FOR IMMEDIATE RELEASE
PRESIDENT AND CO-FOUNDER
ON BEHALF OF THE
HEPATITIS B FOUNDATION
THE UNITED STATES HOUSE OF REPRESENTATIVES
COMMITTEE ON APPROPRIATIONS
SUBCOMMITTEE ON LABOR,
HEALTH AND HUMAN SERVICES,
EDUCATION AND RELATED AGENCIES
THURSDAY, MARCH 13, 2008
This testimony is being provided to highlight the urgent need to address the public health challenges of chronic hepatitis B by strengthening programs at the Centers for Disease Control and Prevention, and the National Institutes of Health.
Mr. Chairman and Members of the Subcommittee, thank you for giving the Hepatitis B Foundation (HBF) the opportunity to testify as the Subcommittee begins to consider funding priorities for Fiscal Year (FY) 2009. We are grateful to the Members for their interest and note how members, such as Congressman Honda, have shown particular concern for hepatitis B.
Today I would like to speak about the urgent need to address the challenge to the public health of hepatitis B. The good news is that there have been great advances and we were getting close to very effective solutions. The worrisome news is that we may be letting down our guard, and the problem is coming back as bad as or worse than ever. I will discuss some of the evidence for this. I will finally speak about ways that we can solve the problem of hepatitis B, which can be accomplished in our lifetime.
My name is Dr. Timothy Block, and I am the volunteer President and Co-founder of the Hepatitis B Foundation (HBF) and its research institute. I am also a professor at Drexel University College of Medicine. My wife, Joan, and I and another couple, Paul and Janine Witte, from Pennsylvania started the Hepatitis B Foundation more than 18 years ago because someone very close to us was affected.
Today, the HBF is still the only national nonprofit organization solely dedicated to finding a cure and improving the lives of those affected by hepatitis B worldwide through research, education and patient advocacy. Our scientists focus on drug discovery for hepatitis B and liver cancer, and early detection markers for liver cancer; outreach staff manages a comprehensive website which receives almost one million visitors each year and a national patient conference; and public health professionals implement research-based initiatives to advance our mission.
The hepatitis B virus (HBV) is the world’s major cause of liver cancer – and while other cancers are declining in rate, liver cancer is the fastest growing in incidence in the U.S. The numbers of people chronically infected with HBV will knock your socks off: there are 400 million people worldwide. Without intervention, as many as 100 million will die from an awful liver disease, most notably liver cancer. In the U.S., up to 2 million Americans have been chronically infected and more than 5,000 people die each year from complications due to HBV.
Every time I speak to a group this size, it turns out someone in the room - or “someone you know” - has been affected.
Most people were infected with HBV from their moms at birth. And most people who are infected are unaware of their infection. Even for people infected at birth, illness, when it happens, doesn’t occur until the individual is in their prime at age 30-50 years. So, you see how tragic this can be. Having chronic HBV is like having a time bomb inside, because you are usually infected for years before suddenly becoming ill, and you don’t know if or when you will become ill.
Additionally, although all ethnic groups are affected - and we started the HBF because of a tragic problem in Bucks County, PA, a very “low risk” place - it disproportionately affects Asians and
Africans. That is, nearly 1 in 10 Asian Americans are chronically infected with hepatitis B. That’s
an incredible number for a community!
But, the news is not all grim. There have been tremendous advances in research and in the control and treatment of hepatitis B over the past 30 years. There is a good vaccine to prevent infection; although, there is now a question as to how long lasting the protection is, if given in infancy. Unfortunately, for the 400 million people already infected worldwide, the vaccine is too late.
For those already infected, there are now several medications that can be taken to control viral replication and prevent disease progression to end-stage liver disease and/or liver cancer; thereby, reducing mortality and the need for liver transplantation. However, most cases of cirrhosis or liver cancer are diagnosed in the late stages, and current methods to treat liver cancer are in the dark ages, literally, and early diagnosis of liver disease is also primitive. HBV screening as part of liver cancer prevention and detection is thought to be one of the best hopes for effective management.
