<DOC> [106th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:59652.wais] VA OUTREACH TO VETERANS AT RISK FOR HEPATITIS C INFECTION ======================================================================= 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 FIRST SESSION __________ JUNE 9, 1999 __________ Serial No. 106-30 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.house.gov/reform ______ U.S. GOVERNMENT PRINTING OFFICE 59-652 CC WASHINGTON : 1999 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania JOHN L. MICA, Florida PATSY T. MINK, Hawaii THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio Carolina ROD R. BLAGOJEVICH, Illinois BOB BARR, Georgia DANNY K. DAVIS, Illinois DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts ASA HUTCHINSON, Arkansas JIM TURNER, Texas LEE TERRY, Nebraska THOMAS H. ALLEN, Maine JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois DOUG OSE, California ------ PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont JOHN T. DOOLITTLE, California (Independent) HELEN CHENOWETH, Idaho Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director David A. Kass, Deputy Counsel and Parliamentarian Carla J. Martin, Chief Clerk Phil Schiliro, Minority Staff Director ------ Subcommittee on National Security, Veterans Affairs, and International Relations CHRISTOPHER SHAYS, Connecticut, Chairman MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York Carolina BERNARD SANDERS, Vermont LEE TERRY, Nebraska (Independent) JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois HELEN CHENOWETH, Idaho Ex Officio DAN BURTON, Indiana HENRY A. WAXMAN, California Lawrence J. Halloran, Staff Director and Counsel Marcia Sayer, Professional Staff Member Robert Newman, Professional Staff Member Jason Chung, Clerk David Rapallo, Minority Counsel C O N T E N T S ---------- Page Hearing held on June 9, 1999..................................... 1 Statement of: Baker, Terry, Vietnam Veterans of America and president of Veterans Aiming Towards Awareness; George C. Duggins, president, Vietnam Veterans of America, accompanied by Rick Weidman, director of Government Relations, Vietnam Veterans of America; Dr. Adrian DiBisceglie, professor, Department of Internal Medicine, St. Louis University, and medical director of the American Liver Foundation; and Dr. Alan Brownstein, president, American Liver Foundation........... 26 Garthwaite, Dr. Thomas L., Veterans Administration, Deputy Under Secretary for Health, accompanied by Dr. Tom Holohan, Chief Patient Care Services Officer; Dr. Toni Mitchell, MBA, chief consultant Acute Care, Strategic Health Care Group; James J. Farsetta, director, VISN Region III; and Dr. Simberkoff, chief of staff, New York Harbor Health Care System..................................................... 3 Letters, statements, etc., submitted for the record by: Baker, Terry, Vietnam Veterans of America and president of Veterans Aiming Towards Awareness, prepared statement of... 30 Brownstein, Dr. Alan, president, American Liver Foundation, prepared statement of...................................... 57 DiBisceglie, Dr. Adrian, professor, Department of Internal Medicine, St. Louis University, and medical director of the American Liver Foundation, prepared statement of........... 46 Duggins, George C., president, Vietnam Veterans of America, prepared statement of...................................... 39 Garthwaite, Dr. Thomas L., Veterans Administration, Deputy Under Secretary for Health, prepared statement of.......... 5 Snyder, Hon. Vic, a Representative in Congress from the State of Arkansas, prepared statement of......................... 17 VA OUTREACH TO VETERANS AT RISK FOR HEPATITIS C INFECTION ---------- WEDNESDAY, JUNE 9, 1999 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 a.m., in room 2203, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Biggert, Towns, Schakowsky, and Sanders. Also present: Representative Snyder. Staff present: Lawrence J. Halloran, staff director and counsel; J. Vincent Chase, chief investigator; Robert Newman and Marcia Sayer, professional staff members; Jason Chung, clerk; David Rapallo, minority counsel; and Jean Gosa, minority staff assistant. Mr. Shays. Let me call this hearing to order. Last year the House adopted our committee's call for a more aggressive, coordinated public health response to the silent epidemic of hepatitis C, HCV, infection. We recommended steps to inform, test and offer treatment to the 4 million Americans affected by the lingering viral liver disease. Among those steps, we urged the Department of Veterans Affairs [VA], to determine the prevalence of HCV among VA patients and reach out to those at risk. Why ask the already burdened VA health system to take a lead in a national public health effort? Because recent studies confirm 8 to 10 percent of all veterans suffer from HCV, four to five times the rate of infection in the general population. At one recent VA screening, more than a third of the veterans tested positive for HCV antibodies, with almost two-thirds of those having served in the Vietnam war era. According to testimony we heard last year from former U.S. Surgeon General Dr. C. Everett Koop, the VA has a 5-year window to ``head off very high rates of liver disease and liver transplants in VA facilities over the next decade'' when those exposed to infected blood and blood products 20 to 30 years ago will seek care for acute symptoms, cirrhosis and liver cancer. Early this year, VA Under Secretary Dr. Kenneth Kizer launched what he termed ``an aggressive public health approach'' to HCV by issuing guidelines to all VA facilities for screening, counseling and expensive drug therapies. His program calls for ambitious initiatives to educate patients and medical providers, expand epidemiological and clinical research and extend treatment to all who might benefit, regardless of other eligibility criteria. He has set the VA on a bold, proactive, high risk course. It was the right thing to do. In less than a year, the VA has made an impressive start toward the HCV awareness, testing, treatment and research some have been demanding for a decade. The challenge now, and the subject of our discussion today, is how the VA plans to sustain and expand that promising beginning. We asked the VA to describe their program to translate a headquarters initiative into effective implementation strategies in all 22 VA service networks. We asked the department's partners in this effort--veterans service organizations and the American Liver Foundation--to describe the barriers to outreach and care they see every day, and which the VA must still overcome. The hepatitis C initiative tests the VA capacity to inform patients, to educate physicians, to counsel those at risk and to deliver consistent care across a decentralized health system. For the VA, the price of success may be too high if estimates of prevalence are low, outreach is effective, and a $15,000 course of treatment is indicated for more than a fraction of those with the disease. For veterans with HCV, and for the Nation, the price of failure will be incalculable. Our goal this morning: To keep the wind in the sails of the VA hepatitis C initiative and help guide the program toward sustainability and success. We appreciate the time, expertise, and dedication our witnesses bring to this important discussion, and we look forward to their testimony. Let me introduce our first panel, Dr. Thomas Garthwaite, Veterans Administration, Deputy Under Secretary for Health, accompanied by Dr. Tom Holohan, Chief Patient Care Service Officer; Dr. Toni Mitchell, chief consultant Acute Care, Strategic Health Care Group; and James Farsetta, director, VISN, and Dr. Simberkoff. Dr. Simberkoff, your background is? Dr. Simberkoff. I am the infectious disease doctor and the chief of staff for the New York Harbor Health Care System, which are two of the facilities in network 3. Mr. Shays. It is wonderful to have all of you here. At this time I will swear you in and then we will see a quick advertisement on the screen and then we will take your testimony. [Witnesses sworn.] Mr. Shays. I note for the record that all have responded in the affirmative. At this time before taking your testimony I would like to see the new public service announcement on hepatitis C which is going to air soon. It is sponsored by the American Liver Foundation and Vietnam Veterans of America. [Video shown.] Mr. Shays. OK, Dr. Garthwaite, you have the floor. My assumption is that we have testimony from you, doctor, and then I will be happy to take comments if any of you want to make a point or two. It is important to put your comments on the record. Thank you for being here. STATEMENT OF DR. THOMAS L. GARTHWAITE, VETERANS ADMINISTRATION, DEPUTY UNDER SECRETARY FOR HEALTH, ACCOMPANIED BY DR. TOM HOLOHAN, CHIEF, PATIENT CARE SERVICES OFFICER; DR. TONI MITCHELL, MBA, CHIEF CONSULTANT ACUTE CARE, STRATEGIC HEALTH CARE GROUP; JAMES J. FARSETTA, DIRECTOR, VISN REGION III; AND DR. SIMBERKOFF, CHIEF OF STAFF, NEW YORK HARBOR HEALTH CARE SYSTEM Dr. Garthwaite. Thank you, Mr. Chairman. We submitted a written statement for the record and I would just like to make several points before we get into the question and answer portion. First, I would just like to say that we believe that we have made significant progress since the previous hearing on hepatitis C. We have developed and promulgated policy about the diagnosis and screening for patients with hepatitis C. We have developed policy and promulgated it to patients with hepatitis C and we have dramatically increased the number of veterans who have been tested for hepatitis C. We have conducted a 1-day surveillance study of patients presenting to our medical centers who have had blood tests for other reasons and tested their blood for hepatitis C, which has given rise to a better sense of what the actual incidence might be in the total veteran population. We have founded two centers for the leadership in study and education, and our strategy is to meet the challenge of providing care for veterans who are infected with the hepatitis C virus. We have conducted a conference where 500 caregivers came to Washington and heard and were educated about strategies for diagnosis and treatment of hepatitis C. We have participated in an interagency work group with the Department of Defense Health and Human Services and VA about strategies of the government toward hepatitis C. We have introduced a budget initiative in our fiscal year 2000 budget to provide additional funding so we might meet the treatment and diagnostic needs for patients. Finally, we have continued our research of about $12 million, 137 projects with 30 investigators. All of this is designed to aggressively approach what is a very significant problem for veterans and for all Americans infected with this virus. We face several challenges. One of the challenges is how to do outreach and how to reach the right people without inducing undo concern in those who don't have the virus, and the video that we just saw will be an important part of that effort, and we will face significant challenges in treating and teaching each of those individuals about the risks and concerns about hepatitis C. Second, we have an issue about how to take all of the patients that we do treat on a regular basis and make sure that we appropriately screen those and then for those who are screened at high risk, make sure that we test and educate them as well. We have a policy that says we will do that today. The question is how do you get policy to happen 100 percent of the time in a very large system. One of the things that we can do is education and we have taken significant steps in education, including various conference calls that we have had, and a variety of other methods. Another way is to improve our computer systems and put automated reminders into the encounter software so that it automatically checks to see if screening and testing has been done, and if it hasn't to remind clinicians to do such things, and we are pursuing that as an avenue to make sure that it only happens because of education, but there are reminder systems to remind the myriad of clinicians who come and go through VA hospitals to take that into account. Finally, we need to make sure that treatment is uniform. We have guidelines, but guidelines require education and human beings are fallible when it comes to education so we need to provide additional systems to make that happen and we are undertaking a match of our pharmacy data bases with that of our test data bases to see whether of those who are tested how many are treated, and then we will sample that to see if those who are not treated, whether the patient has refused treatment or whether there are contraindications. I think our biggest fear is pressures on the budget will prevent people from getting treatment, and we don't find that acceptable and want to make sure that does not happen. We have a series of challenges ahead of us, but we have made significant progress. Like many other diseases of veterans, they are highly complex issues and it is a very large system and it requires a significant amount of teamwork and that is why we brought a number of team members here to the hearing today. We hope that we will be able to answer all of your questions and look forward to dialog on this important topic. Thank you. [The prepared statement of Dr. Garthwaite follows:] [GRAPHIC] [TIFF OMITTED] T9652.001 [GRAPHIC] [TIFF OMITTED] T9652.002 [GRAPHIC] [TIFF OMITTED] T9652.003 [GRAPHIC] [TIFF OMITTED] T9652.004 Mr. Shays. Thank you. Any other comments before the questioning? OK. What is the capacity of the VA to ensure that this program is implemented uniformly and equitably nationwide in all of our facilities? Dr. Garthwaite. When you say capacity? Mr. Shays. Capacity, financial facilities. Dr. Garthwaite. Well, we have certainly made the commitment that we will make resources available to diagnose and treat hepatitis C among those veterans certainly for this year, and we assume into the future. So capacity in terms of budget, at least in the immediate future, I think we made a commitment that that is not an issue. We will diagnose and treat hepatitis C veterans. There are some other clinical issues and I will ask my colleagues to amplify, but one of the issues is how do you get the expertise to each individual place a veteran can show up in the health care system and that has been part of our education initiative in having conferences and educating people from each network. Mr. Shays. What would be helpful--let's just focus on the costs first. Break down the different elements that are involved. One is just educating--one is to educate all of your facilities on what they need to do. Another is how you educate the potential person with the disease in terms of coming forward and being tested. So there are costs involved there. Then there are other costs in terms of just diagnosis and then there are other costs in terms of treatment and maybe you can just--I would think if I were part of the VA system, and if I was one of the veterans groups my biggest concern would be that Congress will simply appropriate