Saundra Pelletier is the CEO and founder of Evofem Biosciences. Saundra was diagnosed with stage III breast cancer while her company was conducting phase III clinical trials on Phexxi, a nonhormonal contraceptive gel for women. She describes herself as a mother, daughter, CEO, and trailblazer. She has more than two decades of experience of executive leadership at companies and nonprofits focusing on women’s health.
Listen to the episode to hear Saundra discuss:
- how she led her company without taking a leave of absence while being treated for breast cancer
- how breast cancer changed her
- how Phexxi, a nonhormonal birth control gel, was developed, how it works, and why it's safe for women who’ve been diagnosed with breast cancer
- her advice for women who’ve just been diagnosed with breast cancer
See full product information at Phexxi.com. Do not use if you have a history of repeated urinary tract problems. Side effects include vaginal burning, itching, discharge, genital discomfort, yeast infection, urinary tract infection or bacterial vaginosis. Phexxi does not protect against STIs.
Running time: 47:05
Show Full Transcript
Jamie DePolo: Hello, thanks for listening. Our guest is Evofem Biosciences founder and CEO, Saundra Pelletier. Saundra was diagnosed with stage III breast cancer while her company was conducting phase III clinical trials on Phexxi, a nonhormonal contraceptive gel for women. She describes herself as a mother, daughter, CEO, and trailblazer. She has more than two decades of experience of executive leadership at companies and nonprofits focusing on women’s health.
Saundra joins us today to talk about leading a company while being treated for breast cancer, as well as why a nonhormonal type of birth control, like Phexxi, is needed.
Saundra, welcome to the podcast. It is a pleasure to have you join us.
Saundra Pelletier: Thank you so much for having me.
Jamie DePolo: So, if you are comfortable — I don’t want you to talk about anything you’re not comfortable with — but if you’re comfortable, could you share the details, or some of the details, of your diagnosis and treatment? Like, did you find the lump yourself? Was it found by a screening mammogram? What were the characteristics of the cancer and your treatment?
Saundra Pelletier: Yes. No. I’m very happy to, by the way. And so, I’ve been in women’s health my whole career, so I might be too comfortable. So say, “TMI, Saundra. Stop it. We don’t need to know about that!”
For me — I’m sure for everyone — the shock was so significant because I have no family history of breast cancer, I have no genetic predisposition, I had a clean mammogram the year before. And so, I was under the impression that I was in very good physical health. And based on my daily behavior, as well, and how I felt, I thought everything was fine. However, my whole life I have always consistently been told I had fibrocystic breasts. Every time I go: I have fibrocystic breasts, I have fibrocystic breasts. And so, anytime I did my own breast exams I couldn’t really tell, because I had fibrocystic breasts. So, I didn’t know what was going on in there, and every time I went, I had a clean mammogram. So, I assumed, “Well, I don’t know, I guess I’m fine.” The short answer is, I did not find it myself.
And I started having vaginal bleeding for no reason, and after my son was born — I have one child — I had an endometrial ablation because I had such severe and heavy bleeding — always, my whole life — with my periods. So, I hadn’t had a period in ten years. So, to all of the sudden vaginally bleed, it was very rare and unusual. So, when I went in to be examined, my OB/GYN said, “We should just test everything. You know what, let’s just test it all. Let’s go in and have your mammogram early.” I wasn’t supposed to have a mammogram for three more months. So, I went in, and I said to the woman, “I have fibrocystic breasts. Don’t worry, I’m sure you’re going to think you see things and there’s probably nothing there; I have fibrocystic breasts.”
