There’s a whole ecosystem of ethics which forbid or strictly limit cost benefit thinking. It’s called deontology. Most folk ethical systems are deontological. The ten commandments don’t say “avoid adultery unless it would be really enjoyable and you are highly certain your wife would never find out.” Nor do they say “thou shalt not lie unless it would protect innocent people from harm .”They are categorical.
Children are taught that morality is categorical and that principled people follow moral rules even at great personal cost. This is a deep part of both Christian and many secular moral traditions.
Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation. One might think this tryst will be really fun and, if my wife never finds out, what’s the harm? Does the federal government really need me to pay all the taxes I owe when it can print money? I can make better use of this money than the military industrial complex!
There’s a related strain of folk thought that “some things are too important to be about money.”. For instance, a family might make very frugal decisions about vacations, housing, even groceries, but bust out the credit card for an unplanned medical expense because “health is more important than money.”
That is a form of the binary thinking MY is criticizing. Once something lands into the health bucket, cost-benefit flies out the window. A family that can’t afford fresh food might shell out $5k for an mri that isn’t really necessary. This is a shitty decision even in pure health terms because fresh food and less stress would probably have better health effects than an mri which was taken mainly to protect a doctor from malpractice liability.
Refusal to optimize also happens when other big abstractions like “safety” and “democracy” get tossed around. The actuarial risk of death by terrorist attack was always minuscule, but this issue has gotten a lot more attention than highway safety or even opiates. “Democracy” is the foreign policy equivalent of “public confidence.”. Anything that can’t be justified in cost benefit terms can be framed as part of a moral crusade to advance democracy. Heroes and martyrs die for principles.
The best way to push back against naive deontological thinking is to impose its costs upon those who insist on thinking that way. A lot of people call me and want to litigate different things because of this or that principle. They never pay me. People who are afraid of jail or prison pay whenever they can. Consequences clarify the mind.
"Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation. "
That's a good argument for not introducing(or at least trying really hard not to introduce) cost/benefit where it isn't there already.
At least in my opinion, for medical treatment, it's always there - at the extreme we can't theoretically pay $10 billion dollars to extend your life by 1 minute, that money could be spent on so many better things. So I don't get up in arms about "nobody should worry about cost for medical care".
Maybe it comes down to fungibility. Cheating on my spouse doesn't generally free up resources for me to spend elsewhere to help them, but not spending money on this Alzheimer's drug might let us spend that money on early childhoold health inverventions, or other medical research, etc. If the resource is fungible, you need to consider cost/benefit, if it's not, then it's too easy to rationalize?
Unless the rules come from god, someone has to make the rules up and that person or group really should weigh costs and benefits. One of the functions of scripture is to take the rule-making process out of contemporary hands. Scripture is like a constitution that can only be amended by prophets, who claim to channel divine mandates. It's worth noting that most people view morality in religious terms and that alot of historical indoctrination inveighs against cost-benefit thinking.
The key line in what you wrote is *personal* cost. Deontology doesn't do very well in giving instructions when *all* available choices violate the categorical rules. It looks to me like people and institutions generally respond by not noticing that those violations exist, or pretending they don't exist, or insist they're someone else's responsibility, or insists that somehow choosing inaction is not a decision (which people are unfortunately quite willing to accept as an explanation as long as the harm is not immediately, physically in front of the person not acting).
The FDA faces genuine trolley problems on a regular basis, but only believes it is responsible for the deaths it causes by approving, not the deaths it causes by denying approval (in accordance with its legal mandate, as the post noted). I do not know if it would be particularly helpful to start pointing out that everyone at the FDA or in Congress who could have changed the policy process and didn't has therefore chosen to commit mass murder, as their inaction has killed X million people over Y years, but it shouldn't be a hard deontological case to make any more than the inverse case that denying approval dangerous treatments saves lives.
hey - thanks for the great comment, I learned something.
Sort of an aside, but if you have a chance and the motivation, would you care to explain how it is that people don't pay lawyers? I had some friends in LA who had a small practice (employment law, mostly) and they complained that clients very often don't pay them. I've never had to personally hire lawyer, but they gave me the impression that I'd be a sucker to pay them full price.
prices are negotiable. attorneys rarely publish their prices because they want to quote according to the client’s ability to pay. i’ll generally offer a discount if the client doesn’t have the means to pay a “full” fee. but i won’t offer discounts to clients with fancy addresses or bad attitudes.
i also find that professional clients tend to me more demanding. i would never offer a discount to a doctor or lawyer
I've never had to deal with this directly (I've only ever worked in government and firms that work on contingency), but in my current position I do find myself having opposing counsel who are billing by the hour. Several have complained about their clients not paying them; these clients tend to be the ones who also had no substantive excuse for not paying my client (the City, either for taxes or water service). Some people are just sleazy. (Not saying everyone who doesn't pay their lawyer is sleazy; plenty of people just get in over their heads. But in my particular area of work, a lot of it is either intentional sleaziness or sleazy negligence.)
Is it true that Philadelphia still tends to simply offer people caught evading the wage and business tax the right to pay up in full with no penalties?
I don't know what the Revenue Department does when taxpayers come to them directly, but the guidelines in my division in the Law Department require full payment of principal plus interest at a minimum on all agreements. Penalty waiver is more discretionary; (near)-full penalty waiver may be available if it gets the rest paid in a lump sum (time value of money, etc.), but it depends on the circumstances.
Reply by way of addendum: I should note that (1) the interest is statutory interest and is significantly higher than the rate of inflation and (2) interest waiver is also possible but requires special approval and only when circumstances warrant. It's certainly not the default.
Interesting. Keep hearing from various news articles that people end up paying basically the original amount, was unsure if this is indicative of the broader reality.
Of course, the city's tax laws are, if anything, even more impenetrable than the federal tax code, so maybe this level of consideration is reserved for "we think you made a good-faith effort and got it wrong"?
He didn't say self-interest was squishy, he said costs and benefits are squishy. I take that to mean that they're often hard to really quantify, which leaves room for people to nudge them in a self-interested direction.
"Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation."
Speaking of squishy, I think this whole sentence and point is kind of squishy.
Do people do this *usually*? Is there really a binary choice between thinking in costs and benefits and whatever exactly you want to call *not* thinking in costs and benefits? Is thinking in costs and benefits the causal factor for people cheating or is it correlated or does it actually have no relation? Is that a post facto explanation?
FDA-er here. The critique here is absolutely spot-on - I'm gob-smacked by how Matt has lined up the relative issues and weighed the subtleties (with one exception, mentioned below). What to do about it is much less well-developed. FDA is an enormous ocean liner; it can't change on a dime. Changes like these take years and are likely to produce all sorts of unintended consequences.
The point that is missing from Matt's analysis is that once a product is approved, it can in most cases be legally used in any way a medical practitioner sees fit. If Medicare or other insurers want a cost-benefit analysis to pay for a given use (particularly if that use is not FDA-approved), they can do it themselves. If it is useful from a public good standpoint for some disinterested party to do that analysis, the best model is to create an agency designed for that purpose like NICE in the
UK.
More importantly, the prospect of a NICE-type agency is anathema to the health care industry. Congress has regularly kneecapped AHRQ, the agency we have that is closest to NICE, whenever it began to take this subject seriously. There is less chance of FDA, Medicare, AHRQ or some other agency creating a sound cost-benefit framework than there is of CDC studying gun violence as a public health problem.
How much do you think that the FDA's decisions on breadth or narrowness of a drug's indication impacts all this? Obviously off-label use is rampant, but narrower indications do help commercial payors limit coverage.
The decision on breadth or narrowness depends on the studies used for approval. The drug company takes a calculated risk: if they test too broad a range of patients it may drown out evidence of benefit in a subgroup and you can't pick out a subgroup post hoc and say, "hey it worked for them" (you would have to do an additional study where that group is identified prospectively). If they test a narrow group, they get the indication for just that group and are not allowed to market it more broadly. Although there may be a whispering campaign encouraging broader use, they can get in big trouble if they are found to be behind it and the commercial payers do push back against this.
You write: "there is a lot of anxiety among both teachers and parents about Covid risk". Just as we rightly call out the vaccine-resistant (more often Republicans, though not all) for ignoring science and not taking the vaccine, we need to call out the irrationally anxious (borderline neurotic) among the other side.
Experience has shown that the COVID-19 virus isn't very dangerous to children, and they aren't a vector for spread. And evidence shows that remote learning is ineffective and especially bad for poor kids. There are risks and costs on both sides of the school debate, and we shouldn't cater to those who exaggerate the COVID side of the equation.
