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NIH chief eagerly awaits Omnibus funds to launch stalled opioids partnership

Francis Collins is as eager as, if not more than, anyone else in Washington for Congress to pass its Omnibus spending bill — the funding needed to keep the federal government open past March 23.

The head of the National Institutes of Health, or NIH, has been waiting for federal funding for nearly a year to start up his public-private partnership aimed at accelerating the development of nonaddictive alternatives to opioids and better overdose-reversal agents.

The NIH first revealed plans for the project in May 2017. And even though there are 33 drugmakers and other medical product companies highly interested in teaming up with the agency, none have officially signed on and been willing to commit funds of their own, the NIH chief confirmed to reporters during a March 20 briefing at the Washington headquarters of the U.S. Department of Health and Human Services, or HHS.

Once the government resources are nailed down, industry would be "prepared to do its share," Stephen Ubl, president and CEO of the trade group Pharmaceutical Research and Manufacturers of America, said during a White House meeting last fall.

"We've had a very productive discussion over several months," Collins told reporters, adding that the 33 companies are "interested in this kind of a partnership."

"And out of that has come a very exciting scientific work plan, which would involve a sharing of information in an unprecedented way, as well as tackling some really important issues, like developing a biomarker for pain, instead of depending upon the typical 'smiley face' assessment of pain," he said.

The companies and the NIH also discussed setting up a clinical trial network, "so that as those new pain treatments come along, they can be quickly tested," Collins said. "All of that seems to have received wide enthusiasm from both the public- and the private-sectors."

Collins told a Senate panel in December 2017 that the plan of action for the public-private partnership was all but ready and the NIH and the potential collaborators were simply waiting for government funding.

He had estimated then that the project would need at least a "couple hundred million dollars," with an expectation that industry would cover half of that amount.

"It is now a matter of figuring out exactly how we would put the funding and the governance together," Collins told reporters at the March 20 briefing. "You may know from the government's perspective, this is an interesting week to figure out exactly what kind of resources we may have for that. So stay tuned."

In his fiscal 2019 budget request, President Donald Trump asked Congress to pour $10 billion into new and ongoing efforts to address the opioid epidemic, which is responsible for about 115 deaths per day in the U.S.

HHS Secretary Alex Azar told the House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee at a March 15 hearing that at least $500 million of those funds would be devoted to the NIH public-private partnership.

Congress also authorized $6 billion in February for fighting the opioid epidemic as part of another short-term spending bill, although how that money will be spent has yet to be determined.

Opioid-free pain drugs

As part of its work to address the opioid crisis, the NIH is trying to identify opportunities to develop treatments for chronic pain that are not addictive and are not opioid-based, Collins told reporters.

"Clearly, that is part of the dilemma of what people with chronic pain face — that there are not a lot of other options out there," he said.

"We are learning a tremendous amount from science about exactly what the neurobiology of pain is all about, and that is leading to the identification of new potential drug targets," Collins explained.

He noted that the NIH has been trying to identify the cause of a 17-year-old boy's congenital insensitivity to pain — a condition that has caused him to not recognize when his bones are broken or his skin is burned.

"We don't know why this is. He probably has a genetic change somewhere in some important gene that is part of the pathway that transmits pain from an injury to the brain," Collins said.

Through the use of a controlled pain stimulus test, the NIH has been able to determine the young man's autonomic system, which controls muscles of the internal organs, recognizes pain, but the "conscious part of the brain is just ignoring this altogether," Collins said.

"If we could figure out what is that particular circumstance in him, that would point us to a new idea of how to provide pain relief" on a temporary basis for other people, he said.

"It's just one example of the many ways we are trying to identify new approaches to develop pain medicines that are not opioids, not addictive, but highly potent," Collins said.

Overdose-reversal agents

The government also wants to pursue more powerful overdose-reversal agents as part of its strategic plan to combat the opioid epidemic, Azar noted during the briefing.

The lethality of fentanyl has prompted the need for such research and development, the HHS chief told reporters.

Nora Volkow, director of the NIH's National Institute on Drug Abuse, noted "fentanyl gets into the brain so fast," that in many cases when first responders arrive, the person who has overdosed is already dead.

"If you are going to be effective, you need to deliver the intervention as fast as possible," Volkow said.

She said the NIH has also been working on vaccines that protect against fentanyl overdoses, which have already demonstrated efficacy in animal studies.

"But the challenge is to bring them into humans," Volkow said.