Pfizer and Merck have developed antiviral drugs that treat people infected with COVID. Pfizer’s drug, in clinical trials, prevented 89% of hospitalizations or deaths. This is a drug that could neuter COVID by making it far, far less lethal.
But Pfizer’s drug and Merck’s drug are both illegal to prescribe, buy, or sell. That’s because the federal Food and Drug Administration, as a practice, outlaws all new drugs, even after their clinical trials show safety and efficacy, and even if there is zero evidence of serious negative side effects, until the FDA can get around, in its occasional meetings, to approving it.
There’s nothing wrong with the FDA reviewing the clinical trials of drugmakers — that’s a good idea. But when a lifesaving drug is available during a pandemic that is deemed extreme enough to drastically suspend all sorts of civil liberties, the FDA’s process is clearly costing lives.
With the Pfizer drug, there’s an added detail that makes it even more maddening.
“The effect of the Pfizer drug,” the Washington Post reported, “was found to be so strong midway through the study that an independent committee monitoring the clinical trial recommended it be stopped early.”
That is to say, independent auditors saw that the drug’s positive effects on infected people were so clear that it was inhumane to continue giving the placebo to half of the trial participants.
So let me get this straight..it was deemed unethical not to make the Pfizer's drug available to participants in the placebo group.. But FDA continues to ban it and everyone is OK with that? Where are the protesters in the streets? Over 1,000 people are dying every day from CV-19! pic.twitter.com/ZM1yz15F4N— Dan Elton (@moreisdifferent) November 9, 2021
So what should we think of the FDA keeping the drug, called Paxlovid, out of the hands of the infected? The FDA’s advisory committee won’t meet to approve the Merck drug until after Thanksgiving, according to the FDA’s website. The meeting is an entirely virtual one, so this isn’t a matter of getting all the advisory committee members into one place. It’s just a matter of scheduling. The earliest we could get Paxlovid into doctors’ offices or pharmacies is mid-December.
It would be different if we had reason to believe Paxlovid would kill people in large numbers. But nobody has contended that. There are concerns about the Merck drug’s safety, but those are long-term concerns that probably won’t stop the FDA from approving it for emergency use in 20 days.
So, set Merck aside for now and consider Pfizer’s Paxlovid. In the past 30 days, more than 37,000 people died of COVID in the United States, according to the CDC. Over the next 35 days, Paxlovid could prevent tens of thousands of avoidable deaths. But instead, the FDA won’t immediately let Pfizer sell a drug it knows to be lifesaving.
This isn’t the behavior of a government set on maximizing public health. This is a bureaucracy religiously devoted to its own tedious rules to the point of defeating its own purpose for existence.