the same amount of money and you will have to find it somewhere else. So just give me a sense and make it a part of the record as to what the range of costs could be. This is kind of a long question so I am happy to have others of you participate in the answer. Dr. Garthwaite. Our budget estimate for the fiscal year 2000 budget was $250 million. But there are a lot of assumptions in there that we don't know whether they are accurate or not, but we think---- Mr. Shays. Which budget, the one that we are in now? Dr. Garthwaite. The fiscal year 2000, the cycle that is being debated at the present time. Mr. Shays. The budget we are going into. By the way, I am taking off my coat and if any of you want to do the same feel free. I would think of you better if you would remove your coat. Mr. Farsetta. Just don't ask us to step outside. Dr. Garthwaite. We believe the cost for testing and treatment per case is about $15,000. Mr. Shays. I just wanted to welcome our member from the minority side, Ms. Schakowsky, and if I could get some business out of the way, I would ask unanimous consent that all members of the subcommittee be permitted to place an opening statement in the record and the record remain open for 3 days for that purpose and without objection, so ordered. And ask further unanimous consent that all witnesses are permitted to include their written statement in the record and without objection, so ordered. Is there any point that you would like to make? Ms. Schakowsky. As a freshman I have proven that showing up counts because I am the ranking member on this side. Mr. Shays. And I want you to treat her with the respect that a ranking member requires. It is very nice to have you here, Ms. Schakowsky. Right now we are going to have the VA walk through the potential cost of getting the system to know how to deal with this issue, how to alert veterans that they need to come forward and also the cost of diagnosis and the cost of treatment. Dr. Garthwaite. Let me ask Tom Holohan, who has done a lot of our cost estimating. Dr. Holohan. Let me briefly go through some of the factors that are involved in any cost estimates and one of the distressing things from a scientific or medical point of view versus a budgetary point of view is the budget people don't like ranges. They like a precise figure. They want a number that they can write a check. Unfortunately in this instance, that is not really possible. The cost of testing an individual patient can run anywhere from $10 to $50. The initial test is an immunoassay antibody test. If that is positive, it is automatically repeated and depending on the risk factors you may ask for an additional test called the RIBA, radio immune blot assay. Subsequent to that testing if the patient is positive and you are considering that they may be treatable, there are other tests that are indicated. The standard of care now includes measuring viral RNA, which is a moderately expensive test. It also requires--it is recommended that a liver biopsy be performed prior to treatment and there are also now recommendations for viral genotype testing which are in the range of $200 to $300 because those provide you with prognostic factors which may tell you how long the treatment should go on for. Mr. Shays. So if we add that up, it amounts to how much per patient? Dr. Holohan. At that point you are probably talking about several thousand dollars before you initiate treatment. That is not including opportunity costs, physician time, nurse time. Mr. Shays. First the test to show if someone has hepatitis C, what does it cost? Dr. Holohan. The initial testing would be in the range of $10 to $20 per head. Mr. Shays. By then we know that they are at risk? Dr. Holohan. Yes. Mr. Shays. And the next test is to decide what kind of treatment is advisable? Dr. Holohan. The next test is the radio immune blot assay. That is a confirmatory test that is in the range of $50. Subsequent to that---- Mr. Shays. And that tells you what? Dr. Holohan. That confirms that the patient is antibody positive, it is not a false positive. Mr. Shays. They are at risk, and the next one is they have it or don't have it, and we are up to about $70 give or take? Dr. Holohan. That is correct. The next set of tests would include measurement of viral RNA, and that is in the range of $200 and that is both diagnostic and prognostic. That is repeated during any treatment phase so you know whether or not you are in fact eliminating the virus. It is recommended that every patient prior to treatment have a liver biopsy, and the private sector estimates of those costs are in the $1,000 to $2,000 range. The VA estimates are that we can do that for about $500 in round numbers. Mr. Shays. You do it internally? Dr. Holohan. Yes. We can do it for less cost than the private sector. The viral genotyping is approximately $300. These are estimates. You might get a better buy in California than in Peoria. Those tests would have to be repeated at various intervals. The viral RNA test you would repeat because one of your determinations at the end of treatment is whether the patient has in fact responded to treatment and there are two measures of that. One are routine liver function tests which are relatively inexpensive and whether in fact you have eliminated the viral RNA. The treatment costs for the currently recommended dual therapy are probably in the range of $12,000 to $15,000 for a course, which is recommended to be 48 weeks or approximately a year. Mr. Shays. What does that buy you? Dr. Holohan. That buys you treatment with interferon and ribavirin. Mr. Shays. And the outcome is what? Dr. Holohan. I am not sure, what do you mean? What proportion of patients---- Mr. Shays. We treat patients because we hope to have a positive impact. What is the positive impact? Dr. Holohan. In general most studies have shown that combined treatment with ribavirin with interferon will clear the virus 6 months after treatment in somewhere between 40 and 50 percent of cases. That is about twice as high as the viral clearance rate with treatment with interferon alone. I should caution, however, that we don't know that those data will necessarily apply when we treat veteran patients because the demographics of the patients treated in most of the published literature with those regimes are dissimilar demographics from our veteran demographics. We have a higher number of minority patients who tend not to respond as well to treatment. In the VA we may get a lower rate of viral clearance, but we don't know that yet. Mr. Shays. I was told that when we do this type of treatment, about 40 percent will see a very noticeable benefit. Dr. Holohan. Right. Mr. Shays. But I didn't pursue it to know--are we extending someone's life? Is the liver going to last a little longer? Are people literally healed? I have been led to believe that hepatitis C, you are not going to be healed, at least what we know now. Dr. Holohan. Again, some of the answers--the difference between what we can provide an opinion on medically---- Mr. Shays. I don't mind a range of possibilities here. Dr. Holohan. There are liver specialists who have used the word ``cure'' with respect to sustained viral elimination in hepatitis C. Dr. Schiff, who works with the VA in the Miami Center of Excellence, has used that word, but then we will routinely qualify it and say as far as we know. Mr. Shays. Your expertise primarily is on the financial side of this? Dr. Holohan. No, which should be apparent as I continue to speak. Mr. Shays. You have endeared me to you already. Dr. Holohan. Thank you. The bottom line is we are not certain if there will be an absolute cure. We do have data that show patients who have cleared virus and have remained virus free for some years after completion of dual treatment therapy. There is some hope that you can put yourself in the circumstance of HIV infection where you can very strongly effect the prognosis of the patient but perhaps not totally cure him. We don't know the answer to that yet. Mr. Shays. We really got into the whole issue of hepatitis C kind of as a silent disease following the infection of blood supply with AIDS. Dr. Simberkoff. Dr. Simberkoff. Yes, if I can amplify on Dr. Holohan's answer, the cure rate that is being quoted involves precisely that, eradication of the virus from the blood. None of the patients have been followed long enough to determine whether their life expectancy is affected by these treatments or whether or not they will go on to develop further liver disease. So I think these treatments are relatively new and we need to have lots and lots of followup of patients, particularly in our population. Mr. Shays. How much is spent so far? How much did we put in this year's budget just capturing from other parts of your budget. You are asking for 250 in our next year's budget, in fiscal year 2000, but what did we put in 1999? Dr. Garthwaite. There is no specific targeted amount for hepatitis C in this budget. Mr. Shays. You are just absorbing it? Dr. Garthwaite. Right. Mr. Shays. Do you know how much you have spent so far? Dr. Garthwaite. I don't know that we are able to make that assessment. Mr. Shays. Can you give me a sense what you have learned to date, and we can go from there. Dr. Garthwaite. We have tested approximately 200,000 veterans and diagnosed 38,000 give or take. Mr. Shays. Out of 200,000? Dr. Garthwaite. Right. 200,000 individual tests have been done in the last 18 months, and about 38,000 unique individuals tested positive for hepatitis C. Mr. Shays. Let me ask you the basic question, a veteran comes in routinely or you ask them to, or is it a combination of both? Then tell me how they are told about hepatitis C and then what you do. Dr. Holohan. Well, the information letter that was sent out last June instructs clinicians to ask patients if they have any of the specific risk factors for hepatitis C. If they do, they are supposed to be counseled on the advisability of antibody testing for hepatitis C. We don't routinely test everyone who walks in the door because the false positive rate is not insignificant in this disease and it would be---- Mr. Shays. Give me a sense of what not insignificant means to you? Dr. Holohan. If the prevalence in the population that you are testing is below 10 percent, the likelihood of the test reported as positive being true positive is lower than the likelihood that it is false positive. And most of that data are available from the routine hepatitis C testing of donated blood. Mr. Shays. You have a double negative in there. I am having a hard time in sorting that out. Dr. Holohan. The likelihood of a positive test being true positive relates to what the pretest probability of the disease was. So if you screen all donated blood from let's say healthy active duty military people and you get a positive result from John Smith, the likelihood is that is a false positive. Mr. Shays. And you have to spend $50 more to find that out? Dr. Holohan. Right. The biggest problems in our assumptions about the financial implications of hepatitis C relate to the problem that we don't know at least two facts, one of which is what is the true prevalence of hepatitis C in our patients. We think we have a better handle on it now than we did 6 months ago, but we are uncertain and the projected cost is very dependent on the prevalence of the disease. The second thing we don't know is what percentage of our patients are treatable. You will hear testimony later today that talks about 10 percent. One of our hepatology experts has provided her opinion that it is 20 percent and other people in the VA who are equally knowledgeable have said 40 percent. So when you are making predictions on the cost, it is extraordinarily dependent on that. Finally, we are not sure what percentage of our patients will continue with the full 48-week treatment course. As you will probably hear, these drugs have very, very significant side effects and it takes a high degree of motivation for a patient who may not feel ill when you start treatment and you make him feel much worse. Mr. Shays. I am going to give up the floor but I will want to come back later and see how we deal with it in a particular area. Mr. Farsetta, I will be coming back to you. Ms. Schakowsky. Thank you, Mr. Chairman. I wanted to ask a couple of questions about health care workers and the exposure and the risk that they are at. According to the Centers for Disease Control, health care workers are one of the groups that are most at risk of hepatitis C infection due to needle sticks and so I was wondering if the Veterans Administration plans to adopt the use of safety design needles and sharps in order to reduce the risk to health care workers? Dr. Garthwaite. Clearly we have already been using universal precautions for a long period of time. To my knowledge a significant number of our medical centers already have adopted safe needles and advanced needle and IV designs that decrease the likelihood of needle sticks in health care workers. Ms. Schakowsky. Is that policy though or is that just procedure at some of the places? Dr. Holohan. It is not policy. Actually this has been around for a little while. There are differences of opinion on the design of various needle arrangements that have automatic sheath retraction and so on and so forth. In fact, I guess within the past 6 months I have discussed this with the FDA, and there doesn't appear to be a single design that stands out above the others, although some of the early studies indicate that there is a reduced likelihood of accidental needle stick. Ms. Schakowsky. Apparently OSHA in California did a cost- benefit analysis on the use of these safety design needles and sharps and found because of the testing and treatment costs it saves, businesses and facilities across the State would save a $103 million each year if safer needles and sharps were utilized, not to mention that we might save--the estimates of the number of workers that become infected, it is a wide range but the outside is 5,900 health care workers who are potentially affected and it seems to me that this would be a reasonable procedure. What would it take--I am a cosponsor of legislation that would require that, but I am wondering if that is in the works anyway. Dr. Mitchell. Actually, the area that is involved, that is not Patient Care Services. It is the Division for Public Health and Environmental Health. And they are reviewing the use of that. I have not seen final data, although I have seen a draft review of that. The major step that was taken that has probably improved that more than anything else is just not recapping needles because the initial reason that most people were--had needle stick injuries was attempting to recap a needle that had already been used. We do have a policy of not recapping open needles and that they should be disposed of and every room should have an appropriate OSHA approved disposal area. So that has been the major thing. And I know that Dr. Fran Murphy is looking at the issue of needle sticks. However, the CDC also does not recommend routine testing for health care workers. What they say is that the testing should take place only