The Case of Compassionate Use of a Life-Saving Drug

The case discusses a managerial ethical dilemma after company chief executive officer who lost his job after releasing a trial drug for compassionate use in 2014. The case also demonstrates the potential influence of social media on managerial decision making. Josh Hardy, then seven years old had survived cancer four times from the time he was baby (Caroline, 2015). He was now fighting a viral infection, adenovirus, he had developed after a bone marrow transplant for myelodysplastic syndrome. The need for an antiviral drug became evident following a complete heart and kidney failures. The Chimerix, a small North Carolina pharmaceutical company, was not willing to give the life-saving drug (Brincidofovir) that was unapproved by the Food and Drug Administration (FDA). The Company’s CEO and President Kenneth Moch knew the decision that could save Josh’s life was on his hand but was faced with the dilemma of giving the patient drug and risking the process for obtaining the FDA approval.  

            Chimerix had given the drug to about 430 patients for compassionate use up to 2012 when the project was partly but stopped when the funds ran out. The CEO reasoned that giving Josh the remaining doses could slow the process towards getting the FDA approval.  Furthermore, Josh did not meet any criteria used by Chimerix to provide drugs for compassionate use (Caroline, 2015). However, following aggressive social media campaigns on Facebook and Twitter, Moch yielded to the pressure and allowed Josh to be enrolled for the clinical trial. The patient’s mother reported dramatic improvement after the administration of the drug. The CEO further highlighted that Josh’s treatment with the drug was not for compassionate use but as part of the clinical data for the FDA approval.

Ethical Issues

            Various ethical issues have risen from the case. First, the CEO is faced with the decision of denying a life-saving drug to a dying. Moch felt morally obligated especially due to the pressure from some patient advocates and the online community as well as the appeal from the boy’s family. Brincidofovir was proven to be effective against all families of viruses that affect people including adenovirus. The virus if not treated could have led to fatal complications arising from the damage in the eye, gastrointestinal (GI) tract, lung problems, and damage to the eye. Secondly, refusal for the provision of the drug while the dying patient had no other alternative was, therefore, a significant ethical issue. Moch considered the financial constraints that could have resulted by allowing the use of the drug to the patients as well as the potential delay in obtaining the FDA approval at the expense of the life of the patient who could have been saved.

            The third ethical concern is the fact that Chimerix was not willing to provide the life-saving drug to the one patient who really needed it most while it had previously allowed the compassionate use of the drug for 430 patients. Finally, the Company’s board ethical stand is also questionable as they proceed to sack Moch for availing the drug to Josh. While, the company’s policy did not allow the provision of the drug in such circumstances, sacking the CEO can be deemed unethical since he acted in the interest of the patient. Furthermore, the board did not consider the impact of the aggressive social media campaign in undertaking the decision to save the boy’s life.

Stakeholder Analysis

            Stakeholders refer to groups or individuals who are affected by organizational decisions. The groups and individuals may also have particular interest or influence on the organization. The stakeholders in the case include Chimerix (represented by the board and the CEO), Josh and his family, patient advocates, FDA, and Biotechnology Industry Organization (BIO). Josh and his family need the drug from Chimerix to cure his condition. Their desire is, therefore, to get healed from the adenovirus from the Company (Caroline, 2015). On the other hand, Chimerix is focusing on getting the drug approved by the FDA at the fastest time possible so as to get into the market inappropriate time. Similarly, Chimerix is concerned about the costs that are associated with the compassionate program.

            BIO is concerned with the need to address the welfare of the biotechnology industry players. The organization seeks to lobby for the interest of the individual biotechnology companies. In the case, BIO is concerned about the influence of social media on decision-making. Furthermore, BIO is working with the small companies to develop a framework for crisis management in preparation towards the handling of the campaigns similar to the one presented in the case (Caroline, 2015). As a stakeholder in the case, FDA is not only presented as a regulator whose approval determines the drugs that can be sold and those that cannot be sold on the basis of certain specifications but also influences the operations of the biotechnology industries. The patient advocates consist of two groups. First, the online community that used Facebook and Twitter to push the agenda and secondly, the nonprofit child cancer advocacy that was interested in highlighting the moral obligations of the Company.

Stakeholders to be involved in resolving the Ethical Issues

            The engagement of all the stakeholders is vital in the ethical decision-making process in any organization. Involving all the stakeholders is also important in resolving the possible conflicts arising from the decision being undertaken. The main stakeholders involved in the resolution of the issues are Chimerix, Josh and his family, FDA, and patient advocates. Chimerix is not willing to provide the drug and should be involved in the undertaking of the cost-benefit analysis in the instance that the patient’s life is saved. Furthermore, the Company is engaged as the sole provider of the drug with the aim of assessing the potential mitigating factors for the short and long-term problems associated with the provision of the drug. Should the patient have died then there would have been a further public outcry as well as an associated adverse impact on the company’s image. Consequently, the board should have been involved to avoid the potential impacts such as the consumers shunning the firm's products in the future. The FDA should be engaged to provide the framework for the use of drugs for compassionate purposes as well as for providing clarification on the drug approval process in similar circumstances. Involving the patient and his family in any decision made on the matter could have been helpful in ensuring that they understand and accept the outcomes of the decisions undertaken. On the same note, both the public and private advocacy groups should be enlightened on the firm’s and FDA’s policies regarding the release of an unproven drug for use by a patient. Additionally, the views of the public should be sought on alternative options that can be used in the resolution of the ethical issues.

