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STATEMENT OF C. EVERETT KOOP, M.D., SC. D.
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Date Posted: Sat, January 12 2002, 6:04:08 PST
Testimony by C. Everett Koop, M.D., Sc. D.
STATEMENT OF C. EVERETT KOOP, M.D., SC. D.
BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
U.S. HOUSE OF REPRESENTATIVE
MARCH 5, 1998
Mr. Chairman and Members of the Committee:
My name is C. Everett Koop, M.D. I am the former Surgeon-General of the United States. During my tenure in the Reagan and Bush Administrations, I spearheaded the campaign to increase public awareness of the AIDS epidemic and encourage a comprehensive federal response to prevention, detection, and treatment of the disease. Now, over a decade later, the federal government is dedicating substantial resources to this disease, including public education, research on transmission, prevention, and treatment and to treatment itself. While more than 700,000 Americans are infected with HIV, new cases of AIDS are thankfully declining. Nevertheless, despite the billions spent on AIDS research, there is still no cure for AIDS.
Mr. Chairman, I would like to thank you for extending me an invitation to appear before you. I commend you and the Committee for your leadership on blood safety issues and in particular for your attention to the disease we are discussing today - hepatitis C.
We are at the edge of a very significant public health challenge - not unlike the AIDS epidemic. We have an infectious disease that is an undisputed threat to the public health. It is a viral disease that millions of people harbor without knowing they have it. It is a disease these millions will carry for a decade or more - possibly spreading to others -while it develops into a serious threat to their health. We can treat the disease during this quiescent period and we can eliminate the infection for a large portion of the infected, preventing progression to serious disease.
But we in the public health community have done practically nothing about it to date. We are starting with a blank slate, and we have a long way to go very quickly if we are to prevent the very serious public health consequences of this disease.
Hepatitis C - The Silent Epidemic
We call hepatitis C the "silent epidemic" because so many Americans have the disease (over 4.5 million), so few know they have it (only 225,000 or 5%), and such a small portion (40,000 or 1%) have had treatment for it. Hepatitis C is a particularly insidious disease. It is a blood borne infection, easily transmitted through blood-to-blood contact. Those who are exposed usually get the disease. It rarely, however, appears as an acute infection. Instead, it develops into a chronic disease with few symptoms and lingers for 10 to 30 years before it results in permanent liver damage and, in many cases, liver cancer or liver failure. The disease is insidious for several reasons:
1. The vast majority of people infected with HCV do not know it -most of the 4.5 million Americans infected with hepatitis C virus are not aware of their risk for the disease, nor do they experience any acute symptoms. Any symptoms they may have are often mistaken for flu symptoms. Their first awareness may come years later with liver dysfunction.
2. There is a sizable pool of HCV infected people - with over 4 million HCV-infected Americans unaware of their infection, there is a danger of unwitting spread of the disease.
3. There is no vaccine for Hepatitis C - unlike Hepatitis A and B, there is no vaccine effective against C, and there is little chance that one can be developed.
4. Much is still unknown about HCV - Ten years ago we knew practically nothing about this disease. Effective tests for Hepatitis C only became available in this decade. As a result, there is still much that medical researchers do not know about how this disease is transmitted or how it progresses in an infected individual. We cannot, therefore, be assured that the means of transmission are clearly understood.
5. Many with HCV have no reason to suspect they are infected - many of those at high risk are average people - middle-aged housewives who had a caesarean section delivery, young adults who had transfusions as high risk babies, or middle-aged men who served in Vietnam. The focus of the public health effort to date, however, has been on marginal populations (e.g. IV drug users, people with tattoos or body piercing). As a result, many average Americans with HCV infection do not suspect it and many may be discouraged from seeking medical attention if a stigma is attached to HCV infection.
Unlike many other viral diseases, hepatitis C, if detected and treated, can often be cured. I want to stress that there are very few viral diseases about which this can be said certainly not AIDS. Treatment with alpha interferon over a period of 12 to 18 months will reduce the viral count or "load" below detectable levels for 25 percent of the treated population, and will improve liver functioning for another 25 percent who still have evidence of the virus. In addition, new combination therapies, such as alpha interferon with ribavirin, that are expected to be approved this year show promise of raising the "cure" rate to 45 percent or higher.
Hepatitis C is Not Just Another Hepatitis
One of the big problems we have with public awareness of hepatitis C is that it is often confused with other forms of hepatitis that are preventable and not as deadly. Unfortunately, this confusion is not helped by public education efforts that discuss hepatitis in general. We need to end this confusion. Hepatitis C - unlike other hepatitis - is a very serious life-long infection for which there is no vaccine, that is not self-limiting, and that will, for many of those infected, lead to serious liver disease, organ failure, and premature death.
When most people hear the word "hepatitis," they think of hepatitis A. Hepatitis A is a food- or water-borne illness, usually transmitted through the contamination of food with fecal matter. It is a short term, acute disease, against which the body develops its own defenses. While there is an immunization for hepatitis A, there is no particular treatment, although the disease usually resolves itself within a month. Very few people die of hepatitis A. There are fewer than 150,000 new cases of hepatitis A per year.
