If Pfizer's COVID wonder drug is so effective, why hasn't the FDA approved it yet?

AP Photo/Virginia Mayo

Another good one from Scott Alexander of Astral Codex Ten, who made the case last week that ivermectin looks effective against COVID in some studies because because those studies were conducted in places where parasites are a major health problem. Ivermectin’s not stopping the virus, he theorized, it’s stopping roundworms from interfering with people’s natural immune response to a COVID infection.

His analysis in his latest post is much simpler. If it’s true that Pfizer has a miracle drug that’s 90 percent effective in preventing severe COVID; and if it’s also true that that drug performed so well in trials that the FDA supported ending those trials early; and if it’s further true that America is facing another killer wave of COVID this winter per the frightening surge of cases Europe is experiencing; then … why the hell hasn’t the FDA already authorized Pfizer’s drug, Paxlovid, for emergency use?

How can the drug be so effective that Pfizer doesn’t need to finish its trial but also not so effective that the FDA won’t grant an EUA immediately?

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?

It wasn’t Pfizer’s scientists alone who chose to end the Paxlovid trials early due to the amazing results they were seeing. Per the company, notes Alexander, those decisions were made “in consultation with” the FDA. The agency itself was impressed enough with the partial data to find it conclusive. So what’s the hold-up?

Michigan is already at near-record levels of hospitalizations and it’s not even December yet. Time is of the essence in making this drug available. The feds already dragged their feet inexcusably once before this fall when they squabbled internally over who should be eligible for booster shots. Remember that? For weeks and weeks, the FDA and CDC and their outside advisors tried to feel their way towards some middle ground in which boosters would be available for the specially vulnerable (e.g., senior citizens) but not available to everyone. The data didn’t support the need — yet — and besides, it would look awful to have healthy Americans lining up for third doses when people in some third-world countries had yet to get their first. So only those with underlying health problems or special health risks due to their jobs were initially eligible.

Then, quietly, last week they opened up boosters to everyone. Potentially there are Americans who would have gotten a third dose weeks ago if they had been eligible sooner, won’t be able to find the time now in the rush before Thanksgiving travel, and will end up getting infected during the holiday and landing in the hospital next month. All because the feds were much slower to move on boosters than Israel was.

Approving Paxlovid quickly so that it’s available next month would help make amends for that. The only reason not to do so immediately, it seems to me, is because they worry that the drug might have some as-yet-unknown side effect. But Pfizer’s trials showed no side effects and the FDA will be relying on Pfizer’s data during the approval process, so what further data are they waiting on? If unknown side effects are a fear, they could always offer the drug to people with a caution that it’s brand new and that they should proceed with it at their own risk. Plenty of Americans infected by COVID will take their chances with the pill despite that warning, trusting that a well-known company that produced an ace vaccine wouldn’t cut safety corners on its new therapeutic.

“Plenty” doesn’t mean “all,” of course:

23% hadn’t heard about the pill at all, and half had heard of it but said they didn’t know much about it.

When the unvaccinated were asked whether they’d rather get a shot to prevent the virus, or wait to catch the virus and then take an approved pill to treat it, the pill drew a slight edge (17% versus 12%) and 15% had no preference, while a majority — 53% — said they’d prefer to take neither.

The ivermectin crowd might be sticking with ivermectin even after Pfizer’s wonder drug is available. It should be a priority for Biden’s administration to raise public awareness about Pfizer’s and Merck’s new pills, though, as that 23 percent figure is alarming. The drugs need to be taken soon after symptoms emerge in order to be effective and someone who’s never heard of them obviously isn’t going to rush out looking for them after they wake up with a fever. Which is a problem:

Consider one likely scenario. On Monday, a man feels tired but thinks little of it. On Tuesday, he wakes up with a headache and, in the afternoon, develops a fever. He schedules a covid test for the following morning. Two days later, he receives an e-mail informing him that he has tested positive. By now, it’s Friday afternoon. He calls his doctor’s office; someone picks up and asks the on-call physician to write a prescription. The man rushes to the pharmacy to get the drug within the five-day symptom-to-pill window. Envision how the week might have unfolded for someone who’s uninsured, elderly, isolated, homeless, or food insecure, or who doesn’t speak English. Taking full advantage of the new drugs will require vigilance, energy, and access.

Currently there’s no access thanks to the FDA and not much energy to promote the pills by the wider federal government. Why not?

I’ll leave you with this new data from YouGov, previewing the ugly pandemic months to come. As I say, time is of the essence in rolling out Pfizer’s drug. Exit quotation: “Caution and concern around Thanksgiving also is greater among people who have gotten doses of a vaccine intended to protect them from infection and serious illness… [T]he people who reject vaccines generally are less concerned than vaccinated Americans about the possibility that they might personally contract COVID-19.”