Episode 105: Women’s Health, Clinical Trials, and Changing the System in Biotech Innovation

What does it take to turn lived experience into lasting change in healthcare? Our guest today shows us how. You're listening to BIO from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes.

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Serving the entire Gulf South, but recorded in the heart of New Orleans. Welcome back to BIO from the Bayou. I'm your host, Dr. Elaine Hamm, the executive in residence at Tulane School of Medicine and Today's guest is Georgie Kovacs. She is the founder and CEO of Fempower Health, a platform dedicated to empowering women and their healthcare journey. Not just a platform, it also is a podcast, a newsletter, and you really serve as a community resource for really bringing trusted experts together for evidence-based healthcare information to women and really helping to drive meaningful change in a very difficult sector. And I'm very excited to talk to you about this. So welcome to the show, Georgie.

Oh, thank you so much for having me, Elaine. I am really excited to be here today.

Before we get into all the different things that you've been up to, I'd love to talk to you a little bit about your history and your incredible career. You've been interested in women's health and clinical trials since I think high school is what I have read. Would love to learn a little bit more about that.

I had forgotten about this until I had a basement flooding situation, 4 feet of water. Had to rescue all of my childhood belongings. And I found this paper that I wrote, and it was written right when the FDA in 1993-ish mandated women partake in clinical trials. And I wrote about it.

Love that. That's great.

And I had forgotten this. I happened to stay in the sciences. I got into pharma. Another interesting one, when I was a drug rep, I remember walking by this one office and it said fertility clinic. And I thought, what's that? Fast forward to me getting married and I had a proactive OB-GYN who asked about my family plans.

Yeah.

And she did some tests and immediately said, You need to go to a fertility doctor. I, the granddaughter of a woman who had 14 children.

Mm-hmm.

And then on and on and on. So it was these weird things that just kind of happened that I now put together that this is now my mission. And they were all a decade apart from each other.

Just telling you something, screaming at your face, like you have to help women as it relates to the healthcare. I mean, gosh, I mean, you and I have been on the same journey of being an endometriosis patient. of learning that we were endometriosis patients, which is a very long journey for most of us in that, in that diagnosis. So.

Yes, no, absolutely. I was told it was unexplained infertility for a very long time. Yeah.

And not until you get opened up, you know, do they say, oh, by the way, this is why there's a whole bunch of problems. And it's, I mean, we'll touch a little bit about that later in the podcast, but let's talk a little bit about this paper that you wrote about clinical trial inclusion of women. And it's that date is so, that's still so shocking to me when we talk about that date of when there was this requirement to include women in clinical trials that we have for years been studying male cells, male animals, men in clinical trials, and that it was not until very, very recently that women were required to be included and that sex is a variable as we do our research studies. Tell me a little bit more about that.

Sure. What's interesting is, let's start with mice first, cuz that's where a lot of the studies happen.

Absolutely.

So, we do know that pain is experienced differently in male mice versus female mice. And that's one of the things we definitely know. And I've actually done a lot of research on this because I do find, because there's so much frustration and there's so much more in social media, et cetera, about this, I feel like people love the one-liners and I love to tend steps down to see what's actually happening.

Right.

And so far the pain part is very clear.

Yeah, it does.

When it comes to some of the others, I haven't, and again, I haven't done like that much more research, but just enough to try to find like, where are some of the obvious understandings from the mice perspective?

Right.

And that's a bit unclear. What I do find is the theme is try harder, don't make assumptions.

Mm-hmm.

About male versus female mice and don't make assumptions about the goals of the clinical trials and what you can or can't do.

Right.

Really try to think of the objectives and figure out ways to ask the right questions to get what you need rather than just making assumptions. And that's the, so far those are the only 2 themes that I've been able to find.

Yeah.

But what does this mean? Somebody be like, who cares? So you can't study the mice.

Why?

