Who better to talk about forbidden markets than Kim Krawiec? Her new podcast is off to a great start.
Kimberly D Krawiec
"A podcast about things we aren’t supposed to trade . . . But do anyway"
Sunday, September 6, 2020
Saturday, September 5, 2020
Friday, September 4, 2020
The Alliance for Paired Kidney Donation has announced its Donor Protection Program
The Alliance for Paired Kidney Donation has announced the details of its Donor Protection Program
"The APKD protects a donor’s finances & family at no cost to transplant centers.
- Lost wage and travel expense reimbursement
- Life, disability, and complication insurance
- A future kidney if needed: The APKD KidneyPledge"
Thursday, September 3, 2020
Peter Cramton on the retail electricity market in California
Peter Cramton* is an astute observer of electricity markets. Here's his op-ed in the San Diego Union-Tribune:
Here's the first paragraph:
"Rolling outages may appear to be a symptom of climate change. Extreme heat and intermittent renewables certainly challenge electricity markets. But these challenges can be met with good market design. The California market has flaws that make California electricity more expensive and less reliable than it should be. Fixing these flaws should be a priority."
and here's the final paragraph:
"California illustrates that good intentions do not necessarily produce good policy. Good policy is designed from what we know about markets and human behavior. Good policy is the only way to provide reliable electricity at least cost"
*"Cramton is a professor of economics at the University of Cologne and the University of Maryland, is an independent board member of ERCOT, the electricity operator in Texas. The views here are his own and not those of ERCOT or ERCOT’s board."
Wednesday, September 2, 2020
Who Gets In, and Why--an inside look at college admissions
Here's an essay from the WSJ, adapted from a forthcoming book with an evocative title, “Who Gets In and Why, by Jeffrey Selingo. The subtitle is A Year Inside College Admissions
The Secrets of Elite College Admissions: In the final ‘shaping’ of an incoming class, academic standards give way to other, more ambiguous factors by By Jeffrey Selingo, Aug. 28, 2020
"The year I was inside Emory University’s admissions office, the school received a record 30,000 applications for fewer than 1,400 spots in its incoming class. In early March, just weeks before official notices were scheduled to go out, the statistical models used by Emory to predict enrollment indicated that too many applicants had been chosen to receive acceptances. In the span of days, teams of admissions officers covering five geographical areas had to shift 1,000 applications from the thin “admit” stack to the much larger “deny” or “wait list” piles.
Tuesday, September 1, 2020
Matching inequality and strategic behavior under the Boston mechanism: Evidence from China's college admissions by Wu and Zhong
Here's a paper that analyses the immediate acceptance ("Boston") algorithm that was in use in China's college admissions system in many provinces, in 2003.
by BinzhenWu and Xiaohan Zhong
Games and Economic Behavior, Volume 123, September 2020, Pages 1-21, https://doi.org/10.1016/j.geb.2020.05.007
Abstract: We examine matching inequality in students' matching outcomes for the Boston Mechanism in a large matching system, by measuring the degree of mismatch for each student. We link a student's mismatch with her reporting behavior of the first choice on her preference list to explore the reasons for matching inequality. Using administrative data from college admissions in China, we find significant gender differences, rural-urban gaps, and ethnic gaps in mismatching and first-choice behavior. These demographic differences exhibit various patterns and may be explained by risk aversion, information disadvantage, and minority-preferential admissions policies, respectively.
Monday, August 31, 2020
The econometrics of deceased kidney donation
Two papers have made me think about the power of econometric methods applied to studies of medical issues related to matching deceased donor kidneys to patients.
I recently heard Chuck Manski give a seminar on this paper published last year in PNAS:
One thing I took away from it is that proportional hazard (Cox) models are very popular in the medical literature, but they assume that effects (e.g. rejection of a graft) are proportional to time, and there are immunological processes that don't in fact have a constant hazard rate, but build up over time, so that isn't a good model for those things.
