If you are in charge of White House's COVID policy, you need to know the difference between bad science and good science

Jha & others push a flawed a study: haste, ignorance, or malice?

Paxlovid works in high risk individuals* who are unvaccinated. There are randomized data and it is persuasive. But does paxlovid improve outcomes in healthy vaccinated people? And if, so, does it work in a 35 year old or merely those older than 65?

We have no idea because the US Federal Government decided to subsidize Pfizer to the tune of 5+ billion dollars without generating these data. Then it aggressively encouraged prescribing. It empowered pharmacists to prescribe the drug. This ensured rampant use outside of the proven benefit. It was a medical and regulatory gamble, as Todd Lee and I wrote.

We still don’t know the answer, but we will someday. The UK has launched PANORAMIC. If PANORAMIC is negative in vaccinated people (or even just people <65) it will be decimating. It will mean the US Government enriched Pfizer without demanding credible data, and squandered taxpayer money. It will lead to books about the failure, and perhaps even investigations of discussions between Pfizer and government officials that led to such an enormous waste of money.

As such, a lot is on the line that Paxlovid works in vaccinated people.

Enter a new website. I can’t call it a study, it is just a website. It is an analysis done by a website. This morning Ashish Jha the White House COVID czar saw this analysis and declared ‘mission accomplished’.

Ashish K. Jha, MD, MPH @AshishKJha46

Analysis @michaelzlin highlights pretty compelling stuff Done using electronic health records of hundreds of thousands of folks with COVID They find: For folks over 50 No matter your vaccine status Paxlovid reduces risk of hospitalizations and deaths epicresearch.org/articles/paxlo…

Michael Lin, MD PhD 🧬 @michaelzlin

Finally the data we've been waiting for: Paxlovid efficacy in preventing hospitalization in vaxxed patients Fairly consistent ~60% relative benefit across groups Findings nicely split by age and into 2x vaxxed vs 3x vaxxed so we can see absolute risks https://t.co/3gzFbBXx6R https://t.co/HFMZfM5hLC

His thoughts were echoed by his former Brown colleagues.

But they are all amplifying garbage.

The analysis is *unadjusted* both for confounding variables— i.e. people eligible for paxlovid who didn’t get it might be poorer or more disadvantaged than those who do, but also immortal time. If you get sick and die quickly, you could not by definition get paxlovid. The analysis makes no attempt to correct for these. It is literally raw data, of which no causal conclusion can be drawn.

That is literally the first thing it says on the webpage.

Of course, most of us saw the problems immediately

Vinay Prasad MD MPH @VPrasadMDMPH

"In an unadjusted analysis" = "compelling stuff" Really? Step 1:. Give Albert Bourla 5++ billion without a randomized trial Step 2: Highlight an analysis that would not even qualify for a high school science fair.

Ashish K. Jha, MD, MPH @AshishKJha46

Analysis @michaelzlin highlights pretty compelling stuff Done using electronic health records of hundreds of thousands of folks with COVID They find: For folks over 50 No matter your vaccine status Paxlovid reduces risk of hospitalizations and deaths https://t.co/7xJdeIK7xQ https://t.co/VhI8lhzSyl

Alasdair Munro @apsmunro

@VPrasadMDMPH IMAGINE submitting this to a journal 👇 I cannot tweet about this anymore I need to cool off

Walid Gellad, MD MPH @walidgellad

@celinegounder This study says nothing about what paxlovid does. It is purely descriptive and should not be disseminated like this as implying anything causal. It's really important we get the issue right of what impact paxlovid has in vaccinated people. This tells you nothing unfortunately.

Why did Ashish Jha amplify this study? First, he has a lot at stake. If PANORAMIC is negative there will be books written about his leadership failure. The USA could have demanded Pfizer run the RCT, but did not. This is a huge failure of drug regulation.

There are three possibilities

Haste— he is busy and did not have time to read. My rule is never to tweet a paper I didn’t read in full, and I would advise him the same.

Ignorance— he doesn’t know this analysis is garbage. If that is true, he should resign.

Malace— he knows it is bad, but doesn’t care. It makes his point. If this is true, he should also resign.

Motivated reasoning can be a powerful thing. It is clear this is his preferred outcome, but only PANORAMIC will adjudicate.

Lots of scientists have taken off their critical thinking cap and put on their support Biden administration hat. That isn’t science but naked politics. I am a life-long liberal, but I take my science hat off for no one.

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*What does high risk mean

Have to be unvaccinated and have at least 1 of these.