It looks like paying donors of bone marrow/ blood stem cells will remain illegal...

The long story of whether some forms of blood stem cell (marrow) donation may be compensated seems to be coming to an end, back where it began.  Here's the new HHS/HRSA regulation, saying that whether as marrow or in the blood stream, these are considered organs under the National Organ Transplant Act, so no valuable consideration can be given...

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HHS/HRSA

RIN: 0906-AB02

Publication ID: Spring 2016

Title: Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984
Abstract:This final rule clarifies that peripheral blood stem cells are included in the definition of bone marrow under section 301 of the National Organ Transplantation Act of 1984, as amended and codified in 42 U.S.C. 274e.
Agency: Department of Health and Human Services(HHS)	Priority: Info./Admin./Other
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 109-129    Stem Cell Therapeutic and Research Act of 2005, as amended in 2010 by Pub. L. 111-264

Legal Deadline:  None

Timetable: Action Date FR Cite NPRM  10/02/2013  78 FR 60810    NPRM Comment Period End  12/02/2013  Final Rule  11/00/2016

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Undetermined
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Dr. James Bowman Medical Director, Division of Transplantation Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857 Phone:301 443-4861

HT: Kim Krawiec

Compensating bone marrow (blood stem cell) donors: still in legal limbo

Whether it will remain legal to compensate donors of bone marrow (blood stem cells) remains in limbo (see my various posts on the subject here).  The WSJ has an op-ed that summarizes the situation: 

Pay Bone-Marrow Donors, Save Lives: Thousands of Americans are waiting for donations—and while bureaucrats fiddle, patients die. By JEFF ROWES and  BOB MCNAMARA

Briefly, the 9th Circuit Court of Appeals lifted the ban on paying blood stem cell donors (if the technology was non-surgical), but the Department of Health and Human Services proposed a new regulation that would restore the ban. The regulation went out for public comment, and many comments were received, mostly against reinstating the ban.  The WSJ op-ed writes about that this way (in a way that makes me reflect on some of the oddities of news coverage):

"But a year after Ms. Flynn won her case, the Department of Health and Human Services announced that it might enact a regulation effectively nullifying the court’s ruling—and thus Ms. Flynn’s victory. In September 2013, HHS sought public comment. Hundreds of comments poured in favoring compensation for blood stem-cell donors who use apheresis, including support from Nobel Prize-winning economist Alvin Roth, who has long written on organ-donation policy. Only a handful of comments were opposed."

As you can imagine, I was one among many signers of the comment that I supported (which you can read here): the others, all economists, were

Theodore Bergstrom, University of California at S. Barbara, Stefano DellaVigna, University of

California at Berkeley, Julio J. Elias, Universidad del CEMA, Argentina,

Rodney Garratt, University of California at S. Barbara,

Michael Gibbs, University of Chicago, Judd Kessler, University of Pennsylvania, Nicola Lacetera,

University of Toronto, Stephen Leider, University of Michigan, John List, University of Chicago,

Mario Macis, Johns Hopkins University, Daniel McFadden, University of California at Berkeley, Matthew Rabin, University of California at Berkeley, Alvin Roth, Stanford University, Damien Sheehan-Connor, Wesleyan University, Robert Slonim, University of Sydney, Alex Tabarrok, George Mason University

If you have the time, you can read all 527 comments here.

Update on compensation for bone marrow donors

Frank McCormick emails about a new movie concerning the 9th Circuit court case which ruled that it might be legal to compensate certain kind of bone marrow/blood stem-cell donors, and the subsequent administrative battle to prevent that: Film inspired by Lewiston mom premieres

"A mission to help her three young daughters — Jordan, Julia and Jorja Flynn — stay healthy despite their Fanconi anemia, a rare genetic blood disorder that destroyed their bone marrow and made them extremely susceptible to cancer.

She's fighting to increase America's pool of bone-marrow donors by getting the federal government to allow some donors to be paid — a significant change she believed would help both donors and those in need, like her daughters.

Four years later, the Lewiston mom is still fighting, both for her daughters' health and against the federal government. But she's getting attention for it in a new way.

Today, a short film inspired by her battles will premiere at the Maine International Film Festival in Waterville.

...
"Hoping to help donors ease the financial burden of donation and give them an incentive to see the process through, Gummoe became lead plaintiff in a lawsuit spearheaded by the Institute for Justice.

For years, federal law has prohibited bone-marrow donors — and organ donors — from being compensated. The suit argued that advances in medicine made bone-marrow donation more like plasma donation, which can be compensated under the law, than to kidney donation, which cannot.

In traditional bone-marrow harvesting, doctors stick a needle through a hip bone and remove bone marrow. The alternative method, peripheral blood stem cell donation, is now used most of the time. In stem cell donation, donors receive injections to increase the production of blood-forming stem cells that are then siphoned out of their blood in a process similar to dialysis.

