Our Mission is to eradicate mesothelioma as a life-ending disease.

Recommendation for a National Mesothelioma Research and Treatment Program - Description and Legislative Language

The battle to ease the misery of the U.S.' mesothelioma victims must be along three fronts: early detection and prevention, laboratory and clinical therapeutic research, and education. The creation of geographically appropriate Centers of Mesothelioma Excellence in Research and Innovative Treatment (MERIT) through a peer review mechanism will ensure collegial, interactive excellence, not only to eradicate the disease, but also to allay the anxieties of the mesothelioma high-risk populations through development of early detection and prevention initiatives.

Early Detection and Prevention

The Centers of MERIT must collaborate with each other in order to investigate the early detection of the disease. The early detection studies should aim specifically to detect intermediate markers which point to the development of the disease in high-risk individuals, defined as those with a significant exposure to asbestos. These individuals could be targeted through collaborations with environmental and occupational health private or university practices, unions, or other groups which tend to the health needs of or advocate for such individuals, and the early detection studies should concentrate on the recording of careful epidemiologic and environmental health data.

Intermediate Markers would be defined as promising, unique genomic or proteomically-defined proteins or nucleic acid changes which would predict an increased chance that an individual may develop mesothelioma. These intermediate markers would be derived from studies which compare the genomic or proteomic changes in mesothelioma to appropriate control populations (other cancers, benign diseases, asbestos exposed but not diseased individuals) using tissues (normal and tumor) or body fluids (serum, pleural effusions, ascites) or other surrogate tissues. These intermediate markers would be validated in prospective studies of patients in order to define their accuracy (specificity and sensitivity). Those intermediate markers which are most promising would be then used in prospective studies examining their prevalence and incidence in the above mentioned "high-risk" individuals. There are already exciting developments in this arena at institutions associated with MARF.

Obviously, the prevention of mesothelioma is paramount, and all measures necessary to ban the use of asbestos should be employed. But the Centers of MERIT must also work to prevent mesothelioma in individuals who have already been significantly exposed. Novel compounds could be developed which, in high-risk individuals who are found to have elevated intermediate markers (but no evidence of disease radiographically), could be tested prospectively to see if these markers normalize. There are already promising compounds which could be investigated if the funds were available for such clinical trials. Parallel with these efforts, we must use these Centers of MERIT to develop novel imaging techniques which could alert physicians to the development of changes in the linings of the chest and abdomen which precede overt mesothelioma development.

Laboratory and Clinical Therapeutic Research

The Centers of MERIT must set forth a strategic plan for grant supported research to develop novel surgical, chemotherapeutic, radiation-associated, and biologic strategies, including gene therapy, for the control of local as well as systemic mesothelioma. Exciting avenues for such research include a multicenter trial comparing clinical therapies, further cooperation with pharmaceutical companies for the easier planning and recruitment of patients for clinical trials, and grant-supported research for the development of proper palliative measures, including pain management, for patients with mesothelioma. We must develop better long-acting slow-release analgesis using epidural or intrathecal implantable devices, which at this time are prohibitively expensive. We must also be better and more uniform in our management of local complications of the disease including pleural, peritoneal, and pericardial effusions.

Many mesothelioma patients are not affluent. The Centers of MERIT must formulate a strategic plan to provide a budget for transportation and lodging of individuals with mesothelioma. This would enable these patients to fly to mesothelioma clinical centers for the newest developing treatment protocols, including pain management. It would also enable the centers to recruit patients in numbers sufficient to conduct the necessary clinical trials.

A high priority for funding should be a program which would allow for newly diagnosed cases of mesothelioma to be registered (with the patients' consent) to a web-based prospective registry. The registration of all such patients would allow for accurate recording of the magnitude of the disease, make prospective epidemiologic studies regarding prevalence and incidence easier in the future, and map trends in the disease in the United States which could point out other, as yet unknown, etiologic causes for the disease. This registry would facilitate communication among centers with established novel treatment options, and allow physicians to inquire about eligibility of the patients for such trials. Such a registry could be located at one central data management center which not only coordinates the registry, but also, coordinates all informatics for the cooperative trials of the Centers of MERIT.

