The American Center for Cures: Hope for actual health, not just healthcare finance
Posted Aug 26 2010 10:00am
Dr. Richard Boxer, co-founder, along with Lou Weisbach, of the American Center for Cures, lays out his argument in ASCO Post , a journal of hematology and oncology. The American Center for Cures has been laboring in the Serious Medicine vineyard for years. To read Dr. Boxer's piece is to be reminded that the ultimate point of medicine is not finance, but medicine--to be reminded that there is still such as thing hope in the medical field.
But Rick can say it much better himself American Center for Cures Could Ensure Health-care Reform Leads to Reform in Health
President Obama and the congressional leadership should call for the creation of a new public/private enterprise dedicated to the pursuit and protection of medical innovation in America. This enterprise-referred to as the American Center for Cures (ACC)-would be designed to achieve breakthroughs in cancer and other devastating illnesses that affect Americans, thereby improving health, health care, and the health of the economy.
The explosion of scientific knowledge in the past 50 years has been astounding, but cancer cases as a percentage of the population constitute the same proportion today as they did in 1950. It is appropriate and compelling to support not only improvements in health-care access, quality, and affordability, but also a new undertaking focused on achieving direct and dramatic improvements in the health of Americans.
The ACC should be an applications and translational center with special emphasis on the discovery of early biomarkers to prevent, diagnose, or cure disease. A well-funded, focused ACC will bring to bear the genius and resources of America to eliminate the scourge of so many chronic debilitating diseases such as Alzheimer's, Parkinson's, diabetes, depression, schizophrenia, arthritis, cancer, heart disease, and others. The ACC would bridge the basic science-to-industrial production gap to safely, efficiently, and expeditiously bring discoveries to the bedside. It would be responsible for bringing together the pieces of the scientific puzzle produced by the world's basic scientists.
The ACC would be supported with public/private funding and directed by leadership from government, industry, academia, and nonprofit sectors. It would be mission-driven, accountable, and authorized to pursue high-risk/high-reward translational and clinical research opportunities. In addition, it would be multidisciplinary, including biologic and physical sciences. The organization would be charged with establishing collaborative centers of excellence in regulatory science defined by transparency, collaboration, and data sharing. Such centers of excellence would be designed to bring best practices from industry into academia and to train a new cadre of investigators skilled in moving products through the development pipeline from proof of concept in humans to commercialization.
The Center would be governed by a Board (Cures Council) appointed by the President, consisting of leaders in basic and clinical science, the physical sciences, patient advocacy, and entrepreneurs, with recommendations from the National Academy of Sciences. It would fall under the authority of the Secretary of Health and Human Services (HHS) with the power necessary to forge a new bridge across the HHS scientific infrastructure. Finally, it would be coordinated by a CEO charged with responsibility, accountability, and a sense of urgent mission to cure diseases targeted through cross-agency, multidisciplinary, global leadership.
The Director of the National Institutes of Health (NIH) would henceforth also be called the Director (or Secretary) of Cures (DOC). This position ideally will be elevated to a cabinet post to demonstrate the commitment of the nation. The ACC will be located within the Office of the DOC.
The new agency would be funded for success with new major appropriations and a bypass budget. The funding should be provided over 10 years for long-term commitment critical to scientific endeavors.
The Cures Council will determine what projects the ACC takes on, based on the intersection of diseases that have the greatest impact on Americans and those with the greatest likelihood of cure. Each disease cure effort will have a CEO accountable for cure within 5 to 7 years. Each unit will invest in researchers and research institutions around the world to get specific answers to specific questions needed for cures and prevention.
A Health Advanced Research Projects Agency (HARPA), modeled after the highly successful Defense Advanced Research Projects Agency (DARPA), will fund strategic high-risk/high-reward research and follow a "challenge model" to support innovative multidisciplinary research between NIH institutes, other federal agencies, grantees, and business partners, for projects with the potential for a significant impact on health. Funding for projects will be flexible and outcomes based.
An Office of Translational and Applications Research will coordinate all clinical research within the NIH and work closely with the FDA, Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), Health Resources and Services Administration (HRSA), etc. The ACC will have a Center for Clinical Trials that will centralize and organize protocols and streamline the institutional review board complexities throughout the NIH to supply the public with new treatments more quickly, safely, efficiently, and economically.
Special emphasis through designated funding and coordination with other agencies (eg, the Small Business Administration) should focus on bridging the so-called "valley of death"-the often lengthy time between research/development and commercial availability-that has killed innovation.
Finally, an office would be established to coordinate efforts to reduce medical errors.
Justification for the ACC
A new mechanism is required to accelerate innovation and applications of basic research that will lead to cures in the diseases affecting Americans. This mechanism must have the authority to work across the Department of Health and Human Services (DHHS), to bridge the widening gaps between laboratory discoveries, early proof-of-concept applications in humans, and ultimate commercialization of lifesaving therapies. Such a mechanism should ultimately improve the health of individuals, health care, and the economy in the United States.
This new entity, the American Center for Cures, will have the authority and capacity to draw upon resources and scientific knowledge developed across DHHS, within health research (NIH, AHRQ), administrative (CMS), and regulatory (FDA) agencies, so that opportunities to leverage the collective strength and genius of the federal health enterprise are aligned and captured. For example, through new funding authorities the ACC may examine and support Centers of Excellence in Regulatory Science within academia, develop broad resource networks with biotechnology firms, create opportunities for federal partnerships with industries in the "precompetitive" space, and forge new models for public/private partnerships across academia, industry, government, and the nonprofit sectors.
The ACC will support America's leadership with global partners in research and therapeutic product development, bringing creative, multidisciplinary focus (ie, physical and biologic sciences) to bear upon diseases and conditions that may be ripe for high-risk/high-reward investments with the potential of driving toward cures. Ideally, the venture will be funded through a new innovative funding source, allowing it to be sufficiently endowed without requiring new taxes. Moreover, this endeavor can achieve the key measurable and ancillary outcomes of creating and protecting millions of jobs and maintaining our nation's global competitiveness in the life sciences.
Answering Great Challenges
America always answers great challenges, whether it is splitting the atom, preventing polio, or sending a man to the moon and returning him safely. It is time to meet the next great challenge and take on a cause greater than ourselves. Let it be said in 50 years that our children and grandchildren will not suffer from the same diseases that our generation and previous generations had because we took a stand in 2010 to do what we all know is needed-to bring the dream of the American Center for Cures to reality.
Never has the time for such a project been better or the need been greater. Never has a more substantial wealth of knowledge been available in the quest to relieve patient suffering. Never has there been a clearer vision of what must be done.
Hope for cures is a lot more compelling to people than healthcare finance. If the Obama administration had led with this, they could have had cures, easy, and health insurance would have fallen to their laps, soon enough, once they convinced skeptical Americans that they weren't just about bureaucrats--or worse. But instead of going the easy way, they went the hard way--with bureaucrats, leaving those skeptical Americans to imagine the worst.
To sum up: Given a choice between downhill and uphill, the Democrats chose uphill.
The question, upcoming is whether the Republicans--who are destined to have a lot more power in the next Congress--choose, also, to go the hard way--uphill, not downhill. Repealing Obamacare will be harder, even, than enacting it--and probably impossible. Yet that hard way will likely consume the Republicans for years to come.
For reasons that you and I have discussed, everyone in DC seems to like doing it the hard way. Not because they are naturally hard workers, but because the easy way has fallen off the mental roadmap that guides them--although Rick has laid out an excellent roadmap.