[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
ASSESSING INITIATIVES TO INCREASE ORGAN DONATIONS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
JUNE 3, 2003
__________
Serial No. 108-36
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas Ranking Member
FRED UPTON, Michigan HENRY A. WAXMAN, California
CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia
CHRISTOPHER COX, California EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina SHERROD BROWN, Ohio
Vice Chairman BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois BART STUPAK, Michigan
HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine
MARY BONO, California JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
Dan R. Brouillette, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
JAMES C. GREENWOOD, Pennsylvania, Chairman
MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida
CLIFF STEARNS, Florida Ranking Member
RICHARD BURR, North Carolina DIANA DeGETTE, Colorado
CHARLES F. BASS, New Hampshire JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
Vice Chairman HENRY A. WAXMAN, California
MIKE FERGUSON, New Jersey BOBBY L. RUSH, Illinois
MIKE ROGERS, Michigan JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana (Ex Officio)
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Augustus, Reginald........................................... 7
Delmonico, Francis L., National Kidney Foundation............ 64
Devos, Richard M............................................. 54
Kantrowitz, Susan............................................ 9
Koller, Cheryl, parent of Caitlyn, successful transplant
recipient.................................................. 13
Metzger, Robert, President-Elect, and Remy Arnoff, Deputy
Director, United Network for Organ Sharing................. 37
Olsen, Tim, Community Development Coordinator, Wisconsin
Donor Network.............................................. 47
Roth, Joseph, President-Elect, Association of Organ
Procurement Organizations.................................. 15
Sade, Robert M., Professor of Surgery, Medical University of
South Carolina............................................. 51
Shaked, Abraham, President, American Society of Transplant
Surgeons................................................... 58
Snyder, Michelle, Director, Office of Special Programs,
Health Resources and Services Administration............... 33
Vacanti, Joseph P., Director of Pediatric Transplantation,
Massachusetts General Hospital............................. 57
Additional material submitted for the record:
Department of Health and Human Services Advisory Committee on
Organ Transplantation, Recommendations to the Secretary.... 76
Gregg, Samuel, Acton Institute, draft dated April 17, 2003... 84
Letter dated May 19, 2003, to Members of Congress............ 81
Shaked, Abraham, President, American Society of Transplant
Surgeons, letter dated June 6, 2003........................ 84
(iii)
ASSESSING INITIATIVES TO INCREASE ORGAN DONATIONS
----------
TUESDAY, JUNE 3, 2003
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2322, Rayburn House Office Building, Hon. James C.
Greenwood (chairman) presiding.
Members present: Representatives Greenwood, Bass, Walden,
Ferguson, Tauzin (ex officio), Deutsch, and DeGette.
Staff present: Casey Hemard, majority counsel; Jill Latham,
legislative clerk; David Nelson, minority counsel; and Nicole
Kenner, Legislative analyst.
Mr. Greenwood. The subcommittee will come to order and the
Chair recognizes himself for an opening statement.
Before then, without objection, the subcommittee will
proceed pursuant to committee rule 4(c). So ordered. The Chair
recognizes himself for an opening statement.
Good morning and welcome, everyone. It has been nearly 50
years since the first successful kidney transplant was
performed in the United States. Since that first operation, the
transplant community has developed into a national network of
organ procurement organizations and 257 transplant centers
where lifesaving operations are performed on a daily basis.
Last year alone, 24,581 transplant operations were performed.
Yet, despite this remarkable achievement, tens of thousands of
people are waiting at any given moment for their chance at a
lifesaving organ transplant. In 2002 alone, approximately
40,000 names were added to the waiting list. Just an hour ago
the number of people waiting for organs was 81,752. Sadly, many
of these people will run out of time. Last year, 6,187 people
died while on the waiting list because there were simply not
enough organs to meet demand.
What is particularly frustrating about these numbers, these
missed chances to save a life, is that we know more organs
could be made available. The Department of Health and Human
Services recently reviewed national data from the Organ
Procurement and Transplantation Network Data base and found
that only 40 percent of individuals who died and had organs
eligible for donation actually became donors.
When you consider that as many as eight lives can be saved
from the gifts of one donor and that there are more than 81,000
people needing a lifesaving organ, 40 percent is just not good
enough. These numbers demonstrate that initiatives being
undertaken in this country to educate people on the merits of
organ donation are failing to meet the ever-growing demand for
organs. What is the solution to this dilemma?
This morning we will hear from members of the organ
donation community who will help us find some potential
answers. We will hear about new measures and initiatives that
hold some promise for increasing donation rates. We will learn
more about what is being done with the organ transplant
community at the local State and national levels.
First we will hear those most affected by the current organ
donation process. On the first panel, we will meet Reginald
Augustus, a 27-year-old man who has been waiting for a kidney
transplant for the past 2 years. Reginald will tell us about
the complications he faces on a daily basis as he juggles
everyday life with the limitation of dialysis.
We will meet Chris and Cheryl Koller of Cary, North
Carolina. The Kollers are parents of 10-year-old Caitlyn
Koller--good morning, Caitlyn--who received a lifesaving heart
transplant when she was just 8 years old, and she has a
birthday coming up in January.
The choice to give up your loved one's organs is a heroic
one. This morning we will also hear from Susan Kantrowitz, one
such hero, to help us understand the struggles she went through
in making the decision to donate the organs of her late husband
William.
Rounding out our first panel will be Joseph Roth from the
Organ Procurement Organizations. Organ procurement
organizations, known as OPOs, are responsible for coordinating
the organ transplant process at the community level. Mr. Roth
will discuss how OPOs facilitate the process of getting donor
organs to those in need.
It is encouraging to see the Bush Administration has been
addressing this issue. Health and Human Services Secretary
Tommy Thompson has made public awareness about organ donation a
priority. In late 2002, Secretary Thompson's Advisory Committee
on Organ Transplantation made 18 recommendations relating to
organ donation and transplant issues.
And on the hearing's second panel this morning, Michelle
Snyder, director of HHS's Office of Special Programs will
discuss those recommendations and how they will affect the
organ donor process. She will address the best practices
initiatives that HHS has undertaken in the past year to
identify organ donation practices at the most effective
hospitals and transfer them to underperforming institutions to
help increase the number of donors nationwide.
Ms. Snyder will be joined by Doctor Bob Metzger, President-
elect of the United Network for Organ Sharing, or UNOS, who can
explain to us how UNOS facilitates the organ-matching and
procurement process throughout the country. UNOS is the
organization that holds the contract for the Organ Procurement
and Transplantation Network.
Our third panel will allow us to expand our inquiry to new
research and other approaches that may help increase the
availability of lifesaving organs for those in need. We will
hear from Tim Olsen, the Community Development Coordinator at
the Wisconsin Donor Network, where his organ procurement
organization has had one of the largest increases in donations
in the country last year.
Dr. Jay Vacanti, Director of Pediatric Transplantation at
Massachusetts General Hospital, will describe some of the
advances in research that have been made to provide other
options to individuals in need of organs.
And Doctor Abraham Shaked, President of the American
Society of Transplant Surgeons, will discuss solutions that the
society has explored.
Another important issue this hearing will explore today is
the current Federal prohibition on payments to donors for their
organs. The National Organ Transplant Act prohibits the sale or
purchase of human organs. However, frustrated by the alarming
shortage of donor organs, many in the medical community have
begun to question whether it might be possible to provide some
sort of ethically acceptable financial incentive to the
beneficiaries of a decedent that may motivate an individual to
formally express his intentions about donation prior to his or
her death.
Given that so many people die each year waiting for an
organ transplant, I believe all options should be put on the
table as we discuss ways to increase organ donations. In this
regard, we will receive testimony from Rich DeVos, a heart
transplant recipient, who will discuss how providing insurance
benefits or a tax credit to cadaveric donors may both increase
donations and save insurers and Medicare money.
And Dr. Robert Sade will be here on behalf of the American
Medical Association to discuss a policy the Association adopted
last summer to encourage study of the use of financial
incentives to increase cadaveric organ donation.
However, the National Kidney Foundation has voiced its
opposition to any sort of financial incentives for donation,
and Doctor Francis Delmonico will be here to explain that
position as well.
Clearly we have many complicated and sensitive issues to
examine this morning, and let me thank all the witnesses for
attending this important hearing. And I turn now to recognize
the ranking member for his opening statement.
Mr. Deutsch. I yield my time.
Mr. Greenwood. The ranking member yields his time to the
gentlelady from Colorado, who is recognized for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman. I am very
pleased that we are having this hearing today to assess various
initiatives that the Federal Government and its agencies have
undertaken to increase organ donation. We all know that organ
donation save lives. Every day, about 63 people receive an
organ transplant; but unfortunately another 16 people who are
on the waiting list die because not enough organs are
available.
So the question of what role the government should play in
increasing the organ donations is an important one. Overall the
national outlook for organ donations is not particularly rosy.
The number of people awaiting organ transplants is up and the
amount of time patients must wait for an organ transplant is
also increasing.
I am very interested in the state of organ donations and
transplants because I am the co-chair of the House Caucus on
Diabetes and I understand the life-giving nature of kidney
transplants for patients with renal failure. I am also
interested in organ donation because my bill in the 106th
Congress, which one of our witnesses will be particularly
interested in today, the Pediatric Organ Transplantation Act,
was fully incorporated into law as part of H.R. 4365, the
Children's Health Act of 2000. What the legislation did was
require the Organ Transplantation Network to adopt criteria,
policies, and procedures to address the unique health care
needs of children. In addition, the legislation required a
study of the unique health care needs of children, including
growth and developmental issues and immunosuppressant drug
coverage and organ transplantation. The study was intended to
give a more complete picture of the full-range picture of
problems in pediatric organ transplantation.
I am going to be very interested during the course of the
testimony today to hear what kind of progress has been made in
advancing the cause of pediatric organ transplantation and
making sure that kids who are on waiting lists get pediatric
organs.
I would like to make one final note. It has been against
the public policy of this country to pay people for organ
donations for many, many years, and the reason is because
legislative bodies have felt that it was repugnant to give
financial incentives to folks to donate their own organs, and
the feeling is that it would unduly put pressure on low-income
individuals to do that.
I see no need to move away from that public policy. In
fact, in light of recent tax cut policies and other financial
policies of this administration, it seems to me we are giving
less and less relief to low-income individuals and more and
more tax relief to high-income individuals. I don't see why we
would even do a study at this point to give financial
incentives for lower-income people to have to sell their
organs, and I am very much opposed to even doing a study on
that idea. I think it would be discriminatory toward low-income
people.
When you couple that with studies that we have seen that
indicate that other kinds of incentives, like education
programs through the States where we could put Federal
resources to work, I don't see any reason to give financial
incentives to individuals for organ donation. I think it is
always interesting to discuss issues, but I would be appalled
by any legislative efforts to change our longstanding policy.
And I think, frankly, most experts, certainly in organ
transplantation, would also be opposed to this issue. I just
put that out.
I am eager to hear the testimony and I want to thank all of
our witnesses for coming. I know that it is particularly
difficult for 10-year-olds to come and testify before Congress,
but the kind of testimony that you can give us is really going
to help us in our deliberations. So thank you so much, and I
yield back.
Mr. Greenwood. Thank the gentlelady. Actually, I think
Caitlyn looks more relaxed than anyone else.
The Chair recognizes the gentleman, Mr. Walden, for an
opening statement.
Mr. Walden. Thank you, Mr. Chairman, and thank you for
convening this hearing.
The fact that advances in medicine and science have brought
us to a point where organs from one individual can be
transplanted into another successfully is extraordinary and
remarkable. It is also very complicated and involved, not only
in the short term but the long term.
In my home State of Oregon, there are 376 Oregonians who
are waiting organ transplants. These aren't just numbers, they
are sons and daughters and wives and husbands and mothers and
fathers, and I applaud those who have signed up to be organ
donors.
I apologize if I am a little emotional. Nine years ago and
5 months, we lost our second son who was awaiting an organ
donation. He came premature, and we were never able to see
through the surgery, which we planned to have at Loma Linda,
for a heart transplant. He suffered from Hypoplastic Left Heart
Syndrome.
I am very dedicated to doing whatever we can to encourage
and facilitate the donations of organs. I know what it means to
families to be a recipient. I know how difficult, or at least I
can only imagine how difficult it is for those who have loved
ones who have to donate or are allowed to donate. I prefer to
think of it as allowing to donate so another can live or see.
And I don't want to get into arguments of class warfare. I
want to get into figuring out how to improve the system so no
parent has to watch and wait until their loved one dies while
we argue and debate. Obviously, we have to do it in a proper
and appropriate way. We don't want to create an ugly incentive
to do bad things. We want to do good things. And so I commend
the medical community for the advancements that have taken
place. I encourage additional scientific review. And certainly
what we all, or a lot of us, do to sign up to be organ donors
on our driver's license I think is really helpful.
So, Mr. Chairman, I appreciate this hearing and I look
forward to working with you on these efforts.
Mr. Greenwood. I thank the gentleman for his statement and
his candor.
The gentleman from New Jersey is recognized.
Mr. Ferguson. Thank you, Mr. Chairman. I, too, am a great
supporter of organ donation. In fact, I was on my way walking
over to this hearing. I just got a replacement license a few
days ago and I had not turned it over, signed the back of it,
and checked off my organ donor box. So if nothing else, this
hearing did some good to remind one person to renew their
commitment to organ donation.
It is imperative, obviously, that we increase organ
donation in our country. Unfortunately, our organ donation
system is not providing enough donor organs to satisfy the
life-sustaining demand we have in our country. There are more
than 81,000 people in the U.S. Waiting to receive an organ
transplant. For those people waiting for a transplant, fewer
than a third of them will receive a transplant this year. Every
13 minutes another name is added to the transplant waiting
list, with approximately 40,000 names that were added to the
waiting list last year in 2002 alone. Tragically, a staggering
average of 16 people a day are lost because they can't be
matched with an organ donor in time, adding up to more than
6,000 people who were lost last year waiting for a transplant.
Our doctors and those who administer the Organ Donor
Networks already do an incredible job, saving as many lives as
they can under the current circumstances. However, we have to
look deeper into the matter and we have to work hard to make
sure the system is more efficient to increase the number of
donations that are made available. Our goal should be that
these people who are seeking donor organs and those donating
organs achieve parity as soon as possible.
Today we will consider several initiatives and we will hear
from our witnesses and others who have sought to improve organ
donation and transmission. And I look forward to hearing about
some of the successes, too, of these programs and any
suggestions that our panelists may have to make the environment
better for organ donation.
Thank you, Mr. Chairman. I thank all of our panelists today
and I look forward to the hearing.
Mr. Greenwood. The Chair thanks the gentleman.
[Additional statement submitted for the record follows:]
Prepared Statement of Hon. Bobby L. Rush, a Representative in Congress
from the State of Illinois
Mr. Chairman: I applaud the Subcommittee for holding this important
hearing on the status of organ donations in the United States. With
more than 81,000 critically ill people in the United States currently
waiting to receive a transplant this year, this hearing is both timely
and appropriate.
In 1984, Congress enacted the National Organ Transplant Act which
created the Organ Procurement and Transplantation Network (OPTN),
designed to increase the supply of viable organs available for
transplant. Under the provisions of the National Organ Transplant Act
(NOTA), the U.S. Department of Health and Human Services has the
responsibility for establishing and administering a national organ
allocation program, through its prime contractor, UNOS.
In 2000, HHS established an Advisory Committee on Organ
Transplantation to advise the Secretary on all issues related to organ
donation and in November of last year, the Committee made a number of
recommendations--18--to the Secretary relating to the treatment of both
living and deceased organ donors.
Several of the recommendations promulgated by the Advisory
Committee are issues which my good friend and colleague, Ray LaHood,
and I attempted to address in legislation which we sponsored in the
106th Congress. As introduced, H.R. 3885 was designed to increase organ
donation by establishing a grant program to assist organ procurement
organizations (OPO) and other non-profit organizations in developing
and expanding programs aimed at increasing organ donation rates;
creating a Congressional Donor Medal to be awarded to living organ
donors or to organ donor families; establishing a system of
accountability and placing the responsibility for increasing organ
donation with the Department of Health and Human Services (HHS must
report its progress to Congress); and establishing a system of support
for state programs to increase organ donation. Although Congress did
not pass H.R. 3885, the dialogue which was initiated around that bill
resulted in several improvements to the donation and allocation system.
Mr. Chairman, I am pleased that this Subcommittee will address some
of these issues today.
Mr. Greenwood. And now we turn to our witnesses. And they
are: Mr. Reginald Augustus from Gaithersburg, Maryland; Ms.
Susan Kantrowitz--am I pronouncing that correctly--from
Alexandria, Virginia; Ms. Cheryl Koller and her daughter
Caitlyn from Cary, North Carolina; and Mr. Joseph Roth,
President-elect of the Association of Organ Procurement
Organizations in McLean, Virginia.
Thank you for being with us this morning. I think you have
been informed that this is an investigative hearing. And when
we hold investigative hearings it is our custom to take
testimony under oath, and I ask if you object to giving your
testimony under oath. And then I need to tell you are
permitted, pursuant to our rules, to be represented by counsel.
Do any of you wish to be represented by counsel? Didn't
think so. In that case, if you would stand and raise your right
hands, I will give you the oath.
[Witnesses sworn.]
Mr. Greenwood. You may be seated, and are under oath, and
we will begin with Mr. Augustus. And you are recognized for
your opening statement.
TESTIMONY OF REGINALD AUGUSTUS; SUSAN KANTROWITZ; CHERYL
KOLLER, PARENT OF CAITLYN, SUCCESSFUL TRANSPLANT RECIPIENT;
JOSEPH ROTH, PRESIDENT-ELECT, ASSOCIATION OF ORGAN PROCUREMENT
ORGANIZATIONS
Mr. Augustus. Good morning. My name is Reginald Augustus,
and I'm here to tell you about my life and how it has been,
dealing with kidney failure while waiting for a kidney
transplant. In May 1999, during a routine physical, my doctor
told me that my kidneys were not functioning properly. On that
day, my life changed forever. As time went on, I began not to
feel well. My blood pressure began to elevate and I felt
shortness of breath and I would feel nauseous often. By the
time I went back to the doctor in March 2001, I needed to be
put on emergency dialysis, given two blood transfusions, and
had to spend 5 days in the hospital.
Since March 2001, I have been on kidney dialysis. I had to
change a lot of things such as my diet. I now have to watch
certain foods and fluids that are high in potassium, which
could cause a heart attack, high-phosphorus foods which
eventually could thin my bones and make them brittle, and also
have to watch my fluid intake which could eventually get into
my lungs. My body no longer gets rid of these fluids like a
normal person would. And I have to watch those types of things.
I have to go about three times a week to kidney dialysis,
where I get stuck with two large needles into my arm where
surgery was performed, called a fitula, and that is where an
artery and a vein are connected to make the vein large enough
to handle the blood being pumped through a filter, which is
called dialyzer, and it cleans my blood and takes out excess
fluids. Not only is this process inconvenient, lasting about 4
hours per treatment, but it also leaves me feeling worn out
afterwards.
Many dialysis patients such as myself cramp badly from
fluids taken off, and we have to deal with our blood pressure
dropping, stripping out of our bodies not only toxins but
minerals and chemicals and vitamins that our body needs. The
process of dialysis affects one's body in a negative way. Long
periods of time on dialysis will shorten a person's life.
Other than dialysis, going about my daily activities, I
don't feel the same as I used to. I get tired faster as the
toxins in my body don't have anywhere to go. They buildup and
kill red blood cells. At the dialysis center, I get epogen
medication to help produce red blood cells, which my kidneys
once did for me. I also get a medication called Zemplar to help
control my phosphorus and potassium levels and my parathyroid.
I have met many people at the dialysis center, some of whom
have been on dialysis for a short time, some for a very long
time. The ones who have been on for several years look
different than the newer ones. Years of dialysis and kidney
failure have darkened their skin and made them look weak and
sickly. My uncle spent 20-plus years on dialysis before dying
in his early forties, and I watched his body deteriorate and
his bones become brittle, and was basically a hunched-over
shell of a man at the end.
For many, work is not an option. Many work part time or not
at all, because they are on dialysis. Every day, more and more
people go on dialysis and the need is even greater for organ
donation. Currently I believe the national average wait is
somewhere over 3\1/2\ years, and that is even longer for
African Americans. I have been on the waiting list for 2 years,
but I know many have been waiting twice as long as I have. The
need again for organs is great and we need to increase the
availability.
Thank you for your time. And I just want to put one more
note on that. Kidney dialysis is available to me.
Unfortunately, for some people who are waiting for organ
donations and on lists, they need to get it sooner. I have
something that can sustain me until the time is right, but
people who are waiting for heart, lung, liver, the need is very
great for them.
[The prepared statement of Reginald Augustus follows:]
Prepared Statement of Reginald Augustus
Hello, my name is Reginald Augustus and I am here today to tell you
about how my life been dealing with kidney failure while waiting for a
kidney transplant. In May of 1999, during a routine physical, my doctor
told me my kidney's were not functioning properly. On that day my life
changed forever. As time went on I began to not feel well. My blood
pressure began to elevate, I felt shortness of breath, and I would feel
nauseous often. By the time I went back to the doctor in March of 2001,
I needed to be put on emergency dialysis, given 2 blood transfusions,
and I had to spend 5 days in the hospital. Since March of 2001, I've
been on kidney dialysis. I had to change a lot of things such as my
diet. I now have to watch certain foods and fluids that are high in
potassium which could cause a heart attack, high phosphorous foods
which could eventually thin my bones and make them brittle. I also have
to watch my fluid intake, since my body no longer gets ridof this fluid
which can cause problems by getting into my lungs which has happened
and around my heart which can lead to other problems. I also have to go
3 times a week for kidney dialysis where I get stuck with 2 large
needles into my arm where a surgery was performed called a fistula
where an artery and a vein are connected to make the vein large enough
to handle your blood being sucked out and pumped through a filter
(dialyzer) that cleans my blood and takes out excess fluid. Not only is
this process inconvenient, lasting about 4 hours per treatment, but it
leaves me feeling worn out afterwards. Many dialysis patients such as
myself, cramp badly from the fluids being taken off. We also have to
deal with our blood pressure dropping and the stripping out of our
bodies not just toxins, but minerals and vitamins are bodies need. The
process of dialysis effects ones body in a negative way. Long periods
of time on dialysis will shorten a persons life. Other than dialysis,
going about my day to day activities, I don't feel the same as I use
to. I get tired faster as the toxins in my body don't have anywhere to
go. They build up and kill red blood cells. At the dialysis center, I
get epogen medication to help produce red red blood cells which my
kidney's once did for me. I also get a medication called Zemplar, to
help control my phosphorous and calcium levels and my parathyroid. I've
met many people at the dialysis center. Some who have been on dialysis
a short time and some a very long time. The ones who have been on for
several years look different than the newer ones. Years of dialysis and
kidney failure have darkened there skin and made them weak and sickly
looking. My uncle spent 20 plus years on dialysis before dying in his
early 40's. I watched his body deteriorate, his bones become brittle,
and was basically a hunched over shell of a man at the end. For many,
work is not an option. Many work part time or not at all because of
dialysis. Everyday more and more people go on dialysis and the need is
greater than ever for organ donation. Currently, I believe the national
average wait is over 3\1/2\ years and it's even longer for African-
Americans. I've been on the waiting list for 2 years but many I know
have been waiting more than twice as long as me. The need for organs is
great and we need to increase there availability. Thank you for your
time.
Mr. Greenwood. We thank you for your testimony and your
courage and candor as well.
Ms. Kantrowitz
TESTIMONY OF SUSAN KANTROWITZ
Ms. Kantrowitz. Good morning. My name is Susan Kantrowitz.
I am here speaking on behalf of myself. My husband Bill was a
deceased donor, and I am here to tell you my story. It is
indeed my pleasure.
For us it was an ordinary Friday night. My mother came for
Friday night. My mother came to dinner. My 4-year-old was
bouncing off the walls and my 1-year-old was trying to do a
little furniture surfing as he was learning how to walk. And we
had dinner, and my husband changed and he went back to work. He
was the Deputy Chief Counsel for the Bureau of Engraving and
Printing and needed to take a deposition from someone on the
night shift.
We had an ordinary evening. I went to bed. I got up around
midnight with the baby. Got him back to bed. Bill had come in
and I went down to see him. He normally put his notes in the
computer in the basement before he retired in the evening. When
I went down there, I found Bill on the floor. It was obvious he
had laid down and put a toy beneath his head. I thought he was
snoring and I hesitated for 1 minute to think, well, maybe I
will let him sleep there; but, you know, the basement is pretty
cold so I decided I would go down and wake him up. When I went
over, it was obvious there was a problem. I couldn't wake him
up, and I called 911 immediately.
We live about a block, if that, from Mount Vernon Hospital.
So when the paramedics came, they gave me a choice of walking
over or going with them. I called the neighbor to stay with the
kids and I went on my way. As I was walking out of the house, a
paramedic came to me and said, ``There is something going on,''
and he pointed to his head, indicating that Bill had a problem
somewhere in his mind or his brain.
As I was walking toward the hospital, I met my neighbor. He
gave me a cell phone and stayed with me so I wouldn't be alone.
So I stayed for awhile; I am sure it was several hours by the
time the nurse came in. She told me that a CT scan had revealed
that Bill had had a stroke, that there was blood in his brain.
It was pretty massive. They called the neurosurgeon. After the
neurosurgeon took a look at Bill and examined him, he called me
into his room and showed me the CT scan, which to me was like
looking at Greek, and we talked a little bit. He tried to show
me Bill had no responses, but I didn't really understand that.
I was in the midst of a tragedy. We went through his particular
case. The neurosurgeon basically said that he wouldn't operate,
that there was no hope, that he didn't think he could save
Bill's life, and if he could save Bill's life, that there would
be no quality of life.
We started the discussion at that point about organ
donation. That discussion lasted at least a full day. Just at
the moment that they talked to me about organ donation, I had a
flashback. Bill and I--and this was way before we had
children--had the TV on, and on came an old episode of ER. And
in this episode there was a teenage girl who had cystic
fibrosis and needed a lung transplant to live, and in the next
room there was a fireman who had been burned severely and was
going to die. And as Hollywood would have it, it was the
perfect match for this teenage girl, but he wasn't dead yet.
And there was an incredible discussion in this episode about
whether they could hasten the death of the firefighter in order
to give the girl the transplant.
I remember this like it was yesterday. I remember it
because the next morning we actually talked about this episode
on our way to work, and Bill said to me, I can't believe how
irresponsible that is, to actually imply that a doctor would
take the life of another so that he could transplant an organ
into a person who is going to live.
We talked about it for quite awhile on our way to work. And
we agreed that if it ever came to pass, we would gladly give
each other's organs. So even though I was remembering this
conversation and even though that I knew that Bill consented to
the organ transplant, I hesitated. My husband was lying in
front of me. He was breathing. His heart was beating. His
kidneys were working. He was sweating. It was warm on an August
evening. And I really felt like I was sending him to his death,
that I was somehow turning my back on him.
Luckily I have a brother-in-law who is a doctor. He looked
at other things. He reiterated, Bill's not coming back, he's
gone. The coordinator for the Washington Regional Transplant
Organization was wonderful. He talked me through a million
questions: What were you going to take--how are you going to
take it? What were you going to do with everything you were
going to take? What would he look like? Would I be able to have
a normal funeral? He walked me through them.
I finally agreed to donate Bill's organs and tissues, but I
had a condition. Bill had his best friend Mark, who needed a
kidney transplant, and if possible I wanted Mark to receive
Bill's kidney. Unfortunately, they were not a match. I was
under a lot of stress. I want you to understand that, because I
tried to borrow the kidney and say, Couldn't we exchange
kidneys somehow so we could get Mark a kidney? At that time,
that was not proper under law. The law is a little more
flexible at this point, but nonetheless that wasn't an option
at the time. So I went ahead and consented.
Three tests--well, several tests had to be done, but three
neurosurgeons had to certify that Bill was brain dead. Started
another whole process in my mind. If he is not really dead, you
are going to kill him when you take him off of oxygen for 5
minutes, and I went through the decisionmaking process all over
again. I signed the papers. They went forward.
I stayed for every test except for the oxygen deprivation
test, probably because I knew in my mind that he was gone and I
wasn't ready to accept it at that point. They were able to take
all of his organs and his tissues. They took the bones in his
arms and his legs. They took the skin off of his back to use
for burn victims. They took all of his organs. When the
neurosurgeon summed up the results of all of the tests, he came
to me and told me there was no reason this man should be dead.
That didn't help, but he was gone and he wasn't coming back,
and there was no reason to allow people who could use his
organs not to go on living.
Bill wasn't coming back. There was no question about it. It
was my ability to do something positive and take a tragedy and
put a positive spin on it. I had lots of help from the
Washington Regional Transplant Consortium. They have lots of
grievance groups and support groups that I was able to take
advantage of.
The one thing that just did it for me was when I asked the
coordinator, What am I going to tell my children? I have two
little boys--at that time who were 4 and 5--what am I going to
tell them? And he looked me in the eye and said, You tell them
that their father was a hero, he saved lives. And to this day,
13 people are alive because we gave Bill's organs and his
tissues. He is a hero.
Thank you. I am available for questions.
[The prepared statement of Susan Kantrowitz follows:]
Prepared Statement of Susan Kantrowitz
Good afternoon! My name is Susan Kantrowitz, and I am representing
myself as a donor family member. My husband, William Colbert, Sr., was
a deceased donor. I am here to tell you my story. Thank you for this
opportunity. It is indeed my pleasure.
It was an ordinary Friday night in August 1999. My mother came for
dinner. My four-year-old son was bouncing off the walls as only four-
year-olds can do, and my one-year-old was doing a little furniture
surfing, testing his newly-acquired walking skills. My husband changed
after dinner and went back to work. Bill was the Deputy Chief Counsel
at the Bureau of Engraving and Printing and needed to take a deposition
from a member of the night shift.
I got up with the baby around midnight and heard my husband return.
He headed down to the basement to begin putting his notes together on
the computer. After the baby was asleep, I decided to go down and see
how Bill was doing.
I found Bill on the floor. He had laid down and put a toy under his
head. It was obvious that something was wrong, and when I couldn't wake
him, I called 911. I called a neighbor to come stay with the boys and
started for the hospital. One of the paramedics took me aside as they
were putting Bill into the ambulance. He told me it didn't look good--
he pointed to his own head and implied that there was something wrong
inside Bill's head.
We live less than a block from Mount Vernon Hospital and I chose to
walk over. On my way, I met my neighbor. He gave me his cell phone and
immediately joined me at the hospital so I wouldn't be alone. After a
long wait, a nurse came in and told me they put Bill on a respirator.
She explained that this was routine practice as a precaution. They also
called in a neurosurgeon.
After examining my husband, the neurosurgeon called me into Bill's
room. Bill had no responses. A CAT scan revealed a massive amount of
blood in the brain. A blood vessel broke--there was no telling why.
Bill had suffered a massive stroke and was gone. Technically he was
brain dead, although his body had not died yet.
It was at that time that we started to discuss organ donation. As
soon as it was mentioned, I had a flashback to an episode of the ``ER''
television program some years earlier. Bill and I never watched ``ER,''
but for some reason, it was on that evening. In that episode, a teenage
girl needed a lung transplant to survive. In the next room, there was a
badly burned fireman who was going to die. As only Hollywood would have
it, he was a perfect match for the teenage girl. In the episode, the
doctors have a great debate about hastening the death of the
firefighter so the transplant could be done and the teenage girl saved.
I remember it well because the next morning on our way to work. We
discussed the episode. We noted how irresponsible the episode was to
infer that those kinds of debates actually happen and that an
individual might not be saved because he/she was an organ donor. We
both felt that it was unconscionable to plant that kind of seed in the
public's mind. Both of us agreed that we wouldn't hesitate to donate
our organs if the opportunity presented itself. It was the right thing
to do.
