Tag Archives: National Academies

 

Valerie Reyna

Valerie Reyna was on the National Academies of Sciences, Engineering and Medicine Committee that produced the report, Pain Management and the Opioid Epidemic. Here are links to media coverage of the report.

Panel calls on FDA to review safety of opioid painkillers

Associated Press

In a sweeping report Thursday, the National Academies of Sciences, Engineering and Medicine pushed the FDA to bolster a public health approach that already has resulted in one painkiller being pulled from the market. Last week, the maker of opioid painkiller Opana ER withdrew its drug at the FDA’s request following a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles to inject the pills.

The U.S. should rethink its entire approach to painkillers and the people addicted to them, panel urges

Los Angeles Times

In a comprehensive report on what must be done to staunch the toll of opiates in the United States, a report released by the National Academies of Science, Engineering and Medicine makes clear that steps taken to prevent the creation of future opiate addicts will drive some now dependent on these drugs toward street drugs such as fentanyl and heroin.

Expert panel to FDA: time to hold opioids to a new standard

Science Magazine

To help bolster its campaign against an epidemic of opioid abuse that now kills about 90 people a day, the U.S. Food and Drug Administration (FDA) last year called for help from an independent advisory panel. The resulting report, released today by the National Academies of Sciences, Engineering, and Medicine, makes some strong prescriptions. Among its assorted recommendations—from supporting state syringe exchange programs to increasing federal funding for neurobiology research—the panel suggests that FDA dramatically expand the types of evidence it requires from companies to show that an opioid is safe and effective, both before and after it gets market approval.

Major Science Report Lays Out a Plan to Tamp Down Opioid Crisis

Scientific American

When the U.S. Food and Drug Administration screens new opioid drugs it should better anticipate how people might abuse them in the real world, the National Academies of Sciences, Engineering and Medicine warns in a major report issued Thursday on the country’s opioid crisis, which kills 91 people a day—often via overdoses on prescription drugs. The FDA needs to move beyond its traditional focus on clinical studies about drug effectiveness and side effects, and to seek public health data on potential abuse, the Academies advises in its 400-page proposal for targeting the deadly issue.

Painkiller Misuse Remains a Pressing Problem Across U.S.

HealthDay

However, experts say there's no quick fix for the opioid epidemic. According to a new report from the U.S. National Academies of Sciences, Engineering and Medicine, it will take years of coordinated effort on the part of local, state and federal agencies to halt and reverse the drug crisis.

Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse

FDA Statement

In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.

 

Valerie Reyna

Dr. Valerie Reyna is a member of National Academies' Committee on Pain Management and Regulatory Strategies To Address Prescription Opioid Abuse.

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the  science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA’s development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Click to download a copy of the report.

This is an important report. Both untreated pain and the epidemic of opioid use are serious problems requiring urgent solutions. Somehow the balance must be found to both manage the increasing problem of pain in the aging US population, while regulating more effectively the diversion of prescription opioids into the broader population. This report represents the best thinking about how the balance might be made more effectively, while acknowledging the social determinants of opioid diversion and use in depressed communities.

Elaine Wethington

- Professor Elaine Wethington, Professor, Department of Human Development, Department of Sociology, and Gerontology in Medicine, Weill Cornell Medicine