Challenge trial for Covid in England reveals airborne superspreaders

 Nature has a news story about a Lancet Microbe paper reporting the challenge trial. See links to and excerpts from both below.

Here's the Nature story:

What makes a COVID superspreader? Scientists learn more after deliberately infecting volunteers. A rigorous study identifies ‘supershedders’ who spew huge amounts of virus into the air — despite having only mild symptoms. by Saima Sidik

"A study of people who were intentionally infected with SARS-CoV-2 has provided a wealth of insights into viral transmission — showing, for example, that a select group of people are ‘supershedders’ who spew vastly more virus into the air than do others1.

"The publication describes data from a controversial ‘challenge study’, in which scientists deliberately infected volunteers with the virus that causes COVID-192. Although the approach drew opposition, the work has now yielded data on questions central to public health, such as whether the severity of symptoms correlates with how contagious people are and whether home COVID-19 tests can play a part in reducing viral spread.

...

"Challenge studies are “very bold”, says Gandhi. Some people argue that it’s unethical to give people an infection that can cause severe illness, but the research design comes with benefits. Challenge studies can substantially speed up vaccine testing, and they’re the only way to understand certain aspects of COVID-19, such as the stage before people test positive or develop symptoms.

"Researchers inoculated 34 healthy young participants by squirting a known quantity of viral particles up their noses. Eighteen developed infections and spent at least 14 days confined to hospital rooms. Each day, researchers measured viral levels in the participants’ noses and throats, in the air, and on the participants’ hands and various surfaces in the rooms.

...

"Of the 18 participants who developed infections, 2 shed 86% of the airborne virus detected over the course of the entire study — even though both had only mild symptoms. Previous research3 has provided evidence for the existence of superspreaders who infect large numbers of people. But whether such people are also ‘supershedders’ who emit copious amounts of virus, or simply have many social contacts, was up for debate

..

"None of the participants emitted a detectable level of virus into the air before testing positive, and only a small proportion of them left detectable virus on their hands, on surfaces or on masks that they donned temporarily.

"By the time they tested positive, most participants had already experienced mild symptoms, such as tiredness or muscle aches. That means that if people test as soon as they detect symptoms, rapid tests “can be a powerful tool” for controlling viral spread, says infectious-disease researcher Christopher Brooke at the University of Illinois at Urbana-Champaign.

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And here's the original paper:

Jie Zhou, Anika Singanayagam, Niluka Goonawardane, Maya Moshe, Fiachra P Sweeney, Ksenia Sukhova, Ben Killingley, Mariya Kalinova, Alex J Mann, Andrew P Catchpole, Michael R Barer, Neil M Ferguson, Christopher Chiu, Wendy S Barclay, Viral emissions into the air and environment after SARS-CoV-2 human challenge: a phase 1, open label, first-in-human study, The Lancet Microbe, 2023, ISSN 2666-5247, https://doi.org/10.1016/S2666-5247(23)00101-5. (https://www.sciencedirect.com/science/article/pii/S2666524723001015)

"After controlled experimental inoculation, the timing, extent, and routes of viral emissions was heterogeneous. We observed that a minority of participants were high airborne virus emitters, giving support to the notion of superspreading individuals or events. Our data implicates the nose as the most important source of emissions. Frequent self-testing coupled with isolation upon awareness of first symptoms could reduce onward transmissions."

Challenge trials for Covid-19 vaccine are being planned (and a recent NBER cost/benefit analysis)

 Here's the NY Times:

To Test Virus Vaccines, U.K. Study Will Intentionally Infect Volunteers--The hotly contested strategy of deliberate exposure, known as a human challenge trial, could speed up the process of identifying effective coronavirus vaccines.  By Benjamin Mueller

"Scientists at Imperial College London plan to deliberately infect volunteers with the coronavirus early next year, launching the world’s first effort to study how vaccinated people respond to being intentionally exposed to the virus and opening up a new, uncertain path to identifying an effective vaccine.

"The hotly contested strategy, known as a human challenge trial, could potentially shave crucial time in the race to winnow a number of vaccine candidates. Rather than conducting the sort of trials now underway around the world, in which scientists wait for vaccinated people to encounter the virus in their homes and communities, researchers would purposely infect them in a hospital isolation unit.

"Scientists have used this method for decades to test vaccines for typhoid, cholera and other diseases, even asking volunteers in the case of malaria to expose their arms to boxes full of mosquitoes to be bitten and infected. But whereas the infected could be cured of those diseases, Covid-19 has few widely used treatments and no known cure, putting the scientists in charge of Britain’s study in largely uncharted ethical territory.

...

"The volunteers in London will be paid roughly Britain’s minimum wage, which is about £9, or $11, per hour, for their time in taking part in the trial and their two to three weeks in mandatory quarantine. The researchers said they were wary of offering additional incentives that could cloud the judgment of volunteers."

