Clinical trials are constantly viewed with scrutiny due to seemingly controversial methods including the use of placebos as well as experimental drugs with unknown effects. As referenced by Beauchamp and Childress, there has been a shift in the way in which society views clinical trials from being primarily concerned with protecting participants from “the burdens and risks associated with research” to now trying to make participation in clinical trials more accessible (Beauchamp and Childress 234). Although there has been an increase in participant interest, it brings about its own problems with regards to who should be illegible and what means are ethical in the name of research.

In Case 7.4, Thomas, Waluchow and Gedge present three main ethical considerations with regards to clinical trial participation and procedures, but for the purpose of this post, I will only focus on one. The ethical dilemma questions if “the principle of autonomy means that very ill people should be able to access any drug they wish if they accept the risk” (Thomas, Waluchow and Gedge 258). In the specific hypothetical case presented, Harald discovered that he was HIV positive and due to his advanced case and poor health status he was rejected from a clinical trial. Although it was unclear exactly how the drug worked and what the outcomes would be, Harald had no better solutions to his rapidly deteriorating health condition. I agree with the approach Harald and his partner Jim pushed for in the case: enacting an open arm alternative where infected individuals who were too sick to be involved in the research aspect of the clinical trial could still receive the drug in the hopes that it would treat or maintain the disease. In this scenario, researchers can continue to explore potential risks, benefits and side effects in otherwise “healthy” individuals while still providing potential treatment to the more “unhealthy” infected patients. While having unknown risks and side effects may appear to violate the principle of nonmaleficence, the fact that the drug is in a clinical trial implies that there is reasonable belief that it has beneficial effects.

Although it is true that many drugs never make it from clinical trials to the market, in this case, as with many other cases we look at, patient autonomy must be taken into consideration. If a patient is fully competent and understands that the risks and benefits of a drug are not explicitly known and still wishes to continue, I believe that the patient should be allowed to try the trial drug if he or she wants to. In Harald’s case, he didn’t appear to have any other options. If his symptoms were worsening, no other treatments were helping and he thought he had nothing else to lose, why not give him the drug? Is it possible that the drug will have harmful effects and make his condition worse? Yes. Is it also possible that the drug could alleviate some of his symptoms or at least maintain the course of the disease? Also yes. I believe that as long as there is a possibility of benefits along with the possibility of harms, and there is no other viable treatment available, the use of trial drugs should be a legitimate option for terminal patients. While there is concern in the research community about how including certain types of participants may skew the results or imply false outcomes, I believe it to be unethical to refuse potentially life-saving drugs from individuals who are deemed to be “too sick” to provide useful information in the name of science. While breakthroughs in biomedical research are extremely important for future patients, physicians have an obligation to their current patients to respect their autonomy, prevent harm and try to alleviate suffering. If continuing without or with useless treatment would inevitably lead to death, offering a drug that could potentially prevent harm, in this case being death, is an act of beneficence as well as respect for autonomy.

On a slightly different note, would the situation change if the risks, benefits and side effects of a drug were all known and the drug was found to be associated with high risks? While recreational marijuana is still illegal in most of the United States, many states have legalized the use of medical marijuana for certain patients in order to alleviate pain. On a similar note, high dosages of morphine are prescribed to many patients in hospice to reduce suffering and keep such terminal patients as comfortable as possible (“Hospice Patients Alliance”). In these cases, the risks and side effects are known, yet still prescribed as viable treatments for certain patients due to the potential benefits. What makes the case of medical marijuana and high dosages of morphine different from a drug on a clinical trial? All three cases exhibit potential risks and benefits. Is it acceptable to prescribe patients drugs with high risks as long as the risks are explicitly known?

References

Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York: Oxford UP, 2001. Print

“Hospice Patients Alliance – When It Is Inappropriate to Have PRN Medical Orders for Morphine.” Hospice Patients Alliance – When It Is Inappropriate to Have PRN Medical Orders for Morphine. Hospice Patients Alliance, n.d. Web. 23 Mar. 2017.

Thomas, John E., Wilfrid J. Waluchow, and Elisabeth Gedge. Well And Good: A Case Study Approach to Health Care Ethics. N.p.: Broadview, 2014. Print