Results for “fda” 465 found
Saturday assorted links
1. Kelsey Piper on Progress Studies.
2. Was public health misinformation less of a problem in the past? (Bloomberg)
3. The Octopus plan.
4. Update on Slate (NYT).
5. The FDA still is not getting this stuff right. And Emily Oster on the same. And some game-theoretic analysis.
Your Presidential Picks
Conor Friedersdorf asks“You can appoint any American citizen to one term as president,” I wrote earlier this week, “so long as your choice has never run for president before. Who do you appoint to the White House and why?”
and gets some interesting answers including these two:
“Austin makes a case for the public-radio host Kai Ryssdal, highlighting parts of his résumé I’d never known about:
Born in the U.S., but grew up partially overseas. MA in national security studies from Georgetown. [Flew] airplanes off of aircraft carriers in the US Navy. Pentagon staff officer. U.S. Foreign Service. Great communication skills, as heard on his hit radio show Marketplace, where he breaks down economics and markets both foreign and domestic. After he left the Navy he would ride his bike to work at a Borders for $7 an hour. He’s got an unbelievably impressive résumé with real world experience in National Security, International Relations, China Policy, US Military policy, economics, and the markets. Plus he knows what it’s like to work a real job like the rest of us. And he speaks Chinese! That’s huge. I would get behind him any day of the week.
Russell picked one of my favorite public intellectuals:
I’d like to appoint Tyler Cowen as president—besides being an uber-rationalist, we should give him a chance to put his state capacity libertarianism idea into practice. He is also one of the best identifiers of talent possibly on Earth, so we know we would get a dream team administration, likely composed of heterodox thinkers of diverse and opposing views who could shake everyone out of complacency. Finally, he has studiously managed to avoid being labeled as particularly associated with either party, so it’s possible that popular opinion wouldn’t know what to make of it all, giving the Cowen administration a chance to chart some new path, independent of pre-established partisan biases. Magical thinking? Maybe, but no less than we’ve got permeating our politics now.”
Good picks. I’d imagine that Cowen would appoint a pretty good FDA commissioner, or at least try.
How many lives were lost because of the vaccines holdup?
…economist Garett Jones recently opined that Trump’s scuttled hopes to release a COVID-19 vaccine a few weeks earlier “likely would have saved at least 100,000 American lives.”
…Pfizer did not reveal its trial’s favorable results until November 9—six days after the election. The company had originally planned to consider submitting an EUA request to the FDA with just 32 data points; instead it gathered 94, and it waited another 11 days to accrue the requested safety data, plus even more data showing how well the vaccine worked, before making its filing.
…If a compassionate use program for COVID-19 vaccines had gone forward, doctors would have been able to prescribe them to nursing-home residents, even as the vaccine makers completed their clinical trials with integrity and gathered all the safety data requested under the “EUA Plus” requirements.
According to Marks, Birx asked Anthony Fauci and FDA Commissioner Stephen Hahn to encourage Pfizer and Moderna to apply for that program…
The actual timing of the COVID-19 vaccines’ release resulted from a complicated mix of bureaucratic caution, political calculations, and the choices made by vaccine manufacturers. While the benefits of the vaccines have become very clear since then, the precise human cost of that short delay remains a mystery.
Here is the full Brendan Borrell piece in The Atlantic, excellent throughout. And don’t forget Brendan’s new and exciting book The First Shots: The Epic Rivalries and Heroic Science Behind the Race to the Coronavirus Vaccine.
Via Rich Dewey.
Raise your hand if you think this is a good idea
…if the Food and Drug Administration decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone.
Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. The approach would ensure decisions are not left solely to individual vaccine manufacturers.
“We can’t have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,’” the official said, referring to the European Medicines Agency. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.”
Designed for flexbility and speedy response? I guess we’ll see. Here is the full StatNews article. And obviously, the entire public health community is up in arms about this…
The Abundance Agenda
Excellent piece by Derek Thompson:
America has too much venting and not enough inventing. We say that we want to save the planet from climate change—but in practice, many Americans are basically dead set against the clean-energy revolution, with even liberal states shutting down zero-carbon nuclear plants and protesting solar-power projects. We say that housing is a human right—but our richest cities have made it excruciatingly difficult to build new houses, infrastructure, or megaprojects. Politicians say that they want better health care—but they tolerate a catastrophically slow-footed FDA that withholds promising tools, and a federal policy that deliberately limits the supply of physicians.
The way I put it in Launching the Innovation Renaissance is that we can be an Innovation Nation or what we are now which is a Welfare-Warfare State.
