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The U.S. Food and Drug Administration (FDA) in December 2021 granted Emergency Use Authorization (EUA) to two COVID-19 early treatment oral drugs: Pfizer’s Paxlovid and Merck’s molnupiravir.
This was a major milestone, as until then, there were no FDA-endorsed pharmaceutical pill options for people diagnosed with COVID-19.
The standard medical therapy for a newly diagnosed person was: Go home, rest, drink water and go to the hospital if things get dire.
Now, after almost two years, people diagnosed with early stages of COVID-19 can be prescribed a pill!
As background, there are three stipulations a drug must meet in order to obtain EUA from the FDA:
- There must be an emergency.
- The treatment in consideration must be safe and offer 50% efficacy.
- There must not be an alternative available treatment that is safe and effective.
Pfizer and Merck oversaw clinical trials that attempted to prove their products were safe and effective. In the letters of authorization issued to Pfizer and Merck, the FDA outlined what tests were done, what the results were, what some of the limitations and concerns are, etc.
The FDA then generated more detailed advisories to healthcare providers (doctors) for Paxlovid and molnupiravir. These documents give more specifics about use restrictions (e.g., not to children), potentially adverse effects of each drug (e.g., not to be used by pregnant women, etc.), potential conflicts with other drugs (quite a few), etc.
Here are four key points to consider regarding the Paxlovid and molnupiravir data:
- The tests were conducted by the pharmaceutical companies themselves (not an unbiased entity).
- No long-term testing was done on either of these drugs (the trials lasted a few months).
- The effects on patients with many other diseases (e.g., Parkinson’s) were not evaluated and remain unknown.
- The reported effectiveness of each drug (hospitalization or death: 88% and 30%) are relative not absolute. (See this explanation about this important point.)
OK, kudos to the FDA for giving consumers some early treatment options for dealing with COVID-19. It’s especially good that they are non-hospital, take-at-home therapies.
However, the question remains: How do these FDA-endorsed drugs compare to other over-the-counter (OTC) and non-patented drugs — especially ivermectin (IVM) and hydroxychloroquine (HCQ) — that are reported to have some early treatment effectiveness against COVID-19?
As a scientist (physicist) I try to be careful in analyzing data, to not only be accurate but to present it objectively and understandably.
In that light, see this table where I juxtapose Paxlovid and molnupiravir to IVM, HCQ and three OTC drugs: curcumin, Vitamin D and zinc. The comparisons made are based on about 20 COVID-19 factors (effectiveness, safety, cost, etc.).
Comparison of Major COVID-19 Early Treatment Oral Pharmaceuticals
Click here to increase the size of the chart and access the hyperlinks.
6 takeaways from comparison of Paxlovid and molnupiravir to IVM, HCQ, and OTCs
- Pfizer’s Paxlovid is reported to have very high effectiveness.
- HCQ and the curcumin have effectiveness comparable to Paxlovid.
- Merck’s molnupiravir has very low effectiveness.
- IVM, Vitamin D and Zinc have effectiveness far superior to molnupiravir.
- Paxlovid and molnupiravir have more serious side effects than the others.
- Paxlovid and molnupiravir cost considerably more than the non-patented options.
Are Pfizer and Merck oral treatment EUAs legal?
Remember, federal law stipulates that an EUA can not be granted unless: “There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”
The data in this analysis indicate there are “adequate and available alternatives for treating” COVID-19. If the data are accurate, then these EUAs have questionable legality.
Adequate and available alternatives for treating COVID-19 do, in fact, exist — the FDA has no scientific justification for ignoring IVM, HCQ, Vitamin D and zinc.
Further, if these FDA-issued EUAs for Paxlovid and molnupiravir violate federal statutes, a closer examination of the FDA’s COVID-19 vaccine EUAs seems warranted.
If the Pfizer and Merck EUAs are legal, then why haven’t HCQ and IVM also been given EUAs?
Considering the six takeaways listed above — plus the fact, as noted in the above table, that there have been successful HCQ and IVM studies much larger (~10x) than those done for Paxlovid and molnupiravir — exactly why has the FDA not issued EUAs for IVM and HCQ?
The comparative in Table 1 adequately demonstrates there is no justification for the FDA’s refusal to grant EUAs to IVM and HCQ.
If the FDA had granted EUAs for HCQ and IVM a year ago, hundreds of thousands of COVID-19 deaths would have been prevented.
What FDA policy, procedure or precedent took priority over preventing hundreds of thousands of American deaths?
What about monoclonal antibody therapies?
Let us now expand our comparisons to include current monoclonal antibody therapies:
Comparison of Major COVID-19 Early Treatment Pharmaceuticals
Click here to increase the size of the chart and access the hyperlinks.
Note that the four key points identified above, regarding the Paxlovid and molnupiravir data, all apply here.
Some of the main takeaways from this comparison are:
- Sotrovimab has the highest effectiveness — but the least amount of data.
- HCQ and curcumin have effectiveness comparable to the bamlanivimab+ and casirivimab+ combinations.
- The first FDA EUA given to bamlanivimab turned out to be a mistake (as health issues were discovered).
- All the monoclonals have more serious side effects than the non-EUA options.
- All the monoclonals cost considerably more than the non-EUA options.
- All the monoclonals have much less safety data than the non-EUA options.
Again, this comparison shows that IVM, HCQ, curcumin, vitamin D and zinc compare very favorably to all of the early treatments that received EUA from the FDA.