And so, that’s how it was determined. I got a call and they said, “Even though we know you have fibrocystic breasts, we think there’s something more than that, and you need to have a biopsy.” And when I went in for my biopsy, the behavior of the doctor doing the biopsy, and the nurse, was very unusual. They behaved in a way that made me nervous. It was almost like they knew something that they thought they shouldn’t say at that point. And then finally when I got the call — I really did this, because I’ve been in healthcare my whole life and I know that there are honest mistakes that happen all the time; there’s lots of paperwork, there’s lots of mix-ups. And when my doctor called and said, “You need to take care of this immediately. You have aggressive, we think late-stage cancer, we want you to know that we need you to make appointments immediately.” And as she started talking, and as I was no longer listening because my mind was going, “waahwaahwaah!” I said, “Hold on just a second. I promise you that I won’t tell anybody, but I know that this is one of those times when you’ve mixed up the patient’s charts. And no one needs to know — no one needs to know — but this is not my diagnosis.” And she said to me, in that second, without even missing a beat, “That kind of denial is going to kill you, Saundra.” And I thought — that was like being pistol whipped. I was just like, “Wow.” So, it was very, very shocking.
And then, what immediately followed was 3 weeks later I had a double mastectomy, followed by 6 months of chemo of Cytoxan and Taxotere. And then they said that they were so worried that my cancer was so aggressive that I needed — it was prudent — to have my ovaries and my uterus removed. So, I started my treatment in August. But, I did very aggressively say to my oncologist, “I need to treat this like killing a fly with a sledgehammer. I don’t want to be subtle. I want this to go as fast as possible. I want to be as aggressive as possible. I want to do everything I can at the speed of light. I can take it, I think my body can take it, my mind can take it. And I don’t want to wade into the water — I want to take off all my clothes, I want to dive in nude, off the deep end.” And that’s what we did. And so, it was aggressive, and it was a very condensed time frame because it was aggressive.
I’ll stop being so verbose. But I did get three total opinions before I decided to go forward with my treatment team, and the opinions were unbelievably different. None of them were similar.
Jamie DePolo: Oh, really?
Saundra Pelletier: Well, it was interesting, one group wanted me to start in a clinical study. They thought I should start in a clinical study — that I should participate in a new treatment, maybe this new immunotherapy might be useful, it would shrink my tumor, then I would have surgery after the clinical study. And then I had another doctor say that I should just remove one breast and have reconstruction, and I didn’t need to do anything with the other breast — because as far as they could tell it wasn’t in my lymph node, it hadn’t spread to my other breast. And then finally, I wanted to kill a fly with a sledgehammer, as I said. So, the doctor in the group that I chose to go with said, “Look, we understand that you are very actively engaged in this process, we get that you want to be aggressive.” And I said, “I want to have a double mastectomy. I am not the kind of person that can be thinking about this every minute of every day. In general, that’s what I do, I over analyze and overthink. And I have to believe that I have done everything that I can, and I want a double mastectomy, period.” And she said, “I understand.”
And after my surgery, by the way, my cancer had spread into my right breast. The surgeon did say to me, “Thank goodness you chose a double mastectomy, because otherwise we would be right back here again in short order, because your cancer was in your right breast.” And I kept thinking to myself, “Oh my goodness.” And I just did that because my style in general is, I am: If I love you, I love you, and if I don’t, I don’t, right? I said, “Let’s just skip all the superficial nicety — let’s just get married, let’s go right to intercourse, shall we?” So, I did that with my cancer. But I think about if I hadn’t. And I think about these women who — they haven’t spent their careers in healthcare. They think about things differently. And so — my whole time, and even now, I worry. I worry for other women, because I know that it’s so incredibly hard and there’s so many different opinions — and all smart people, but different opinions, nonetheless.
Jamie DePolo: I’m assuming that the treatment team that did not recommend double mastectomy was not also recommending having your ovaries and uterus removed, too, which could have been an issue. I mean, it sounded like they were just being very conservative and only recommending having a single mastectomy?
Saundra Pelletier: Correct. Absolutely correct. They were conservative all the way around in the entire protocol. Yes. That is definitely a correct assumption.
Jamie DePolo: Okay. And I’m assuming — it sounds like from your treatment — the cancer was triple-negative, is that correct? Meaning, it was hormone-receptor-negative, HER2-negative, or was it positive for something?
Saundra Pelletier: No. It was positive. It was positive.
Jamie DePolo: Oh, so then did you take hormonal therapy after surgery and chemo, then?
