Microsoft Word - 031510 Deadly Cancer Sug Revs to July 30 Draft FINAL.docx

March 16, 2010
The Honorable Lois Capps
United States House of Representatives
1110 Longworth House Office Building
Washington, DC 20515
Dear Representative Capps:
We are writing you today on behalf of the hundreds of thousands of patients with the deadliest
forms of cancer to respectfully offer our legislative recommendations for your legislation which
will serve as the House companion to the 21st Century Cancer ALERT (Access to Life-Saving
Early detection, Research and Treatment) Act (S. 717). The suggested revisions below refer to
the July 30, 2009 (4:47pm) draft of your bill.
Section 5. Enhanced Focus and Reporting on Cancer Research & Section 13. Targeted
Cancers Program
We recommend combining these provisions to reduce the amount of overlap. As currently
written, the sections are very similar and there is also overlap between the cancers that would be
covered.
The primary focus of the Deadly Cancer Coalition is to create a new research programs and thus
increase research funding for high-mortality cancers. While the overall five-year survival rate for
all forms of cancer was 50% in the 1970s, it is now 66%. However, the high mortality cancers
are those that have not yet even gotten to the starting point that was established in the 1970s
they all continue to have five-year survival rates below 50%.
We believe that the new program for high mortality cancers created in Sections 5 and 13 should
include a strategic plan, improved reporting on any progress made on the plan, and a grant
program with an authorization amount that truly creates the opportunity for progress in these
cancers. To minimize the overlap between Sections 5 and 13 and to ensure that these objectives
are met for high-mortality cancers, we suggest combining the language from Section 13 into
Section 5 along with the edits, noted below.
Since your last draft of this legislation, Senator Feinstein's staff has expressed to us an interest in
exploring a way to create a "bridge" program for cancers that "graduate" out of being considered
a deadly cancer. The suggested language below reflects those changes. We are also now
proposing a five-year strategic plan and measuring annual progress against it instead of re-starting
the strategic planning process each and every year.
Further, as you consider our suggested changes, we wanted you to also be aware of some
potential issues resulting from overlap with the provisions that are meant to help very low-
incidence cancers, defined in the legislation as those in which the incidence rate is fewer than 15
cases per 100,000 people or fewer than 40,000 cases per year. This definition would establish a
new category of cancers with very low incidence, different from what has been established in the
Rare Disease Act. We would recommend clarifying this definition and using only the definition
based on the incidence rate of 15 cases per 100,000, a definition which is able to adjust for any
changes in population.
We also wanted to be sure that you were aware that almost, but not all, deadly cancers would fall
under this new definition, regardless of whether you make our recommended change. Lung
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cancer as a stand-alone category would not, but there are some sub-types of lung cancer that
would. Similarly, there are many cancers that would fit into this new category of "very low-
incidence" such as testicular and localized cervical cancer that have very good survival rates.
While there is some overlap in the research issues that need to be addressed for each of these
populations cancers with very low incidence and deadly cancers the need remains to have a
separate research program focused on the cancers for which we have made the least amount of
progress (i.e., deadly cancers), regardless of incidence.
Suggested Revisions
SEC. 5. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH.
Part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.), as amended by
inserting after section 417A the following:
SEC. 417B. ENHANCED FOCUS AND REPORTING ON CANCER RESEARCH
``(a) ANNUAL INDEPENDENT REPORT.--
``(1) IN GENERAL.--The Director of the Institute shall complete an annual independent
report that shall be submitted to Congress on the same date that the annual budget estimate
described in section 413(b)(9) is submitted to the President.
``(2) CONTENTS OF REPORT.--
``(A) CANCER CATEGORIES.--The report required under paragraph (1) shall
address the following categories of cancer:
``(i) Cancers that result in a 5-year survival rate of less than 50 percent.
"(ii) As of the date of the Act, each cancer identified by the Director of the
Institute as resulting in a 5-year survival rate of 50 percent or more for fewer than
five consecutive years.
``(iii) Cancers in which the incidence rate is less than 15 cases per
100,000 people, or fewer than 40,000 new cases per year.
``(B) AGGREGATE INFORMATION.--With regard to each of the categories of
cancer described in subparagraph (A), the report shall contain information regarding--
``(i) a strategic plan for reducing the mortality rate for the annual year,
including specific research areas of interest and budget amounts;
``(ii) identification of any barriers to implementing the strategic plan
described in clause (i) for the annual year;
``(iii) if the report for the prior year contained a strategic plan described in
clause (i), an assessment of the success of such plan;
``(iv) the total amount of grant funding that is at least 50% relevant to the
cancers specified in subparagraph (A), specifying the total dollar amount
awarded per grant and per funding year, under--
``(I) the National Cancer Institute; and
``(II) the National Institutes of Health.
