The White House’s “moon shot” to accelerate the search for a cancer cure has the scientific research community abuzz over the possibilities raised by such a high-profile push. Vice President Joe Biden may announce some specifics as soon as Friday when he visits a cancer center in Philadelphia to kick off the effort outlined in the State of the Union address.
Biden and his staff are already talking to top experts about the most effective role for government. Here are five of the challenges and opportunities that are already clear.
Why Biden’s involvement matters
Yes, cancer researchers throughout industry, academia and government have been working on cures and early detection tools for decades, including many of the ideas Biden wants his moon shot to tackle. But advocates don’t discount the power of the White House in spurring progress.
“There’s a system already working on this, of course,” Ellen Sigal, chair of Friends of Cancer Research, a think tank and advocacy group, said. “But there isn’t a coordinated effort. We do lived in a siloed world.”
Sigal said the attention Biden will bring, as well as the creation of a formal program, can spark action that people assume might occur on its own — but usually won’t.
For instance, her organization pushed for the FDA Breakthrough Therapies Program to be created by law in 2012. At the time people said, “Why can’t FDA do it on their own?” Technically the agency may have had the authority — but it took passage of a law to bring forth cultural changes in and outside of FDA that were needed to expedite the development of certain drugs.
And there’s precedent for the vice president to step in — and get results, a senior FDA official told POLITICO.
Back in 1996, Vice President Al Gore convened groups working on HIV, including patients, advocates, academics, government, the drug industry and insurers. That public-private partnership was instrumental in helping to validate the surrogate endpoint, HIV-1 RNA, a measure of a patient’s viral load. With that scientific seal of approval, drug companies were able to use it to conduct clinical trials and get treatments approved by FDA faster.
In addition, given Biden’s obvious passion about fighting cancer after his son Beau’s death, advocates see him remaining a force long after the Obama administration bids farewell to Washington. “There’s every reason to think that the vice president’s commitment … can carry over for many years to come.” said Mary Woolley, CEO of Research!America.
Money
Research advocates will be looking at what resources the White House can muster in its 2017 budget request, due out next month. But appropriators are likely to have less new money to work with in 2017 than they did this year. The budget cap deal for 2016 included an extra $25 billion in domestic spending, which enabled a $2 billion increase for NIH. Next year only an additional $15 billion will be on the table.
Inflation-adjusted funding for the National Cancer Institute has dropped substantially since 2003. The NIH’s recommended cancer budget for 2016 was $5.75 billion — that would still have been $1 billion less than 2003 levels in real dollars. But even with the big NIH boost, NCI funding grew to just $5.2 billion — a substantial increase but well short of what advocates say is needed.
The American Association for Cancer Research consistently calls for “robust, sustained and predictable funding increases for the NIH,” of about 7 percent annually, said Jon Retzlaff, head of government relations and science policy.
Chris Hansen, president of the American Cancer Society Cancer Action Network, said NCI funding “is absolutely critical” to make headway on the White House goal of doubling the pace of research.
Tumor genetics
Tumor sequencing is gaining ground as a cancer treatment tool, helping identify the best drugs for a given patient. According to David Solit, director of the Center for Molecular Oncology at Memorial Sloan Kettering Cancer Center, it could be considered standard of care for about a third of cancer patients. And it might have broader value, for instance in some prostate cancer patients.
As new discoveries push the frontier of clinical oncology, patients often can only access promising drugs in a clinical trial setting — and relatively few are currently in trials. If the patient can’t get those drugs, Solis said, there’s no use sequencing the tumor.
Genetic testing includes everything from checking for a few mutations to whole-genome sequencing that scans for millions. It depends on the type and stage of the cancer, said Jonathan Hirsch, president of Syapse, a company making software that integrates genetic and clinical data for providers.
CMS has no consistent national policy to cover such sequencing in Medicare, even though some of its contractors do pay in some cases. Research and advocacy groups have have talked with Biden’s staff about broadening Medicare coverage, in hopes that private insurers would follow suit. Earlier this week, Independence Blue Cross announced that starting in March it would cover genome sequencing in certain cases, such as rare cancers, children with cancer, and patients with metastatic disease who have exhausted conventional therapies.
Collaborations
Biden has already engaged in efforts to move public-private partnerships to drive research, and one big initiative began this week dubbed “Cancer Moonshot 2020.” The coalition of pharma, biotech, health insurers, academic centers and community oncologists, along with Bank of America, announced an ambitious goal. They want to complete clinical trials with up to 20,000 cancer patients, at all stages of disease, for up to 20 different tumor types by 2020. Much of that will involve immunotherapy, a cutting edge class of medicines designed to harness the body’s own immune system.
Participating drug companies will make available more than 60 novel cancer drugs. Independence Blue Cross will provide insurance coverage of whole genome tumor sequencing for trial patients.
Patrick Soon-Shiong, a billionaire entrepreneur and founder of NantWorks, who is spearheading the partnership called the National Immunotherapy Coalition, said Biden was far more than a cheerleader.
“We’ve been able to create a collaborative — unprecedented collaboration — that was really only possible because the vice president acted as a catalyst help and convene,” he said.
And there’s more for him to do. “The VP in the next 15 months could really help us work with FDA and CMS, bring together different parties,” Soon-Shiong said.
Data sharing
Sequencing tumors also fattens databases, providing scientists genetic evidence they can combine with information on how particular patients fared on different treatments. But there are barriers to making that information accessible for broad-based collaborative research.
The White House’s “moon shot” to accelerate the search for a cancer cure has the scientific research community abuzz over the possibilities raised by such a high-profile push. Vice President Joe Biden may announce some specifics as soon as Friday when he visits a cancer center in Philadelphia to kick off the effort outlined in the State of the Union address.
Biden and his staff are already talking to top experts about the most effective role for government. Here are five of the challenges and opportunities that are already clear.
The Obama administration’s Precision Medicine Initiative — and the million-person cohort it aims to assemble by 2019 — is working to address that issue.
The National Cancer Institute, which is receiving the lion’s share of PMI money this year, is building ways to integrate two kinds of data about tumors — genetics and response to therapy. The goal is to use the massive data from precision medicine trials to build predictive models for cancer treatment.
Still unsolved is how to translate that genomic data into the electronic health record, the computer software doctors use in the practice of medicine. For now, it is hard enough to put even family history into EHRs in a way that’s useful to doctors, let alone provide complex genetic information.
Some private companies are stepping in with software that merges clinical and genetic cancer data. UC San Francisco, Stanford Cancer Institute and Utah’s Intermountain Healthcare, among others, work with Palo Alto-based Syapse, which crunches the data and provides it to doctors through a button on the EHR.
At present, few physicians have easy access to the data pouring out of research centers, which is what companies like Syapse are trying to provide. The Precision Medicine Initiative may help.
“Precision Medicine can step in and try to catalyze the knowledge and data creation,” Hirsch said. “Someone needed to give industry a kick in the butt, and they’ve done that, if nothing else.”
Sharing this data opens new doors to researchers, helping them figure out which mutations to target, which types of drugs to develop — ideas and discoveries needed for a moon shot.
https://www.politicopro.com/ehealth/story/2016/01/cancer-moon-shot-face…