Even remembering this conversation, I didn't agree immediately. My
husband was lying in a hospital room--for all intents and purposes
alive. Yes, he was breathing with the help of the respirator, but as
the nurse told me, that was routine. His kidneys were functioning, his
skin was warm to the touch, and on this hot August night, he was
sweating.
I sat with my brother-in-law, also a doctor. He looked at the CAT
scan. He confirmed that Bill wouldn't survive. Regardless, I still had
an overwhelming feeling of abandoning him. I felt that I was turning my
back on him and sending him to his death. My heart and my head were
telling me two different things.
The coordinator from the Washington Regional Transplant Consortium,
Mr. David DeStefano, was fabulous. He sat with me and answered all of
my questions. He explained that one donor can save 50 lives, not only
through organs, but through tissues and bone as well. He met with me
endlessly answering question after question: What would happen to the
body? How would he look?
I agreed to donate Bill's organs and tissues, with one condition.
Bill's best friend Mark needed a kidney. I wanted Bill's kidney to go
to Mark, if they were a match. We agreed that Bill would become a
deceased donor. Unfortunately, Bill and Mark were not a match. I asked
if we could ``barter'' his kidney for another that would match Mark.
The law at that time, did not allow that kind of arrangement. I went
forward with the donation. It was the right thing to do.
Bill underwent a thorough examination to be sure that there was no
disease or damage to the organs. Part of that was a test to ensure that
Bill was in deed brain dead. Three different doctors had to certify
that he would not recover from the stroke. I had another conversation
with Mr. DeStefano. If there was any chance whatsoever that Bill was
going to survive, I didn't want the organ donation tests to kill him.
One of the tests was oxygen deprivation for five minutes. Again, I was
assured that Bill was not returning. I had to trust the doctors that
they were telling me the truth. I was still dealing with this tragedy.
I was now a widow and my boys were fatherless.
I signed the papers allowing the doctors to take everything and
anything usable. Before going into the operating room, I met with the
leader of the surgical team. He cried with me as I asked that Bill be
treated with the utmost dignity--as if he would survive the surgery. He
assured me that they would, and I kissed him good bye as he went into
surgery.
They were able to take and use all of his organs, his corneas, the
skin off his back (to be bandages for burn victims) and the bones from
his arms and legs. A few days after the funeral, a friend called to
apologize that his wife couldn't attend the funeral with him because
she was with their granddaughter who was having surgery. She was born
with deformities in her leg bones and they were going to remove the
affected bone and replace it with bone from a cadaver. I was able to
tell my friend that I knew all about the procedure, because Bill's bone
had gone to just such a bank.
In donating Bill's organs and tissues, I was able do something
positive with a tragedy. I have never been sorry. The Washington
Regional Transplant Consortium has been wonderful. I have been able to
take advantage of numerous support groups that they sponsor, and
faithfully attend the Annual Family Gathering where deceased donors are
remembered and thanked. This has become crucial for my boys, who are
now seven and four years old. With them, I hope to soon meet the
recipients of Bill's organs and tissues. I have received tremendous
support from them and am now enjoying returning the favor. I am always
happy to talk on behalf of organ and tissue donation.
Before I finally decided to donate Bill's organs and tissues, I
asked Mr. DeStefano about dealing with my boys. I wondered what I
should tell them. He told me to tell them that their father was a hero.
He said that Bill was no different from a fireman or policeman. He
saved lives. He was a hero.
Thank you for your attention. I am happy to answer your questions.
Mr. Greenwood. We thank you for your courage today as well
as on that day.
Ms. Koller.
TESTIMONY OF CHERYL KOLLER
Ms. Koller. Good morning. Thank you for inviting me this
morning. My name is Cheryl Koller, and I am the mother of a 10-
year-old little girl named Caitlyn, and Caitlyn was 8 years old
when she was the recipient of a heart transplant. She had just
celebrated her 8th birthday in January 2001 when she became ill
with what we thought was just a stomach virus.
Caitlyn had always been a healthy and active child and
there seemed to be no cause for any immediate concern. After 2
weeks of waiting for her to get better, our pediatrician sent
us to the hospital to have some routine testing done. An x-ray
revealed that Caitlyn's heart had enlarged and was twice the
normal size and she was in heart failure. At that time, Caitlyn
was transferred to the Pediatric Intensive Care Unit at the
University of North Carolina's Childrens Hospital in Chapel
Hill. And for 2 weeks, the doctors attempted to control the
situation with medications, but they were unsuccessful.
On February 23, 2001, Caitlyn's name was placed at the top
of the National Transplant List. We were told that we had the
sickest child in the southeastern United States, and just a few
weeks earlier she had been perfectly healthy.
This was an extremely sad time for our family. We were very
afraid of the possibility of facing the future without our
daughter, and there was also the confusion of her ever-changing
health status, and now a desperate wait for a new heart to
become available. Eight days into our wait, the doctors told us
to prepare ourselves to say goodbye, because they didn't
believe that Caitlyn could make it through another night. But
this tough little girl did make it through that night, and 2
days later surgeons at UNC attached a ventricular assist device
that was meant for adults to Caitlyn's heart, and this machine
kept Caitlyn's heart pumping for the next 10 days as we
continued our wait.
On the evening of March 14, my husband and I had gone to
the hospital chapel to pray. We spent a lot of time praying and
asking God to inspire a family faced with the death of their
child, to give the gift of life to our child. It is a very
difficult prayer to offer up, but we prayed with a great deal
of faith and hope that God would show us His way.
When we returned to Caitlyn's room a few moments later, we
were told that a heart had been found for Caitlyn. We spent a
lot of time that evening praying for a very brave family that
we didn't know but we owed our future happiness to.
The 8-hour transplant surgery began in the early hours of
March 15. One week after the transplant, Caitlyn was taken off
the ventilator. A dedicated team of doctors, nurses, and
therapists were there with us to greet a little girl who was
ready to live and play again.
Three days later Caitlyn stood up and took her first steps
in nearly a month-and-a-half. It has now been 2 years and 3
months since Caitlyn's transplant. She went back to school full
time this past school year, and she just finished the third
grade. She loves to ride her bike to the playground, go
swimming, and play with all the girls on our street. She has
conquered a lot of obstacles, including a post-transplant
stroke, to return to a fairly normal life. The doctors still
cannot tell us exactly what caused Caitlyn's heart to fail, but
they say she is a true miracle child.
This past February, we had the honor of meeting Phyllis and
Nathan Slifer, the parents of Joseph Michael Ebert, Caitlyn's
donor. And we brought a picture of Joseph with us. Joseph was a
sweet, big-hearted little boy who loved life. He was 7 years
old when a dirt bike accident tragically ended his life. When
doctors approached Phyllis about organ donation, she said yes
right away. She didn't think who would benefit. She was
thinking about the son she had just lost. But something inside
told her that this was the right thing to do, and she didn't
want any other family to suffer the same loss that she was
experiencing.
Phyllis and Nathan have found comfort in getting to know
Caitlyn and us, and knowing that their son lives on through
her. Joseph also lives on in a 9-year-old girl who received his
liver, a 23-year-old man who received one of his kidneys, and
another 7-year-old little girl who received his other kidney.
The power of one organ donor is truly amazing. One donor
can potentially save 58 other lives, 8 lives through the
donation of a major organ and 50 through tissue donations. And
there are nearly 81,000 people waiting for an organ transplant
today in the United States.
We are very fortunate that Caitlyn only waited 20 days for
her transplant. A short wait is truly an exception rather than
the rule.
Today I understand you will be hearing from many experts in
the transplant field on ways to help increase the number of
organ donations. And certainly educating Americans, the
American public on organ donations will hopefully increase the
number of donations and reduce the time that patients must wait
for that second chance at life.
Thank you for listening to our family's story. We are truly
blessed, and we are very glad that we are able to share this
story with others in the hopes that it will encourage more
people to give life by becoming an organ donor.
[The prepared statement of Cheryl Koller follows:]
Prepared Statement of Cheryl Koller
My name is Cheryl Koller and I am the mother of a 10 year old
little girl named Caitlyn. Caitlyn was 8 years old when she was the
recipient of a heart transplant.
Caitlyn had just celebrated her 8th birthday in January 2001, when
she became ill with what we thought was a stomache virus. Caitlyn had
always been a healthy and active child and there seemed to be no cause
for any immediate concern. After two weeks of waiting for her to get
better, our pediatrician sent us to the hospital to have some routine
testing done. An x-ray revealed that Caitlyn's heart was twice the
normal size and she was in heart failure.
Caitlyn was transferred to the pediatric intensive care unit at the
University of North Carolina Children's Hospital in Chapel Hill. For
two weeks the doctor's attempted to control the situation with
medications but were unsuccessful. Caitlyn's name was placed at the top
of the national transplant list on February 23, 2001.
This was an extremely sad time for our family. We were very afraid
of the possibility of facing the future without our daughter. There was
also the confusion of her ever changing health status and the desperate
wait for a new heart to become available. Eight days into our wait, the
doctors told us to prepare ourselves to say goodbye because they didn't
believe that Caitlyn could make it through the night.
But our tough little girl did make it through that night. Two days
later, surgeons at UNC attached a ventricular assist device to
Caitlyn's heart. This machine kept Caitlyn's heart pumping for the next
ten days as we continued our wait.
On the evening of March 14th, my husband and I had gone to the
hospital chapel to pray. We'd spent a lot of time praying and asking
God to inspire a family faced with the death of their child, to give
the gift of life to our child. It's a very difficult prayer to offer
up, but we prayed with a great deal of hope and faith that God would
show us His way. When we returned to Caitlyn's room a few minutes
later, we were told that a heart had been found for Caitlyn . We spent
a lot of time that evening praying for a very brave family that we
didn't know, but owed our future happiness to.
The eight hour transplant surgery began in the early hours of March
15th. One week after the transplant, Caitlyn was taken off the
ventilator. A dedicated team of doctors, nurses and therapists were
there with us to greet a little girl who was ready to live and play
again. Three days later, Caitlyn stood up and took her first steps in
nearly 1 1/2 months.
It's been 2 years and 3 months since Caitlyn's transplant. She went
back to school full-time this past school year and has just finished
the third grade. She loves to ride her bike to the playground, go
swimming, and play with the girls on our street. She's conquered a lot
of obstacles, including a post-transplant stroke, to return to a fairly
normal life. The doctors cannot tell us exactly what caused Caitlyn's
heart to fail, but they say she's a true miracle child.
This past February, we had the honor of meeting Phyllis and Nathan
Slifer, the parents of Joseph Michael Ebert, Caitlyn's donor. Joseph
was a sweet, big-hearted little boy who loved life. He was seven years
old when a dirt bike accident tragicly ended his life. When doctors
approached Phyllis about organ donation, she said yes right away. She
wasn't thinking about who would benefit. She was thinking about the son
she had just lost. But something inside told her this was the thing to
do. She did not want any other family to suffer the same loss that she
was experiencing. Phyllis and Nathan have found comfort knowing Caitlyn
and knowing that their son lives on through her. Joseph also lives on
in a 9-year-old girl who received his liver, a 23-year-old man who
received one kidney, and a 7-year-old girl who received his other
kidney.
The power of one organ donor is truly amazing. One donor can
potentially save 58 other lives; eight lives through the donation of a
major organ, and 50 lives through tissue donation.
There are nearly 81,000 patients waiting for an organ transplant
today in the United States. A new name is added to the list every
thirteen minutes. Caitlyn was very fortunate to have waited only 20
days for her new heart. A short wait is an exception rather than the
rule. Seventeen people die each day waiting for a transplant.
Today you will be hearing from many experts in the transplant field
on ways to help increase the number of organ donations. Educating the
American public on organ donation will hopefully increase the number of
organ donations and reduce the time that a patient must wait for a
second chance at life. Thank you for listening to our family's story.
We are truly blessed and we're glad to be able to share our story with
others in the hopes that it will encourage more people to give life and
become an organ donor.
Mr. Greenwood. Thank you, Mrs. Koller and Caitlyn.
Mr. Roth.
TESTIMONY OF JOSEPH ROTH
Mr. Roth. Chairman Greenwood, members of the committee,
subcommittee, good morning. I appreciate the opportunity to
appear before you and discuss an issue that literally is life
and death, that is of life-and-death importance for the tens of
thousands of Americans waiting to receive organ transplants.
I am Joseph Roth, President and CEO of the New Jersey Organ
and Tissue Sharing Network, the organ procurement organization
serving New Jersey. I am testifying today in my capacity as the
President-elect of the Association of Organ Procurement
Organizations, AOPO, the organization representing all 59
federally designated OPOs in this country.
First let me say I am deeply honored to sit at the same
table as such courageous people who have testified before me,
and I am humbled at the honor. I applaud the subcommittee's
leadership in holding today's hearing to examine how organ
donation can be increased. Even though our country is blessed
with the best medical technology and doctors, for a patient in
need of an organ transplant, it seems almost nothing can be
done to reduce the anguished wait for an organ to become to
become available. Far too often time runs out before an organ
can be found, if at all.
Over 80,000 people, as has been said, are waiting to
receive organ transplants. While 63 people receive transplants
every day, and thus a second chance at life, another 17 die on
the waiting list without getting the chance, simply because not
enough organs are available. The shortage of life-giving organs
is a serious and chronic problem that will not be resolved
without meaningful attention from policymakers.
Although there has been an increase in the number of organ
donors in recent years, the rate of increase has not kept pace
with the need of donated organs. Studies have found that less
than 50 percent of potential eligible donors actually become
donors. As a result, there is a significant potential for
increased organ donation to take place and for an increased
number of lives to be saved.
We simply need thoughtful policies to take advantage of
this potential. No single approach is sufficient by itself to
achieve large-scale increases in organ donation. The organ
procurement organization community, frequently in partnership
with the Department of Health and Human Services transplant-
related organizations and others, instead supports a multitude
of different but strategic approaches to address the national
organ shortage. I would like to highlight briefly a few of
them.
First, as part of a National Donation Initiative, Secretary
Tommy Thompson and HHS have launched a new program to implement
best practices in organ donation at the 200 hospitals with the
highest potential for organ donation. The program is designed
to increase organ donation rates at these hospitals to 75
percent of eligible donors. Since our national study indicates
that, with some local exceptions, 80 percent of eligible donors
can be found in 20 percent of the Nation's hospitals, primarily
large hospitals. We believe this effort, grounded in shared
accountability for organ donation needs broad-based support and
we look forward to promising results from this major
initiative.
Second, HHS and the Joint Commission on Accreditation of
Health Care Organizations are acting on recommendations by the
Secretary's Advisory Committee on Transplantation to establish
policies such that a hospital's failure to identify a potential
organ donor and/or refer the donor to the organ procurement
organization in a timely manner, as required by law, would be
considered a serious medical error. Major national meetings
have been planned to address how hospitals with these missed
organ donation opportunities would face appropriate review,
comparable to what currently is expected for major adverse
health care events.
Third, the placement of organ procurement organization
staff and hospitals to be onsite organ donation coordinators is
showing tremendous promise. The organ procurement organization
coordinators work directly with health care professionals and
families of potential donors to help them understand the
importance of donation. Hospitals in which OPO coordinators are
in place have experienced a significant increase in organ
donation, including in inner-city settings where higher consent
rates have been difficult to sustain. The Association of Organ
Procurement Organization strongly endorses Federal legislation
and funding to place Organ Procurement Organization
coordinators in all large hospitals.
Finally, the advancement of donor rights legislation by all
States is critical for giving organ donors control over their
decision to donate. Eligible individuals who have declared
themselves as donors deserve to have their wishes respected,
with no further authorization from family members necessary.
Donor rights legislation should ensure that an individual's
desire to give the gift of life is carried out.
AOPO believes that advancement of this approach, with
attention to public outreach, is a vital component of increased
donation. We also want to assure the public that sensitivity to
the needs and considerations of donors' families should not be
diminished. We intend to work closely with the National
Conference of Commissioners on Uniform State Laws on Donor
Rights legislation and other matters of significant import,
such as strengthened legislation regarding collaboration
between OPOs and medical examiners and coroners.
In conclusion, policymakers and the public alike need to
confront the challenge of organ shortage. Over 80,000 Americans
are on the transplant waiting list. They and the thousands more
who need transplants in the future deserve no less than a
sustained, broad-reaching effort to increased donation.
Approaches such as the ones I have described today give us hope
but are useless unless they are discussed and acted upon as
part of a national policy. We must work together to ensure that
no one will be denied the second chance at life given by a
donated organ.
Once again, thank you for the opportunity to testify today,
and I will be happy to answer any questions.
[The prepared statement of Joseph Roth follows:]
Prepared Statement of Joseph Roth, President Elect, Association of
Organ Procurement Organizations
INTRODUCTION
Chairman Greenwood and Members of the Subcommittee, I appreciate
the opportunity to appear before you and discuss an issue that
literally is of life and death importance for the tens of thousands of
Americans waiting to receive organ transplants. I am Joseph Roth,
President and CEO of the New Jersey Organ and Tissue Sharing Network,
the organ procurement organization (OPO) serving New Jersey. I am
testifying today in my capacity as the President Elect of the
Association of Organ Procurement Organizations (AOPO), the organization
representing all 59 federally-designated OPOs in the country.
PROBLEM OF ORGAN DONATION SHORTAGE
AOPO applauds the Subcommittee's leadership in holding today's
hearing to examine how organ donation can be increased. Even though our
country is blessed with the best medical technology and doctors, for a
patient in need of an organ transplant, it seems almost nothing can be
done to reduce the anguished wait for an organ to become available. Far
too often, time runs out before an organ can be found, if at all. Over
80,000 people wait to receive organ transplants. While 63 people
receive transplants everyday, and thus, a second chance at life,
another 17 people die on the waiting list without getting that chance
simply because not enough organs are available.
The shortage of life-giving organs is a serious and chronic problem
that will not be resolved without meaningful attention from
policymakers. Although there has been an increase in the number of
organ donors in recent years, the rate of increase has not kept pace
with the need for donated organs. Studies have found that less than 50
percent of potential eligible donors actually become donors. As a
result, there is significant potential for increased organ donation to
take place and for an increased number of lives to be saved. We simply
need thoughtful policies to take advantage of this potential.
APPROACHES TO INCREASING ORGAN DONATION
No single approach is sufficient by itself to achieve large-scale
increases in organ donation. The OPO community, frequently in
partnership with the Department of Health and Human Services (HHS),
transplant-related organizations, and others, instead supports a
multitude of different but strategic approaches to address the national
organ shortage. I would like briefly to highlight a few of them:
1) First, as part of a national Donation Initiative, Secretary Tommy
Thompson and HHS have launched a new program to implement
``best practices'' in organ donation at the 200 hospitals with
highest potential for organ donation. The program is designed
to increase organ donation rates at these hospitals to 75% of
eligible donors. Since our national study indicates that, with
some local exceptions, 80 percent of eligible donors can be
found in 20 percent of the nation's hospitals, primarily large
hospitals, we believe that this effort grounded in shared
accountability for organ donation needs broad-based support and
we look forward to promising results from this major
initiative.
2) Second, HHS and the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) are acting on recommendations by the
Secretary's Advisory Committee on Transplantation to establish
policies such that a hospital's failure to identify a potential
organ donor and/or refer the donor to the OPO in a timely
manner--as required by law--would be considered a serious
medical error. Major national meetings have been planned to
address how hospitals with these ``missed organ donation
opportunities'' would face the appropriate review, comparable
to what currently is expected for major adverse healthcare
events.
3) Third, the placement of OPO staff in hospitals to be onsite organ
donation coordinators is showing tremendous promise. The OPO
coordinators work directly with health care professionals and
families of potential donors to help them understand the
importance of donation. Hospitals in which OPO coordinators are
in place have experienced a significant increase in organ
donation, including in inner city settings where higher consent
rates have been difficult to sustain. AOPO strongly endorses
federal legislation and funding to place OPO organ donation
coordinators in all large hospitals.
4) Finally, the advancement of Donor Rights legislation by all States
is critical for giving organ donors control over their decision
to donate. Eligible individuals who have declared themselves as
donors deserve to have their wishes respected, with no further
authorization from family members necessary. Donor Rights
legislation would ensure that an individual's desire to give
the ``gift of life'' is carried out. AOPO believes that
advancement of this approach, with attention to public
outreach, is a vital component of increased donation. We also
want to assure the public that sensitivity to the needs and
concerns of donor families should not be diminished. We intend
to work closely with the National Conference of Commissioners
on Uniform State Laws on donor rights legislation, and other
matters of significant import, such as strengthened legislation
regarding collaboration between OPOs and Medical Examiners and
Coroners.
CONCLUSION
In conclusion, policymakers and the public alike need to confront
the challenge of the organ shortage. Over 80,000 Americans are on the
transplant waiting list. They and the thousands more who will need
transplants in the future deserve no less than a sustained, broad-
reaching effort to increase donation. Approaches such as the ones I
have described today give us hope but are useless unless they are
discussed and acted upon as part of national policy. We must work
together to ensure that no one will be denied the second chance at life
given by a donated organ.
Once again, thank you for the opportunity to testify today. I will
be happy to answer any questions.
Mr. Greenwood. Thank you, Mr. Roth. And I appreciate your
participation this morning. The Chair notes the presence of Mr.
Tauzin, the chairman of the full committee who has joined us,
and recognizes him for an opening statement.
Chairman Tauzin. Thank you Mr. Chairman and I appreciate
it. I really wanted to hear our witnesses before welcoming them
because I knew their stories would be compelling, and indeed
they were.
What you have assembled in this committee room today, Mr.
Chairman, is an example of the courage and generosity of the
organ donation story. And, Susan, your courage and the
generosity of donors like Bill and others who willingly join
these programs to help indeed extend the lives of our fellow
citizens is not just admirable, it's amazing; and we want to
thank you today for coming to share with us. I know it's
difficult, extraordinarily encouraging and an uplifting story.
And we also hear of the anxiety of those who wait and who
know that, you know, that organ transplants might make the
difference in not only quality of life, but their life itself.
One of my staffers is an organ transplant patient who has
gone through more than one transplant. She has gone through
transplant rejection and transplant again and a difficult
periods of complications and additional operations. I have
lived this saga with her all through these various operations,
and I know the anxiety she feels as she has gone through it and
waited, hoped and prayed, and eventually received an organ,
only to find out later on it was rejected and she had to go
through the process once again.
We also have with us an example of the joy of the success
stories in young Caitlyn and the extraordinary opportunities
that organ donations have made in the lives of not just young
people like Caitlyn but so many of our friends and relatives
and fellow Americans. And so we see it all today laid before
us: the courage, the generosity, the anxiety, the joy, and
success.
We are also looking at three features of the organ
transplant story. One we see the glorious sort of development,
and that is the amazing success and advancement of science in
this field, the extraordinary reach that science is extending
in terms of organ transplant, capability of survival rates. The
Wall Street Journal yesterday had a great story on new research
and the use of anti-rejection machines that may well extend
dramatically the success rates of organ transplants and
therefore the lives of recipients of organ donation.
We also celebrate the glorious success stories of Caitlyn
and others and we know have the benefit of that new medicine
now. At the same time, we witness the tragedy of people who
wait and wait, and suffer the anxiety of knowing that if only
an organ donor came forward with a match, if the science
advanced quick enough, that their lives might be extended.
At the same time, we also examine the promise of changes
and that are going to make a difference, I think in this organ
transplant story, and I hope as we hear the ongoing
recommendations and the ongoing suggestions for policy changes,
are going to make a difference in the success rates of the
program.
I think it's important we commend Secretary Thompson at the
Department of Health, who, as Governor of Wisconsin, turned his
State into a model of improving rates of organ donation. He
brought that same big heart, if you will, to the issue of how
can we make the Nation now a model for organ transplant rates
and for increasing the rates of donation throughout America. We
know the recommendations of his Advisory Committee on
Transplantation and we are going to hear this morning about
what those recommendations consist of and how quickly can we
implement.
But we will do something later on in the third panel that I
wanted to highlight, and I wanted our colleagues to hear this.
Not so long ago--I love ``Discover'' magazine, it is a great
lay science journal and I read it every month when it comes
out--and not so long ago, in an issue of ``Discover'' volume 22
number 7 July 2001, I read of a pair of brothers in
Massachusetts who were doing some extraordinary work on cell
regeneration and cell growth and tissue engineering. And the
story in ``Discover'' magazine outlined how the Vacanti
brothers in Massachusetts discovered spore-like cells and human
mammalian tissue. That they began to work with that seemed to
have potential capabilities much like stem cells; in fact,
extraordinarily using these spore-like cells, they were able to
build biodegradable scaffolding structures that were able to
create bridges and damage tissue.
In the story--these are the guys that you might recall that
built the human ear on the back of a mouse, reconstructed it.
We are not just talking about organs that might save human
lives, we are talking now about the possibility of using your
own tissue to regenerate organs, to regenerate features of the
human body that were missing or damaged, such as an ear, a
damaged pancreas that might need to produce insulin, or a
damaged lung that might need to be repaired. In fact, I think
they took a lamb's lung, living tissue, and removed it and
built the scaffolding; and with the spore cells from that lamb,
rebuilt that lung tissue, according to this story, which I
think is about 14 different types of cells regenerated and
reconstructed. They took rats and severed their spines and
regenerated in some cases a spinal connection using these spore
cells.
Now, Dr. Vacanti, I think, is going to be here on the third
panel, but it is going to be an amazing panel. If this is true,
if this is the future of medicine, of tissue regeneration and
tissue engineering, what extraordinary promise science may hold
yet in terms of not only waiting for someone else to donate an
organ to you but the potential or capability of your own body
tissue, these spore-like cells that could be used to regenerate
organs and tissues that are missing or damaged in the human
body.
And so today it is a story of tragedy, but also success and
glory and promise. And in structuring this subcommittee, Mr.
Chairman, I want to thank you for doing it because you have
laid it out for us in the future panels. And from it all I hope
we can be a force as a committee to encourage the
implementation of some of these ideas and the advancement of
some of these technologies and to spread the hope and to spread
the success stories and to cherish and celebrate the courage
and the generosity of American donors, and to end the anxiety
of those who wait, like Reginald, and so many others like you.
So again, Mr. Chairman, this is an extraordinary hearing
you are conducting today, and I wanted to encourage you and the
members of the subcommittee and the full committee to take this
as a very important first step, but to walk the long mile until
we fully explore all the promise that this hearing is going to
lay before us.
And I thank you and yield back the balance of my time.
Mr. Greenwood. The Chair thanks the chairman for his
statement and recognize myself for 10 minutes for questions.
Let me tell you that the primary motivation for me to hold this
hearing and to bring all of our witnesses today is to learn how
we can expand dramatically the number of organs that are
donated so that we stop what's happening in America right now,
and that is 16 or 17 people dying every single day, waiting for
an organ.
That's 6,000 people a year, while a number comparable to
that, 6,000 people are buried or cremated with perfectly good
organs that could save the other 6,000 lives but don't. So we
know that so many different programs have been attempted to try
to expand the number of potential donors, but with little
result, frankly. The percentage of Americans who are donating
organs is pretty much of a flat line.
And so I want to--I want to make sure that what happened to
Caitlyn happens to Mr. Augustus. And I want to make sure that
the heroism of Ms. Kantrowitz--the accent is on the first
syllable, right, Kan'trowitz--is something that every American
that has the opportunity makes.
And so I want to ask this question. Now, you heard in her
opening statement the gentlelady from Colorado, Ms. DeGette,
express in very strong terms her opposition to any financial
incentive, and she correctly states that for most of our
history that has been the policy of not only of the Federal
Government, where it still is, but of most organizations,
ethical organizations, medical organizations. That's changing.
The AMA has said now that it favors at least study on what
might be the impact of financial incentives.
I will tell you candidly that I don't share the
gentlelady's view on this. I take the opposite view. I believe
in financial incentives, that could for instance place Federal
dollars into the estate of a donor, would probably serve as an
incentive to get--we know that many Americans voluntarily check
off the form when we renew our driver's license or in some
other way we fill out an organ donor card. But many Americans,
most Americans I believe, don't do that.
So the question is, would some kind of--would the notion
that you can leave something a little extra in your estate for
your family, should the unusual circumstance occur to you as
happened to Mr. Kantrowitz, would that expand the donation rate
and would that save more lives? And to me, saving an additional
life or thousands of lives certainly overcomes any ethical
argument that I can see for creating a financial incentive. So
I just want to go down the panel and ask--I don't know if you
have thought about these things--but I'd like to ask each of
our witnesses whether--what your view is of that.
Ms. Koller. I do not believe that compensating someone for
this gift should be necessary. I think that there are many
Americans who are quite willing to make this gift, and I'm
hoping that through more education that more Americans will be
organ donors. So I don't agree with the idea of compensating.
One interesting thing, though, when my parents went to
renew their licenses in Georgia, they were given a $5 discount
for signing up to be an organ donor, which I thought was quite
interesting. And they took it. And so maybe just something
little like that could be something that, you know, we could
consider just a suggestion to the States maybe, just to make
people stop and think about it for a second, because I think
that a lot of people do want to donate but they just don't
think to do it at the time when they are renewing their
licenses.
Mr. Greenwood. Okay. I thank you very much.
Ms. Kantrowitz.
Ms. Kantrowitz. I'm not sure that compensation would have
made a difference in whether I chose to donate Bill's organs
and tissues, and I do believe that education is key here
because there is so much out there that works against organ
donation. However, I am open to financial compensation, and I
think the key here is the type and amount of compensation
you're talking about. Are you talking about giving people
money? Are you talking about helping with funeral benefits? Are
you talking about support and grievance help? Are you talking
about help with the children afterwards? There are so many ways
I think that you can do that without actually just handing
people cash to make it seem--it just--actually it just seems
horrible that somebody would pay me money for my liver. On the
other hand, you know, there are people dying and we need to
create an incentive.
So what other kinds of contributions can you make to that
person? I would be in favor of looking at that. I'm not--I'm
not saying that I'm not open to downright cash. I'm just saying
I would like the committee to look at other ways such as I just
suggested.
Mr. Greenwood. And if I may add, before we continue, I'm
not aware that anyone has considered a cash payment to a person
while they are alive. The question would be some kind of an
insurance policy that would be reclaimable by the estate in the
event where someone dies and their organs in fact are donated.
Mr. Augustus.
Mr. Augustus. As you mentioned before, there are some
strong ethical concerns in regards to, you know, any type of
financial or monetary payments to somebody or someone's family.
You just have to be careful when you know you're talking about
this, because this could open, you know Pandora's box, you
know. To do something like that, you know, you could have, say,
people out here widespread trying to, you know, if you start
with--let's say there's somebody, as she mentioned before, if
you just want to pay for their funeral services or give some
type of benefits or some type of insurance plan, then what's
going to happen after that? Someone's going to continue to try
to push the envelope and, you know, then you'll have people out
trying to get, you know, thousands of dollars, you know, to get
the organs for people who have low income. There could be a
variety of reasons.
You know, there's other countries where that does happen,
where people actually sell their organs, you know, I guess on
the black market. But, yeah, I have some concerns about that,
you know; how would you go about doing that? I mean, that's a
very slippery slope you'd slide down if you tried to do that.
And that's----
Mr. Greenwood. Thank you, sir.
Mr. Roth.
Mr. Roth. Mr. Chairman, the Association of Organ
Procurement Organizations has said as a public policy that they
would support well-controlled public demonstration projects,
pilot projects, as you know. But, again, what shape those
should take is really to be determined by the entire community
and not just by AOPO.
Mr. Greenwood. Okay, thank you. In the time that remains,
one of the approaches--I'd like to address this question to
you, Mr. Roth. One of the approaches to increasing organ
donation that you mentioned is placement of OPO organization--
organ procurement organization staff in hospitals to be onsite
organ donation coordinators. At the present time, how does OPO
staff interact with the hospital in the organ donation process?
