Results for “fda” 461 found
Approve the AstraZeneca Vaccine Now!
Here’s Marty Makary, M.D., a professor of surgery and health policy at the Johns Hopkins University School of Medicine:
Finally, the FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine. It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute. It does not require freezing and is already approved and being administered in the United Kingdom.
Sadly, the FDA is months away from authorizing this vaccine because FDA career staff members insisted on another clinical trial to be completed and are punishing the company for inadvertently giving a half-dose of the vaccine to some people in the trial.
It’s like the FDA is holding out, pontificating existing excellent data and being vindictive against a company for making a mistake while thousands of Americans die each day.
Ironically, those in the Oxford-AstraZeneca trial who inadvertently received half the initial vaccine dose had lower infection rates. And this week Dr. Moncef Slaoui, the chief adviser to Operation Warp Speed, acknowledged that using half a dose might be a good broader strategy for the U.S. to double our supply as long our supply is severely constrained. That’s a good strategy that makes sense.
See also my post The AstraZeneca Factory in Baltimore. Thousands of people are dying every day. We have a vaccine factory ready to go. The FDA should lifts its ban on the AstraZeneca vaccine.
Be Prepared! Sars-COV-3
The federal government was unprepared for the pandemic, despite multiple, loud and clear warnings. State and local governments were unprepared for vaccines, despite multiple, loud and clear warnings. The Capitol Police were unprepared for rioters, despite multiple, loud and clear warnings.
The record isn’t good but as a Queen’s Scout I persist. We now have multiple, loud and clear warnings that new variants of the SARS-COV II virus are more transmissible and thus much more dangerous. But we can do something. As wrote in The New Strain and the Need for Speed
One of the big virtues of mRNA vaccines is that much like switching a bottling plant from Sprite to 7-Up we could tweak the formula and produce a new vaccine using exactly the same manufacturing plants. Moreover, Marks and Hahn at the FDA have said that the FDA would not require new clinical trials for safety and efficacy just smaller, shorter trials for immune response (similarly we don’t do new large-scale clinical trials for every iteration of the flu vaccine.) Thus, if we needed it, we could modify mRNA vaccines (not other types) for a new variant in say 8-12 weeks.
Thus, let’s start doing much more sequencing to discover new strains–and also think about potential new strains–and start phase I and phase II trials of new vaccines. Florian Krammer suggested an even more ambitious plan to do the same thing for all potential pandemic viruses:
From each of the identified virus families, which should certainly include the Paramyxoviridae, Orthomyxoviridae, and Coronaviridae families, a handful of representative strains with the highest pandemic potential should be selected for vaccine production. Up to 50–100 different viruses could be selected and this would broadly cover all phylogenies that may give rise to pandemic strains….It should be possible to choose candidates that are close to viruses that might emerge in the human population. The idea is that once viruses are selected, vaccines can be produced in different platforms and tested in phase 1 and phase 2 trials with some of the produced vaccine being stockpiled. This would likely cost 20–30 million US dollars per vaccine candidate resulting in a cost of 1–3 billion US dollars.
What I am suggesting is less ambitious–just do this for Sars-COV-3, 4, 5 and 6. But do it now!
Hat tip: Daniel Bier.
Broken Record Addendum: We should make better use of our limited vaccine supply by moving to First Doses First and/or fractional dosing and approve the AstraZeneca vaccine immediately and spend billions to increase the rate of vaccinations and to speed new vaccines (such as those from J&J and Novavax) to market.
A legal and regulatory question about First Doses First
It isn’t clear to me who in the United States is legally entitled to make this decision. An FDA EUA is required before a vaccine can be used in the U.S. But once an EUA has been issued, is “off-label use” permitted? The CDC’s Advisory Committee on Immunization Practices recommends how scarce vaccine doses should be prioritized, but “states” (governors?) are free to make contrary prioritization decisions. Can states also decide to give half-doses or lengthen the interval between first and second doses? Can a hospital, a nursing home, or an individual doctor make such a decision? (If so, can it also deviate from its state prioritizations?) Can HHS or the President specify how these decisions must be made, or alternatively can they explicitly free lower-level decision-makers to use their own judgment?
