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.”

Human Challenge Trials (aka Controlled Human Infection studies) for corona virus vaccines

What do we want?  A vaccine for covid-19.

When do we want it?  After clinical trials and peer review.

How can we get it faster?  By asking healthy young (not at too much risk) volunteers to permit themselves to get infected with covid-19, so we can try out vaccine candidates.

Is that crazy?  Well, maybe not. (But not everyone is sure of that.)

Here's a recent paper considering the proposal.

Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure 
Nir Eyal, Marc Lipsitch, Peter G Smith
The Journal of Infectious Diseases, jiaa152, https://doi.org/10.1093/infdis/jiaa152
Published: 31 March 2020

Abstract: Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care.
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Here's another paper, in Science, 07 May 2020, by a big group of authors consisting of medical ethicists and physicians: they think it might be ok.

Ethics of controlled human infection to study COVID-19
Seema K. Shah, Franklin G. Miller, Thomas C. Darton, Devan Duenas, Claudia Emerson, Holly Fernandez Lynch, Euzebiusz Jamrozik, Nancy S. Jecker, Dorcas Kamuya, Melissa Kapulu, Jonathan Kimmelman, Douglas MacKay, Matthew J. Memoli, Sean C. Murphy, Ricardo Palacios, Thomas L. Richie, Meta Roestenberg, Abha Saxena, Katherine Saylor, Michael J. Selgelid, Vina Vaswani, Annette Rid

 Abstract: High social value is fundamental to justifying these studies

 Here are the articles opening lines:

"Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of people have expressed interest in participating in, controlled human infection studies (CHIs) with severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) (1, 2). In CHIs, a small number of participants are deliberately exposed to a pathogen to study infection and gather preliminary efficacy data on experimental vaccines or treatments. We have been developing a comprehensive, state-of-the-art ethical framework for CHIs that emphasizes their social value as fundamental to justifying these studies. The ethics of CHIs in general are underexplored (3, 4), and ethical examinations of SARS-CoV-2 CHIs have largely focused on whether the risks are acceptable and participants could give valid informed consent (1). The high social value of such CHIs has generally been assumed. Based on our framework, we agree on the ethical conditions for conducting SARS-CoV-2 CHIs (see the table). We differ on whether the social value of such CHIs is sufficient to justify the risks at present, given uncertainty about both in a rapidly evolving situation; yet we see none of our disagreements as insurmountable. We provide ethical guidance for research sponsors, communities, participants, and the essential independent reviewers considering SARS-CoV-2 CHIs."

Kim Krawiec points out to me that, among the things the authors disagree about among themselves is compensation to donors:
"Members of our group disagree about the ethical permissibility of offering payment to CHI participants, and there may be relevant regulatory limits in different jurisdictions. Nevertheless, as SARS-CoV-2 CHIs require confinement and follow-up, fairness seems to demand offering participants compensation for their time. This may total several thousand dollars in the United States, assuming compensation at a fair minimum wage for unskilled labor, as in other CHIs. By contrast, incentives beyond compensation could be avoided, given the number of people already indicating willingness to participate. Concerns that the undue influence of monetary compensation compromises risk judgments are unsupported by the available data, as financial motivations are associated with greater attention to risk (15). Moreover, a rigorous informed consent process could maximize understanding. In case payment tempts participants to withhold disqualifying information, eligibility criteria should be objectively verifiable."
************

And here is a group of activists, at an organization called 1 Day Sooner.
You can sign up here*,

COVID-19 Human Challenge Trials
"Human challenge trials deliberately expose participants to infection, in order to study diseases and test vaccines or treatments. They have been used for influenza, malaria, typhoid, dengue fever, and cholera. Researchers are exploring whether human challenge trials could speed up the development of a vaccine for COVID-19, saving thousands or even millions of lives."

