My Body, My Choice
On August 5, economist Tyler Cowen wrote:
How about that Russian vaccine they will be trying in October?
To be clear, I won’t personally try it, and I don’t want the FDA to approve it for use in the United States.
I was shocked, not by Tyler’s own decision not to try it–we all make our own risk/reward tradeoffs–but by his willingness to have the FDA prevent me and other Americans from trying it.
Now you might say that Tyler didn’t say he wanted the FDA to disallow the vaccine; all he said is that he doesn’t want the FDA to approve the Covid-19 vaccine.
That would be a legitimate objection to my criticism if Tyler didn’t understand that as long as the FDA doesn’t approve a drug or test, it also doesn’t allow it.
I have long advocated that the FDA be stripped of its power to disallow drugs and, instead, simply be an information agency. Under my proposal, the FDA could insist on information about safety and efficacy before approving, but it would not be able to prevent drugs that it hasn’t approved.
I’m disappointed that Tyler seems not to agree.
A separate issue, of course, is whether it’s a good idea to take the vaccine. David Friedman gives his view here and, I think, overstates the case for the Russian vaccine’s efficacy. My own view is that I would happily be the one millionth person to take it.
READER COMMENTS
Garrett
Aug 13 2020 at 3:04pm
You said:
Friedman said in his post:
Without having any familiarity with Friedman’s writing, I can only assume “probably” to mean >50% since he unfortunately doesn’t specify a probability. Are you implying that you believe the probability of efficacy, which I will define as being sufficient to lead to a return to regular life if everyone had access to it, is less than 50%?
Steve
Aug 13 2020 at 3:47pm
It seems unlikely that any insurance company would approve listing or paying for a drug/vaccine that wasn’t FDA approved. Some may even restrict payment for treatments that are directly tied to the side-effects of a non-approved drug.
So even if the FDA is stripped of it’s powers to disallow drugs, the market for non-approved items will be limited to those paying retail prices, potentially with their own private insurance riders or conceirge doctors that agree to treat any potential side effects.
It would take generations to undo these forces.
David Henderson
Aug 13 2020 at 4:34pm
You wrote:
Probably true.
You wrote:
Possibly true. I think, though, that most insurance companies pay for treatments for the side effects of drinking alcohol and smoking cigarettes. These are not approved but are grandfathered.
You write:
That could be. But precisely because insurance wouldn’t cover them, buyers would be much more price sensitive. That would constrain prices. So many millions would likely be willing to pay the prices that the drug providers would charge.
You write:
And you’re saying that that’s bad?
Garrett
Aug 13 2020 at 4:26pm
In what way does Friedman’s post overstate the case for efficacy?
David Henderson
Aug 14 2020 at 3:33pm
By not making much of a case.
Mark Z
Aug 13 2020 at 5:20pm
I wonder what specifically Tyler’s position is. Does he think the FDA shouldn’t approve the Russian vaccine when it comes out, or shouldn’t ever approve it unless subjected to the FDA’s own process on American soil? The former position may be understandable, latter position less so. If the vaccine appears to be safe (and we’ll probably know if it’s safe before the US vaccines are available, probably several months later) and especially if it shows signs of effectiveness (which we may have an idea before US vaccines come out), then the case for refusing to approve it at that point seems weak and dogmatic.
It’s one thing to say, prospectively, that we don’t know if it’s safe, it’s too risky, and it shouldn’t be released. But once it’s released, if the gamble pays off, even if it was a bad gamble to begin with and Russia just got lucky, that isn’t a good argument against using a vaccine that in retrospect did turn out to be safe and effective.
Alan Goldhammer
Aug 13 2020 at 7:20pm
This question will be answered in time. The Russian vaccine uses an adenovirus vector and is similar to a number of other vaccine constructs made by US, European and Chinese countries. The Johnson & Johnson vaccine is similar and at least we have animal and human Phase 1 data that we can look at.
Best way to track progress is via the New York Times Tracker.
I’ll not comment on the remainder of David’s post as he knows where I stand on those issues.
Bob Murphy
Aug 13 2020 at 6:05pm
But David, how many ethics articles have you published in the top journal?
Peter
Aug 13 2020 at 11:30pm
Umm why? I respect you Mr. Henderson but let’s not pretend to notice where Mr. Cowen’s has been going ideologically the last four, if not longer, years.
David Henderson
Aug 14 2020 at 3:38pm
You write:
I appreciate your respect.