Predicting kidney transplant outcomes with partial knowledge of HLA mismatch
Charles F. Manski, Anat R. Tambur, and Michael Gmeiner, PNAS October 8, 2019 116 (41) 20339-20345
"Abstract: We consider prediction of graft survival when a kidney from a deceased donor is transplanted into a recipient, with a focus on the variation of survival with degree of human leukocyte antigen (HLA) mismatch. Previous studies have used data from the Scientific Registry of Transplant Recipients (SRTR) to predict survival conditional on partial characterization of HLA mismatch. Whereas earlier studies assumed proportional hazards models, we used nonparametric regression methods. These do not make the unrealistic assumption that relative risks are invariant as a function of time since transplant, and hence should be more accurate. To refine the predictions possible with partial knowledge of HLA mismatch, it has been suggested that HaploStats statistics on the frequencies of haplotypes within specified ethnic/national populations be used to impute complete HLA types. We counsel against this, showing that it cannot improve predictions on average and sometimes yields suboptimal transplant decisions. We show that the HaploStats frequency statistics are nevertheless useful when combined appropriately with the SRTR data. Analysis of the ecological inference problem shows that informative bounds on graft survival probabilities conditional on refined HLA typing are achievable by combining SRTR and HaploStats data with immunological knowledge of the relative effects of mismatch at different HLA loci."
************
And here's a recent working paper that says that if we want to maximize life years added by transplant, more organs should go more quickly to healthier patients:
Choices and Outcomes in Assignment Mechanisms: The Allocation of Deceased Donor Kidneys
Nikhil Agarwal, Charles Hodgson, Paulo Somaini, August 17, 2020
"Abstract: While the mechanism design paradigm emphasizes notions of efficiency based on agent preferences, policymakers often focus on alternative objectives. School districts emphasize educational achievement; and transplantation communities focus on patient survival. However, it is unclear whether choice-based mechanisms perform well when assessed using these outcomes. This paper evaluates the assignment mechanism for allocating deceased donor kidneys on the basis of the additional patient life-years from transplantion (LYFT). We examine the role of choice in increasing LYFT and compare equilibrium assignments to benchmarks that remove choice. Our approach combines a model of choice and outcomes in order to study how selection induced in the mechanism produces the outcome of
interest, LYFT. We show how to identify and estimate the model using quasi-experimental variation resulting from the mechanism. The estimates suggest that the design in use selects patients with better survival prospects after a transplant and matches them well. It results in an average LYFT of 7.97, which is 0.88 years higher than a random assignment. However, there is scope for increasing the aggregate LYFT to 12.07. While some of this increase can be achieved by assigning transplanted patients to different donors, realizing the majority requires transplanting relatively healthy patients, who would have longer life-expectancy
even without a transplant. Therefore, a policymaker faces a dilemma between
transplanting patients that are sicker and those for whom life will be extended
the longest."
Sunday, August 30, 2020
Profile of Amy Finkelstein in the PNAS
Profile of Amy N. Finkelstein by Jennifer Viegas
"“It is a very exciting time to be an economist,” says Amy Finkelstein, a professor of economics at the Massachusetts Institute of Technology (MIT) who was elected to the National Academy of Sciences in 2018. “Economics has become a rigorous science, combining theory and data to better understand how the world works and how to improve it.” Focusing on the healthcare sector in the United States, Finkelstein integrates economic models, empirical methods, and data to find solutions for problems facing health insurance markets and healthcare delivery systems. Her research carries implications for healthcare policy. Finkelstein’s Inaugural Article (1) reports that a nationwide Medicare reform influenced the treatment of patients who were covered by other kinds of health insurance. The findings suggest that such broad effects should be taken into account when formulating future healthcare policies.
"Three Generations of Women with Doctorates
"Finkelstein was born in New York City in 1973 to biologist parents, who both earned doctorates at The Rockefeller University. In 1940, her mother immigrated to the United States from Poland, where her maternal grandmother had received a doctorate in comparative literature at the University of Warsaw. Finkelstein says, “It is remarkable that a Jewish woman in the 1920s was able to earn a doctorate in Eastern Europe.” The Finkelstein family papers documenting their lives are archived at the US Holocaust Memorial Museum in Washington, DC."
Saturday, August 29, 2020
Poets and Quants celebrates Professor Övül Sezer
Two days ago I received a note of encouragement by email from Övül Sezer, a former student in my Harvard class on experimental economics, which she spoke about while being celebrated by Poets and Quants.
BY: NATHAN ALLEN
Here's that Q&A from her interview:
"Professor I most admire and why:
"There have been so many professors who inspired me and influenced me in several ways and I am so grateful for all the things I learned from them. But one class that I took in college changed the course of my path. Back in college, I was studying math, spending a lot of time on equations and mathematical proofs. In a very serendipitous way, I ended up trying to take a graduate-level economics class, called “Experimental Economics” because I wanted to take a class where I didn’t have to do any weekly “problem set” but it still counted as credit. To be able to take the class as an undergrad, I needed the professor’s permission. The professor teaching the course happened to be Al Roth, who allowed me to the class and introduced me to the love of experiments. Through him, I started learning a lot about experiments, and how we can take our very own observations about life and test them. This was the first time I fell in love with experimental science, and this is where I am today. In addition to being a great professor, Al Roth is also a very thoughtful and a kind person. I feel tremendously grateful to have taken that class."