*"Sign up here if you may wish to participate in a human challenge trial for COVID-19 if one were to occur, and, potentially, advocate for safe and rapid vaccine development. "

Antitrust and competition in an internet economy: conference at the Stigler Center

Here's where I'll be today (unfortunately only for the first day of a two day conference), speaking about promoting/preserving competition in matching markets:

2018 ANTITRUST AND COMPETITION CONFERENCE - DIGITAL PLATFORMS AND CONCENTRATION

APRIL 19–20, 2018
GLEACHER CENTER, 450 N CITYFRONT PLAZA DRIVE

About the Conference

The economic and societal role of the handful of large companies known as “digital platforms" has grown dramatically in the last decade. Google, Amazon, and Facebook are not only transforming communication, media, and retail but have the potential to transform many other industries. While they invest billions in research and development and propel important innovation, they also raise many policy questions with regard to their dominance in many markets, the vast consumer data they collect and own, and their influence on the markets for news, information, and ideas. On April 19 and 20, 2018, the Stigler Center at the University of Chicago Booth School of Business will dedicate its annual Antitrust and Competition conference to the topic of “Digital Platforms and Concentration.”

Issues to be discussed at the conference include, among others:

• The characteristics and market power of two-sided markets 
• How competition can be promoted in a world of network effects 
• The economics of free products and the challenges they pose to antitrust and existing law 
• The collection, monetization, and ownership of personal data 
• Digital companies’ foray into the physical world
• How and to what degree digital companies are involved in political decision making
• How the startup ecosystem is affected by the presence of big players 

The invitation-only conference will bring together approximately 50 economists, law scholars, intellectuals, venture capitalists, and business people for two days of discussion. The keynote speakers will be Makan Delrahim, assistant attorney general of the Department of Justice’s Antitrust Division, Alvin Roth, the 2012 Nobel laureate in economics, and Jean Tirole, the 2014 Nobel laureate in economics.

The conference will be by invitation only. Individuals interested in receiving an invitation, please submit your invitation request here.

Watch Live

The conference will be LIVE-STREAMED. See video link HERE. 

Schedule

Times are listed in Central Time.

Times are listed in Central Time.