Thus, we were getting close to solutions, but lack of sustained support for public health measures and scientific research is threatening to allow the problems to come roaring back. Clearly, the nation is faced with a major public health challenge that cannot be ignored. If we don’t act with urgency, more and more people will suffer. Let me share just a few examples to dramatize the risks to us all.
The recent crisis in a Nevada clinic, where as many as 40,000 people were placed at risk for infection with HBV, HCV and HIV, is a problem that the Centers for Disease Control and Prevention (CDC) thinks might just be the “tip of the iceberg”. The Nevada incident highlights critical deficiencies with national surveillance of chronic hepatitis B and C infections that are needed to rapidly identify problems such as the one that occurred in the Nevada clinic.
The frightening increase in the incidence of liver cancer, while most other cancer rates are on the decline, represents another example of shortcomings in our system. In the U.S., 20,000 babies are born to mothers infected with hepatitis B each year, and as many as 1,200 newborns will be chronically infected with the hepatitis B virus. More needs to be done to prevent new infections.
But, fortunately, there is a good and proven way to avoid these tragedies. The vaccine and medications were the result of successful innovation and public/private partnerships between industry, academia and the government. People concerned about this problem continue to turn to Congress and the CDC and the National Institutes of Health (NIH). The CDC and NIH have formulated plans and have the ability to, if not solve the problem, get it entirely under control.
Mr. Chairman, may I now turn attention to requests regarding two federal agencies that are critical in our effort to help people concerned with hepatitis B: the CDC and the NIH.
THE CENTERS FOR DISEASE CONTROL, DIVISION OF VIRAL HEPATITIS
We believe a strong, well equipped CDC is our best hope to manage the public health problem of hepatitis B. The HBF strongly supports U.S. Senator Reid’s interest for urgent, supplemental funding dedicated to the CDC, and we believe that a FY 2008 supplemental of at least $7 million for the Division of Viral Hepatitis (DVH) is needed to address and prevent an incident like what occurred
at the Nevada clinic.
The DVH has had “flat funding” for the past five years, despite the urgency and growth of this problem. DVH is included in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC, and is responsible for the prevention and control of viral hepatitis. Currently, DVH focuses primarily on acute hepatitis A, B and C. While that’s been very successful in decreasing new infections, little has been done about chronic hepatitis B and C, which impacts more than 6 million Americans and if left untreated, often leads to fatal liver failure or liver cancer.
The HBF calls for a “zero tolerance” policy against new HBV infections, particularly among newborns, and against leaving infected pregnant women uneducated and unprotected. All pregnant women who test positive for hepatitis B should be referred to appropriate follow-up care and treatment. With a safe vaccine and six approved therapies for hepatitis B, no woman or child should be left behind. HBF also urges an expansion of cooperative agreements to test and validate evidence-based interventions focused on the mother-child transmission issue, and the prevention and management of HBV in high-risk ethnic communities.
The HBF supports increased resources to build the capacity for the Division of Viral Hepatitis to improve public health interventions by building a robust national active surveillance of chronic HBV and HCV, strengthening state and local viral hepatitis prevention networks, and educating the community and providers to raise awareness about the importance of early detection and intervention of chronic hepatitis. Strengthening chronic hepatitis B education, testing, and referral to care programs will make an enormous difference in decreasing new infections and decreasing the mortality and morbidity associated with chronic viral hepatitis.
Both Drs. Kevin Fenton and John Ward, of the CDC, have shown great leadership and spoken eloquently on the state of hepatitis B in the U.S. Dr. Ward, for example, has observed that “Hepatitis B is the deadliest disease that can be prevented through infant vaccination.” Dr. Ward also recognizes the need for recommendations to ensure HBV-infected pregnant women are educated and referred to care, rather than treated merely as vessels of disease. More investment in DVH, however, is required to bolster their programs to address the problems of chronic viral hepatitis.
To meet these needs, we request $50 million in FY 2009 for the DVH. This would allow for a comprehensive, aggressive approach. However, an additional annual increase of at least $5 million, beginning in FY 2009, is considered the minimum increase needed to sustain existing program and allow for minor reinforcements, in particular, to fund an Institute of Medicine Study to characterize and document the true burden of chronic viral hepatitis disease in the U.S., which is urgently needed.
