Suppressing vaping is hard

 The WSJ has the story:

Major effort needed to remove illegal vaping products, review finds. Group says FDA regulators are overwhelmed and reactive  By Laurie McGinley

"An independent review of the Food and Drug Administration’s tobacco regulators described them as overwhelmed, reactive and fatigued by an oppressive workload involving e-cigarettes and called for a major effort, by several parts of the Biden administration, to remove millions of illegal vaping products from the market.

"The report, by the Reagan-Udall Foundation for the FDA, also said the agency’s Center for Tobacco Products, created by federal law in 2009, has fallen short in laying out clear priorities and has been besieged by lawsuits brought by tobacco and vaping companies, on the one hand, and public health groups on the other.

"The review said there are millions of illegal vaping products on the market — involving companies that should have applied for FDA authorization and never did, or others that had their applications rejected — and that a major effort is needed to remove them."

Surrogacy guidelines: necessity, not convenience

 As surrogacy becomes increasingly well established in the U.S., it is regulated not only by state laws, but  also via voluntary standards put forward by trade organizations as conditions of membership.

One is  the SOCIETY FOR ETHICS IN EGG DONATION AND SURROGACY (SEEDS), which calls itself "a nonprofit organization founded by a group of egg donation and surrogacy agencies, whose purpose is to define and promote ethical behavior by all parties involved in third party reproduction." 

They have a set of guidelines published this year which member organizations are supposed to subscribe to.  One of those guidelines seems to say that surrogacy agencies should only work with intended parents who can't have children on their own. That is, they want to facilitate surrogacies that they regard as necessary rather than those that might be merely convenient.

SOCIETY FOR ETHICS IN EGG DONATION AND SURROGACY, STANDARDS of ETHICAL CONDUCT for SEEDS MEMBER AGENCIES

"24.Agency Screening of Intended Parents

"a. An Agency shall not provide service to Intended Parents unless they demonstrate a need for surrogacy associated with a disease, condition or status characterized by:

"i. the failure to establish a pregnancy or to carry a pregnancy to live birth after regular, unprotected sexual intercourse;

"ii. a person’s inability to reproduce either as a single individual or with their partner without medical intervention; or

"iii. a licensed physician’s or mental health professional’s findings based on a patient’s medical, psychological, sexual, and reproductive history, age, physical findings and/or diagnostic testing. 

*******

The legal blog Above the Law has a post about this:

Should 'Social Surrogacy' Be Permitted? by Ellen Trachman

It says in part:

"What does the law say? States like Louisiana and Illinois specifically require documented medical need of intended parents in a surrogacy arrangement to comply with the state surrogacy law. Louisiana requires that a doctor “who has medically treated the intended mother … submits a signed affidavit certifying that in utero embryo transfer with a gestational carrier is medically necessary to assist in reproduction.”

"Utah previously required “medical evidence … show[ing] that the intended mother is unable to bear a child or is unable to do so without unreasonable risk.” But that provision was struck down by the State Supreme Court after determining it was unconstitutional as applied to a same-sex male couple and could not be read a in gender-neutral way. (The SEEDS standard is, by contrast, gender neutral.)

"Other states with surrogacy-specific statutes — like California, Washington, Colorado, New Jersey, and New York — are silent on medical need and, therefore, implicitly permit social surrogacy arrangements. And then those states with no surrogacy law, much of the country, permit social surrogacy by default.

"The SEEDS standard, of course, only applies to member agencies and does not prevent nonmember agencies from supporting social surrogacy arrangements or for those arrangements to occur independent of agencies."

***********

Stephanie Wang and I anticipated to some extent that this could be an issue in our paper

Roth, Alvin E. and Stephanie W. Wang, “Popular Repugnance Contrasts with Legal Bans on Controversial Markets,” Proceedings of the National Academy of Sciences (PNAS),  August 18, 2020 117 (33) 19792-19798.

