[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
HEPATITIS C: ACCESS, TESTING, AND TREATMENT IN THE VA HEALTH CARE
SYSTEM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
VETERANS AFFAIRS, AND INTERNATIONAL
RELATIONS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
JULY 12, 2000
__________
Serial No. 106-241
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
__________
U.S. GOVERNMENT PRINTING OFFICE
73-167 WASHINGTON : 2001
_______________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Printing
Office
Internet: bookstore.gpo.gov Phone: (202) 512-1800 Fax: (202) 512-2250
Mail: Stop SSOP, Washington, DC 20402-0001
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on National Security, Veterans Affairs, and International
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California
JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York
Carolina BERNARD SANDERS, Vermont
LEE TERRY, Nebraska (Independent)
JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH-HAGE, Idaho
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Lawrence J. Halloran, Staff Director and Counsel
Kristine McElroy, Professional Staff Member
Jason Chung, Clerk
David Rapallo, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on July 12, 2000.................................... 1
Statement of:
Baker, Terry, executive director, Veterans Aimed Towards
Awareness, Inc............................................. 16
Brau, Dr. Norbert, M.D., staff physician, Bronx VA Medical
Center..................................................... 83
Bryant, James A., Vietnam veteran........................... 24, 27
French, Heather, Miss America 2000........................... 5
Ho, Dr. Samuel B., M.D., staff physician, Minneapolis VA
Medical Center............................................. 72
Holohan, Dr. Thomas V., M.D., Chief, Patient Care Services
Officer, Veterans Health Administration, accompanied by
Jimmy Norris, Chief Financial Officer, Veterans Health
Administration............................................. 51
Iber, Dr. Frank, M.D., hepatologist, volunteer at Hines VA
Medical Center, Hines, IL.................................. 88
Lesinski, Martin P., Vietnam veteran......................... 37
Letters, statements, etc., submitted for the record by:
Baker, Terry, executive director, Veterans Aimed Towards
Awareness, Inc., prepared statement of..................... 19
Brau, Dr. Norbert, M.D., staff physician, Bronx VA Medical
Center, prepared statement of.............................. 86
Bryant, James A., Vietnam veteran, prepared statement of..... 30
French, Heather, Miss America 2000, prepared statement of.... 9
Ho, Dr. Samuel B., M.D., staff physician, Minneapolis VA
Medical Center, prepared statement of...................... 75
Holohan, Dr. Thomas V., M.D., Chief, Patient Care Services
Officer, Veterans Health Administration, prepared statement
of......................................................... 54
Iber, Dr. Frank, M.D., hepatologist, volunteer at Hines VA
Medical Center, Hines, IL, prepared statement of........... 90
Lesinski, Martin P., Vietnam veteran, prepared statement of.. 40
Shays, Hon. Christopher, a Representative in Congress from
the State of Connecticut, prepared statement of............ 3
HEPATITIS C: ACCESS, TESTING, AND TREATMENT IN THE VA HEALTH CARE
SYSTEM
----------
WEDNESDAY, JULY 12, 2000
House of Representatives,
Subcommittee on National Security, Veterans
Affairs, and International Relations,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:06 a.m., in
room 2154, Rayburn House Office Building, Hon. Christopher
Shays (chairman of the subcommittee) presiding.
Present: Representatives Shays, Souder, Tierney, and Allen.
Also present: Representative Snyder.
Staff present: Lawrence J. Halloran, staff director and
counsel; Robert Newman and Kristine McElroy, professional staff
members; Jason M. Chung, clerk; David Rapallo, minority
counsel; and Ellen Rayner, minority clerk.
Mr. Shays. The hearing will come to order.
I would like to welcome our witnesses and our guests.
In confronting the epidemic of hepatitis C virus [HCV]
infection, which afflicts veterans five to six times more often
than the general population, the Department of Veterans Affairs
[VA] is leading other public health systems in the development
of screening, diagnostic, and treatment protocols. But since
the program announcement 18 months ago, we have begun to
question whether the VA health care system is capable of
carrying out those protocols and delivering on the promise to
conduct a sustained campaign against the silent killer.
Time is running out. A potentially fatal biological clock
is ticking down for many thousands infected by HCV-tainted
blood and blood products during the 1970's and 1980's. Unless
they are told they are at risk, tested, and appropriately
treated, many will suffer liver damage beyond the reach of
current medical therapies.
VA acknowledges the potential scope and genuine urgency of
the problem, with 18 to 20 percent of veterans testing positive
for HCV antibodies. Yet veterans' advocates report inordinately
long waits for appointments with liver specialists and
inconsistent approaches to HCV care between VA regions. The
percentage of HCV-positive veterans enrolled in the only
effectively, but costly, drug treatment is well below some VA
projections of just a year ago. The scarcity of qualified
specialists and the rigid criteria used to exclude so many from
treatment in some areas raise legitimate questions whether VA
medical network directors are being given the organizational
and budgetary support needed to drive this ambitious program.
Recently, VA addressed the apparent fiscal disincentives to
aggressive hepatitis C outreach by allocating $20 million in
reserve funding to the networks based on HCV-related expenses
this year. More permanent incentives will be included in
regional funding formulas for next year.
This is our third oversight hearing on the VA's hepatitis C
program. Last year, witnesses described the fiscal and
operational challenges posed by the still new-born program.
Last June, testimony described growing pains, but progress in
contacting veterans, standardizing care, and making treatments
more available.
But today the question remains whether a consistent,
effective, and truly national hepatitis C program is being
constructed across the decentralized VA health care system. How
can a sometimes resistant, sluggish bureaucracy adapt to the
unique, changing demands for HCV treatment? These are the
critical questions we are asking our witnesses to address this
morning.
Speaking for veterans affected by hepatitis C, our first
panel is graced by the presence of the reigning Miss America,
Miss Heather French. She has made it a central element of her
public life to advocate on behalf of homeless veterans. We
thank her for all she does to heighten public awareness of
veterans' needs, and we are grateful she is able to join us
today.
All our witnesses bring important perspectives and
experiences to our discussion of the VA hepatitis C initiative,
and we look forward to their testimony as well.
[The prepared statement of Hon. Christopher Shays follows:]
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Mr. Shays. Let me now turn to the ranking member of the
committee, Mr. Tierney, if he would like to make any statement.
Mr. Tierney. I have no opening statement, Mr. Chairman, but
I will defer to either one of my colleagues if they would care
to say something.
Mr. Shays. Mr. Allen.
Mr. Allen. Very briefly, Mr. Chairman. I just would say I
thank you for holding this hearing. I think those of us, no
matter where we live in this country and whom we represent, we
are dealing with a struggle that so many of our veterans,
particularly of the Vietnam era, are homeless and have a
variety of disabilities and a variety of problems that go along
with that. I think this hearing is an important one today, and
I simply want to say thank you for holding it.
Mr. Shays. I thank the gentleman.
We are also privileged to have Vic Snyder from Arkansas,
who serves on the Armed Services Committee and also on the
Veterans Committee, I think on the subcommittee on health. It
is nice to have you here as well. Welcome. If you would like to
make any comment?
Mr. Snyder. No, thank you.
Mr. Shays. As is our custom and practice, we swear in all
our witnesses. I would welcome you all to stand and we will
swear you in.
Raise your right hands, please.
[Witnesses sworn.]
Mr. Shays. For the record, all of our witnesses have
responded in the affirmative.
And if I could, just to get some housekeeping out of the
way and then we will recognize you, Miss French. I ask
unanimous consent that all members of the subcommittee be
permitted to place an opening statement in the record and that
the record remain open for 3 days for that purpose. Without
objection, so ordered.
I ask further unanimous consent that all witnesses be
permitted to include their written statement in the record.
Without objection, so ordered.
Miss French, I know you have an extraordinarily busy
schedule and that you will need to leave here in about a half
an hour. We are going to have you give your testimony. I think
we will be able to have Mr. Baker, Mr. Bryant, and Mr. Lesinski
give their testimony, it will be within 5 minutes I think, and
then we will proceed to ask you a question or two. And if we
are not able to get through the testimony, we will interrupt
and make sure that we have some questions for you. Welcome.
Great to have you.
STATEMENT OF HEATHER FRENCH, MISS AMERICA 2000
Miss French. Chairman Shays and members of the
subcommittee, I thank you from the bottom of my heart for
allowing me to be here to represent millions of our American
veterans, especially those who are continuing to fight for
their health, fighting to regain their health. For so many, as
you know, the war continues on. It did not end when they came
home.
As Miss America 2000, I have been able to travel this
country with a great trophy--not a trophy that since September
18 belongs to me, but a trophy that belongs to 25 million
American veterans. I have carried this crown around the country
with me to represent every veteran. Every stone, every sparkle,
it is their trophy, not mine. I know a lot of you today ask
yourselves why does a 25 year-old fashion designer who has
become Miss America care about veterans' issues. I will tell
you why.
First and foremost, beyond being Miss America, I am the
very proud daughter of a disabled Vietnam veteran. At the age
of 4 my father started taking me into the VA hospital with him
to receive treatment. At that time, there was a very long
waiting period for his treatments. But it was at that time that
I learned the greatest lesson of responsibility concerning our
veterans. And that is, where veterans are concerned, it is so
much better to listen, not just with your ears but with your
heart, because it does not just make a difference in how you
treat our veterans, it makes the difference in how we respect
their service.
Then growing up, as a young adult I started running for
Miss America and realized that the spotlight for Miss America
could spread a spotlight on issues that this country did not
know about. We could expose issues that our veterans needed to
have exposed. We could gain them a better present and, more
importantly, a better future.
This year I have recorded about 20,000 miles each month, 1
day off a month, and have been able to see the different faces
of the Nation where veterans' issues are concerned. I have
travelled State to State. I have been able to embark upon many
wonderful issues this year. One of those not just being
homelessness among veterans, but because of Vietnam Veterans of
America and Veterans Aimed Toward Awareness, I have now
embarked upon a tour fighting the silent enemy hepatitis C.
At one of the screenings that we have done together this
year, almost 30 percent of the veterans at a particular event
were diagnosed positive for hepatitis C. I do not think I need
to tell you that 4 million Americans today are infected with
hepatitis C. And as Chairman Shays said earlier, veterans are
five, six times more likely to receive hepatitis C because of
their one common denominator, and that would be their service
to our country.
It has come to my attention that many of our veterans are
scared to get tested. Many do not know how they could have been
infected. But what we want to see is a more consistent approach
to hepatitis C across the country. My father has told me
countless stories of carrying his friends' bodies off the
battlefield, being drenched in blood for days. Of course, we
have to look at a very high risk factor of blood transfusions.
Two years alone in Vietnam there were over 365,000 blood
transfusions. And what about the helicopter pilots, the medics,
the nurses, the surgeons who were over there as well. And I do
not think I even have to express my opinion about the 5 to 8
percent of those in the Vietnam population who are hepatitis C
positive.
We sent 2 million of our soldiers, we deployed them to
Vietnam, into combat, they were unprotected from hepatitis C.
Therefore, I do not think it is a coincidence that almost 10
percent of our American veterans are infected with hepatitis C.
I believe that one common denominator comes down, again, to
their service to this country.
There is an effective treatment we have been able to tell
millions of veterans across the country who have gotten
screened. However, we do not believe that treatment is
consistent across the country. Some of the veterans I have
talked to have expressed their concern of not being able to
receive treatment, getting screened, or getting tested. My
question is, why?
I understand that we have a very decentralized VA system. I
understand that the veterans in Louisville, KY are not the same
as the veterans in New York City. However, a veteran who has
hepatitis C in Louisville, KY is the same as a veteran who has
hepatitis C in New York City. I am interested in why even the
Centers of Excellence in our country do not have the funding or
the staff to meet the needs of the veterans that are coming in
their doors.
I have visited the Miami Medical Center. They are a Center
of Excellence. Yet, it was expressed to me that they received
less than $300,000 last year for hepatitis C treatment. I have
been to the New York Harbor Side Health Care System. They are a
Center of Excellence for hepatitis C. Their hepatitis C team
expressed to me that they had to use their vacation time, their
lunch time, their breaks in order to meet the needs of their
current hepatitis C-positive population. My question is what
happens in a year or two when 2,000 more hepatitis C-positive
patients come to them for treatment. What happens then?
So again we ask you to look at the VA health system. We
need to implement a plan that is consistent across the board
from all VA perspectives, throughout all regions, because our
veterans in this United States deserve that much. They deserve
the chance to walk into a VA and be welcomed. When a dear
friend of mine, Butch Silvey came to me in Augusta, KY, a
disabled Vietnam veteran, during my homecoming he handed me a
present that reminds me every single day why I fight and the
price that he paid. This gentleman was sent to Vietnam, was
shot not once, not twice, but three times. He received this
Purple Heart. He gave this to me to remember why I fight every
day. This is the price that has been paid.
Everyday our veterans are being left behind. They are not
being treated, not being screened, not being respected for
their service. My question again, how many have to suffer, how
many have to die before we wake up and take notice? This is our
responsibility to this Nation.
Also, it is our responsibility to set the stage for our
coming generations, our children. I understand that 1 day we
will wake up and the voice we had will have been passed on to
our children. So what type of legacy are we leaving for our
children. Are we leaving a legacy of responsibility, of
accountability? Do they know how to take care of our veterans?
I think the mistreatment of thousands of hepatitis C-positive
veterans would say otherwise. It tells a whole different story.
So today it is your choice to make that stand. It is your
choice to face the wind. We need to be a hero to these
veterans. We need to be a hero to our children, because I
believe the American people are looking for those who dare to
talk the talk and walk the walk. I think a lot of veterans in
this room will agree with me that we are long tired of the
patronizing speeches of Veteran's Day, those who patronize our
veterans 1 day, leave them in a waiting line the next. It is
time to live up to that promise.
I encourage you, as you listen to my remarks, as you take
them to ponder on, remember this one thing: The choices you
make today reflect upon the American society. Their character
is a reflection of you. You make their choices for them. So I
ask that you please be wise, be compassionate where veterans
are concerned because the decisions you make will depict how
our veterans are proud of their service. I would ask you that
you make the decisions that let them be proud to be American
veterans. Thank you.
