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August 31, 2015 12:00 AM

Lawmakers enlist researchers and patient advocates to support 21st Century Cures bill

Steven Ross Johnson
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    Congressman Bob Dold of Illinois on Monday tapped researchers and patient advocates in Chicago to help support the 21st Century Cures Act. Nearly $9 billion in funding for the National Institutes of Health is meant to advance medical innovations.

    The GOP member of the House Ways and Means Committee is just one of many lawmakers who recently have held events to raise awareness of the bill. The gathering of constituents has also served as a reminder of the bipartisan effort to get the bill through the body.

    Dold on Monday was joined by researchers at Northwestern University's Feinberg School of Medicine who expressed concern over the lack of interest and participation in academic research.

    “There are a lot of very talented people out there; it's a buyer's market,” said Dr. Alfred George, chair of Feinberg's department of pharmacology. “What keeps me up at night is the fact that a lot of these vary talented people will probably not be in academic science.”

    Part of the problem, George said, has been the drop in research funding that's lead younger scientists to abandon the field.

    In a January issue of the journal Perspective, Johns Hopkins University President Dr. Ronald Daniels wrote the average age in which researchers with a medical degree are awarded their first major NIH grant has increased from under 38 in 1980 to over 45 by 2013. The trend has coincided with a decline in the number of younger researchers. Daniels found the share of researchers under the age of 36 decreased from 18% in 1983 to 3% by 2010.

    “Are we going to be losing a generation of scientists that we can't find homes for,” George asked. “And part of that is about funding and about opportunities to invest in people who have shown promise and succeeding in the non-ending quest to seek support for their research.”

    Dold and supporters of the 21st Century Cures Act think the bill can help that cause.

    The bill, which passed the House overwhelmingly in July, is expected to be considered by the Senate this fall.

    It would provide an additional $8.75 billion in NIH funding over the next five years, as well as $550 million in added funds for the Food and Drug Administration.

    Critics have argued the bill lowers the standards for approval by the U.S. Food and Drug Administration, which they say increases the risk that a greater number of potentially harmful products will be sold to patients.

    A recent study that appeared in JAMA highlighted critics' safety concerns. It found that many high-risk medical devices that received expedited FDA approval did not complete post-market testing for safety in a timely manner, with only 13% of products having completed studies between three and five years after approval.

    When asked about the criticisms and others like them, Dold said he thought the Act struck the right balance in terms of streamlining the FDA's review process while maintaining appropriate safety standards.

    “It's not that we don't want the FDA reviewing, we want to streamline it a little bit to make sure it can move forward more quickly,” Dold said. “Safety is obviously the top concern, but there's got to be a balance, and I think the bill strikes that right balance.”

    Meanwhile, other criticisms of the 21st Century Cures Act say it doesn't go far enough in accelerating the development and delivery of new medical treatments.

    A report released in July by a Washington D.C.-based think tank, the Bipartisan Policy Center, found that $1.5 trillion invested in research and development over the past 20 years resulted in fewer drugs actually coming to market compared with the 1950s.

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