The lawsuit was successful: The 9th Circuit Court of Appeals ruled that the new form of bone-marrow donation did not fall under the category of organ donation as the law was written and could be compensated. At least one nonprofit was planning a pilot program to see how compensation — a $3,000 housing allowance, scholarship or charity donation — might boost bone-marrow donation.

But in 2013, the U.S. Department of Health and Human Services proposed a new rule that would explicitly include peripheral blood stem cell donation in the definition of organ donation. With that looming for nearly three years, no group has felt comfortable moving forward with a pilot program to compensate donors.

"If they were to raise money and start pursuing this research and then the department issued its rule and blocked it, it would be a waste of their time and resources, which are precious," Kramer said. "In good faith, they couldn't move forward."

The department has until the end of this year to either move forward to prohibit bone-marrow donors from being compensated or drop the issue. A Health and Human Services spokesman said Wednesday that the department was "working toward being responsive to this deadline."

The department has said a ban on compensation would help ensure that, among other things, donors aren't coerced or exploited.

Gummoe and the Institute for Justice believe a ban only ensures that there aren't enough people willing to donate.  "

Banks for blood and sperm

At The Atlantic,  Rebecca Rosen writes about Banks of Blood and Sperm: How the idea of a "bank" shapes the way people think about storing and distributing body fluids, in an interview of  Kara Swanson, the author of Banking on the Body (which I blogged about here).

Very interesting.  For example:

"What happened as the metaphor [of a bank] became more used in the 1950s and 1960s, was that a backlash developed against the market implications of the metaphor. The doctors and lay people who ran blood banks in the 1950s and 1960s, pushed the metaphor to its extremes—they told patients that each transfusion was a “loan” that needed to be repaid. Patients could repay in kind, or pay stiff replacements fees instead—fees that a bank could use to buy blood from a professional donor—always with the goal of keeping sufficient inventory.

The emphasis on buying and selling led blood banks into trouble in the courts—attorneys for patients injured from transfusions (which happened sometimes, if mismatched blood was given, or the blood contained a disease) argued that banked blood was a product. Product liability law was developing to find the manufacturer of a dangerous product liable even without negligence. Doctors, blood banks, and hospitals were horrified to have themselves considered product manufacturers. They began to backpedal from the banking metaphor by trying to make banked blood seem less like a product exchanged in markets.

What happened, with blood banks, and also with other kinds of banks, is that the banking metaphor and the backlash encouraged doctors, patients, and those of us who might be suppliers, to focus on one aspect—the supplier. Was the supplying body paid or unpaid? Paid suppliers, who were obviously entering into a market transaction, were treating their bodies as a source of private property, and were acting as though they were selling a product. Unpaid suppliers, were seen as giving gifts, out of altruism, and keeping themselves out of a market."
...
"In law, we thus divide body products into two categories: those which we legally mandate as gifts only—all organs—and everything else, which can be gifted or sold, at the discretion of the supplier. Organs is defined broadly—bone marrow, for example, is an “organ.” This means that bone marrow, which can now be extracted from the blood in a procedure similar to the way blood plasma is harvested, cannot be sold by anyone. (Blood plasma is routinely sold, by the way.)
...
"I argue in the book that the simple pay-suppliers/don’t-pay-suppliers approach to thinking about body products, which resulted from the banking metaphor, needs to be replaced with more nuanced thinking. Should we treat different types of organs (hearts v. bone marrow) differently? Can we think about compensation schemes that are not free markets, but are managed to support the public goals of increasing body-product supply? Can those schemes protect suppliers and recipients alike by keeping suppliers safe from exploitation, and recipients safe from diseased products? I use history to suggest that the answers can sometimes be yes. Body products used to be routinely paid for, and doctors thought about these potential problems and addressed them. Over time, we have forgotten this past, and come to assume that buying body products is always dangerous and bad.

I like to remind people that lots of altruistic gestures are compensated—the doctors, and nurses, and everyone who works on a transplant operation are all in caring professions. They are doing those jobs because they want to help people (at least we hope and assume so). But we wouldn’t suggest that they shouldn’t be paid because to offer payment for such efforts would be insulting or immoral or cause their altruistic tendencies to be replaced by mercenary concerns.

Yet that is how we treat organ supply—that offering money would do all those bad things. Why should the supplier of a body product be the only person in that life-saving supply chain who is not compensated? People might choose not to be compensated, but if they want to be, and if more folks will act as suppliers with that incentive, why not?

To give a more specific historical example, let’s think about mothers’ milk stations in the 1930s. At that time, in most cities, such a station existed. It was established and supervised by a doctor or doctors, and its daily operations were run by nurses. Lactating women came to the station to express their breast milk and were paid by the ounce. Payment was used to ensure an adequate supply. The supply was used for sick and/or premature infants who lack a maternal source of milk."