You’re not a specialist in pharmaceutical law, I realize. But I doubt you’ll let that stop you! When you recommend a less risk-averse approach to COVID-19 vaccination, to whom are you addressing the recommendation? Who has a right to implement it?
That is from MR reader Peter Sandman. Can any MR reader inform us on this?
Tuesday assorted links
1. Comment on the electoral fraud result.
2. Sadie Alexander in Teen Vogue.
3. Saudi Arabia lifts blockade of Qatar.
4. Virginia just barely reaching twenty percent distribution.
5. Good Ivermectin results? And more here. Speculative.
6. A modeling exercise favoring First Dose First, the most extensive treatment I have seen to date.
First Doses First? — show your work!
Alex has been arguing for a “First Doses First” policy, and I find his views persuasive (while agreeing that “halfsies” may be better yet, more on that soon). There are a number of numerical attempts to show the superiority of First Doses First, here is one example of a sketched-out argument, I have linked to a few others in recent days, or see this recent model, or here, here is an NYT survey of the broader debate. The simplest numerical case for the policy is that 2 x 0.8 > 0.95, noting that if you think complications overturn that comparison please show us how. (Addendum: here is now one effort by Joshua Gans).
On Twitter I have been asking people to provide comparable back-of-the-envelope calculations against First Doses First. What is remarkable is that I cannot find a single example of a person who has done so. Not one expert, and at this point I feel that if it happens it will come from an intelligent layperson. Nor does the new FDA statement add anything. As a rational Bayesian, I am (so far) inferring that the numerical, expected value case against First Doses First just isn’t that strong.
Show your work people!
One counter argument is that letting “half-vaccinated” people walk around will induce additional virus mutations. Florian Kramer raises this issue, as do a number of others.
Maybe, but again I wish to see your expected value calculations. And in doing these calculations, keep the following points in mind:
a. It is hard to find vaccines where there is a recommendation of “must give the second dose within 21 days” — are there any?
b. The 21-day (or 28-day) interval between doses was chosen to accelerate the completion of the trial, not because it has magical medical properties.
c. Way back when people were thrilled at the idea of Covid vaccines with possible 60% efficacy, few if any painted that scenario as a nightmare of mutations and otherwise giant monster swarms.
d. You get feedback along the way, including from the UK: “If it turns out that immunity wanes quickly with 1 dose, switch policies!” It is easy enough to apply serological testing to a control group to learn along the way. Yes I know this means egg on the face for public health types and the regulators.
e. Under the status quo, with basically p = 1 we have seen two mutations — the English and the South African — from currently unvaccinated populations. Those mutations are here, and they are likely to overwhelm U.S. health care systems within two months. That not only increases the need for a speedy response, it also indicates the chance of regular mutations from the currently “totally unvaccinated” population is really quite high and the results are really quite dire! If you are so worried about hypothetical mutations from the “half vaccinated” we do need a numerical, expected value calculation comparing it to something we already know has happened and may happen yet again. When doing your comparison, the hurdle you will have to clear here is very high.
When you offer your expected value calculation, or when you refuse to, here are a bunch of things you please should not tell me:
f. “There just isn’t any data!” Do read that excellent thread from Robert Wiblin. Similar points hold for “you just can’t calculate this.” A decision to stick with the status quo represents an implicit, non-transparent calculation of sorts, whether you admit it or not.
g. “This would risk public confidence in the vaccine process.” Question-begging, but even if true tell us how many expected lives you are sacrificing to satisfy that end of maintaining public confidence. This same point applies to many other rejoinders. It is fine to cite additional moral values, but then tell us the trade-offs with respect to lives. Note that egalitarianism also favors First Doses First.
h. “We shouldn’t be arguing about this, we should be getting more vaccines out the door!” Yes we should be getting more vaccines out the door, but the more we succeed at that, as likely we will, the more important this dosing issue will become. Please do not try to distract our attention, this one would fail in an undergraduate class in Philosophical Logic.
i. Other fallacies, including “the insiders at the FDA don’t feel comfortable about this.” Maybe so, but then it ought to be easy enough to sketch for us in numerical terms why their reasons are good ones.
j. All other fallacies and moral failings. The most evasive of those might be: “This is all the more reason why we need to protect everyone now.” Well, yes, but still show your work and base your calculations on the level of protection you can plausibly expect, not on the level of protection you are wishing for.
