United States. Congress. House. Committee on Scien.

Organ transplants : hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representatives, Ninety-eighth Congress, first session, April 13, 14, 27, 1983 online

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Online LibraryUnited States. Congress. House. Committee on ScienOrgan transplants : hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representatives, Ninety-eighth Congress, first session, April 13, 14, 27, 1983 → online text (page 1 of 82)
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BOSTON

PUBLIC
tlBRftRY




ORGAN TRANSPLANTS



HEARINGS

BEFORE THE

SUBCOMMITTEE ON
INVESTIGATIONS AND OVERSIGHT

OF THE

COMMITTEE ON

SCIENCE AND TECHNOLOGY

U.S. HOUSE OF REPRESENTATIVES

NINETY-EIGHTH CONGRESS

FIRST SESSION



APRIL 13, 14, 27, 1983



[No. 16]



Printed for the use of the
Committee on Science and Technology




»-



ORGAN TRANSPLANTS









HEARINGS

BEFORE THE

SUBCOMMITTEE ON
INVESTIGATIONS AND OVERSIGHT

OF THE

COMMITTEE ON

SCIENCE AND TECHNOLOGY

U.S. HOUSE OF REPRESENTATIVES

NINETY-EIGHTH CONGRESS

FIRST SESSION



APRIL 13, 14, 27, 1983



[No. 16]



Printed for the use of the
Committee on Science and Technology




23-029 O



U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1983



For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402



COMMITTEE ON SCIENCE AND TECHNOLOGY



DON FUQUA, Florida. Chairman



ROBERT A. ROE, New Jersey
GEORGE E. BROWN, Jr., California
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
TOM HARKIN, Iowa
MARILYN LLOYD, Tennessee
DOUG WALGREN, Pennsylvania
DAN GLICKMAN, Kansas
ALBERT GORE, Jr., Tennessee
ROBERT A. YOUNG, Missouri
HAROLD L. VOLKMER, Missouri
BILL NELSON, Florida
STAN LUNDINE, New York
RALPH M. HALL, Texas
DAVE McCURDY, Oklahoma
MERVYN M. DYMALLY, California
PAUL SIMON, Illinois
NORMAN Y. MINETA, California
RICHARD J. DURBIN, Illinois
MICHAEL A. ANDREWS, Texas
BUDDY MacKAY, Florida
TIM VALENTINE, North Carolina
HARRY M. REID, Nevada
ROBERT G. TORRICELLI, New Jersey
FREDERICK C. BOUCHER, Virginia

J. H. Poore, Executive Director

Robert C. Ketcham, General Counsel

Regina A. Davis, Administrator

David S. Jeffery, Minority Staff Director



LARRY WINN, Jr., Kansas
MANUEL LUJAN, Jr., New Mexico
ROBERT S. WALKER, Pennsylvania
WILLIAM CARNEY, New York
F. JAMES SENSENBRENNER, Jr.,

Wisconsin
JUDD GREGG, New Hampshire
RAYMOND J. McGRATH, New York
JOE SKEEN, New Mexico
CLAUDINE SCHNEIDER, Rhode Island
BILL LOWERY, California
ROD CHANDLER, Washington
HERBERT H. BATEMAN, Virginia
SHERWOOD L. BOEHLERT, New York
ALFRED A. (AD McCANDLESS, California
TOM LEWIS, Florida






Subcommittee on Investigations and Oversight



ALBERT GORE, Jr.,

HARRY M. REID, Nevada
HAROLD L. VOLKMER, Missouri
ROBERT A. ROE, New Jersey
RICHARD J. DURBIN, Illinois
JAMES H. SCHEUER, New York



Tennessee, Chairman

JOE SKEEN, New Mexico

ALFRED A. (ALJ McCANDLESS, California

CLAUDINE SCHNEIDER, Rhode Island



Robert B. Nicholas, Chief Counsel/Staff Director

Steven A. Owens, Counsel

James E. Jensen, Investigator

Donald L. Rheem, III, Minority Technical Consultant



(II)



