Working Together to Overcome Cancer Through Public Policy
In this section you will learn:
Increasing federal support for biomedical research and crosscutting research initiatives is crucial for progress against cancer.
Regulatory science and policy play a key role in making continued progress against cancer.
Federal support is needed to develop and train the biomedical research workforce of tomorrow.
This is a time of incredible promise in cancer research. Scientific opportunities to spur advances against cancer that were previously unimaginable are now within reach. The progress is being made thanks to the efforts of countless researchers, physician-scientists, other health care professionals, and patient advocates working together across the continuum of biomedical research to unravel the complexity of cancer (see sidebar on What Is Basic Research and How Does It Drive Progress against Cancer?). This hard-won knowledge is leading to the development of new approaches for preventing, detecting, diagnosing, and treating cancer. More effective interventions improve patient quality of life and ultimately, save more lives from cancer.
As detailed in this report, the progress can be illustrated by the numbers. Between August 1, 2016, and July 31, 2017, the FDA approved nine new anticancer therapeutics and a new optical imaging agent to help visualize cancerous tissue during surgery. During this same period, the FDA also approved new uses for eight previously approved anticancer therapeutics.
The pace and scope of the advances are remarkable. Our knowledge of the complexities of cancer has been significantly enhanced, innovative new technologies have been developed, the number of uses for molecularly targeted therapeutics and immunotherapeutics has been dramatically expanded, and important progress has been made in cancer prevention and toward a better understanding of cancer health disparities.
The progress chronicled in this report would not be possible without strong, bipartisan leadership in Congress and federal support for the NIH, NCI, and FDA (see sidebar on Building Blocks of Further Progress against Cancer). The AACR is deeply grateful to U.S. House and Senate leaders for making medical research a high national priority and establishing a new trend of significant, annual funding increases for the NIH and the NCI. For two consecutive years, robust funding increases have begun the process of reversing the troubling pattern of stagnant budgets that persisted for more than a decade and provided a much-needed investment at a critically important time. In addition, the NIH Innovation Fund, a multiyear, targeted funding stream created by the 21st Century Cures Act, will provide dedicated resources for the Beau Biden Cancer Moonshot to further accelerate progress in key areas where researchers are poised to make great strides.
Robust, Sustained, and Predictable Funding Increases for Biomedical Research
Federal funding through the NIH and NCI is the lifeblood of biomedical research and forms the foundation upon which most scientific and medical discoveries in the United States are made. In the years since President Nixon signed the National Cancer Act, investments in the NIH and NCI, in large part due to overwhelming bipartisan support from Congress, have resulted in the extraordinary progress against cancer detailed in this report.
As discussed by Congressman Charlie Dent, strong federal investment in biomedical research is essential, both for our nation’s health and for our economy. More than 80 percent of the funds appropriated by Congress to the NIH are distributed to scientists in all 50 states, the District of Columbia, and around the world to conduct research. In FY 2016, thanks to funding increases, the NIH supported 54,200 research grants, an additional 3,147 grants more than in FY 2014. The impact of federal support for NIH, NCI, and FDA reaches well beyond the laboratory and the clinic, supporting nearly $64.8 billion in economic activity last year alone.
Stagnant budgets at the NIH for more than a decade led to a 25 percent decline in its purchasing power, when adjusted for inflation. This factor, when combined with the growth in public funding of biomedical research by other countries, threatens the United States’ position as the world leader in biomedical research. In the past two years through an extraordinary bipartisan effort, Congress halted this troubling downward trend with consecutive budget increases that outpaced inflation (see Figure 18).
However, the NIH now faces new threats to funding. In the spring of 2017, the Trump White House released a budget proposal that called for drastic cuts of more than 20 percent to the NIH in FY 2018 (see sidebar on Turning Back the Clock). Unless a new budget agreement is reached between Congress and the White House, sequestration will return in FY 2018, in accordance with the Budget Control Act of 2011. It is imperative that Congress reject calls for cuts to this vital investment and instead, continue its commitment to robust, annual increases for the NIH so that funding can continue to recover lost ground and thereby yield results for all Americans and people around the world.
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The Beau Biden Cancer Moonshot: Toward “Ending Cancer As We Know It”
The Beau Biden Cancer Moonshot is entering its second year, and in December 2016, the initiative received its first federal funding of $300 million through the NIH Innovation Fund, which was established in the 21st Century Cures Act (see sidebar on Working Together to Implement the Beau Biden Cancer Moonshot). The initiative seeks to double the rate of progress toward a cure for cancer by making ten years of progress in five years.
Prior to leaving office, Vice President Biden delivered the Cancer Moonshot Task Force’s comprehensive report to President Obama (210). In this report, Biden and his colleagues set forth a strategic plan for transforming cancer research and care through five overarching goals. The first goal, which is to catalyze scientific breakthroughs, will be accomplished through implementation of the recommendations of the Blue Ribbon Panel. The second goal is to unleash the power of data through several approaches, including the NCI Genomic Data Commons, which was unveiled in late 2016. This resource promotes the sharing of genomic and clinical data between researchers and serves to facilitate precision medicine in oncology. The third goal, to accelerate the delivery of new therapies to patients, is being accomplished in part through the creation of the FDA Oncology Center of Excellence (OCE) and the Partnership for Accelerating Cancer Therapies (PACT), which is a collaboration between the NIH and twelve biopharmaceutical companies, research foundations, and philanthropies.
