FDA Revokes Controversial Orphan Drug Status For Opioid Addition Treatment In Unusual Move
Critics had argued that the FDA goofed in granting the orphan status in the first place. Stat takes a dive into the complicated background of the case. In other news from the national drug crisis: chronic pain, how Germany avoided an opioid epidemic, needle exchanges, and more.
Stat:
FDA Says It Goofed Granting Orphan Status To Opioid Addiction Treatment
In an unusual move, the Food and Drug Administration has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing the way for another injection of buprenorphine to possibly reach the market. Specifically, the agency withdrew orphan designation and exclusivity for Sublocade, which was approved nearly two years and hailed as a potential game changer for combating the opioid crisis. But the move generated controversy because of a quirk in the law that critics complained should not have allowed the manufacturer, Indivior, to win orphan status and crowd out competitors. (Silverman, 11/8)
NPR:
Meditation Reduced The Opioid Dose She Needs To Ease Chronic Pain By 75%
There's new evidence that mind-body interventions can help reduce pain in people who've been taking prescription opioids — and lead to reductions in the drug's dose. In a study published this month in JAMA Internal Medicine, researchers reviewed evidence from 60 studies that included about 6,400 participants. They evaluated a range of strategies, including meditation, guided imagery, hypnosis and cognitive behavioral therapy. (Aubrey, 11/11)
Kaiser Health News:
How Germany Averted An Opioid Crisis
In 2016, 10 times as many Americans as Germans died as a result of drug overdoses, mostly opiates. Three times as many Americans as Germans experienced opioid addiction. Even as the rates of addiction in the U.S. have risen dramatically in the past decade, Germany’s addiction rates have been flat.That contrast, experts say, highlights a significant divergence in how the two countries view pain as well as distinct policy approaches to health care and substance abuse treatment. (Luthra, 11/11)
MPR:
How One Minnesota Clinic Slashed Its Number Of Opioid Prescriptions
Health experts say the epidemic in its early years was fueled by prescription painkillers like Oxycontin or Vicodin. Some of the state's highest numbers of opioids were prescribed in Douglas County in west-central Minnesota, where Alexandria is the county seat. But after revolutionizing its approach to treating pain and addiction, Alexandria Clinic has reduced the amount of opioids it prescribes by nearly two-thirds. (Collins, 11/11)
St. Louis Public Radio:
Giving St. Louis Drug Users Syringes Could Help Curb HIV, Other Diseases
Addiction treatment providers in St. Louis could soon begin distributing clean syringes to intravenous drug users under a program overseen by the city’s health department. Alderwoman Cara Spencer, D-20th Ward, introduced a bill supporting the proposal on Friday. The board sent the bill to the Health and Human Services Committee, which could consider it next week. (Fentem, 11/8)
St. Louis Post Dispatch:
St. Louis Aldermen Consider Stronger Legal Backing For Needle/Syringe Exchanges
Privately run needle and syringe exchange programs for drug abusers aimed at preventing hepatitis C and other communicable diseases could be legalized in the city under a bill introduced Friday at the Board of Aldermen. The measure would cover such efforts if they are part of a proposed city health department pilot program also aimed at getting drug abusers into treatment for their addiction. (Schlinkmann, 11/9)
