply with the moral obligation of caring for the welfare of individuals, which in this case can be accomplished by releasing drugs for compassionate-use. Josh and other severely ill patients have the power to moral suasion, which can be very effective with the support of activists and non-profit 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 primary stakeholders because they hold the power to affect the decisions, actions, and policies at Chimerix. For instance, one of the decisions that Chimerix and the board members decided on was to replaced CEO Moch with another individual. Kenneth Moch is a stakeholder because he is affected by the ethical decisions that are implemented by the board members of Chimerix and the unethical actions that arose by the Hardy family and the community (media). Chimerix’s board members, Moch, and the employees are more concerned with benefiting from the drugs that the company produce and have a desire of successfully completing the clinical trial and submitting the safety and efficacy data that would allow brincidofovir to become available to the market for healthcare providers and patients around the globe. The federal agency is known as, The Food and Drug Administration (FDA), is another powerful stakeholder in this case. One of the Food and Drug Administration’s (FDA) responsibilities is to protect the public health by ensuring the safety, efficacy, and security of human drugs, biological products, and medical devices.

Therefore, the FDA has the power to regulate the approval of brincidofovir, which then would permit Chimerix to make brincidofovir widely available. The FDA affects Chimerix because, without the FDA approval of brincidofovir, Chimerix would only be able to release brincidofovir as a compassionate-use drug, which would eliminate any accumulated revenue for Chimerix and will eliminate the company’s protection of being liable for medical negligence. Josh Hardy and his family, patient advocates, and the community are also stakeholders in this case. They do not have legal or economic power, however, they have the power of moral suasion. They all are affected by Chimerix’s and Moch’s decision and actions. Josh is in need of the experimental drug, brincidofovir, to treat his respiratory virus. The Hardy family have the desire of influencing 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. Non-profit organizations are powerful stakeholders in this case. Although they do not hold legal power and have less legitimacy than stockholders because they are more distant from the firm, they have the power of moral suasion. Most non-profit organizations, such as the nonprofit advocacy group for children with cancer, Kids v Cancer, help publicize campaigns for children that 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 ill patients by any means necessary. The biotechnology industry is a stakeholder in the case. After witnessing the chaos that Chimerix had undergone with the decision of whether to release an experimental drug for compassionate-use, other biotechnology companies determined that they should implement a future plan in case they encountered the same predicament as Chimerix and Moch had experienced with the Hardy family. Although Chimerix’s experience did not directly affect the biotechnology industry, their experience intimidated other biotechnology companies by illustrating how they could be potentially affected in the future. Future generations are stakeholders in the case. Future generations are affected by Chimerix’s and the FDA’s decisions as to whether they will approve the experimental drug, brincidofovir, for compassionate-use. If the FDA approves the drug, permitting Chimerix to release the drug for compassionate-use and Josh’s respiratory virus is cured, then the future generations that may encounter the same respiratory virus as Josh will have access to brincidofovir. Hence, the future generations will have a cure for this disease.

Stakeholder Involvement in Solving Ethical Issues

The stakeholders that would be helpful in solving the ethical issues that emerged in the case are: the stockholders (Chimerix and Kenneth Moch) and the federal agency (the Food and Drug Administration (FDA)). Chimerix has the economic and legal power to solve the ethical issues. Moch is the CEO of the company which means that he has the power to authorize decisions for Chimerix such as his approval of the FDA clinical trial. Although Moch was publically criticized and under intense pressure, Moch solved the ethical issue by initiating the FDA clinical trial, so that Josh respiratory virus would be treated and he could have the chance to survive. Unfortunately, after granting Josh, his family, and the community of their desire of releasing brincidofovir for compassionate-use, he lost his job as CEO from Chimerix.

On the other hand, the FDA also has the legal power to solve the ethical issues. It is because of the FDA that Chimerix and Moth refused to release brincidofovir as a compassion-use drug. The FDA has the power to regulate the approval of brincidofovir. If the FDA is more involved with the administration of brincidofovir, Chimerix and Moch would not have to face the burden of making the life-threatening decision as to whether they should release brincidofovir as a compassionate-use drug. The FDA could speed up the approval process and Chimerix and Moch could eliminate the releasing of brincidofovir 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 securely approved by the FDA, not only will the patient be able to get treated with a safe and an effective drug but Chimerix will be able to accumulate revenue from the drug. Overall, this would be a win-win situation for everyone.

Ethical Theories and Principles

Ethical theories and principles offer guidelines to assist people with making ethical decisions, especially leaders that often encounter obstacles and conflicts of interest. In the case, there are several ethical theories and principles that can be utilized for solving the ethical issues that are presented throughout the case.

The teleological theories could be utilized by Chimerix and Moch to resolve the ethical issues. Instead of focusing on the actions taken, teleological theories focus on the consequences that are derived from the actions, such as Moch being publically criticized for refusing to release brincidofovir to Josh for compassionate-care. Even though brincidofovir was under experimentation, the employees and Moch knew about the legality of that the drug could be utilized to treat Josh’s respiratory virus, because not only did Chimerix develop drugs to treat severely ill patients but Chimerix had previously released brincidofovir for compassionate-use to treat other patients. Utilizing the teleological theory would be useful for Chimerix and Moch to solve the ethical issue of deciding whether to collaborate 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 utilized for Chimerix and Moch to resolve the ethical issues. This principle focuses on producing the greatest good for the greatest amount of people. Essentially, this principle will force Chimerix and Moch to engage in utilitarian thinking and think about the general welfare of the individual. Also, this principle will provide Chimerix and Moch a broader perspective of the results and consequences that are derived from the ethical decision.

