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

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.

Valentine's day

What do Valentine's day and National organ donor day have in common?  Well...hearts.  And love. And the same day...

February 14: National Donor Day

Focused on five points of life: organs, tissues, marrow, platelets, and blood. Many nonprofit health organizations sponsor blood and marrow drives and organ/tissue sign-ups across the nation. National Donor Day was started in 1998 by the Saturn Corporation and its United Auto Workers partner with the support of the U.S. Department of Health and Human Services and many nonprofit health organizations.

February 14 is National Donor Day

Each year, February 14th is significant for more than just Valentine's Day.  Today is designated as National Donor Day focusing on the "five points of life"  organ, tissue, marrow, platelets, and blood donation.  Donation drives are held throughout February nationwide.  Be a hero!  Be a donor!  And THANK YOU!

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Valentine's day celebration is also repugnant in some places:
Pakistan bans Valentine's Day for being unIslamic
Ban on the traditional Christian celebration of love follows a similar move by Saudi Arabia
"Pakistan has become the latest country to ban Valentine's Day.

It has prohibited all public celebrations and any media coverage because the celebration is not part of Muslim traditions."

And (I'm sorry to say) this: Mob Kills Eloped Lovers After Storming Afghan Police Station

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.

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."

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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."

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.

Today is (also) National Donor Day

Happy Valentine's Day! Isn't it good to love and be loved?

Food for thought: Today is also National Donor Day.

"February 14 is the 10th National Donor Day -- a day to give the gift of life.
Fill out an organ and tissue donation card, register with your State Donor Registry and make sure your family knows you want to be a donor.
Join the National Registry of potential volunteer marrow and blood stem cell donors.
Learn how you can donate your baby's umbilical cord blood stem cells at birth.
Donate blood.
Why be a Donor?
The need is great and growing.
Almost 95,000 people are in need of an organ for transplant.
Approximately 35,000 children and adults in our country have life-threatening blood diseases that could be treated by a marrow/blood stem cell or cord blood transplant.
Every two seconds someone in America needs blood, more than 39,000 units each day, according to the American Red Cross.
Why do it Today?
Valentine's Day is the day of love and donation is the gift of life. Can you think of a more loving gesture than making February 14 the day you join thousands of Americans in making the donation decision?

National Donor Day was started in 1998 by the Saturn Corporation and its United Auto Workers partners with the support of the U.S. Department of Health and Human Services and many nonprofit health organizations. "

Matchmaker Exchange: Matching genes and symptoms for patients with very rare diseases ("lonesome exomes")

There's a lot of genetic matchmaking going on in the world. In kidney transplantation we worry about HLA matching, which is even more important in bone marrow matching. Both of those matching processes mostly involve common gene sequences--if you have very rare HLA's, you will have less luck at finding a bone marrow match.

But as more patients with very rare disease have their exome sequenced, there are patients with particular phenotypes and symptoms and "lonesome exomes," which have a suspect gene that may be responsible for their disease, which will remain only a suspect until more patients with that disease and that gene variant can be identified. These data are mostly in separate databases at different clinical research institutions.

That's where Matchmaker exchange comes in--it's a protocol for looking for patients with the same gene variants and the same diseases, so that matches can be made and the genes responsible for rare diseases can be identified.

Here's the paper:
Philippakis AA, Azzariti DR, Beltran S, Brookes AJ, Brownstein CA, Brudno M, Brunner HG, Buske OJ, Carey K, Doll C, Dumitriu S, Dyke SOM, den Dunnen JT, Firth HV, Gibbs RA, Girdea M, Gonzalez M, Haendel MA, Hamosh A, Holm IA, Huang L, Hurles ME, Hutton B, Krier JB, Misyura A, Mungall CJ, Paschall J, Paten B, Robinson PN, Schiettecatte F, Sobreira NL, Swaminathan GJ, Taschner PE, Terry SF, Washington NL, Züchner S, Boycott KM, Rehm HL. 2015. The Matchmaker Exchange: A Platform for Rare Disease Gene Discovery. Human Mutation, 36: 915–921. doi:10.1002/humu.22858 

ABSTRACT: There are few better examples of the need for data sharing than in the rare disease community, where patients, physicians, and researchers must search for “the needle in a haystack” to uncover rare, novel causes of disease within the genome. Impeding the pace of discovery has been the existence of many small siloed datasets within individual research or clinical laboratory databases and/or disease-specific organizations, hoping for serendipitous occasions when two distant investigators happen to learn they have a rare phenotype in common and can “match” these cases to build evidence for causality. However, serendipity has never proven to be a reliable or scalable approach in science. As such, the Matchmaker Exchange (MME) was launched to provide a robust and systematic approach to rare disease gene discovery through the creation of a federated network connecting databases of genotypes and rare phenotypes using a common application programming interface (API). The core building blocks of the MME have been defined and assembled. Three MME services have now been connected through the API and are available for community use. Additional databases that support internal matching are anticipated to join the MME network as it continues to grow.

