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The NIH wants to develop alternative painkillers to opioids that are just as effective without causing addiction as one way of combating an overdose epidemic linked to more than 33,000 deaths in 2015.
New drug development is part of a three-pronged approach announced May 31 by the National Institutes of Health in partnership with the pharmaceutical industry. NIH Director Francis Collins and Nora D. Volkow, director of the NIH’s National Institute on Drug Abuse (NIDA), described their plan in a special report in the New England Journal of Medicine (NEJM).
“We are very much committed to bringing all hands on deck to address what is clearly a major public health crisis in our nation,” Collins said in a May 31 teleconference with reporters. “Every bit of energy that we can bring to this is well worth it.”
The NIH announcement falls on the same day Health and Human Services Secretary Tom Price announced that more than $70 million is available in two grant programs to aid first responders, health-care providers, and others trying to prevent opioid overdose deaths and treat opioid use disorder. Ending the crisis a top priority for President Donald Trump, Price said, adding the HHS is “committed to bringing everything the federal government has to bear on this health crisis.”
Collins echoed the HHS secretary, telling reporters, “I’ve been encouraged by none other than the president of the United States to make this a very high priority for medical research.”
But the Trump administration also is proposing to slash federal research dollars by historic amounts, to $25.9 billion for the NIH in fiscal year 2018 from $34.1 billion in FY 2017. Under the proposal, NIDA would see a $210 million cut.
“We don’t know exactly at this point what we’re going to end up with as far as a research program,” Collins said. “But I can assure you, this will be something that we put very high on the list of things we just have to do.”
Elias Zerhouni, president of global research and development for Sanofi and Collins’s predecessor at the NIH, also said opioid misuse is a national crisis.
“Sanofi R&D believes innovation has a role to play in developing safe new non-addictive forms of pain management, treating addiction and better understanding the neurobiology of pain,” Zerhouni said May 31 in a response to Bloomberg BNA’s request for comment. Zerhouni was one of several whom Collins and Volkow thanked for helping to draft and edit an earlier version of their NEJM report.
Addressing the epidemic isn’t as simple as getting rid of the opioids, Volkow said, because of bad outcomes for patients who have chronic pain without providing alternative medications. Otherwise, she said, those patients will rely on opioids from the black market.
“If we want to address the opioid crisis, we need to address the needs of patients suffering from pain,” Volkow said.
In addition to developing drugs that won’t cause addiction, the NIH also wants to research ways to reverse or prevent an overdose and develop new treatment strategies for opioid use disorders. Representatives from the NIH, the Food and Drug Administration, and research and development heads of major drug companies convened in April to lay out this strategy.
The FDA is “signaling that they’re interested in a regulatory framework that might be more friendly towards the development of new medication,” Collins said. “They recognize that pain medicines need not be completely devoid of any side effects to be approvable when you consider the side effects of opioids which are, sadly, addiction and sometimes death.”
Over the next six weeks, the NIH plans to hold “a series of three very intense workshops” with drug companies to accelerate the process of finding answers in areas where current solutions are inadequate to respond to the crisis.
“The stars are aligning now between the science, the industry seeing this as a potential market opportunity, [and] the recognition we need to get away from opioids,” Collins said. “I think we can make real progress now.”
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
Collins's and Volkow's New England Journal of Medicine article is available at http://www.nejm.org/doi/full/10.1056/NEJMsr1706626?query=featured_home.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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