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Paxlovid, the five-day wonder

But what happens on day six?

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Y Rabinovitz

Y Rabinovitz

Y Rabinovitz

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June 03, 2022

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04:55 AM

Paxlovid, the five-day wonder

Over 660,000 courses of Pfizer’s latest bonanza drug, Paxlovid, have been administered so far in the United States alone, with almost 200,000 in the last few weeks. Pfizer earned $1.5 billion from Paxlovid in the first quarter of 2022 and has great expectations for the drug’s future; CEO Albert Bourla said just a few days ago that he believes antiviral drugs will replace vaccines as the first-line defense against severe COVID and added that his company is “doubling down” on production.

But does Paxlovid work?

The first answer to that question is: yes, it does. It apparently does have some anti-viral activity and can help people recover without becoming seriously ill.

The second answer is: yes, but… not for long. (In other words: no.)

More and more reports are coming in of a phenomenon common enough to have been named: COVID rebound. Paxlovid is a drug designed to be administered over five treatment days. People experiencing rebound say that their symptoms returned almost immediately after concluding treatment, and when they took a COVID test it came back positive. The CDC has now issued emergency guidance on the rebound phenomenon.

Official CDC Health Advisory on COVID-19 Rebound After Paxlovid Treatment

... to update healthcare providers, public health departments, and the public on the potential of recurrence of COVID-19 or “COVID-19 rebound.”

... rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative...

Pfizer claims just one to two percent of those treated experience rebound and have admitted that it occurred during the drug’s clinical trials. Rebound after treatment was even described in Pfizer’s submission to the FDA when seeking approval in December of 2021; interestingly, it was omitted from Pfizer’s New England Journal of Medicine paper, and therefore, the general public had no way of learning of it.

In an interview conducted on May 3, Bourla appeared to blame those experiencing rebound for not being strong enough to complete the job his drug started:

Paxlovid does what it has to do: it reduces the viral load. Then your body is supposed to do the job. [If it doesn’t] then you give a second course, like you do with antibiotics, and that’s it.

A day later, the FDA issued a response of sorts, noting that “there is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.

“There is no evidence of benefit at this time for a longer course of treatment,” said FDA Office of Infections Diseases Director John Farley, “or for repeating a treatment course of Paxlovid.”

However, not to worry, Dr. Fauci may be coming to the rescue. Several weeks ago he announced that the National Institutes of Health are already in discussion with Pfizer regarding conducting trials for longer courses of Paxlovid – to prevent rebound.

Indeed, the rebound phenomenon is garnering an inordinate amount of media attention considering that officially, it only affects one to two percent of people who take the drug. Anecdotal reports, however, indicate that rebound is far more widespread than that, and a closer study of the Pfizer trial results suggests that the one to two percent cited is a cunning manipulation of the numbers.

Twelve people in the trials were documented as experiencing rebound, apparently out of the 1,120 people in the study cohort (those who took Paxlovid rather than a placebo). But only 97 people had their virus levels tested subsequently by PCR. Twelve out of these 97 gives a rate of 12.3 percent. Based on informal polls, the figure is probably far higher, even approaching 30 percent or more.

Why might this be happening?

Aside from Bourla’s “explanation,” Yale University immunologist Akiko Iwasaki suggested a reason. “If you start treating the patients very early during the infection, they may not generate much of an immune response to the virus,” she said, because Paxlovid shuts down production of viral proteins, the very proteins that the immune system responds to.

But there are other possible explanations. How many of those experiencing rebound are vaccinated against COVID? You might think that’s an irrelevant question; after all, the drug was already tested in clinical trials and presumably the effect of vaccination was controlled for or at least studied.

It’s not irrelevant, though, because Paxlovid has never been tested on vaccinated people. Correction: Pfizer has never released any trial results for the effects of Paxlovid on vaccinated people. Has the FDA asked Pfizer to correct this seeming oversight? Apparently not.

Vaccinated people were excluded from Pfizer’s initial Paxlovid trials. In December, Pfizer announced that it was enrolling participants in a follow-up study for people not considered at high-risk of developing severe COVID. A few months later, they quietly altered the eligibility criteria for trial participants, barring anyone who had received a COVID shot in the prior 12 months.

Are vaccinated people more likely to “rebound” into COVID infection?

Or, more pointedly, are vaccinated people more likely not to respond to Paxlovid at all?

On June 1, 2022, researchers from the Israeli Clalit Health Fund, the largest health insurer in Israel, published extremely worrying data related to Paxlovid's efficacy. For those over the age of 65, they found, Paxlovid reduced hospitalization by 67 percent and COVID-related mortality by 81 percent, significant figures though not quite as impressive as the numbers Pfizer presented to the FDA and the general public. However, for those between the ages of 40 and 64, the reduction in hospitalization rates was just 22 percent, and COVID-related mortality rates actually increased, by 64 percent.

