Showing posts sorted by relevance for query marrow. Sort by date Show all posts
Showing posts sorted by relevance for query marrow. Sort by date Show all posts

Monday, January 23, 2012

Justice department appeals recent court ruling allowing bone marrow donors to be compensated

I recently posted about the 9th circuit court of appeals' decision to allow some bone marrow donors to be compensated: Paying bone marrow donors is now legal (depending on how it's done)
Here's the court's decision.

But it turns out that transactions mostly don't become illegal without someone finding them repugnant. Just in case you thought bone marrow had been accidentally included in the ban on compensating donors, the latest news (pointed out to me by Joseph Colucci) is that the Justice Department is contesting the recent court decision:  Government fights court decision that says bone marrow donors may be paid .

"the Obama administration last week asked a San Francisco appeals court to overturn a recent decision that said bone marrow donors can be paid for what their bodies produce.
"A unanimous three-judge panel last month ruled for a nonprofit group, MoreMarrowDonors.org, that wants to encourage bone marrow donations by offering $3,000 scholarships, housing allowances or charitable donations to those who are matched with blood disease patients.
...
"When the transplant act was written in 1984, marrow extraction was painful. Needles thick enough to suck out the fatty marrow were inserted into a donor’s anesthetized hip bones, and the cells were taken from the marrow.
Today, a process called apheresis is used about 70 percent of the time. Donors are injected with a medication that accelerates blood stem cell production so there are more cells in the bloodstream. The donor sits for hours in a recliner as a machine collects the “peripheral” blood stem cells and recycles the blood back into the donor.
The donor group said the application of the organ transplant law violated the equal-protection clause, because there is no rational basis for government to treat donors undergoing apheresis differently from blood or sperm donors.
But the three-judge panel said there was no reason to reach the constitutional question. It is up to Congress if it wants to include blood marrow in its list of items that cannot be sold, the court said. But the apheresis method extracts only blood and thus there is no prohibition on paying for it, the court said.
“It may be that ‘bone marrow transplant’ is an anachronism that will soon fade away” as the blood extraction method replaces needle-extraction of bone marrow, Judge Andrew J. Kleinfeld wrote, “much as ‘dial the phone’ is fading away now that telephones do not have dials.”
The Justice Department and the National Marrow Donor Program have moved quickly to try to get the decision overturned.
“The panel’s ruling rests on legal errors of exceptional importance, threatens to disrupt current patient care and undermines Congress’s clear policy of encouraging voluntary bone marrow donations,” the Justice Department said in asking the full U.S. Court of Appeals for the 9th Circuit to rehear the case.
The donor registry, which last year matched 5,000 patients with unrelated donors, said in a statement that the decision could have “unexpected and disastrous consequences” for patients.
The panel’s decision in Flynn v. Holder noted that there are obvious reasons for prohibiting selling organs or even blood marrow cells, which requires a precise genetic match. “Congress might have been concerned that every last cent could be extracted from sick patients needful of transplants, by well-matched potential donors making ‘your money or your life’ offers,” the opinion said.
The donor registry said its experience is that “a donor system that relies on the human desire to help others is far superior to one that focuses on self-gain.”
Mitchell and Institute for Justice lawyer Jeff Rowes got both more and less than they wanted from the 9th Circuit decision. Mitchell said the ruling indicates that his group could directly pay donors rather than offering scholarships or charitable donations.
Rowes, meanwhile, said he had hoped the court would look at the constitutional question and whether the government had a rational basis for including bone marrow in its list of organs. His group is eager for the Supreme Court to weigh in on that test, which he said is “code for the government gets to do whatever it wants.”
Depending on what the 9th Circuit does with the government’s appeal, he still might get the chance."

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Background:

Who better than Kim Krawiec to blog about the legal decision to allow compensation for bone marrow donors under some circumstances (if the marrow is gotten from the blood rather than the bone).

She points to an article by Harvard Law prof I. Glenn Cohen in the New England Journal of Medicine, Selling Bone Marrow — Flynn v. Holder, which says that the ruling is a narrow one, that is unlikely to impact the debate about compensation for other kinds of donation. (That was of course under the assumption that the court's decision will stand...)