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And here's a recent NBER paper on the efficiency of challenge trials:

A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

Donald A. Berry, Scott Berry, Peter Hale, Leah Isakov, Andrew W. Lo, Kien Wei Siah & Chi Heem Wong

ID w27882, DOI 10.3386/w27882, October 2020

Abstract: We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

Human infection challenge trials for Covid vaccine to move forward in UK

 The BBC has this story:

Covid-19: World's first human trials given green light in UK

"Healthy, young volunteers will be infected with coronavirus to test vaccines and treatments in the world's first Covid-19 "human challenge" study, which will take place in the UK.

"The study, which has received ethics approval, will start in the next few weeks and recruit 90 people aged 18-30.

"They will be exposed to the virus in a safe and controlled environment while medics monitor their health.

...

"The Human Challenge study is being delivered by a partnership between the UK government's Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the company hVIVO, which has pioneered viral human challenge models.Clive Dix, interim chair of the Vaccines Taskforce, said: "We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19.

"We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection."

...

"Initially, the study will use the virus that has been circulating in the UK since the pandemic began in March, which is of low risk to healthy adults, to deliberately infect volunteers.

"In time, a small numbers of volunteers are likely to be given an approved vaccine and then exposed to the new variants, helping scientists to find out the most effective jabs - but this phase of the study has not yet been given the go-ahead."

HT: Tom Darton

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And here's a story from the NY Times, which touches on the issue of compensation for participants (and the associated debate about whether that is repugnant):

U.K. Approves Study That Will Deliberately Infect Volunteers With Coronavirus. Researchers hope to learn things about how the immune system responds to the coronavirus that would be impossible outside a lab.  By Benjamin Mueller

"After being exposed to the virus, the participants will be isolated for two weeks in the hospital. For that and the year’s worth of follow-up appointments that are planned, they will be paid 4,500 pounds, or about $6,200. The researchers said that would compensate people for time away from jobs or families without creating too large an economic incentive for people to participate."

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Related posts on challenge trials:   https://marketdesigner.blogspot.com/search/label/challenge

Broad public support for challenge trials for Covid-19 vaccines

 A broad based survey suggests that challenge trials are not generally regarded as repugnant.

Broad Cross-National Public Support for AcceleratedCOVID-19 Vaccine Trial Designs

by David Broockman, Joshua Kallay, Alexander Guerrero, Mark Budolfson, Nir Eyal, Nicholas P. Jewell , Monica Magalhaes,  Jasjeet S. Sekhony

Abstract: A vaccine for COVID-19 is urgently needed. Several vaccine trial designs may significantly accelerate vaccine testing and approval, but also increase risks to human subjects. Concerns about whether the public would see such designs as ethically acceptable represent an important roadblock to their implementation, and the World Health Organization has called for consulting the public regarding them. Here we present results from a pre-registered cross-national survey (n = 5,920) of individuals in Australia, Canada, Hong Kong, New Zealand, South Africa, Singapore, the United Kingdom, and the United States. The survey asked respondents whether they would prefer scientists to conduct traditional trials or one of two accelerated designs: a challenge trial or a trial integrating a Phase II safety and immunogenicity trial into a larger Phase III efficacy trial. We find broad majorities prefer for scientists to conduct challenge trials (75%, 95% CI: 73-76%) and integrated trials (63%, 95% CI: 61-65%) over standard trials. Even as respondents acknowledged the risks, they perceived both accelerated trials as similarly ethical to standard trial designs, and large majorities characterized them as "probably" or "definitely ethical" (72%, 95% CI: 70-73% for challenge trials; 77%, 95% CI 75-78% for integrated trials). This high support is consistent across every geography and demographic subgroup we examined, including people of diverging political orientations and vulnerable populations such as the elderly, essential workers, and racial and ethnic minorities. These findings bolster the case for these accelerated designs and can help assuage concerns that they would undermine public trust in vaccines.

Human infection challenge trial(s) for covid-19 vaccine likely to start in UK in January

 The Financial Times has the story:

UK to test vaccines on volunteers deliberately infected with Covid-19--‘Human challenge trials’ intended to accelerate vaccine development programmes   by  Clive Cookson.

"London is to host the world’s first Covid-19 human challenge trials — in which healthy volunteers are deliberately infected with coronavirus to assess the effectiveness of experimental vaccines.

"The UK government-funded studies are expected to begin in January ...

"The researchers, who did not want to comment publicly ahead of the launch, said the trials would play a vital role in narrowing the large field of promising Covid-19 vaccines likely to move into clinical testing early next year.

"Volunteers will be inoculated with a vaccine and a month or so later receive a “challenge” dose of Sars-Cov-2, the virus that causes Covid-19, under controlled conditions."

"About 2,000 potential volunteers have signed up for challenge studies in the UK through the US-based advocacy group 1Day Sooner, which campaigns for Covid-19 infection trials and has enlisted 37,000 people worldwide. Traditional clinical trials need tens of thousands of participants and researchers would struggle to attract enough for multiple vaccine studies."

