Richard Yetter Chappell on Lessons from the Pandemic

It’s generally recognized that our (American) response to the Covid-19 pandemic was disastrous. But I think far fewer appreciate the full scale of the disaster, or the most significant causal levers by which the worst effects could have been avoided. (Yes, Trump was bad.  But his public health disinformation and politicization of masking—while obviously bad—may prove relatively trivial compared to the mammoth failings of our public health institutions and medical establishment.) Much of the pandemic’s harm could have been mitigated had our institutions been properly guided by the most basic norms of cost-benefit analysis.

This is the opening paragraph of Richard Yetter Chappell, “Lessons from the Pandemic,DailyNous, January 19, 2021.

The whole thing is excellent. Chappell is a philosopher but the piece reads like a well-written analysis by a policy economist.

Another excerpt:

In ordinary circumstances, the status quo is relatively safe and so untested medical innovations present asymmetric risks. That is, until they are proven safe and effective, it may be reasonable to assume that the potential risks of an untested product outweigh its potential benefits, and so block public access to such products until they pass stringent testing requirements. (There are arguments to be made that FDA regulations are excessively onerous even in ordinary circumstances, but I remain neutral on that question here. I take it that there is at least a reasonable case to be made in the FDA’s defense ordinarily. No such case for the FDA’s stringency seems possible in a pandemic.)

A pandemic reverses the asymmetry of risk. Now it is the status quo that is immensely dangerous, and a typical sort of medical intervention (an experimental drug or vaccine, say) is comparatively less so. The potential benefits of innovation likely outweigh the potential risks for many individuals, and vastly so on a societal scale, where the value of information is immense. So the FDA’s usual regulations should have been streamlined or suspended for potential pandemic solutions (in the same way that any ethics barriers beyond the minimum baseline of informed consent should have been suspended for pandemic research). This should be the first thing the government does in the face of a new pandemic. By blocking access to experimental vaccines at the start of the pandemicthe FDA should be regarded as causally responsible for every Covid death that is occurring now (and many that occurred previously).

This last sentence is almost correct and similar to what Charley Hooper and I argued last month in “The FDA’s Deadly Caution,” AIER, December 16, 2020. Surely there are some deaths that would be occurring now, even without FDA intervention, due to people not taking the vaccine or due to the vaccines’ not being 100% effective

Yet another excerpt:

Closely related to the above mistake is the implicit assumption that it’s somehow better to do (or allow) nothing than to do (or allow) something imperfect. Letting the perfect be the enemy of the good in a pandemic is disastrous. Blocking quick Covid tests for having lower accuracy than slow ones is an obvious example of this form of stupidity. Deciding in advance that a vaccine must prove at least 50% effective in trials to receive FDA approval is another. (Obviously a 40% effective vaccine would be better than nothing!  Fortunately it didn’t come to that in the end, but this policy introduced extra risk of disastrous outcomes for no gain whatsoever.)

Compare Dr. Ladapo’s argument in the WSJ that “Doctors should follow the evidence for promising therapies. Instead they demand certainty.” (Steve Kirsch expands on the complaint.) Again, this is a very basic form of irrationality that we’re seeing from the medical establishment.

Misguided perfectionism has also damaged the vaccine rollout due to prioritizing complex allocation schemes over ensuring that as many people are vaccinated as quickly as possible. (Some are letting doses spoil rather than “risk” vaccinating anyone “out of turn”!)

More examples are discussed here.

Do read the whole thing.

HT2 Daniel Shapiro.

 

 

 

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Noubar Afeyan on Academia, Business, Immigration, and the American Dream

Tyler Cowen has posted an outstanding interview of Noubar Afeyan, co-founder of Moderna, which produces one of the two COVID-19 vaccines approved so far by the Food and Drug Administration. Tyler is at the top of his game, asking really good questions, and you can just see the respect that that creates in Afeyan.

Some highlights follow.

On individualized medicine

We have a program in cancer vaccines. You might say, “What does a cancer vaccine have to do with coronavirus?” The answer is the way we work with cancer vaccines is that we take a patient’s tumor, sequence it, obtain the information around all the different mutations in that tumor, then design de novo — completely nonexistent before — a set of peptides that contain those mutations, make the mRNA for them, and stick them into a lipid nanoparticle, and give it back to that patient in a matter of weeks.