It's clear that schools should reopen no matter what. But it's also clear that given that schools are reopening, you'd rather more kids were vaccinated, and it's madness that it's still illegal to vaccinate young kids.
"Illegal" and "unauthorized" or "unapproved" are different things. The FDA EUA legalized distribution; it allowed the manufacturer to distribute the vaccine for public use. If a doctor vaccinates a 10-year-old, he's not going to jail. In theory, he could lose his license for exercising bad judgment or be sued for malpractice if something went wrong but in either case, he can defend himself by arguing his actions were reasonable.
Nah, it's appropriate for America to care more about American children than non-Americans. Imagine applying this standard to e.g. the Child Tax Credit - why give American kids $300/month when there are much poorer kids overseas?
That said, the current spending on Americans vs. foreigners (100s:1? trillions vs. billions) re: COVID (and everything else!) is way too skewed, and we should try and help non-Americans more than we are, especially by scaling up vaccine production by any means necessary. But denying vaccines to American kids for this reason is way too far.
This is a cute argument, but I can't imagine being convinced that the best thing *for American kids* is for them to forgo being vaccinated - just before school starts! - in favor of vaccinating people overseas. The first-order effect is so clearly negative and the second-order positive effect is very uncertain.
So? This is the same line of reasoning the vaccine-resistant use: "We don't know the long-term effects of the vaccine, so I will just wait and see." We cannot and should not wait decades to make a decision about opening up the schools.
I agree with your conclusion (cost benefit analysis). But I also think I'd vaccinate 11 year olds based on the observation of what happened to the 2 million 12 year olds that have been vaccinated instead of waiting for a phase 3 that includes 4,000 11 year olds. My point is that I think the fear of long term effects from the virus are not irrational. We have evidence that some viruses have long term effects (like herpes cold sores that reappear for the rest of your life). While no vaccine has ever demonstrated long term negative side effects.
"There has never been an mRNA vaccine, so we don't know the long term risks." Focusing on potential, unknown and unknowable risks sows fear and distrust. We can, and should, take action based on what we know now and adjust as necessary.
I thought about the novelty of the mRNA vaccine and chose to get vaccinated anyway. I disagree that people are irrational for having a different cost benefit analysis regarding sending their kids to school if everyone is unvaccinated. I am not focusing on potential longer term risks; just including them in the equation.
Respectfully, I disagree. The mask-refusers make a "different cost benefit analysis" and they are wrong. Keeping schools closed based on a "different cost benefit analysis" is also wrong.
How can it possibly be justified, morally, to vaccinate 11 year old American children - who are at *vanishingly low* risk from this virus, even the delta variant - when like 90% of elderly people in developing countries have not been vaccinated?
I just don't see how vaccinating small children is a morally sustainable solution in any kind of system of morality that acknowledges a world beyond America's borders. Doing teenagers was bad enough, but this is even worse.
How can it be justified to do anything we do for the benefit of Americans when it would all go much further overseas?
We should generally spend much more helping internationally.
But the US government has a special obligation to its own citizens, and the FDA here is acting out of risk-aversion and inertia, not concern for the welfare of the rest of the world.
Anyway, the right solution to this problem is to step up vaccine production (eg by reducing dosages) not to deny vaccines to American kids.
I'd agree with you if that were the real trade-off. But it is vanishingly unlikely that deciding not to vaccinate 11year old's is going to get Congress to approve more money for vaccinating more vulnerable people abroad.
The chicken pox virus causes shingles because the virus persists in neurons. Basically, the virus’s (DNA) genome is tethered to the host’s chromosomes so every time a cell copies its DNA, it copies the virus’s DNA. That’s why herpes viruses are forever. I’m not aware of any decent quality evidence that coronaviruses cause persistent infections in immune-competent people. Coronaviruses are RNA viruses so their genome is extremely unlikely to persist in a cell long term
For people who were in the ICU, it probably is similar to other post-ICU syndromes -- being in the ICU means you're in a bed for a long time, you lost muscle mass, and there may be damage to the organs either due to the virus or the medications they took
For people who were sick but not that sick, it's probably persistent immune activation. There is a post-viral persistent immune activation syndrome that occurs with other viruses such as influenza, so it's probably similar to long flu. As an aside, I know someone who had covid and had long-covid like symptoms for about five months after recovering from the typical symptoms. They are now fully recovered and back to normal, so it is possible that for some people long covid will go away with time.
The UK's solution has been to separate the "is this safe and effective" determination from the cost-benefit determination.
So the EMA (before Brexit) or the MHRA (now) determines whether it is legal to prescribe a drug and then NICE (for drugs) or JCVI (vaccines) determines whether it's cost-effective and considers availability vs demand and then prioritises who should get it first if it's supply-constrained.
It is perfectly legal to pay for a private dose of a vaccine in the UK. You can't actually do so because Pfizer and Moderna have sold every dose they manufacture to governments and private suppliers don't have any.
The US separates those too. FDA decides if a drug is safe and effective enough to be legally available. And the private insurers and large health systems decide cost-effectiveness for the commercial market. And CMS (Medicare/Medicaid) sets reimbursement rates for government programs, based on requiring drug manufacturer to report the average prices paid in the private sector (simplifying a bit).
Yes, but as I suspect you know, the CMS price-setting mechanism gets gamed because it's typically a price-plus scheme and private insurers rarely make coverage decisions that are significantly different than CMS.
Not sure what you mean by price-plus. Medicaid reimburses drugs based on the lowest, or "best", price the manufacturer has negotiated with private insurers (ie, MFN pricing), or a statutory discount from the average price, whichever is lower. Medicare Part B reimburses based on Average Sale Price, or ASP, which is the average price paid by commercial customers, and Part D plans negotiate their own prices.
Agree, though, that private insurers generally haven't had much incentive or ability to control prices in any part of the healthcare system - drugs or otherwise, because they've been pass-through entities that don't really care what the absolute price is as long as their premiums exceed their outflows in a given year. And when they do try to control prices by refusing coverage or kicking providers or drugs out of their network, patients squawk and insurers get vilified by politicians.
But traditional pass-through insurer incentives are changing, as more large insurers are becoming vertically integrated and buying up providers. And naturally, they're getting criticized for that in the press too, though its actually a good systemic change that aligns incentives better.
Pet peeve: use of the term "reimbursement" as a euphemism for payment. Reimbursement is money received to offset an expense. Payment is what is given in exchange for a good or service. As you may know, once upon a time patients paid their medical bills from their own pockets then submitted a claim to their insurance to be reimbursed. Eventually it became more efficient for insurers to pay doctors and hospitals directly. The term "reimbursement" was retained by health care providers to make it appear that they could not contaminated by pecuniary incentive and filthy lucre. The euphemistic use of "reimbursement" unfairly colors the terms of discussion; there is no reason to use it. Plus all that extra typing!
It's hard to think of a more misguided idea than the notion FDA should refuse to approve "me too" drugs in the same therapeutic classes without proof they're more effective than the first one - unless maybe it's the idea that the way to get more affordable housing is to prohibit the construction of expensive new housing.
When there's only one drug in a class, whether it's statins for cholesterol or SGLT2 inhibitors for diabetes, or whatever, the manufacturer has more leverage to charge higher prices. When there are therapeutically equivalent alternatives, PBM and other payers that make formularies can bargain the price down by preferring the drug from the manufacturer that agrees to the biggest price concession.
Came here to say exactly this. Additionally, no two drugs have exactly the same safety profile, even those in the same class (like statins). So there may be a very good reason to prescribe Lipitor instead of Crestor for a patient based on that patient's other conditions.
Matt actually makes this point. What he criticizes is the introduction of "me too" drugs that provide no clear advantage but cost many times more than older drugs and that manufacturers still manage to sell by muddying the waters and taking advantage of blind spots in the health care system. It may make sense to prescribe Lipitor rather than Crestor for a specific patient, but Lipitor shouldn't cost 20 times as much
If it's a new class and all the drugs in it are still are still on patent, equivalent "me too" drugs introduce price competition even if they don't offer any clinical advantage.
And if some of the drugs in the class are off patent, then the only reason any right-thinking insurer would pay for one of the drugs that's still on patent is if it has a special clinical advantage for some patients who for whatever reason can't take the generic drug.
I think one thing he's saying there is that there should be one body that just considers "is this safe" and "is this effective" and decides whether or not to approve it, and another body that considers "how much does this cost" and "how effective is this" and "how safe is this" and decides what to recommend.