[Applause.]
[The prepared statement of Miss French follows:]
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Mr. Shays. Thank you, Miss French.
Mr. Baker.
STATEMENT OF TERRY BAKER, EXECUTIVE DIRECTOR, VETERANS AIMED
TOWARDS AWARENESS, INC.
Mr. Baker. Dear Mr. Chairman and other distinguished guests
of the subcommittee, on behalf of Veterans Aimed Toward
Awareness [VATA], a support group for veterans with hepatitis
C, and Vietnam Veterans of America Chapter 83, I am honored to
be here a second time regarding the VA's handling of the
hepatitis C epidemic.
Since June 9, 1999, when we last met, I have been traveling
around the country talking to veterans, offering them hepatitis
C testing and counseling, visiting VA hospitals and clinics,
and corresponding with Dr. Garthwaite and his counterparts. I
have attended one of the VA's training symposiums on hepatitis
C and visited the Miami Hepatitis C Center of Excellence.
Members of the committee, other than the efforts of my
organization to provide education, counseling, and testing, I
have not seen the proactive or aggressive efforts on the part
of the VA which they promised this committee on June 9, 1999.
Talking with veterans, I have found that the VA's approach
to treatment is only to treat those veterans who have high
liver enzyme levels, those who have symptomatic liver disease,
and those who are possibly beyond help, instead of treating the
veterans who could benefit most from the dual therapy. In my
view, the VA is treating the veterans who will benefit the
least.
In fact, in a letter to this committee dated June 28, 2000,
Dr. Garthwaite seemed proud of the fact that 78 percent of
veterans receiving treatment within the VA are designated into
the ``complex care'' category. I believe that Dr. Garthwaite
intended to impress upon you and this committee that HCV cases
are being properly reimbursed to the medical centers. In fact,
78 percent of all veterans being treated fall into the complex
care category because the VAMCs are treating only those
veterans who are sick enough to meet the strict criteria of
being a complex care patient in the VA.
Furthermore, it is my humble opinion that most treatment is
being reserved for complex care patients because VAMCs realize
that they cannot afford to start basic care patient on the
expensive therapy because they only generate $4,000 per patient
per year. They are well aware that the estimated VA HCV patient
needs care with an average cost to the VA of between $25,000
and $40,000. To treat HCV patients who fall into the basic care
category would bankrupt the particular hospital delivering the
care. The VA medical centers must wait for their HCV patients
to progress to more serious complications, like ascites, in
order for the medical records of the patients to note the
appropriate diagnostic codes to allow the VA medical center to
collect the complex care funding.
One of the only VISNs that treats the virus as the sole
enemy is VISN 13, under the supervision of Dr. Sam Ho. If VA
ever designates another Center of Excellence in hepatitis C
care, it should be Dr. Ho's. He and Dr. Petzel treat veterans
with real respect and see HCV as a disease that can and should
be eradicated from every veteran, no questions asked.
Following last year's hearing, we approached Dr. Garthwaite
about assisting the individual VISNs with their HCV programs
and helping them improve particular HCV-related shortcomings
witnessed is various VISNs. He told us to direct our concerns
to the individual VISNs, which we did by letters to each VISN
this past March. To our surprise, instead of working with the
particular VISNs on HCV, as originally instructed by Dr.
Garthwaite, we received one letter from VA central office on
behalf of all 21 VISNs. So much for a decentralized system.
Concerning all the correspondence that we have had with
central office, it certainly seems to me that someone is trying
to placate me. Because there are more important matters to
discuss, and there is little time now, I have brought these
letters and correspondence so that you can review them at a
later date.
I have been asked to followup on the examples that I
produced last year. Mr. Chairman, I am sorry to report that
these veterans' lives have gotten dramatically worse. The
veteran from Idaho was finally tested, but has not yet been
allowed to receive treatment in VISN 19. In fact, he has been
told that despite evidence of fibrosis of the liver, his enzyme
levels are not elevated enough to consider him for treatment.
As for the veteran from Montana, the VA has done a fine job. He
was never treated for his hepatitis C, and in November of last
year he succumbed to complications from a liver transplant due
to hepatitis C. I attended his funeral.
In the case of my personal friend from New Jersey that
served with the 173rd Airborne, he is now No. 7 on the liver
transplant waiting list. Even though we personally delivered
his case to Dr. Garthwaite, no, I repeat no action has been
taken. The VA continues to maintain that this recipient of the
Bronze Star for Valor cannot show a nexus between his service
and his hepatitis C infection because his duty assignment was
not ``medic.'' So much for serving one's country and believing
that one's country will bind up the wounds of battle.
Committee members, I must stress that while the VA tells us
that they are doing all that they can, the veterans caught in
the middle of this war do not have the time for the VA to
continually drag their feet. I have personally, along with some
fine people, brought forth more awareness from my little office
than all of the VA.
I find it appalling and take great umbrage at the
duplicitous nature of the VA's central office. There are
solutions to these problems, and I think that if a simple,
long-haired country boy like me can figure them out, so can
these highly educated people. Simple things, like letting
infectious disease physicians actively assist in providing
treatment for this disease. If the VA has a shortage of
gastroenterologists, then let us use the currently under-
utilized infrastructure that was built within the VA to provide
treatment for AIDS. Let us use them to treat HCV. After all,
the therapy is very similar and HCV is an infectious disease.
If we still do not have enough manpower, let us look at
flexible hiring schemes.
Another important point to consider is that the VA should
really be one VA when it comes to this disease. For example, a
veteran from Montana should not have to relocate to Phoenix to
get treatment. For more suggestions, I will be glad to meet
with the committee and the VA to develop a more productive
program for our hepatitis C patients. In fact, I would like to
volunteer to serve on the Advisory Committee that the VA Office
of the Inspector General recommended that the VHA establish to
deal with the HCV health delivery issue.
Dear Chairman Shays and members of the subcommittee, on
behalf of the men and women who risked their lives for our
country and who now face an even greater battle against
hepatitis C and the Department of Veterans Affairs, I beg you
to examine the actions that the VA has taken regarding the
hepatitis C issue, and for you, the committee, to take action
to ensure that the VA does what it is designed for. And I quote
Joe Thompson, Under Secretary for Benefits, in the February/
March issue of the VVA Veteran, ``We're the ones who have been
entrusted by American citizens to help veterans. That's our
mission.''
Mr. Chairman and members of the committee, thank you very
much.
[Applause.]
[The prepared statement of Mr. Baker follows:]
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Mr. Shays. Thank you, Mr. Baker.
We are going to suspend due to the applause from the
audience. I am sorry, I should have stated that before Miss
French spoke.
Mr. Baker, I apologize for not properly introducing you.
You are the executive director of the Veterans Aimed Toward
Awareness, Inc., and also a Vietnam veteran. Correct?
Mr. Baker. Yes, sir.
Mr. Shays. Also, we have Mr. James A. Bryant, a Vietnam
veteran, who will speak next, and then Mr. Martin Lesinski,
also a Vietnam veteran.
It is the practice of this committee to have our veterans
speak before the Department speaks. We appreciate the
Department waiving their protocol, in a sense, to address
first. It is appreciated that they come to listen to what you
have to say.
Mr. Bryant.
STATEMENT OF JAMES A. BRYANT, VIETNAM VETERAN
Mr. Bryant. Good morning, Mr. Chairman and members of the
subcommittee. I am beyond honored to be here this morning. My
name is James Bryant. I am a military veteran, a 100 percent
service-connected veteran for issues other than hepatitis C. I
currently reside in Stevens County in Washington State. I am
honored to tell you about my experiences as a veteran with
hepatitis C seeking treatment through the VA health care
system.
During my service in the Navy I made two 9-month cruises to
the Gulf of Tonkin as an aviation fire control technician.
After being medically discharged in 1973 for ulcerative
colitis, which is an inflammation of the small bowel or colon,
I underwent colon surgery at a VA hospital in 1978.
Mr. Shays. Mr. Bryant, I am going to have you start your
testimony when we get back from voting. My concern is that Miss
French is going to be unable to be here when we get back. There
are just one or two questions that I think we would just like
to quickly ask here, and then we will treat all three of you as
a separate panel.
Mr. Bryant. Absolutely. That is fine, sir.
Mr. Shays. Miss French, I would just start by saying that
in your travels, which are extensive, you focus on entirely on
veterans' issues, is that correct?
Miss French. Yes. Approximately 99.9 percent of my time is
veterans' issues-related.
Mr. Shays. So almost every day you are in contact with
veterans.
Miss French. Yes, that is true.
Mr. Shays. In your role, how would you evaluate the
veterans' knowledge of the services that are available, and
particularly as it relates to hepatitis C?
Miss French. It has been brought up to me more than a
handful of times the fact that veterans do not know what they
are entitled to. I just spoke with a panel of veterans 2 days
ago in Allentown, PA, and they expressed their displeasure in
not being able to find out about the services that could help
them. When I told them about hepatitis C, they did not know
about the increase in the veteran population, about the
epidemic. So I do think it is something that needs to be
addressed on getting information to the veterans. We talked
about several ways to do that--perhaps a data base. I
understand that the VA cannot advertise their services because
they are a Federal agency, however, it is a large issue.
Mr. Shays. I was at an event in the Fairfield/Bridgeport
area of Connecticut and I was pretty amazed with how open the
veterans were to you in discussing their challenges. Have you
had occasion to sit down with the people from the VA and talk
about what you are learning?
Miss French. Actually, I was Miss Kentucky before I was
Miss America, and I was brought up to Washington and met with
several of the dignitaries from the VA system nationally. What
we have discussed throughout the year is my experience with the
veterans, what I have seen, and we have constant
correspondence. However, the meeting yesterday with the
veterans produced some new questions for me to ask. One of them
is, if Medicare and Social Security can advertise for increased
enrollment, then why can't the VA system with their veterans?
It is a concern of mine, something that I do intend to address.
They want to get hepatitis C information, they want to
increase the enrollment, they want veterans to come in and get
tested and treated, however there has been no action taken to
increase the staffing. If we see 2,000 new veterans come into a
hospital in a year or two, it has been said that they intend on
keeping the same number of staff members to treat those
veterans as well. I do not see that as a possibility.
Mr. Shays. We have limited time before we have to go vote,
so I would welcome questions from Mr. Tierney and any of the
other Members.
Mr. Tierney. Thank you, Mr. Chairman.
I do not have a question, I just want to thank you very
much. I thought your testimony was well done, and you are doing
a great service for everyone by using your position, I might
say, to full advantage.
Miss French. Thank you.
Mr. Tierney. The chairman was with me on a hearing we had
about community-based outreach clinics within the veterans
service. I think there is more that we can do with those
entities in terms of outreach on that. I suspect that there is
nothing to stop any of the Members of Congress from tying it to
their Web sites some information about that as a matter of
outreach on that. I would think that might be one avenue for us
all to pursue. And last, many of us send out newsletters
periodically under our franking privilege. We sent out one that
just mentioned veterans benefits for prescription drugs and got
500 phone calls the very next day. So that if we use those
resources, and with your assistance, also the VA and tying
those things together, we might have some success on that. So
again, I want to thank you for what you have been doing, and I
would defer to my colleagues if they have any questions.
Mr. Allen. Thank you very much. An excellent job. Just a
quick question. In talking to veterans, do you find any pattern
emerging, either specifically with respect to hepatitis C or
any others, just in terms of the administration, how difficult
it is for them to get care? You are talking to lots of veterans
and a quick question is what are you picking up?
Miss French. Right. Every other day I am in a different
city across this country, and every other day I hear the same
stories about the difficulties with getting treatment,
difficulties in getting screened, especially filling out the
paperwork. Probably my greatest displeasure is in seeing the
hope being lost in veterans who for 4 and 6 weeks have to keep
coming back in to the VA to stand in another line to be told
that they need to wait another 4 or 6 weeks to even see a
physician. That is something that is reoccurring too often. And
when you think that I travel 20,000 miles a month, I think it
is hitting the majority of our veterans.
Mr. Allen. Thank you very much.
Mr. Shays. Mr. Snyder.
Mr. Snyder. Thank you, Mr. Chairman, and thank you for
allowing me to participate in the hearing today.
Heather, the number that you have in here, the 365,000
blood transfusions, I assume the majority of those were
probably in 1968 which was a very bloody year there. I think
one of our VA witnesses later on has an anecdote there of a
patient he talks about that may or may not have received a
blood transfusion but when some ordinance went off, a piece of
bone from the man next to him was imbedded in his leg. It seems
like the tougher issues are not the transfusion issues, they
are the exposure to blood issues. But I think that figure
really brings home the number, that for every 365,000 that had
transfusion there were a whole lot of others that were exposed
to blood. The issue is how likely is it in a combat situation
to acquire the virus through splattered blood if you did not
get the transfusion itself.
I want to make the point too, and I know you agree with
this, I think this focus on veterans and this issue is very
important. As a Vietnam veteran, I feel very strongly about it.
But I do not want our non-veteran population out there to
somehow think they are immune from this. This was brought home
to me 2 years ago when one of my employees received a call from
her husband 1 day that he was not feeling well, had been in
good health at age 43, and 2 weeks later passed away from
undiagnosed hepatitis C. This is a very real issue out there,
and not just for veterans but for our entire population, and I
appreciate your work on these issues.
Miss French. Thank you. Something I would like to share
with you, too. Representative Allen, you had asked what was
occurring in our system. A woman wrote me a letter about her
husband who in 1978 was diagnosed with non-A/non-B, which now
we attribute to hepatitis C. He went back into the service,
then went into the hospital again, and this is 1978 we are
talking about, was discharged medically, came home and became
very ill in 1997. Of course, hepatitis C can take 28 to 30
years to show any symptoms at all. He was sent away from the VA
with flu.