To give one example, the debate over the Patient Protection and Affordable Care Act was long and vociferous. One of the reasons the debate was vociferous is that the PPACA is part of the vision of the welfare state, a redistributive vision.
How would the innovative state approach the issue of health care? From an innovation perspective two facts about health care are of great importance. First, a huge amount of health care spending is wasted. A strong consensus exists on this point from health care researchers all along the political spectrum. More money will get you a much bigger house, but once you have basic health insurance more money won’t get you much better health care. Should Bill Gates get prostate cancer, his billions will get him a private room and a personal physician, but they won’t do much to extend his lifespan beyond that of a middle-class man with the same disease.
…The second fact is that although spending more on health care now doesn’t get you much, spending more on health care research gets you a lot. It has been estimated, for example, that increases in life expectancy from reductions in mortality due to cardiovascular disease over the 1970-1990 period were worth over $30 trillion–yes, 30 trillion dollars. In other words, the gains from better health over the period 1970-1990 were comparable to all the gains in material wealth over the same period.
Looking at the future, if medical research could reduce cancer mortality by just 10 percent, it would be worth $5 trillion to U.S. citizens (and even more taking into account the rest of the world). The net gain would be especially large if we could reduce cancer mortality with new drugs, which are typically cheap to make once discovered. A reduction in cancer mortality of this size does not seem beyond reach, and the value of such a reduction in mortality far exceeds that of spending more on medical care today. Yet because the innovation vision is not central to our thinking, we overlook potentially huge improvements in human welfare.
The numbers would be higher now due to inflation, population and income growth but you get the idea.
Where are the Variant Specific Boosters?
I wasn’t shocked at the failures of the CDC and the FDA. I am shocked that our government still can’t get its act together in the third year of the pandemic. Consider how lucky, yes lucky, we have been. Here’s Eric Topol:
…the original vaccines were targeted to the Wuhan ancestral strain’s spike protein from 2019. The spike protein, no less the rest of the original SARS-CoV-2 structure, is almost unrecognizable now in the form of the Omicron strain (see antigenic drift from prior post). While there’s naturally been much focus on the extraordinary number of mutations in the receptor binding domain and the rest of the spike protein, over 50 mutations are spread out throughout Omicron, making the prior major variants of concern (Alpha, Beta, Gamma, Delta) lightweights with respect to changes in structure that are not just linear or uni-dimensional. Each mutation can interact with others (epistasis); any mutation or combination of mutations has the potential to change the 3D structure of the virus. In this sense, Omicron is an overwhelming reboot of the ancestral strain.
Omicron is very different from the Wuhan ancestral strain and it’s only a matter of luck that the vaccines continue to work and that Omicron is likely less severe than Delta. Don’t tell me that viruses evolve to be less severe over time–that isn’t correct in theory or practice. The most one might say is that a very deadly virus may be difficult to transmit but that only closes off a small part of the evolutionary design-space. There is plenty of room for transmission and lethality to both increase. So the vaccines continue to work well. We got lucky. But for how long will our luck last? Do we really have to wait for a more transmissible, more deadly, more vaccine escaping variant before we act?
Where are the variant-specific boosters? The FDA has said they would approve them quickly, without new efficacy trials so I don’t think the problem is primarily regulatory. Why not catch-up to the virus and maybe even get a jump ahead with pan-coronavirus vaccines?
More generally, in our February 2021 paper in Science my co-authors and I argued that we were still leaving trillion dollar bills on the sidewalk by not investing in more vaccine capacity. I am sorry to say that we were right. Why the failure to invest more broadly?
Mostly I blame American lethargy. After 9/11 the country was angry and united and we had troops in Afghanistan within a matter of weeks and we had taken over the country in a matter of months. For better or worse, we acted quickly and with resolve. Yet, when the virus was killing at 9/11 levels every day the public never reached the same level of anger or resolve. Even now Congress has spent trillions on unemployment insurance, business protection, money for schools and stimulus but has not passed the American Pandemic Preparedness Plan, a pretty decent, mostly science-based investment plan.
80,000 hours ranks research and investment against Global Catastrophic Biologic Risk (GCBR) as among the most pressing and yet tractable problems to work on and yet they estimate that quality-adjusted only about a billion dollars is being spent on these risks. Moreover, COVID doesn’t even count as a GCBR, i.e. 80000 hours at least recognizes that things could be much worse.
I understand that future people don’t vote but even so I expected a little bit more foresight.
