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'Tremendous progress' in cancer research leads to 'ferocious competition' for funding, outgoing NCI director says
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ATLANTA — The cancer research engine is “clearly working,” with an influx of new scientists and groundbreaking discoveries prolonging survival curves across a variety of cancer types, Norman E. “Ned” Sharpless, MD, director of the NCI, said during the opening ceremony of the American Association for Cancer Research Annual Meeting.
But this “massive influx” of scientists also means competition for a limited pool of funding is fiercer than ever, said Sharpless, who has served as NCI director since 2017, and who will soon serve as acting commissioner of the FDA, replacing resigning FDA Commissioner Scott Gottlieb, MD.
Sharpless said his feelings about this transition are “complex and bittersweet.”
“On the one hand, I’m excited to work at the FDA, the world’s most important guardian of public health,” he said. “But, on the other hand, I’m more than a little sad to give up the role of NCI director. The people, the passion and the sense of mission of the NCI are spectacular. I’ll miss the science and the excitement that permeates the NCI.
“Leading the NCI has truly been a highlight of my career and of my life,” he added. “Over the past 18 months, I learned the NCI is a rich and dynamic place, and I am inspired by the amount of dedication and passion there.”
‘Warmed by fires we did not build’
Leaving the NCI for the FDA has left Sharpless thinking about legacy, continuity and how research of today will be built upon in tomorrow’s advances.
“Each time I attend the AACR meeting, I compare the progress to years past, and I remember the ‘bad old’ days of oncology care, a time when we had so little to offer our patients and so little hope against aggressive cancers,” Sharpless said. “But, the tremendous progress we have made in the last few years has been amazing and, as a long-time cancer doctor, I find it really satisfying to note this progress.”
Researchers of today cannot take credit for all this good news, Sharpless added.
“It brings to mind an old saying: ‘We drink from wells we did not dig, and we are warmed by fires we did not build,’” he said. “We make progress by building on previous discoveries. As cancer researchers, our knowledge is built on breakthroughs that were shared with us by people who we will never meet.”
Most important of these are the patients who knew they stood no chance to benefit from treatment, but instead would help advance research for patients of the future, Sharpless said.
“It’s our charge to continue their progress for those who come after us,” he added. “Now is an exceptional time in cancer research — overall mortality rates are dropping fast, and in some instances, they are plunging.”
This widespread benefit can be seen through long-term mortality declines among both men and women, across age groups, and for all races and ethnicities, Sharpless said.
“These data show that the cancer research engine is clearly working, with steady declines in mortality going back to the 1990s,” he said. “Because of our progress in early detection, screening therapy and prediction, the NCI predicts these strong declines in mortality will continue for years to come.”
Drug approvals are another way to track progress. Last year, 48 new oncology therapies received approval — include eight for acute myeloid leukemia alone — compared with just two in 2005.
“These new therapeutic discoveries are built on yesterday’s progress, just as tomorrow’s treatments will come from the work that we do today,” Sharpless said. “Declining mortality rates, dramatic improvements in certain cancer types, new therapies and industry investment tell us that our efforts are paying off. Research is fueling meaningful improvements for patients.”
Demands on funding
The progress in cancer research and the excitement it has generated has led to the “good” problem of having a “massive influx” of new scientists, Sharpless said.
The influx is reflected in AACR’s membership, which has increased by 20% since 2015. This includes a 30% increase among women members and 35% among minority members, he said.
“This is good news for cancer progress, but all of these new scientists have also led to ferocious competition for NCI funding at present,” Sharpless said. “NCI’s challenge then lies in deciding how to apply limited resources to what seems like unlimited opportunities.”
However, the pharmaceutical industry has increasingly contributed to cancer progress, Sharpless said.
“Despite the fact that it’s difficult to make a cancer drug — it takes a long time and success rates for new cancer therapeutics are low — oncology drugs make up an increasing proportion of late-stage assets in clinical testing by therapeutic class. Industry is investing more and more heavily in cancer research, and this trend reflects the improved basic biologic understanding of cancer. Pharmaceutical executives who choose how to allocate resources are increasingly finding the development of oncology drugs to be a good use of their money.”