If your point is that Tyler is no longer a libertarian, I agree. But there are 2 factors that make his statement shocking to me:
(1) Tyler is a good economist who understands, I think, the bad incentives FDA officials have. Also, relatedly, the downside of waiting on this particular vaccine would be, in Tyler’s view, very large. Recall that he is one of the economists who most hyped the Covid-19 threat.
(2) Tyler also has as a co-blogger one of the best critics of the FDA. I would have thought that Tyler would have learned from Alex Tabarrok.
Tom Jackson
Aug 14 2020 at 9:06am
I agree with David that Americans should be allowed to take any drugs/substances they want, but isn’t that a separate issue from whether the FDA should approve it? It seems to be there are at least three issues here: (1) Whether the FDA should approve a specific Russian vaccine (2) Whether the FDA should have that much power, and (3) whether there should actually be an FDA at all. (I get it that (3) will seem bizarre to non-libertarians, but I’ve gotten really tired of reading about the FDA blocking needed COVID-19 testing.) Perhaps Tyler will clarify what he meant in the two sentences David cites, and the rest of us can more easily make up our minds about Tyler’s opinion.
Matthias Görgens
Aug 14 2020 at 1:41pm
You don’t even need to be a libertarian to object to the FDA: you can simply argue against the need for a federal agency. But leave it open whether you’d prefer a state agency or responsibility at the county level or even individual responsibility.
Especially ‘responsibility at the state level’ should be a pretty plausible position. (Obviously allowing multiple states to voluntarily cooperate and coordinate.)
Jonathan Seder
Aug 14 2020 at 3:49pm
Fear, misinformation, and political risk aversion have brought us to the point where the only way out is a vaccine that the public believes to be highly effective.
Mr Putin can label sterile saline as “Covid-19 vaccine,” administer it universally (with no doubt a large number of serious side-effects), and get his country working again.
A placebo vaccine would bring similar huge benefits here – but it’s a cultural impossibility, so we must wait and wait while the virus slowly burns itself out.
David Seltzer
Aug 14 2020 at 4:38pm
David, I wasn’t shocked. Hyperbole aside, I agree that his call to limit my choices via government edict was curious if not surprising.
Charley Hooper
Aug 14 2020 at 6:21pm
Mathematics works against vaccines.
Assume that an additional 100,000 Americans will die from COVID-19 in the next year and that 100,000 more will have serious health issues short of death.
That means that each of us faces a 0.0006 chance of a bad outcome from COVID-19 (ignore the range of risk among people based on age and comorbidities).
If the Russian vaccine has 100% efficacy but the chance of a bad outcome from the vaccine is anywhere near 0.0006 (one out of 1,650 people), then it’s a loser. If the efficacy is lower (say, 30%) or the chance of a bad outcome is higher, then the vaccine a loser.
To get a handle on such a low rate of bad outcomes (1 in 1,650), we’d need to see data on at least 50,000 patients. As far as I can tell, the Russians don’t have that safety and efficacy data.
Absent good data, we need to form our own judgment about whether the vaccine has sufficient efficacy and safety to pass the hurdle described above. (If we had access to it, which we don’t, and likely won’t.) At this point, I’d pass. But I wouldn’t stop others from taking it.
Lidiya Ivleva, 70, out for a walk in a Moscow park, called the vaccine “a great achievement” for Russian scientists, but said she would not rush to get it herself because of the “hasty” testing.
“’Those who fear the pandemic more will take it first, and good for them,’ she said. If in a year or so it is clearly shown to be safe, she said, then she will reconsider.” [WSJ]
Mark Z
Aug 14 2020 at 10:05pm
Right now, it looks like the annual death toll even with extensive public health measures is probably over 300k per year (~240k just by the end of this year, ). So I think a more realistic change of death is 0.1% (I’ll use percentages; it’s probably worth being consistent though, and not using a mix of percentages and decimal probabilities). A 100% effective vaccine would allow us to basically return to normal. So even if the vaccine were as deadly as the virus, it would mean we would achieve the same mortality rate we currently have but also be allowed to live normal lives again. I think that has to be taken into account.
Severe side effects from vaccines nowadays in general tend to be on the order of 1 per million as I understand it. In one infamous case of a bad vaccine, the 1976 swine flu vaccine caused Guillain-Barré syndrome in 1 per 100,000 people who received it (5-10% of cases of Guillain-Barre are fatal). This article I found was pretty good review of fatal vaccine side effects: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4599698/.