Friday, August 28, 2020
Surrogacy in the time of covid travel restrictions
The NY Times has the story:
Mothers, Babies Stranded in Ukraine Surrogacy Industry--Virus travel bans are wreaking havoc on surrogacy agencies that help same-sex couples build families By Maria Varenikova
"In one of the more bizarre consequences of coronavirus travel restrictions, biological parents, babies and surrogate mothers have become scattered and sometimes stranded in multiple countries for months this year.
"Ukraine, with its relatively permissive reproductive health laws and an abundance of willing mothers among a poor population, is a hub of the international business, executives in the industry and women’s rights advocates say.
"But Ukrainian law bans surrogacy for same-sex couples or for clients who wish to select the sex of the child. In response, a branch of the Ukrainian industry began moving women to other jurisdictions for impregnation and birth, often to legal gray zones like the largely unrecognized, Turkish-backed, splinter state of Northern Cyprus.
...
"The women travel to have an embryo implanted, return to Ukraine for seven months of pregnancy, then travel again to give birth.
"Virus travel restrictions drew attention earlier this year for blocking heterosexual parents from retrieving their babies inside Ukraine. At one point, 79 babies were stacked up in Kyiv, cared for by nurses, in cribs at a hotel.
...
"It is a very common illegal business in such countries as Northern Cyprus, Transnistria, Abkhazia and other unrecognized statelets, said Sergii Antonov, a lawyer and authority on reproductive law in Ukraine.
"In Northern Cyprus, the Ukrainian mothers give birth without a legal surrogacy contract. Instead, they renounce custody after birth, which allows the genetic parents to adopt the children. It is a legal process that can stretch for several weeks.
"In February and March, 14 Ukrainian mothers, fearful of being stranded by virus travel bans, left Northern Cyprus after giving birth but before completing the transfer to the genetic parents, leaving behind a crop of babies in legal limbo.
Thursday, August 27, 2020
School choice with common preferences and incomplete information admits a winner's curse, by Kloosterman and Troyan
Suppose that schools have an intrinsic quality that would affect the preferences of all students if they knew it, but some students are better informed than others. Then, for uninformed students, there can be a kind of winner's curse associated with being accepted to a school: the fact that it had seats available suggests that it might not be high quality. Kloosterman and Troyan propose mitigating this by giving each student a secure school for which he/she has high enough priority to be admitted regardless of others' preferences: " a secure school is one with enough seats for j and every student who has higher priority than j. " When all students have the same ordinal preferences at every state of the world, then the deferred acceptance algorithm with students proposing continues to make it a dominant strategy for informed students to state their true preferences, and there is an equilibrium that avoids the winners curse in which each uninformed student lists their secure school as their first choice.
School choice with asymmetric information: Priority design and the curse of acceptance
by Andrew Kloosterman and Peter TroyanTheoretical Economics, Volume 15, Issue 3, July 2020, Pages: 1095-1133
Abstract: We generalize standard school choice models to allow for interdependent preferences and differentially informed students. We show that, in general, the commonly used deferred acceptance mechanism is no longer strategy‐proof, the outcome is not stable, and may make less informed students worse off. We attribute these results to a curse of acceptance. However, we also show that if priorities are designed appropriately, positive results are recovered: equilibrium strategies are simple, the outcome is stable, and less informed students are protected from the curse of acceptance. Our results have implications for the current debate over priority design in school choice.
...
"How do secure schools help the uninformed? The problem for them is the curse of acceptance, and a secure school allows for them to have a default option that they can get in every state. Hence, the curse is entirely eliminated by allowing them to expect to get average utility, rather than always being left with the worst schools in every state. Theorem 1 formalizes this intuition to all markets in the common ordinal preferences model."
Wednesday, August 26, 2020
Information from the AEA on this year's new Ph.D. job market
Here's an announcement that came by email from the American Economic Association:
|
Webinar on the new
Ph.D. Job Market, hosted by the AEA ad hoc Committee on the Job Market |
|
August 25, 2020 *********** The communications page includes the following:
|
Tuesday, August 25, 2020
Surrogacy and citizenship in the U.S.