That has been an ongoing — for a couple of years — clinical trial that we’re doing. Well, guess what? For every one of those patients, we’re doing what we did for the virus, over and over and over again. We get DNA sequence. We convert it into the antigenic part. We make it into an RNA. We put it in a particle. In an interesting way, we had interesting precedents that allowed us to move pretty quickly.

Big question I wish Tyler had asked as a follow-on: Do you think the FDA will loosen its reins enough that Moderna and others can deal that way with individual patients without getting permission and doing large-scale tests?

The Academic Scientific Community vs. the Business Scientific Community

Look, the scientific method, the scientific community — it works on advances that are predicated on current and prior advances. Incremental advances are the coin of the realm. It’s not that they’re conservative. It’s just that the process, the communal process of accepting truth as that which can’t be negated, causes you to therefore be, in every which way, questioning everything.

I learned long ago the expression organized skepticism. That’s what science is predicated on. As a result, if you come forward with something that is not fully supported by and connected to the current reality, people don’t know what to do with it. What many academic scientists do is to spend the next 5, 10 years putting the connections in place to make what’s being proposed a natural extension of what existed before.

In industry, we don’t have that need, and the reason Moderna was able to really be the pioneer in the space of establishing a therapeutic platform, even before a vaccine platform, is because for us, the lack of connection between what we were able to do and what had been done before was marginally interesting, but we weren’t trying to publish it.

When you patent something, you don’t have to show that it’s a natural extension of what people did. You just have to describe something that is novel, that is unobvious. In fact, the less connected, the more unobvious, and/or the less connectible.

Note this sentence: “What many academic scientists do is to spend the next 5, 10 years putting the connections in place to make what’s being proposed a natural extension of what existed before.” It reminds me of the old joke about the academic who, observing that a TV works in practice, wants to understand whether it works in theory.

On Immigration and the American Dream

This next is my absolute favorite of the interview.

I also would say that as a country, there’s so many people who have the experience of coming here, that that experience can also be transmitted to people who are born here, for whom the same mindset of being willing to imagine a better . . . If you look, every single person who comes to this country imagines a better future for themselves. That’s my belief. Maybe not every single person — 99 percent.

Imagine if all of us were also born imagining a better future for ourselves. Well, we should be, but we’ve got to work to get that. An immigrant who comes here understands that they’ve got to work to get that. They have to adapt. The problem is, if you’re born here, you may not actually think that you’ve got to work to get that. You might think you’re born into it.

This will be a funny thing to say, and I apologize to anybody that I offend. If we were all Americans by choice, we’d have a better America because Americans by choice, of which I’m one, actually have a stronger commitment to whatever it takes to make America be the place I chose to be, versus not thinking about that as a core responsibility.

That brings up two memories, one old, one relatively recent.

The old memory is that when I came to this country in 1972, at age 21, I had the American dream in mind and I noticed right away that a large swath of the people I ran into in Los Angeles, whether at UCLA or in the city generally, who had grown up in the United States, didn’t.

The more-recent memory is of an interaction I had with a man who was considering running for the Republican nomination for president in 2016. I think the conversation happened in 2015, and it was at a Hoover Institution roundtable I had been invited to. I can’t name the person without violating the confidentiality rules.

He made a statement about immigrants that surprised me. He said (and I think I’m getting his words almost word for word), “So many immigrants come here and act right away as if they just arrived at home base after hitting a home run.”

When it was my turn to talk, I said, “Person X, I’m an immigrant and I thought when I got my green card I’d arrived at home base or at least at third base. I was given a list of crimes that, if I committed them, would get me booted out of the country and none of these crimes were ones I planned to commit.”

Then I made the mistake of asking about his record in a previous office he had held. He answered about his record but didn’t address my point about immigration. This man had the attitude that Afeyan attributes to many Americans: Simply by being born here, he seems to think that he’s made the rounds to home base.

I really don’t know what some politicians and some Americans expect out of us immigrants.