At the risk of venturing into psychoanalysis, it is hard for me to avoid the feeling that a lot of public health experts are very risk-averse and they are used to hiding behind RCT results to minimize the chance of blame. They fear committing sins of commission more than committing sins of omission because of their training, they are fairly conformist, they are used to holding entrenched positions of authority, and subconsciously they identify their status and protected positions with good public health outcomes (a correlation usually but not always true), and so they have self-deceived into pursuing their status and security rather than the actual outcomes. Doing a back of the envelope calculation to support their recommendation against First Doses First would expose that cognitive dissonance and thus it is an uncomfortable activity they shy away from. Instead, they prefer to dip their toes into the water by citing “a single argument” and running away from a full comparison.
It is downright bizarre to me — and yes scandalous — that a significant percentage of public health experts are not working day and night to produce and circulate such numerical expected value estimates, no matter which side of the debate they may be on.
How many times have I read Twitter threads where public health experts, at around tweet #11, make the cliched call for transparency in decision-making? If you wish to argue against First Doses First, now it is time to actually provide such transparency. Show your work people, we will gladly listen and change our minds if your arguments are good ones.
Half-Doses as Good as Full?
NYTimes: A top official of Operation Warp Speed floated a new idea on Sunday for stretching the limited number of Covid-19 vaccine doses in the United States: Halving the dose of each shot of Moderna’s vaccine to potentially double the number of people who could receive it.
Data from Moderna’s clinical trials demonstrated that people between the ages of 18 and 55 who received two 50-microgram doses showed an “identical immune response” to the standard of two 100-microgram doses, said the official, Dr. Moncef Slaoui.
Dr. Slaoui said that Operation Warp Speed was in discussions with the Food and Drug Administration and the pharmaceutical company Moderna over implementing the half-dose regimen. Moderna did not respond immediately to a request for comment.
Each vaccine would still be delivered in two, on-schedule doses four weeks apart, Dr. Slaoui said in an interview with “CBS’s Face the Nation.” He said it would be up to the F.D.A. to decide whether to move forward with the plan.
Half dosing would double Moderna doses permanently rather than temporarily (as with First Doses First). Thus, I would be very happy to see half-dosing and it would obviate the need for FDF.
I and a handful of others started to discuss and advocate First Doses First on Dec. 8 and many times since then. The advocacy was then joined by Tony Blair and by many epidemiologists, immunologists, vaccine researchers, physicians and public health experts as well, of course, by the British experts on the Joint Committee on Vaccination and Immunisation. It’s clear that the FDA and Operation Warp Speed are now feeling the pressure to take some serious actions to increase supply. If so, my small efforts will have had a very high return.
Keep the pressure on.
Addendum: By the way, the British have yet to approve the Moderna vaccine (probably because they can’t get doses for some time anyway) and the AstraZeneca vaccine appears to work better with a longer dosing interval. So FDF makes sense for the British and we can do half-dosing on Moderna, potentially setting a new and beneficial standard for the entire world.
The New Strain and the Need for Speed
I was going to write a long blog post on the new strain but Zeynep Tufekci has written an excellent piece for The Atlantic. I will quote from it and add a few points.
