April Pride sat down with Co-Founder of GALILEA, Stephanie Karzon Abrams, to discuss the realities of psychedelic therapies and women’s care, asking the questions that can start turning advocacy into action.
April: Starting on a personal note; you come from Greek, Egyptian, and Syrian women. When you say “ecology was theology” once upon a time — what did you actually inherit? Not the idea of it. The specific thing your mother or grandmother knew that no journal ever published.
Stephanie: Their intuitive powers bordered on psychic. I think we all have this as women. Perhaps society and culture led to its suppression, but we all have it to varying degrees. We know things, we sense things, and we should remember this when making choices about our body, our minds, and our lives.
I’ve thought a lot about how it can sound when a scientist like myself talks about her intuitive strengths, and at this point, I just want to embrace and normalize it. I think we can embrace the mystical parts of our human experience, our womanhood, and at the same time value the scientific method, data, and evidence.
[They] were so strong. They were so talented, smart, artistic, sharp, but also so warm, so all-knowing. They were tremendous examples of womanhood.
About the evidence
April: Compass has now run two successful Phase 3 trials for psilocybin and plans to file with the FDA this quarter. It could be the first classic psychedelic to reach approval. At ICPR this year, researchers pointed out that cycle phase, hormonal status, and contraceptive use still aren’t being systematically tracked in these trials. So if psilocybin gets approved — what will the label not tell a woman?
Stephanie: (laughs) How her hormonal status; her cycle phase, menopause, HRT, or oral contraceptives may alter her response to the drug. We have preclinical data, we have mechanisms; that’s all. We don’t have the data from real women in a any formal study format. We have their anecdotes and those are very valuable. Providers can certianly integrate their lived experience into practice. But systems change on formal evidence. We must create it. Short form post on this here:
Beyond Pregnancy and Breastfeeding, here's what the Comp360 label will not include
Cycle phase, menopause, HRT, or oral contraceptives can plausibly alter response to a psychedelic, but none of this has been studied in women.
April: In February, the FDA gave breakthrough therapy designation to luvesilocin for postpartum depression. Roughly seven in ten women in the Phase 2 responded, and the breast-milk transfer data looks minimal. It’s the first psychedelic program built entirely around a female indication. Is that the moment the field is finally forced to study female biology — or does an eight-hour in-clinic protocol create a new access problem for a woman with a newborn at home?
Stephanie: This is the Reunion drug. The inclusion limit was 15 months post-delivery at screening. That’s more than a year. At that point, a mother could be away from her infant for several hours, but that’s her choice. There are also shorter treatments like 5-MEO-DMT and ketamine therapy showing promise for the treatment of PPD. This means less time away from baby. This also means you can address your PPD sooner and not wait a year or more. I think that would be in the best interest of both mother and child as first few months represent a highly sensitive time for bonding.
Some people are non-responders to certain drugs. We’ve certainly seen it in clinic. I think the more options the better!
April: Last November the FDA pulled the black box warning off estrogen therapy. A lot more women are about to be on hormones. You’ve made the point that a woman on estradiol isn’t necessarily in a high-estrogen state. What does a facilitator need to ask now that they weren’t asking a year ago?”
Stephanie: The ACOG recommends a target estradiol level of 40–100 pg/mL as a reasonable range for symptom relief when monitoring is warranted. Many women on estradiol therapy remain in a low-estrogen or physiologic-replacement range. Replacement therapy targets the low end of the premenopausal spectrum, while the normal range spans a much wider and cyclically dynamic territory. The clinical context like route, dose, formulation, BMI, smoking status, and time since menopause can determine whether exogenous estradiol produces a meaningfully estrogenic systemic state.
I think facilitators or providers should be asking about cylce and phase, whether a woman is on HRT; ask them how do you feel across the cycle or in their current life phase. When do they feel most resourced and when they do you not. Any and all questions relevative th cycle, mentrration, life phase, and medications/supplements has more relevance than we’ve given attention to.
April: 15% of adult women in this country are currently on a GLP-1. Among adults fifty to sixty-four, it’s twenty-two percent. In a room of midlife women, that’s one in five. I know it’s early, but do you have an idea of a protocol that’s emerging?
Stephanie: I think it’s too variable to protocolize. Instead, follow guidelines. If we know GLPs slow gastric emptying, then we know that a pro-drug like psilocybin will be affected. It’s best to wait to administer psilocybin, if they can. If they can’t wait then there are other routes of administration that go directly to the bloodstream, and there are other drugs that do not need to be converted into their active metabolite, that can provide relief. Here’s the GALILEA Women’s Health Toolkit which includes a flag sheet for GLPs and medication mgmt.
April: McKinsey and the World Economic Forum put a number on this: women spend twenty-five percent more of their lives in poor health than men, and closing that gap is worth a trillion dollars a year by 2040. Their blueprint’s first instruction is simply — count women. Psychedelic medicine is being built right now, from scratch. Is it repeating the mistake in real time, or is it young enough to be the one field that gets it right?
