SEC. 417E. 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 (NMRT), for the purpose of investigating
and advancing the detection, prevention, treatment and cure
of malignant mesothelioma, a cancer which
disproportionately afflicts veterans of the United States
armed forces.
The NMRT shall include a Medical Advisory Board,
consisting at a minimum of eight (8) medical and
scientific experts and two (2) patient advocates. The
purpose of the Board (MAB) is to make recommendations to
the Director of the NIH, the Secretary of Veterans
Affairs and the Secretary of Defense regarding the merits
of research applications and initiatives - including
applications for designation as a MIRE as provided in
section (b) below, as well as the research and
educational priorities of the NMRT.
(b) MIREs.-The Director of the NIH, the Secretary of
Veterans Affairs and the Secretary of Defense shall provide
through the NMRT $2,500,000 for each of fiscal years 2004
through 2008 for up to ten (10) Mesothelioma
Institutes for Research Endeavors (MIREs) similar
to the NIH's Specialized Programs of Research
Excellence (SPOREs). These are to be chosen through
competitive peer review application, and announced with a
"Request for Applications" (RFA). If less than 10
Centers are chosen, the remaining funds will be used to
extend the period of support for the MIREs beyond the 5
years mandated by this bill and not for any other purpose.
The MIREs should develop programs to address the priorities
and issues described in subsection (c) below.
(c) RESEARCH PRIORITIES. - The Mesothelioma Institutes for
Research Endeavors will:
(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 (c) below.
(6) coordinate their research efforts with the other
MIREs, and encourage non-MIRE investigators and
institutions involved in exemplary mesothelioma research
to partner in their research efforts with one or more of
the MIREs.
(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
fiscal years 2004 through 2008 for the creation,
maintenance and operation of a National Mesothelioma
Registry and Tissue Bank. The Registry will develop an
informational system that addresses the issues described in
subsection (e) and the 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 will be chosen preferably from
among the MIREs awarded under (b) above.
(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 MIRE must participate in the Registry;
and
(6) After insuring 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 MIRE 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 insuring 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) AUTHORIZATION OF APPROPRIATIONS.-There is authorized to
be appropriated to carry out this section $27,000,000 for
each of fiscal years 2004 through 2008.