Thursday, April 19, 2018

8:00 a.m. – 8:20 a.m.	Breakfast
8:20 a.m. – 8:25 a.m.	Welcome remarks - Guy Rolnik, Conference Organizer, University of Chicago Booth School of Business
8:25 a.m. – 8:30 a.m.	Opening remarks - Daniel Diermeier, Provost, University of Chicago
8:30 a.m. – 10:00 a.m.	The Rise of Digital Platforms The economic and societal role of digital platforms has grown dramatically in the last decade. Are the large Internet companies really “platforms”? Can they have outsized influence in many market and industries? What explains the size and success of these companies? Are they designing their products to be addictive? What are the most important policy questions that these companies raise? Moderator: Patrick Foulis, New York Bureau Chief, The Economist Robert Epstein, Senior Research Psychologist, American Institute for Behavioral Research and Technology Tristan Harris, Co-Founder and Executive Director, Center for Humane Technology Kevin Murphy, George J. Stigler Distinguished Service Professor of Economics, University of Chicago Booth School of Business Fiona Scott Morton, Theodore Nierenberg Professor of Economics, Yale University School of Management Chad Syverson, Eli B. and Harriet B. Williams Professor of Economics, University of Chicago Booth School of Business Ben Thompson, Author and Founder, Stratechery
10:00 a.m. – 10:15 a.m.	Break
10:15 a.m. – 11:45 a.m.	Big Data: Economic, Ownership, Legal, and Political Aspects User data is arguably digital platforms’ most valuable asset. How data are used has profound economic, social, and political implications. What are these implications? Where along the value chain do data belong? Could reassigning ownership of the data and making it easily available to users promote competition and address privacy concerns? Moderator: Ludwig Siegele, Technology Editor, The Economist Julia Angwin, Senior Reporter, ProPublica Dennis Carlton, David McDaniel Keller Professor of Economics, University of Chicago Booth School of Business Richard Schmalensee, Howard W. Johnson Professor of Economics and Management and Dean Emeritus, MIT Sloan School of Management Jonathan Taplin, Director Emeritus, Annenberg Innovation Lab, University of Southern California Luigi Zingales, Robert C. McCormack Distinguished Service Professor of Entrepreneurship and Finance; Faculty Director, Stigler Center, University of Chicago Booth School of Business
11:45 a.m. – 12:00 p.m.	Break
12:00 p.m. – 1:15 p.m.	Lunch Keynote - Makan Delrahim, Assistant Attorney General, Antitrust Division, US Department of Justice
1:15 p.m. – 1:30 p.m.	Break
1:30 p.m. – 3:15 p.m.	The Big Five and Political Power The largest technology companies—Google, Facebook, Amazon, Microsoft, Apple—are active political players, using the traditional levers of lobbying and financing of research, think tanks, and political campaigns. However, it is their market power, and leverage over media outlets, that opens up new avenues for these platforms and foreign actors that exploit vulnerabilities in their systems to dominate and control the flow of political information among voters. How do they influence political discourse, the marketplace of ideas, and democracy more broadly? Moderator: Matt Stoller, Fellow, Open Markets Insitute Scott Cleland, President, Precursor LLC Ellen Goodman, Professor of Law, Rutgers Law School and Co-director, Rutgers Institute for Information Policy & Law Barry Lynn, Executive Director, Open Markets Institute Guy Rolnik, Clinical Associate Professor of Strategic Management, University of Chicago Booth School of Business
3:15 p.m. – 3:30 p.m.	Break
3:30 p.m. – 5:00 p.m.	Digital Platforms: Market Power and Market Failures Digital platforms (e.g. Facebook, Google, Twitter) rely on network effects to build vast ecosystems of users, advertisers and third-party developers, and to attain substantive market power. How should that market power be measured and what concerns does it raise for competition and entry? What are the market failures left unaddressed by these digital platforms and how should we expect them to govern their respective ecosystems?  Moderator: Jesse Eisinger, Senior Reporter and Editor, ProPublica Jay Pil Choi, University Distinguished Professor, Michigan State University Andrei Hagiu, Visiting Associate Professor of Technological Innovation, Entrepreneurship, and Strategic Management, MIT Sloan School of Management Sarit Markovich, Clinical Associate Professor of Strategy and Associate Chair of the Strategy Department, Northwestern University Kellogg School of Management Fiona Scott Morton, Theodore Nierenberg Professor of Economics, Yale University School of Management Carl Shapiro, Professor of the Graduate School, Haas School of Business and Department of Economics, University of California at Berkeley
5:00 p.m. – 5:30 p.m. 5:30 p.m. – 6:30 p.m.	Reception and dinner Dinner Keynote - Alvin Roth, Nobel Laureate and Craig and Susan McCaw Professor of Economics, Stanford University

                                                   