Ethical Payment in Human Infection Challenge Studies in the American Journal of Bioethics

 There are likely more vaccine trials ahead of us, of new vaccines and modifications of old ones to defend against new variants of covid. Here's a just-published paper, written when vaccine trials were still in the future. It's still relevant, because challenge trials (in which volunteers are exposed to a particular virus) can be much more focused than ordinary vaccine trials (particularly as the prevalence of disease begins to decline...see yesterday's post).

Promoting Ethical Payment in Human Infection Challenge Studies

Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley and Emily A. Largent            

Published online: 04 Feb 2021, The American Journal of Bioethics,  https://doi.org/10.1080/15265161.2020.1854368

Abstract: To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

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Here's a link to the original (long) working paper:

Wednesday, August 19, 2020

The ethics (and some economics) of paying participants in Human Infection Challenge Studies, for a coronavirus vaccine

HAL R. VARIAN CHAIR IN INFORMATION ECONOMICS

Berkeley has a great new endowed chair, joint in Economics and the I-School, named for (and partly endowed by) the remarkable Google chief economist and former I-School Dean Hal Varian.

I SCHOOL'S FIRST ENDOWED CHAIR WILL BE THE HAL R. VARIAN CHAIR IN INFORMATION ECONOMICS

Hal R. Varian

More information:

• Hal R. Varian
• The Hewlett Challenge

January 19, 2012

The School of Information is delighted to announce the creation of its first endowed chair, the Hal R. Varian Chair in Information Economics, thanks to a generous gift from Hal R. Varian and matching funds from the William and Flora Hewlett Foundation.
“This is terrific for the school,” said I School Dean AnnaLee Saxenian, “and it’s fitting that the founding dean of the school is endowing its first chair. This will be a wonderful legacy for Hal.”
The Hal R. Varian Chair in Information Economics will fund the work of an eminent faculty member, with a joint appointment in the School of Information and the Department of Economics, whose work involves research and teaching in the area of Information Economics.
“I made this donation to support teaching and research in Information Economics,” explained Varian. “Information is the lifeblood of the economy. Everybody who works in the information field should know something about economics, and every economist should know something about information.”
Varian was the founding dean of the I School (then known as the School of Information Management & Systems) and is now the Chief Economist at Google, where he has been involved in auction design, econometric analysis, finance, corporate strategy, and public policy. He is also a UC Berkeley professor emeritus in business, economics, and information management.
A world-renowned economist, Varian has published numerous papers in economic theory, industrial organization, financial economics, econometrics, and information economics. He is the author of two major economics textbooks and the co-author of a bestselling book on business strategy,Information Rules: A Strategic Guide to the Network Economy. Varian also wrote a monthly column for the New York Times from 2000 to 2007.
“No area of research could be more exigent than the economics of information,” said Carla Hesse, the university’s Dean of Social Sciences. “This is a pathbreaking gift from a pathbreaking scholar.”
Dean Saxenian agreed. “The field of Information Economics is very important for understanding information and information behavior,” she said. “We couldn’t be where we are without a strong foundation in economics.”
The School of Information and the Department of Economics plan to hire a new faculty member by Fall 2013 to fill the endowed chair.
Varian’s gift allows the school to take advantage of a matching gift from the William and Flora Hewlett Foundation, through the Hewlett Challenge. The Hewlett Challenge is a $110-million challenge grant — the largest gift in the university’s history — to endow a total of 100 new faculty chairs across the university.
“The Hewlett matching grant offered a once-in-a-lifetime opportunity, and provided me a strong incentive to make a donation now,” said Varian. With the creation of the Hal R. Varian Chair in Information Economics, the Hewlett Challenge has now funded more than 90 of the 100 professorships and is on target to reach the full 100 soon.
“I have written a couple of papers on the incentive effect of matching grants,” commented Varian, “so in this case, it seems that ‘life imitates art.’”

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And here's the ad: you could apply for the position...
HAL R. VARIAN CHAIR IN INFORMATION ECONOMICS

Compensation for participating in clinical trials

 Here's an opinion piece from Medpage Today:

It's Time to Pay Clinical Trial Participants More — Accelerating trial enrollment can catalyze access to much-needed medications  by Gunnar Esiason 

He writes:

"Most people I know with cystic fibrosis have participated in at least one, if not several clinical trials. 

...

"Participating in a trial can be like working for a company that hasn't invested in its employees in a long time. In this case, the employees are clinical trial participants. The pay is low despite the time required to participate in research and the growing number of trials that need participants.

"From 2019-2022, the number of registered clinical trials grew by 25%opens in a new tab or window globally -- yet participant pay remains arbitrary and inconsistentopens in a new tab or window between studies. It's almost like mismatched supply and demand curves, where participants are in high demand but unwilling to participate.

"Increasing trial participant pay might be a path toward alleviating the participant supply crunch in trials hungry for patients. One key benefit of increasing pay for patients could be substantial: namely, speeding up clinical trials through a more competitive enrollment process.