We surveyed populations in the U.S. and several other countries on transactions that were legal in some of them and illegal in others. We presented vignettes, and asked if they should be legal.  Because we wanted to give surrogacy a good chance of being perceived as repugnant, we made clear in the surrogacy vignette that there was no medical necessity, it was sought for convenience:

"James and Erica are a married couple in [home country]. They want to have a child, but Erica does not want to become pregnant due to the demands of her career as a model. Maria is a married mother in the Philippines. Maria’s husband is out of work, and Maria has decided to become a surrogate mother to earn additional income. James and Erica hire Maria to carry and give birth to a child from James and Erica’s sperm and egg. James and Erica pay Maria a year’s average income in the Philippines, and everyone signs a contract making it clear that James and Erica are the child’s biological parents and will have custody after the child is born."

You can see in the paper (or in this 2020 blog post) that (even) under these circumstances, clear majorities favored making this kind of voluntary surrogacy legal, not only in the U.S. and Philippines where surrogacy is legal, but also in Spain and Germany where surrogacy is illegal.

Decriminalizing drugs at the head of the supply chain--Colombia

 The criminalization of drugs has different consequences on different parts of the supply chain. Here's a harm reduction proposal from Columbia--the Washington Post has the story.

Colombia, largest cocaine supplier to U.S., considers decriminalizing. By Samantha Schmidt and Diana Durán 

"It’s the largest producer of cocaine in the world, the source of more than 90 percent of the drug seized in the United States. It’s home to the largest Drug Enforcement Administration office overseas. And for decades, it’s been a key partner in Washington’s never-ending “war on drugs.”

"Now, Colombia is calling for an end to that war. It wants instead to lead a global experiment: decriminalizing cocaine.

"Two weeks after taking office, the country’s first leftist government is proposing an end to “prohibition” and the start of a government-regulated cocaine market. Through legislation and alliances with other leftist governments in the region, officials in this South American nation hope to turn their country into a laboratory for drug decriminalization.

“It is time for a new international convention that accepts that the war on drugs has failed,” President Gustavo Petro said in his inaugural address this month."

Elizabeth "Betsy" E. Bailey (1939-2022)

 Betsey Bailey, an economist of many parts, has passed away.

I knew of her both as an academic dean at CMU and as a proponent of airline deregulation, in theory and practice.  The theory had to do with the idea that even markets with big players who had lots of market share might be perfectly competitive (and hence not need lots of regulation) if they were "contestable," i.e. if new entrants could enter the market at low cost if they saw profitable opportunities.  The idea was that the airline market would keep prices low to ward off new entrants, or entry by competitors into profitable routes.  Her stint on the Civil Aviation Board led to much reduced regulation of commercial airlines, after which airlines adopted the 'hub and spoke' patterns we see today. (When they were regulated, airline routes looked more like railroads, e.g. some had northern routes, some southern...)

Here's the Washington Post obituary:

Elizabeth Bailey, pathbreaker for women in economics, dies at 83. She was the first woman to receive a PhD in economics from Princeton and helped deregulate airlines as the first woman on the Civil Aeronautics Board  By Emily Langer

"Dr. Bailey, 83, who died Aug. 19 at her home in Reston, Va., was widely credited with opening opportunities for women in her field.

"In 1972, she became the first woman to receive a PhD in economics from Princeton University. Five years later, President Jimmy Carter appointed her the first female member of the Civil Aeronautics Board, where she helped provide the intellectual framework for the deregulation of the airline industry.

...

"Later, at Carnegie Mellon University in Pittsburgh, Dr. Bailey became the first woman to serve as dean of a Top 10 graduate business school."

*******

See 

Morrison, Steven A., Clifford Winston, Elizabeth E. Bailey, and Alfred E. Kahn. "Enhancing the performance of the deregulated air transportation system." Brookings Papers on Economic Activity. Microeconomics 1989 (1989): 61-123.

Bailey, Elizabeth E., David R. Graham, and Daniel P. Kaplan. Deregulating the airlines. Vol. 10. MIT press, 1985.

Bailey, Elizabeth E., and William J. Baumol. "Deregulation and the theory of contestable markets." Yale J. on Reg. 1 (1983): 111.

