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November 11, 2016 12:00 AM

Hopes for Precision Medicine Initiative, Cancer Moonshot rest with lame-duck Congress

Elizabeth Whitman
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    The election of Donald Trump to the presidency is poised to turn healthcare upside down, given his and other Republicans' vows to repeal and replace the Affordable Care Act.

    Also uncertain are the fates of initiatives by President Barack Obama's administration to galvanize medical progress in cancer and precision medicine specifically. A lame-duck Congress could help preserve them, amid fears that a Trump presidency portends severely diminished support for scientific and medical research.

    “There is a great deal of bipartisan support for continuing these efforts,” Janet Marchibroda, director of the Bipartisan Policy Center's Health Innovation Initiative, said of the Cancer Moonshot and Precision Medicine Initiative. She added that several provisions in the bipartisan 21st Century Cures package, which a lame-duck Congress is expected to take up, aim to support both.

    When Obama launched the Cancer Moonshot in January, he tasked Vice President Joe Biden with overseeing the effort to double the pace of cancer research and achieve a decade's worth of progress in five years.

    The White House laid aside $1 billion for the initiative as “an initial down-payment” but said Congress would have to continue providing funding to ensure the moonshot's long-term success.

    The Precision Medicine Initiative began a year earlier with $215 million to “pioneer a new model of patient-powered research” and shift medical care from one-size-fits-all to individualized treatments, tailored to a patient's genetic makeup, environment and lifestyle.

    The 21st Century Cures Act, which would fund new medical research over the next five years to the tune of nearly $9 billion, passed the House last year, but the Senate has yet to pass it.

    The latest version of the bill proposes to create the NIH and Cures Innovation Fund, which would receive $1.86 billion in funding every year from 2016 through 2020. Nearly $1.75 billion of that would be for biomedical research under the NIH. At least $500 million would go toward the Accelerating Advancement Program, under which the NIH director “partners with national research institutes and national centers to accomplish important biomedical research objectives.”

    At the end of September, Democrats and Republicans in the House and Senate pledged that passing the legislation would be a priority before the end of the year.

    In the three weeks of Congress following the election, “my own personal priorities are funding the government and the 21st Century Cures bill, which I think could end up being the most significant piece of legislation we pass in the whole Congress,” Senate Majority Leader Mitch McConnell (R-Ky.) said at the time. “No matter who does win in November, we still have the same government in place until the end of the year and we need to accomplish as much as we can for the American people in the limited amount of time that we have left.”

    Sens. Lamar Alexander (R-Ten..) and Patty Murray (D-Wash.), the leaders of the Senate health committee, have said they would continue working on the 21st Century Cures legislation.

    “We are committed to getting a result this year that will lead to lifesaving medical breakthroughs and advance President Obama's Precision Medicine Initiative and Vice President Biden's Cancer Moonshot,” they said in a statement from September that a Congressional staffer said still stands.

    Dr. Stan Gerson, president of the Association of American Cancer Institutes and director of the Case Comprehensive Cancer Center, expressed hope that congressional support for the NIH would continue, calling it “bipartisan in its respect” for the institutes.

    Still, “whether Congress can approve funding for the Moonshot during the lame duck session...is a complete unknown,” Gerson said.

    Prior to the election, Democrats and Republicans clashed over provisions to change regulatory processes for drugs and medical devices, leaving some to conclude that a deal for the legislation would be unlikely before the end of the year.

    During his campaign, Trump did not comment or offer his views on the moonshot initiative. Greg Simon, the chair of the moonshot task force, told STAT news prior to the election that he had not been contacted by Trump's team.

    “It's tough to say,” said John Graham, a senior fellow at the libertarian National Center for Policy Analysis. Trump has promised to repeal and replace the Affordable Care Act, a goal that Graham expected to “consume all the oxygen.”

    The Cancer Moonshot and Precision Medicine initiative are “really going to take a backseat,” he predicted.

    In the past, Republicans who reportedly are now being considered for Trump's cabinet have voiced support for the NIH and their work.

    In April 2015 in an op-ed for the New York Times, former House Speaker Newt Gingrich called for doubling the NIH's budget. Gingrich's name has surfaced as a possibility for Trump's HHS secretary, as well as secretary of state.

    The NIH would spend $1.3 billion researching Alzheimer's and dementia in 2015, Gingrich pointed out, while those same diseases would cost Medicare and Medicaid $154 billion treating them.

    “As a conservative myself, I'm often skeptical of government 'investments,'” he admitted. “But when it comes to breakthroughs that could cure -- not just treat -- the most expensive diseases, government is unique. It alone can bring the necessary resources to bear.” When the government is covering the costs of those diseases, “it's irresponsible and shortsighted, not prudent, to let financing for basic research dwindle.”

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