...

"More than 80% of clinical trials fail to enroll on time, leading to costs of anywhere from $600,000 to $8 million per dayopens in a new tab or window and making trials take up to twice as longopens in a new tab or window.

"And yet it has been shownopens in a new tab or window that moderately increasing pay can motivate participation without being an "unjust inducement." In other words, patients are encouraged to participate -- but not coerced to do so.

"If increasing participant pay can accelerate trial enrollment, then a safe and effective drug can reach the market faster and therefore reduce the amount of time products remain in the pre-revenue stage. The return on investment for study sponsors who increase participant pay should be clear from a business perspective.

"From a patient perspective, even a marginal improvement in time to accessing new drugs is something worth celebrating. For patients, we pay the cost of delays with our health."

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Some earlier related posts:

Monday, February 22, 2021

Ethical Payment in Human Infection Challenge Studies in the American Journal of Bioethics

Monday, March 1, 2021

Compensating challenge vaccine trial participants: further discussion in the American Journal of Bioethics

Thursday, October 29, 2020

Paying participants in challenge trials of Covid-19 vaccines, by Ambuehl, Ockenfels, and Roth

"we note that increasing hourly pay by a risk-compensation percentage as proposed in the target article provides compensation proportional to risk only if the risk increases proportionally with the number of hours worked. (Some risky tasks take little time; imagine challenge trials to test bulletproof vests.) "

Sunday, November 1, 2020

What do we know about the effects of payments to participants in challenge trials for vaccines, and other public spirited activities?

Wolverines beat Buckeyes in organ donation this year

For you Michigan fans who were disappointed this weekend on the football field, here's some heartening news:U-M beats Ohio State in annual organ donation challenge

"Ann Arbor, Mich. - U-M racked up a victory over Ohio State this week, signing up more people to the state’s organ donor list and winning the annual Wolverine-Buckeye challenge.

"U-M signed up 79,958 donors to Ohio State’s 57,083 in the challenge that ended at midnight on Thanksgiving.

"We all enjoy winning a victory against our rival from Ohio," says Tony Denton, Executive Director of University Hospitals and Chief Operating Officer, U-M Hospitals and Health Centers.

"But the real winners will be the people who rely on these life-saving gifts, organs and tissues that will give thousands of people a second chance at life," Denton says.

"Every day, 19 people die while waiting for an organ transplant and another 138 people are added to the national waiting list. The University of Michigan Health System began a new effort this year, dubbed Wolverines For Life, to encourage organ, tissue, eye, blood, and bone marrow donation by U-M employees, patients, students, alumni, fans and everyone in the state of Michigan.

"To kick off this effort, U-M Football Coach Rich Rodriguez, along with Health System leaders, encouraged people to join in the annual Wolverine-Buckeye challenge. The challenge allowed people to sign up as organ donors upon their death and have their pledge tallied for their favorite school.

HT: Steve Leider

Preparing for a drug-resistant bacteria pandemic---vaccines and challenge trials

 Axel Ockenfels recently alerted me that "The German National Academy of Sciences Leopoldina has established a working group to analyze the economic causes of the problem of global increase in pathogens resistant to antimicrobial agents, and develop better incentives for developing antibiotics and possible solutions. "

I sent him some quick thoughts, as follows:

"one direction that seems potentially worth exploring is vaccines for bacteria pathogens.  Most of our vaccines are antiviral, but there are some vaccines against bacterial infection, even though we mostly deal with bacteria through post-infection antibiotics.  But antibiotic discovery has lots of problems, both economic and technical. And it appears that vaccine technology has advanced a lot, given the speed with which Covid vaccines were developed.  So I wonder if it wouldn’t make sense to start now to develop vaccines against some of the bacteria that we think might be candidates for developing antibody resistance, so that when those variants show up, we’ll be able to protect lots of people from getting infected by vaccinating them. 

 And challenge trials would be very useful for that, since pre-pandemic it’s hard to do conventional trials of a vaccine against a disease that most people don’t get. Challenge trials wouldn’t necessarily be very hazardous if the relevant bacteria aren’t yet highly antibiotic resistant, since the diseases would be curable… (The assumption here is that a vaccine against say, conventional tetanus, would also be protective against antibiotic-resistant tetanus, which might be true since the evolutionary pressure to evade a new vaccine is likely very different from the long evolutionary path that leads to resistance to an existing antibiotic..)"

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Earlier posts, on antibiotics here, and vaccine challenge trials.

What do we know about the effects of payments to participants in challenge trials for vaccines, and other public spirited activities?

There is starting to be an empirical literature associated with payments for socially productive activities, such as participating in challenge trials of vaccines, donating plasma, etc.