Education

Funds must be allocated for a National Mesothelioma Awareness Campaign to educate the public about these new initiatives. Funds should also be allocated for the training of Clinical Specialists in mesothelioma by the creation of a fellowship of 1 or 2 years in which the fellows are exposed to various initiatives at Centers of MERIT. Such a program would also have a specific didactic curriculum. Moreover, funds should be allocated for a yearly International Mesothelioma Symposium to be held at cities with Centers of MERIT. This conference would highlight the newest benchwork and clinical advances in the disease.

We must utilize the power of the Internet and establish an electronic Mesothelioma Educational Resource Center ("MERC-e"). This resource would be a "one stop shop" for mesothelioma patients, family members and front-line physicians to get comprehensive, current information on mesothelioma. Information and articles about the disease itself, as well as current information on all available clinical trials and drugs, with protocols, eligibility criteria, etc. could be provided. A discussion group encouraging stories to overcome hopelessness would be available, along with information on general financial assistance, insurance coverage, obtaining VA benefits, pain management, hospice information, etc.

Proposed legislative language establishing the National Mesothelioma Research and Treatment Program follows

MESOTHELIOMA TREATMENT PROGRAMS.

(a) GENERAL-The Director of the NIH, the Secretary of Veterans Affairs and the Secretary of Defense shall jointly create and administer a National Mesothelioma Research and Treatment Program (NMRTP), to investigate and advance the detection, prevention, treatment and cure of malignant mesothelioma.

The NMRTP shall include a Medical Advisory Board (MAB), consisting at a minimum of eight medical and scientific experts and two patient advocates. The purpose of the MAB is to make recommendations to the NMRTP regarding the merits of research applications and initiatives - including applications for designation as a Center of MERIT as provided in section (b) below, as well as the research and educational priorities of the NMRTP.

(b) Centers of MERIT-The Director of the NIH, the Secretary of Veterans Affairs and the Secretary of Defense shall provide through the NMRTP $2,500,000 for each of fiscal years 2004 through 2008 for ten Centers of Mesothelioma Excellence in Research and Innovative Treatment (MERIT) similar to the NIH's Specialized Programs of Research Excellence (SPOREs). These are to be chosen through competitive peer review application announced with a "Request for Applications" (RFA). The Centers of MERIT shall develop programs to address the priorities and issues described in subsection (c) below.

(c) RESEARCH PRIORITIES-The Centers of MERIT shall:

(1) be geographically distributed throughout the U.S. with special consideration given to areas of high incidence of asbestos-related disease;

(2) be closely associated with 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;

(3) be engaged in research to provide mechanisms for detection and prevention of mesothelioma, palliation of the disease symptoms -- particularly in the area of pain management, as well as a cure for mesothelioma;

(4) be engaged in public education about asbestos-related malignant diseases and prevention, screening, and treatment.

(5) be full participants in the National Mesothelioma Registry as described in subsection (e) below, and the National Mesothelioma Tissue Bank as described in subsection (f) below.

(6) coordinate their research efforts with the other Centers of MERIT, and encourage non-MERIT investigators and institutions involved in exemplary mesothelioma research to partner in their research efforts with one or more of the Centers of MERIT.

(d) MESOTHELIOMA REGISTRY AND TISSUE BANK-The Director of the NIH, the Secretary of Veterans Affairs and the Secretary of Defense shall provide $2,000,000 for each of fiscal years 2004 through 2008 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). 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 director of the Registry and the

(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

(6) After ensuring that patient privacy will be absolutely protected, 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 ensuring that patient privacy will be absolutely protected, the Bank must supply 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) MESOTHELIOMA AWARENESS AND EDUCATION-The Director of the NIH, the Secretary of Veterans Affairs and the Secretary of Defense shall provide through the NMRTP $1,000,000 for each of fiscal years 2004 through 2008 for mesothelioma awareness and education, to include:

(1) A National Mesothelioma Awareness Campaign to educate the public about the new initiatives above.

(2) Training of Clinical Specialist Fellows in mesothelioma .

(3) A yearly International Mesothelioma Symposium to be held at cities with Centers of MERIT.

(4) An Internet-based electronic Mesothelioma Educational Resource Center (MERC-e) providing mesothelioma patients, family members and front-line physicians with comprehensive, current information on mesothelioma.