CONTENTS



WITNESSES



April 13, 1983:

H< Ten?e a sse 1 e d E ' F ° rd ' * Representative in Congress from the State of Page

Bi IL ie ^j 1 ' With S T ° n ' **%$? Haili'Capt- Jo^'a BlSric£'^ift"di^ii:
tor, Adriane; James Williams, M.D., associate professor of surgery,
University of Tennessee College of Medicine, Memphis, Tenn.; and
Cxary Hall transplant coordinator, University of Tennessee College of
Medicine, Memphis, Tenn s fi

School of Medicine, Stanford, Calif.; Thomas E. Starzl, M.D., professor
of surgery, University of Pittsburgh School of Medicine, Pittsburgh,
Pa.; and G Melvil e Williams, M.D., professor of surgery Johns Hop-
kins Hospital, Baltimore, Md jr,wumu.XMjp

Donald W. Denny director of organ procurement,' 'transplantation' 'office;
W S Vn Pltts ^rgh School of Medicine, Pittsburgh, Pa, William
W. Ptaff, M.D past president Southeast Organ Procurement Founda-
tion, University of Florida College of Medicine, department of surgery
alertfwar^ick Rf 11 Raym0nd Coleman > founding president, donor

April 14, 1983: ' 126

H Mas'sachu I s e a tte ey ' * Representative in the Congress from the State of

Michele Jones, kidney transplant recipient; David Ogden, M.D., profes-
sor of medicine, chief, renal section, University of Arizona Health

H,wT C A enter; and T Thel ™ King Thiel, vice chairman and executive
director, American Liver Foundation. 919

fn X r a thf^°/ gan f ^ r ° n ,' Executive Director, Presidents' Commission
R.W 1 p y ° f Ethical Problems in Medicine and Biomedical and
Behavioral Research; Dr James Childress, professor of religious studies
Un1vPrS e v SS n f r v medlcal education, department of religious studies,
University of Virginia; and Dr. Robert M. Veatch, professor of medical
town Universit 1 " 6363 scholar ' Kennedy Institute of Ethics, George-

Da £ d Rnf ki ^' IP"' o^'^he7chie'Fmedic^ 281

ppn'tPr C^i ? Va ^f' , res ^ arc ^ scientist, health and population study
ft. le r InS f tltut6 ' S % at $ e ' Wash ' ; and John McCabe, legal coun-

Chic o 111 Conference of Commissioners on Uniform State Laws,

April 27, 1983:' 374

^S^^^J^^s^' Secretary for Health ' Department 499

C. Everett Koop, M.D Surgeon General, U.S. Public H^ih&iriceZZZ 514
Carolyne K. Davis Administrator, Health Care Financing Administra-
turn; accompanied by Dr. Donald Young .... 591

£ • " ? e £ ry 'l U ' MD ;. Acting Assistant Secretary of Defense [health
aitairs], Department of Defense; accompanied by Alexander Rodriquez,
M.D medical director O-Champus; and Robert L. Gilliat, Esq., Assist-
Defense 1161 " 3 ° Unsel t man P° w er and health affairs], Department of

Hon. Dale Bumpers, a U.S.' Senator i^m"the Stete of Aribixis^s"'.;;!!;;!;!;;;;;;;; 588

(Hi)



IV

April 27, 1983— Continued

Dr. H. David Banta, M.D., Assistant Director for Health and Life Sci- Page
ences, Office of Technology Assessment 591

Kenneth W. Sell, M.D., Ph. D., American Association of Tissue Banks 637

Peter Safar, M.D., university professor and director of resuscitation re-
search center, University of Pittsburgh 647

Dr. Richard A. Rettig, professor and chairman, department of social
sciences, Illinois Institute of Technology 696

Dr. Jeffrey M. Prottas, visiting professor, center for health policy analysis
and research, Florence Heller Graduate School, Brandeis University 709

Winifred B. Mack, president, North American Transplant Coordinators

Orcra, ization, SUNY at Stony Brook 752

Appenc^.-v. Additional material submitted for the record 769



ORGAN TRANSPLANTS



WEDNESDAY, APRIL 13, 1983

House of Representatives,
Committee on Science and Technology,
Subcommittee on Investigations and Oversight,
„,, , Washington, D.C.

