Market design at Stanford

 Two recent Stanford news stories focus on market design:

Symposium inaugurates Center for Computational Market Design. The new center will bring interdisciplinary expertise to bear on crafting rules and procedures for creating and improving markets.

"In an interview, Amin Saberi, a co-director of the center and professor of management science and engineering, said he hopes that research by the center’s members can inform market-related policy decisions in health care, education, transportation, electricity, and the environment.

“One of our goals is to collaborate with industry and the government to analyze existing markets and improve their performance,” Saberi said. “We also hope that the center becomes a launchpad for prototyping new marketplaces.”

Itai Ashlagi, the center’s other co-director and a professor of management science and engineering, said in an interview that the rise of artificial intelligence played a role in the decision to launch the center. “AI is going to be a big player in marketplaces,” he said.

########

For the Colorado River and beyond, a new market could save the day. Stanford economist Paul Milgrom won a Nobel Prize in part for his role in enabling today’s mobile world. Now he’s tackling a different 21st century challenge: water scarcity.

#########

Earlier:

Sunday, January 7, 2024

Market Design for Surface Water , by Ferguson and Milgrom

Global pacemaker retransplantation

 There are innovative approaches to global health care.  Here is one, that involves reusing pacemakers recovered from deceased donors and refurbished for use in countries where pacemakers are too expensive for wide use.  Unlike some of what we encounter in kidney transplants across borders, the legal bans that have to be overcome may not come from the war against the poor.  A careful clinical trial is underway. There is also an unregulated black market...

Here's the encouraging story from Helio.com:

After death, a new life for refurbished pacemakers in low-, middle-income countries, February 23, 2024

"Lack of access to pacemakers is a major challenge to the provision of CV health care in low- and middle-income countries; however, postmortem pacemaker utilization could offer an opportunity to deliver this needed care, according to Thomas Crawford, MD, an electrophysiologist and associate professor of internal medicine at University of Michigan Health and the medical director of My Heart Your Heart, a cardiac pacemaker reuse initiative at the University of Michigan Cardiovascular Center

...

"Crawford: The need is great. Each year, somewhere between 1 million and 2 million people worldwide die due to a lack of access to pacemakers and defibrillators. There is literature reflecting this. When you query pacemaker implantation data for the United States, it is roughly 800 pacemakers per 1 million population. When you query countries like, for example, Nigeria, it says four pacemakers per million. Quite a difference.

"Per capita gross domestic product is such that, in many countries, a pacemaker costs more than a person’s annual income.

...

"Healio: What are the regulations around using a refurbished pacemaker?

"Crawford: Pacemaker reuse is illegal in all jurisdictions. The FDA states that pacemaker reuse is an “objectionable practice.” We know we can do it, but we need to develop partnerships with other entities to give us credibility. One of those methods to do this is by engaging the government. FDA issues export permits for this type of activity. We created a protocol where we reprocess the device, working with Northeast Scientific, which provides the pacemaker cleaning and sterilization. We have received permission from the FDA to export them. We have to put a sticker on them saying “not for use in the United States.” We are doing this in countries in which governments will allow it. One of the limitations is needing a government letter from each of the recipient countries. We have about 12 countries now, and the collection of countries we are working with is purely accidental. It is not a normal methodological process. A lot of it is through contact with individuals and opportunities that arise.

...

"Healio: You are leading a randomized controlled trial called Project My Heart Your Heart: Pacemaker Reuse. What is the study design, and what do you and your colleagues hope to learn?

"Crawford: The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in low- and middle-income countries without resources. The target enrollment is 270 patients, all from outside the United States, who each have a class I indication for pacing and who attest that they do not have the ability to purchase a device on their own. They must consent to be randomly assigned to receive either a brand-new pacemaker, which we purchase, or a reprocessed pacemaker, for which we provide the leads and accessories. Donated devices are inspected according to specific protocols that evaluate physical and electrical suitability, including battery longevity, for future use. Devices deemed to be acceptable are shipped to a third-party vendor, Northeast Scientific, for disassembly, cleaning and re-sterilization. There will be about 130 participants in each arm. We will follow those patients and report any adverse events. The countries that have contributed patients include Kenya, Nigeria, Paraguay, Sierra Leone and Venezuela. We hope to soon begin enrolling patients in Mexico and Mozambique.

"I have had clinicians outside the U.S. who tell me they removed a pacemaker device, cleaned it, reprocessed it and then implanted it in someone else — but the government does not know about it. This practice does happen and it is not regulated in any way; patients and physicians know about it and keep it quiet. The difference with what we are doing and these other efforts is we bring it to a much higher level, because that is what the FDA requires. "

The DOJ on competition for workers

 A lot of market design is done by regulators, and some of that is done to enforce existing laws.  Here's a report from the Department of Justice, focusing on four cases involving payment to workers (including authors of books).

Athey, Susan, Mark Chicu, Malika Krishna, and Ioana Marinescu. "The Year in Review: Economics at the Antitrust Division, 2022–2023." Review of Industrial Organization (2024): 1-20.

