A Q&A with Mary Woolley, President and CEO of Research!America
Q: You attended the December 2016 signing by President Obama of the 21st Century Cures Act and are recognized to be a strong supporter. Yet harsh criticism of it has quickly appeared in JAMA, BMJ, a variety of other venues, as well as on these pages. Please tell our readers why this is good legislation and how the public health will be protected from exploitation in this very different regulatory world.
A: The bi-partisan 21st Century Cures Act is grounded in a commitment to assuring that our nation’s research ecosystem has the capacity to accelerate the pace at which safe and effective medical advances reach patients. The Act will expand the efficiency, reach and impact of medical discovery in a manner that sustains crucial safeguards against unsafe or ineffective products. The law finances more research, helps to reduce the administrative cost surrounding basic research, and takes additional steps to overcome challenges the Food and Drug Administration (FDA) faces. Patient groups, health care professionals, academic leaders, industry leaders and the FDA and the National Institutes of Health (NIH) were frequently consulted regarding provisions of this bipartisan bill, and their insights were incorporated. We at Research!America were closely involved throughout development of the bill, and are pleased that it crossed the finish line last December. Continue reading…
“Vice President Joe Biden outlined a plan to improve the efficiency and transparency of the U.S. clinical research system as part of the national cancer moonshot initiative.
“The plan includes specific steps to help patients locate trials quickly, incentivize clinical trial design to broaden participation while reducing burden and risk, and strengthen the transparency of trial results.”
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“Cancer immunotherapies are treatments that stimulate the immune system to target and attack cancer. Researchers now believe that combining immunotherapy with traditional therapies could open up new possibilities for cancer treatment.
“For instance, radiation is one of the oldest and most commonly used forms of cancer treatment out there. But there are limits to how much radiation a person can receive, and it can’t kill every cancer cell. However, in combination therapy, radiation could be paired with immunotherapy to pack a one-two punch against cancer cells.”
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“As the nation embarks on an ambitious ‘moonshot’ to accelerate progress against cancer, our system for delivering today’s cancer treatments must be better prepared to bring advances to all patients, warns a new report from ASCO.
“The State of Cancer Care in America: 2016, published March 15 in the Journal of Oncology Practiceand presented at a Congressional briefing in Washington, DC, is ASCO’s third annual assessment of national trends in cancer care delivery. The report highlights many promising cancer care developments, including new drugs and technologies, declining mortality rates, expanded access to healthcare generally, and a shift towards value-based care. But ASCO also highlights major challenges for patients and physicians, including uneven health insurance coverage, rapidly rising costs, and other barriers to accessing new treatments.”