The Cancer Innovation Coalition (CIC) has gone to Capitol Hill to call for early legislative and regulatory action in 2015 that will reinvigorate cancer innovation in the U.S.
The reason, according to a panel of cancer researchers, clinical specialists and patient advocates, is that important gains in cancer may have reached a plateau in the U.S. at a time when cancerous tumors are evolving and becoming resistant to existing treatments, and the number of new cancer cases diagnosed yearly in the U.S. are projected to increase 45% by 2030—to 2.3 million Americans.
Speaking at a Washington policy briefing hosted by the CIC, cancer experts further warned that because the effectiveness of cancer treatments depends primarily on preventing resistance, new studies are needed now to show whether alternative approaches to treatment can improve outcomes. The policy briefing was convened as part of Project Innovation, a new movement spearheaded by the CIC to elevate cancer innovation as a national priority.
"The need to accelerate cancer innovation has never been greater," said Nancy Davenport-Ennis, founder of the National Patient Advocate Foundation (NPAF), which is spearheading the CIC and Project Innovation. "Just as this nation took the lead in finding the cure for polio and turning HIV into a chronic disease, we need policy solutions that will restore the U.S. as a leader in delivering new cancer breakthroughs so many more Americans with cancer will live longer, better lives."
When it comes to charting the future course of cancer innovation, the experts taking part in the policy briefing called for a reprioritization of funding from the federal government, as well as the private sector, so the U.S.—which used to be the great engine of medical innovation—can regain its competitive edge in cancer research and clinical trials.
John Harrington, a cancer survivor and retired Chief Commercial Officer for Sanofi Global Oncology, said the immediate problem is not a lack of resources, but what he called the nation's "collective complacency" regarding the continued position of the U.S. as a world leader in oncology care. While the U.S. has adopted a "Just Good Enough" attitude to biomedical discovery, other regions of the world are forging ahead of the U.S. in investing in research and drug discovery. As a consequence, 70% of clinical trials now are conducted outside the U.S.
In terms of the immediate impact of outsourcing research to other countries, the nearly 20% drop in government-funded basic research since 2010 is having a negative effect on the number of cancer patients who can participate in clinical trials. Due to significant budget cuts, the National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program only will be able to enroll about 12,000 adult patients in clinical trials over the coming year—a 50% drop from the historical yearly average of 25,000 cancer patients enrolled in NCI-sponsored clinical trials.
Compounding the situation, reductions in federal funding for cancer research are accelerating an already serious shortage of the research workforce at a time when the nation's cadre of highly skilled scientists is aging. According to Harrington, who spent three years overseeing global commercial development of Sanofi Oncology's cancer compounds, the budget cuts are far more damaging than the policymakers recognize. Researchers at cancer centers are curtailing projects and laying off staff, and many younger investigators are giving up their careers.
Harrington said, "In my global role, I often met U.S. investigators who were working in other countries, as a high percentage of clinical trial patients now are enrolled outside the U.S. This impacts the premier research sites, fellowships and staffing. We need to know that this is coming at a cost to our own medical schools and research institutions, and we could be in danger of losing a generation of cancer researchers in this country."
Experts attending the CIC policy briefing also called for implementing policies that will ensure American cancer patients reap the benefits of the nation's investment in the Human Genome Project, an international effort led by the U.S. that ran from 1988 to 2003 and resulted in the mapping of the human genome.
Although research equates the U.S. investment in the Human Genome Project with nearly $1 trillion worth of economic growth for the country, the panel cautioned that other countries, especially China, now are spending billions on gene sequencing and other aspects of genomic research. In particular, the Chinese company BGI recently acquired the world's largest capacity for human genome sequencing by purchasing a U.S. genomics company.
This development is of great concern to the cancer community, which is pressing for policies that will accelerate the move from a one-size-fits-all treatment approach to molecularly based medicine, also known as precision medicine, where the genetic and molecular profile of the patient's cancer determines the best treatment strategy. This means regulatory approaches that support the increased use of large-scale trials based on the molecular characteristics of specific cancers, including the recently initiated Lung Cancer Master Protocol (Lung-MAP), where patients with advanced squamous cell lung cancer are assigned to one of five different investigational drugs based in part on their genetic profiles.
While citing positive developments in moving toward molecularly based cancer research in the U.S., cancer leaders nonetheless cautioned that without legislative action, many Americans will not have access to genomic testing due to major differences in the way these tests are regulated and difficulties getting commercial payers to cover the costs. At the same time, experts called for immediate action to address the inequities that are limiting patient access to innovative cancer treatments, especially when Medicare and commercial health insurers move newer cancer therapies into the highest specialty tier and charge patients a percentage of the drug's cost, from 25% up to 71%, according to recent estimates.
Moreover, the panel of experts took aim at outdated federal policy that covers oral chemotherapy drugs differently than those administered intravenously or by injections, burdening patients with far greater co-payments for oral cancer medicines, even though these therapies have been shown to help reduce overall cancer treatment costs. To correct this situation, the cancer advocacy community helped pass oral parity laws in 33 states and the District of Columbia and advocates now are pressing for federal legislation that will require health plans to cover oral anticancer medications and injectable therapies equitably so that patients pay the same cost percentage for each type of treatment.
Based on the issues raised at this policy forum and other meetings being held across the country, the CIC will develop a national policy agenda with specific recommendations for Congress and federal and state governments to accelerate the delivery of promising new treatments and to patients. Plans call for announcing this cancer innovation policy agenda in early 2015.
"Our goal is simple and straightforward," said Nancy Davenport-Ennis. "We plan to submit a cancer innovation blueprint to Congress and the FDA that advances specific policy solutions that will move cancer discovery forward in the U.S."
The CIC and Project Innovation are spearheaded by the National Patient Advocate Foundation (NPAF). Primary funding for the Project Innovation initiative comes from NPAF with additional support through educational grants from Celgene, Eli Lilly, Novartis and Pfizer.
Members of the CIC include Amgen, American Association for Cancer Research, American Cancer Society Cancer Action Network, Association of Community Cancer Centers, Bladder Cancer Advocacy Network, Bristol-Myers Squibb, Cancer Support Community, Celgene, Colon Cancer Alliance, Community Oncology Alliance, Council for Affordable Health Care, CureSearch, Cutaneous Lymphoma Foundation, Fight Colorectal Cancer, Friends of Cancer Research, Eli Lilly, Genentech, GlaxoSmithKline, National Patient Advocate Foundation, Novartis, Oncology Nursing Society, Personalized Medicine Coalition, Pfizer, Prevent Cancer Foundation and U.S. Oncology Network.