publication date: Mar. 17, 2017

Trump’s proposed 2018 budget launches a surprise attack on NIH

By Paul Goldberg and Matthew Bin Han Ong

FDA may have escaped the devastating cuts in President Trump’s first budget proposal, while NIH ended up taking the brunt of its fury.

Consider two “bullets” in the President’s Budget Proposal for fiscal 2018, released March 16, and you might agree that the second of the two—the one flying toward the NIH campus in Bethesda—is more akin to a literal, lead bullet than a typographic device:

  • [The President’s Budget Proposal] reduces the National Institutes of Health’s spending relative to the 2017 annualized CR level by $5.8 billion to $25.9 billion. The budget includes a major reorganization of NIH’s Institutes and Centers to help focus resources on the highest priority research and training activities, including: eliminating the Fogarty International Center; consolidating the Agency for Healthcare Research and Quality within NIH; and other consolidations and structural changes across NIH organizations and activities. The budget also reduces administrative costs and rebalance federal contributions to research funding.

  • Recalibrates Food and Drug Administration medical product user fees to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level, and replaces the need for new budget authority to cover pre-market review costs. To complement the increase in medical product user fees, the budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.

Insiders in both sides of the aisle say they were surprised by the magnitude of the cut the president proposed for NIH—18.3 percent below the current continuing resolution level of $31.7 billion.

Even without accounting for inflation, this would knock the budget to $1.2 billion below the FY 2003 level, the year when the doubling of funding for NIH was completed. The budget document doesn’t include numbers for NCI and other institutes.

Many predicted flat funding or, at worst, a small cut, that—of course—would have run into vigorous opposition on Capitol Hill.

In his address to a joint session of Congress, President Trump had lambasted FDA for being “slow and cumbersome,” but, as far as anyone could remember, he hasn’t slammed NIH in public (The Cancer Letter, March 3).

Last week, Trump nominated Scott Gottlieb, a physician who has worked on Wall Street and done stints at FDA and CMS to lead FDA.

In naming Gottlieb, who is seen as a solid choice by many patient groups and the industry, Trump had refrained from selecting an FDA-basher. The more optimistic observers saw the Gottlieb appointment as a signal of the new administration’s sober attitude toward science.

The only explanation for slashing the NIH budget was offered on March 16, when Press Secretary Sean Spicer repeatedly referred to “duplicity” at NIH. Presumably, he meant “duplication.”

“There’s this assumption in Washington, that if you get less money, it’s a cut, and I think the reality is, is that in a lot of these, there’s efficiencies, duplicity, ways to spend money better,” Spicer said at the media briefing. “And I think if you’re wasting a lot of money, that’s not a true dollar spent.

“And I think when you look at [the Office of Management and Budget] Director [Mick] Mulvaney and the president’s approach to this budget, it was, ‘Can we ask, can we get more with the same dollar? Can we find duplicity?’”

In a press conference, White House spokesman Sean Spicer said proposed budget aims to reduce “duplicity” at NIH.

The text of Spicer’s explanation appears here.

Many insiders declared that Trump’s budget proposal, titled America First – A Budget Blueprint to Make America Great Again, was dead on arrival.

“I don’t think the budget that the President sent is serious at all,” said John Porter, an advocate for biomedical research and a former House appropriator who led a successful push to double the NIH budget. “It’s playing to his base. It just says what his base wants to hear. I don’t think Congress has any intention to adopt it and support it. So, I am not overly concerned that the things that he is proposing in his budget would happen. I think that’s very remote.”

However, Porter urges advocates for science to take the document as a serious threat and make their voices heard on Capitol Hill. “What has to happen is that people have to protest—loudly! They have to let their representatives know that these are all bad things,” Porter said. 

A conversation with Porter appears here.

A few short months since the Obama administration’s popular cancer moonshot program and the passage of the 21st Century Cures Act, the cancer groups will have to fight like hell in what will surely be a free-for-all to maintain research funding that has been won over decades of hard work.

“I think we have to hope that the members of the current Congress will be very much like the members of the last Congress, who were very supportive in a bipartisan way of the importance of medical research and cancer research,” said Nancy Davidson, president of the American Association for Cancer Research.

A conversation with Davidson appears here.

Trump’s proposed cuts would turn the United States into a “second-rate scientific country,” said Blase Polite, chair of the American Society of Clinical Oncology Government Relations Committee.

“Let’s look at the one that probably worries me more than anything else, from a big-picture perspective: this is a generational-level cut, and what I mean by that is, a cut of this magnitude will basically devastate what we could see 15, 20 years down the road,” said Polite, associate professor of medicine and associate director of the Center for Clinical Cancer Genetics at the University of Chicago. “I mean, it’s going to have immediate impact, but the research that should’ve been done that won’t be done, we can’t even contemplate what the effect of that is going to be.

“And most importantly, who’s going to get hurt by this? You’re going to kill the young scientists. That crop of innovative, energetic young scientists who are thinking about going into basic science research or going into research along this line, and all of a sudden, a cut of this magnitude where you’re going to be funding 5 percent of grants, 7 percent of grants? Who in the right mind is going to go into that field? It would kill it.”