Debate: The Ethics of Tuberculosis Challenge Trials
On Wed. Jan 12 there will be a live online debate on the bioethics question, If wild type tuberculosis challenge studies would be useful, would they be ethical to conduct? The debate will feature debaters from the The Rikers Debate Project:
- Jerusalem Demsas, Policy Writer at Vox.com
- Kaamilya Finley, Senior One Team Ambassador, Deloitte & Rikers Debate Project Fellow
- Charles Hopkins, President, National Action Network – PG County, Maryland & Rikers Debate Project Fellow
- Brian Patrick, Activist, Artist, & Rikers Debate Project Fellow
and will be judged by a panel of experts, policy makers and interested parties including myself:
- Gabriel Bankman-Fried, Director, Guarding Against Pandemics
- Camilla Broderick, Community Navigator for Midtown Community Court & Rikers Debate Project Fellow
- Ann M. Ginsberg, Deputy Director, TB Vaccines Global Health
- Phil Krause, Former Deputy Director, FDA/CBER/OVRR
- Jake Liang, Chief of Liver Diseases Branch & Deputy Director of Translational Research, NIDDK, NIH
- Larissa MacFarquhar, Staff Writer, The New Yorker
- Matt Memoli, Director, Clinical Studies Unit, IRP’s Laboratory of Infectious Disease, NIAID
- Jerry Sadoff, Head of Early Development, Crucell Vaccine Institute, Janssen Pharmaceutical Companies of Johnson & Johnson
- Alex Tabarrok, Professor of Economics, George Mason University
- Nikki Teran, Senior Biosecurity Fellow, The Institute for Progress
- Matthew Yglesias, Founder, Slow Boring
Should be fun. Admission is free and you can register for attendance here.
Arnold Kling’s proposal for regulatory reform
To improve our agencies’ performance, we need to think about restructuring the federal bureaucracy itself.
I propose we do so by creating two positions within the executive branch that operate in tension with each other. The first would be the chief operating officer, charged with managing the administrative agencies. The second would be the chief auditor, charged with leading a watchdog agency that monitors the administrative state for effectiveness and abuses of authority. Both the president and Congress would oversee the balance of power between the two positions.
Much like that of a private firm, the chief operating officer (COO) of the regulatory state would direct the operations of the entire executive branch, including independent agencies like the FDA, the Federal Trade Commission, the Federal Communications Commission, the Federal Reserve Board, and the Patent and Trademark Office. The COO’s charge would be to maximize operational effectiveness. He would have the authority to make decisions without the approval of the president.
Unlike presidents, who tend to enter the Oval Office without having supervised anything larger than a Senate staff, the COO should come into office with strong organizational-management experience — ideally based on having led a large, private-sector firm. This person should be familiar with the challenges of improving incentive systems, streamlining organizational processes, planning, budgeting, facilitating coordination among disparate units, articulating objectives, and aligning organizational efforts toward those objectives. He should have the authority to put this experience to work within the regulatory state.
To unravel the tangle of agencies that are the legacy of so many congressional bills, the COO should be empowered to re-organize, restructure, merge, or eliminate any existing agencies, refine their missions, and appoint their directors.
And:
With a COO in charge of managing government agencies, the roles of Congress and the president would adjust accordingly. Congress would act more like a board of directors with respect to the agencies, and the president would act more like a board chairman. The COO would assume the responsibility of presenting a plan and budget to Congress for approval, while the president would have the authority to hire and fire the COO at will. In a spirit of conservative incrementalism, we could first apply the COO model to one functional domain, such as domestic infrastructure, before extending it to the others.
The second new position — the chief auditor (CA) — would lead a powerful audit agency that provides independent evaluations of agency performance.
Wednesday assorted links
2. Composers fit “the small group theory.”
3. Mayda, Peri, and Steingress (AEA gate): “Our main contribution is to show that an increase in high-skilled immigrants decreases the share of Republican votes, while an inflow of low-skilled immigrants increases it.”
4. Paul Krugman on credibility, deficits, and inflation.
5. Half of the unvaccinated claim they wouldn’t take the Pfizer pill.
Most Popular MR Posts of the Year!
As measured by page views here are the most popular MR posts of 2021. Coming in at number 10 was Tyler’s post:
10. Best non-fiction books of 2021
Lots of good material there and well worth revisiting. Number 9 was by myself:
9. Revisionism on Deborah Birx, Trump, and the CDC
TDS infected many people but as the Biden administration quickly discovered the problems were much deeper than the president, leading to revisionism especially on the failures of the CDC and the FDA. Much more could be written here but this was a good start.