**************
In the meantime, here's a news article published around the same time, from the business side:
More blood banks merging to cut costs--Officials cite need for new model

"The proposed merger of Green Tree’s Institute for Transfusion Medicine with Florida-based OneBlood is the latest in a series of blood bank consolidations nationally, symptomatic of lean times for hospitals as they try to cut costs and reduce transfusions.

The deal, announced July 25, would create one of the largest blood banks in the country, with combined revenues of $480 million, if it goes through. The two firms jointly distribute nearly 2 million units of blood annually, serving 313 hospitals in eight states.

Only the American Red Cross would collect and distribute more blood."

Lacetera, Macis and Stith on removing financial barriers to bone marrow donation

Removing financial barriers to organ and bone marrow donation: The effect of leave and tax legislation in the US

Lacetera, Nicola ; Macis, Mario; Stith, Sarah S.

JOURNAL OF HEALTH ECONOMICS

Volume: 33, Jan 2014, 43-56

Many U.S. states have passed legislation providing leave to organ and bone marrow donors and/or tax benefits for live and deceased organ and bone marrow donations and to employers of donors. We exploit cross-state variation in the timing of such legislation to analyze its impact on organ donations by living and deceased persons, on measures of the quality of the transplants, and on the number of bone marrow donations. We find that these provisions do not have a significant impact on the quantity of organs donated. The leave laws, however, do have a positive impact on bone marrow donations, and the effect increases with the size of the population of beneficiaries and with the generosity of the legislative provisions. Our results suggest that this legislation works for moderately invasive procedures such as bone marrow donation, but these incentives may be too low for organ donation, which is riskier and more burdensome. 

Cash for Kidneys: The Case for a Market for Organs. Becker and Elias in the WSJ

Gary Becker and Julio Elias have a reprise of their 2007 Journal of Economic Perspectives paper in this weekend's Wall Street Journal, in a cogent column called Cash for Kidneys: The Case for a Market for Organs.

Their 2007 JEP paper was called  Introducing Incentives in the Market for Live and Cadaveric Organ Donations (slightly more direct link here).

Between then and now the number of people on the waiting list for kidneys has gone up. Their 2007 article has these sentences: "Almost 17,000 persons were waiting for a kidney transplant in 1990. But this number grew rapidly, so that about 65,000 persons were on this waiting list by the beginning of 2006."

This weekend's WSJ column starts with the sentence "In 2012, 95,000 American men, women and children were on the waiting list for new kidneys, the most commonly transplanted organ."

So, the arguments that they repeat have gotten stronger over time: the shortage of organs is costly in every sense, and could likely be relieved by allowing kidneys to be bought and sold by live donors, and allowing the purchase of organs from deceased potential donors, i.e. by repealing the part of the 1984 National Organ Transplant Act that makes such sales a felony in the United States. (Similar laws exist in most of the developed world: the only country that seems to have an explicitly legal market for kidneys is Iran, although many black and grey markets exist.)

So, why hasn't this argument made any headway, either in the U.S. or overseas? Is patient repetition of the argument the best way to make the case? I don't know the answers, but I think that the repugnance of organ sales is a subject worth studying, not just for science but also for those who might like to influence policy.

In the same issue of the JEP as Becker and Elias (2007) was my article Repugnance as a Constraint on Markets (more direct link here), which sought to understand not just the repugnance to kidney sales, but to many economic transactions, in different places and times, e.g. to charging interest on loans, or having markets for slaves or indentured servants. I noted that kidney exchange doesn't arouse the repugnance that sales do. I've since blogged about a lot of different repugnant transactions including compensation for donors (as of this writing my most recent post on transactions that some regard with repugnance is headlined Womb transplants in Sweden (where surrogacy is illegal)...)

Note that the prohibition on organ sales is not some law that remains on the books merely through inattention. This is illustrated by the recent events surrounding the tug of war over whether it might be legal to compensate (even) bone marrow donors. Briefly, the ninth circuit court of appeals issued a ruling that said that in some circumstances bone marrow donors could be compensated, but then the Department of Health and Human Services proposed regulations that would keep the ban in place.   So the opposition to organ sales--even to compensating bone marrow donors--is alive and well.

But things don't go all in one direction. Bob Slonim reminds me that while we rely on unpaid donation of whole blood in the United States, most of our supply of blood plasma comes from paid donors.

I've participated in some efforts to understand better the repugnance to compensating organ donors, e.g. here's a survey with Steve Leider about who disapproves of kidney sales, and some correlates of such disapproval:
Leider, Stephen and Alvin E. Roth, ''Kidneys for sale: Who disapproves, and why? American Journal of Transplantation  10 (May), 2010, 1221-1227.

More recently, Muriel Niederle and I conducted a different sort of survey, which assessed the relative willingness of Americans to contemplate monetary rewards for the heroism associated with kidney donation:
"Niederle, Muriel and Alvin E. Roth, “Philanthropically Funded Heroism Awards for Kidney Donors?” forthcoming in Law & Contemporary Problems, 77:3, 2014.