"In this review article, we report on five enforcement matters that expanded the scope of enforcement by the Division. The first four enforcement matters highlight a number of the Division’s actions to protect labor market competition in criminal and civil merger and non-merger cases. These include: criminal enforcement against a provider of contract health care staffing services that allocated nurse employees through a no-poaching agreement and agreed to fix the wages of those nurses; civil enforcement to stop an e-Sports league from effectively imposing a salary cap on its players; civil enforcement to stop a conspiracy among poultry processors to share information about worker compensation; and the successful challenge of a merger between two of the largest book publishers in the U.S., which preserved competition for books that will benefit authors."

Guns and drugs on the U.S. Mexico border

 Here are two stories about some of the illegal traffic on the border between the U.S. and Mexico.

First, the war on drugs is fought with American guns on both sides:

The NY Times has the story:

Appeals Court Revives Mexico’s Lawsuit Against Gunmakers. The decision, which is likely to be appealed, is one of the most significant setbacks for the gun industry since passage of a federal law that provided immunity from some lawsuits.  By Glenn Thrush  Jan. 22, 2024

"A federal appeals panel in Boston ruled on Monday that a $10 billion lawsuit filed by Mexico against U.S. gun manufacturers whose weapons are used by drug cartels can proceed, reversing a lower court that had dismissed the case.

"The decision, which is likely to be appealed, is one of the most significant setbacks for gunmakers since passage of a federal law nearly two decades ago that has provided immunity from lawsuits brought by the families of people killed and injured by their weapons.

"Mexico, in an attempt to challenge the reach of that law, sued six manufacturers in 2021, including Smith & Wesson, Glock and Ruger. It contended that the companies should be held liable for the trafficking of a half-million guns across the border a year, some of which were used in murders.

...

" lawyers for Mexico, assisted by U.S. gun control groups, claimed that the companies “aided and abetted the knowingly unlawful downstream trafficking” of their guns into Mexico.

"Gun violence is rampant in Mexico despite its near-blanket prohibition of firearms ownership.

"About 70 to 90 percent of guns trafficked in Mexico originated in the United States, according to Everytown Law, the legal arm of the gun control group founded by the former mayor of New York Michael R. Bloomberg.

"Gun control advocates hailed the decision on Monday by a three-judge panel, describing it as a milestone in holding the gun industry accountable."

***********

As for drugs, it turns out that harm reduction drugs are highly controlled in Mexico, so illegal drugs also flow both ways.

Here's that story, from the Guardian:

Carriers sneak life-saving drugs over border as Mexico battles opioid deaths  People forced to bring overdose-reversal drug naloxone from US, as critics accuse Mexican government of creating shortage. by Thomas Graham in Tijuana, Tue 23 Jan 2024 

"Every day, people cross the US-Mexico border with drugs – but not all of them are going north. Some head in the opposite direction with a hidden cargo of naloxone, a life-saving medicine that can reverse an opioid overdose but is so restricted as to be practically inaccessible in Mexico.

"This humanitarian contraband is necessary because Mexico’s border cities have their own problems with opioid use – problems that activists and researchers say are being made more deadly by government policy.

“Mexico has long seen itself as a production and transit country, but not a place of consumption,” said Cecilia Farfán Méndez, a researcher at the University of California at San Diego. “And a lot of the conversation is still around that being a US problem – not a Mexican one.”

...

"The situation has been exacerbated by a government policy that, aside from cutting budgets for harm reduction services like PrevenCasa, has also created shortages of life-saving medicines for opioid users.

"In response to the fentanyl crisis, authorities in the US made naloxone available without a prescription. Naloxone vending machines have proliferated across the country.

"But in Mexico naloxone remains strictly controlled – despite the efforts of some senators from Andrés Manuel López Obrador’s own party, Morena, who proposed a law to declassify it.

"The president, popularly known as Amlo, has criticised naloxone, asking whether it did any more than “prolong the agony” of addicts, and questioning who stood to profit from its sale."

###########

Earlier:

Sunday, January 22, 2023

The trade in guns and drugs on the Mexico-US border

The EU proposes strengthening bans on compensating donors of Substances of Human Origin (SoHOs)--op-ed in VoxEU by Ockenfels and Roth

 The EU has proposed a strengthening of European prohibitions against compensating donors of "substances of human origin" (SoHOs).  Here's an op-ed in VoxEU considering how that might effect their supply.

Consequences of unpaid blood plasma donations, by Axel Ockenfels and  Alvin Roth / 4 Nov 2023

"The European Commission is considering new ways to regulate the ‘substances of human origin’ – including blood, plasma, and cells – used in medical procedures from transfusions and transplants to assisted reproduction. This column argues that such legislation jeopardises the interests of both donors and recipients. While sympathetic to the intentions behind the proposals – which aim to ensure that donations are voluntary and to protect financially disadvantaged donors – the authors believe such rules overlook the effects on donors, on the supply of such substances, and on the health of those who need them.

