Straight Talk: New Thinking on Tough Challenges
“The biomedical research enterprise underpins the health of the nation and much of the world, and is in dire need of substantial infusion to meet the great medical needs of our time,” said William N. Hait, M.D., Ph.D., global head, Janssen Research & Development. Hait, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, the keynote speaker at the 2016 National Health Research Forum, added that we’re losing time in addressing threats like the Zika virus, Ebola and cancer while waiting for funding to improve for biomedical research.
The program, held Thursday, September 8 at the Newseum in Washington, D.C., featured panel discussions with leaders representing academia, industry, patient groups, government and scientific societies. Noting recent breakthroughs in research and innovation, Hait said we are making progress towards preventing diseases before they occur.
The first panel, moderated by Nsikan Akpan, digital science producer, PBS Newshour, assessed the benefits of bold initiatives like the cancer moonshot and the BRAIN initiative. Anthony S. Fauci, M.D., director, National Institute of Allergy and Infectious Diseases, recognized the importance of such initiatives but stressed that long-term support for basic biomedical research must remain a priority. “I would like to see a balance between initiatives and undifferentiated research that serves as an incubator for future initiatives,” he said.
John W. Danaher, M.D., MBA, president, Elsevier Education, Elsevier, emphasized that the conversation should be less about whether we’re picking the right initiatives, and more about how we ensure our nation’s research agenda is understood by the American people. Albert A. Lauritano, M.S., CLP, director, strategic technology partnerships, BD, raised the importance of leveraging new technology and diagnostics to improve treatment and prevention.
Panelists agreed that national initiatives are crucial to bringing researchers together to foster collaboration and data sharing. “The word partnership has taken on a new meaning,” said France A. Córdova, Ph.D., director, National Science Foundation. “It’s more about real true engagement and looking at what are your unique strengths as a private foundation, federal agency or research institute, and what can you contribute to these grand challenges.”
Donna Cryer, president and CEO, Global Liver Institute, said patients are key to breaking down information silos, and patient advocacy organizations are in an important position to instill a sense of excitement in research initiatives and generate new ideas. Mobilizing the scientific community as a whole is necessary to respond to the public’s needs, added Keith Yamamoto, Ph.D., vice chancellor for science policy and strategy; vice dean for research, school of medicine, University of California, San Francisco.
The second panel, moderated by Natalie Azar, M.D., NBC News medical contributor, touched on the role of prevention research as it relates to emerging infectious diseases, pain management and opioid abuse, antimicrobial resistance and other conditions.
Anne Schuchat, M.D., principal deputy director, Centers for Disease Control and Prevention and other panelists discussed the critical need for an emergency public health fund that would allow federal health agencies to respond quickly to threats like Zika, which she said is an extremely complex disease.
Social determinants of health that include socioeconomic conditions must be considered in efforts to reduce the risk of chronic disease, noted Hortensia Amaro, Ph.D., associate vice provost for community research initiatives and dean’s professor of social work and preventative medicine, University of Southern California. She said prevention should start further upstream before it reaches the clinic. Stronger investments in the health care system and more progress in reducing medical and diagnostic errors would also improve population health, said Andrew B. Bindman, M.D., director, Agency for Healthcare Research and Quality.
“If we address the major causes of morbidity– obesity, cigarette smoking, alcohol/substance abuse– trauma, we would reduce every one of the scourges of chronic diseases,” said Joe V. Selby, M.D., MPH, executive director, Patient-Centered Outcomes Research Institute. One of the best ways to reduce rates of hospital errors is to prevent hospitalization, he added.
A proper diet, exercise, yoga can prevent frequent, bad headaches and the overuse of opioids, noted Stephen D. Silberstein, M.D., FAHS, FACP, professor of neurology, director of the Jefferson Headache Center, Thomas Jefferson University. “Prevention is the way to go,” he said, to keep episodic illnesses like migraines from becoming chronic.
The mission of the Food and Drug Administration was the focus of the third panel, moderated by Geneva Overholser, senior fellow and consultant of the Democracy Fund, and former national syndicated columnist and editor.
When asked about agency priorities, FDA commissioner Robert M. Califf, M.D., said a strong workforce is crucial to regulating science like gene editing. Generating evidence, he noted, is also a priority to ensure the agency has good data to make sound regulatory decisions.
Public-private partnerships have accelerated innovative research, the panelists agreed, as collaborations continue to advance the work of various sectors. “This is not your father’s FDA,” said Sudip S. Parikh, Ph.D., senior vice president and managing director, DIA Global. “This FDA is proactively engaging with industry in ways they never have before. They have come a long way.”
The Honorable Kweisi Mfume, former U.S. Representative, expressed concerns that clinical trials are not inclusive enough to secure accurate data. Jean-Christophe Tellier, M.D., CEO and chairman of the Executive Committee, UCB, added that data sharing is equally important to find solutions to complex diseases.
Emil Kakkis, M.D., Ph.D., president and founder, EveryLife Foundation for Rare Diseases, said real world data can support the development of new treatments for rare diseases. He acknowledged the constraints of the FDA, adding that it needs sufficient resources to address patient needs and evolving science.