Judd Kessler and I have a paper forthcoming in the American Economic Review papers and proceedings (May 2014) called "Getting More Organs for Transplantation," in which we summarize the issue this way:

"Kidney sales are often the leading example of a repugnant transaction cited by those who would put stricter limits on markets in general (e.g. Sandel 2012, 2013), because of their sense that such sales arouse widespread opposition. A representative sample survey of Americans conducted by Leider and Roth (2010) suggests that disapproval of kidney sales correlates with other socially conservative attitudes, but that it does not rise to the level of disapproval of other repugnant transactions such as prostitution. In addition, there is evidence that the manner of the payment to an organ donor may mitigate some of the repugnance concerns. Niederle and Roth (forthcoming 2014) find that payments to non-directed kidney donors are deemed more acceptable when they arise as a reward for heroism and public service than when they are viewed as a payment for kidneys."

That paper closes with this thought on the presently available options: 
"While these potential donors could save thousands of additional lives, at current rates of medical need, these donors alone would not be able to supply all the demand. Consequently, we must continue working on numerous fronts to solve this growing problem. "

In summary, the issue of whether and how organ donors might be compensated is an important policy issue that also touches on an important and still poorly understood social science phenomenon. Repetition of the basic arguments may move the discussion forward as the background facts become more severe, and it's great to see the issue addressed in such a public forum as the WSJ. But it may also be that repetition of arguments is not enough. To make progress in the face of opposition, it seems likely to be useful to understand better the nature of the opposition.

Comment on the proposed federal regulation limiting bone marrow compensation

I've written earlier about the proposed regulations that would reverse the effect of the 9th circuit court of appeals decision to allow some bone marrow donors to be compensated. The opportunity to comment on the proposed regulation closed Monday at midnight Eastern time. (Here are all the comments.) Below is a comment on the proposed regulations, signed by a number of economists, myself included. Note point 2 in particular, which points out that the regulation would cut off research on the effect of incentives.

December 2, 2013

Shelley Grant, MHSA, Branch Chief,
Blood Stem Cell Transplantation Program, Division of Transplantation Healthcare Systems Bureau,  Health Resources and Services Administration 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857


Comment on Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the National Organ Transplant Act of 1984. Health Resources and Services Administration, HHS. RIN 0906–AB02.

We are academic economists who study how incentives and other mechanisms affect individual behavior and whose research is concerned with improving public welfare. We are writing in opposition to the proposed rule changes by the Department of Health and Human Services (HHS) that would ban compensation for bone marrow donations. The reasons we oppose the proposed rule change are that it ignores the most critical benefits of offering economic incentives (point 1 below) and prevents the ability to properly assess and improve the benefits of offering incentives (points 2 and 3 below) despite the HHS proposed regulation explicitly stating (Section III. Impact Analysis) “Economic and Regulatory Impact Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives” (Italics added). The HHS document also states that “The provisions of this rule will not affect the following elements of family well-being: Family safety, … parental rights in the education, nurture, and supervision of their children,” and this regulation could prevent parents such as the lead plaintiff in Flynn v. Holder from obtaining bone marrow transplants for their children.1

1. The proposed regulation entirely ignores potential benefits to bone marrow recipients. The motivation for the ban focuses entirely on concerns for potential donors and gives no weight to the consideration of the patients in need of a bone marrow transplant. There are many patients whose health conditions worsen each year waiting unsuccessfully for a matched bone marrow donation. Depending on the patient's race, there is between an 8 and 50 percent chance that there will be no match in the existing registry. As a result, hundreds of patients die each year due to an
inadequate supply of donors.2 Economic incentives have the potential to motivate more bone marrow donations thereby saving and prolonging the lives of potentially thousands of patients. Indeed, the benefit-cost of adding one potential donor to the registry indicates enormous positive value, between 5 and 7 times the benefit to the cost.3 By entirely ignoring these potential benefits, the proposed regulation fails to accurately present the welfare consequences of the ban.

2. The proposed ban will prevent the most policy relevant academic research that is critically needed to determine whether and how economic incentives can be used to save lives. Alternative research methods that do not directly examine actual incentives for actual bone marrow donations (e.g., surveys), or uncontrolled studies that do not appropriately account for confounding factors (i.e., differences in incentivized and non-incentivized populations), will produce unreliable policy evidence. Recent work, consisting mainly of Randomized Controlled Studies (RCTs) examining economic incentives to motivate blood donations, shows positive results when evaluating actual incentives for actual blood donations in natural contexts. This robust evidence contrasts with earlier results using alternative methods not examining actual incentives and donations.4 This is not just an academic point; empirical evidence obtained with rigorous methods should be used to inform policy. This rigor should apply in general, but it is especially critical in the context of bone marrow donations where thousands of lives are at stake every year and where adopting a ban without appropriate evidence could have disastrous  consequences.