in the circumstance where the needle stick occurred with a known hepatitis C positive patient so that the testing is very focused in that particular situation. Dr. Garthwaite. I would just say that we totally agree with you that we must do everything that we can to minimize any chance of a health care worker being infected and we will double-check where the review from our occupational health people is and get back. We have no disagreement whatsoever, we fully believe that we have to do everything to protect our health care workers. Mr. Shays. Bernie, do you want to vote? Mr. Sanders. First of all, my apologies for being late and thank you for calling this hearing on this very important issue. If I am asking a question that you already asked, Chris, I apologize. Many of us have been concerned that the budget for VA health care has been grossly inadequate, no ifs, ands or buts. My understanding is that treating hepatitis C is a very expensive proposition. I ask you a very simple question. If you treat folks with hepatitis C, what does this mean? Do you have the resources to do it? If you do it, are you taking money away from other desperately needed areas? We won't tell anybody what you said, just between us. Dr. Garthwaite. We put forward a budget initiative in the fiscal year 2000 budget for an additional $250 million to treat hepatitis C. The President's budget that was submitted did contain the initiative for $250 million. The total budget level kept to the previously agreed upon balanced budget agreement which was no increase, only any increase of medical cost recovery funds we could make. Therefore, any money for hepatitis C will come from offsets in efficiencies in other parts of the system. Mr. Sanders. In other words, you are going to have to take from Peter to pay Paul? And Peter is really hard pressed today. Dr. Garthwaite. In the ideal circumstance, we will find efficiencies that don't affect patient care, obviously. Mr. Sanders. I know that you share that concern. Mr. Shays. The bottom line is that there is a line item in the budget but no money in essence for it. Dr. Garthwaite. Right. There is no additional money because the President's budget did conform to the previously agreed upon balanced budget agreement. Mr. Shays. It is important for that to be part of the record for me because I want to stay within the budget agreement if we can, but you would do a disservice if we don't acknowledge it up front. The ball is in our court now how we deal with it. Mr. Sanders. I don't agree that we should stay within the caps. Mr. Shays. But we both agree that this is going to cost a plenty sum, and the money has to be there. I can't say that it has to come from within the budget. Mr. Sanders. I don't think there is any great secret that VA hospitals all over this country are hurting and to take money away from already underfunded areas to deal with this tragedy, people are going to be worse off. Mr. Shays. In Connecticut, we combined some hospitals and made some tough decisions. We didn't see that same success in Boston. So we have some disputes within our own district which says there are some savings to be made but frankly those savings are needed in a whole host of areas besides this. Mr. Sanders. But we don't want to see VA health care undermined, and we are at that point. Now we have to vote. Mr. Shays. We are going to have to recess. This is the only vote that we have for about 2 hours. We are just going to walk over and come back but it will probably take us about 15 minutes. [Recess.] Mr. Shays. I would like to call this hearing back to order and Bernie Sanders will begin asking questions and also I recognize Vic Snyder from Arkansas. It is great to have you here. Mr. Sanders. Having come--just one question and again I apologize if this issue has been gone into before. The rate of infection for veterans of hepatitis C is much higher than in the general population. Can somebody explain briefly why that is the case? Is that because veterans in general being young males primarily are more at risk or what is the connection? Dr. Garthwaite. We believe right now we can say that when we tested veterans who showed up for care and were getting blood treated, it was at the 8 to 10 percent level. What we can't tell you exactly is whether that is a true representation of the entire veteran population since smaller number--only a portion of the total number of veterans use the VA health care system. I think our population is skewed in that we take people who are disabled, often combat disabled, which implies that they were wounded in service or had transfusions in relation to their disabilities perhaps or we have patients--one of the other selection criteria is the highest priority for veterans is that they are poor. Often in America people are poor because they are ill to begin with or in some cases because they suffer from mental illness or disability, including drug and alcohol use, and we know that drug use is highly correlated as well. So we think that at least the population that we have tested so far has some significant risk factors, combat wounds, transfusions, multiple surgeries with transfusions prior to 1990 when testing was available. Certainly the theaters of Vietnam in particular where we see the highest prevalence certainly had risk factors associated with them. These are areas in which medics were often called upon to treat people who were bleeding so there was a fair amount of mixture and potential cross infection out in the field. Mr. Sanders. You think that service in Vietnam is a significant cause for--perhaps for the disparity of incidence? Dr. Garthwaite. I am not sure---- Dr. Holohan. There is an increased risk for patients with hepatitis C who have been in country in Vietnam, yes. They have a higher ratio of being positive than veterans who were not. Mr. Sanders. On top of the fact that they may be low income and may use drugs, just presence in Vietnam, everything being equal, will give you a higher risk factor? Dr. Holohan. Yes. Mr. Sanders. Thank you. Mr. Shays. Congressman Snyder. Mr. Snyder. Thank you. I am sorry I'm late, there was a Veterans Subcommittee meeting on health. I have an opening statement that I ask to be submitted in the record. Mr. Shays. Without objection, so ordered. [The prepared statement of Hon. Vic Snyder follows:] [GRAPHIC] [TIFF OMITTED] T9652.005 [GRAPHIC] [TIFF OMITTED] T9652.006 [GRAPHIC] [TIFF OMITTED] T9652.007 Mr. Snyder. I have been grappling with this issue of how a veteran picked up an illness in 1968 and we didn't test for until 1989 or 1990. No. 1, do any of you have any comments on this issue of how well we are doing in the VA system in terms of our accuracy of either affirming or turning down claims for service connection with regard to hepatitis C? And No. 2, what do we think at this current state of knowledge is the percentage of those with hepatitis C that we don't have a good guess what the etiology is and we just put them in the unknown category? I don't know who to direct those questions to. Dr. Garthwaite. With regards to the accuracy of ratings, no one here is really an expert on that. We could get you for the record obviously what a reasonable response is about the rating decisions that have been made. We are reviewing I believe your bill on presumption and getting comments on that so I think as part of our analysis of that rating, the rating decisions being made, we would like to provide that for the record. Tom, do you have any comment on the other part? Dr. Holohan. I think the bottom line is that in an individual case from a medical point of view, not a medical legal necessarily but from a medical point of view, it is almost impossible to determine what the precise proximate cause of infection with hepatitis C is. A patient may have one, two or many risk factors and to determine which was in fact the proximate cause of the disease is in my opinion impossible. Mr. Snyder. And that does have some revocations. I like your phrase almost impossible to determine because in 20 to 30 years of history, some risk factor may be service connected and some risk factors may not be service connected. I don't know if my bill is the best way to get at this problem. I haven't seen anything better out there and I think there really are some challenges, having talked to some of the people who do the ratings. I am a family doctor and I would hate to be the one who had to flip that coin and make that kind of determination on this illness. I think doctors are used to making evaluations on things that you can evaluate, but this is different. You are talking about a point in time. We are physicians, not detectives. At what point in time did that virus enter that bloodstream. I will say any comments, criticisms, suggestions on H.R. 1020, I would be more than receptive to. We are trying to solve what I think is a problem for some veterans. Thank you, Mr. Chairman. Mr. Shays. Thank you very much. I have a few questions before we go to the next panel that I would just like to get on the record. The first, what outreach initiatives does the VA have underway to reach the veteran population considered most at risk? If you just put it in fairly simple terms, what the outreach initiatives are? Dr. Mitchell. I think that we have tried to approach the problem in general by first educating our clinicians because they will be the front line contact with all veterans and the point of the information letter was to help us in risk stratification, which patients are at greatest risk and therefore need testing and are more likely to be eligible for treatment. Second, we have developed a Web site which will be Internet accessible by patients and their families. Mr. Shays. When will that be done by? Dr. Mitchell. It is actually up now. It is not terribly sophisticated at this point in time, and we are working on that and plan on soliciting articles both from veteran service organizations, from our networks, from the facilities, from the American Liver Foundation, from other Federal agencies to provide further information, but I will be glad to provide to you later the exact Web address because I have learned quickly that a number of them are Web savvy. We are working with the American Liver Foundation to develop specific materials, one of which was the PSA that you just saw; others are written materials which will be delivered to them. We also have asked and have been working directly with the networks to have counselors specifically trained to discuss these issues with patients and their families. We have also been working with the networks and the ALF to set up support groups so that when a patient tests positive, whether or not they are eligible for treatment yet, that support groups will be made available to them so that they can meet on a regular basis. So there are a number of activities that are going on, both nationally and at the local level. When there has been a request for assistance for testing, for instance in New York State, the VA had asked for our assistance in helping to set up a testing program, and we participate in those kinds of collaborative outreach kinds of programs as well. Mr. Shays. The testimony so far is that some say 10 percent can be treated, some 20 and potentially up to 40 percent successfully, and we still haven't defined success. We would all agree I am assuming that everyone has a right to know that they have hepatitis C, not knowing that it would be a tragedy for them not to know how and to begin to find ways to deal with it, and certainly not to spread the disease and so on. My first question is even if we didn't think that we could successfully treat someone with hepatitis C, we do feel that it is important that they know that they have it; is that correct? Dr. Mitchell. That is correct. Dr. Garthwaite. One of the criteria is patient requests for screening. Mr. Shays. Any patient who requests will be tested? Dr. Garthwaite. Yes. Mr. Shays. But you don't test everyone. Everyone who comes in is not tested for hepatitis C? Dr. Mitchell. As I said, with the information letter the point was if they have absolutely no risk factors, we would not test them unless they requested to be tested because, as Dr. Holohan described earlier, the risk of a false positive is fairly high. So if they have no risk factors we do not test. We say you have none of the known risk factors and we have been more inclusive than the CDC in that by adding the Vietnam veteran as one and---- Dr. Holohan. Even alcohol abuse, tattooing, or body piercing, none of which are considered to be risk factors by CDC we do include. Mr. Shays. Mr. Farsetta, you have one of the VA service networks? Mr. Farsetta. That is correct. Mr. Shays. Can you describe your area? Mr. Farsetta. My area is New York City, Hudson Valley and most of New Jersey. Mr. Shays. As I recall, we had a hearing in one of your areas. Mr. Farsetta. Yes, we had a hearing in Waterville, which is about 2 miles north. Mr. Shays. I will never forget that hearing as long as I live. Mr. Farsetta. Neither will I. Mr. Shays. I felt like I was a western judge preventing a lynching. Mr. Farsetta. Thank you very much. Mr. Shays. And in the process I almost got lynched myself. If the choice was between you or me at the end I would have made---- Mr. Farsetta. The right choice. Public service, wonderful. Go ahead. Mr. Shays. I got out all right, just a few bad articles in the process. Describe how the HCV initiative has been implemented in network 3? Mr. Farsetta. First of all, we have the highest prevalence of HIV in the Nation in my network. We really have been dealing with HIV and hepatitis C for a number of years. We actually have had a collaborative effort between the infectious disease physician, the GI physicians and the chiefs of medicine and we have been looking at hepatitis C and have been concerned about hepatitis C, as I say, for a number of years. We have tested in excess of 14,000 people in the network. This year alone we have tested from October 1 to the current date over 10,000 veterans. Mr. Shays. You tested 14,000 total? Mr. Farsetta. Roughly, and 10,000 since October 1. We have 2,700 who are positive and we have about 250 who are in treatment and we are adding about 50 per month for treatment. We are actively testing about 800 veterans per month. Mr. Shays. You just answered the next three questions and you did it the right order. Are you taking this out of your own budget? Mr. Farsetta. Yes, I am. Mr. Shays. Have you put a cost to it? Mr. Farsetta. So far probably this year about $4 million. And in essence every time we engage a veteran in treatment, we will be incurring over the course of 48 weeks roughly $15,000. So I am incurring costs of perhaps $750,000 each month and it doesn't work out to be each month but I am essentially using a credit card and saying whatever it costs to treat you, we will treat you. While this year is not problematic, with what we are hearing about the budget for next year it will be terribly problematic and I don't know how I will be able to continue to do that. Mr. Shays. I think it is important that the VA know that alarm bells are going off and putting Congress on