PHI FPX 3200 Assessment 2 A Right to Experimental Drugs
PHI FPX 3200 Assessment 2 A Right to Experimental Drugs
Experimental drugs are offered to patients when all other options were used and unsuccessful. Practitioners have an ethical and moral obligation to care for their patient’s well-being with the goal of improving optimal living. Patients facing death are more incline to use experimental drugs they believe may prolong life. Bound by ethical principles non-maleficence, to do no harm and beneficence, to act for the benefit of a patient. If the risks outweigh the benefit than non-maleficence is violated. Making sure that the patient is informed of the risk to give consent to participate in a trial for unapproved drugs is important. This oppose the question; do terminally ill patients have the right to experimental drugs? Does the patient have all the information needed to give inform consent? “Before you can be given an investigational drug either through a clinical trial or through expanded access, your healthcare provider must give you additional information about the potential risks and potential benefits of the drug” (April 2019).
Informed Consent
“The provider must make a recommendation and provide their reasoning for said recommendation” (June 2019). This would allow a patient to make a confident decision regarding care such as being prescribed experimental drugs. Consent should be voluntary and without force from health care professionals to proceed. The patient should be informed that the medication is still in the trial phase, and there are risks of taking a drug not approved by the FDA.
Costs and Benefits
Participants in clinical trials receive treatment free of charge and is monitored for adverse effects from the drugs. Data is collected to make necessary changes based on the information obtained from the patients and their reactions. Drugs in the experimental phase can cost millions of dollars to develop and therefore receive funding from the government and private fundraising. According to the FDA, “Evidence that the drug will benefit the target population should outweigh any risks and uncertainties” (August 2022).
Ethical Theories and Moral Principles
Health care professionals’ duty is to offer the best possible treatments for their patients. “Some situations in which. experimental treatments are considered to create challenges for decision making. Patients may be in pain, distress or in a potentially life-threatening situation which could affect their ability to weigh risks and benefits” (April 2018). There are ethical components to consider in favor for and against the use of experimental drugs. However, in 38 states it was signed into law for terminally ill patients who have tried government approved options and is ineligible for clinical trials to have access to investigational drugs (known as the right to try law). These treatments must meet the following criteria:
PHI FPX 3200 Assessment 2 A Right to Experimental Drugs
- Completed an FDA approved Phase 1 trial
- In an active clinical trial
- Be in ongoing active development or production
Utilitarianism theory imply that the use of experimental drugs for terminally ill patients can be ethically and morally justified if it has a beneficial impact on the illness and can produce good from its outcomes. It can be argued that experimental drugs should not be used on human participants since there are unknown side effects. However, I am in favor of its use if a clear informed consent can be obtained from the patient. I do think that it would be unethical to not take the patients wishes into consideration especially if there is a DNR in place and patient state comfort care only.
Conclusion
The right to try Act give patients access to investigational drugs when all other options were tried, it is the hope that these drugs may benefit the patient. When no known outcomes of these experimental drugs patients are faced with the dilemma of do they try or do they let their illness progress without trying any alternative methods. Practitioners need to inform the patient and families of essential information, including risks and benefits, or if the medication is in a clinical trial and not yet approved this is needed to allow them to make an informed decision about their care of choice.
References
Bibler TM, Shinall Jr MC, and Stahl D (2018) Responding to those who hope for a miracle: (“Responding to Those Who Hope for a Miracle: Practices for Clinical …”)
Practices for clinical bioethicists Am J Bioethics 18: 40-51.
Development & Approved Process Drugs (August 2022). Food and Drug Administration (.gov)
https://www.fda.gov
Slim K, Bazin JE. From informed consent to shared decision making in surgery. J Visc Surg.
2019 Jun; 156 (3): 181-184. [PubMed] [Ref list]
Understanding Investigational Drugs (April 2019). Food and Drug Administration (.gov)
https://www.fda.gov
