FDA considers considering MDMA

Should the FDA consider MDMA (known on the mean streets as ecstasy or molly^*) as a treatment for PTSD? The Multidisciplinary Association for Psychedelic Studies (MAPS) has filed a new drug application — the first ever for any kind of psychedelic-assisted therapy.

The assisted part is important, as the drug would be “used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.”

MAPS says it’s got 30 years of research, including phase 3 trials, to back up its application. The FDA now has 60 days to decide whether to accept the application for review or even priority review.

^* Today I learned there’s a difference. Both are MDMA, but ecstasy is usually a pill and molly is purer and thus a powder (or capsule).

Another item about male birth control

A phase 1 trial of a male birth control has just begun in the UK, where YourChoice Therapeutics is testing out a hormone-free pill that blocks vitamin A, which sperm need to … well, to live.

When tested in male mice during preclinical trials, the male contraceptive showed 99% efficacy in preventing pregnancy, was 100% reversible without any side effects and the mice were fertile again four to six weeks after stopping the pill.

This trial is expected to list into the middle of next year. After that, who knows? If it pans out, though, the question will be how much you trust the guy who says, “Don’t worry, I’m on the Pill.”

Congress and the FDA

The Senate: Spurred by the too-late recall of Philips’s (allegedly) deadly CPAP machines, two US senators are asking the head of the Government Accountability Office to open a probe into the FDA — specifically, to update a 2011 GAO report on how the agency handles recalls.

Since 2011, their data show…

Recalls have gone up about 125%, from just under 400 events in 2012 to nearly 900 last year, while adverse event reports have risen more than 500% from almost 500,000 a decade ago to nearly 3 million in 2022.

The House: Republicans on the House Committee on Energy and Commerce are demanding that the FDA answer their earlier request “for information related to the agency’s foreign drug inspection program” — specifically “insufficient foreign drug inspections conducted in India and China.”

We never noticed this before

Apparently there’s not just long Covid, there’s also long flu. Researchers at Washington University School of Medicine found that “people hospitalized with seasonal influenza also can suffer long-term, negative health effects, especially involving their lungs and airways.”

The flu, it seems, can also jump from being acute to being chronic, but no one thought to actually look for that until the pandemic.

Many people think they’re over COVID-19 or the flu after being discharged from the hospital. That may be true for some people. But our research shows that both viruses can cause long-haul illness.”

The good(ish) news is that the risk of long-term issues caused by the flu is much lower the the risk from Covid.

UGA looking to honor diversity

Hey, UGA folks: Do you know someone in the College of Pharmacy community — alumnus/a, faculty, staff, student — who you think deserves the William T. Robie III Diversity, Equity, and Inclusion Award?

The criteria is straightforward: “Nominees should have led efforts and advanced conversations around making their communities more inclusive as it pertains to diversity and equity.”

Nominate him, her, it, or them ASAP, ’cause the award is being presented Thursday, February 8 at 12:30 pm at the award luncheon. Click here to do just that.

The Long Read: Depression is Complicated edition

The weird thing about SSRIs is that no one knows just why they work against depression. (The how is in the name.) The “serotonin hypothesis” is the best we have. Recently, though, that’s come under scrutiny as biochemists and their kin rethink whether tweaking serotonin is how you treat depression.

Then again, SSRIs often do work, so what’s going on? As one neuropharmacologist put it, “Just because aspirin relieves a headache, [it] doesn’t mean that aspirin deficits in the body are causing headaches. Fully understanding how SSRIs produce clinical change is still a work in progress.”

Read on, MacDuff.