notice. We will be debating the VA-HUD bill and it has less money total than last time, and we really have to come to grips with this and you should not allow me or anyone else to escape the reality of that. We have been joined by Judy Biggert. I don't know if you have any questions. Mrs. Biggert. I have one question. I understand that there really is no cure, but there is the antiviral treatment. And if somebody is not a good candidate for that and you find out that they have this, what happens to them? Dr. Simberkoff. The risk factors that preclude treatment are often things like alcohol, drug abuse and depression. One of the things that we are doing is to try to counsel patients about the fact that either alcohol or drug abuse perpetuates the problem and often makes it much worse so we are trying to get the patients into treatment programs so that they can--can deal with those problems. Certainly depression itself is a treatable medical problem. So again, we are trying to get patients into treatment for those things which for the most part are keeping them from being candidates, individuals who are not candidates for treatment. Mrs. Biggert. Is something like depression as a result of having this or is it a cause? Dr. Simberkoff. In some cases the medical illness may lead to the depression. If it doesn't respond, we will try to deal as best we can with the medical illness. But in many instances there are other medical problems. PTSE is another, and these are illnesses that the VVA has a great experience in trying to deal with. So I think we are hoping that many of these patients who are not candidates for treatment today will be better candidates for treatment in days or weeks to come. Mrs. Biggert. Thank you. Dr. Mitchell. I would like to add, if they need other supportive therapy, in other words they are cirrhotic and that is the reason that they have advanced liver disease, the reason they are not eligible for treatment, we would continue to provide all of that ongoing supportive medical care to which they would normally be provided. So we do not stop or not do any of the other things simply because they are hepatitis C positive. Mrs. Biggert. Thank you. Thank you, Mr. Chairman. Mr. Shays. Mr. Sanders. Mr. Sanders. Let me get back to dealing with the financial situation of the VA. My understanding, I think, Mr. Farsetta, you indicated that or somebody had mentioned to me in the past if I understand correctly, the VA treats more HIV patients than any other institution in the world; is that correct? Mr. Farsetta. Yes. Dr. Simberkoff. Yes. Mr. Sanders. And that is pretty expensive? Dr. Simberkoff. Yes. Mr. Sanders. Is that also true with hepatitis C? Dr. Garthwaite. I don't know that we have the data on that. Mr. Sanders. I ask that question for the following reason. Treatment of AIDS is obviously very expensive. Treatment of hepatitis C is very expensive and you asked a moment ago about outreach. He who has an institution struggling with inadequate financial resources, if in fact somebody said to them we want you to be very aggressive and do the right thing for this country and for the people involved, reach out, bring all of those people in who are veterans and who have AIDS, bring all of those people who are suffering with hepatitis C, and it is going to cost you $10,000 or $15,000 to treat hepatitis C, of course we are cutting the budget in the process but we want you to be very aggressive and do the right thing. I think we are sending you a rather mixed signal, and I think if I were an administrator, I would probably turn my back. Or if I were aggressive, I would have to cut back on the World War II veterans that we are not treating with the respect that they are due. What am I missing here? Try to be as honest as you can. I think because ultimately we are going to have to deal with this issue, if we want these people to do the right things, we are going to have to fund them or else we say don't do the right things. Mr. Shays. I know he is going to be more honest because he hasn't been in Washington long enough to know he has to be careful. Mr. Sanders. Yes. Be honest. I think it is important that the U.S. Congress hear the truth, because it is not acceptable because we want to help the veterans, we are deeply concerned about the veterans but we are going to cut them and, by the way, we are critical of you for not doing the right thing. Mr. Farsetta. I am not sure you have missed anything. I think it is as we approach 2000, it is really problematic. I think it is something that from an ethical perspective--I had a conference call with many of my treating clinicians yesterday on this very issue. And they are troubled not by today, but by the uncertainty about tomorrow, that when you engage in screening and make a diagnosis and treatment, then you are really ethically committed to provide that treatment. And do we want to engage a population that we are not quite certain that we are going to have the wherewithal to treat 6 months from today when we know the treatment is 48 weeks. So it is really problematic. Mr. Sanders. In other words, something is coming in, we have bad news for you, hepatitis C, but we can't treat you. Mr. Farsetta. Well, I think what we are doing is we are saying, we have bad news, you have hepatitis C, we are going to treat. The clinicians right now are not saying, but in 6 months we are not going to have the money, but they are saying to me, based upon the dialog we have had about based upon what the budget looks like for next year, do you have the resources to provide the wherewithal that is necessary for next year, and my response is A, I don't know; and if I don't, then something else will have to go, because we are really committed to doing this. Mr. Sanders. But in the back of your mind--you were asked about outreach. I would assume if I were sitting in your chair, I would not be all that aggressive. I mean you don't have to tell me whether you are or not and I know there are ethical concerns here, but in the real world, how are you going to launch a major outreach campaign if you are going to have to tell folks that you can't treat them? Anyone else want to comment on that? Dr. Garthwaite. I think you raise very valid concerns. We have had internal discussions where we have really talked about what are some alternatives if the money doesn't stretch, to provide all benefits to all comers, does that mean we then stop seeing priority 7 veterans. The reality is with the third-party insurance payments we get from priority 7 veterans and the fact that on average they cost less, it appears that they do not cost the VA a lot of money; i.e., if we stop seeing priority 7 veterans, we wouldn't save a lot of money. So that I think was at least an initial concern about how to make all, you know, balanced budget numbers work was, in part, if you really get tight for money, you don't have to see the higher income veterans. The reality is they don't necessarily--by stopping seeing them, you don't necessarily save a lot of money. So then you are really talking about, since there aren't really that many priority 6 veterans, you are really talking about priority 5 veterans who do meet a means test for poverty. My guess is if you had a hepatitis C-positive priority 5 veteran who meets a means test for poverty, that they are likely going to seek public resources for the treatment of their hepatitis C. You know, if the VA is not seeing them, I don't think that means that the taxpayer isn't going to help out here, and I think that we do a good job and would like to see us be able to do that. So I think we just have to work our way through how many we can see within the budget we are given, but I think it is probably good public policy to let the VA treat a fair number of hepatitis C patients. We learn a lot, I think we do a lot of research at the same time, and I think we do it compassionately as well, over the years that we have seen these patients, and I think it makes a lot of sense. Mr. Sanders. Let me just conclude by making a request. I think, and Chris or anybody else can disagree with me, but I am not sure that the average Member of Congress is fully aware of the financial stress that the VA system is under, given the load that they have to deal with, and I don't know that the VA has done--and I know that you are not able to lobby also, but I think you could do a better job in saying to the Members of Congress, just explaining. I talked to Dr. Kizer about this as well, but to say, look, with this amount of money, this is what we can't do. Congress ultimately has to make that choice and they should make that choice with their eyes open, and I would hope that you would give us those facts. What does it mean if your budget is cut? Tell us the honest truth. Is that something you think you could perhaps work on a little bit? Dr. Garthwaite. In fact, we are in the process, fairly far along in the process of looking at scenarios of the exact President's budget and at several increments as to what that would mean in terms of what we could or couldn't do at a local level and at a national level. Mr. Sanders. I know there are political ramifications to it, but I think you are not doing your job well unless you tell Congress what the truth is; and I would appreciate it. We are going to have to make those decisions very shortly, so the quicker you could get us that information, the better. Mr. Shays. It makes it more awkward if the administration hasn't honored a request, because then you are in the administration having to speak out about something that wasn't put in your budget. But I do think that there really is almost a moral necessity that happens. I think one way we can help your cause is to ask the GAO to step in and try to look at the cost of some of your big ticket items. I would assume HIV is one; another is hepatitis C potentially, and another is the costs dealing with Gulf war veterans based on our hope that we will make presumptions, and that will certainly increase costs a lot. Let me do this. There are other questions that if we need to, we will put them to you in writing, and we will get to our next panel. Thank you very much. Our next panel is Mr. Terry Baker, Vietnam Veterans of America and president of Veterans Aiming Towards Awareness; Mr. George C. Duggins, president, Vietnam Veterans of America, accompanied by Mr. Rick Weidman, director of Government Relations, Vietnam Veterans of America; and Dr. Adrian DiBisceglie, professor, Department of Internal Medicine, St. Louis University, and medical director of the American Liver Foundation; and finally, Dr. Alan Brownstein, president of the American Liver Foundation. It is very good to have all of you here. The first thing we do is, as you know, we swear in all of our witnesses, and I would ask you all to stand and I will give you the oath. [Witnesses sworn.] Mr. Shays. For the record, all have responded in the affirmative. We will use our clock, but let me explain how we will proceed. You have 5 minutes, and then I will tip it over again, and if you didn't finish in the first 5 minutes, if you would certainly finish within that 5 to 10 minutes, that would be helpful. So we will start with you, Mr. Baker. STATEMENTS OF TERRY BAKER, VIETNAM VETERANS OF AMERICA AND PRESIDENT OF VETERANS AIMING TOWARDS AWARENESS; GEORGE C. DUGGINS, PRESIDENT, VIETNAM VETERANS OF AMERICA, ACCOMPANIED BY RICK WEIDMAN, DIRECTOR OF GOVERNMENT RELATIONS, VIETNAM VETERANS OF AMERICA; DR. ADRIAN DIBISCEGLIE, PROFESSOR, DEPARTMENT OF INTERNAL MEDICINE, ST. LOUIS UNIVERSITY, AND MEDICAL DIRECTOR OF THE AMERICAN LIVER FOUNDATION; AND DR. ALAN BROWNSTEIN, PRESIDENT, AMERICAN LIVER FOUNDATION Mr. Baker. Mr. Chairman and members of the subcommittee, my name is Terry Baker. As the executive director of Veterans Aiming Towards Awareness, a support group for veterans with hepatitis C, and national service officer for the Vietnam Veterans of America, I am honored to be here today to present my views on the Department of Veterans Affairs' handling of the hepatitis C epidemic. I want to thank you for your leadership and for holding this hearing on the VA's responsibility to help the men and women who risk their lives for their country and who now face an even greater risk. I am particularly pleased that the committee is focusing on if the national VA initiative is being carried out. As a veteran with hepatitis C, I want to begin by saying thank you to Dr. Kenneth Kizer and the Department of Veterans Affairs for recognizing the seriousness of this disease and for launching a major initiative to address it. In June 1998, the Department of Veterans Affairs issued guidelines to the VA health system regarding the proactive testing of veterans with any of 10 risk factors for hepatitis C. Beginning last June, every patient visiting a VA facility should have been evaluated for HCV. The results should have been entered into the patient's chart and an antibody test should have been performed on any veteran presenting with one or more risks. In January of this year, Dr. Kenneth Kizer announced further initiatives to deal with the hepatitis C virus. Among these was the creation of two hepatitis C Centers of Excellence where medical professionals and research scientists could coordinate treatment and research efforts, as well as develop education for patients and their families, health care providers and counselors. When Dr. Kizer established these centers he stated that, ``VA's goal is that every patient who needs and wants treatment will receive it.'' Mr. Chairman, Dr. Kizer's initiative and his leadership on this issue are appreciated. However, the Department's ineffectiveness at the service delivery level in actually providing screening, counseling and treatment to hepatitis C infected veterans is most disconcerting. The VA hepatitis C initiative has been in place for 1 year now. During this time, the Department has not succeeded in communicating the objectives of this initiative to hospital personnel. I know of numerous cases of veterans who are not being assessed for hepatitis C risks, not being offered testing in a systematic fashion, and not being evaluated routinely for the suitability for treatment. In fact, many veterans have gotten just the opposite from the VA, the old runaround, by VA personnel and roadblock after roadblock in their pursuit to be treated for HCV, a disease they most probably contracted while defending their country. For example, I know a veteran in Idaho who was wounded in combat in Vietnam. I suggested he request a test for hepatitis C the next time he visited the VA hospital in Spokane, WA. When he did ask to be tested the staff at that facility gave the impression they had no idea of what he was talking about, and claimed that they were not aware of any such test. To date, the service-connected veteran has yet to be tested for hepatitis C even though he specifically and proactively went out and asked to be tested. Another veteran, this one from Montana, was actually diagnosed with hepatitis C during a nonVA-sponsored HCV testing last year. After discovering he was positive, he attempted to have the test confirmed at his local VA clinic, but