As it so often is, Thursday's U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing on NIH research was a showcase of innovation and the realization of what once seemed the realm of science fiction. But the show-and-tell session wasn't limited to the wonders springing from what NIH Director Francis Collins likes to call the "National Institutes of Hope."

Citing an ongoing investigation into federally funded research, at least some of which was conducted by foreign nationals, HELP Chairman Lamar Alexander (R-Tenn.) invited Collins to open his testimony by discussing the increasing risks to the security of biomedical research and steps the agency has taken this week to deal with those risks.

"I want to acknowledge the great advantage to our country of attracting the brightest people from around the world to our universities and laboratories – as long as they follow the rules and conduct their research in appropriate ways," Alexander said in the lead-up to Collins' testimony.

Sen. Michael Bennet (D-Colo.) echoed the chairman's concerns. "Breakthroughs in medical research cannot happen in the silo of any one country," he said. "But we also want to ensure that we prioritize its transparency and appropriately deal with bad actors who are taking steps that actually undermine the science and American efforts to do research."

While Collins didn't disclose details about the investigation, he said intellectual property (IP) stemming from NIH-supported research and the integrity of the agency's peer-review process have been under constant threat of risk. The magnitude of the risks is increasing, he added.

Considering those risks (and presumably the investigation), Collins said he wrote to senior officials at more than 10,000 NIH grantee institutions Wednesday asking that they review their records for evidence of malfeasance in three areas of concern that have emerged:

  • • failure by some researchers at NIH-funded institutions to disclose substantial contributions from other organizations, including foreign governments – a failure Collins said threatens to distort decisions about the appropriate use of NIH funds;

  • • diversion of IP in grant applications or produced by NIH-supported biomedical research to other entities, including other countries;

  • • sharing of confidential information by peer reviewers with others, including with foreign entities, or other peer reviewer attempts to influence funding decisions.

In addition, Collins announced that he has formed a new working group of the director's advisory committee and charged it with identifying robust methods to improve accurate reporting of all sources of research support, financial interests and affiliations; mitigate the risk to IP security; and explore additional steps to protect the integrity of the peer review process.

The group's recommendations must reflect NIH's long tradition of partnerships and "emphasize the compelling value of ongoing, honorable participation by foreign nationals in the American scientific enterprise," Collins told the committee.

"We must move effectively to root out examples where our system is being exploited but make sure to preserve the vibrancy of the diverse workforce that has played a major role in the American biomedical research success story," he continued.

The NIH's peer review panels have raised concern in the past. Alexander noted that the quality of the panels, which together award about 11,000 grants, has been a sore point with researchers.

The agency is addressing that problem, Collins said. Since 2015, a condition of every grant is that the researcher must serve on an NIH peer review panel if asked. As a result of that change, 80 percent of the people serving on peer review panels are now grantees.

Who pays

Thursday's hearing was held as the full Senate prepared to vote on a minibus package that included $2 billion in new funding for the NIH, which would give the agency a record $39 billion for fiscal 2019. If the spending bill becomes law, the NIH will have been given a 30 percent increase, a total of $9 billion in new funding, since 2015.

Because of the government's support, the U.S. has been the global leader in scientific research. It's hard to think of a major scientific advancement since World War II that hasn't involved federal funding, Alexander said, adding that other countries are figuring out the importance of government investment in research. China, for instance, has increased its funding of science by a factor of four over the past 11 years and may pass the U.S. this year in terms of total spending on R&D, Alexander said.

While the NIH relies on federal money for its research grants, it also gets contributions from the private sector via its nonprofit foundation. Sen. Elizabeth Warren (D-Mass.) took issue with that practice, citing a $100 million study on the potential benefits of alcohol that was canceled earlier this year following the disclosure that it was being funded in part by industry donations to the foundation.

That wasn't an isolated incident, Warren said, as the agency also pulled the plug on its plan to use contributions from drug companies, including those that produce opioids, to help fund research on addiction.

Collins said the NIH must be thoughtful about how it uses donations from the private sector, and it needs to watch out for vested interests that could color study outcomes. But there is a need for the foundation funding, which comes with no strings attached, as it advances science more rapidly, he explained.

"I think the NIH should get more funding," Warren said, but it shouldn't come from industry donations. Instead, drug companies can pay more through higher taxes, she added.

Prioritizing research

While the title of Thursday's hearing was "Prioritizing Cures," Sen. Bill Cassidy (R-La.) was the only HELP member to question how the agency prioritized research areas. He brought out charts that showed the societal costs of various diseases and the amount the NIH spent on research for those diseases. His concern was that obesity research is underfunded, especially when compared with the funding for other diseases that have a considerable lower societal cost.

"Obesity is the match that lights the fire for many more diseases," Cassidy said. Thus, its annual societal cost is $190 billion, and yet the NIH only spends about $95 million a year on obesity research. Noting recent research that shows possible links between obesity and Alzheimer's, Cassidy wanted to know why more obesity research isn't being funded.

Obesity is a multifactorial problem, Collins responded, and many of the factors are in areas the NIH can't address.

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