Overall, the HBF joins with the CDC Coalition, a nonpartisan coalition of more than 100 groups, in supporting $7.4 billion for the Centers for Disease Control and Prevention in FY 2009. The CDC programs are crucial to the health of all Americans and key to maintaining a strong public health infrastructure to protect us from threats to our health. At a time when the CDC is faced with unprecedented challenges and responsibilities ranging from chronic disease prevention, eliminating health disparities, bioterrorism preparedness, to combating the obesity epidemic the Administration has cut the CDC’s budget by $412 million. We urge the Committee to restore this cut and fund the CDC at $7.4 billion.
THE NATIONAL INSITUTES OF HEALTH
We depend upon the U.S. NIH to search for new interventions to treat people with hepatitis B and liver cancer.
In FY 2008, NIH is expected to spend approximately $42 million on hepatitis B funding overall. Although it is unseemly to compare one disease with another, since for anyone affected it is the disease that afflicts them that is the most important, it may be useful to know that the NIH currently spends $2.9B on HIV and billions on biodefense. Current estimates predict that HBV research funding will be flat or decline for FY 2009.
Please help correct this situation. There are good plans that show how an additional $40 million per year can make transformational beneficial advances for HBV research. If this is not possible in the current funding climate, we urge that the level of funding for HBV research be increased by at least 6.7% in FY 2009.
Mr. Chairman, I would like to take this opportunity to commend the leadership of NIH, and especially the leadership of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute, and the National Institute of Allergy and Infectious Diseases for their continued interest in liver disease research. They have performed admirably with the limited resources they are provided; however, more is needed.
The NIH published a 10 year Liver Disease Research Action Plan in 2004, and to date, NIDDK has succeeded in several important areas such as funding a network of HBV Clinical Research Centers and hosting the first HBV Consensus Conference focused on identifying best treatment practices for chronic hepatitis B infections. The growing number of treatment options is encouraging and suggests a strong rationale for conducting a consensus conference to provide state-of- the- art treatment guidelines for the practicing physician community.
Mr. Chairman, HBF joins the Ad Hoc Group for Medical Research Funding, a coalition of some 300 patient and voluntary health groups, medical and scientific societies, academic research organizations and industry, in recommending $31.2 billion (6.7% increase) for the National Institutes of Health in FY 2009. The FY 2009 Administration budget request for NIH is flat compared to FY 2008 funding levels, which is due to the effects of biomedical inflation, and translates to a cut. In the five years through 2008, NIH has lost approximately 11% in purchasing power due to inflation. Therefore, if the President’s FY 2009 request becomes law, NIH will have lost one-seventh of its purchasing power due to inflation.
SUMMARY AND CONCLUSION
While the HBF recognizes the demands on our nation’s resources, we believe the ever-increasing health threats and expanding scientific opportunities continue to justify higher funding levels for the CDC’s Division of Viral Hepatitis and the National Institutes of Health than proposed by the Administration.
In the words of Dr. Jay Hoofnagle, Director of the Liver Branch at NIDDK, “We have this virus by the legs.” We ask that you not let it get away, since the consequences will be grave. This is a public health problem we can fix!
Mr. Chairman, we wish to thank the Subcommittee for its past leadership. I recognize Congressman Honda and others on this Subcommittee as having been sympathetic and helpful to the cause.
Significant progress has been made in developing better treatments and cures for the diseases that affect humankind due to your leadership and the leadership of your colleagues on this Sub-committee. Significant progress has also similarly been made in the fight against hepatitis B.
In conclusion, we specifically request the following funding for a FY 2008 supplemental and for FY 2009 programs:
- Provide at least $7 million in the FY 2008 supplemental to improve and expand the DVH chronic hepatitis surveillance program to help prevent problems such as what recently occurred at the Nevada clinic;
- In FY 2009, restore the CDC budget to $7.4 billion, with a $50 million increase to the Division of Viral Hepatitis (or at least an increase of $5 million) to strengthen the public health response to chronic viral hepatitis; and
- In FY 2009, provide a 6.7% increase for the NIH bringing the total funding level to $31.2 billion, including a $40 million increase per year for hepatitis B research.
The Hepatitis B Foundation appreciates the opportunity to provide testimony to you on behalf of our constituents and yours.