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Mesothelioma Treatment | Mesothelioma Research

April 15, 2005

Recommendation for a National Mesothelioma Research and Treatment Program – Proposed Legislative Language
NATIONAL MESOTHELIOMA RESEARCH AND TREATMENT PROGRAM.


(a) GENERAL—Congress hereby establishes the National Mesothelioma Research and Treatment Program (NMRTP), to investigate and advance the detection, prevention, treatment and cure of malignant mesothelioma.

(b) ESTABLISHMENT OF CENTERS OF MERIT—The Director of the National Institutes of Health (NIH) shall establish a network of no fewer than eight (8) and no more than twelve (12) Centers of Mesothelioma Excellence in Research and Innovative Treatment (Centers of MERIT) similar to the NIH’s Specialized Programs of Research Excellence (SPOREs). For the fiscal years of 2006 through 2015, each Center of MERIT shall receive grant funding of $3,00,000 per year to investigate and advance the detection, prevention, treatment and cure of malignant mesothelioma. The NIH shall provide $1,000,000 per year per Center of MERIT of such grant funding (inclusive of indirect costs), and the [adminstrators of the FAIR act trust fund] shall provide $2,000,000 per year per Center of MERIT of such grant funding. [include this provision in the FAIR act]

(c) SELECTION OF CENTERS OF MERIT—The individual Centers of MERIT shall be selected every five (5) years through competitive peer review application announced with a Request for Applications (RFA). The NIH shall oversee, regulate and manage the NMRPT. The NIH shall establish a Medical Advisory Board, which shall consist of at a minimum of eight (7) mesothelioma medical and scientific experts, two mesothelioma patient advocates, and the director of the Center for Mesothelioma Education, as described herafter in subsection (g). In selecting Centers of MERIT, the NIH, with the advice and consent of the Medical Advisory Board, shall:
(1) seek to maximize excellence in laboratory and clinical research, including clinical
trials, to provide mechanisms for effective therapeutic treatment of mesothelioma, as well as detection and prevention of mesothelioma, palliation of the disease symptoms and pain management;
(2) seek to achieve geographic distribution throughout the U.S., with special consideration given to areas of high incidence of asbestos-related disease, so as to facilitate travel to a Center of MERIT for a maximum number of patients;
(3) seek to achieve close association between Centers of MERIT and Veterans Affairs hospitals, so as to provide research benefit and care to U.S. armed forces veterans who have suffered excessively from asbestos-related malignant disease;
(4) consider the applicant’s existing excellence, experience and qualifications in mesothelioma research and treatment;
(5) consider the excellence of the applicant’s proposed used of the grant funds in advancing mesothelioma research and treatment;
(6) consider the applicant’s existing and proposed coordination of its research efforts with other Centers of MERIT, and with other investigators and institutions involved in exemplary mesothelioma research;
(7) consider the quality, practicality and cost-effectiveness of the applicant’s proposed plan to facilitate transportation and lodging for mesothelioma patients, so as to enable patients to participate in the newest developing treatment protocols, and to enable the Centers of MERIT to recruit patients in numbers sufficient to conduct the necessary clinical trials;
(8) consider the cost effectiveness of the applicant’s proposed use of the grant funds, including the extent to which indirect or overhead costs requested to be paid through the grant are minimized;
(9) require that each selected Center of MERIT be a nonprofit hospital, university, or medical or research institution incorporated or organized in the U.S;
(10) require that each selected Center of MERIT participate fully in the National Mesothelioma Registry as described in subsection (e) below,the National Mesothelioma Tissue Bank as described in subsection (f) below, and the annual International Mesothelioma Symposium; and
(11) require that each selected Center of MERIT train at least one clinical and research fellow in the area of mesothelioma medicine each year and require that at least $500,000 of the annual award be allocated to innovative, experimental, exploratory and basic benchwork or pre-clinical mesothelioma research.


(d) MESOTHELIOMA REGISTRY AND TISSUE BANK—The Trust Fund Administrator and the NIH shall each provide $1,000, 000 for each of fiscal years 2006 through 2015 (for a total of $2 million per fiscal year) for the creation, maintenance and operation of a National Mesothelioma Registry and Tissue Bank. The Registry, which shall be known as the Admiral Elmo Zumwalt, Jr., Memorial Registry, will develop an informational system that addresses the issues described in subsection (e) below. The Tissue Bank, which shall be known as the Congressman Bruce Vento Memorial Tissue Bank, will address the issues described in subsection (f) below. At least $500,000 of the total $2,000,000 per year shall be allocated for the collection and maintenance of tissue specimens. The NIH, with the advice and consent of the Medical Advisory Board, after soliciting grant applications and subjecting same to competitive peer review, shall select the director of the Registry and the Tissue Bank, preferably from among the Centers of MERIT awarded under subsections (b) and (c) above, and oversee that the operation of the Registry and the Tissue Bank is in accordance with subsections (e) and (f) below.


