Showing posts with label blood. Show all posts
Showing posts with label blood. Show all posts

Tuesday, February 11, 2020

An experiment with a blood donor registry in Australia

Forthcoming in Management Science:
Redesigning the Market for Volunteers: A Donor Registry
Stephanie A. Heger, Robert Slonim, Ellen Garbarino, Carmen Wang, Daniel Walle

Abstract. This paper addresses volunteer labor markets where the lack of price signals, nonpecuniary motivations to supply labor, and limited fungibility of supply lead to market failure. To address the causes of the market failure, we conduct a field experiment with volunteer whole blood donors where we introduce a market-clearing mechanism (henceforth: the Registry). Our intention-to-treat estimates suggest that subjects invited to the Registry, regardless of joining, are 66% more responsive to critical shortage appeals than control subjects. While the Registry increases supply during a critical shortage episode, it does not increase supply when there is no shortage; thus, the Registry significantly improves coordination between volunteer donors and collection centers, thereby improving market outcomes. We find evidence that the Registry’s effectiveness stems from crowding-in volunteers with purely altruistic motives and volunteers with a preference for commitment.

"In partnership with the Australian Red Cross Blood Service, we introduced a Registry throughout Australia using a large-scale field experiment that unfolded over two rounds. We drew the sample for our experiment from the population of long-lapsed donors. Long-lapsed donors are donors who have given at least one successful whole blood donation but have not donated in at least the past 24 months"
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Update: Management Science, Volume 66, Issue 8, August 2020
 

Saturday, August 17, 2019

Poll: majority of Canadians approve of paying plasma donors

New survey results from Peter Jaworski
Canadians think that pay-for-plasma is “morally appropriate.”

"A significant majority of Canadians (63%) believed that paying Canadians for plasma donations was “morally appropriate.”

By age, 18-34 year-olds were most likely to think that pay-for-plasma was “morally appropriate,” with 75% saying so. 70% of 35-54 year-olds, and 49% of those 55 or older thought pay-for-plasma was morally appropriate.

By region, 64% of Atlantic Canada, 69% in Quebec, 61% in Ontario, 70% in the Prairies, 65% in Alberta, and 56% in British Columbia held that opinion.

The provinces of Ontario (2014), Alberta (2017), and British Columbia (2018) have all recently banned pay-for-plasma citing moral objections as part of the motivation behind the prohibitions"

Friday, July 12, 2019

Peter Jaworski on paid and unpaid plasma donation in Canada

Peter Jaworski in the Globe and Mail:
There’s a way to avoid blood plasma shortages: pay donors

and on the radio in Calgary (it isn't Peter in the picture:)


Some quotes from the Globe and Mail article:
" Canada collects only about 17 per cent of the plasma necessary to meet domestic demand for immune globulin. Paid donors in the United States are how we meet (and exceed) our country’s demand."

"Only countries that pay donors are self-sufficient in plasma. The rest have to import it from countries that pay. Paid donors in the United States are responsible for more than 60 per cent of the entire world’s plasma used to make plasma medicine."

"In terms of safety, a Health Canada Expert Panel report from May of last year noted that paid plasma is not less safe than unpaid plasma and it is less expensive than trying to recruit and retain unpaid donors. Paying donors is also the most likely way of ensuring security of supply. Paid donations having a negative effect on unpaid blood donations is also unlikely. The United States has more than 800 paid plasma centres, and still has higher blood donation rates than Canada."

"Claims that paid plasma exploits the poor are also mistaken. Pay is about $30 an hour in Canada (it takes 1.5 hours to donate plasma), and represents about 30 per cent of the total revenue from a litre of plasma (a much larger share than profits, which are less than 3 per cent of revenue). That’s a fair deal."

"Opponents also like to point out that plasma collected in the paid plasma centres in Canada is exported, with none of it staying in Canada. That’s true, but it’s true because Canadian Blood Services choose not to buy Canadian plasma in spite of its lower price and domestic origins."

