Reconsideration of covid convalescent plasma

Recently Statnews reported that Covid convalescent plasma (CCP) may in fact be useful in preventing severe illness, despite the fact that earlier clinical trials did not show success in reversing severe illness:

Covid convalescent plasma: the ‘little engine that could’  By Michael J. Joyner, Nigel Paneth and Arturo Casadevall

"Unlike monoclonal antibodies, which can be defeated by new SARS-CoV-2 variants, CCP collected from vaccinated donors after recent breakthrough infections (VaxCCP) evolves with the variants and retains the ability to neutralize them. What makes CCP an even more promising therapy is that there are now many potential donors available in the U.S. who have been vaccinated and had recent breakthrough infections.

...

"An array of data, including randomized controlled trials and careful retrospective studies, show a clear survival benefit when CCP is given to immunocompromised individuals who test positive for SARS-CoV-2. There are also impressive case reports and case series showing that Covid convalescent plasma, especially VaxCCP, is effective in patients with smoldering Covid-19.

...

"the early “major” RCTs that tested the efficacy of CCP on survival in hospitalized patients tested the wrong use case. These studies treated patients who were too sick for too long to benefit from antibody therapy. But the major “negative” trials all showed evidence of effectiveness among people who received CCP earlier, who were not already desperately ill, who were immunocompromised, or who received the most antibodies. Unfortunately, these positive signals, which were consistent with impressive real-world data on Covid-19 and CCP, were buried under the top-line results."

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Earlier posts on convalescent plasma

Australia legalizes medical use of psychedelics

 Scott Cunningham points out that Australia has become the first country to legalize the medical use of certain psychedelics. 

Here's the announcement from the Australian Government's Therapeutic Goods Administration (TGA)

Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists

"From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

The Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients.

Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients.

The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials."

*********

Scott shares a post by Shane Pennington on drugs that contrasts the Australian (medical) decision with the U.S. Drug Enforcement Agency's (legal) decision to maintain the ban on these drugs, despite the growing medical evidence (from U.S. studies, on which the Australian government relied) that psychedelics have some important medical uses.

"To support its decision, the TGA relied heavily on studies conducted in the U.S. and recent U.S. Food and Drug Administration (FDA) decisions recognizing psilocybin and MDMA’s extraordinary therapeutic potential. Around the same time, DEA shot down a petition—based on those same arguments and evidence—that Matt and I submitted on behalf of a palliative-care doctor, requesting rescheduling of psilocybin under U.S. law. The DEA’s four-sentence analysis completely ignored the same studies and FDA decisions that persuaded the Australian regulator to reschedule.  

"The dramatically different fates of these similar petitions reveal a troubling reality about U.S. drug law: Under DEA’s watch, the scientific and medical determinations of the nation’s leading public health agency carry considerable weight around the world but are often ignored at home. That revelation should terrify anyone interested in rational, evidence-driven drug policy. "

******

But the States are the laboratory of democracy: here's an earlier related post.

Sunday, November 13, 2022

Colorado legalizes magic mushroom/psilocybin therapies

Illegal to sell fur coats in California

 The NY Times has the story. (And you still can't eat horsemeat here.)

Fur Sales Are Illegal in California. Does Anyone Care?.The popularity of fur products had been diminishing in the state even before the new ban. By Max Berlinger

"a law banning the sale and manufacture of luxury pelts like mink, sable, chinchilla, lynx, fox, rabbit and beaver that went into effect in California in January has so far been largely met with a shrug 

...

“There was a bigger ripple when Chanel stopped selling crocodile.” 

"With California’s mild climate and eco-conscious reputation, some have said that a ban on fur sales in the state is more of a symbolic gesture than practical measure.

"The statewide ban, the first of its kind in the country, codifies what was a growing movement happening at the city level in recent years. (Los Angeles, West Hollywood, San Francisco and Berkeley had similar bans before.) This law extends the city bans already in effect in some areas across the country’s most populous state, one that, despite certain clichés, encompasses a wide variety of landscapes and political affiliations."

**********

Here's the bill, California Assembly Bill 44, which forbids sale or manufacture of new fur products (but permits sale of existing garments):

"This bill would make it unlawful to sell, offer for sale, display for sale, trade, or otherwise distribute for monetary or nonmonetary consideration a fur product, as defined, in the state. The bill would also make it unlawful to manufacture a fur product in the state for sale. The bill would exempt from these prohibitions used fur products, as defined, fur products used for specified purposes, and any activity expressly authorized by federal law."

Kidney exchange in Mexico

 Here's a report from the journal Cirugia y Cirujanos  (Surgery and Surgeons) on the experience with kidney exchange (aka kidney paired donation) at the Central Military Hospital in Mexico City, where 

Donación renal pareada: beneficio de este programa en la tasa de trasplantes y sobrevida del injerto

Kidney paired donation: benefit of this program on the transplant rate and graft survival  by Lucino Bahena-Carrera, Héctor F. Noyola-Villalobos, Edgar E. Ramos-Díaz, Marco A. Loera-Torres, Ricardo Mendiola-Fernández y Mónica L. Razo-Padilla, Cirugia y Cirujanos 91, no. 1 (2023): 50-57.