 

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The FDA’s Deadly Caution

The earliest Moderna probably would have sold the mRNA-1273 vaccine would have been after it began scaling up manufacturing. A company doesn’t begin manufacturing until it believes in a product. In the timeline above, that’s March 23. But manufacturing takes some time to get going. Let’s assume that by April 1, five weeks from the date the first batch was shipped, Moderna begins offering mRNA-1273 for sale.

Sales start slowly. Supplies are limited. Only the bold and brave get inoculated. The rest of us, and Moderna, get some early, albeit messy, safety and efficacy data. This data helps Moderna improve the vaccine, dose, and dosing schedule. Having a ready market and a steady source of revenue, Moderna scales up production faster than in the timeline above.

In this scenario, inoculations could have begun at least 8.5 months earlier and, perhaps, the pandemic would have ended 240 days and 240,000 lives earlier. There’s little talk of lockdowns and the economy remains resilient.

This is from Charles L. Hooper and David R. Henderson, “The FDA’s Deadly Caution,” AIER, December 16, 2020. In it, we consider various scenarios for what would have happened had we had a truly free market in pharmaceuticals.

The one above is the most optimistic.

Read the whole thing.

 

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We Could Have Had the Vaccine in Early Spring at the Latest

You may be surprised to learn that of the trio of long-awaited coronavirus vaccines, the most promising, Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public in an act of scientific and humanitarian generosity that resulted in China’s Yong-Zhen Zhang’s being temporarily forced out of his lab. In Massachusetts, the Moderna vaccine design took all of one weekend. It was completed before China had even acknowledged that the disease could be transmitted from human to human, more than a week before the first confirmed coronavirus case in the United States. By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial. This is — as the country and the world are rightly celebrating — the fastest timeline of development in the history of vaccines. It also means that for the entire span of the pandemic in this country, which has already killed more than 250,000 Americans, we had the tools we needed to prevent it.

This is from David Wallace-Wells, “We Had the Vaccine the Whole Time,” New York, December 7, 2020.

HT to my Hoover colleague John Cochrane, who hits home run after home run, but this is one went out of the park.

If you do nothing else today, read his post.

Wallace-Wells writes:

To be clear, I don’t want to suggest that Moderna should have been allowed to roll out its vaccine in February or even in May.

To be clear, I want not only to suggest that but to advocate that.

John Cochrane explains why:

Even under operation Warp Speed — a truly commendable accomplishment of the Trump Administration that, maybe a year or so from now the TDS crowd might acknowledge — the only thing we have been waiting for is FDA certification: Randomized clinical trials to prove safety and efficacy, before anyone is allowed to take the vaccine.

What’s the free-market way? A drug company can sell a vaccine on January 14, and you can buy it, without fear of going to jail.

Sure, there is an FDA, and a Federal Trade Commission which monitors drug labeling. The vaccine has to say “this is totally untested, and has not been proven safe or effective in clinical trials” and offer a stack of paper about known risks. You sign a stack of consent forms. If you take it, you’re enrolled in our big national database — you just volunteered for the national non-random clinical trial. (We don’t collect much data on drugs that are out there).  The FDA rapidly collects information. At the same time, randomized clinical trials are going on. Drugs can give more and more hopeful labels as the results roll in. At some point after Phase III and FDA review, a drug can get the official FDA seal of approval. No, insurance and medicare don’t pay for non-approved stuff. This is free-market nirvana, you pay for unapproved medicines if you want them (see part 1). There is an FTC and a tort system. Drug companies that sell things they know are unsafe or ineffective pay billions.

Sunk costs are sunk, of course. But wouldn’t it be great if we took some learning from this so that we could be more prepared for the next pandemic and not shut down the economy and lose lives both from the pandemic and from the shutdown?

 

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When regulators engage in “white lies”

Regulators are supposed to protect us from making foolish decisions. When doing so, they often believe the public interest is served by promoting “white lies’, that is, false statements that are intended to be for our own good. If fact, the short run benefits of white lies are almost always outweighed by their much bigger long run costs.

1. Early in the pandemic, experts said there was no reason for a travel ban. Presumably they were trying to prevent panic, or xenophobia, or something. But in retrospect, an international travel ban would have been helpful if instituted back in January. Indeed travel bans largely explain why some countries have mostly avoided Covid-19, although in fairness other policies such as masks and test/trace/isolate also played a big role.