Thursday, July 11, 2019

Plasma shortage alert from the IDF--the Immune Deficiency Foundation

Patients with primary immunodeficiencies don't produce antibodies, and depend on immunoglobulin, one of the primary plasma products produced by donated plasma (the other is albumin, and there are other life-saving and life-improving pharmaceuticals as well).  The IDF is a foundation dedicated to this complex of diseases:

Immune Deficiency Foundation
Dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiencies

In recent years immunoglobulin has been used around the world to treat other immune deficiency diseases also, as well as to modulate the immune systems of people with auto-immune diseases.

But shortages occur, because the U.S. remains the primary supplier of donated plasma (since it is legal to compensate plasma donors in the U.S., but not everywhere...)

Here's a blog post from John Boyle, the IDF president

Immunoglobulin Product Availability Issues: The Sky Is Not Falling but the World Needs More Plasma
"IDF is working with those who are seeking to increase yields of Ig from plasma, introduce new fractionation technologies, grow plasma donations at collection centers, and more, but those are long term solutions.

"Ultimately, the issue is that the world needs more plasma, and the only good way to make that happen is to collect more plasma. The one thing that we can all do right now is to encourage people to become regular plasma donors if there’s a collection center anywhere near them."
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"Biologic" medicines are regulated by the Food and Drug Administration's
Center for Biologics Evaluation and Research (CBER)

"CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products."

Here is their list of CBER-Regulated Products: Current Shortages
"GAMMAGARD LIQUID® Immune Globulin Infusion (Human) is currently available, though patient shipping schedules may be impacted as continued high demand exceeds production plans and available inventory."
which they attribute to: "Demand increase in the drug or biological product."

Friday, September 7, 2018

Societal Support for Paying Plasma Donors in Canada By Nicola Lacetera and Mario Macis


Here's a concise summary of recent work by Lacetera and Macis, as a Cato Institute Research Brief:

Societal Support for Paying Plasma Donors in Canada
By Nicola Lacetera and Mario Macis

They begin with a concise statement of why repugnance is important for economics:

"The legal status and regulation of economic transactions do not depend only on considerations regarding their economic efficiency, but also on whether a society supports the occurrence of trades through a price mechanism (if at all). Concerns that individuals engaging in certain transactions may be exploited or unduly influenced, that the terms of trade may not be fair, or that some transactions violate human dignity, the sanctity of life, or traditional institutions may lead a society to prohibit certain trades. These principles may take priority over material considerations and may contribute to defining common identities or a collective conscience that allows complex societies to be tied together. "

The article is "based on and includes excerpts from Nicola Lacetera and Mario Macis, “Moral NIMBY-ism? Understanding Societal Support for Monetary Compensation to Plasma Donors in Canada,” Law and Contemporary Problems 81 (2018): 83–105, https://scholarship.law.duke.edu/lcp/vol81/iss3/5.

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."
********

HT: Frank McCormick

Tuesday, July 17, 2018

Compensation for plasma donors--calls for a ban in Canada

At the same time as there are calls for decriminalizing drug use in Canada (see yesterday's post), there are calls for bans on compensating plasma donors. (Repugnance is a big topic..)

This post collects some thoughts on compensation for plasma donors, following my participation in the recent Plasma Protein Forum.

Much discussed there is the rash of recent legislation and proposed legislation in Canada to ban compensation for donors (a sort of repugnance event...).

E.g.
B.C. joins 3 other provinces in banning payment for blood and plasma
Alberta, Ontario and Quebec already have laws prohibiting profit from blood donations

Senator introducing bill to ban payments for blood donation
"“The point of this bill is better safe than sorry,” Wallin said.

“Canadian blood donors are not meant to be a revenue stream.”


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One perplexing feature of this debate is that Canada already buys lots of plasma from the U.S., where it is supplied by paid donors. No one seems to be suggesting that should be changed.


