Month: February 2021
I’ve long argued that if a drug or medical device is approved in another country with a Stringent Regulatory Authority it ought to be approved in the United States. But, of course, the argument is even stronger in the other direction. Drugs and devices approved in the United States ought to be approved elsewhere. Indeed, this is how much of the world actually works because most countries do not have capability to evaluate drugs and devices the way the FDA or say the EMA does. Although it’s the way the world works, few will admit it because that would violate pretensions of regulatory nationalism. Moreover, keeping up with pretenses means transaction costs and unnecessary delays.
The price of such regulatory nationalism can be very high as indicated in this interview with Adar Poonawalla, chief executive of the Serum Institute of India (SII), the world’s largest producer of vaccines.
Some people think the reason that rollout has been slow in many countries is because the developers who hold the patents on the vaccines have licensed too few manufacturers to make them. Do you agree?
No. There are enough manufacturers, it just takes time to scale up. And by the way, I have been blown away by the cooperation between the public and private sectors in the last year, in developing these vaccines. What I find really disappointing, what has added a few months to vaccine delivery – not just ours – is the lack of global regulatory harmonisation. Over the last seven months, while I’ve been busy making vaccines, what have the US, UK and European regulators been doing? How hard would it have been to get together with the World Health Organization and agree that if a vaccine is approved in the half-dozen or so major manufacturing countries, it is approved to send anywhere on the planet?
Instead we have a patchwork of approvals and I have 70m doses that I can’t ship because they have been purchased but not approved. They have a shelf life of six months; these expire in April.
Did you get that? Regulatory nationalism has added months to vaccine delivery and now threatens to put to waste millions of stockpiled doses.
Addendum: See also Scott Sumner on the costs of regulatory nationalism.
So what would you all like to hear about? It can’t hurt to ask, right?
The author is Robert Paarlberg and the subtitle is Straight Talk About the Food We Grow and Eat. This book is a refreshing change of pace from most of the other food books, which tend to be illiterate on the economic side. Here is one excerpt:
Modern farming protects the environment not only by using less land compared to several decades ago; it also uses less water, less fossil energy, and fewer chemicals for every bushel produced. One major contributors here is no-till farming, which is a method for planting seeds in unplowed fields. This method requires specialized equipment, but it reduces soil erosion, protects soil moisture, sequesters carbon, and requires much less burning of diesel fuel, which is why farmers began doing it in the 1970s, a decade of high fuel prices. According to the latest USDA Census of Agriculture, more than twice as much cropland is now under no-till or reduced-till compared to intensive tillage. In parallel fashion, new irrigation systems such as center-pivot and drip have replaced simple flooding, thus conserving water. Lasers are employed to help level farm fields, which eliminates surface runoff. GPA auto-steering eliminates wasteful overlaps in the field. Genetically engineered seeds help farmers protect against insects and weeds with fewer and less toxic chemical sprays.
Recommended, sensible throughout.
Here is the NYT obituary for Danny Ray, who (among other things) handled the cape for James Brown.
That is what people did and watched before they had an internet, and for years I treasured the battered video cassette I had of that televised performance, playing it for guests who would come over.
In the wake of high-profile police shootings of Black Americans, it is important to know whether the race and gender of officers and civilians affect their interactions. Ba et al. overcame previous data constraints and found that Hispanic and Black officers make far fewer stops and arrests and use force less than white officers, especially against Black civilians. These differences are largest in majority-Black neighborhoods in the city of Chicago (see the Perspective by Goff). Female officers also use less force than male officers. These effects are supportive of the efficacy of increasing diversity in police forces.
A new phase II study from Moderna shows that half-doses (50 μg) appear to be as good as full doses (100 ug) at generating correlates of protection such as neutralizing antibodies.
In this randomized, controlled phase 2 trial, the SARS-CoV-2 vaccine candidate mRNA-1273, administered as a two-dose vaccination regimen at 50 and 100 μg, exhibited robust immune responses and an acceptable safety profile in healthy adults aged 18 years and older. Local and systemic adverse reactions were mostly mild-to-moderate in severity, were ≤4 days of median duration and were less commonly reported in older compared with younger adults. Anti-SARS-CoV-2 spike binding and neutralizing antibodies were induced by both doses of mRNA-1273 within 28 days after the first vaccination, and rose substantially to peak titers by 14 days after the second vaccination, exceeding levels of convalescent sera from COVID-19 patients. The antibodies remained elevated through the last time point assessed at 57 days. Neutralizing responses met criteria for seroconversion within 28 days after the first vaccination in the majority of participants, with rates of 100% observed at 14 and 28 days after the second vaccination. While no formal statistical testing was done, binding and neutralizing antibody responses were generally comparable in participants who received the 100 μg mRNA-1273 and the 50 μg dose at all time points and across both age groups. Overall, the results of this randomized, placebo-controlled trial extend previous immunogenicity and safety results for mRNA-1273 in the phase 1 study in an expanded cohort including participants older than 55 years of age [16, 19].