Number 8 was Tyler’s post:
8. The tax on unrealized capital gains
which asked some good questions about a bad plan.
7. We Will Get to Herd Immunity in 2021…One Way or Another
Sadly this post, written by me in January of 2021, had everything exactly right–we bottomed out at the end of June/early July as predicted. But then Delta hit and things went to hell. Sooner or later the virus makes fools of us all.
6. Half Doses of Moderna Produce Neutralizing Antibodies
One of my earlier pieces (written in Feb. 21) on fractional dosing. See also my later post A Half Dose of Moderna is More Effective Than a Full Dose of AstraZeneca. We have been slow, slow, slow. I hope for new results in 2022.
5. A few observations on my latest podcast with Amia Srinivasan
Listener’s took umbrage, perhaps even on Tyler’s behalf, at Srinivasan but Tyler comes away from every conversation having learned something and that makes him happy.
4. The Most Impressive AI Demo I Have Ever Seen
Still true. Still jaw-dropping.
3. Patents are Not the Problem!
I let loose on the Biden administration’s silly attacks on vaccine patents. Also still true. Note also that as my view predicts, Pfizer has made many licensing deals on Paxalovid which has a much simpler and easier to duplicate production process (albeit raw materials are still a problem.)
2. A Nobel Prize for the Credibility Revolution
A very good post, if I don’t say so myself, on this year’s Nobel prize recipients, Card, Angrist and Imbens.
1. How do you ask good questions?
Who else but Tyler?
To round out the top ten I’d point to Tyler’s post John O. Brennan on UFOs which still seems underrated in importance even if p is very low.
Erza Klein’s profile of me still makes me laugh, “He’s become a thorn in the side of public health experts…more than one groaned when I mentioned his name.” Yet, even though published in April many of these same experts are now openly criticizing the FDA and the CDC in unprecedented ways.
UFOs going mainstream or Tabarrok’s view of the FDA going mainstream. I’m not sure which of these scenarios was more unlikely ex ante. Strange world.
Let us know your favorite MR posts in the comments.
Sunday assorted links
1. Some red states take action to limit the power of their public health authorities.
2. Redux of my earlier post “Don’t judge Covid conditions by the current rate of Covid growth.”
3. Spencer Greenberg podcast with me:
Why might it be the case that “all propositions about real interest rates are wrong”? What, if anything, are most economists wrong about? Does political correctness affect what economists are willing to write about? What are the biggest open questions in economics right now? Is there too much math in economics? How has the loss of the assumption that humans are perfectly rational agents shaped economics? Is Tyler’s worldview unusual? Should people hold opinions (even loosely) on topics about which they’re relatively ignorant? Why is there “something wrong with everything” (according to Cowen’s First Law)? How can we learn how to learn from those who offend us? What does it mean to be a mentor? What do we know and not know about success? What is lookism? Why is raising someone else’s aspirations a high-return activity?
The Covid pandemic is not taking the very best of turns
This was emailed to me, but I am not doing a double indent…in any case I fear the person might be right…
“The prevailing sentiment is that the COVID pandemic is close to over. The vaccines are of course miraculous but we are not currently on a good trajectory.
- It is increasingly clear that two shots plus a booster of our current vaccines are the least one needs to have effective medium-term protection. Almost nowhere (least of all the US) is on track to reach this kind of coverage. The messaging in the US remains mistaken, where the CDC to this day recommends boosters only for those aged 50 and older. More broadly, the institutional confusion around boosters shows that the adults are not yet in charge.
- Even though Delta arose in the spring, we are still vaccinating (and boosting) people with the original Wuhan strain. This is insane, and probably meaningfully less effective, and yet nobody is up in arms about it.
- Severe outbreaks are manifestly possible even in exceptionally vaccinated populations, especially when booster uptake is low. See: Singapore, Gibraltar, Ireland. One should assume that almost every part of the US will see significant waves before COVID “ends”, whatever that turns out to mean. Note that just 60% of the US population is vaccinated today with two doses.
- There is early suggestive evidence from Israel that boosters may wane.
- Waning aside, it’s clear that breakthrough infections in boosted individuals are not uncommon. While the vast majority of those infections are not severe, this does mean that there will still be plenty of mutagenesis.
- It’s unclear that longitudinal cross-immunity is strong. Getting COVID is not enough to confer long-term protection. We probably can’t just “get this over with”, even if we are willing to tolerate a large number of one-time deaths.