Well, well, it turns out Well, because those are the early things that people do study in trials. A lot of it is for safety, et cetera, but it paves the way for what happens after that when you get into first-in-human subjects, et cetera. And we've had a lot of— so, it's not even just the trials, it's the systems built around it. So, to understand the impact, we've had tragedies like the thalidomide tragedy where— these babies were being born with all these birth defects. And I dove into that one.

Yeah.

And it was actually a woman at the US FDA who had said no to thalidomide in the US. But what she said was, we just need better trials. And I think a lot of people have made that into US banned it, and it's been oversimplified.

Yeah.

But there's a whole reason why that happened, which we don't need to dive in here. Generally speaking, like, it was someone who, again, said, yes, this— these children had birth defects. Yes, this was terrible. But she didn't say, therefore, this is bad.

It was— Right.

Let's reassess how we run trials to better understand these things. Then we had with Ambien. This is another interesting case where the news reports say that women need to take half the dose as men, but that was not studied Early on in the clinical trials, this happened in part because people were sleep driving, sleep eating.

Sleep eating.

Yeah. Sex, everything.

Yeah.

Like crazy things that were happening. But what's interesting, when I dug in, it's still unclear to me whether or not it really was a gender difference.

Mm-hmm.

Because there were other complicated things that they needed to look at, but because it wasn't studied, it's unclear.

So the question is—

I mean, I, I Is that really what we need for women? I would love to give you this answer of here's the exact data, but when I dig underneath the headlines, what I'm getting is we just have to design things better. And here's another impact is 74, 75% of the withdrawals from the market for pharmaceutical drugs are because of the women reporting adverse events.

Adverse events. Yeah.

Yeah. So it's, here are just a bunch of examples to say, here's all these little things that keep happening, but it's not like we have this very systematic pathway to make it really clear. So we just don't have the right data to give us the answers that we need to be certain. And let's also add, the FDA just held 2 hearings related to women. One was menopause, and it was more how labeling is done and how the data was misanalyzed 20-plus years ago. And then the last one, which is even more relevant to this, is SSRIs in pregnancy.

Yeah. Very hot, hot topic these days.

Yes. And the, and really what was interesting is because of the way they ran the panel, it was much more around informed consent because a lot of people felt you could spin the data however you want to say the story you want to tell, which also goes to how effectively are the studies done.

Right.

And then there were others who were flat out, do not say women can't take the SSRIs because mental health is really important. You just hear all this buzz right now. I would love us to have this app that just says, I am woman, I am at this age.

Can I?

I am at this stage of my menstrual cycle. And as a result, what is going to happen? And, you know, I'm pregnant, I'm not pregnant. And we can just do this questionnaire.

Do this decision tree. Yeah, absolutely. It, 'cause it gets confusing.

It's confusing. And I wish I could give you a very clear answer, but I haven't seen the data that makes it black and white enough, except to say it's concerning that we're not looking at sex and gender differences.

Yeah. And that it really wasn't a hot topic until of late. Actually, Tulane has Tulane Center of Excellence in Sex-Based Precision Medicine. That's a mouthful, but it's to help advance knowledge of how biological sex modifies biology, disease, and then ergo medicine and being able to think about sex as a biological variable. And I know, I mean, when we think about making streamlined studies and taking out as many variables as we can in the early stages of drug development, I mean, you want to have a nice clean study, you take out as many variables as you can. And so sex is one of those. And so we first study in male mice and then we realize, oh, like we also need to make sure that we can account for if there's any differences in female mice too. And so it's slowly becoming More, I guess, recognized because if you're NIH funded, you basically have to show that in your grant proposals of why you're studying it in only male mice, et cetera. But still with clinical trials, I think that people get really nervous of including women because, oh my gosh, what if they're pregnant? Even though you tell them to be on 2 types of birth control, there's the horrifying thought that you might accidentally give a drug to somebody that is pregnant and then they get some kind of birth defect despite your best intentions. But we still have to power through because that 75% Statistic you said is startling. And if we talk to pharma companies, do you want your product to get pulled off the market just because you didn't take women, half the patient population in the world, into account at the very beginning stages?