[These data] confirm that a robust immune response is generated at both 50 and 100 ug dose levels.
As I wrote earlier, halving the dose is equivalent to instantly doubling the output of every Moderna factory.
See my piece in the Washington Post on getting to V-day sooner for an overview of dose stretching strategies.
Addendum: France says one dose is sufficient for previously COVID infected.
4. Scott Sumner on middlebrow. And the Jason Crawford guide to Scott Alexander. And Scott Alexander himself. A devastating reply, though I think the screw-up is less competent than a conspiracy. Do notice Scott’s Straussian choice of photo. Here is Matt. A very good piece. I can’t recall the last time I saw such near-unanimous and bipartisan and also highly reasoned condemnation of a feature profile. And Douglas Murray. Those last two paragraphs are a doozy.
1. Alex Ross on Tarkovsky (New Yorker).
2. On the Facebook Supreme Court (New Yorker). A very good piece.
6. Shooting luck matters more in the NBA than ever before. Are there broader lessons in here about how optimized systems behave?
7. Alas the great Svetozar Pejovich has passed away.
In the Washington Post I have an extensive piece on accelerating progress to V-day, Vaccine or Victory day, the day everyone who wants a vaccine has gotten one. I cover themes that will be familiar to MR readers, including First Doses First, Fractional Dosing, Approving More Vaccines and DePrioritization to Expand Delivery. I won’t belabor these points here but the piece is useful at collecting all the arguments in one place and there are lots of authoritative links.
One point I do want to make is that all the pieces of the “Tabarrok plan,” if you will, fit together. Namely, use First Doses First to make a big push to get as many people vaccinated with first doses as possible in the next 90 days. Approve more vaccines including Johnson & Johnson, AstraZeneca and others and make them available to anyone, anywhere–that is possible because these vaccines don’t require significant cold storage, J&J is a single shot and AZ is better with a second shot at 12 weeks or later all of which eases distribution.
…some people argue that adding a third (or fourth) vaccine might not help because of persistent delivery logjams at the state and local levels. But we know there is unused distributional capacity, even for the supply we do have. The United States is currently administering about 1.5 million coronavirus vaccine shots per day. While that sounds like a lot, for comparison consider that in September — during the pandemic, when social distancing measures were in full effect — we vaccinated for the seasonal flu in some weeks at the rate of 3 million people a day.
There are two main reasons the rollout has been so slow. First, the Moderna and especially the Pfizer vaccines require ultracold storage. (The Johnson & Johnson and AstraZeneca doses can be stored at ordinary refrigerator temperatures.) Second, we have tried to prioritize vaccinations using a confusing mishmash of age, health conditions and essential-worker status that differs by state and sometimes even by county. “Confirming such criteria is complicated at best, and it’s probably not even feasible to try under conditions of duress,” as Baylor’s Hotez puts it.
Arguments continue about prioritization lists, and the idea of tossing them entirely would cause a political fight. But there is a compromise at hand: Quickly approve the Johnson & Johnson and AstraZeneca vaccines and make them — and only them — available to anyone, anywhere. Keeping things simple is a sure way to increase total vaccinations. With no cold-storage requirement, the new vaccines could be administered by any of the 300,000 pharmacists and more than 1 million physicians in the United States authorized to deliver vaccines, most of whom are not now giving Pfizer or Moderna shots.
Ye Hong and William Neilson have solved for the equilibrium:
This paper models cybercrime by adding an active victim to the seminal Becker model of crime. The victim invests in security that may protect her from a cybercrime and, if the cybercrime is thwarted, generate evidence that can be used for prosecution. Successful crimes leave insufficient evidence for apprehension and conviction and, thus, cannot be punished. Results show that increased penalties for cybercriminals lead them to exert more effort and make cybercrimes more likely to succeed. Above a threshold they also lead victims to invest less in security. It may be impossible to deter cybercriminals by punishing them. Deterrence is possible, but not necessarily optimal, through punishing victims, such as data controllers or processors that fail to protect their networks.
