Category: Law

UK to fast track drug trials

Drugmakers will be offered fast-tracked approvals for innovative medicines in the UK as ministers seek to build on the country’s world-leading approval of a Covid vaccine and attract life sciences companies to invest post-Brexit.

The UK’s medicines regulator will become independent of EU pharmaceutical rulemaking when Britain quits the European Medicines Agency at the end of the year, which means companies will need to apply separately to register drugs.

With ministers eager to try to refashion the UK as a post-Brexit hub for global life sciences, companies with drugs that promise to treat unmet medical needs will be offered help through the development process, including manufacturing, according to three people familiar with the situation.

Under the so-called Innovative Licensing and Access Pathway, companies are set to be offered the same rolling review of data that speeded approval of the Pfizer/BioNTech Covid-19 vaccine ahead of the rest of the world.

Here is more from Sarah Neville at the FT, via J.

Potential yet still thwarted Filipino nurse vaccine barter markets in everything?

The Philippines will let thousands of its health care workers, mostly nurses, take up jobs in Britain and Germany if the two countries agree to donate coronavirus vaccines, a senior official said on Tuesday.

Britain’s health ministry said it was not interested in such a deal and its priority was to use shots domestically, but added it would share surplus vaccine internationally in the future.

The Philippines, which has among Asia’s highest number of coronavirus cases, has relaxed a ban on deploying its health care workers overseas, but still limits the number of medical professionals leaving the country to 5,000 a year.

Alice Visperas, director of the labor ministry’s international affairs bureau, said the Philippines was open to lifting the cap in exchange for vaccines from Britain and Germany, which it would use to inoculate outbound workers and hundreds of thousands of Filipino repatriates.

Here is the full story, via Marvin Vista.

A Majority of Doses are Now Second Doses

As of Feb. 18 (last day of full data) we gave out 817,708 second doses and just 702,426 first doses. In other words, a majority of doses are now second doses. As Daniel Bier writes this means that we are boosting some people from ~85% to ~95% protected when we could be vaccinating more first timers and getting them from 0% protected to ~85% protected.

If we followed the British rule and delayed the booster to 12 weeks, we could immediately more than *double* the number of people going from 0% protected to to ~85% protected. More first-doses would be great for the newly protected and more people at ~85% protection would also reduce transmission so there would be fewer new infections and less threat to the non-vaccinated.

The opportunity cost of not delaying the booster is measured in lives lost.

Duke is a Trademark Bully!

Duke University has gone to incredibly and absurd lengths to contest other people’s trademark applications. For example, Duke opposed the following marks by filing with the Trademark Trial and Appeal Board :

  • “The Dude Diet” for a diet-related website
  • “Kuke” for electronic products
  • “Goluke” for clothing
  • “Le Duc” for food and drink services

they have even tried to claim they own “devil” and filed oppositions against:

  • “Werdo” with this scribbled image of a devil for shirts and hats
  • “Devils Nightmare” for beer
  • “Devil’s Garden” for alcoholic beverages
  • “Pretty Devil” for slot machines

It gets worse, Duke claims the letter D and the word blue with filed oppositions against:

  • “Beach’d” for beach bags and cosmetic bags
  • “D’Grill” for barbecue smokers and grills
  • “DLove” for advertising and other services
  • “True Blue” for auto parts
  • “Stay Blue” for denim clothing
  • “Blue Ball Chiller” for alcoholic beverages
  • “Blue Solutions” for various goods and services related to car rentals and car sharing.

None of this is remotely consistent with trademark law which doesn’t convey an ownership right but is merely meant to help consumers purchase the products they intend to purchase. Yet, many of Duke’s oppositions have been successful since it’s often easier for the group asking for a trademark to simply give up and change their mark. Duke bullies far more than do other similar universities.

All of this is from an excellent paper, Mark of the Devil: The University as Brand Bully by James Boyle and Jennifer Jenkins both of whom are professors at the Duke University of Law! Bully for them!

The AstraZeneca Vaccine Works Well

A new study looking at essentially the entirety of the Scottish population finds that both the Pfizer and AstraZeneca vaccine work very well at preventing hospitalizations from the first dose.

UK policy for use of vaccines against COVID-19 involves an offer of a first dose followed by a second dose 12 weeks later. To our knowledge, this is the first study of COVID-19 vaccine effect against hospitalisation for an entire nation after a single dose of vaccine. We found that a single dose of BNT162b2 COVID-19 vaccine was associated with a vaccine effect (VE) of 85% (95% CI 76 to 91) for COVID-19 hospitalisation 28-34 days post-vaccination. A single dose of ChAdOx1 vaccine was associated with a vaccine effect 94% (95% CI 73 to 99) at 28-34 days post-vaccination. VEs increased over time with a peak at 28-34 days post-vaccination for both vaccines. Comparable VEs were seen in those aged ≥80 years for prevention of COVID-19 hospitalisation with a high combined VE of 81% (95% CI 65 to 90) at 28-34 days post-vaccination.

Arne Akbar, president of the British Society for Immunology, noted “…overall these new findings should provide reassurance around the UK’s decision to offer the two doses of the vaccine 12 weeks apart.”

Another important point is that the AstraZeneca vaccine actually shows a higher effectiveness than the Pfizer vaccine. The study wasn’t designed to compare the vaccines and the populations getting the vaccines aren’t random samples. Nevertheless, the AstraZeneca vaccine appears to work well and it was actually given to a greater proportion of elderly patients.

