Category: Uncategorized
What is the FDA Doing Now??!
My long-running skepticism about the safety and efficacy of the FDA is fast becoming conventional wisdom. Even normal people can’t believe what they are doing. This piece on the FDA in the New York Times reads like something I might have written for CATO.
An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.
…the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.
…the Seattle program …has wide backing, including from public health leaders, the Fred Hutchinson Cancer Research Center and Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.
Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it had “emerged as leading lights in this whole Covid-19 crisis.” He said it was “bizarre” that the F.D.A. would halt such a project.
By the way, Dr. Helen Chu, one of the leaders of the Seattle project, was one of the first Emergent Ventures prize winners for her work fighting the coronavirus (excellent pick, Tyler!). As you may recall, Chu started testing for coronavirus in an already running flu study without permission. Until she was shut down.
To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.
By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.
Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.
The failure to tap into the flu study, detailed here for the first time, was just one in a series of missed chances by the federal government to ensure more widespread testing during the early days of the outbreak, when containment would have been easier. Instead, local officials across the country were left to work in the dark as the crisis grew undetected and exponentially.
History repeats itself, first as tragedy then as farce.
Addendum: I see now that Tyler covered this a bit earlier in the post below. I’ll leave this post up, however, as I have more details including Tyler’s connection.
The F.D.A. halts a virus testing program backed by Bill Gates
An innovative coronavirus testing program in the Seattle area — promoted by billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.
Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases in a program based on home test kits sent out to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns.
But the research groups and the public health department of Seattle and King County, which had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the U.S. Food and Drug Administration directed the partnership to cease its testing and reporting until the agency grants further approval.
Here is the NYT link, ahem.
Friday assorted links
1. Did the dual-career model peak in the mid-1990s?
2. Long summit on vaccines, long video, many top names represented.
3. List of possible coronavirus benefits?
4. Notes on the dynamics of subsequent epidemic waves.
5. Tokyo deaths do not seem to be up. What is the best model for this?
6. What is school in Denmark looking like these days?
7. David Beckworth on the ngdp gap.
8. Budget allocation cuts going to higher ed appear to be brutal. Again, the “free college” idea is a complete non-starter.
10. NYT covers Navy reports of UFOs, and no they’re not just a few simple, repeated optical illusions like maybe you saw in that YouTube video, for instance radar evidence too.
How to think about uni-disciplinary advice
Let’s say its 1990, and you are proposing an ambitious privatization plan to an Eastern bloc county, and your plan assumes that the enacting government is able to stay on a non-corrupt path the entire time.
While your plan probably is better than communism, it probably is not a very good plan. A better plan would take sustainability and political realities into account, and indeed many societies did come up with better plans, for instance the Poland plan was better than the Russia plan.
It would not do to announce “I am just an economist, I do not do politics.” In fact that attitude is fine, but if you hold it you should not be presenting plans to the central government or discussing your plan on TV. There are plenty of other useful things for you to do. Or the uni-disciplinary approach still might be a useful academic contribution, but still displaced and to be kept away from the hands of decision-makers.
Nor would it do to claim “I am just an economist. The politicians have to figure the rest out.” They cannot figure the rest out in most cases. Either stand by your proposed plan or don’t do it. It is indeed a proposal of some sort, even if you package it with some phony distancing language.
Instead, you should try to blend together the needed disciplines as best you can, consulting others when necessary, an offer the best plan you can, namely the best plan all things considered.
That might fill you with horror, but please recall from Tetlock that usually the generalists are the best predictors.
Ignoring other disciplines may be fine when there is no interaction. When estimating the effects of monetary policy, you probably can do that without calculating how many people that year will die of air pollution. But you probably should not ignore the effects of a major trade war, a budgetary crisis (“but I do monetary policy, not fiscal policy!”), or an asteroid hurtling toward the earth.
If that is too hard, it is fine to announce your final opinion as agnostic (and explain how you got there). You will note that when it comes to blending economics and epidemiology, my most fundamental opinion is an agnostic one.