More on UNOS in the hot seat and calls for reform of the U.S. deceased donor transplant system

 Here's another report about the recent Senate Finance Committee hearing about UNOS, which includes a redacted version of the U.S. Digital Service report calling for UNOS's functions to be broken up. (UNOS, the United Network for Organ Sharing, is the federal contractor that runs the U.S. deceased donor transplant system.)

Transplant System Urgently Needs Overhaul, Experts Say— UNOS CEO skewered for alleged failures in management during a Senate Finance Committee hearing by Shannon Firth, Washington Correspondent, MedPage Today

"Members of the Senate Finance Committee and fellow witnesses roasted the head of the United Network for Organ Sharing (UNOS) during a hearing on Wednesday, over what Committee Chair Ron Wyden (D-Ore.) characterized as "gross mismanagement and incompetence."

...

"A report from the U.S. Digital Service issued last year determined that the network lacks the technical capacity to modernize the system. The report recommended that the contract for the system, worth $248 million, be separate from a contract for policy management, according to The Washington Post.

"Sen. Elizabeth Warren (D-Mass.), not one to mince words, told Brian Shepard, CEO of UNOS, "I'll just be clear. You should lose this contract. You should not be allowed anywhere near the organ transplant system in this country. And if you try to interfere with the process of turning the contract over to someone who can actually do the job, you should be held accountable for that."

HT: Frank McCormick

**********

And here is a Senate memo issued just prior to the hearing:

“A System in Need of Repair: Addressing  Organizational Failures of the U.S.’s Organ Procurement and Transplantation Network”

"This bipartisan investigation began in February 2020 when then-Chairman Charles Grassley, then-Ranking Member Ron Wyden, Senator Todd Young, and Senator Benjamin Cardin sent a letter to UNOS expressing their concerns about the adequacy of patient safety standards and belief that OPOs are failing to recover thousands of viable organs each year. 16 The letter also highlighted an investigation by the Department of Health and Human Services, Office of Inspector General (HHS OIG) and news reports, shining a light on “lapses in patient safety, misuse of taxpayer dollars, and tens of thousands of organs going unrecovered or not transplanted,” leading to questions about the adequacy of UNOS’ oversight of OPOs.”17

"In 2021, the investigation continued under the leadership of now-Chairman Wyden and Ranking Member Grassley of the Senate Judiciary Committee with a series of bipartisan requests for information sent to HHS,18 CMS,19 HRSA, and the Office of Management and Budget. Staff also broadened the scope of the investigation to include concerns about the inadequacy of the OPTN information technology system and its impact on patients. 

...

Based on documents and internal memoranda, the Committee found that:

• The OPTN is failing to provide adequate oversight of the nation’s 57 OPOs, resulting in fewer organs available for transplant.

• The lack of oversight by UNOS causes avoidable failures in organ procurement and transplantation resulting in risks to patient safety. These failures include testing procedure errors, transportation issues resulting in life saving organs being lost or destroyed in transit, and process and procedure failures.

• UNOS lacks technical expertise to modernize the OPTN IT system, resulting in risk of system interruption or technical failure with the potential to harm patients across the country."

...

"While not the sole focus of the Committee’s investigation, Senator Grassley and Senator Wyden’s staff also heard concerns from patients, transplant center staff, and OPO staff that UNOS lacks technological expertise or the willingness to develop and maintain an adequate IT infrastructure. Staff also heard concerns that the archaic IT system results in delays in placing organs, organs being discarded, and inaccurate data being used to place organs because of its dependence on staff manually entering hundreds of donor and transplant candidate data points rather than upgrading to systems better able to transfer data across Electronic Medical Record platforms.

"These concerns were validated in a report from the independent U.S. Digital Service (USDS), which is housed within the Executive Office of the President and provides consultation services to federal agencies on information technology.115 The report, titled Lives Are at Stake, states that UNOS has been able to wiggle through and around most new contract requirements for the OPTN technology by hand-waving at change with technical jargon, while making no substantive progress. The USDS also states that:116

• UNOS is incapable of modernizing the OPTN IT infrastructure;

• the core systems are fragile;

• OPTN technology limits policy development;

• UNOS is resistant to change; and,

• OPTN system is dependent on a disjointed and inadequate user experience.