they refused to test him. He then visited an Arizona VA clinic and the diagnosis was confirmed. Even though the VA doctor from Arizona contacted the Montana clinic and recommended followup, the VA clinic has continued to refuse the vet treatment for his hepatitis C. My final example comes from a hepatitis C-infected veteran in Newark, NJ. This veteran served with the 173rd Airborne Brigade in Vietnam where he was twice awarded the Bronze Star for Valor for coming to the aid of wounded soldiers on the battlefield. His military service records contained clear evidence that he was directly exposed to blood during combat in Vietnam. Even so, the VA denied his claim for service connections stating that he met none of the risk factors for hepatitis C, and that his records contained zero evidence of having hepatitis C. This statement completely contradicts VA's public acknowledgment that HCV symptoms often do not manifest for 10 to 30 years after the victim is infected. So right now, there is a Vietnam veteran who has been forced to seek out private medical attention at his own expense, because now he is in the last stages of liver disease. Members of the committee, I must stress that while I applaud VA's plan for dealing with hepatitis C, it is not enough to have a plan. This war against a deadly disease will require a fully deployed assault by all of us. The VA must act swiftly to educate its physicians, staff and all rating officers all about this disease. While training one physician and one nurse from each of the 172 medical centers may seem ambitious, it is not adequate. Mr. Shays. Excuse me. Mr. Baker, this is a little unusual. But ma'am, how many students do we have? Because they could sit up here if we don't have too many. How many students do you have? They can just sit on the side. You don't mind, do you? Mr. Baker. No. Mr. Shays. I find any time--you young people can sit right up along this side here. Mr. Towns. They come from my district, Mr. Chairman. Mr. Shays. I figured as much. Any way we can get Mr. Towns here, we will take it, because he has been such a wonderful member of this committee. How many other students do you have? You can sit right up over here if you want. You can sit on the floor up front. If you don't mind sitting on the floor, you can do that. You young people, if you don't mind, we are running out of seats up here, but you can sit up front here if you don't mind sitting on the floor. You can come in, and sit this way. Thank you for letting me do this. For the benefit of our guests, we are having a hearing on our veterans who have been affected with hepatitis C and ways that we can help them. There is some more room over here. The gentleman speaking now is a veteran. Mr. Baker, you are coming close to finishing and then we will get to the next speaker. Thank you. Mr. Baker. Members of this committee, I must stress that while I applaud the VA's plan for dealing with hepatitis C, it is not enough to have a plan. This war against a deadly disease will require a fully deployed assault by all of us. The VA must act swiftly to educate its physicians, staff and all rating officers all about this disease. While training one physician and one nurse from each of the 172 medical centers may seem ambitious, it is not adequate. The Portland VA Medical Center sent a computer specialist to the HCV training session held last week here in Washington. This does not seem to indicate a clear commitment from the Portland VA Medical Center. If VA's efforts must be limited, these efforts must also be focused, focused on persons most likely to interact with people affected by HCV. Something as simple as large posters at every VA medical center enumerating the risk factors for HCV and encouraging veterans to get tested have not been posted in VA facilities. These posters do not even exist. The VA said it would aggressively fight this disease, and yet few, if any, VA medical centers advertise hepatitis C testing. It was even brought to our attention that the VA Excellence Center in Miami was not receiving the proper funding to combat this disease. Dr. Mitchell herself had to personally address that problem. This approach seems inappropriate when a systematic plan has already been outlined. Or has it? Therefore, VA must ensure that every directive about hepatitis C is taken seriously and carried out completely by every VA medical center. I respectfully request, myself a veteran and on behalf of all veterans, that you hold the VA 100 percent accountable for its plans to fight this battle. If necessary, Congress must give Dr. Kizer the authority for centralized activities against hepatitis C. You alone have the authority to make sure the VA does precisely what it says it will do. Please aggressively pursue answers and results from the VA. I assure you all of America's veterans are counting on you. Please don't let them down. Thank you. [The prepared statement of Mr. Baker follows:] [GRAPHIC] [TIFF OMITTED] T9652.008 [GRAPHIC] [TIFF OMITTED] T9652.009 [GRAPHIC] [TIFF OMITTED] T9652.010 [GRAPHIC] [TIFF OMITTED] T9652.011 [GRAPHIC] [TIFF OMITTED] T9652.012 [GRAPHIC] [TIFF OMITTED] T9652.013 Mr. Shays. Thank you, Mr. Baker. What we will do, I want to acknowledge that the first panel who spoke has stayed to hear your presentation, and that is really appreciated; second, that the particular cases that you have presented should be shared with the VA, and it would be instructive for us to have, Dr. Garthwaite, just follow them up and then just see what the story is of breakdown or where there are other factors involved, and that would be instructive to helping you and helping us understand the system. Thank you for your testimony. Mr. Duggins, you are here to give testimony and then you are accompanied by Mr. Weidman who will respond to questions afterwards, is that correct? Mr. Duggins. We both will respond. Mr. Shays. I just meant that Mr. Weidman, you are not here to give testimony, but you will be responding along with Mr. Duggins and the others, as an equal member responding afterward, but Mr. Duggins, if you would give your testimony. Mr. Duggins. Mr. Chairman, my name is George Duggins and I serve as national president of Vietnam Veterans of America. On behalf of Vietnam Veterans of America [VVA], I wish to congratulate and thank you and your distinguished colleagues for your leadership in holding this hearing this morning on the subject of the hepatitis C virus and the efforts of the Vietnam Veterans Health Administration at the U.S. Department of Veterans Affairs to effectively deal with this epidemic that is disproportionately affecting veterans. Of particular interest to VVA is the apparently high prevalence among Vietnam veterans, particularly those veterans who served ``in country;'' i.e., the Vietnam theater of operations. Because of combat wounds, exposure to blood on the battlefield and other factors that attend to the most basic and messy nature of warfare, a large number of veterans were exposed and unaware that they should have been tested. VHA response is: The Veterans Health Administration has responded admirably following the outstanding report issued by this subcommittee in October 1998. The policy directive issued to all VHA facilities on June 11, 1998 is a very reasonable plan for a starting place to begin the process of testing and treatment. The treatment protocol issued by the VHA to all clinical coordinators at the end of December 1998 is a reasonable approach and a good starting basis for each medical facility to move forward with treatment. While we would hope that each of these policy statements and guidance documents will eventually be strengthened, they would be a reasonable start toward dealing with the veterans' aspect of this epidemic, if there is a means of ensuring relative uniform implementation. Earlier this year, many of the VVA local leaders in virtually every part of the Nation told us that VHA officials in their area were saying that the test would be given and that VHA had the resources and the means to set up their system to properly treat those who are tested and are shown to have hepatitis C virus. Today, it is our belief that most of the facilities are still doing an inadequate job of actually testing for hepatitis C virus in a systematic manner and are slow to treat in many cases. We are still hearing of Pharmacy Chiefs and VAMC directors who are reluctant to order enough of the relatively expensive medication necessary to begin treatment in sufficient quantities to begin early treatment of suitable candidates for this very arduous process. This lack of a concerted and highly visible outreach and rigorous testing campaign could have potential devastating effects on the veterans involved, as well as on the VA health care system that will have to deal with the aftermath of this not so benign neglect in the future. If left untreated, many of those veterans will develop symptoms of the virus, leading to very serious and debilitating diseases that may result in liver transplant as their only option. The extreme pressures of the VHA over 3 years of a flat line budget and the disastrous and woefully inadequate requests from the President for the fiscal year 2000 budget for VHA has cast a chilling effect on the motivations of the administrators in the field to move ahead with doing their jobs properly for veterans potentially affected with hepatitis C. Finally, while it is unacceptable and unconscionable for medical personnel to act this way, it is inexcusable for the President and the Congress to put these people in a situation of extreme and needless scarcity. We ask your help, Mr. Chairman, and that of your distinguished colleagues in helping secure a more reasonable budget for VHA for fiscal year 2000. While VVA believes that $3 billion more than the President's budget request is truly needed, obviously the $1.7 billion more being currently discussed in Congress would help keep the system from diminishing any further. VHA should work with the veteran service organizations and American Liver Foundation and other public and private entities to mount a comprehensive, significant, extended and prolonged public service campaign to give veterans who may have been exposed to come into the VA, enroll, and be tested. Most veterans do not use the regular VHA facilities for their health care needs and since the virus is silent, most do not know that they are affected or even potentially at risk. This would perhaps be most effectively done as a part of an overall coordinated Federal response to hepatitis C epidemic, while it is still in a relatively early stage. VVA stands ready to do our part in such an outreach effort to spur testing of veterans and encouraging individuals to get tested now. It is our belief that many private groups as well as public entities and the media will be responsible for such a concrete and organized effort. However, VHA must take steps to assure that the key personnel at the local level stand ready to work with the veterans groups and the rest of the community in a meaningful and sustained manner. VVA would also note that such efforts must be designed and implemented in such a manner that all subgroups in the veterans population are effectively reached. Ensuring that the community-based groups that serve homeless veterans and others under several populations in greatest need is very important in this matter. VHA should begin to rigorously ensure that all veterans currently registered for the VHA services who meet the at-risk profile have their blood tested for signs of the hepatitis C virus. This is not happening at many of the medical facilities we are aware of at this moment. Many veterans at risk, such as the former medic accompanying me today, have been trying to get tested for hepatitis C at a VHA facility, but on their own initiative, not that of the VA. It is our belief at VVA that this can be set up as a regular part of intake and yearly physicals by the VHA by making it part of a computer program to indicate certain tests must be given to veterans based on his or her full military medical history that is logged in as a matter of course. This is something that VVA believes should be done for many sound medical reasons in a veterans health care system. VVA has engaged in discussions with top VHA leaders on this subject for several months and VHA has agreed this week to proceed with setting up a task group to begin the process of framing the design and implementation of the basic process. VHA must also take steps to ensure that much more effective accountability mechanisms are put in place that would enable the key national managers to monitor what is happening in the field. VVA has consistently called for much better and more effective modern accountability mechanisms within the VHA. The problem is one of the top officials in VHA not knowing what is going on at the service delivery level, except by anecdotes told to them by others. There is no mechanism for systematic quality assurance review in regards to hepatitis C or for other vital measures. This is simply no way to manage a system that is as large and complex as the VA Health Administration. VHA should closely work with the Surgeon General, the National Institutes of Health, and the Congress, to ensure that additional research is undertaken into more effective cures for eradicating the hepatitis C virus. While VVA is appreciative of the approximately $5 million in research funds which will be made available this year, the sum is inadequate in the face of the potential danger of the medical epidemic. Our Nation can do better in pursuit of a more effective cure for this virus. VVA would urge that the Department of Defense be involved in this effort and that you and your distinguished colleagues help DOD keep a positive attitude that is open to the virus being a potentially serious problem as opposed to denying beforehand that there could possibly be any substantial risk. Mr. Chairman, this concludes my remarks. I will be pleased to answer any questions you may have. Thank you again for allowing us to present our views here today and for your strong and vigorous leadership on so many vital issues that confront our Nation's veterans. [The prepared statement of Mr. Duggins follows:] [GRAPHIC] [TIFF OMITTED] T9652.014 [GRAPHIC] [TIFF OMITTED] T9652.015 [GRAPHIC] [TIFF OMITTED] T9652.016 [GRAPHIC] [TIFF OMITTED] T9652.017 [GRAPHIC] [TIFF OMITTED] T9652.018 Mr. Shays. Thank you very much. At this time we are going to do the video for the 3 Members that weren't here, and then we will go to you, Mr. DiBisceglie, and then we will go to Mr. Brownstein. [Video shown.] Mr. Shays. Dr. DiBisceglie, if you would give us your testimony. Mr. DiBisceglie. Thank you, Mr. Chairman and other members of this committee. I have submitted written testimony. First, I will say that I am a physician, a hepatologist, that is a liver doctor, and I have been involved in the care of patients with hepatitis and researching viral hepatitis for more than 15 years now. Part of that was while I was at NIH and when I left there I was chief of the liver diseases section. I am currently at St. Louis University and medical