2. Early in the pandemic, experts suggested that masks don’t help average people. Even then they must have known that was wrong—why else would doctors wear masks? Their white lies seem to have been motivated by a feeling that masks might make people feel overly self confident (which might be true), as well as the fear that a mask shortage might deprive health care workers of masks.  Unfortunately, these “white lies” had extremely negative long run consequences.

3. More recently, Dr. Fauci suggested that it was important for the FDA to spend several weeks evaluating the Pfizer trial data before making a decision. According to experts cited by Tyler Cowen, that also seems to have been inaccurate. Alex Tabarrok suggests that the motivation seems to have been to make the public feel like the FDA was being careful:

I am getting very angry at people like Anthony Fauci who say that FDA delay is necessary or useful to alleviate vaccine hesitancy.

Fauci told Fox News that the FDA “really scrutinises the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine. I think if we did any less, we would add to the already existing hesitancy on the part of many people because … they’re concerned that we went too quickly.”

The WSJ says much the same thing just with a slightly different flavor:

…this regulatory rigmarole is essentially a placebo to reassure the public it will be safe to get inoculated.

The ‘we must delay to allay’ argument is deadly and wrong.

Tabarrok points out that the effect could easily go in the opposite direction, making the public even more wary of vaccines, and Matt Yglesias is rightly skeptical of public health officials becoming amateur social psychologists:

The internet is full of conspiracy theories about almost everything.  Most of the theories are unsubstantiated.  Unfortunately, if our experts believe that white lies are frequently in the public interest, this will gradually erode confidence in expert opinion, breeding even more conspiracy theories.

As an analogy, deposit insurance is often useful in the midst of a financial crisis.  But in the long run, the existence of deposit insurance encourages banks to take excessive risks, and this makes financial crises more likely in the long run.

Tabarrok and Yglesias are right that Dr. Fauci should not try to be an amateur psychologist.  And this is true for reasons even beyond those that they cite—the fact that he’s not very good at it.  Even if Fauci were an expert in knowing just how to manipulate public opinion at a point in time, the long run effect of his action would to reduce public trust in experts, with consequences much greater than any short run benefit.

When it comes to regulators, there are no “white lies”.

 

 

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The Real Cost of Expensive Cancer Drugs

In the news this week was the release of a congressional probe into high drug prices, particularly for cancer medications. One of the prime exhibits in the hearings was the drug Revlimid, produced by Celgene. In one sequence, Representative Katie Porter (D-CA) held up a whiteboard showing the increase in the cost of one Revlimid pill from $215 in 2005 to $763 today. Accusations of price gouging and profiting from illness quickly followed. However, the story behind Revlimid and other drugs is a lot more complicated than “evil villain drug companies bankrupt suffering patients.”

 

I should know. I was on Revlimid for several months in early 2019, and I have dealt with other, similar drugs in my multiple myeloma treatment.

 

Revlimid is a derivative of thalidomide, the infamous anti-nausea drug that led to so many birth defects in the 1960s. In the early 2000s, Revlimid was found to be an effective treatment for multiple myeloma, and it, along with its cousin Pomalyst, is still taken by patients today. (Because of its history, male patients still have to take a monthly survey making sure we haven’t donated blood or sperm and that we are not having sex with a woman who can become pregnant). For some myeloma patients, Revlimid is part of their first-line treatment. Others, like me, who were candidates for a stem-cell transplant using our own stem cells, get a different combination early on, but use Revlimid as maintenance therapy following the transplant. 

I was on Revlimid after my first set of post-transplant maintenance drugs stopped working. Unfortunately, the side effects of Revlimid were particularly bad for me and I had to stop using it after a couple of months. My experience with Revlimid and other high-priced anti-cancer drugs is relevant to the current policy debate.

 

The two most important things to remember about the prices of drugs like Revlimid are: 1) prices are much higher than they would otherwise be thanks to a variety of poor public policies, from intellectual property protections to our insane system of health insurance; and 2) very few patients pay the sticker price that Rep. Porter was discussing. 