Thursday, May 6, 2010

Compensation for bone marrow donors: opposing views

In November I wrote about a lawsuit to overturn the ban on compensation for bone marrow donors: Compensating donors: how about bone marrow? . Commentary in support of the lawsuit suggested that perhaps bone marrow had been unintentionally included in the more general ban on compensation for organ donors.

More recently, some of the organizations connected with bone marrow have come out against compensation: Leading Transplant and Transfusion Organizations Join Forces in Effort to Keep Bone Marrow Donation Voluntary .

"Voicing concern about the potential impact on patient and donor safety, nine leading international health organizations have formed a coalition to oppose compensating people who provide bone marrow for transplantation.

"The organizations — each a leader in the field of transplantation and transfusion therapies — have joined forces in the face of a lawsuit aimed at overturning current U.S. law regarding bone marrow donation. The Institute for Justice is seeking to reverse the National Organ Transplant Act of 1984, as it applies to the prohibition on compensating bone marrow donors. ...

"The coalition includes the NMDP, America’s Blood Centers, AABB (formerly American Association of Blood Banks), the American Society for Blood and Marrow Transplantation, American Society of Histocompatibility and Immunogenetics, the American Society of Transplantation, International Society of Cellular Therapy, The Transplantation Society, and the World Marrow Donor Association.
They oppose changing the current law, citing these reasons:
Protecting Recipient and Donor Safety
A complete and truthful health history is critical to ensure that individuals are eligible to donate and that donated cells are free from infectious diseases. There is a substantial body of experience that people wanting to sell their body parts are more likely to withhold medical details and information that could harm patients.
Maintaining Altruistic Motivations
Studies have shown that compensating donors would deter those who are willing to donate for purely altruistic reasons. The eight million members of the Be The Match Registry® — in addition to the five million volunteer donors on international registries — are proof that people do not need material incentive to save a life. Current law already allows donors to be reimbursed for out-of-pocket expenses and lost wages. The NMDP and other organizations maintain funds expressly for this purpose.
Avoiding the Creation of Markets in Marrow Donation
Compensation has the potential to create markets for marrow, which could have detrimental effects for both donors and patients. Sellers influenced by possible financial gain could ignore the health risks associated with donation or be coerced by third-party organizations that would profit from a marrow sale. In addition, markets put physicians in the morally dubious position of carrying out medical procedures solely so that sellers may profit.
”The creation of markets is likely to elicit criticism from groups that oppose treating the human body and its parts as property,” said Art Caplan, professor of bioethics at the University of Pennsylvania. “To risk potentially undermining support for marrow donation by allowing donor compensation is irresponsible and short-sighted.”
Ensuring Patients’ Access to Treatment
While the Institute for Justice’s lawsuit alleges compensation might increase patients’ access to bone marrow, the opposite is true.
Changing the U.S. law to allow compensation for marrow donors would set a precedent that could hurt the current voluntary systems for organ and blood donation, potentially undermining some patients’ access to safe organ transplants and blood transfusions. If donors were compensated, the United States would no longer conform to international standards for the use of volunteer donors in cell therapies. Thus, patients in the United States may be unable to have access to the worldwide search process. This would restrict Americans’ chances of finding a match and lives may be lost. "

Tuesday, August 8, 2017

Trump Administration Withdraws Proposed Ban on Compensation for Bone Marrow

After the Ninth Circuit ruled that compensation for blood stem cells (sometimes simply referred to as bone marrow) could be compensated in some cases, the department of Health and Human Services moved to reinstate the ban.  (I coauthored one of many of the public comments they received "in opposition to the proposed rule changes by the Health Resources and Services Administration (HRSA) that would ban compensation for bone marrow donations.")

On August 1 the new administration (which hasn't done much else that I approve of)  withdrew the proposed rule change (which I gather should leave the Ninth Circuit decision as the law of the land).

Here's a news story and an editorial (the only reports I've seen so far).