- The currently-breaking news about the South African Nu strain shows that arguments about how the spike protein is running out of mutation search space are almost certainly wrong.
- While the fog of war is thick right now, the early data on Nu suggests that it may be a big deal. Even if it’s not, however, it has been obvious since we got the vaccines that vaccine escape is a concern. You can debate whether the probability of a vaccine escaping variant is 20% or 80%, but in any case we need effective contingency plans in place. If we fail to respond effectively to Nu, that will be a considerably greater institutional failure than anything that happened at the outset of the pandemic. We’ve had almost two years since the first COVID case and one year from the vaccine approvals to prepare. So I ask: what is the plan for the vaccine-escaping variant?
On current trends, it looks like we will probably need one of two things to effectively end the pandemic: (1) very effective COVID therapeutics (paxlovid, molnupiravir, and fluvoxamine all being candidates but my guess is that none is a silver bullet) or (2) pan-coronavirus vaccines (with broader protection than what is currently available).
It isn’t over yet.
P.S. Has any U.S. health body recommended the clinical use of fluvoxamine (an already-approved drug), or has the FDA given any guidance as to when it might approve paxlovid? If not, can they outline their reasoning? 1,600 Americans died of COVID on Nov 24.”
Milton Friedman has become underrated, but is being vindicated
That is the topic of my latest Bloomberg column, here is one excerpt of some super-simple (but neglected) arguments:
Education is another area where Friedman’s ideas seem newly relevant. Friedman was a strong supporter of school choice, but over time the movement stalled, as a variety of studies showed scholastic gains from school-voucher programs that were either modest, zero or negative. Advocates for school choice then moved on to the argument that vouchers allow parents to choose the kind of education they want for their children, whether or not test scores go up. That argument, too, went nowhere.
Then came the pandemic, when millions of American parents encountered a public school system that didn’t seem to care too much about educating their children. Schools stayed closed or offered inferior remote instruction, and generally followed their own bureaucratic imperatives. All of a sudden, home schooling, charter schools, private schools, micro-schools — in short, an entire host of “school choice” alternatives — rose in popularity. It remains to be seen how much those trends will stick, but Friedman may yet win this intellectual battle, at least partially.
And it’s not just the bureaucracy, it’s what’s taught in the classroom. Consider critical race theory and other instructional practices affiliated with wokeism. Whatever your views on this movement, it seems clear that it provokes strong and perhaps irresolvable differences among parents, teachers and administrators. Within a single public school district, those matters will probably never be settled to everyone’s satisfaction. Rather than pursuing a polarizing “fight to the death,” perhaps all sides can see that the case for school choice is stronger and more compelling than they had thought.
There are periodic attempts to knock Milton Friedman off his pedestal. For the most part, however, his legacy remains strong.
And who was the guy who predicted the recent problems with the FDA?
Thursday assorted links
1. Milton Friedman’s 1959 price theory exam.
2. The sex recession continues.
3. Questions that are rarely asked: “Does It Matter if I Eat the Stickers on Fruits and Vegetables?” (NYT) And does it matter for FDA regulatory issues?
4. New, updated results on economic growth convergence.
5. David Kedrosky on the greatest paper in economic history of all time (by Peter Temin…in his opinion).
6. New Krugman remarks on inflation.
7. David Brooks on the national conservatives (Atlantic).
The Paxlovid Paradox
Zvi at LessWrong rounds up the COVID news including this excellent bit on Pfizer’s anti-Covid pill Paxlovid which looks to be very effective but is not yet FDA approved.
The trial was stopped due to ‘ethical considerations’ for being too effective. You see, we live in a world in which:
- It is illegal to give this drug to any patients, because it hasn’t been proven safe and effective.
- It is illegal to continue a trial to study the drug, because it has been proven so safe and effective that it isn’t ethical to not give the drug to half the patients.
- Who, if they weren’t in the study, couldn’t get the drug at all, because it is illegal due to not being proven safe and effective yet.
- So now no one gets added to the trial so those who would have been definitely don’t get Paxlovid, and are several times more likely to die.
- But our treatment of them is now ‘ethical.’
- For the rest of time we will now hear about how it was only seven deaths and we can’t be sure Paxlovid works or how well it works, and I expect to spend hours arguing over exactly how much it works.
- For the rest of time people will argue the study wasn’t big enough so we don’t know the Paxlovid is safe.
- Those arguments will then be used both by people arguing to not take Paxlovid, and people who want to require other interventions because of these concerns.
- FDA Delenda Est.