publication date: Feb. 12, 2016

Obama’s $4.1 Trillion Budget Request Proposes Mandatory Funds for $1 Billion Cancer Moonshot 



President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

“It appears the President’s final budget will continue to focus on new spending proposals instead of confronting our government’s massive overspending and debt,” said Senate Budget Committee Chairman Mike Enzi (R-Wy.) in a Feb. 4 joint statement with House Budget Committee Chairman Tom Price (R-Ga.). “It is clear that this President will not put forth the budget effort that our times and our country require. Instead of hearing from an Administration unconcerned with our $19 trillion in debt, we should focus on how to reform America’s broken budget process and restore the trust of hardworking taxpayers.”

Since Obama took office in 2009, annual deficits have been cut by three-quarters, to 2.5 percent of the gross domestic product, and the country’s unemployment rate has gone down by more than half, to 4.9 percent.

The president’s budget request, which describes spending priorities from reducing poverty to fighting Islamic State, also includes additional details on the $1 billion initiative to jumpstart the national cancer program. The moonshot proposal was announced during Obama’s final State of the Union address Jan. 12. Vice President Joe Biden is leading the program, which aims to achieve a decade’s worth of progress within the next five years.

The $1 billion proposal establishes a game plan for how the funds will be spent: the moonshot initiative will begin with $195 million in cancer research at NIH in fiscal 2016, according to the White House.

The fiscal 2017 budget proposes to allocate $755 million in mandatory funds for new cancer-related research activities—$680 million for NIH and $75 million for FDA. The remaining $50 million is expected to go to the Departments of Defense and Veterans Affairs through funding Centers of Excellence.

FDA’s budget would remain roughly flat in the president’s request, receiving an increase just shy of 1 percent. The president also slates $4.4 million for the agency’s work in the Precision Medicine Initiative—nearly twice the funds budgeted for 2016. On Feb. 9, the agency published its budget request, seeking $5.1 billion in fiscal 2017, an eight percent increase over the enacted 2016 budget.

“Funding is a perennial challenge at the FDA. This is an agency that over time has been given more and more responsibilities by Congress,” said Ellen Sigal, chair and founder of Friends of Cancer Research. “The administration’s moonshot increases FDA funding by $75 million, a crucial funding increase needed to implement the types of programs proposed here. The White House has said this is part of an initial investment representing a down payment on the National Cancer Moonshot.”

A conversation with Sigal appears on page 1.

The White House proposes $33.1 billion for NIH in 2017, a 2.6 percent boost over current levels. This $825 million infusion includes the $680 million for Biden’s moonshot, $100 million for the Precision Medicine Initiative for a total of $230 million, and $45 in new money for the BRAIN initiative.

In fiscal 2016, NIH received a $2 billion raise to $31.3 billion, and NCI’s budget was increased from $4.95 billion to $5.2 billion.


Mandatory Funding for Moonshot?

The administration proposes using mandatory funds—as opposed to appropriated discretionary funds—to pay for the moonshot as well as some of the new raises for NIH, which means that lawmakers would need to establish a dedicated funding source.

For instance, the 21st Century Cures Act, an initiative passed by the House to modernize clinical trials and expedite drug development, would provide NIH with $9 billion in new money over five years by selling some of the federal government’s petroleum reserve.

Oncology groups applaud the moonshot proposals, which promise a much-needed infusion of funds for research. However, it is unclear whether Congress will honor the president’s $1 billion request for the cancer moonshot program.

“The president’s fiscal year 2017 budget sets an ambitious course to accelerate discovery in the fight against cancer,” said Christopher Hansen, president of the American Cancer Society Cancer Action Network. “The proposed 13 percent increase for NCI would go a long way to restore funding shortfalls that have severely hampered progress in the last decade and builds on the support provided by Congress in FY16.”

Over 185 state and national organizations and cancer centers issued a joint statement Feb. 9 thanking Biden for leading the moonshot program.

“We have heard your call for a greater degree of collaboration and interaction, and we are writing to express our collective ambition and enthusiasm to work with you to carry this mission forward,” the groups said in the letter. “Our goal is shared—defeat all forms of cancer.”

Several advocacy organizations expressed concern about the administration’s proposal to cut NIH’s existing budget by $1 billion from the appropriations process, and make up the difference with mandatory funding.

“One notable omission from the president’s proposal, however, is a significant increase in NIH discretionary spending,” said Julie Vose, president of the American Society of Clinical Oncology. “ASCO urges predictable research funding through the traditional discretionary spending process. Mandatory funding should supplement—not supplant—reliable annual increases for the NIH that at least keep pace with the rate of biomedical research inflation.”

