Would you be a good girl
if the FDA approved MDMA? And other health news I think you should read
The FDA doesn’t trust that we’re going to behave if they approve a party drug for PTSD. (New York Times)
Beyond drug abuse, they’re also concerned about heart + liver damage. Are those of you who use MDMA also thinking about your heart + liver? Lykos Therapeutics submitted a New Drug Application, and the FDA granted them priority review (this is a good thing). The FDA is Drug Daddy. They review drug company (and other manufacturers) submissions to assess whether new drugs/health technologies are effective and safe. Ahead of the Psychopharmacologic Drugs Advisory Committee Meeting, the FDA released a briefing document (normal), where they cite evidence concerns. Mostly study flaws like potential bias, where study participants + therapists could tell whether someone received a placebo, AKA functional unblinding. It’s obvious for study participants to know whether they’re rolling vs not.
Psychedelics have gained momentum over the last few years. Think ketamine for depression (approved, with strict controls in place) and Compass Pathways, which is exploring psilocybin therapy for treatment-resistant depression (when you’re still depressy after trying available treatments/drugs), PTSD, and anorexia. Lawmakers also support them because a lot of Americans suffer from depression and PTSD—especially veterans—and current treatments aren’t enough.
If you feel strongly about this topic, do something about it: The FDA is taking public comments (in person, online, or written submissions) on June 4th (tomorrow!) during their Psychopharmacologic Drugs Advisory Committee Meeting. It’s pretty cool to participate in drug development as a private citizen.
A reproductive rights showdown (The Hill)
Chuck Schumer has scheduled a vote on the Right to Contraception Act, which would cement our right to use contraception and allow healthcare providers to discuss it, prescribe, and refer patients for contraceptive services. Schumer scheduled it for June 5th, aligned with the second anniversary of the Supreme Court's decision to overturn Roe v. Wade. What I tell my Christian Pastor Parents is that if you want to reduce the number of abortions, we have to ensure people have access to contraception. Meanwhile, in Louisiana, they’re making moves to classify abortion pills as controlled substances.
This feels obvious to me, but don’t cut costs on your Botox (Axios)
In April, Glamour shared the story of three women who got HIV from vampire facials at an unlicensed med spa. This isn’t a super regulated industry, and the states pretty much do what they want in terms of enforcing their own rules. Do you trust your state government to give a fuck about whether your med spa could disfigure your face? I don’t! And I like New York! When looking at the same cosmetic services, the likelihood of a flop is way higher in med spas than in doctors’ offices. The risk is too high: counterfeit Botox, paralysis, botulism? No, thanks. If I were doing any of these things, I’d only trust my sweet angel dermatologist. NOT AN AD, she’s just really good at telling you when you don’t need something. Yearly since I turned 30, I’ve asked her if I should start Botox, and I stopped asking when she was like, “Girl, NO. I can tell you when it’s time if you wish.”
Some cool updates from ASCO this week
In case you didn’t work in oncology for most of your adult life (fair), ASCO is the American Society of Clinical Oncology. It’s THE professional society for doctors who treat people with cancer. They always (to my knowledge) hold their annual meeting in Chicago for some reason. It’s an opportunity for companies to flaunt their research and have the most impact.
Highlights:
Palliative care for seriously ill cancer patients is just as effective virtually vs in person (STAT News)
IMO this is a win in a pandemic era and for areas with access, and affordability concerns. For instance, if a region has a limited number of palliative care doctors, training more doctors takes a long time. However, providing care virtually can save those same doctors time so they can treat more patients. But would I feel the same if my grandmother were receiving palliative care on Zoom vs having an actual human present?
Positive GSK data read-out for a drug that was previously seen as a failure
After assessing Phase 3 data for Blenrep, GSK found that their antibody-drug conjugate (ADCs are essentially the new CAR-Ts in terms of excitement) reduced the risk of multiple myeloma cancer progression (cancer getting worse) or death by 48% when compared to other available treatments. With this evidence, GSK plans to submit for drug approval with the FDA.
Novartis used augmented reality in their booth to show the patient burden of CML
Chronic Myeloid Leukemia is one of those cancers that feels fixed (in part because Novartis took it from something that could kill you to something you could potentially live with). But with all cancers, surviving isn’t enough. To demonstrate this, Novartis employed AR tech to build an immersive experience that can help conference attendees better understand the CML patient burden. I love the intersection of health and technology.
I’m back in Marseille and to regular programming!
goodnight,
xxsem