The list of policies that keep prices high is a long one, but it certainly starts with a third-party payer system in which demanders are not price conscious and suppliers have no incentive to be transparent about their real costs. When you throw on top of that the large role for Medicare as a third-party payer who does not have to turn a profit, it’s no surprise that prices for drugs and procedures are high. In the case of drugs, intellectual property laws that create patent protection and needlessly extend the time needed to produce cheaper generics are part of the problem, as is the prohibition on drug importation. The various reimbursement systems, both private and public, pay higher fees to medical professionals who use more expensive treatments. And the FDA’s overly cautious regulatory regime adds a great deal of cost to drug research and development. Enabling drugs to get to market more quickly would reduce those costs. In general, this is a market lacking in meaningful competition and prices thanks to poor public policies.

The sticker prices of most drugs and medical procedures often mean very little as providers and insurance companies end up negotiating final prices that are below what appears on the first round bill. Beyond that, most patients pay neither the sticker price nor the negotiated price, including for drugs like Revlimid. One general point to keep in mind is that most cancer patients with insurance reach their deductibles and out of pocket maximums very quickly. If their plan has a health savings account, they are paying for those with pre-tax dollars and saving 30 or 40 percent right there. 

Because Revlimid is an oral cancer treatment and not a chemotherapy infusion, it’s covered by the drug plan of those with insurance. Myeloma patients will tend to hit their drug maximums quickly too, which means that they face no co-pays for the drug for much of the year. Even so, the costs can be significant. One way that insurance companies are dealing with this is by creating medically integrated pharmacies. I get both of my current cancer drugs this way (one of which is the previously mentioned Pomalyst). It’s a pharmacy run by my insurance company, which enables them to negotiate directly with the manufacturer and creates incentives for the insurance company to keep the cost to the patient as low as possible. It also means that the insurer can combine the insurance, drug provision, and medical care. I cannot get my monthly Pomalyst without speaking to both an insurance representative and a pharmacist, both of whom have access to my complete medical record. This is one strategy that reduces the final cost to the patient and provides better care. And I get the drugs delivered either directly to the house or to my usual CVS location. 

But the more important thing to know is that the drug manufacturers themselves offer substantial discounts directly to patients. With both Revlimid and my later use of Darzalex (an immunotherapy infusion), the manufacturers had “means-tested” discount programs that I was encouraged to apply for. Given our household income, which is well into the top 5%, I was skeptical that I would qualify, but I did in both cases. The discount program for Revlimid wiped out all but $25 of what would have been a co-pay of over $4900 on my first month’s supply of the drug. The manufacturer of Darzalex gave me a similar deal. If I qualified for this price cut, there aren’t going to be many people who don’t. It’s hard for me to accept arguments that the companies who developed drugs that have saved my life and who then make them available to me at a mere fraction of their sticker price are greedy SOBs who care little about cancer patients.

My experience is backed up by medical data. A 2016 study reported that patients using specialty drugs like Revlimid experienced a median copay of $35. An earlier study in the Journal of Medical Economics concluded, after examining over 80,000 cancer drugs that when financial assistance was accounted for, the median copay was $80, and 91% of patients paid less than $100. In the same way that people who are horrified by the rising cost of college often forget that most students don’t pay the sticker price thanks to financial aid, those horrified by the largely meaningless sticker prices of cancer drugs need to understand that that overwhelming majority of people are not paying those prices.

Finally, we need to engage in double-entry bookkeeping here. Even at the high prices some people do pay, these drugs have delivered incredible value. People like me have been given years of life they would not have had otherwise. The monthly Velcade shots I had in my first round of treatment were billed to insurance at over $9000 per injection, though the final cost was less. But if those shots kept me alive to be here writing this, that’s not irrelevant. More generally, if better drug treatments enable myeloma patients to avoid even more expensive in-patient hospital stays, they are saving money compared to a world without the drugs. If Revlimid keeps myeloma under control and prevents metastasis or makes broken bones less likely, it reduces hospitalization costs, and that must be accounted for in thinking through its full costs and benefits. 

 

As is always the case in economics, we have to ask what the value is that we’re getting for the price we pay. There have been amazing advances in the treatment of multiple myeloma, from early drugs like Revlimid and Velcade through to the just approved Blenrep, the first anti-BCMA therapy that promises a whole new set of drugs for patients who have become unresponsive to standard treatments. None of this is cheap, but the longer, better lives it gives patients and their loved ones is of significant value. 