9 J? e p SU K COmi £ ttee m j*> Pursuant to call, at 10 a.m., in room
2325, Rayburn House Office Building, Hon. Albert Gore, Jr. (chair-
man of the subcommittee) presiding.
Mr. Gore. The subcommittee will come to order
I would like to welcome all of our witnesses and guests

pJ wiTi! 71111 * u, he subco ™ m . ittee be ^ ns 3 da y g of hearings to
evaluate the problems in obtaining organs for transplant surgery.
Each of us has been moved by the stories of families seeking life-
savings organs for their critically ill loved ones. And no sooner has
one family s plight been resolved, when it seems as if another, and
then another, comes forth to stand in their place

I am sure that many of you have wondered, as I have, why there
isn t some system to help meet these compelling needs in a more
rational way. Certainly there has to be a better way than relying
on bursts of media publicity during what is an emotionally difficult
time for the patient s family. It was for this very reason, especially
H^LiT P er K sonall y contacted to assist in such a search" that I
directed the subcommittee staff to conduct the investigation which
has brought us here today.

n Jl WiU n ° d ° ubt ? 0me M a sur Prise to many of us here that some
organ procurement systems are already in place. These systems

Th£ ?i tiaUy d T evel0ped by local sur ^ cal tea ™ to find transplant-
Pnn1n^h eyS> In man y. ca ses, these local agencies were poorly
Xnflv t Z anSW f r f hB ™ reasm 8 demands for kidneys and, more
recently, demands for other organs brought about by the great
strides in transplant surgery. We will hear this morning from iome
?o tm t °^ ai t P r ° cu . rement . agencies who have struggled valiantly
to fill a constantly increasing demand for transplantable organs,
trli 1 ?? 1 ^ m ° St ei ? m t n t Panel of surgical pioneers who will de-
scribe the advances in this life-saving area of science.
^or!L lr0ny ° ^he problem facing us, as we look at the present
shortage of available transplantable organs, is that we have a
flwSSL 0f A °/ gans ™ the face . of Plenty. Let me cite some figures to
n wS P n eSe £> approximately 5,000 kidneys are being trans-

fc 1 T^ aUy - ? 1Ve t} \ ousands P^ents who are suitabll candi-
s«vfL hLi dney * rans PJ ants are currently maintained on life-
saving dialysis waiting for a suitable kidney. The potential life



quality improvements for these patients from successful transplant
surgery and the cost savings potential are enormous.

A similar situaton exists for liver transplants. Dr. Starzl— from
whom we will hear shortly— and his group at the University of
Pittsburgh have performed 111 liver transplants in the 2-year
period ending in January. Let me correct that and make it 112 be-
cause Dr. Starzl has been up all night transplanting yet another
liver, and comes to this hearing room from the operating room.
During this same time span, another 54 patients died while waiting
for a donor liver.

Artificial hearts may, in time, provide hope for those thousands
who could benefit from a heart transplant— currently there are 100
heart transplants per year — but development of artificial livers,
kidneys, and organs of similar complexity are many, many years
away.

An estimated 20,000 Americans will die this year from head inju-
ries, brain tumors, and other circumstances that leave organs
usable for transplantation. Only a small percentage of those people
actually donate their organs, even though a Gallup poll taken some
years ago indicated that 70 percent of all Americans were willing
to have their organs donated for transplantation at the time of
death.

Relatively few people actually sign a donor card or some other
designated document for organ donation. In Maryland, for exam-
ple, where the donor card is placed on the back of the driver's li-
cense, a recent survey showed that only 1.5 percent participated.
Nationally, what is the net result of this disparity between pro-
fessed intention and actual action by potential donors? Figures
from a Center for Disease Control study— which we will also hear
about today — found that 2 percent of the patients who die in
American hospitals could be considered suitable donors, yet organs
are actually being obtained from less than one-fifth of those poten-
tial donors.