This is all well-known, and it has been largely accepted for some time now.
If a public health person presents what is “only an estimate of public health and public health alone” to policymakers, I view it as like the economist in 1990 who won’t consider politics. Someone else should have the job. Right now public health, politics, and economics all interact to a significant extent.
And if you present only one of those disciplines to a policymaker, you will likely confuse and mislead that policymaker, because he/she cannot do the required backward unthreading of the advice into its uni-dimensional component. You have simply served up a biased model, and rather than trying to identify and explain the bias you are simply saying “ask someone else about the bias.”
If an economist claims he is only doing macroeconomics, and not epidemiology (as Paul Krugman has said a few times on Twitter), that is flat out wrong. All current macro models have epidemiology embedded in them, if only because the size of the negative productivity and negative demand shock depends all too critically on the course of the disease.
It is fine to be agnostic, preferably with structure to the opinion. It is wrong to hide behind the arbitrary division of a discipline or a field.
We need the best estimates possible, and presented to policymakers as such, and embodying the best of synthetic human knowledge. Of course that is hard. That is why we need the very best people to do it.
Addendum: You might try to defend a uni-disciplinary approach by arguing a decision-maker will mainly be fed other, biased uni-disciplinary approaches, and you have to get your discipline into the mix to avoid obliteration of its viewpoint. But let’s be clear what is going on here: you are deliberately manipulating with a deliberately non-truthy approach (I intend those words as a description, not a condemnation). If that’s what it is, I wish to describe it that way! I’ll also note I’ve never done that deliberately myself, and that is along many years of advising at a variety of levels. I’d rather give the best truthful account as I see it.
Request for requests
I haven’t asked for a while — so what would you all like to read more about on MR?
Thursday assorted links
1. The dark side of Coase: a crypto tale.
2. The Covid-19 rave culture that is German.
3. Wisconsin Supreme Court rejects stay-at-home order (NYT).
4. How much of health care spending is discretionary?
5. What it is like to land in Hong Kong and try to enter (recommended, short photo essay).
6. New data from France. And a Twitter thread on same.
7. What is the cost of reining in wild horses?
8. World 2.0: chess does indeed move to the internet, and Magnus Carlsen is calling the shots.
9. Is Virginia mixing up its test results and reporting the wrong numbers?
10. I find this kind of defense convincing for many research efforts, but not for actual real world problems with immediate decisions to be made: “I don’t know the 2 Swedish models in question but in general it is disingenuous to say the models that do not try to take into account changes in human behavior failed because people behaved in ways the models didn’t model. The models were upfront about the scenarios addressed.”
Will Our Military State Fail Us?
I always assumed that for all its failings the US government was good at blowing things up. Now, I am not so sure. We did better than I expected in Desert Storm and I don’t blame the military for failures in Iraq and Afghanistan but those were not exactly major powers. I certainly don’t want war but could we handle one if it came to us? David Ignatius writing in the Washington Post says no:
The general lesson still has yet to sink in
Apple Store’s Temperature Checks May Violate EU Privacy Rules, Says German Data Protection Office
Of course they do. And yes, I know that is a small thing, and furthermore temperature checks may not even be effective.
The general point is this: you cannot over the longer run have a society based on such inflexible rules of adjustment. For decades it may seem possible, due to underlying stasis, but eventually the truth will be revealed. No single anecdote will be so convincing, and it will take a long time for the failures to pile up. And in the meantime this will breed disrespect for the more valuable laws.
What I’ve been reading
1. Jordan Mechner, The Making of Prince of Persia: Journals 1985-1993. A memoir and game development journal from a game developer. The content is foreign to me, but this is one of the most beautiful and artistic books I ever have seen and I suspect some of you will find the narrative gripping. A product of Stripe Press — “Ideas for Progress.”
2. Jeffrey D. Sachs, The Ages of Globalization: Geography, Technology, and Institutions. This book is a series of lectures, based on Sachs’s earlier work on economic geography and development, yet somehow with a vaguely Yuval Harari sort of glow. Some parts are a good introduction to the earlier work of Sachs, other parts are pitched a bit too low or too generally. It is strange to see chapter subheadings such as “Thalassocracy and Tellurocracy.” As an economist, I still maintain that Sachs is considerably underrated.