One of the big virtues of mRNA vaccines is that much like switching a bottling plant from Sprite to 7-Up we could tweak the formula and produce a new vaccine using exactly the same manufacturing plants. Moreover, Marks and Hahn at the FDA have said that the FDA would not require new clinical trials for safety and efficacy just smaller, shorter trials for immune response (similarly we don’t do new large-scale clinical trials for every iteration of the flu vaccine.) Thus, if we needed it, we could modify mRNA vaccines (not other types) for a new variant in say 8-12 weeks. As Zeynep notes, however, the vaccines are very likely to work well for the new variant. It’s nice to know, however, that we do have some flexibility.
The real worry is not that the vaccines won’t work but that we won’t get them into arms fast enough. We were already going too slow but in a race against the new more transmissible variant we are looking like tortoises.
A more transmissible variant of COVID-19 is a potential catastrophe in and of itself. If anything, given the stage in the pandemic we are at, a more transmissible variant is in some ways much more dangerous than a more severe variant. That’s because higher transmissibility subjects us to a more contagious virus spreading with exponential growth, whereas the risk from increased severity would have increased in a linear manner, affecting only those infected.
Here’s a key example from epidemiologist Adam Kucharski:
As an example, suppose current R=1.1, infection fatality risk is 0.8%, generation time is 6 days, and 10k people infected (plausible for many European cities recently). So we’d expect 10000 x 1.1^5 x 0.8% = 129 eventual new fatalities after a month of spread. What happens if fatality risk increases by 50%? By above, we’d expect 10000 x 1.1^5 x (0.8% x 1.5) = 193 new fatalities.
Now suppose transmissibility increases by 50%. By above, we’d expect 10000 x (1.1 x 1.5)^5 x 0.8% = 978 eventual new fatalities after a month of spread.
…the key message: an increase in something that grows exponentially (i.e. transmission) can have far more effect than the same proportional increase in something that just scales an outcome (i.e. severity).
I argued that the FDA should have approved the Pfizer vaccine, on a revocable basis, as soon as the data on the safety and efficacy of its vaccine were made available around Nov. 20. But the FDA scheduled it’s meeting of experts for weeks later and didn’t approve until Dec. 11, even as thousands of people were dying daily. We could have been weeks ahead of where we are today. Now the epidemiologists are telling us that weeks are critical. As Zeynep notes holding back second doses looks like a clear mistake and the balance of the evidence also suggests we should move to first doses first:
All this means that the speed of the vaccine rollout is of enormous importance.
…Meanwhile, the United States was reportedly planning to hold back half the vaccine it has in freezers as a hedge against supply-chain issues, and some states may be slowed down by murky prioritization plans. Scott Gottlieb—the former FDA chief and a current board member of Pfizer—has argued that the U.S. should also go ahead with vaccinating as many people as possible right now and trust that the supply chain will be there for the booster. Researchers in Canada—where some provinces decided to vaccinate now as much as possible without holding half in reserve, and will administer the booster with future supplies—estimate that this type of front-loading can help “avert between 34 and 42 per cent more symptomatic coronavirus infections, compared with a strategy of keeping half the shipments in reserve.” (Note that this strategy, which is different from the one the United Kingdom just announced it will adopt in prioritizing the first dose, does not even necessarily involve explicitly changing booster timing protocols in order to maximize vaccination now; it just means not waiting to get shots into arms when the vaccines are currently available.) These were already important conversations to have, but given the threat posed by this new variant, they are even more urgent.
Perhaps most critically, the FDA should approve the AstraZeneca vaccine if not as part of Operation Warp Speed then on a right to try basis. We need every weapon in the arsenal. How many times must we learn not to play with exponential matches?
Addendum: See also this excellent Miles Kimball post, How Perfectionism Has Made the Pandemic Worse.
Most Popular MR Posts of the Year
Here is a selection of the most popular MR posts of 2020. COVID was a big of course. Let’s start with Tyler’s post warning that herd immunity was fragile because it holds only “for the current configuration of social relations”. Absolutely correct.
The fragility of herd immunity
Tyler also predicted the pandemic yo-yo and Tyler’s post (or was it Tyrone?) What does this economist think of epidemiologists? was popular.