Here's a video presentation by Dr Kym Boycott, one of the authors.

Two papers on repugnance and payments for body parts

Here's an NBER paper by Nicola Lacetera, which includes this in the acknowledgments: "I dedicate this paper to the memory of my friend Julia Fletcher, whose life could have been longer if a bone marrow match were found for her."

Incentives and Ethics in the Economics of Body Parts

Nicola Lacetera

NBER Working Paper No. 22673
Issued in September 2016
NBER Program(s):   HE      PE 

Research shows that properly devised economic incentives increase the supply of blood without hampering its safety; similar effects may be expected also for other body parts such as bone marrow and organs. These positive effects alone, however, do not necessarily justify the introduction of payments for supplying body parts; these activities concern contested commodities or repugnant transactions, i.e. societies may want to prevent certain ways to regulate a transaction even if they increased supply, because of ethical concerns. When transactions concern contested commodities, therefore, societies often face trade-offs between the efficiency-enhancing effects of trades mediated by a monetary price, and the moral opposition to the provision of these payments. In this essay, I first describe and discuss the current debate on the role of moral repugnance in controversial markets, with a focus on markets for organs, tissues, blood and plasma. I then report on recent studies focused on understanding the trade-offs that individuals face when forming their opinions about how a society should organize certain transactions.

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And here's another, by Julio J. Elias, Nicola Lacetera, and Mario Macis

Efficiency-Morality Trade-Offs in Repugnant Transactions: A Choice Experiment

Julio J. Elias, Nicola Lacetera, Mario Macis

NBER Working Paper No. 22632
Issued in September 2016
NBER Program(s):   HE   LE   PE 

Societies prohibit many transactions considered morally repugnant, although potentially efficiency-enhancing. We conducted an online choice experiment to characterize preferences for the morality and efficiency of payments to kidney donors. Preferences were heterogeneous, ranging from deontological to strongly consequentialist; the median respondent would support payments by a public agency if they increased the annual kidney supply by six percentage points, and private transactions for a thirty percentage-point increase. Fairness concerns drive this difference. Our findings suggest that cost-benefit considerations affect the acceptance of morally controversial transactions, and imply that trial studies of the effects of payments would inform the public debate.

Kidney paired donation conference: financing kidney exchange

A conference in Philadelphia today will take a look at a so far unresolved aspect of kidney exchange: how to finance it. Since transplantation is far cheaper than dialysis, this shouldn't in principle be a big problem, but there are still lots of kinks to iron out in determining who pays for what. I spoke to a similarly constituted group in Minneapolis in 2007...
Kidney Paired Donation Conference, Philadelphia, Pennsylvania, WEDNESDAY, OCTOBER 27, 2010

8:00 a.m. Welcome and Opening Remarks, Chris Pricco, Chief Operating Officer, Complex Medical
Conditions, OptumHealth Care Solutions

8:05 a.m. Introduction and Conference Overview, Dennis Irwin, MD, National Medical Director, Transplant Solutions, Complex Medical Conditions, OptumHealth Care Solutions

8:15 a.m. Kidney Transplantation: Alternative Donors, Lloyd E. Ratner, MD, New York-Presb - Columbia
Campus

8:35 a.m. The Unmet Need for Kidney Transplantation as Viewed by the National Kidney Foundation,
Bryan Becker, MD, University of Illinois-Chicago

8:55 a.m. The OptumHealth/UnitedHealthcare Experience with End Stage Renal Disease, Kidney
Transplantation and the Unmet Need, F. Gregory Grillo MD, National Medical Director, Kidney
Resource Services, OptumHealth Care Solutions

9:15 a.m. The United Network for Organ Sharing (UNOS) Pilot, Kenneth Andreoni, The Ohio State
University Hospitals

Representation and Overview from UNOS Coordinating Centers

9:45 a.m. Ruthanne L Hanto RN MPH, New England Program for Kidney Exchange

10:00 a.m. Dorry Segev, MD, PhD, Johns Hopkins Hospital

10:15 a.m. Michael Rees, MD, PhD, Alliance for Paired Donation

10:30 a.m. Jeffrey L. Veale MD, Ronald Reagan UCLA Medical Center

Successful Single Center Experience with Paired Kidney Donation

10:45 a.m. John Friedewald, MD, Northwestern University Hospital

11:00 a.m. Adam Bingaman, MD, PhD, Texas Transplant Institute

11:30 a.m. National Kidney Registry, Garet Hil, National Kidney Registry (Invited)