Some rules seem clear: anyone born in the U.S. is an American citizen, as is any child of an American parent. But in these partisan times, even clear rules are subject to argument, and questionable distinctions can be brought up to litigate old repugnances.
ABC has the story:
State Dept. fighting to deny US citizenship to gay couple's child: A federal judge ruled in June that the agency had to grant citizenship. By Conor Finnegan
"The State Department is appealing a federal judge's decision that it must recognize the U.S. citizenship of a young girl born via surrogate to a gay couple -- prolonging one of many legal fights over its controversial policy that was deemed unconstitutional in June.
"Roee Kiviti and Adiel Kiviti of Chevy Chase, Maryland, are legally married and both U.S. citizens. Their daughter Kessem was born in Canada via a surrogate, so the State Department has argued in federal court that she is "born out of wedlock" and not entitled to birthright citizenship.
...
"The Kiviti's are not the only family in a legal battle with the department on this issue.
"According to Immigration Equality, Derek Mize and Jonathan Gregg, a gay couple in Atlanta, are also awaiting a ruling by a federal judge over their daughter Simone's citizenship.
"The group also represents Allison Stefania and Lucas Zaccari -- a lesbian couple fighting for their daughter's citizenship. She was born to Lucas, an Italian citizen, via in vitro fertilization, so the State Department ruled she was born out of wedlock to a non-U.S. citizen, disregarding Allison's U.S. citizenship and their marriage. The couple is also awaiting a decision."
HT: Kim Krawiec
Monday, August 24, 2020
The Canadian Resident Matching Service: a history
Here's a brief history of the Canadian medical residency match:
Gallinger J, Ouellette M, Peters E, Turriff L. CaRMS at 50: Making the match for medical education [Les 50 ans du CaRMS: jumelage pour l’éducation médicale]. Can Med Educ J. 2020;11(3):e133-e140. Published 2020 Jul 15. doi:10.36834/cmej.69786
Abstract: "Entry into postgraduate medical training in Canada is facilitated through a national application and matching system which establishes matches between applicants and training programs based on each party’s stated preferences.
"Health human resource planning in Canada involves many factors, influences, and decisions. The complexity of the system is due, in part, to the fact that much of the decision making is dispersed among provincial, territorial, regional, and federal jurisdictions, making a collaborative national approach a challenge. The national postgraduate application and matching system is one of the few aspects of the health human resources continuum that is truly pan-Canadian.
"This article examines the evolution of the application and matching system over the past half century, the values that underpin it, and CaRMS' role in the process."
Sunday, August 23, 2020
More on Deceased donors as non‐directed donors in kidney exchange chains
I anticipate that we will be reading more in the future about kidney exchange chains started by a deceased donor kidney. In the meantime, here are two recent papers:
From the American Journal of Transplantation:
Deceased donors as non‐directed donors in kidney paired donation
First published: 16 August 2020
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi:10.1111/ajt.16268
Abstract
As proof of concept, we simulate a revised kidney allocation system that includes deceased donor (DD) kidneys as chain‐initiating kidneys (DD‐CIK) in a kidney paired donation pool (KPDP), and estimate potential increases in number of transplants. We consider chains of length 2 in which the DD‐CIK gives to a candidate in the KPDP, and that candidate’s incompatible donor donates to the deceased donor (DD) waitlist. In simulations, we vary initial pool size, arrival rates of candidate/donor pairs and (living) non‐directed donors (NDDs), and delay time from entry to the KPDP until a candidate is eligible to receive a DD‐CIK. Using data on candidate/donor pairs and NDDs from the Alliance for Paired Kidney Donation, and the actual DDs from the Scientific Registry of Transplant Recipients (SRTR) data, simulations extend over two years. With an initial pool of 400, respective candidate and NDD arrival rates of two per day and 3 per month, and delay times for access to DD‐CIK of 6 months or less, including DD‐CIKs increases the number of transplants by at least 447 over two years, and greatly reduces waiting times of KPDP candidates. Potential effects on waitlist candidates are discussed as are policy and ethical issues.