3. Susanna Clarke, Piranesi. Yes this is a work of fiction. Clarke of course wrote Jonathan Strange and Mr. Norrell, a very long novel that I have read twice, an odd mix of fantasy, science, magic, and Enlightenment esotericism, the only novel I know with fascinating footnotes. I was thrilled to receive this one, and on p.51 I am still excited.
4. Mieko Kawakami, Breasts and Eggs. The hot new novel from Japan, it comes with a Murakami rave endorsement. To me it seems like “ordinary feminism” (not that there’s anything wrong with that), and so far it is a bore. If it doesn’t get better soon, I’ll write it off as a “mood affiliation text,” not that there’s anything wrong with that. It probably makes most sense read in a very specific cultural context.
5. Douglas Boin, Alaric the Goth: An Outsider’s History of the Fall of Rome is a fun look at one part of ancient history through alternative eyes. I always wonder what to trust about this era other than primary sources, and if you can’t understand them or grasp them intelligibly maybe that is itself the correct inference, namely that we have no idea what the **** went on back then. Still, as imaginary reconstructions go, this is one that ought to be done and now it is.
6. Ryan Patrick Hanley, Our Great Purpose: Adam Smith on Living a Better Life. Smith as a practical moral philosopher, this short volume pulls out the side of Smith closest to Montaigne and the Stoics. You can ponder Smithian sentences such as “The great source of both the misery and disorders of human life, seems to arise from over-rating the difference between one permanent situation and another.”
7. Sonia Jaffe, Robert Minton, Casey B. Mulligan, Kevin M. Murphy, Chicago Price Theory. A very good intermediate micro text, patterned after how Econ 301 is taught at Chicago. Apparently in the current Coasean equilibrum, this book ends up published by Princeton University Press. Get the picture?
From a legal perspective there is Ron Harris, Going the Distance: Eurasian Trade and the Rise of the Business Corporation, 1400-1700.
Wednesday assorted links
1. Sentences to ponder: “He’s in London with his girlfriend, in the apartment the Batman folks rented for him…’I went for a run around the park today,’ he says. ‘I’m so terrified of being, like, arrested. You’re allowed to run around here. But the terror I feel from it is quite extreme.’…I was so obsessed with watching Christopher Hitchens debates.”
2. The man feeding a remote Alaska town with a Costco card and a ship.
4. “We find that talking about white privilege causes a major reduction in support for a politician.”
5. Leisure-enhancing technological change.
6. How are bookstores doing? (NYT)
A simple question about space aliens
If you thought non-hostile but highly disruptive aliens would arrive within the next ten years, which of your decisions would change? Should change?
Should you save more or less? Long or short crypto? Contribute less to Wikipedia pages and other public-minded ventures?
What else? To be clear, I’m not interested in debating space aliens here, I want to hear about optimal responses, taking the aliens as a given.
By the way, will a Tom Cruise movie actually be shot in outer space?
“Our regulatory state is failing us”
A number of commentators suggest that the real problem is President Trump, rich people overly concerned with tax cuts, a Republican Party with a deregulatory ideology, and so on.
Instead I have been repeating insistently that “our regulatory state is failing us.” The FDA and CDC, for instance, have through their regulations made it harder for testing and also widespread mask supply to get off the ground.
I don’t see how you can blame (supposed) deregulatory fervor for the presence of too many regulations, as we have been observing in these instances.
I do think you can blame President Trump, along multiple dimensions, for a poor response to the pandemic, see my grades here. (If there were a separate risk communication grade, Trump would get an F minus for that.) Nonetheless a regulatory state cannot be said to work well if it requires such extraordinary attention from a sitting president.