"Largely unnoticed by the general public, the European Commission and the European Parliament’s Health Committee have been drafting new rules to regulate the use of ‘substances of human origin’ (SoHO), such as blood, plasma, and cells (Iraola 2023, European Parliament 2023). These substances are used in life-saving medical procedures ranging from transfusions and transplants to assisted reproduction. Central to this legislative initiative is the proposal to ban financial incentives for donors and to limit compensation to covering the actual costs incurred during the donation process. The goal is to ensure that donations are voluntary and altruistic. The initiative aims to protect the financially disadvantaged from undue pressure and prevent potential misrepresentation of medical histories due to financial incentives. While the intention is noble, the proposal warrants critical analysis as it may overlook the detrimental effects on donors themselves, on the overall supply of SoHOs, and consequently on the health, wellbeing, and even the lives of those who need them. We illustrate this in the context of blood plasma donation.

"Over half a century ago, Richard Titmuss (1971) conjectured that financial incentives to donate blood could compromise the safety and overall supply. This made sense in the 1970s, when tests for pathogens in the blood supply were not yet developed. But Titmuss’ conjecture permeated policy guidelines worldwide, despite mounting evidence to the contrary. Although more evidence is needed, a review published by Science (Lacetera et al. 2013; see also Macis and Lacetera 2008, Bowles 2016), which looked at the evidence available more than 40 years after Titmuss’ conjecture, concluded that the statistically sound, field-based evidence from large, representative samples is largely inconsistent with his predictions.

"Getting the facts right is important because, at least where blood plasma is concerned, the volunteer system has failed to meet demand (Slonim et al. 2014). There is a severe and growing global shortage of blood plasma. While many countries are unwilling to pay donors at home, they are willing to pay for blood plasma obtained from donors abroad. The US, which allows payment to plasma donors, is responsible for 70% of the world’s plasma supply and is also a major supplier to the EU, which must import about 40% of its total plasma needs. Together with other countries that allow some form of payment for plasma donations – including EU member states Germany, Austria, Hungary, and the Czech Republic – they account for nearly 90% of the total supply (Jaworski 2020, 2023). Based on what we know from controlled studies and from experiences with previous policy changes, a ban on paid donation in the EU will reduce the amount of plasma supplied from EU members, prompting further attempts to circumvent the regulation by importing even more plasma from countries where payment is legal. At the same time, a ban will contribute to the global shortage of plasma, further driving up the price and making it increasingly unaffordable for low-income countries (Asamoah-Akuoko et al. 2023). In the 1970s, it may have been reasonable to worry that encouraging paid donation would lead to a flow of blood plasma from poor nations to rich ones. That is not what we are in fact seeing. Instead, plasma supplies from the US and Europe save lives around the world.

"In other areas, society generally recognises the need for fair compensation for services provided, especially when they involve discomfort or risk. After all, it is no fun having someone stick a needle in your arm to extract blood. This consensus cuts across a range of services and professions – including nursing, firefighting, and mining – occupations, most people would agree, that should be well rewarded for the risk involved and value to society. To rely solely on altruism in such areas would be exploitative and would eventually lead to a collapse in provision. Indeed, to protect individuals from exploitation, labour laws around the world have introduced minimum compensation requirements rather than caps on earnings. In addition, payment bans on donors, even if they’re intended to protect against undue inducements, raise concerns about price-fixing to the benefit of non-donors in the blood plasma market. In a related case, limits on payment to egg donors have been successfully challenged in US courts. 1

"In addition, policy decisions affecting vital supplies such as blood plasma should be based on a broad discourse that includes diverse perspectives and motivations. Ethical judgements often differ, both among experts and between professionals and the general public, so communication is essential (e.g. Roth and Wang 2020, Ambuehl and Ockenfels 2017). Payment for blood plasma donations is an example. We (the authors of this article) are from the US and Germany, countries that currently allow payment for blood plasma donations while most other countries prohibit payment. On the other hand, prostitution is legal in Germany but surrogacy is not, while the opposite is true in most of the US. And while Germany currently prohibits kidney exchange on ethical grounds, other countries – including the US, the UK, and the Netherlands – operate some of the largest kidney exchanges in the world and promote kidney exchange on ethical grounds.

"The general public does not always share the sentiments that health professionals find important (e.g. Lacetera et al. 2016). This tendency is probably not due to professionals being less cognitively biased. In all areas where the question has been studied, experts such as financial advisers, CEOs, elected politicians, economists, philosophers, and doctors are just as susceptible to cognitive bias as ordinary citizens (e.g. Ambuehl et al. 2021, 2023). Recognising the similarities and differences between professional and popular judgements, and how ethical judgements are affected by geography, time, and context, allows for a more constructive and effective search for the best policy options.

"In our view, the dangers of undersupply of critical medical substances, of inequitable compensation (particularly for financially disadvantaged donors), and of circumvention of regulation by sourcing these substances from other countries (where the EU has no influence on the rules for monitoring compensation to protect donors from harm) are at least as significant as those arising from overpayment. Carefully designed transactional mechanisms may also help to respect ethical boundaries while ensuring adequate supply. Advances in medical and communication technologies, such as viral detection tests, can effectively monitor blood quality and ensure the safety and integrity of the entire donation process – including the deferral of high-risk donors and those for whom donating is a risk to their health – without prohibiting payment to donors. Even if it is ultimately decided that payments should be banned, there are innovations in the rules governing blood donation that have been proposed, implemented, and tested that would improve the balance between blood supply and demand within the constraints of volunteerism; non-price signals, for instance, can work within current social and ethical constraints.

