Ethical Considerations of Placebos in Clinical Trials

Ethical Considerations of Placebos in Clinical Trials

When people think about the use of medicine, a term that is often tossed around is the “placebo effect”. There are two very distinct, yet equally fundamental, definitions of a placebo. First, a placebo can be thought of as a pharmacologically inactive pill/medicine that is prescribed more so for the mental relief of the patient than for its actual effect on a disorder [1].  A placebo is sometimes used in this manner with patients who have a history of opioid addiction. Healthcare workers make this call after weighing the risks and benefits of giving at-risk (of re-addiction) patients placebo pills instead of painkillers.

The logic behind a placebo is fairly straightforward. Placebos, even though they lack active ingredients, have been shown to have a beneficial, therapeutic effect on people. This positive impact is a result of complex neurobiological mechanisms involving neurotransmitters and the brain [2]. When patients take a placebo, they often report feeling better. This is due to certain neurotransmitters being released as a result of specific cognitive activity that occurs in particular areas of the brain. Placebos are very unique in the sense that they exemplify the link between psychosocial factors and physiological processes [3].

The second way to define a placebo is as an inert substance used in experiments as a control in order to test the efficacy of a certain medication/treatment [1]. An example of a placebo would be a sugar pill that physicians performing a clinical trial give to patients instead of the drug that is being tested. The purpose of this is to create a type of “baseline” to compare actual drug effectiveness to [4]. This baseline shows the sole impact that a patient’s belief of receiving a treatment might have. This definition of a placebo is what I will focus on for the rest of this article.

The use of placebo controls in clinical trials remains extremely controversial. Over the last few decades. Randomized placebo-controlled trials (PCTs) have become the gold standard of evaluating the efficacy of new treatment options [5]. The majority of the scientific community accepts the use of placebo controls in trials for conditions without an effective treatment.. On the other hand, PCTs raise many ethical concerns when there is in fact an alternate and proven effective treatment. This is because the use of placebos in such situations would significantly expose patients to the potential harms of non-treatment [5].

From an morality standpoint, the biggest dilemma with the use of placebos in clinical trials is balancing the protection of human subjects with doing what is best for society on a macro-scale.  Applying different ethical frameworks and perspectives to PCTs yields many different and conflicting solutions to such issues.

Viewing PCTs from a utilitarian perspective is very interesting. According to this ethical approach, a decision is considered to morally ethical only if it produces the most good for the most people [6]. The entire point of placebo controlled trials is to confirm that potential drugs/treatments can effectively used on a global scale by clinicians around the world to try and save lives. With this logic, it might seem that ethically, PCTs are very easy to justify, but this is far from the truth. Even though the end goal of PCTs can be viewed as undoubtedly ethical, the process might not be.

The basis behind placebo controlled trials violates both the ethical principles of beneficence and nonmaleficence. Beneficence can be defined as protecting and defending others, whereas nonmaleficence can be defined as not causing pain or suffering [7]. When a physician gives a patient a sugar pill instead of a potentially helpful medication, he or she is not doing all he or she can to help alleviate the pain and suffering of the patient. In the same breath, the physician is potentially exposing the patient to circumstances that are more dangerous for his or her wellbeing. Although many are quick to proclaim that placebos are justifiable due to the large scale benefits in the future, they should not forget to consider the more immediate ethical dilemmas.

In my opinion, in many placebo controlled drug studies, the respect for the autonomy of patients is also indirectly violated. Respect for autonomy is defined as hearing and respecting the decision making capacity and preferences of individuals [7]. On the surface, there does not seem to be an autonomy issue because patients “willingly” sign up for clinical studies and consent to the idea that they may or may not be assigned to a placebo medication instead of the drug in question. I believe that one must look a step further to see where a patient’s autonomy might be violated here. For example, if a patient is diagnosed with a terminal disease with no present cure, what other option do they have than to sign up for any trials possible? They do not have the freedom to refuse the placebo and instead demand only the medication that could potentially save their lives. They can only hope that they get chosen for the experimental group instead of placebo group in these PCTs.

I believe that there needs to be dialogue regarding in which scenarios PCTs are valid or invalid. Currently, PCTs are typically only used with diseases that have no potential remedy available. The reason for this is that the threat of non-treatment with placebos is no worse than going an alternate direction and not entering the trial in the first place. Conversely, PCTs are not often uses in cases where there is at least some sort of alternate treatment present. Although I understand the logic behind this thinking, this really skews the illnesses that scientists and doctors aim to create new treatments for. They are much more likely to spend their time trying to create treatments for diseases without a cure, rather than working on improving the drugs already being used for certain illnesses. Although there is no clear cut way to balance the dilemmas present in each of these ethical frameworks, moving forward, healthcare workers, ethicists, and policy makers must work collectively to try and create more effective standards for the implementation of placebo controlled studies.

References

  1. “Placebo.” Merriam-Webster, Merriam-Webster, www.merriam-webster.com/dictionary/placebo.
  2. Kaptchuk, Ted J., and Franklin G. Miller. “Placebo Effects in Medicine.” New England Journal of Medicine, vol. 373, no. 1, Feb. 2015, pp. 8–9.
  3. Raz, Amir, et al. “Placebos in Medicine: Knowledge, Beliefs, and Patterns of Use.” McGill Journal of Medicine, 11 Nov. 2008.
  4. “Placebos and Placebo Effects.” Chapter 5 The Nazi Eugenics Programs, highschoolbioethics.georgetown.edu/units/cases/unit3_8.html.
  5. Millum, Joseph, and Christine Grady. “The Ethics of Placebo-Controlled Trials: Methodological Justifications.” Content Clin Trials, 12 Sept. 2013.
  6. Driver, Julia. “The History of Utilitarianism.” Stanford Encyclopedia of Philosophy, Stanford University, 27 Mar. 2009, plato.stanford.edu/entries/utilitarianism-history/.
  7. Jahn, Warren T. “The 4 Basic Ethical Principles That Apply to Forensic Activities Are Respect for Autonomy, Beneficence, Nonmaleficence, and Justice.” Journal of Chiropractic Medicine, vol. 10, no. 3, 10 Sept. 2011, pp. 225–226., doi:10.1016/j.jcm.2011.08.004.
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