(C) CANCER-SPECIFIC INFORMATION With regard to each of the cancers
that are included in the categories described in subparagraph (A), the report shall contain
information regarding--
``(vi) the percentage of all grant applications favorably reviewed by the
Institute and that the Institute funded in the previous annual year;
``(viii) the total number of grant applications, with at least 50 percent
relevance to each of the cancers included in the categories of cancer described
in subparagraph (A), received by the Institute for awards in the previous annual
year;
``(viiiii) the total number of grants awarded, with at least 50 percent
relevance to each of the cancers included in the categories of cancer described
in subparagraph (A), for the previous annual year and the number of awards per
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grant type, including the Common Scientific Outline designation specific to each
such grant; and
``(iv) the total number of principal investigators who received grants from
the Institute for projects with at least 50 percent relevance to any of the cancers
included in the categories of cancer described in paragraph (1), including the
total number of awards from the National Institutes of Health granted to
established investigators and the total number of awards from the National
Institutes of Health granted to new investigators.
``(3) DEFINITION.--In this section, the term `annual year' means the year for which the
strategic plan described in paragraph (2)(B)(i) applies, which shall be the same fiscal year for
which the Director of the Institute submits the annual budget estimate described in section
413(b)(9) for that year.
(b) VERY LOW-INCIDENCE CANCER GRANT PROGRAM
``(1) IN GENERAL.--The Director of the Institute, in cooperation with the Director of the
Fogarty International Center for Advanced Study in the Health Sciences and the Directors of
other Institutes, as appropriate, shall award grants to researchers to conduct research regarding
cancers for which the incidence rate is less than 15 cases per 100,000 people or the incidence is
fewer than 40,000 new cases per year.
``(2) PRIORITIZATION.--In awarding grants for research regarding cancers described in
paragraph (1), the Director of the Institute shall give priority to collaborative research projects
between adult and pediatric cancer research, with preference for projects building upon existing
multi-institutional research infrastructures.
``(3) TISSUE SAMPLES.--
``(A) IN GENERAL.--Except as provided in subparagraph (B), the Director of the
Institute shall require each recipient receiving a grant under this subsection to submit
tissue samples to designated tumor banks.
``(B) WAIVER.--The Director of the Institute may grant a waiver of the
requirement described in subparagraph (A) to a recipient who receives a grant for
research described in paragraph (1)(B) and who submits an application for such waiver to
the Director of the Institute, in the manner in which such Director may require.''
(c) TARGETED CANCERS GRANT PROGRAM [NOTE: FROM SECTION 13]
``(1) ESTABLISHMENT.--The Director of the Institute shall establish a targeted cancers
program under which the Director may enter into agreements and shall award make grants to
conduct, coordinate, and report and coordinate research activities, with respect to cancers that
result in a 5-year survival rate of less than 50 percent and cancers for which the 5-year survival
rate has been 50 percent or more for fewer than five consecutive years for purposes of increasing
such survival rate for such cancers. Such program shall include each of the elements described
in subsections (2) through (11).
(2) STRATEGIC PLAN FOR PROGRESS [NOTE: Given that these provisions are all
under the Targeted Cancers Program, we didn't think that it was necessary to spell it out for each
provision, but Leg Counsel will likely have a better read.]
(A) IN GENERAL.--Under the targeted cancers program, tThe Director of the
Institute, in coordination with relevant stakeholders and other appropriate Federal agencies, shall
develop a comprehensive plan for the next five years and for every subsequent five-year period
thereafter, including budget amounts, for the implementation of the research activities described
in this subsection (a1) as well as the identification of additional research activities that will be
necessary to increase the survival for patients diagnosed with a cancer described in such
subsection 1.
(B) The Director of the Institute, in submitting the annual report described in SEC.
417B.(a), shall identify any barriers to implementing the strategic plan for that year and
shall also assess any successes in implementing such plan.
(i) Cancer reporting.--The strategic plan described in subparagraph (A) shall
address the following:
Recommendations from the Deadly Cancer Coalition on the July 30, 2009 Draft
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"(I) Each cancer identified by the Director of the Institute as resulting in a
five-year survival rate of less than 50 percent.
"(II) and cancers for which the five-year survival rate has been 50
percent or more for fewer than five consecutive years
"(ii) Content of strategic plan.--
"(I) In general.--For each cancer described in subsection (I), the
strategic plan shall contain information regarding appropriate efforts to reduce
the mortality rate for the proceeding five-year period, including proposed, specific
research areas of interest and amounts budgeted for such research.
