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New NIH Liver Disease Research Branch: Action Plan For Liver Disease Research

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  • claudine intexas
    NATAP - www.natap.org New NIH Liver Disease Research Branch: Action Plan For Liver Disease Research Newly Initiated Liver Disease Branch to focus and
    Message 1 of 1 , Nov 26, 2003
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      NATAP - www.natap.org

      New NIH Liver Disease Research Branch: Action Plan For Liver Disease
      Research

      Newly Initiated Liver Disease 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 ���Top 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
      surrogate markers and correlation with 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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