Well, as many know, hepatitis C has flu-like symptoms. The
VA failed to check his medical records to see that he was
diagnosed with non-A/non-B back in 1978. So the very next day
he came back into the emergency room with liver failure, had to
get a liver transplant, and as this woman said, and I quote
from her letter, ``Again I am sorry for taking up your time and
I hope that you understand my point, because you see, Miss
French, on April 23, 1999, a big part of my life died that day
when my husband died.'' I believe that these things could be
prevented with more consistent health care.
Mr. Shays. We have about 5 minutes to vote. You have many
duties to attend to as well.
Gentlemen, we will be back to continue this panel after the
vote.
We stand in recess.
[Recess.]
Mr. Shays. Mr. Baker, we thank you for your testimony you
have completed, but, Mr. Bryant, we are going to start you over
again, OK?
Mr. Bryant. Yes, sir.
Mr. Shays. We will go from the beginning. We have no rush,
so you take your time.
STATEMENT OF JAMES A. BRYANT, VIETNAM VETERAN
Mr. Bryant. Before I start, I want to say that I am
overwhelmed with the honor and the responsibility that has been
given me that I have just begun to realize in listening to
stories of three people, including yourself, Mr. Shays, that I
have never met before and they are all the same but were all
different.
Mr. Chairman and members of the subcommittee, good morning.
My name is James Bryant. I am 100 percent service-connected
military veteran and I was 100 percent service-connected for
other issues before my HCV. I currently reside in Stevens
County, WA. I am honored to be here to tell you about my
experience as a veteran with hepatitis C seeking care and
treatment through the VA health care system.
During my service in the Navy, I made two 9-month cruises
to the Gulf of Tonkin as an aviation fire control technician.
After being medically discharged in 1973 for ulcerative
colitis, which is an inflammation of the small bowel or colon,
I underwent colon surgery at a VA hospital in 1978. During this
surgery to remove my colon I was given several units of blood.
This blood, I am told, is my most likely point of infection
with hepatitis C.
I was diagnosed with hepatitis C in 1994 when the doctors
at the Spokane VA hospital told me about my hepatitis C
infection. I had many questions but I received very little
information and even less support. Instead, all the VA doctors
said was, ``Don't worry, your liver function tests are only
slightly elevated so there is no reason to believe there is any
on-going liver damage.'' In essence, don't sweat it, just don't
drink alcohol. The VA doctors at the Seattle VA hospital also
told me that since my LFTs were less than twice normal, I was
not a good candidate for interferon treatment and they would
let me know if they saw any problems developing or if there
were any advances or improvements in treatment.
That was mid-1994. From then until early 1999, the VA never
contacted me for any consults or check-ups regarding my
hepatitis C. During that time though, I began to see an
escalating theme in my life of fatigue and what I now call
brain fog. Any physical exertion wore me out. I decided to do
my own research on the internet. I became concerned that I
really had absolutely no information about the health of my
liver.
In early 1999 I went to an appointment at the Spokane VA
hospital and I shared my concerns about my hepatitis C and the
health of my liver with a VA doctor. I asked for a liver biopsy
and a viral load test, as those were the VA's own procedures
for treatment of hepatitis C. I was shocked and surprised by
his answers, that: (1) This hospital has a policy of not doing
liver biopsies; (2) In looking at your past LFT tests, you do
not meet the protocols for interferon treatment as they are
below twice normal; and (3) I will order you a viral load test
and we will discuss it at your next appointment in 3 months.
On my next appointment, my viral load tests revealed high
hepatitis C activity. I asked for a genotype test because some
hepatitis C genotypes are much more resistant to treatment than
others. This test was also refused. I did, however, get an
appointment for a consultation at the GI clinic at the Spokane
VA hospital. I was told that it would be a lengthy wait as
there was now no full-time GI doctor at the hospital, only a
part-time retired doctor handling the GI clinic.
At my first GI clinic visit, I again asked for a liver
biopsy, a viral load test, and a genotyping test. Dr. Roberts
apologized and said that the hospital had a policy against
liver biopsies and does not, as a matter of course, do
genotyping. He said he had tried with previous patients and had
been refused by the hospital administration. Dr. Roberts then
put me through the required hoops to rule out other possible
causes for my high liver function numbers.
At my next visit to the Spokane VA hospital in early
January 2000, I again asked for a liver biopsy, a viral load
test, and a genotype test. The then VA physician, Dr. Pavey
told me that all of these tests were a waste of time and VA
money, that biopsies were risky and that I should be glad for
Rebetron treatment as it is very expensive. Finally, I started
Rebetron combination therapy January 18th of this year.
The last part of my hepatitis C story is bittersweet. The
good news is that just last month viral load tests came back
``undetectable,'' meaning a count below 8,000. The bad news is
that there was not enough virus in my system for a genotype
test when the VA finally did decide to run the test. Now there
is no way for the doctors to determine whether I should
continue with hepatitis C treatment or not. You see, different
hepatitis C genotypes respond differently to treatment and
dictate how long a person should remain on treatment. But in my
case, they do not know because they do not have the information
they need.
So they have left the decision up to me--do I continue with
an extremely exhausting treatment for another 6 months, even
though it may be completely unnecessary, just in case? Saving
money by not testing in my case may well have cost the VA
another $7,500.
To summarize, I have found the following things to be true
during the past 6 years of dealing with my hepatitis C and the
VA health care system: I truly believe that had I not been the
proverbial squeaky wheel, the VA would still have done nothing
to followup my hepatitis C condition.
The VA diagnosed me with hepatitis C in 1994. To this day,
however, I have no concrete evidence as to how much hepatitis C
has destroyed my liver. I really want to know what shape my
liver is in.
My local VA hospital and the Seattle VA hospital lulled me
into a false sense of security about hepatitis C for almost 5
years.
I am deeply concerned about access to hepatitis C care, or
the lack thereof, at my local VA hospital. According to Spokane
VA hospital staff who do not wish to be named, more than 60
hepatitis C-positive veterans are waiting for their first
appointment with a GI doctor, but only 3 veterans, including
myself, are currently being treated at that hospital for
hepatitis C. There are currently about 250 people waiting for
appointments in the GI clinic. From January to the end of May
2000, only one doctor worked 2 days a week seeing all of the
hepatitis C and GI patients, and then only in the afternoon.
For the entire month of June no hepatitis C doctor was on
staff. Now there is another temporary replacement doctor but
only for the next 2 months. I cannot be certain, but I have
spoken to other veterans who say this is the typical situation
at their VA hospitals too.
The VA may be moving in the right direction but things
could be much better. How many veterans have lost their lives
because the VA told them not to worry, hepatitis C is not a big
thing. How many of my brothers and sisters are in end-stage
liver disease because the Veterans Administration has dropped
the ball, never followed up on their hepatitis C conditions, or
tested them in the first place, or counselled them on how
important it is to refrain from alcohol and drug use because of
their hepatitis C.
I read somewhere that complacency is hepatitis C's best
friend. That is precisely what the VA cannot be--complacent.
Veterans need full-time doctors focused on just hepatitis C in
every VA hospital in the country. Veterans need a consistent
plan of treatment for hepatitis C so that no matter where a
veteran goes for treatment they will get the same high quality
care for hepatitis C.
I wish to thank the members of this committee for inviting
me to speak about my personal experiences regarding hepatitis C
and the VA. I also want to thank Congressman Nethercutt and
Senator Murray for answering my letters regarding this matter,
especially Congressman Nethercutt for contacting the Spokane VA
to find out for himself what was going on.
[The prepared statement of Mr. Bryant follows:]
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Mr. Shays. Thank you, Mr. Bryant.
Mr. Lesinski.
STATEMENT OF MARTIN P. LESINSKI, VIETNAM VETERAN
Mr. Lesinski. Thank you, Chairman Shays and members of the
subcommittee. My name is Martin Lesinski. Thank you for this
opportunity to speak of my personal experiences with hepatitis
C. I hope my testimony will be of benefit not only to fellow
disabled veterans, but also to the honorable Congressmen who
play so principal a role in determining the quality of their
lives. Following my testimony, I welcome your questions and
concerns.
I am a disabled veteran of the Vietnam war. My service-
connected disabilities include hepatitis C. I served as an Army
infantry sergeant in Vietnam from the fall of 1970 until being
wounded near the end of February 1971. I stepped on a booby
trap, received multiple fragment wounds which required several
blood transfusions, both in-country in Vietnam and also later
in the Philippines. At my annual VA blood draw in March 1998,
my liver function tested abnormal. A followup test for
hepatitis C revealed I was positive. Until hearing this
diagnosis, I was essentially unaware of hepatitis C, its
causes, and its potentially fatal consequences.
As a veteran, one returns from war either dead or alive;
and if fortunate to be alive, either wounded or not. Here's the
thing, if you are wounded, you made it home alive, you know the
extent of your injuries, your disabilities, and there is no
further risk of death. Well, that is what I thought before this
diagnosis. It was a shock. After nearly 30 years of living with
my service-connected disabilities, suddenly there is a new
consequence of my service--hepatitis C, and this one can kill
me. It really took some adjusting.
In June 1998, I was referred to the Liver Clinic at the San
Francisco VA Medical Center and came under the care of Dr.
Teresa Wright. A liver biopsy was performed. My liver was
enlarged and early stage scarring had occurred and was
continuing. I was experiencing increasing fatigue and weakness.
At this point my situation got complicated and challenging.
My hepatitis C was severe enough that I required treatment. I
was screened for admission into a research study program being
conducted by Dr. Wright through the VA. Unfortunately, given
the extent of my PTSD, for which I am 70 percent service-
connected, I was rejected. Great disappointment. What to do and
how to obtain treatment?
Fortunately, during this process the FDA approved
combination therapy for naive patients. But even more
fortunately for myself, I reside in San Francisco, one of the
two Hepatitis C Centers of Excellence, and where Dr. Wright was
able to make treatment available to me.
In February 1999, I began combination therapy, continuing
through August. The treatment was extremely debilitating. It is
disheartening to be 6'4'', 200 plus pounds and unable to climb
a single set of stairs without resting mid-flight. There were
weeks when I just could not get out of bed except to go to the
bathroom. It was November 1999 before my blood counts returned
to normal. Six months after the completion of treatment I was
virus free and my liver functions normal. Quite simply, I have
gotten my life back. I am the fortunate one. I have returned to
my base line disabilities, the non-fatal ones.
Mine is a success case in the treatment of hepatitis C.
Unfortunately, I have also learned that simply obtaining
hepatitis C treatment from the VA can in itself be considered a
success. It should not be. Think about it--2 years after being
diagnosed with a debilitating disease, I am testing virus free.
I know that had it not been for several key factors falling
into place at the right time, I would not be here before you
with my hepatitis C currently in remission. A number of factors
converged--annual blood testing necessitated by my other combat
injuries which detected my liver problems, living in San
Francisco VA region where hepatitis C treatment is available,
coming under the excellent care of Dr. Teresa Wright, a broad
support team during my treatment, and believe me, the prayers
of many.
However, I should not be the only fortunate one. I believe
screening and treatment for hepatitis C should be uniformly
available throughout all VA medical centers, and readily
available to all veterans exposed to any risk factors
associated with their military service. Until hepatitis C is
viewed as a disease that affects all veterans, Congress will
continue to witness and veterans will continue to experience
this disparate level of care for hepatitis C within the VA's
regions.
This disease is not only destructive, but asymptomatic,
often stealth-like until far advanced. Such a disease requires
a broad and uniform access to screening for the entire veteran
community. Hepatitis C is a silent killer. Only in looking back
after my hepatitis C diagnosis did it become apparent to me
that the fatigue and abdominal discomfort I was experiencing
was the result of a fatal virus, and not simply the demands and
stress of my daily job. How many other veterans are unknowingly
enduring these symptoms, carrying this additional burden daily
for having answered their country's call?
Veterans are not just fellow Americans. We are the sons and
brothers, the daughters and sisters in families across America.
No matter the individual circumstances, we answered our
country's call at a time when the options not to step forward
were more numerous, more available, and more broadly supported
than ever before. As young men and women, we put on the
uniforms and shouldered the responsibilities of soldiers,
sailors, airmen, and marines. Twenty-five years after the end
of the Vietnam war America's veterans, America's sons and
daughters continue to pay the physical and psychological costs
of their service.
I ask you honorable Congressmen and your colleagues to
provide the necessary oversight and resources for a consistent
and comprehensive hepatitis C treatment program for all of
America's veterans, not just those veterans lucky enough to be
living in select VA regions, but for all veterans across
America. It is particularly painful for us to be denied medical
treatment in this time of surplus.
I want to thank this committee and you, Chairman Shays, for
your attention to this critical issue. I applaud this
committee's oversight to ensure that veterans receive quality
access, testing, and treatment for hepatitis C. This I ask of
you: May not just the fortunate ones, but all veterans be
provided unwavering screening and treatment for hepatitis C
throughout the VA health care system. Please grant all veterans
the opportunity to live their lives to their full potential.
Thank you.
[The prepared statement of Mr. Lesinski follows:]
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Mr. Shays. Thank you, Mr. Lesinski.
We will begin with Mr. Tierney, Mr. Allen, and Mr. Snyder,
and then I will ask some questions.
Mr. Tierney. Thank you, Mr. Chairman.
Gentlemen, I am very concerned about the complacency issue
here, the aspect that it is your worst enemy if you have
hepatitis C. I note the committee took a review of some of the
veterans agents in my district and some of the clinics up
there, and what we noted, from the agents at least, is they do
not see much in terms of outreach, particularly from the VISNs.
They might catch a letter occasionally from the Armed Services
newsletters or whatever.
What would your respective recommendations be as a way to
reach out to veterans and to let them know about the wisdom of
having a test, the need for it, and so on down the line on
that. I will start with you, Mr. Baker.
Mr. Baker. We gave those suggestions the last time we were
here, which is simple posters and brochures, which the VA told
us they were going to do. To date, we still have not seen a
brochure or a poster. Like I said, my mere office, I have
posters and brochures here that we send out all across the
country to different clinics and different VA physicians asked
us for them.
Mr. Tierney. Mr. Bryant.