"Ultimately, USDS determined that these technological failings are in fact placing lives at stake and recommended that HHS take action to create a better organ transplant system and enable better patient outcomes, including updating NOTA to create flexibility in how the OPTN is serviced by contractors."

...

"Based on the investigation’s findings, Committee staff makes the following recommendations to improve the OPTN:

• Remove barriers to competition by removing the specific requirement for HHS to contract only with a “non-profit entity that has an expertise in organ procurement and transplantation;”

• Increase the pool of potential bidders by clarifying that the OPTN functions described in NOTA and subsequent amendments may be operated by more than one contractor, since few contractors will have adequate clinical knowledge and expertise in IT, policy development, and data collection and reporting, and policy compliance activities;

• Promote innovation in all OPTN functions (e.g., policy development, compliance and patient safety mentoring, IT infrastructure, coordinating transport of organs, etc.) as the best qualified entities with distinct skill sets could compete for contracts for these functions;

• Remove a major barrier for entry for bidders by providing authority for HHS to procure a government owned, contractor operated modern IT system to facilitate the OPTN functions;

• Increase security and innovation in the OPTN system by ensuring the new IT system is based on current technologies and operated and maintained by a contractor with adequate IT knowledge and experience;

• Ensure the continued viability of the OPTN by authorizing HHS to collect fees from transplant hospitals when adding a patient to the national organ transplant waitlist. This would replace a current fee structure authorized by regulation which is not flexible enough to provide funding for multiple contracts;

• Increase transparency and accountability for chain of custody and transportation of organs procured for transplant by providing for public reporting, as appropriate, on the status of organs in transport; and,

• Increase accountability for organs lost, damaged, or delayed in transport by requiring oversight and corrective action for such incidents.

**********

Earlier:

Wednesday, August 3, 2022

UNOS and organ transplant technology

Thursday, August 4, 2022

UNOS hearing in the Senate

UNOS hearing in the Senate

 Yesterday in D.C. ... a tough hearing of the Senate Finance committee.  You can listen to the video now, but it looks like the committee will populate the links to documents only slowly.

[Update: better video link-- 

https://www.youtube.com/watch?v=iA2wuSN7POs ]

A System in Need of Repair: Addressing Organizational Failures of the U.S.’s Organ Procurement and Transplantation Network

---

Date: Wednesday, August 3, 2022Time: 02:30 PMLocation: 215 Dirksen Senate Office Building

OPEN IN NEW WINDOW

Agenda

---

Pursuant to guidance from the CDC and OAP, Senate office buildings are not open to the public other than official business visitors and credentialed press at this time. Accordingly, in-person visitors cannot be accommodated at this hearing. We encourage the public to utilize the Committee’s livestream of the hearing, available on the website at https://www.finance.senate.gov/. 

Member Statements

---

1.  Ron Wyden (D - OR)
   •  Download Statement
2.  Mike Crapo (R - ID)

Witnesses

---

1. Brian Shepard
   Chief Executive Officer
   United Network for Organ Sharing (UNOS)
   Richmond , VA
   • Download Testimony
2. Diane Brockmeier, RN
   President And CEO
   Mid-America Transplant
   St. Louis , MO
   • Download Testimony
3. Barry Friedman, RN
   Executive Director
   AdventHealth Transplant Institute
   Orlando , FL
   • Download Testimony
4. Calvin Henry
   Region 3 Patient Affairs Committee Representative
   Organ Procurement and Transplantation Network (OPTN)
   Atlanta , GA
   • Download Testimony
5. Jayme Locke, M.D., MPH
   Director, Division Of Transplantation, Heersink School Of Medicine,
   University of Alabama at Birmingham
   Birmingham , AL
   • Download Testimony