"As the EU deliberates on this legislation, it is imperative to adopt a balanced, empirically sound, and research-backed approach that considers multiple effects and promotes policies to safeguard the interests of both donors and recipients.

References

Asamoah-Akuoko, L et al. (2023), “The status of blood supply in sub-Saharan Africa: barriers and health impact”, The Lancet 402(10398): 274–76.

Ambuehl, S and A Ockenfels (2017), “The ethics of incentivizing the uninformed: A vignette study”, American Economic Review Papers & Proceedings 107(5), 91–95.

Ambuehl, S, A Ockenfels and A E Roth (2020), “Payment in challenge studies from an economics perspective”, Journal of Medical Ethics 46(12): 831–32.

Ambuehl, S, S Blesse, P Doerrenberg, C Feldhaus and A Ockenfels (2023), “Politicians’ social welfare criteria: An experiment with German legislators”, University of Cologne, working paper.

Ambuehl, S, D Bernheim and A Ockenfels (2021), “What motivates paternalism? An experimental study”, American Economic Review 111(3): 787–830.

Bowles S (2016), “Moral sentiments and material interests: When economic incentives crowd in social preferences”, VoxEU.org, 26 May.

European Parliament (2023), “Donations and treatments: new safety rules for substances of human origin”, press release, 12 September.

Iraola, M (2023), “EU Parliament approves text on donation of substances of human origin”, Euractiv, 12 September.

Jaworski, P (2020), “Bloody well pay them. The case for Voluntary Remunerated Plasma Collections”, Niskanen Center.

Jaworski, P (2023), “The E.U. Doesn’t Want People To Sell Their Plasma, and It Doesn’t Care How Many Patients That Hurts”, Reason, 20 September.

Lacetera, N, M Macis and R Slonim (2013), “Economic rewards to motivate blood donation”, Science 340(6135): 927–28.

Lacetera, N, M Macis and J Elias (2016), “Understanding moral repugnance: The case of the US market for kidney transplantation”, VoxEU.org, 15 October.

Macis M and N Lacetera (2008), “Incentives for altruism? The case of blood donations”, VoxEU.org, 4 November.

Roth, A E (2007), “Repugnance as a constraint on markets”, Journal of Economic Perspectives 21(3): 37–58.

Roth A E and S W Wang (2020), “Popular repugnance contrasts with legal bans on controversial markets”, Proc Natl Acad Sci USA 117(33): 19792–8.

Slonim R, C Wang and E Garbarino (2014), “The Market for Blood”, Journal of Economic Perspectives 28(2): 177–96.

Titmuss, R M (1971), The Gift Relationship, London: Allen and Unwin.

Footnotes: 1. Kamakahi v. American Society for Reproductive Medicine, US District Court Northern District of California, Case 3:11-cv-01781-JCS, 2016.

HBS Dean Datar's statement about Hamas, Gaza, and antisemitism on campus

During World War II, many anti-Nazi people of good will  might have been disturbed by the firebombing of Dresden (sometimes said to be in retaliation for the firebombing of Coventry).   But I imagine that it would have been clear that their opposition to bombing the city of Dresden was not in any way support for the Nazi regime and its aims in the war and in the Holocaust. 

One of the disturbing things about current campus protests in support of the dire situation in which civilians find themselves in Gaza is that they often seem to be expressed as support for Hamas, and the goals that Hamas has so clearly expressed in words and in actions, to kill all the Jews living in Israel and perhaps elsewhere. Indeed the celebrations of Hamas began before Israel began to counterattack, while Hamas was still killing civilians in Israel.

Another disturbing thing is that American university leaders, who have often made clear moral statements about other matters, seem to subscribe to the view that regarding Hamas, 'there are fine people on both sides.'

I don't doubt that some demonstrators are supporting Hamas out of ignorance or indifference to its goals and its atrocities, not to mention of its mis-governance of Gaza.  But others are clearly anti-Semitic, and support genocide against Jews.

Harvard Business School's dean, Srikant Datar, has (in contrast to Harvard's top leadership), issued a statement that seems to me to include both recognition of the tangled politics of the Middle East, and a distinction between political opinions and hate speech. (Universities, which aren't government bodies, have some flexibility about regulating speech on campus, and don't universally protect hate speech, e.g. in general swastikas and nooses are condemned, even though the First Amendment to the Constitution limits what government bodies in the U.S. can do to curtail even hate speech.)

Here is Dean Datar's nuanced letter (that still manages to have relevant content):

Our Values 24 Oct 2023

 "Dear members of the HBS community,

Two weeks have passed since the horrific attack by Hamas on Israeli citizens. As I noted in my letter on October 10^th, terrorist actions against civilians are not only unconscionable, they are inconsistent with our most fundamental values; as humans, we must condemn them. The atrocities carried out were heinous and they have left the Israeli and Jewish members of our community, and all of us, reeling.