(Here are my posts to date on plasma in Canada.)
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In related notes, China seems to be ramping up it's "source" plasma collection (obtained at the source via plasmapheresis, as distinct from "recovered" plasma obtained from whole blood donations), with collection of about 7 million liters in 2017.  My understanding is that Chinese law forbids the importation of blood products except for albumin.

See this Lancet editorial from 2017:
"China,  a  country  that  holds  the  questionable  honour  of  being a world leader in liver disease, is now also the highest consumer  of  serum  albumin,  using  300  tonnes  annually,  roughly  half  of  the  worldwide  total  use,  according  to  an  article  in  the  Financial  Times. 
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In Brazil, compensation of plasma donors is forbidden (along with compensation of organ donors) in the Constitution, article 199
"(4) The law establishes the conditions and requirements to allow the removal of human organs, tissues, and substances intended for transplantation, research, and treatment, as well as the collection, processing, and transfusion of blood and its by products, all kinds of sale being forbidden."



Monday, June 11, 2018

The market for blood plasma: different tissues, same issues

I'll be speaking at The Plasma Protein Forum, June 12-13 in Washington D.C., on "REPUGNANT TRANSACTIONS AND FORBIDDEN MARKETS: DIFFERENT TISSUES, SAME ISSUES"

Here's the whole program:

DAY ONE:    JUNE 12, 2018

7:00 am–5:30 pmRegistration and Exhibit Hall Open
7:00–8:30 amBreakfast—Available in Exhibit Halls 1 & 2
8:30–8:45 amWELCOME & “How Is Your Day?Jan M. Bult, President & CEO, PPTA
8:45–9:00 amCHAIRMAN'S MESSAGE
David Bell, Chair, PPTA Global Board of Directors; Executive Vice President & General Counsel, Grifols
9:00–10:30 am  PERSPECTIVES: ACCESS TO CARE
Moderator:  Larisa Cervenakova, M.D., Ph.D., Medical Director, PPTA
Speakers: 
  • Tony Castaldo, President, US Hereditary Angioedema AssociationHAE perspective
  • Joanna Chorostowska-Wynimko M.D., Ph.D., D.Sc., Professor, Scientific Director National Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
    Alpha-1 perspective

  • Professor Paolo Caraceni, Associate Professor, Department of Medical and Surgical Sciences, University of Bologna, Bologna, ItalyANSWER: Long term albumin administration improves survival in patients with decompensated cirrhosis
10:3011:00 amBREAK
11:00 am–12:30 pm  CURRENT INDUSTRY AND REGULATORY INITIATIVES IN THE AREAS OF INSPECTIONS AND DONOR HEALTH
Moderator:  John Delacourt, Vice President Legal Affairs & Global Operations, PPTA
Speakers:
  • Ginette Y. Michaud, M.D., Director, Office of Biological Products Operations, U.S. Food & Drug AdministrationFDA’s Office of Biological Products Operations – Form Follows Function
  • Toby L. Simon, M.D., Senior Medical Director, Plasma & Plasma Safety, CSL PlasmaDonor health perspectives: Insights from industry plasma vigilance data and future safety initiatives
  • George B. Schreiber, Sc.D., DirectorEpidemiology, PPTA
    Iron depletion in Source plasma donors; A non sequitur.
12:30–2:00 pm
LUNCHBuffet Available in Exhibit Halls 1 & 2    Sponsored by:  DIAMOND Roche Logo 01
2:00–4:00 pm  INTERNATIONAL ACCESS TO CARE LANDSCAPE
Moderator:  Jan M. Bult, President & CEO, PPTA
Speakers:
  • P. Martin van Hagen, M.D., Ph.D., Professor, Head, Clinical Immunology Unit Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
    Is personalized medicine a national or cross border issue?
  • Dr. Ranjeet S. Ajmani, CEO, PlasmaGen BioSciences Pvt Ltd.
    Initiatives to improve access to care in India
  • Antonio Condino-Neto, M.D., Ph.D., President, Latin American Society for Immunodeficiencies (LASID)What needs to be done to improve access to Immunoglobulin therapy in Brazil? Diagnosis, Access, Supply
4:00 pm BREAK – Ice cream social
4:30 pmOtto Schwarz Award presentation
5:00 pmREPUGNANT TRANSACTIONS AND FORBIDDEN MARKETS: DIFFERENT TISSUES, SAME ISSUES
  • Alvin E. Roth, Craig and Susan McCaw Professor of Economics, Stanford University; George Gund Professor of Economics and Business Administration, Emeritus, Harvard University; and 2012 recipient of the Nobel Memorial Prize in Economic Sciences
5:45 pmDAY 1 CLOSING ANNOUNCEMENTS
5:45–7:30 pmReception        PPTA How is your day logo v2