Tyler has an amazing ability to be ahead of the curve. A case in point, What libertarianism has become and will become — State Capacity Libertarianism was written on January 1 of last year, before anyone was talking about pandemics! State capacity libertarianism became my leitmotif for the year. I worked with Kremer on pushing government to use market incentives to increase vaccine supply and at the same repeatedly demanded that the FDA move faster and stop prohibiting people from taking vaccines or using rapid tests. As I put it;
Fake libertarians whine about masks. Real libertarians assert the right to medical self-defense and demand access to vaccines on a right to try basis.
See my 2015 post Is the FDA Too Conservative or Too Aggressive for a good review of ideas on the FDA. A silver lining of the pandemic may be that more people realize that FDA delay kills.
My historical posts the The Forgotten Recession and Pandemic of 1957 and What Worked in 1918? and the frightening The Lasting Effects of the the 1918 Influenza Pandemic were well linked.
Outside of COVID, Tyler’s 2005 post Why did so many Germans support Hitler? suddenly attracted a lot of interest. I wonder why?
Policing was also popular including my post Why Are the Police in Charge of Road Safety? which called for unbundling the police and my post Underpoliced and Overprisoned revisited.
Tyler’s great post The economic policy of Elizabeth Warren remains more relevant than I would like. On a more positive note see Tyler’s post Best Non-Fiction Books of the Year.
One of the most popular posts of the year and my most popular post was The Gaslighting of Parasite.
But the post attracting the most page views in 2020 by far, however, was Tyler’s and it was…
You people are weird. Don’t expect more UFO content this year. Unless, well you know.
Vaccinate, 24/7
On Christmas I tweeted:
Operation Warp Speed makes me think that America isn’t finished. We have now vaccinated more people than any other country in the world.
I hope Biden awards Slaoui, Perna, Marks and Bourla the Presidential Medal of Freedom.
and a bit later “Today we celebrate. Tomorrow back to demanding more, faster.” Well, it’s tomorrow and we do need to do more, faster. Israel, for example, is doing better than the United States on vaccinations per capita and they are rolling out 24/7 vaccination clinics.
Health Minister Yuli Edelstein called Thursday to keep the vaccine operation going 24 hours a day, 7 days a week, including on Shabbat.
Regarding the push to carry out vaccinations on Shabbat, Edelstein, who is Orthodox, cited the Jewish legal principle of saving a life, or “pikuah nefesh,” which trumps nearly all other religious requirements.
According to a Channel 12 report Saturday, Clalit, Israel’s largest health maintenance organization, will open 24/7 vaccination centers in Tel Aviv, Haifa and Herzliya in the coming days to help ramp up the pace of the vaccine drive. Additional centers are expected to be opened at a later date.
Israeli hospitals are also to join the vaccination effort next week, and hundreds of IDF medics will also participate, to help expedite the process.
Also, if Britain approves the AZ vaccine this week, as I think they will, it should be immediately approved in the United States, if not as part of Operation Warp Speed then on a right to try basis until fully FDA approved.
Dr. Fauci, Straussian
Recently, a figure to whom millions of Americans look for guidance — Dr. Anthony S. Fauci, an adviser to both the Trump administration and the incoming Biden administration — has begun incrementally raising his herd-immunity estimate.
In the pandemic’s early days, Dr. Fauci tended to cite the same 60 to 70 percent estimate that most experts did. About a month ago, he began saying “70, 75 percent” in television interviews. And last week, in an interview with CNBC News, he said “75, 80, 85 percent” and “75 to 80-plus percent.”
In a telephone interview the next day, Dr. Fauci acknowledged that he had slowly but deliberately been moving the goal posts. He is doing so, he said, partly based on new science, and partly on his gut feeling that the country is finally ready to hear what he really thinks.
Hard as it may be to hear, he said, he believes that it may take close to 90 percent immunity to bring the virus to a halt — almost as much as is needed to stop a measles outbreak.