Mr. Roth. Under the Federal conditions of participation,
Medicare conditions of participation for organ donation, all
Medicare hospitals must refer potential--well, all deaths and
potential--imminent deaths to the OPO servicing them in a
timely manner. An imminent death is someone who may be on a
ventilator who meets certain criteria that would lead to brain
death. That would allow the OPO to triage the referral and then
send a staffer, someone we call a transplant coordinator, that
is usually a highly trained nurse or ancillary medical
professional, to go onsite to do a chart review and determine
whether that potential donor could possibly become a real
donor.
Of course, at that point, we interact with the staff in the
hospital. Sometimes that's a very good collaborative type of
system. The conditions of participation require that the
hospital and the OPO work collaboratively to determine how they
would approach the family for donation. Again, that doesn't
work in 100 percent of the cases. It's a system that--where we
spend a lot of time developing the hospitals to understand the
protocol, but there's staff turnover at times, people who
haven't been hit in a timely manner. But for the most part, we
try to deal with a collaborative approach to the family, when
brain death is declared, to offer them the option of donation
at that point.
Mr. Greenwood. In your opening statement you said that
inner-city hospitals have difficulty sustaining high consent
rates for donation. Do you know why that is?
Mr. Roth. It's a cultural issue, I believe. It's the
demographics of the inner city. There are a lot of myths and
misconceptions about organ donation, Mr. Chairman. For
instance, there are beliefs by people that it is against their
religion to donate. Well, in fact, there is no prohibition by
any major religion against donation. In fact, in most religions
it's considered the highest charitable act. I believe Pope
John, 2 years ago, issued a statement in Rome saying that it's
a Catholic's duty to become an organ donor if the option is
presented to them. So it is not--there is no major religious
prohibition.
There are other myths and misconceptions that are
perpetrated by the media, by television, and so on, such as
organs being sold for profit within the country, people being
found in alleyways cut up with organs missing. Those are all
myths. That's never happened in this country. But again they
are perpetrated and people get scared when they have to think
about the finality of their life. And that's what really I
think gets to the crux of the matter. When you talk to somebody
about organ donation, you're talking to them about them dying
because you have to die to become an organ donor, and most of
us just don't want to discuss that.
Mr. Greenwood. Right. Okay, thank you. My time has expired.
The gentleman from Florida is recognized.
Mr. Deutsch. Thank you, Mr. Chairman. Thank you all for
being here today and sharing your stories of pain and
frustration and joy in times of bereavement. The decision of
whether or not to donate a loved one's organs can indeed be a
difficult and trying choice to make.
Mrs. Kantrowitz, I have to commend you for your bravery,
strength, and generosity in choosing to give life to others
while you yourself were forced to face the tragic loss of your
husband, as well as the idea of having to live day in and day
out with the knowledge that there is nothing a parent can do to
help their critically ill child is a terrifying and humbling
reality for many families.
Ms. Koller, I cannot tell you how happy I am to hear your
daughter's good fortune, improving health as a result of a
heart transplant. I wish her a full and happy life filled with
many joys. Unfortunately Mrs. Koller's story of a successful
transplant is not a more common occurrence today.
Mr. Augustus, I am sorry for the pain and suffering but I
am nevertheless impressed and touched by your dedication to
this cause and your obvious courage. I wish you the very best.
I can only hope that you will be able to receive a successful
kidney transplant sometime in the near future. Thank you for
being here, and you know that our thoughts are with you during
this difficult time.
I would like to inquire as to whether or not any of you
have any recommendations about how to increase organ donations
in the United States; specifically, any programs, proposals,
ideas, that you have heard about or read about that are
especially noteworthy or deserving of more consideration.
Ms. Koller. In North Carolina, we recently added a
curriculum unit to the ninth and tenth grade health curriculum
and so all ninth and tenth graders are introduced during a
health education class to organ donation. So that's the new
initiative being done in North Carolina.
Ms. Kantrowitz. I would agree with that. I think education
at an early age is very very important. When I was in the
fourth grade--and we won't say how long ago that was--there
were these two ugly lungs in my science class. And they were
the antismoking campaign. And to this day, I can see those ugly
lungs in my mind. And my parents smoked and I never did. I
never did that once.
Part of the problem is that when I'm thinking about--when
someone's thinking about organ donation, they are in the midst
of a tragedy. I mean, their loved one is going to die; and then
to be hit with ``And are you ready to give up their organs?''
which is not what the hospitals are necessarily saying, but
that's how it appears to someone in that spot. You know, wait a
minute, you're taking my husband from me and now you want his
organs and tissues, too. If you're not well versed or even
familiar with what goes on, it's very difficult to make those
decisions.
So anything you can do, starting young, or even hitting
adults to educate--you know, a public education campaign I
think is only helpful because it gets people thinking. I think
the gentleman is right. It has to do with thinking about your
mortality. But at the same time, then, when the hospitals do
come to you and say are you willing, at least you've heard of
it, you understand what's going on and what's at stake. To wait
till the tragedy occurs is difficult.
Mr. Deutsch. Mr. Augustus.
Mr. Augustus. I have to agree with these two ladies here
that education, first and foremost, is probably the most
important thing that we need to do. You know, get the awareness
out to the community, you know. That will really help to get
people to understand who are ignorant to, you know, as you
mentioned before, really what organ donation is all about and
the myths and things like that.
Speaking on other programs that they have, I had read some
time ago about the process that she was saying before, when it
wasn't an option for her husband's friend to get the organ, if
you have one willing ready to give and if they have a match for
him somewhere else, they could switch; which I don't see that
there's anything wrong with that if there's an organ that wants
to be donated, there's another organ, and this person needs
this one and this person needs that one. And I saw where they
have done that here, even in this area, at the Washington
Hospital Center. I think it was in the Post. It was maybe over
a year ago now. But they have a program, I don't know how much
anyone's aware of that, where they can do that, where you can
actually if you have an organ for a donation, you can get a
match for someone else and they can get a match for what you
need it for.
Mr. Deutsch. Mr. Roth.
Mr. Roth. Thank you, Mr. Deutsch. I have laid out four
issues that we support, obviously, as policy positions that
should be looked at as ways to increase organ donation. And I
support many of the comments made here at the table by the
other witnesses.
Certainly education is important. Look at how much money
has been put behind smoking and drug abuse and it's had some
impact, obviously. That should happen to organ donation.
I certainly applaud Congress in the last few years for
making appropriations available for grants and research into
organ donation. And I say more should be done. The last
appropriation for organ donation was around $10 million. When
you think about that compared to organ donation--I mean to
smoking and to drug abuse, antidrug abuse campaigns, it's just
a drop in the bucket. We're looking at a need for a campaign
that crosses generations. As was said, you have to start early
to change people's ideas. With the diversity of our country,
one message is not enough. We have to talk about many messages
to help people understand why it is important that they become
organ donors when the option is presented to them.
Mr. Deutsch. Thank you. Mr. Roth, in your testimony you
state that your organizations supports implementation of best
practices at the 200 hospitals with the highest potential for
organ donation. You further state, ``We believe that this
effort, grounded and shared accountability for organ donation,
needs broad-based support.'' Could you please elaborate as to
exactly what those practices should be?
Mr. Roth. Well, the interesting thing is when one examines
the organ procurement organization community, you will find
that there's no one best practice. When you walk into one
hospital, you've only really seen one hospital. Each hospital
is a culture unto itself. Each organ donation region is a
region unto itself. One has to look at the uniqueness of those
donors, donation service areas, to see what might work best
with them.
One thing we think that has great potential across all the
OPO community is the in-hospital transplant coordinator. The
early data from pilot studies in several different locations
have shown a substantial--a potential for substantial increase
in organ donation in high-potential hospitals. We certainly
support Secretary Thompson's initiative to look at best
practices and work toward improving the consent rates in the
200 hospitals with the highest donation potential. That in
itself could probably yield some significant results when it is
fully implemented.
Mr. Deutsch. What department within HHS would be
responsible for this implementation that you described? How do
you view it?
Mr. Roth. It's under HRSA, the Division of Transplantation.
Mr. Deutsch. You shared--when you spoke, you shared about
the accountability within the organ donation community. I guess
what I hear you saying, that there's no one successful program;
that it really is multifaceted. And how do you sort of judge
that in terms of evaluating those types of programs?
Mr. Roth. Well, I mean in my service area, northern New
Jersey, we have one of the most diverse populations in the
country. And the messages that we have to get out to the
various constituencies we deal with, from the people, you know,
the citizens of that area, to the staff of the various
hospitals that we serve is different for each different group.
We have--we work very closely with the African American
community. We work very closely with the Latino Hispanic
community. We approach the Hispanic--I mean the Asian
community, and each one of those takes a different message.
Yet in some areas of the country, they don't have as much
of that diversity, so their approach is different as to how
they address their communities. And so one has to look at how
one has to focus their resources. And our resources obviously
are limited so as a not-for-profit agency, you know, there's
just so much we can put behind donor enhancement education
efforts.
Mr. Deutsch. You state in your testimony that you believe
onsite donation coordinators show tremendous promise. Is
funding the major impediment to deploying OPO coordinators in
all large hospitals? And also has HHS been receptive and
supportive of that proposal?
Mr. Roth. The answer to the first question is funding, yes,
is crucial to this project. And yet--and the second question
is, yes, HHS has been supportive. The results of the pilot
studies are as a result of a Division of Transplantation grant
to look into that.
So the thing about in-house coordinators, Mr. Deutsch, is
that studies have shown that there are several things that
impact the immediate donation situation. One of them,
obviously, is recognizing the potential donor in a timely
manner. Things happen out in the system. The trauma departments
change the way they address patients that are brought in with a
traumatic injury. One of the things we're seeing in our service
areas is that the trauma departments are moving toward earlier
asking of families for a ``do not resuscitate'' or DNR order,
which they then implement as a do not treat. So by the time we
get onsite, the potential donor may not be as viable for
donation as we would like them to be. So we're actually moving
to get onsite earlier, before this discussion goes into place.
But there are other issues that go on. A lot of it is how
the family is treated when they go onsite for their loved one's
crisis. Here is a family in crisis. And a lot of them walk into
the hospital, and nobody's paying attention to them. Now, it's
not because they're deliberately not paying attention to them;
it's because if you walk into a trauma unit that's very busy,
people are running around trying to save lives. So having an
in-hospital coordinator onsite who can address the needs of the
family during their time of crisis can hopefully predispose
them toward donation.
Mr. Deutsch. If I can just ask for unanimous consent that
the ranking Democrat on the full committee's statement be
entered into the record.
Mr. Greenwood. Without objection, it shall be.
The gentleman from Oregon is recognized for 10 minutes.
Mr. Walden. Thank you, Mr. Chairman. I don't have a lot of
questions, but I guess just a reflection on some of the
comments, and I appreciate your testimony.
I think for a lot of people when they think about organ
donation, what happens to a loved one, you almost in your mind
conjure up a picture of Frankenstein and pieces being put
together, and so I think your comments about the need for early
education are extraordinarily important so people understand
early on in the process just what's involved at a young stage
in their lives, so it just becomes a natural thing to do. And
certainly the more we can facilitate the decision way ahead of
time, the better.
And that's where these license--driver's license programs
make a lot of sense. And I wonder, too, about any work that's
being done with health insurance companies. It seems to me--or
life insurance companies--that as you go through those
processes, signing up for life insurance or health insurance,
that maybe there's another opportunity to network and make this
opportunity available and work on the education point.
Mr. Roth, or any of you, would like to respond?
Mr. Roth. If I might just, you know, Secretary Thompson has
implemented the Business Partnership for Donation in which they
are recruiting corporations, working with the organ procurement
community and transplant community, to recruit businesses all
across the country to implement organ donation. So your
question, Mr. Walden, actually goes much further, where you're
taking it past the insurance companies to major corporations,
small businesses and so on, to where you can implement programs
to talk up donation amongst the employees of that business.
Mr. Walden. But do you know on the issue of health
insurance and life insurance----
Mr. Roth. On the insurance, no, there is nothing that I am
aware of at this moment.
Mr. Walden. Is there a check-off that we can encourage?
Mr. Roth. No, I'm not aware of that at the moment.
Mr. Walden. At least when you sign up for your driver's
license in a State like Oregon, you get that option. You make a
decision. And I just wonder if that might be another way to get
people to make that decision.
Mr. Roth. That's certainly worth discussing.
Mr. Walden. Does anyone else have a comment along those
lines?
Then the other issue I have is just if you could speak to
the issue of the advancement in immunosuppressant drugs and how
this is evolving, and I'd be curious from a firsthand status to
OPO.
Ms. Koller. Caitlyn is doing very well on her
immunosuppressants. Over the last 2 years they have been able
to go lower and lower so that she's on very few drugs at this
time. But of course, we're always interested in what the drug
companies are, you know, researching in hopes that they can get
her on a drug with the least amount of side effects as
possible. But we have been very fortunate. There's very few
signs of rejection, so she's doing very well on her
immunosuppressants.
Mr. Walden. And what about cost and coverage? Does your
insurance----
Ms. Koller. Once again we are very fortunate, because her
immunosuppressants would cost us well over $1,000 a month,
probably closer to $2,000 a month. And because of our copay
situation, I would say that her monthly cost of medications may
be about $60. But we are blessed to be under a very good
insurance program. Our benefits will go up to $2 million, I
believe, for her.
Mr. Walden. You're worried about the cap.
Ms. Koller. Right. And the insurance company has assured us
it takes a long time to rack up bills of $2 million. So--but I
know that we're probably halfway there, at least to the million
dollar mark, because just the whole cost of being in an
intensive care unit for so long and a rehab hospital. So at
some point we may be, you know, forced with the decision of how
are we going to pay for drugs, especially if we hit that cap at
any time.
Mr. Walden. Right. Okay. Any other comments? Mr. Augustus.
Mr. Augustus. When I first got set up----
Mr. Greenwood. Go ahead and pull it right up to you.
Mr. Augustus. When I first got set up at the Washington
Hospital Center a couple of years ago on the transplant list, I
went through a process where I spoke with the social worker,
transplant coordinator, the surgeon. We went through a whole
list of people and they explained that process. And it is quite
expensive for the immune suppressant drugs. But they've--from
what they've told us and what, you know, I've learned is that
they've come a long way, finding out what works best, they
adjust them depending on the person's body and how they affect
them. They try to get down to the lowest dosage as possible.
But it is expensive.
And for a person who is on dialysis, such as myself, under
55 you can get Medicare, which I do have as my secondary
coverage and I believe that they pay, they told me, about 80
percent of those immune suppressant drugs. But I believe that
currently, after 36 months after a transplant or if you come
off dialysis or anything, the Medicare will be gone if you're
under 55. So that is a concern because they are expensive. But
I think they're trying to pass legislation now to get it for,
you know, for a lifetime. But I don't know right now what the
current status is, but I know about a year and a half ago they
just got it where certain people who met certain criteria could
get it for a lifetime. But I don't fall under that category at
this time. But they're working to try to get that.
Mr. Roth. Mr. Walden, I'm not a physician so I can't
comment on the medical aspects of immunosuppression. I can echo
what I do know about the cost. Certainly a lot of tremendous
progress is being made daily in the development of new
immunosuppressants therapies: Witness the article in
yesterday's Wall Street Journal. And having worked in the
pharmaceutical industry for 20 years before I entered this
field, I do know that they are working at it.
Certainly there are going to be a lot of breakthroughs in
the next 10 to 20 years. But as Mr. Augustus pointed out, the
cost of immunosuppressant therapy is certainly a substantial
issue for people waiting for transplant and people that receive
transplant.
There have been some improvements in the coverage for the
safety net for people who don't have the insurance coverage,
but I'm not sure it's enough. And in the context of today's
debate about outpatient Medicare drug coverage, this will get,
you know--this is subservient to that coverage. But I do
believe that if a person--if the country is willing to pay to
have a person transplanted, there's got to be a way to cover
them to maintain the integrity of that organ for the life of
that organ as opposed to telling them that there's going to be
a cutoff after 36 months if they don't have a sufficient drug
coverage for that.
Mr. Walden. Okay. Thank you.
Mr. Greenwood. Would the gentleman yield?
Mr. Walden. Absolutely.
Mr. Greenwood. I just wanted to ask, Mr. Roth, are you
aware of individuals in this country who either don't get
transplants or don't gain--have continued access to the anti--
--
Mr. Roth. Immunosuppressants.
Mr. Greenwood. [continuing] immunosuppressant drugs for
lack of insurance and for lack of funds?
Mr. Roth. I am not immediately aware of anybody. There have
been stories of people who have had to have fundraising
campaigns to pay for transplants and so on. I personally am not
aware of that. And I'm personally--I have heard stories that,
again anecdotally, about patients who have had to stay on
disability--who could be leading a productive life--but if they
stayed on disability, they will get their drugs through some
program or another. And the shame of it is, is here are some
people who could be productive in America, make money, pay
taxes, help pay for their costs, but have to stay on disability
so they can get their immunosuppressive therapy.
Mr. Greenwood. Ms. DeGette and I were having a side-bar
conversation a little earlier about the financial issues, and
it seems to me that this country spends an enormous amount of
money on dialysis that goes on for years and years and years.
We spend an enormous amount of money through Federal health
programs, as does the private sector, on people who are
patients in hospitals only because they are waiting for organs
so that they can leave. So it seems to me that the cost/benefit
analysis goes--always is improved by having the donation
available and having that transplantation occur, not only
talking about the measures of living and extending lives and so
forth; but from a pure dollar-and-cent perspective, I think it
makes sense to do everything we can to get the organ donations
going.
The gentlelady from Colorado is recognized for 10 minutes.
Ms. DeGette. Thank you, Mr. Chairman. And I agree. As I
mentioned, I'm the co-chair of the Diabetes Caucus, and as well
as kidney transplants--it occurred to me when Mr. Tauzin was
speaking about the tremendous potential of islet cell
transplantation in actually curing diabetes and how critical
pancreatic organ donation is for diabetes research. And as the
chairman says, if we can increase islet cell transplantation
and refine it, the hundreds of millions of dollars that would
be saved every year in diabetes treatments will be
significant--not to mention the increase in the quality of
life.
I want to add my thanks particularly to these three
witnesses at this end of the table for coming. I was mentioning
to counsel that I think your testimony has been some of the
most compelling and poised testimony that we've heard in this
committee for many years. So I want to thank all of you for
your perspectives. It never hits home harder than when you hear
people's personal stories of what they live with every day.
And, Ms. Kantrowitz, in particular, I want to say how sorry
I am for your loss and how courageous you are to be raising
these boys by yourself now. But it must give you some comfort
in knowing that 13 lives have been saved.
I wanted to ask you, Mr. Roth, about a couple of things. As
I said, I've been interested in pediatric transplantation for a
number of years and have passed legislation. When Ms. Koller
was testifying about how Caitlyn was at the top of the list for
heart transplants, I don't think a lot of people intuitively
realized what I learned a few years ago, which is that
pediatric organs can be used in adults but adult organs cannot
be used in children. Yet for many years, what happened on organ
donation lists was everybody would just be placed on the list,
irrespective of age. And if your name came up first, then you
would get the transplant, whether or not it was--in other
words, adults were getting pediatric organs when there were
very sick children like Caitlyn on the list. And to add to that
problem, with many diseases, adults that might have--liver
disease is an example. Adults that might have those diseases
would be able to sustain life through treatments or dialysis
for much longer than kids with pediatric diseases.
And so what my legislation was aimed to do and what I've
heard anecdotally from different folks involved, is it was
aimed to give--it seems so simple but yet it wasn't happening--
is kids would have preferential treatment on organ donation
lists for pediatric organs.
I'm wondering if you can tell me what the status of that is
right now through the different organ networks. And is that
happening?
Mr. Roth. Yes, Ms. DeGette, and I'm sure that Dr. Metzger
and the follow-on panel could address that in more detail.
Ms. DeGette. I'm planning to ask him.
Mr. Roth. But there have been some substantial changes made
to the allocation paradigms to try and give preference to
pediatric recipients.
Ms. DeGette. And has that been done on a voluntary basis?
Mr. Roth. It was done through the UNOS policymaking
procedure.
Ms. DeGette. Great. Thank you. And has that helped kids get
access to pediatric organs?
Mr. Roth. I don't have the figures.
Ms. DeGette. Well, I'll ask him. A second thing I wanted to
ask you, because you testified about donor rights legislation--
--
Mr. Roth. Yes.
Ms. DeGette. And that seems to me to be a big issue.
Listening to Ms. Kantrowitz talk about the very difficult
decisions--here you are and your loved one is unexpectedly
dying before you, but yet they are alive. You know they can be
kept alive, and how hard it is--you know, I don't think we
should infer bad motives to the family members, but you know
they've got someone and they're essentially brain dead, but
they can see them breathing or perspiring or whatever.
I'm wondering what the status of donor rights legislation
is, because that seems to me to be something that would really
not just help increase the percentage of organ donations, but
increase the level of comfort for the families as they're
sitting there in this very difficult situation.
Mr. Roth. Right now I believe there are 19 States that have
donor rights legislation in some form or another, including my
State, New Jersey. I think there are several issues still that
attend to donor rights legislation. First and foremost, the law
does make the donor's decision inviolable, so that if they
legally executed an organ donor card, an advance directive, a
living will, that says they wish to be a donor, their family
cannot--and a majority of their family cannot deny that
donation.
Where we find the difficulty in implementing those laws is
in finding out if those wishes have been made. There are donor
registries, but they don't--they aren't sufficiently large
enough yet to catch everybody that could possibly have donated.
There have been attempts to make living will registries and so
on.
There are other potential issues which have not been
broached as yet as, you know, the scenario where a family
objects so strongly that the hospital staff will not assist the
organ procurement organization in recovering the organs. That
has not happened, but that is certainly something that's out
there to discuss about this. And if the family does not wish to
move ahead with the donation, we would have some problem
because we have to go to the family to ask for a medical social
history so that we can have the appropriate information.
Yet I do believe, and as we state in our publicity, the
Coalition on Donation, you know: Share your wishes, share your
life. Not only should a person sign an organ donor card, become
a willing organ donor, but make it known very strongly to their
family members. Many times a patient is brought in in a
traumatic injury to a hospital, and we can't find a document of
gift because it was left at home or something like that. And if
the family is not sure what the donor's wishes are, many times
the default answer is no, just because they're not sure what
that----
Ms. DeGette. And I assume folks are exploring better
registries, better ways to give.
Mr. Roth. Yes. The HHS has looked at that. There has been a
consensus on that.
Ms. DeGette. A second question I have is, you mentioned
that many people assumed that there are religious reasons for
not donating. Has your organization or other organizations made
an effort through churches to educate? Can you talk for just a
moment about that?
Mr. Roth. Yes. Certainly every organ procurement
organization in the country has some outreach program to clergy
within their service area. There is a national donor Sabbath in
November, which all organ procurement organizations make a
concerted effort to have clergy speak from the pulpit during
that Sabbath to talk about organ donation. But clearly, having
councils or task forces or advisory committees involving
churches is an important part of an organ procurement
organization's public education.
Ms. DeGette. I was just thinking, for example, in Denver
our Black Ministerial Alliance sponsors Diabetes Day at the
black churches at all the Baptist churches and some others, and
they have diabetes educators and others. I would think we could
even ratchet the organ transplantation and donation up a notch,
you know, and have people really preaching from the pulpit on
this especially, as we were discussing, in urban communities
where donation rates are lower but the need is higher.
Mr. Roth. Well, Ms. DeGette, as you're pointing out, it is
a question of just having many voices out there talking about
organ donation.
Ms. DeGette. Yes. And my last question to you is do you
know about any efforts for, say, public service advertising on
television and radio outlets?
Mr. Roth. I know that, again, as part of our public
relations campaigns, most OPOs do get public service
advertising in outlets all around the country.
Ms. DeGette. Do you know what the level of that is at all?
Mr. Roth. I can't give you any numbers on that at all. I am
just not aware of what the numbers are.
Ms. DeGette. Is that information out there? We could obtain
that? The lady behind you is shaking her head yes.
Mr. Roth. Yes, I believe that information is out there.
Ms. DeGette. Mr. Chairman.
Mr. Greenwood. She's testifying next.
Ms. DeGette. Oh, she's testifying next. Good. I'll ask her
then. Thank you very much and I will yield back the balance of
my time.
Mr. Greenwood. The Chair thanks the gentlelady. The Chair
thanks our witnesses for your courage in being here this
morning and for your advising this committee. You are excused.
And we'll call forth our next panel which consists of Ms.
Michelle Snyder, who is the Director of the Office of Special
Programs, Health Resources and Services Administration, HRSA;
and Dr. Robert Metzger, M.D., President-elect of the United
Network for Organ Sharing. We welcome both of you. Thank you
for being here.
As you know, this is an investigative hearing and it's our
practice to take our testimony here under oath. Do either of
you have any objections to giving your testimony under oath?
Seeing no objection, I should advise you that you have the
right to be represented by counsel pursuant to the rules of the
House. Do either of you wish to be represented by counsel?
Okay. In that case, if you would stand and raise your right
hands.
[Witnesses sworn.]
Mr. Greenwood. I think we need to ask the gentleman to my
left to identify himself.
Mr. Aronoff. Yes. My name is Remy Aronoff, and I am with
Michelle Snyder.
Mr. Greenwood. Okay. All right.
Ms. Snyder, you are recognized for an opening statement.
TESTIMONY OF MICHELLE SNYDER, DIRECTOR, OFFICE OF SPECIAL
PROGRAMS, HEALTH RESOURCES AND SERVICES ADMINISTRATION; REMY
ARNOFF, DEPUTY DIRECTOR; AND ROBERT METZGER, PRESIDENT-ELECT,
UNITED NETWORK FOR ORGAN SHARING
Ms. Snyder. Thank you. Good morning, Mr. Chairman and
members of the subcommittee. My name is Michelle Snyder and I
am the very newly appointed Director of the Office of Special
Programs within the Health Resources and Services
Administration. Accompanying me today is Mr. Remy Aronoff who
is the Deputy Director of the Office of Special Programs, who
will assist me in answering any questions that you may have.
We are pleased to appear before you----
Mr. Greenwood. I believe you've been on board about 3 weeks
now.
Dr. Snyder. Well actually 2. I took a week off.
Mr. Greenwood. Welcome.
Ms. Snyder. We are pleased to appear before you today to
discuss organ transplantation and donation, a topic that is one
of Secretary Thompson's highest priorities. In fact, I think it
is safe to say that the Secretary is passionate about
increasing organ donation and transplantation, the true gift of
life.
We have seen many recent examples of the selfless giving of
individuals from many walks of life in our country. Some of the
most selfless and unheralded people are those who sign organ
donor cards and share their decision with their families and
loved ones, families who decide to donate the organs of a loved
one who has just died, and living donors who agree to share a
kidney or part of a liver or bone marrow.
I am proud that many important efforts in organ donation
and transplantation reside in my agency, the Health Resources
and Services Administration. On October 19, 1984, when
President Reagan signed into law the National Organ Transplant
Act, he said, I believe that that act strikes a proper balance
between private and public sector efforts to promote organ
transplantation.
Almost 20 years later, that private/public relationship is
a productive one. HRSA's Division of Transplantation oversees
the contract held by UNOS, the United Network for Organ Sharing
that runs the Organ Procurement and Transplantation Network, or
OPTN. The OPTN, whose numbers include the professionals
involved in the donation and transplantation system, maintains
the organ wait list and matches patients to donor organs 24
hours a day, 365 days a year.
Today there are over 80,000 people awaiting an organ. We
estimate that 17 people die each day while waiting for an
organ. We need to close the gap between the number of people
needing organs and the number of organs available. We and our
transplant community partners are currently involved in a
couple of activities that are intended to increase organ
donation and improve the transplantation system. I'd like to
mention some of them briefly and refer you to my written
testimony for details.
The Workplace Partnership for Life, which is part of
Secretary Thompson's Gift of Life Donation Initiative, reaches
out to people in their workplaces to increase awareness of the
needs for organs. So far, over 7,000 businesses of all sorts
have signed on to this program.
Another element in the Secretary's Gift of Life Initiative
is the Best Practices Initiative. We have found that 50 percent
of potential organs come from 200 of the largest hospitals.
Therefore, we are working to identify and then to replicate the
practices that lead to high donation rates in these hospitals.
Secretary Thompson, on April 25, announced our goal of
raising the average rates of donation in the Nation's 200
largest donation potential hospitals to 75 percent from the
current rate of 46 percent. Some hospitals and organ
procurement organizations are already exceeding this goal so we
know that it's possible. The Advisory Committee on Organ
Transplantation, a group of 34 nongovernment organ
transplantation experts from many different fields, sent 18
recommendations intended to improve the transplantation system
to the Secretary last November. The Secretary reported 2 weeks
ago at the most recent ACOT meeting held here in Washington
that he supports all of these recommendations in principle and
is committed to working with the committee.
Finally, HRSA's Division of Transplantation supports two
extramural grant programs designed to increase the number of
donors and donor organs available for transplant: clinical
interventions to increase organ procurement and social and
behavioral interventions to increase organ and tissue donation.
The results from some of these projects have been received and
are being replicated. We expect to receive more results and
share more ways to increase organ donation in the coming
months.
Next year we celebrate the 50th anniversary of organ
transplantation in the United States. The first organ
transplant took place in Boston in 1954. A kidney was
successfully transplanted from a donor to his identical twin
brother. This field of organ transplantation has come a long
way from this beginning 50 years ago. My hope is that the life-
giving endeavor of organ transplantation will grow even more,
and that there will come a time when every American in need of
a new organ will be provided one. HRSA is committed to this
ambitious goal. We will do everything in our power to achieve
it.
I was much struck at the recent ACOT meeting when Dr. Phil
Berry, who received a new liver 16 years ago, said that the
great miracle of transplantation is that you can be so sick and
then you can be so well. We want this miracle to be available
for each patient who can benefit from a transplant.
Thank you for your support and your efforts to increase
organ donation and transplantation. And we look forward to
continuing to work with you on this important issue, and we
would be happy to answer any questions that you might have.
And I also have to add--I do have to do a brief commercial.
For anyone in the room, on the back table there are organ
donation cards, and we would be very happy for anyone to pick
those up. Thank you.
[The prepared statement of Michelle Snyder follows:]
Prepared Statement of Michelle Snyder, Director, Office of Special
Programs, Health Resources and Services Administration
Mr. Chairman and Members of the Subcommittee: My name is Michelle
Snyder. I am the newly appointed Director of the Office of Special
Programs within the Health Resources and Services Administration. I
would also like to introduce Mr. Remy Aronoff, Deputy Director of the
Office of Special Programs, who will assist me in answering any
questions that you may have. We are pleased to appear before you today
to discuss organ donation and transplantation, a topic that is one of
Secretary Thompson's highest priorities. In fact, the Secretary is
passionate about increasing organ donation and transplantation--the
true gift of life. Thank you for all of your efforts to increase organ
donation. We look forward to continuing to work with you on this
important issue.
We have seen many recent examples of the selfless giving of
individuals from many walks of life in our country. Some of the most
selfless and unheralded people are those who sign organ donor cards and
share their decision with their families and loved ones, families who
decide to donate the organs of a loved one who has just died, and
living donors who agree to share a kidney or part of a liver or bone
marrow. I am proud that many important efforts in organ donation and
transplantation reside in my agency, the Health Resources and Services
Administration.
On October 19, 1984, when President Reagan signed into law the
National Organ Transplant Act, he said, ``I believe that this act
strikes a proper balance between private and public sector efforts to
promote organ transplantation.'' Almost 20 years later, we still
believe that. HRSA's Division of Transplantation oversees the contract
held by UNOS, the United Network for Organ Sharing, that runs the Organ
Procurement and Transplantation Network or OPTN. The OPTN, whose
members include the professionals involved in the donation and
transplantation system, maintains the organ wait list and matches
patients to donor organs 24 hours a day, 365 days a year. It is
dedicated to increasing the equity, effectiveness and efficiency of
organ sharing through our national system of organ allocation and to
increasing the supply of donated organs.