 Abstract: 

"Objective: To demonstrate the experience since the transplant program under paired kidney donation implementation; program that increases the donation rate by 25-30% in hospitals with no inferior graft survival compared to directed living donor kidney transplantation. 

"Method: Observational, analytical, longitudinal and prospective study from December 2018 to July 2021. All G5 KDIGO chronic kidney patients who were HLA or ABO incompatible with their original donors in the pretransplant protocol and who were transplanted under the paired kidney donation program, were included. 

"Results: 22 kidney transplants were performed under this program. Survival of the graft and the patient 1 year after transplantation was 100%. The post-transplant glomerular filtration rate was 72.5 ± 17 ml/min/1.73 m2  body surface. 36.3% of hypersensitized patients were successfully transplanted. The in-hospital donation rate increased by 33.33%. 

"Conclusions: Transplantation under the kidney paired donation program constitutes a real modality of successful transplantation when there is incompatibility with the original donor. The greater use and socialization of this program can increase the country kidney transplantation rate, reducing the waiting list. Our hospital represents the largest experience published in Mexico with this transplant program

First kidney exchange between Cyprus and Israel

 The Cyprus Mail has the story

First exchange kidney transplant between Cyprus and Israel, By Jonathan Shkurko, March 1, 2023

"The first ever crossover organ transplant involving Cyprus and Israel took place on Wednesday after two kidneys were exchanged at the old Larnaca airport in the morning.

"The effort follows an exchange agreement signed between the two countries.

"The agreement stipulates that organs belonging to donors in Cyprus that are incompatible with the recipients, will be exchanged with compatible organs arriving from Israel.

"The kidney received from Israel was transported to the new transplant clinic at Nicosia general, whereas the one donated by Cyprus was flown to Tel Aviv.

...

"During the organs’ exchange at Larnaca airport, the director of Israel Transplant Organisation Tamar Ashkenazi said she was very happy to see the results of the transnational agreement.

“I hope we will continue with more organs exchanges in the future, as we are already doing with Austria, Czech Republic and United Arab Emirates,” Ashkenazi said. 

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Earlier:

Thursday, December 19, 2019

International kidney exchange between Israel and Czech Republic

Monday, October 4, 2021

More on the UAE-Israel kidney exchange

Itai Ashlagi's kidney exchange software has played a role in all these exchanges.

Evaluating kidney patients and donors without consideration of race

 Somewhere in the history of nephrology, a patient's race was included as a factor in estimating their kidney function.  This has at various times been important for various kinds of treatment, including of course preventive treatment, as well as starting dialysis, and entry and perhaps priority on kidney transplant waitlists. And it has also been important for evaluating the quality of deceased donor kidneys that can be offered for transplantation. There have been important recent changes in this, and more may be on the way. The current issue of JAMA devotes a number of articles to that, linked below.

Viewpoint Redressing the Harms of Race-Based Kidney Function Estimation Dinushika Mohottige, MD, MPH; Tanjala S. Purnell, PhD, MPH; L. Ebony Boulware, MD, MPH Audio: Race-Neutral Estimates of Kidney Function: Enhancing Equity Video: Race-Neutral Estimates of Kidney Function: Enhancing Equity Time to Abolish Metrics That Sustain Systemic Racism in Kidney Allocation John S. Gill, MD, MS; Burnett Kelly, MD, MBA; Marcello Tonelli, MD, SM Medical News & Perspectives Race-Based Equations Delayed Black Patients From Getting Onto Kidney Transplant Lists—An Unprecedented New Policy Seeks to Undo the Damage Jennifer Abbasi PREVIOUSLY PUBLISHED JAMA | Research Association of Estimated GFR Calculated Using Race-Free Equations With Kidney Failure and Mortality by Black vs Non-Black Race Orlando M. Gutiérrez, MD, MMSc; Yingying Sang, MS; Morgan E. Grams, MD, MHS, PhD; et al JAMA | Opinion Race-Free Estimation of Kidney Function: Clearing the Path Toward Kidney Health Equity L. Ebony Boulware, MD, MPH; Dinushika Mohottige, MD, MPH; Matthew L. Maciejewski, PhD JAMA Network Open | Research Association of the Estimated Glomerular Filtration Rate With vs Without a Coefficient for Race With Time to Eligibility for Kidney Transplant Leila R. Zelnick, PhD; Nicolae Leca, MD; Bessie Young, MD, MPH; et al Audio Race-Neutral Estimates of Kidney Function: Enhancing Equity Video

Join the conversation. Follow JAMA on Twitter.

Democracy & “Noxious” Markets, by Debra Satz

 The Winter 2023 issue of Daedalus is about Creating a New Moral Political Economy, edited by Margaret Levi & Henry Farrell.

The article by Debra Satz will strike a chord with market designers: she takes very seriously that markets are tools that need thoughtful design.

Democracy & “Noxious” Markets, by Debra Satz

"my argument is not a lawyer’s brief against markets. No large democratic society can or should entirely dispense with markets. Not only are markets among the most powerful tools we have for generating growth in living standards and incentivizing innovation, but also Smith was right to see their democratic potential as ways of enabling cooperation among independent, free, and equal individuals. As tools, however, we should think carefully about where to use them and how to design them when we do. While a neoliberal worldview sees efficient markets enhancing freedom and well-being everywhere, the reality is more complex. Some markets foreclose options that would better support democratic institutions and culture. Sometimes, closing off market options makes everyone better off. Consider that if individuals are free not to purchase health insurance on the market, the cost of publicly provided insurance will increase: healthy individuals are more likely to opt out of health insurance, leaving sicker individuals in the pool to be insured and raising the costs of their insurance, leading more people to forgo holding such insurance, driving the prices up even higher."