When you combine the reality of what most patients pay with the benefits that these drugs deliver, it’s hard to vilify the people who have risked their reputations and their capital in developing them. Demagoguery, unlike developing cancer drugs, is cheap. And attacking drug companies is no less profitable for vote-seeking politicians than selling drugs is for Celgene and the rest. But that doesn’t mean that the story politicians are telling is an accurate one. There are plenty of problems with the way we pay for medical care in the US, many of which could be fixed by better public policy. Unfairly demonizing drug companies for what is largely a problem of poor policies and institutional incentives is not the way to get the constructive change we need. 

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The Dysfunctional FDA

 

A front-page article in Wednesday’s print edition of the Wall Street Journal is titled “Three Lost Weeks Stalled Virus Testing.” (The title in the linked e-version is slightly different.) The reporters are Stephanie Armour, Brianna Abbott, Thomas M. Burton, and Betsy McKay. The investigative report is quite good.

It talks about a number of mistakes made up front by the CDC. But here’s a whopper about the FDA:

Complicating matters for commercial and hospital labs, a public-health emergency Mr. Azar declared Jan. 31 created a new regulatory hurdle: They would soon have to seek emergency-use authorization from the FDA, a potentially time-consuming process, before their tests could be used. In a nonemergency, hospital and academic labs are typically allowed to design and implement their own in-house tests without much regulatory oversight. The FDA spokeswoman said that, in many cases, the FDA can do this review in as little as a day.

Get that? If there’s not an emergency, commercial and hospital labs are allowed to use their own tests. But if there is an emergency, these labs must seek and get FDA authorization.

I do not think that word “emergency” means what the FDA thinks it means.

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Tyler Cowen’s Shocking Post on the Russian Vaccine

 

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.

 

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How strong is the paternalist argument for drug regulations?

We are often told that we cannot leave the pharmaceutical market unregulated, as uninformed consumers will make poor choices. I don’t doubt that there would be many examples of poor choices in a free market, but that’s not the same as claiming that the choices would be poor, on average.

This article caught my eye:

Nearly 200 covid-19 vaccines are in development and some three dozen are at various stages of human testing. But in what appears to be the first “citizen science” vaccine initiative, Estep and at least 20 other researchers, technologists, or science enthusiasts, many connected to Harvard University and MIT, have volunteered as lab rats for a do-it-yourself inoculation against the coronavirus. They say it’s their only chance to become immune without waiting a year or more for a vaccine to be formally approved.

Among those who’ve taken the DIY vaccine is George Church, the celebrity geneticist at Harvard University, who took two doses a week apart earlier this month. The doses were dropped in his mailbox and he mixed the ingredients himself.

Church believes the vaccine designed by Estep, his former graduate student at Harvard and one of his proteges, is extremely safe. “I think we are at much bigger risk from covid considering how many ways you can get it, and how highly variable the consequences are,” says Church, who says he has not stepped outside of his house in five months.

Before going any further, let me emphasize that I have zero knowledge as to whether this is a good idea, and I don’t plan to discuss this vaccine.  The effectiveness of this vaccine has no bearing on this post.

Instead, I’m going to claim that the people taking this vaccine are relatively bright and welli nformed on the subject.  These are not the sort of people whom the FDA was set up to protect from making foolish decisions about their own healthcare.  The “uninformed consumer” rationale for regulation does not apply to them, even if, ex post, their decision turns out to have been a mistake.

There are costs and benefits to taking unapproved vaccines.  Given that fact, there’s a question as to whether the FDA should allow but discourage vaccines still in development (as they do with certain approved drugs like hydroxychloroquine) or ban them outright, as they do with drugs or vaccines not formally approved for any use.

Reading this article on the Harvard and MIT scientists self-vaccinating makes me wonder if the FDA’s official policy is actually the policy that maximizes expected utility.

If I were told tomorrow that I had lung cancer, my next question would not be, “What do you recommend I do?”  Instead my question would be, “What do the majority of cancer doctors do when they themselves are faced with a similar diagnosis.”  Based on what I’ve read, the answer to these two questions would be quite different.

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