Via the excellent Kevin Lewis.
In order to break down the information barrier, I partnered with my local faith community to set up a vaccine outreach program. We have a dedicated vaccine information email address and a website consolidating information about vaccine eligibility, sites, and benefits. We call community members who don’t have email, offer personal assistance making appointments and connecting to ride services, and provide information about best practices for riding safely in a car with masks and open windows. After vaccine appointments, we check in to see how they are feeling, make sure their second dose is scheduled, and offer to drop off comfort foods. One recipient replied, “It makes this daunting time just a little easier knowing there is someone out there to guide one through this process. My technology skills are minimal!”
By Margaret Scharle, for Oregon. We need much more of this.
1. Ezra Klein on California (NYT), right on the mark.
2. Interview with Michael Mina, too much common sense for it ever to be heeded.
I will be doing a Conversation with her, most of all about her forthcoming and very good translation of Virgil’s Aeneid. She is a professor of classics at the University of Chicago, and here is Wikipedia:
She is an expert on Lucan, Persius, Seneca, and other writers of the time, most of all the age of Nero, and she is now working on a book on the reception of the classical authors amongst the Chinese intelligentsia. Here is Shadi on Twitter.
So what should I ask her?
We congratulate the Department of Economics at the University of Missouri-Columbia for winning the AEA’s inaugural Award for Outstanding Achievement in Diversity and Inclusion.
Eric Parson’s, one of the leaders of the initiative, credits our textbook, Modern Principles of Economics, with providing the springboard for fruitful discussions and explorations of these ideas. He writes:
[The Economics, Ethics, and Public Policy chapter] really illustrates the authors’ willingness to address these important issues and make them part of the economic conversation. It is also a chapter that I think is unique among Principles textbooks (at least the ones that I have examined, which covers quite a few). This chapter directly exposes students to questions of exploitation and fair and equal treatment and also introduces them to the work of John Rawls, as well as other social justice paradigms. It also includes a discussion of whose views generally count the most in the policy process (in the context of immigration) and, with some additional questioning along these lines, allows students the opportunity to explore their own (sometimes contradictory) viewpoints on this question. Hence, overall the chapter provides a great springboard for thinking about these issues and how these ideas compare and contrast with the typical economic viewpoint.
I always tell the students that this chapter is more about getting them to think critically about the topics and begin asking questions than it is about providing answers. It also gives another nice opportunity to highlight the positive versus normative distinction that we take so seriously in economics and hopefully provides students with some of the tools they will need to discuss these issues intelligently and civilly with one another while considering other viewpoints and worldviews. In fact, I think this chapter is so important that I save it until the end of the term, as it provides an excellent bookend to our semester’s worth of economic study.
Here from a podcast is Michael Osterholm, Regents Professor, McKnight Presidential Endowed Chair in Public Health, the director of the Center for Infectious Disease Research and Policy (CIDRAP) and state epidemiologist for the Minnesota Department of Health.
…Imagine you are setting across the table from two people both of whom are 65 or older, both with underlying health conditions. You have two doses of vaccine, one in each hand. And you say to them I can give two doses to you or to you but then the other person gets nothing. Or I can give one dose to both of you. And this is what I know. At the very least, one dose is likely to prevent serious illness, hospitalization and death. Two doses will probably even prevent clinical disease with B.1.1.7. But the other one of you; if you get infected with this virus, which I think substantial numbers of Americans will, things are not looking good for you. What do you want me to do?
If that is your Mom or Dad. Your Grandpa or Grandma. What would you do?
This is where the rubber meets the road. I think if the data bears it out we can save so many lives in the upcoming weeks and we are missing that opportunity.
I have already made my choice. I am postponing my second dose. I want my second dose. But I am confident that I can wait. And I can only hope that my second dose, which I have just deferred, will go to someone who it will save their life. It will make a totally different world for that family.
You know some could argue that this could be the end of my career. But I could not sleep with myself at night if I didn’t do this. I just know in my heart of hearts that this is something we must do if we are going to save lives.
The entire podcast is worthwhile, this is from around minute 44:30 (my imperfect transcription).
Hat tip: Anon.
Addendum: Many other countries should be looking very closely at dose-stretching policies.
In other news, South Korea approves the AstraZeneca vaccine. It’s not like we have anything to learn from South Korea about managing a pandemic, right? Right?