************
And from Transplant International:
Lucrezia Furian Antonio Nicolò Caterina Di Bella Massimo Cardillo Emanuele Cozzi Paolo Rigotti
First published: 09 August 2020 https://doi.org/10.1111/tri.13712
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi:10.1111/tri.13712
PDFPDFTOOLS SHARE
Abstract: "Kidney paired donation (KPD) is a valuable way to overcome immunological incompatibility in the context of living donation, and several strategies have been implemented to boost its development. In this article, we reviewed the current state of the art in this field, with a particular focus on advanced KPD strategies, including the most recent idea of initiating living donor (LD) transplantation chains with a deceased‐donor (DD) kidney, first applied successfully in 2018. Since then, Italy has been running a national program in which a chain‐initiating kidney is selected from a DD pool and allocated to a recipient with an incompatible LD, and the LD’s kidney is transplanted into a patient on the waiting list (WL).
"At this stage, since the ethical and logistic issues have been managed appropriately, KPD starting with a DD has proved to be a feasible strategy. It enables transplants in recipients of incompatible pairs without the need for desensitizing and also benefits patients on the WL who are allocated chain‐ending kidneys from LDs (prioritizing sensitized patients and those on the WL for longer)."
****************
Previous posts:
Monday, October 14, 2019 A kidney exchange chain initiated by a deceased donor, in Italy
Tuesday, September 5, 2017 UNOS proposal: Allowing Deceased Donor-Initiated Kidney Paired Donation (KPD) Chains
Monday, April 11, 2016 Using deceased donor kidneys to start living donor kidney exchange chains
Saturday, August 22, 2020
Organs for sale
Given the heated discussions and intense repugnance that often accompany questions concerning compensation for organs, you might be surprised to find an American Organ Clearing House that has a section devoted to Organs for Sale.
The site appears to get a lot of support from religious institutions
Needless to say, although money plays an important role, this kind of commerce still involves a good deal of matching.
"There is more to placing a pipe organ than checking physical dimensions. We will work with you to choose an instrument appropriate for the acoustics, liturgy, and other activities of your church."
Friday, August 21, 2020
Brain death (death by neurological criteria)
Defining human life is hard, but defining death used to be easy: no heartbeat or respiration. That changed with modern technology--e.g. a patient in the midst of a heart transplant may have no heart, but may have a long life ahead.
And of course, if we are who we think we are, it is brain death that matters most: loss of heartbeat and respiration kills our brains, our selves. But defining brain death is not so easy, especially for a patient on a ventilator who may have a pulse and be visibly breathing.
A recent discussion in JAMA seeks to standardize definitions of brain death, which are of more than academic interest, because deceased donor organ transplantation mostly goes on after brain death but while the organs are still receiving oxygen from (artificially maintained) heartbeat and respiration.
Greer DM, Shemie SD, Lewis A, et al. Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project. JAMA. Published online August 03, 2020. doi:10.1001/jama.2020.11586
"The concepts of life and death have always been complicated, but ever more so as medical and technological advances continue to extend the limits to saving life and prolonging physiological function. For previous generations, cardiorespiratory death was the sole clinical definition of death, often without any standard criteria, leading to the risk of misdiagnosis. As resuscitation techniques and mechanical ventilation developed, a new definition of death was needed.
"The idea of brain death/death by neurologic criteria (BD/DNC) was first recognized in 1959 as “coma depassé”1 and subsequently described as “brain death” with the first published clinical definition in 1968, commonly known as the Harvard Brain Death Criteria.2 Since then, many other guidelines and protocols have been published, adopted, and revised throughout the world with general acceptance of the concept of BD/DNC among medical groups, major religions, and governments.3
'However, there continues to be confusion and dilemmas that arise regarding BD/DNC. The wide variance in practice reflects this confusion and numerous other challenges. Inconsistencies in concept, criteria, practice, and documentation exist internationally and within countries.3,4 Difficulties in conducting randomized clinical trials and large-scale studies on BD/DNC have resulted in a lack of robust data from which to develop evidence-based recommendations. Challenges to the validity of BD/DNC continue to promote controversy. These factors initiated this project to harmonize practice and improve the rigor of BD/DNC determination."
**********
Here's an earlier take, with a more philosophical slant:
Sarbey, Ben. “Definitions of death: brain death and what matters in a person.” Journal of law and the biosciences vol. 3,3 743-752. 20 Nov. 2016, doi:10.1093/jlb/lsw054
Here are the concluding sentences:
"The neurological criteria for death represent a remarkable advance in our ways of responding to changes in death and dying. However, as medical technology and life extension techniques develop, we must also develop increasingly precise notions of what aspects of our neurological lives are the most important. While the current total brain death standard currently suffices in the vast majority of cases, the standard does not fully line up with what we value in persons. Should we retain the current brain death standard despite its mismatch with our values and despite negative consequences in determining death and in organ donation? Technological advances seem as if they will inevitably make this question inescapable."