Here's a blog post in the Medical Ethics blog of the Journal of Medical Ethics:

Is it acceptable to pay nothing or little to challenge trial participants?  By Sandro Ambuehl, Axel Ockenfels and Alvin E Roth.   October 30, 2020

Here's a paragraph (with some links).:

"we hope that the debates about payments in medical research, and on other transactions subject to restrictions on payments such as blood plasma donations, will converge as empirical results accumulate. To date, there is empirical evidence on the underlying motivations for volunteering, on the impact of high payment on human risk taking, on decision quality and well-being, on the signal value of small payments, on strategies to evade regulation, and on the general public’s assessment of appropriate activities and  payments. Moreover, there are studies that document biases affecting normative judgment in general, and biases affecting paternalistic restrictions and moral intuitions in particular.

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This blog post was written in connection with our paper in the JME:

Payment in challenge studies from an economics perspective 

by Sandro Ambuehl, Axel Ockenfels, and Alvin E. Roth

published online early, Oct 28, 2020. http://dx.doi.org/10.1136/medethics-2020-

The ethics (and some economics) of paying participants in Human Infection Challenge Studies, for a coronavirus vaccine

 

Here's a paper (that is perhaps not too long when you divide by the number of authors) seeking to provide some background for payment decisions in connection with  human infection studies (i.e. challenge trials) of covid-19 vaccines.

Lynch, Holly Fernandez and Darton, Thomas and Largent, Emily and Levy, Jae and McCormick, Frank and Ogbogu, Ubaka and Payne, Ruth and Roth, Alvin E. and Jefferson Shah, Akilah and Smiley, Thomas, Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations (August 14, 2020).  

Abstract: To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, this report offers an expert analysis of ethical approaches to paying research participants in these studies, as well as HICS more broadly. The report first provides an overarching ethical framework for research payment that divides payment into reimbursement, compensation, and incentive, focusing on fairness and promoting adequate recruitment and retention as counterweights to ethical concerns about undue inducement. It then describes variables relevant to applying this framework to any type of study, including the prospect of direct medical benefit, early participant withdrawal, study setting and location, pandemic circumstances, study budget, and participant perspectives. We conclude that there is no need for a unique payment framework specific to HICS or SARS-CoV-2 HICS, but that there may be features of particular relevance to ethical payment for these studies. Participants have varied motivations for enrolling in HICS, including financial considerations, altruism, and other interests, but undue inducement does not seem to be a significant problem based on available evidence. Payment in these studies should reflect the nature of participant confinement, anticipated discomfort from induced infection, risks and uncertainty, participant motivations, and the need to recruit from certain populations, as relevant. Where HICS involve significant risks and highly contingent social value, special review confirming the ethical permissibility of these studies can help promote confidence in the ethical permissibility of offers of payment to participate in them. We do not propose specific payment amounts for potential SARS-CoV-2 HICS, as these will be highly variable based on the relevant factors described in the report. Instead, we note that it is reasonable to start from payments offered in other similar studies, while adopting a systematic approach based on the ethical framework herein, as reflected in a pragmatic payment worksheet describing goals, coverage, factors to consider, and potential benchmarks.

Attacks on the Defense of Marriage Act

The 1996 Defense of Marriage Act, designed to 'defend' marriage from those States that have legalized same sex marriage, is under renewed attacks in the courts. (The Obama administration has indicated that it does not believe the Act is constitutional, so it will not defend it's key provisions, but this doesn't mean that it will die an easy death...)

Mass. leads fight on right to marry
"Massachusetts will once again take center stage in the national debate over same-sex marriage as the state becomes the first to go before a United States appeals court to challenge a federal law that defines marriage as a union only of a man and a woman.

"The US Court of Appeals for the First Circuit in Boston on Wednesday will hear two cases that challenge the 1996 Defense of Marriage Act: The first is a lawsuit brought by 17 local plaintiffs who say it deprives them of the federal benefits that other married couples receive.

"The second, brought by the state, alleges the Marriage Act forces Massachusetts to discriminate against gay couples when the state’s highest court has already declared their marriages constitutionally protected."
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Noncitizens Sue Over U.S. Gay Marriage Ban
"Five legally married same-sex couples filed a lawsuit on Monday to challenge the 1996 law that bars the federal government from recognizing  same-sex marriages, arguing that its impact is particularly harsh on couples that include an American citizen and a foreigner.

"The lawsuit, filed in United States District Court for the Eastern District of New York, was brought by Immigration Equality, a gay rights legal organization that focuses on immigration issues. Same-sex marriage advocates said it was likely to become the most prominent suit seeking to overturn the law, known as the Defense of Marriage Act, based on its effect on gay or lesbian immigrants who want to gain legal residence through marriage to American citizens.

"Under immigration law, a citizen can apply for a foreign spouse to obtain legal permanent residency, with a document known as a green card. Since unlike many other visas, there are no limits on the number of green cards available to spouses of citizens, those applications are among the fastest and most straightforward procedures in the immigration system. "Under the marriage act, which is called DOMA, federal authorities do not recognize same-sex marriages, even from states that allow them. In recent years, as same-sex marriage became legal in several states, gay and lesbian couples have come forward to say they were facing a painful choice: either deportation for the immigrant or exile to life in a foreign country for the American. ...