Among the markets she is concerned about are school choice, and military service:

"some of the ways parents prioritize their own children can lead to worse outcomes for other children and to the furthering of educational inequities, as well as to other social ills like instability and conflict. Evidence indicates, for example, that choice schools in the United States are more homogenous than public schools with respect to social class and race. Researchers have also shown that when public school choice is available, educated parents are especially likely to factor child demographics in their school selections.11 This may be because school quality is very hard to judge and parents default to markers such as the reading and math levels of other students. These levels, in turn, are heavily influenced by social class. It is likely that some parents take race and class directly as proxies for school quality."

...

"Extending the reach of markets even more, war has been further outsourced to private military contractors: in 2009, there were more private military contractors in Afghanistan than U.S. military troops.17 Hiring private mercenaries and outsourcing national security to a subsection of our population might spare our citizens, but as political philosopher Michael Sandel has noted, it changes the meaning of citizenship.18 In what sense are we “all in this together” if most citizens never need to think hard about decisions to go to war? Whatever the efficiency pros and cons of the decision to outsource fighting and allocate military service through market means, doing so changes our relationships with one another and our sense of a common life."

"My argument so far suffers from treating the state and market as two stark alternatives for the allocation of goods and services in society. So I now want to consider ways in which the benefits of markets can be harnessed—through design—to better serve important democratic goals. "

...

"One important mechanism is providing greater roles for worker voice. This can be done through such reforms as changing labor laws to support forms of worker association, like trade unions, allowing worker representatives on company boards, and strengthening democracy at work through diverse forms of ownership including worker-managed and -owned firms. Empowering the associational organization of labor would also help redress the background social conditions that render workers vulnerable to the oligarchic power of their employers.

"There are other examples in which careful design and policy can limit the “noxiousness” of a particular market for democracy. Policies such as a negative income tax can strengthen the power of workers, and campaign finance laws can diminish the power of money in elections. Others have argued for reforms to our current system of commodified legal representation within an adversarial system, and for single-payer health care systems."

Here's her concluding paragraph:

"Beyond education, we need to pay special attention to particular markets that affect democratic functioning and stability. Such markets include but are not limited to markets in legal representation, media and news markets, markets relating to national defense, and markets governing political rights. Politicians and other commentators usually write unreflectively, as if all markets were the same. They are not. Markets affect not only the distribution of income and wealth, but also our capacities, and our views of each other. Their strengths but also their limits depend on the fact that they are radically individualizing. But in some contexts, that individualizing threatens the practice of democracy. Markets have moral and even “spiritual” consequences relevant to our shared public life, and our evaluations of them must also attend to those consequences. A new political economy needs to take this larger evaluative frame into account."

******

The next article in the issue is a thoughtful essay on markets for personal care of the young and the elderly, organized in various ways, including care within families, written as a commentary on the Satz article: 

Is There a Proper Scope for Markets?  by Marc Fleurbaey

AEA committee on the job market considers early and exploding offers

 John Cawley chairs the AEA committee on the job market, and recently tweeted the request for information below.  Feel free to communicate with him on twitter or directly, as I'll be glad to rely on him to compile and forward all the responses. (I'm one of the few economists not on most social media...but I really will try to read all responses:) (Click to enlarge...)

Judge shopping for abortion rulings

 Justice (like politics, sausage and econometrics) is constructed in complex ways. The Washington Post has a story on the case against an anti-abortion drug, now being heard by federal judge Matthew Kacsmaryk in Amarillo Texas, which could result in a nationwide ban on that drug.  The case concerns medical issues about drug regulation, and isn't directly concerned with the legal controversy about abortion rights.

The Texas judge who could take down the abortion pill. A devout Christian, Matthew Kacsmaryk has been shaped by his deep antiabortion beliefs. By Caroline Kitchener and  Ann E. Marimow  February 25, 2023 

"The abortion pills lawsuit, which Kacsmaryk could rule on any day, is the latest in a long line of politically explosive cases to appear on the judge’s docket. In a practice known as “forum shopping,” conservative groups have zeroed in on the Amarillo division of the Northern District of Texas as a go-to place to challenge a wide range of Biden administration policies. Because Amarillo is a federal district with a single judge, plaintiffs know their arguments will be heard by Kacsmaryk — who, like any federal judge, is positioned to issue rulings with nationwide implications.

"Appeals from Kacsmaryk’s district follow a path that has regularly yielded favorable outcomes for conservatives — reviewed first by the U.S. Court of Appeals for the 5th Circuit, which upheld a strict Texas abortion ban long before Roe v. Wade was overturned, then ultimately by the conservative-controlled Supreme Court."