In 1992, 14,000 organs were transplanted. Ten years later, in 2002,
almost 25,000 organs were transplanted. There has been progress. But at
the same time, we are all sadly aware that more needs to be
accomplished. At the end of 1992, 27,630 patients were awaiting an
organ. Today, over 80,000 people are on the waiting list in need of an
organ. Because of this shortage of organs, we estimate that each day 17
people die waiting for an organ. We and our transplant community
partners are always seeking ways to improve the process of organ
donation and transplantation and reduce this number of needless deaths.
I'd like to tell you about some of the positive things that are
currently happening.
One initiative that I am especially excited about is something we
call the ``Workplace Partnership for Life,'' which is part of Secretary
Thompson's Gift of Life Donation Initiative. The Workplace Partnership
for Life began about two years ago. The idea is to invite employers and
employees through their workplaces to sign up as partners to create a
donation friendly workplace. The workplace is a great environment in
which to create awareness of the need for donation. We are inviting
corporations and unions, small businesses, associations, government
agencies, schools, and volunteer organizations to join the campaign. As
of May 15th, 7,334 organizations across the country had joined our
Workplace Partnership. The organizations represent the diversity of
America--from A.G. Edwards and Sons of Virginia to the 7 O'Clock
Barbershop, Incorporated, to the National Republican Legislators
Association to the National Benevolent and Protective Order of Elks.
These groups are educating their members and employees through
newsletters, and at health and wellness fairs. Fax cover sheets include
organ donation slogans. Posters are displayed by elevators. All in
support of organ donation. At the end of 2002, General Motors/UAW and
Blue Cross/Blue Shield of Tennessee reported more than 6,000
individuals signed-up to be donors. We estimate that our Workplace
Partners at this time can reach 50 million Americans. The Secretary
issued a challenge this past April for the Partners, in the coming
year, to generate and document at least 1 million new people who have
committed to organ donation.
On April 25, Secretary Thompson announced the newest element of his
Gift of Life Initiative: A Best Practices Initiative on organ donor
consent. Specifically, the Secretary announced our goal of improving
donor protocols and donor management to raise the average rate of
donation in the nation's 200 largest donor-potential hospitals to 75%
from the current rate of 46%. We believe this is possible because some
hospitals and Organ Procurement Organizations or OPOs are already
exceeding this goal! We have chosen to focus on these largest hospitals
because 50 percent of all potential donors are in these largest
hospitals. Thus, we have the potential to save or enhance thousands of
lives each year by achieving this goal. The major organizations of the
donation and transplant community have joined the Secretary in this
effort and we are already working together to pursue it.
We are working together to identify the best practices of high
performing areas and will then assist other large hospitals and OPOs to
systematically replicate these best practices, thereby increasing
donation rates in these large donor-potential hospitals. We are using
the collaborative method of the Institute for Healthcare Improvement,
which has been successfully used to achieve dramatic improvements in
hospital efficiency, clinical outcomes, and other activities in
hospitals across the country.
Another important part of improving our organ transplantation
system is the Secretary's Advisory Committee on Organ Transplantation.
There are 34 members on the ACOT, all non-governmental experts and
professionals who come from fields such as health care public policy,
transplantation medicine and surgery, critical care medicine, other
medical specialties, and non-physician transplant professions. They
have expertise in areas such as surgery, nursing, epidemiology,
immunology, law and bioethics, behavioral sciences, economics, and
statistics. The Committee also has representatives of transplant
candidates, transplant recipients, organ donors, and family members. It
meets twice a year.
The ACOT is charged with grappling with the serious issues that
affect both recipients and donors. At last November's meeting the
Committee made 18 recommendations to improve our organ transplantation
system. Just two weeks ago our Advisory Committee met again here in
Washington. When we opened this meeting our first task was to
immediately address the Committee's recommendations from the November
meeting. It was with a great sense of pride and teamwork that it was
announced that Secretary Thompson had agreed in principle with all of
the recommendations; in fact, we have already begun implementation of
most of those recommendations. Let me highlight some notable examples:
Of special emphasis were issues relating to living donation. One
recommendation said that each living donor should have an independent
donor advocate to ensure that informed consent standards and ethical
principles are applied to the practice of all live organ donor
transplantation. The Secretary fully supports this concept.
It was also recommended that the Secretary of HHS, in concert with
the Secretary of Education, should recommend to states that organ and
tissue donation be included in core curricula of professional schools,
including schools of education, schools of medicine, schools of
nursing, schools of law, schools of public health, schools of social
work and of pharmacy. The Secretary has announced that he is
collaborating with the Secretary of Education to develop model
curriculum for use in our schools. They will be sending a joint letter
to the nation's school systems to encourage them to adopt these modules
in their curriculum.
In addition, as part of the Secretary's Education Initiative,
Secretary Thompson and Secretary Paige will launch three projects for
children and young adults from ages 10 to 22:
(1) ``Decision: Donation'' is a model donation program for high school
students, which will be launched this summer; it focuses on
high school students in health education and driver's education
classes, includes hard copy, videos, CDs, and will be on-line.
(2) Internet-based learning tool, ``Sandrine's Gift,'' is aimed at both
middle and high school students. It's available on an
international Internet-based education site, and has the
potential to reach children around the world. It includes
discussions between students in classrooms and other students
who have experienced donation/transplantation themselves or in
their families.
(3) The ``College Donor Awareness Project'' is a ``tool kit'' for
college students to use to conduct campaigns and presentations
in order to explain the critical need for organ, tissue,
marrow, and blood donation.
Another Committee recommendation I want to mention concerns the
concept of encouraging state legislative practices that promote
increased donation and transplantation. We are in the process of
identifying model state legislation that promotes donation and
transplantation. Examples of productive state legislation include the
Michigan and Illinois state-wide registries of donors, Arizona's and
Florida's requirement to follow donor wishes for donation, and the
Texas and New Jersey laws requiring medical examiners not to withhold
life saving organs. We will be raising these actions to the attention
of all states as model practices.
I would like to share with you one final aspect of our efforts to
increase donation and transplantation. Our Division of Transplantation
supports two extramural grant programs designed to increase the number
of donors and donor organs available for transplant: Clinical
Interventions to Increase Organ Procurement; and Social and Behavioral
Interventions to Increase Organ and Tissue Donation. Five grantees are
currently testing and evaluating medical techniques at hospitals and
other health care facilities capable of increasing the number of
possible organ donors and the number of transplantable organs. Eleven
grantees are testing the success of outreach efforts and education
campaigns in increasing donation rates. The results of some of these
grants are already being replicated in some high-performing OPOs and
hospitals. We look forward to having the results of other research
efforts in and replicating positive results elsewhere in the next 3 to
5 years.
Next year, we celebrate the 50th anniversary of organ
transplantation in the United States. The first organ transplant took
place in Boston in 1954. A kidney was successfully transplanted from a
donor to his identical twin brother. The recipient has since died from
causes unrelated to the transplant. His brother, the donor, is still
alive. The field of organ transplantation has come a long way from this
humble beginning 50 years ago. My hope is that the life-giving endeavor
of organ transplantation will prosper even more and that there will
come a time when every American in need of a new organ will be provided
one. HRSA is committed to this high goal. We will do everything in our
power to achieve it. At the recent ACOT meeting, Dr. Phil Berry, who
received a new liver 16 years ago, said that the great miracle of
transplantation is that you can be so sick and then you can be so well.
We want this miracle to be available for each patient who can benefit
from a transplant. I look forward to working with you and am happy to
answer any questions you have.
Mr. Greenwood. We thank you. Thank you very much.
Dr. Metzger.
TESTIMONY OF ROBERT METZGER
Mr. Metzger. Chairman Greenwood and members of the
subcommittee, I appreciate the opportunity to appear before you
to discuss new initiatives for increasing organ donation. I'm
Dr. Robert Metzger, transplant physician and medical director
of the Organ Procurement Organization and Kidney Transplant
Program at Florida Hospital in Orlando. I am testifying today
in my capacity as the incoming Vice President, President-elect
of UNOS, United Network for Organ Sharing, the organization
contracted to manage the Organ Procurement and Transplantation
Network.
Over 81,000 patients are on the wait list for
transplantation in the United States today, and more than 5,000
will die this year without receiving a transplant. More
startling is that almost 60 percent of those on the list today
will die without receiving a transplant. Yet organs from
deceased donors are recovered from less than 50 percent of
actual potential donors, resulting in the loss of thousands of
lifesaving transplants.
Most of the small annual 1 to 2 percent increase in the
number of deceased donors has come from expanding the medical
and social conditions previously used to eliminate potential
donors, while the wait list continues to grow at a rate of 12
percent annually.
In late April, UNOS sponsored a national consensus
conference, ``Maximizing the Consent Process from Research to
Practice'' in Orlando, Florida. Over 100 experts from the organ
procurement and transplant community came together to address
best practices for (1) training and maintaining recovery
coordinators; (2) improving the consent process; (3) supporting
the needs of donor families; and (4) evaluating the impact of
``first person consent'' or ``donor authorization.'' the
recommendations from the work groups will soon be published,
and I will limit my discussion to those from the Work Group on
Donor Authorization, moderated by Helen Leslie, Executive
Director of LifeNet OPO in Virginia and myself.
In 1968 the National Conference on Commissioners for
Uniform State Laws drafted the Uniform Anatomical Gift Act, the
UAGA, that authorized anyone 18 years of age or more to gift
any part of his body, to take effect upon death, and that this
could not be rescinded without his consent by anyone. Over the
next decade this was adopted by the legislature of all 50
States. However, this has been virtually ignored by all OPOs
because of the small numbers of potential donors with legal
donor documents and the difficulty in documenting their
existence at the time of death.
In 1995 the Center for Organ Recovery and Education, or
CORE, the OPO for western Pennsylvania and part of West
Virginia, began accepting the donor document as legally
binding. In the subsequent 7 years, they found that donation
occurred 100 percent of the time when the donor document was
available, but only the usual 51 percent where consent from the
family was utilized.
Our work group's recommendation was to develop an
aggressive national effort to increase recovery of donor organs
by moving to an emphasis on the donor authorization process.
The work group then developed the following position:
One, the decedent's right to donate should take precedence
in the donation process.
Two, this should be accomplished in the framework of
honoring the donor's wishes, respecting the needs of
recipients, and continuing to support and care for the donor
family.
Three, the approach should provide a consistent level of
support for the donor family; sensitivity to the needs of
diverse populations; and the achievement of an effective
paradigm shift by hospital staff and donation specialists in he
process of recovering organs.
An action agenda was developed to create national synergy
and momentum to enlist a broad-based coalition within the
procurement and transplant arena and government agencies; to
seek allies from the general public and greater health care
community; explore the need for UAGA revisions; advance a
supportive public relations strategy; and to pursue donor
rights legislation in all 50 States. Also, promote donor
registries as a vehicle for perhaps a national donor card and
depository, and to develop multiple online access sites.
One of the problems is that a lot of us when we go to the
Motor Vehicle Administration are not even old enough to sign a
donor card. And in Florida, don't think you have to go back for
another 6 years; and in Arizona I think it's 15 years. So
you're not given the opportunity to do that license--driver's
license event.
I'm happy to report that in the short month following the
conference, this proposal has been endorsed by the Executive
Committee of the Association of Organ Procurement
Organizations, the Advisory Committee on Organ Transplantation
to the Secretary of Health and Human Services, ACOT; was just
this week, at the American Transplant Congress, endorsed by
both the American Society of Transplantation and the American
Society of Transplant Surgeons; and is under discussion by the
National Kidney Foundation and the Coalition on Donation.
I am hopeful that over the next 2 years this program could
result in a significant increase in the number of our citizens
willing to come forward in authorizing their gift of life to
their fellow citizens in need.
Thank you, and I will be willing to answer any questions.
[The prepared statement of Robert Metzger follows:]
Prepared Statement of Robert Metzger, President-Elect, United Network
for Organ Sharing
INTRODUCTION
Chairman Greenwood and members of the Subcommittee, I appreciate
the opportunity to appear before you to discuss new initiatives for
increasing organ donation. I am Dr. Robert Metzger, a transplant
physician and Medical Director of the Organ Procurement Organization
and kidney transplant program at Florida Hospital in Orlando. I am
testifying today in my capacity as the in-coming Vice President/
President-Elect of UNOS, the United Network for Organ Sharing, the
organization contracted to manage the Organ Procurement and
Transplantation Network.
ORGAN DONOR SHORTAGE
Over 81,000 patients are on the wait-list for transplantation in
the United States today and more than 5000 will die this year without
receiving a transplant. More startling is that almost 60% of those on
the list today will die without receiving a transplant. Yet organs from
deceased donors are recovered from less than 50% of actual, potential
donors, resulting in the loss of thousands of life-saving transplants.
Most of the small, annual 1-2% increase in the number of deceased
donors has come from expanding the medical and social conditions
previously used to eliminate potential donors, while the wait-list
continues to grow at a rate of 12% annually.
UNOS CONSENT CONFERENCE
In late April, UNOS sponsored a national consensus conference,
``Maximizing the Consent Process, From Research to Practice'' in
Orlando, Florida. Over 100 experts from the organ procurement and
transplant community came together to address ``best practices'' for
(1) training and maintaining recovery coordinators, (2) improving the
consent process, (3) supporting the needs of the donor families, and
(4) evaluating the impact of ``first person consent'' or ``donor
authorization''. The recommendations from these work groups will soon
be published and I will limit my discussion to those from the Work
Group on ``donor authorization'' moderated by Helen Leslie, executive
director of LifeNet OPO in Virginia and myself.
DONOR AUTHORIZATION
In 1968, the National Conference on Commissioners for Uniform State
Laws drafted the Uniform Anatomical Gift Act (UAGA) that authorized
anyone 18 years of age or more to ``gift'' any part of his body to take
effect upon death and that this could not be rescinded without his
consent by anyone. Over the next decade this was adopted by the
legislatures of all 50 states. However, this was virtually ignored by
all OPOs because of the small numbers of potential donors with legal
donor documents and the difficulty in documenting their existence at
the time of death. In 1995, the Center for Organ Recovery and Education
(CORE), the OPO for western Pennsylvania and part of West Virginia,
began accepting the donor document as legally binding. In the
subsequent 7 years, they found that donation occurred 100% of the time
when the donor document was available but only the usual 51% when
consent from the family was utilized. The Work Group's recommendation
was to develop an aggressive national effort to increase the recovery
of donor organs by moving to an emphasis on the ``donor authorization''
process.
The Work Group then developed the following position:
1. The decedent's right to donate should take precedence in the
donation process.
2. This should be accomplished in the framework of:
a. honoring the donor's wishes
b. respecting the needs of the recipient
c. continuing to support and care for the donor family.
3. The approach should provide:
a. a consistent level of support for the donor family
b. sensitivity to the needs of diverse populations
c. the achievement of an effective paradigm shift by hospital staff
and donation specialists in the process for recovering
organs.
An action agenda was developed to:
1. Create national synergy and momentum to:
a. enlist a broad-based coalition within the procurement/transplant
arena and government agencies
b. seek allies from the general public and greater healthcare
community
c. explore the need for UAGA revisions
d. advance a supportive public relations strategy
e. pursue ``donor rights'' legislation in all 50 states
2. Promote donor registries as a vehicle for:
a. a ``national'' donor card and depository
b. ``online'', multiple access sites.
I am happy to report that in the short month following the
conference, this proposal has been endorsed by the Executive Committee
of the Association of Organ Procurement Organizations (AOPO), the
Advisory Council on Organ Transplantation to the Secretary of Health
and Human Services (ACOT), and is under discussion by the National
Kidney Foundation, the Coalition on Donation, the American Society of
Transplantation, and the American Society of Transplant Surgeons.
I am hopeful that over the next 2 years, this program could result
in a significant increase in the number of our citizens willing to come
forward and authorizing their ``gift of life'' to their fellow citizens
in need.
Thank you.
Mr. Greenwood. Thank you Dr. Metzger.
The Chair recognizes himself for 10 minutes and I'd like to
address my first question to Ms. Snyder.
HHS received the Advisory Committee on Transplantation's 18
recommendations in November. What has the Department done with
the recommendations over the past 6 months since receiving
them?
Ms. Snyder. Over the last 6 months, a large part of that
time has been spent understanding the recommendations,
exploring those recommendations, making sure that all
interested parties have been represented and have had an
opportunity to bring those viewpoints to the table. There has
been--as I'm sure you're aware, given the seriousness and the
breadth of issues in the transplantation community, each one of
the 18 recommendations has a great deal of follow-up work that
we will need to do. Even though the Secretary has said that he
agrees in principle to them, actually taking them and
implementing and operationalizing them is now the point where
we are, and now we plan to move forward.
The 18 recommendations were really divided into two groups,
and the first 7 of them were really around ways to improve the
safety of living donors. It was interesting that in 2001, I
believe, the number of living donors for the first time
exceeded the number of nonliving donors. And so that issue has
become more and more pressing as to those rights and
responsibilities around that set of individuals. And so many of
the recommendations dealt with that and, for instance, informed
consent standards to be implemented for all living donors.
We've asked the OPTN to address those consent standards to make
them available and to work them through, looking at, for
instance, a data base of health outcomes for those people who
are living donors, what happens to them after the process, and
more in terms of longitudinal looks at their health.
And so the Secretary has asked NIH to look within their
research protocols to accommodate that request so that they can
see what is the best way to track outcomes and the best way to
know what happens to that group of people to make sure that the
living donation process is as safe as it can be and works as
well as it can for that group of people.
Those are just some examples of the type of recommendations
that came out of that committee.
There is also another group of them on ways to improve
nonliving consent rates and the allocation process. What we've
done is take each recommendation, say who is it that needs to
work through it. The Secretary has formed work groups across
the Department of Health and Human Services. The Centers for
Medicare and Medicaid Services is certainly impacted by the
recommendations, the National Institutes of Health is impacted
by them, our partners in the private sector, the UNOS
organization, certainly HRSA.
So now what we need to do is to take all of those and turn
them, you know, into actual plans that can happen. And that's
what we'll be doing.
Mr. Greenwood. Do you have a timeframe as to--anticipated
timeframe that you anticipate that these recommendations will
be in force?
Ms. Snyder. I think it's different for each recommendation
so I couldn't give you an average. Do we have a--so it's
separate for each one. What we could do is provide the
committee with our matrix of recommendations and our estimated
timeframes.
Mr. Greenwood. Would you do that, please?
Ms. Snyder. Certainly.
Mr. Greenwood. Do you have a sense of how long you think it
will take before the targeted hospitals meet the goal of
conversion rate of 75 percent?
Ms. Snyder. That's an excellent question and, in fact, in
preparing for this hearing it's one that I asked just
yesterday. I think the answer to that is it's a little bit--if
you will allow me, it's a little bit like losing weight. The
first 20 pounds comes off pretty easily; the last 5 is really
hard. So depending on the individual hospital and where it
stands on that scale; is it someone who's already at 65 percent
that you're trying to move to 75 percent; is it someone who is
at 20 percent that you're trying to move to 50 percent? You
know, which one is going to be harder? You know, getting it on
this side of the scale.
We believe that the 75 percent is the target. I had hoped
that we could be there within a year. The staff tells me that
that would be a very, very ambitious goal, but that we do
believe we will have significant increases in the 46 percent,
but may not achieve the 75 percent in the first 12 to 18
months.
Mr. Greenwood. Have you calculated what the additional
number of donors would be if you did get the hospitals to 75
percent?
Ms. Snyder. I believe it was 6,000 organs a year would
become available, which would be a significant increase.
Mr. Greenwood. That would--that's roughly equal to the
shortage, is it not?
Ms. Snyder. That's correct.
Mr. Greenwood. Okay.
Dr. Metzger, you discussed the fact that OPOs have
difficulty documenting a decedent's intent to donate at the
time of death. Yet for donor authorization to be effective,
documentation of the decedent's intent is critical. So how do
you propose that this be done?
Mr. Metzger. Well, this has always been a difficult problem
in the country and there's always been a lot of naysayers. And
to me it seems like with modern technology that we should be
able to overcome this. We have smart cards now that people can
carry around with them with their medical history and different
things. We have computer technology, where there are, I heard
on CNN last--2 months ago--there are 750 million active
MasterCard and Visa cards in the United States. We're dealing
with looking at signing up 150 or 200 million people. And with
the ability with modern technology, I think we can create
registries that we will have access to onsite in the hospital
with modern technology.
Mr. Greenwood. What is the status of registries?
Mr. Metzger. Registries, I think, are mired in remote
technology. They often have 386 computers, the inability to
input data. But they're becoming more effective. We are
actually using ours daily in the State of Florida now. We have
scanned in documents of wills.
Mr. Greenwood. It's done on a State-by-State basis.
Mr. Metzger. Yes.
Mr. Greenwood. And how many States have registries, do you
know?
Mr. Metzger. I'm not sure the exact number, but it's a
little over a majority now, I think.
Mr. Greenwood. Is there a reason to have one central
Federal registry?
Mr. Metzger. I think this would be an optimal way to do it.
But there already are State registries that are operational,
and it might be easier to make them transparent across State
lines and utilize that mechanism rather than----
Mr. Greenwood. You said there are naysayers. What are the
arguments?
Mr. Metzger. The argument was that you have to enroll
several--or many millions of people to get to the 15,000 to
20,000 potential donors out there in any 1 year. But I think
that's possible today.
Mr. Greenwood. Are there confidentiality issues that make
this difficult?
Mr. Metzger. I don't think so. The people that work in this
area tell me that you can have very secure networks. In fact,
one of the concerns of OPOs has always been how would they know
that the potential donor hasn't rescinded his documentation?
Mr. Greenwood. Right.
Mr. Metzger. And that's always a problem with that with
donor cards. But if we had this on line with an access site,
all they have to do is call 1-800 and say for some reason, no,
I don't want to do it anymore, and it's there. So it has
opportunities on both ends.
Mr. Greenwood. And are there those who argue that names
might get on registries that don't belong on registries?
Mr. Metzger. Well, there's always the potential of that,
but there are secure ways of making these registries.
Mr. Greenwood. Okay. Later this morning we will be hearing
from the AMA about the policies it adopted last summer
recommending studies of the impact of financial incentives on
donations. Has UNOS addressed this issue; and, if so, how?
Mr. Metzger. Yes. UNOS, a year and a half ago, endorsed the
proposal to look at studies and support the study of financial
incentives to see if there would be any benefit in the organ
donation process with financial incentives. In essence it
backed the AMA stance.
Mr. Greenwood. In order to study the impact of financial
incentives, you actually have to provide them, don't you. It's
pretty hard to study it hypothetically?
Mr. Metzger. Yes. You would need actual data.
Mr. Greenwood. So we would have to actually in some pilot
way offer financial incentives to see what the response rate is
and see if that differs from some other group. Does HRSA or HHS
have a stated position with regard to financial incentives?
Ms. Snyder. I think the position has been--very much played
out in the discussion among yourselves this morning that there
are many different points of view, and those points of view
need to be fully examined before moving forward with a public
policy. I do know that the ACOT has agreed that this year it
will take up the issue of financial incentives, and we are
looking very much forward to the results of those deliberations
and discussions because there is a great representation of the
community and those impacted in the community within that
group.
Mr. Greenwood. My time has expired. The gentlelady from
Colorado is recognized for 10 minutes.
Ms. DeGette. Dr. Metzger, I don't want to put words in your
mouth but what I am hearing you and others say is part of the
problem we have is that hospitals don't have accurate
information as to whether someone has made the decision to
donate their organs or not, correct?
Mr. Metzger. Correct.
Ms. DeGette. And so one thing we're trying to figure out,
and I agree completely with this, is how to improve our
registries. So that if I go down to the driver's license
bureau, or however else I do it, and say, ``Yes, I want to be
an organ donor,'' when I am lying there brain dead on life
support there's some way that the medical personnel will know
that, irrespective of whether my family has provided that
information or not, right?
Mr. Metzger. Right.
Ms. DeGette. And Ms. Snyder, it sounds to me like your
targets are to try to get it up to 75 percent at the 200
hospitals where they are doing most of the donations; is that
right?
Ms. Snyder. That's correct.
Ms. DeGette. And certainly, registries would help with
that, because health care personnel would then know did someone
agree or not and they wouldn't have to rely on distraught
family members or incomplete information, right?
Ms. Snyder. I think our issue from HHS's perspective is
that it is a matter of State law, which is what governs the
establishment of those kinds of registries where people consent
and who can revoke it and who can honor the wishes of those
individuals who have given consent. The approach we have been
looking at is taking model legislation, if you will, to try to
get States to at first address the issue of making sure you
have a nonrevokable agreement to donate and then moving from
that point to the registry.
Ms. DeGette. Right. And if you had that, it would make the
decisions a lot more clear, right?
Ms. Snyder. It would make the decisions more clear. I think
the issue around registries is one that people don't like to
talk about, but it is simply the technology is probably there,
but it becomes the issue of funding for it, who would maintain
the registries, how would you ensure that privacy rights are
protected.
Ms. DeGette. I don't want to interrupt you, but you are
exactly right. But what the Federal Government has done with
other kinds of registries, sex offender registries, we put
resources into them--you know, DWAI registries. We put
resources into helping States to coordinate and update their
registries, and this is something we can easily do with organ
donation registries. Do you think that would be a financial
need that you would see down the road?
Ms. Snyder. There would definitely be a cost of
establishing any kind of data base that would interface.
Ms. DeGette. What just occurred to me, while I was
listening to Dr. Metzger, Mr. Chairman, is that this idea that
the chairman has of giving financial incentives to donors to
agree to donate, that may not be the thing that solves this
problem. You could say to me, okay, I am going to give you a
$10,000 life insurance policy if you agree to donate your
organs. But if I am hit in a car crash, and I am in a hospital
and no one knows about that, it doesn't matter. It sounds to me
like, if we worked on the issue of donor registration and
education, that that might go a long way to solving the
problem.
What do you think about that, Dr. Metzger?
Mr. Metzger. We do have to adopt the donor registration
process prior to the next step, whichever that might be. Once
we do that, we have to figure out how to get people to sign the
card and sign on.
Ms. DeGette. Sounds like a lot of people are signing up,
and we could always use more. Don't get me wrong. I think there
are a lot of things we can do to get people to agree to be
donors. But it seems to me that just today, today, if you could
have hospitals, particularly these top 200 hospitals, knowing
that someone had agreed to be a donor, and if you had an
irrevocable donation decision that was there, that would help a
lot more in the short-term with getting more organs.
Mr. Metzger. It's definitely a need. And it would take a
significant segment of that population where you only have 51
percent consenting into that population where you have 100
percent donation.
Ms. DeGette. Right. Ms. Snyder, before when I was asking
Mr. Roth the question about what kinds of public service
announcements, and so on, that have been made, you were
nodding. I wonder if you could expand to the answer to that
question.
Ms. Snyder. As part of the Secretary's initiative to
increase donation rates, there have been a number of education
activities that have been launched and are being launched. One
component of that includes some dollars from the increased
appropriation that we received for this activity that will go
to radio and television ad campaigns in the 15 biggest markets.
So there is a small dollar amount.
Ms. DeGette. How much is it?
Ms. Snyder. I think it is about $1 million. And a number of
public service announcements would supplement that, in addition
to what we would have to pay to do the ads.
The other thing that I think is really exciting around the
education efforts are two initiatives that I think are very
important. One is a workplace partnership. The Secretary had a
goal of signing up 5,000 businesses by April 2003, and to date,
we have actually enrolled over 7200 businesses. And part of
that is just having the, if you will, the poster at the
watercooler that says ``have you thought about donation?'' and
making it something that's on peoples' minds.
Another part that we're doing around education is school-
based education curricula, where we're hitting the group from
age 10 to 22 through various educational interventions. And one
to me that anybody who has teenage children knows that the
first place that kids pay attention is drivers' ed. So
introducing it in drivers' ed, I think, will start the
conversation. That is more a long-term strategy. You have got
to start the education campaign and that is a long-term
strategy, and get people when they're young to start to think
about it.
Ms. DeGette. Have there been any studies done to show the
effect of public education on increasing organ donation rates?
Ms. Snyder. I don't know that it has been specific to organ
donation rates, but certainly folks have looked at what
happened around seat belt laws, what happened around helmet
laws.
Ms. DeGette. Do you think that would be an interesting
study to see if increased public service announcements work--
otherwise, why make the effort if it is not making a
difference?
Ms. Snyder. I think it would be interesting, but I think
this is one of those where you can look at research that has
already been done in the community, and perhaps rather than
putting funds forward to do that, you can extrapolate to it.
Ms. DeGette. Dr. Metzger, are you aware of any efforts that
the donation networks have made? I go back to this diabetes
example where some of the private diabetes organizations have
really worked with religious leaders and others to educate.
Mr. Metzger. Over the past 20 years, we spent millions of
dollars in public education but haven't gotten too far with it,
and one of your comments was about some of the public ads that
are usually on at 3 o'clock in the morning. We actually had--
one of our recovery coordinators thought during one of the
shuttle launches, why don't we have astronauts sign organ donor
cards in space, and she got NASA to do it. Unfortunately, they
wouldn't tell us when the signing was going to be. It was 2:30
one morning when they found time to do it. So there weren't
very many people watching it. It's hard to get the public
education.
We have a very successful program called Get Carded at
universities in Florida. We started it in Orlando at the
University of Central Florida. We distributed over 85,000 donor
cards to college students. And we know in looking at it that 80
percent of them sign on to the card. We expanded that into the
University of Florida, University of South Florida and Florida
Atlantic University. So these are some things that you have to
get really almost one to one with these people to get them to
think about this. Billboards, TV ads and that, when you are not
even thinking about dying and donations, don't make that big of
an impact.
Ms. DeGette. That's why I'm thinking of efforts with the
churches, this effort that Mr. Roth was talking about to get
the ministers preaching from the pulpit, but then to have
people there with the cards to get people to sign up.
Mr. Metzger. All of our OPOs have programs to do that. And
then you have to look at the demographics. In the African
American community, usually my generation of African Americans
respond very positively to the clergy. When you go down to the
next generation, it may be sports figures and community
leaders. So you have to get to all those groups.
I would like to say one thing about the OPTN and
pediatrics, if I may. We have established preferential
allocation to children. In the kidney program, children under
the age of 11 get four extra points in the allocation process.
And over the age of 11 to 18, they get three extra points and
they carry those past age 18. For a lot of the other organs,
the problem is the size. You can't put big adult organs in
children. So they need child organs, but you can put segments
of adult organs into children. So there has been, over the last
5 years, considerable movement to using liver segments and lung
segments in children for transplantation.
Unfortunately, the heart has to be the size of the
individual, but there are very few pediatric hearts, if any,
going to adults because they don't size. Pediatric----
Ms. DeGette. Do they give extra points for the heart?
Mr. Metzger. The heart and liver programs are primarily
based on a severity of illness process now, but there is a
separate one for children.
Ms. DeGette. Thank you.
Mr. Greenwood. The Chair thanks the gentlelady.
The gentleman from Oregon is recognized for 10 minutes.
Mr. Walden. Thank you, Mr. Chairman.
We talked about public service announcements. I wonder if
your agencies are looking into what the National Guard bureaus
are doing around the State with what's called an NCSA,
noncommercial spot announcement where they work with broadcast
associations in each State, make a donation to the State in
return for multiples of announcements that run. As a
broadcaster, I am somewhat familiar with the program, and it
has worked very effectively.
Ms. Snyder. I am not aware of any efforts, but we will take
that suggestion back, and we're certainly looking for ways to
get the word out and do it in the most cost effective way we
can.
Mr. Walden. Sometimes it as much as 7 or 8 to 1. The
stations donate the time, and the moneys go to the State
associations, and I think for many organizations, it has been
very helpful. I know the situation in the Oregon Health Plan,
the State got involved in trying to get employers involved in
some things, and based on marked increase in participation
after the in NCSA campaign ran it, it might be a way to stretch
your million dollars nationwide. And I congratulate you on
signing up those 7,200 businesses. And I think it will enure to
the benefit of the program. Mr. Chairman, I really have no
questions from this distinguished panel, and I appreciate your
input and your work, and I yield back my time.