Mr. Bryant. I do not know that I have an answer for you. In
the last few months, I have seen a few pamphlets at my VA
hospital. I feel like the gentleman on my left, I feel like one
of the lucky ones. I just happened to be in the right place at
the right time and asked the right questions. Otherwise, I
think I would still be sitting there complacent if I had not,
for my own reasons, gone on the Internet and found the
information myself.
Mr. Tierney. There is nothing that the Veterans
Administration had done that prompted you to do that?
Mr. Bryant. No. I have been a service-connected disabled
veteran, or at least partially so, since 1974. I have received
on other matters better treatment in the VA than I think I got
in civilian hospitals for various things. And up until this
hepatitis C thing, I would never have been here to say anything
bad about the VA because I felt almost like royalty. I was
treated well for things that were not even service-connected. I
ran out of money after a motorcycle accident and they took care
of my leg. But I feel like there was a brick wall on this. So I
am sorry, sir, I do not have an answer for you.
Mr. Tierney. OK. Thank you.
Mr. Lesinski.
Mr. Lesinski. Excuse me, Mr. Tierney, I did not quite hear
your question.
Mr. Tierney. It was for suggestions as to what could be
done specifically in terms of better outreach. I take it that
you did not get prompted to have your tests because you heard
anything in particular from the Veterans Administration or
clinics or hospitals.
Mr. Lesinski. No, it actually came up in the course of
normal annual blood work for other service-connected. I think
the heart of the matter really is within the VA and the fact I
realize how extremely fortunate I am in being in San Francisco,
that it just fell into place. I just feel that the VA should
have this in place everywhere. We should not have to be doing
additional outreach to say to veterans, hey, you might be a
problem here. We should just be checking them.
Mr. Tierney. Thank you. I note that in my district at least
they do check in all of the clinics and the hospitals. If that
is not the case nationwide or whatever that they check, then we
are fortunate to have Dr. Ignello down at the Bedford facility
who runs the hepatitis C clinic and basically does followup on
that if somebody tests positive. The one thing he does talk
very carefully about is the recommendation that testing be done
very early. It is asymptomatic early on and that the longer you
wait the more likely you are to have serious liver damage, and
also the prospect of warning them against alcohol and things of
that nature if they are subject to having this situation.
So I would suspect we will probably want to have some
questions for the Veterans Administration about the depth of
their testing and why it is not done everywhere, and what they
can do about following up on that.
Mr. Baker, you want to add something?
Mr. Baker. That is why we suggest and we feel it should be
a one VA on this issue. Like you are saying, where you are
there is outreach and they are testing. There are facilities
across the country that are so inconsistent with everybody
else's policies, the guys just do not even know what is going
on. There is not random testing in every facility. And even
after the facilities do test, some of them still tell the guys
to go home and they will have a notice that they will have a
clinic in 6 months. Some of these veterans do not have time for
6 months. So the VA has to be consistent with their policy
everywhere, and they are not.
Mr. Tierney. Thank you. Thank you, Mr. Chairman.
Mr. Lesinski. If I might add something to Mr. Tierney's
question. Perhaps one place for them to start in terms of
concrete things to be done, since we know the blood supply was
not really cleaned up until about 1990-1991, they could easily
go through their records and send a letter to anyone who has
received any kind of blood work or blood transfusions through
their system up until that time to come in and do testing and
be screened. I am sure they have that data base. I know it
would incur great numbers, but that alone would identify
everything.
Mr. Tierney. Thank you.
I yield back, Mr. Chairman.
Mr. Shays. Mr. Allen.
Mr. Allen. Thank you, Mr. Chairman.
Mr. Baker, in your testimony you say that you found the
VA's approach to treatment was to treat only those veterans who
had high liver enzyme levels or those who have symptomatic
liver disease. I am wondering if you are suggesting that the
treatment guidelines for the VA should be modified, and, if so,
how they should be modified.
Mr. Baker. They definitely should be modified. Some
facilities, even the facility that I am at, if you do not have
high liver enzyme levels, you are not going to go any further.
The data shows, and I gave it to the committee, that in 30
percent of the cases there is no liver enzyme elevation, so
these fellows just continue to go on. I have an instance in my
own facility like the one in Montana--liver damage, slighted
elevated enzyme levels, they told him to go home, nothing to
worry about.
They need to change their guidelines. They need to be
consistent with the other leading hepatologists across the
country that are not within the VA system. What it shows us is
that they are only taking the sickest ones so they can get the
$40,000 that complex care patients get. The bottom line, we all
know, is dollars and cents sometimes with a lot of these
people. There are good people in the VA; I work with them. But
something is wrong in this picture with hepatitis C. Those
veterans are not out there getting treated properly.
Mr. Allen. How often does the issue of whether the
condition is service-connected or not arise with veterans in
your case?
Mr. Baker. In my case, because I am a service officer, it
arises every time I talk to a veteran with hepatitis C. I want
to know what his risk factors are and if he knows what his risk
factors are. There are a lot of veterans out there that cannot
find a risk factor, but there are others, like we said, combat
veterans with no transfusions, some were wounded, some not, but
we know in a combat scene everybody has got something.
Mr. Allen. Mr. Snyder has some legislation that he can talk
about but that would be helpful.
I yield back. Thank you, Mr. Chairman.
Mr. Shays. Thank you.
Mr. Snyder, you have the floor.
Mr. Snyder. Thank you, Mr. Chairman.
Mr. Bryant, in your testimony you make mention of having
had several units of blood during a surgery and that, in the
opinion of some, is where they think was your most likely point
of infection with hepatitis C. Of course, there are a lot of
good reasons for that. But you also make the point that it is
impossible for us ever to know for sure. I think that is the
challenge that so many of our veterans have, is this is like
the game of Clue but you never know the answer. There is a
point in time at which infected veterans received that virus.
We can play odds and say it must have been during that
transfusion, but the reality is it is very difficult because of
our state of knowledge up until 10 years ago or so to know when
that point in time was. I appreciated your candor about the
fact that you are not really sure when you got it either.
I want to ask a little broader question than Mr. Tierney
did. For each of you, if you were the new Secretary of Veterans
Affairs, or a member of this committee or the Veterans
Committee, what would be your No. 1 specific priority in this
whole area of hepatitis C and the VA?
Mr. Baker. My No. 1 priority would be to just get the word
out to every veteran that they need to be tested. Whether they
get tested through their local insurance that they have, or
come into a VA. We have an epidemic here and the first thing is
to identify who has it and who does not.
From there, we straighten up our guidelines properly to
coincide with what the regular population is doing, and we
treat these people so that they do not become symptomatic to
when they are in the hospitals and it is costing the Department
of Veterans Affairs and the taxpayers thousands and thousands
of dollars to take care of these guys. Myself, I got treated in
time. I am OK. The other fellows here, we have been treated in
time. But we are the fortunate ones. So we need to get the word
out first. And that was supposed to have been done.
Mr. Snyder. Mr. Bryant.
Mr. Bryant. I want to go back to something that you said
about where we might have gotten it. I believe personally that
I probably contracted it in boot camp with either air gun shots
or a gamma globulin shot. But that does not really matter to me
now. But there are people out there, and I look at the rest of
my life other than my military service and the fact that I was
in a VA hospital for surgery for a service-connected-related
disability, and they tell me that is the most possible place,
but how many people just like me went to boot camp, got a few
shots. I worked in an air conditioned shop on board a carrier
fixing bombing and navigation computers for the A-6. I got out
and went home and was fortunate enough to have gone back in the
service when I came down with ulcerative colitis. So there was
no doubt that I had a direct link to it. But how many of my
brothers and sisters went in, did their time, did not have any
known risk factors, but they have hepatitis C. They went out
and behaved themselves, they did not do drugs, they did not
drink alcohol, they did not do any of the other things they
said are risk factors. But they are going to die of hepatitis C
all the same.
Mr. Snyder. Thank you.
Mr. Lesinski, do you have a specific No. 1 priority?
Mr. Lesinski. Yes, Congressman Snyder. I would make the
first priority uniform screening and testing. It has just got
to happen. We cannot let the unlucky ones go.
Second, I would broaden, as you spoke to earlier, and Jim
Bryant just spoke to, the risk factors and exposure points.
Mine was a clear-cut case where I had blood transfusions. I had
been exposed to blood on the battlefield. I had no other risk
factors. But it should be uniform screening and testing as the
No. 1 priority, and under that, to broaden it. If someone is
exposed to any of the risk factors, they should be brought in
for screening.
Mr. Snyder. Thank you. Thank you, Mr. Chairman.
Mr. Shays. Thank you, gentlemen.
The value of your testimony it seems to me is to now have
the VA respond to it. I think your testimony and the questions
that have been asked make it very clear that the protocol that
we have is not really being followed. I guess I want to ask
each of you why you think we need to have two hospitals that
specialize in hepatitis C care when we do not have our veterans
who have hepatitis C just in those areas.
I will start with you, Mr. Baker.
Mr. Baker. First of all, I think there should be more than
two Excellence Centers if they are going to lead the way in how
the VA treats their veterans with hepatitis C. But again it
comes down to uniformity within the VA. One facility does one
thing, another one does another. It is just so scattered. If we
are going to have Excellence Centers, and I visited Dr. Ho's
Excellence Center as well, he is doing an excellent job up
there, but nobody even follows what he is doing. Everybody is
on a different page.
The VA needs to get on the same page. I do not know what is
so hard about getting on the same page and all of them
following the criteria that is out there. Leading hepatologists
in the world have shown the VA what criteria to follow and they
choose to follow their own. Do not understand that. But I know
that they need to be on the same page, all these facilities.
Let's make them all Centers of Excellence, because if they are
all on the same page they are all doing the right thing.
Mr. Shays. Mr. Bryant.
Mr. Bryant. I think I have to echo both of these
gentlemen's words. I am not nearly as eloquent. I can only
reiterate that I do not think that the VA would have treated me
had I not stepped up and said here I am and I need treatment. I
have a son in the military now and he has yet to be tested for
hepatitis C. I know people in different parts of the country,
only because I talk to them on the computer, who not only had
no outreach from the VA, but they cannot even get service-
connected because they have to wait 2 years for an appointment
to be service-connected. But they are going to die before their
appointment comes up because they cannot get treatment for
something that I think every one of us in this room, or at
least from here forward, knows is service-connected. That may
not be quite the answer to your question, but it was what was
on my mind.
Mr. Shays. Thank you.
Mr. Lesinski.
Mr. Lesinski. Simply make every region a Center of
Excellence. That is all we need to do. It is easy.
Mr. Shays. Again, your testimony is very powerful. If what
you have encountered is indicative of the problem other
veterans encounter, it is a strong indictment that the protocol
is just not being practiced.
Yes, sir?
Mr. Baker. I would just like to add one thing, and Miss
French brought this up, and that is the issue of the funds and
how the VA Central Office has sent it down to their VISNs. I
was at the Miami facility as well when they told us that they
did not have the money. We had corresponded with VA at an
earlier date about that and had been told that more money was
sent. We need to make these VISN directors accountable for this
money that is designated for hepatitis C. That $350 million
that was supposed to go to help toward that has gone to a lot
of other places, and we know that. So we need to really make
them accountable and somehow designate that this money is
exactly for that purpose, not for parking lots, not for a bunch
of people to go to different places in the country to
supposedly take care of certain issues.
Mr. Shays. Any other comments any of you would like to add?
Mr. Bryant. Yes, sir. I have not been involved in this
nearly as long as any of these other people here. I have never
met them before the last day or so. But everything that they
said about lack of treatment, lack of outreach I have found
true in my own life and with people whom I have talked to.
My VA hospital chooses not to do liver biopsies, until the
last month or so they chose not to do viral load testing or
genotyping. I think, pardon my French, but it is going to come
back and bite them in the butt because now they are going to
find out that the little things that they did not do before are
going to end up costing them more money. I have got to do 6
more months of treatment that I do not want to do because they
cannot tell me whether I should stop or not.
Mr. Shays. Mr. Lesinski, we are going to have three
recorded votes, but go ahead.
Mr. Lesinski. Chairman Shays, two things very quickly. One
is, they do know how to do it right. I am sitting here because
they do know how to do it right. They can do it right. They
need to do it right uniformly. And second, the other thing I
would like to say in closing, is once again I would like to
applaud this committee for your efforts and oversight in
assuring that veterans get the resources they need to live to
their full potential. Thank you, gentlemen.
Mr. Shays. Thank you. I just would use that as an occasion
to say that we first became aware of this problem when we had a
hearing on the safety of the blood supply. We were looking at
the HIV/AIDS virus and in there was just an off-handed comment
that 300,000 people had become infected with hepatitis C and
that a good chunk of them were veterans. And that is kind of
how we learned of it and that is how we began to followup. It
is an extraordinarily important issue, and I appreciate all
three of you willing to be here and testify. Thank you very
much, gentlemen.
I think we will try to get in at least the first testimony
of the next panel. So if we could call our next panel, which
will be Dr. Thomas V. Holohan, Chief of Patient Care Services
Officer, Veterans Health Administration; Dr. Samuel B. Ho,
staff physician, Minneapolis VA Medical Center; Dr. Norbert
Brau, staff physician, Bronx VA Medical Center; and Dr. Frank
Iber, Hepatologist, a volunteer at Hines VA Medical Center,
Hines, IL.
Thank you, gentlemen. We will swear you in. If you would
raise your right hands, please.
[Witnesses sworn.]
Mr. Shays. Thank you. Note for the record that all
witnesses responded in the affirmative.
We will start with you, Dr. Holohan. I think we will hear
your testimony and then we will break for the vote and come
back.
Let me state again for the record there is a protocol that
usually has the executive branch go first. We appreciate your
willingness to listen to the witnesses. That way we will not
have to ask some of the questions and then have to bring you
back up afterwards. So it serves our purpose well and I hope
yours, too. So thank you very much for your cooperation.
Dr. Holohan, you have the floor.