********

Here's a related story from Medpage Today:

A Ban on the Abortion Drug Mifepristone Is Looming— A Texas lawsuit may be disastrous for effective abortion access and FDA's authority by Lawrence O. Gostin, JD, LLD, and Sarah Wetter, JD, MPH, February 23, 2023

"In the most consequential and controversial attack on reproductive rights since the overturning of Roe v. Wade, a Texas judge could ban the safest, most effective, and most common method for abortion in all 50 states. The hyper-conservative anti-abortion group Alliance Defending Freedom  (ADF) is seeking to overturn the FDA's approval of mifepristone (Mifeprex), a medication in a two-pill regimen used to terminate pregnancies through the first 10 weeks gestation. The lawsuit does not target the other medication, misoprostol (Cytotec), which FDA approved to treat stomach ulcers, and can be prescribed off-label for abortion.

...

"Given the FDA's rigorous risk evaluation and mitigation strategy (REMS) for mifepristone and its safe use for 23 years, the case is utterly frivolous and political, but due to "judge shopping" the repercussions for reproductive health and equity are real. Perversely, a single federal trial judge has the power to block a federal law, rule, or action on a national scale. The case could make its way to the Supreme Court, with potentially disastrous consequences for safe, effective abortion access and the authority of the FDA."

opens in a new tab or windowfor mifepristone and its safe use for 23 years, the case is utterly frivolous and political, but due to "judge shopping" the repercussions for reproductive health and equity are real. Perversely, a single federal trial judge has the power to block a federal law, rule, or action on a national scale. The case could make its way to the Supreme Court, with potentially disastrous consequences for safe, effective abortion access and the authority of the FDA.

Judd Kessler on Market Rules

 Judd Kessler is writing a book (that I'm looking forward to reading):

Harm reduction at work in NYC's opioid crisis

 The NY Times follows some harm reduction workers through their work in New York City, including a city-sponsored safe injection facility.  Not so easy to do, and not so easy to read.

One Year Inside a Radical New Approach to America’s Overdose Crisis. By Jeneen Interlandi

"Since its official opening on Nov. 30, 2021, OnPoint has met with both praise and protest. Shopkeepers and school principals routinely thank Mr. Jones and his colleagues for their daily rounds of needle collection. But local civic groups have been furious about yet another substance abuse program in a neighborhood dense with them and have argued that, however well intentioned, the organization’s approach will only make a bad problem worse. People who are addicted to drugs need tough love and harsh consequences, they insist, not coddling. Community outreach’s mission was therefore twofold: Convince skeptics that programs like these can be a net positive for the community and persuade those with substance use disorders to accept the lifeline that OnPoint was offering."

Incarceration isn't always the best treatment for drug addiction

 Here's a NY Times editorial:

America Has Lost the War on Drugs. Here’s What Needs to Happen Next.  Feb. 22, 2023

It begins with this bit of history, and ends with a call for evidence-based solutions:

"For a forgotten moment, at the very start of the United States’ half-century long war on drugs, public health was the weapon of choice. In the 1970s, when soldiers returning from Vietnam were grappling with heroin addiction, the nation’s first drug czar — appointed by President Richard Nixon — developed a national system of clinics that offered not only methadone but also counseling, 12-step programs and social services. Roughly 70 percent of the nation’s drug control budget was devoted to this initiative; only the remaining 30 percent went to law enforcement.

"The moment was short-lived, of course. Mired in controversy and wanting to appear tough on crime, Nixon tacked right just months before resigning from office, and nearly every president after him — from Reagan to Clinton to Bush — followed the course he set. Before long, the funding ratio between public health and criminal justice measures flipped. Police and prison budgets soared, and anything related to health, medicine or social services was left to dangle by its own shoestring.

...

"Study the solutions. Leading public health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention, failed to prevent or even adequately respond to the opioid epidemic that has engulfed the nation. But health officials can still step up. As opioid settlement funds are deployed (along with federal dollars) and harm reduction programs are begun, the C.D.C. especially should impartially study what is working and what is not. The response to this crisis should finally be based on evidence.

"The nation’s leaders are not the only ones with work to do. To fully replace the war on drugs with something more humane or more effective, the public will have to come to terms with the prejudices that war helped instill. That means accepting that people who use drugs are still members of our communities and are still worthy of compassion and care. It also means acknowledging the needs and wishes of people who don’t use drugs, including streets free of syringe litter and neighborhoods free of drug-related crime. These goals are not mutually exclusive. In fact, they go hand in hand. But to make them a reality, lawmakers and other officials will have to lead the way."

Money Laundering

 Financial regulation plays a big role in law enforcement, by helping investigators to follow the money, which is often easier than following the crimes that generate the money. So, for example, drug dealers and others have trouble turning their income (which is often in cash) into bank accounts that can be used to buy the things that legal money can buy.  Money laundering involves turning ill got gains into reportable income.  Gambling, it turns out, offers some possibilities: if I come into the casino with some cash, and come out with some cash, it's hard to prove that I'm paying tax on more than my winnings.

Here's a story that touches on that, from the WSJ:

Cantor Fitzgerald Gambling Affiliate to Pay $22.5 Million to Settle Probes. CG Technology is said to have admitted aiding and abetting illegal gambling and money laundering   By Kate O’Keeffe and Alexandra Berzon

"Cantor Fitzgerald LP’s sports-betting affiliate has agreed to pay $22.5 million in penalties and forfeiture to the U.S. government in conjunction with its involvement in illegal gambling and money laundering, according to people familiar with the matter.