Not quite - right now it's a semi-adversarial process between your insurance company and your physician. Physicians often pay zero attention to cost, and only pay attention to whether it is covered by the insurance, and the insurance company makes the decision about cost vs effectiveness, but without information about particular patients.
I'd modify that a bit and say the other body is your insurance company, or your insurance company's pharmacy benefit manager.
Whether you're on a government plan or a private, no insurance plans cover treatments that aren't "medically necessary", a concept whose definition in most plans includes an element of cost-effectiveness.
But Americans like a lot of health care, and don't like anyone telling them they can't have everything covered, so any time an insurance plan, public or private, tries too hard to enforce price controls and keep costs down, patients get mad (death panels! greedy HMOs!) and politicians respond accordingly.
One of the few disciplines we have on healthcare costs is that for people with insurance through their job, ultimately your healthcare insurance costs come out of your wages. It's a crude, weak market signal, but the share of total compensation that American employers earmark for healthcare costs are one of the few objective indicators of how much Americans are willing to spend on healthcare.
I am a big advocate of HSAs and high-deductible health plans. Each year at enrollment time I create an analysis of both the standard and the high-deductible plans that my employer offers, and I share the analysis with anyone who will listen. The way the math works out is that if you take the difference in cost of the two and make that your HSA contribution, the annual total will be just about the difference in deductibles. Once I prove out the math I point out that taking the traditional plan means that if you don’t need much healthcare over the year, and therefore do not meet the deductible, the company keeps the difference.
This is a pretty minor nit, but it still bugged me. Regarding Canada's one-shot strategy, MY writes: "But then you can see how first shots first worked by looking at how they caught up to and then surpassed us."
That's not why Canada is passing us by. It's because we ran out of people who wanted to get vaccinated. We hit a peak of 3.7 million shots/day in mid-April; we're under 600,000/day now. If we were populated by Canadians, we'd have a lot more vaccinated people now.
My answers would be: (1) as the number of PhDs and professionals increases, you increase the number of people who get power, prestige and pay by insisting on procedures; (2) the economy has become so productive that many forms of decadence can flourish without having an obvious impact on living standards. Eg, the number of people living on SSDI has shot up snd this isn’t perceived as a huge problem because we can support a large non-working population.
I would also add that there's a culture war component to it.
MAGA chuds are anti-establishment, so in response I'm going to be super establishmentarian. People like Fauci becoming a villain to some will inevitably make them a folk hero to others.
I often say that most arguments I get into on the internet are more about me saying "you're too confident" rather than "you are wrong". However, the English language and the way arguments work almost always ends up with it sounds like I'm saying "you are wrong".
This dynamic supports and leads to what you're saying here.
1. Adding a process creates people with an incentive to keep the process in place for their own reasons. For instance, builders unions in California will sometimes oppose lifting housing restrictions, because they can use those restrictions as leverage to force developers to use unionized labor.
2. The Trump era (especially early on) created a situation where Democrats were able to use administrative stuff to frustrate Republicans, which may have caused a halo effect. Look at DACA and the back and forth regarding public comment.
3. Polarization by education means that Republicans are making fewer arguments about "lets make things more efficient", while at the same time Democrats are more sympathetic to skilled professional bureaucrats.
My husband called around lots of places and got the first available vaccine - J&J (I was slightly less of a go-getter and got Moderna about 2 weeks later). Unfortunately, Walgreens (and seemingly other places) aren't approved to give out Pfizer/Moderna to previously vaccinated individuals(he tried last night - the pharmacist said they would have done it themselves but the system didn't allow it). Neither of us wanted him to lie about his vaccination status - for ethical/legal/or medical contraindication reasons (not that we think there are any of the last category).
So it may be good for J&J patients to get a dose of something else, but seems to currently not be allowed at the easy-to-access vaccine places (the local Walgreen's also made sense as a place that seems to have sufficient doses - he would not be taking them from someone who needs them more (Barring export issues to other countries - but that doesn't seem to be the limiting factor right now)
Two days ago, I got a shot of Pfizer on top of my J&J vaccine from March. I only lied by omission.
It looked to me like making an appointment would get my vaccination status checked. Certainly, it did with my insurer, Kaiser, which wouldn't even let me start making an appointment.
So I walked in to CVS. They asked me for my driver's license or an insurance card and I gave them my driver's license. The only other question they asked was whether this was for my first or second shot, which I chose to interpret as my first or second shot of Pfizer.
I think you have to lie to get another dose (or at least not mention you already had one).
In this case, the lie seems very justifiable; your husband is being prevented from taking a safe and effective medicine for no good reason, and both he and everyone else around him will be safer if he gets another shot.
For me, it wasn't really about the morality of lying, but I preferred not to get into a confrontation with anyone, and I also didn't want to get into a situation where I was denied the vaccine, so I looked for a way that was minimally lying.
I wouldn't judge anyone for doing what you did. I wouldn't do it myself (yet - if the evidence came out much stronger in favor of getting something other than J&J) I might decide to overcome my aversion a little - I don't lie to my kids but... there's the Santa clause - I trust they'll forgive me)
I think you have this wrong. I would think you have enough experience as a writer to understand how you are haunted by real or perceived bad takes. Well that works for everyone and in every business. And that is the way it works for the FDA too. And the CDC and the WHO as well. Accrued bad takes and mistakes are NEVER forgotten. Which is why the decision making processes for drug approvals are inherently conservative. And the FDA by the way is a much admired and copied institution around the world. They do, of course, have a process for dealing with exceptions and that is EUAs. And so they should.
It is probably a good thing to remember that many drugs with good efficacy (say statins) wind up getting withdrawn from the market and result in monster class action suits even though clinical trials did not reveal and could not statistically reveal lethal side effects. These often do not become evident until millions of prescriptions have been written. I seriously doubt that the long term confidence in the FDA is going to be enhanced by loosening standards and creating more fuckups. The lawyers will love it though.
My trust in the FDA has been irrecoverably shattered by their terrible, way-too-conservative handling of this pandemic. I’ll never forget their disastrous mistakes that have killed so many people and continue to kill many more.
Maybe take people like me into account when you’re weighing how to maintain public trust. There’s no reason to believe the public prefers doing nothing to doing something.
I will never forget that when Pfizer announced on Friday, November 20th, 2020 that they had just submitted their application for their vaccine EUA, the FDA issued a press release later that day saying,
“The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted.”
Then they went home for the weekend. And they took Thanksgiving off. And the next weekend. This when there were around 1,200 people in the US dying from COVID every day.
Colleague-of-colleage of mine was a drug reviewer for the FDA who died by suicide this past year, it’s said because of the intense work pressure during COVID.
My thinking about it is twofold: no such pressure seemed to have actually shown up on the timeline for vaccine and treatment approvals, and more frankly, at a rate of one death every two minutes from COVID, there being only one work-pressure-related suicide among approval panelists indicates we weren’t pressuring panelists anywhere close to hard enough.
Good for you. It gets shattered a lot more when approved drugs turn out to have lethal or even damaging side effects rare though they be and get withdrawn from the market. If you consider making vaccines available to everyone who wants them a mistake I will enjoy hearing why.
Is there actual evidence that the current level of risk-aversion is optimal for public trust? It’s plausible, but it seems clear to me that the real reason for current procedure is doctors are super risk-averse and imposing their preferences on the rest of us and then backfilling justifications later.
Some mistakes from the FDA (and other public health folks):
Not allowing others to come up with a covid test and then botching their own test
Not considering challenge trials to approve vaccines faster (the worst mistake)
Never approving AstraZeneca even though Britain did (even though we had a domestic supply and vaccine shortages for months)
Not giving vaccines full approval
Slow approvals for kids (it’s been many months since the vaccines were approved for adults; why so long?)
Lying about face masks
Never studying different vaccine dosages (the biggest problem remaining today)
Not considering delaying second vaccine doses
Not telling people who got one dose of J&J to get another dose. Not studying this.
Not saying they shouldn't, but I think why they're not is that the party that would hold them up as villains in the pandemic story are not currently in power in the legislative or executive branches, and the party that would hold them up as heroes in the pandemic story are.
The party that believes in functioning government and regulation, should be especially motivate to address failed bureaucracy. The American people are well aware that the CDC did not succeed.
A few weeks after saying that the CDC shouldn't be doing cost benefit analysis and just putting out the science, you're arguing that the FDA should. This is wrong.