DAY TWO:    JUNE 13, 2018

7:30 am–1:00 pmRegistration and Exhibit Hall open
7:30–8:30 amBreakfast—Available in Exhibit Halls 1 & 2
8:30–8:35 amWELCOME
Joshua Penrod, J.D., Ph.D., Vice President, Source & International Affairs, PPTA

8:35–8:50 amSOURCE DIVISION OUTLOOK
Roger Brinser, ‎Chair, PPTA Source Board of Directors; Director, Regulatory, BioLife Plasma Services/Shire

8:50–11:00 am CURRENT CHALLENGES 
Moderator: Joshua Penrod, J.D., Ph.D., Vice President, Source & International Affairs, PPTA
Speakers:
  • Nicola Lacetera, Ph.D., Associate Professor at the University of Toronto
    Crowding Out
  • Prof Dr. Liu ZhongVice President, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS)Which is safer source plasma for manufacturing in China: apheresis plasma or recovered plasma?
  • Chen BinDeputy Director, Medical Safety and Transfusion Division, Department of Medical Regulatory and Management, National Health CommissionThe current situation and challenge of the Chinese plasma management

11:00–11:30 amBREAK
11:30 am–1:00 pm CAN COUNTRIES DELIVER ON THEIR OWN?
Moderator:  Julia Fabens, Senior Manager International Affairs, PPTA

Speakers:
  • Bill Bees, Vice President, Plasma Technologies, Prometic Plasma ResourcesCanada–Debunking the Krever Commission Report
  • Peter Jaworski, Ph.D., Professor, Georgetown University, Washington, D.C.
    Ethics of Compensation
  • Joshua Penrod, J.D., Ph.D., Vice President, Source & International Affairs, PPTAGlobal sufficiency: Obstacles and opportunities

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Here are my blog posts on plasma, sorted by date (most recent first), going back to one from 2009.

Saturday, June 2, 2018

The Economist on blood plasma

The Economist comments on Canada's repugnance towards paying Canadians to donate blood plasma (when you can buy as much as you need from U.S. donors..see previous posts.)

Vital fluids
America’s booming blood-plasma industry
Paid-for plasma is both less exploitative than often recognised, and invaluable

"The World Health Organisation lists immunoglobulins and coagulation factors—both plasma-derived products—as essential medicines. Yet poor countries are often desperate for them and rich countries rely on American imports. Without financial incentives, supplies are hard to come by. “It’s not in people’s nature”, says Mr From, “to let a phlebotomist poke a needle in your arm and suck your blood out.”
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Vein attempts
Bans on paying for human blood distort a vital global market
The market in life-saving blood-plasma products depends on Americans who are paid for it

"The global demand for plasma is growing, and cannot be met through altruistic donations alone. Global plasma exports were worth $126bn in 2016—more than exports of aeroplanes. But paid plasma raises ethical, social and medical concerns: that it will lead to health catastrophes, as in the 1980s when tainted blood spread HIV and hepatitis; that it exploits the poor; and that it reduces the supply of “whole” blood, which is almost all donated voluntarily.