Yeah, no, absolutely. And as, as a consultant who's worked for biopharma companies and at biopharma companies, it's complicated. Like, I know that people want to attack pharma. That could be a whole other—

It's a whole other podcast.

I'll just leave it at, it's so complicated and how all of these things are done.

Yeah.

And I really wanna give you a black and white answer, so I'm just—

There's not gonna be. Yeah, it's not going to be. It's complicated. Science, hey, guess what? Science is complicated. I think that wouldn't come to a surprise to any of our listeners.

So, but complicated should— Well, because it's complicated does not mean don't try harder.

Don't try harder. No, absolutely. Because I mean, let's be frank. I mean, that's, you're cutting out half of, you know, the world population. And as you think about your business and your market potential of your drugs, so you might wanna take that into consideration. As you said, it's complicated. And that's where I think it gets really hard for women as patients trying to navigate all of that. So let's talk a little bit about Fempower Health and how, how you built this platform where you're bringing the evidence-based information to women, because there's just all kinds— I mean, just, you mentioned the menopause. I mean, HRT, I mean, it's still confusing for me and I'm in the industry of, well, what can I take? And there's probably decades of women that didn't get the care that they needed because of the confusing information out there. So talk to me about Fempower Health.

Sure. Thank you. What I do is I interview leading experts around the world on various women's health topics. And obviously because of my own journey, I started out with fertility, but what I learned through those interviews is, wow, there are so many true experts in women's health, but we find them As the 10th doctor, like I did with my journey.

Right.

And so my whole philosophy as I started these interviews and had my own journey was, why don't I just find that 10th doctor for everything in women's health and just interview them and give everyone access to that expert?

Yeah.

Via what they have to say. And then let's have the women advocate for themselves.

Yeah.

And so that was kind of the premise of how this started. And it's been such a journey because I see just how interconnected things are. So I'll give you an interesting insight. So pelvic health is unbelievably important. And I have done so many interviews on that and anything pelvic pain related, obviously endometriosis.

That's so many different things.

And the thing is, I can cover these topics in so many different ways. And I had one listener send me note and she said, oh my gosh, I found out about you. I binged on your episodes and I now know how to explain to my doctor what is going on with me.

Absolutely.

And now I know what is going on with me because I didn't for a long time and the pieces are clicking.

Yeah.

So like one example, so like the healthcare system and as a consultant, the way I see things is structures and incentives drive behavior. And our healthcare system, like all of that is everything gone wrong. Right. So it makes it really tough for both the doctor and the patient. And so really all the things surrounding the healthcare system are what drives the success of that appointment. Yeah. And so when you think of pelvic health, like pelvic PTs are super specialized in it, right? Yep.

Yep.

And when you think of a hysterectomy, you're going to have a surgeon. So I happened to decide to do interviews on hysterectomy and a pelvic PT had reached out and said, oh, by the way, I'd love to do an interview with you on hysterectomy because they are now the only patients I see because as a pelvic PT.

Yeah.

Because they are not getting the help they need. Like that's how much it's become a big deal.

Yeah.

And so what I help do now because of all the experts I interview and their pillar of expertise is Now, how do these pieces fit together?

Yeah.

And so now what I've transitioned to is less guests, and I'm much more strategic now with the guests, 'cause it's all about the healthcare systems now.

Right.

And I now write in the newsletter to put those pieces together. So now it's like the hysterectomy summary is, if you are getting a hysterectomy, you need to meet with a pelvic PT before. Meet with them after. Oh, and by the way, talk to your doctor and have informed consent around what they're actually removing.

Yeah.

Because yeah, there was a whole New York Times article that women wake up and they're like, I have no idea what was removed.

Yeah. You think it's pretty straightforward. It's not. I mean, did they remove my ovaries? Did they leave them in? I mean, it's not, I mean, there's lots of variations that can occur and absolutely.

But those are the types of things that come up, but they only would come up through these deep experts. And we expect the OB-GYN to know everything. They can't. They can't.