First the story (which seems to incorrectly attribute the administrative agency behind the move to the Office of Management and the Budget instead of to the Department of Health and Human Services (HHS):

Trump Administration Withdraws Proposed Obama Ban on Compensation for Bone Marrow

"The Office of Management and Budget has withdrawn a proposed rule banning compensation for hematopoietic stem cells. In other words, you can get paid when someone harvests stem cells from your bone marrow.
Bone marrow transplantation is used to treat a variety of ailments, including aplastic anemia, sickle cell anemia, bone marrow damage during chemotherapy, and blood cancers such as leukemia, lymphoma, and multiple myeloma. In 1984, Congress passed the National Organ and Transplant Act, which outlawed compensation to the donors of solid organs like kidneys and livers. Oddly, the act also defined renewable bone marrow as a solid organ.



Originally, hematopoietic stem cells were obtained from bone marrow obtained by inserting a needle into donors' hip bones. Researchers later developed a technique in which donors are treated with substance that overstimulates the production of hematopoietic stem cells, which then circulate in their bloodstreams. In a process similar to blood donation, the hematopoietic stem cells are then filtered from the donors' blood. The red blood cells and plasma are returned to the donors.
More Marrow Donors, a California-based nonprofit, wanted to set up a system to encourage hematopoietic stem cell donations with $3,000 awards, in the form of scholarships, housing allowances, or gifts to charity. The Institute for Justice, a libertarian law firm, brought suit on their behalf, and in 2012 a federal appeals court sensibly ruled that the law's ban on compensation for solid organ donations did not apply to stem cells obtained from donors' bloodstreams. The Obama administration reacted by proposing a regulation defining stem cells obtained from blood as the equivalent of a solid organ.
Now the new administration has withdrawn the proposal."
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Here's the editorial, from yesterday's WSJ:
Money for Marrow, Finally

"last week the Department of Health and Human Services withdrew a proposed Obama -era regulation that would have prohibited compensation for bone-marrow donation. About 11,000 ailing Americans are currently searching the national marrow registry, hoping to find a compatible donor. This year at least 3,000 people will die waiting for a transplant."

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Here are my previous posts on bone marrow donation and the compensation controversy.


HT: Philip Held and Frank McCormick

Wednesday, December 4, 2013

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.

Monday, November 4, 2013

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."
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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.)

Wednesday, July 20, 2016

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.  "

Sunday, November 1, 2009

Compensating donors: how about bone marrow?

The National Law Journal reports: Cancer patients seek to overturn ban on paying for bone marrow

"Prohibiting someone from making money for donating an irreplaceable kidney is one thing. But what about donating bone marrow, which replenishes itself within weeks?

That question is at the heart of a new lawsuit, filed Monday, challenging the constitutionality of the federal law that prohibits compensating bone marrow donors. The plaintiffs want to make modest recompense for such donors legal — say, paying partial tuition for a college student or making a mortgage payment for a first-time home buyer.

In the lawsuit filed Oct. 26 in the U.S. District Court for the Central District of California, cancer and blood disease patients and health care advocates are suing U.S. Attorney General Eric Holder Jr. to enjoin enforcement of provisions of the National Organ Transplant Act of 1984 that criminalize compensating donors. They argue the statute violates due process rights and interferes with public health.

"This constitutional challenge is about an arbitrary law that criminalizes a promising effort to save lives," the complaint states. A bone marrow transplant is often the "only hope" for tens of thousands of Americans diagnosed with a deadly blood disease such as leukemia. "There is a desperate shortage of unrelated marrow donors, particularly for minorities," the complaint says.

Offering modest incentives to attract more donors could end that shortage, argued Jeff Rowes of the Arlington, Va.-based Institute for Justice, who is the lead attorney for the plaintiffs. "

Megan McArdle links to the Institute of Justice press release, and suggests that inclusion of bone marrow in the National Organ Transplant Act was simply a mistake.


A paper on bone marrow donation recently appeared in the American Economic Review, you can find an ungated version here: One Chance in a Million: Altruism and the Bone Marrow Registry
by Ted C. Bergstrom, Rod Garratt, and Damien Sheehan-Connor.

The paper argues that (because of the need for bone marrow matches to be perfect on the 6-vector of Human Leukocyte Antigens, and because of different distributions of these by race and ethnicity), we would get more bang for the buck by investing in recruiting more minority donors than additional random donors.

As it happens, for non-minority donors, the present policy in many places is just the opposite of compensating donors; if you want to register as a bone marrow donor you may have to pay the costs, presently around $65.