Testimony during the next 2 days — and then on the third day,
April 27— will describe the efforts of those who toil in this field. We
will be hearing from experts in organ procurement and donor so-
licitation efforts, as well as from some of the families who have had
direct experience with the system. We will also hear testimony
from expert witnesses who will discuss the bioethical and legal
issues involved. On the third and final day, we will hear from the
Department of Health and Human Services and from a variety of
witnesses who will suggest changes to improve the present systems.

I am extremely hopeful that these hearings will provide a focal
point for improvements in the process and procedures for obtaining
organs for transplantation so that families will no longer feel com-
pelled to mount a solitary nationwide campaign.

I want to call on my colleagues for opening statements, but let
me note first that we are going to have a change in the sequence of
the panels. Panel 2 is going to come first — Mrs. Billie Hall with her
son, Brandon, age 13 months; Dr. James Williams, associate profes-
sor of surgery at the University of Tennessee, Memphis; Mr. Gary
Hall, transplant coordinator at the University of Tennessee, Mem-
phis; and Capt. John H. Broderick, and Mrs. John Broderick, with
their daughter, Adriane, age 28 months from Minden, La.



The reason for the change is good news, happy news. The long-
awaited donor for Brandon Hall was located at 7 a.m. this morning.
Mrs. Hall and her son will be flying back to Tennessee, along with
Dr. Williams and Gary Hall, for surgery this afternoon. It is a very
happy announcement. We are delighted you can be here with us
for a short time before you have to go. We are going to change the
panels for that reason.

Let me call on the ranking minority member of this subcommit-
tee, Mr. Skeen.

Mr. Skeen. Thank you very much, Mr. Chairman.

The 3 days of hearings beginning today take the subcommittee
into one of the most impressive areas of recent scientific break-
throughs. Nowhere is the human drama surrounding science great-
er than it is for organ transplants. The fate of waiting organ recipi-
ents, hoping that somewhere in the United States someone with
matched organ characteristics has had the vision and the charity
to provide for the donation of their organs after death, is always a
poignant story.

I know, because my niece, who will be testifying tomorrow, has
recently undergone kidney transplant surgery after 3 years of bi-
weekly dialysis treatments. I know the pain and trauma of adjust-
ing to a lifestyle completely dependent on a machine. I am learning
now, 2 months after Michelle's surgery, how the recent break-
through in transplant technology can make a bright and hopeful
new life from one burdened with debilitating medical treatments or
death.

Let me congratulate and express my gratitude to those members
of the medical community with us during our hearings for bringing
us to the point we are today. It seems such a short time ago that I
lost my sister to glomerulonephritis. She died in 1962; she was 28
years old. There were no options then, despite the best attention of
the medical profession. There simply wasn't anything they could
do.

The situation is illustrative of the rate or pace of change current-
ly underway in the scientific community. We are seeing it more
and more on this committee as major breakthroughs occur almost
every day. In less than two generations, we have progressed from a
situation where someone such as my sister was left with no option
but death, to the situation today where my niece, Michelle, has the
option of life either by machine or by transplant surgery. Certainly
there is a lot to be grateful for, and much more to look forward to.

The key to what some observers are referring to as a Renais-
sance in transplant surgery is the drug cyclosporine. First used in
Great Britain in 1978, this drug fights the body's rejection of trans-
planted organs, thereby improving the 1-year survival rate. The
chances for successful transplants for such organs as heart, lung,
kidney, and liver have more than doubled in the last 5 years.

With the improvements in surgical techniques and new drugs,
over 5,000 people benefited from organ transplants in 1981. The
number is growing all the time, and more organ recipients are ex-
periencing successful transplants. The future of this field of re-
search is, in my opinion, without limit. A decade from now, we will
find a medical community capable of major feats of not only trans-



planting organs, but of reconstructing damaged ones as well. The
benefits to many Americans will be truly astounding.