Mr. Greenwood. The Chair thanks the gentleman.
And the Chair thanks our witnesses and we excuse you now.
And for everyone's information, we will have a series of
votes probably in about half an hour, but I would like to call
the next panel forward and at least take their testimony before
we have to break for votes, and maybe have to return after
votes for questions.
We would invite Tim Olsen, Community Development
Coordinator for the Wisconsin Donor Network; Mr. Robert Sade,
M.D., Professor of Surgery at the Medical University of South
Carolina; Mr. Richard DeVos from Michigan; Dr. Joseph Vacanti,
M.D., Director of Pediatric Transplantation, Massachusetts
General Hospital; Dr. Abraham Shaked, M.D., President of the
American Society of Transplant Surgeons; and Dr. Francis L.
Delmonico, M.D., of the National Kidney Foundation. Welcome all
of you. Thank you for your patience. I think all of you have
been present. As I informed the previous panels and that this
is an investigative hearing, and it is our practice to take
testimony for these hearings under oath, and I ask if you
object to giving your testimony under oath. Okay. I need to
advise you pursuant to the rules of this committee and the
House, you are entitled to be represented by counsel. Any of
you wish to be represented counsel? The Enron folks did, but
most others don't.
I would ask if you would stand and raise your right hands,
please.
[Witnesses sworn.]
Mr. Greenwood. I believe we will begin with Mr. Olsen.
TESTIMONY OF TIM OLSEN, COMMUNITY DEVELOPMENT COORDINATOR,
WISCONSIN DONOR NETWORK; ROBERT M. SADE, PROFESSOR OF SURGERY,
MEDICAL UNIVERSITY OF SOUTH CAROLINA; RICHARD M. DEVOS; JOSEPH
P. VACANTI, DIRECTOR OF PEDIATRIC TRANSPLANTATION,
MASSACHUSETTS GENERAL HOSPITAL; ABRAHAM SHAKED, PRESIDENT,
AMERICAN SOCIETY OF TRANSPLANT SURGEONS; AND FRANCIS L.
DELMONICO, NATIONAL KIDNEY FOUNDATION
Mr. Olsen. Thank you very much for inviting the Wisconsin
Donor Network to be represented at this hearing. It's an honor
for us to participate, and we applaud your efforts to increase
organ donation.
Wisconsin Donor Network is one of two organ procurement
organizations in Wisconsin. There are also three tissue banks
and an eye bank. We all work together in many ways, but also
pursue awareness opportunities as individual organizations and
have each been very successful with our organ and tissue
recovery efforts. With that in mind, I am only speaking on
behalf of the Wisconsin Donor Network today, not all of the
State organizations.
Wisconsin is often looked to as an excellent donor State,
and we are very proud of that status. Unfortunately, we have no
way of knowing what we have done, if anything, that has made
donation in Wisconsin so successful. We don't have a registry,
and we don't have any methods of determining how many people
act on our awareness efforts. I can share with you many
characteristics and programs that we believe have made a
positive impact on donation in Wisconsin.
Two of the biggest influencing factors over the past 10 to
15 years, I believe, are our former Governor and our successful
transplant center. During Tommy Thompson's 14 years as
Wisconsin Governor, he was the State's biggest proponent of
organ donation. He was very outspoken about it, as he continues
to be, and serves as an excellent leader for organ donation
awareness throughout Wisconsin. He also implemented an annual
ceremony and Governor's Medal to honor donors and their
families, a tradition we expect to continue this summer, its
tenth year.
We have also benefited from having four outstanding
transplant centers in the State. Even though Wisconsin is only
the 18th most populated State, only seven other States in the
country performed more transplants than the 796 that took place
in Wisconsin last year.
One successful transplant center is returning their
patients to their homes, jobs, schools, churches and social
circles. That shows others, by example, that organ donation is
saving lives and a great way to help others which, in turn,
makes others inclined to donate.
We have also tried to be aggressive with our awareness
activities. Wisconsin Donor Network relies on the assistance of
300 outstanding volunteers, almost all of whom have a personal
connection to donation as transplant recipients, family members
of recipients or family members of donors. They speak to groups
about their experience, hand out information and answer
questions at health fairs and special events and serve as great
examples of the success and importance of organ donation and
transplant.
We also staff the Wisconsin Donor Network information booth
at the Wisconsin State Fair and other county fairs. Last year
more than 1,100 people signed up to be donors at our three fair
booths, and nearly 2,500 people took donor information or
materials at the booths.
We hold an annual run/walk, Sarah's Stride, held in memory
of a local teenager who died while awaiting a transplant. The
fifth annual Sarah's Stride 3 weeks ago attracted more than
1,250 participants and raised more than $55,000 for donor
awareness efforts in Wisconsin. The funds raised through
Sarah's Stride and other donations are used to fund special
donor awareness projects.
One of the most important projects that it funded, and
continues to fund, is the drivers' education curriculum that we
developed to provide to drivers' education instructors. In the
summer of 2000, Wisconsin passed a law requiring at least 30
minutes of organ and tissue donation information as part of
drivers' education programs. To support that mandate, the
Wisconsin Donor Network developed a curriculum tailored for
drivers' education instructors to use in the classroom and
provided it at no cost to every drivers' education program in
the State that fall. A few months later, in early 2001, the
Wisconsin Donor Network finished a more comprehensive
curriculum on organ and tissue donation for health education
instructors and sent it free to every high school in the State.
We are very proud of our Wisconsin Coalition on Donation,
which is a group of organizations with a common interest in
donation from throughout the State that have joined together to
work on awareness project that we ordinarily wouldn't be able
to address at the State level on our own. Both State organ
procurement organizations, all three tissue banks, the eye
bank, a blood bank, the kidney liver and heart associations and
others have spearheaded some very successful awareness efforts
in the past 2 years and continues to increase its efforts.
More recently the Wisconsin Donor Network launched its
Website, which is a little more than a year old. Traffic to the
Website continues to grow and serves as a great online resource
for organ donation information for State residents.
Also last year, the Wisconsin Donor Network developed its
own television ad and for the first time, committed to a
substantial paid advertising campaign. We chose to target women
in our service area, aged 35 to 54, for several reasons, and
ran the ad throughout 2002. We have no way of knowing what
effect, if any, the ad had, but we do know that our 2002
consent rate of 66 percent was significantly higher than the
national average, which is typically measured at between 45 and
54 percent. Even more dramatic, our donations increased 33
percent from 2001 to 2002. That 33 percent increase contrasts
with the 1.6 percent overall national increase last year and
was the third highest increase of all organ procurement
organizations in the Nation last year.
Thank you for allowing me to provide a brief overview of
our efforts in Wisconsin. We truly appreciate your interest in
this very important public issue.
[The prepared statement of Tim Olsen follows:]
Prepared Statement of Tim Olsen, Community Development Coordinator,
Wisconsin Donor Network
Thank you very much for inviting the Wisconsin Donor Network to be
represented at this hearing. It's an honor for us to participate and we
applaud your efforts to increase organ donation.
The Wisconsin Donor Network is one of two organ procurement
organizations in Wisconsin. There are also three tissue banks and an
eye bank. We all work together in many ways, but also pursue awareness
opportunities as individual organizations and have each been very
successful with our organ and tissue recovery efforts. With that in
mind, I am only speaking on behalf of the Wisconsin Donor Network
today, not all of these state organizations.
Wisconsin is often looked to as an excellent donor state and we're
very proud of that status. Unfortunately, we have no way of knowing
what we have done, if anything, that has made donation in Wisconsin so
successful. We don't have a registry and we don't have any methods of
determining how many people act on our awareness efforts. I can,
though, share with you many characteristics and programs that we
believe have made a positive impact on donation in Wisconsin.
Two of the biggest influencing factors over the past 10-15 years, I
believe, are our former governor and our successful transplant centers.
During Tommy Thompson's 14 years as Wisconsin governor, he was the
state's biggest proponent of organ donation. We was very outspoken
about it, as he continues to be, and served as an excellent leader for
organ donation awareness throughout Wisconsin. He also implemented an
annual ceremony and governor's medal to honor donors and their
families, a tradition that we expect to continue this summer, its 10th
year.
We have also benefited from having four outstanding transplant
centers in the state. Even though Wisconsin is only the 18th most
populated state, only seven other states in the country performed more
transplants than the 796 that took place in Wisconsin last year. When
successful transplant centers are returning their patients to their
homes, jobs, schools, churches and social circles, that shows others by
example that organ donation is saving lives and is a great way to help
others, which in turn makes others more inclined to donate.
We have also tried to be aggressive with our awareness activities.
The Wisconsin Donor Network relies on the assistance of 300 outstanding
volunteers, almost all of whom have a personal connection to donation
as transplant recipients, family members of recipients, or family
members of donors. They speak to groups about their experience, hand
out information and answer questions at health fairs and special events
and just serve as great examples of the success and importance of
donation and transplant.
They also staff the Wisconsin Donor Network information booths at
the Wisconsin State Fair and other county fairs. Last year more than
1,100 people signed up to be donors at our three fair booths, and
nearly 2,500 people took donor information or materials at the
booths.We hold an annual run/walk, Sarah's Stride, held in honor and
memory of a local teenager who died while awaiting a transplant. The
fifth annual Sarah's Stride three weeks ago attracted more than 1,250
participants and raised more than $55,000 for donor awareness efforts
in Wisconsin.
The funds raised through Sarah's Stride and other donations are
used to fund special donor awareness projects. One of the most
important projects that it funded, and continues to fund, is the
driver's education curriculum that we developed to provide to drivers'
education instructors. In the summer of 2000 Wisconsin passed a law
requiring at least 30 minutes of organ and tissue donation information
as part of drivers' education programs. To support that mandate, the
Wisconsin Donor Network developed a curriculum tailored for driver's
education instructors to use in the classroom and provided it at no
cost to every drivers' education program in the state that fall. A few
months later, in early 2001, the Wisconsin Donor Network finished a
more comprehensive curriculum on organ and tissue donation for health
education instructors and sent it free to every high school in the
state.
We're also very proud of our Wisconsin Coalition on Donation, which
is a group of organizations with a common interest in donation from
throughout the state that have joined together to work on awareness
projects that we ordinarily wouldn't be able to address at the state
level on our own. Both state organ procurement organizations, all three
tissue banks, the eye bank, a blood bank, the kidney, liver, lung and
heart associations, and others have spearheaded some very successful
awareness events within the past two years and continues to increase
its efforts.
More recently, the Wisconsin Donor Network launched its website,
which is now a little more than a year old. Traffic to the website
continues to grow as it serves as a great on-line resource for organ
donation information for state residents.
Also last year, the Wisconsin Donor Network developed its own
television ad and for the first time committed to a substantial paid
advertising campaign. We chose to target women in our service area, age
35 to 54, for several reasons, and ran the ad throughout 2002. We have
no way of knowing what effect, if any, the ad had, but we do know that
our 2002 consent rate of 66 percent was significantly higher than the
national average, which is typically measured at between 45 and 54
percent. Even more dramatic, our donations increased 33 percent from
2001 to 2002. That 33 percent increase contrasts with the 1.6 percent
overall national increase last year and was the third highest increase
of all organ procurement organizations in the nation last year. (VHS
tape of the ad available.)
Thank you for allowing me provide a brief overview of our efforts
in Wisconsin. We truly appreciate your interest in this very important
public health issue.
Mr. Greenwood. Thank you Mr. Olsen.
Dr. Sade.
TESTIMONY OF ROBERT M. SADE
Mr. Sade. Good afternoon, and thank you, Chairman
Greenwood, for inviting the American Medical Association to
participate in today's hearing. In particular, Mr. Chairman, we
thank you for your leadership in this particular issue which we
take as very important.
I am Dr. Robert Sade, a member of the AMA's Council on
Ethical and Judicial Affairs. I'm a cardiothoracic surgeon and
Medical Director of the Organ Procurement Organization for
South Carolina. AMA policy is developed through a broadly
representative process involving physician delegates from every
State, over 100 national medical specialty societies, Federal
service agencies and other groups. You have heard already about
the 6,000 deaths a year while organs are not being donated but
rather are buried or cremated, so I won't pursue that any
further.
AMA policy developed last year supports the scientific
study of financial incentives and other motivators to increase
the supply of organ donations from patients who recently died.
This policy was recommended by the AMA Ethics Council on the
grounds that financial incentives are not intrinsically
unethical, but may be ethical depending upon the balance of
benefits and harms as established by factual data. Currently,
there is no scientific data showing whether modest financial
incentives, such as direct payments to families, tax credits,
funeral reimbursements, or charitable contributions would
increase or decrease the supply of organs.
Almost all of the arguments against financial incentives
are based on assumptions that could be proven or disproven by
scientifically designed studies. Factual evidence could
determine the presence or absence of harm to individuals,
groups or society as a whole and resolve many of the policy
debates about financial incentives. Therefore, the AMA supports
studying the impact of moderate financial incentives and other
motivators on cadaveric organ donation.
I would like to make two important points. First, the
studies should apply only to organ donation. The current system
of organ distribution should be continued under UNOS
guidelines. In other words, no one could buy an organ. Second,
studies should be limited to understanding motivation only for
donation from newly deceased patients and not for donation by
living donors. Scientific design is essential, so each study
should be limited to a small, but broadly representative
population segment, should provide financial incentives at the
lowest level that could reasonably be expected to increase
organ donation, should have measurable outcomes to assess their
effectiveness and should be completed within defined
timeframes.
The studies should not only measure the effect of
incentives on donation rates but also on the public perception
of the meaning of organ donation. Studies should be undertaken
only after three things occur. First, a new law would be needed
for the purpose of collecting data on financial incentives.
Currently the National Organ Transplantation Act prohibits
providing any valuable consideration for organ donation.
Second, guidance and advice should be sought from the
particular under study to assure that the proposed research is
consistent with their needs, values and mores. And third,
protocols that meet ethical standards and are scientifically
rigorous must be reviewed and approved by appropriate oversight
bodies, such as institutional review boards. All ethical
safeguards that generally guide the participation of human
subjects and clinical research should be followed when studying
the impact of financial incentives on organ donation rates.
Last year, Chairman Greenwood introduced legislation that
would have authorized the Department of Health and Human
Services to carry out demonstration projects to increase the
supply of organs donated for human transplantation. Such
demonstration projects, if scientifically designed, would be an
important first step in exploring the motivation behind
cadaveric organ donation.
Once again Mr. Chairman, thank you for inviting us to
testify before you today.
[The prepared statement of Robert M. Sade follows:]
Prepared Statement of Robert M. Sade on Behalf of the American Medical
Association
The American Medical Association (AMA) appreciates the opportunity
to share its views on appropriate strategies to increase organ donation
rates and thanks Chairman Greenwood and members of the Subcommittee for
holding today's hearing on this important issue.
BACKGROUND
In the United States, there is a striking gap between the demand
for transplantable organs and the available supply of such organs.
Annually, approximately 6,000 patients with end-stage organ failure--
the equivalent of 16 per day--die because of the lack of available
organs. Successes of solid-organ transplantation have greatly increased
the need for organ donors. Unfortunately, donation rates have not kept
up with the need for organs which has grown nearly five times faster
than the number of cadaveric donors. The annually compounded rate
(1990-2000) of increase in number of patients on waiting lists has
averaged 14.1% a year. Meanwhile, the rate of increase of donors has
averaged only 2.9% a year. Unrealized potential accounts for much of
the donation gap, with studies suggesting that each year only 35-50% of
potential donors consent to donation. Because the number of potential
donors far exceeds current procurement rates, the AMA, like many other
groups, has identified the urgent need to develop new strategies to
increase donation rates in an effort to alleviate our country's organ
shortage.
THE NEED FOR INNOVATIVE APPROACHES
In the past, initiatives to increase organ donation have included
vigorous educational campaigns to motivate individuals to become
donors. Other efforts have been directed at health professionals urging
them to educate patients regarding donation, or legislatively mandating
that they present relatives of a newly deceased with a choice to
donate. All these initiatives have been expanded through the
establishment of the Organ Procurement and Transplantation Network
(OPTN), donor card programs and donor registries, and the creation of
specialized organ donation teams within hospitals that discuss organ
donation with patients and families. Unfortunately, these efforts have
failed to increase cadaveric donation rates significantly.
The AMA believes that these efforts should be maintained. It is
essential that physicians and other organ donation advocates continue
to promote voluntary donation of organs. Beyond these programs,
however, the AMA supports innovative approaches that are informed by a
more comprehensive understanding of what motivates and what hinders
individuals' decisions to donate.
REEXAMINING DONOR MOTIVATION
The AMA applauds recent efforts by various groups to determine best
practices in organ donation. Thorough study of these practices and
their replication should increase donation rates.
The AMA applauds the attention that has been given to the issue of
organ donation by the Secretary of Health and Human Services, Tommy
Thompson. Under his leadership, the membership of the Advisory
Committee on Organ Transplantation (ACOT) has doubled in size, and, it
has successfully pursued its mission to enhance organ donation by
ensuring that the system of organ transplantation is grounded in the
best available medical science, while assuring the public that the
system is as effective and equitable as possible. In November 2002, the
ACOT issued a set of recommendations to the Secretary, some pertaining
to the effectiveness of living donation and appropriate protection of
potential living donors, and others relating to increasing the supply
of organs from deceased donors.
Similarly, the United Network for Organ Sharing (UNOS) convened
organ donation and transplantation professionals last month to build a
consensus on best practices regarding techniques related to donation
requests. Considering that the most common reason for missed donation
opportunities is denial by the donor's family, this conference marked a
concerted national effort to improve consent rates by examining shared
characteristics among professionals who are routinely successful when
approaching families and potential donors about organ donation. These
findings, once implemented, could lead to increased rates of donation.
Creative proposals must continue to be examined for their potential
to increase the number of cadaveric donations to help supplement
current initiatives and address the shortage. Whether expanding
criteria for donation, systematizing the use of asystolic donors, or
incorporating organ donation as a specialized form of end-of-life care,
ethical strategies should be investigated to establish their
effectiveness in raising donation rates.
Against this background, the AMA recently considered issues related
to donor motivation. We acknowledged the medical profession's
obligation to continue to encourage the voluntary donation of organs in
appropriate circumstances and also to support innovative approaches. We
have noted that financial incentives might be an important motivational
factor in the context of cadaveric organ donation but that it remains
inadequately explored because of federal prohibition. In our view, such
incentives are not intrinsically unethical even though they are counter
to current customs, and, if proven effective, could save the lives of
many patients suffering from end-stage organ failure.
ENCOURAGING THE STUDY OF FINANCIAL INCENTIVES
In June 2002, the AMA adopted a policy encouraging the medical
community to support the reexamination of motivation for cadaveric
organ donation. In particular, the report explored financial incentives
as a possible strategy to increase organ donation, and recommended that
the impact of these incentives on donation rates be studied.
Theoretical concerns regarding harms that could result from offering
financial incentives for organ donation were carefully considered:
Currently, individuals see donation as a gift. To put a
financial incentive on cadaveric organ donation might deter
some individuals from wanting to be donors.
Financial incentives for cadaveric organ donation might fuel
what is considered by some as a disturbing trend towards
viewing the human body as a source of profit.
Payments might be unduly coercive to certain segments of the
population, interfering with the voluntary nature of donation.
Even if financial incentives initially are permitted for
cadaveric organ donation only, pressure might build to allow
payments to live donors.
Several of these concerns led a panel of experts convened by the
American Society of Transplant Surgeons (ASTS), in April 2002, to
oppose any form of direct payment for cadaveric organs. The panel was
asked to determine whether an ethically acceptable pilot trial could be
designed whereby a family would be offered a financial incentive to
consent to the donation of organs from a deceased relative. The panel
unanimously agreed that such direct payment would violate the standard
of altruism in organ donation, leading to a system that would commodify
human organs. The panel was divided with regard to the acceptability of
other indirect incentives such as funeral reimbursements or charitable
contributions, which would convey society's appreciation to a family
for their gift of life.
For its part, the AMA notes that there is a dearth of scientific
data supporting those concerns. Nearly all of the arguments against
financial incentives are based on assumptions that can be proven or
disproved by objective empirical studies. Factual evidence that would
determine the presence or absence of harm to individuals, groups of
individuals, or society as a whole could resolve many of the policy
debates between those who object to financial incentives for cadaveric
organ donation and those who favor such incentives. It is on this basis
that the AMA supports the study of motivation, to gain a better
understanding of the impact of moderate financial incentives and other
motivators on cadaveric organ donation. Whether or not such incentives
and other motivators are ethical depends, at least in part, upon the
balance of benefits and harms that result from them.
In its June 2002 policy, the AMA articulated parameters for
research studies investigating the effects of financial incentives for
cadaveric organ donation. First and foremost, these studies should
apply only to organ donation; the current system of organ distribution,
as developed and administered by the United Network for Organ Sharing
should be maintained. Also, the studies should be limited to
understanding motivation for cadaveric organ donation only, and not its
effect on living donors.
With respect to their design, each study should be limited to a
small population, provide financial incentives at the lowest level that
could reasonably be expected to increase organ donation, have
measurable outcome variables to assess their effectiveness, and be
completed within defined time frames. Altogether, it would be desirable
that data be gathered from broad population segments and that they not
only help measure the effect of incentives upon donation rates but also
on public perception of the transplant enterprise and of the meaning of
organ donation.
Moreover, studies should be undertaken only after:
A new law is enacted for the purpose of collecting these data
which would waive the National Organ Transplantation Act's
legal prohibition against providing valuable considerations for
organ donation.
Guidance and advice have been sought from the particular
population under study to ensure that the proposed research is
consistent with their needs, values, and mores.
Protocols that meet ethical standards and are scientifically
rigorous have been reviewed and approved by appropriate
oversight bodies, such as Institutional Review Boards.
All other ethical safeguards that generally guide the participation
of human subjects in clinical investigations also should be adhered to
when studying the impact of financial incentives on organ donation
rates.
Models have been proposed by several organizations, including the
ASTS and UNOS, whose Board of Directors agreed, days after the AMA
adopted its policy, to support legislation that would enable studying
the impact of incentives to encourage organ donation and to honor organ
donors. Among the suggested models are: future contracts, as was
proposed in a bill before Congress several years ago, that would have
allowed for the implementation of a tax credit of up to $10,000 on the
estate of the deceased donor; reimbursement for funeral expenses, as
was passed into law in Pennsylvania, but was never implemented because
of the federal prohibition; charitable donations; direct payment; and
medals of honor. Moreover, Congressman Greenwood's leadership with this
issue was displayed through the introduction of H.R. 5224 during the
last Congress which would have authorized the Department of Health and
Human Services to carry out demonstration projects to increase the
supply of organs donated for human transplantation.
The potential benefits to be gained from each proposal discussed
above remain speculative and must be weighed against possible harms
before any such program is widely implemented. For example, if research
shows that little discernable harm to potential donors, their families,
or society results from offering modest financial incentives, thereby
saving more lives through increased organ donation rate, everyone
benefits. But if serious harms are found, physicians and policymakers
will need to search for other means of increasing donation rates.
A thorough discussion of this matter also must include
consideration of the costs of foregoing such studies. Currently
patients die each day waiting for available organs. Therefore, a better
informed debate is necessary, one that can occur only after the
effectiveness of various incentive models has been measured. It is for
this reason that the AMA will continue to advocate for the study of
financial incentives as a strategy for increasing organ donation.
We thank the members of the Subcommittee for initiating a review of
this important matter and for inviting the AMA to share its views.
Mr. Greenwood. Thank you very much.
Mr. DeVos.
TESTIMONY OF RICHARD M. DEVOS
Mr. DeVos. Sounds like I am the lightning rod. I am the
only person here not a doctor or not involved in this
organization or industry. I am just a heart recipient, 6 years
and 1 month ago today I received my new life. I was 71 years
old at the time. I am now 77. My heart is now 45, so my average
age is 60.
Anyway, I thank God for the miracle that brought me a new
heart. Therefore, I have no interest in this, other than a
citizen trying to get involved and do something in gratefulness
for my new heart. I began to wonder what we could do and why
this line was flat on finding new organs. So I engaged my first
heart physician, who did my first bypass surgery to work for me
full-time to try to find out what we could do to make a
difference in getting more organs so other people can be
blessed. So I am grateful to you, Chairman Greenwood, for your
interest and inquiry. And I am just a citizen trying to make a
difference in this whole process.
Being a business guy, I kind of come down to, if you want
more of something, pay for it. I understand all the rest of it
and all the promotion and all the effort we ought to go into to
give it PR and give it effort, but why don't you give the money
to the person who gives the organ and maybe we will get some
further organ donation. So I come down on that side and we
tried to fashion a way to do this. I am way off what I propose
doing here. But first of all, we support making the donor the
real person who signs that card, make that stick and make it
count. And I don't care how you work the donor lists. You'll
get it all done, and I think we'll have a huge impact.
Now, once we do that, we go on to say how do we get people
to sign the card, and how do we increase the number of people
who will sign the card, and especially for the young people who
we are seeking the most to do this. And so we thought throw
some money at it. Now, I know that is not very sophisticated,
but I say let's test it and find out. And so we said, throw
$10,000 on the table and see how many people will jump and say
I'll sign for that. And when we look at that in the realm of
talking of $6,000 or $7,000 at--7,000 organs at $10,000, it
doesn't amount to much, not compared to the savings that will
exist by getting people off dialysis and getting them some life
and hope for their future.
And so we come down to the simple conclusion, let's see
what we can do. Give us a chance to do a little financial test
and see if we can excite a whole bunch of people.
Now, this is not our idea. It was originally proposed by
somebody in Greenwood's district. Project Donor was done by
Gene Epstein and Al Boessmann, and they were the first ones who
brought it to our attention. So we got on board with them and
said let's see if we can can't get somewhere with this. We are
carrying the mail for them. We decided that it was worthy of a
test. And I couldn't believe the resistance I ran into when I
tried to do this. It was just kind of a wow, what is wrong? I
kind of felt like the people who write about this are not on
the waiting list like I was. If you're on the waiting list,
you'll have a different view on this whole subject whether or
not it's okay to throw a little money at somebody. So I know we
will need to have sign up millions of people, but that's what
we need. We need millions of people to sign up, so we can get
down to that 6 or 7 or 10,000 people that will do it. They're
there, they're available, and if we launch that campaign, put
the money in the hands of the people who will sign the cards,
and maybe we'll get somewhere, but at least find out.
I salute Tommy Thompson for all his efforts. We had a
wonderful visit with him up at that Department and talked about
all of this. We're concerned with the minorities who are
fearful of things of this type. But if you put them on the list
and keep it confidential, and it's not available until someone
is brain dead, then you check the list, then nobody has to be
fearful of all of this. This is not something to be afraid of.
I know the joy of it. I met my donor and my donor was so happy
to talk to me and be grateful. She came out of the room 1 day
and said, ``Did you get a heart on June 2?'' and I said,
``Yes.'' she said, ``You have my heart.'' Fortunately for her,
she received a new heart and lungs. She happened to have bad
lungs and they found for her a new heart and lung. I will be so
grateful for that woman who said, I will give my heart out if
you can get me a new heart and lung. What a decision to make.
Thank God she made the right one. And her heart was made just
for me.
And so we rejoiced together over this wonderful event in
our lives and we praise God for it and people are willing to
take a chance on an old guy with diabetes and an old guy who
had a stroke and a few heart attacks and a few other things.
And I spend my life now trying to find ways to help other
people have a joy that I have in living with a brand new heart.
Thank you very much for your time.
[The prepared statement of Richard M. DeVos follows:]
Prepared Statement of Richard M. Devos
I want to thank the Energy and Commerce Committee for giving me the
opportunity to testify on the subject of ``Assessing Initiatives to
Increase Organ Donations.'' The subject of increasing organ donations
is very close to my heart, and I feel very passionate about doing
something to improve it. While years of deliberations have taken place,
16 patients die every day waiting for available organs that our present
system fails to have donated. In their names, we should act now to
correct this tragic failure of our system.
The key of our proposal is to shift the decision to the donor
(Donor Authorization), as the previous speakers have proposed. Having
been on the Board of the second largest donor hospital of deceased
organs in the country and still missing a large number of possible
donors, we became aware that when the patient's desires are known,
almost always the organ donation follows. In the best American
tradition, it is right that each individual make provisions to decide
when they are able to participate in the decision of what is to be done
with their organs in the event of brain death. This notion has finally
taken hold in the transplant communities around the country and is now
favored by many professional and family associations.
To be successful and access the 50% of the donor candidates that we
are missing now, it will require the massive enrollment of millions of
citizens. Educational campaigns, advertisements, enrollment drives, and
all the methods tried up to now have yielded less than 40% of the
population signing, where available, on the back of driver's licenses
or donor cards, and proportionally even less people joining potential
donor organizations.
For these reasons and based upon ``Project Donor'' of Gene Epstein
and Al Boessmann, we propose to offer a $10,000 free term insurance-
like benefit or a similar tax credit only to induce the individuals to
sign the witnessed document when offered with the tax return form or
driver's license application. These two activities reach almost 100% of
the USA population at one time or another in their life. Why $10,000?
Because it is an amount significant enough to make the individuals
focus on the document offered and the designation of the after-death
beneficiary of their generosity.
To address the right concerns of minorities that they would not be
given adequate terminal care if an insurance or tax credit exists, this
document can be accessed only when the patient has been declared brain
dead and the family has been notified.
Each kidney transplanted alone saves between $200,000 and $400,000
to the insurers paying to keep these patients alive on the waiting
list. Medicare pays 60% of these bills.
This proposal respects the autonomy of the individual, has been
accepted by many diverse religious and ethical organizations, addresses
the concern of minorities about their possible terminal care, empowers
the poorer members of society to bequeath to their families the
societal recognition of their generosity, and it makes economical
sense, saving billions of dollars to the present payers.
Mr. Greenwood. That's what I would call straight talk.
Dr. Joseph Vacanti.
TESTIMONY OF JOSEPH P. VACANTI
Mr. Vacanti. Thank you, Mr. Chairman. I hope you analyze
mine as well rather than gobbledygook. Thank you for the
opportunity for me to testify today before this subcommittee.
I am a surgeon who practices pediatric surgery, as well as
pediatric transplantation surgery. I have been in the practice
of these two special areas of surgery in children since
completing my training in 1983. My remarks today are in regard
to the ever-increasing problem of vital organ shortages, and
the work that I have done in trying to solve this problem.
As you are all aware, organ transplantation has been
enormously successful and one of the major advances of 20th
century medicine and surgery. However, it's this very success
that has led to the ever-worsening problem of the organ donor
shortage. We have all of the tools at our disposal of being
successful in the transplantation of vital organs, but the
fundamental thing we need is the vital organ itself. You have
heard its numbers, over 80,000 Americans waiting, many die.
Now, this field that I represent, tissue engineering and
regenerative medicine, has been developed to try and meet this
need. Over the last 18 years, my laboratory, and many of my
collaborators, have been developing technologies using biology,
medicine and engineering to actually build these organs so that
they're available on demand. This challenging and novel
approach has advanced from fiction to reality. The work has now
advanced into human therapy in several circumstances, but not
yet for vital organs.
As an example, several commercially available skin products
have been developed. In fact, the tragedy of September 11
produced many patients with horrible burn wounds. Tissue-
engineered skin was donated to help these patients both survive
and then have an improved quality of life. Besides skin, living
cartilage, living bone, living blood vessels, and some early
investigation into living human bladder are now available. The
fundamental scientific and technologic basis of this approach
has been developed over these past 18 years. There have been
many new advances in the understanding of living cells and
advances in material science to produce better and better
living tissues. Given all this, the ultimate challenge is the
creation of a life saving whole organ to solve the subject of
this subcommittee.