3. The ban will eliminate the opportunity to offer any form of economic incentive, not just cash payments. The policy would thus prevent even non-cash rewards that have been shown to significantly increase blood donations with no harm to the quality of the blood supply.5 The proposed change will thus prevent many potential types and sizes of incentives that could be effective. Appropriately designed research could shed light on whether different types of incentives and incentive amounts would have different effects on donations, but the proposed regulation would make this type of research illegal.

In addition to inappropriately assessing the cost-benefit analyses, we oppose the ban for the
following two reasons. First, allowing for the compensation of bone marrow donors does not mean
that donors have to accept the compensation. When offered, donors could still choose to not accept the incentive or could even donate it to charity. Second, donating bone marrow through the
apheresis process and donating whole blood or plasma share a critical characteristic: donors
provide renewable material that is extracted with minimal risk and that their body regenerates
quickly. The US government has never prevented compensation for these other blood products despite deliberations,6 thus from this renewable material perspective there is no reason to have different policies for these types of donations.

In summary, the proposed regulation ignores the potential beneficial effects that offering compensation to bone marrow donations will have on the well-being of patients who need a transplant but are unable to find a match in an uncompensated-only donation system. This implies that “all costs and benefits of available regulatory alternatives” have not been assessed. Moreover, it makes it illegal to conduct the very research that would be critically necessary to establish the effects that incentives can have on donations. For these reasons, we oppose this regulation proposed by HHS that would ban all forms of compensating bone marrow donors.

Signed,
Theodore Bergstrom, University of California at S. Barbara Stefano DellaVigna, University of
California at Berkeley Julio J. Elias, Universidad del CEMA, Argentina
Rodney Garratt, University of California at S. Barbara
Michael Gibbs, University of Chicago Judd Kessler, University of Pennsylvania Nicola Lacetera,
University of Toronto Stephen Leider, University of Michigan John List, University of Chicago
Mario Macis, Johns Hopkins University
Daniel McFadden, University of California at Berkeley Matthew Rabin, University of California at
Berkeley Alvin Roth, Stanford University
Damien Sheehan-Connor, Wesleyan University
Robert Slonim, University of Sydney
Alex Tabarrok, George Mason University



Footnotes:
1 The lead plaintiff, Doreen Flynn, has three daughters afflicted with Fanconi anemia who may need
multiple bone marrow transplants during their teen years.
2 Bergstrom, Garratt, and Sheehan-Connor 2009, Tables 2 and 4.
3 Ibid, Table 7.
4 Lacetera, Macis and Slonim 2013.
5 Ibid.
6 Starr, 1998.


References
Bergstrom, T., Garratt, R., Sheehan-Connor, D. 2009. One chance in a million: altruism and the bone marrow registry. American Economic Review 99, 1309–1334.
Lacetera, N., Macis, M., Slonim, R. 2013. Economic rewards to motivate blood donations. Science 340: 6135, 927–928.
Starr, D. 1998. Blood: An epic history of medicine and commerce. Imperial College, London.

More on the law and politics of compensating bone marrow donors

The legal battle is shaping up over the decision of the department of Health and Human Services to circumvent the decision of the ninth circuit court of appeals that it is legal to compensate bone marrow donors.  The Institute for Justice, which was a successful litigant in the court ruling, has outlined their current thoughts here:
Federal Officials Move to Block Life-Saving Research
HHS’ Proposed Rules Would Undo Court Ruling Legalizing Bone Marrow Compensation

They say in part:
"The proposed regulation would ban marrow compensation just when empirical research has begun into the effects of compensating donors.  A team of economists—Nicola Lacetera of the University of Toronto, Mario Macis of Johns Hopkins University, and Robert Slonim of the University of Sydney—were in the process of finalizing a research proposal that would have investigated the effects of donor compensation when they learned of the new rule.

“These new regulations make it impossible for researchers to obtain the necessary evidence to inform policy.  Our proposed studies would be made illegal by these new provisions,” explained Macis, who, along with Lacetera and Slonim, has published some of the leading work showing that economic incentives can be effectively used to increase blood donations without affecting blood supply safety.  “Properly designed compensation for bone marrow donors could similarly lead to significant increases in donations, thus giving potentially hundreds or thousands of people in need of a transplant every year a greater chance of survival.  At a minimum, the federal government should not make it illegal for researchers to find out whether incentives can help address the shortage of bone marrow donors.”

“I don’t think that anybody should go to jail just for trying to save somebody’s life,” added Doreen Flynn, who has three children with Fanconi anemia, a blood disease that frequently requires a bone marrow transplant and who was the lead plaintiff in the original lawsuit.  “If paying donors results in more marrow donations, we should pay them.  And it shouldn’t be a crime to investigate it.”
“We know what doesn’t work,” said Robert McNamara, also a senior attorney with the Institute and co-lead counsel in the case.  “We have 30 years of experience with an altruism-only marrow-donor program, and we know that has not succeeded in recruiting enough donors.  The only question is whether offering compensation can achieve better results.  We will not allow the federal government to make it a felony to find out the answer.  Hopefully, we will do that by persuading the government not to adopt this rule, but if we have to, we will sue them again.  And we will win—again.”