"None of these worries is well-founded. But Canadian reservations about paid plasma are shared across most of the world. America, China, parts of Canada and some European countries are among the few places that permit it. Those countries are extremely effective in securing supplies: three-quarters are collected in America alone, and another 10% in China, Germany, Hungary and Austria, where payment is also allowed. Of over 1,000 plasma-collection centres worldwide, 700 are in America. Jan Bult, head of a trade association representing companies that manufacture more than half of the world’s plasma products, says none collects plasma in countries that have banned compensation.

"Only countries that pay for plasma are self-sufficient in it. (Italy, where donors are given time off work, is close to self-sufficiency.) Half of America’s plasma is shipped to Europe—20m contributions-worth. Canada imports 80% of its plasma products from America. Australia imports 40% of its plasma products, too.

"Drug firms from countries that have banned pay-for-plasma do much of their collection in America. Three of the largest collection companies are European: Grifols of Spain, Shire of Ireland and Octapharma of Switzerland. The parent company of another big collector, CSL Behring, is Australian. Together these four firms run nearly eight out of ten plasma-collection centres. Some of their manufacturing capacity is in America, but much is located elsewhere. Switzerland, which collects very little plasma, exported $26bn-worth of plasma products in 2016.

...

It remains legal to pay for whole-blood donation in America today. But hospitals refuse to accept it. Today’s plasma, however, is safe from the contamination risks of the past. Modern screening and sanitisation are extremely effective. Graham Sher, chief executive of Canadian Blood Services, a non-profit, says plasma products from paid donors are “as safe as those from our unpaid donors”.

Other prejudices against pay-for-plasma are equally deep-seated. Some data, for example, lend weight to the suspicion that it preys on the poor. American plasma centres are concentrated in less well-off bits of the country. Typically they are in postal districts where 27.4% of the population are poor, according to The Economist’s analysis of census data. This is much higher than the average American poverty rate of 16.5%.

The other worry, shared by Dr Sher, is that paying for plasma may lead to a reduction in whole-blood donation. But, if that were true, the problem would be intensifying, as pay-for-plasma centres have nearly doubled worldwide in the past five years. But Peter Jaworski, of Georgetown University, is sceptical, suggesting that, anecdotes aside, the evidence shows paid plasma donation “does not crowd out voluntary blood-donation”. Americans, for example, continue to donate as much voluntary blood per head as do Canadians.

The aversion to paid-for plasma carries its own risks. According to Grifols, the geographic imbalance puts supplies of plasma products at risk. At the plasma industry’s main annual conference, held this year in Budapest in March, over-reliance on imports from America was a hot topic. Representatives from several countries (including Canada) recognised they must do more to diversify their supplies. Making it legal to pay for plasma is an obvious first step."

This article appeared in the International section of the print edition under the headline "Thicker than water"
 Print edition | International
May 10th 2018
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And here's a letter to the editor https://www.economist.com/letters/2018/06/02/letters-to-the-editor. (The highlighted sentence seems to reflect that the editor who decides what letters to publish is a different person than the economics editor  who writes that I study repugnance only to dismiss it, and whose views I remarked on here and here.)

"In your series of articles advocating for payments to plasma donors, you stress the positive supply effects that payments may have. Appeals to increased efficiency, however important, are unlikely to persuade politicians and the public when the opposition to payments resides in deep-rooted ethical concerns. Starting with the seminal work of Nobel laureate Alvin Roth, economists have begun to seriously consider how to design effective market mechanisms while respecting moral beliefs, in order to reach a virtuous balance in the trade-offs between morality and efficiency.

"Based also on our own research on ethically contentious transactions, we would suggest that policymakers collect two types of evidence before adopting extreme policies such as outright bans. First, pilot projects would help assessing the impact of various policy options. Second, policymakers should inform the public about this evidence, and take into account the ensuing prevailing opinions and ethical concerns in the population, instead of being based on pressures (in one direction or the other) from vocal but often scarcely representative groups.