STATEMENT OF DR. THOMAS V. HOLOHAN, M.D., CHIEF, PATIENT CARE
SERVICES OFFICER, VETERANS HEALTH ADMINISTRATION, ACCOMPANIED
BY JIMMY NORRIS, CHIEF FINANCIAL OFFICER, VETERANS HEALTH
ADMINISTRATION
Dr. Holohan. Thank you, sir. Let me begin by making a
personal comment. I am a Vietnam-era veteran, 70 percent
service-connected. I thought that was an important statement to
make given the tenor of the testimony we are hearing.
VA has already submitted written testimony for the record.
What I would like to do at this time, Mr. Chairman, is to
briefly summarize some of that information and then address the
additional questions that were submitted by your staff on July
7th.
Since our last testimony to this subcommittee in June 1999,
we have achieved a number of goals in our attempts to establish
a national system-wide and an evidence-based approach to this
disease.
We have established the Emerging Pathogens Registry as our
primary mechanism for tracking both hepatitis C testing and
those individual patients who have been shown to have the
disease. This Registry uses an automated computer program that
forwards the information to a central data base. We have
reviewed and updated our treatment guidelines, and have put in
place a risk assessment reminder system to improve our
diagnostic capabilities.
Our Centers of Excellence in Miami and San Francisco have
developed educational materials and counseling guidelines for
patients and practitioners. They are participating in and
monitoring a number of investigations, including VA studies of
hepatitis C prevalence, an industry-sponsored study of
treatment outcomes of combined therapy in veteran patients, and
clinical studies of new drugs.
VA has developed cooperative outreach programs with
Veterans Service Organizations, and private groups such as the
American Liver Foundation, and the Hepatitis Foundation
International. We are currently in the planning stages of the
mailing of 4 million brochures, one to each enrolled veteran in
VA.
The Acting Under Secretary for Health has released an
additional $20 million in reserve funds this fiscal year for
hepatitis C initiatives. The amount provided each Network is
proportional to their current fiscal year expenditures for this
disease. In fiscal year 2001, we intend that the VERA funding
will include recognition of the costs and the distribution of
hepatitis C throughout VA and further adjustments will be made
appropriately.
VA has also established a Web site that provides
educational materials, guidelines, and information that has
been presented at our various national clinical and counseling
symposia.
Now, Mr. Chairman, with respect to the additional
information sought by your staff, I will address those specific
issues of interest.
From fiscal year 1998 throughout the first half of fiscal
year 2000, approximately 325,000 veteran patients have been
tested for hepatitis C. Approximately 65,000 have been found to
be positive for those antibodies; that is about 20 percent of
those tested.
You also asked about the number of veteran patients with
hepatitis C who have received or are receiving treatment. This
is difficult to determine precisely because there is no single
data base that lists unique patients and drug treatment that is
specific for hepatitis C. The Pharmacy data base can identify
from June 1999 individual patients on Rebetron or combined
interferon/ribavirin, and hepatitis C is the only indication
for that product. However, another treatment alternative is
interferon alfa, and that drug is used to treat a number of
diseases in addition to hepatitis C, for example, chronic
myelogenous leukemia.
So in order to determine the total number of hepatitis C
patients on either Rebetron or interferon alfa, we will have to
compare patient lists by social security number across the
pharmacy data base and the Emerging Pathogens Registry. This
work is currently underway but is not yet completed. However,
we do know, on the basis of these two data bases, the mean
number of new patients started on Rebetron each month
approximates 14 percent of the mean number of newly diagnosed
hepatitis c patients each month, as reported in the Registry.
You asked what percentage of veterans with hepatitis C are
eligible or appropriate for drug therapy. This is a question
which we have been quite interested in, as you may imagine. The
original estimates of our VA experts in liver disease were that
about 20 percent of our patients would be eligible. Their
estimates were based upon the observation that there are a
number of absolute or relative contraindications to such
therapy. The benefits, for example, often do not outweigh the
risks for those with very mild liver disease or for advanced
liver disease. Other contraindications include age greater than
60, significant extrahepatic disease, depression, autoimmune
diseases, uncontrolled diabetes, moderate to severe anemia or
low white cell or platelet counts, pregnancy or refusal to use
contraception. The possibility of poor compliance with complex
regimens must be considered. And finally, it is widely believed
that ongoing alcohol or illicit drug use is an absolute
indication.
As I have noted above, we have evidence that on average the
number of new patients started on Rebetron each month
represents about 14 percent of the total number of newly
diagnosed patients each month. In addition, the San Francisco
Center of Excellence has obtained risk factor and treatment
candidacy information on veteran patients with hepatitis C at
26 medical centers across the country. Approximately 15 percent
of the patients sampled were on treatment.
So we believe that when additional data are available in
larger samples and the patients on interferon alfa alone are
added to those on combination therapy the original 20 percent
estimate will prove to have been reasonably close to the actual
treatment rates that we are observing.
You asked when the direct comparisons of the Emerging
Pathogens Registry and the Pharmacy data base would be
complete. As stated, we have performed an initial match, but
the two sources do not reflect the same period of time. We will
attempt to select our patients from the same time interval in
the two data bases. However, reducing the figures to a monthly
average and comparing hepatitis C-positive patients with
patients on treatment, an approach we have described above, the
data suggests that the proportion on treatment with Rebetron,
interferon alfa alone, or interferon alfa plus ribavirin is
approximately 16 percent.
Mr. Shays. I am sorry, Dr. Holohan, we are going to have to
go vote. We have three votes and you gentlemen need to get on
your way. I do not know if you want to quickly get a bite to
eat or something and we would come back in about 20 minutes.
Dr. Holohan. Twenty minutes?
Mr. Shays. If we could be here at five after.
[Recess.]
Mr. Shays. Gentlemen, sorry to keep you waiting. I
underestimated the time it would take to do three votes.
Dr. Holohan, if you would like to continue your statement.
Thank you, and sorry to interrupt you.
Dr. Holohan. Thank you, Mr. Chairman. I am not going to
repeat what I have said except to again emphasize the numbers.
We talked about the numbers that have been tested and that
about 20 percent of the 325,000 tested have been positive. We
talked about different mechanisms for looking at the data we
have available to us about the percentage of positive patients
who are treated, and those three different methodologies return
14, 15, and 16 percent respectively, which we believe is very
similar to the predictions that some of our VA liver experts
made several years ago about 20 percent of veteran patients who
are positive being appropriate candidates for treatment.
The final statement, related to a question that your staff
posed, was how the hepatitis C assessment reminder would be
used, I think the phrase they used was ``clinical reminder,''
and when it would be implemented. The way this system operates
is that when a VA practitioner selects a patient's record for
display, there is a computer program that automates the process
of detecting and then excluding patients who have already been
tested, whether they have positive or negative results, and it
also excludes patients whose records indicate an established
diagnosis of hepatitis C based on ICD-9 codes. So the clinician
then knows whether the patient in question has already been
tested, has an established diagnosis, or needs to be assessed
for risk factors. If the latter situation obtains, presumably
assessment then would be initiated.
The earliest version of this program was released to all
sites in March of this year, 2000. The Information Office has
informed us that an enhanced reminder program was distributed
in June of this year. I believe the VA clinicians testifying
here today will endorse the effectiveness of this assessment
clinical reminder. And software currently under development
will collect and provide more comprehensive data that will
include other laboratory results, medication usage, and
information related to status with regard to hepatitis A and
hepatitis B for issues of coinfection.
That concludes my oral testimony, Mr. Chairman. I am
pleased to answer any questions.
[The prepared statement of Dr. Holohan follows:]
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Mr. Shays. Thank you, Dr. Holohan.
We will now go to Dr. Ho.
STATEMENT OF DR. SAMUEL B. HO, M.D., STAFF PHYSICIAN,
MINNEAPOLIS VA MEDICAL CENTER
Dr. Ho. Chairman Shays and members of the committee, thank
you for this invitation to speak regarding hepatitis C: access,
testing, and treatment. I have been the supervising
gastroenterologist for the hepatitis C clinic at the
Minneapolis VA Medical Center for the past 10 years. I have
worked closely with our administrators in our Veterans
Integrated Service Network [VISN 13] over the last 3 years to
develop a comprehensive health care product line for hepatitis
C diagnosis and treatment. Over that period of time, I have
learned much from my patients with hepatitis C, and I
appreciate the comments of Mr. Baker, Mr. Bryant, and Mr.
Lesinski. I would like to tell you about my experience with one
patient because it illustrates the challenges and opportunities
that we face.
Mr. B was referred to our clinic 2 years ago because he was
diagnosed with hepatitis C through his primary care clinic. He
had served in the Army and was stationed in South Vietnam in
1971. He was hit during a rocket attack, which blew off his
left lower leg and partially destroyed his right calf. He was
most likely infected with hepatitis C after receiving a blood
transfusion during surgery when they had to amputate his left
leg.
He never experienced symptoms from hepatitis C until 3
years ago, 26 years after being infected. The symptom that he
developed was incapacitating fatigue, and he was found to have
cirrhosis, or severe scarring of the liver, after undergoing a
liver biopsy.
We treated him with a new treatment, a combination of two
drugs, interferon and ribavirin, which was available to us at
that time only on an experimental basis. This drug therapy
lasted 1 year and required visits to our clinic every 2 to 4
weeks for blood test monitoring. The treatment, as the others
have testified, was not easy for him. He developed severe
headaches and worsening phantom leg pain requiring narcotics.
He also experienced a worsening of his previous depression
problem, which required additional therapy from our
psychiatrists. He was, however, able to finish 1 year of
therapy. Since then, I am happy to say, he has had normal liver
enzyme tests and all tests for hepatitis C virus have been
negative. We consider him to be cured from this infection.
He feels much better and tells me he has been out golfing
quite frequently now. Recent publications indicate that his
cirrhosis may actually start regressing, and that his risks for
the need of a liver transplant and/or treatment for liver
cancer are markedly reduced.
This patient I believe is typical of our patients. One, he
was a Vietnam veteran who has carried the virus for 25 to 30
years and typically was without symptoms until he developed
severe liver disease. This has largely been the reason why many
of these patients have gone unrecognized until relatively
recently. Of the last 200 liver biopsies we have done at our
institution on veterans referred for hepatitis C treatment, we
have found that 33 percent had pre-cirrhosis or cirrhosis,
which I believe is a greater degree of severity than others are
finding in the general population of hepatitis C. Third, he had
a pre-existing, psychiatric diagnosis. Again, in our last 200
patients referred for treatment, we found that 50 percent of
our patients with hepatitis C experienced greater problems and
need more care in order to get them through the hepatitis C
treatment, and 50 percent have these established psychiatric
diagnoses that make their treatment much more complicated.
Last, he illustrates the fact that within the last 2 years we
have had improved therapies for hepatitis C and that it appears
that we can cure 40 percent of patients who are able to receive
this therapy.
Mr. Chairman, we realized that, due to the long duration of
infection in most of our patients and their current burden of
disease, we had a narrowing window of opportunity to identify
and treat our patients before it was too late. Further
improvements in hepatitis C therapies that are becoming
apparent on the horizon have been compelling us with an
increasing degree of urgency to find and treat as many of these
patients as possible. We were convinced that a greater
investment in resources now would help us reduce the tragedy
and expense of complications of end-stage liver disease due to
hepatitis C that we face over the next two decades. I was
pleased that the administration of the VA health care system
here in Washington has provided such strong leadership on these
issues and has come to these same conclusions over the last 2
years that I did in my institution.
The VA Upper Midwest Health Care Network (VISN 13) consists
of six medical facilities serving approximately 97,000 patients
in portions of seven States. There is one tertiary care medical
center located in Minneapolis. Our initial screening study
indicated that we may have as many as 5,000 patients with
hepatitis C in our VISN patient population. Again, over the
last 2 years, we have worked to try and address many of the
issues that have been brought up today in establishing a VISN-
wide program for the diagnosis and management of these
obviously complex patients.
To summarize, the five key elements of the plan that we
have come up with include: One, to initiate standard hepatitis
C screening procedures for all primary care and specialty care
clinics. We have been assisted in this by the automated
``clinical reminder'' system, that Dr. Holohan just mentioned,
for identifying and recording patients who need hepatitis C
screening. Since our system began last February, we have been
screening 1,143 patients per month.
Two, for hepatitis C-positive patients, we have standard
education, evaluation, and referral protocols performed by
personnel in primary care clinics or by the hepatitis clinic.
Three, we have a centralized VISN 13 Chronic Hepatitis C
Clinic in Minneapolis to provide specialty care by
gastroenterologists and infectious disease physicians to
evaluate eligible patients and initiate treatment according to
the VA treatment guidelines. Again, since how we understand
hepatitis C and its treatment is continually changing, the role
of specialists will continue to be important in guiding what we
do for these patients.
Four, we are establishing hepatitis care teams at each VISN
medical center to provide hepatitis C chemotherapies and assist
in all aspects of screening and diagnosis.
Five, we have a centralized outcome monitoring system and
coordination of patients being offered treatment using
investigational protocols. Ongoing research at VA medical
centers continues to be critical for improving therapies for
patients with hepatitis C and many other diseases.
The details of this plan have been published in the
Veterans Health System Journal, and more details are outlined
in my written statement.
In my experience, the most important element of this plan
is the establishment of a hepatitis C care team at each medical
center. And the most important part of this team is a full-time
nurse level position which would be responsible for
coordination of screening tests, patient notification, patient
education, and patient monitoring during therapy. Again, we
have found it very important to involve a psychologist or
psychiatrist at each medical center, since 50 percent of our
patients with hepatitis C have established psychiatric
diagnoses such as post-traumatic stress disorder or depression.
Mr. Chairman, this really is a new disease for the VA with
new and expensive treatments that are difficult to administer.
I believe that the key elements outlined above will provide the
foundation for VISN 13 to provide quality care for veteran
patients with hepatitis C and I hope may serve as a model for
other VISNs in the VA health care system.
Thank you very much for this opportunity to testify.
[The prepared statement of Dr. Ho follows:]
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Mr. Shays. Thank you, Dr. Ho.
Dr. Brau.