The fourth and fifth goals are to strengthen the prevention and diagnosis of cancer, and to improve patient access and care, respectively. In conjunction with the release of the Cancer Moonshot Task Force report, Vice President Biden announced new commitments from both the public and private sectors to accomplish the goals set forth in the plan, including partnerships to advance data tools and patient services such as affordable and reliable transportation.
Enhancing Support for Regulatory Science and Policy Activities at the FDA
The FDA is an integral part of the biomedical research cycle (see Figure 8). Support of this critical agency through robust, annual appropriations from Congress is crucial if we are to continue to make advances against cancer through the delivery of safe, effective, and precise medical products to patients. This is because annual funding for the FDA from Congress goes toward the agency’s regulatory science initiatives that seek to promote and develop new evidence-based regulatory policies that balance innovation and the expedited approval of medical products that are safe and effective.
As research leads to more sophisticated and complex approaches to treatment, the process of approving those therapies must keep pace. Likewise, the FDA must keep abreast of the latest scientific and technological progress through discourse, cooperation, and collaboration with academia, industry, patient advocacy groups, and government. In recent years, Congress has recognized that it must equip the agency with the resources it needs to support these regulatory processes. Thus, the 21st Century Cures Act included important provisions that provide a dedicated stream of funding to assist with innovation, expand hiring authority at the agency, and ensure continued professional development of staff.
The 21st Century Cures Act also authorized the establishment of the FDA OCE (see sidebar on The Aims of the FDA Oncology Center of Excellence). The OCE is streamlining the work that the FDA does in the field of oncology by bringing together staff from the Center for Drug Evaluation and Research, the Center for Biologics and Evaluation Research, and/or the Center for Devices and Radiological Health. This crosscutting review team design will expedite the evaluation of drugs, biologics, and devices for the treatment of cancer, and thereby help advance the goals of the Beau Biden Cancer Moonshot.
Developing and Training the Cancer Workforce of Tomorrow
Many of the innovative research questions and fresh ideas come from scientists early in their careers (see sidebar on Supporting Early-Career Investigators). Ensuring the continued, rapid pace of progress against cancer requires that the next generation of cancer researchers be encouraged, recruited, and supported. A strong pipeline of talented researchers to whom current leaders in the field can pass the baton in the years to come will allow the work to continue in earnest to conquer this disease.
The current generation of early-career investigators has been privy to the exciting advancements that have been thus far described. At the same time, they came of age in a decade when the NIH budget declined by 25 percent, when adjusted for inflation, and the path forward was uncertain. Even though the funding landscape has improved in the past two years, many young investigators saw the stagnant budgets of prior years and opted for alternative career paths, thereby putting future generations of innovative research in jeopardy.
Our country must continue to invest in the education and training of scientists at all career levels, but especially at the dawn of their careers. The cancer workforce of tomorrow also must reflect the increasing diversity in our country, including disciplinary, gender, racial, ethnic, and geographic diversity. Robust, sustained, and predictable funding increases for the NIH, coupled with state and private sector-funded programs to assist early-career scientists, play an irreplaceable role in cultivating tomorrow’s scientific leaders.
Members of Congress and NIH officials have recognized the importance of supporting scientists early in their careers, and they have taken important steps to assist young investigators through legislative provisions in the 21st Century Cures Act and new policies enacted through the NIH Office of Extramural Research, including the Next Generation Researchers Initiative (see sidebar on Supporting the Future of Cancer Research).
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Policies to Advance Patient-centered Research and Care
In addition to supporting science and research, public policies also must support the beneficiaries of this research—the patients. Above all else, access to comprehensive health insurance coverage is critical for all Americans, especially those who have experienced acute and chronic diseases, including the 1.7 million Americans who will be diagnosed with cancer this year, and the 15.5 million cancer survivors. The Affordable Care Act has provided major benefits for those affected by cancer, including a prohibition on the denial of insurance coverage based on preexisting conditions; Medicaid expansion; dependent coverage until age 26; a prohibition on annual and lifetime coverage caps; and coverage of prevention, early detection, treatment, and survivorship services. Any replacement of the current law must retain these provisions that are so vital for cancer prevention, detection, diagnosis, treatment, and survivorship.
Every year, thousands of individuals, including cancer patients and survivors, make the selfless choice to participate in federally funded cancer research so that effective preventive strategies and treatments continue to make a difference in the lives of those affected by cancer. National policies need to support this participation at every level, from protecting information, to covering routine costs of care, to ensuring that the patient experience is taken into consideration.
Current protections based on basic ethical principles for federally funded research involving human subjects stem from the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” Until January 2017, the Common Rule had not been updated since 1991, even though the field of biomedical research had evolved dramatically. However, on January 18, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final update to the rule intended to safeguard individuals who participate in cancer and other biomedical research, while making it easier for scientists to conduct lifesaving research on samples provided by these individuals (see sidebar on Revisions to the Common Rule).
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