Related Files

---

	Report On Organizational Failures Of The United States Organ Procurement
	Exhibit List Of The Report On Organizational Failures Of The United States Organ Procurement
	Appendix A - ABO Incompatibility Case 1
	Appendix B - ABO Incompatibility Case 2
	Appendix C - Cancer Transmission Case 1
	Appendix D - Cancer Transmission Case 1
	Appendix E - Kidney Death Case
	Appendix F - Courier Case 1
	Appendix G - Courier Case 2
	Appendix H - Airline Case 1
	Appendix I - Airline Case 2
	Appendix J - Allocation Error Case
	Appendix K - Donation After Circulatory Death Case 1
	Appendix L - Donation After Circulatory Death Case 2
	Appendix M - Kidney Trash Case
	Appendix N - Financial Allegations Case
	Other Documents Related To The Report On Organizational Failures Of The United States Organ Procurement

 How do I submit a statement for the record?

Any individual or organization wanting to present their views for inclusion in the hearing record should submit in a Word document, a single-spaced statement, not exceeding 10 pages in length. No other file type will be accepted for inclusion. Title and date of the hearing, and the full name and address of the individual or organization must appear on the first page of the statement. Statements must be received no later than two weeks following the conclusion of the hearing.

Statements can be emailed to:

Statementsfortherecord@finance.senate.gov

Statements should be mailed (not faxed) to:

Senate Committee on Finance
Attn. Editorial and Document Section
Rm. SD-219
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

************

Here's a Washington Post story that came out yesterday, while the hearing was in progress:

70 deaths, many wasted organs are blamed on transplant system errors An investigation by the Senate Finance Committee blamed the fatalities on errors in screening organs for disease, blood-type mix-ups and other mistakes  By Lenny Bernstein and Todd C. Frankel August 3, 2022 at 2:30 p.m. EDT

Drugs, drug regulation, and chemistry: the case of nicotine (following Rob Jackler)

 My Stanford colleague Dr. Rob Jackler has a longstanding interest in nicotine as an addictive drug that continues to be effectively marketed and ineffectively regulated.

Lately he's been concerned with novel delivery systems, such as the non-combustion vaping devices offered by sellers like Juul (which  has recently been on a regulatory roller coaster.)

You can find many of his papers at the Stanford Research into the Impact of Tobacco Advertising (SRITA) site.  The most recent of these papers concerns the fact that a lot of regulation is focused on "tobacco products," but that nicotine itself--the addictive chemical in tobacco--has been successfully synthesized in the lab, and so can be marketed as a "tobacco free" product.

Here's a recent NY Times article on his work:

The Loophole That’s Fueling a Return to Teenage Vaping. Sales are rising of flavored e-cigarettes using synthetic nicotine that evades regulatory oversight, a gap that lawmakers are now trying to close.  By Christina Jewett

And here's the paper:

Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products. Ramamurthi D, Chau C, Lu Z, Rughoobur I, Sanaie K, Krishna P, Jackler RK. SRITA White Paper. March 8, 2022.

"Executive Summary:

• A 2009 US law assigned tobacco regulation to the FDA, created its Center for Tobacco Products, and defined a tobacco product as derived from any component of the tobacco plant.

• As the September 2020 deadline for submission of application to the for FDA authorization of novel tobacco products (PMTA) approached, major tobacco companies submitted application for their brands, but innumerable smaller companies lacked the resources needed to undertake the extensive studies required.

• In an effort to circumvent FDA tobacco regulations, and thus exempt their products from the PMTA process, numerous brands claimed to be formulated with tobacco-free and/or synthetic nicotine.

• Following the late 2021denial of their PMTA applications, some brands which were ordered off the market promptly relaunched claiming that they had been reformulated with tobacco-free or synthetic nicotine.

• Brands claiming to use non-tobacco derived nicotine are offered in a wide array of youth-appealing sweet & fruity flavors – which have been systematically denied market authorization during the ongoing FDA PMTA process.

• Synthetic nicotine is currently expensive, costing approximately 4x tobacco derived nicotine. 

• While residuals from tobacco leaf derived nicotine are well known, byproducts of the chemical synthesis of nicotine have not been characterized for potential human toxicity and carcinogenicity.