Now, we continue to work on this most difficult problem at
the Massachusetts General Hospital, Harvard, MIT and Draper
Laboratories. Based on the work we have performed over the past
5 years, it is my feeling and my opinion that this problem is
solvable and that the goal is achievable. It will require the
firm commitment of intellectual resources for creative problem
solving and financial resources to actually achieve the
seemingly impossible. This year marks the 100th anniversary of
the first human flight. All previous human civilizations had
dreamed of human flight. However, it was American know-how and
American determination that ultimately achieved this seemingly
impossible goal 100 years ago. This new problem in biologic
engineering can also be solved.
Thank you for the privilege of discussing this at this
hearing.
[The prepared statement of Joseph P. Vacanti follows:]
Prepared Statement of Joseph P. Vacanti, Director, Pediatric
Transplantation, Massachusetts General Hospital, Boston
Thank you for the opportunity to testify today before the
Subcommittee on Oversight and Investigations in the hearing ``Assessing
Initiatives to Increase Organ Donations''.
I am a surgeon who practices pediatric surgery as well as pediatric
transplantation surgery. I have been in the practice of these two
special areas of surgery in children since completing my training in
1983. My remarks today are in regard to the ever increasing problem of
vital organ shortages and the work that I have done in trying to solve
this problem. As you all are aware, organ transplantation has been
enormously successful and is one of the major advances of twentieth
century medicine and surgery. However, its very success has led to the
ever-worsening problem of organ donor shortage. We now have all of the
tools at our disposal of being very successful in transplantation of
vital organs. However, the fundamental thing we need is the vital organ
for transplantation. Currently, there are over 80,000 Americans waiting
for a vital organ to become available. The field of tissue engineering
and regenerative medicine has been developed to try and meet this need.
Over the last 18 years my laboratory with many of my collaborators have
been developing technologies in biology, medicine, and engineering to
actually make living tissues and organs for replacement therapy. This
challenging and novel approach has advanced from fiction to reality.
The work has now advanced into human therapy in several circumstances
but not yet for vital organs. As an example, several commercially
available skin products have been developed and commercialized. In
fact, the tragic of September 11th produced many patients with horrible
burn wounds. Tissue engineered skin was donated to help these patients
both survive and then have an improved quality of life. Besides skin,
products of living cartilage, living bone, living blood vessels, and
some early investigation into living human bladder are now available.
The fundamental scientific and technologic basis of this approach
has been developed over these past 18 years. There have been many new
advances in the understanding of living cells and advances in material
science to produce better and better living tissues.
Given all this, the ultimate challenge is the creation of a life-
saving whole organ to solve the organ shortage. We continue to work on
this most difficult problem at Harvard and the Massachusetts General
Hospital, MIT, and the Draper Laboratories. Based on the work that we
have performed over the past five years, it is my feeling that this
problem is solvable and that the goal is achievable. It will require
the firm commitment of intellectual resources for creative problem
solving and financial resources to actually achieve the seemingly
impossible. This year marks the 100th anniversary of the first powered
human flight. All previous human civilizations had dreamed of human
flight. However, it was American know-how and American determination
that ultimately achieved this seemingly impossible goal 100 years ago.
This new problem of biologic engineering can also be solved.
Thank you for the privilege of discussing this at this hearing.
Mr. Greenwood. Thank you. No gobbledygook at all. Rather
straightforward.
Dr. Abraham Shaked.
TESTIMONY OF ABRAHAM SHAKED
Mr. Shaked. Chairman Greenwood and distinguished members,
thank you for the opportunity to submit this testimony on
behalf of the American Society of Transplant Surgeons.
I am the Chief of Transplantation Surgery at the University
of Pennsylvania and the Children's Hospital of Philadelphia.
Myself, I have been an adult liver transplant surgeon. And if I
may add a personal thing, it is going to be very exciting to
come tonight and to tell my family and my children that I met
you, Representative of our State. And one other thing about
them, they all signed, by themselves, donor cards and God
forbid something happens, our wishes will be respected.
This committee assesses the initiative to increase organ
donation and would like to offer our comments on four different
topics, two of them I would like to discuss in brief and two
maybe a little bit more. In brief, we the American Society of
Transplant Surgeons are a society of full transplant surgeons
in this country including, by the way, Senator Frist, who is
still a member and paying dues. We would like to offer our
support for honoring donor wishes, what is referred in this
country as donor rights. This is clearly something that should
be supported, and we join other organizations in this
initiative.
The second thing that we have to mention is the importance
of research as mentioned by my friend Jay of research in this
area. About a year ago or so, our society contributed about
$2.1 million from a donation we had from members and the
community to study, for example, what happened to donors and
recipients after leaving donor liver transplantation. We did it
with NIH. Our center is one of nine centers in the country
studying this issue. And we truly believe that more research
and what's going to come out from this NIH study is going to
help citizens of our country, and we really thank you for
support of the NIH in this initiative.
The two issues that I would like to expand a little bit
more is the support for--the support for the use of organ
coordinators in hospitals. And this--there is a lot of interest
in this country on this issue. And a couple of years ago our
society sponsored--we went to Spain for a couple of days, and
we were able to spend some time with our great Spanish allies
and we learned a lot from them and there is much to learn from
that model. They were able to do something that should be done
here. They were able to increase the number of donors per
million, and they could show it to us clearly. And
interestingly, there was an increase in all the donor
population, and we used a lot of organs from these donors. And
I think that is a nice thing to support. And we should provide
some funds of some sort to initiate this model in this country.
We think this is going to work, and we support legislation in
this area.
Now, the other thing that we want to comment is this
payment or incentive for donor organs and things like that. The
ASTS is clearly opposed to payment for organs. And as a private
citizen and as a representative of this organization, I have to
say this was debated a lot, and we thought about it. This
country has a lot of history--as a new immigrant to this
country, I learned about the history here. This country has a
lot of history in selling and buying human life. And there was
a whole Civil War about it. And now we are talking about
commercializing organs. This is not something that I think the
culture in this country is ready for, and I hope will never be
ready for.
However, there are all kinds of things that we should
learn. And me as a scientist, I want to learn models, whether
there is any opportunities to increase donations via project.
One thing is for sure. We should never--not disincentivize the
issue of donation. My family member was once a donor and it's
terrible. You have to go there and spend time and to go back
and forth. And there is more payment, believe it or not, for
prepping the cadaver for viewing and all things coming out of
pocket and the pocket is from the family and this should not be
done. So we support projects to examine the issues. We may
support projects to examine other issues that are acceptable
and ethically acceptable and justified by our moral standards.
And we want to do that in a scientific way, like what I do in
my lab when I want to investigate, set up a model, see whether
it's going this way or not and modify it so on and so forth. We
think it should be studied in a careful way. Now, I understand
there are a lot of restrictions within the law of how to do it
and what to do. I am not a lawyer and I look at you, you are
the leaders and you have to provide some kind of means or some
kind of legal authority for us to study. At the same time you
hold the money, and you should provide some kind of funds. We
are there to conduct the study. We are there to provide you the
results, and you should judge whether it's working or not.
Our society is engaged for quite awhile examining all
models. We are willing to work with you at any time. Our
problem is not to tell you how to change the law. That's what
you're doing. That's your responsibility. Our responsibility is
to provide you the results and to see whether it's working or
not and we are there at any time.
And thanks very much.
[The prepared statement of Abraham Shaked follows:]
Prepared Statement of Abraham Shaked, President, American Society of
Transplant Surgeons
Chairman Greenwood, Ranking Member Deutsch, and distinguished
Members of the Subcommittee: On behalf of the American Society of
Transplant Surgeons (``ASTS''), thank you for the opportunity to
testify before this Subcommittee on the important issue of assessing
initiatives to increase organ donation rates. My name is Abraham Shaked
and I am Chief of Transplantation Surgery at the University of
Pennsylvania, Department of Surgery.
Today marks my first day as President of ASTS, an organization
comprised--of over 900 transplant surgeons dedicated to promoting and
encouraging education and research with respect to organ and tissue
transplantation so as to save lives and enhance the quality of life of
patients with end stage organ failure. As this Subcommittee assesses
initiatives to increase the rate of organ donation in this country, we
would like to offer comments on four topics:
1. The use of organ coordinators in what is often referred to as the
``Spanish model'';
2. The ethical use of financial incentives to increase organ donation
rates;
3. Honoring the donor's wishes, what is sometimes referred to a ``donor
rights''; and
4. The importance of living donor liver transplantation and related
research.
BACKGROUND
Mr. Chairman, as you well know, one of the most pressing problems
in the field of organ transplantation is the lack of available organ
donors. This creates long waiting lists of potential candidates for
organ transplants. Every individual who needs an organ transplant
should be able to receive one in a timely manner but, as a nation, we
are not even close to achieving this goal. The Bush Administration is
providing strong leadership in this area, both in terms of funding of
the programs under the Division of Transplantation within the Health
Resources and Services Administration and with the assistance of his
Advisory Committee on Transplantation (``ACOT''). Secretary Thompson,
in particular, deserves great credit for his personal commitment to the
organ donation issue. Along with a concerted effort in the transplant
community and with the private sector, we are starting to turn the
corner on this national problem, but there is much more progress to be
made.
ASTS is very encouraged by the Bush administration's support for
increased organ donation activities. In April 2001, Secretary of Health
and Human Services Tommy Thompson first announced a five-point
initiative to encourage organ, tissue, marrow, and blood donations.
More recently, the Department of HHS has been working to implement the
18 recommendations of the ACOT. In past years, the third week in April
was designated as ``National Organ and Tissue Donor Awareness Week.''
This year, however, the Administration changed this to a month-long
observance. Thousands of people have already recognized the importance
of giving the ``gift of life'' to others. In 2002, 22,741 organ
transplants and more than 46,000 corneal transplants were performed in
the United States, and an average of 173 transplants were facilitated
each month by the National Bone Marrow Donor Registry.
The need, however, is still enormous. Close to 81,000 individuals
are on the waiting list for organ transplants, and thousands need
tissue and corneal transplants each year. About 30,000 people per year
are diagnosed with blood diseases that may be cured by a marrow/blood
stem cell transplant. And each day, approximately 32,000 units of blood
are needed, yet only about 5 percent of eligible blood donors give
blood regularly.
Sadly, more than 6,000 people die unnecessarily each year because
they did not receive the organ they needed. Currently, sixteen people
die every day waiting for a donated organ--that is one death every 91
minutes. And the problem is getting worse, not better. Regrettably, in
the past ten years, the number of registrations on the waiting list has
quadrupled.
Mr. Chairman, there are many strategies to combat this problem,
some more controversial than others. More often than not, simple
awareness by patients and their families about the facts of organ
donation can make the difference between life and death. Studies have
shown that over 95% of families would consent to organ donation if they
knew it was the wish of their loved one. As recent increases in organ
donation rates demonstrate, education and awareness can be an effective
tool in saving the lives of patients needing transplants. Consequently,
the ASTS strongly favors initiatives that foster education and public
awareness efforts. The commitment of federal resources to address the
nationwide shortage of donated organs is essential to both increase the
success rate in organ transplantation and increase the number of organ
donors available.
While additional spending is critical on public awareness, grants
for organ coordinators, grants for studies to eliminate disincentives
to organ donation, and other programs, ASTS also supports changes in
public policies to encourage donation. Several years ago, ASTS worked
with a number of transplant-related organizations to craft a set of
organ donation proposals for Secretary Thompson's consideration, and
ultimately for the consideration of Congress. Now the bulk of these
recommendations are represented in legislation introduced by Senate
Majority Leader Bill Frist, who, as you know, is a transplant surgeon.
This legislation, S.573, the ``Organ Donation and Recovery Improvement
Act,'' has widespread support and we hope to see it serve in the Senate
as a vehicle to enact an organ donor bill into law this year.
THE USE OF ORGAN COORDINATORS
There has been significant U.S. interest in the potential promise
that organ coordination programs, such as the program utilized in
Spain, may offer. In fact, grants to fund organ coordination activities
are proposed in Senator Frist's organ donation legislation, S. 573. In
the House, Congressmen Wilson (R-SC) and Inslee (D-WA) have each
sponsored similar legislation in the past. The so-called ``Spanish
Model'' has been outlined as a structure of national, regional, and
local or in-hospital efforts to increase organ donation. The management
structure consists of a front-line in-hospital transplant coordinator
who is fully involved and accountable for the donor recruitment effort.
Furthermore, transplant donor coordination has been
``professionalized'' and most coordinators are qualified doctors,
mainly intensive care specialists and nephrologists, who have dedicated
time allocated to transplant coordination. Moreover, the Spanish system
adheres to the principles of decentralization of the donor coordination
effort through the use of regional coordinators and the establishment
of organ procurement as the main priority for national, regional, and
hospital coordinators.
In an attempt to assess and study whether organ coordination models
could be effective for the U.S. in raising organ donation rates, the
ASTS organized and funded a study group in the late 1990's to
investigate methods of maximizing organ donor potential and improving
the recovery of organs from these donors. The study group consisted of
three transplant surgeons (John Roberts from the University of
California San Francisco, Bruce Rosengard from the University of
Pennsylvania, and myself as chair of the group) as well as four
representatives from the Association of Organ Procurement Organizations
(AOPO). The study group spent two days in Madrid, Spain at the
Organizacion Nacional de Transplantes (ONT), that country's national
transplant program.
Since the creation of the Organizacion Nacional de Trasplantes
(ONT) in 1989, the organ donation rate in Spain has doubled. This
effort has been so successful that it produced a 28% decrease in the
size of the waiting list for kidney transplantation in Spain between
1991 and 1997. During this same time period, the US kidney waiting list
nearly doubled in size. Although often attributed to improved donor
recruitment efforts, the increase in donor rates in Spain may also
represent higher utilization of marginal donors. Recently, a study
examined age-related donor recruitment in Spain and the U.S. Chang,
George J., MD, Mahanty, Harish D., MD, Ascher, Nancy L., MD PhD,
Roberts, John P., MD, ``Expanding the Donor Pool--Can the Spanish model
work in the United States?'' (Division of Transplantation, Department
of Surgery, University of California, San Francisco).
Data from the ONT, the US Scientific Registry of Transplant
Recipients (SRTR), the US Census Bureau, and the Tempus databank of
Spain's Instituto Nacional de Estadistica (INE) were analyzed. Between
1989-1999, the number of donors in Spain increased from 14.3 to 33.7
per million population (pmp), (136% increase) compared to an increase
in the US from 16.2 to 21.5 donors pmp (33%). The largest difference
between Spain and the US in the increased number of donors was in the
45 year old group representing 30.3% of donors in Spain in 1999 (44
donors pmp). If the U.S. increased its older donor rates to match
Spain's, an incremental 1235 donors per year would be realized. The
high Spanish organ donation rates are largely attributable to increased
use of older donors. Utilizing similar proportions of older donors in
the US would increase the donor pool by almost 40%.
As already stated, there has been significant interest in
implementing a ``Spanish Model'' for organ donation in the US and other
countries. Calls for funding similar types of organizational structures
have been made on the grounds that this change will result in an
increase in organ availability. ASTS supports legislation that would
create such organ coordination programs in the U.S. and believes that
such a model can be effective, along with the practice of expanding the
donor pool by utilizing older donors.
THE ETHICAL USE OF FINANCIAL INCENTIVES TO INCREASE ORGAN DONATION
The use of financial incentives to increase organ donation rates
can be quite controversial and, of course, payment for organs is
prohibited by current law under the National Organ Transplant Act
(NOTA). NOTA prohibits the exchange of ``valuable consideration'' for
the use of a person's organs. 42 U.S.C. 274e. To do so would run the
risk of turning what is now often referred to as the ``gift of life''
into a commodity to be bought and sold. This potentially cheapens the
sanctity of human life and raises profound moral, ethical and religious
questions. These questions, however, must be weighed against the
morality of tolerating huge organ donor waiting lists with thousands of
people dieing each year unnecessarily.
The ASTS clearly opposes payment for organs. The United States must
not send a signal to the international ``black market'' that the United
States tolerates the commoditization of human organs. However, ASTS
does not oppose efforts to study various methods and programs to
increase donation rates that may have a financial component. For
instance, ASTS would support a demonstration project that assessed the
effectiveness of providing a modest funeral expense benefit to the
family of a decedent donor, not as a payment for a donated organ, but
as a token of thanks. ASTS also supports initiatives to eliminate
financial disincentives to donation such as the provision of travel and
subsistence expenses for living donors and similar initiatives.
Mr. Chairman, ASTS is well aware of your bill introduced in the
107th Congress, H.R. 5224, that addressed the issue of financial
incentives without permitting such incentives to override the
provisions of NOTA. Senator Frist's bill in this Congress, S. 573,
takes a slightly different approach by stating that demonstration
projects on financial incentives may be conducted ``Notwithstanding
[the provisions] of NOTA . . .'' This language appears to open the door
to financial incentive demonstration projects that may not be
considered permissible under current law. However, Senator Frist's bill
contains two important provisions that help ensure that such
demonstrations will be ethically sound before being funded by the
Department of Health and Human Services. First, the Secretary is
required to submit a report to Congress before funding any initiatives
that evaluates ``the ethical implications of proposals for
demonstration projects to increase cadaveric donation.''
Second, the bill requires the Secretary to provide ``ongoing
ethical review and evaluation.'' While ASTS would prefer that this
review be provided by an entity that is independent from HHS, such as
the President's Council on Bioethics, and will continue to work in the
Senate to accomplish this goal, ASTS supports S. 573 and looks forward
to the day that an organ donation bill will be signed into law.
ASTS SUPPORTS DONOR RIGHTS
ASTS recently formally endorsed a policy of honoring donor wishes
in the donation decision, notwithstanding familial objections. This
policy is consistent with current federal law but many states are
currently considering ``donor rights'' laws of their own. Formal
endorsements of donor rights by AOPO and the Advisory Committee on
Transplantation preceded ASTS's decision, all of which have occurred in
the last several weeks. It is ASTS' hope that raising the awareness
level of donor rights will have an impact on the number of people who
take affirmative steps to witness their intent to donate their organs
upon death.
ASTS AND NIH PARTNERSHIP
ASTS and the NIH have a solid history of partnering on projects
that will increase the rates of organ donation, improve existing
transplant protocols, and provide basic research into transplantation.
This year, the NIH announced, in coordination with ASTS, the Adult to
Adult Living Donor Liver Transplant Cohort Study (A2ALL), to take place
at 10 U.S. transplant centers over the next seven years. ASTS has
committed over $2.1 million over a seven year period for this joint
project. The national project will investigate the experience of a
group of patients eligible for living donor liver transplantation,
focusing on the factors influencing outcomes of living donor liver
transplants for both donors and recipients. Researchers will compare
outcomes of this new procedure with the outcomes for patients who
receive donor livers from cadavers.
The goal of the study is to gather accurate data in a disciplined,
careful way so that liver transplant patients and potential donors have
reliable information about the risks and benefits of living organ
donation. In addition to vital clinical issues, the A2ALL will
investigate important research issues such as liver regeneration, liver
cancer, and infectious hepatitis.
Liver transplantation is the only cure and a life-saving measure
for people with end-stage liver disease. Although liver transplants
have become relatively common in the U.S. in recent decades, in 2001
some 17,000 patients waited for livers to be donated, while fewer than
5,000 cadaveric livers were actually transplanted that year. The
shortage of cadaveric organs has led physicians and researchers to look
to live donors to close that gap. The liver is a large segmented organ
that can potentially be split without harm to the donor and with
benefit to the recipient. Because the liver, unlike most organs, has a
remarkable ability to regenerate, the donor's remaining liver grows to
its original size within weeks. Likewise, the donated lobe will also
grow in the recipient's body.
For children in need of liver transplantation, living donor
transplantation from an adult has been very successful and has become
an accepted medical option. Adults in need of liver transplantation
require a larger segment, as much as half or more of the donor's liver.
This requires a more extensive and complex surgery, with potentially
greater risks for the donor and the recipient. The procedure has
evolved so rapidly that over half of the living donor transplants
performed to date have occurred since 2000. Evaluation of donors as
well as surgical procedures vary from one transplant center to another.
Although the large majority of living donor liver transplants have been
successful, there are few data to inform potential donors about risks.
Post-surgical problems for donors can include infection, pneumonia, and
leaking bile, which can require further surgery.
Because the procedure is expanding across the country, a group of
concerned physicians recently called for more research on the risks and
benefits of this procedure as well as an outside regulator to certify
hospitals that would perform the procedure in the New England Journal
of Medicine (April 4, 2002). They also asked for uniform medical
criteria in selecting donors and recipients.
Mr. Chairman, transplant surgeons place a great deal of importance
on the well-being of both donors and recipients. ASTS's partnership
with NIDDK should give us credible data for the high quality patient
care we all want to provide.
CONCLUSION
Thank your, Mr. Chairman, for the opportunity to present the views
of the ASTS before this Subcommittee. Please do not hesitate to contact
me in the future if I can be of any further assistance. Thank you.
Mr. Greenwood. Thank you.
Dr. Delmonico.
TESTIMONY OF FRANCIS L. DELMONICO
Mr. Delmonico. Thank you.
I am Francis Delmonico. I am a transplant surgeon of 25
years, Medical Director of the New England Organ Bank. I am a
member of the Secretary's Advisory Committee on
Transplantation. And I am honored to represent the National
Kidney Foundation, and thank you for having this opportunity to
appear before you.
The NKF acknowledges the support of Congress previously
about disincentives for live donors to be donors and that ought
not to be. So I wish to acknowledge, on behalf of the NKF, the
passage of the Organ Donation Improvement Act of 2003. This
kind of mind-set, to say to people we shouldn't have them bear
the expenses of being a live donor, is very important, but that
is clearly different than saying someone's going to step
forward to be a donor by the motivation of being monetarily
enriched. So that is an ethical distinction I would hope that
you would really take into consideration. The NOTA of 1984
prohibits anyone from acquiring and transferring, as has been
stated this morning, a human organ for valuable consideration.
The NKF supports this legislation. In fact, so do all the
folks who have been here this morning. We know them personally,
and they have called the caution of overruling that in the
following sense, that now the reason someone comes forward is a
valuable consideration by money or property. That is a very
important ethical distinction, and it goes to the payments of
organs. That would be the headline as it would come if there
were these financial incentives applied. Payments do the
following; they exploit vulnerable members of society. And that
degree of exploitation, I would say to you, as we now know from
the black market around the world of organ sales, is influenced
by where they live, by their gender, by their ethnicity, by
their social status. That is a reality that is well-described.
So to suggest that the Congress now is going to endorse
financial incentives, please, if I may respectfully say, think
through what the impact of that headline will be, payments for
organs. That then, in a State such as Michigan or some locale
where is there a demonstration project that you wish to have
that financial incentive applied, please don't have it
perceived that the Federal or State government is the
proprietor of an organ sale which could be misconstrued, which
are the headlines that are taking place now, when these kinds
of financial incentives are being proposed, because that will
have an impact around the world as if to say, there's a
sanction now for a market for organs and it's impossible.
Once you get into that market to say, well, we will have it
government regulated around the world, I don't think so.
Another piece of this, if I might say this personally, I had an
opportunity to debate a columnist at the University of Chicago
a week ago, a Nobel lawyer, a bit over my head academically,
but his posture was that in a global economy, we might be able
to import individuals to sell their kidney. And then the
question was, and then the NKF would have this question as
well, when we are done selling a kidney, can she sell a part of
her liver, or then can there be the sale of the lung. So where
do the sales stop? Where does the element of coercion and
exploitation not be the overriding concern.
There is another aspect of this that I would like to bring
to the committee's attention as a transplant surgeon. Advocacy
for organ vendors presents an inherent conflict in the
physician's relationship with the patient. I have a donor
before me now. I have had this for 25 years. Now, put money in
the mix of that equation. How are they going to trust my
medical decisionmaking, that this person should be a donor or
not if there are medical reasons why that are not medically
suitable? Think of the patient coming before me saying, ``I
need the $40,000. You have got to enable me to be a donor, no
matter what the medical problem might be.'' Let's say there is
a medical history of cancer or some medical contraindication,
will that surface in the mix of that patient-physician
relationship? I would only bring to you a very ernest concern
about that trust and relationship.
Organ sellers around the world know the difference of this,
and there have been reports in the literature regarding the
consequences of being a black marketed organ seller and the
difficulties that these individuals have had. So now you get
into financial incentives and you are applying, arbitrarily, a
monetary assignment for this. Well, the difficulty of this
becomes will we throw $10,000 at it, and does that not become a
way of evaluating the very human life that all of us at this
table have had for all of our years.
The proponents of financial incentives for nonliving organ
donation assert that demonstration projects should be conducted
to determine whether it will increase the organ supply. The
concern the NKF has is that the headline will be payment for
organs and that it's impossible to distinguish that financial
incentive for nonliving donation from this practice that we
just elaborated about selling human organs. The experience of
this goes to the integrity of the organ donor pool, as well as
paid blood donations.
I would say to you, another factor of this, that the NKF
has been confronted with is that it will undermine the good,
the altruism that has been by half of the donors who have come
forward and not been compensated. So in the interest of time,
let me say the NKF--that the medical community commends what we
have heard this morning from Dr. Metzger and Joe Roth and this
opportunity to honor the potential organ donors' wishes. The
notion of the decedent's self-determination not being overruled
and yet at the same time, I know the NKF wishes to underscore
that while fulfilling donors' wishes, the OPO staff and
hospital staff must be sensitive to the needs of the families
at that time of crisis.
So on the one hand, we are propelling donor authorization
and donor rights, but at the same time let us not overlook the
families that are there in their time of crisis. So this
approach of honoring donor wishes which is the thrust behind
the Uniform Anatomical Gift Act--and by the way, as a member of
the ACOT we wrote--we endorsed this at the ACOT--a wonderful
development. We would hope that you would consider that very
seriously and work with ways to see that becomes endorsed and
implemented joining the entire transplant community to embrace
a social responsibility about organ donation, rather than say
we'll throw money to it. This is an alternative approach. And I
would say to you, rather than the perception of a financial
incentive to be buying and selling of organs, that would derive
an ethical consensus that I think we could all devote ourselves
to.
[The prepared statement of Francis L. Delmonico follows:]
Prepared Statement of Francis Delmonico, National Kidney Foundation
Good Morning. I am Francis Delmonico, a transplant surgeon at
Massachusetts General Hospital, Professor of Surgery at Harvard Medical
School, and a volunteer for the National Kidney Foundation (NKF), as a
member of the NKF's Medical and Scientific Advisory Board. On behalf of
the 30,000 members of the NKF, including several thousand solid organ
transplant recipients, we appreciate the opportunity to present
testimony today.
The NKF acknowledges the support that Congress has provided for
organ donation in legislation to assist living organ donors with non-
medical expenses such as travel and subsistence, which is included in
the recent House passage of H.R. 399, the ``Organ Donation Improvement
Act of 2003.'' Surveys of living kidney donors conducted by the NKF
have revealed that 1 in 4 respondents experienced a burden with non-
reimbursed expenses. We are encouraged that H.R. 399 will enhance the
opportunity for live organ donation.
Remuneration of expenses related to donation, whether living or
non-living, is ethically different than a monetary payment that
enriches a person as the motivation to be an organ donor. The National
Organ Transplant Act (NOTA) of 1984 prohibits anyone from acquiring,
receiving, or transferring a human organ for valuable consideration for
use in human transplantation. The NKF supports this legislation because
the sale of bodies or body parts would undermine the fundamental values
of our society. Payments would exploit the most vulnerable members of
our society, with the degree of exploitation influenced by gender,
ethnicity, and the social status of the vendor. This exploitation has
been the experience of a black market for organs throughout the world.
To suggest that the Federal Government or individual States be the
proprietor of a market for organs is contrary to the proper role of
government. For those global economists who would import a poor person
into this country even for the noble reason to feed her family by
selling her kidney, the NKF would ask: will these market forces next
suggest that our government sanction her selling a part of her liver,
then a lobe of her lung?
Advocacy for organ vendors (versus donors) also presents an
inherent conflict for the physician's professional relationship with a
patient. In that relationship, patients are not clients, nor
commodities. It should be evident that money as a motivation for
``donation'' distorts the basis of the physician patient relationship:
the trust of each other. The medical decision and procedure that may be
forced upon the organ seller and the physician are not by the priority
of best care, but rather by the dictate of the sale.
Organ sellers are now reported to know the difference between a
proper patient-physician relationship and the complicated interaction
they have experienced, much to their regret. These unfortunate
individuals are not considered as patients but objects of an arbitrary
monetary calculation, driven by the going rate in the market place
(government regulated or not). Any attempt to assign a monetary value
to the human body or its body parts, even in the hope of increasing
organ supply, diminishes human dignity and devaluates the very human
life we seek to save.
Proponents of financial incentives for non-living organ donation
assert that demonstration projects should be conducted to determine
whether it will increase the organ supply. However, the NKF believes
that it is impossible to separate the ethical debate of financial
incentives for non-living donation from the unethical practice of
selling human organs. Payments for organs could undermine the integrity
of the organ donor pool as was the experience of paid blood donations.
Furthermore, the advocates of such demonstration projects have given no
formula as to how they will make a distinction of endorsing live donor
sales, nor have they assured appropriate ethical oversight to prevent
potential donor families from perceiving this project as merely a
payment for organs.
For demonstration projects of financial incentives to be initiated
in the United States, it will require a revision of the federal law by
Congress. The consequence of a congressional endorsement of a payment
for organs would be profound. It could propel other countries to
sanction an unethical and unjust standard of immense proportions, one
in which the wealthy readily obtain organs from the poor, justified by
the citation of congressional sanction. In that reality, the poor
person will remain poor but lose health and maybe more than one organ
in the process of a government authorized abuse of the poor for the
rich.
Opposition to payment for organs is not limited to the NKF. The
American College of Surgeons has said that compensation of any kind for
organs is wrong. The President of The American Society of Transplant
Surgeons (ASTS) has testified this morning that the ASTS opposes
payments for living or deceased organs.
What can we all do now to increase deceased organ donation beyond
recent efforts? The NKF commends the approach brought to the
Committee's attention today by Robert Metzger of the United Network for
Organ Sharing (UNOS) in concert with Joe Roth representing the
Association of Organ Procurement Organizations (AOPO): to honor the
potential organ donor's wishes. What better way could a mournful family
reconcile some of its grief, than to honor their loved one's desire to
provide an altruistic gift to individuals in need? The decedent's self
determination to donate should not be overruled. However, the NKF also
wishes to underscore that while fulfilling donor wishes, the OPO and
hospital staff must be sensitive to the needs of families at the time
of crisis. The NKF supports the needs and expectations of donor
families through its National Donor Family Council (NDFC), which we
founded in 1992. With more than 10,000 donor family and professional
members, the NDFC represents donors of all organs and tissues.
This approach of honoring the donor's wishes was the thrust behind
the Uniform Anatomical Gift Act (UAGA) promulgated in every state many
years ago and recently endorsed by the Secretary of Health's Advisory
Committee on Transplantation. Thus, the NKF joins today with the all of
the transplant community to create a timely national momentum to
embrace a social responsibility conveyed by the donor authorization
initiative. The NKF affirms the right of individuals to authorize the
donation of their organs and tissues at death. This alternative
approach to buying and selling organs brings an ethical consensus to
which we all can devote ourselves.
Thank you. I would be pleased to respond to any questions.
Mr. Greenwood. The Chair recognizes himself for 10 minutes,
and we have heard the spectrum of views on this issue.