Stephanie: If there's value in it, we'll study it. If there's economic value in it, we'll study it faster. Money has a remarkable way of making blind spots visible. If women's health is truly a trillion-dollar opportunity, it’ll get studied. It’s harsh and I wish it wasn’t so. I think we’ve already made some mistakes in this field, but I also see that we’ve dodged some major ones. We can do this right. Course correction will always be part of a new journey. And I think when we invest in the people who have been carrying wisdom for so long, and those who’ve been working with these medicines before Pharma tapped in — inclusive of those practicing underground— then we have a great chance at not losing the plot. We have to invest in supporting the care givers. They will have the biggest impact, even when it comes to the FDA approved versions of all these drugs. And if we want to avoid a monopoly or crack downs that make alternative ways of practice obsolete, then all the most reason to keep all of these voices loud and alive! I have hope.
April: You want women’s lived experience treated as data, not anecdote. But data needs structure to count. How do you actually get from a woman saying ‘it hit harder the week before my period’ to something an IRB or a regulator will accept?
Stephanie: I believe that gap isn’t fully methodological. It’s more that most non-gynecologic drug trials have simply not included these measures. It’s also work and effort. There has to be a willingness to invest time and resources.
Here’s what I think needs to be a part of the equation:
Use a validated prospective daily rating instrument
The single most important methodological move is replacing retrospective recall (”it hit harder before my period”) with prospective daily symptom recording anchored to menstrual cycle days. The gold standard is the Daily Record of Severity of Problems (DRSP). Other validated instruments include the Calendar of Premenstrual Experiences
At least 2 months of prospective data
Accurately define menstrual cycle phase->Best: Daily urinary hormone sampling (Mira, Inito are home devices).
A major source of noise in cycle research is misclassification of cycle phase. A comprehensive methodological review identified six different methods used across 146 studies, with poor consistency. That’s problematic!
Stratify or analyze by cycle phase
Use realignment methods — statistical techniques that align data to the LH surge rather than to calendar days, correcting for variable cycle lengths — followed by multiple imputation for missing data points.
Analyze symptom severity as a function of cycle phase (follicular vs. luteal) using mixed-effects models with cycle phase as a within-subject factor. So you’ll need appropriate statistical plans.
Meet FDA PRO and IRB guidelines …obviously.
About GALILEA
April: Is Galilea building a registry?
Stephanie: That’s where we want to go. And we plan to create a validated tool as well help practices track data and outcomes, publish case reports. All this moves the needle. We’re here; we have fantastic research partners. We’re ready!
April: The intake work is the part I keep thinking about. Structured intakes, hormonal data, tracking response over time. If a few hundred providers all start using the same addendum, that’s a dataset nobody had to fund — and it might arrive faster than a trial that stratifies women by cycle phase. Is that the plan? And who owns that data?
Stephanie: Practice-based research network (PBRN) generating prospective real-world evidence is very valuable. We’ve seen approvals with postmarket RWE (real world evidence) requirements rise from 10% in 2016 to 49% in 2024. The critical requirement is a common data model — standardized.
Who owns the data? The tricky part and the answer depends on governance design. Under current US law:
If individual practices collect data using a shared addendum but store it locally, a federated model preserves local data ownership while enabling centralized queries. patient-level data never leave the institution where they were collected — instead, the analysis travels to the data
HIPAA governs individually identifiable health information held by covered entities (hospitals, clinicians, insurers).
De-identified data can be shared for essentially any purpose without patient consent.
However, re-identification risk is increasingly recognized as a real concern given modern data-linking capabilities.
The Common Rule (updated 2018) requires that research consent forms disclose whether identified data may be de-identified and reused for future studies without additional consent. Secondary analysis of existing de-identified healthcare databases is generally exempt from informed consent requirements.
In practice, the entity that controls the data infrastructure typically controls access. If a professional society or nonprofit builds the registry, it sets the data use agreements. If a commercial platform (e.g., TriNetX) hosts the data, the platform’s terms govern access. If individual practices collect data using a shared addendum but store it locally, a federated model preserves local data ownership while enabling centralized queries.
April: Thank you!
Stephanie: Thank you! Thanks everyone for coming together for women’s health today. It’s possible. We need the will and the resources. Join us here to get involved: www.galileahealth.community
-Thank you April and big thanks to the Shulgin Foundation for hosting us on this beautiful summer afternoon!
Thank you for shedding light on where psychedelic medicine is going and what that means for women's health. Understanding the complicated history of women's health research and the continued impact of a lack of interest and funding can feel defeating, but the parallel progress of these two categories means that women have a better chance of using OG and novel psychoactive compounds to their advantage. We're lucky to have you and the broader GALILEA team supporting the clinicians who will support them.