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Letter to the Editor: Concerned about lack of informed consent

Dear Community Members,


I am very concerned about the lack of informed consent I have observed in our health care system. The National Institutes for Health define informed consent as “the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention.” (NIH, 2022) My concern is that the treatments available for COVID-19 have been administered to us without our informed consent. It is my hope that the information and perspective offered in this letter will inspire our medical providers, county officials and news providers to take a few minutes to evaluate their own behaviors.

Case in point, the experimental drug Paxlovid. Pfizer’s website, http://www.paxlovid.com states that “PAXLOVID is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PAXLOVID to treat people with mild-to-moderate COVID-19.” (Pfizer, 2022) Paxlovid is a new combination of two different medications, one of which is new and experimental, the other is FDA approved. To clarify, one of the ingredients is experimental. The combination of the two ingredients is experimental also. Nevertheless, Paxlovid is being prescribed by our hospital, prescriptions are being filled by our pharmacies and our newspaper is touting it as an option to treat COVID-19 (Moore, 2022) without any mention of its experimental nature or the potential risks involved with taking it. To be accurate, you can read this information on the packaging, or you can go to Pfizer’s website to read all the warnings about this experimental drug. However, it has been my observation that doctors, nurse practitioners and pharmacists are not having this conversation with patients prior to offering Paxlovid. Why not?

Informed Consent is “both an ethical and legal obligation of medical practitioners in the US and originates from the patient’s right to direct what happens to their body.” (NIH, 2022) So again, why are our medical providers not explaining these risks to patients? Why is our paper talking about Paxlovid without explaining the risks? Why is it up to us, the subjects (Definition of Human Subjects Research), to do our own research. Why are our doctors, pharmacists, friends, neighbors, fellow humans who are aware (or certainly should be) not talking about the health risks associated with these treatments with their patients? Why is our paper not explaining the risks associated with Paxlovid when they mention it? All of the COVID-19 treatments which have been administered, even pushed on us, are lacking this transparency in my opinion. I have heard many hospital and county officials state that COVID-19 treatments are “safe and effective”. However, I have not heard them speak at any length of the experimental nature or unknown risks involved with these treatments. Why not? Why no conversation about possible adverse effects? Why no conversation about the limited information we currently have on these treatments? Are we just simply overlooking our legal and ethical duties out of naivety? If so, please accept this as a reminder.

I truly believe in the good nature of people. I believe that the individuals working in our hospital are committed to providing the best care they can. Why else would they have chosen the careers they are in? I believe that our papers’ journalists are committed to sharing reliable information. I believe that our county officials are good people doing the best they can within the confining walls of bureaucracy and one-sided policy. I also believe my own eyes, ears and experiences and they are telling me that basic ethical and legal requirements with regard to informed consent are not being followed. I’m not trying to divide us; I’m trying to unite us on matters that pertain to our health and well-being. I’m not trying to change anyone’s opinion; I’m asking that all information regarding the safety of medical treatments is made available so that we can all make informed decisions about our health. Please, if this letter pertains to you, consider how you can be part of the solution rather than part of the problem. Please, if you have your own examples of where informed consent was not achieved, share them, respectfully and appropriately. This way we can help to improve our systems or hold those accountable who would deny us of our legal and ethical rights.

Thank you for listening to my perspective,

Dan Kearns

Moore, D. (2022). Tridemic hits Plumas: cases of flu, RSV and COVID on the rise. Plumas News. Retrieved from https://www.plumasnews.com/tridemic-hits-plumas-cases-of-flu-rsv-and-covid-on-the-rise/

NIH. (2020, JAN 13). Definition of Human Subjects Research. Retrieved from NIH: GRANTS & FUNDING: https://grants.nih.gov/policy/humansubjects/research.htm

NIH. (2022). Informed Consent. Retrieved from NIH: National Library of Medicine: https://www.ncbi.nlm.nih.gov/books/NBK430827/

Pfizer. (2022). PAXLOVID. Retrieved from Pfizer: https://www.paxlovid.com/?source=bing&HBX_PK=s_paxlovid&skwid=43700068281647229&gclid=358de88ea3671a4eb9368b1d11b432da&gclsrc=3p.ds

U.S. Department of Health & Human Services. Nuremberg Code: Directives for Human Experimentation. Retrieved from Office of Research Integrity: https://ori.hhs.gov/content/chapter-3-The-Protection-of-Human-Subjects-nuremberg-code-directives-human-experimentation

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