The ensuing days also have been deeply unsettling as the conflict has escalated in the Middle East. Shock has given way to deep pain and grief, sadness, and anger. Many in our community are afraid: uncertain whether they are welcome at Harvard Business School, unsure how to engage in class discussions, and even feeling physically unsafe for themselves and their loved ones. In the U.S. and around the world, examples of antisemitic hate speech, graffiti, vandalism, riots, and fire bombings, as well as violence such as the stabbing of a young Palestinian boy and his mother in Chicago, have only heightened this fear. Other individuals are afraid in a different way: that what they say might offend or make people angry, that they don’t understand the history behind the current events, and that if they try to offer support or speak up, they will get it wrong and be seen as insensitive or even complicit.

Moreover, the pro-Palestinian demonstration that crossed from Cambridge onto our campus last Wednesday, which included a troubling confrontation between one of our MBA students and a subset of the protestors, has left many of our students shaken. Reports have been filed with HUPD and the FBI, the facts are being evaluated, and it will be some time before we learn the results of an investigation. But the protest has raised questions about how we address freedom of speech, hateful speech that goes against our community values, and security and safety for everyone at the School.

In this context, I am reaching out to all members of the Harvard Business School community to discuss these and other issues that are affecting our School and campus. This is my purview as Dean and this is my responsibility to each of you.

Our Values

“And Thinking” is the idea that we can go beyond traditional either/or dichotomies and think expansively about the challenges we face. Hearing the pain and anguish so many of you have shared, I have debated whether to apply And Thinking to the moment we are facing now—it may be perceived as being too equivocal, or the wrong moment. But, not saying And has perhaps kept me from saying things that are important to say.

Let me start, then, by acknowledging that antisemitism exists on our campus, and stating unequivocally there is no place for it here. We have a strong and deeply valued Jewish and Israeli community at Harvard Business School. In recent days, many have shared with me their anger at Harvard’s history of antisemitism and their dismay that it continues today. We can and must start by making a difference at HBS. Antisemitism is insidious and we simply cannot allow it to persist in any form. We must ensure that our Jewish and Israeli faculty, staff, students, and alumni feel not only safe and supported by our community, but also a deep sense of belonging and understanding.

And, let me say emphatically that Islamophobia exists at HBS, and has no place on our campus either. We have a strong and deeply valued Muslim and Arab community. We must ensure that these faculty, staff, students, and alumni feel safe, supported, and at home at our School; Islamophobia, too, is insidious and cannot be allowed. We must be a place that embraces diversity—of culture, of religion, of ethnicity, and of every other aspect of identity and experience. This is what enriches our classroom discussions and the learning environment, and this principle is codified in our community value of respect for the rights, differences, and dignity of others. We must ensure we live up to that value.

Let me also state that I condemn violence and hateful speech, words, and actions like doxing that damage the fabric of our community, detract from learning, and can incite violence. Some protestors at Wednesday’s demonstration held banners and chanted words widely understood to call for the end of Israel—inciting the eradication of a nation and its people. There is no place for hateful speech on our campus. It violates our community values—values that hold all of us to a higher standard than simply protecting free speech.

And, we must enable robust dialogue and the expression of divergent points of view. At a University whose motto is Veritas, we should strive to ensure that our arguments and claims are true and rooted in fact. But we must be okay with being uncomfortable, even offended, at times. We must allow peaceful protests, demonstrations, and gatherings, and I will defend the right to voice dissent without hate. This is a fundamental principle of a strong democratic society that respects civil liberties.

I believe that we can do more than one thing at the same time—and that we must do so now, when there are many values we must uphold. I also believe that, by doing so, we can come together as a community and deliver on the promise we make to the students who come to our School: an engaging learning experience, and an education in business, management, and leadership. Yet we must also create the space necessary to grieve, to console, to express, to understand, to challenge, to debate, and to inspire.

Action

It also is a time for action. Let me outline efforts either underway or planned to launch this week.

First, we will undertake an effort to understand the experience of antisemitism at Harvard Business School—investigating more deeply the concern I have heard that noxious elements of antisemitism persist on our campus and in our classrooms. After this assessment—which will engage faculty, staff, students, and alumni—is complete, we then will develop an action plan outlining specific steps we might take to address antisemitism at the School. The lessons we learn from this effort will help us examine other hidden forms of discrimination that persist at HBS, including Islamophobia. Throughout my time as Dean, I have expressed my aspiration that Harvard Business School be a place where every individual is able to be the best they can be. It pains me to acknowledge this is not our current reality, and so we must take on this work with energy and urgency. Toward that end, we will announce the leadership and composition of this group before the end of the month.

Second, I am mobilizing small groups of faculty, staff, and students to revisit and clarify aspects of our campus culture. One group will look at our classroom norms and how we continue to deliver our planned curriculum while providing opportunities to discuss and deepen understanding of the conflict. A second group will examine demonstration guidelines, ensuring we protect and balance our community values, rights of expression, restrictions on hateful speech, and the safety and well-being of every member of our community. This will necessitate developing a deeper and shared understanding of hate speech: what constitutes it, how we define it, and the repercussions for members of our community who use it. Both groups will be asked to develop recommendations we can implement quickly and modify as circumstances change.