"In February 2011, the Obama administration announced that it regarded the central provision of the marriage act as unconstitutionally discriminatory, and said officials would no longer defend it in the courts.

 "On Wednesday, the United States Court of Appeals for the First Circuit in Boston will hear arguments in the first marriage act case to advance to the appeals level. That case contends that the act is unconstitutional because it denies federal benefits to same-sex couples married in Massachusetts, the first state to make same-sex marriage legal."

"Justice Department officials have said that they will not defend the core provision of the marriage act in that hearing, but will dispute other claims in the case. A conservative legal group appointed by the House of Representatives will argue in favor of the act."

Does criminalizing the purchase of sex endanger sex workers?

A lawyer who is also sex worker brings suit to overturn the law that makes purchasing sex a crime, on the grounds that this endangers prostitutes.

Northern Ireland sex worker bids to overturn ‘dangerous’ ban on hiring escorts
Laura Lee brings legal challenge to law that makes women ‘vulnerable to abuse’

"Sex worker and law graduate Laura Lee is steeling herself for a battle in Belfast’s high court that she believes could make European legal history. The Dublin-born escort is now in the final stages of a legal challenge to overturn a law in Northern Ireland that makes it illegal to purchase sex.

Not a single person in the region has appeared in court charged with trying to hire an escort, though Public Prosecution Service figures show that three are under investigation. The region is the first in the UK to make buying sex a crime. The law was introduced in 2014 by Democratic Unionist peer Lord Morrow and supported by a majority of members in the regional assembly.

But Lee will enter Belfast high court with her team of lawyers aiming to establish that the criminalisation of her clients violates her right to work under European human rights law. Since the law was established, Lee insists that the ban has put her and her fellow sex workers in more peril from potentially dangerous clients.

Just before flying out to address an international conference on sex workers’ rights in Barcelona this weekend, Lee told the Observer that most men currently seeking escorts in Northern Ireland no longer use mobile phones to contact her and her colleagues.

“They are using hotel phones, for example, to contact sex workers in Belfast rather than leaving their personal mobiles. This means if one of them turns violent there is no longer any real traceability to help the police track such clients down. Men are doing this because they fear entrapment and arrest due to this law.

“So in a sense the law is actually putting sex workers at greater risk than before, when there was some ability to trace and track down any client that was violent and abusive. The law to protect women in the sex trade has done the opposite of what it was intended to do. Every escort I know working in Belfast now insists on working side by side with another woman for protection. The law has not in any way reduced demand and supply, which is still the same. It has only driven the business further underground.”

...

"Lee’s Belfast legal battle is only the start of a Europe-wide campaign to overturn the model in which Scandinavian countries pioneered the outlawing of men buying sex. Lee’s next target is the Irish Republic, which, under new anti-trafficking laws, has introduced a similar ban aimed at criminalising clients.

“A win for us in Belfast will have a knock-on effect and set a precedent across Europe. If successful up north there will be a challenge in Dublin and sex workers across Europe can use the precedent to overturn the so-called ‘Nordic model’ in their countries,” she said."

DARPA Red balloons at MIT

The DARPA network challenge has been won by the MIT team: MIT wins $40,000 prize in nationwide balloon-hunt contest

"On MIT's Web site, a link was posted inviting people to sign up to help find the balloons and urging them to invite their friends. It said the MIT Red Balloon Challenge Team "is interested in studying information flow in social networks, so if we win, we're giving all the money away to the people who help us find the balloons!"
It detailed a chain for giving away the money, beginning with $2,000 given to each person who first sent in the coordinates of each balloon.
"We're giving $2,000 per balloon to the first person to send us the correct coordinates, but that's not all -- we're also giving $1,000 to the person who invited them. Then we're giving $500 whoever invited the inviter, and $250 to whoever invited them, and so on..." it said."

Here are some of the details from the MIT site linked to above...
The Challenge
This Saturday, December 5th, DARPA will be deploying 10 large, red weather balloons at 10 fixed locations in the United States. (more info) DARPA is giving $40,000 to the first team of people to find all 10 balloons. Join the MIT team, invite your friends and you can win money, help science, and help charity! (see how it works) .

Repugnance watch: Appeals court in SF allows challenge to state law banning prostitution

The SF Chronicle has the story: Appeals court in SF allows challenge to state law banning prostitution

"Advocates of legalized prostitution took their challenge to California’s 145-year-old ban on commercial sex before a federal appeals court Thursday and appeared to get a hint that they’ll have another chance to show why the law should be cast aside.


The case was brought by three former prostitutes, a would-be client and the Erotic Service Providers Legal, Educational and Research Project. They contend the law violates the right to engage in consensual sex, as defined by the U.S. Supreme Court in a 2003 ruling overturning criminal laws against gay sexual activity.

U.S. District Judge Jeffrey White of Oakland rejected their argument last year, saying the high court ruling protected only intimate personal relationships, not commercial sex. He said the state had adequately justified the current law as a deterrent to violence against women, sexually transmitted diseases and human trafficking.