Saundra Pelletier: Anti-estrogen. Yes. I’m taking anti-estrogen now, every day, for 10 years. Yes.
Jamie DePolo: Okay. Okay. So, you are on it long term. Okay.
Saundra Pelletier: Yes.
Jamie DePolo: You said you wanted the most aggressive treatment possible, that’s part of your style. Did the fact that you were in these phase III clinical trials with Phexxi at the time and — did anything else play into it besides it being your style?
Saundra Pelletier: Yes. Two things played into it. My whole career, I have been in women’s health. But my whole career, I have been working my way up the corporate ladder to get to a seat that was the final decision-maker. And the reason why: it was not about power, it was about freedom, and change, and benevolence. And, what I mean by that is, I don’t think, “Oh, I’m such a good person, I’m holier than thou.” It’s because I have been in male-dominated environments in corporate America my whole life, and I did not feel that women got a fair shake. I didn’t feel that equality existed. I didn’t feel that we met women where they were. I know that when you give women a chance to run their personal life, their families, and their kids, and you throw them a bone, they will work harder and longer for you all night, all weekend. I wanted to be the CEO so that I could make better emotionally intelligent, emotionally centered corporate culture changes. And the only way you can do that, by the way, is when you’re the boss.
And so, my whole life I worked to get to this spot. I’m not just running the company, but running a company for and about women. And a company that was about to bring, in my opinion, the biggest innovation in this contraceptive category in decades. And then as crazy as this is, I have to tell you — I mean, Jamie, imagine this — that I end up being the CEO that’s bringing the only nonhormonal birth control to the market! And when women have cancer, most times they can never use a hormone again. And the serendipity, the craziness of that! And you know what I felt like? Is that sometimes what you chose, chooses you.
And I was at this place where... I met this doctor who said to me that when men go in for treatment for prostate cancer, one of the things they very first ask is how is it going to impact their sexuality and their intimacy with their partner. And this woman oncologist said to me, “Can you imagine if a woman being treated for breast cancer said, ‘Now, how are these treatments going to affect my sexuality?’ We would think, what is wrong with her? She should be worried about saving her life. What is she, some promiscuous woman who, like, goes out on the town every day?” So, there’s still an inequality even in the way we treat cancer patients.
So, I thought what women want — or what I wanted after conquering cancer — was, I wanted my life back. I loved the life that I had, and I wanted it back. And for some women, maybe that includes having an intimacy with their partner — maybe it doesn’t — but if it does, think about this. I talked to another woman, and she said it’s like the Sahara desert, right? You’re just dry, everywhere. And vaginal dryness, and bleeding, and pain with intercourse is real. And our product, by the way, is lubricating — and it is a gel that has no hormones. And I thought, “Wow.” So, yes, I wanted to kill a fly with a sledgehammer because it’s my style, but I wanted to get back to running this company.
And the other thing that was even more important than that is that I’m a single mother of a boy who is 14. And, even though I’m friends with his dad and my ex, friends is one thing. Him being the raiser of my son — yeah, not so much. So, I knew I’m trying to raise a feminist and a gentleman. And I’m convinced that no one can do that better than me, and I need to be around to do it. And you know, he’s special sauce. So anyway, it was for him, and it was for this love of this company I have.
Jamie DePolo: Okay. I do want to ask you more detailed questions about Phexxi later, but I’m curious, do you think breast cancer changed you at all?
Saundra Pelletier: It forever changed me. It has forever changed me because I now take the shortest distance between A and B. I always feel like I’m out of time. I used to be long-term, and strategic, and look around the corner. And I used to plan out 3-, and 4-, and 5-year strategic plans, and now I’ve thrown that all out the window. If it’s going to be done, why not do it now? If we want to go, why don’t we go now? We want to go on that trip, why don’t we just take it? So, it’s made me — I’ve never been impulsive, I’ve always been a little bit too responsible, which is a little boring. And now I’m less responsible, meaning I do a lot more fun things, and I do them a lot more often.