...

"The agreement comes as the U.S. Treasury and Justice Departments have been increasingly focused in recent years on potential money-laundering violations at casinos. The probes generally center on how the gambling companies allegedly help to facilitate money laundering or fail to report suspicious activities.

...

"Two people who were running their own illegal bookmaking operations elsewhere laundered money through Cantor as part of this system, the people said."

The market for (and marketing of) baby formula

 The Lancet has a series of articles on baby formula.  It begins with this editorial, and is followed by three articles:

Unveiling the predatory tactics of the formula milk industry, The Lancet, Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(23)00118-6

"For decades, the commercial milk formula (CMF) industry has used underhand marketing strategies, designed to prey on parents' fears and concerns at a vulnerable time, to turn the feeding of young children into a multibillion-dollar business. The immense economic power accrued by CMF manufacturers is deployed politically to ensure the industry is under-regulated and services supporting breastfeeding are under-resourced. These are the stark findings of the 2023 Breastfeeding Series, published in The Lancet today."

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VOLUME 401, ISSUE 10375, P472-485, FEBRUARY 11, 2023 Breastfeeding: crucially important, but increasingly challenged in a market-driven world, by Prof Rafael Pérez-Escamilla, PhD  Cecília Tomori, PhD Sonia Hernández-Cordero, PhD Phillip Baker, PhD Aluisio J D Barros, PhD MD France Bégin, PhD Donna J Chapman, PhD Laurence M Grummer-Strawn, PhD Prof David McCoy, PhD Purnima Menon, PhD Paulo Augusto Ribeiro Neves, PhD Ellen Piwoz, PhD Prof Nigel Rollins, MD Prof Cesar G Victora, PhD MD Prof Linda Richter, PhD on behalf of the 2023 Lancet Breastfeeding Series Group†  Open Access Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01932-8

"When possible, exclusively breastfeeding is recommended by WHO for the first 6 months of life, and continued breastfeeding for at least the first 2 years of life, with complementary foods being introduced at 6 months postpartum.9 Yet globally, many mothers who can and wish to breastfeed face barriers at all levels of the socioecological model proposed in The Lancet's 2016 breastfeeding Series."

 VOLUME 401, ISSUE 10375, P486-502, FEBRUARY 11, 2023 Marketing of commercial milk formula: a system to capture parents, communities, science, and policy by Prof Nigel Rollins, MD  Ellen Piwoz, ScD Phillip Baker, PhD Gillian Kingston, PhD Kopano Matlwa Mabaso, PhD Prof David McCoy, DrPH  Paulo Augusto Ribeiro Neves, PhD  Prof Rafael Pérez-Escamilla, PhD  Prof Linda Richter, PhD  Prof Katheryn Russ, PhD  Prof Gita Sen, PhD  Cecília Tomori, PhD  Prof Cesar G Victora, MD  Paul Zambrano, MD  Prof Gerard Hastings, PhD  on behalf of the 2023 Lancet Breastfeeding Series Group  Open Access Published:  February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01931-6

"Despite proven benefits, less than half of infants and young children globally are breastfed in accordance with the recommendations of WHO. In comparison, commercial milk formula (CMF) sales have increased to about US$55 billion annually, with more infants and young children receiving formula products than ever. "

 VOLUME 401, ISSUE 10375, P503-524, FEBRUARY 11, 2023 The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress by Phillip Baker, PhD Julie P Smith, PhD Prof Amandine Garde, PhD Laurence M Grummer-Strawn, PhD Benjamin Wood, MD Prof Gita Sen, PhD Prof Gerard Hastings, PhD  Prof Rafael Pérez-Escamilla, PhD  Chee Yoke Ling, LLB  Prof Nigel Rollins, MD Prof David McCoy, DrPH  on behalf of the 2023 Lancet Breastfeeding Series Group†  Open Access Published: February 07, 2023 DOI:https://doi.org/10.1016/S0140-6736(22)01933-X

"The first and second papers in this Series8,  9 present several reasons for the global rise of CMF in human diets, including the CMF industry's exploitation of parental anxieties; ubiquitous marketing; and absent or inadequate protection and support for breastfeeding within health-care systems, work settings, and households. In this Series paper, we look further upstream and examine the root causes of low worldwide breastfeeding rates10 to understand why so many women and families are prevented from making and implementing informed decisions about feeding and caring for infants and young children; why so many policy makers and health-care professionals are co-opted by CMF marketing and other commercial forces; and why so many countries have not prioritised and implemented policies to protect, promote, and support breastfeeding. It is important to note that we use the terms women and breastfeeding throughout this Series for brevity, and because most people who breastfeed identify as women; we recognise that not all people who breastfeed or chestfeed identify as women."

**********

Among my previous posts on milk are some noting that there are shortages of human breast milk, and that in many places the sale of breast milk is banned (in some places out of concern that poor mothers would sell their milk instead of feeding their children, and in some places out of concerns that the sale of breast milk is repugnant even from mothers who produce milk in excess to their children's needs.)  

Thus (in different times, places, and circumstances) there is repugnance both to the sale of mothers' milk and to the sale of substitutes for it.

