NIH announces new initiative to address opioid epidemic

Plan dovetails with APA recommendations to president’s opioid commission.

On April 4, 2018, Francis Collins, director of the National Institutes of Health (NIH), announced an ambitious new plan to stem the tide of the opioid epidemic.  Through the HEAL Initiative (Helping to End Addiction Long-term), NIH is nearly doubling its commitment to opioid research from $600 million in 2016 to $1.1 billion in 2018.

In remarks delivered at the seventh National Rx Drug Abuse and Heroin Summit in Atlanta, Collins said: "Every day, more than 115 Americans die after overdosing on opioids, that is a four-fold increase since 2000, and the numbers continue to climb.  NIH has been deeply invested in efforts to counter this crisis through research, but we are determined to do even more. Over the last year, NIH has worked with stakeholders and experts across scientific disciplines and sectors to identify areas of opportunity for research to combat the opioid crisis. The focus of these discussions has centered on ways to reduce the over prescription of opioids, accelerate development of effective non-opioid therapies for pain, and provide more flexible options for treating opioid addiction. NIH is committed to bringing the full power of the biomedical research enterprise to bear on this crisis."

Among the priority areas Collins identified were several that the American Psychological Association (APA) had advocated for in its response last year to the Draft Interim Report of the President’s Commission on Combatting Drug Addiction and the Opioid Crisis, including expanding therapeutic options for treating addiction, increasing access to non-pharmacologic treatments for chronic pain, an expanded focus on neonatal abstinence syndrome, and integrating substance use treatment within primary care and criminal justice settings. 

On the latter, Nora Volkow, director of the National Institute on Drug Abuse (NIDA) said:  "With these additional resources, we can develop more customized, high-quality treatments for addiction and pain, as well as harness implementation science to bring evidence-based changes to our healthcare system, including treatment for those in the criminal justice environment." 

Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, the lead NIH institute on pain, highlighted another area APA had voiced concern about, the transition from acute to chronic pain: " A major focus will be to understand why some people go from acute to chronic pain, with the intent to prevent that transition.  Importantly, the Initiative will drive the science to enable the development of powerful, non-addictive pain treatments that would limit the need for opioid medications in the future."

Missing from the rollout of the HEAL Initiative was any reference to NIDA’s highly successful community prevention research portfolio, which has demonstrated decreases in prescription drug misuse in rigorously designed randomized controlled trials.  APA will continue to be a vocal advocate for primary prevention research as the HEAL Initiative moves forward.

For more information on APA’s work on the opioid crisis, contact Geoff Mumford of APA’s Science Government Relations Office. 

Science fares well in FY 2018 appropriations bill

Funding is healthy, and NIH clinical trial policy is suspended.

[updated 3/27/18]

The congressional appropriations committees have labored mightily and produced a $1.3 trillion final funding bill for Fiscal Year 2018, the current fiscal year. In February Congress raised the budget caps that had made reaching agreement on a full year’s spending legislation difficult. With a two-year budget agreement and extra money in hand, the appropriations committees produced a bill that passed both houses of Congress and was signed by the President before the temporary funding bill expired.

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President’s Budget Picks a Few Science Favorites

But Congress Will Have the Last Word

There has been quite a bit of budget-related news this month.  Last week Congress passed a two-year agreement to raise the budget caps put in place by the Budget Control Act of 2011, allowing for $312 billion in additional spending on defense and nondefense accounts in Fiscal Years 2018 and 2019.  This is a major victory for research advocates who weighed in on many occasions about inadequate budgets.  Many were frustrated with years of sub-inflationary budget increases and long months during which the agencies operated on temporary funding authority, as they continue to do for FY 18 (through March 23). The budget agreement is not ideal, but it allows room for the House and Senate Appropriations Committees to advance funding bills that promise to be friendlier to research budgets than the Continuing Resolutions have been (friendlier, too, than the Administration has been).  For example, the budget deal calls for an additional $2 billion for the National Institutes of Health over the next two years, though the FY 18 omnibus funding bill has not yet appeared for final action. See this update for more details on the budget agreement.

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FDA initiates review of all research with nonhuman animals

APA raises concerns about precedent, channels for scientific advice, and importance of animal models.

In a statement released on January 26, 2018, Scott Gottlieb, MD, Commissioner of the Food and Drug Administration (FDA) announced that he had initiated an “independent, third-party investigation of the agency’s animal research programs.”  However, he provided no details about who would conduct this investigation or what processes it would follow.

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We break down a potential shutdown: What will and won’t happen?

Yes, the federal government will likely shut down at midnight.

Temporary funding for the federal government will expire at midnight tonight (Jan. 19, 2018) unless both houses of Congress approve a temporary extension or a longer-term funding deal that includes several pieces of legislation that have been negotiated for the past couple of weeks. The House of Representatives yesterday approved a one-month Continuing Resolution (CR), the fourth since September 30, 2017, when the 2018 fiscal year began.

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Implementation of revised Common Rule delayed by at least six months

Revision raises complex challenges for research institutions. 

On January 17, 2018, just two days before the newly revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule) was scheduled to go into effect, the Department of Health and Human Services’ Office for Human Research Protections announced an Interim Final Rule that delayed the effective and general compliance date of the new rule by six months, making it effective on July 19, 2018.

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