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

MEMORANDUM

From:	Harvey Pass, M.D., Chairman, MARF Science Advisory Board
To:	Mr. Kevin O'Scannlain Office of Senator Orrin G. Hatch 104 Hart Office Building Washington, DC 20510
Cc:	Ms. Rebecca Seidel
Date:	April 8, 2003

Re: Creation of Mesothelioma Research and Treatment Program:
"The Asbestos Claims Criteria and Compensation Act," S. 413

Dear Kevin:

As the Chairman of the Scientific Advisory Board for the Mesothelioma Applied Research Foundation, I am sure I speak for all Board members and Directors, in congratulating you for your visionary attempts to ease the misery of the mesothelioma victims of the United States. The timing of such a monumental effort is appropriate since we are seeing an increasing number of patients per year with the disease, and this rise is not predicted to stabilize for another 20 years. Veterans, as well as individuals in the private sector, are being robbed of the years which should be a reward for a productive life. Mesothelioma rewards them with unrelenting pain, suffocating collections of fluid and tumor, and a horrific end of life which frustrates all caregivers who deal with the disease.

There is an increased awareness of the disease among individuals who served their country, and it is fitting that this must be a battle along three fronts: early detection and prevention, laboratory and clinical research, and education. The creation of geographically appropriate Mesothelioma Institutes of Research Endeavors through a peer review mechanism will insure collegial, interactive excellence, to not only eradicate the disease, but allay the anxieties of the "high-risk" for mesothelioma populations through development of early detection and prevention initiatives.

These Institutes must collaborate with each other in order to investigate the early detection of the disease. The early detection studies should have as specific aims the desire to detect intermediate markers which point to the development of the disease in high-risk individuals. High-Risk individuals would be defined as those with a significant exposure to asbestos either in the workplace or in the military. The exposures/occupations would include but not limited to shipbuilding, service in the navy, construction, insulation, oil and chemical refinery, power plant, railroad, automotive, steel plant, asbestos manufacturing, paper mills, ceramics and glass industry. The target occupations could include pipefitter, boilermaker, maintenance, machinist, electrician and sheetmetal worker. These high-risk individuals could be targeted through collaborations with environmental and occupational health private or university practices, through unions, or other groups which tend to the health needs 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 potentially predict that there is an increased chance that such high-risk individuals with these markers 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 as stated in the Bill to ban the use of asbestos should be employed. In addition, 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 MIREs 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.

The Institutes 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 such trials, and grant-supported research for the development of proper palliative measures for patients with mesothelioma including pain management. As the clinicians and researchers in this disease, 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 of these patients are not affluent. A strategic plan developed by the sponsoring agencies and the MIREs needs to be formulated to provide a budget for transportation and lodging of individuals with mesothelioma. These patients could fly to high-volume mesothelioma clinical centers treatment if they are eligible for non-standard NCI-approved protocols. This would also include pain management.

We have no idea how many mesotheliomas there are in the United States, little less what happens to these individuals. 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 possibly 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 MIREs.

Education may be the most important battle in this war, and funds must be allocated for a National Mesothelioma Awareness Campaign in order 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 individual(s) are exposed to various initiatives at MIREs. 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 MIREs. This conference would highlight the newest benchwork and clinical advances in the disease.

We must use the power of the WEB and establish an electronic Mesothelioma Educational Resource Center which does not represent individual interests, but is coordinated by the MIREs and the sponsoring agencies. This resource would be a "one stop shop" for mesothelioma patients, family members and even local doctors to get comprehensive up to date info 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 listserve discussion group encouraging stories to overcome hopelessness would be available with information on general financial assistance, pain management, hospice information, obtaining VA benefits.

I hope that this letter from MARF transmits the willingness and excitement of our Directors, Scientists, and Family Advocates to take the first step in finding a solution to the anxiety of risk and the eventuality of death that define the mesothelioma problem in the United States. Our organization, our hospitals and our Universities want to be the foot soldiers in this battle, and we want to do it responsibly through the peer-review mechanism. Our hope is that our enthusiastic and persistent advocacy for the disease will translate into targeted funding so that we and others can make the "return on investment" for this endeavor be longer and less painful lives for our patients. The responsibility for such a return would be for those serious about this disease, and I am sure that such a cadre of talented and motivated individuals would welcome the challenge.