It's hard to navigate the Ophthalmology and Urology labor market without a couples match

The Ophthalmology and Urology matches are earlier than the NRMP resident match, and do not offer a couples match. Based on a survey of Ophthalmology and Urology match participants, the authors outline the need for a couples match.

Navigating the Ophthalmology & Urology Match with a Significant Other by lSamantha S. Massenzio MD *, Tara A. Uhler MD †, Erik M. Massenzio MD †, Emily Sun BS *, Divya Srikumaran MD *, Marisa M. Clifton MD ‡, Laura K. Green MD §, Grace Sun MD ║, Jiangxia Wang MS ¶, Fasika A. Woreta MD, MPH *  https://doi.org/10.1016/j.jsurg.2022.07.026  Journal of Surgical Education, Volume 80, Issue 1, January 2023, Pages 135-142

"Highlights:

• There is an increasing number of couples applying for residency

• Ophthalmology and urology applicants cannot utilize the NRMP Couples Match system

• A Couples Match is highly desired by applicants to these two specialties

• The lack of a Couples Match is a deterrent to these specialties for some applicants

• Systems to aid applicants to these specialties with significant others are needed"

Will Italy criminalize foreign surrogacy?

 It's hard to ban something that people want and need and is legally available in other jurisdictions, but it looks like Italy might try it regarding surrogacy.  Here's a story from Britain's Sunday Times:

Italian families seeking surrogates abroad could face jail or €1 million fines by Tom Kington

"Italians travelling abroad to seek surrogate mothers to start families could face jail time and a million euro fine thanks to a new bill introduced by senators close to Giorgia Meloni, the Italian prime minister.

"The proposed law, which must be approved by the Italian parliament, describes surrogacy as “an execrable example of the commercialisation of the female body and the treatment of babies as merchandise”.

...

"An Italian law passed in 2004 banned surrogate pregnancies in Italy, forcing couples to travel to countries such as the United States and Canada to find surrogate mothers."

Computational and Experimental Economics Summer School June 11-16, 2023, Barcelona

 Rosemarie Nagel sends me the following announcement:

We invite graduate students and young faculty to the
2nd Computational and Experimental Economics Summer School
June 11-16, 2023, BESLAB, UPF, Barcelona, Spain

The goal of the summer school is to develop a foundation for using computational models
and simulations to complement and/or explain results from human subject experiments.
In particular, throughout the curriculum, students will learn how to implement a variety of agent-based models
that have successfully captured regularities observed in the experimental and field data.
They will participate in experiments and develop an original project in groups of 3-4 participants.

In addition, the summer school will include a two-day workshop on computational and experimental economics (June 14-15)
with presentations by leading researchers who are interested in experimental and computational economics.

The deadline for applications is March 31, 2023.

You can find how to participate here:

Organizers
Herbert Dawid (Bielefeld University)
John Ledyard (Caltech)
Rosemarie Nagel (ICREA-UPF, and BSE)

Yaroslav Rosokha  (Purdue University)

Guest lecturers

Mikhail Anufriev (University of Technology Sydney)
Cars Hommes (University of Amsterdam and Bank of Canada)
Annie Liang (Northwestern. University)
Valentyn Panchenko (University of New South Wales)

 

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?

A tale of two Organ Procurement Organizations, in JAMA Surgery

 Here's a report of two Organ Procurement Organizations with very different rates of recovery of organs:

Variability in Organ Procurement Organization Performance by Individual Hospital in the United States, by Wali Johnson, MD1; Kathryn Kraft, MD2; Pranit Chotai, MD3; Raymond Lynch, MD4; Robert S. Dittus, MD5; David Goldberg, MD6; Fei Ye, PhD7; Brianna Doby, BA8; Douglas E. Schaubel, PhD9; Malay B. Shah, MD2; Seth J. Karp, MD1, JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7853

"Design, Setting, and Participants  A retrospective cross-sectional analysis was performed of organ donation across 13 different hospitals in 2 donor service areas covered by 2 organ procurement organizations (OPOs) in 2017 and 2018 to compare donor potential to actual donors. More than 2000 complete medical records for decedents were reviewed as a sample of nearly 9000 deaths. Data were analyzed from January 1, 2017, to December 31, 2018.

"Exposure  Deaths of causes consistent with donation according to medical record review, ventilated patient referrals, center acceptance practices, and actual deceased donors.

"Main Outcomes and Measures  Potential donors by medical record review vs actual donors and OPO performance at specific hospitals.

"Results  Compared with 242 actual donors, 931 potential donors were identified at these hospitals. This suggests a deceased donor potential of 3.85 times (95% CI, 4.23-5.32) the actual number of donors recovered. There was a surprisingly wide variability in conversion of potential donor patients into actual donors among the hospitals studied, from 0% to 51.0%. One OPO recovered 18.8% of the potential donors, whereas the second recovered 48.2%. The performance of the OPOs was moderately related to referrals of ventilated patients and not related to center acceptance practices.

"Conclusions and Relevance  In this cross-sectional study of hospitals served by 2 OPOs, wide variation was found in the performance of the OPOs, especially at individual hospitals. Addressing this opportunity could greatly increase the organ supply, affirming the importance of recent efforts from the federal government to increase OPO accountability and transparency.