Hepatitis B is another, very different form of hepatitis. Hepatitis B is, like C, a blood borne virus. However, B can be readily transmitted through exchange of body fluids. There is an effective vaccine for hepatitis B that is now being given to young children and to people who travel abroad. Hepatitis B usually appears in acute form, with over 70 percent of these cases resolved by the body's defenses. Only 20 to 30 percent of hepatitis B cases become chronic. There are between 150,000 and 300,000 new cases of hepatitis B a year. The sum of hepatitis cases other than C is fewer than a half a million.
Hepatitis C is a very different disease. The hepatitis C virus is not as easily transmitted as A and B. When there is an exposure, however, the patient almost always contracts the disease. There is no vaccine for hepatitis C and is not likely to ever be one. The body does not have natural defenses, so that the patient that contracts the disease develops it in chronic form and, without treatment will carry it for life. The only known treatment for it is alpha interferon, which is effective in eliminating the disease for about 20 to 30 percent who seek treatment. While there are fewer than 200,000 new cases of hepatitis C a year, there are a large number of people (over 4.5 million) who are carrying chronic HCV infections.
A Present Opportunity to Detect and Treat Hepatitis C
We stand at a critical point with hepatitis C. We have very sensitive and reliable screening available - and will soon have these in forms suitable for mass screening. We have a hope of curing the disease for some and improving liver functioning for others, and this hope is growing every day with new research and new treatments. We have a consensus in the medical community on management of the disease. We are still within the window of opportunity where we can head off serious liver disease for a large portion of the infected population. If we do not act, we will see a tragic increase in liver disease, the demand for liver transplants, and in the death rate from hepatitis C related liver failure. Education about the virus is key, for both the public and their doctors. Remarkably, virtually none of those who have this disease know they have it. We are in virgin territory. We can significantly increase recognition of the disease. We can vastly increase screening, detection, and treatment. We can have a significant impact, if we act now.
The U.S. Department of Health and Human Services is prepared, as you know, to launch its first serious efforts to fight this disease. Based on the recommendations of its Advisory Commission on Blood Safety and Availability, the Department is preparing to launch a substantial look back to identify blood donors who were found to be HCV positive once screening became available and to notify anyone receiving blood from these donors in the period between 1987 and 1992. While this look back will be a massive undertaking for the Department, we need to recognize that it will affect only a very small portion of those who are at risk for HCV infection.
The guidance currently being developed may limit the look back population those who received blood from donors who were later confirmed HCV positive through two tests and initial screening test and a confirmatory test. There are many more people infected through transfusions of blood from HCV positive donors whose donation predated the availability of screening in 1987, or whose blood was only screened once. I commend the Secretary for her leadership in launching this initiative. It is good to have her interest, and that of her colleagues, on this issue.
A Reluctant Federal Response
The Department's leadership on Hepatitis C, however, does not reflect what I otherwise perceive to be a general reluctance in the federal government as a whole to address this issue. I am well aware of the concern with this disease - as there was with AIDS - that we approach it carefully so as not to panic the public. I believe this excess of caution is unnecessary and is putting millions of people who are infected with HCV needlessly at risk. There are several places where I am concerned about the position the federal government is taking.
1. Known risk factors - the Centers for Disease Control (CDC) has taken the position that we can explain virtually all of the transmission of this disease, and therefore understand the risk factors. CDC contends that with transfusion risk reduced substantially as a result of improved screening, the major risk factor today is IV-drug use. While CDC previously stated that 40 percent of the transmission was unexplained, they now believe that many of these individuals were infected through IV drug use, which they now believe explains the majority of the cases of new infection. Yet we continue to have confusing information from the CDC about transmission. Just a few weeks ago, they announced that one-fourth of the transmission may be through sexual activity - a factor previously thought to be insignificant. The fact is we are not really certain how the disease is transmitted for a large portion of the cases.
2. Focus on new HCV infection only - CDC's focus on acute disease and the prevention of acute disease has led to a strange position on hepatitis C - which is rarely manifest in acute form. CDC has focused on the very tip of the iceberg, which is the incidence of the hepatitis C - the new cases of infection. Because this is a relatively small and declining number, the CDC has viewed this as a disease largely under control. However, there are over 4.5 million people currently infected, who will remain infected for decades. We have a coming tidal wave of liver disease. Our focus in prevention should be on preventing the liver disease and not just the HCV infection. I do not believe the CDC has begun to do enough to understand chronic HCV infection among the millions who have it.
3. Focus on marginal populations - The focus at the CDC on the causes of new infection has led them to view this as a disease of marginal populations who have high-risk behaviors (e.g. IV drug users). This misses the fact that among the millions who now have chronic HCV infection are many who got HCV through blood transfusions or other activity that was completely normal. The failure to acknowledge the more average characteristics of those currently infected marginalizes the disease and keeps people who have hepatitis C from recognizing they have it and seeking treatment.