Our subcommittee applauds all of our witnesses, doctors, and pa-
tients alike, and we welcome you to Washington. We also bid you
farewell if you need to get out of here for that transplant today,
and we appreciate your time that you have given us. It is my hope
that we might be able to listen to you in these 3 days and find
some way to help this process along. Most of the networking for
organ donors and recipients has been from the ground up, and the
support organizations you now have are very impressive. If you
think the Federal Government can help, I would like to hear about
it. Under the leadership of our chairman, Mr. Gore, I am confident
that the subcommittee will take the necessary and proper steps to
aid in this progress.

Thank you, Mr. Chairman.

Mr. Gore. Thank you very much.

Congressman Scheuer has an opening statement.

Mr. Scheuer. Thank you, Mr. Chairman. I will make it brief. I
know we are all eager to get to the witnesses.

We are at a wonderful point in time. I want to thank you for
your leadership in bringing us all together. These transplants that
were once unthinkable are now a practical therapeutic alternative
to such expensive and life debilitating procedures as renal dialysis.
Now the transplant technology is here to stay, thanks to the drug
cyclosporine that has apparently solved the rejection problems.

We in Congress must evaluate and analyze how the Federal Gov-
ernment can aid in organ procurement and how we can make sure
that every patient who needs an organ for a transplant has one.
We must also examine the adequacy of the medicare coverage for
transplants, both in terms of the procedures and the length of time
that the benefits are available.

In no way should the Federal reimbursement mechanism act as
a disincentive to transplants which are far more live-saving, far
more live-enhancing, and far cost effective than conventional ther-
apies.

Let me congratulate you again on scheduling this remarkable
hearing, Mr. Chairman.

Mr. Gore. Thank you very much.

Congresswoman Schneider.

Mrs. Schneider. I would like to thank you, Mr. Chairman, for or-
ganizing and pulling together what I think is a very timely and in-
teresting hearing. I think all we need to do is to look at the news-
papers or turn on the television set and see the remarkable ad-
vances that have occurred in the area of organ transplants.

The thought of vital organs, such as livers, hearts, and kidneys,
being transplanted routinely at our Nation's best medical centers is
a tribute to how far transplant technology has evolved since its
earliest days a decade and a half ago. The works of Doctors Shum-
way, Starzl, and Williams — to name some of the leaders — combined
with the R&D of the pharmaceutical industry in perfecting a pow-
erful, yet safe and practical drug, cyclosporine, demonstrates great
hope and promise of modern medicine.

Now that the medical technology is so very advanced, we have to
make certain that its support system in terms of organ procure-



ment keeps pace. One of the witnesses later today, I am proud to
say, is from my State of Rhode Island, and very actively involved in
helping connect the supply with demand. I think it would certainly
be a tragedy if, after realizing that we have the technological
breakthrough medically and pharmaceutically, that we don't take
full advantage by affording this remarkable therapy to all needy
patients.

I feel certain that, through the work of the subcommittee and
elsewhere in Congress, we can have a very meaningful impact on
the availability of transplant surgery, and I look forward to the tes-
timony of our distinguished witnesses at this morning's hearing.

Thank you very much.

Mr. Gore. Thank you very much.

Mrs. Hall, if you and Brandon could come to the witness table.
We are delighted to have you here. Captain Broderick, I would like
you and Adriane to join them at the center of the table there. Dr.
Williams, you are already at the witness table. Mr. Hall, if you
could join us as well.

By way of introduction, let me say that Mrs. Billie Hall lives in
Walnut, Miss., with her son, Brandon, age 13 months. Brandon has
been awaiting a liver transplant for quite a long time now. As I
mentioned before, there was happy news just this morning which
will take Mrs. Hall and Dr. Williams and Mr. Gary Hall back to
Tennessee.

Capt. John Broderick and his daughter, Adriane, age 28 months,
live in Minden, La. They are also patients at the UT Health Center
with Dr. Williams, who is joining us. We also have Gary Hall, who
is the transplant coordinator at the University of Tennessee.

To introduce our Tennessee witnesses, I am honored to recognize
our distinguished colleague, Congressman Harold Ford.