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And here's an accompanying editorial:

It Is Time for the Light to Shine on Organ Procurement Organizations by Robert M. Cannon, MD, MS1; Jayme E. Locke, MD, MPH1 JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7857

"Many explanations have been put forth as to why some OPOs carry out their mandate more effectively than others. One argument is that mechanisms of death in some parts of the country are more conducive to organ donations than in others. We have refuted this phenomenon as a significant factor in OPO performance variability in our previous work.3 Others have even tried to place the blame for poorly performing OPOs at the feet of “risk-averse” transplant centers, a factor that the data presented in this current study also refute. The cold truth is that we have no good understanding of why some OPOs are better than others, or even what an acceptable level of OPO performance should be, because the environment in which OPOs operate is so completely obscure."

Arms for children but not women in Missouri

 The Washington Post has the story:

Missouri Republicans block proposed ban on kids carrying guns in public By Timothy Bella

"The Republican-controlled Missouri House of Representatives rejected a proposal Wednesday that would have banned children from being able to openly carry firearms on public land without adult supervision.

"The proposal, which was part of a long debate in the chamber on how to fight crime in St. Louis, was soundly defeated by a vote of 104-39, with just one Republican voting in support of the ban.

...

"Since 2017, Missouri residents have not been required to have a permit for concealed carry, after lawmakers in the Missouri House voted to override a veto by then-Gov. Jay Nixon (D) of a broad gun-rights bill. The law does not require gun owners to take safety training or have a criminal-background check to carry concealed firearms in most public places. The move was celebrated by Republicans, but law enforcement officials warned that the law was “going to make officers a lot more apprehensive,” St. Louis Public Radio reported at the time.

"The proposal’s defeat this week comes almost a month after Missouri Republicans in the state House made news for a voting to tighten the dress code for women legislators, while leaving the men’s dress code alone. Missouri House Republicans sought to require women to wear a blazer when in the chamber. The state House eventually approved a modified version of the proposal, which allows for cardigans as well as jackets but still requires women’s arms to be concealed."

Domestic abusers have the right to bear arms--5th Circuit Court of Appeals

 In the U.S., the right to bear arms is a protected transaction. That can lead to some controversial decisions. 

Here's the story from Bloomberg:

Gun Ruling Giving Domestic Abusers Rights Prompts Garland Rebuke By Erik Larson

"The decades-old US law barring domestic abusers from possessing firearms contradicts the nation’s “historical tradition” of access to guns even for people who may not be “model citizens,” an appeals court said in a ruling that prompted a Justice Department rebuke.

"The statute is unconstitutional because it gives too much power to Congress to determine who qualifies as “law-abiding, responsible citizens” when it comes to gun ownership, the 5th US Circuit Court of Appeals said Thursday.

...

"The ruling vacated the conviction of a Texas man, Zackey Rahimi, who pleaded guilty to violating the law by keeping a pistol at home despite being subject to a civil domestic-violence restraining order for assaulting his former girlfriend. It’s the latest fallout from a US Supreme Court ruling in June that paved the way for courts to reconsider a wide variety of gun restrictions.

...

“Rahimi, while hardly a model citizen, is nonetheless part of the political community entitled to the Second Amendment’s guarantees, all other things equal,” said the appellate panel, comprised of two judges appointed by former President Donald Trump and one by Ronald Reagan.

"Rahimi’s home was searched after he was involved in five shootings in a two-month span, including firing at a law enforcement vehicle in December 2020, firing at a driver after getting in a car accident and shooting multiple rounds in the air in January 2021 “after his friend’s credit card was declined at a Whataburger restaurant,” the appeals court said."

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Here's the Supreme Court decision, NRA v. Bruen on which the 5th Circuit relied:

NEW YORK STATE RIFLE & PISTOL ASSOCIATION, INC., ET AL. v. BRUEN, SUPERINTENDENT OF NEW YORK STATE POLICE, ET AL.

No. 20–843. Argued November 3, 2021—Decided June 23, 2022 

Syllabus:

"New York’s proper-cause requirement violates the Fourteenth Amendment by preventing law-abiding citizens with ordinary self-defense needs from exercising their Second Amendment right to keep and bear arms in public for self-defense."

Canada experiments with decriminalization of opioids and other drugs in British Columbia

 From the CBC:

What you need to know about the decriminalization of possessing illicit drugs in B.C.  B.C. granted exemption by federal government in November 2022; pilot will run until 2026  by Akshay Kulkarni ·

"it is no longer a criminal offence to possess small amounts of certain illicit drugs in B.C. for people aged 18 or above.

"It's part of a three-year pilot by the federal government, which granted B.C. an exemption from the Controlled Drugs and Substances Act (CDSA) on May 31, 2022. 

...

"Under the exemption, up to 2.5 grams of the following four drug types can be legally possessed:

"Cocaine (crack and powder). Methamphetamine. MDMA. Opioids (including heroin, fentanyl and morphine).

"Fentanyl and its analogues were detected in nearly 86 per cent of drug toxicity deaths from 2019 until 2022, according to the latest report from the B.C. Coroners Service."

