[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
---------------------------------------------------------------------------
                               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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \7\ See Pius XII, Papal Teachings: The Human Body (Boston, MA: 
Daughters of St. Paul, 1960), p.380.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    4. People may choose in their wills to dispose of their bodies 
after natural death for legitimate medical purposes.10
---------------------------------------------------------------------------
    \10\ See Pius XII, Papal Teachings: The Human Body, p.381
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \15\ Pius XII, Papal Teachings: The Human Body, p.381.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \16\ See Pius XII, Papal Teachings: The Human Body, p.374.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \17\ See Pius XII, Papal Teachings: The Human Body, p.376.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \18\ John Paul II, ``Blood and Organ Donors, August 2, 1984,'' The 
Pope Speaks Vol.30, no.1, 1985: pp.1-2.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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
---------------------------------------------------------------------------
    \20\ Pontifical Council for Pastoral Assistance, ``Guidelines for 
Health Care Workers,'' 1 April 1996, para.88.
---------------------------------------------------------------------------
                                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
---------------------------------------------------------------------------
    \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.''
---------------------------------------------------------------------------
    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.