It can be the case that both Trump and the permanent bureaucracy are at fault. If something takes a long time to get done for reasons relating to preexisting rules, regulations, and laws, usually the current president is not directly at fault for that particular problem. Was it only Trump’s fault, for instance, that the permits to build a mask factory can take months to acquire? Or that the HHS did not respond to inquiries about gearing up mask production in Texas? Or that a law had to be changed to allow industrial companies to sell quality masks to hospitals? Or that so many a-legal or extra-legal activities (e.g., rich people arranging deliveries by plane, etc.) had to occur to sneak masks into this country? That the trade barriers on masks persisted for so long? (And yes likely the Trump administration is at fault for de facto toughening restrictions on masks from China.)
It is fine to say “the buck stops here,” and to criticize Trump for not having erected processes to be more aware of these problems and to dissolve them more quickly. I would agree with some of those criticisms, while noting the Trump administration also has tried to ease many of the regulations hampering adjustment.
This is more something on the horizon, but how do these apples make you feel? Comforted? The fault of plutocratic Republicans most of all?
And in both cases, vials and stoppers, a vaccine manufacturer cannot just switch to a slightly different product or another brand. They typically have to run manufacturing changes by FDA first, which could make quick supplier changes to curb shortages a difficult prospect.
The FDA can decide how flexible it will be about this type of change, says Sklamberg. The agency said in a December 2017 draft guidance that companies could note some changes in their annual reports rather than waiting for approval, but it has not finalized the policy.
The ability to switch products could be crucial as the entire world readies for a possible vaccine and vies to secure their supplies.
If you wish, consider a simple question. When the CDC pooh-poohed masks early on, or botched their testing kit thereby delaying U.S. testing by weeks or maybe months, did the permanent staff of the CDC rise up and rebel and leak howling protests to the media, realizing that thousands of lives were at stake? That is surely what would happen if say the current FDA announced it was going to approve thalidomide.
Those are still cases of our regulatory state failing us.
Tuesday assorted links
1. Why mass testing is harder for the United States.
2. Coronavirus hairdo in Kenya.
3. Ross Douthat is back from paternal leave (NYT).
4. Norway will not proceed with the RCT for school reopening.
5. How much of the world will end up with the Swedish strategy?
6. What are the macro benefits of large cities?, by Salim Furth.
*The WEIRDest People in the World*
That is the new 655 pp. book by Joseph Henrich, due out September 8, and yes it is “an event.” The subtitle is “How the West Became Psychologically Peculiar and Particularly Prosperous,” and that is indeed one of the very most important questions in all of social science.
“WEIRD” of course refers to “Western, Educated, Industrialized, Rich, and Democratic.” And is it not weird that we (some of us, at least) are WEIRD?
Here is an excerpt from the opening segment:
Let’s close by returning to the core questions of this book:
1. How can we explain the global psychological variation highlighted above?
2. Why are WEIRD societies particularly unusual, so often occupying the extreme ends of global distributions of psychology and behavior?
3. What role did these psychological differences play in the Industrial Revolution and the global expansion of Europe during the last few centuries?
If you are wondering how this material might differ from Henrich’s previous output, there is above all much more on marriage customs and monogamy, for instance:
…I’ll make the case that monogamous marriage norms — which push upstream against our polygynous biases and the strong preferences of elite men — create a range of social and psychological effects that give the societies that possess them a big edge in competition against other groups.
Obviously recommended, and you will be hearing more about this both from me and from others. You can pre-order here.
Germany R estimate of the day
Germany is being closely watched worldwide as the most successful large European country in curbing the spread of the virus, partly thanks to massive testing, which has prompted a partial reopening of the economy. Merkel has frequently said the reproduction rate of the new coronavirus must be held below 1 to prevent the health system from being overwhelmed.
But the Robert Koch Institute for public health said the rate hovered above this critical threshold for the third consecutive day with an estimated value of 1.07 on Monday, after 1.13 on Sunday.
That Germany does not have its R below one is, in a nutshell, why short-run measurements of coronavirus responses are not very reliable. And why “we need to lock down until full testing is up and running” is not necessarily convincing. Here is the full story.