Thursday, August 20, 2020
Opioid deaths in Canada during the pandemic, and what to do about it.
Canada has a different political culture than the U.S., and attitudes towards drug abuse are one place in which that shows through clearly.
The Washington Post has the story--drug overdoses have risen during the pandemic:
By Amanda Coletta
"a growing chorus, including top public health officials, the premier of British Columbia and the nation’s police chiefs, is calling on Prime Minister Justin Trudeau to decriminalize the possession of illicit drugs for personal use.
...
"British Columbia, the epicenter of the crisis, recorded its deadliest month in May — and then surpassed it in June. Nearly four times as many people in the province have died of a suspected overdose this year as have died of the coronavirus.
...
"Border closures have disrupted drug markets, making the street supply more unpredictable and toxic. Authorities have urged people to stay at home, pushing some to use drugs alone, without anyone nearby to help when dosages go wrong. Some supervised consumption sites and treatment centers have reduced operations, cutting people off from support networks.
...
"For the pandemic, officials have marshaled extraordinary financial resources and provided daily updates. Lawmakers have stood side-by-side with public health officials, largely deferring to their advice.
"But they’ve not always backed the remedies those same officials have offered to fight overdoses.
...
"“The most important thing we can do is make it okay for people to talk about their drug use and to seek assistance for it,” Henry said. “Labeling somebody a criminal is one of those major barriers that keeps people hiding and afraid and ashamed.”
...
"That followed an extraordinary endorsement from the Canadian Association of Chiefs of Police, which said police resources would be better spent on cracking down on drug trafficking, illegal production and importation than on pursuing users.
"The chiefs said that arresting people for simple possession has been “ineffective” and that police should instead direct users to social services and health care, which could reduce recidivism and ancillary crimes."
Wednesday, August 19, 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.
Tuesday, August 18, 2020
Organizing tests of drugs to treat, and vaccines to prevent, coronavirus
Here's a story on some of the difficulties in drug testing: among the difficulties are that positive test results for infection are taking too long after testing to allow prompt treatment...
Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected By Katie Thomas
Aug. 14, 2020
"Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a dearth of tests, overwhelmed hospitals and reluctant patients."
...
"While much of the world’s focus has been on the race to create a coronavirus vaccine, new drugs could also help curb the pandemic by making the disease less deadly. Because drugs are typically tested in sick patients in smaller clinical trials, they can also be developed more quickly than vaccines.
...
"The fast-moving disease has presented opportunities and challenges for the researchers testing antibodies. As the number of infections mounted in states like Florida, Texas and Arizona, there was no shortage of patients who would be eligible for trials. But at the same time, the outbreaks overwhelmed the very hospitals that would be overseeing the studies.
...
"“That doesn’t happen when you’re setting up diabetes trials or cancer trials,” he said. “We’ve had investigators say: ‘Look, I’d love to do research, but I don’t have time to set up a new trial. I’ve got an I.C.U. full of patients.’”
...
"Both the Regeneron and Eli Lilly trials require giving the drug within three days of taking a positive test.
"But with turnaround times in some areas lagging for five days or more, keeping within those time frames has proved difficult."
**********
With conventional (non-challenge) vaccine trials, having a high level of infection is important, to allow the effectiveness of vaccine candidates to be tested. So, Brazil (and the U.S.):
Coronavirus Crisis Has Made Brazil an Ideal Vaccine Laboratory By Manuela Andreoni and Ernesto Londoño Aug. 15, 2020
"Widespread contagion, a deep bench of scientists and a robust vaccine-making infrastructure have made Brazil an important player in the quest to find a vaccine."
...
"Some 5,000 Brazilians have also been recruited to support a vaccine trial conducted by AstraZeneca, a British-Swedish pharmaceutical company in partnership with Oxford University. An additional 1,000 volunteers in Brazil were recruited to test a vaccine developed by New York-based Pfizer.
"Researchers need countries with large enough outbreaks to assess whether a vaccine will work. Some volunteers are given the potential vaccine while others are given a placebo, but they have to be in a place where enough virus is circulating to test the vaccine’s efficacy.
"Brazil, where the virus has infected more than three million people, has clear conditions for these trials. And it will be the only country other than the United States to be playing a major role in three of the leading studies as an unparalleled quest for a vaccine has led to unusually fast regulatory approvals and hastily brokered partnerships."
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