The researchers also divided the data according to “immunity” status. Unfortunately, their categories are somewhat blurry, given that they defined “immune” as two or more shots, or prior COVID infection, or both. Those presumed not to be immune were people with one or no shots and no documented prior infection. (All the same, it is certainly refreshing to see authorities recognizing natural immunity as equivalent to vaccine-induced.)

Analyzed this way, Paxlovid still appeared beneficial for those over the age of 65, but for those “with prior immunity,” the reduction in hospitalization rates dropped to just 60 percent.  (Those without immunity saw a 86 percent drop.)

For those between 40 and 64, however, people with prior immunity were 18 percent more likely to be hospitalized if they took Paxlovid, as opposed to 79 percent less likely if they were “immune.”

Could this be why Pfizer chose to confine their clinical trials to the unvaccinated?

But even for vaccine-naïve trial participants, the presentation of the results provokes a good deal of skepticism. The “fact” that Paxlovid reduces the risk of hospitalization or death by 89 percent compared with placebo was all most people noticed in the media’s portrayal of this drug. How did Pfizer come up with that stunning figure?

There were just over 2,000 people enrolled in the trial, 1,120 in the treatment cohort and 1,126 in the placebo cohort. 6.5 percent of people who were given a placebo experienced severe COVID or death as opposed to 0.7 percent who were given Paxlovid. For some unstated reason, these results only refer to those people whose course of Paxlovid began within three days of displaying symptoms, even though people were included in the trial if they commenced treatment up to and including the fifth day.

So Pfizer moved the goalposts during the trial. Did the FDA ask why? Apparently not.

People taking Paxlovid have complained about a terrible taste in the mouth throughout the entire period of taking the drug. Pfizer claims that less than 10 percent of people experience this; anecdotal evidence suggests that the phenomenon is common enough to be described as almost universal.

Why does this matter? It matters because it essentially unblinds the study. Did Pfizer somehow craft a placebo that mimics this effect? Presumably not, or they would have told us about it.

And then there’s the question of the big O - Omicron. Paxlovid was trialed between July and December, 2021, when Delta was the prevailing variant. No longer – but is Paxlovid effective against Omicron (and its subvariants)?

“It is also expected to be effective against the Omicron variant,” says the FDA’s John Farley (italics added). But does he know? No more than anyone else, it seems.

Lots of questions, no answers. Meanwhile, doctors continue to prescribe Paxlovid, generating ever more profits for one of the most successful companies in the world. And lo and behold, Paxlovid is now being touted for the treatment of another illness: Long COVID!

A Reuters article from April 18, 2022, describes reports of two patients who supposedly experienced relief from long COVID after taking Paxlovid. Neither of them should have had access to Paxlovid in the first place based on the timing of their symptoms, but never mind that.

Long COVID is a curious diagnosis for a disease that has yet to be proven to exist. According to Reuters, “More than 200 symptoms have been associated with the condition ... estimated to affect up to 30 percent of people infected with the coronavirus.”

“Drug companies tend to discount single-patient case studies,” Reuters continues – and well they might, especially as they discount even multi-patient case studies when the drug concerned isn’t one that might prove lucrative. But according to one Dr. Steven Deeks, a professor of medicine at the University of California (UCSF), these two cases “provide really strong evidence that we need to be studying antiviral therapy in this context.”

What’s more, Reuters also informs that Pfizer has two large clinical trials underway to investigate whether Paxlovid can prevent initial COVID infection. No details forthcoming on how people would know when to start taking this new prophylactic – or should they just take a daily dose?

The idea of using Paxlovid – a combination of two powerful drugs – as a prophylactic is quite bizarre. Paxlovid is made up of nirmatrelvir and ritonavir, one new drug and one older one. Ritonavir is what’s known as a “booster,” because it inhibits the activity of liver enzymes. Pfizer paired it with its new anti-viral drug, nirmatrelvir, because the ritonavir stops the body from clearing the anti-viral too soon and thus “boosts” its effect. But ritonavir is a nasty drug with a long, long list of side effects. Just glance below at what WebMD has to say about ritonavir – no need to read it all, but you get the picture:

 

WebMD also has an entry for Paxlovid, which, as we just noted, is a combination of this nasty, dangerous ritonavir, and Pfizer’s nirmatrelvir. Here it is:

If any Frontline News readers contact WebMD and ask for an explanation, please let us know what they reply.

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