• Justified by concerns for unknown safety risk, the FDA should insist upon toxicity/carcinogenicity studies of synthetic nicotine products before they are marketed.

• The FDA should also consider systematic testing of products claiming to be tobacco-free as at least a portion of them may prove to have chemical signatures indicative of tobacco origin.

• Some brands marketed as “tobacco-free” or “tobacco leaf-free” use a purified form of tobacco derived nicotine and thus are legally tobacco products under US law and thus subject to the PMTA requirements.

• Terms describing nicotine products as “tobacco-free,” “non-tobacco,” and “zero tobacco” need regulation as consumers may perceive such products as having reduced addictive potential.

• Marketing claims such as “clean,” “pure,” and “free of carcinogens” should be disallowed absent modified risk designation by the FDA.

• “Tobacco-free” nicotine brands have been allowed to post paid advertisements, and are widely sold on major online stores (e.g., Amazon, eBay, Google Shopping), which prohibit sale of all tobacco products.

• Underage sales of “tobacco-free” nicotine products are common via major online stores.

• As it is a potently addictive substance, and harmful to the developing adolescent brain, there is no justification for nicotine, regardless of its source, to be exempt from regulation.

• The synthetic nicotine regulatory loophole should be closed by designating such products as unauthorized drugs requiring pre-market authorization. "

********

Congress closed the synthetic nicotine loophole in March, and since July 2022 synthetic nicotine products can only be on the market if they have been authorized by the FDA – none have been so yet.   Here's the story from the Washington Post:

Congress moves to give FDA new powers over synthetic nicotine products including a youth favorite — Puff Bar e-cigarettes By Laurie McGinley, March 8, 2022

**********

There have also been bans on flavored nicotine, aimed at children as well as adults. These may be doomed to be at least partly ineffective. Menthol flavored cigarettes are likely to be banned in the U.S., and have already been banned in Britain and elsewhere. But just as cocktail mixes can be sold separately from alcohol (but ready to mix), so apparently can flavorings for cigarettes and e-cigarettes... e.g. search for "menthol flavour cards for cigarettes" or "menthol crush balls" to see how to add menthol back into your smokes in England.

Here's a recent NBER working paper comparing menthol smokers to non-menthol smokers:

Are Menthol Smokers Different? An Economic Perspective, by Yu-Chun Cheng, Donald S. Kenkel, Alan D. Mathios & Hua Wang, WORKING PAPER 30286, DOI 10.3386/w30286, July 2022

 **********

And here's an old NYT story in which Rob describes himself as “an accidental tourist in the world of advertising.”

When Doctors, and Even Santa, Endorsed Tobacco, By Stuart Elliott, Oct. 6, 2008

**********

earlier: 

Sunday, January 30, 2022

Chemistry is replacing agriculture in the supply of black market drugs

Sunday, May 2, 2021

Repugnance as paternalism: bans on flavored tobacco products

Tuesday, February 12, 2019

The new market for (and marketing of) nicotine--Robert Jackler (followed by the CDC)

Personal data as a national (not international) resource

 The NY Times has the story:

The Era of Borderless Data Is Ending. Nations are accelerating efforts to control data produced within their perimeters, disrupting the flow of what has become a kind of digital currency.  By David McCabe and Adam Satariano

"France, Austria, South Africa and more than 50 other countries are accelerating efforts to control the digital information produced by their citizens, government agencies and corporations. Driven by security and privacy concerns, as well as economic interests and authoritarian and nationalistic urges, governments are increasingly setting rules and standards about how data can and cannot move around the globe. The goal is to gain “digital sovereignty.”

...

"In Washington, the Biden administration is circulating an early draft of an executive order meant to stop rivals like China from gaining access to American data.

"In the European Union, judges and policymakers are pushing efforts to guard information generated within the 27-nation bloc, including tougher online privacy requirements and rules for artificial intelligence.

"In India, lawmakers are moving to pass a law that would limit what data could leave the nation of almost 1.4 billion people.

"The number of laws, regulations and government policies that require digital information to be stored in a specific country more than doubled to 144 from 2017 to 2021, according to the Information Technology and Innovation Foundation.