Finally, we are taking additional steps to ensure the safety and well-being of our community. We have a sophisticated security plan as our baseline, including a state-of-the-art Security Operations Center that is staffed 24/7 and the ability, for example, to lock down a classroom, an office, or a building almost instantly. Campus security can be reached, night and day, by calling 617.495.5577, and HUPD is available at 617.495.1212 if any individual senses a threat to their personal safety. Both HUPD and HBS have increased patrols by officers and other security personnel. And our Operations team works daily with HUPD, local, state, and federal agencies to evaluate threat levels and to support events and campus activities in a coordinated way. While no credible threat has yet been identified, we are considering additional steps such as requiring ID-card access to more buildings on campus.

Additionally, two Harvard-wide Community Spaces—one to support Jewish, and one to support Arab, Muslim, and Palestinian community members—have been launched which aim to foster a sense of belonging through dialogue with peers. Gatherings have been scheduled through the end of the month and additional details can be found here in the Quick Links. The University also has published a Guide for Protecting Against Online Abuse and Harassment, which can be found here. We will work closely and individually with any student, faculty member, or staff member who comes to us with concern, and are open to other suggestions and ideas. We want our campus to be safe, secure, and vibrant.

Closing Thoughts

We must find a way forward. Why? Because if we can’t do it here—drawing on the strength of our community, the knowledge and experience among us, and the resources of Harvard University—then where else can this work be done? I recognize the grief and pain of so many at the School. I feel it myself. I also firmly believe that by educating leaders who make a difference in the world, and by learning and working together across our differences, we can contribute to peace and prosperity around the globe. Now is the time to recommit to our mission with a sense of urgency and purpose."

########

Earlier related posts:

Sunday, October 15, 2023

Hamas, Gaza and American universities: more letters, and two speeches

Thursday, October 12, 2023

Thinking locally about Hamas, and murderous antisemitism, on college campuses

Scientists deliberately gave women Zika--challenge trials for diseases whose incidence has dropped too far for conventional clinical trials

 Nature has the story (despite the somewhat inflammatory headline).

Scientists deliberately gave women Zika — here’s why. ‘Human challenge’ results suggest that such trials could be used to test vaccines when Zika incidence is low.  by Mariana Lenharo, Nature, 21 October 2023

"For the first time, scientists have deliberately infected people with Zika virus to learn whether such a strategy could help to test vaccines against the pathogen.

The virus can cause severe birth abnormalities in babies born to parents infected during pregnancy. It also has been associated with neurological problems in adults, although those cases are rare. But infected study participants had only mild symptoms, and none became pregnant during or immediately after the trial. The results raise hopes that ‘human challenge’ programmes — in which volunteers are exposed to a pathogen in a controlled setting — could make it feasible to test vaccines at a time when Zika incidence is low.

“This is a great scientific gain in terms of the development of a vaccine,” said Rafael Franca, an immunologist at the Oswaldo Cruz Foundation in Ribeirão Preto, Brazil. The results are scheduled to be presented today at the annual meeting of the American Society of Tropical Medicine and Hygiene in Chicago, Illinois.

...

"In 2022, after a long process to address ethical concerns around the study, Durbin and her team recruited 28 healthy women, aged 18 to 40, who were neither pregnant nor lactating. All agreed to be admitted to a research facility and remain there until they were no longer infectious; they stayed at the unit for 9 to 16 days. They were tested for pregnancy several times before receiving the virus, to avoid the risk of congenital problems associated with Zika, and were counselled to use birth control for at least two months after the study.

Hope for smaller trials

The researchers injected 20 participants with one of two strains of Zika virus and eight with placebo. All of the participants who received the virus were infected; of those, 95% developed a rash — a common symptom of Zika — and 65% had joint pain. None of the placebo recipients had those symptoms.

Durbin says the findings indicate that the two strains of Zika administered in the trial can be safely and effectively used to infect participants in a Zika vaccine trial. She estimates that the controlled human infection model could be used in a phase III clinical trial for vaccine efficacy with as few as 50 to 100 participants. “With the challenge model, where you have 100% of infections, you could get an efficacy result with many fewer people” than in a conventional trial, says Durbin.

...

The new study represents a turnaround in the thinking about challenge trials. In early 2017, a report by researchers convened by the National Institute of Allergy and Infectious Diseases and the Walter Reed Army Institute of Research concluded that the risks of a human-infection study for Zika, at that time, surpassed the potential benefits.

...

But “from that time to now, we learnt a lot,” says Palacios. “Now we know that the risk of the virus being transmitted to another person through sexual relationships is limited and something that can be controlled,” he says. And regulators have signalled that they might consider data from human challenge trials in vaccine development, “in particular for those diseases that don’t have enough incidence to test in the field.”

Despite the low number of Zika cases, researchers say that it’s important to continue the efforts to develop a vaccine, because the virus might make a comeback. “Infections are much lower than they were during the epidemic in 2016. However, they are still occurring,” says Neil French, an infectious-disease specialist at the University of Liverpool, UK, who is involved in a Zika vaccine-development project. “The justification for a vaccine remains strong.”