11:45 a.m. Kidney Paired Donation from the Donor’s Perspective, John Milner, MD, Loyola University
Medical Center

12:00 p.m. The OPO perspective, Speaker TBD

12:15 p.m. Summary of the recent Living Kidney Donor Follow-Up: State of the Art and Future Directions
conference, Alan Leichtman, MD, University of Michigan

12:30 p.m. National Marrow Donor Program (NMDP): 23 Years of Experience in Establishing and
 Managing a Successful Program for Matching Willing Donors to Recipients, Jeffrey W. Chell,
MD, Chief Executive Officer, National Marrow Donor Program

1:30 p.m. Facilitated Discussion, Clifford Goodman, PhD, Vice President, The Lewin Group

4:00 p.m. Closing Remarks

Note: OptumHealth reserves the right to make any necessary changes to this program. Efforts will be made to keep presentations as scheduled. However, unforeseen circumstances may result in the substitution of faculty or content. Last Updated: 10/05/10

Organ donation legislation in California

Judd Kessler (who you could hire this year) writes about changes in CA law regarding organ donation, including live donation:

On Tuesday, October 5, California Governor Arnold Schwarzenegger ceremonially signed new organ donor legislation. There are two new bills that make a variety of changes to policy for both live and deceased organ donation in California. Here is a summary.


SB 1395 makes two changes. First, it authorizes the creation of an:
"Altruistic Living Donor Registry" where individuals can state their willingness to be a live kidney donor. (The bill allows for the possibility of extending the registry to other organs and tissues in the future.) The living donor registry would make information about potential donors available to facilitate pairwise exchanges and donor chains. According to the bill: "(a) ... The donor registry shall be designed to promote and assist live kidney donations, including donor chains, paired exchanges, and nondirected donations. The registrar shall be responsible for developing methods to increase the number of donors who enroll in the registry. (b) The registrar shall make available to the federally designated organ procurement organizations (OPOs) and transplant centers in California information contained in the registry regarding potential altruistic living donors. This information shall be used to expedite a match between identified organ donors and potential recipients."

Second, SB 1395 changes how the department of motor vehicles asks people whether they would like to register to be an organ and tissue donor upon death (i.e. a deceased donor). Currently the DMV allows potential donors to opt in. The application for a new or renewal driver's license or ID card has space to indicate a willingness to join the registry. Starting July 1, 2011, the donor registration question will require an "active" or "mandated" choice. According to the bill, the application will now: "contain a space for the applicant to enroll in the Donate Life California Organ and Tissue Donor Registry. The application shall include check boxes for an applicant to mark either (A) Yes, add my name to the donor registry or (B) I do not wish to register at this time." In addition, the DMV: "shall inquire verbally of an applicant applying in person ... at a department office as to whether the applicant wishes to enroll in the Donate Life California Organ and Tissue Donor Registry."

In Governor Schwarzenegger's speech at the bill signing he called this change to mandated choice "the next best thing" to an opt out system, where individuals would be deceased organ donors by default. He said an opt out system had been suggested to him by Steve Jobs, who recently received a liver transplant and was also in attendance at the bill signing, but that an opt-out system was not plausible due to constitutional concerns. In the Governor's words: "And we have to give [Steve Jobs] a lot of credit, because he came back, apparently from Europe or from somewhere where he called me and he said that, you know, in Europe, in Spain, they have no waiting list because you can only opt out; that if you don’t opt out then you are automatically on a donor list. So we tried to copy the same thing and we talked about that seven months ago. But our Constitution in the United States is different than the Spanish Constitution, so we could not legally do that. So we did the next best thing."

Another bill generated protections for employees who want to be living organ donors or bone marrow donors. SB 1304 requires private employers to provide paid leave for their employees who are organ donors (up to 30 days) or bone marrow donors (up to 5 days) and prevents private employers from blocking such donations by its employees or punishing them for donating. State employees already had this paid leave.

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

Alabama adopts a paid leave program for organ donations

Here's the story:
Alabama adopts a paid leave program for organ donations

"Under a new state provision, a permanent employee with at least one year of state service may be granted living donor leave, with pay, for donating an organ or bone marrow.
...
"Based on physician orders, the employer may receive up to 30 days to donate an organ and up to seven days to donate bone marrow. The employee does not have to exhaust his or her leave accruals for the procedures."