(e) Purpose and Operation of Registry—The Registry must satisfy the following criteria:
(1) Input of data to the Registry must be accessible through the Internet;
(2) Whether through the Internet or otherwise, inclusion of data in the Registry must be available for all mesothelioma patients and physicians throughout the U.S.;
(3) The Registry must respect patient confidentiality and adhere to all patient privacy laws and regulations;
(4) The Registry must collect data regarding symptoms, pathology, evaluation, treatment, outcomes, and quality of life;
(5) Each and every Center of MERIT must participate in the Registry and the Registry shall be made accessible to any mesothelioma patient or authorized family member regardless of his or her consultation or affiliation with any selected Center of Merit; and
(6) The Registry must provide data to approved researchers who apply for such data in order to further the understanding, prevention, screening, diagnosis, and/or treatment of malignant mesothelioma.

(f) Purpose and Operation of Tissue Bank—The Tissue Bank must satisfy the following criteria:
(1) Inclusion of tissue in the Bank must be available to all mesothelioma patients and physicians throughout the U.S.;
(2) Each and every Center of MERIT must participate in the Tissue Bank;
(3) The Bank must include pre- and post-treatment blood (serum and blood cells) specimens as well as tissue specimens from biopsies and surgery;
(4) The Bank must be linked to clinical data regarding the specimens in such a manner as to adhere to all patient privacy laws and regulations; and
(5) After obtaining approval by a tissue bank oversight committee, the Bank must supply reasonably available tissue samples to approved researchers who apply for such data in order to further the understanding, prevention, screening, diagnosis, and treatment of malignant mesothelioma.


(g) ESTABLISHMENT OF CENTER FOR MESOTHELIOMA EDUCATION—The NIH shall establish a Center for Mesothelioma Education (C-ME) to promote mesothelioma awareness and education, specifically assist mesothelioma patients and their family members in obtaining necessary information, and work with the Centers of MERIT in advancing mesothelioma research. For the fiscal years of 2006 through 2015, the NIH and the Trust Fund Administrator shall each award grant funding of $2,000,000 per year for a total of $4,000,000 per year to the C-ME to:
(1) educate the public about the new initiatives above through a National Mesothelioma Awareness Campaign;
(2) develop and maintain a Mesothelioma Educational Resource Center on the Internet (MERCI) providing mesothelioma patients, family members and front-line physicians with comprehensive, current information on mesothelioma and its treatment, as well as on the existence of, and general claim procedures for, [The National Trust Fund];
(3) through MERCI and otherwise, educate mesothelioma patients, family members and front-line physicians about, and encourage them to participate in, the Centers of MERIT, the Registry and the Tissue Bank;
(4) complement the research efforts of the Centers of MERIT by awarding competitive, peer-reviewed grants for the training of young investigators and/or training of clinical specialist fellows in mesothelioma, and for highly innovative, experimental benchwork or pre-clinical research;
(5) issue Requests for Applications for mesothelioma research in the amount of $2,000,000 per year to be allocated among not fewer than 3 or more than 5 grantees, to be determined after competitive peer review; and
(6) conduct an annual International Mesothelioma Symposium.

Additionally, pursuant to subsections (c) and (d) above, the NIH may separately contract with the C-ME for selection and oversight of the ten Centers of MERIT, and/or selection of the director of the Registry and the Tissue Bank and oversight of the Registry and the Tissue Bank.

(h) SELECTION OF C-ME—The NIH shall select the C-ME every five years. The NIH shall select as the C-ME an organization which:
(1) is a 501(c)(3) non-profit corporation;
(2) is a separate entity from and not an affiliate of any hospital, university, or medical or research institution;
(3) as evidenced by at least three prior years of its program spending, is devoted specifically to the mission of extending the survival of current and future mesothelioma patients through medical research and awareness;
(4) has at least three years’ experience in soliciting, peer-reviewing through a competitive process, and funding research grant applications relating to the detection, prevention, treatment and/or cure of mesothelioma; and
(5) the NIH determines to be most likely to effectively carry out the purposes enumerated in subsection (g) above.
(h) AUTHORIZATION OF APPROPRIATIONS—There is authorized to be appropriated to the NIH to carry out this section $15,000,000 for each of fiscal years 2006 through 2015.

(i) _________—[requires the trust fund to spend $22,000,000 per year for each of fiscal years 2006 through 2015.]

(j) NIH REPORT AND RECOMMENDATION—By [beginning of 2015 fiscal year] after opportunity for public comment and review, the Director of the NIH shall publish and provide to Congress the NIH’s report and recommendation on the results achieved and information gained through the NMRTP, including:
(1) the status of mesothelioma as a national health issue, including annual U.S. incidence and death rate and whether these are increasing or decreasing, average prognosis, and effectiveness of treatments and means of prevention;
(2) promising advances in mesothelioma treatment and research which could be further developed if the NMRTP program were to be renewed; and
(3) whether advances in mesothelioma treatment made in the prior ten years would justify reduction or elimination of the NMRTP program or whether it should be renewed for an additional ten years.


(k) NIH RESPONSIBILITY FOR DETAILS—To any extent not provided here, the NIH shall be responsible and authorized to develop remaining details of the NMRTP program and the [administrators of the FAIR ACT trust fund] shall comply with the NIH’s determination of these details.

(i) SEVERENCE CLAUSE—if any provision of the Fair Act is found unconstitutional or
unenforceable, these provisions shall neverthelless remain in effect.