4. Inadequate monitoring of hepatitis C - The CDC's focus on acute disease means that they do not permit reporting of chronic hepatitis C infection. Since hepatitis C rarely occurs in acute form, much of CDC's reporting of data is for a skewed population - those who show up with acute disease. While CDC does analyze data from sentinel county studies, and develops prevalence data based on cases in the Health and Nutrition Survey (HANES)with chronic disease, these data are limited and do not permit adequate tracking or analysis of chronic disease.
A Prescription for Action on Hepatitis C
If we are to get hepatitis C under control and prevent a huge increase in liver disease, the federal government needs to do several things:
· Public Education-We need a very visible public education effort to alert people who are in the high risk groups about the consequences of the disease and the opportunities for screening, treatment, and management of hepatitis C.
· Training of Primary Physicians - Primary care doctors are our first line of defense against this disease. Because the symptoms are not always that apparent, many physicians miss the signs of the disease or misdiagnose it. CDC launched an effort this year to educate primary physicians. We need a far more extensive effort, and one that clarifies the tools available for detection and treatment.
· Comprehensive Government-Wide Effort - The Administration needs to assign overall coordination responsibility for federal programs in a number of federal agencies that can have a substantial impact on identification and treatment of hepatitis C. It is my understanding that there has been a lack of attention to this disease in the Department of Defense or in the Department of Veterans Affairs where rates of infection are likely to be high and where screening and treatment can have a positive impact.
· Chronic HCV Reporting - The CDC should revise their reporting forms to permit reporting of chronic HCV infection in order to improve monitoring and understanding of this disease. CDC currently proposes collecting data on liver disease. Chronic HCV infection precedes onset of liver disease and needs to be measured as part of an effort to prevent liver disease.
· Proactive Strategies- There are particular populations with unusually high rates of infection where an aggressive effort to seek out and eradicate the disease could substantially and immediately affect future liver disease rates and be beneficial to the public health.
Specifically, we need to focus on the following populations:
· Veterans and Military Personnel - In some studies of veterans entering the Department of Veterans Affairs health facilities, half of the veterans have tested positive for HCV. Some of these veterans may have left the military with HCV infection, while others may have developed it after their military service. In any event, we need to detect and treat HCV infection if we are to head off very high rates of liver disease and liver transplant in VA facilities over the next decade. I believe this effort should include HCV testing as part of the discharge physical in the military, and entrance screening for veterans entering the VA health system.
· Prisons - About 40 percent of all prisoners in the U.S. - in federal and state prisons - are infected with HCV. These are alarming rates. In some prisons, the rate of infection has reached 80 percent - virtually saturation level. These prisons are a pool of infection that can affect the community health when prisoners are released into the community. The confinement of prison offers a suitable environment for treatment, and we should make every effort to testing and treat those who are infected.
· AIDS - a substantial portion of the HIV-infected population is co-infected with HCV. HCV co-infection interferes with the effectiveness of the protease inhibitors in the new HIV "cocktails." Screening and treatment for HCV should be an important part of the overall HIV treatment protocol. Specifically, the AIDS Drug Assistance Program, provided for in the Ryan White Act, may be more effectively utilized if HCV treatment was incorporated in the protocol.
· Women with a History of C-Section Delivery - Women with no recollection of
any history of high-risk activities are beginning to appear in middle age with symptoms of serious liver disease resulting from HCV infection. For a number of these, the trail leads back to blood transfusions they received unknowingly when they had Cesarean section surgery during childbirth. Studies in the 1970s and early 1980s indicated that during this time of high risk of HCV infection through the blood supply, as many as 20 percent of C-section patients were given transfusions. An estimated 8 to 10 percent of these women would have HCV infection today. This population needs a special effort because it is beginning to develop serious liver disease, and will fall outside the period of the HCV lookback.
· Young Adults who were Critically Ill Newborns - The risk of hepatitis C virus (HCV) infection is also suspected to be unusually high among persons who were critically ill at birth. From the mid-l970s to the early 1990s, low birth weight and other critically ill babies were routinely given multiple transfusions of small amounts of blood during a period when the blood supply was not screened for HCV. These young people would now be between 5 and 25 years of age. With few exceptions, only the oldest would be experiencing symptoms of liver disease, making this a particularly consequential group for screening and treatment. Only a portion of this group will be identified through the HCV lookback.
I would like to close by again commending the Secretary of HHS for taking the leadership in making the blood lookback a priority. This will be a substantial and critical undertaking. We cannot afford, however, to get carried away with the lookback effort and miss the imperative of addressing hepatitis C infection more broadly. We need a coordinated federal effort that reaches across the relevant agencies and identifies activities that can be significant in training physicians, raising public awareness, and seeking out target populations for screening and treatment. I believe we have a 5-year window to identify and treat a significant proportion of the infected population if we are to head off the huge increase of liver disease I believe is ahead.
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