For instance, if brincidofovir is released to treat Josh for compassionate-use and the drug cures his respiratory virus, Chimerix and Moch will be influenced to move on with the FDA approval because they will be informed that brincidofovir will produce the greatest good for the greatest amount of people. The Deontological Principle (Kant's Categorical Imperative) would also be appropriate to solve the ethical issues that are 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. Moreover, his duty was to ensure that the experimental drug brincidofovir FDA approval was not delayed. In addition, the principle of rights would be appropriate to resolve the ethical issues in the case.

The principle of rights focuses on an individual’s moral and legal rights, which should be honored and respected. Stakeholders such as the Hardy family, patient-advocates, the community, and NPO’s, can express their morality and argue that Josh has the right to life and should be given the privilege of receiving brincidofovir for compassionate-use. Moral rights are significant, justifiable entitlements, that do not depend on a legal system to be valid but instead should be formed upon moral reasoning, whereas, legal rights are rights that are proposed by governing authorities. Chimerix is a biotechnology company that formulates drugs, such as brincidofovir, to help treat the ill. 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 morality reasoning versus legality reasoning. The principle of justice could also be utilized as a similar approach in solving the ethical issues presented in the case, as stakeholders 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.

The Aretaic Theory (theory of virtue ethics) includes servant leadership, which is also an approach that could be utilized to solve ethical issues. This approach focuses on serving the individual first. Chimerix and Moch were so focus on trying to complete the criteria for the FDA approval process that they dismissed the idea and the purpose of developing brincidofovir was to help treat the ill efficiently and effectively. Instead of Chimerix and Moch waiting until brincidofovir is released to the market to help treat ill patients, Chimerix should listen and empathize with stakeholders about helping treat the patients that are severely and desperately ill now, such as Josh being severely ill with a respiratory virus.

In addition, the golden rule is the most significant approach that can be utilized to resolve the ethical issues that are presented throughout the case. Essentially, the golden rules mean to treat others as you would want to be treated. Chimerix and Moch could use the golden rule as a reminder of how they would want to be treated as a company and as individuals in contrast of how they are treating the stakeholders who are affected by their unethical actions. Chimerix and Moch could utilize this principle to develop a plan of action that will remedy the effects of their actions and to make sure that the stakeholders involved, are treated in the same respect that Chimerix and Moch would want to be treated as a company and an individual.

Plan of Action

After further analyzing the ethical theories and principles presented above, there are several actions that could be utilized by Chimerix. The first recommendation is that the Food and Drug Administration (FDA) should not only be involved in the drug approval process on a federal level but also be involved in the administration of experimental drugs on the company level. When the Hardy family contacted Chimerix and Moch about releasing brincidofovir to Josh for compassionate care, Moch refused to grant their request because of the legal rights required by the FDA. This violates the principle of utilitarianism because the decision of releasing a drug for compassionate-use should be based on the greatest good for the greatest number of people. Moreover, if the FDA were to get involved in the drug administration process on a company-level, severely ill patients that are in need of a certain drug before the drug has been securely approved will be able to receive the drug for compassionate-use more rapidly.

Furthermore, Chimerix should apply the teleological theories and the principle of rights to their decision making and reasoning to help remedy the results of their actions. Instead of focusing on the legality and consequences that may derive from their decisions, Chimerix should engage in utilitarian thinking and focus on the patient’s moral rights and general well-being of the individual, which in this case is to release brincidofovir to Josh for compassionate-use.

In addition, Chimerix should apply the Deontological Principle (Kant's Categorical Imperative) and the Aretaic Theory (servant leadership) approach in their decision making by making it an obligated duty to always serve the needs of the patient. While the experimental drug is processing for FDA approval, Chimerix can monitor the patient while they are being treated. This will prevent any delays in the FDA approval process.

The principle of justice approach can also be taken with the servant leadership approach because if Chimerix releases brincidofovir or any experimental drug for compassionate-use then not only will they be prioritizing by complying to a moral obligation of putting the patient needs first but Chimerix will also be serving justice to the patient by valuing the patient’s right to life and providing fair treatment. Not to mention, this will allow Chimerix to establish a better reputation as the media and community will support Chimerix for valuing the patient’s rights.

There are several positive and negative consequences that may derive from the recommended plan of action. In terms of the principle of utilitarianism approach, the positive expectation from utilizing this approach is that Josh will receive the treatment and may have a chance at survival. However, if the drug is not effective enough to save Josh’s life, not only would CEO Moch lose his job for releasing the drug for compassionate-use but the FDA approval process for brincidofovir will be delayed or even terminated.

The positive expectations of applying teleological theories and the principle of rights to the plan of action are that Josh will have the right to life and the Hardy family, the community, and the media will respect Chimerix and Moch because their decision was based on morality versus legality. In contrast, the negative consequences that may derive from the decision of releasing brincidofovir for compassionate-use is that if Josh dies even after taking brincidofovir, the Hardy family, the community, and the media will blame Chimerix for not producing an effective drug and the FDA will not approve the drug to be released into the market. The positive and negative factors also apply to the Deontological Principle (Kant's Categorical Imperative), the Aretaic Theory (servant leadership) approach, and the principle of justice approach.