Another encouraging trend and “good problem” in cancer research is the increasing number of grant applications that have been sent to the NCI, Douglas R. Lowy, MD, who will take over as acting director of NCI, said during the opening ceremony.
“There has been a huge spike in recent years — about 50% since 2013,” Lowy said. “This increase in the number of applications submitted to NCI accounts for about two-thirds of the total increase of grants to the NIH during this period. Most of this increase is attributable to additional investigators submitting R01 applications to the NCI. These statistics reflect an enthusiastic workforce that sees a lot of opportunity in the field of cancer research, and that is a great sign.”
However, the NCI receives only 16% of the total NIH budget, with a 20% increase since 2013.
This imbalance reflects that the truism “we always run out of funds before we run out of promising research ideas is truer today than it ever has been in the past,” Lowy said.
Solving the current mysteries of cancer research will require continued investment into basic science, Lowy said. In fiscal year 2018, the NCI added more than $170 million to the pool of funding available for grants, some of which came from the cancer moonshot initiative, representing the largest increase since 2003. For 2019, the goal is to increase the funding by $100 million.
“While the NCI must continue to prioritize investigator-initiated research, we will be challenged to do that if our budgets do not meet the pace of the application curve,” Lowy said. “Investing in basic science is how we will identify new targets and new mechanisms, and they will lead to new, more effective approaches for prevention, screening and treatment of cancer.”
In his 2019 State of the Union address, President Donald J. Trump presented a budget proposal that included a little over $5 billion for the NCI — which is less than the $6.144 billion in the current fiscal year budget and the $5.965 billion in the fiscal year 2018 budget.
Funding for the cancer moonshot initiative peaks this fiscal year, but decreases by about 50% in 2020 and disappears entirely by 2024.
“Cancer moonshot funding has helped to establish several new networks that are facilitating collaboration and will accelerate progress for the field and our patients,” Lowy said.
Pediatric oncology
Trump also said that his budget proposal would ask Congress for $500 million over the next 10 years to fund pediatric cancer research.
Approximately 16,000 children and adolescents in the U.S. are diagnosed with cancer each year.
“Given the number of patients, and the cohesion of the institutions where most of them receive their care, we have an opportunity to provide state-of-the art clinical care for each child, and to learn from every child in an intentional and organized manner,” Lowy said.
The NCI has developed a childhood cancer data initiative to make more efficient the way researchers use and share pediatric cancer research data. The initiative involves developing a national database and collection protocol, establishing interoperability, integrating the data, and making the data available to researchers for faster and more seamless sharing, Lowy said.
“Collaboration is key,” he said. “We must collaborate to coalesce existing data sets. We must collaborate to consistently collect and share data across the field. We must collaborate to move forward in ways that protect the privacy of patients.”
The NCI is planning a scientific meeting for this summer to further shape this initiative.
“When we break down silos and truly cooperate, we as a community can learn from every child,” Lowy said.
‘An even bolder course’
Researchers and clinicians at the AACR Annual Meeting have the opportunity to hone their areas of research, learn new things, make new connections and build on previous discoveries, Lowy said.
“Cancer research is an amazing enterprise, with each of us making our distinct contributions to something much bigger than us,” he said. “Another way of thinking about it is that when what we do goes well, the whole is always greater than the sum of its parts.
“This week let us all discover some new truths, let us endeavor to drink from wells we did not dig, let us warm ourselves by fires we did not build,” he added. “As we stand on the shoulders of giants, let us see farther, and chart an even bolder course by digging the well deeper and building the fire ever brighter for ourselves, the cancer research community and, most importantly, our patients.” – by Alexandra Todak
Reference: Sharpless NE and Lowy DR. Digging wells and building fires. Presented at: AACR Annual Meeting; March 29-April 3, 2019; Atlanta.