STATEMENT OF DR. NORBERT BRAU, M.D., STAFF PHYSICIAN, BRONX VA
MEDICAL CENTER
Dr. Brau. Mr. Chairman, members of the subcommittee, I
would like to thank you for inviting me to speak before the
subcommittee on how VISN Network 3 meets the challenge of
hepatitis C. I am an infectious disease physician at the Bronx
VA medical center where I am also the director of the Viral
Hepatitis Clinic, and I am the founder and co-chair of the VISN
3 Hepatitis C Task Force.
As you all know, infection with hepatitis C virus [HCV]
does become chronic in 75 percent of infected individuals, and
chronic hepatitis C can lead to liver cirrhosis and liver
cancer. Today, it is the most common cause for liver
transplantation in this country. Combination therapy with
interferon and ribavirin can cure the chronic infection and
then the liver disease in about 38 percent of the patients.
U.S. veterans are much more commonly afflicted with
hepatitis C than the general population. A VA-wide study from
March 1999 revealed that 6.6 percent of U.S. veterans have been
infected compared to 1.8 percent of the general population. The
prevalence is much higher in networks with a large number of
urban centers, like the Washington, DC area, New York City, or
southern California.
Veterans Integrated Service Network 3 is comprised of five
VA medical centers in the New York City metropolitan area. Our
network has the highest prevalence of hepatitis C, based on
that survey, amongst all networks, with 13 percent. Two of the
five VA medical centers rank among the top five VA hospitals
nationwide in terms of the hepatitis C rates. In addition, we
conducted a study in network 3 where we found that amongst the
HCV-positive veterans there is a substantial rate of
coinfection with HIV-I of 21 percent which further complicates
the matter.
Based on the VA survey, we estimate that there are
currently about 11,000 veterans receiving care in network 3 who
are infected with hepatitis C virus that do not know it because
typically the disease does not cause any symptoms. Therefore,
network 3 has started a program of actively identifying all
infected veterans by actively reaching out to veterans who
might be at-risk but do not know that they are infected.
The way that we do it is that every veteran who attends a
primary care clinic will receive a hepatitis C risk screen
based on the number of risk factors, and every veteran who has
one or more risk factors will be tested for hepatitis C. The
Computerized Patient Record System, which I think is probably
one of the best clinical software systems anywhere, helps the
clinician do the screening by putting in clinical reminders, as
it was mentioned.
A patient who tests HCV-positive is then referred to a
specialty clinic. These specialty clinics are usually run by
either infectious disease physicians or gastroenterologist or
hepatology specialists. After referral to such a clinic, the
veteran will typically be counselled by a social worker or
nurse on the impact of the disease, possible modes of
transmission to family members, on alcohol abstinence, and
vaccinations, and also information brochures will be handed out
to the veterans. Then a specialty physician will do a thorough
evaluation of that veteran and also have a thorough discussion
on the pros and cons of treatment, and where possible, the
patient will be put on treatments. Also, we will invite
veterans, where appropriate, to participate in clinical
research studies.
The care of hepatitis C-positive veterans in network 3 is
coordinated by the hepatitis C network 3 task force which meets
monthly by teleconference. We started our work in July of last
year. Since our inception, we have achieved a number of goals:
One, we centralized all the molecular testing, including viral
load and genotyping, at the Bronx Va microbiology lab, which
also was the first lab in the VA system that introduced the HCV
genotyping.
Two, we are coordinating research studies within our
network, including the one with HIV coinfection and another one
with genotype distribution.
Three, we have established an ongoing systematic collection
of data on both risk factor screening, testing, and treatment
of veterans.
Based on this data base, we have learned that just in the
first 4 months of systematic screening with the help of the
clinical reminders for risk factors, the primary care
clinicians in network 3 have already screened 22 percent of all
veterans that receive care there. Of those who were screened,
29 percent had a risk factor for hepatitis C or had already
tested positive. Over the last 1\1/2\ years, 21,000 veterans at
risk were tested for hepatitis C virus, and 27 percent tested
positive.
As a result of the intensive screening and referral of
hepatitis C-positive veterans, the number of veterans who
received treatment for chronic hepatitis C in network 3 is
growing. In all of fiscal year 1999, we treated 383 veterans.
In the first three-quarters of fiscal year 2000, which just
finished in June of this year, we treated 365 veterans for
hepatitis C, which represents an increase of 27 percent over
the same time period of last year.
Now as we already heard, not all veterans with chronic
hepatitis C are candidates for treatment. About 25 percent of
those who have chronic viremia, meaning the virus is
detectable, or 15 percent of those who have the antibody will
ultimately be put on treatment. The main reasons for not
treating patients for hepatitis C include: the patient is
reluctant to receive treatment, she/he has minimal liver
disease, or there are serious medical or psychiatric illnesses
that would represent a contraindication to treatment with
ribavirin and interferon.
Taking care of veterans and treating them for hepatitis C
is labor-intensive and requires expensive tests and treatments.
VA Central Office has estimated that it costs approximately
$20,000 to put one veteran through a course of treatment. And
this estimate does not include a possible second course of
treatment that may be necessary when the first one fails.
Until now, hepatitis C care in network 3 has continued at a
very high level of quality regardless of funding issues. In
fact, every single hospital director in our network has been
extremely supportive of the ongoing and growing care of
hepatitis C treatment, even though it does strain their
budgets. Already, waiting times for a referral to the hepatitis
specialty clinics averages 2 months, and reaches up to 4 months
in some centers, although we would like to keep it less than 4
weeks.
As the number of veterans who are identified with hepatitis
C is growing, additional staffing and funding for drugs and
laboratory tests will be required. One of the promising ideas
that is currently being discussed in VA Central Office would be
to follow the example of HIV treatment, whereby veterans who
are receiving treatment for hepatitis C would be put under
specialty care category and each medical center, through its
network, would receive special funding for that treatment.
Mr. Chairman, in summary, an effort by dedicated
professionals can buildup a systematic program of reaching out
for veterans, testing them, and treating them for hepatitis C.
Given the proper support, this effort can be sustained even as
the growing number of veterans are referred.
[The prepared statement of Dr. Brau follows:]
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Mr. Shays. Thank you, Dr. Brau.
Dr. Iber.
STATEMENT OF DR. FRANK IBER, M.D., HEPATOLOGIST, VOLUNTEER AT
HINES VA MEDICAL CENTER, HINES, IL
Dr. Iber. Chairman Shays and members of the subcommittee, I
am a trained liver expert who has taught and done liver
research in medical schools for nearly 50 years including 25
years in the VA medical system, most recently at the Hines VA
Hospital in Chicago. I am now retired but continue to work 1
day a week treating veterans with hepatitis C.
When interferon therapy was shown effective for hepatitis C
in 1995-1996, I started a program at Hines treating all
appropriate veterans. In the next 2 years, we treated 60
patients, representing about one-third of our patients then
recognized with hepatitis C. Of those who started treatment,
some 90 percent stayed on treatment for the required 6 months.
Treatment requires close supervision, as you have heard
from many, because there are unknowing and life-threatening
complications. Frequent visits, laboratory tests, special
systems must be created to accommodate these patients in order
to keep their cooperation in treatment. Over time, an effective
treatment program was established using the machinery already
present at our hospital.
After 18 months of supervising the HCV program, I retired
for reasons of age. I was not replaced with another liver
doctor because of budgetary restrictions and our administration
did not recognize the need for a specialist. The followup of
patients was left to primary care doctors who usually had only
one HCV patient under treatment.
Four months after my departure, only one-tenth of the
patients requiring treatment remained on their drugs. The
supervising physicians often stopped medications due to limited
familiarity with possible toxicity, and the patients stopped
medication because they could not obtain prompt evaluation.
After 5 months of retirement, I returned to Hines as a
volunteer 1 day each week to supervise the HCV treatment
program. My primary focus is counseling patients before they
start treatment, advising and reviewing results of treatment
and side effects, reassuring many patients who are frightened
or discouraged about continuing treatment. Our VAMC has
identified more and more veterans who have hepatitis C.
However, the harsh reality is that the numbers identified,
now almost 450 patients, have overwhelmed our system for
evaluating and following these patients. This inundation has
led to delays of 4 to 6 months in initiating treatment, of
fewer identified patients being admitted to treatment, and
failure to keep patients on treatment. All of these problems
exist because there are just too few doctors and nurses
assigned to the hepatitis C program.
In my experience, special needs of hepatitis C treatments
are present, and many of them have already been pointed out.
You need access to a physician experienced with hepatitis C;
you need an integration in an expedited fashion of lab,
pharmacy, consultants, particularly psychiatry; you need a
full-time professional coordinator, usually a nurse; and you
need a committed administration. Currently, all of these
elements are not yet in place in our VA hospital even though we
have treated more than 200 patients.
Let me elaborate on these unique needs. An experienced
hepatitis C physician is needed because only 8 percent of VA
patients meet every nuance of the current VA guidelines for
treatment, yet at least a third, and maybe even more presenting
patients will benefit from treatment. Determination of which
details are important require experience and training. Upon
completion of current treatment, two-thirds of the patients,
not the veterans we heard here today who were success stories,
but the majority still have the infection and these veterans
want and even demand informed information on what they should
do next. This requires special help.
Second, an expedited system. Interview and laboratory
testing must be performed at least monthly. Drugs cannot be
provided until these safety checks are completed. About 1 in 10
of our visits require consultation with another type of doctor
to evaluate the severity of side effects. The four-fifths of
our current patients who have no extra problems complete all of
this in a single monthly visit of 1 hour's duration, and this
allows people to continue a full-time job. If the ordinary
clinic procedure were followed, a minimum of three visits,
taking at least 6 hours, would be required to accomplish the
same thing.
And finally, you need a nurse or other professional to
supervise, interfacing when the unexpected occurs, and assuring
the patients at all times.
What can Congress do to help? I think that we have already
heard some of these things are approaching being in place, but
I think every health unit should report not only the new
hepatitis C patients identified, but those entered into
treatment in the same time and those who have a cure. Because
if we put in the cure, this will provide a superb scorecard of
how well each unit is doing.
Second, and I think others have mentioned this, hepatitis
C, like HIV, is a disease that requires a lot of resources to
manage. It should be reimbursed as a complicated disease,
certainly not a simple one.
Every facility should have access to the elements of a
hepatitis C evaluation, as presented by Dr. Ho, and treatment.
This, whenever possible, should be onsite, but sometimes it
will be necessary for it to be in a nearby VA facility or even
purchased through civilian outlets through the consultation
process.
And it is my opinion that every facility that has at least
10 patients under treatment with HCV should have a full-time
professional assigned priority to manage these patients and
that this should be specifically funded centrally so that the
money cannot be used for other things, to make sure that such a
person is available at every site.
Thank you very much for your attention.
[The prepared statement of Dr. Iber follows:]
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Mr. Shays. Thank you very much, Dr. Iber.
Mr. Snyder, you are going to have the floor, then I am
going to take it, and then I may have to leave, but I will let
you come back and ask some questions afterwards as well, and
then you can just adjourn the committee. So why don't you
start.
Mr. Snyder. You all heard the testimony by our veterans
this morning and some of them had some fairly strong worded
statements to make about some of the evaluation and treatment
processes that they saw. Dr. Iber, in your written statement,
and I think you said it also, ``the harsh reality is that the
numbers identified have overwhelmed our system,'' and then you
say, ``The infrastructure needed to evaluate, advise and treat
the volume of veterans presenting with hepatitis C is simply
not there.'' That is a pretty confirmatory statement of what
our veterans said this morning.
Dr. Holohan, do you agree with that?
Dr. Holohan. I have no evidence to disagree with that.
Mr. Snyder. So that we currently have a VA system
overwhelmed with numbers and more is to come?
Dr. Holohan. I think it is probably premature to say the
entire system is overwhelmed with numbers. I think that some of
the testimony you heard today indicate that people are working
hard but they seem to be able to meet the challenges. I would
be naive, and you would consider me dissembling, to say that I
thought that was the case throughout the country.
Mr. Snyder. In terms of specifics, Dr. Holohan, is this a
problem of money, a problem of just catching up with a
relatively new disease entity? Where do you see we are in this?
I have a lot of praise for the VA in terms of over the last
decade I think you all have been ahead of the curve most of the
time in terms of research and trying to get a handle on it. But
it is obvious there are some problems from your own statement
just a moment ago.
Dr. Holohan. Right. I think probably all of the factors
that you mentioned obtain. No. 1 is the absolute number of
veteran patients that will require evaluation and treatment is
large. The systems that existed did not exist to meet that
demand. So I think there are going to be inevitable
bottlenecks. I think the issue of funding was probably raised
by the VA several years ago when we requested additional
funding for hepatitis C initiatives. One of the problems is in
terms of the specialists. It is a lot easier to take money from
your wallet today and buy drugs than it is to take the same
amount of money and find a hepatologist willing and able to
work in VA. So I think it is a number of those things that are
happening at the same time.
Mr. Snyder. Are there statutory things getting in your way?
Dr. Holohan. Not to my knowledge, sir.
Mr. Snyder. Pay scales for hepatologists, is that statutory
or is that something you all set?
Dr. Holohan. Those are reviewed. I will have to defer, but
I think those pay scale issues are reviewed on a routine basis
every 4 years, and it is coming up again. But in my experience,
and it is not limited to hepatologists, the pay scales are
issues for many, many, many specialties--interventional
radiologists, anesthesiologists, etc.
Mr. Snyder. One of you had somewhere in your written
statement I think it was a $30,000 figure. Was that you, Dr.
Iber?
Dr. Iber. Yes, sir.
Mr. Snyder. Which is less than what you would get in the
private world.
Dr. Holohan, what is your assessment of the current status
of the screening aspects of things. Dr. Iber's statement is
that we do not have the infrastructure to evaluate and advise.
Do you agree with that also?
Dr. Holohan. Not entirely. I alluded to the automated
clinical reminder system, which was put into effect because we
came to believe that the response to the Under Secretary for
Health's information letter in 1997 that listed risk factors
that each veteran patient was to be quizzed about, and I am
sure you have seen the document, we did not seem to be getting
the kind of response that we had hoped. So it was decided that
we would spend the time, effort, and money to develop an
automated risk assessment reminder system.