The FDA should be approving drugs. For an amazing vaccine, perhaps accelerated full approval makes sense, but unfortunately we have a frequentist rather than a bayesian org. (Your/Rosenthal's critiques of the FDA approving marginally useful expensive drugs is on point, but not useful for the EUA argument).
The CDC is literally there for *Control*. It should be responsible for doing what is required for controlling epidemics.
Critically, I think, this is the question. What if we had only Sinopharm or some other much more crappy much more side effect ridden vaccine? In a pandemic would *still* want to require everyone to take it. The value to the country as a whole is worth much more than the individual side effects. Once the pandemic is under control, you wouldn't want the vaccine to be used though.
To do this, in the "FDA cost effectiveness model" you'd want the FDA to approve it, and then disapprove it. This makes zero sense. The FDA doesn't even have people thinking about epidemics. The CDC, on the other hand, does have a lot of people thinking about epidemics, and should be capable of requiring a vaccine for the greater good in an emergency.
The problem is the politics - as soon as you're past the emergency, once there is no pandemic, especially if you start vaccinating early and the pandemic doesn't happen (as would be ideal) then the people who did have the side effects from the crappy vaccine start feeling quite grumpy about the whole thing.
And that's why we can't deal with an emergency. The problem is us.
I thought Matt supported the CDC reporting out facts as they know them and letting elected officials and the populace decide on how to change/not change their behaviors based on those facts. For example, I thought Matt believed that the CDC should have been upfront about the benefits of masking right away and not have engaged in a cost-benefit like analysis in opting not to recommend mask wearing to preserve PPE for frontline medical personnel.
Cost-benefit analysis sounds great until you disagree with the decision makers' weighing of the costs and benefits.
He did not say there should be no cost-benefit analysis going on, he said the CDC and other public health authorities should not be *lying about the product of that analysis* to the American people in the hopes of manipulating them to end up where they believe the best outcome to be.
Given the context in which he said it, he didn't seem to think the CDC not doing cost-benefit was a bad thing. Rather, he suggested it is something people should be aware of and act accordingly with respect to CDC guidance.
"Biden's CDC has done the right thing — they say true things about public health."
You're right, it's a little hard to tell exactly what Matt thinks the CDC should be doing here, but it looks like model based recommendations isn't it.
Learn something new! Thank you, I stand corrected. Based on what (Wikipedia says) the FDA does vs. the CDC I'm not sure I understand why. I mean, sure, to issue an EUA you have to know you have an E but surely other orgs know this? Is this just the FDA taking over part of the CDC's job?
One reason is that the FDA is more “muscular” than the CDC - I work in food, so if there’s an outbreak of Listeria in (say) ice cream, all the CDC can do is recommend that retailers pull the ice cream off the shelves and that consumers check their lot numbers and throw it away.
The FDA can actually force a manufacturer recall, force a contaminated plant to cease operations, seize and destroy affected foods, and even pursue prosecutions of company executives who acted with disregard for food safety practices to the public’s detriment. Much of that authority stems from the E coli poisonings in hamburgers (Jack in the Box) from the 90’s. I actually knew a guy whose girlfriend was in a coma for a while due to a hamburger-related E coli infection.
And of course since it’s inception the FDA has had the power to interdict the sale of food and drug products that were dangerous to public health. The FDA is a regulator; the CDC’s role is primarily in study, surveillance, and public health control of diseases. But the CDC either needs your permission or a court order to come onto your property and treat a mosquito swamp; the FDA can do it on its own authority provided you’re a facility the FDA regulates.
I think your main point (convergence of dichotomous political critics) is legitimate, and I agree with your focus on cost/benefit analysis. But something is certainly wrong, and I think it goes beyond that. Consider the outrageous failures to approve good tests at the onset of the pandemic. I'm still unclear whether primary blame lies with FDA or CDC, but it's a Fail far more consequential than the errors that led to 9/11.
Is the malfunction intrinsic to bureaucracy, or is there a clear and solvable problem? The current dysfunction even in the face of the triumph of the mRNA vaccines may allow the kind of analysis of failure that will lead to meaningful future improvements.
Whether a drug provides enough benefit to merit approval and its pricing are related but separate questions. FDA approval gives license for companies to set prices based on the FDA approval -> CMS coverage -> payor coverage and payment equation, as MY states. I don't think that FDA consideration of pricing would improve their decision-making; better would be to allow Medicare to play a negotiating role. Also, it's not a pure free-for-all. Commercial insurers choose what formulary status to give a drug. Whether a drug is covered as first-, second-, or third-line therapy by insurers has a massive impact on sales. Drug companies will generally reduce prices if they fear being assigned second- or third-line formulary status. While the resource-allocation mentality of international regulators probably does lead to different drug evaluations, it doesn't suggest making the FDA think about economic cost-benefit analysis. The UK cost benefit work is done by NHS when it decides what to cover and what to pay. That is totally distinct from the drug approval, which has been done by the European Medicines Agency (but will change to the UK post-brexit).
There are good questions as to whether the FDA could be better at weighing the medical cost-benefit of each drug it evaluates. The agency weighs these differently across different disease states and therapeutic classes. Partly this is because it relies on experts in each field (oncology, infectious disease, etc.) who bring their own biases. But patient groups, institutional bias, play a role. Some are criticizing the FDA for being risk adverse to prior failures, but is that really unfair? Wouldn't we want them to tighten standards when they find that previous standards led to ill effects?
What I most wish for is a bit better judgement from FDA. They are strict about trial protocols because there is a long history of drug companies post-hoc digging for statistically-significant findings to support claims (p-hacking their way to coverage). The FDA is right to guard against this. But then they apply this to the AZ vaccine trial, where the issue is completely different. Ultimately we have to trust regulators to exercise good judgment.
Adding to your thought that "information is a public good". I'm also frustrated that the FDA hasn't funded (do they ever actually fund studies?) a study to determine optimal dosing sizes and intervals. Since over 6 billion people on earth haven't been vaccinated yet (people that might incubate the Zeta variant), this would be incredibly valuable information to have.
I feel basically the same way. I don't know if the FDA funds anything itself per se, but I wish it would be more pro-active. On the boosters, instead of slapping Pfizer down, I wish they had said: we don't have the evidence for boosters yet, but the evidence is piling up internationally that they may be a good idea and we'd welcome trials on different options and will fast-track an effective booster authorization as soon as we see reasonable evidence. That's a pretty modest ask in the midst of a global health crisis.
"There is a very strong presumption among public sector entities that you cannot mandate a vaccine based on an EUA."
On what is that very strong presumption based? Does it come from the FDA itself? Why is the problem not with the presumption (or whatever it is the presumption based on)?
I can only speak for military members but in that case it’s illegal. The historical reasons for this are due to the government literally experimenting on military personnel. So the FDA either needs to approve the vaccines or Congress needs to change the law.
There’s a whole ecosystem of ethics which forbid or strictly limit cost benefit thinking. It’s called deontology. Most folk ethical systems are deontological. The ten commandments don’t say “avoid adultery unless it would be really enjoyable and you are highly certain your wife would never find out.” Nor do they say “thou shalt not lie unless it would protect innocent people from harm .”They are categorical.
Children are taught that morality is categorical and that principled people follow moral rules even at great personal cost. This is a deep part of both Christian and many secular moral traditions.
Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation. One might think this tryst will be really fun and, if my wife never finds out, what’s the harm? Does the federal government really need me to pay all the taxes I owe when it can print money? I can make better use of this money than the military industrial complex!
There’s a related strain of folk thought that “some things are too important to be about money.”. For instance, a family might make very frugal decisions about vacations, housing, even groceries, but bust out the credit card for an unplanned medical expense because “health is more important than money.”
That is a form of the binary thinking MY is criticizing. Once something lands into the health bucket, cost-benefit flies out the window. A family that can’t afford fresh food might shell out $5k for an mri that isn’t really necessary. This is a shitty decision even in pure health terms because fresh food and less stress would probably have better health effects than an mri which was taken mainly to protect a doctor from malpractice liability.
Refusal to optimize also happens when other big abstractions like “safety” and “democracy” get tossed around. The actuarial risk of death by terrorist attack was always minuscule, but this issue has gotten a lot more attention than highway safety or even opiates. “Democracy” is the foreign policy equivalent of “public confidence.”. Anything that can’t be justified in cost benefit terms can be framed as part of a moral crusade to advance democracy. Heroes and martyrs die for principles.