But I also am much more straight with people. I’ve always believed in direct communication, but I now say exactly what I mean. All the time. You never have to guess what I’m thinking. And it’s not to be kind or unkind, frankly, it’s just to be candid, and truthful, and authentic. And I’m very decisive now, and I don’t mince my words. And I also, after cancer, decided to get out of a very long-term relationship that I was in that I kept tricking myself to think that it was going to change. And, after cancer, I realized the only way it’s going to change is if I change it and end it.
And so, I did a lot of changing, and I’m a lot happier now. But if I had not had cancer, I wouldn’t have had the courage, I don’t think, to make those kinds of dramatic changes.
Jamie DePolo: Okay. Now, you worked all through this very aggressive treatment, no leave of absence, at your company, Evofem. So, I’m wondering if you could talk a little bit about that. Was it what you expected? I know you were doing these clinical trials, getting ready to launch a product — what did the shareholders think? What did other people in the company think? I mean, did you tell them, how did that play out? Because I know we hear from a lot of our visitors that it’s a struggle to go through treatment and keep up with work — and not all those people that are saying this are CEOs of a company, so, I’ve got to imagine that was kind of tough?
Saundra Pelletier: It was really tough. It was, perhaps, the toughest thing that I have done. And it was the toughest thing that I have done because I had to become an Academy Award-winning actress. And even though I believe in radical transparency, when you’re sick like that, it hurts the heart of people. You can see it on their faces. They feel sorry for you because they’re kind human beings, and I didn’t want that. I didn’t want their pity, and I didn’t want their sadness, and so, you fake it. You fake it.
And I don’t regret faking it, but I faked it. I faked it for my mother. I faked it for my son. I faked it for my team. I faked it for everybody, except for me. And I really would take a couple of showers a day — it was the only time I could actually be at peace by myself with the bathroom door shut, in the shower, and just say, “Wow, I feel really terrible.” And just feel terrible by myself. And then I would get up and purposely shake it off.
And I have to be honest — it wasn’t that I was trying to be super tough, it was that it was easier and better, and it helped the mindset of everybody that I knew I was going to beat cancer. I knew it, and it just helped everybody else believe it, which I do think created a much more positive energy and momentum, frankly.
But the one thing about my staff that I did differently — anything outward-facing, I definitely put on a pretense, no question. However, with my internal staff, I did not. Now, I didn’t say I felt bad, but what I loved is that I called a meeting with everybody — and the lawyers advised me that I shouldn’t tell all the shareholders until I was at my last treatment, because they might worry that things might go wrong, and I should wait until I was done with treatment. But, I brought the whole staff together and I said, “Look, here are the facts, here’s my diagnosis, here’s my treatment, here’s what’s going to happen. I’m staying, I’m coming in, if I can’t handle it, I promise you I will not — I respect and love this company too much — if I can’t do it, I will not do it, I will step aside. But in the interim, we’re not going to talk about it. We’re not giving cancer any of airtime. We’re not discussing it. I don’t want to discuss it with you. I’m going to assume that you care about me, that’s great, but it’s going to be business as usual, and no matter how I look and how I act, we’re going to act like it’s normal.” And everybody said, “Okay.” And I think it took pressure off them, too — do you know what I mean? Like, everybody acted normal. I came in with less and less hair, finally I was bald, you know? I weighed 100 pounds, and everybody acted normal. They were amazing, by the way. Amazing. The people here at Evofem are great. But everybody acted normal, and it made it so much better for me. It was actually — when you can’t look in the mirror, you don’t know. I mean, you’re kind of like, “Ah, I seem fine.”
