Case Study: Compassionate Use

Compassionate Use
Michele Pitka, Keegan Batson, Allen Moore, Connor Jennings, and Lucia Novoa
PHL323
May 18, 2015
Dr. Leo Stevens

Compassionate use
In recent years, many pharmaceutical companies have received petitions directly from terminally ill patients requesting “the right to obtain drugs still in the testing phase that show promise for treating their diseases” (Thomas, 2015, para. 2). Because the time needed by the Food and Drug Administration (FDA) to complete the testing and development process proving a medication effective and safe for general use can be lengthy, many desperately ill people have pursued this method of early access. Thus an ethical question arises from this situation; is it fair to give some people early or expanded
14). Another is the difficulty to judge fairness between all of the applicants. Because the number of a desperately ill people who apply for compassionate use of experimental medications is growing each year, pharmaceutical companies find it ethically perplexing and often financially difficult to meet all of their requests. Unfortunately, as mentioned previously, there is no fair or consistent way to address the situation. Recently, The New York Times reported that one major pharmaceutical company proposed an industry- leading approach. Thomas (2015) stated, “Johnson & Johnson has appointed a nationally known bioethicist to create a panel that will make decisions about patient’s requests for potentially lifesaving medicine” (para. 1). The bioethicist appointed by Johnson & Johnson is Dr. Arthur L. Caplan of New York University. As Thomas suggests, Dr. Caplan was selected by executives at Johnson & Johnson because he is an authority on the topic of compassionate use, having written many articles on the subject. It is believed that his input could lead the company in the right direction towards a fair and consistent method of answering compassionate use requests from
Caplan “would oversee an independent panel of doctors, ethicists and patient advocates that will review requests for access to a limited array of experimental medicines and decide how Johnson & Johnson should respond” (para. 4). This unique alliance has an independent panel making ethical decisions on requests for access to its experimental therapies under the compassionate use program (McKee 2015). As Thomas suggests, the organizational leadership at Johnson & Johnson was influenced by the ongoing emotional debates surrounding the terminally ill and whether or not they should have access to unapproved drugs. Employees at all levels should have an opinion on compassionate use, and it is the role of the management team to have open discussions about potential implications, and the impact of their decisions for the sake of maintaining ethical