Support for hepatitis C human challenge studies, in The Lancet Gastroenterology & Hepatology

 Here's a call for action, in The Lancet Gastroenterology & Hepatology:

Joint statement in support of hepatitis C human challenge studies by Harvey J Alter, Eleanor Barnes, Mia J Biondi, Andrea L Cox, Jake D Eberts, Jordan J Feld, T Jake Liang, Josh Morrison, Charles M Rice, Naglaa H Shoukry, David L Thomas, Jennifer Van Gennip, Charles Weijer, on behalf of other signatories †, Published:September 20, 2023 DOI:https://doi.org/10.1016/S2468-1253(23)00314-X

"We, the 121 undersigned, believe that human challenge studies among adult volunteers will be critical in the development of hepatitis C vaccines.

...

"Despite the advent of safe and highly effective direct-acting antiviral (DAA) treatments, the ongoing toll of hepatitis C remains high among low-income and middle-income countries and vulnerable populations such as people who inject drugs. Millions of new infections occur annually, outpacing cures in some regions,1 with progress further disrupted by the COVID-19 pandemic. Without a change in strategy and the development of new tools, we will not reach the ambitious goal set out by WHO of elimination of viral hepatitis as a public health threat by 2030. This will require an effective hepatitis C vaccine—“the best insurance for the future”, as highlighted by a recent announcement of the White House national hepatitis C elimination programme.2

...

"Human challenge studies for a hepatitis C vaccine could accelerate vaccine development dramatically. The effort to establish the model and test an initial vaccine candidate could take as little as 3 years. If that candidate fails, subsequent studies to test others could provide evidence of efficacy as quickly as 1 year.

"It is only because of the remarkably effective treatments that we can now consider human challenge studies for hepatitis C. With DAAs, cure rates of people without cirrhosis are reliably over 98%, with highly effective salvage regimens for the few who do not respond to a first course of therapy.5,  6 We are confident that in the era of DAAs, human challenge studies can be done in accordance with the highest ethical and safety standards. Healthy volunteers providing fully informed consent would be infected for at most 6 months before treatment and would be free to go about their lives with the right to request treatment and withdrawal from a study at any time. Acute infection causes no or few symptoms in most, and unlike in most challenge studies, where the risk of transmission necessitates quarantine of participants, the risk of passing hepatitis C to others is very low in day-to-day life.

"The impact of a vaccine would be enormous: reducing transmission, preventing cirrhosis, and most importantly, markedly reducing the rate of liver cancer, the world's second-most deadly cancer in terms of total fatalities.7 The global success of hepatitis B vaccine in achieving these goals exemplifies the importance of an effective hepatitis C vaccine. With the prospect of such a significant advance, we have confidence that people will volunteer to participate in hepatitis C challenge studies, and with such a strong team of experts worldwide, we are confident this approach will lead to the development of a successful hepatitis C vaccine."

**********

† Here's the full list of 121 signers of the letter

*********

1Day Sooner has a related web page with some background: https://www.1daysooner.org/hepatitis-c-open-letter

**********

Earlier related posts:

Monday, May 15, 2023

Eliminating Hepatitis C, now that there's a cure (even though it's expensive)

Saturday, August 26, 2023

Challenge trials for a Hepatitis C vaccine

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?

Challenge trials for a Hepatitis C vaccine

 The Journal Clinical Infectious Diseases has a special supplement on challenge trials (human infection trials) of a Hep C vaccine (now that Hep C is a curable disease):

Volume 77, Issue Supplement_3, 15 August 2023

Controlled Human Infection Model for HCV Vaccine Development

SUPPLEMENT ARTICLES

Controlled Human Infection Model for Hepatitis C Virus Vaccine Development: Is It Time to Be Real? 

T Jake Liang and others

Clinical Infectious Diseases, Volume 77, Issue Supplement_3, 15 August 2023, Page S215, https://doi.org/10.1093/cid/ciad343

• Hepatitis C virus (HCV) elimination has been a goal of the public health and scientific communities since its identification in 1989. Despite the advance and availability of highly effective antiviral regimens to treat HCV infection, it is unlikely that global HCV elimination can be achieved without an effective preventive vaccine. Because of the lack of appropriate animal models for preclinical testing and the perception that highly effective treatments would suffice in addressing the global burden of HCV, HCV vaccine development has not been a high priority. To accelerate vaccine development, the concept of a controlled human infection model (CHIM) for HCV has been proposed, in which healthy human volunteers would be deliberately infected with HCV for the purpose of testing the efficacy of candidate vaccines. This concept of challenge studies is not new and has been applied to more than 25 infectious agents, including the cholera vaccine, for which all efficacy data that served as the basis for regulatory approval were obtained from CHIM studies. Without a CHIM strategy, HCV vaccine development may not be feasible. In a recent phase 2 randomized controlled trial, over 900 people who inject drugs were screened to enroll 548 individuals to receive a T-cell–based HCV vaccine candidate or placebo. After a monumental effort that took over 6 years to complete, the trial documented 75 incident HCV infections overall, with only 45 included in the final analysis, and showed no protection against initial infection or progression to chronicity with the vaccine. While this study demonstrated that vaccine testing in the at-risk population can be done, future testing of additional HCV vaccine candidates using a similar pathway may be impractical in light of the duration and cost. With the ability to cure those who do not clear the virus, HCV CHIM is now a conceivable approach that could be a critically important, if not necessary, intermediate stage of vaccine development. HCV CHIM could de-risk vaccine candidates, accelerate development, reduce cost, and allow the selection of more promising candidates for further testing in larger clinical trials. CHIM may conceivably be used for larger phase 2/3 efficacy trials as a basis for clinical approval. In developing such a model, many challenges and questions must be addressed. In this Supplement issue, we, the editors of this Supplement commissioned various articles written by respective subject matter experts who provide their perspectives and opinions on these challenges and questions, ranging from the source of viral inoculum and the safety of transient HCV infection to the perspective of potential volunteers and the ethics of CHIM. While we strive to be data-driven and evidence-based, some of the opinions represent the views of the authors of each article and may be controversial. Ultimately, we hope these perspectives will enable fulsome discussion about the feasibility of HCV CHIM and lead to the development of well-designed clinical protocols.

