Paxlovid's Moment of Truth

Imminent, or illusory? Also: More illustrations!

Continued from “Unfinished Business.”

Pfizer and the FDA both claim that the full data from the Paxlovid trial demonstrates no association between the drug and viral “rebound” (gee, if only there were some way for them to have “published” their own trial data when reporting the results in the first place!).

Also, new illustrations added to the original Official Unglossed explanation of the mechanism behind rebound.

Pfizer and the FDA have both entered “not guilty” pleas regarding the charge of causing viral rebound, and with an air of confidence that is impressive. They’ve also doubled down on pleading against counts that aren’t actually relevant to the crime, i.e. “resistance,” “mutants,” etc.

In Part 2 of “Unfinished Business,” I concluded that the FDA resistance-analysis-based “Rebound Chart” is fairly strong evidence, but not conclusive, that the drug is causing aberrant rates of viral rebound, regardless of whether the virus mutates.

Pfizer’s statements amount to a claim that my analysis was wrong. I don’t think they’re going to take this one to the bank, but on the other hand, it’s their paper-shredders between us and the real evidence.

• Pfizer Claim 1:

Rebound also occurred in the placebo group.

Claimed by company spokesman Kit Longley in a comment to the Washington Post published on April 27,¹ and then reinforced by an interview given by Pfizer executives and telegraphed by Bloomberg on May 3.²

For the record, I predicted this would prove false the moment it was first uttered by Longley. See “Updates to ‘Unfinished.’” So if it does turn out to be false, that would be quite a vindication for the prosecution (me). What “false” means is that the placebo group will not turn out to have PCR/viral-load results that match the standards I used to flag the 4 possible and 4 probable rebounds in the FDA chart:

For full analysis, see “Unfinished Business, Pt 2” My claim: No brown, and potentially no orange or pink “rebounders” exist in the corresponding PCR/viral-load data for the placebo group.

• Pfizer claim 2

“Patients Who Relapse After Covid Pill Can Repeat Treatment”

This nugget was also dropped in the executive interview transcribed by Bloomberg on May 3.³ No, rebounding patients cannot “repeat treatment,” because Pfizer was not issued an EUA for double-coursing Paxlovid, because their trial was not for double-coursing Paxlovid. I know: Weird, but true.

Perhaps the executives at Pfizer are all new at this whole “medicine” thing…?

Here, again, I staked the opposite claim beforehand, way back on April 23, in Part 3 of this series.

My instinct, voiced at the time, is that the best response to Paxlovid rebound is to “get it over with,” and embrace a shortened treatment course.

I am especially pessimistic that “restarting” the course after a return of symptoms can do anything but repeat the first experience, though maybe only in a certain percentage of cases. In fact, it may be just as well to shorten the course, to capture the benefit (against severe outcomes) of the “pause” but allow for a quicker arrival at post-rebound recovery.

• Pfizer claim 3

Patients who experience post-Paxlovid relapse are essentially experiencing innate immune failure.

Again, as relayed by Bloomberg:

“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.

Well… yeah. This is what I said from the start, in Part 1. Good job, Bourla. Bright future lies ahead for this guy, etc. However, even if the reasons are “unknown,” there are some reasonable “guesses” that can be made.

• FDA claim 1

Only “1-2%” of trial participants “had one or more positive SARS-CoV-2 PCR tests after testing negative, or an increase in the amount of SARS-CoV-2 detected by PCR, after completing their treatment course.”

This claim was issued by FDA Office of Diseases director John Farley on May 4.⁴ It is simply implausible.

For example, assuming that the 8 possible and probable rebounders in my analysis above represent all possible rebounders in the Paxlovid treatment group, this implies that they make up:

8/1039 = .7%, or “1% rounded to the nearest 1%,” of Paxlovid-receiving trial participants.

Despite the fact that these 8 are within a small, apparently random sample of 97 out of 1039 treatment-receiving participants. So either the remaining 942 only add another ~8 or so rebounders, or Farley is lumping the not-rebound-having placebo group in with his denominator. Observe the wiggle-room he leaves in his language, in this regard: Only “1-2%” of trial participants. Well, great, but tell us the rate you found in participants who received Paxlovid…

As with the claim that the placebo group has any true rebounders at all, I formally declare my doubt that Farley’s assertion of the rebound rate is accurate if limited to the Paxlovid group only.

So in almost every matter, I have placed my “bet” in opposition to the official line issued by Pfizer and the FDA. We’ll see how well my bets hold up in the coming days.

For a further critique of Farley’s statement, see Igor Chudov, who naturally retains credit for discovering the Paxlovid rebound trend in the first place.

FDA Dismisses Paxlovid Concerns, Gaslights Recurrence Sufferers

Harris

A certain obscure government employee has reportedly been back in the White House since Monday, following a positive antigen test which itself was followed by a course of Paxlovid. This particular official reported prompt elimination of symptoms and positive-antigen-testing. Today and tomorrow comprise the anecdotally common 10 day timing for post-Paxlovid rebound.

This may have interesting political consequences.

New Illustrations

Part 1 of “Unfinished Business” now features illustrations which hopefully help convey the math underlying my two models of Paxlovid “pause.” It’s not the animation marvel I would be able to offer if I had access to some of that “Veritasium Money,” but it hopefully helps make things more clear nonetheless:

Head on over to Part 1 to check out the new, updated version!

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1. Johnson, Carolyn. “Another rare virus puzzle: They got sick, got treated, got covid again.” (2022, April 27.) The Washington Post Democracy Dies in Darkness.

2. Langreth, Robert. “Pfizer Says Patients Who Relapse After Covid Pill Can Repeat Treatment.” (2022, May 3.) Bloomberg.

3. (Langreth, Robert.)

4. https://www.fda.gov/drugs/news-events-human-drugs/fda-updates-paxlovid-health-care-providers