Support for an independent judiciary in Israel

 Democratic institution are under threat in many parts of the world, involving elections, insurrections, and the courts.  Israel is no exception these days.  Yesterday's Jerusalem Post featured several stories about expressions of concern from friends of Israel, including an open letter from economists:

Biden calls for Israeli judicial reform consensus in first comment. US Secretary of State Blinken made a similar comment during his visit to Israel a few weeks ago. By TOVAH LAZAROFF,  FEBRUARY 12, 2023 

Seven Israeli Nobel laureates warn against judicial overhaul. In their letter, the Nobel Prize winners said that scientific excellence can only thrive in democratic nations with full freedom. By TOVAH LAZAROFF Published: FEBRUARY 12, 2023 

56 US economists sign letter opposing Israeli judicial reform By JERUSALEM POST STAFF FEBRUARY 12, 2023

Here's the open letter in full, organized by Professor Lucian Bebchuk at Harvard:

Statement By Leading U.S. Economists Regarding Proposed Israeli Reforms

February 8, 2023​ 

"The governing coalition in Israel is considering an array of legislative acts that would weaken the independence of the judiciary and its power to constrain governmental actions. Numerous Israeli economists, in an open letter that some of us joined, expressed concerns that such a reform would adversely affect the Israeli economy by weakening the rule of law and thereby moving Israel in the direction of Hungary and Poland. Although we significantly vary in our views on public policy and on the challenges facing Israeli society, we all share these concerns. A strong and independent judiciary is a critical part of a system of checks and balances. Undermining it would be detrimental not only to democracy but also to economic prosperity and growth.

"The 56 signatories to this statement are all economists who are current or former professors at leading U.S. universities and who also are:

(A) Recipients of the Nobel Memorial Prize in Economic Sciences (11);

(B) Winners of the John Bates Clark, Fischer Black, and/or BBVA Foundation prizes (10); 

(C) Current or former Presidents of the American Economic Association, American Finance Association, and/or the American Law and Economics Association (16);

(D) Individuals who formerly served as U.S. Chair of the Council of Economic Advisors, the World Bank Chief Economist, or the International Monetary Fund Chief Economist (5); and/or 

(E) Elected members of the National Academy of Sciences and/or the American Academy of  Arts and Sciences (50).

Signatories

Each signatory joined solely in their individual capacity, and the universities/organizations with which they are associated are noted for identification purposes. The superscripts next to each individual’s name indicate as stated below the list.

Daron Acemoglu (Massachusetts Institute of Technology) B, E

Alan Auerbach (University of California, Berkeley) E

David Autor (Massachusetts Institute of Technology) E

Lucian Bebchuk (Harvard University) C, E

Marianne Bertrand (University of Chicago) E

Jagdish Bhagwati (Columbia University) E

Nicholas Bloom (Stanford University) E

Samuel Bowles (Santa Fe Institute) E

Timothy Bresnahan (Stanford University) B, E

Jeremy Bulow (Stanford University) E

John Campbell (Harvard University) C, E

Janet Currie (Princeton University) C, E 

David Cutler (Harvard University) E

Stefano DellaVigna (University of California, Berkeley) E

Peter Diamond (Massachusetts Institute of Technology) A, C, E

Barry Eichengreen (University of California, Berkeley) E

Drew Fudenberg (Massachusetts Institute of Technology) E

Mark Gertler (New York University) B, E

Claudia Goldin (Harvard University) B, C, E

Roger Gordon (University of California, San Diego) E

Gene Grossman (Princeton University) E

Oliver Hart (Harvard University) A, C, E

R. Glenn Hubbard (Columbia University) D

Matthew Jackson (Stanford University) B, E

Paul Joskow (Massachusetts Institute of Technology) E

Kenneth Judd (Stanford University) E

Daniel Kahneman (Princeton University) A, E

Lewis Kornhauser (New York University) C

Laurence Kotlikoff (Boston University) E

Anne Krueger (Johns Hopkins University) C, D, E

David Laibson (Harvard University) E

W. Bentley MacLeod (Columbia University) C

Ulrike Malmendier (University of California, Berkeley) B, C, E

Charles Manski (Northwestern University) E

Eric Maskin (Harvard University) A, E

Marc Melitz (Harvard University) E

Paul Milgrom (Stanford University) A, B, E

Joel Mokyr (Northwestern University) E

Maurice Obstfeld (University of California, Berkeley) D, E

Edmund Phelps (Columbia University) A, C, E

Andrew Postlewaite (University of Pennsylvania) E

Matthew Rabin (Harvard University) B, E

Kenneth Rogoff (Harvard University) D, E

Paul Romer (New York University) A, D, E

Alvin Roth (Stanford University) A, C, E

Daniel Rubinfeld (University of California, Berkeley) C, E

José Scheinkman (Columbia University) E

Ilya Segal (Stanford University) E

Robert Solow (Massachusetts Institute of Technology) A, B, E

A. Michael Spence (Stanford University) A, B, E

Richard Thaler (University of Chicago) A, C, E

Michael Whinston (Massachusetts Institute of Technology) E

Michelle White (University of California, San Diego) C

Michael Woodford (Columbia University) E

Richard Zeckhauser (Harvard University) E

Luigi Zingales (University of Chicago) C

 "Any inquiries or communications may be sent to the Statement’s coordinator Professor Lucian Bebchuk at info@Statement-By-Leading-US-Economists.net."