HT: Mary O'Keeffe and Steve Leider

Update, 11/4/09: Some comment on the legal theory of the case over at the Volokh Conspiracy, with a second and third post here and here and more to come...

Tuesday, November 19, 2013

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

Sunday, July 29, 2018

Compensation for bone marrow/blood stem cells: where are we now?

Here's a paper in the Johns Hopkins series of mostly student papers, Studies in Applied Economics, that brings us up to date on the state of bone marrow compensation in the U.S.

An Examination of the Issue of Bone Marrow Compensation
By Valerie VilariƱo

"Although  compensation  for  bone  marrow  is  no  longer  regulated  by  the federal  government, there are many obstacles it must overcome before it becomes commonplace. Citizens who live in states that ban it may not be able to participate in either end of compensation. This is due to grey areas between the laws of the state governments and the Commerce Clause of the U.S. Constitution. For example, a patient living in a state that bans compensation may not be able to receive bone marrow from a donor who was compensated, even if the donor lives in a state where compensation is allowed, because it breaches the law of the state in which the patient lives. However, this exchange constitutes interstate commerce since the donor and the patient are not in the same state. These types of legal uncertainties often result in cases being heard before the Supreme Court to determine precedents for similar scenarios in the future.36

"Then  there  are  the  practical  difficulties.  At  the  moment,  no  compensatory  bone  marrow registries exist. According to Doug Grant of Hemeos, the main reason for that is that the NMDP opposes  the  compensation  of  bone  marrow.  Both  MoreMarrowDonors.Org  and  Hemeos, despite  having  had  different  business  plans  in  the  way  they  were  planning  on  going  about compensating donors, were forced to close because of procedures indirectly imposed on them by  Be  the  Match.  Grant  told  me  in  an  interview  that  he  closed  Hemeos  in February  2017 because as a startup, the fight against regulation was too much for Hemeos to overcome. By the time that compensation became unquestionably legal, the startup had run out of capital. For compensation to become a reality, there must be registries that are willing to compensate. Because the NMDP so strongly opposes compensation, the experts I talked to agreed that the only option for a compensatory bone marrow registry to exist is for it to be a competitive, parallel registry to that of BE the Match.

"This  presents  other  logistical  difficulties  because  currently  Be  the  Match  is  the  registry  that most,if not all,physicians use when looking for a match for their patient. For a new registry to compete with Be the Match, not only would it, like Hemeos, have to develop its own software to provide transplant centers with, but it would also need to make connections with individual hospitals so that they begin to search the registry. Growing a registry to fully compete with Be the Match’s could take years  given  that  there  is nocentralized  process  by  which  hospitals partner  with  bone  marrow  registries.  Each  hospital  would  have  to  make  an  individual partnership with the compensatory registry. Furthermore, there is currently little incentive for entrepreneurs  to  tackle  this  seemingly  daunting  startup  possibility  since  the  entire  bone marrow market accounts for only $3 million to $4 million a year.
...
"Lastly,  as  previously  mentioned,  47  percent  of  the  matches  made  by  Be  the  Match include either  a  foreign  donor  or  recipient.  Compensation  poses  a  problem  in  those  cases  because many  of  the  cooperative  registries  that  partner  with  Be  the  Match  are  national  registries  of countries where compensation is not legal. By making compensation legal in the United States, some  of  these  partnerships  could  be  strained, potentially leading  to  a  significant  loss  of international matches. All of these are barriers that would need to be somehow overcome in order for compensation not only to be realistic but also for it to accomplish its goal of helping to relieve the scarcity of bone marrow matches."
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HT: Frank McCormick

Thursday, February 17, 2011

Lawsuit against ban on compensating bone marrow donors moves forward

Compensating Bone Marrow Donors Could Save Lives But the Government Bans It



"Arlington, Va.—Every year, nearly 3,000 Americans die because they cannot find a life-saving bone marrow donor match—a trend that disproportionately impacts minorities.  But on Tuesday, Feb. 15, 2011, cancer patients from across the nation who can’t find a donor match will square off in court against the U.S. Attorney General seeking to strike down part of a federal law that bans anyone from offering even modest compensation to bone marrow donors.  If the cancer patients are successful in their suit, compensation could be offered to those who donate bone marrow, thus attracting more donors and saving more lives.