The information I have been given from both the Chief
Information Officer and from our clinicians, some of whom
mentioned it in their testimony, is that it appears to be
pretty effective as a screening and evaluation tool. So I am
not quite as critical as I might have been in the past before
this was instituted.
Mr. Snyder. I had one specific question, Dr. Holohan. You
quoted a 20 percent figure, 65,000 out of 325,000 I believe.
Dr. Holohan. Right.
Mr. Snyder. Which is substantially higher than the national
``dip stick'' day.
Dr. Holohan. Correct.
Mr. Snyder. I guess what you are saying that this is just
not a typical population?
Dr. Holohan. Actually, the percentage positive out of all
tests done has been diminishing over time. My suspicion when we
first began to get the data from Dr. Roselle's Registry was
that people were not actually being ``screened'' simply on the
basis of risk factors. What was happening was most tests were
being done because the clinician suspected the patient had
liver disease for some other reason. The initial data we got in
the first year of the Registry was that 30 percent of all
patients screened were positive, and that is very high. That
indicates to me that they were not routinely following the risk
factor list and screening on that basis, they were using more
compelling information. But that has dropped to 20 percent now.
It probably should be a little lower than that, I am not sure
how much lower. But I think the change indicates that there is
more screening than testing for cause.
Mr. Snyder. Let me see if I understand what you are saying.
Are you saying that if people are following your screening
procedures, you are going to have some of your risk factors
that are lower risk factors but they need to be tested also.
Dr. Holohan. Correct.
Mr. Snyder. And if all of them are tested, a substantial
number of them are not going to be positives and so you should
have a higher negative rate than you think you have right now.
Is that correct?
Dr. Holohan. That is my belief, yes, sir.
Mr. Snyder. I understand. There was some criticism earlier
by our panel of veterans about the treatment protocols. With
regard to the treatment of patients that are treated in the VA
system, is the treatment that you begin on individual veterans
and the protocols that you follow, is that the same as would be
found in a non-veteran hospital, in a civilian hospital, or has
it been modified?
Dr. Holohan. I will defer to the clinicians. But the first
thing I would say is I am not sure what most civilian hospitals
use. There are no systems that have provided that. I disagree
very much with a statement made by one of the earlier panelists
that our guidelines are wrong and need revision. I do not
believe that is the case. I think the people who put that
together are among the top liver experts in the country. But I
will defer to our active clinicians as to the treatment
guidelines.
Dr. Ho. I think the VA treatment guidelines are pretty much
exactly as what is being followed in the community. They are
largely based on the NIH consensus statement which now is a
couple years old. These guidelines are just guidelines, and we
are getting new data everyday and so there is some evolution of
those guidelines. There is one area of people who have normal
liver function tests that is highly controversial among the
experts right now and that still is evolving. The current VA
and NIH guidelines call for perhaps not treating those
patients. But I consider that is one area that will continue to
evolve and we will have to wait for the experts. But at the
current time, I am very satisfied with the VA guidelines and
believe it is the same as in the community.
Dr. Brau. I would think that in the VA the veterans with
hepatitis C receive the same good care that they would receive
anywhere else in the civilian world. The treatments are
changing and things like the liver enzymes and whether one
should treat by liver enzymes or by liver biopsy is being
discussed and is controversial in the hepatitis C community.
But typically the experts who treat the veterans do go to those
international conferences where they do hear the latest opinion
on that and keep themselves up to date.
Mr. Shays. I thank the gentleman. We will go back to you
later. Before I have to leave at 1, I would like to ask a few
questions. They relate to the conceptual issue of two Centers
of Excellence and a whole number of other facilities that are
not so-called centers of excellence. I do not understand the
concept, and you will understand why when I ask the question
later. But maybe you could explain the concept to me, Dr.
Holohan.
Dr. Holohan. I am actually glad you brought that up. The
impression that I got from previous discussions is that the
view of the two Centers of Excellence is that they are
designated as centers of clinical excellence for the treatment
of hepatitis C. And such is not the case.
Those two centers were selected and are centrally funded
for their work, not centrally funded for clinical care, in two
areas. One is educational production and distribution of
educational and informational materials, counseling, and so on
and so forth, which is the major responsibility of the Center
at the VAMC in Miami. The second is on evaluation of treatment
guidelines, editing of items that go into the VA Web site, and
monitoring and supervision of research, such as the industry-
funded 26 center study of combination therapy and studies of
new drugs such as pegylated interferon, which is from San
Francisco.
So they are not designated as a Center of Excellence
specifically for the treatment of hepatitis C. They are Centers
of Excellence for the VA as a whole in areas of educational
materials, counseling, guidelines, and clinical research. I
dare say that the clinicians at Miami or at San Francisco would
not hold themselves out to be members of a Center of Excellence
greater than that in New York or in Minneapolis.
Mr. Shays. You heard witnesses who testified earlier who
basically described I think some pretty alarming examples of
how they wanted the service, they felt they were entitled to
it, they were sick and were either being told they did not have
a problem, or they had a problem but we couldn't treat you a
particular way. You have been kind of silent to that. I would
love for you to just talk a little more about what you heard
and tell me what I should infer from that and what the
committee should infer.
Dr. Holohan. Well, I will speak for Central Office. There
have been a number of times when such statements or claims have
been made and I have always said to VSO representatives or in
some cases VA employees that if you have an incident like that,
you tell me. I have given my phone number and e-mail out at our
national meetings. It is something I want to know about and it
is something I am sure that Dr. Garthwaite wants to know about.
It is difficult for me to understand why, assuming this is in
fact accurate, that a VAMC would tell a patient known to be
positive for hepatitis C that it is their practice not to do
liver biopsies and not refer them. That does not make any
sense.
Mr. Shays. It does not make any sense, but we had testimony
that in fact was happening. So are you saying that it does not
happen, or are you----
Dr. Holohan. I am saying, chairman, that this is the first
time this has been called to my attention.
Mr. Shays. We had testimony last year that there were cases
where people were not being covered, and we cited three cases.
Mr. Baker came back today and just said:
I have been asked to followup on the examples that I
produced last year. Mr. Chairman, I am sorry to report that
these veterans' lives have gotten dramatically worse. The
veteran from Idaho was finally tested, but has not yet been
allowed to receive treatment in VISN 19, in fact, he has been
told that despite evidence of fibrosis of the liver, his enzyme
levels are not elevated enough to consider him for treatment.
As for the veteran from Montanan, the VA has ``done a fine
job''--he was never treated for his hepatitis C and in November
of last year he succumbed to complications from a liver
transplant due to Hep-C. I attended his funeral. In the case of
my personal friend from New Jersey that served with the 173rd
Airborne, he is now number 7 on the liver transplant waiting
list. Even though we personally hand-delivered his case to Dr.
Garthwaite, NO, I repeat NO action has been taken. The VA
continues to maintain that this recipient of the Bronze Star
for Valor cannot show a nexus between his service and his
hepatitis C infection because his duty assignment was not
``medic.''
Dr. Holohan. I can respond to at least two of those, not
the patient who has died. The patient in Idaho, according to
information I have received from VA people, refused to allow
his name or social security number to be made known to the VA,
so we cannot track him. The patient in New Jersey, I have, and
I can forward it to you, a letter from Mr. Eppley to the
regional office in New Jersey saying that the evidence they
had, despite the fact that the diagnosis of hepatitis C was
made in the civilian sector, established a nexus because of his
service in Vietnam and that the regional office should consider
his claim as well-grounded.
Mr. Shays. And what is the status of that?
Dr. Holohan. All I can tell you is that I received
yesterday a copy of the letter from Mr. Eppley to the regional
office telling them they should consider his claim for a
service-connection as well-grounded.
Mr. Shays. But that is yesterday.
Dr. Holohan. I am not sure what you mean.
Mr. Shays. This was an example at a hearing we had many,
many, many, many months ago.
Dr. Holohan. We were unable to get names and social
security numbers of the people cited last year until very
recently.
Mr. Shays. When Mr. Bryant spoke, he said: ``In early 1999
I went to an appointment at the Spokane VAMC. I told the VA
doctor of my concerns about my hepatitis C and the health of my
liver. I asked for a liver biopsy and a viral load test, as
those were the VA's own procedures for treatment of HCV. I was
shocked and surprised by his answers: One, this hospital has a
policy of not doing liver biopsies. Two, in looking at your
past LFT tests, you do not meet the protocols for interferon
treatment as they are below twice normal. Three, I will order a
viral load test and we will discuss it at your next appointment
in 3 months.''
What should I infer from that?
Dr. Holohan. That is wrong. That is inadequate medical
treatment.
Mr. Shays. Right.
Dr. Ho. Mr. Chairman, if I might just add something. I
think there is a lot of frustration on the part of veterans who
are informed by the Internet and by support groups and who have
certain information and who perceive that there is a lack of
education on the part of their health care professional. It is
an ongoing issue about education of our health care
professionals. You optimally need a liver specialist who has
been able to keep up to date to really give the appropriate
recommendations. There just are not that many in the VA medical
centers. In the entire State of Minnesota, there are maybe a
couple hundred gastroenterologist, but of those couple hundred
there is maybe 20 who really have kept up to date and who are
treating the majority of liver, and hepatitis C patients in the
entire State. So you can see that confusion about
interpretation of current data might happen in a clinical
setting.
Mr. Shays. Miss French used the statistic of 10 percent of
our veterans, Dr. Iber, having hepatitis C. That seemed to me a
bit inflated. Would that be a statistic you would agree with?
Dr. Iber. I think it is pretty close to that. I feel that
it is 8 percent, but that is not recognizing that the two
coasts of America have a much higher percentage. So I think 10
percent may well be an accurate figure.
Mr. Shays. Dr. Brau, in your facility, what are you finding
as the statistic?
Dr. Brau. We take the statistics from the survey which was
done really on an unselected population in March 1999, which is
not the same as if you look at the antibody tests of those who
are tested because of risk factor or liver disease. And by that
statistic, our network has 13 percent, and our facility in
excess of 14 percent.
But to catch up on what was mentioned earlier, I believe
every VA medical center should have a dedicated center for
hepatitis C. I am particularly encouraged by the growing number
of my infectious disease colleagues who are interested in going
to this field and get themselves educated and become experts.
Mr. Shays. Given the number of 14 percent, somewhere in
that range, just use the number 10 percent, we are saying that
10 percent of particularly our Vietnam veterans----
Dr. Iber. All veterans.
Mr. Shays. All veterans.
Dr. Iber. Higher in Vietnam.
Mr. Shays. All veterans, not 1 percent, not 2 percent, 10
percent have hepatitis C and we know it to be a silent killer.
It would strike me that this is a gigantic percentage and one
which, Dr. Ho, your comment, though truthful, is somewhat
alarming that we do not have the expertise in our facilities.
Hence, Dr. Holohan, we have this problem. You have restraints
based on dollars. But I always believed if I were in your shoes
or anyone else's shoes in the administration, I would lay it on
the line to Congress and then say Congress it is in your lap.
But it is not presented that way. I would think VA would say we
need this amount to deal with this problem, to deal with the
protocols that we have, and anything less than that will mean
that you will get substandard care. And then it is on Mr.
Snyder's table, my table, and Mr. Souder's table. But I do not
think we are getting that yet. So then it goes back on the VA.
We get a lot of stories like this that you say are
unacceptable. But I do not think these are exceptions, I think
they are more the rule based on, as you have pointed out, Dr.
Ho, that we just do not have the expertise. And do we all agree
that if they are not treated they become ill and die. Is there
anyone who disagrees with that?
Dr. Brau. Mr. Chairman, not everybody who tests positive
for the antibody actually has the chronic viral illness. If you
count the false-positive rates and those who cleared the virus
through their own immune system, about two-thirds of those who
have antibody test positive have the virus. And of those who
have chronic virus in their blood and in their liver, some
patients do not progress that far. So we see patients who have
been infected 40, 50 years and on biopsy have minimal liver
disease. So for them, they will probably not be killed by the
virus. But others progress much faster and that is why we need
to do a specialty evaluation including liver biopsies to see
who is most urgently in need of treatment.
Mr. Shays. That should be able to take place at any VA
hospital?
Dr. Brau. Yes.
Dr. Iber. Agree.
Mr. Shays. And it does not right now, correct?
Dr. Holohan. That appears to be the case.
Mr. Shays. Mr. Souder is here to Chair, but I will yield
the time now to Mr. Snyder and then he can claim time.
Thank you very much, gentlemen.
Mr. Snyder. Thank you very much, Mr. Chairman. I just have
three or four more questions.
Dr. Ho, I wanted to ask you a bit of an unrelated question.
You talked about the combat blood exposure in your comments.
You had the fairly dramatic example of a piece of a leg bone
being implanted in one of your patients. I assume that we are
talking about exposure to kind of the large amounts of blood
that can occur in combat situations, not just the fact of being
under fire, but the subsequent people that would treat,
potentially the folks that load them into helicopters, the
folks that are at the field medical facilities. Is that
correct.
Dr. Ho. I have one patient who was an ambulance driver
actually at a base here in the States during the Vietnam war,
and at that time it was not common practice to use plastic
gloves. If someone was bloody, you just grabbed them and hauled
them in. And as far as we know, that is the only risk factor
that particular patient had for hepatitis C. So it involves
that, the blood transfusions, and then the actual combat
injuries and blood exposures that are risk factors. These are
significant risk factors, as shown by research done by Dr.
Wright's group in San Francisco, and of course unique to this
patient population.
Mr. Snyder. Dr. Brau, you mentioned earlier that you expect
waiting times will become longer, which is kind of an ominous
sign for Members of Congress who hear about waiting times, and
of course for the veterans who want to be treated. Do you agree
that if you have longer waiting times that is kind of a symptom
of what Dr. Holohan and Dr. Iber describe as an overwhelmed
system. Is that how you would describe where you are at today?