But at Thursday’s hearing, members of a three-judge panel of the Ninth U.S. Circuit Court of Appeals in San Francisco suggested that the law might need closer scrutiny, given today’s less restrictive standards, as recognized by the high court, on sex between consenting adults.

“Why should it be illegal to sell something that it’s legal to give away?” asked Carlos Bea, one of the court’s most conservative judges.

Another conservative, Judge Consuelo Callahan, pointed out that prostitution, like gay sex, had historically been “subject to moral disapproval.” Just as in 2003, the current case, she said, “deals with individuals’ rights,” so why wouldn’t a ruling for the right to engage in prostitution be “a natural extension of Supreme Court precedent?”


Deputy Attorney General Sharon O’Grady, the state’s lawyer, responded that the difference is in “the commercial aspect ... the commodification of sex.”

“The state is not telling anyone who they can sleep with,” O’Grady said. It is prohibiting only a harmful category of business transactions, not intimate or enduring relationships, she said.

But Bea said the 2003 Supreme Court ruling might require the court to send the case back to White for another review, and perhaps even a full-scale trial, in which the state would have to show a compelling need for the law.

California made prostitution a crime in 1872, defining “every common prostitute” as a “vagrant” subject to a $500 fine and six months in jail. The law was updated in 1961 to reclassify prostitution or soliciting prostitution as disorderly conduct, a misdemeanor punishable by a $1,000 fine and six months in jail.

The Ninth Circuit left the state law intact in a 1988 ruling that said the relationship between a paid escort and a client “possesses few, if any, of the aspects of an intimate association.” H. Louis Sirkin, the plaintiffs’ lawyer in the current case, argued that the ruling is no longer binding.

The Supreme Court’s 2003 decision established “the right of individuals to make their own individual choices as to how they want to behave” in consensual sexual relationships, Sirkin told the court. “If people put a dollar amount on it, that should not alter the intimate relationship.”

Removing disincentives from kidney donation: pro and con in the American Journal of Kidney Diseases

 Two dueling papers in the American Journal of Kidney Diseases consider the effects of compensating kidney donors to remove disincentives from kidney donation.  The first (by McCormick et al.) suggests that including payments to compensate for risk would increase donation. The second paper (by Danovitch et al.) agrees, but says that this is what would make  compensation unethical, since it is unethical to pay for risk, as that might convince some to donate who otherwise would not.

Reducing the Shortage of Transplant Kidneys: A Lost Opportunity for the US Health Resources and Services Administration (HRSA)

Frank McCormick, Philip J. Held, Glenn M. Chertow, Thomas G. Peters, John P. Roberts   DOI:https://doi.org/10.1053/j.ajkd.2020.10.007 

"If the government removes all of these disincentives, it would not only be a major step toward economic fairness, but it would also significantly increase the number of living donors. "

The True Meaning of Financial Neutrality in Organ Donation

Gabriel M. Danovitch, Alexander M. Capron, Francis L. Delmonico, DOI:https://doi.org/10.1053/j.ajkd.2020.11.006

"Although McCormick et al discuss this principle  in the accompanying Policy Forum Editorial,4 it is our opinion that they distort the meaning of financial neutrality.5 The authors expand the legitimate costs of donation, including travel, lodging, lost work, and other verifiable expenses, to reach a $38,000 fixed payment to donors by including a dollar value for wholly subjective factors such as pain, fear, risk, and quality of life. For example, “risk” is assigned a value of $6,500. These factors are intrinsic to the process of organ donation, and it is disingenuous to include them under the rubric of financial neutrality.

...

"Critically, HRSA explicitly rejects the suggestion that payment be made for “undertaking a ‘risk,’ whether it be a long-term health risk or surgical risk.”

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I have to assume that people who reject payments for risk live in rural parts of America where we have volunteer fire departments, rather than in cities, where we pay fire fighters, partly for the risk they take.

In a different context, here's a recent post about a paper in the Journal of Medical Ethics that considers payments for risk in vaccine trials:

Thursday, October 29, 2020

Paying participants in challenge trials of Covid-19 vaccines, by Ambuehl, Ockenfels, and Roth

"we note that increasing hourly pay by a risk-compensation percentage ... provides compensation proportional to risk only if the risk increases proportionally with the number of hours worked. (Some risky tasks take little time; imagine challenge trials to test bulletproof vests.) To ensure that equal consequences are compensated with equal amounts across a wide variety of studies, we instead recommend a three-part contract consisting of: (1) salary for time involvement that is adjusted to account for the amount of discomfort experienced during participation, (2) insurance against ex post adverse outcomes and (3) ex ante compensation for risks that cannot be compensated ex post (such as death). Such a scheme also increases transparency about what is requested from participants and thus contributes to high-quality participation decisions."

NSF "Grand Challenge" white paper on market design

The National Science Foundation has asked for two-thousand-word 'white papers' on challenges worth exploring over the next decade.