The best way to push back against naive deontological thinking is to impose its costs upon those who insist on thinking that way. A lot of people call me and want to litigate different things because of this or that principle. They never pay me. People who are afraid of jail or prison pay whenever they can. Consequences clarify the mind.
"Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation. "
That's a good argument for not introducing(or at least trying really hard not to introduce) cost/benefit where it isn't there already.
At least in my opinion, for medical treatment, it's always there - at the extreme we can't theoretically pay $10 billion dollars to extend your life by 1 minute, that money could be spent on so many better things. So I don't get up in arms about "nobody should worry about cost for medical care".
Maybe it comes down to fungibility. Cheating on my spouse doesn't generally free up resources for me to spend elsewhere to help them, but not spending money on this Alzheimer's drug might let us spend that money on early childhoold health inverventions, or other medical research, etc. If the resource is fungible, you need to consider cost/benefit, if it's not, then it's too easy to rationalize?
Unless the rules come from god, someone has to make the rules up and that person or group really should weigh costs and benefits. One of the functions of scripture is to take the rule-making process out of contemporary hands. Scripture is like a constitution that can only be amended by prophets, who claim to channel divine mandates. It's worth noting that most people view morality in religious terms and that alot of historical indoctrination inveighs against cost-benefit thinking.
Cost benefit analysis has always been there for modern medical treatments.
https://bit.ly/3rv02T0
The key line in what you wrote is *personal* cost. Deontology doesn't do very well in giving instructions when *all* available choices violate the categorical rules. It looks to me like people and institutions generally respond by not noticing that those violations exist, or pretending they don't exist, or insist they're someone else's responsibility, or insists that somehow choosing inaction is not a decision (which people are unfortunately quite willing to accept as an explanation as long as the harm is not immediately, physically in front of the person not acting).
The FDA faces genuine trolley problems on a regular basis, but only believes it is responsible for the deaths it causes by approving, not the deaths it causes by denying approval (in accordance with its legal mandate, as the post noted). I do not know if it would be particularly helpful to start pointing out that everyone at the FDA or in Congress who could have changed the policy process and didn't has therefore chosen to commit mass murder, as their inaction has killed X million people over Y years, but it shouldn't be a hard deontological case to make any more than the inverse case that denying approval dangerous treatments saves lives.
hey - thanks for the great comment, I learned something.
Sort of an aside, but if you have a chance and the motivation, would you care to explain how it is that people don't pay lawyers? I had some friends in LA who had a small practice (employment law, mostly) and they complained that clients very often don't pay them. I've never had to personally hire lawyer, but they gave me the impression that I'd be a sucker to pay them full price.
prices are negotiable. attorneys rarely publish their prices because they want to quote according to the client’s ability to pay. i’ll generally offer a discount if the client doesn’t have the means to pay a “full” fee. but i won’t offer discounts to clients with fancy addresses or bad attitudes.
i also find that professional clients tend to me more demanding. i would never offer a discount to a doctor or lawyer
I've never had to deal with this directly (I've only ever worked in government and firms that work on contingency), but in my current position I do find myself having opposing counsel who are billing by the hour. Several have complained about their clients not paying them; these clients tend to be the ones who also had no substantive excuse for not paying my client (the City, either for taxes or water service). Some people are just sleazy. (Not saying everyone who doesn't pay their lawyer is sleazy; plenty of people just get in over their heads. But in my particular area of work, a lot of it is either intentional sleaziness or sleazy negligence.)
Is it true that Philadelphia still tends to simply offer people caught evading the wage and business tax the right to pay up in full with no penalties?
I keep hearing this. I find it hard to believe.
I don't know what the Revenue Department does when taxpayers come to them directly, but the guidelines in my division in the Law Department require full payment of principal plus interest at a minimum on all agreements. Penalty waiver is more discretionary; (near)-full penalty waiver may be available if it gets the rest paid in a lump sum (time value of money, etc.), but it depends on the circumstances.
Reply by way of addendum: I should note that (1) the interest is statutory interest and is significantly higher than the rate of inflation and (2) interest waiver is also possible but requires special approval and only when circumstances warrant. It's certainly not the default.
Interesting. Keep hearing from various news articles that people end up paying basically the original amount, was unsure if this is indicative of the broader reality.
Of course, the city's tax laws are, if anything, even more impenetrable than the federal tax code, so maybe this level of consideration is reserved for "we think you made a good-faith effort and got it wrong"?
self interest isn't squishy... its a valid benefit.
He didn't say self-interest was squishy, he said costs and benefits are squishy. I take that to mean that they're often hard to really quantify, which leaves room for people to nudge them in a self-interested direction.
I like this whole comment, but...
"Costs and benefits are squishy and once people are allowed to think in those terms, they usually smuggle their self interest into the equation."
Speaking of squishy, I think this whole sentence and point is kind of squishy.
Do people do this *usually*? Is there really a binary choice between thinking in costs and benefits and whatever exactly you want to call *not* thinking in costs and benefits? Is thinking in costs and benefits the causal factor for people cheating or is it correlated or does it actually have no relation? Is that a post facto explanation?
I concur. I lived in Germany. And now work for a major Germany. Germans are some bureaucratic dudes.
Only problem with Germans... they spend to much time telling others how much better they are.
Also... I hate the way they wake up early to put towels on the best seats at the pool.
FDA-er here. The critique here is absolutely spot-on - I'm gob-smacked by how Matt has lined up the relative issues and weighed the subtleties (with one exception, mentioned below). What to do about it is much less well-developed. FDA is an enormous ocean liner; it can't change on a dime. Changes like these take years and are likely to produce all sorts of unintended consequences.
The point that is missing from Matt's analysis is that once a product is approved, it can in most cases be legally used in any way a medical practitioner sees fit. If Medicare or other insurers want a cost-benefit analysis to pay for a given use (particularly if that use is not FDA-approved), they can do it themselves. If it is useful from a public good standpoint for some disinterested party to do that analysis, the best model is to create an agency designed for that purpose like NICE in the
UK.
More importantly, the prospect of a NICE-type agency is anathema to the health care industry. Congress has regularly kneecapped AHRQ, the agency we have that is closest to NICE, whenever it began to take this subject seriously. There is less chance of FDA, Medicare, AHRQ or some other agency creating a sound cost-benefit framework than there is of CDC studying gun violence as a public health problem.
How much do you think that the FDA's decisions on breadth or narrowness of a drug's indication impacts all this? Obviously off-label use is rampant, but narrower indications do help commercial payors limit coverage.
The decision on breadth or narrowness depends on the studies used for approval. The drug company takes a calculated risk: if they test too broad a range of patients it may drown out evidence of benefit in a subgroup and you can't pick out a subgroup post hoc and say, "hey it worked for them" (you would have to do an additional study where that group is identified prospectively). If they test a narrow group, they get the indication for just that group and are not allowed to market it more broadly. Although there may be a whispering campaign encouraging broader use, they can get in big trouble if they are found to be behind it and the commercial payers do push back against this.
You write: "there is a lot of anxiety among both teachers and parents about Covid risk". Just as we rightly call out the vaccine-resistant (more often Republicans, though not all) for ignoring science and not taking the vaccine, we need to call out the irrationally anxious (borderline neurotic) among the other side.
Experience has shown that the COVID-19 virus isn't very dangerous to children, and they aren't a vector for spread. And evidence shows that remote learning is ineffective and especially bad for poor kids. There are risks and costs on both sides of the school debate, and we shouldn't cater to those who exaggerate the COVID side of the equation.
It's clear that schools should reopen no matter what. But it's also clear that given that schools are reopening, you'd rather more kids were vaccinated, and it's madness that it's still illegal to vaccinate young kids.
"Illegal" and "unauthorized" or "unapproved" are different things. The FDA EUA legalized distribution; it allowed the manufacturer to distribute the vaccine for public use. If a doctor vaccinates a 10-year-old, he's not going to jail. In theory, he could lose his license for exercising bad judgment or be sued for malpractice if something went wrong but in either case, he can defend himself by arguing his actions were reasonable.
Nah, it's appropriate for America to care more about American children than non-Americans. Imagine applying this standard to e.g. the Child Tax Credit - why give American kids $300/month when there are much poorer kids overseas?
That said, the current spending on Americans vs. foreigners (100s:1? trillions vs. billions) re: COVID (and everything else!) is way too skewed, and we should try and help non-Americans more than we are, especially by scaling up vaccine production by any means necessary. But denying vaccines to American kids for this reason is way too far.