"(II) Outcomes reporting.--In addition to the information described in
clause (I), each strategic plan submitted after the initial strategic plan shall
include information regarding the outcomes of research conducted during the
preceding five-year period in accordance with the strategic plan for that period,
including--
"(a) changes in progression-free survival rates;
"(b) changes in survival related to treatment; and
"(c) changes in overall survival and survivorship.
(B) REPORT.--Not later than 6 months after the date of the enactment of this
section and on the same day for every subsequent five-year period, the Director of the Institute
shall submit to Congress [and make publicly available] the comprehensive plan described in
paragraph (1A).
(3) ANNUAL REPORT ON STRATEGIC PLAN -- The Director of the Institute shall
complete an annual independent report on the strategic plan that shall be submitted to Congress
on the same date that the annual budget estimate described in section 413(b)(9) is submitted to
the President.
(A) CONTENTS OF REPORT
(i) a strategic plan for reducing the mortality rate for the annual year,
including specific research areas of interest and budget amounts;
``(ii) identification of any barriers to implementing the strategic plan
described in clause (i2) for the annual year; and
``(iii) if the report for the prior year contained a strategic plan described in
clause (i), an assessment of the success of such plan.
``(4) DEDICATED FUNDING FOR BASIC RESEARCH.-- Under the targeted cancers
program, tThe Director of the Institute shall establish a separate funding mechanism that can be
used to fund basic research grants for investigators with a primary interest in one of the cancers
described in subsection (1).
``(5) IMAGING RESEARCH.-- Under the targeted cancers program, The Director of the
Institute shall provide for research to expand and advance the potential of imaging to assist in
early detection, disease management, and drug development related to one or more of the
cancers described in subsection (1).
``(6) INCUBATOR GRANT PROGRAM.-- Under the targeted cancers program, tThe
Director of the Institute shall establish a high-risk, high-reward incubator grant program for each
cancer described in subsection (1) to allow investigators with a primary interest in such cancer an
opportunity to build data for future grants provided by the Institute or the National Institutes of
Health.
``(7) SPECIALIZED TRAINING PROGRAMS.-- Under the targeted cancers program,
tThe Director of the Institute shall provide for advanced specialized training and education
programs for early career PhD and clinician scientists that ensure sufficient time of such scientists
is reserved for research in order to attract and retain a broader pool of investigators for the
cancers specified in subsection (1).
``(8) SURVEILLANCE AND SCREENING.-- Under the targeted cancers program, tThe
Director of the Institute shall, as prevention, early detection, and treatments are identified for
cancers described in subsection (1), develop pilot programs for the surveillance and treatment of
such conditions that are precursors to such cancers.
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``(9) COOPERATIVE RESEARCH AGREEMENTS.-- Under the targeted cancers
program, tThe Director of the Institute may enter into cooperative research agreements with other
Federal agencies on programs targeting cancers specified in subsection (1), including other
Institutes at the National Institutes of Health, other agencies within the Department of Health and
Human Services, the Department of Defense, and the Department of Veterans Affairs.
"(10) OTHER PROGRAMS DEEMED NECESSARY.--The Director of the Institute shall
establish additional programs deemed necessary to advance the goals of the strategic plan in
order to increase the survival rates for the cancers described in subsection (1).
``(11) GRANT REVIEW BY RELEVANT SCIENTIFIC EXPERTS. -- Under the targeted
cancers program, tThe Director of the Institute shall provide for a peer-review process of
applications submitted for a grant under this section. Such process shall be conducted by grant
peer-review teams that include scientific experts in the specific disease area involved, as well as
patient advocates. The Director of the Institute, in consultation with the Director of the Office of
Extramural Research, shall establish within the Center for Scientific Review Scientific Review
groups with expertise in cancers referenced in (c)(1) who shall review research proposals related
to the study of cancers referenced in (c)(1) that are submitted in accordance with NIH guidelines
and who shall make recommendations to the Director of the Institute regarding awards of grants
under this subsection.
``(j) IOM REPORT.--
``(1) IN GENERAL.--The Secretary of Health and Human Services shall enter into an
arrangement with the Institute of Medicine of the National Academies to provide an independent
assessment [with respect to cancers described in subsection (a),] of funding of the National
Cancer Institute, progress of such Institute, and the additional improvements that should be
implemented by the Department of Health and Human Services, by the National Institutes of
Health, and by the National Cancer Institute to make sufficient progress on research related to
such cancers.