The new results from Scotland support the UK, EU, and WHO decisions to authorize the AstraZeneca vaccine. If the US had authorized the AstraZeneca vaccine in late December at the same time as did the UK, millions more Americans could have been vaccinated saving many lives.

Where is the FDA’s cost-benefit calculation?

Clementine Jacoby, Emergent Ventures winner

More than 2 million people are imprisoned in the U.S., among them hundreds of thousands who experts say don’t pose a public-safety threat and could be released. One problem: the data that could trigger those releases get backlogged, because they’re often spread out among different departments. That’s why in 2019, Clementine Jacoby, a software engineer, launched Recidiviz, a nonprofit that has worked with more than 30 states to log into one system key data points—such as whether an incarcerated person has served most of their sentence or has shown progress by completing a treatment program, or more recently, how well equipped a correction facility is to handle a COVID-19 outbreak. It then uses an algorithm to recommend certain prisoners for release. “Our hope is that the people who are succeeding get off early,” Jacoby says, “and that frees up attention for officers to spend time with the people who actually need it.” Of course, no algorithm is perfect, and algorithms alone won’t solve the issues of the criminal-justice system. But so far, Recidiviz has seen early signs of success. To date, the nonprofit has helped identify as appropriate for release nearly 44,000 inmates in 34 states, including North Dakota, which last spring saw its prison population drop by 20%.

That is from the Time100 Next.  The initial grant helped Clementine quit her job to do Recidivez full-time.

Hungary’s Vaccine Approval Rule

AP: Hungarian health authorities were the first in the EU to approve the Sinopharm jab for emergency use on Jan. 29. That came after a government decree streamlined Hungary’s vaccine approval process by allowing any vaccine administered to at least 1 million people worldwide to be used without undergoing review by the country’s medicines regulator.

The country expects to receive 5 million total doses of the Sinopharm vaccine over the next four months, enough to treat 2.5 million people in the country of nearly 10 million.

Authorize any vaccine already used by at least 1 million people is a type of reciprocity or peer-review rule in which you speed up approval in your country based on data from another country. As with all such rules, it’s imperfect–new and extensive use will reveal common, serious side effects and many uncommon ones as well but extensive use is not a guarantee of safety or efficacy. Nevertheless, when time is of the essence the 1 million+ rule is a smart rule.

Hat tip: Bart Madden.

Should unemployment benefits be taxed?

A number of people on Twitter were mocking this earlier idea of Martin Feldstein’s, now a policy since 1986.  But of course unemployment benefits should be taxed at the federal level.  If your income that year was low, you won’t pay any tax anyway.  As of 2018, about 44 percent of American households paid no federal income tax in any case, so that is covering quite a few of the lower earners.

if you are in the taxable range, in your choices you should be comparing taxable income to taxable unemployment benefits, otherwise there is a distortion in your labor supply decision.  If need be, raise the level of unemployment benefits.  No, that isn’t a wash, because different individuals and households face different possible rates of marginal taxation.  The higher earners (at least potentially the higher earners) should face a higher tax on their unemployment benefits than the lower earners will.  So it is in fact a “progressive” policy.

Marty was right, as indeed he was about many things.  Here is a good CRS overview of the issue.  Here is Marty’s (partially gated) 1974 piece on the issue.  This is exactly the kind of issue Twitter is ill-suited to considering.

Against Regulatory Nationalism

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.

Diversity in policing

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.

That is a new paper in Science by Bocar A. Ba, Dean Knox, Jonathan Mummolo, and Roman Rivera.  Via Anecdotal.

Half Doses of Moderna Produce Neutralizing Antibodies

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.

The Big Push: A Plan to Accelerate V-Day

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.

Cybercrime and Punishment

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.

Osterholm on First Doses First

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?

My Conversation with Brian Armstrong

He is the co-founder and CEO of Coinbase, here is the video, audio, and transcript.  Here is part of the CWTeam summary:

Brian joined Tyler to discuss how he prevents Coinbase from being run by its lawyers, the value of having a mission statement, what a world with many more crypto billionaires would look like, why the volatility of cryptocurrencies like Bitcoin is more feature than bug, the potential for scalability in Ethereum 2.0, his best guess on the real identity of Satoshi, the biggest obstacle facing new charter cities, the meta rules he’d institute for new Martian colony, the importance of bridging the gap between academics and entrepreneurs, the future of crypto regulation, the benefits of stablecoin for the unbanked, his strongest and weakest interpersonal skill, what he hopes to learn from composing electronic music, and more.

And an excerpt:

COWEN: Recently, you cited an estimate that if bitcoin were priced at $200,000, that about half the world’s billionaires would be from crypto. How is that world different? What does it look like? How does it feel different from the world we have?

ARMSTRONG: That’s a big question. I guess the most honest answer is, I don’t know for sure. One thought I’ve had, though, is that if there are more people who generate a lot of wealth with crypto — which I think is already happening, and it will probably keep happening. Most of the people who bought crypto early on — they’re believers in the power of technology to change the world. They’re interested in the ethos of crypto in many cases, and I suspect that they would allocate their capital towards more things in that vein.

You could almost have this — I don’t know if you’d call it a renaissance or a golden age or something, of people who are technology believers. They want to see a better future coming from science and technology, and they’re going to use their capital for good in that direction. That could be one outcome.

There is much more at the link, interesting throughout.