"While countries like China have long cordoned off their digital ecosystems, the imposition of more national rules on information flows is a fundamental shift in the democratic world and alters how the internet has operated since it became widely commercialized in the 1990s.

High prices and moral outrage, by Elias, Lacetera, and Macis

 Is Uber-style surge pricing immoral, or efficient?  How about price rises during a pandemic? Does discussion of the economic consequences change the assessments of morality? Here's a new NBER paper:

Is the Price Right? The Role of Morals, Ideology, and Tradeoff Thinking in Explaining Reactions to Price Surges  by Julio J. Elias, Nicola Lacetera & Mario Macis, NBER WORKING PAPER 29963, DOI 10.3386/w29963, April 2022

Abstract: "Price surges often generate social disapproval and requests for regulation and price controls, but these interventions may cause inefficiencies and shortages. To study how individuals perceive and reason about sudden price increases for different products under different policy regimes, we conduct a survey experiment with Canadian and U.S. residents. Econometric and textual analyses indicate that prices are not seen just as signals of scarcity; they cause widespread opposition and strong and polarized moral reactions. However, acceptance of unregulated prices is higher when potential economic tradeoffs between unregulated and controlled prices are salient and when higher production costs contribute to the price increases. The salience of tradeoffs also reduces the polarization of moral judgments between supporters and opponents of unregulated pricing. In part, the acceptance of free price adjustments is driven by people’s overall attitudes about the function of markets and the government in society. These findings are corroborated by a donation experiment, and they suggest that awareness of the causes and potential consequences of price increases may induce less extreme views about the role of market institutions in governing the economy."

From the conclusions:

"Our findings support the claim that people do not perceive prices as only signals of relative scarcity, but they attribute moral valence to them. Consistent with prior studies, price spikes in response to demand increases receive widespread opposition and generates moral aversion, mainly out of concerns for fairness toward and exploitation of consumers. Moreover, underlying ideological positions about the role of the market (and the government) in society significantly affect the perceptions and acceptance of price surges. However, when made explicit, economic or tradeoff considerations substantially increase the public’s acceptance of price increases in response to demand surges. The reaction to these economic considerations also concerns moral judgments; tradeoff salience increases people’s acceptance of price surges and changes their moral reactions to these increases. When individuals are prompted to consider the economic consequences of freely adjusting prices versus price controls, their moral judgments are less radical and less different from one another. 

...

"Despite the large positive impact of explicit cost-benefit considerations on the acceptance of the free price mechanism to organize markets, most respondents, even when assigned to scenarios with salient tradeoffs, did not support a “laissez faire” solution to price surges. This suggests that this opposition is rooted in strong beliefs and norms whose violation could represent a cost to society. Policy choices and organizational practices that reduce the likelihood of price spikes may therefore be supported by the public."

Transplant wait lists and patient finances

 Here's a disturbing commentary on how the regulation of transplant centers interacts with patient finances and the decision of who to put on transplant wait lists. The authors suggest extending to all organs the financial coverage that Medicare currently gives to kidney transplants.

Viewpoint March 31, 2022

Medical Need, Financial Resources, and Transplant Accessibility by Sharad I. Wadhwani, MD, MPH1; Jennifer C. Lai, MD, MBA1; Laura M. Gottlieb, MD, MPH  JAMA. Published online March 31, 2022. doi:10.1001/jama.2022.5283

"In the US, the need for lifesaving organ transplants exceeds the availability of transplantable organs, and in 2021, approximately 12 000 patients died or developed complications that precluded a transplant while awaiting an organ.1 Transplant centers are thus forced to ration these scarce resources. The first step for patients to receive an organ is for them to be placed on a national waiting list, ranked according to objective clinical criteria intended to reflect medical necessity. However, the listing system permits transplant centers to factor in patient financial resources in making this initial wait listing decision, which equates to withholding lifesaving medical therapy from those deemed to have insufficient financial resources. This approach contributes to inequities in transplant accessibility and outcomes.

...

