As FDA Ponders MDMA Approval, Questions Linger Over Drug Trial Data
Some people who took part in the studies for a PTSD treatment reported worsening thoughts of suicide — a side effect that wasn't included in the study's final results.
The Wall Street Journal:
Ecstasy Drug Trials Missed Suicidal Thoughts Of Subjects
Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias. The Food and Drug Administration is expected within days to decide whether to approve the drug, known as MDMA, for treatment of post-traumatic stress disorder. Approval would be a milestone in decades of efforts to decriminalize the use of psychedelics. Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results. (Whyte, 8/5)
Politico:
How A 3-Star General Came To Believe In Psychedelic Medicine
A 77-year-old retired Marine Corps general has emerged as an unlikely advocate for treating veterans suffering from post-traumatic stress disorder with the psychedelic drug ecstasy. Jack Bergman flew helicopters in Vietnam, earned three stars, and is now in his fourth term representing a northern Michigan district in the House. A Republican, he sees promise in psychedelics that a group of mostly psychiatry professors who advise the FDA didn’t when they recommended the nation’s drug regulator turn down a pharmaceutical company’s application to offer MDMA along with therapy as a PTSD treatment. (Schumaker, 8/5)
Vox:
MDMA Is On The Brink Of Becoming Medicine
The psychedelic drug is at a make-or-break point, with the FDA scheduled to make an announcement this month on whether it is ready to move forward as a PTSD treatment. In a three-part series, Today, Explained’s Haleema Shah reports on the promise and precarity of MDMA. Starting with the rogue chemist and therapists in the 1980s who believed it could change psychotherapy, the series traces the decades-long effort to make a dance-floor drug medicinal, journeying through the war on drugs, the rave era, and the psychedelic renaissance to explain how a once-maligned drug became an emblem of healing — and how, no matter what the FDA decides, therapy will never be the same. (Shah, 8/2)
In other news about illegal drug use —
The Boston Globe:
Narcan To Combat Overdoses Now Stocked At Some MBTA Stops
There are no simple solutions to the ongoing opioid crisis, which last year claimed more than 2,100 lives in Massachusetts alone. But making sure naloxone is within arms reach is as good a strategy as any, say Harvard students behind an effort to put the overdose reversal drug — commonly referred to by the brand name Narcan and usually given via disposable nasal spray — in as many public places as possible. (Buell, 8/4)
Stat:
Politics Is Holding Back The Best Tool For Treating Meth Addiction
When it comes to treating methamphetamine addiction, the use of behavioral incentives is settled science. Offering financial rewards, like gift cards, to people who demonstrate that they’ve reduced or stopped their meth use, is highly effective: Studies show that contingency management, as it is known, can promote abstinence from drugs, increase utilization of health care services, and even reduce high-risk sexual behavior. (Facher, 8/5)