NICOLA LACETERA
University of Toronto
MARIO MACIS
Johns Hopkins University
Baltimore, Maryland 

Wednesday, May 23, 2018

Still bleeding for Canada

Here's a paper on the ongoing debate in Canada about whether it should be legal to pay plasma donors.

Moral NIMBY-ism? Understanding Societal Support for Monetary Compensation to Plasma Donors in Canada
by
Nicola Lacetera, Mario Macis
NBER Working Paper No. 24572 May 2018

Abstract: "The growing demand for plasma, especially for the manufacture of therapeutic products, prompts discussions on the merits of different procurement systems. We conducted a randomized survey experiment with a representative sample of 826 Canadian residents to assess attitudes toward legalizing payments to plasma donors, a practice that is illegal in several Canadian provinces. We found no evidence of widespread societal opposition to payments to plasma donors. On the contrary, over 70% of respondents reported that they would support compensation. Our Canadian respondents were more in favor of paying plasma donors elsewhere than in Canada, but the differences were small, suggesting a weak role for moral “NIMBY-ism” or relativism. Moral concerns were the respondents’ main reason for opposing payments, together with concerns for the safety of plasma from compensated donors, although most of the plasma in Canada does come from paid U.S. donors. Among those in favor of legalizing payments to donors, the main rationale was to guarantee a higher domestic supply. Finally, roughly half of those who declared to be against payments reported that they would reconsider their position if domestic supply plus imports did not cover domestic demand. Most Canadians, therefore, seem to espouse a consequentialist view on issues related to the procurement of plasma.

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.

Wednesday, October 25, 2017

Bleeding (and more) for Canada

Peter Jaworski in USA today discusses Canadian repugnance for paying for blood or sperm.

If it weren’t for America's free-market ways, more Canadians would have trouble getting pregnant.

"Canada used to have a sufficient supply of domestic sperm donors. But in 2004, we passed the Assisted Human Reproduction Act, which made it illegal to compensate donors for their sperm. Shortly thereafter, the number of willing donors plummeted, and sperm donor clinics were shuttered. Now, there is basically just one sperm donor clinic in Canada, and 30-70 Canadian men who donate sperm. Since demand far outstrips supply, we turn to you. We import sperm from for-profit companies in the U.S., where compensating sperm donors is both legal and normal.
...
"Canada has never had enough domestic blood plasma for plasma-protein products, such as immune globulin. Our demand for those products, however, is increasing. Last year, we collected only enough blood plasma from unremunerated donors to manufacture 17% of the immune globulin demanded. The rest we imported from you, in exchange for $623 million, or $512 million U.S.
Reliance on your blood plasma looked like it might change a little bit when, in 2012, a company called Canadian Plasma Resources announced plans to open clinics in Ontario dedicated to collecting blood plasma. The trouble is that its business model included compensating donors. Almost immediately, groups such as the Canadian Union of Public Employees and the Canadian Health Coalition began to lobby the Ontario government to pass a law to stop CPR from opening clinics. Ontario obliged in 2014, passing the Safeguarding Health Care Integrity Act, which among other things made compensation illegal.
When CPR shifted attention to Alberta, so did the groups opposing them. Just this year, the Alberta government introduced the Voluntary Blood Donation Act, which would prohibit compensation.
British Columbia’s government is just now looking at options to ban it as well.
What persuaded these governments? The anti-compensation groups argued that blood plasma from compensated donors was less safe, that people should donate blood plasma for free rather than for money, and that there is something wrong with having a for-profit business model in health care.
The latter two concerns are strangely specific. They don’t seem to apply to you Americans. If they did, the groups would have lobbied to make importation of anything other than products made from unremunerated donors also illegal. But they didn’t.
Instead, they object to a Canadian for-profit company compensating Canadian blood plasma donors in Canada, but American for-profit companies compensating American donors in America does not appear to register on their moral radar. Like the importation of sperm from for-profit U.S. companies that compensate donors, it has all the appearance of moral NIMBYism. It’s fine if it happens in your backyard, and we’ll happily buy the products, but we object to it happening in our backyard."
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And here, in Canada's National Post:

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."
************
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."