This video (appears above) explains the life-or-death legal battle:
http://www.youtube.com/watch?v=RMcXvMxVFUA"
...
"Under the National Organ Transplant Act (NOTA) of 1984, giving a college student a scholarship or giving a new homeowner a mortgage payment for donating marrow could land everyone—doctors, nurses, donors and patients—in federal prison for up to five years.  NOTA’s criminal ban violates equal protection because it arbitrarily treats renewable bone marrow like nonrenewable solid organs (such as kidneys) instead of like other renewable or inexhaustible cells (such as blood) for which compensated donation is legal.  Unlike organs such as kidneys, donated bone marrow replenishes itself in just a few weeks after it is donated, leaving the donor whole once again."

HT: Greg Mankiw

Thursday, November 18, 2010

More on compensation for marrow donors

Representatives of the major world marrow donation clearinghouses come out against compensation for donors:

Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association by Michael Boo, Suzanna M. van Walraven*, Jeremy Chapman, Brian Lindberg, Alexander H. Schmidt, Bronwen E. Shaw, Galen E. Switzer, Edward Yang and Torstein Egeland, Blood, 2010 Oct 4. [Epub ahead of print]

Abstract: Hematopoietic stem cell transplantation (HSCT) is a curative procedure for life threatening hematological diseases. Donation of hematopoietic stem cells (HSC) from an unrelated donor, frequently residing in another country, may be the only option for 70% of those in need of unrelated HSCT. To maximize the opportunity to find the best available donor, individual donor registries collaborate internationally. To provide homogeneity of practice among registries, the World Marrow Donor Association (WMDA) sets standards against which registries are accredited, and provides guidance and regulations concerning unrelated donor safety and care. A basic tenet of the donor registries is that unrelated HSC donation is an altruistic act; non-payment of donors is entrenched in the WMDA standards and in international practice. In the United States, the prohibition against remuneration of donors has recently been challenged. In this document we describe the reasons that the WMDA continues to believe that HSC donors should not be paid due to ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others."

Previous posts:
Compensating donors: how about bone marrow? (in connection with which see Flynn v. Holder Challenge to the National Organ Transplant Act

Compensation for bone marrow donors: opposing views

HT: Rod Garratt (whose related papers are
One Chance in a Million: Altruism and the Bone Marrow Registry” with Ted Bergstrom and Damien Sheehan-Connor, American Economic Review

and
Stem Cell Matching for Patients of Mixed Race” with Ted Bergstrom and Damien Sheehan-Connor


(About this latter paper he writes "Ted Bergstrom and I will be presenting this work at a session on The Economics of Blood, Stem Cell and Organ Donation at this year's winter meeting of the American Economic Association in Denver.  If you are interested in attending, the session will take place Jan 08, 2011 10:15 am at the Sheraton, Director's Row H.

Thursday, December 1, 2011

Paying bone marrow donors is now legal (depending on how it's done)

Joshua Gans forwards me this, just in on the AP wire from the Washington Post: Court says some bone marrow donors can be paid, overturning law that made compensation a crime

But the ruling makes for some odd distinctions:

"A federal appeals court ruled Thursday that most bone marrow donors can be paid, overturning a decades-old law that made such compensation a crime.

"In its ruling Thursday, the 9th U.S. Circuit Court of Appeals said a technological breakthrough makes donating bone marrow a nearly identical process as donating blood plasma. It’s legal — and common — to pay plasma donors. Therefore, the court ruled, bone marrow donors undergoing the new procedure can be paid as well and are exempt from a law making it a felony to sell human organs for transplants.

"The unanimous three-judge panel of the court did say it remains a felony to compensate donors for undergoing the older donation method, which extracts the marrow from the donors’ bones.

"The ruling overturns a lower court decision barring compensation for all bone marrow donations."
****

See my previous post on that lawsuit here.

Tuesday, March 18, 2014

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. 

Friday, October 27, 2017

Bone marrow and blood stem cell update

Here's an article that recounts the recent events regarding payment to donors of blood stem cells.

