Community Practices Say Moonshot May Sputter

John Powderly, MD

There’s a place for Vice President Joe Biden to stay in North Carolina if he would like to come and witness some of the problems the National Cancer Moonshot is going to encounter before its lofty goal of doubling the pace of clinical discovery is achieved. John Powderly, MD, of the Carolina BioOncology Institute, would welcome Biden to stay in his second floor guest bedroom, if only for the chance to show him how tough it is to get coverage for clinical trial patients.

“Joe Biden can come see how, on a daily basis, insurance companies deny patients routine care, how much the federal regulations have made it impossible to do day-to-day routine patient care, and how much money I have lost and the debt I have incurred in fighting insurance companies to just do the right thing,” Powderly said.

Powderly’s clinic specializes in early phase trials for immunotherapy and personalized medicine. He says a number of well-intentioned government actions designed to guarantee coverage of routine costs of care associated with trial participation have been compromised by concessions to the payer industry, Powderly said.

Physicians who have been active in clinical trials programs were divided in their opinions of how well the Moonshot initiative would succeed, and whether it would benefit independent oncology practices. Powderly and Luke Nordquist, MD, of the Urology Cancer Center and GU Research Network in Omaha, said that private industry-sponsored research is likely to be the more successful source of innovation in cancer research and treatment. Industry payments amply cover trial costs—to the point of supporting other practice activities—and process efficiency is far greater than can be achieved through government supported research efforts, such as are carried out through the Cooperative Group System, they said.

On the other hand, Stephen Grubbs, MD, a longtime practicing oncologist and clinical trials researcher who participated in talks with Biden and his White House staff on developing the Moonshot, said that curing cancer is a major bipartisan goal and Biden’s involvement could unlock government-led discovery and result in many exciting advances. “This family tragedy of losing his son has really motivated him to do the right thing and advance where we are with cancer,” said Grubbs, who also serves as vice president of Clinical Affairs for ASCO.

“I think he’s sincere about this. As an oncologist, what I heard from him that I found encouraging, was that he wants to move research and advances at a faster pace and get more done quickly. He’s also looking at how we can improve cancer care delivery—how do we get the discoveries into the hands of physicians who are taking care of patients all over the US, even in remote areas. Those are the two take-home messages from him that I thought were very important.” He added that the Moonshot could be a turning point signifying increasing government funding for research.

Under the Moonshot, public and private partnerships will be developed to streamline research and the government’s vast computing and medical resources could be tapped to give a solid boost to compiling and understanding the large volumes of medical data already collected and still accumulating, much of which may contain clues to meaningful advances in cancer treatment, such as ASCO hopes to achieve through its CancerLinQ initiative, Grubbs said. “We think there are abilities to partner with the Departments of Defense and Veteran’s Affairs. We’re hoping there’s more help with electronic health records and interoperability,” he said.

Powderly contends that the $755 million in funds promised for the Moonshot in the FY2017 budget will not achieve much. He expects very little of this money, if any, to trickle down to the independent oncology practice level. Government compensation for trial participation was scant to begin with, he said.

Nordquist also is doubtful about the impact the money will have. He expressed the view that government spending is often diluted by the siloed character of research institutions and the tendency for grant money to serve institutional goals, rather than pure research interests. “These grants usually provide academic careers for people, because they’ll apply for a grant, and that funding solidifies their job at the university, and then they have to support their staff and their lab techs, etc. That’s a very necessary form of investigation, but it’s a very slow process for doing cancer research because everybody’s working in their siloes. Very rarely do they work in some sort of network where people are learning from what the others are doing. It’s more, how do we keep funding these people’s careers through that money?” he said.

Many independent oncologists would like to participate in publicly funded trials, but the financial support is too slim, Nordquist said. Affected by declining compensation for IV chemotherapy and other activities, investigative practices like Nordquist’s would be in peril without the financial support that comes from privately funded research, he said. In addition, doing clinical trials requires a large staff, which Nordquist said is another reason why adequate funding is vital.

“The cooperative group studies are a dying thing because they keep cutting the funding for it,” he said. “You don’t make any revenue on that as an independent practitioner. In fact you kind of do it altruistically, because you have to supply all of the time, effort, and resources to do those studies. It’s important research; and that’s mainly why it’s done in academic centers, because they have all the extra staff.”

