Recent revelations about PAXLOVID™ should lead to serious questions for the FDA, CDC and Pfizer

By Kent R. Kroeger (Source:, September 13, 2022)

“In politics, not all lies are all lies. And not all truths are complete.” — Mark McKinnon (American political advisor, reform advocate, media columnist, and television producer)

“The most effective propaganda is surrounded by truths.” — Hanno Hardt (University of Iowa Journalism and Mass Communication Professor)

“Half a truth is often a great lie.” — Benjamin Franklin

Our understanding of social and political issues is incomplete or inaccurate, in part, due to our own mental limitations, but also because those providing us with information on these issues are, themselves, often ill-informedtrying to limit the our knowledge, or simply lying.

No information source has been more responsible for those three information deceits than our own government.

One of the first political science books I read in college was journalist David Wise’s The Politics of Lying — as pertinent today as it was when it was published in 1973. The book outlines how government deception has been enhanced over the years through “official secrecy, a vast public relations machine, and increasing pressures on the press.”

Ironically, it was Wise’s quoting of Richard M. Nixon that has stayed with me all these years:

“When information which properly belongs to the public is systematically withheld by those in power, the people soon become ignorant of their own affairs, distrustful of those who manage them and, eventually, incapable of determining their own destinies.” — Richard M. Nixon

The number of times the U.S. government officials get caught in deliberate deceptions of the U.S. public grows by the day. In my lifetime, it spans from Watergate to Russiagate (with a few –gates in between), but perhaps no deception has been more upsetting than the poor information that has defined too much of the government’s communications effort during the COVID-19 pandemic.

No, I am not an anti-vaxxer or convinced that the virus originated in a Wuhan lab. I am, however, increasingly convinced that the American people were propagandized into believing only expensive vaccine and drug treatments would get us out of this worldwide health crisis — when, in fact, much more cost-effective measures were known or could have been discovered with more high-quality (for example, randomized controlled trials) scientific research.

I am confident in saying that billions of dollars were most likely wasted on the one-size-fits-all vaccine and antiviral policies promoted by the Centers for Disease Control and Prevention (CDC) and pharmaceutical companies. which were ill-conceived and, most certainly, cost-ineffective.

Case in point, the COVID-19 antiviral treatment: PAXLOVID™:

On November 5, 2021, Pfizer announced “its investigational novel COVID-19 oral antiviral candidate, PAXLOVID™, significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.”

On December 23, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the use of PAXLOVID™ to treat COVID-19 and the Biden administration has since purchased 20 million treatment courses of the antiviral for use in the U.S.

After initialing reporting that PAXLOVID™ “reduced risk of hospitalization or death by 89 percent (within three days of symptom onset) and 88 percent (within five days of symptom onset) compared to placebo,” in June 2022 Pfizer released the final research findings for the Phase 2/3 EPIC-HR and had to admit their drug offers little benefit to healthy people who are fully vaccinated — which is about one-third of the U.S. population based on data from the CDC and the Yale-Griffin Prevention Research Center.

While PAXLOVID™ is still very effective for people who are unvaccinated or have significant co-morbidities (for example, obesity, hypertension, etc.), Pfizer’s failure to be upfront about a large percentage of the U.S. population who would not benefit from the drug is informative about the forthrightness of not just Pfizer, but the FDA.

The EUA application requirements, as stated in Section E.1 of the FDA’s guidance to industry stakeholders seeking an EUA, are clear in the importance of providing comprehensive evidence as to a drug’s benefits:

A producer of the the drug pursing EUA must provide data on “the significant known and potential benefits and risks of the emergency use of the product, and the extent to which such benefits and risks are unknown.”

In authorizing the emergency use PAXLOVID™, there is no evidence the FDA knew of Pfizer’s clinical study data showing that the antiviral drug was unnecessary for healthy, vaccinated COVID-19 patients.

It would have been a nice thing for family doctors and their patients to know.

An untold millions of Americans (including my wife) received the PAXLOVID™ treatment course for no substantive medical reason. Considering that a five-day course of PAXLOVID™ presumably costs around $530 (the U.S. government paid $5.3 billion for 10 million courses of PAXLOVID™ in November 2021), how many billions of dollars has the U.S. government squandered in facilitating the use of this antiviral treatment for COVID-19?

Before Pfizer’s revelation of the circumstances in which PAXLOVID™ treatments are less effective than originally advertised, in May 2022 the CDC had warned that around 2 percent of people who receive the PAXLOVID™ treatments will have their symptoms return after their initial reduction.

While the CDC says the ‘rebound’ outcome and the drug’s lower effectiveness among healthy, vaccinated people are not serious enough concerns to discourage use of PAXLOVID™, when did Pfizer, the FDA and the CDC know of these effectiveness issues and why didn’t the EUA process bring them to the public’s attention sooner?

This lack of candidness might make someone wonder whether the FDA’s EUA process is more concerned about providing a rationalization for the drug companies’ record-breaking profits than helping the American people make informed medical decisions.

These questions gain relevance after The Economist recently reported that PAXLOVID™ — in the aggregate — has not been particularly significant in saving lives or reducing hospitalizations during the COVID-19 pandemic.

“The impact of Pfizer’s antiviral drug is hard to detect in official statistics,” says The Economist.

It is not just about the money, but that is a good place to start.

All told, the government tab for the COVID-19 pandemic has been staggering:

$10 billion spent on PAXLOVID™ alone.

$20 to $40 billion in total spent on Operation Warp Speed (the joint government-private industry research effort to develop, manufacture and deploy COVID-19 vaccines and antivirals).

Not to mention the $2.2 trillion spent on the CARES Act of 2020 and another $1.7 trillion on the American Rescue Plan Act of 2021.

The U.S. Congress shows no formal interest in asking hard questions of our federal bureaucracy or the drug companies about the critical information kept from the public during the EUA process for PAXLOVID™, not to mention other equally important questions, such as the scientifically specious data used to justify mass COVID-19 vaccinations and boosters of healthy children — money and effort that could have been better spent protecting those most vulnerable to COVID-19.

Adding to the tsunami of secrecy and scientific short-cuts that have helped define the U.S. response to COVID-19, is the FDA’s recent approval of the “bivalent” booster that was issued with no new clinical research to support its deployment into the general public. This virus is too survivable now not to be doing the proper due diligence on the science.

And for all this money and fast-tracking, the U.S. still experienced among the world’s worst fatality rates for COVID-19 (14th worst among over 180 countries with reliable data, according to You can thank our fragmented health care system for much of that failing.

Perhaps inadvertently confirming Modern Monetary Theory (MMT) — an economic theory that says countries that issue their own currencies can never “run out of money” the way people or businesses can  our politicians, bureaucrats and corporations appear more than happy to spend government money like drunken sailors, so long as they or their friends get their normal cut.

MMT is probably a closer approximation of our vast economy than its critics want to admit, but nothing in MMT or mainstream economic theory suggests that squandering the government’s money on unproductive endeavors is a good thing.

The opportunity costs alone justify a deeper investigation into how well our money was spent during the pandemic.

Moreover, such an investigation would further expose our dysfunctional health care system and a political culture that is increasingly comfortable with unwarranted secrecy and lack of accountability among its most powerful people — and, hopefully, would prevent our country from making similar mistakes during the next pandemic or health crisis.

  • K.R.K.

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