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New NIH Liver Disease Research Branch: Action Plan For Liver Disease Research
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New Branch to focus and accelerate research in liver disease
1st meeting held Tuesday November 26 at NIH
Reported by Jules Levin
As of June 1, 2003, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) created the Liver Disease Research Branch within the Division of Digestive Diseases and Nutrition and appointed Dr. Jay Hoofnagle as its founding director. Yesterday, Tuesday November 26 the first meeting was held to plan for this new initiative. About 40 attendees including NIH researchers, academicians, and community participated in a discussion of the strategies to plan for the initiative. Further details of the meeting follow below. One of the key areas for focus of this initiative will be viral hepatitis including HCV & HBV.
The new Branch will also include Dr. Leonard Seeff, special expert on viral hepatitis, and Dr. Jose Serrano, Director for the Liver and Biliary Disease Program. A fourth professional will be hired to direct a liver research program, help supervise cooperative agreements in clinical liver diseases, and serve as the director of the Liver Disease Interagency Coordinating Committee, to coordinate coolaboration between Institutes within the NIH. The Branch will also rely upon the expertise and contributions of other members of the Division of Digestive Diseases and Nutrition, including Dr. Patricia Robuck, Director of the Digestive Disease Clinical Trials Program; Dr. Jay Everhart, Director of the Data Systems and Epidemiology Branch; and Dr. Judith Podskalny, Director of the Training and Career Development Program.
The Liver Disease Research Branch will serve to focus and accelerate research on liver disease in the NIDDK and help coordinate and stimulate liver-related research across the NIH and within other Federal agencies such as the Centers for Disease Control and Prevention, the Department of Defense, the Bureau of Prisons, and the Veterans Affairs Administration. The mission of the Liver Disease Research Branch will be:
- To plan and direct the program of research grants, cooperative agreements, epidemiological studies, clinical trials, contracts, fellowships and training awards in liver and biliary disease;
- To provide consultation to investigators in preparation of proposals for research;
- To maintain surveillance over developments and assess needs for basic research in liver diseases; to prepare analyses of national research efforts and help identify gaps in research;
- To assess needs for clinical and translational research in liver diseases; to provide advice and direction to development and design of protocols; and ultimately to provide supervision and oversight for conduct of clinical trials;
- To develop recommendations to the NIDDK Advisory Council regarding priorities, initiatives, and funding of liver and biliary disease research;
- To advise and participate with outside lay organizations in responding to needs of patients with liver disease;
- To conduct meetings and workshops to help stimulate research, set research priorities and disseminate knowledge about liver and biliary diseases and recent research findings;
- To prepare, evaluate and distribute teaching and educational materials on liver and biliary diseases.
An initial important task set for the Liver Diseases Research Branch is to prepare an Action Plan for Liver Disease Research. This Action Plan will provide an overview of current research funding in liver disease, summarize challenges to advancing liver disease research, delineate the major needs for future research, and prepare a tactical plan for meeting these needs. The plan will be supervised by a working group consisting of representatives from the NIH institutes and Federal agencies involved in liver disease research funding as well as representatives from the community of extramural researchers. The structure and process of developing this Action Plan is currently being formulated and was discussed at the initial meeting November 26. During this process, the advice, suggestions and participation of all members of the liver disease research community is actively sought.
Action Plan for Research in Liver Disease
Liver disease is an important cause of morbidity and mortality in the United States, affecting persons of all ages, but most frequently individuals in the productive years of life, between the ages of 40 and 60 years. Liver disease also disproportionately affects minority individuals and the economically disadvantaged. Medical research on liver disease is critically important and further progress in research promises to bring the major toll of liver disease on health under control. Indeed, the last 25 years of medical research in liver disease has resulted in major improvements in the survival and quality of life of patients with liver disease. The next 25 years should bring even more profound and important changes.
- To address the burden of liver diseases in the United States, the National Institute of Diabetes and Digestive and Kidney Diseases is developing an Action Plan for Research in Liver Disease. The Action Plan will provide a framework for advancing research, guided by five major principles:
- Stress basic research. Important, fundamental advances in management and prevention of liver disease will come primarily from major fundamental advances in knowledge of liver and liver diseases.
- Strive to translate rapidly findings from basic research to practical means of prevention, control and cure of liver diseases. Findings from basic research should be applied to clinical issues (bench-to-bedside research) in a timely and reasoned manner. In like manner, clinical research should help to stimulate further basic research based upon the success or failure of applying newly discovered biologic principles to clinical medicine (bedside-to-bench research).
- Insure that the clinical advances made in research are disseminated to the medical community and patients with liver disease. If basic and clinical research provide avenues for prevention and control of liver disease, these need to be fully applied in clinical medicine.
- Use all mechanisms and sources for support of research and promote cooperation and coordination. No single means of support of research (NIH R01, P01, U01, center grants, contracts, intramural funding; FDA awards; Veterans Affairs awards; academic socity funding; private grant support and funding; industry awards and support) is adequate or ideal for all situations or types of research. Coordination of approaches in funding will help ensure the most efficient use of resources.