Asked about Dr. Fauci’s conclusions, prominent epidemiologists said that he might be proven right…
Dr. Fauci said that weeks ago, he had hesitated to publicly raise his estimate because many Americans seemed hesitant about vaccines, which they would need to accept almost universally in order for the country to achieve herd immunity.
Here is the full NYT story. A few points:
1. Surely Straussianism by now should be persuasive as a general theory.
2. Fauci is idolized by many as a kind of anti-Trump, but he is a terrible risk communicator, as evidenced also by his recent attacks on some of the “lesser” vaccines (which still would work if applied collectively). Not to mention his earlier remarks on masks, and also the mid-March safety of cruises. How a person understands Fauci is in fact a pretty good litmus test.
3. Should you be trusting everything the insiders are telling you about FDA processes?
4. I genuinely do not know what the herd immunity threshold is, but I assure you I am trying to tell you the truth on this one (and other matters). My Straussianism is not a normative theory of my own communication, but rather a positive theory of how the world works, and it has been vindicated once again.
The Tremendous Success of Operation Warp Speed
I am annoyed at Fauci for the second time, this time for dissing the AZ vaccine:
But even if the vaccine ends up being approved, it will probably only have an efficacy of 60 to 70 percent. “What are you going to do with the 70 percent when you’ve got two (vaccines) that are 95 percent? Who are you going to give a vaccine like that to?” Anthony Fauci, the leading American expert on vaccines, recently wondered.
This attitude is counter-productive. As I wrote earlier:
In the big picture, the efficacious of a vaccine doesn’t matter per se what matters is getting to herd immunity. If you have a less efficacious vaccine you need to vaccinate more people but herd immunity is herd immunity, i.e. vaccines mostly protect people not because they are efficacious but because we reach herd immunity.
As a result, it can be much better to start vaccinating now with a 70% efficacious vaccine than wait for a 95% efficacious vaccine–thus, we need to encourage early vaccination. Indeed the AZ vaccine ought to be approved immediately (I predict the UK will approve by next week) and be made available to anyone who doesn’t want to wait for another vaccine.
For the next year or two, we will be operating under conditions of scarcity and we need to use every tool at our disposal. A 70% effective vaccine is great, well above what the FDA required and better than the flu vaccine. If you live in a country in which everyone has been vaccinated you won’t give a damn whether they were vaccinated with a 95% effective vaccine or a 70% effective vaccine–both will give you nearly 100% safety and allow life to return to normal.
Les priorités
F.D.A. Wants to Stop Regulating French Dressing
The federal agency said it was seeking to revoke its definition for the carrot-colored dressing, effectively erasing a government-required list of ingredients at the request of an industry group…the federal government has shown great interest in the humble dressing, painstakingly regulating since 1950 the ingredients that it must contain and revising the rules at least five times since then…
The lengthy and legalistic regulations for French dressing require that it contain vegetable oil and an acid, like vinegar or lemon or lime juice. It also lists other ingredients that are acceptable but not required, such as salt, spices and tomato paste.
Ahem. Here is the full NYT story.
p.s. It is disgusting, and it is not even French.
Friday assorted links
2. Don Boudreaux open letter to me. Here is my original post, and here is AIER being useful. If the GBD had been this second link here, I would be wrong. But it wasn’t.
3. Chinese to vaccinate 50 million for lunar new year.
4. Model and evidence for the IPO market being efficient.
5. Why Iger is a bad pick for ambassador to China.
6. Whether you agree or not, the method and approach of the government/CDC here on vaccine allocation are so low quality as to almost defy belief. Again, whether or not you are convinced by Matt Yglesias, his simple Substack on this same question did a better job (and at a profit, presumably!). A useful reminder for those of you who “blame the CDC problems on Trump.” Here is related NYT coverage. And never forget Glazer. Why do we not prioritize men, who are at higher risk? And from “an expert in ethics.”
8. “Atlantic City has launched an auction in which the winner will get to virtually push the button that starts the long-anticipated implosion of the former Trump Plaza Hotel and Casino building.” Link here.