STATEMENT OF HON. HAROLD E. FORD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE

Mr. Ford. Thank you very much, Mr. Chairman and other mem-
bers of the subcommittee, for your kind words and for granting me
the opportunity to introduce two distinguished professionals from
the great State of Tennessee and from my district at the Medical
Center.

Before I continue my introduction of our Tennessee guests, let
me say that I, too, am cognizant of the fact that there are problems
related to the organ procurement for transplants. Not long ago, my
office in Memphis, Tenn., was contacted by our local media to help
in the search for a liver donor for a child hospitalized in my dis-
trict. I was shocked and dismayed to learn that a media campaign
of that magnitude had to be launched in order to procure a suit-
able donor.

I commend both Chairman Gore and the Committee on Science
and Technology for this hearing today and for this subcommittee
taking the time out of its busy schedule to arouse the awareness
from the congressional standpoint, as well as public awareness, of
the problems associated with organ procurement for transplants.

The University of Tennessee's Center for Health Sciences has
made a giant stride in the science of organ transplants. It is one of



the three major centers engaged in liver transplants, and the only
designated kidney transplant center in west Tennessee. Since May
19, 1982, when the center conducted its first liver transplant, seven
other transplants have been successful in that medical center.

It is my distinct pleasure to introduce Dr. James W. Williams,
who heads the surgical team at the University of Tennessee that
has performed five liver transplants since last May; and Mr. Gary
Hall, the university's transplant coordinator. Without the invalu-
able services and knowledge of these two professionals, much of the
progress that we have made in our hometown would not be there.
We are proud today to have the two before this subcommittee in
the Congress.

Once again, let me say that it is my sincere pleasure to introduce
them, and to know that we do have a donor as of 7 o'clock this
morning for the son of Mrs. Hall.

Thank you, Mr. Chairman and the members of this subcommit-
tee.

Mr. Gore. Thank you very much, Congressman.

We want to hear first from Mrs. Billie Hall. Mrs. Hall, I know
this is a dramatic day for you. It is our hope, as I know it is yours,
that the experience you have been through will be of some benefit
to others who will be undergoing the same challenge of finding a
donor for a child who needs an organ to live. We are delighted to
have you here on this special day. If you could share some thoughts
with us, we would appreciate it.

STATEMENTS OF BILLIE HALL, WITH SON, BRANDON HALL;
CAPT. JOHN H. BRODERICK, WITH DAUGHTER, ADRIANE;
JAMES WILLIAMS, M.D., ASSOCIATE PROFESSOR OF SURGERY,
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM-
PHIS, TENN.; AND GARY HALL, TRANSPLANT COORDINATOR,
UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE, MEM-
PHIS, TENN.

Mrs. Billie Hall. Thank you very much for having us. I thank
you not only for Brandon, but for everybody else who is here with
children that have Brandon's problems.

I would like to tell you a few things that happened to Brandon
over the last 13 months. Brandon was 2 weeks old when we found
out that he has biliary atresia. He had surgery at that time, and
they were hoping that the surgery that they did would correct the
problem long enough, at least until he could get big enough for a
transplant.

He did fine for 3 or 4 months, and then he started having bleed-
ing problems around his stomach. Dr. Whittington, Brandon's
doctor, told me that to live, Brandon would have to have a trans-
plant. He told us that we would have to have so much money to get
Brandon in the hospital. Brandon has SSI, and I don't have any in-
surance. He told me that medicaid would not pay. So, we were
faced with another problem. We had to get at least $30,000 togeth-
er to get Brandon in the hospital.

We have a small religious radio station in Walnut, and they got
behind us, and we worked for 5 months and raised $81,000. We
were fortunate. God was with us. There are so many people who



won't be as fortunate as we have been. There needs to be some-
thing done about the medicaid helping these children. It is so terri-
ble to see a child die because they do not have the money to pay
for getting help for their child. We did raise the money.



Online LibraryUnited States. Congress. House. Committee on ScienOrgan transplants : hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representatives, Ninety-eighth Congress, first session, April 13, 14, 27, 1983 → online text (page 1 of 82)