They can't. No. Well, I love the, I mean, first of all, I love the phrase, the 10th doctor. That could almost be the secondary name for Fem Health, for Fem Power Health is the 10th doctor, but it's really telling of the different sort of Checklist you can provide women of just the verbiage to use with their doctor, because I think we all are aware that women get dismissed quite a bit in the medical field, but even well-intentioned, intelligent women, their understanding of the medical, the field. I myself, so my own doctor, Harvard-trained physician woman said, are your periods normal? And I said, yes. Well, I didn't know what normal meant. So those getting more specific and making sure that when you ask those questions, You ask them differently, or that you as the patient make sure that you have the information to say, I think they are, but here's what I'm experiencing. And is that—

Exactly.

Yeah. How do you know? And so I think it's really great to have that information for women and giving them the power to go into a doctor's office and ask the hard questions.

Absolutely. And I don't think women realize that they can. I don't think any patient necessarily realizes that they can. What I find, it's usually the people who've been struggling for a while. If they're kind of like, oh yeah, oh no, I'm coming in and I am managing this appointment.

Right. Yeah.

Yeah. Like when you're early on, it's just like, what, you know?

Yeah.

Yeah.

You get, you see that white coat and you kind of freeze sometimes and, you know, you think you go, I have to write down all my questions because you just forget in those moments. And so, especially if you're in a lot of pain and that's something that we should pivot to. I mean, speaking of mice and pain. Female mice experience pain differently, but pain in general, as we talk about women's health, is complicated. It's— let's talk about endometriosis, for example.

Yes.

I mean, you and I both have had endometriosis. We didn't find out for many, many years in our journey that we had endometriosis, but there's a lot of struggle to come up with new treatments for endometriosis. Usually it's surgery or birth control. Or some type of treatment that, I mean, your choices are trick your body into thinking you're pregnant, trick your body into thinking you're in menopause, and those are your choices.

Right.

And the endpoint for clinical trials right now is pain. And that's complicated. It's one, it's a subjective measurement. Let's be clear. I mean, what's painful to someone may be excruciating to others and not that big a deal for others. And then in endometriosis, you can have lesions and not have pain, and you can have pain and not have lesions. And so, that's right. Having this endpoint is, is challenging to our entire industry as we think about drug development. And when we look at our mice with endometriosis, we're measuring hot plate tests and tail pinches, and that doesn't really recapitulate the kind of pain that women are experiencing.

No, no, it does not. Not at all.

You and I, I mean, so I'm working on a drug specifically for endometriosis, and there are many of us in the industry that are not okay with this being the endpoint. Let's talk a little bit about sort of like, how can people within the industry or patients Start to affect change? Hey, pain isn't the only thing going on here. Let's think about health differently.

Well, I think from a broader perspective, so there's the broad piece and the very specific DA piece is because we have patients that are struggling to get diagnosed. We have limited doctors that are trained, all these companies. There's not a ton of funding in women's health anyways. And so all the companies are small, trying to get by. Whether it's developing diagnostics or therapeutics.

Yeah.

And it's really, really tough. There are not a lot of expert surgeons, which I think I'd mentioned. And so I actually put my consulting hat on because of all these interviews I've done. I thought, could we do something for women's health? No, I think we need to do disease-specific, make it a proof point, and then see if we can broaden it to women's health.

Yeah.

So I've started an endometriosis working group, which is how you and I had met.

Yeah.

And right now what I'm doing is gathering intel from whether it's patient advocates, venture capitalists that are interested in endometriosis. I'm actually talking to the World Endometriosis Society. So if it's a surgeon, you name it, I want to hear from them. It's a 5-minute survey.

Yeah.

Because I wanna understand the landscape because I believe I have hypotheses over the different things we can do.

Yeah.

Where we can help all of the people working in this space succeed. And it would take it like we did with breast cancer where it went from stigma.

Yeah.

To a movement. Yeah. We need that with endo. We need so much, much more structure. Yeah. And until we have that, I think it's going to be a slog. And it is. We just really need to know who everyone is.