Can You Hear Me Now? No.
I know, I know, you are tired of me beating on the FDA. Too bad. The beatings will continue until mortality improves.
Today’s beating, however, concerns hearing aids rather than than vaccines. The current system, much like the optometry racket, requires that hearing aids be purchased through an audiologist:
WEBMD: A pair of hearing aids runs $5,600 on average — a cost that health insurance doesn’t typically pick up. In order to get the devices, people with hearing loss must have a medical exam to rule out the slim chance of a serious medical problem that is causing the hearing loss, or they must sign a waiver opting out of the exam. You can only buy hearing aids through an audiologist or a licensed hearing aid dispenser, who is authorized to test hearing and sell hearing aids.
…choosing a hearing professional limits a person’s hearing aid choices, and changing audiologists as a result of location or personal preference could require a person to change hearing aids, too.
Due in part to these hurdles, once a person starts to lose their hearing, they wait an average of 7 years before they seek help.
The NYTimes continues the story:
By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration….in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.
Of course, the FDA is likely to miss the deadline. But even I am willing to cut them some slack, given other more pressing concerns. The real issue, however, is one that the NYTimes doesn’t confront and that is why does the FDA regulate hearing aids at all?
Headphones and earbuds are not regulated as medical devices and hearing aid technology is similar to hearings buds with a sophisticated equalizer. Indeed, you can even buy “personal sound amplification products” that are not FDA regulated or approved. It’s only the somewhat arbitrary declaration that these products are “medical devices” that brought them under FDA regulation to the detriment of consumers. The National Academy of Sciences report agrees writing:
FDA has established regulations for hearing aids, including quality system regulation requirements, mandatory labeling, and pre-purchase medical evaluation (or a documented waiver). These regulations, along with a number of state regulations, have largely restricted the availability of hearing aids to being mainly dispensed through medical, audiology, or hearing instrument specialist venues.
…In examining the Food and Drug Administration’s (FDA’s) requirements for physician evaluation prior to obtaining hearing aids, the committee finds no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit.
Addendum: In some positive news the FDA lifted its ban on the first non-prescription, at-home SARS-COV test and also on a prescription, paper-strip test. Now all we need is a non-prescription paper-strip test! Come on guys.
From David Splinter, from my email
This is all David:
A related paper by BEA came out today with their updated distributional estimates of personal income. Marina Gindelsky has done a lot of work to produce these estimates.
I have a couple new papers on tax progressivity and redistribution that may be of interest to you. Both used CBO data to avoid the PSZ-AS differences. Abstracts below.
The first paper is about the ends of the distribution: tax progressivity has increased significantly since 1979 (and steadily since 1986) due to more generous tax credits for the bottom, while average tax burdens of the top have been relatively unchanged because lower marginal rates were offset by decreased use of tax shelters. The online appendix shows why the CBO estimates differ from those of Saez and Zucman (see Fig. B7 at the end; it’s mostly due to refundable credits at the bottom and imputed income at the top) and the Heathcote et al. paper you blogged about a couple months ago (it’s technical differences and their inclusion of some transfers, but their most similar measure of tax progressivity was not flat—it increased 21 percent since 1979).
The second paper, with Adam Looney and Jeff Larrimore, is about the middle of the distribution. Since 1979, we found that non-elderly middle-class market income increased 39 percent in real per person terms. The increase was 57 percent when accounting for taxes and transfers. This seems to fit with the “updated” view of stagnation—expanding male wages to also look at untaxed compensation and including female compensation and taxes/transfers shows larger median growth. But there was a structural break in 2000. Before then, middle-class incomes grew at the same rate before and after taxes and transfers, and since then income after taxes and transfers grew three times faster (Fig. 6 on page 19). We don’t discuss the recent market income slowdown (maybe related to the debated labor share break around 2000), but we show that the additional fiscal support that filled the gap looks like an unsustainable way to boost middle-class disposable incomes going forward.”