This is a cute argument, but I can't imagine being convinced that the best thing *for American kids* is for them to forgo being vaccinated - just before school starts! - in favor of vaccinating people overseas. The first-order effect is so clearly negative and the second-order positive effect is very uncertain.
This is why we're sending our kids to school (1st grade) when it starts up again soon.
But...
Delta seems to spread among kids more readily than the other versions.
We can still wish our kids were vaccinated so we didn't have to worry as much.
I agree
Keep in mind that the chicken pox virus causes shingles in many people decades later. Our experience with the covid virus is still relatively short.
So? This is the same line of reasoning the vaccine-resistant use: "We don't know the long-term effects of the vaccine, so I will just wait and see." We cannot and should not wait decades to make a decision about opening up the schools.
I agree with your conclusion (cost benefit analysis). But I also think I'd vaccinate 11 year olds based on the observation of what happened to the 2 million 12 year olds that have been vaccinated instead of waiting for a phase 3 that includes 4,000 11 year olds. My point is that I think the fear of long term effects from the virus are not irrational. We have evidence that some viruses have long term effects (like herpes cold sores that reappear for the rest of your life). While no vaccine has ever demonstrated long term negative side effects.
"There has never been an mRNA vaccine, so we don't know the long term risks." Focusing on potential, unknown and unknowable risks sows fear and distrust. We can, and should, take action based on what we know now and adjust as necessary.
I thought about the novelty of the mRNA vaccine and chose to get vaccinated anyway. I disagree that people are irrational for having a different cost benefit analysis regarding sending their kids to school if everyone is unvaccinated. I am not focusing on potential longer term risks; just including them in the equation.
Respectfully, I disagree. The mask-refusers make a "different cost benefit analysis" and they are wrong. Keeping schools closed based on a "different cost benefit analysis" is also wrong.
How can it possibly be justified, morally, to vaccinate 11 year old American children - who are at *vanishingly low* risk from this virus, even the delta variant - when like 90% of elderly people in developing countries have not been vaccinated?
I just don't see how vaccinating small children is a morally sustainable solution in any kind of system of morality that acknowledges a world beyond America's borders. Doing teenagers was bad enough, but this is even worse.
How can it be justified to do anything we do for the benefit of Americans when it would all go much further overseas?
We should generally spend much more helping internationally.
But the US government has a special obligation to its own citizens, and the FDA here is acting out of risk-aversion and inertia, not concern for the welfare of the rest of the world.
Anyway, the right solution to this problem is to step up vaccine production (eg by reducing dosages) not to deny vaccines to American kids.
If we were actively shipping out doses that are sitting unused, so that there was a margin here, that reasoning would make sense.
I'd agree with you if that were the real trade-off. But it is vanishingly unlikely that deciding not to vaccinate 11year old's is going to get Congress to approve more money for vaccinating more vulnerable people abroad.
Very good point. I'd be happier if that were the reason for the FDA's delay.
The chicken pox virus causes shingles because the virus persists in neurons. Basically, the virus’s (DNA) genome is tethered to the host’s chromosomes so every time a cell copies its DNA, it copies the virus’s DNA. That’s why herpes viruses are forever. I’m not aware of any decent quality evidence that coronaviruses cause persistent infections in immune-competent people. Coronaviruses are RNA viruses so their genome is extremely unlikely to persist in a cell long term
Thanks!
Would you have any ideas about the potential causes of long covid?
For people who were in the ICU, it probably is similar to other post-ICU syndromes -- being in the ICU means you're in a bed for a long time, you lost muscle mass, and there may be damage to the organs either due to the virus or the medications they took
For people who were sick but not that sick, it's probably persistent immune activation. There is a post-viral persistent immune activation syndrome that occurs with other viruses such as influenza, so it's probably similar to long flu. As an aside, I know someone who had covid and had long-covid like symptoms for about five months after recovering from the typical symptoms. They are now fully recovered and back to normal, so it is possible that for some people long covid will go away with time.
Thanks
The UK's solution has been to separate the "is this safe and effective" determination from the cost-benefit determination.
So the EMA (before Brexit) or the MHRA (now) determines whether it is legal to prescribe a drug and then NICE (for drugs) or JCVI (vaccines) determines whether it's cost-effective and considers availability vs demand and then prioritises who should get it first if it's supply-constrained.
It is perfectly legal to pay for a private dose of a vaccine in the UK. You can't actually do so because Pfizer and Moderna have sold every dose they manufacture to governments and private suppliers don't have any.
The US separates those too. FDA decides if a drug is safe and effective enough to be legally available. And the private insurers and large health systems decide cost-effectiveness for the commercial market. And CMS (Medicare/Medicaid) sets reimbursement rates for government programs, based on requiring drug manufacturer to report the average prices paid in the private sector (simplifying a bit).
Yes, but as I suspect you know, the CMS price-setting mechanism gets gamed because it's typically a price-plus scheme and private insurers rarely make coverage decisions that are significantly different than CMS.
Not sure what you mean by price-plus. Medicaid reimburses drugs based on the lowest, or "best", price the manufacturer has negotiated with private insurers (ie, MFN pricing), or a statutory discount from the average price, whichever is lower. Medicare Part B reimburses based on Average Sale Price, or ASP, which is the average price paid by commercial customers, and Part D plans negotiate their own prices.
Agree, though, that private insurers generally haven't had much incentive or ability to control prices in any part of the healthcare system - drugs or otherwise, because they've been pass-through entities that don't really care what the absolute price is as long as their premiums exceed their outflows in a given year. And when they do try to control prices by refusing coverage or kicking providers or drugs out of their network, patients squawk and insurers get vilified by politicians.
But traditional pass-through insurer incentives are changing, as more large insurers are becoming vertically integrated and buying up providers. And naturally, they're getting criticized for that in the press too, though its actually a good systemic change that aligns incentives better.
Pet peeve: use of the term "reimbursement" as a euphemism for payment. Reimbursement is money received to offset an expense. Payment is what is given in exchange for a good or service. As you may know, once upon a time patients paid their medical bills from their own pockets then submitted a claim to their insurance to be reimbursed. Eventually it became more efficient for insurers to pay doctors and hospitals directly. The term "reimbursement" was retained by health care providers to make it appear that they could not contaminated by pecuniary incentive and filthy lucre. The euphemistic use of "reimbursement" unfairly colors the terms of discussion; there is no reason to use it. Plus all that extra typing!
Fair point. It is a little pedantic even if technically accurate...
In other he US, “private” doses of vaccine would certainly lead to profound levels of public upset.
It's hard to think of a more misguided idea than the notion FDA should refuse to approve "me too" drugs in the same therapeutic classes without proof they're more effective than the first one - unless maybe it's the idea that the way to get more affordable housing is to prohibit the construction of expensive new housing.
When there's only one drug in a class, whether it's statins for cholesterol or SGLT2 inhibitors for diabetes, or whatever, the manufacturer has more leverage to charge higher prices. When there are therapeutically equivalent alternatives, PBM and other payers that make formularies can bargain the price down by preferring the drug from the manufacturer that agrees to the biggest price concession.
Came here to say exactly this. Additionally, no two drugs have exactly the same safety profile, even those in the same class (like statins). So there may be a very good reason to prescribe Lipitor instead of Crestor for a patient based on that patient's other conditions.
Matt actually makes this point. What he criticizes is the introduction of "me too" drugs that provide no clear advantage but cost many times more than older drugs and that manufacturers still manage to sell by muddying the waters and taking advantage of blind spots in the health care system. It may make sense to prescribe Lipitor rather than Crestor for a specific patient, but Lipitor shouldn't cost 20 times as much
If it's a new class and all the drugs in it are still are still on patent, equivalent "me too" drugs introduce price competition even if they don't offer any clinical advantage.
And if some of the drugs in the class are off patent, then the only reason any right-thinking insurer would pay for one of the drugs that's still on patent is if it has a special clinical advantage for some patients who for whatever reason can't take the generic drug.
I think one thing he's saying there is that there should be one body that just considers "is this safe" and "is this effective" and decides whether or not to approve it, and another body that considers "how much does this cost" and "how effective is this" and "how safe is this" and decides what to recommend.
“…and another body that considers ‘how much does this cost’ and ‘how effective is this and ‘how safe is this’ and decides what to recommend.”
The other body is your personal physician.
Not quite - right now it's a semi-adversarial process between your insurance company and your physician. Physicians often pay zero attention to cost, and only pay attention to whether it is covered by the insurance, and the insurance company makes the decision about cost vs effectiveness, but without information about particular patients.