director of the American Liver Foundation. I was asked to comment specifically on some aspects of hepatitis C, including appropriate standards for diagnosis. I think Dr. Holohan in panel I covered those points adequately enough; nothing to add, really. Next was appropriate standards for treatment. Here I would say that the standards I think were set by the NIH consensus conference which was held in 1997. It laid out criteria for selecting patients for treatment. For example, they needed to have raised liver enzymes, positive hepatitis C RNA, a liver biopsy showing significant liver disease, and then they said also that patients who already have advanced liver disease, cirrhosis, or those where the liver disease was very mild could still be treated, but on an individual basis. Then they laid out conditions for categories of patients who should not be treated outside of clinical trials or with extreme caution, those who have normal liver enzymes, decompensated or very advanced cirrhosis, or the contraindications that we have heard about already this morning, active alcohol or drug abuse or a history of severe depression. I believe that these standards still are appropriate today. What has changed since that NIH consensus conference is the development of an expanded array of therapies to treat patients. There are now 4 forms of interferons available and approved by the FDA. In addition, we have the use of ribavirin, which is used as an adjunct to interferon. To give you some numbers on that, because this came up with panel I, the data on developing a sustained response to the combination treatment overall is about 36 percent versus 16 percent using interferon alone. I was also asked to comment on my view of the status of the VA program to test and treat veterans, and I am certainly aware of the designated VA Centers of Excellence and the information reported by panel I, and their achievements in such a short time have been remarkable and I commend them for that. But in order to find out what was happening at the local level, I sought information from the director of the division of gastroenterology at my local VA, the St. Louis VA Medical Center, to find out what was actually happening on the ground. This is an unusual VA because it is affiliated with two major medical schools, both of which have a strong interest in viral hepatitis, great expertise. They in fact had established a hepatitis C clinic about 2 years ago. So far in this clinic they have evaluated and counseled more than 200 patients testing positive for hepatitis C. They found that only about 1 in 10 of the patients in their specific clinic met the criteria for treatment and they are currently treating about 20 such patients. This director of gastroenterology pointed out to me several problems that they have identified. Although they have been successful on the service, they have several problems. The first was the waiting list. To be seen in this clinic is about 6 months, so a patient diagnosed with hepatitis C to be evaluated by an expert would need to wait 6 months to be seen by these specialists. Second, he felt that he was receiving insufficient support by pathology and laboratory services, and this concern relates to the limitations put on the use of HCV RNA testing, the blood test, and lack of formal training and experience in liver pathology by people seeing the liver biopsies done in these patients. Third, really insufficient knowledge about hepatitis C by their referring sources. Thus, many patients are referred inappropriately to the hepatitis C clinic or may not have had an adequate workup before they are referred then. So I suspect that these issues at the St. Louis VA represent a microcosm of the situation nationally with some local variability. Moving on from there, I would make a couple of additional points. Most of the focus so far has been on getting the veterans tested and evaluated for antiviral therapy now, but I think thought needs to be given to the future, to the expected rise in the incidence of liver failure and liver cancer or a hepatocellular carcinoma that will occur over these veterans over the next 2 decades and the resources for the wave of morbidity and mortality need to be developed. Another important element of the VA program that I believe could be strengthened is research. Although there is already considerable VA-funded research, not much of it appears to be VA-specific. That is, there are many important questions to be addressed that could best be answered in the VA system. For example, what exactly is the role of combat exposure in the transmission of hepatitis C? What are the mechanisms of resistance to therapy in some patients and how does this apply to the VA? Finally, an issue key to the success of the VA program I believe is that it not be required or seem to require taking away resources from other VA programs. This is an element of discussion earlier with panel I. Mr. Chairman, I will conclude my remarks there. [The prepared statement of Mr. DiBisceglie follows:] [GRAPHIC] [TIFF OMITTED] T9652.019 [GRAPHIC] [TIFF OMITTED] T9652.020 [GRAPHIC] [TIFF OMITTED] T9652.021 [GRAPHIC] [TIFF OMITTED] T9652.022 [GRAPHIC] [TIFF OMITTED] T9652.023 [GRAPHIC] [TIFF OMITTED] T9652.024 [GRAPHIC] [TIFF OMITTED] T9652.025 [GRAPHIC] [TIFF OMITTED] T9652.026 Mr. Shays. Thank you very much. Mr. Brownstein, we will go with you and then I will have Mr. Towns ask questions, Mr. Sanders, and then I will ask questions. Mr. Brownstein. Mr. Chairman and members of this subcommittee, my name is Alan Brownstein, and I am the president and CEO of the American Liver Foundation. I thank you for giving us an opportunity to have our organization present our views to you today concerning the risk of hepatitis C infection to veterans. As a national voluntary health agency, our mission is to prevent, treat and cure hepatitis and other liver diseases through research and education. We are made up of chapters throughout the country, and we provide information to over 400,000 patients and families and over 70,000 physicians in America. The prevalence of hepatitis C in the United States is staggering. We have 4 million Americans who have hepatitis C, 10,000 with hepatitis C die every year, and as you heard before, hepatitis C is the leading cause of liver transplantation. Overall, 1.8 percent of all Americans have hepatitis C. What is shocking for this meeting here, as if that isn't shocking enough, is that 8 to 10 percent of all veterans have hepatitis C. Clearly, hepatitis C is a major health challenge for America, and in fact, will be the most significant infectious disease challenge as we enter the 21st century for us, but it is also an incredible challenge for U.S. veterans. Because hepatitis C is a quiet, a silent kind of virus, the vast majority of veterans with hepatitis C are not aware that they have it, because they do not have symptoms. We have heard a lot about treatment and that somewhat less than 40 percent of those who are eligible for treatment to receive it have a sustained response. It is also important to identify all veterans who have hepatitis C because there are other interventions that can help. Concretely, it is incredibly important that people with hepatitis C not drink. Drinking is like throwing gasoline onto a fire, so it is very important that this kind of message is given to those with hepatitis C. Also, it is of great importance that those with hepatitis C be vaccinated to protect them against hepatitis A and hepatitis B. While that is important for all Americans in many important areas, it is especially important for those who are infected with hepatitis C so that they are protected against additional liver damage. I would like to thank this committee and the chairman of this committee, because we appreciate the leadership that you have provided to focus America on hepatitis C. In your October 1998 report, Hepatitis C: Silent Epidemic, Mute Public Health Response, that is incredible, because I think the humor in that title really underscores how serious the problem is. You have really opened our eyes, so I thank you for that. It says indeed, your input has paved the way for this veterans initiative, as the report pointed out, to the problem in U.S. veterans where you said that the Department of Veterans Affairs should conduct additional studies of the prevalence of hepatitis C in veterans' populations. As the chairman knows, on March 17, 1999, the VHA conducted a very significant national blood test of 26,000 veterans for hepatitis C antibody and found a prevalence rate of 8 to 10 percent as I mentioned before. This is more than 5 times the national rate. And we also--the committee's foresight in calling for this test has confirmed the need and has paved the way for the $250 million that we hear has been requested by the Department of Veterans Affairs for fiscal year 2000. Our view of what the Veterans Health Administration has done is, others say that we are really very impressed with the mobilization that they have put forward in launching an attack against hepatitis C among veterans, and that the mobilization has been put into place. Now we are looking at implementation, full implementation in the year, in the years ahead. We believe that this implementation presents several critically important challenges. 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 reconvening this body next year and finding 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 that there isn't a need, it would signify that we haven't effectively translated that need into an effective demand that can be responded to. So that is the first challenge, and we believe that this is an important challenge to the Department of Veterans Affairs; it is also an important challenge to Congress and also to the private sector and the American Liver Foundation is prepared to assist in whatever way we can from the private side, as I know other organizations are willing to do as well. The second challenge is that $250 million of treatment will not happen unless providers, the health care providers, the primary care providers within the VA are well--and all of those who are associated with the VA are well educated, well educated about hepatitis C. It is interesting because the American Liver Foundation has done many consumer awareness campaigns and our hotline gets about 15,000 calls a month. After we do campaigns, what we have learned is that people call us and they tell us we followed your advice, we went to the doctor and the doctor said it wasn't necessary to get tested, or we were tested and the doctor told us that it wasn't necessary to pursue treatment or not to worry about it. So while we are doing this campaign, we have an incumbent responsibility to make sure that the providers who are associated with treating veterans are well educated about hepatitis C. The third challenge is that the $250 million of treatment will not occur unless there is an effective awareness campaign directed at U.S. veterans. In other words, most are not aware they have it; most don't have the--the overwhelming majority don't have symptoms. Often, when you have symptoms, it is too late. So it is very important that we spark public awareness. And this again, public and private sector partnerships offer a great potential for us to really attack hepatitis C among veterans. One example is the public service announcement that you see here, but a heck of a lot more is needed to get that message across. So we have to use health education techniques, but also commercial techniques at selling hepatitis C, explaining what hepatitis C is all about to veterans in the broadest sense. But again, the broadest sense is not enough. The attention of veterans is captured. Once that happens, we will not succeed unless we meet the challenge of veteran education and outreach. It is extremely important that we reach those who are affected in culturally appropriate ways. We need to address the different subgroups within the veterans population. It is no longer a one-size-fits-all world. We must have targeted messages at veterans from different cultural, racial and ethnic backgrounds. There need to be different literacy levels to make sure those messages reach those veterans, and there needs to be a system of support groups so that the veterans have that background of support as they are struggling through the difficulties that many experience in their treatment, as well as the difficulties that will be faced by many who will not respond well to the treatments. The next challenge is that if we are going to commit $250 million to fighting this disease among veterans, it is extremely important that we put accountability mechanisms in place so that we can figure out and we can look in the mirror and say, are we succeeding in this enterprise, and if we are not, how can we develop the corrective strategies to better do what we need to do to reach the veterans who are affected by hepatitis C, and to us, we believe accountability includes performance measures for testing, diagnosis and treatment; performance measures for outreach and education, establishing a data base to measure performance, and also having an annual report of results so that we can constructively move forward. And then the last challenge that I would like to present in closing is that we need to maintain the momentum. As Dr. DiBisceglie and others have pointed out, it is extremely important that we understand this is not going to be a 1-year solution. We have to be in this for the long haul. And from the private sector side, the American Liver Foundation has formed its own veterans hepatitis C and liver disease council that will include members from leadership from the top veterans service organizations and top medical and scientific people in and out of the VA. So we are prepared to work with you, and we need to have that kind of a partnership. We really need to look at this headline that was in yesterday's USA Today. It says millions hit hepatitis C deadline. What it means is that unlike HIV, which moves pretty quickly, hepatitis C is a slow burn in its natural history progression for most people. However, even though it progresses slowly, we now have veterans who have been exposed to hepatitis C for 10, 20 and even 30 years. So now we are in a race against time for those where there is inexorable damage that is being done to their livers. So that really now is the time to act and we need to have the urgency. I thank you, Mr. Chairman and the members of this subcommittee, for creating this sense of urgency about this very serious public health challenge that we face today. Thank you. [The prepared statement of Mr. Brownstein follows:] [GRAPHIC] [TIFF OMITTED] T9652.027 [GRAPHIC] [TIFF OMITTED] T9652.028 [GRAPHIC] [TIFF OMITTED] T9652.029 [GRAPHIC] [TIFF OMITTED] T9652.030 [GRAPHIC] [TIFF OMITTED] T9652.031 [GRAPHIC] [TIFF OMITTED] T9652.032 [GRAPHIC] [TIFF OMITTED] T9652.033 [GRAPHIC] [TIFF OMITTED] T9652.034 [GRAPHIC] [TIFF OMITTED] T9652.035 [GRAPHIC] [TIFF OMITTED] T9652.036 [GRAPHIC] [TIFF OMITTED] T9652.037 [GRAPHIC] [TIFF OMITTED] T9652.038 [GRAPHIC] [TIFF OMITTED] T9652.039 [GRAPHIC] [TIFF OMITTED] T9652.040 [GRAPHIC] [TIFF OMITTED] T9652.041 Mr. Shays. Thank you. Mr. Brownstein, Mr. Towns and I were very involved, as well as Mr. Sanders, in this when we were looking at HIV, and it was that silent epidemic, just kind of that shadow epidemic, and it really hit us all that we needed to deal with it. So we thank you for your nice words, but it just kind of hit us in the face and slapped us around. We needed to deal with it. We appreciate all that you are doing and others on the panel that you are doing, and we also appreciate what the VA is doing to try to get a good handle on this. We have a ways to go, though. Mr. Towns. Mr. Towns. Thank you very much, Mr. Chairman. Let me begin by thanking you for really sticking with this and working on it. You have put a lot of time on this, and of course it is a very serious problem and I want to congratulate you on the kind of effort that you have put forth. Also Mr. Sanders, who has also been involved in this issue for quite some time, and I want to salute both of you before I raise any questions. The first question I have, why do you think that it is much higher among veterans? I saw the video, but is there anything else that we need to know as to why it is so much higher among veterans than the general population? Mr. Duggins. Well, I think one of the reasons is it is the exposure to blood products in the combat environment. The general population do not have that effect. We might be seeing it in the cities now, but what I am saying in a combat situation, if your friend is wounded or you may have a scratch or something and you are dealing with his blood products, you don't have time to put on rubber gloves or take the necessary precautions to make the environment safe for you to deal with blood products. For us who are Vietnam veterans, at the time we were getting blood transfusions and blood products, the testing for hepatitis C or the testing of the blood products wasn't anywhere near where it is now. So we got bad blood. That is just the bottom line. I think more veterans were exposed to that. I don't think our conduct and behavior is any different than any other portion of our society. Mr. Baker. I also believe that in the veteran community, even though combat is definitely one of the biggest risk factors, veterans, they acclimate back into their own communities, they acclimate back into the armed forces, they are still with veterans, they are still amongst each other, and there are possibilities of transmitting other ways. As we said, possibly tattooing and other ways like that. So as they acclimate back in with other veterans and even when they come into the civilian world, veteran communities seem to stay together. So there is that process that we are more of a community and we are interacting more together, so the possibilities and the risk factors are higher for us as well, from point of service to being in the world again, and still to this day we interact with each other. We are always with each other. Mr. Towns. You just said something there that raises another question in my mind. You mentioned tattoos. All the young people today are going out and getting tattoos. Mr. Baker. Correct. Mr. Towns. It is a big thing among the young people. Nobody seems to be making the statement that this might be a connection here and nobody is saying it. So I am concerned about the education and prevention part of all of this. I would like to hear you on that. Mr. DiBisceglie. Let me comment specifically on tattoos, Mr. Towns. I think that the CDC has not been able to identify tattoos as a risk factor, but I think what they are thinking of is the kind of tatoo that is what is done commonly these days, in a tatoo parlor where there is awareness of the risk of transmitting blood borne viruses. I think what is of more concern is tattoos that are done perhaps in other countries while somebody was in the service, for example, in a back street or by a friend or something like that, where we are uncertain about the sanitary conditions. That does pose a potential risk. The usual kind of tatoo that is done commonly these days I don't believe represents a big risk. Mr. Brownstein. I agree completely with what Dr. DiBisceglie has said, because tatoo parlors now by and large are aware of it. But I would just say, for any young person who is considering getting a tatoo, you ought to think twice and make sure you check out whether there are the sterilization techniques. Ask to be shown what techniques are being used, and it should not be done in any casual way. So tattoos themselves do not spread it, it is when unsanitary conditions exist, if I might add that. Mr. Towns. The other thing that--do you want to add something? Mr. Weidman. I did want to mention just one other thing, Mr. Towns. Things that President Duggin pointed out having to do with the very nature of the combat situation itself and exposure to blood for those of us who served in Vietnam on the ground was one of the factors, as well as the other known risk factors. But there is something else that began that everybody went through, whether you served in country or not, that we have raised as an issue continuously with the CDC just recently, again with a long letter to them, and that is the air guns. The Department of Defense earlier this year has discontinued any use of the air gun whatsoever of any manufactured variety. You talk to any veteran in your district, Mr. Towns, or anywhere who went through, particularly the Vietnam era, they can tell you stories about long lines of hundreds of folks lined up with the air gun moving person to person with the blood running down their arm and dripping off the air gun. So because we know from the work of Dr. Siev at NIC and others that as early as 1948 the hepatitis C virus was present in the United States, you had transmission before people even got into basic training. Mr. Towns. I am concerned about the fact that the education prevention part is not stressed enough for me. Why, doctor, do we not deal with the education prevention? There are some things, based on what people are saying, that if people do it is possible for them to avoid it. Mr. DiBisceglie. We are coming along. I think one needs to recognize that is a fairly recently discovered virus. This was only discovered in 1989, 1990. It is only 8 or 9 years old. So it took 3 or 4 years after that to recognize how big of a problem, how widespread of a problem it was in the United States. So with that now, we have seen more and more. In the last 3 years I would say we have seen an acceleration of awareness among both physicians and the general medical public, and I think that education is coming along. However, I think more is clearly needed, as we have heard from the testimony today. Even among physicians who are not involved in treating these patients, their awareness may be somewhat limited, and I think we need more efforts in this area. Mr. Towns. What would you say to the veterans? What recommendations would you have to the VA regarding the nationwide implementation of the hepatitis C testing treatment initiative? I am listening to Mr. Duggin and Mr. Baker, and I am hearing that people are having difficulty getting tested. What suggestions do you have or recommendations do you have to the Veterans Administration? Mr. Duggins. I think one of the recommendations I would have to the Veterans Administration is that they have to do more outreach. I heard them say that they had a web page, but I also heard them say that the people at the most who would be affected are the underemployed and the unemployed. You can't convince me that these guys are going to sit there in front of a computer. Mr. Towns. And a lot of them don't have computers. Mr. Duggins. Right. So the outreach effort has to be rethought. One of the things that I have seen here recently is that in the State of Virginia, and I am from the Virginia Beach area, is that the Commonwealth of Virginia is dealing with the problem of convicts who are HCV positive. And they say well, I don't have the resources to treat these guys. So I am saying, how many of these guys are veterans and who should be treating them. Should the commonwealth be treating them if they are service connected? I can see 50 governments coming to Congress and saying look, guys, this is your problem, clean it up. Therefore, the outreach is limited. I found out about hepatitis C at a leadership conference that we were having and Terry and I both were tested at the same time. Hadn't heard about hepatitis C from the VA system up to that point. It wasn't the VA system that was doing the testing, it was an independent concern who was doing the testing. I ask veterans in my every day walk of life, have you heard of hepatitis C, have you been tested for it, and they look at me like what are you talking about? What is hepatitis C? So the VA can reach people in the system, but they are not reaching the people outside of the system who are veterans. I think that outreach has to be broadened. Mr. Brownstein. I think that you had mentioned your involvement with HIV earlier. I think we have a lot of lessons we could learn about HIV. I would venture to say that probably every one of these young people here knows about AIDS, knows something about AIDS. I bet a whole lot of them didn't know too much about hepatitis C until today. I think that we need to get that word out so that it is on the street. It needs to be on the street, because 400 percent more people are infected with hepatitis C than with AIDS. So just looking at the order of magnitude, we have a heck of a lot of work ahead of us. And the same applies to veterans. The average veteran has no idea about hepatitis C until you were tested just about a year or so ago. Mr. Duggins. Right. Mr. Brownstein. I think that what we need--I don't think every veteran should be tested, but I do think every veteran should be screened with some sort of a health risk assessment that doesn't have--put the burden on them to acknowledge what risks they are acknowledging, but just to say, if any of these eight areas apply to you, you ought to be tested, and those in that health risk assessment should be directed at the known risk associated, both on the battlefield as well as other risks that the veterans may have. Dr. DiBisceglie can speak to those risks. Mr. Towns. I have to go vote. That is the reason I am jumping up. Mr. Shays. Kind of weird talking to somebody who asks a question and he gets up and leaves. Mr. Brownstein. Maybe it is because of what I said before. Mr. Duggins. I also think that veterans who have third- party insurance, if they knew about the hepatitis C virus, they would go to their own PCP for testing. I don't think they would overburden the system any. But I do think it is up to the system to get the word out to veterans. I know I would have gone to my own PCP to be tested, and I came to the VA system to be tested. I think all veterans who have that insurance would do that versus burdening down the system. Mr. Shays. Let me ask you about the intake process. What could be done, and I will start with you, Mr. Baker. What could be done to follow a process where we guarantee that there is some uniformity, and that we are making sure that no one is--we are missing anyone. If you put the mic a little closer to you. Mr. Baker. I think the first thing that could be done is the VA has a data base of all of their veterans within their system, and if the VA can send out form letters for issues about how much money on a cost of living allowance that a veteran gets every year, they could send out a form letter to every veteran within the system and explain to get tested for hepatitis C at your local VA clinic or your local VA hospital. That is an easy step to send out that form letter there. Second is when veterans come into the system or come into a VA hospital and request to be tested or also when veterans are there to explicitly make it a point that these veterans be tested, to talk to their directors of VA medical centers and directors of VISNs who have their own priorities on how they want to run their VISN or their hospitals and what they feel is important to bring it down from the top that this is the No. 1 priority issue that all people, all veterans be tested and we do our outreach to make sure that everybody finds out about it. Mr. Shays. Before I go to the other panelists, when you say all veterans, some veterans don't need to be tested, correct? Mr. Baker. That is a--I tend to disagree. I think because we have an epidemic on our hands and because it is within our veteran community that sometimes is spread to our spouses and to other family members, that maybe we should aggressively just test all veterans and get a real idea of what is going on here instead of testing 141 veterans at one hospital when you have 15,000 at that one hospital. Mr. Shays. Let me throw it out to the others. The first part of the question, do you recommend a particular procedure that should be followed to guarantee that there is some uniformity. Mr. Duggins. I think what they should do is to clone the director of division 3. I mean as I travel around the country, VISN 3 seems to be the poster child and others should adopt the procedure that they are using in VISN 3. That is the problem that veterans have. They hear good things that are going on in one division, and then they get denied these kinds of services and then they wonder why. Mr. Shays. Mr. Duggins, if we cloned and had more than one Mr. Farsetta in this world, this would be a dangerous world. Mr. Duggins. Right. And truly VISN 3 is the poster child of VISNs. I always hear good things about that VISN. But some of them don't seem to be getting in the ballpark. Mr. Shays. They have gotten in it early and we should be seeing their successes and failures and so on. Mr. Weidman. Mr. Weidman. Incidentally, I am from New York, and Jim Farsetta loves to come to Washington because sometimes he is more popular here than he is up there. But he is an excellent VISN director. You will notice that a question was skirted earlier today. There is no rigorous plan for taking the entire catchment of each hospital of folks already enrolled for treatment, matching that up against the 10 risk factors and then making sure that everybody who meets the 10 risk factors is tested, it is not happening. It is not happening in any facility that we are aware of. I met one of those risk factors by having been a medic in I Corps in 1969. I asked about testing at the Washington VA Medical Center last July. I was put off and asked again in October and was put off. I have been put off several times and then I started pressing the matter beginning in March. I am due to be--scheduled to be tested this Friday. I am a fairly tenacious guy, and it took that long to get the test even though I had requested it, even though I met one of the risk factors. The one thing that is missing from the plan, and we would agree at VVA that VA has done a good job in putting together a plan, but putting together a plan is not the action part, No. 1. No. 2, within the actual procedures of testing, it is just simply not there at the local hospital nor is it in the protocol