  Supplement sponsorship. This article appears as part of the supplement “Controlled Human Infection Model for HCV Vaccine Development,” sponsored by Toronto General Research Institute, United States National Institutes of Health, Johns Hopkins University, the Canadian Institutes of Health Research (CIHR), and the Canadian Network on Hepatitis C (CanHepC). CanHepC is funded by a joint initiative of CIHR (HPC-178912) and the Public Health Agency of Canada.

• View article

Ethics of Controlled Human Infection Studies With Hepatitis C Virus 

Annette Rid and others

Clinical Infectious Diseases, Volume 77, Issue Supplement_3, 15 August 2023, Pages S216–S223, https://doi.org/10.1093/cid/ciad382

• Global elimination of hepatitis C virus (HCV) will be difficult to attain without an effective HCV vaccine. Controlled human infection (CHI) studies with HCV were not considered until recently, when highly effective treatment became available. However, now that successful treatment of a deliberate HCV infection is feasible, it is imperative to evaluate the ethics of establishing a program of HCV CHI research. Here, we evaluate the ethics of studies to develop an HCV CHI model in light of 10 ethical considerations: sufficient social value, reasonable risk–benefit profile, suitable site selection, fair participant selection, robust informed consent, proportionate compensation or payment, context-specific stakeholder engagement, fair and open collaboration, independent review and oversight, and integrated ethics research. We conclude that it can be ethically acceptable to develop an HCV CHI model. Indeed, when done appropriately, developing a model should be a priority on the path toward global elimination of HCV.

• View article 
• Supplementary data

Volunteering for Infection: Participant Perspectives on a Hepatitis C Virus Controlled Human Infection Model 

Jake D Eberts and others

Clinical Infectious Diseases, Volume 77, Issue Supplement_3, 15 August 2023, Pages S224–S230, https://doi.org/10.1093/cid/ciad350

The perspectives of former challenge study participants and a survey of other potential volunteers can inform the design of hepatitis C virus controlled human infection models, including on topics such as transparency, volunteer safety and risk, and compensation.

• Ethical human subjects research requires participants to be treated safely and respectfully, yet much bioethical debate takes place without participants. We aim to address this gap in the context of controlled human infection model (CHIM) research. Based upon our own experience as study participants, and bolstered by a survey of 117 potential hepatitis C virus CHIM participants, we present ideas to inform efficient, ethical, and scientifically useful study design. We advocate for full protocol transparency, higher compensation, commitment to the rapid dissemination of study results, and proactive efforts to detail risk-minimization efforts as early as possible in the recruitment process, among other measures. We encourage researchers to proactively partner with volunteer advocacy organizations that promote collective representation of volunteers to maximize their agency, and guard against ethical issues arising from healthy human subjects research.

• View article 
• Supplementary data

First Do No Harm? Modeling Risks and Benefits of Challenge Trials for Hepatitis C Vaccine DevelopmentGet access

Alyssa Bilinski and others

Clinical Infectious Diseases, Volume 77, Issue Supplement_3, 15 August 2023, Pages S231–S237, https://doi.org/10.1093/cid/ciad379

• Background

  In 2019, about 58 million individuals were chronically infected with hepatitis C virus. Some experts have proposed challenge trials for hepatitis C virus vaccine development.

  Methods

  We modeled incremental infections averted through a challenge approach, under varying assumptions regarding trial duration, number of candidates, and vaccine uptake. We computed the benefit-risk ratio of incremental benefits to risks for challenge versus traditional approaches. We also benchmarked against monetary costs of achieving incremental benefits through treatment.

  Results

  Our base case assumes 3 vaccine candidates, each with an 11% chance of success, corresponding to a 30% probability of successfully developing a vaccine. Given this probability, and assuming a 5-year difference in duration between challenge and traditional trials, a challenge approach would avert an expected 185 000 incremental infections with 20% steady-state uptake compared to a traditional approach and 832 000 with 90% uptake (quality-adjusted life-year benefit-risk ratio, 72 000 & 323 000). It would cost at least $92 million and $416 million, respectively, to obtain equivalent benefits through treatment. BRRs vary considerably across scenarios, depending on input assumptions.

  Conclusions

  Benefits of a challenge approach increase with more vaccine candidates, faster challenge trials, and greater uptake.

• View article 
• Supplementary data
• **********
  Earlier:

  Monday, May 15, 2023

  Eliminating Hepatitis C, now that there's a cure (even though it's expensive

  and here are my posts on challenge trials (and Covid vaccines).