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March 23, 2018

Why Geisinger and Kaiser just rejected tens of millions of dollars from NIH

Daily Briefing

    NIH is in the midst of a large-scale precision medicine program to compile and analyze millions of people's genetic data—but some industry experts have raised concerns about the program's viability, and two health systems have returned money they were granted to participate in the initiative.  

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    The initiative, called the All of Us Research Program, aims to collect biological samples, as well as genetic and lifestyle data on more than 1 million U.S. residents.

    NIH in 2017 enrolled 17,000 participants in the pilot phase of the program. Researchers have not sequenced the DNA of any of the participants, but have collected blood and urine samples and taken the measurements of participants. NIH has contracted with scientists from top universities, as well as with technology companies such as Verily, a subsidiary of Alphabet, which is the parent company of Google.

    According to the New York Times, the initiative is one of many efforts designed to construct a large collection of biological data. For example, the Department of Veteran Affairs (VA) and other health systems and organizations have launched similar efforts on a smaller scale. 

    But Eric Dishman, director of the NIH program, said the All of Us Research Program is the first that seeks to capture data on a nationally representative sample of U.S. residents, including minorities who have historically been underrepresented in research. "We will have an unprecedented amount of data at a scale never done before," Dishman said.

    Concerns emerge over the initiative

    But stakeholders increasingly are voicing concerns over NIH's progress and methodology.

    For example, Sean Harper, EVP for research and development at Amgen, said Amgen's subsidiary DeCode Genetics works with a biobank of 160,000 people from Iceland. He said, "It took about 20 years and over a billion dollars of investment to get to the point where we are able to routinely extract from the data the necessary information to validate or invalidate drug targets."

    George Yancopoulos—president and chief scientific officer of the biotech company Regeneron, which was sequenced the DNA of more than 300,000 individuals for similar initiatives—was concerned that NIH had not yet collected genetic sequences and was not near its target of enrolling 1 million individuals. He said, "I think someone needs to ask tough questions about whether this is the best use of precious NIH resources," adding, "Should the funding instead go to individual researchers who are doing truly basic and innovative science?"

    Health systems opt out of national program

    And two health systems, each of which runs its own biobank initiative, have ended their participation in the program.

    David Ledbetter, EVP and chief scientific officer of Geisinger Health Systems, said his organization felt the program was too complex and slow moving, requiring participants to attend frequent meetings and conference calls. Ultimately, Ledbetter said "We decided it was not the right expenditure of our time," and the health system returned its five-year, $50 million grant.

    Elizabeth McGlynn, vice president of Kaiser Permanente Research, cited different reasons for Kaiser's decision to return its grant. McGlynn said the health system, which has made good progress in developing its own biobank, expected to be able to share its experience with recruiting and data analysis. However, McGlynn said was "not able to engage as a scientific partner" and "felt increasingly that [it was] just being asked to give [NIH] access to [its] members."

    McGlynn also voiced concerns over whether NIH would be able to deliver genetic information to the program's participants, noting, "Genetic counselors are in terribly short supply." She said that Kaiser "wanted to be sure [it was] well organized to deliver results in a way that was ethical and not scary to members."

    Overall, Ledbetter said he expects the NIH program will be "very valuable someday," but Geisinger could not wait. "I think the idea is great," he said, adding, "It is ambitious. It is expensive. It will take a while" (Kim Cohen, Becker's Health IT & CIO Report, 3/22; Kolata, New York Times 3/19).

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