The health insurance reform bill signed today by President Obama includes a provision to speed the translation and application of promising new treatments for diseases from the laboratory bench to a patient's bedside.
The provision, championed by U.S. Senator Arlen Specter (D-Pa.), is known as the Cures Acceleration Network (CAN). CAN, as authorized, would award grants through the National Institutes of Health (NIH) to biotech companies, universities, and patient advocacy groups to bridge the chasm between a basic scientific discovery and its application as a new health treatment. Many biomedical discoveries with the potential for development are slowed due to lack of resources and insurmountable red tape; the issue is so prevalent that researchers have coined the term "the valley of death" to describe this loss of scientific knowledge with great potential for health and economic benefits.
"Today is a great day for health care and a great day for medical research," Sen. Specter said. "The valley of death is why many promising discoveries such as genes linked to cancer, Parkinson's disease, and Lou Gehrig's disease, languish in the laboratory and on the pages of scholarly journals. If the Defense Department can convert research discoveries, like radar and lasers, into battlefield tools, there is no reason we should not be able to convert promising health care research into saving lives."
"The Cures Acceleration Network will address the significant challenges associated with translating early phase research to clinically meaningful treatments," said Dr. Ellen Sigal, Chair & Founder, Friends of Cancer Research. "By bridging the gaps that currently exist, new and innovative treatments can get to the patients that need them most."
"With an aging baby boomer population at risk for developing Alzheimer's disease which already touches more than 5 million Americans, it is more urgent than ever that every effort be made to strengthen the entire research enterprise," said Robert J. Egge, the Alzheimer's Association's Vice President of Public Policy and Advocacy. "The Cures Acceleration Network, included in the recently passed health care reform legislation, is a critical provision aimed at developing treatments and cures for high need diseases, such as Alzheimer's. The Cures Acceleration Network is an important, innovative approach to bridging the gap between laboratory discoveries and actual treatments. The Alzheimer's Association commends Senator Specter for his commitment to all Americans living with devastating diseases and his foresight in championing this effort."
Senator Specter has been a long-time champion for medical research. As chairman and ranking member of the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, Senator Specter worked to more than double the funding for the NIH from $12 billion to over $30 billion since 1991. Most recently, Senator Specter worked to include an additional $10 billion for the NIH in the Recovery Act of 2009.
CAN grants of up to $15 million will be used to fund clinical trials and hasten the approvals process. Many groups for lack of adequate funding have eliminated or postponed clinical trials to treat such diseases as melanoma, cervical cancer, lupus, multiple sclerosis, diabetes, atherosclerosis, and non-Hodgkin's lymphoma.
"Without adequate funding, scientists and companies will be unable to take their products to the development stage, the basic research done by NIH will be lost, and Americans will not benefit from the better quality of life these drugs and devices could provide," said Sen. Specter.
To provide for expedited FDA approval, the grantees must establish protocols that comply with FDA standards to meet regulatory requirements at all stages of medical product development, review and approval.