Letter Regarding PAXLOVID and Informed Consent

The Following letter was sent to Plumas District Hospital directors and staff after my mother was prescribed the drug PAXLOVID without being informed that it is an experimental drug:

​To the board members, administrators, doctors, nurse practitioners, nurses and staff of Plumas District Hospital,
 
I would like to make you aware that the practice of administering and/or prescribing experimental drugs to patients without offering them informed consent is illegal, unethical, and violates patient rights set forth in the Nuremberg Code, the Hippocratic Oath and your Mission Statement.
 
According to the NIH, informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. 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. Informed consent is mandatory for all clinical trials involving human beings. (Shah, Thorton, Turrin, & Hipskind., 2022)
 
It has come to my attention that your hospital is prescribing the experimental drug, PAXLOVID, to patients without informing them that it is an experimental drug.
 
Pfizer states that PAXLOVID is an investigational medicine. “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)
 
Possible side effects include hives and skin rash, trouble swallowing and breathing, liver problems, high blood pressure, to name only a few. Pfizer continues: “These are not all the possible side effects of PAXLOVID. Not many people have taken PAXLOVID. Serious and unexpected side effects may happen. PAXLOVID is still being studied, so it is possible that all of the risks are not known at this time.” (Pfizer, Possible Side Effects)
 
As such, humans who receive PAXLOVID are participating in an experiment which will help to determine the safety and effectiveness of the drug. Are you informing patients of this? Why or why not? Anyone who takes this drug is at risk of unknown and potentially serious side effects. Are you informing patients of this? Why or why not?
 
The Nuremberg Code, Article 1, states that “The voluntary consent of the human subject is absolutely essential.” (The Nuremberg Code) Are you adhering to this code in your practices of prescribing PAXLOVID? We remember the circumstances under which this Code was created, right?
 
The Hippocratic Oath states “I will use those dietary regimens which will benefit my patients according to my greatest ability and judgment, and I will do no harm or injustice to them.” (NIH, Greek Medicine, 2012) Can you say without a doubt that you are doing no harm when you prescribe a drug with limited safety information? Are you adhering to the practice of “First do no harm” when you prescribe a drug whose side effects are unknown? Are you suggesting any dietary regimens which boost immune systems and help patients fight off infection first? Are you doing an injustice to patients by not giving them all the information available regarding PAXLOVID?
 
The PHD Mission Statement is "We provide outstanding compassionate care with exceptional customer service." Are you providing outstanding and compassionate care when you prescribe experimental drugs to patients without informing them? Is this your definition of “exceptional customer service”?
 
I am aware of the pressures that may have been put on many of you to conform to these new, unethical and illegal practices. I’m aware that the education you received in order to become health care providers was not cheap and that many of you are in debt as a result. I understand that your positions and jobs may have been threatened if you would not conform to a system of medicine where informed consent is no longer honored. I want to remind you that your family members, friends, neighbors, fellow humans are trusting you with their health and well-being, their lives. I want you to know that there are many that will support you and have your back if you choose to no longer conform to unethical and illegal medical practices. I am aware that many of you have gone against your own judgement with regards to what is right for your bodies in order to keep your jobs. I want you to know that you are not alone. It is our silent conformity that allows the whittling of our rights and freedoms. I am aware that there is new legislation, AB 2098, which will legalize the silencing of your professional medical opinions by your superiors. I remind those who now have the authority to “punish” employees who do not conform to their agenda of denying informed consent that we are watching you. God is watching you. Though you have this new legal option, you are not required to use it. You have a duty to your fellow humans and yourself as well.
 
I have used the prescription of PAXLOVID as a specific example of where legal and ethical standards have been violated because of its current status as an experimental drug. However, I think many of you can see how these legal and ethical violations apply to many of the new “treatments” which have been administered during the COVID-19 pandemic. There are many treatments which are tried and true in combating Influenza like illnesses. These treatments have little to no known adverse side effects. Why have these been set aside to make room for new, experimental "treatments"? Why are these trusted methods less prescribed than the new, experimental ones? Is there a reason other than increasing profit margins for this practice? Has profit been placed above patient safety on your list of priorities? If not, prove it. 
 
Lastly, I want you to know that you are all loved and appreciated. I am so grateful that you chose to undertake this life and profession of service. We need you! We need you to help keep us well and safe! Please do not allow this community to lose a trustworthy source of medical care. What will we do if we cannot trust our local hospital?
 
Thank you for your time and consideration. May you make decisions that bring you and yours peace of Heart and Mind.
 
Sincerely,
 
Dan Kearns
 
References

NIH. (2012, FEB 7). Greek Medicine. Retrieved from National Institutes of Health:
https://www.nlm.nih.gov/hmd/greek/greek_oath.html

NIH. (n.d.). The Nuremberg Code. Retrieved from National Institutes of Health: Office of NIH History and Stetten Museum:
https://history.nih.gov/display/history/Nuremberg%2BCode

Pfizer. (2022). Now Authorized for Emergency Use. Retrieved from PAXLOVID:
https://www.paxlovid.com/?source=bing&HBX_PK=s_paxlovid&skwid=43700068281647229&gclid=ebd0fc4eb44c16fc7d749f8ef1887c1b&gclsrc=3p.ds

Pfizer. (n.d.). Possible Side Effects. Retrieved from PAXLOVID:
https://www.paxlovid.com/side-effects

Shah, P., Thorton, I., Turrin, D., & Hipskind., J. E. (2022, JUNE 11). Informed Consent. Retrieved from NIH: National Library of Medicine:
​https://www.ncbi.nlm.nih.gov/books/NBK430827/