Friday, April 20, 2018

8:00 a.m. – 8:40 a.m.	Breakfast Keynote - Mario Monti, President, Bocconi University; Former Prime Minister of Italy; Former EU Competition Commissioner
8:40 a.m. – 10:00 a.m.	Who’s Benefiting? Revisiting the Innovation and Start-Up EcosystemHow does the dominance of the digital platforms impact the startup ecosystem? As big digital players often scoop up startups or replicate startups’ ideas, what constitutes success for emerging startups? How does acquisition versus IPO serve competition and innovation? Is innovation concentrated mainly in the pre-acquisition phase?  Moderator: Adam Lashinsky, Executive Editor, Fortune Elvir Causevic, Managing Director and Co-Head, Tech+IP, Houlihan Lokey  Matt Perault, Director, Public Policy, Facebook Albert Wenger, Managing Partner, Union Square Ventures Glen Weyl, Principal Researcher, Microsoft Research New England and Visiting Senior Research Scholar, Department of Economics and Law School, Yale University
10:00 a.m. – 10:15 a.m.	Break
10:15 a.m. – 11:45 a.m.	Can Government Resist Corporate Influence? The Big Five have met little government intervention as they have gained dominance and brought about market consolidation. Has government treated digital platforms differently than other corporations? Are digital platforms more politically influential than other big corporations and, if so, why? Moderator: Rana Foroohar, Global Business Columnist and Associate Editor, Financial Timesand Global Economic Analyst, CNN Alejandra Palacios, Commissioner and Chair, Mexico Federal Economic Competition Commission (COFECE) Randal Picker, James Parker Hall Distinguished Service Professor of Law, University of Chicago Law School Daniel Stevens, Executive Director, Campaign for Accountability, Google Transparency Project Tim Wu, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School Luigi Zingales, Robert C. McCormack Distinguished Service Professor of Entrepreneurship and Finance; Faculty Director, Stigler Center, University of Chicago Booth School of Business
11:45 a.m. – 12:00 p.m.	Break
12:00 p.m. – 1:00 p.m.	Lunch Keynote - Jean Tirole, Nobel Laureate and Chairman, Toulouse School of Economics
1:00 p.m. – 1:15 p.m.	Break
1:15 p.m. – 2:45 p.m.	The Amazon Phenomenon Amazon has transformed e-commerce and now begins its foray into the physical world with its acquisition of Whole Foods. The giant e-tailer offers a quintessential case study in how digital platforms are reimagining traditional markets and impacting society at large. Who will be “Amazoned” next? What lessons can we learn from Amazon’s experience with antitrust? As Amazon looks to situate its second headquarters, some believe the bid is a race to the bottom. What is the anticipated net impact of hosting the headquarters on a winner city and state? Moderator: David Dayen, Contributing Writer, The Intercept Joshua Gans, Jeffrey S. Skoll Chair of Technical Innovation and Entrepreneurship and Professor of Strategic Management, Rotman School of Management, University of Toronto Austan Goolsbee, Robert P. Gwinn Professor of Economics, University of Chicago Booth School of Business Lina Khan, Director, Legal Policy, Open Markets Institute Maurice Stucke, Professor of Law, University of Tennessee College of Law and Of Counsel, The Konkurrenz Group Ben Thompson, Author and Founder, Stratechery
2:45 p.m. – 3:00 p.m.	Break
3:00 p.m. – 4:30 p.m.	US vs EU: Antitrust, Data, and Privacy Policy Questions about digital markets and competition have begun gaining prevalence and commanding more regulatory attention. While the EU has taken aggressive measures against the digital platforms, including a €2.4 billion fine on Google and introducing significant privacy laws (GDPR), regulators in the United States have demonstrated a more lenient approach. What are the strengths and weaknesses of the EU versus US policy choices?  Moderator: John O'Sullivan, Economics Editor, The Economist Ariel Ezrachi, Slaughter and May Professor of Competition Law and Director, Centre for Competition Law and Policy, University of Oxford Justus Haucap, Director, Duesseldorf Institute for Competition Economics, Heinrich-Heine University of Duesseldorf William Kovacic, Global Competition Professor and Director, Competition Law Center, George Washington University Law School Gary Reback, Of Counsel, Carr & Ferrell LLP Thomas Vinje, Partner and Chairman, Global Antitrust Group, Clifford Chance LLP
4:30 p.m. – 4:45 p.m.	Closing Remarks - Luigi Zingales, Faculty Director, Stigler Center, University of Chicago Booth School of Business

Futbola eta Ekonomia by Ignacio Palacios-Huerta in the NY Times

Would fútbol by any other name be as interesting?* It is to the economist Ignacio Palacios-Huerta, who has a column in the NY Times motivated by the World Cup and by his recent book "Beautiful Game Theory".