Let me direct a question right back to you, Dr. Delmonico,
if I may, because you had indicated that something to the
effect that it would be impossible to distinguish between
financial incentives that went to a decedent's estate versus
buying an organ from a living person and creating that
incentive. And I want to challenge that assertion, because I
think people don't have a lot of difficulty making
discrimination between someone who is alive and someone who is
dead. And, obviously, since no one that I am aware of is
advocating a policy that would actually pay someone to donate a
kidney while they are alive, I think that is ethically
abhorrent to all of us. You are putting that person's life at
risk. And what I understand, it is more dangerous to live with
one kidney than with two. So that would be financial incentive
that would put someone at significant risk. But when someone is
making a decision whether or not to sign up to be a donor, this
is not something that is occurring at the moment--this is not
when they're on their death bed or not at a moment when they're
anticipating this would actually happen to them. Most people
know when they sign up to be an organ donor, it is very
unlikely that they will be one. Takes very special
circumstances to be an appropriate donor. So I don't see--your
testimony talks a lot about the blurring of this distinction,
that somehow that even if we had a study program in which there
would be some kind of financial remuneration to an individual's
estate or to a charity of an individual's choice upon their
death, that that would incentivize black market organ donation
in China. And I don't see the slope as being slippery in that
regard. And when I take into consideration the ethics of
allowing 6,000 people to die every year, it's a pretty
extraordinary value to put on one side of the scale, 6,000
lives when we're talking about some kind of mild incentive. We
heard talk about $5 off on your driver's license. That is a
financial incentive. I don't see anyone screaming about that
and arguing that people are selling their organs or headlines
are blurring the distinction.
Mr. Delmonico. Could I respond to that, please?
We agree we have got to get people to sign up. You have
expressed this morning your desire to do this in such a way
that it applies to a financial incentive. The issue is--now, I
am saying this respectfully--how do you go about it.
Mr. Greenwood. Of course.
Mr. Delmonico. I had the experience--I am a member of the
American Society of Transplant Surgeons. They asked that the
Ethics Committee address this issue. We did. And the conclusion
was that there should be a study, and perhaps with the use of a
funeral reimbursement, the headline read, Surgeons Endorse
Payments for Organs in the Washington Post. The Society was
understandably quite concerned that there was the wrong
perception. It is by that experience that I wish for you--only
that I respectfully say, one has to be careful about how this
is perceived because once it goes to the Federal Government and
endorses payments for organs by such a financial incentive or a
particular State does, then I don't see how you rein that in
throughout the world.
So it's by that experience that I express that concern, but
we both agree, let's get folks to sign up.
Mr. Greenwood. But if I may, it seems to me that for the
years that I have been interested in this subject, everything--
I have heard that a thousand times, let's get more people to
sign up and yet we have a flat line. Nothing has made a
significant dent in the number of donors.
Mr. Delmonico. Yes, sir. But Dr. Metzger's approach has not
been tried, and that's the best way I can respond. We are both
wanting the same objective to have people sign up. It's just a
matter of how we go about getting them to do it.
Mr. Greenwood. We need to be extraordinarily careful, and I
think Dr. Sade as he went through the precautions that need to
be taken, was very clear about how this needs to be done.
And if you would respond to Dr. Delmonico on the question
of whether or not this can be done in an ethically appropriate
way and in a way that doesn't produce the unintended
consequences that he fears.
Mr. Sade. Well, the short answer is, yes, indeed, it can be
done in an ethically appropriate way. That is financial
incentives can be used in ethically appropriate ways. I would
like to make a couple of comments about several of the speakers
so far. We heard them talk about putting money into the
equation as far as donations are concerned, places a value on
human life and somehow this doesn't feel right and this is
repugnant in some way. Well, the other side of that is, they
are also putting a value on human life of the potential
recipients who will never get those organs and the value in
that case is very low. It's not very valuable at all. Well, I
beg to differ with that. I think that the lost lives are very
important.
Also, I personally don't worry very much about headlines. I
worry more about 6,000 people dying every year. There were lots
of big headlines about all kinds of issues in the past. For
example, in vitro fertilization was terribly controversial and
people yelled and screamed about how unethical it is and how
terrible it is. That made headlines. Today there are thousands
of woman every year who benefit from in vitro fertilization and
have children that they never could have had otherwise.
So I am not concerned about headlines. We can get past
those. I think that the first business of physicians and
Federal legislation in supporting the health care system is to
make sure that as many patients live as possible within the
boundaries of ethical behavior and ethical means. And there's
no reason why we can't design studies that meet ethical
standards that do involve financial incentives.
Mr. Greenwood. I would like ask Mr. DeVos to respond to Dr.
Shaked or Dr. Delmonico who obviously have a different point
than you do with regard to financial incentives.
Mr. DeVos. Dr. Delmonico and I have visited and I respect
him greatly. I am hardly in a league to even talk because of
his position and his experience. I am just a guy on the other
end of the list, and so I look at it from if I wanted a new
knee, they would pay for a new knee. I mean I would pay for
that. I mean the idea that we came up with and your guys in
Philadelphia--your guys in Pennsylvania came up with, find a
way around rewarding and buying and selling organs, which was
let's just put some money in, the idea of getting somebody to
sign. It's a reward for signing a card. It has nothing to do
with use of the organs ultimately. It does because it ends up
that way, but of the millions that we need, only a few thousand
will end up there, and most of them will die.
Mr. DeVos. But nevertheless we have got to get those
millions to sign. And if a stiff--and if 10 bucks will do it,
fine. But if I'm talking to a bunch of college kids, and I say,
``Hey, we will put 10,000 into your estate if you do this,''
they might say, ``Yeah, that's okay. I'll go do that.'' Well,
that's all we're looking for. This is an encouragement, like an
automobile discount. I know that's pretty crude for these
people, but, you know from a business guy's standpoint, those
are incentives people offer to get people to do things.
And so all this is, is incentive to get people to do
things. I respect their fears. Those are all great fears. And
so we've got to find a way to do this to where we package it
correctly and present it correctly. It is a payment for the act
of signing a card. That's all it is. It's nothing more than
that. And if we can keep that there, maybe we can get this
done. All I want to do is get more organs, and I want to do it
ethically and all. But if I'm a guy waiting on the list, I'm
not quite as concerned about all the other things that might
happen somewhere else in the world as I am about, how about a
heart for me, guy?
Mr. Greenwood. Thank you. It seems to me there's a three-
step process here. You'd have to design some kind of a system,
and then you'd have to pilot program it, and then you'd have to
see whether it's worth expanding or not.
My time has expired. I'm just going to ask Dr. Sade, very
briefly, has anyone--you talked about the need to set this up
in a way that would be ethical and have an IRB? Is there a
design on paper that meets those tests yet, whether we change
the law or not?
Mr. Sade. Not as far as I know. Not the specific tests that
we have suggested. There have been suggestions for various
kinds of financial incentives that make a lot of sense.
Pennsylvania offered to pay for funeral expenses. The
delegation from Utah presented a bill a couple of years ago, 3
years ago to allow a $10,000 tax benefit in inheritance taxes.
And talking about poor people being--the focus of organ
donation. That would actually focus at the higher end of the
economic spectrum. Studies could be designed in a number of
ways that could spread the donation of organs over the--over a
wide range of the population.
Mr. Greenwood. My time has expired. The gentlelady from
Colorado.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. DeVos I do appreciate your can-do attitude. However, I
don't think that there is one single person who's testified
today who would equate organ donation to an automobile
discount, and I think we all need to understand that.
I do have a question for you though, and here's my
question. In your testimony, you state, and I'm quoting
verbatim, to address the right concerns of minorities, that
they would not be given adequate terminal care if an insurance
or tax credit exists. This document can be accessed only when
the patient has been declared brain dead and the family has
been notified. That's your written testimony, right? Here's my
question. Why is it you single out minorities for this concern?
And wouldn't white people and everybody have that same concern?
Mr. DeVos. Yes, I think so.
Ms. DeGette. So why did you just say minorities in your
testimony?
Mr. DeVos. I don't know. They stuck it in here, and I----
Ms. DeGette. Who's they?
Mr. DeVos. They thought, well, because of the people who
object always that it's a class issue, and so my doctor, who I
work with, you know----
Ms. DeGette. Who put the word minority in there?
Mr. DeVos. All the objections we get is on class
distinctions about who would be----
Ms. DeGette. Now, some minorities are rich, right. I mean
not all minorities are poor. It's a class issue, not a race
issue, right?
Mr. DeVos. To me, this is, you know----
Ms. DeGette. It's not a racial issue really. It's a class
issue that you're trying to do, right?
Mr. DeVos. Well, I don't know. It's only an issue of people
who are concerned about this.
Ms. DeGette. And you think that's minorities?
Mr. DeVos. That will give somebody an incentive to take my
life to get an organ because then I would be incentivized by
that.
Ms. DeGette. Okay. Dr. Sade, I'm wondering if you have any
idea how many people in this country have volunteered to donate
their organs either through drivers' license programs or other
kinds of organ donations programs.
Mr. Sade. Yeah, it's very difficult to get a precise count
of that, but the best estimates that I've seen are under 20
percent probably.
Ms. DeGette. In numbers of Americans, how many numbers of
Americans? Would it be in the----
Mr. Sade. Fifteen percent of the adult population.
Ms. DeGette. So in the millions of people?
Mr. Sade. It's in the millions of people.
Ms. DeGette. And the organ shortfall in this country, as
everybody's been saying, is around 6,000 people? Around 6,000
people die per year because they don't get a donated organ,
right?
Mr. Sade. That's correct.
Ms. DeGette. And so what we're talking about is increasing
it from the millions of Americans who've already agreed to
donate organs to some more millions of Americans in the hopes,
essentially, that we can find those 6,000 organs plus more,
right?
Mr. Sade. Yes.
Ms. DeGette. Okay. Now, under what the AMA has been
thinking about, who would the financial incentives go to, the
donor or the donor's family?
Mr. Sade. That would depend on how the study is designed.
The AMA has not recommended any particular form of financial
incentive. What we're recommending is that financial incentives
be designed according, in accord with the ethos, the mores of,
the opinions of the population in which the study is going to
be carried out.
Ms. DeGette. The reason I'm asking this question is because
I asked the previous panel, and I think Mr. Greenwood's idea is
that the financial incentives would go to the donor. But you
don't have any particular opinion. So under what the AMA is
thinking, there could be a study designed where someone is
lying there in the hospital, and the doctor would come to their
family and say, ``Okay, we'll give you a $10,000 death benefit
if you donate the organs.'' Could that be a possibility of a
study?
Mr. Sade. I doubt that that would be--that such a study
would be designed.
Ms. DeGette. And why?
Mr. Sade. Because there would be a great deal of feeling,
as you're expressing very clearly, against it.
Ms. DeGette. Right. I agree. And I think appropriately so,
don't you?
Mr. Sade. Perhaps. I'm willing to listen to any possibility
that a group of investigators, in accord with the population
that they wish to study, have agreed upon.
Ms. DeGette. Okay.
Mr. Sade. I'm not going to impose my values on a different
section of the country.
Ms. DeGette. Okay. It sounds to me like the AMA hasn't
settled on one type of study here. They just think it'd be a
good idea to study, right?
Mr. Sade. To study a variety of different kinds of
incentives; that's correct.
Ms. DeGette. Okay. Because how would this study be
designed? Would there be a limited, well-defined experiment
with a tight protocol? Or would there be a general repeal of
the ban to allow all of these different things to happen?
Mr. Sade. Oh, no. What we would envision, and I don't know
that this is the way it would happen, is that there would be
waivers for a specific demonstration project for example.
Ms. DeGette. And who would give those waivers the HHS?
Mr. Sade. Well, the waivers would have to come through
Congress because it's a national law.
Ms. DeGette. So Congress--so suddenly, Mr. Greenwood and I
would be deciding?
Mr. Greenwood. Will the lady yield?
Ms. DeGette. I'd be happy to yield. Maybe you can clear it
up.
Mr. Greenwood. I think the theory is that we would amend
the law so that it would still remain illegal, in general, to
provide incentives, but it would give the Secretary of Health
and Human Services the opportunity to approve very limited
pilot projects pursuant to the language that we would use in
the legislation.
Ms. DeGette. Okay. So maybe I can ask the chairman then,
would one of the studies that might be allowed be financial
incentives to the families of the potential donors? Because the
AMA seems to think we should explore everything.
Mr. Greenwood. If the gentlelady would yield again.
Ms. DeGette. Be happy to.
Mr. Greenwood. I think it seems obvious to me that we
would--that no one would ever want to do anything that would
create that kind of an adverse situation. Nobody wants to see,
certainly not this Member of Congress, and I don't think any of
our witnesses would think it would be appropriate to provide a
financial incentive for a family to make a decision about a
member of that family based on their financial consideration.
That would be ethically abhorrent and neither the Congress nor
the Secretary of Health and Human Services should approve such
a thing.
Ms. DeGette. Reclaiming my time, Dr. Sade, do you have any
idea how the study would be limited? Would it be limited by
type of organ? Initially?
Mr. Sade. That depends on the people who design the study.
Ms. DeGette. Okay. So you don't have any--the AMA has no
view on that.
Mr. Sade. No specific view; that's correct.
Ms. DeGette. Would it be limited by area of the country?
Mr. Sade. As far as the AMA is concerned, any area of the
country that desires to carry out such a study would be welcome
to do so. The more data we have, the more we know, and the more
intelligent decisions we can make.
Ms. DeGette. So you could have a variety of studies, maybe
a whole State would do one thing and one study maybe one of the
transplantation centers would do it by organ. The AMA hasn't
settled on one type of study?
Mr. Sade. Absolutely. I think that the kind of diversity of
investigation that you're talking about is exactly what we
would be after. We need information. We need data because we
can't make intelligent well-informed decisions about what is
ethical, what works, what doesn't work without information that
tells us what the harms are and what the benefits are.
Ms. DeGette. Okay. But, see, here's the thing. In your
testimony, you said that the AMA proposes that IRBs would
oversee the types of studies, right?
Mr. Sade. The function of the IRB is to assure that certain
processes are followed in protecting the human subjects and
that sort of thing.
Ms. DeGette. But how do you that, when you haven't narrowed
down what type of study you're going to do? Let me give you an
example. The reason I asked you how many have signed organ
donor forms, I've done some work with IRBs and usually what
happens is an IRB approves a study that's going to be targeted
at one type of patient. So for example, in the diabetes
context, let's say you're doing an islet cell transplantation.
You have defined subjects. You have defined human subjects, and
the study protocol says we're going to use these types of
patients and here's what we're going to do. What you have here
is, you have incentives that you're trying to get people who
you don't know to be organ donors, to agree to be organ donors.
How's that going to work? How are you going to have an IRB
approving that kind of study? I don't think there's any
precedent for that.
Mr. Sade. I think what you are describing is the role of an
IRB in the evaluation and approval or disapproval of a
randomized clinical trial. That's not what we're dealing with
here. We're dealing with a much--with a different kind of
research project and IRBs deal with those. They just make sure
that all of the rules that are part of the common--that come
from the common rule, as well as their own local rules
regarding how human subjects are handled in research, are
followed. And they put a stamp of approval or not, depending on
the design of the study and whether certain guidelines have
been followed. They can do more than look at randomized
clinical trials.
Ms. DeGette. With all due respect, sir, I think that some
of the kinds of studies you're talking about would be perfectly
appropriate for IRB approval. Other kinds I think would be far
too generalized to even begin to come up with a protocol. And
the thing I'm worried about, and, you know, Mr. Greenwood and I
fight a lot of battles together, and we hardly fight any
battles against each other, but sometimes we do. What I'm
concerned about is that in essence, to do these kinds of
studies--the AMA's thinking is so broad here that we would, in
essence, have to repeal the ban in order to make this happen.
And I'm very concerned about this for many of the reasons some
of the witnesses talked about.
And if I may, Mr. Chairman, let me just ask unanimous
consent for an additional 30 seconds.
Mr. Greenwood. Barely because we're going to have a vote
any minute, and I want the gentleman from Oregon to have his
opportunity.
Ms. DeGette. We've had lots of experts testify today. We've
only had three people testify who have had direct involvement
with the United States transplantation system. Mr. DeVos had
his transplant abroad because he was ineligible here. All of
those people said these kinds of decisions are very personal
decisions, and they don't think financial incentives work. I'm
all for working with you and everybody here on increasing the
number of donors and increasing the number of organ transplant
donors, but I don't think financial incentives is the way to
go, and I think this is so broadly construed that it would have
PR problems, but more importantly, it would have great ethical
concerns.
So I look forward to working with you, and I thank you for
your comity and the extra time.
Mr. Greenwood. The Chair thanks the gentlelady, and looks
forward to working getting on the same page with you. And I
have no doubts that we will.
The gentleman from Oregon.
Mr. Walden. I appreciate the confidence my chairman just
expressed about getting on the same page with my colleague and
friend from Colorado. Hope blossoms eternal.
Mr. DeVos, if my recollection serves me right, you've had
some level of experience in creating organizations that
motivate people to do things, is that not----
Mr. DeVos. Well, I hope so.
Mr. Walden. A little organization called Amway?
Mr. DeVos. I built a little company that motivates people
all over the world. I keep trying to find ways. I do it with
recognition, rewards and money. And they all work for different
people.
Mr. Walden. Recognition, rewards and money. And do you--do
you share the ethical concerns that have been raised? If you
could develop a system that would work, would you apply it to
live donors as well as to dead donors or dying donors?
Mr. DeVos. I wasn't ever thinking of live donors because
that's kind of a new thing, I think. And I think it requires a
whole different set of thought and conditioning. You know, my
experiences where I come from as a guy waiting and given new
life, and I just said what can I do to help more people do
that. So I'm kind of a simplistic soul in this deal. I like
money and most people like money. And I look at it simply.
She's got it all complicated, and I guess if you start from--
you're opposed to the principle of it, then you look at all
those things, and those are all legitimate things you have to
look at. I was just saying, hey if I got a bunch of people and
I want to motivate them--I love reward. I love the altruistic
idea of giving it. I wish everybody in America would work for
the love of work. But they seem to get moved by getting a
little incentive. And our incentive has got nothing to do with
the family. We've removed it totally from the family. It's all
over on the signing of the card, so that when they get to the
hospital, it's an automatic deal. Nobody has to be traumatic
about it. Oh, I hate to do this. And I have listened to those
people who wish they had when they didn't. And I've been
hanging around this crowd for 6 years now. So it's kind of new
for me, not technically, but all I know is my frustration has
stopped. So all I want to say is, hey, I think there's--find us
some way to get some young people to do it altruistically for
some. We've got a lot of people signing, but that flat line
bothered me, and I just said, well, let's try money. We tried
reward, recognition. Let's try a little money and see what
happens.
Mr. Walden. Is that the flat line on donations or the
potential flat line on an EKG that bothered you the most?
Mr. DeVos. Both ways. It's the flat line. We haven't been
able to increase donations in 5 years. I hang around with the
people at Mayo and all these places, and they all are
complaining and closing because they don't get enough organs.
So those--I said, well, let's try something new.
Mr. Walden. I appreciate that. And I obviously share the
concern that you had about trying to get people to donate. And
I certainly, from obviously the personal experience, know that
that frustration, that new enlightenment about this issue, when
someone close to you or yourself has to stare down that tunnel
and not know if anything is going to appear. And so I think we
do need an incentive. But I--obviously, it's got to be done
correctly. I mean you don't want to get into the ghoulish kinds
of things we've heard, those potential worst-case scenarios. I
found Dr. Delmonico's testimony to probably be the most thought
provoking of the day in many respects, because I sense you
really come from this from your heart and have been on the end
of the scalpel that matters most, and you've raised some really
valid issues that cause us to think. But I sense from Dr. Sade
that what you're talking about, and the AMA is talking about,
isn't predetermined. You don't come in here today with a study
or the plan. What you're saying is give us an opportunity to
work around and see what may work within the common ethical
bounds of science with a review boards approval. Is that
correct?
Mr. Sade. Yeah. That's correct. I think that you can
imagine the quality of research that would come out of the NIH
if the NIH told the researchers, here's which projects to write
and which objectives to have in their studies. I mean, you
know, you wouldn't get very good science out of that. And we're
trying to make this as productive and scientific a system as we
possibly can, that doesn't result in a ban on all organ
donation. It doesn't mean repealing the No Prohibition on
Valuable Consideration. It only removes that ban for the
studies that are properly designed in an ethical format and in
a scientific format that will give us good information on which
we can make future decisions.
Mr. Walden. It seems to me there'd be a real value in that
if it could get done properly. I share a concern about driving
the wrong incentive the wrong way. It can produce some
unwelcome outcomes. But it looks to me like the more we could
do to incent people to sign up and participate sooner in life,
the better off we would be.
I don't know that I have any additional comments or
questions. I do appreciate the testimony of all of our
panelists today. You've all made us think deeper about this
issue as we all struggle for the same outcome, which is to get
more people to sign up to be organ donors because we know the
miracle that results when they do.
Thank you Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman. The Chair
thanks the panel.
We have a series of votes right now, so our timing has
turned out to be perfect.
Thank you. This is obviously a controversial, but important
subject, and you have contributed mightily to it today. The
hearing is adjourned.
[Whereupon, at 1:22 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
U.S. Department of Health and Human Services Advisory Committee on
Organ Transplantation
RECOMMENDATIONS TO THE SECRETARY
Following more than a year of deliberations and meetings, Secretary
Tommy G. Thompson's Advisory Committee on Organ Transplantation (ACOT)
met on November 18-19, 2002, in Arlington, Virginia, and unanimously
agreed upon a series of consensus recommendations with respect to a
number of serious organ donation and transplantation issues, affecting
all recipients as well as both deceased and living donors.
The first day of that meeting was devoted by the Committee to
responding to Secretary Thompson's specific request to them that they
look into several concerns he had with respect to the process of live
organ donation and transplantation--particularly regarding the kidney,
liver and lung--so as to ensure that the donation and transplantation
process would be as safe and effective as possible, for both the living
organ donor and the recipient of the donor's organ.
ACOT believes that the implementation of these first seven
recommendations will ensure the protection of potential living donors
and simultaneously enhance the effectiveness of living donation and
transplantation.
Recommendation 1: That the following ethical principles and
informed consent standards be implemented for all living donors.
The Secretary's first request was that ACOT consider the
desirability of national disclosure standards. ACOT responded by
recommending a series of ethical principles and elements of informed
consent that should be implemented for all living donors.
ACOT agrees upon a set of Ethical Principles of Consent to Being a
Live Organ Donor, which includes the view that the person who gives
consent to becoming a live organ donor must be:
competent (possessing decision making capacity)
willing to donate
free from coercion
medically and psychosocially suitable
fully informed of the risks and benefits as a donor and
fully informed of the risks, benefits, and alternative
treatment available to the recipient.
Two related ethical principles that ACOT endorses are:
Equipoise; i.e., the benefits to both the donor and the
recipient must outweigh the risks associated with the donation
and transplantation of the live donor organ; and
A clear statement that the potential donor's participation
must be completely voluntary, and may be withdrawn at any time.
ACOT recommends that each institution develop an informed consent
document that would be understandable to all potential donors. Such a
document should be accessible to people at all educational levels, and
appropriate for the potential donor's level of education. Apart from
the need to employ specifically defined medical terms, the document
should in most circumstances be written for readers with no higher than
an 8th or 9th grade level of education. If the potential donor does not
speak English, there should be an independent interpreter to facilitate
understanding in the patient's language. Where appropriate,
translations of such a document and accompanying materials should be
made available.
ACOT further recommends that the following Standards of Disclosure:
Elements of Informed Consent be incorporated in the informed consent
document given to the potential live organ donor, with specific
descriptions that would ensure the donor's awareness of:
the purpose of the donation
the evaluation process--including interviews, examinations,
laboratory tests, and other procedures--and the possibility
that the potential donor may be found ineligible to donate
the donation surgical procedure
the alternative procedures or courses of treatment for
potential donor and recipient
any procedures which are or may be considered to be
experimental
the immediate recovery period and the anticipated post-
operative course of care
the foreseeable risks or discomforts to the potential donor
the potential psychological effects resulting from the process
of donation
the reported national experience, transplant center and
surgeon-specific statistics of donor outcomes, including the
possibility that the donor may subsequently experience organ
failure and/or disability or death
the foreseeable risks, discomforts, and survival benefit to
the potential recipient
the reported national experience and transplant center
statistics of recipient outcomes, including failure of the
donated organ and the possibility of recipient death
the fact that the potential donor's participation is
voluntary, and may be withdrawn at any time
the fact that the potential donor may derive a medical benefit
by having a previously undetected health problem diagnosed as a
result of the evaluation process
the fact that the potential donor undertakes risk and derives
no medical benefit from the operative procedure of donation
the fact that unforeseen future risks or medical uncertainties
may not be identifiable at the time of donation
the fact that the potential donor may be reimbursed for the
personal expenses of travel, housing, and lost wages related to
donation
the prohibition against the donor otherwise receiving any
valuable consideration (including monetary or material gain)
for agreeing to be a donor
the fact that the donor's existing health and disability
insurance may not cover the potential long-term costs and
medical and psychological consequences of donation
the fact that the donor's act of donation may adversely affect
the donor's future eligibility for health, disability, or life
insurance
additional informational resources relating to live organ
donation (possibly through the establishment of a separate
resources center, as separately recommended)
the fact that Government approved agencies and contractors
will be able to obtain information regarding the donor's health
for life and
the principles of confidentiality, clarifying that:
communication between the donor and the transplant center will
remain confidential;
a decision by the potential donor not to proceed with the
donation will only be disclosed with the consent of the
potential donor;
the transplant center will share the donor's identity and
other medical information with entities involved in the
procurement and transplantation of organs, as well as
registries that are legally charged to follow donor outcomes;
and
confidentiality of all patient information will be maintained
in accord with applicable laws and regulations.
ACOT also prepared two specific informed consent documents that
embody these principles and elements. The first relates to the
potential donor's initial consent for evaluation as a possible donor,
Living Liver Donor Initial Consent for Evaluation (appendix 1). The
second deals with the potential donor's informed consent for surgery,
Living Liver Donor Informed Consent for Surgery (appendix 2).
ACOT recognizes that institutions operating in different states
across the nation may have different laws and needs that will affect
the precise wording of the informed consent document(s) they will use.
For that reason, these consent documents are submitted as examples and
possible models only. Note as well that, although the specific examples
are for living liver donation, ACOT is recommending such forms for all
potential living organ donors.
Moreover, ACOT does not believe that these or any forms are a
substitute for in-person communication between physicians and other
involved professionals and the potential donor. These forms should be
viewed instead as only the written evidence of discussions leading to
informed consent based upon full disclosure.
Recommendation 2: That each institution that performs living donor
transplantation provide an independent donor advocate to ensure that
the informed consent standards and ethical principles described above
are applied to the practice of all live organ donor transplantation.
The Secretary's second request was that ACOT consider the
desirability of an independent donor advocate (or advocacy team) to
represent and advise the donor so as to ensure that the previously
described elements and ethical principles are applied to the practice
of all live donor transplantation.
ACOT agrees with this principle and herein provides detailed
recommendations as to how such an independent donor advocate should be
established, as well as the role and qualifications of such an
advocate.
ACOT recommends that each transplant center identify and provide to
each potential donor an independent and trained patient advocate whose
primary obligation would be to help donors understand the process, the
procedure and risks and benefits of live organ donation; and to protect
and promote the interests and well being of the donor.
ACOT recognizes that there is an acknowledged limitation of
objectivity and independence, given the realities of the processes that
take place within a transplant center among medical colleagues who
regularly interact professionally; a modern, practicing physician does
not work in a vacuum and cannot perform in a way that is wholly apart
from other institutional staff. Moreover, the donor advocate should not
be totally independent of events affecting the recipient, as there must
be interaction of the advocate with the transplant surgeon of the
recipient team. However, the concept of preserving a separate care
physician for the donor is underscored as the reason to retain the word
independent in the identity of the advocate.
Recommendation 3: That a database of health outcomes for all live
donors be established and funded through and under the auspices of the
U.S. Department of Health and Human Services.
The Secretary's third request was that ACOT consider the
desirability of establishing a living organ donor registry. ACOT
concurs with the Secretary's suggestion and recommends that a database
of health outcomes of all live donors be established and further
recommends that the registry or database should build upon existing
smaller databases, but believes that a comprehensive national database
will be necessary to answer the Secretary's desire that all potential
organ donors be fully informed and aware of the likely consequences of
their decisions.
The Secretary asked ACOT where such a database should be
established and ACOT believes that only the Department of Health and
Human Services has the authority and resources to establish such a
registry. There are valid competing arguments as to what component of
DHHS should have primary responsibility for funding and managing such a
registry, and ACOT therefore offers no consensus suggestion on this
question, but ACOT stands ready to assist the Department in further
deliberations on this question.
ACOT further stands ready to assist the Secretary in suggesting
information or data elements (and the time periods for the collection
of such data) that should be included in such a registry, but it was
felt that further discussions within the Department, and with the OPTN,
as well as with the SRTR, would be necessary, given ACOT's
understanding that the substantial cost implications in establishing
and maintaining such a registry must be fully explored.
In order to guide Departmental deliberations on those questions,
ACOT responds to the Secretary's request for its opinion on how the
information collected should be used. ACOT believes that the primary
purpose of such a registry should be to enable the medical community to
define accurately the donor risks and benefits of live organ
transplantation so as to give potential donors an accurate risk
assessment.
Recommendation 4: That serious consideration be given to the
establishment of a separate resource center for living donors and their
families.
ACOT recommends advancing the information and resources available
to living donors and their families through the implementation of
detailed consent forms, the creation of independent donor advocates and
the establishment of a living donor registry. To similar effect, ACOT
recommends the establishment of a separate office, a resource center,
for potential living donors, those who choose to donate, as well as
their families. The primary function of such a resource center would be
to ensure that each potential donor receives a complete and current set
of information about living organ donation.
An existing model for such a resource center is in place at the
OPTN, which has both a person to contact for information, and a web
site with information specific to the needs of transplant candidates
and recipients. The resource center could either be located under the
aegis of the OPTN or the living donor registry. Such a distinct
resource center would have the benefit of being clearly distinguished
as separate and apart from the transplant team and hospital. Until such
time as such an independent resource center is established, ACOT
recommends that transplant centers should give consideration to
providing such a resource center on their own, again with the purpose
of ensuring that each potential donor receives a complete and current
set of information about living organ donation.
Recommendation 5: That the present preference in OPTN allocation
policy--given to prior living organ donors who subsequently need a
kidney--be extended so that any living organ donor would be given
preference as a candidate for any organ transplant, should one become
needed.
This recommendation states that there should be a preference
accorded to the living organ donor. The point value or other means of
assigning such a preference is left to the OPTN.
Recommendation 6: That the requirements for HLA typing of liver
transplant recipients and/or living liver donors should be deleted.
This testing may, however, be appropriate for some donors and
recipients and in such cases should be compensated by Medicaid,
Medicare or private insurers as appropriate, when specifically ordered,
as for all other appropriate laboratory tests.
Recommendation 7: that a process be established that would verify
the qualifications of a center to perform living donor liver or lung
transplantation.
ACOT believes that a process needs to be established that would
verify the qualifications of a center to perform living donor liver or
lung transplantation. ACOT believes that the process for performing
living kidney transplantation is sufficiently mature and established
that no further verification processes are required. ACOT believes
that, owing to the relative newness of the procedures, as well as the
inherent intricacies of the operations, that centers performing and
seeking to perform living donor liver and living donor lung
transplantation each require further review and verification within the
medical community.
The purpose of such a verification process would be to give
patients an increased level of confidence in the institutions
performing such operations, and to provide a guide for centers seeking
to enter this field.
Although the Secretary's recent letters to the Committee have
focused on living donation, his overall charge to the Committee has
been much broader, and ACOT has responded to that charge by
promulgating an additional series of recommendations not specific to
living donation.
The second day of the ACOT meeting was devoted by the Committee to
issues affecting equitable access to transplantation, and those
relating to deceased or cadaveric donors.
ACOT believes that the implementation of the following two
recommendations, which relate to access to transplantation, will
especially benefit minority populations.
Recommendation 8: That specific methods be employed to increase the
education and awareness of patients at dialysis centers as to
transplant options available to them.
Available information indicates that too many patients at dialysis
centers are unaware of the transplant options available to them. Too
many of these patients are members of minority groups. Given the cost
of sustained dialysis treatment, both to patients and to the Centers
for Medicare and Medicaid Services, as compared to the cost of
transplantation, this would also be cost-effective as well as life-
saving.
