Cutting red tape and addressing patient concerns
Dr. Mary-Claire King, the American Cancer Society Professor of Medicine at the University of Washington and an affiliate Fred Hutch researcher, offered the vice president two suggestions. Her first would be to streamline and speed up research at no extra cost by cutting regulatory hoops for adding a person to an existing research grant.
“If we have a new project that requires a young person who transcends certain disciplines, if there were a way we could add that person to our team quickly by adding a simple supplement to an existing grant, rather than take a year to a year and a half, [it would give us] a way we could build our teams very quickly,” she said.
King, who was the first to show that breast cancer is inherited in some families as a result of mutations in BRCA genes, also advised Biden to take steps to help breast cancer and other patients by giving the National Cancer Institute enough funding to pay for Phase 3 clinical trials that pharmaceutical companies don’t want to sponsor.
Human drug and treatment clinical trials are typically divided into three phases; the final, Phase 3 trial is the most expensive to conduct because it tests for both safety and efficacy in hundreds or thousands of patients. Pharmaceutical companies, King pointed out, have little incentive to fund a costly trial that won’t result in a new drug — a trial that, for example, tests how a particular three- or four-drug combination would work if the drug with the worst side effects was left out.
“That’s not of interest to Pharma but of great interest to patients seeking effective and less harsh options,” King said.
Dr. Angelique Richard, chief nurse executive and vice president of clinical operations at Seattle Cancer Care Alliance, also focused on patients.
“We need to establish a system that supports cancer patients and families getting clear information about their best treatment options and full access to these options, regardless of [insurance] coverage,” she said.
Encouraging innovation and quality through pricing
The pricing of cancer treatment is also of concern to Dr. Jeffery C. Ward, a medical oncologist/hematologist with the Swedish Cancer Institute and an advocate of community-based cancer care who has practiced in the Edmonds community since 1993. The hopes invested in personalized medicine will not be realized, he said, unless another paradigm shift occurs first in how both drug development and cancer care are reimbursed. His advice: The United States needs to provide better incentives for pharmaceutical companies to be innovative, nimble, and willing to take risks and for oncologists to provide the best, safest, and most effective treatments.
“I would tell the vice president that a great impediment to the development of personalized therapies and personalized care is the way in which we pay for it,” Ward said. “Pharmaceutical prices have little, if anything, to do with the value they bring to the care equation. Instead, every new drug is the same price, or a little bit more, than the last drug irrespective of how good a drug it is. Copy-cat drugs routinely cost more than the innovator drug. Competition occurs through marketing, but never through price.”
Similarly, a “fee for service” health care delivery system encourages physicians to give as much care as possible, not necessarily “the right care or the best care.”
But neither, Ward cautioned, should care be rationed.
“As we develop personalized, but very expensive, therapies, we need a system that will pay the oncologist to provide the correct therapy in the safest and most efficient way,” he said. “Only a reimbursement system that rewards quality and value will fuel a cancer moonshot.”
Pediatric approaches and a plug for basic research
Dr. Julie R. Park, an attending physician at Seattle Children’s Hospital, a pediatrics professor at UW Medicine and a Fred Hutch researcher, suggested new approaches to pediatric cancer. Many of her recommendations touched on themes that have emerged in recent months as a focus for the moonshot initiative. These include personalized medicine, which uses molecularly targeted therapies based on, among other factors, genomic drivers in cancer found through genomic profiling and enhanced data sharing:
- Invest in infrastructure needed for banking biologic specimens as a resource to scientists worldwide and for genomic profiling of a broad spectrum of rare and high-risk childhood tumors;
- Support an expansion of bioinformatics infrastructure to leverage existing clinical research and translational data in pediatric cancer;
- Invest in research that will focus on targeting molecular pathways and the microenvironment in pediatric cancer, including attracting a larger group of both new and established scientist to better understand pediatric cancer.
Dr. Stanley Riddell, who led the vice president on a brief lab tour before taking part in the March panel, took a different tack, avoiding the specific to praise the benefits of undirected research. Although his recent advances in immunotherapy have attracted national attention, Riddell’s advice was to remember that such advances are rooted in far more basic research.
“We have to continue this fundamental research into understanding how cancer develops, understanding how the immune system interacts with cancer,” he told the vice president.
“The power of understanding cancer at the genetic level, understanding the immune response to cancer will really yield new insights that will develop new therapies. But I think the reality is if we really want big breakthroughs, we are going to have to invest in good old fashioned R&D.”
Launching the moonshot
President Barack Obama launched a “new moonshot” to speed up cancer cures during his final State of the Union address in January. He put Biden, who inspired the effort, in charge of “mission control.” The vice president dedicated himself to the cause after losing his older son, Beau, to brain cancer in 2015.
Since the initiative was announced, Biden has visited seven cancer research centers, including Fred Hutch, and met with more than 200 scientists, physicians, patients and philanthropists to gather ideas. Earlier this month, the National Cancer Institute named a blue ribbon panel to provide scientific guidance on how to advance the themes that emerged from these meetings. The panel is expected to deliver its recommendations by late summer to the NCI’s National Cancer Advisory Board. The White House Cancer Moonshot Task Force, an interagency group chaired by Biden and led by cancer patient and industry executive Greg Simon, will deliver a final report to President Obama by the end of the year.
More ideas?
According to the National Cancer Institute, as part of this process, the cancer community, including patients and caregivers, will be provided a forum to post comments and insights to help inform deliberations. Until then, join the conversation on our Facebook page, and let us know your ideas for how to speed up the development of cancer cures.