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


HT: Philip Held and Frank McCormick

Saturday, February 11, 2017

Thursday, February 9, 2017

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.





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.

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

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

Thursday, August 25, 2016

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: 

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.

Wednesday, November 18, 2015

To help Paris, donate blood... later (guest post by Carmen Wang)

Carmen Wang writes:

To help Paris, donate blood... later.

Paris needs blood donations in the aftermath of the Attacks, although not that much more than a typical Saturday (EFS press release). Real shortages, however, are very likely in the upcoming winter and holiday season. Market designers point out that blood donations, with kind intention, can happen at wrong times. Instead, would-be donors can register their names and availability with the blood service, and help later when blood is most needed.

Paris:
Long queues to donate blood everywhere 



EFS (French Blood Service) informing of enough blood supply and asking donors to come back later



Boston in 2013:
Various calls for blood donations after the Boston Marathon Bombing, for example


(Notice the time of this tweet and that of the next tweet)

The American Red Cross politely declining more blood donations



What happened in the two cities are not coincidences.

Similar phenomenon in blood donations has happened during so many disasters like 9/11, Hurricane Katrina, Victoria Bushfire in Australia. In severe cases, it leads to blood, the gift of life, being left expired on the shelf. However, in 'normal' times most countries suffer recurring blood shortages, especially during winter, due to the holiday season and that many regular donors are affected by cold and flu. Particularly this time in Paris, the winter is coming. The blood collected today will expire in a few weeks right at beginning of the winter months. Moreover, donors who donated today, when there is no real blood shortage, will not be able to donate in winter when shortages do occur. We can only donate blood approximately once every 3 months. Blood is so precious, so donate wisely.

The reason why the above phenomenon repeats itself across the world is because blood donations need to follow the demand for blood, but most people do not have the necessary information. In addition, other people's donations also affects the supply of blood in real time, which makes it impossible for an individual donor to decide whether it is a good time to donate blood. In Paris, we do want to help those who are injured in the Attacks, but not all donors need to respond at the same time. Too many donations can quickly lead to wasteful congestion and oversupply, and worse, potentially affect the blood supply immediately afterwards.

The solution is surprisingly simple, which is to set up a blood donation registry. People who want to help now can sign up in a registry, and commit to donate later when a blood shortage does occur. After all, a need for blood anytime is a need for blood. What difference does it make if it occurs during the Paris Attacks, Boston Marathon Bombing, Australia's Victoria Bushfire versus other 'ordinary' times? The blood service, which knows the need for blood at any given time, can contact donors in the registry to meet any excess demand for blood, and maintain an adequate level of blood supply in the long term. With the help of the registry, registered donors can be informed correctly not only when there is a potential shortage in aggregate, but more importantly, when their donations are needed and when others have donated enough. 
So to people in Paris, how about a registry in memory of Paris Attacks? The registry not only helps smooth out supply in disaster times, but also helps donors to stay informed, and donate whenever there is a need in normal times. And to donors anywhere in the world, the need for blood in your local area might be more than that in Paris as today. If you would've helped were you in Paris, maybe someone needs your help right now right around you.


More details, see paperSlonim, Robert, Carmen Wang, and Ellen Garbarino (2014). The Market for BloodThe Journal of Economic Perspectives, 28(2), 177-196.
And two upcoming working papers (inquire authors for more information)Slonim, Robert and Carmen Wang (2015), Market design for altruistic supply: Evidence from the Lab


Garbarino, Ellen, Stephanie Heger, Robert Slonim and Carmen Wang, Redesigning markets for blood donations: A blood donation registry