Organ transplantation in Iran

Robert Gutman draws my attention to this article from the English language Iranian Financial Tribune:  Sunday, April 23, 2017 Strides in Organ Transplant

I'm not sure where the claim in the first sentence of 50,000 organ transplant "surgeries" comes from, but the rest of the article (which seems to talk about a total closer to 5,000 transplants) is an interesting view of the situation in Iran.


"Over 50,000 organ transplant surgeries were conducted during the last fiscal year that ended on March 20.

Around 2,500 kidney, 802 liver, 119 heart, 30 pancreas and several intestine and lung as well as 1,040 bone marrow transplants were performed in Iran during the period, said Seyyed Mohammad Kazemeini, head of the Organ Transplant Management Office at the Health Ministry.

“This impressive number of transplant surgeries has helped save many lives as well as more than $1.8 billion in foreign exchange, as patients would otherwise have paid huge amounts for the medical help abroad. Some were even treated free,” the official was quoted as saying by ISNA.

However, he regretted that insurance companies still refuse to cover expenses of organ transplants despite a government directive last year.

“Insurance companies are not complying and the Health Ministry has to draw on its own resources to provide free services for some patients,” he said and hoped the ministry’s support would continue.

“During this year’s New Year holidays (March 21- April 2), 93 transplants were performed,” which shows the preparedness of the medical fraternity.

Iranian organ transplant teams are capable of providing assistance and training to neighboring countries, he said.

Last year a team of experts from Mashhad, capital of the northeastern Khorasan Razavi Province, carried out 47 renal transplants in Afghanistan, and medical teams from Shiraz, capital of the southwest Fars Province, conducted 20 operations in Pakistan and Tajikistan.

Shiraz University of Medical Sciences is known for its accomplishments in liver transplants and the hospitals under its coverage are among the top medical centers in the world with regard to the number of surgeries performed. On average, 500 liver transplants and 300 kidney surgeries are annually undertaken in Shiraz, which also has the distinction of performing the first kidney transplant in Iran in 1968 at the prestigious Namazi Hospital.

A specialized hospital is now planned to be established in Shiraz for organ transplants.

Iran ranks third worldwide in organ donation and is the only country in the world that has addressed the shortage of transplant organs through a legal payment system since 1988 when living non-related donation (LNRD) was legalized,  making it the only country where organ sale is legal.

There are currently 46 organ transplant centers in the country and 25 facilities for organ donation.

  Increase in Brain-Dead Organ Donation

According to Kazemeini, people’s tendency to donate organs of brain-dead patients in their families has increased significantly.

“Last year, 57% of transplant kidneys were donated by brain-dead patients,” he said.

In the past organ donation or sale by living people was predominant. The acceptance of organs of brain-dead patients has improved remarkably due to legal and religious decrees and widespread awareness campaigns on the issue.

Organ transplant is a medical procedure in which an organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ.

Today, over 1.4 million people have voluntary organ donation cards in the country. On average, 700 organ donations (nine per million people) are made annually according to official statistics.

Organs that have been successfully transplanted include heart, kidney, liver, lung, pancreas, intestine, and thymus. Worldwide, kidneys are the most commonly transplanted organs, followed by liver and heart. Organ donors may be living, brain dead, or dead via circulatory death.

In the fiscal year that ended in March 2016, from among the 8,000 people confirmed as brain dead at Iranian hospitals, 1,400 kidneys (and 2,300 organs) were donated.

Kidney transplants account for nearly 75% of all organ replacement surgeries while liver and heart transplants comprise 22% and 3% of the total number. More than half of all transplanted kidneys (56%) were from brain-dead donors and 44% were from living people.

Kazemeini had earlier pointed to Iran’s top position in the field of kidney transplant in the Middle East. On average, 3,000 kidney transplants are conducted every year and Iranian surgeons have transplanted over 35,000 kidneys so far."

Ethicists on compensation for blood stem cells (aka bone marrow aka hematopoietic cells) donors

The site http://donationethics.com/ hosts a letter signed by many ethicists opposing an amendment to the National Organ Transplant Act to reverse the court decision outlawing payment to blood stem cell donors. (Got that? the letter is pro compensation.)

The site is full of interesting related links.

Here's the site's front page:

This site houses an open letter to Shelley Grant of the Department of Health and Human Services regarding a proposed amendment to the National Organ Transplant Act that would effectively outlaw offering compensation for hematopoietic cells donation. The signatories are professional ethicists who believe that the proposed amendment is unethical and should be rejected.

The details of the proposed amendment can be found here.

The case that prompted the amendment, Flynn v. Holder, is explained here.

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Peter M. Jaworski conceived of the letter and is its primary author.

David Faraci was a major contributor to the letter and maintains the website.
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Here's a link to Hemeos, a startup service for matching stem cell donors to patients, which plans to compensate donors.

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

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  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?