``(2) REPORT.--The agreement entered into under paragraph (1) shall provide for the
Institute of Medicine to submit to the Secretary and the Congress, not later than 1 year after the
date of the enactment of this section, a report containing a description of the results of the study
conducted under such paragraph and the conclusions and recommendations of the Institute of
Medicine regarding the issues described in such paragraph.''.
ADDITIONAL PROVISIONS of INTEREST TO OUR COMMUNITY
In addition to the edits proposed above, we would also encourage you to consider the following
additional revisions to the draft legislation.
Section 2. Findings and Purpose
We believe that an important difference between cancer research when the National Cancer Act
was signed into law and now is the understanding that "cancer" is not one disease. We therefore
believe that the findings and purpose of the legislations should recognize that difference. In
addition, new data has been released indicating that cancer incidence is projected to significantly
increase over the next twenty years and that several of the cancers currently considered the
deadliest cancers will also face the most significant increases in incidence rates. We therefore
suggest making the following changes to the findings section.
·
p. 2, line 15: (5) In recent decades, the biomedical research enterprise has made
considerable advances in the knowledge required to understand, prevent, diagnose, and
treat some forms of cancer;
·
p. 4, line 1: (11) Yet in the 38 years since the national declaration of the War on Cancer,
the overall age-adjusted mortality rate for cancer is still extraordinarily high. Eight forms
of cancer have a five-year survival rate of less than 50 percent (pancreatic, liver, lung,
esophageal, stomach, multiple myeloma, brain, and ovarian).
Recommendations from the Deadly Cancer Coalition on the July 30, 2009 Draft
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·
NEW: (12) According to a recent article in the Journal of Clinical Oncology, certain high
mortality cancers will be among those with the greatest relative increase in cancer
incidence over the next 20 years, including stomach (67%), liver (59%), myeloma (57%),
pancreas (55%), and lung (52%), requiring substantial improvements in cancer therapy,
prevention and early detection strategies for these and other high mortality cancers.
·
p. 5, line 10: (4) To support the National Cancer Institute in establishing relationships and
scientific consortia with an emphasis on public-private partnership development, which
will further the development of advanced technologies that will improve prevention,
diagnosis, and treatment of all forms of cancer.
Section 3. Advancement of the National Cancer Program
Clarify that high-mortality cancers should be a specific area of focus in the new National
Cancer Program
As you have noted in the Findings section of your legislation and in the new high-mortality and
very low-incidence cancers grant program, there is a specific need to identify high-mortality
cancers as an area of special focus in a new and updated National Cancer Program. To that end,
we also respectfully request that you consider the following changes to bring consistency
throughout the legislation:
·
Defining the National Cancer Program Just as you have specifically called out research
into the prevention of cancer where occupational or environmental carcinogens may be
involved as a needed area of focus in the new program, we request that you also
specifically identify research into cancers with the highest mortality rates.
o
p. 6, line 6: replace "carcinogens; and" with "carcinogens; cancers with survival
rates of less than 50 percent; cancers for which the 5-year survival rate has been
50 percent or more for fewer than five consecutive years; and"
·
Programs to Encourage Early Detection Research Early detection research is one of the
most critical areas for cancers with the highest mortality rates as early detection tools are
lacking for most if not all of these cancers. We therefore propose the following changes
on p. 8, lines 17-22:
o
``(d) PROGRAMS TO ENCOURAGE EARLY DETECTION RESEARCH.--The
Director of the Institute shall develop a coordinated process through which
Federal agencies, including the Department of Defense, and administrators of
federally funded programs may collaborate on early cancer detection research.
These programs shall include but are not limited to research grants focused on
cancers with survival rates of less than 50% and cancers for which the 5-year
survival rate has been 50 percent or more for fewer than five consecutive years
to enhance understanding of the earliest systemic alterations associated with
these malignances to enable early detection and cure.
·
The NCI's Process to Develop Biorepository Guidelines Should be Completed Before
Adoption is Legislated - While we greatly support the development of guidelines for
establishing a biorepository network, we note that NCI has not yet completed their
development process and that the cancer community has not yet had an opportunity to
review and comment on the final guidelines. We therefore urge you to consider revising
this section, starting on p. 11, so that the adoption of the guidelines is not enforced until
the community has had an opportunity to review and comment on them.
[NOTE: We believe that these guidelines have been completed and released by NCI,
therefore, this provision may no longer be relevant. We tried to reach out to Carolyn
Compton at the NCI to confirm, but have not yet heard back. A call from you may help
expedite clarification.]
