Leaders from NIH, FDA, Academia Urge US Government to Invest in Medical Innovation
Medical discoveries are not getting to patients as fast as they could and young researchers are not being adequately supported because the United States considers medical research a “discretionary” investment, the director of the National Institutes of Health (NIH) said at a roundtable held in Washington, DC, on May 6, 2014. The roundtable of scientists, industry representatives, and academic leaders was the first step in a unique bipartisan effort to optimize how new advances are developed and delivered.
Representatives Fred Upton (R-MI), chair of the House Energy and Commerce committee, and Diana DeGette (D-CO) formed the collaboration called 21st Century Cures to investigate ways to accelerate the pace of cures and medical breakthroughs.
In a white paper inaugurating the effort, Reps. Upton and DeGette assert that “input, answers, and feedback” from many areas is needed to ensure that the United States “owns the discovery, development, and delivery cycle” of drugs and devices.
“We are interested in both how the individual pieces of the cycle can improve and modernize, but also how all the pieces of this cures cycle can work together more efficiently and effectively,” they write.
The white paper makes several references to Project FDA, an initiative of the Manhattan Institute that aims to reform the US Food and Drug Administration (FDA). Project FDA is led by former FDA Commissioner and former Director of the National Cancer Institute Andrew C. von Eschenbach, MD, who also participated in the roundtable, calling for an “investment of intellectual as well as financial capital.”
The Project FDA website states that the agency “can become a bridge for innovation, rather than a barrier to it, and that this can be achieved without sacrificing patient safety. For instance, advances in molecular medicine that allow companies to target specific subgroups of patients, combined with electronic health records, should allow the FDA to streamline and improve time-consuming and expensive pre-market product testing that can take a decade or more, and implement vigorous post-market surveillance of ‘real world’ patients after drugs or devices demonstrate safety and efficacy in early testing.”
Clinical Trials Need Help
During the roundtable, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, asserted that the clinical trials system is “outdated” and suggested that networks may “turn the paradigm on its head” by reducing time and effort and saving money while getting new discoveries to patients.
“We need clinical trial networks because they are faster and more independent,” she said, citing the European Cystic Fibrosis Clinical Trial Network as a successful example of this concept. “[Y]ou get to do head-to-head comparisons in this network, because you’re testing multiple products as well as approved therapies at the same time.”
Dr. Woodcock also expressed interest in having the government invest more in drug manufacturing innovation. “There are drug shortages in hospitals all across this country. We buy many of our drugs from other countries,” she said, adding that natural disasters or hostilities could potentially impinge on the ability of the United States to get needed drug supplies.
‘Angst” Among Young Scientists
According to Reps. Upton and DeGette, gaps between science and regulation are putting the United States at risk of no longer being the leader in medical innovation.
NIH director Francis Collins, MD, who rose to fame by leading the effort to map the human genome, expressed frustration at the endless paperwork carried out by NIH—much of which is completely unnecessary, he said—while budget cuts continue to squeeze out positions at the agency for gifted young scientists.
Dr. Collins also questioned why investment in medical research is considered “discretionary,” adding, “We are leaving half the science on the table” because funding is inadequate and unreliable.”
He reiterated that the issue should not be considered one of spending. “This is an investment. An investment that pays rewards for human health, for the economy,” he said. Dr. Collins also suggested that the most important entrepreneur in the American system is the Federal government, “and yet we have not allowed that entrepreneur to be what it could.”
James O. Woolliscroft, MD, of the University of Michigan Medical School (Ann Arbor, MI), related to roundtable participants the “angst that is instilled by lack of reliable funding,” among today’s young scientists. Dr. Woolliscroft added that regulatory burdens make it difficult to create partnerships with industry.
Rep. DeGette said she believes Congress can help in the effort to improve the situation and added that all these groups must work together in order to not fall further behind. The 21st Century Cures initiative plans to hold more roundtables over the next 6 months. Any reform plans the group might propose would need to pass the House and Senate before being signed into law by the President.
Source:
Upton F, DeGette D. 21st century cures: a call to action. http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140501WhitePaper.pdf. Published online May 1, 2014. Accessed May 9, 2014.
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L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
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