Funding increases for NIH should be consistent, United for Medical Research said in a statement.

“While we appreciate that President Obama’s overall goal is to increase funding for biomedical research, we are disappointed his proposed budget would actually decrease the baseline funding level for the NIH in FY2017,” UMR said. “We commend the president’s inclusion of funding to support cancer-related research activities for the recently launched moonshot initiative, however, UMR believes that both strong annual appropriations plus the use of mandatory funding are needed to put the NIH back on a sustainable growth path.”

The president’s budget also proposes cuts to Medicare payments for cancer drugs, reducing payment by half to Average Sales Price plus 3 percent as a cost savings measure.

Critics say that the proposed cut would actually reduce payments to a little above ASP, considering that the Centers for Medicare and Medicaid Services has already reduced payments from ASP+6 percent to ASP+4 percent, when it applied sequestration cuts to the cost of cancer drugs.

“These cuts to cancer care increase costs to patients and handicap community cancer practices that are the primary participants in vital clinical trials,” said Bruce Gould, president of Community Oncology Alliance and a practicing community oncologist with Northwest Georgia Oncology Centers in Marietta, Ga. “The president calls for a moonshot on cancer, but his budget, with misguided cuts and insufficient research funding, scuttles the rocket before it even gets to the launch pad.”

ASCO is concerned about some aspects of Obama’s proposal that would “undermine” the goals of the moonshot program, Vose said.

“Proposals to withdraw resources from the cancer care delivery system by reducing drug payments, specifically from 106 percent to 103 percent of average sales price—without overall payment reform—will jeopardize the very system needed to deliver on the promise of science,” Vose said. “ASCO will continue to work closely with Vice President Joe Biden, who is leading the National Cancer Moonshot initiative, and with members of Congress as they commence the budget and appropriations process.

“We urge Congress to build on last year’s bipartisan support for federal research by providing FY 2017 funding levels that will speed advances in cancer prevention, diagnosis and treatment—and will reduce the human suffering and loss of life that cancer inflicts on millions of Americans each year.”


Biden: The “Profit Motive” of Data Sharing

Speaking at Duke University Feb. 10, Biden focused on data sharing, describing his astonishment at the way cancer organizations are building separate, and potentially duplicative bioinformatics databases.

Following is an excerpt of Biden’s remarks:

We have to figure out a way to share information more. I’d like to focus on Big Data. I think as an outsider looking in, trying to become as informed as I possibly can, the greatest hope lies in the aggregating of enormous amounts of data that exist out there already. And a few years ago, it took more than a decade and $3 billion to sequence the human genome—the head of NIH [Francis Collins] was one of the leaders in that effort—and it now takes less than a day and costs about $1,500.

But it’s spread all over the world: a piece of data is at Duke, another at MD Anderson, pieces are at other institutions. Imagine if we could collocate that information; imagine if we had full access in one form of the Utah population data, imagine what could happen.

I met with four incredibly competent, advanced groups that have put themselves together—leading cancer institutions, SAP’s involved, Oracle—and I listened to them, and they’re all doing the same thing. They’re all about to spend hundreds of millions of dollars, well over $1 billion, for them to have their own data collection.

And I asked them all whether they’d be willing to meet with me alone in a room in the vice president’s residence to answer the question, ‘Why?’ No, I’m not being facetious! I’m being deadly earnest about this. I understand the way the system is built, and there’s nothing wrong with it, the profit motive is there.

We’ve got to figure out modalities to help break down some of these silos, and maybe the only I’ll be able to do is to be a convener and maybe help negotiate some of the transitions that have to take place. But Big Data takes on more than promise, because of the incredible advances in computing capabilities. Just in the last few years, of course, when we talk about the patients’ data, we also have to take into account that which we haven’t solved yet completely, which I think is in our reach—the privacy concerns.

And also, who owns the data? Does the patient own the data? I’m working with the Department of Energy and our national laboratories—probably the best kept and one of the most vital assets that United States of America possesses—and I met with Secretary Ernie Moniz, a brilliant scientist in his own right. He heads the Department of Energy national labs and we’ve initiated a project called National Strategic Computing Initiative with the goal of making supercomputers capable of a billion billion calculations per second. Our scientists in the labs think it’s within reach.

They’re working on a project with enormous focus, but the promise, if that occurs, is equally enormous. If we can get data in one place, the bottom line is that we need all hands on deck. Big Data captures the big picture. We can use that data to understand a person’s cancer—uncover similarities and responses across large patient groups to help design the best course of therapy. But we have to break down those silos and share the data.

Copyright (c) 2018 The Cancer Letter Inc.