FDA vs. Astra-Zeneca; bureaucracy vs. evolution and exponential growth

By John Cochrane.

"From Alex Tabarrok at Marginal Revolution, quoting Marty Makary, M.D., a professor of surgery and health policy at the Johns Hopkins University School of Medicine:

... the FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine.  It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute. It does not require freezing and is already approved and being administered in the United Kingdom.

Sadly, the FDA is months away from authorizing this vaccine because FDA career staff members insisted on another clinical trial to be completed and are punishing the company for inadvertently giving a half-dose of the vaccine to some people in the trial.

It’s like the FDA is holding out, pontificating existing excellent data and being vindictive against a company for making a mistake while thousands of Americans die each day...

My emphasis. Alex:

See also my post The AstraZeneca Factory in Baltimore. Thousands of people are dying every day. We have a vaccine factory ready to go. The FDA should lifts its ban on the AstraZeneca vaccine.

Alex understates the case. It is not just that "thousands of people are dying every day." It is that we are in the phase of exponential growth, and a new more infectious variant has just arrived bumping up the growth rate further. Every hour of delay means tens of thousands more will die.  

We are in a fight of bureaucracy vs. exponential growth and evolution. Exponential growth and evolution are winning. Just how many thousands have to be on the left side of the trolley switch before the FDA stops allowing Astra-Zeneca to pull it? What's the risk aversion coefficient that justifies months of delay and another clinical trial?  

More deeply, can the FDA ever figure out that the point here is to stop a pandemic? The mentality is traditional: we must provide a perfect vaccine to protect individuals, taking the disease as given, and people who die while we do more studies are worth the cost. That is simply not what's going on right now. The point of the vaccine is to stop a pandemic. The disease is growing exponentially, and mutating and evolving. The externality is everything. I know, it's awfully hard for bureaucracies to innovate and change mindset. Well, sometimes you have to.  

For years the FDA was focused on, don't repeat thalidomide. Drugs must be safe. AIDS forced a hard reckoning. The people who are dying while you wait matter. But this is a third, even harder conceptual change. Stopping the spread of the disease matters. And the FDA does not have the years it took to make the AIDS change of mindset. 

Alex, by the way, gets the award for most influential economist of the year. It looks like his campaign for first doses is going to be Biden Administration policy. Well done Alex! 

But it turns out vaccine supply is not even the short run constraint, it is unbelievably snafued rationing rules. Virginia Postrel, summarizing many stories you've heard: 

When the federal government turned state agencies into the country’s vaccine distributors, it bypassed the usual supply chains. Doctors and hospitals couldn’t get Covid-19 vaccines the way they order other inoculations.

Distribution also became politicized in ways that slow down vaccination. Every shot comes with a ton of paperwork, and the rationing rules are hard to understand. Who exactly qualifies as a health-care worker or an essential employee? Is it OK for hospitals to give shots to janitors or billing clerks?

n Minnesota hospitals, one doctor who asked to remain anonymous noted in an interview, “there was a lot of focus on scheduling appointments and dividing up by departments to be sure they were fair” even if that meant delaying vaccines and potentially letting some supplies go to waste. It’s a widespread problem.

As he threatens fines for hospitals that don’t use all their vaccines, New York Governor Andrew Cuomo also signed an executive order requiring providers to certify that every recipient qualifies under the current rationing protocol. Letting someone jump the queue now risks a $1 million fine and the loss of a state license. “If you wanted to make sure that rapidly expiring vaccines distributed in 10-dose vials end up in the trash, this is how you'd do it,” observed commentator Mason Hartman on Twitter.

Micromanagement is impeding the rollout. In South Carolina, for instance, a medical assistant often gives injections in a doctor’s office, and the job requires no special certification. For Covid-19 vaccines, however, the state says that even someone with decades of experience can’t administer a shot unless they have an official credential.

In Europe it is common to give yourself a shot, without a covid-risky trip to a doctor's office, stating in line, filling out paperwork and taking up half an hour of time of a highly trained person. I found this out one day many years ago, with a case of bronchitis. The pharmacist just handed me the shot and said go home, take this. It's not hard, folks. Amazon could just send it to you. Imperfect? Yes. Will there be problems? Yes. Will we beat evolution and exponential growth and save tens of thousands? Yes. 

Distribution is hard enough without these roadblocks. Start with the numbers. At Kaiser Permanente facilities, a single vaccinator can give about 10 shots an hour, with much of the time spent filling out forms. To get to herd immunity, the U.S. needs to inject two doses several weeks apart to something like 240 million people. At 10 injections an hour, that’s 48 million hours of vaccinators’ time, 4.8 million hours a week over 10 weeks to get to early March. We’d need 120,000 vaccinators working 40-hour weeks. ...

10 shots an hour is very efficient. Other numbers I've heard go up to .5-1 person-hours per shot, including the paperwork and monitoring afterwards. The 1 hour per shot comes from nursing homes. 

This is basic math. We are supposed to revere the "scientists" at FDA and CDC. Did anyone add up 240 million people (more likely 300, per Dr. Fauci), estimate person-hours per shot with all the restrictions, and figure out when the shots will be given? 

The last thing we need in these circumstances are special restrictions on who can administer vaccines — restrictions that send the perverse message that vaccines against this disease are somehow more questionable than those against the flu or measles.

A correspondent reports:

I actually got the Moderna vaccine first dose yesterday. In a lot of US, including where I live, only certain healthcare workers are eligible for appointments so far. The limited size of the cohort and the fact a lot of healthcare workers don’t want it after actually having the virus, means appointments are being missed and vaccines wasted. I simply queued for an hour in a standby line last night at my local Safeway pharmacy. They had 8 vaccines reaching expiry if unused, and I was no. 6 in queue. I would have given up my slot for an elderly couple behind me, but there was enough for them too and those that missed out were all early 20s. Mad, Soviet-like system (queuing literally in the frozen meat section of the store for an hour or so), limited eligibility and queueing and I felt kinda dirty getting it, but I’ll be damned if I’m going to pass it up when it will be otherwise wasted.

Note this is a state where Safeway pharmacies are allowed to give it, and Gov. Cuomo will not fine then $10 million for letting my friend skip the line 

In the U.K. I’m hearing even more insane stories. Only paying general practitioners cost price on delivery of the second dose, so some not bothering to offer it. And paying doctors nearly half the hourly rate they could obtain doing locum work. Penny wise and pound foolish. Literally: the U.K. currently has an incredibly expensive furlough scheme. 

I am often asked, "what can the government do to solve x problem?" My stock answer is, get out of the way. It's not always right, but it's often a good start. 

Update: From Jennifer Smith reporting in WSJ

Instead of seeking to halt the spread of transmission in communities, said Dr. Swann, who advised the CDC during the H1N1 pandemic, the focus has been on reducing mortality, especially among high-risk populations.

Reducing short-run mortality. When you halt the "spread of transmission" you reduce long-run mortality a lot more. Get on top of exponential growth, please. A lovely encapsulation of the mentality. Grumpy just spilled his coffee again."