Here's mine, on Market Design.

Abstract

In the past fifteen years, the emerging field of Market Design has solved important practical problems, and clarified both what we know and what we don’t yet know about how markets work. The challenge is to understand complex markets well enough to fix them when they’re broken, and implement new markets and market-like mechanisms when needed.

Among markets that economists have helped design are multi-unit auctions for complementary goods such as spectrum licenses; computerized clearinghouses such as the National Resident Matching Program, through which most American doctors get their first jobs; decentralized labor markets such as those for more advanced medical positions and for academic positions; school choice systems; and kidney exchange, which allows patients with incompatible living donors to exchange donor kidneys with other incompatible patient-donor pairs.

These markets differ from markets for simple commodities, in which, once prices have been established, everyone can choose whatever they can afford. Most of these markets are matching markets, in which you can’t just choose what you want, you also have to be chosen. One of the scientific challenges is to learn more about the workings of complex matching markets, such as labor markets for professionals, college admissions, and marriage.

Horsemeat in Canada

Top Chef trots into taboo territory

"Producers of the competitive culinary TV show Top Chef Canada galloped headlong into an internet outcry after news spread about an upcoming episode's focus on horse meat as an ingredient. In the challenge, scheduled to air on May 16th on Food Network Canada, contestants were required to cook traditional French dishes, including both foie gras (also a controversially-obtained food) and horse.

Protesters took to the show's Facebook page after promos for the episode aired, flooding the comments with mentions of Top Chef boycotts, links to anti-horse meat websites and advice on how to contact the show's advertisers. A specifically targeted Facebook group called "Boycott Top Chef – Protect the Horses" was swiftly established as a central location to share resources including educational material and contact information for the show's advertisers and the network's executives.

"Food Network Canada has issued a statement saying, "Please be assured it is not our intention to offend our viewers. The challenge in this episode involves having the competitors create a truly authentic, traditional French menu. One of the most traditional French foods is horsemeat. Horsemeat is also considered a delicacy in many cultures around the world. While we understand that this content may not appeal to all viewers, Food Network Canada aims to engage a wide audience, embracing different food cultures in our programming."

...

"Protesters, however, argue that not only is eating horse meat a moral taboo on par with the consumption of dogs and cats - it's also insufficiently regulated in Canada.

...

While horse meat is not an especially predominant ingredient in Canadian cuisine, and the majority of the meat processed in the country is exported internationally, it can be found for sale in supermarkets and at butcher shops.

An Eatocracy poll from earlier this year indicates that a substantial potion of the population expects to see a shift in perception toward horse meat consumption in the United States.

Do you think Americans will ever accept horse meat as part of their diet?
- No way. Never. 34.82%
- Only if there is no other option and we run out of other food sources 13.71%
- People don't really care that much what they put in their mouths, so yes 5.55%
- Possibly, but only after its health benefits are really proven 3.47%
- It'll take time, but why not? 14.3%
- It would be a huge success now if it were legal 4.11%
- People might try it as a novelty, but not as a staple - it'll always have a bit of a taboo 13.73%
- Maybe some food freaks will consider it a delicacy, but most people won't touch it 9.28%
- Other (please share below) 1.05% 

HT: Joshua Gans (the Canadian professor:) 

Alex Chan on deceased organ donation policy, in JAMA

Alex Chan comments on an earlier article in JAMA:
US Organ Donation Policy
Alex Chan, January 21, 2020

"To the Editor Ms Glazier and Mr Mone touted the success of the current opt-in organ donation system and argued for focusing on increasing registered donors to 75% of the adult population.1 A challenge is the intrinsic difficulty of such a task: more coordinated promotional efforts and new incentives like giving registered donors priority on organ waiting lists would likely be required.

"Even if such an increase in donor registration is possible, another challenge is the extent to which transplant centers recover organs from registered donors. Although the number of registered donors is more than half of the US population, only 36.3% of possible donors become actual donors.2 This loss of approximately one-third of registered donors suggests that obstacles to recovery of organs, such as family objection, transplant center rejections of imperfect organs, and OPO performance, are pivotal. Anecdotal evidence suggests that rejections of imperfect organs account for approximately 10% to 20%,2 leaving 10% to 20% of the loss still unaccounted for. Family consent or its lack may be a big part of the gap.
...
"Furthermore, 2 of the 3 states with the highest donor registration rates (Montana, 93%; Washington, 89%) have lower-than-average actual donation rates,1,2 but states like Nevada and Pennsylvania with registration rates lower than 50% have actual donation rates much higher than the national average.2 This suggests that registration is only part of the solution, and the ability of OPOs to obtain family consent and convert registrations into donations can bound the effectiveness of the current system."

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Here's the earlier post, about the article on which Alex is commenting

Wednesday, August 14, 2019

How is the U.S. opt in system of organ donation doing compared to an opt out system? Alex Glazier and Tom Mone in JAMA