A conversation with Polite appears here.

“I just think there’s nobody there that has an appreciation, candidly, at the White House, who is passionate about these issues, or understands biomedical research,” said Ellen Sigal, founder and chair of Friends of Cancer Research. “We’ve seen budget cuts and we’ve seen decreases and we’ve seen people that feel that NIH or FDA is not efficient, but we’ve never seen anything like this.

“This is wanton disregard for medicine and public health. But, again, I want to stress, the impact of this won’t only be felt in academic institutions. Patients will feel the impact, and that’s whom I care about.”

A conversation with Sigal appears here.

Beth Caldwell, a patient with metastatic neuroendocrine breast cancer, said her life now depends on investigational drugs. She is undergoing treatment at the Fred Hutchinson Cancer Center.

“People like me will die because of these [budget] cuts,” said Caldwell, who spoke at a Fred Hutch news conference broadcast via Facebook Live. “We just spent all this effort getting the 21st Century Cures Act passed, which slated more funding for research, including into cancer. And to see that undone, I feel like our government will have blood on its hands if these cuts go through. The only treatments left for me are going to be ones that are experimental.”

Caldwell’s comments appear here.

The impact of these proposed cuts would be exacerbated by the repeal of the Affordable Care Act, said Patricia Goldsmith, president and CEO of CancerCare.

“I would see a huge impact, because it’s also coupled with the repeal of Obamacare,” Goldsmith said. “We looked at what the Congressional Budget Office has put out and, also, what seems to be the statistics of showing many, many, many individuals, perhaps, 10 to 20 million losing their insurance coverage. We also are seeing that Medicare funding could be jeopardized.

“If you put all of this together, of repealing a system—Obamacare is not perfect, and it has its flaws, and it has its warts. But on the other hand, it has provided some insurance for many millions of people. I think that there will be a decrease in those individuals that are insured, there will a decrease in funding of Medicaid, decrease in funding of research. I would say that it’s a bleak future if all these things actually converge in a way that I understand it at this moment.”

A conversation with Goldsmith appears here.

While the White House submits its funding proposals, Congress is responsible for drafting appropriations bills, and cancer research clearly has support on both sides of the aisle.

Insiders say the $25.9 billion Trump proposes likely includes the nearly $500 million NIH was slated to receive in fiscal 2018 under the 21st Century Cures Act, which makes the cut even more devastating. It’s unclear how the current functions of the Agency for Healthcare Research and Quality would be incorporated into NIH and what impact this would have on its budget.

At NIH, the Trump administration has asked NIH Director Francis Collins to stay in office—at least for now. If he stays, he will likely have to defend the proposed budget.

This is not some remote, hypothetical situation. Collins is scheduled to get his first opportunity to do so on March 21, at a hearing of the House subcommittee on Labor, HHS, Education, and Related Agencies.

While it appears that the FDA budget has been left alone, this is by no means certain. The White House states only that revenues from user fees would be doubled. This provision is puzzling, said Ryan Hohman, vice president of public affairs at Friends of Cancer Research.

“I don’t think anyone quite understands this,” Hohman said. “The White House budget references it as $2 billion in 2018 and $1 billion in 2017. User fees, in the latest agreement, are $1.9 billion, so arguing to reopen the user fee agreement, for $100 million—is the president saying then that he will reduce FDA’s budget by $100 million and make up for it with that extra user fee money?

“You almost can’t react to it; it’s so unclear. It shows a baseline misunderstanding—or not understanding—of how the FDA functions.”

The Centers for Disease Control and Prevention can expect to be refocused on the needs of each state. The budget proposal reads:

“Reforms key public health, emergency preparedness, and prevention programs. For example, the budget restructures similar HHS preparedness grants to reduce overlap and administrative costs and directs resources to states with the greatest need. The budget also creates a new Federal Emergency Response Fund to rapidly respond to public health outbreaks, such as Zika Virus Disease. The budget also reforms the Centers for Disease Control and Prevention through a new $500 million block grant to increase state flexibility and focus on the leading public health challenges specific to each state.”

Several Republican leaders were lukewarm on the budget request. Sen. Marco Rubio (R-FL) said the president’s proposal should be seen as no more than a statement of the administration’s priorities.

“While this budget blueprint offers insights into the president’s thinking about what’s important to his administration and the American people, it is Congress that will actually set the nation’s policy priorities and fund them,” said Rubio, who serves on the Senate Committee on Appropriations and the Special Committee on Aging. “I will continue to review all the details of this budget proposal for areas of common interest we can work on together.”

Rep. Nita Lowey (D-NY), ranking Democrat on the House Appropriations Committee, said that “the lack of detail in the President’s 2018 budget request would be embarrassing for an administration with basic competence.

“Congress writes the appropriations laws that fund the federal government, and Democratic votes will likely be needed to enact these laws, just like in the 114th Congress when Republican majorities were larger in both chambers,” Lowey said. “The goal of this administration is to help the most fortunate at the expense of working families, seniors, and other vulnerable populations.”

Copyright (c) 2017 The Cancer Letter Inc.