U.S. GOVERNMENT PRINTING OFFICE

73–167 DTP WASHINGTON : 2001

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

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH-HAGE, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

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

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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

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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 organiVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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zational and budgetary support needed to drive this ambitious program.

Recently, VA addressed the apparent fiscal disincentives to ag- gressive 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

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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 yearold 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 comVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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mon 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.

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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

17

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

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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.

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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?

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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

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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.

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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

29

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

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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,

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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

46

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

47

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

48

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

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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.

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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.

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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 serviceconnected. 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

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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.

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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 precirrhosis 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

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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

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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 abstiVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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nence, 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 11⁄2 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 Cpositive 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 reVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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ferral 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 coorVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00092 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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dinator, 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 fulltime 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.

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Mr. SNYDER. One of you had somewhere in your written state- ment 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?

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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 nonveteran 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 reVerDate 11-MAY-2000 09:34 Aug 28, 2001 Jkt 000000 PO 00000 Frm 00104 Fmt 6633 Sfmt 6633 C:\DOCS\73167.TXT HGOVREF1 PsN: HGOVREF1
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search, 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 handdelivered 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

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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?

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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.

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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

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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

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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.

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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

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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.

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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

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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.]

[Additional information submitted for the hearing record follows:]

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