The Secret Studies of Paxlovid
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The Secret Studies Of Paxlovid
Headlines have repeatedly wagged a finger at doctors for not prescribing more Paxlovid, Pfizer’s $1,400 COVID pill. During a recent media blitz for the drug a New York Times article claimed Paxlovid could save tens of thousands of lives. Let us review the data.
Pfizer’s first Paxlovid study reported a 6% reduction in serious illness (defined as hospitalization or death) among high-risk people with COVID. On this basis Paxlovid became the first pill approved for non-hospitalized people with COVID. But the study had a quirk: only people never vaccinated and never exposed to COVID were allowed to participate.
That group no longer exists. Earthlings have now pretty much all been exposed to COVID or vaccinated against it, which changes how they respond to the virus and how well drugs work. Of keen interest then was Pfizer’s next study, testing the drug in present-day earthlings. But the drug failed so resoundingly the company halted the trial midstream, for futility. That is grand failure since company-run trials are designed (and sometimes brazenly rigged) to muster even tiny benefits.
Pfizer claims Paxlovid worked in the first study because participants were ‘high-risk’ based on factors like obesity and hypertension. But FDA documents show1 the second trial enrolled the same high risk participants as the first—except vaccinated or previously exposed. Therefore Paxlovid does not work, at least not on this planet.
But NY Times journalists, like most people (doctors included), do not know about this second trial, because Pfizer never published it. Details are thin and available only on industry websites and a government registry, and no report of it can be found in any medical journal.
Unaware of this second randomized trial, the NY Times therefore resorted to quoting retrospective studies of Paxlovid. But randomized trials are the gold standard. Retrospective studies, which look back at people who took Paxlovid or didn’t, are irrelevant once trials are available. One reason is healthy user bias, in which people prescribed a new drug are often healthier, wealthier, with better access to care than those who were not. Thus retrospective studies of Paxlovid don’t show people get healthier because of the drug, they show people get the drug because they’re healthier. Pfizer’s secret trial proves it: When the drug was assigned randomly, rather than prescribed based on money and access, outcomes were the same among those who took the drug as those who took a placebo.
Worse yet, the drug isn’t just ineffective, it’s harmful. In a recent study over 20% of those who took Paxlovid experienced virologic rebound, a second illness after recovering. Among those who didn’t take Paxlovid the rate was 2%. Other studies confirm this finding.
A third Paxlovid trial may shed more light, currently underway by the same researchers that retested Merck’s molnupiravir, the second approved COVID pill. Merck reported an eerily similar 7% benefit with molnupiravir, but their first trial also enrolled only unvaccinated people. When tested in present-day earthlings molnupiravir was also completely ineffective.
The real problem, of course, is not credulous reporters or uninformed doctors. It is laws that allow companies to hide data when results don’t favor their drug. Paxlovid also failed in trials for Long COVID, for preventing COVID, and for people hospitalized with COVID. Only the last was published, however, because the first two were paid for by Pfizer and remain unavailable to the public.
Research participants routinely sacrifice themselves by taking on the dangers of untested treatments. This is considered ethical only because of an implied compact between researcher and participant that society will benefit from the knowledge gained. But society doesn’t benefit when studies are hidden.
Given the option companies will always do what maximizes profits. In this respect they are neither ethical nor unethical, just rational actors following a different code. Which is why Pfizer is selling snake oil for the plague of the century, and secretly hiding the proof it doesn’t work.
*See page 15 of the link, final paragraph. Vaccinated participants were enrolled only if they were “high risk”. Then again on page 16, 2nd paragraph, “59% were fully vaccinated high-risk subjects.” Also keep in mind the remaining 41% of subjects would have had previous illness or exposure, which many studies including this one find offers protection as effective as being vaccinated. This means the only remaining group Pfizer could conceivably claim Paxlovid might hypothetically work for would be those who are unvaccinated and never had COVID, and also have ‘high-risk’ characteristics.