- Emphasize training and career development in research on liver diseases. The future of liver disease research is dependent upon attracting bright and committed investigators into the field. The growing complexity of medical science and methodologies has made research training and career development more challenging and prolonged. All avenues should be pursued to ensure the adequacy of training of new investigators in liver disease research.
The Action Plan will address the broad range of liver disease research, and will help guide NIH initiatives in liver disease research. The Action Plan will be completed in 2004.
The above principles will be applied to development of the Action Plan for Liver Disease Research. The plan will be directed by a Liver Disease Subcommittee made up of representatives across the NIH, working in collaboration with members of the liver disease research community to create a broad-based plan for pursuing futute research priorities in liver disease supported by the NIH.
The Action Plan will address the broad range of liver disease research. The Action Plan will be structured around topic areas defined by the Liver Disease Subcommittee. For each topic area, a working group will meet and prepare a document outlining the current status of knowledge and research in the area, the major gap areas and challenges to further advances, and specific goals for future research. The documents from the topic areas will then be integrated and edited by the Subcommittee to prepare a final Action Plan document. The Action Plan will help guide initiatives in liver disease research and will be regularly reviewed for progress.
The Liver Disease Subcommittee held an open meeting on Tuesday, November 25, 2003 on the NIH campus to initiate the Action Plan for Liver Disease Research, which included the participation of representatives from NIH and other federal agencies, the research community, and health organizations and professional societies. The Action Plan will be completed in 2004.
At the meeting the plan was further fleshed out. Special areas of attention (topic areas) include pathogenesis, epidemiology, surveillance, major needs, major goals, means of assessment, and opportunities for funding (recommendations). There are plans for a website that describes the process, summarizes information & data accrued on burden of liver disease & status of research funding, invites input from the community of liver disease investigators and lay persons with interests in promoting liver disease research. Communications on the website will be monitored and summarized by NIDDK information office and distributed to appropriate groups. Multiple academic and lay organizations were asked to participate in the meeting and the subcommittee and the process of developing a plan: AASLD, ALF, AGA, ASTS, ASGE, IDSA, ILTS, NASPGHAN, Hepatitis B Foundation International, Hepatitis C Action Coalition, Hepatitis B Foundation, National AIDS Treatment Advocacy Project, Treatment Action Group, Harm Reduction Coalition.
Twelve topic areas were assigned and membership was nominated. I am in the Viral Hepatitis Topic Group. Each working group will be asked to prepare a 3-5 page report giving overview of research area, major recent advances, most critical future needs, and recommendations for future initiatives. Viral Hepatitis includes Hepatitis A & E, Hep B & D, HCV, other infectious diseases of the liver, and HIV and liver disease. Other topic groups include Fatty Liver Disease (includes alcohol metabolism & NASH), Pediatric Liver Disease, Liver Transplantation, Complications of Liver Disease (includes cirrhosis, ascites, portal hypertension, etc), Liver Cancer.
There was a discussion about how to evaluate progress of the Action Plan and many measures for evaluation were discussed. It was suggested that the subcommittee develop łTop Ten˛ Goals; for example: safe and effective therapies that can control disease activity in >90% of patients with chronic HBV; safe and effective therapy that can eradicate HCV in >90% of patients with chronic HCV; a hepatitis C vaccine that shows efficacy in experimental animal models & is immunogenic in man; reliable means of assessing sage of liver disease without biopsy or other invasive methods; reliable serum markers for HCC that will identify >90% of patients with small HCC; effective therapy that improvrs survival in acute alcoholic hepatitis; define the molecular pathogenesis of NASH.
Of course in my usual vocal fashion I was an active participant at the microphone and suggested a number of goals including developing and testing equivalence between surrogate markers and long term outcomes as we have in HIV, following long term outcomes, broadening access to care, increasing testing & counseling, increased public awareness, studying the affect of providing support services, focusing on HIV/HCV coinfection issues, and issues related to substance abusers.
The meeting was from 8:30am to 5pm. There was a series of speakers in the morning delineating many important concerns. The afternoon was dedicated to strategizing and planning. In the morning we heard special presentations: Overview of Liver Diseases in the US, which addressed funding in hepatitis, various areas of liver research and funding for each; Chronic Liver Disease, which discussed the burden of hepatitis, chronic liver disease, morbidity, HCC, death rates for HCV & HBV, alcohol-related morbidity & liver disease, prevalence, speculation on the large numbers of undiagnosed cases; Liver Transplantation in the USA; Liver Disease in HIV+ Patients. Session two in the morning was an Overview of NIH Funding, and Initativies in Liver Disease Research in various NIH institutes (NIDDK, NIAID, NCI, NIAAA, NIEHS).
I am pleased that this initiative is being started. I was also pleased by the first meeting. Many key researchers attended this initial meeting and key researchers were nominated to sit on the various key topic areas. I am pleased and encouraged that Drs Hoofnagle and Seefe had the insight to invite community participation. The follow-up will be the key. I hope and expect that the Action Plan will be developed and implemented appropriately. The Action Plan is supposed to be implemented next year. Impetus for this initiative came from interested parties who wanted immediately increased attention for hepatitis. The right people in the right places can accomplish anything if they want, without delay, bureaucratic process, committee processing, and a bunch of baloney.
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