That, bluntly, in other than very high risk people its worthless (but of course expensive):
Among the 1288 participants who received at least one dose of nirmatrelvir–ritonavir or placebo and had at least one postbaseline visit, the median time to sustained alleviation of all targeted Covid-19 signs or symptoms through day 28 was 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group, a difference that was not significant (P=0.60) (Table 2). Similar results were observed in the high-risk subgroup (i.e., participants who had been vaccinated and had at least one risk factor for severe illness) and in the standard-risk subgroup (i.e., those who had no risk factors for severe illness and had never been vaccinated or had not been vaccinated within the previous 12 months).
It had zero impact statistically on the time to alleviation of symptoms. The drug was bought and did not work.
However:
In a planned subgroup analysis involving high-risk participants, hospitalization or death occurred in 3 (0.9%) in the nirmaltrelvir–ritonavir group and 7 (2.2%) in the placebo group (difference, −1.3 percentage points; 95% CI, −3.3 to 0.7).
Problem: There was only one death in total so the difference here begs the obvious question on matching of morbidities and such in the trial arms. How well was that done, given that they did find among the high-risk people a difference in hospitalization and ICU admittance? It is not logical for these results to occur when the improvement time did not vary between the high risk and not-high-risk groups.
However, it is what it is.
But the real punchline is this:
From August 25, 2021, to July 25, 2022, a total of 1296 participants underwent randomization and were included in the full analysis population (Figure 1), and 1288 received at least one dose of nirmatrelvir–ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit.
In other words before full approval by roughly a year the study outcome was known but hidden and not published. As you probably recall you've seen "If Covid, Paxlovid" commercials yet the study says it won't help you get better faster. Of course the government was paying for it and had been since late 2021 but again, within just a few months it was known that it didn't work and yet this was concealed.
In fact the FDA had no evidence when they made this statement:
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
And yet just a few months later the company had in its hands evidence that there was no statistical improvement in recovery time between using it and not, yet that study was not published, the FDA was (apparently) not notified and no statement correcting the record was made by anyone.
Now here we are in 2024 and the data comes out -- after being hidden for nearly two years.
This is the world we live in folks -- plenty of money to be made and yet what you're sold doesn't have to work and nobody has a duty to tell anyone as soon as they know, via a formal study, that it doesn't. In fact the FDA went on to give full approval nearly one year after these study results were known.
Should we expect anything different given what we know happened with Remdesivir where the government continued to pay for it and hospitals continued to push it on patients even after a huge multinational study was completed and published showing it was worthless -- and using it came with the significant risk of destroying your kidney function.
I guess not.
Oh by the way, marketing something as effective when you know that it is statistically worthless is fraud. It is like selling "brake pads" that you know do not stop a car. If the law meant anything the entirety of the firm's Board of Directors and all their officers would be under indictment since the money stolen from both the government and patients is in the billions.
PS: Have you noticed anything interesting? When did "new variants" stop showing up and getting all manner of press?
WHEN PEOPLE STOPPED TAKING MORE SHOTS.