Scott Alexander asks a rather pointed question: when will the FDA approve Paxlovid?
Metaculus predicts January 1 as the median date for the FDA approving Paxlovid. They estimate a 92% chance it will get approved by March.
For context: a recent study by Pfizer, the pharma company backing the drug, found Paxlovid decreased hospitalizations and deaths from COVID by a factor of ten, with no detectable side effects. It was so good that Pfizer, “in consultation with†the FDA, stopped the trial early because it would be unethical to continue denying Paxlovid to the control group. And on November 16, Pfizer officially submitted an approval request to the FDA, which the FDA is still considering.
As many people including Zvi, Alex, and Kelsey have noted, it’s pretty weird that the FDA agrees Paxlovid is so great that it’s unethical to study it further because it would be unconscionable to design a study with a no-Paxlovid control group – but also, the FDA has not approved Paxlovid, it remains illegal, and nobody is allowed to use it.
One would hope this is because the FDA plans to approve Paxlovid immediately. But the prediction market expects it to take six weeks – during which time we expect about 50,000 more Americans to die of COVID.
Perhaps there’s not enough evidence for the FDA to be sure Paxlovid works yet? But then why did they agree to stop the trial that was gathering the evidence? Or perhaps there’s enough evidence, but it takes a long time to process it? But then how come the prediction markets are already 90% sure what decision they’ll make?
I think there’s an obvious answer to the first question: it’s Parkinson’s Law at work. To refresh your memory back in 1955 naval historian C. Northcote Parkinson earned his place in public administration and management history when he published his famous law: in a bureaucracy work expands to fill the time allotted to it. The FDA is a bureaucracy. QED.
I heard one holdup was Pfizer’s trial consisted of only high-risk non-vaccinated patients.
Which is a problem for who should get the drug since 70-80% of the adult population and about 30-40% of deaths are those who have been vaccinated.
Another criticism of the FDA is they continue to not insist on rigorous data collection / trials after EUA approval. Just look at the vaccines — why was it the Israelis was the source of data that boosters were needed/recommended, and not from the original US vaccine trials last year?
Don’t forget rapid testing; propublica had an excruciating article about FDA delays in approving them. They are a prerequisite to taking the pill (since the trial consisted of people who took the pill within 3 days of symptoms).