Overall, severe side effects tend to occur at most on the order of 1 per several tens or hundreds of thousands of cases even in comparatively ‘dangerous,’ older vaccines the results of which are most studied. A totally untested vaccine like the Russian one may be comparatively risky, but severe adverse effects are almost always apparent soon after getting the vaccine, not months later, so we’ll learn what’s safe an what isn’t fairly soon, and we can expect the risk from well-tested vaccines ultimately widely distributed presumably next year, I’d guess, to be at least 2 to 3 orders of magnitude lower risk than the current risk of death from the virus (again, even assuming our current way of life persists indefinitely). A typical modern vaccine would probably have to be pretty close to completely ineffective for the risk of death from it to supersede risk of death from the virus. So I just don’t see the claim “mathematics works against vaccines” being remotely true in general (for coronavirus). It’s doubtful it’s even true of an untested Russian vaccine. A vaccine that kills even 1 in 10,000 (probably even 100,000) people that gets it would be one of the worst vaccines in history.
Dylan
Aug 15 2020 at 8:06am
I think this mixes up the fact that vaccines on the market are the ones that have been heavily tested to try and minimize the chances of an AE. It’s not clear to me that this is true of experimental vaccines, especially those that are using a new mechanism of action. A quick search on Clinicaltrials.gov shows 449 vaccine trials that were suspended or terminated. Not all of these are going to be for safety or efficacy reasons, but many likely will be. I’ve not been able to find any data on typical success rates for vaccines under investigation. My guess is that they are better than the average of other investigational drugs, but that’s not saying much, ~90% of drugs that make it to human trials still fail.
Mark Z
Aug 15 2020 at 5:48pm
But it seems even vaccines (like the 1976 flu vaccine) that caused severe side effects in more people than was considered acceptable and were discontinued, the rate of severe side effects and mortality was still much lower than the mortality rate for covid19, and I doubt these viruses had been, before their initial release, significantly better tested than the ones expected to be released next year, especially considering that both regulations and the science of vaccines were more primitive decades ago than today (and often those vaccines were speedily developed and released for similar reasons to today, to deal with ongoing outbreaks). .
Dylan
Aug 16 2020 at 11:11am
I’m going to preface this by saying vaccines really aren’t my area, but I don’t think you can use the data that you have to draw conclusions about novel vaccine techniques. The Russian vaccine is using an adenoviral approach that has been looked at for 3 decades, but so far only has one approved vaccine, which was approved for Ebola in China, but hasn’t been proven effective. Most other trials have been halted due to lack of efficacy, but there are also hints that in some patients that the vaccine could end up making them more susceptible to the very thing they were trying to protect against. The below link gives a good overview of the history for adenoviral vectors.
https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19?utm_source=LJ&utm_medium=Social&utm_campaign=CEN
Michael
Aug 16 2020 at 8:01am
In Tyler’s post, he both endorses the Russian effort to develop a vaccine while also stating that he doesn’t want the FDA to approve it or to try it himself. And he links to articles making the point that Russia is rushing (NPI) the vaccine through clinical development without adequate phase 3 safety and effecacy trials.
My read on this is that Tyler isn’t going to personally take, and doesn’t want the FDA to approve, a vaccine that hasn’t been adequately tested.
David Henderson
Aug 16 2020 at 9:03am
That’s my read also. Did you think that my read is different from yours? If so, why?
David Henderson
Aug 16 2020 at 9:04am
For those who may have missed it, the discussion above, led off by Charley Hooper and joined by Mark Z and Dylan, is excellent.
I find myself persuaded by Mark Z.
Dylan
Aug 16 2020 at 11:23am
David,
Thanks for the kind words. I agree that both Mark and Charley’s points are excellent. Thought it was nice to find myself agreeing with Charley for a change.
Mark’s points are well taken but, as I said above, I think the error is lumping all vaccines in as a single class. The leading candiadtes so far in the race to develop a vaccine are genetic vaccines. There’s a lot of promise in the approach, and a lot of reason that they should work. However, people have been working on them for a long time without a lot of success. The article I link to above provides a pretty good history of adenoviral vectors, like the Russian vaccine. The good news is that most vaccines that have been tried in this area in the past seem to be safe based on limited testing (not all though!). However, they also haven’t been effective.
Comments are closed.