Accepting private money doesn’t come with the stigma that it used to, and new opportunities have arisen that now represent lifeblood for independent oncology centers, Nordquist said. “Private industry only used to want to do work with academic centers. Now I get several calls a week to open studies. In the past that was looked down upon as kind of getting into bed with pharma, but more and more—even large academic centers—are seeing the importance of this. Memorial Sloan Kettering has even developed its own research LLC, basically as a way of doing more efficient cancer research.”

Nordquist is involved in developing networks of practices of various sizes that can supply the large patient base and resources necessary to make privately funded trials a success. Comprehensive private funding is not just supporting research centers like his, he said. “Last year alone, we saved over $3 million dollars for Medicare and insurance companies just by the studies that we did here. So, it’s really a win for the patient getting a free drug; and it’s a win for society where the drugs are now being paid for by the drug companies; and it’s a win for me, because, 1) I can say that I have these studies that others may not have and, 2) they’re paying me, and that’s helped offset the loss in revenue from cuts in IV therapy.”

Powderly’s experience has been similar: “The only way that I am able to survive is because we are 90% supported by clinical research from biopharmaceutical companies. What really pays for my accrual and my overhead and the research, is investors.”

Additionally, Powderly and Nordquist said delays and administrative burdens connected with public trials amount to disincentives for community oncologists to participate in federal trials. “Even the Medicare compliance is so overwhelming that clinicians would give up before they would participate in a clinical trial,” Powderly said. “In fact, there’s data now that less than 3% of physicians are principal investigators on trials.” That’s a shame, he said, because it used to be a matter of pride for community oncology practices to participate in federal trials.

In addition, the predominantly older drugs examined in federally sponsored research represent a problem for the oncologist whose patients are demanding newer drugs because of their growing awareness of the strength of personalized medicine, Powderly added. “The current model is cooperative groups. They don’t develop and invent new drugs, they just look at combinations of old drugs, and there is an important role for that, but the pipeline of new drugs that industry is developing is gi-normous, and there’s no good infrastructure to get all of those new drugs to the community practices efficiently.”

Grubbs said that ASCO and the White House are aligned in their desire to solve that problem. “We are working on trying to get clinical trial availability to as many physicians as possible for all of the targeted molecules that are coming out, that need to be tried in all of these new genomic variations that we see in cancer, so that you don’t have to go to any single cancer center and there’s a limit [on enrollment]; so I think that’s another area where there’s going to be some important help in that,” he said.

To pick up the pace of cancer innovation, Powderly said, the White House should plug the coverage holes that make it difficult to enroll patients and that threaten to send more clinical trials work overseas. During his time in office, former President Clinton ordered Medicare to cover routine costs of care for trial patients, but the rise of Medicare Advantage plans in which payers manage Medicare payments has undermined the scope of that directive. “How sad is that?” Powderly asked.

In 2001, North Carolina joined with more than 20 other states in passing laws requiring coverage of routine costs; however, payers have declined to place trial-active physicians in-network. “Joe Biden would not be covered by his insurer for a trial at our clinic today if he had cancer, because his insurance company has declared me off-network for the sole reason that I participate in clinical trials,” Powderly said.

And an amendment to the Affordable Care Act, was meant to guarantee payment for routine costs of care starting in 2014, but that was diluted by a grandfather clause that exempted preexisting plans, Powderly noted.

Such things give him and Nordquist cause to think that the Moonshot may be more of a Fourth-of-July rocket than a trip to the moon. Grubbs said he is inspired to believe that the Moonshot can succeed, based on the sincerity he has detected in the vice president’s message and based on what the Delaware doctor believes is a plan with true substance.

“To have successful advances in cancer, it requires government and private funding. There are trials that need to be done that will never be done in the private sector—quality of care trials, surgical trials, and things like that, and that’s the importance of public funding. New drugs, new pharmaceuticals—certainly, the private side can build those trials themselves; but you really need a combination of both of those to make the advances go forward, so I think more money in the public sector will push along the type of trials that need to be funded in the public arena,” he said.