PHI-FPX3200_ArkettAndrew_Assesment2-1

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Feb 20, 2024

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1 A Right to Experimental Drugs? Andrew W Arkett Capella University PHI-FPX3200: Ethics in Healthcare Dr. Ginger Raya

2 A Right to Experimental Drugs? Relevant Ethical Theories and Moral Principles In demonstrating my support for individuals who have no other treatment options than experimental drugs, I believe these persons should be allowed to take part in receiving these medicines. According to the Natural Law Theory, If available evidence shows that a sick person may gain benefits from participating in a research project, then the research is justified. But if the evidence shows that the benefits may be slight or if the chance of serious injury or death is relatively great, then the research is not justified. Munson, R. (2013). Kant’s view of people as autonomous rational beings requires that informed consent be obtained for both medical treatment and research. We cannot be forced to accept treatment for “our own good,” nor can we be turned into research subjects for “the good of others.” We must always be treated as ends and never as means only. To be treated in this way requires that others never deliberately deceive us, no matter how good their intentions. In short, we have a right to be told what we are getting into so that we can decide whether we want to go through with it or not. Munson, R. (2013). How the Principle of Informed Consent Is Relevant to Experimental Drugs Informed consent is relevant to experimental drugs in many ways. It’s generally agreed that, in order to be valid, consent must be voluntary. The person must, of his or her “own free will,” agree to become a research subject. This means that the person must be capable of acting voluntarily. That is, the person must be competent. Munson, R. (2013). For consent to be morally and legally meaningful, individuals must be (1) competent to understand what they are told about their condition and capable of exercising judgment; (2) provided with relevant information about

3 their illness and the proposed treatment for it in an understandable form and allowed the opportunity to ask questions; (3) given information about alternative treatments, including no treatment at all; and (4) allowed the freedom to make a decision about their treatment without coercion. Munson, R. (2013). Depriving a terminally ill patient of experimental drugs is not an option when their life hangs in the balance. Experimental drugs could provide a patient with time. Time is a valuable resource. Explaining the Cost and Benefits of Offering Unapproved Experimental Drugs to Patients First, we will examine the cost of providing unapproved experimental drugs to patients. The cost can be defined in several ways. The cost of developing the drug can sometimes be over 1 billion dollars. On average, it costs nearly $4 billion to develop a new medicine, but this can sometimes exceed $10 billion. (Gupta, 2013) The cost that patients incur can include transportation, out-of-pocket expenses, extra blood tests, and additional appointments. The “Right to Try” Act gives physicians the approval to offer experimental or unapproved drugs to patients that are terminally ill. Additionally, the ingestion of experimental drugs is fraught with risks, it is known that only a very small percentage of drugs that are clinically tested on humans actually end up being marketed. Therefore, it is highly possible that the drug being given is actually harmful or ineffective. (Kasper Raus, 2016) Experimental drugs are not covered by insurance, but most of the time, the company will provide the drug at no charge. The benefit to the patient and company can be breakthroughs, prolonged life, cures for diseases, and improvements or enhancements gleaned from experimental use.

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4 Analyzing Arguments For and Against Offering Pre-Approved Drugs to Wider Pools of Patients Arguing for the support of offering pre-approved drugs to a wider pool of patients would provide patients with more options for treatment when they may not have had the option previously. The clinical trial for the pre-approved drug may provide treatment pathways that have opened up because of the approval. For instance, a drug that may have been approved for cancer may now treat Parkinson’s disease. Parkinson’s disease (PD) is a lifelong condition that affects the nerve cells in the brain that produce dopamine. As a result, people with this neurodegenerative disease experience tremors, changes in speech, gait issues, and muscle rigidity. Though it has no cure, a new drug used to treat cancer shows promise in treating Parkinson’s. (Cancer drug shows promise in battling Parkinson’s disease.) In an experimental clinical trial performed by the researchers, the cancer drug nilotinib, which was previously approved in treating leukemia, helped increase dopamine levels in the brain. (Cancer drug shows promise in battling Parkinson’s disease.) An argument against the use of pre-approved drugs on wider pools of patients would be the duration the drug would be on the market may not be enough time to factor in the long-term effects of this drug. Of course, even taking market-approved drugs is always potentially risky. Drugs that are approved for market have been successfully tested in RCTs (randomized controlled trials), but most patients in clinical practice do not fulfill the RCT inclusion criteria. One should therefore be careful not to overstate benefits for every individual patient of an approved drug. Even approved drugs do not work (properly) in a significant number of patients or might result in severe adverse events. (Kasper Raus, 2016)

5 References Cancer drug shows promise in battling parkinson’s disease. (2019-12-17T18:57:00.0000000- 05:00). https://www.news-medical.net/news/20191217/Cancer-drug-shows-promise-in- battling-Parkinsons-disease.aspx Capella: Intervention and reflection: Basic issues in bioethics, concise edition. https://capella.vitalsource.com/reader/books/9781337015332/epubcfi/ 6/10[idloc_004.xhtml-itemref ]!/4[eid1466]/2[page_break_inline_59] Munson, R. (2013). Intervention and Reflection: Basic Issues in Bioethics, Concise Edition. Cengage Limited. https://capella.vitalsource.com/books/9781337015332 Gupta, U. C. (2013). Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research, 4 (1), 26-32. https://10.4103/2229-3485.106373 Kasper Raus. (2016). An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics, 17 , n/a. https://10.1186/s12910-016- 0145-x Source type: Scholarly Journals; Object type: Article; Object type: Feature; Copyright: Copyright BioMed Central 2016; DOCID: 4236295481; PCID: 102970372; PMID: 58507; ProvJournalCode: BCMT; DOI: 10.1186/s12910-016-0145-x; PublisherXID: ICABMDD_BCMT_20160101_5AD7F996C8FC6FF36B2A Untitled. https://www.fda.gov/media/133864/download

6 Why does it cost so much to develop new drugs? | proclinical blogs. https://www.proclinical.com/blogs/2020-9/why-does-it-cost-so-much-to-develop- new-drugs

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