"The OPTN policy specifically prohibits allocation to be based on race and ethnicity or socioeconomic status. Wait listing decisions (a prerequisite to allocation) are instead made based on a transplant candidacy evaluation, a process undertaken to assess transplant suitability. This includes an assessment of the patient’s insurance and financial security for expenses associated with the transplant surgery and lifelong posttransplant immunosuppression and enables transplant centers to circumvent the final rule mandate prohibiting allocation based on socioeconomic status. For instance, expenses for immunosuppression medications can exceed several thousand dollars a month; even insured patients can incur out-of-pocket, noncovered expenses that may exceed $1000 a month, including parking costs, missed work, and medication co-payments.2

"In theory, financial evaluations are included in listing determinations because low-socioeconomic status (measured by neighborhood socioeconomic deprivation and public insurance) has been associated with wait list mortality and posttransplant outcomes, and these outcomes are closely monitored for the approximately 250 US transplant centers.3 If transplant outcomes deviate from national benchmarks, the center risks losing accreditation and center of excellence designations, thus jeopardizing the ability of the center to offer transplants to other patients in need. The financial implications for a transplant center with poor outcomes are substantial: the average billed charges during the 30 days prior through the 180 days after a transplant range from an estimated $440 000 for a kidney transplant to an estimated $1.7 million for a heart transplant.4 Considering that in 2018, each US transplant program performed a median of 250 kidney transplants in adults, the financial implications of losing accreditation may motivate transplant centers to select transplant candidates most likely to survive until and after receiving a transplant. The system appears designed to disadvantage patients with inadequate financial resources thereby excluding them from the transplant waiting list."

...

"One strategy for improving insurance coverage could be to expand Medicare coverage to every individual requiring a transplant. Patients with end-stage kidney disease of all ages qualify for Medicare insurance in the US, and this coverage extends for the life of the transplant, thereby ensuring that patients continue to receive organ-preserving immunosuppression. A similar bill could extend Medicare coverage to any organ transplant recipient, starting when entered on the waiting list and continuing for the life of the transplant. This could help alleviate the potential risks that transplant centers may perceive around care adherence but would not comprehensively address all financial barriers to care. To ensure patients have adequate resources for long-term graft survival and patient health, changes to insurers’ incentives will need to be accompanied by other national, state, and local strategies to strengthen financial stability for families experiencing medical hardship.

"Solid organ transplantation is one of the greatest medical achievements of the 20th century and has transformed many terminal illnesses to treatable conditions. Yet almost 70 years after the first successful transplant surgery, this procedure remains out of reach for too many. As the nation continues to grapple with racism and classism, medicine must continue to identify and reform policies and procedures that contribute to health inequities. Withholding a transplant from those with inadequate insurance, limited financial resources, or both, is a tragic example of ongoing injustice."

Sex Work: Last Week Tonight with John Oliver (HBO)

Laughing through the tears about the plight of sex workers, and the complicated and often ridiculous legal environment. (He notes that there are no Hallmark cards with which a sex worker can thank her arresting officer.)

 

Freakonomics MD on deceased donor organs for transplants

 Freakonomics MD has a podcast focusing on the scarcity of deceased donor kidneys for transplant, and why recovered organs are sometimes discarded. They interview (separately) Dr. Sumit Mohan at Columbia, and me. (I was in fact interviewed by Jessica Wapner, not by the narrator, Dr. Bapu Jena, using a fancy microphone which they FedExed to me beforehand and I FedExed back to them afterwards...so my snippets probably sound like me...)

You can listen to it right below, or at the link...

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Why Do So Many Donated Kidneys End Up in the Trash? (Freakonomics, M.D. Ep. 11)

November 11, 2021 @ 11:00pm

by Dr. Bapu Jena
Produced by Jessica Wapner

  

LISTEN NOW:

Every year, thousands of people in the U.S. die while they’re waiting for a new kidney, yet thousands of available organs get thrown away. Bapu talks to a kidney doctor and an economics Nobel laureate about why this happens and how the system could improve.

Follow Freakonomics, M.D. on Apple Podcasts, Spotify, Stitcher, or wherever you get your podcasts.