In order to assure the accuracy of this assessment, ACOT recommends
that procedural methodologies be developed to evaluate dialysis patient
access and referral for organ transplant, as well as an accurate cost/
benefit analysis, using existing data and/or new sources of data.
ACOT further recommends that, as soon as possible, a health
education program be implemented, and/or that an educational
coordinator be placed on site at individual dialysis centers so as to
provide patients with adequate education about transplant options
available to them. This would be a reinforcement of the implementation
of existing regulations stipulating that dialysis patients be educated
and evaluated by personnel from the transplant center concerning this
therapeutic option.
Recommendation 9: That research be conducted into the causes of
existing disparities in organ transplant rates and outcomes, with the
goal of eliminating those disparities.
The fact of such disparities, particularly with regard to kidney
transplantation rates, appears to be undisputed, and data developed by
the SRTR for ACOT highlights this issue. HRSA, NIH and other DHHS
agencies are presently committed to research aimed at ending such
disparities with respect to health care delivery in other areas, and
research should be undertaken to establish whether any separate reasons
may exist for such disparities within the transplantation area, and, if
so, how they may be eliminated.
ACOT believes that the implementation of the following nine
recommendations, which primarily relate to increasing the supply of
deceased donor organs, will ultimately, and in some cases very quickly,
mean many more additional organs becoming available to potential
recipients.
Recommendation 10: That legislative strategies be adopted that will
encourage medical examiners and coroners not to withhold life-saving
organs and tissues from qualified organ procurement organizations.
Studies indicate that coroners and medical examiners across the
United States are not uniform in their approach to making organs
available to organ procurement organizations, and that many
unnecessarily withhold from retrieval organs that could be used for
transplantation. Indeed, it is estimated that if all states followed
the example of Texas, which has enacted a law containing a provision
similar to the one below, then 700-1,000 additional organs would be
made additionally available each year.
The Secretary is specifically encouraged to use his good standing
with the National Governor's Association, the National Association of
State Legislatures, the Uniform Commissioners of State Laws, and/or
with individual states to seek the following change:
To amend the Uniform Anatomical Gift Act (UAGA) to add a new
subsection at the end of section 4, as follows:
(d) If the medical examiner is considering withholding one or more
organs or tissues of a potential donor for any reason, the medical
examiner shall be present during the removal of the organs or tissue.
In such case, the medical examiner may request a biopsy of those organs
or tissue, or deny their removal. If the medical examiner denies
removal of any organ or tissue, the medical examiner shall explain in
writing the reasons for the denial and shall provide the explanation to
the qualified organ procurement organization.
In the alternative, the Secretary is asked to encourage individual
states to adopt state laws to the same or similar effect.
Recommendation 11: That the secretary of HHS, in concert with the
Secretary of Education, should recommend to states that organ and
tissue donation be included in core curriculum standards for public
education as well as in the curricula of professional schools,
including schools of education, schools of medicine, schools of
nursing, schools of law, schools of public health, schools of social
work, and pharmacy schools.
The Secretary of HHS, in collaboration with the Secretary of
Education, should identify relevant core curriculum standards, and
survey those courses and curricula that presently include education as
to organ and tissue donation, with a view to promoting a model standard
that can be broadly employed in public education. This would, at a
minimum, include all high schools.
In addition, hospitals should establish ongoing basic introductory
(new hire) programs, focused on organ and tissue donation that would be
similar to CPR certification and recertification, and might in fact be
accommodated within the same new hire program.
Efforts should also be made to ensure that organ and tissue
donation be a part of the professional educational curricula at all
professional schools related to health. Law schools are included
because of the relevance of such issues to courses in elder law, estate
planning, and health law.
Recommendation 12: That in order to ensure best practices, organ
procurement organizations and the OPTN be encouraged to develop,
evaluate, and support the implementation of improved management
protocols of potential donors.
This recommendation builds upon those made at previous conferences
held by various transplantation related organizations, as well as work
performed under contract to the Department. A novel and improved
standard of titrated care for heart and lung donors has been
established and ACOT believes that it should be more generally
implemented. It is known as the Critical Pathway for the Organ Donor
(appendix 3, .pdf--get the free Reader). Similar improved standards of
management and care should be developed to optimize the potential
recovery of other organs.
Recommendation 13: That in order to ensure best practices at
hospitals and organ procurement organizations, the following measure
should be added to the CMS conditions of participation: each hospital
with more than 100 beds should identify an advocate for organ and
tissue donation from within the hospital clinical staff.
Such a designated advocate for organ and tissue donation would be
responsible for assuring that the facility is in compliance with the
Conditions of Participation as well as any other policies that pertain
to organ and tissue donation. In addition, this designated advocate's
responsibilities would include assuring that efforts are made to
promote donation in the local community. (Given varying hospital
management structures, such an advocate may not always be a member of
the clinical staff; what is essential, however, is that the advocate
have the institutional authority to effect change.)
Recommendation 14: That in order to ensure best practices at
hospitals and organ procurement organizations, the following measure
should be added to the CMS conditions of participation: Each hospital
should establish, in conjunction with its OPO, policies and procedures
to manage and maximize organ retrieval from donors without a heartbeat.
Such donation is often referred to as donation after cardiac death,
and such donors are variously referred to as donors without a heartbeat
or non-heart-beating donors, These policies and procedures will need to
be developed in collaboration with the OPTN, the transplant centers and
AOPO.
Recommendation 15: That the following measure be added to the CMS
conditions of participation: Hospitals shall notify organ procurement
organizations prior to the withdrawal of life support to a patient, so
as to determine that patient's potential for organ donation. If it is
determined that the patient is a potential donor, the OPO shall
reimburse the hospital for appropriate costs related to maintaining
that patient as a potential donor.
Recommendation 16: That the regulatory framework provided by CMS
for transplant center and Organ Procurement Organization certification
should be based on principles of continuous quality improvement.
Subsequent failure to meet performance standards established under such
principles should trigger quality improvement processes under the
supervision of HRSA.
The relevant committee of the OPTN is encouraged to develop
baseline measures/principles to guide the process of continuous quality
improvement, a part of which process is the development of baseline
measures. The quality improvement process envisioned by ACOT might
resemble one that is presently utilized in some hospitals/facilities,
and known as FOCUS-PDCA (appendix 4).
Recommendation 17: That all hospitals, particularly those with more
than one hundred beds, be strongly encouraged by CMS and AHRQ to
implement policies such that the failure to identify a potential organ
donor and/or refer such a potential donor to the organ procurement
organization in a timely manner be considered a serious medical error.
Such events should be investigated and reviewed by hospitals in a
manner similar to that for other major adverse healthcare events.
This measure could be added to the sort of physician profile which
most facilities currently employ. (See example physician profile
(appendix 5, .pdf--get the free Reader). ACOT expects that this
Recommendation will have its greatest impact at those hospitals with
trauma centers, as well as those with residency programs and/or
academic affiliations.
Recommendation 18: That the Joint Commission on Accreditation of
Healthcare Organizations ( JCAHO) strengthen its accreditation
provisions regarding organ donation, including consideration of
treating as a sentinel event the failure of hospitals to identify a
potential donor and/or refer a donor to the relevant Organ Procurement
Organization in a timely manner. Similar review should be considered by
the National Committee on Quality Assurance (NCQA).
JCAHO presently defines and identifies a sentinel event as: An
unexpected occurrence involving death or serious physical or
psychological injury, or the risk thereof. Serious injury specifically
includes loss of limb or function. The phrase, ``or the risk thereof''
includes any process variation for which a recurrence would carry a
significant chance of a serious adverse outcome. Such events are called
``sentinel'' because they signal the need for immediate investigation
and response.
Failing to identify or refer a potential donor in a timely manner
carries the serious risk of that donor's organs not being made
available to a potential recipient. Given the shortage of organs and
the fact of so many potential recipients dying while awaiting the
possibility of transplantation, such a failure would appear to fall
within the JCAHO definition of a sentinel event
Monitoring hospitals for compliance with organ donation standards
should become an integral part of the JCAHO hospital survey process. In
addition to examination of the standard, the hospital JCAHO survey
should include the OPO referral records which are submitted back to the
hospital, as well as the supporting documentation of corrective
measures or follow-up. There should be a compliance benchmark set
(e.g., 90-100%), with anything below that benchmark requiring a gap
analysis.
______
May 19, 2003
Dear Honorable Members of Congress,
The problem is simple and stark. While transplant surgery has
become progressively more routine, every year tens of thousands of
organs (50 to 75 percent of those potentially available) that could
restore the health and prolong the lives of Americans are instead being
taken to the grave, unutilized. At the same time, about 6,000 Americans
die each year while waiting for organs that never arrive, in most cases
after years of incredible suffering endured by themselves, their
families, and their friends.
Were the failure to retrieve these vital and irreplaceable organs
the result of deeply felt religious or cultural beliefs, we would not
be writing to you. It is not. The only thing that stands in the way of
retrieving these organs and saving many thousands of lives each year is
a failure of the collective imagination--a failure to devise a policy
that, while respecting traditional social norms, provides an increased
incentive for cadaveric organ donation.
We believe we have a compromise plan that both comports with human
dignity, and constitutes the tiniest imaginable step toward utilizing
the power of financial incentives to bring the supply of cadaveric
organs up to meet the demand. All available evidence suggests that such
incentives will be as effective in this sphere of human need as they
are in supplying all other products and services that we value. Please
note that we are not proposing any change in the current system of
organ allocation.
We write to you as a diverse group of academics from the legal,
economic, philosophic and scientific communities who have written and
spoken on this question over the years. Also joining us are transplant
surgeons and leaders of Organ Procurement Organizations (OPOs) with
many years of experience on the front lines of organ procurement. Our
ranks also include actively interested citizens and religious and civic
leaders. We are all persuaded that a properly designed system of
financial incentives for cadaveric organs is likely to have a powerful
salutary effect on alleviating human suffering, and we think the time
has come to begin pilot studies of such a system.
We offer a consensus proposal that, we believe, will result in an
almost immediate and substantial increase in the rate of cadaveric
organ donation. We believe it constitutes the most viable compromise
between using the power of market forces to satisfy human need while at
the same time recognizing the widespread reluctance to having human
body parts being treated, undignifiedly, as commodities.
The proposal involves the partial lifting of Public Law 98-507,
Title III, Section 301, the section of the National Organ Transplant
Act of 1984 forbidding financial incentives, insofar as it applies to
cadaveric donation. Specifically, we propose that Congress instruct the
Secretary of the Department of Health and Human Services to initiate
demonstration projects of a policy that rewards the estates of brain-
dead donors with a set donation of, for example, $5,000, for the
decision of their family to give the gift of life. This policy would be
instituted by the currently existing OPOs. The gift could be used to
help pay for funeral or hospital costs, as a donation to the deceased's
favorite charity, or could simply remain with the estate. We even
propose specific language the OPO personnel could use, after their
normal humanitarian appeal, in order properly to convey to families the
nature of the decision they are being asked to make and of the gift
they are being offered:
Dear Mr. Smith/Mrs. Jones, as you may know, it is our
standard policy to offer a gift of $5,000 to the estate of the
deceased, as a way of saying ``Thank you for giving the gift of
life.'' The money can be used to help offset funeral or
hospital expenses, to donate to your loved one's favorite
charity, or simply to remain with the estate, to be used in any
manner the heirs see fit. No price can be placed upon the many
lives that can be saved by your gift. Our donation in return is
merely society's way of honoring the sacrifice you are being
asked to make, and is a token of our deep and sincere
appreciation for your generosity at this most difficult time.
A crucial aspect of the proposal is that the gift be a set amount
that is given to the estates of all brain-dead patients who are judged
to be good donor candidates, and whose families do indeed donate. There
should be no possibility of unseemly haggling. Neither should there be
any reduction of the amount of the gift if a presumptively good donor
turns out to have few or no usable vital organs. We think this approach
would avoid, as much as possible, any slippage from a system that
maintains human organs in a category wholly separate from all other,
more mundane, commodities.
A second crucial aspect of the proposal is that the amount of the
gift be large enough so that the family members do not feel as though
the memory of their loved one is being insulted or their loss
trivialized, or that they are being asked to allow themselves to be
taken advantage of, especially in the hospital environment, where
surgeons and top hospital administrators are known to make high six-
figure salaries. We feel that $5,000 is a round and respectful sum that
tangibly conveys a sense of the grave importance we as a society place
upon the decision the family is being asked to make. In any case, we do
not think the fixed gift amount should be less than $3,000.
This proposal is, we believe, the smallest and most effective step
that can be taken away from our current system, which relies purely on
altruism, to a policy that allows something of a quid pro quo--a reward
for community service, much like the death benefits that currently are
provided to the families of service personnel who die in the line of
duty.
We note that if our proposal is successful in doubling or tripling
the rate of cadaveric organ donation, as is well within the realm of
possibility, our nation's deadly organ shortage would become a life-
saving surplus, the growing problem of black market payments for living
organ donation would largely disappear, and surgeons would have much
less occasion for compromising their Hippocratic oath by endangering
the lives of healthy donors.
Additionally, we note that if the project is successful, it will
eventually more than pay for itself in terms of reduced dialysis
expenditures by the federal End-Stage Renal Disease Program.
As you may also know, the American Medical Association, at their
2002 annual meeting, advocated experimenting with allowing compensation
for cadaveric organ donation. The American Society of Transplant
Surgeons and the United Network for Organ Sharing--the organization
that operates the organ allocation system in the United States--have
made similar proposals.-- But, none of these proposals can proceed
without someone in Congress taking charge to amend current law.
If, as we fervently hope, you do wish to redress this tragic
situation, we are available to meet and discuss it with you or your
staff at your convenience. Every moment we delay, more untold suffering
occurs and more Americans die needlessly. The time to act is now.
Sincerely, Signed (in alphabetical order)
Father Phillip L. Adams, Minister and Director, Lighthouse
Christian Ministries; Richard Amerling, M.D., Nephrologist, Beth Israel
Medical Center of New York, Albert Einstein College of Medicine; Brian
A. Broznick, President and CEO, Center for Organ Recovery & Education
(CORE); Charles T. Carlstrom, Ph.D., Economic Advisor, Federal Reserve
Bank of Cleveland; Father John Chakos, Priest, Holy Cross Greek
Orthodox Church; Lloyd Cohen, J.D., Ph.D., Professor, George Mason
University School of Law; Reverend Gary W. Denning, Minister, First
Baptist Church of Pittsburgh; Richard A. Epstein, James Parker Hall
Distinguished Service Professor of Law, University of Chicago, Peter
and Kirsten Bedford Senior Fellow, Hoover Institution; John J. Fung,
M.D., Ph.D. Thomas E. Starzl Professor of Transplantation Surgery and
Chief, Division of Transplant Surgery, University of Pittsburgh School
of Medicine, Director, Thomas E. Starzl Transplantation Institute,
Board Member, United Network for Organ Sharing (UNOS); Rabbi Mel
Gottlieb, Ph.D., Dean, Academy for Jewish Religion; David L. Kaserman,
Ph.D., Torchmark Professor of Economics, Department of Economics,
Auburn University; Baburao Koneru, M.D., Associate Professor and Chief,
Division of Transplant Surgery, New Jersey Medical School-Newark,
University of Medicine and Dentistry of New Jersey, Former Board
Member, New Jersey Organ & Tissue Sharing Network; Harold Kyriazi,
Ph.D., Research Associate, Department of Neurobiology, University of
Pittsburgh School of Medicine; Merrill Matthews Jr., Ph.D., Director,
Council for Affordable Health Insurance; Gregory Pence, Ph.D., Medical
Ethicist, School of Medicine and Department of Philosophy, University
of Alabama at Birmingham; Thomas G. Peters, M.D., Director,
Jacksonville Transplant Center, Shands Jacksonville Medical Center,
Former Board Member, UNOS; William Russell Robinson, 7-term member,
Pennsylvania State House of Representatives 1989-2003, Sponsor,
Pennsylvania Organ Donor Trust Fund legislation, Sponsor, state
legislation authorizing $300 funeral benefit for organ donor families,
Member, Pittsburgh City Council, 1978-1985; Robert M. Sade, M.D.,
Professor, Dept. of Surgery, Medical University of South Carolina,
Medical Director, LifePoint, Inc., Director, Institute of Human Values
in Health Care, Member, UNOS Ethics Committee, Member, AMA Council on
Ethical and Judicial Affairs; Lawrence L. Schkade, Ph.D., CCP, Garrett
Professor of Information Systems, University of Texas-Arlington, Heart
Transplant Recipient, 1992, Member, UNOS Board of Directors, Member,
Board of Directors, LifeGift Organ Donation Center; Alexander Tabarrok,
Ph.D., Professor, Department of Economics, George Mason University,
Director of Research, The Independent Institute; Mark Thornton, Ph.D.,
Economist, Ludwig von Mises Institute; and David J. Undis, Executive
Director, LifeSharers.
______
June 6, 2003
The Honorable Jim Greenwood
Chairman
Subcommittee on Oversight and Investigations
Energy and Commerce Committee
U.S. House of Representatives
Washington, DC 20515
The Honorable Peter Deutsch
Ranking Member
Subcommittee on Oversight and Investigations
Energy and Commerce Committee
U.S. House of Representatives
Washington, DC 20515
Dear Chairman Greenwood and Ranking Member Deutsch: On June 2,
2003, I testified on behalf of the American Society of Transplant
Surgeons (ASTS) during the hearing entitled ``Assessing Initiatives to
Increase Organ Donations.''
In written testimony submitted to the Subcommittee during the
hearing, the American Medical Association's Robert M. Sade, MD, made a
statement that included the following:
``Models have been proposed by several organizations, including
ASTS and UNOS, whose Board of Directors agreed, days after the
AMA adopted its policy, to support legislation that would
enable studying the impact of incentives to encourage organ
donation and to honor organ donors. Among the suggested models
are: future contracts, as was proposed in a bill before
Congress several years ago, that would have allowed for the
implementation of a tax credit of up to $10,000 on the estate
of the deceased donor; reimbursement for funeral expenses, as
was passed into law in Pennsylvania, but was never implemented
because of the federal prohibition . . .''
ASTS would like to correct this statement for the record. At no
time did the ASTS endorse a tax credit of $10,000 on the estate of the
deceased donor. The AMA testimony is correct, however, that ASTS
endorsed a study on the concept of reimbursement for funeral expenses.
Thank you for allowing us the opportunity to testify at the hearing
on these and other important issues relating to organ donation. We look
forward to working with you and your Subcommittee in the future on this
issue. If you have any questions, please contact Peter W. Thomas,
ASTS's Legislative Counsel, at (202) 466-6550.
Sincerely,
Abraham Shaked, M.D., Ph.D.
President
cc: Robert M. Sade, MD, American Medical Association
______
Ethical Opinion on ``The Richard M. De Vos Position Paper on Financial
Incentives for Organ Donation''
dr. samuel gregg, acton institute
April 17, 2003*
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*Copyright 2002 by Samuel Gregg. For
permission to cite, reproduce or circulate this paper, please contact
the author at [email protected], or Acton Institute, 161 Ottawa Ave NW,
Suite 301, Grand Rapids, MI 49503, USA. Ph. 1-616-454-3080
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SITUATION
1. The progress and spread of transplant medicine and surgery
nowadays makes possible treatment and cure for many illnesses which, up
to a short time ago, could only lead to death or, at best, a painful
and limited existence. This ``service to life,'' 1 which the
donation and transplant of organs represents, shows its moral value and
legitimizes its medical practice. There are, however, some conditions
which must be observed, particularly those regarding donors and the
organs donated and implanted. Every organ or human tissue transplant
requires an explant which in some way impairs the corporeal integrity
of the donor.
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\1\ John Paul II, ``To the participants at the First International
Congress on the Transplant of Organs,'' June 20, 1991, in Insegnamenti,
XIV/1 (1991), p. 1710.
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2. The present shortage of available organs for transplant has
resulted in a number of propositions for improving the situation so as
to preserve the life of those in danger of imminent death, and/or to
improve the health of those who are suffering from various ailments.
These propositions range from state-funding of more Organ Donation
coordinators, to the establishment of a free market in organs.
3. Not all options, however, are morally acceptable. Moreover,
every option must be subject to clear, coherent and rationally
defensible ethical analysis. The approach used in this opinion is that
of the authoritative moral teaching of the Magisterium of the Roman
Catholic Church and the natural law tradition (specifically that
articulated by the Magisterium). It does so on the basis that (a) all
other approaches that purport to be based on reason alone are
essentially deficient and ultimately incoherent; and (b) that the moral
truth of natural law is, by definition, accessible to all. The Church
thus rejects those approaches to morality, such as all forms of
utilitarianism, that require people to engage in the epistemologically
and intellectually impossible task of measuring and weighing all the
certain and possible good and evil effects of an action.2 To
cite John Paul II, ``How could an absolute obligation resulting from
such debatable calculations be justified?'' 3 Instead, the
Catholic analysis of a policy's moral dimension focuses upon asking
whether an option is choice-worthy, or if it is excluded from upright
choice by its opposition in some way to the human goods (bona humana)
to which St. Thomas Aquinas says all people, religious or otherwise,
are directed by the first principles of practical
reasonableness,4 the basic reasons for action which the
encyclical letter Veritatis Splendor calls ``fundamental human goods.''
5
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\2\ See John Finnis, Fundamentals of Ethics (Washington, D.C.:
Georgetown University Press, 1983): pp.86-94.
\3\ See John Paul II, Encyclical Letter Veritatis Splendor, 1993,
para. 77.
\4\ In Aquinas's words, ``The good of the human being is being in
accord with reason, and human evil is being outside the order of
reasonableness.'' ST, I-II, q.71, a.2. Or, as Aquinas states elsewhere,
``good is the first thing that falls under the apprehension of the
practical reason, which is directed to action: since every agent acts
for an end under the aspect of good. Consequently the first principle
in the practical reason is one founded on the notion of good.'' ST, I-
II, q.94, a.2. Thus for Aquinas, the way to discover what is morally
right (virtue) and wrong (vice) is to ask, not what is in accordance
with human nature, but what is reasonable. See John Finnis, Natural Law
and Natural Rights (Oxford: Clarendon Press, 1980), p.36; and Samuel
Gregg, Morality, Law, and Public Policy (Sydney: St. Thomas More Press,
2001), p.23.
\5\ Veritatis Splendor, para.48.
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4. This opinion considers only one proposition: that is, ``The
Richard M. De Vos Position Paper on Financial Incentives for Organ
Donation'' (hereafter the Position Paper). This proposition involves
the establishment of a tax incentive or an insurance benefit to be
received by the designated beneficiary of a donor upon the successful
transplant of the donor's organs following the donor's natural death.
This policy encourages people to designate, unambiguously, if they wish
to have their organs recovered after death with the object of an act
being the saving of human life.
5. Should there be any change in the composition of the Position
Paper, this opinion should be considered null and void until the author
has had the opportunity to consider the ethical implications of the
changes.
6. Should the Magisterium of the Roman Catholic Church pronounce
authoritatively and specifically on the proposition articulated in the
Position Paper or a similar proposition, then the author's position
should be henceforth assumed to adhere to that of the Church.
THE CATHOLIC POSITION ON ORGAN TRANSPLANTATION AND COMPENSATION FOR
DONATION OF HUMAN ORGANS
There are positive and negative dimensions to the teaching of the
Catholic Church on organ transplantation and the question of
compensation.
Positive Dimensions
1. Transplantation between species, specifically from animal to
human, in general, is not morally forbidden. ``It cannot be said that
every transplant of tissues (biologically possible) between two
individuals of different species is morally reprehensible, but it is
even less true that every heterogeneous transplant biologically
possible is not forbidden and cannot raise objections. A distinction
must be made between cases, depending on which tissue or organ is
intended for transplant. The transplant of animal sexual glands to
humans must be rejected as immoral; but the transplant of the cornea of
a non-human organism to a human organism would not create any problem
if it were biologically possible and advisable.'' 6
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\6\ Pius XII, ``To the delegates of the Italian Association of
Cornea Donors and the Italian Union for the Blind'', May 14, 1956, AAS
48 (1956): pp. 462-464.
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2. Transplantation from a corpse requires that the corpse be
treated with the respect due to the abode of a spiritual and immortal
soul, an essential constituent of a human person whose dignity it
shared.7
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\7\ See Pius XII, Papal Teachings: The Human Body (Boston, MA:
Daughters of St. Paul, 1960), p.380.
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3. Transplantation from a corpse to a living being is permissible.
Physicians should not, however, be permitted to undertake excisions or
other operations on a corpse without the permission of those charged
with its care and perhaps even in the face of objections previously
expressed by the person in question.8 ``Organ transplants
are not morally acceptable if the donor or those who legitimately speak
for him have not given their informed consent. Organ transplants
conform with the moral law and can be meritorious if the physical and
psychological dangers and risks incurred by the donor are proportionate
to the good sought for the recipient. It is morally inadmissible
directly to bring about the disabling mutilation or death of a human
being, even in order to delay the death of other persons.''
9
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\8\ See Pius XII, Papal Teachings: The Human Body (Boston:
Daughters of St. Paul, 160), p.379, p.382.
\9\ Catechism of the Catholic Church, para. 2296.
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4. People may choose in their wills to dispose of their bodies
after natural death for legitimate medical purposes.10
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\10\ See Pius XII, Papal Teachings: The Human Body, p.381
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5. Organ transplantation from a live donor is also permissible.
People are not, however, free to destroy or mutilate their members or
in any other way render themselves unfit for their natural functions,
except when no other provision can be made for the good of the whole
body. This does not rule out live organ donation for transplantation,
provided that the donor's own health, identity, or adequate biological
functioning is not endangered. ``One can donate only what he can
deprive himself of without serious danger to his life or personal
identity, and for a just and proportionate reason.'' 11
Vital organs may only be donated after death.12
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\11\ John Paul II, ``To the participants at the First International
Congress on the Transplant of Organs,'' p. 1711.
\12\ See John Paul II, ``Many Ethical, Legal, and Social Questions
must be examined in greater depth,'' Dolentium Hominum, June 1991:
pp.12-13.
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6. Organ donation is neither a duty nor ``an obligatory act of
charity.'' 13 But ``a transplant, and even a simple blood
transfusion, is not like other operations. It must not be separated
from the donor's act of self-giving, from the love that gives life. The
physician should always be conscious of the particular nobility of this
work; he becomes the mediator of something especially significant, the
gift of self which one person has made--even after death--so that
another might live.'' 14
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\13\ Pius XII, Papal Teachings: The Human Body, p.381.
\14\ John Paul II, ``To the participants at the First International
Congress on the Transplant of Organs,'' p. 1711.
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7. Specifically regarding the issue of incentives for organ
donation, compensation (financial or otherwise) is not in principle
ruled out. ``In advertising (for cornea donors) an intelligent reserve
should be maintained to avoid serious interior and exterior conflicts.
Also, is it necessary, as often happens, to refuse any compensation as
a matter of principle? The question has arisen. Without doubt there can
be grave abuses if recompense is demanded; but it would be an
exaggeration to say that any acceptance or requirement of recompense is
immoral. The case is analogous to that of blood transfusion; it is to
the donor's credit if he refuses recompense, but it is not necessarily
a fault to accept it.'' 15 Hence, while organ donation is
commendable, acceptance of compensation may be permissible.
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\15\ Pius XII, Papal Teachings: The Human Body, p.381.
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Negative Dimensions
1. The following conditions would render compensation for donating
human organs morally impermissible: (a) if the compensation were
carried out in a manner that obfuscates, denies, or undermines the
belief in the divine origin of human life or the dignity thereby due
the corpse; (b) if the intention and object of seeking compensation for
either oneself or others was an illegal, immoral, or irreligious end,
or directly violated one or more of the fundamental human goods; or (c)
the act of compensation amounted to merely instrumentalising the donor
or the donor's mere self-instrumentalization.
2. The transplantation of the sexual glands from animals to humans
is to be rejected as immoral 16 because such a transplant
would directly deny the sacred element in humanity and the goods of
human love.
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\16\ See Pius XII, Papal Teachings: The Human Body, p.374.
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3. Society, specifically in the form of its political organization,
the State, may not commandeer the organs of a deceased human being
without the prior permission of that person or the consent of his
family.17 The relation of individual human persons to the
body politic is moral, not organic. This rules out any form of coercive
donation, including organ procurement strategies such as presumed
consent in which, absent a specific refusal, one is presumed to have
consented to donation.
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\17\ See Pius XII, Papal Teachings: The Human Body, p.376.
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4. It is forbidden for any form of organ donation, be it by a
living donor or from a corpse, to involve any mere instrumentalization
of the person from whom the organ is taken. This prohibition includes
any mere self-instrumentalization by a living donor. John Paul II
states, ``The body cannot be treated as a merely physical or biological
entity, nor can its organs ever be used as items of sale or exchange.
Such a reductive materialist conception would lead to a merely
instrumental use of the body and therefore of the person. In such a
perspective, organ transplantation and the grating of tissue would no
longer correspond to an act of donation but would amount to the
dispossession or plundering of the body.'' 18 Acceptance of
compensation for oneself or others, as described above, however, need
not proceed from a choice merely to instrumentalise oneself.
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\18\ John Paul II, ``Blood and Organ Donors, August 2, 1984,'' The
Pope Speaks Vol.30, no.1, 1985: pp.1-2.
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5. It is forbidden to engage in the commercial trafficking of
bodies. ``Also, in the case of dead fetuses, as for the corpses of
adult persons, all commercial trafficking must be considered illicit
and should be prohibited.'' 19
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\19\ Congregation for the Doctrine of the Faith, Instruction on
Respect for Human Life in its Origin and on the Dignity of
Procreation--Replies to certain questions of the day, Donum vitae,
1987, I, 4.
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6. ``Ethically, not all organs can be donated. The brain and the
gonads may not be transplanted because they ensure the personal and
procreative identity respectively. These are organs which embody the
characteristic uniqueness of the person, which medicine is bound to
protect.'' 20
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\20\ Pontifical Council for Pastoral Assistance, ``Guidelines for
Health Care Workers,'' 1 April 1996, para.88.
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ANALYSIS
1. The policy outlined in the Position Paper does not appear to
violate any of the negative precepts of the moral teaching of the Roman
Catholic Church. This is critical as the Church has always taught that
it is never permissible to do evil that good may come of
it.21 St. Augustine among others notes the idea that one may
do evil that good may come was something ``which . . . the Apostle Paul
detested.'' 22 While the positive moral precepts of the
Church's teaching allow room for prudence, the negative moral precepts
do not allow for legitimate exception.23
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\21\ See Rm 3:8; 1 Co 6:9-10.
\22\ St. Augustine, Contra mendacium, i. 1.
\23\ See Veritatis Splendor, para.52: ``The negative precepts of
the natural law are universally valid. They oblige each and every
individual, always and in each circumstance . . . the negative
commandments oblige always and under all circumstances . . . The Church
has always taught that one may never choose kinds of behavior
prohibited by the moral commandments expressed in negative form in the
Old and New Testaments.''
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2. The Position Paper does not violate any of the points listed
under the Positive Dimension. It would appear to fall under the
legitimate compensation position stated in point 7 of the Positive
Dimension. While it is to the donor's credit if he permits particular
organs to be used after his death (in accordance with the guidelines
outlined above) without compensation, it is not necessarily a fault to
direct compensation for the use of such organs to designated
beneficiaries.
3. The Position Paper does not violate any of the points listed
under the Negative Dimension. The family of the deceased may, for
example, still object to the removal of organs, though this would
nullify any insurance benefit or monetary compensation. Nor does the
Position Paper amount to allowing the use of organs as items of sale
and exchange.
4. It is very important that the Position Paper uses the word
compensation when defining the nature of any form of monetary payment.
It should also specify that any organs gathered under this proposition
would not consequently be sold or used as items of exchange by either
the family or the institution paying the compensation. This will
prevent any violations of points 4 and 5 of the Negative Dimension of
the Church's teaching about organ donation and compensation.