Results for “fda” 324 found
A Bloody Waste
Hemochromatosis is a disorder in which extra iron builds up in the body. A potential treatment is phlebotomy so patients with hemochromatosis want to donate blood and donate regularly. The American Red Cross, however, does not permit people with hemochromatosis to donate blood. Why not? The blood is safe and effective. The blood of these patients doesn’t have much, if any, extra iron (the iron builds up in the body not so much in the blood per se). The “problem” is that people with hemochromatosis benefit themselves by giving blood and for this reason their blood is considered tainted by the American Red Cross.
The American Red Cross, which controls about 45% of the nation’s blood supply, does not currently accept donations from people with known hemochromatosis. Everyone agrees that the blood is safe and of high quality. There is no risk of passing on a genetic disease through blood transfusions. But the Red Cross has a long-standing policy that potential donors are not allowed to receive direct compensation for their donation (beyond the usual orange juice and cookie). Because people with hemochromatosis would otherwise have to pay for their therapeutic phlebotomies, they would in effect be getting something of value for being able to donate for free. Thus the Red Cross has ruled that such donations violate their policy.
The FDA does allow patients with hemochromatosis to donate blood so long as there is no charge for phlebotomy (i.e. so long as patients don’t have an incentive to lie to obtain free phlebotomy via donation.) Some countries and some blood banks within the US do accept donations from people with hemochromatosis as do some Kaiser locations. But the American Red Cross is the biggest collector of blood and so it is very often the case that when people with hemochromatosis get a phlebotomy their blood is simply thrown away.
Once a week, Dan Gray pays to have a pint of blood taken at Franklin Memorial Hospital. And once a week, that blood is thrown out rather than donated to someone in need.
It frustrates him.
“You could take a pint out of me, a pint out of you and a pint out of somebody else and play three-pint monte with it and they wouldn’t know whose is whose,” Gray said. “As far as the analysis of it, no one would know.”
and here:
The Cape Fear Valley Blood Donor Center put out a desperate call this past week for blood donations.
…Every time Carol Barbera hears of such pleas, she gets upset. She was once an avid blood donor and would be one still.
She also has plenty of blood to give.
A medical condition requires her to have a pint of blood drawn at least every two months. The blood is perfectly usable as donor blood. Instead, it goes straight into medical waste.
The Red Cross’s antipathy towards donations from people with hemochromatosis appears to stem from a confused ethical view that incentivized donations are either “coerced” or “non-altruistic” and an old bias against paid donations coming from Titmuss. Actual studies of paid donation, however, show that incentives increased donations without reducing quality.
Thus, as far as the evidence is concerned, there are no good reasons to prohibit people with hemochromatosis from donating blood and given the repeated shortages of blood in the United States there are many good reasons for allowing them to donate.
Hat tip: The tireless Peter Jaworski.
Saturday assorted links
1. Thomas Schelling 1963-64 syllabus and final exam.
3. Transitioning to post-quantum cryptography?
6. “The FDA won’t allow European formulas to be sold here because of inane labeling concerns…”
7. “New funding effort will deploy a corps of scientist ‘scouts’ to spot innovative ideas.”
8. Biden administration seeking to stymie charter schools (NYT). #TheGreatForgetting
Thursday assorted links
2. Do beautifying filters improve your job chances?
3. Brian Eno documentary on the way.
4. FDA still crazy with the vaccines for kids. Keep in mind the only thing the “experts” have ever resigned over is when boosters were pushed through.
5. Can the Solomons PM use Chinese police to stay in power? Don’t they know about Lando K.?
6. How to read intellectuals like a portfolio. Including Ann Coulter and Matt Yglesias and yours truly, among others.
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.
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?
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).
Our regulatory state is failing us, edition #1637
The U.S. Food and Drug Administration (FDA) has authorized the SalivaDirect PCR COVID-19 test created by the Yale School of Public Health for use with pooled saliva samples.
Pooled testing allows labs to combine saliva samples from multiple individuals into a single tube and process the batch as a single test. This approach maintains the clinical sensitivity associated with the real-time reverse transcription polymerase chain reaction tests — the gold standard for detecting SARS-CoV-2, the virus that causes COVID-19 — and gives labs the ability to process the tests far more quickly. The FDA authorizes Yale-designated laboratories to use the SalivaDirect test to pool as many as five samples at a time for SARS-CoV-2 testing.
That is November 2021. In July 2020, Alex wrote: “Tyler and I have been pushing pooled testing for months.”
Better to have nothing in the meantime I guess! In the meantime, only a handful of pooled spit tests have been approved.
Here is the full piece, via DR.
What I’ve been reading
1. Stephen Crane, The Red Badge of Courage. I read this as a kid, and was surprised how well my reread held up. To the point, subtle, and with an economy of means. I hope the new Paul Auster biography of Crane (which I will read soon) will revive interest in this classic.
2. Frank Herbert, Dune Messiah. #2 in the Dune series, I disliked this one as a tot, but currently am marveling at its political sophistication. Somewhat uneven, but better than its reputation. The Wikipedia page for the book also indicates that Villeneuve is likely to do a Dune 3 based on this story.
3. Elisabeth Anderson (not the philosopher), Agents of Reform: Child Labor and the Origins of the Welfare State. Considers the political economy of child labor reform Germany, France, the United States, and the failed case of Belgium. Pathbreaking, a major advance on the extant literature. The explanations are messy rather than monocausal, but often focus on the success or failure of individual policy entrepreneurs.
4. Gordon Teskey, Spenserian Moments. No one seems to care about poor old Edmund Spenser, yet there seem to be quite a few good books about him.
5. Patrick McGilligan, Alfred Hitchcock: A Life in Darkness and Light. The best book on Hitchcock, John Nye recommended it to me eight years ago.
There is Howard Husock, The Poor Side of Town, And Why We Need It.
And Mary Roach, Fuzz: When Nature Breaks the Law.
Richard A. Williams, Fixing Food: An FDA Insider Unravels the Myths and Their Solutions, covers the food regulatory side of the FDA, and:
Markus K. Brunnermeier, The Resilient Society.