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Section 7. Early Recognition and Treatment of Cancer Through Use of Biomarkers
Include risk stratification as well as early detection as a biomarker goal
Biomarkers can be used not only to detect cancer early, but also to determine the aggressiveness
of cancers, survival, and responsiveness to certain drugs. Research and development of
biomarkers and technologies for the clinical application of early cancer detection strategies
provide a tremendous opportunity to improve the outcome for people with cancer by enhancing
these detection and treatment approaches. We understand that you are working with the Society
of Gynecologic Oncologists on this issue and support their efforts to include language that would
authorize new centers for biomarker research targeting risk stratification and early detection and
to ensure that these new centers are for high-mortality cancers.
Section 13. Activities of the Food & Drug Administration
Expedite Review Procedures at the Food and Drug Administration
In order to have safe drugs come to market quickly, the Office of Oncology Drug Products needs
to modernize. We suggest the following additions to the Sense of the House Statement on page
109:
(3) modernize the Office of Oncology Drug products by examining and addressing internal
barriers that exist within the current organizational Structure; specifically, the Office shall
(a) Convene a panel of physicians, scientists, patient advocates, industry representatives,
including biotechnology, drug and device development companies, and Federal agency
officials to identify impediments to an expedited review for new cancer therapies,
diagnostic protocols, treatments and chemoprevention treatments for those cancers with
five-year survival rates of less than 50 percent and for those cancers for which the 5-year
survival rate has been 50 percent or more for fewer than five consecutive years. Said
panel shall provide a report of its findings and its recommendations for procedural and/or
scientific changes to alleviate these impediments to the Office within 12 months of being
convened.
(b) Address through fact finding, public testimony, and expert advice what the appropriate
balance of patient benefit versus risk is for cancer therapeutics in each stage of clinical
development and educate all parties on this information.
ADDITIONAL SECTION OF INTEREST TO OUR COMMUNITY
Finally, we note that the July 30, 2009 version of the bill does not include a provision on the
Cancer Genome Atlas (TCGA) similar to the one in Section 6 (d) in S. 717 on page 46, lines 17-
25. Should you decide to include this section, we would encourage you to broaden the language
in S. 717 to include cancers with five-year survival rates below 50% and also to include specific
language that indicates that cancers that have already been included in the TCGA would not be
excluded. We also suggest slightly modifying the section heading from S. 717 to more accurately
reflect the content of the section.
Section XXX. ACCESS TO PREVENTION AND EARLY DETECTION
16 FOR CERTAIN CANCERS Access to Cutting-Edge Programs on Prevention, Detection, and
Treatment
(1) THE CANCER GENOME ATLAS- The Secretary of Health and Human Services,
acting through the National Cancer Institute, shall provide for the inclusion of cancers with
survival rates of less than 50% percent at 5 years in The Cancer Genome Atlas.
(2) PHASE IN- The Director of the National Cancer Institute shall phase in the
participation of cancers described in paragraph (1) in the Cancer Genome Atlas Consortium.
(3) CONTINUED INCLUSION OF CERTAIN CANCERS--cancers that have already
been included in TCGA would not be excluded with the addition of the cancers described in (1).
Recommendations from the Deadly Cancer Coalition on the July 30, 2009 Draft
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(4) WORKING GROUPS- The Secretary of Health and Human Services, acting through
the National Cancer Institute, shall establish formal working groups for cancers with survival rates
of less than 50 percent at 5 years within the Early Detection Research Network.
(5) COMPUTER-ASSISTED DIAGNOSTIC, SURGICAL, TREATMENT AND DRUG
TESTING INNOVATIONS TO REDUCE MORTALITY FROM CANCERS- The Director of the
National Institute of Biomedical Imaging and Bioengineering shall ensure that the Quantum Grant
Program and the Image Guided Interventions programs expedite the development of computer
assisted diagnostic, surgical, treatment and drug testing innovations to reduce mortality from
cancers with survival rates of less than 50 percent at 5 years.
Thank you for the opportunity to provide comments on the July 30, 2009 draft of your legislation.
We look forward to working with you as your bill moves towards introduction and passage.
Should you have any questions, please feel free to contact Megan Gordon Don, Director of
Government Affairs at the Pancreatic Cancer Action Network at 202.742.6776 or
mgdon@pancan.org.
Sincerely,
American Association for the Study of Liver Diseases
American College of Gastroenterology
American Gastroenterological Association
American Pancreatic Association
Digestive Disease National Coalition
Esophageal Cancer Action Network (ECAN)
Hepatitis Foundation International
International Myeloma Foundation
Leukemia & Lymphoma Society
Lung Cancer Alliance
National Brain Tumor Society
National Ovarian Cancer Coalition
National Pancreas Foundation
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Sarcoma Foundation of America
Society of Gynecologic Oncologists
cc:
The Honorable Frank Pallone
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