The Beautiful Data Set: The World Cup Can Help Test Economic Theories


*Soccer is  futbola in Euskara, and the Times identifies Ignacio as follows
Ignacio Palacios-Huerta, a professor of management at the London School of Economics, is the head of talent identification at Athletic Club Bilbao, a professional soccer club in Spain, and the author of “Beautiful Game Theory: How Soccer Can Help Economics.”

The Financial Times on looking into the future "In 100 Years"

Simon Kuper at the FT reviews the recent book of essays ‘In 100 Years: Leading Economists Predict the Future’, by Ignacio Palacios-Huerta (ed), MIT Press

The economist’s guide to the future

Prediction is hard, but so is summary. About my essay, he writes

Roth foresees parents manipulating their children’s genes. Some such methods, he writes, “may come to be seen as part of careful child rearing”. He also thinks people will become more efficient thanks to performance-enhancing drugs that improve “concentration, memory, or intelligence”.
Once humans have more years in good health, they will probably reorder their lives. Roth says that if child rearing takes up less of the lifespan, people may want different spouses for different phases of life. “New forms of polygamy-over-lifetime relationships” could arise, he writes.

You can see a longer summary and a link to the full essay here.

And here's the book on Amazon:‘In 100 Years: Leading Economists Predict the Future’

In 100 years (my predictions)

Ignacio Palacios-Huerta is editing a volume, In 100 Years, inspired by Keynes' 1930 essay, "Economic Possibilities of our Grandchildren."

Here is my contribution: In 100 Years, and its opening and concluding paragraphs (to tempt you to read the paragraphs in between, or to save you the trouble...).

"For those of you reading this in 2112, let me introduce myself by saying that in the late 20^th and early 21^st centuries I studied the design of matching markets, which are markets in which price alone doesn’t clear the market, and so participants can’t just choose what they want (even if they can afford it), they also have to be chosen. These are markets that involve application or selection processes or other forms of courtship. Matching markets determine some of the most important events of our lives: where we go to school, who we marry, what jobs we get, even whether we get a lifesaving organ for transplant if we should happen to need one (see Roth 2002, 2008 for overviews). So I’ll concentrate my predictions on these things, namely schools, jobs, marriage and family, and medicine, along with some thoughts about the possible state of economic expertise, i.e. the things that economists produce and sell. 
...
"I’ve also spent some time studying how some kinds of transactions are regarded as repugnant, in some times and places, and how this constrains what markets we see... 

...
...
...

"To summarize the predictions I’ve made here about 100 years from now, I think that the trend of increasing prosperity will continue, but that it will not necessarily (as Keynes predicted in 1930) bring us all lives of leisure.  Many will work harder than ever, and some of the things some of us will do to work more efficiently—like taking performance enhancing drugs--will go from being repugnant today to ordinary in the future. Other things we do eagerly today, like use computers for access to more and more data, may become repugnant in some respects, as privacy of personal data moves to the forefront of civil rights issues. And while medical advances will continue on all fronts, and advances in preventive medicine will make medical care and long-lived good health more widely available, some kinds of medicine, including reproductive medicine along with other aspects of reproduction, will become commoditized, while others, such as genetic manipulation of various sorts, may become repugnant. Some kinds of education will become commoditized, but among the matching markets that we see today, selective admissions to elite universities will remain, as will networking and matchmaking for family formation (under a wider variety of marital forms) and perhaps increasingly, for research collaborators and other kinds of business partners.  And there will still be economists, and economic mysteries to unravel, including those that will arise from the increased computerization of markets and marketplaces. Much of market design that we struggle to understand today will have become commoditized and be found in off the shelf software, but understanding how to design novel markets and fix market failures will remain an active concern of our economist grandchildren.

"Keynes, in writing about the future of economics, said “If economists could manage to get themselves thought of as humble, competent people, on a level with dentists, that would be splendid!” Perhaps if we replace “dentists” with “engineers,” that is still a good goal for the next hundred years."