Dr. Brau. That is correct. And that sort of stresses the
fact that the support for the treatment includes not just the
drug cost and the laboratory cost, but also staffing which
needs to be added to have really a comprehensive
multidisciplinary team to take care of the problem. One thing
that we have found also is the longer the waiting time, the
higher the drop-out rate. So patients get scheduled but then
they do not show up. We will call them to reschedule them. But
we would like to have the waiting time as short as possible.
Mr. Snyder. You mentioned infectious disease specialists,
not just GI doctors as becoming potential providers of
treatment. Are you within your system looking at some creative
ways, taking some general internists, for example, already
within the system and giving them additional training, or is it
going to have to be a gastroenterologist that is primarily the
specialist that does the ongoing care?
Dr. Brau. I think we should look first at the specialists
who are most involved in this disease. This is an infectious
disease that does involve the liver. And while traditionally
the studies on the non-A, non-B hepatitis, which was not known
to be virally caused, was done by gastroenterology, more
infectious disease experts are getting into the field and they
bring in all of the experience with the other big viral
disease, HIV. So I think it lends itself to a collaboration.
There might be the occasional general internist who has a lot
of dedication to the disease and is willing to educate herself
or himself to the illness, but I think we do have a number of
infectious disease and gastroenterology, hepatology specialists
who together can put a comprehensive treatment program in
place.
Mr. Snyder. HIV has been mentioned several times I guess
because you use comprehensive teams. Are there other diagnoses
within the VA that also have special care teams or
comprehensive teams? What are some examples of that, Dr. Iber,
you are nodding your head.
Dr. Iber. Chemotherapy I think uses a superb specialty
team, albeit usually a little shorter than hepatitis C. But I
think actually we incorporate the chemotherapy team and our
patients get great care in fact when the chemotherapy team of
nurses and consultants is responsible for them.
Mr. Snyder. Do we have a shortage, Dr. Holohan, of
oncologists in the VA system also?
Dr. Holohan. Yes, sir, we do.
Mr. Snyder. Would you describe our treatment of cancer
within the VA system as ``the harsh reality, it is overwhelmed
by our system,'' or not?
Dr. Holohan. No. In fact, I think we have adapted better in
the oncologic arena than we have in hepatitis C. I think part
of that is simply a function of time and learning how to save
energy and resources while getting the job done.
Mr. Snyder. The last question I want to ask you, Dr.
Holohan, I assume that the chairman will want to do followup or
maybe the VA will want to do hearings in the future, 6 months
from now, will the harsh reality of our veterans' system for
care of hepatitis C be that we are overwhelmed?
Dr. Holohan. I think trying to respond to that prediction
is the surest way to appear a fool in 6 months. I hope not, but
I am not sure.
Mr. Snyder. Do you have a specific action plan in mind that
is going to change that reality over the next 6 months?
Dr. Holohan. Well, some we have already talked about. I
think the clinical assessment reminder system has dramatically
improved the evaluation and screening. I think that the
additional funds released this fiscal year by the Under
Secretary will help, and I think the adjustments, whatever they
may be, in fiscal year 2000 about increasing funding for
hepatitis C based on the workload and predictions as to cost
will change the budgetary circumstances significantly. Now in
terms of being able to go out and dramatically increase the
number of gastroenterologists or infectious disease experts, I
am not quite so sanguine because that is a perennial problem
for VA or any salaried medical care system.
Mr. Snyder. Dr. Iber, do you have a comment?
Dr. Iber. Yes. I think that the VA has great success
particularly with this computerized recognition of screening
and the need for it in identifying more patients. My concern is
what do we do with them then. I think that they are very slow.
The principal use of moneys has been to pay for the drugs which
are very expensive, but I think availability of drugs has not
been a problem in my experience for at least 2 years. We have
made them available, we get what we need in any quantity we
need them. But the personnel assigned with priority to
supervise the safe administration of these drugs is the big
ingredient that is lacking, at least in the center that I am
familiar with, and as I talk to colleagues in the greater
Chicago area, that is a pretty uniform problem in our five VA
hospitals there, we cannot keep up with the load.
Mr. Snyder. My last question for each of you is just a
general question. Knowing you as somebody who has practiced
medicine for 20 years and have been around academicians, you
are a pretty independent minded group. Is there anything, Dr.
Brau, that you would like to comment on today that you think we
ought to know about?
Dr. Brau. I think the effort is ongoing in the VA system,
in some centers more than in others, but everybody is going in
the right direction. I think if we get the right support, we
can maintain a very high level for the treatment of our
veterans with hepatitis C. The issue of personnel that is
dedicated to this does need to be addressed in the support
system.
Mr. Snyder. Dr. Ho, any last comments?
Dr. Ho. I think the concerns expressed today are important
and I know the commitment of the administration of VA is very
much there and I think, in general, ahead of the ball game. The
big issue now is finding these patients with hepatitis C and
educating them. I think it boils down to each VA medical center
needs at least one or two full-time personnel dedicated to
hepatitis C. We need to find the patients with hepatitis C
because in a year, a year and a-half, our treatment is going to
change, and it is going to be much better, I believe, and then
we are going to need to start treating these people. We have a
lot of people just waiting for that.
Mr. Snyder. Dr. Iber, any final comments?
Dr. Iber. I have some concern that the VA is putting a lot
of thrust on developing their own materials, their own
guidelines as though the veteran with hepatitis C is completely
a different species of cat from the civilian one. I think that
is totally incorrect. There has been a tremendous amount of
work done, there are wonderful educational materials out there
on the civilian side that are reproduced by industry. I wonder
if the VA, rather than develop their own through a Center of
Excellence designed to this and creating what has been in my
experience third-rate and mediocre pamphlets and educational
materials compared to what is already out there, that they
might be well off just to incorporate existing ones into the
thing and get on the problem of using their resources for the
task at hand of treating the veterans in the various
facilities.
Dr. Holohan. Let me interject by saying we do that, we use
materials produced by Hepatitis International and the American
Liver Foundation, not intending to reinvent the wheel.
Mr. Snyder. Dr. Holohan, do you have any last comments?
Dr. Holohan. Only one, and that is there was a statement
made in an earlier panel that VA treats those patients who
benefit the least, that the people who could benefit the most
are not treated by VA. I would like to see evidence of that. I
think my two colleagues who are treating patients both in the
midwest and in New York would probably not agree that they are
personally treating patients that benefit the least.
Mr. Snyder. Thank you all for your time today. Let me just
say in closing, Congress is your ally in this business. This is
a whole new entity. You all have been perhaps leaders in the
world in dealing with this disease and we want to help you with
it. I know Mr. Shays feels that way, I know the Veterans
Committee feels that way. But I hope you will feel free to let
us know when there are things that we need to be doing. I
appreciate your time today. Thank you all.
Mr. Souder [presiding]. Dr. Ho, I wanted to followup on a
comment that I heard you say a little bit ago, which is that in
all of Minnesota you only had was it 20 people or 50 people who
could effectively be current on this disease.
Dr. Ho. It is a rough estimate. The people who are familiar
with hepatitis C are ones who go to the annual meetings and
keep up. It is a constantly changing and evolving area. Again,
to my knowledge, there is a small minority of
gastroenterologists who are doing the large majority of the
care of hepatitis C patients in the State of Minnesota.
Mr. Souder. Are you saying that there is a shortage in the
general population as well as in the VA of people who----
Dr. Ho. The State of Minnesota currently has a shortage of
gastroenterologists in the entire State. Every single private
group, to my knowledge, is looking to hire more
gastroenterologists and are having some difficulty doing that.
Mr. Souder. Does that tend to be true nationally, do you
know, Dr. Holohan?
Dr. Holohan. Yes. In general, that is the case. I do not
want to get on a philosophical course about the push toward
primary care and what we are seeing now as new technology
develops, the shortage of interventional radiologists, medical
oncologists, gastroenterologists, cardiologists, but in fact
that is a common thread. That is one of the reasons why the VA
is one of the few agencies that still will issue waivers for J-
1 visas for medical specialists.
Mr. Souder. It is my understanding that you have asked for
$20 million in the national reserve fund to supplement funding
for hepatitis C testing and treatment but that you have only
spent $39.2 out of the $190 million that we allocated in last
year's budget. Could you explain why that money was not spent?
Dr. Holohan. Since I have gotten your snap from center, I
will now punt to the Chief Financial Officer.
Mr. Norris. First of all, let me say that I am a Vietnam
veteran and am one of the medevac pilots that Miss French
referred to from that war. In fact, due to the timing, I may
very possibly have been the medevac pilot that evacuated Mr.
Lesinski when he was wounded. So I go back a long way with
concern for these veterans and I do not think that feeling is
unique within the VA; I think that feeling permeates the
organization.
We have concerns about that because we do have $195 million
in the budget this year for hepatitis C. As best we can tell,
as you stated, we spent about $39 million through the first
half of the year, and we currently expect to spend about $100
million of that by the end of the year. The money is out there.
We are perplexed as to why it is not being spent. I suspect
that part of it is for the reasons that have been stated in
terms of access, availability of providers to screen, to
provide the treatment, and to get the patients in.
We do want to provide more visibility for that. So we have
sent out $20 million tied specifically to those costs that have
been experienced in the system so far this year. We hope before
the beginning of the fiscal year to change our VERA allocation
model so that it will actually highlight that we have money
tied to hepatitis C for complex care patients and get that out
so that everybody will be aware that the money is available. We
have $340 million in the budget next year for hepatitis C. But
we do have concerns about hepatitis C spending and there is an
effort to make sure that we are doing all we can do from a
financial standpoint to make the resources available.
Mr. Souder. So what I understood you to say is you do not
know why it is not being spent. And how are you trying to find
out?
Mr. Norris. One of the problems we have had is actually
tracking the expenditures. So because we do not have data, as
Dr. Holohan mentioned earlier with tracking patients, we do not
have data specifically designed to track and record hepatitis C
costs. So it is possible that we are spending more than that
and we just cannot identify it. We have set up a pretty
elaborate system to identify those patients and to identify the
cost associated with them, made some assumptions about cost
associated with those patients for screening and testing of
patients who turn out to be negative, because there is a cost
to that.
So we are doing everything we can to determine what we are
spending, and the fact that we are not spending everything that
we should be is a concern. But, as I said, I suspect it is
because of the lack of ability to get this up and running. It
took us a few years to get the AIDS program up to the status
that it is now, and we do that pretty well I think. So I think
we want to pattern what we are doing here with hepatitis C
after that and employ some of the lessons learned there and
hopefully improve our tracking hepatis C costs. But it does
take a little time to get that going.
Mr. Souder. My understanding is it has taken almost 2 years
to try to get a data set together that you can compare. Because
you are just telling me that part of your problem is you do not
have the data, and my understanding is it has been about 2
years in trying to develop this data. Why is it taking so long
to figure out what you need to compare to? Did this suddenly
just drop in your lap?
Mr. Norris. No. The point I was trying to make is that we
are concerned about the lack of the spending. And to date, the
amount that we have identified as spending on hepatitis C does
not approach the estimates for our projections based on various
assumptions that we made that may be incorrect. But it at least
raises the issue. And so we have scoured the data bases, we
have actually established now this registry, that Dr. Holohan
mentioned, which we are bumping these various data bases
against to make sure we are accounting for every patient. I am
simply saying that we are looking to see if there is something
we are missing. We are not sure that we are, but if there is
something, we want to know about it.
Mr. Souder. I would yield to Mr. Snyder.
Mr. Snyder. The staff has put in my hand a copy of the
transcript from the hearing that Mr. Shays conducted in June
1999. Mr. Brownstein, who was the president of the American
Liver Foundation, if I just might read a paragraph of his
testimony looking prospectively at this issue of how to spend
the money. He said: ``First of all, the $250 million of
treatment that has been committed will not happen. It will not
occur unless the infrastructure is developed. You cannot just
have money for treatment without having the mechanisms to
deliver the care. So the worst thing that could possibly happen
is you reconvene this body next year and find out that only $30
million, $50 million, or $75 million was spent in the year
2000. That would indeed be a tragedy because that would not
signify there isn't a need, it would signify that we have not
effectively translated that need into an effective demand that
can be responded to.'' Mr. Brownstein gets some points for
prediction, doesn't he. Thank you, Mr. Chairman.
Mr. Souder. The concern I have is not that we should not be
spending the money, and that in fact sometimes does happen when
the money doesn't get spent that people will question it, but
in this case your request is even going up. A problem that I
would have, as somebody who is not an expert in this at all, is
if the general population is 1.8 to 2 percent, veterans are
looking at 8 to 10 percent, we have heard here this morning
that this did not suddenly occur, the Vietnam war was not over
last year, and what I am hearing is that you are trying to
figure out, trying to sort that through, and trying to rectify
data bases. It may be that there are not sufficient people even
to treat it if you find that. But I have a concern as to why
this took so long.
Second, the funds are there. We need to have clear
explanations as we are moving through, and we will have budget
questions, but we also need to make sure our veterans are
covered and that with all due diligence we find that so. And if
it is an infrastructure problem that we do not have enough
people in the specialty area, that is identified to Congress
and that becomes a focus. If it is a problem that there is not
enough outreach to the veterans, then that becomes a focus. But
there needs to be some clarity as we move through this and your
execution of this program.
I want to thank each of you for being here, as well as
those veterans who were willing to speak out on the first
panel, as well as Miss America.
I think one thing that Chairman Shays has proven, both in
this committee and over in the human services side and the
Medicare where I worked with him for a number of years, is that
he is aggressive in followup and in continuing interest,
whether it has been the Persian Gulf Syndrome question, whether
it has been in anthrax vaccinations, or hepatitis C. He will be
persistent, he will continue to monitor, and he will work for
the legislative and funding needs that we need. And while not
all the members may be here today, we have aggressively backed
him up in that because we know the thoroughness that the staff
pursues in these issues.
So we would appreciate it if you will stay in touch with us
and be aggressive with us. Nobody deserves our care more than
those who sacrificed for our country and often they are in the
back seat
in how they get their care. So we want to be more aggressive in
making sure that they are covered.
With that, this subcommittee now stands adjourned.
[Whereupon, at 1:25 p.m., the subcommittee was adjourned.]
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