Ethical Theories and Principles

            The ethical principles and theories are vital for the determination of the appropriate actions and decisions to be undertaken in various circumstances. The fourteen ethical principles include the categorical imperative, the golden rule, the intuition ethic, hedonistic ethics, utilitarian ethics, revelation ethic, organization ethics, professional ethics, the conventionalist ethic, the means-ends ethic, the disclosure rule, and the proportionality principle (Jones, 2013). The principle of the golden rule

emphasizes the premise that people should do unto others what they would have done to them while highlighting the concept of win-win philosophy and is accepted by most people. Consequently, the principle of golden rule can be used by Chimerix to make a decision that presents a decision that favors all the stakeholders. The principle enables the CEO to put himself in the position of the patient and hence make an empathetic decision.

            The disclosure rule is based on the principle of transparency in which the organization is required to reveal all the information to all the stakeholders. Chimerix was thus required to disclose all the relevant information associated with the ethical issues such as the rationale for denying the provision of the drug. Specific information that can be disclosed to the stakeholders can include the company’s financial position and the constraints that are associated with the decision to be made. The categorical imperative refers to the principle that entails doing what an individual must do. As an ethical theory, categorical imperative can be used in the case by guiding the CEO to make appropriate decisions that can be accepted as a universal law. The organization could have also used professional ethics

as the basis of his decision (Jones, 2013). Professional ethics refers to a set of personal and corporate rules that determine how individuals’ behavior in a particular work context and are usually provided by the associations and regulatory bodies that govern certain industries. In the case, the CEO should have used the professional ethics as provided for by the Biotechnology Industry Organization and FDA among other regulatory agencies.  

            The principle of intuition ethic refers to the perception of issues as morally right in their prevailing context (De Colle & Werhane, 2008). Ethical intuitionism asserts that all the ethical factors in particular situations have some moral justifications that can be used for particular decisions. The theory can be used in the case by having the CEO make decisions with moral justifications. The concept of conventionalist ethics refers to the philosophical attitude that the fundamental principles or decisions are based on the implicit or explicit agreements of the society and not on the external realities. The principle of conventionalist ethic should have therefore been used in the case by applying the agreements made with the social media campaigners and patient advocacy as compared to depending on the realities such as the fact that Josh did not fit into the criteria for the compassionate use of the drug. The proportionality principle refers to the concept that can be used for balancing the competing ideas and notions. The proportionality principle can be applied in the case to describe how Chimerix could balance the competing aspects of saving the boy’s life and the objective to obtain an approval for the drug at the most appropriate time.

Action Plan

            Ethical theories and principles are essential for the formulation and implementation of policies that can be used as a framework for resolving the organizational conflicts (Jones, 2013). The recommended action plan for the organization should also entail consideration of the financial impact as well as the resulting public image of the company. The recommended plan of action, therefore, includes measures to control costs associated with the release of an unproven drug for use in desperate times. Consequently, the organization should budget for the forecasted number of patients who may be requiring the drug for compassionate use. Using the proportionality principle, Chimerix should an evaluation of the outcome of the compassionate-programme by focusing on the expected expenses. Such analysis can be used for raising funds from sources such as the government and other non-governmental groups that may be interested in the case. The disclosure rule should also be incorporated into the financial plan to allow all the stakeholders to comprehend the magnitude of the decisions that are undertaken by the firm. Consequently, the organizational processes should be as transparent as possible.

            The utilitarian ethics should be included in the plan to maintain a positive organizational image. In all the cases, Chimerix should seek to evaluate the consequences of the actions and decisions that are made by the CEO or board. The guiding principle for the decisions should be based on the positive outcomes that can be obtained in the process as compared to the basic realities that underlie the policies that are used by the organization to operate. Efforts to ensure positive public image enable a competitive advantage as the majority of the consumers will seek to associate with a company that focuses on the overall public good. On the same note, Chimerix can utilize the principle of the categorical imperative as the basis of undertaking corporate social responsibility (CSR) activities in the community to enhance the relationships with the public. The CSR efforts are aimed at ensuring goodwill as well as for ensuring brand visibility in the market.  The company should also seek to operate within the professional ethics as provided for by the regulatory frameworks and from the associations such as the Biotechnology Industry Organization.

            Expected positive consequences include the fact that increased engagement of all the stakeholders through the disclosure principle is expected to improve brand visibility and hence increased sales. The improved public image will be essential for gaining a competitive advantage as the consumers will favor the organization’s products as compared to the competitors in the market. Another positive outcome is based on the well planned and budgeted financial elements of similar cases. The firm has a clear knowledge of the sources and uses of funds. On the other hand, the negative consequences of the plan may occur in the form of resistance to change, organizational disorientation, and the fact that the plan may take a longer time to be implemented. In conclusion, the ethical issues arising from the case of Chimerix can be resolved by the engagement of all the stakeholders concerned. Similarly, ethical theories and principles are observed as critical in influencing the decisions made by the organization

References

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

October 2016: http://www.bloomberg.com/news/articles/2015-01-22/biotech-drug-approvals-social-media-storm-hits-chimerix

De Colle, S., & Werhane, P. H. (2008). Moral motivation across ethical theories: What can we learn for designing corporate ethics programs?. Journal of Business Ethics, 81(4), 751-764.

Jones, G. R. (2013). Organizational theory, design, and change. Upper Saddle River, NJ: Pearson,.