The proposed regulation is currently open for a period of public comment through December 2, 2013.  Individuals who have been impacted by blood-borne cancer or bone marrow donations are encouraged to leave comments on the Department of Health and Human Services’ website:  http://www.regulations.gov/#!submitComment;D=HRSA_FRDOC_0001-0115."
****************

You can follow some of the story in my earlier posts on bone marrow and compensation.

Nalini Ambady, RIP

Stanford psychology professor Nalini Ambady passed away after a long search for a matching bone marrow donor:
Nalini Ambady, Stanford psychology professor, dies at 54
"A distinguished social psychologist, Ambady was well known for her research that showed that people can form accurate first impressions about others based only on seconds-long observations of their nonverbal behavior."

"Nalini Ambady, a Stanford professor of psychology, died Oct. 28 after a long battle with leukemia. Her passing followed a yearlong, worldwide effort by family, friends and students to find a bone marrow donor match."
**************

Professor Ambady's students and friends organized an active campaign to help her find a bone marrow donor, which you can follow here: http://ambadylab.stanford.edu/helpnalininow/

Here's a story from New Delhi TV (NDTV) that in passing emphasizes how the inability to compensate donors can make the search tragically difficult (emphasis added): Professor Nalini Ambady's death highlights lack of awareness on bone marrow transplants in India

"Because of genetic markers, a person is likely to find a match from one's own ethnic gene pool. In Ms Ambady's case her match would most likely have been from someone from her birthplace - Kerala.

"For the past six months, the Ambady family has been carrying out drives in India to encourage people to sign up for the bone marrow registry in the hopes of finding her a potential match.

"But in a country of 1.2 billion, only about 45,000 people have signed up to be bone-marrow donors. In comparison, there are over 10 million donors on the United States' National Marrow Donor Program.

"This is despite the fact that becoming a bone marrow donor is simple. All it takes is a swab test-rubbing an ear bud on the inside of one's cheek. An actual transplant is as painless as donating blood. Still, because of ignorance, lack of awareness, cultural taboos or psychological fears Indian's don't sign up to become donors.

"Ms Ambady found at least six potential matches from India. But they all dropped out. According to a childhood friend Ann Ninan, "It was heart breaking for the family."

"Ms Ambadi's family will not be able to celebrate this Diwali with her but during this festive season let's all sign up as donors. It's a few minutes of your time but it could save someone's life."
***************

My colleague Muriel Niederle, who took a class from Professor Ambady at Harvard, reflects on her passing here.

See some of my other posts on bone marrow donation, and the ongoing political/legislative/legal disputes concerning whether bone marrow donors can be compensated, or whether this should be forbidden as a repugnant transaction. (Long story short: The conventional interpretation that paying bone marrow donors was outlawed by the National Organ Transplant Act was upset by a decision of the 9th Circuit Court of Appeals, but the Department of Health and Human Services is taking steps to change the relevant regulations so that it will continue to be illegal despite the court ruling.)

The law and politics of bone marrow and compensation for donors

The Department of Health and Human Services is proposing new regulations that would put bone marrow more clearly into the class of organs for which payment is forbidden by the National Organ Transplant Act of 1984. This is in response to the decision by the Ninth Circuit to make compensation legal for bone marrow donations made through the harvesting of blood stem cells directly from the blood.

Here's the relevant page from the Federal Register: Federal Register/ Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules

Here are my earlier posts on the courts and compensation for bone marrow donation.

Since I'm not licensed to practice law in North Carolina or anywhere else, I wrote to Kim Krawiec to ask whether HHS could simply overrule the Ninth Circuit with a regulation, or whether Congress would have to get involved.

Here is Kim's reply:
"... new legislation is probably not needed to overturn the 9th circuit ruling -- that is certainly the position of HHS.  Here is the relevant language from NOTA (with emphasis mine): (1) The term “human organ” means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.  

The only question would be whether HHS exceeded its authority in some way through this change. I'm sorry to say that such a claim would be an uphill battle.  One might imagine, for example, a claim that the statute only permits the addition of "organs" and HSCs drawn from peripheral blood are not an organ (as the 9th Circuit concluded).  But courts are extremely deferential to agencies on these questions of interpretation (the term is "Chevron deference", named after a Supreme Court case establishing the standard). Courts are very reluctant to overturn agency interpretations of this sort and defer to the agency interpretation unless it is unreasonable.  Hopefully the interpretation (assuming the proposed reg is enacted) will be challenged, but I think this one will be a tougher fight than the first case."

HT: Bob Slonim

Economic rewards to motivate blood donations, by Lacetera, Macis and Slonim

This just out in Science: Economic rewards to motivate blood donations. It suggests that old conclusions need to be revisited based on new evidence.