Hope for to-marrow: the status of paid peripheral blood stem cell donation under the National Organ Transplant Act 
Kelly Todd
Journal of Law and the Biosciences, Volume 4, Issue 2, 1 August 2017, Pages 412–423

Abstract




The National Organ Transplant Act (NOTA), enacted in 1984, bans the exchange of bone marrow and a number of other human organs for valuable consideration. At the time NOTA was enacted, bone marrow could only be harvested by aspirating bone marrow tissue from a donor's bone cavities. However, recent medical and technological advances now allow doctors to use a much less invasive apheresis method, which collects the transplantable stem cells from a donor's peripheral blood stream. In 2009, the Court of Appeals for the Ninth Circuit held that such donations do not fall into the category of “bone marrow” under NOTA, and can therefore be compensated. Not long after the court's final ruling, the Department of Health and Human Services (HHS) proposed a rule to explicitly bring hematopoietic stem cells back under the purview of NOTA. The transplant community, seeing compensated donation as a solution to the shortage of altruistic bone marrow donors, fiercely opposed the rule. After years of limbo, HHS officially withdrew the proposed rule in August, 2017, which will allow groups to financially incentivize potential peripheral blood stem cell (PBSC) donors. This commentary addresses the moral and ethical issues implicated by paid PBSC donation, the role that regulation could play, and the potential impacts of paid PBSC donation on the transplant community, Ultimately, this article concludes that providing financial incentives to PBSC donors will likely have an overall positive impact on the transplant community by encouraging more donors to join the registry, and motivating donors to follow through with their donations once matched.

Friday, December 17, 2010

Bone marrow donor scam

I've blogged before about bone marrow donation, but recent news stories report what appears to be a financial scam by a bone marrow registry.
Officials rip health chain’s aggressive bone-marrow campaign

"Condemning the practice as a scam involving “suspect marketing and billing practices,’’ New Hampshire Attorney General Michael A. Delany yesterday announced a major probe of shopping-mall bone marrow donor recruitment drives by UMass Memorial and its subsidiary, the Caitlin Raymond International Registry.
James T. Boffetti, New Hampshire senior assistant attorney general, said in a telephone interview yesterday afternoon that his office will investigate potential criminal violations of New Hampshire’s Consumer Protection Act as part of a joint probe with the state’s Insurance Department.
Caitlin Raymond staff and the models from a Boston agency, which charged UMass Memorial between $40,000 and $50,000 a week for about a year and a half, told potential donors that the DNA test required to join the registry did not cost anything, Boffetti said.
However, UMass Memorial billed the potential donors’ insurance companies as much as $4,300 per test, far more than the roughly $100 charged by most labs, according to Boffetti."

Update: here's a more sympathetic story: Surge in marrow testing probed


Tuesday, November 15, 2016

Should Compensation for Bone Marrow Donors be Legal? a panel discussion in Washington

If you're at loose ends in DC today: 
It’s a felony to compensate organ donors, but what counts as an organ is not always so clear. The stem cells contained in bone marrow are also present in the bloodstream, and are routinely extracted to be used in transplants to treat cancers and many blood and immune disorders. Should these cells be treated as an organ like bone marrow, or should the law permit compensation for blood stem cells just as it does for other non-invasive procedures like plasma or whole blood donation?
This a question the Health Resources and Services Administration is currently considering. With a substantial gap in the supply and demand for bone marrow transplants, particularly among racial minorities, how they choose to regulate will affect the lives of thousands of patients each year.
Join the Niskanen Center and the Georgetown Institute for the Study of Markets and Ethics for an expert panel on the legal, ethical and economic issues surrounding compensation for bone marrow, including:
Robert McNamara
Senior Attorney, Institute for Justice
Mario Macis
Associate Professor of Economics, Johns Hopkins Carey Business School
Peter Jaworski
Assistant Teaching Professor, Georgetown University
Doug Grant
CEO, Hemeos
Samuel Hammond
Poverty and Welfare Policy Analyst, Niskanen Center


Where:428a Russell Senate Office Building
Senate Committee on Small Business and Entrepreneurship Hearing Room
When:
November 15 from 3:00-4:30pm

Sunday, November 3, 2013

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


Thursday, September 29, 2016

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...

View EO 12866 MeetingsPrinter-Friendly Version     Download RIN Data in XML

HHS/HRSARIN: 0906-AB02Publication 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 AgendaAgenda 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:
ActionDateFR 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

Sunday, May 13, 2012

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.