Current Ethical Issue in Business Paper Team A SUBMISSION FOR GRADING

Topics: Ethics, Pharmacology, Clinical trial Pages: 7 (1888 words) Published: May 25, 2015


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 access to an experimental medication before its effectiveness and safety is proven? The issue of early or expanded access to experimental medications is known in the pharmaceutical industry as compassionate use or compassionate access. Compassionate use refers to a system that allows patients with life-threatening conditions to receive experimental drugs before the final product is thoroughly tested, approved and released to the market (Darrow, Sarpatwari, Avorn, & Kesselheim, 2015). Because of the possible legal, practical and ethical issues that could arise from this system, many pharmaceutical companies are not willing to allow patients to access these drugs. However, some patients who have received compassionate access have greatly benefited from the treatment. Hence, there is need for a plan to revise ethical standards within the industry to allow more patients to take part in these programs, as well as a fair, equitable, and consistent system for deciding who gets access to these experimental medications. The main problem with compassionate use is that many pharmaceutical companies do not have proper processes and procedures in place when it comes to granting experimental drugs. While some corporations choose to provide access to these drugs, others decline to allow access altogether (Chedekel, 2015). Pharmaceutical companies are not legally required to give patients access to unapproved drugs, so companies must decide if giving access to the drug is worth the risk. This can be problematic because companies must make this decision with conflicting pressures. Some companies fear that they will be held liable if a patient dies on their drug, or that any complications with the drug will later hurt its chances of approval with the FDA. As a result, the approval process for compassionate use drugs can be unfair or inefficient (Chedekel, 2015). Patients who have sought treatment with experimental drugs have been denied based on underlying company policy and availability. To get companies to agree to consent for the use of their experimental drugs, patients have used news to feed the population into persuading companies for their help. Direct pleas to pharmaceutical companies have been accompanied by social media campaigns on Twitter and Facebook started by family members, friends and other concerned persons. According to Thomas (2015) these campaigns have tried to “shame companies into granting their request” (para. 11). Unfortunately, as Thomas suggests, this type of campaign has created a new type of inequality among terminal ill patients. Success comes to those who know how to effectively campaign on social media. The main problem according to Thomas (2015) is “inconsistent approaches” to the problem by pharmaceutical companies (para. 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,...

References: Chedekel, L. (2015, March 8). Debating the ethics of experimental drugs. Retrieved May 15, 2015 from http://www.bu.edu/today/2015/ethics-of-experimental-drugs/
Cuccia, J. (2012). Compassionate Use: Balancing compassion and risk in clinical trials. New Jersey: ACE Group.
Darrow, J., Sarpatwari, J., Avorn, J., & Kesselheim, A. (2015). Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs. The New England Journal of Medicine , 372 (15), 1473-1474.
Guido, G. W. (2010). Legal & ethical issues in nursing (5th ed.). Upper Saddle River, NJ: Pearson.
McKee, S. (2015). J&J seeks ethical advice on compassionate use requests. Retrieved from www.pharmatimes.com
Thomas, K. (2015, May). Company Creates Bioethics Panel on Trial Drugs. The New York Times, A1. Retrieved from http://www.nytimes.com/2015/05/07/business/company-creates-bioethics-panel-on-trial-drugs.html?_r=0
Treviño, L. K., & Nelson, K. A. (2011). Managing business ethics: Straight talk on how to do it right (5th ed.). Hoboken, NJ: Wiley.
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