Vice President Joe Biden released a Cancer Moonshot Task Force report Monday morning that lays out a roadmap for the next administration to continue his effort to achieve a decade’s worth of cancer progress in five years.
But critics said the moonshot’s lofty goals won’t be met without major new funding that Congress has yet to approve.
The report describes five categories corresponding to the moonshot’s goals of accelerating scientific breakthroughs and treatments for patients, making better use of data, strengthening cancer prevention and diagnosis, and improving access to care.
While the president has asked for a $1 billion boost in cancer funding, the moonshot’s executive director, Greg Simon, said the government projects outlined in the report are all tasks that the 20 federal agencies involved in the task force were currently undertaking or preparing within their current budgets.
Their proposals “are intended to make clear the opportunities on the horizon and the importance of the President’s $1 billion proposal to invest in the cancer moonshot,” the report says. However, the bulk of the additional money is needed to accomplish the recommendations that a blue ribbon panel for the National Cancer Institute put forth in September, Simon told reporters Monday. “That is where the new money is more crucial.”
The president asked for $755 million for new cancer-related research activities at NIH and FDA in fiscal year 2017. Congress already provided $195 million for cancer activities in FY 2016. Cancer advocates are pushing for the additional money in appropriations bills, and through the 21st Century Cures legislation, which could come together in the lame duck period post-election.
The vice president waxed lyrical in his report to President Barack Obama on the moonshot Monday. “The mission of this Cancer Moonshot is not to start another war on cancer, but to win the one President Nixon declared in 1971. At that time, we didn’t have the army organized, didn’t have the military intelligence to know the enemy well, and therefore didn’t have the comprehensive strategy needed to launch a successful attack — now we do,” Biden wrote.
But many of the projects described by the task force were set in motion prior to the moonshot itself or even required by existing federal laws. That’s given critics an opportunity to say that Biden has overpromised.
“It is as if someone said, ‘Make a list of all the things we are already doing or would do anyway,’ and then write at the top ‘moonshot,’” oncologist Vinay Prasad said of the Moonshot Task Force report. “The major beneficiaries seem to be the commercial partners who are getting the free advertisement … but I see zero efforts that would actually constitute a moonshot.”
Real progress would require a longer-term sustained commitment to basic science funding on the order of $200 billion over 20 years, said Prasad, who conducts research on health policy at Oregon Health and Sciences University.
The task force projects are popular, however, and they are being cheered by many in the medical advocacy community.
Personalized Medicine Coalition President Edward Abrahams praised the plan to accelerate research in precision medicine. “Scientists know that cancer is more than one disease, and the Cancer Moonshot is our opportunity to identify more and more subsets of this disease so that we can develop targeted strategies to treat each of them,” he said.
Highlights of the taskforce report include recommendations to make clinical trials more efficient to help speed new treatments to market. The report calls for the continuation of an FDA collaboration with the American Society of Clinical Oncology, Friends of Cancer Research and other partners to reevaluate clinical trial entrance criteria. Removing certain exclusion criteria could speed study enrollment and make trial results more generalizable to patients who eventually receive the drugs outside of trials.
The report calls for larger and simpler cancer trials that focus on easily evaluated outcomes, like whether patients are still alive. This can minimize the amount of data needed, make it easier to enroll patients and create studies that are more reflective of real-world treatment situations.
The report calls for the development of regulatory approaches that could allow for drug approval based on studies of treatments that target molecular abnormalities in cancer versus tumors located in a particular part of the body. And it says regulators should clarify how to seek approval for trials that involve multiple drug companies testing many experimental medicines against a control arm.
The U.S. Patent and Trademark Office is working to increase the incentives for investing in new treatments by improving the quality and clarity of patents issued so that companies have more confidence in their intellectual property rights.
A number of data-sharing efforts would ensure that scientific findings are shared more widely. The task force highlighted a two-year CDC and FDA project to create a computer program that can take unstructured health data — like text from clinical notes — and return standardized data for integration into shared databases and analyzed quantitatively.
On the prevention end, the task force calls for CMS and CDC to help states implement tobacco cessation strategies in Medicaid, citing the success of a Massachusetts program that reduced smoking prevalence by 10 percent over 2.5 years, leading to better health care outcomes and reduced costs.
To improve patient access to care, the task force suggests expanding outreach and leveraging technology like telemedicine and virtual cancer centers that allow experts to guide patient cancer care at a distance.
In his memo to Obama, Biden calls for “a national conversation” on drug pricing “to ensure that high-quality treatments are financially accessible to all patients, including vulnerable and medically under-served populations and that we have a more rational system to price and pay for new medications.” But he offered no concrete next steps toward lowering drug prices.
The report also lacks any effort to evaluate or quantify whether the moonshot projects are speeding progress in cancer research and care.