Paxlovid doesn't help long COVID; The Biden Administration Gave Pfizer 10 billion dollars for a bad drug
Out Friday night in JAMA IM, a randomized trial of Paxlovid (Nirmatrelvir-Ritonavir) in people with long COVID reported results and it is totally negative. Let’s recap Paxlovid, and discuss the new study.
A brief history of Paxlovid.
Without ANY randomized data in vaccinated American, the Biden administration initially bought 5 billion dollars of Paxlovid (it is now 10 bi +). This was based on a study in unvaccinated high risk individuals who did not previously have COVID, which, at the time, had little resemblance to America at the time.
Then, many experts— including all of those in the Biden administration (Walensky, Califf, and Jha)— pushed Paxlovid in people in whom the trial data did not apply— vaccinated Americans. We wrote about this for City Journal and called it a gamble.
The gamble has largely failed. EPIC -SR the largest randomized trial in vaccinated people was published, after lengthy delay, and is totally negative.
Now there is a new study asking in Paxlovid can help people who already have long COVID. It is a small 177 person RCT from Stanford. Before I walk through the paper, remember this tweet by Dr. Califf— FDA commish. Ironically, if Pfizer had tweeted it, the FDA could fine them for illegal promotion.
This is a 2:1 RCT (PS this design is suboptimal and sacrifices power). It randomizes long COVID sufferers to Paxlovid or placebo-Ritonavir. The study is mostly women, and nearly no Blacks.
Placebo-ritonavir is a bad control arm, which I discuss in a prior video. Pfizer should have made an active placebo: a sugar pill with aftertaste, and not used 100mg Ritonavir, which is actually a harmful product when taken by someone who doesn’t need it. Evidence of that is AEs on control arm (check it out).
Now, here is the main result. On the left is Paxlovid, right is placebo/Ritonavir. Darker colors are bad, and the X axis is time. You see that Fatigue, Brain fog and body aches are most common, and they get better over time, but Paxlovid is no better than placebo
Paxlovid fails in long covid is the take away.
The discussion however might be one of the worst I have read. It is full of speculation. Some examples.
“It is important to underscore that this study alone does not rule out NMV/r as a potential therapy for PASC.”
Sure, no study does, but this provides no reason to be excited, and is totally negative.
They add “PASC is likely not a single entity, and therefore, treatment will likely differ among PASC subtypes”
Really? Now you are inventing subtypes? I missed the memo where you proved there are subtypes. How did you validate that?
Check this out: “We found that many participants with PASC in the PBO/r group improved over time, as did a control group in another trial in PASC. Therefore, an effective intervention needs to substantially accelerate that process to see a meaningful difference.”
OOOOH you don’t say. If you have a condition that people improve naturally over time, an intervention has to accelerate that to see a difference! WOW, WHO KNEW! Usain Bolt gains speed when he runs, so to see an improvement over him, I have to accelerate faster! What an insight!
This is also inappropriate: “This randomized clinical trial demonstrated the overall safety…”. How exactly did you demonstrate safety. It didn’t work and you had adverse events. Are you happy it didn’t kill people?
Paxlovid failed to improve long covid symptoms even when tested against a harmful product (ritonavir) and not a true active placebo. It failed to improve outcomes in vaccinated people. The ongoing PANORAMIC study is massive— and if it were overwhelmingly positive it would have resulted by now— but investigators have said nothing. If it is negative (or the ARR is trivial), it will mean that the Biden administration made a 10 billion dollar mistake.
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