"The position and guidelines of the World Health Organization (WHO) and several national blood collection agencies for nearly 40 years have been based on the view that offering economic incentives to blood donors is detrimental to the quantity and safety of the blood supply (1). The guidelines suggest that blood should be obtained from unpaid volunteers only (2). However, whether economic incentives positively or negatively affect blood donations (and other prosocial activities) has remained the subject of debate since the positions were established (2–8).

"Evidence consistent with the WHO position came originally from uncontrolled studies using nonrandom samples and, subsequently, from surveys and laboratory studies indicating that economic incentives can “crowd out” (decrease) intrinsic motivations to donate and can attract “worse” donors (9). This evidence arguably affected policies, such as bans on compensation for blood and organ donations in many countries.
...
"With a few early exceptions based on small, nonrepresentative samples (12), field trial evidence on how economic incentives affect blood donations has been absent. But field-based evidence from large, representative samples has recently emerged. The results are clear and, on important questions, opposite to the uncontrolled studies, surveys, and laboratory evidence preceding them."
...
"Conclusion

"In light of the recent evidence, it is time to re-examine policy guidelines for increasing and smoothing blood supply, including whether incentives can play a role. There are efforts under way from different parts of society toward using rewards to increase donations. The U.S. 9th Circuit Court of Appeals' 2012 ruling legalizing compensation for bone marrow donations through apheresis was initiated by private individuals (32). A company prompted a 2010 European Court of Justice ruling that allowed importation of blood products obtained from compensated donors (33). Researchers and clinicians have noted that some WHO guidelines (e.g., emphasis on exclusive use of nonremunerated donors and centralizing blood collection organizations) are unintentionally adversely affecting blood collection in sub-Saharan Africa (34).

"In addition to economic incentives, policy-makers should consider nonpecuniary rewards (e.g., symbolic and with social recognition) and various appeals. Debates on ethical issues around giving rewards for donations (35) should be encouraged. But there should be little debate that the most relevant empirical evidence shows positive effects of offering economic rewards on donations."

Compensation for bone marrow donors is no longer being contested

After a long fight (see these posts), it appears that bone marrow donors can be compensated (if they donate in the right way:

Final Victory for Cancer Patients In Bone Marrow Donor Case

U.S. Attorney General Won’t Seek Supreme Court Review; Bone Marrow Donors May Now Be Compensated

HT: Bob Slonim

Public attitudes on compensation for donors

Poll: Americans Show Support For Compensation Of Organ Donors

"Federal law bans payments for organs. But given the need, we wondered what Americans thought about compensation for three kinds of donations that can be made while people are alive: kidneys, bone marrow and a portion of liver big enough to help someone whose liver is failing.

"So we asked 3,000 adults across the country as part of the NPR-Thomson Reuters Health Poll, and here's what they told us.
  "If compensation took the form of credits for health care needs, about 60 percent of Americans would support it. Tax credits and tuition reimbursement were viewed favorably by 46 percent and 42 percent, respectively. Cash for organs was seen as OK by 41 percent of respondents.

"Among people who said some form of compensation was acceptable, 72 percent said it should come from health insurers, followed by private charities at 62 percent and the federal government at 44 percent.
"For all forms of compensation, rates of support tended to fall among older respondents.

"There's been longstanding resistance to compensating donors financially in this country. There are concerns about exploitation and also worries that even small amounts of compensation would undercut a system that depends on altruism."

HT: Steve Leider (and see Leider, Stephen and Alvin E. Roth, “Kidneys for sale: Who disapproves, and why?” American Journal of Transplantation, 10 (May), 2010, 1221-1227.)

NY Times debate: Is Prostitution Safer when It's Legal?

The debate Is Prostitution Safer When It’s Legal? mirrors in many ways the debate over whether legalizing compensation for kidney donors (and bone marrow donors, etc.) would be better or worse than the illegal markets that currently exist...

DEBATERS

• 

  Labor Laws, Not Criminal Laws, Are the Solution

  CAROL LEIGH, BAY AREA SEX WORKERS ADVOCACY NETWORK
• 

  Legality Leads to More Trafficking

  RACHEL LLOYD, AUTHOR, "GIRLS LIKE US"
• 

  Criminalize Only the Buying of Sex

  MAX WALTMAN, UNIVERSITY OF STOCKHOLM
• 

  Ignore the Stigma and Focus on the Need

  MARTHA C. NUSSBAUM, UNIVERSITY OF CHICAGO
• 

  Nevada’s Legal Brothels Make Workers Feel Safer

  BARBARA G. BRENTS, UNIVERSITY OF NEVADA, LAS VEGAS
• 

  Legality Brings Protection and Better Care

  CHIKA UNIGWE, AUTHOR, "ON BLACK SISTERS STREET"
• 

  Such Oppression Can Never Be Safe

  NORMA RAMOS, COALITION AGAINST TRAFFICKING IN WOMEN

INTRODUCTION

Jim Wilson/The New York TimesProstitutes wait for customers at a legal brothel in Nevada.