that they should go through as part of their normal physical and make sure that this test happens. The other thing is when people initially enroll in reaching outside of the VA, as George Duggins just commented on, to draw people in, people can enroll and if they can go through a battery of tests having to do with what happens to folks, what branch of service did they serve, what years did they serve, what was their military occupational specialty, where did they do service and what actually happened to them, and that is not just hepatitis C, that is lots of other things, ranging from exposure to dioxin to exposure to cortisol, exposure to DU, all kinds of things that would be reasonable for folks to screen for if in fact it is a veterans health care system, and that is not currently happening. We have had discussions with VHA on this and have what we believe is agreement to move forward to put together a task force of veterans service organizations, VA officials and DOD officials to move in that direction so when you go into the VA hospital in my instance automatically because of when and where I served, I would have gotten a hepatitis C screen. Mr. Shays. Let me do this. We are probably going to have a 2-minute recess to enable our young people who are probably a little awkward sitting down all this time to leave if they want. That would probably be helpful. So we will just take a 1- minute recess to allow our students--is that good? Mr. Duggins. That is great. Thank you. Mr. Shays. We welcome you to our hearing and thank you for coming. [Brief recess.] Mr. Shays. Let me call the hearing back to order. What I really think is on the table is the first panel is obviously having to wrestle with the fact that there are limited resources and we are starting to find ways to get the word out and then the question is who gets tested and who doesn't get tested. It is such a gigantic network some VISNs are going to do a good job and some are not. The VA has to find a way to get a handle on that. What I want to do is ask what recommendations would you make to the VA regarding the nationwide implementation of the testing and treatment? One, should we agree that all of the ones at risk should be the ones first and foremost? Second, is there a protocol that you are aware of that is there that you are certain that the right questions are being asked to determine the people at risk, and are you convinced that there is the proper follow on. And I would be happy to have VA respond to this question as well. Mr. DiBisceglie. Well, I think certainly the CDC has considered the question should we be screening the general population, and they have discarded that option. They feel it is not cost effective. Along those lines I would say the same for the VA, but it depends on what the definition of screening is. Everybody should be screened by a health risk assessment questionnaire. If everyone has the 9 or 10 risk factors, if there is any one that is positive, that should move you to the next step of getting a blood test, which is very doable, I think. Mr. Duggins. I think that the main thing that the VA has to do is make certain that the VISN directors buy into the program. If they don't, the implementation is going to fail in their area and the veterans are not going to be tested. I agree that the at risk categories should be the first ones tested and, if dollars allow, any other veterans who seeks this test should have it. I know some of the at risk factors but I think we should put all of the at risk factors out there and then those veterans will know whether they should bother being tested for this. Mr. Shays. Anyone else? Mr. Brownstein. I think that--your part of the question about getting the word out, the American Liver Foundation last week conducted a market research survey of 700 veterans across America, Bruskin survey research firm and I will share this data with you in the next week or two. We are basically trying to find out what the veterans know and don't know about hepatitis C. Also what their behaviors would be if they thought they might be at risk for hepatitis C as well as what they see as perceived provider responses. So based on that data we are going to try to target messages that are directed at veterans to try to capture, to best educate people about that. And toward that end we are preparing a brochure that we are prepared to distribute to 3\1/2\ million veterans associated with the VA and we are already talking with VA officials, and we are going to get their involvement. But the first step is entry into the system. In other words, it has to be stimulating that unmet need into and effective demand based on knowledge from those veterans. Mr. Shays. I am going to be asking one last question on research, Dr. DiBisceglie, probably directed toward you but let me ask if Mr. Sanders has any other questions. Mr. Sanders. I do have questions. Mr. Shays. Why don't we go to your questions. Mr. Sanders. I thought this was an excellent panel and I think all of your presentations were important. What I am hearing, and correct me if I'm wrong, and maybe, Mr. Brownstein, you want to start off and others can pipe in, is that there are large numbers of veterans who are sitting out there with hepatitis C who don't know it. Are we all agreed on that? Dr. DiBisceglie. That is correct. Mr. Sanders. The other panel was indicating that perhaps the numbers that they had seen were perhaps disproportionately high or we don't know the answer to that but I gather that we are looking at--how many folks are sitting out there with hepatitis C who are veterans who don't know it now? Does anyone have a wager or guess? Dr. DiBisceglie. I think we are lacking the data, but those who tested positive in that 1 day sample is 8 to 10 percent. Extrapolating from the general population, 80 to 90 percent of the population with hepatitis C do not know it; 8 to 10 percent would make 350,000, and 80 to 90 percent do not know it. This is a silent disease. It either has no symptoms or they are so vague and nonspecific that would not lead you to think of hepatitis as being the likely cause. Mr. Weidman. Our estimate is 8 to 10 as a minimum and it may be greater, 8 to 10 percent. Mr. Sanders. You think that is the low end? Mr. Weidman. Yes. And you asked the question before having to do with resources of the panel, if we don't test now and start to deal with--first of all, I think it is unconscionable not to test. And second, it flies in the face of the wellness model and we are going to pay a heck of a lot more down the line if we don't catch people before they start to show symptoms. It is just not reasonable for--don't ask, don't tell. Don't ask, don't treat is not a policy that we should be pursuing in this, and so rigorous testing and outreach of people already in the catchment who are doing blood work anyway is simply not reasonable to move forward in a methodical manner. Mr. Sanders. I agree. If VA tomorrow did all of the right things, you are talking about a mammoth outreach and beginning treatment for these hundreds of thousands of people. That is a monumental effort, is it not? Dr. DiBisceglie. Yes. Mr. Sanders. The only other question I would ask is have we tested for incidence of hepatitis C in Korean veterans? Is there anything particular about Vietnam as opposed to World War II or Korea? Dr. DiBisceglie. I think it is 4 percent of Korean veterans have hepatitis C? Mr. Brownstein. I don't know. I did see data presented last Thursday that showed it was somewhat of a bimodal distribution. It was real heavy on Vietnam and then there was some data that showed that Korean and I think even World War II, and I would defer to anyone from the VA who is more familiar with that data. Mr. Sanders. Should there be any difference of incidence? Should there be differences between Vietnam and Korea? Dr. DiBisceglie. I think hepatitis C was a disease that was emerging in the general population after Korea and that explains it in good part. Mr. Sanders. Thank you. Mr. Shays. Thank you. Just to end the hearing, tell me is there any value in having research that is focused directly on veterans' populations? Dr. DiBisceglie. I think there definitely is. Clearly just getting patients tested and evaluated for therapy is just the beginning step. There will be some who don't meet the criteria for treatment now or do not clear the virus therapy, and so those individuals will remain within the system and some will have their liver disease progressing or require medical care there. And there are some I think veteran specific questions that can be answered related to perhaps the demographic variation of the veterans versus the general population. I think we need to look toward the future as well in terms of new treatments. I think the VA needs to stay at the forefront of new treatments as they become available to be able to test and develop them or ways of minimizing the liver disease to avoid it progressing. I think all of these are very valid areas for research. The VA has a large infrastructure and there is now this large cohort of patients, a couple hundred thousand, I think that represents a wonderful research opportunity. Mr. Shays. Yes, sir. Mr. Baker. I think the other thing, and Mr. Sanders talked about it before with the other panel, is their funding. I didn't hear anyone actually say out of that panel but they are underfunded, and they know that they are. Their employees are overworked, understaffed at most facilities and now they have this tremendous new incident that has come upon them. Sure, directives will come down, and I even talked to a director at an RO, and he said directives will come down. But how are we supposed to take care of it. They are losing people every day. Kizer has to make more cuts but we are asking that patients with hepatitis C and veterans be taken care of. And the issue is really money. The VA is trying to do a job at the top to the bottom and their facilities don't have the resources, don't have the people to even try to take, like I said, from Portland. They had a computer specialist more than likely because there was nobody else that they could spare. The other issue is they need funding real bad. Mr. Duggins. We have heard the rob Peter to pay Paul scenario, but Peter doesn't have any money. You are robbing somebody who is already broke. Mr. Weidman. There was talk of the caps and how we need to squeeze in under the caps. Let me say that veterans health care was the only health care for a discrete group of Americans that was flat lined in 1997. Had that been done to African- Americans, to women or to any other discrete group of people that you were going to take over the next 5 years a 50 percent cut in your health care because we are going to flat line you, all the dickens would have broken loose, and we did it to veterans in that kind of a discriminatory way and it slid on through. The cap was wrong to begin with. Let the Congress not be like George Armstrong Custer. Let's go back on this Custer decision and set it right by raising the cap on veterans health care. Mr. Shays. Let me ask you, though, as related to the cap on veterans, there was no determination that we would flat fund it for 5 years. It was a determination that the overall budget would have a slight growth. So I am not quite comfortable with your description. Mr. Weidman. If we went back to 1990 and we charted out medical inflation, we charted out Medicaid, the Federal portion of it and Medicare---- Mr. Shays. So is your point that more money is being spent but less than the required need? Mr. Weidman. And when you factor in inflation. Mr. Shays. So you are basically saying that we are losing ground on inflation. Mr. Sanders. I would just add to what Mr. Weidman says, and correct me if I'm wrong, if the VA does the right thing and they reach out to all of the veterans, the 10 percent who are infected are treated, you must be talking about astronomical numbers that there is no way on God's green Earth you can deal with within the budget. Mr. Brownstein or Dr. DiBisceglie, is that correct? Dr. DiBisceglie. That is correct. Mr. Sanders. If they do the right thing and respond to hepatitis C---- Mr. Shays. I think the record will demonstrate that we are putting tremendous demands on the VA and someone like myself, who does believe that we need to find a way to honor this agreement as best we can, we either have to find the money from some other area, not within VA, or we have to break the cap. Those would be my two options. Let me do this. Since I said responding to the cloning of Mr. Farsetta would make the world a more dangerous place, he is clearly allowed to come back and make any comment he would like. I would like to dismiss this panel and thank them and just invite the VA. If they have any closing comments I am happy to have them make any comments, Dr. Garthwaite, or anyone that accompanied you. Dr. Garthwaite. Thank you, Mr. Chairman. I would just echo your comment for any specific cases, we would very much like to fix the individual case and understand why it happened. Mr. Shays. Mr. Baker, we are hearing that request. Given that you have come forward with some individual cases, it is important that you share them with the VA and share them with our office as well. Let's followup. There is no attempt to blame anyone, but let's say why is this not working and what can be done. And if there are other factors, we would like to know that. Dr. Garthwaite. We have already fixed some specific communication issues. It helps us get uniformity. I am very much interested in how we can use posters and letters to veterans and other things to improve our outreach and to make sure that we let veterans know what else we can do. I think the panel did an outstanding job and we are basically in agreement. Mr. Shays. The only other thing, and I am happy to have you do this in communication with my staff, is how do you provide some uniformity so that everybody is getting that message and it is not just going to a few, and I do think that a lot can be learned from your VISN where you are actually finding that they are already into it, and by reexamining what they are doing well and see how you can use it in other facilities. Dr. Garthwaite. Certainly. One of the concerns people have had about some decentralization of control is the nonuniformity. The good news is that allows creativity which often identifies much better ways of doing business. It is our challenge to find that creativity and the better ways and export that to the other networks. Mr. Shays. I happen to agree that I will take creativity over uniformity, so I have a lot of license in that. In other words, you don't want to hold anyone down who is able to do some things, but to at least make sure that there is a minimum standard of communication, a minimum standard that guarantees you that this word is getting out. Dr. Garthwaite. I agree. Mr. Shays. Thank you very much. With this we will call the hearing adjourned. [Whereupon, at 12:45 p.m., the subcommittee was adjourned.] [Additional information submitted for the hearing record follows:] [GRAPHIC] [TIFF OMITTED] T9652.042 [GRAPHIC] [TIFF OMITTED] T9652.043