PAXLOVID AND UNINFORMED CONSENT

Disregarding oaths and ethics

I have had 3 of my cardiac patients recently present for their follow up appointments and in the course of discussing their recent health history, they stated they had Covid since their prior visit to my office. All three had taken the Pfizer “vaccine” shots in early 2021 and 2 had a later third shot of the drug. No surprise here; we all know these mRNA drugs do not prevent infection or transmission of the virus to others.

I have had many patients stating they were infected with Covid weeks to months following “vaccination” - that is becoming a very common part of a medical history. But what was different and new about these 3 patients is they had been prescribed Paxlovid by primary care or the ER doctor for the recent infections. This concerns me because these patients are on various medications for their cardiac and metabolic problems. They denied they were given informed consent prior to receiving Paxlovid which is being actively promoted as a treatment for COVID. Paxlovid has emergency use authorization (EUA) from the FDA for this purpose.

I am beginning to see a few articles on various news sites expressing concern about Paxlovid as if this is new news. I wrote about my concern regarding this drug 2 months ago in a piece on this substack: LATE BREAKING NEWS FLASH! THE CDC AND DR. FAUCI NOW ALLOW INDIVIDUAL DECISIONS. That essay is rather long and I extracted the Paxlovid portion for reprint and review here.

One last thing to mention from the updated “guidance” from the CDC.  In the section of the guidance release dealing with antiviral agents, Paxlovid is mentioned in the context of “expansion of prescribing authority of Paxlovid to pharmacists intends to further facilitate access”.  Is there a precedence for pharmacists prescribing an investigational drug?  Paxlovid is a combination drug consisting of nirmatrelvir which is a protease inhibitor that inhibits viral replication and also contains ritonavir which boosts the nirmatrelvir drug levels in the body.  Paxlovid is an investigational drug from Pfizer that has an emergency use authorization (EUA) only and is for use in a person testing positive for Covid and needs to be given in the first 5 days of infection.

Look up the list of drug interactions and incompatibilities with Paxlovid.  In 40 years of writing prescriptions, I have never seen a drug with that many drug interactions and potential incompatibilities.  The lengthy list of interactions represents 35 categories of drugs (not 35 drugs, but 35 categories of drugs).  I scanned all those drugs where caution needs to be considered if taken with Paxlovid and just about anything I would prescribe as a cardiologist for a cardiovascular problem is on that list.  I suspect other medical specialties would find similar drug conflicts with medications they prescribe. This begs the question, who is prescribing this drug?  Emergency room physicians?  Infectious disease specialists?  Who?

And who is doing the informed consent since it is investigational and only has an EUA?  Oh wait, the mRNA drugs from Pfizer and Moderna are investigational and only have an EUA (the FDA “approved” versions are not available in the US) and we haven’t bothered to provide informed consent for those drugs given en masse during a pandemic and now are to be given to infants and older children.  Persuant to the federal EUA statute, people are entitled to be informed about the right to accept or refuse administration of these drugs, the known consequences of either choice, and the risks and benefits of alternatives to these drugs. I doubt the parents of children are being given adequate informed consent prior to their children receiving these drugs.  Incidentally, if you are objecting to my use of the term “investigational” then go onto your Epocrates app and read how they term Paxlovid’s authorization from the FDA.  Same as the mRNA drugs - EUA and investigational.

And now pharmacists are being encouraged to “prescribe” Paxlovid.  Are they going to take a medical history and perhaps do a physical exam to determine the possible contraindications to receiving the drug?  Of course not!  Will they determine if there are liver problems or renal insufficiency, and if so, there are no data to support use or safety of the drug?  Will they determine the full medication list the patient is taking and caution them about common over-the-counter drugs they should not take with Paxlovid?  Will the patient stop prescription drugs they should not discontinue in order to take the Paxlovid “prescribed” by the pharmacist (or a poorly informed physician or nurse practitioner)?  Will they do follow-up to observe for problems with a problematic, investigational drug?  There is a high rebound infection rate after the 5 day course authorized by the FDA for this drug.  Will the pharmacist attend to that and prescribe a second 5 day course “off label” for the patient as was done for Biden?  I can’t imagine a coherent pharmacist (or any prescriber) would want to take on the responsibility of providing Paxlovid to a patient walking in off the street.

As a senior and well-seasoned physician, I would not consider prescribing Paxlovid for a Covid patient.  Too many problems and better alternatives.  Paxlovid costs $530 for the 5 day course (paid for by the U.S. government to Pfizer with $5.3 billion taxpayer dollars for 10 million courses of the drug) so they can dispense the drug for “free”.  Pfizer scores again!   

There is a better alternative protease inhibitor drug (and also has other anti-viral activities and anti-inflammatory qualities) that costs a fraction of the Paxlovid cost and the only drug interaction it has is with warfarin.  It has been given billions of times around the world with safe results and won a Nobel prize in medicine a few years ago.   Numerous studies (randomized and observational) have testified to its efficacy in COVID-19 if administered early in the clinical course, just as recommended for Paxlovid (viral replication occurs in the first few days of infection).  Figure it out yet?  Go read about repurposed drugs for the treatment of COVID-19 on brownstone.org and learn about a bunch of other stuff while you are there.  It is a great source for rational viewpoints on COVID but also delves into many other aspects of our society.

It has been very disappointing to witness healthcare providers prescribing investigational EUA drugs and not providing the right to informed consent and the right to informed refusal. My fear is that EUA “approval” of inadequately studied investigational drugs is becoming the new normal.

Whenever a health care provider administers a “vaccine” with an EUA or writes a prescription for a drug like Paxlovid which has EUA approval only, the provider should realize their patient has now become a test subject in an investigational trial. These drugs have not been tested with the rigor the FDA has historically required for full FDA approval. And Pfizer has been lax in doing follow up data safety monitoring. If our country was not still in a declared state of emergency, these drugs would have no FDA approval.

The coercion to take these EUA drugs and the absence of informed consent has all been in violation of the Hippocratic Oath, the Nuremberg Code, and the Helsinki Declaration - three documents that describe the ethics and morality all health care providers should be familiar with and should follow. The ethical and morality tenets in these documents are explicit and take precedence over the dictates, mandates, and coercion coming from the CDC and other government entities. Nothing will change unless we have accountability for those who have violated these ethical standards.