Some say laws against prostitution unfairly victimize women. A Canadian court recently ruled that laws preventing brothels endangered prostitutes by forcing them to work on the streets. And as the recent Secret Service scandal makes clear, in Colombia, prostitution is legal in “tolerance zones.” But in Spain, prostitution is essentially legal, and the nation has become a magnet for sex trafficking. Can legalized prostitution ever be safe and free of exploitation? Or should laws against prostitution remain?

Bone marrow registries

The NY Times reports on an effort to start a bone marrow registry in Nigeria, and to increase donation among African Americans: Finding a Match, and a Mission: Helping Blacks Survive Cancer

"Now he is trying to repay that debt, with an effort that experts say may save the lives of both Nigerians and black Americans. In February, he helped start Nigeria’s national bone-marrow registry, the first in Africa outside South Africa. He is now raising money to start a cord-blood bank there.

Millions of Nigerians have blood cancers like leukemia or lymphoma, and about 4,000 black Americans die annually of them. Less than 20 percent of black Americans now find the perfect donor matches that could save their lives, while more than 70 percent of whites do. Without a registry and cord-blood bank, no Nigerians do.

“This is a slam-dunk, from my point of view,” Mr. Adebiyi said. “The U.S. registries are trying to figure out how to increase the population of minority donors; this is a solution they should be interested in.”

Becoming a donor is relatively simple nowadays; only a cheek swab is needed to test for a match. Donating rarely requires the painful hip punctures that used to be routine. Instead, an intravenous blood line runs through a cell separator after the donor takes drugs to push the stem cells into the bloodstream. The process is no more burdensome than dialysis, experts say.

But for African-Americans like Mr. Adebiyi, finding matches is particularly difficult. Blacks are less likely to register as donors; while blacks are 12.6 percent of the population, only 8 percent of registered donors are black.

“It’s lack of education about it, and mistrust of the medical system after scandals like Tuskegee,” said Shauna Melius, co-founder of Preserve Our Legacy, citing the Tuskegee, Ala., experiment in which government doctors recruited black farmers for research and let those with syphilis go untreated for decades. Her organization recruits donors at Harlem Hospital and through drives featuring black celebrities.

“Plus,” she added, “people are skeptical because you’re collecting DNA.”

Complicating the problem, blacks are more genetically diverse than whites. Anatomically modern Homo sapiens existed in Africa for 200,000 years before migrating north to Europe a little over 40,000 years ago, so all Europeans descend from the shallower end of the gene pool.

Compensation for bone marrow donors, continued

The latest in the controversy over compensation for bone marrow donors is that the government's petition for a rehearing has been denied: Kim Krawiec has the story, with links... Flynn V. Holder Rehearing Denied

Is economic repugnance closely related to biological disgust?

Colleagues often send me articles related to this blog, but the one I have received the most copies of recently is yesterday's NY Times article: Survival’s Ick Factor, about recent studies related to the emotion of disgust, and its possible evolutionary significance in e.g. keeping people away from sources of infection such as feces.

Many people have sent me the article because of my own interest in ickonomics, aka repugnant markets and transactions. A repugnant transaction is one that some people want to engage in, and others think they shouldn't be allowed to. I'm willing to exclude the case of ordinary, pecuniary negative externalities. The issue that initially made all of this very salient to me is the ban, almost everywhere, on buying and selling kidneys (which generated my interest in kidney exchange). But I quickly realized that there are lots of repugnant transactions, and I began a 2007 article on the subject by asking why you can't eat horse meat in California. (It's against the law, passed by popular referendum in 1998.)

Which brings me to the point of this post.

I don’t think the kind of repugnance I study is fundamentally related to biological/evolutionary disgust. The reason there are laws against eating horsemeat, for example, is that it isn’t innately disgusting, so some people want to do it, and others don’t want them to. But there aren’t any laws against eating feces…(sorry, yuck).

Now, I bet that your brain is economical, and that you might recruit some of the same neurons you use to feel disgust to remind you of things you don't like. So I'm not surprised that there are correlates between propensity to feel disgust and some political opinions, for example.

But, to come back to kidney sales, I can't see that the repugnance to selling transplant kidneys for money can be closely related to the disgust that may be inspired by transplantation itself (and the associated blood and guts), since transplantation itself is almost universally regarded as a good thing. That is, the part of the transaction that involves bodily fluids, and might inspire the kind of disgust that would keep you from contamination in other people's innards, isn't regarded as repugnant. Nor is kidney donation, which involves the surgical removal of a kidney. It's only the introduction of money into the transplant transaction that makes it repugnant. (And as we've recently seen with bone marrow, this repugnance to introducing money is alive and well, and crosses party lines.)

And I'm pretty sure there's no evolutionary disgust aroused by money (if only because money was invented pretty late in the evolutionary game...).