Physicians will pay attention to cost if you ask them to.
I'd modify that a bit and say the other body is your insurance company, or your insurance company's pharmacy benefit manager.
Whether you're on a government plan or a private, no insurance plans cover treatments that aren't "medically necessary", a concept whose definition in most plans includes an element of cost-effectiveness.
But Americans like a lot of health care, and don't like anyone telling them they can't have everything covered, so any time an insurance plan, public or private, tries too hard to enforce price controls and keep costs down, patients get mad (death panels! greedy HMOs!) and politicians respond accordingly.
One of the few disciplines we have on healthcare costs is that for people with insurance through their job, ultimately your healthcare insurance costs come out of your wages. It's a crude, weak market signal, but the share of total compensation that American employers earmark for healthcare costs are one of the few objective indicators of how much Americans are willing to spend on healthcare.
I am a big advocate of HSAs and high-deductible health plans. Each year at enrollment time I create an analysis of both the standard and the high-deductible plans that my employer offers, and I share the analysis with anyone who will listen. The way the math works out is that if you take the difference in cost of the two and make that your HSA contribution, the annual total will be just about the difference in deductibles. Once I prove out the math I point out that taking the traditional plan means that if you don’t need much healthcare over the year, and therefore do not meet the deductible, the company keeps the difference.
And we have a wide range of data that shows exactly how corrupt *that* process is, and how piss-poor the outcomes are.
Where is the data about corrupt physicians?
https://jamanetwork.com/journals/jama/fullarticle/2623606?resultClick=1
You won't call it corruption. I and everyone else do.
“The median per-physician value of general payments was $201.”
That a lot of money!
This is a pretty minor nit, but it still bugged me. Regarding Canada's one-shot strategy, MY writes: "But then you can see how first shots first worked by looking at how they caught up to and then surpassed us."
That's not why Canada is passing us by. It's because we ran out of people who wanted to get vaccinated. We hit a peak of 3.7 million shots/day in mid-April; we're under 600,000/day now. If we were populated by Canadians, we'd have a lot more vaccinated people now.
Why has historically gungho America been infected by proceduralism in the past few years?
This is a really good question!
My answers would be: (1) as the number of PhDs and professionals increases, you increase the number of people who get power, prestige and pay by insisting on procedures; (2) the economy has become so productive that many forms of decadence can flourish without having an obvious impact on living standards. Eg, the number of people living on SSDI has shot up snd this isn’t perceived as a huge problem because we can support a large non-working population.
I would also add that there's a culture war component to it.
MAGA chuds are anti-establishment, so in response I'm going to be super establishmentarian. People like Fauci becoming a villain to some will inevitably make them a folk hero to others.
I often say that most arguments I get into on the internet are more about me saying "you're too confident" rather than "you are wrong". However, the English language and the way arguments work almost always ends up with it sounds like I'm saying "you are wrong".
This dynamic supports and leads to what you're saying here.
I think there are a few things
1. Adding a process creates people with an incentive to keep the process in place for their own reasons. For instance, builders unions in California will sometimes oppose lifting housing restrictions, because they can use those restrictions as leverage to force developers to use unionized labor.
2. The Trump era (especially early on) created a situation where Democrats were able to use administrative stuff to frustrate Republicans, which may have caused a halo effect. Look at DACA and the back and forth regarding public comment.
3. Polarization by education means that Republicans are making fewer arguments about "lets make things more efficient", while at the same time Democrats are more sympathetic to skilled professional bureaucrats.
But the question is why the procedures are not designed with cost-benefit analysis?
My husband called around lots of places and got the first available vaccine - J&J (I was slightly less of a go-getter and got Moderna about 2 weeks later). Unfortunately, Walgreens (and seemingly other places) aren't approved to give out Pfizer/Moderna to previously vaccinated individuals(he tried last night - the pharmacist said they would have done it themselves but the system didn't allow it). Neither of us wanted him to lie about his vaccination status - for ethical/legal/or medical contraindication reasons (not that we think there are any of the last category).
So it may be good for J&J patients to get a dose of something else, but seems to currently not be allowed at the easy-to-access vaccine places (the local Walgreen's also made sense as a place that seems to have sufficient doses - he would not be taking them from someone who needs them more (Barring export issues to other countries - but that doesn't seem to be the limiting factor right now)
Two days ago, I got a shot of Pfizer on top of my J&J vaccine from March. I only lied by omission.
It looked to me like making an appointment would get my vaccination status checked. Certainly, it did with my insurer, Kaiser, which wouldn't even let me start making an appointment.
So I walked in to CVS. They asked me for my driver's license or an insurance card and I gave them my driver's license. The only other question they asked was whether this was for my first or second shot, which I chose to interpret as my first or second shot of Pfizer.
At that point they gave me the shot.
I think you have to lie to get another dose (or at least not mention you already had one).
In this case, the lie seems very justifiable; your husband is being prevented from taking a safe and effective medicine for no good reason, and both he and everyone else around him will be safer if he gets another shot.
For me, it wasn't really about the morality of lying, but I preferred not to get into a confrontation with anyone, and I also didn't want to get into a situation where I was denied the vaccine, so I looked for a way that was minimally lying.
I wouldn't judge anyone for doing what you did. I wouldn't do it myself (yet - if the evidence came out much stronger in favor of getting something other than J&J) I might decide to overcome my aversion a little - I don't lie to my kids but... there's the Santa clause - I trust they'll forgive me)
I think you have this wrong. I would think you have enough experience as a writer to understand how you are haunted by real or perceived bad takes. Well that works for everyone and in every business. And that is the way it works for the FDA too. And the CDC and the WHO as well. Accrued bad takes and mistakes are NEVER forgotten. Which is why the decision making processes for drug approvals are inherently conservative. And the FDA by the way is a much admired and copied institution around the world. They do, of course, have a process for dealing with exceptions and that is EUAs. And so they should.
It is probably a good thing to remember that many drugs with good efficacy (say statins) wind up getting withdrawn from the market and result in monster class action suits even though clinical trials did not reveal and could not statistically reveal lethal side effects. These often do not become evident until millions of prescriptions have been written. I seriously doubt that the long term confidence in the FDA is going to be enhanced by loosening standards and creating more fuckups. The lawyers will love it though.
My trust in the FDA has been irrecoverably shattered by their terrible, way-too-conservative handling of this pandemic. I’ll never forget their disastrous mistakes that have killed so many people and continue to kill many more.
Maybe take people like me into account when you’re weighing how to maintain public trust. There’s no reason to believe the public prefers doing nothing to doing something.
I will never forget that when Pfizer announced on Friday, November 20th, 2020 that they had just submitted their application for their vaccine EUA, the FDA issued a press release later that day saying,
“The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted.”
Then they went home for the weekend. And they took Thanksgiving off. And the next weekend. This when there were around 1,200 people in the US dying from COVID every day.
Colleague-of-colleage of mine was a drug reviewer for the FDA who died by suicide this past year, it’s said because of the intense work pressure during COVID.
My thinking about it is twofold: no such pressure seemed to have actually shown up on the timeline for vaccine and treatment approvals, and more frankly, at a rate of one death every two minutes from COVID, there being only one work-pressure-related suicide among approval panelists indicates we weren’t pressuring panelists anywhere close to hard enough.
Two thoughts:
1. If you think that a suicide has a simple and obvious explanation, you are likely wrong.
2. The FDA has shown themselves to be culturally incapable of responding to an emergency. They should never be allowed to try to do so again.
Good for you. It gets shattered a lot more when approved drugs turn out to have lethal or even damaging side effects rare though they be and get withdrawn from the market. If you consider making vaccines available to everyone who wants them a mistake I will enjoy hearing why.
Is there actual evidence that the current level of risk-aversion is optimal for public trust? It’s plausible, but it seems clear to me that the real reason for current procedure is doctors are super risk-averse and imposing their preferences on the rest of us and then backfilling justifications later.
Some mistakes from the FDA (and other public health folks):
Not allowing others to come up with a covid test and then botching their own test
Not considering challenge trials to approve vaccines faster (the worst mistake)
Never approving AstraZeneca even though Britain did (even though we had a domestic supply and vaccine shortages for months)
Not giving vaccines full approval
Slow approvals for kids (it’s been many months since the vaccines were approved for adults; why so long?)
Lying about face masks
Never studying different vaccine dosages (the biggest problem remaining today)
Not considering delaying second vaccine doses
Not telling people who got one dose of J&J to get another dose. Not studying this.