So that's like the big step one. Yeah.

Yes.

Yes. Who's out there? And we'll put a link in our show notes to that survey if you're—

please.

Oh, wonderful. We'd love to put that out there for our listeners. Whether you're in the industry or you're a patient or you know someone who's a patient, getting this information is really the first step. Well, and so one thing that we're going to do as a takeaway from our many conversations as it relates to endometriosis is a coalition of the willing as we start trying to find ways to work with the FDA and helping change that endpoint as it relates to endometriosis and making it not so black and white. It's pain or nothing. It begins with that information that you're talking about with your survey of who else is out there and being able to share our journey and put that story together for the FDA.

Yep. No, absolutely. Absolutely. And it's been great getting to know you through this process. And this is why it's so cool doing this working group, cuz this is the stuff I get to learn about.

And you realize that you're not alone.

Yes.

That there's so many other women out there.

Oh my gosh.

Exactly.

And that 1 in 10 is probably just the tip of the iceberg as we think about the market. Well, we talked about a couple things as it relates to women in clinical trials. We talked about the inclusion of them in clinical trials, but, and we talked a little bit about the clinical trials of women-specific diseases like endometriosis and menopause. But let's talk about the reality as it relates to women in clinical trials, and that a lot of diseases, especially as we talk about inflammatory diseases, neurodegenerative diseases, they disproportionately impact women. So when we talk about like MS, women are 3 to 4 times more likely to get MS than men. So if you're not including women in those trials, you're Cutting out a big proportion of your patient, i.e., your consumer customer. So talk to me a little bit about that.

Sure. Well, there's all these reports now, McKinsey, the World Economic Forum, et cetera, and they've been finally changing the way we talk about women's health, 'cause it really should be the health of women. There are diseases that impact women differently, disproportionately, and uniquely. And I think a lot of people, when they think women's health, They think of diseases that impact women uniquely.

Yeah.

And we really need to look at it from that perspective. And if you think about it from all the way from R&D to commercialization, it makes sense to do that. And I know it may be harder in the beginning, but the commercial teams will really be struggling— Down the road.

Yeah.

—to use that data, right? And like Alzheimer's disease, for example, Affects mostly women, right?

Yeah.

But my understanding is a lot of the trials have not been done on women.

Right.

And we're also having trials not succeed, right? So there really is a big impact. And I think people, like I said before, it's just asking the right questions, but looking at things from a different way and clinical trials, they're expensive, time-consuming, but if we don't do the homework upfront, it's more painful down the line. Like we've seen, it's really important to look at it from that perspective.

Yeah, just smart business at the end of the day. And for all of our startup companies out there, be thinking about this early, of sex as a variable and how women are really a different patient population as you start to design your clinical trials. And same thing for large pharma is to really to take that into consideration sooner rather than later, because of that 75% you brought up in the beginning of this episode is a startling number. So. Any last words you'd like to leave us with, Georgie?

I would just say, if you are a woman navigating the system, I hope this helped you understand that you're not alone and it is complicated, but the doctors want you to advocate for yourself and they're working with limited resources and doing the best that they can. And when it comes to venture capital, I would just say this. Clearly, we know that healthcare is a business, but I wouldn't dismiss startups simply because someone doesn't understand the condition, because I bet you, if you're a male VC, if you would go home and talk to your female loved ones, whether it's a spouse, a daughter, you will learn so much. So before you say no, simply because you don't understand, and just make sure that you're saying no because it's not a good business decision for you rather than it's because you don't understand it, because we need those investment dollars.

And if they're looking for resources, they can go to your website and find those KOLs that can help them understand their investment opportunity.

That's right. I would be more than happy to help connect them because if I don't, didn't talk to the KOL, I'll probably know them.

Yeah, that's exactly right. That's, and that's how we met. Well, as always, we'll have Georgie's contact information and a lot of the informational links that we've talked about throughout the show in our show notes. Make sure to check them out. And thank you once again, Thank you so much.

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