How are the FDA and CDC not facing Dodd Frank style reforms?
Not saying they shouldn't, but I think why they're not is that the party that would hold them up as villains in the pandemic story are not currently in power in the legislative or executive branches, and the party that would hold them up as heroes in the pandemic story are.
The party that believes in functioning government and regulation, should be especially motivate to address failed bureaucracy. The American people are well aware that the CDC did not succeed.
You're not wrong. The tribalism leads people to focus on the flaws of their opponents and ignore, downplay, or justify the flaws of their allies.
A few weeks after saying that the CDC shouldn't be doing cost benefit analysis and just putting out the science, you're arguing that the FDA should. This is wrong.
The FDA should be approving drugs. For an amazing vaccine, perhaps accelerated full approval makes sense, but unfortunately we have a frequentist rather than a bayesian org. (Your/Rosenthal's critiques of the FDA approving marginally useful expensive drugs is on point, but not useful for the EUA argument).
The CDC is literally there for *Control*. It should be responsible for doing what is required for controlling epidemics.
Critically, I think, this is the question. What if we had only Sinopharm or some other much more crappy much more side effect ridden vaccine? In a pandemic would *still* want to require everyone to take it. The value to the country as a whole is worth much more than the individual side effects. Once the pandemic is under control, you wouldn't want the vaccine to be used though.
To do this, in the "FDA cost effectiveness model" you'd want the FDA to approve it, and then disapprove it. This makes zero sense. The FDA doesn't even have people thinking about epidemics. The CDC, on the other hand, does have a lot of people thinking about epidemics, and should be capable of requiring a vaccine for the greater good in an emergency.
The problem is the politics - as soon as you're past the emergency, once there is no pandemic, especially if you start vaccinating early and the pandemic doesn't happen (as would be ideal) then the people who did have the side effects from the crappy vaccine start feeling quite grumpy about the whole thing.
And that's why we can't deal with an emergency. The problem is us.
When did he say CDC shouldn't do cost/benefit analysis?
I thought Matt supported the CDC reporting out facts as they know them and letting elected officials and the populace decide on how to change/not change their behaviors based on those facts. For example, I thought Matt believed that the CDC should have been upfront about the benefits of masking right away and not have engaged in a cost-benefit like analysis in opting not to recommend mask wearing to preserve PPE for frontline medical personnel.
Cost-benefit analysis sounds great until you disagree with the decision makers' weighing of the costs and benefits.
He did not say there should be no cost-benefit analysis going on, he said the CDC and other public health authorities should not be *lying about the product of that analysis* to the American people in the hopes of manipulating them to end up where they believe the best outcome to be.
He did say that the CDC does not do cost-benefit. (https://www.slowboring.com/p/cdc-normal)
Given the context in which he said it, he didn't seem to think the CDC not doing cost-benefit was a bad thing. Rather, he suggested it is something people should be aware of and act accordingly with respect to CDC guidance.
Clearly he feels very differently about the FDA.
"Biden's CDC has done the right thing — they say true things about public health."
You're right, it's a little hard to tell exactly what Matt thinks the CDC should be doing here, but it looks like model based recommendations isn't it.
The FDA definitely has people thinking about epidemics! I work with a ton of them; indeed, I’m one of them.
Learn something new! Thank you, I stand corrected. Based on what (Wikipedia says) the FDA does vs. the CDC I'm not sure I understand why. I mean, sure, to issue an EUA you have to know you have an E but surely other orgs know this? Is this just the FDA taking over part of the CDC's job?
One reason is that the FDA is more “muscular” than the CDC - I work in food, so if there’s an outbreak of Listeria in (say) ice cream, all the CDC can do is recommend that retailers pull the ice cream off the shelves and that consumers check their lot numbers and throw it away.
The FDA can actually force a manufacturer recall, force a contaminated plant to cease operations, seize and destroy affected foods, and even pursue prosecutions of company executives who acted with disregard for food safety practices to the public’s detriment. Much of that authority stems from the E coli poisonings in hamburgers (Jack in the Box) from the 90’s. I actually knew a guy whose girlfriend was in a coma for a while due to a hamburger-related E coli infection.
And of course since it’s inception the FDA has had the power to interdict the sale of food and drug products that were dangerous to public health. The FDA is a regulator; the CDC’s role is primarily in study, surveillance, and public health control of diseases. But the CDC either needs your permission or a court order to come onto your property and treat a mosquito swamp; the FDA can do it on its own authority provided you’re a facility the FDA regulates.
I think your main point (convergence of dichotomous political critics) is legitimate, and I agree with your focus on cost/benefit analysis. But something is certainly wrong, and I think it goes beyond that. Consider the outrageous failures to approve good tests at the onset of the pandemic. I'm still unclear whether primary blame lies with FDA or CDC, but it's a Fail far more consequential than the errors that led to 9/11.
Is the malfunction intrinsic to bureaucracy, or is there a clear and solvable problem? The current dysfunction even in the face of the triumph of the mRNA vaccines may allow the kind of analysis of failure that will lead to meaningful future improvements.
Whether a drug provides enough benefit to merit approval and its pricing are related but separate questions. FDA approval gives license for companies to set prices based on the FDA approval -> CMS coverage -> payor coverage and payment equation, as MY states. I don't think that FDA consideration of pricing would improve their decision-making; better would be to allow Medicare to play a negotiating role. Also, it's not a pure free-for-all. Commercial insurers choose what formulary status to give a drug. Whether a drug is covered as first-, second-, or third-line therapy by insurers has a massive impact on sales. Drug companies will generally reduce prices if they fear being assigned second- or third-line formulary status. While the resource-allocation mentality of international regulators probably does lead to different drug evaluations, it doesn't suggest making the FDA think about economic cost-benefit analysis. The UK cost benefit work is done by NHS when it decides what to cover and what to pay. That is totally distinct from the drug approval, which has been done by the European Medicines Agency (but will change to the UK post-brexit).
There are good questions as to whether the FDA could be better at weighing the medical cost-benefit of each drug it evaluates. The agency weighs these differently across different disease states and therapeutic classes. Partly this is because it relies on experts in each field (oncology, infectious disease, etc.) who bring their own biases. But patient groups, institutional bias, play a role. Some are criticizing the FDA for being risk adverse to prior failures, but is that really unfair? Wouldn't we want them to tighten standards when they find that previous standards led to ill effects?
What I most wish for is a bit better judgement from FDA. They are strict about trial protocols because there is a long history of drug companies post-hoc digging for statistically-significant findings to support claims (p-hacking their way to coverage). The FDA is right to guard against this. But then they apply this to the AZ vaccine trial, where the issue is completely different. Ultimately we have to trust regulators to exercise good judgment.
Adding to your thought that "information is a public good". I'm also frustrated that the FDA hasn't funded (do they ever actually fund studies?) a study to determine optimal dosing sizes and intervals. Since over 6 billion people on earth haven't been vaccinated yet (people that might incubate the Zeta variant), this would be incredibly valuable information to have.
I feel basically the same way. I don't know if the FDA funds anything itself per se, but I wish it would be more pro-active. On the boosters, instead of slapping Pfizer down, I wish they had said: we don't have the evidence for boosters yet, but the evidence is piling up internationally that they may be a good idea and we'd welcome trials on different options and will fast-track an effective booster authorization as soon as we see reasonable evidence. That's a pretty modest ask in the midst of a global health crisis.
The FDA does not fund studies. Pharmaceutical companies fund the studies in order to get FDA approval.
Thanks. That's something that we should consider changing.
The NIH can also fund studies, but this is of less interest to the kind of people who review grant applications.
Cost benefit and risk analysis are two big victims of this pandemic, and probably modern society as a whole.
When 1 in a million hits the headlines (whatever the subject), people go bonkers.
Half the country thinks they are dire danger from Covid. Half the people think they are at zero risk.
It explains why people think crime is going up (well it is now.... but it wasn't for the longest time).
Or why people go nuts over AR-15s despite the real danger being glocks.
The only modern exception I can think of is professional sports. They have moneyball down.
"There is a very strong presumption among public sector entities that you cannot mandate a vaccine based on an EUA."
On what is that very strong presumption based? Does it come from the FDA itself? Why is the problem not with the presumption (or whatever it is the presumption based on)?
I can only speak for military members but in that case it’s illegal. The historical reasons for this are due to the government literally experimenting on military personnel. So the FDA either needs to approve the vaccines or Congress needs to change the law.
You'd think that in an *emergency* you should be able to mandate a drug authorized for *emergency use*.