So, I did tell them the honest truth, but it was hard. What was hard was that I worried that there were hidden and secret perceptions that my weakness was going to bleed into the company’s success and the company’s progress. And, that how could I really be making the right decisions as a leader when I had my mortality in question, and when I must have felt physically bad? And — I really mean what I’m going to say, at the risk of sounding crazy here — I think women carry such an incredible burden, all the time, for their significant others, and their kids, and their parents, and their husband’s parents. I think there are women that every day, don’t have cancer, that feel as much pressure and feel as bad as I did in the throes of it. And I kind of really thought to myself, “You know what, there’s a lot women that go through stuff just as bad, if not worse, and they hold the nerve, and nobody even knows because they don’t lose all their hair and lose a hundred pounds.” And, you know, that made it better for me — that I was one of many of these warriors that are women who are badass. Who power through it and just get stuff done. And so, that’s how I didn’t feel sorry for myself. I would say it, “Get over yourself. Don’t cry for me, Argentina, get up, put on your clothes, and go to work!” And I kind of liked that side of myself, do you know what I mean? Like, “Get over yourself honey, a lot of people have had a lot worse situations than you.” And so, it worked for me.
Jamie DePolo: So, that must have taken an incredible amount of strength to do that. Do you think of yourself as a strong person? Like, I’ve talked to other people, and they say, “I didn’t think I was strong and then this happened to me, and somehow, I just found it.” But it kind of goes along with your thought that there are women going through this crazy thing and nobody even knows because they’re just dealing with it.
Saundra Pelletier: I won’t go too far down this, but where I started in life was this place that is literally the furthest point you can fly to from where I live now in the United States. It’s called Caribou, Maine. It’s the northernmost city in the U.S. It’s on the border of New Brunswick, Canada. And I would tell you, I came from a very shockingly meager beginning. And my mother had 12 brothers and sisters, she grew up on a farm with outdoor plumbing. And I was raised — and a lot of people say, “From the School of Hard Knocks.” Well, I want to tell you: It was the School of Hard Knocks. And I always did think I was tough.
I was raised to be tough. I was tough when I was little because I had to be. And tough was my survival mechanism. And tough is what we got me out of Caribou. Very few people left. Very few people moved on. And my mother, without question, would say to me — even when I was young and something would go wrong, I can always remember this — if I was really sad and it was home at night and something happened to me, she would say, “Do you think that they are sitting at home thinking about you?” And I’d say, “No.” “Well, then why are you sitting at home thinking about them? Does that seem like a good use of your time? Well, I don’t think so!” And she’d say, “You have one day, and tomorrow morning you wake up and you shake this off. You have one day to be sad, that’s all, one day.” Can you imagine, you’re five years old, and you think, “What?” So, we only got one day to be sad about whatever it was — you just get one day — and then you got to move on the next day.
And so, I was raised to be tough, and I did think of myself as tough, I did. And the day after my diagnosis, I really did say to myself in the mirror — I looked in the mirror and said to myself, “Cancer, although it does not discriminate — it will knock on any door — it is going to rue the day it knocked on this door. It got lost. It is definitely mistaken, and it definitely knocked on the wrong door. And if anybody’s going down here, it’s cancer. It’s not going to be me.” I really decided right then, and that’s also when I started my aggressive search on everything that I could do to have a good quality of life, both Eastern and Western. I wasn’t just going to do what the doctor said, I was going to do everything, all the time, every day, to do everything that I could in my power to get better.
Jamie DePolo: Okay. Okay. So, I want to switch gears a little bit. I want to ask you about Phexxi now, which I believe was originally called Amphora, if that’s correct?
Saundra Pelletier: Yes.
Jamie DePolo: So, where did the idea for this type of nonhormonal contraceptive gel come from, and how was it developed, how does it work?
Saundra Pelletier: So, originally it was developed by Rush University in Chicago. At the time, when it was developed, which was in the early 80’s, there were a number of academic institutions across the country trying to figure out a way for HIV prevention. That was the original origin of this particular gel.
What Rush University discovered is that the combination of L-Lactic acid — so not lactic acid, L-Lactic acid — citric acid, and potassium bitartrate not only would provide benefit against pregnancy — so contraception — but it also had these microbicidal properties that would help in the prevention of chlamydia, the prevention of gonorrhea, when combined with another product could have HIV prevention, it could look at herpes prevention — HPV. This asset is really extraordinary because you can continue to invest in it, do clinical studies, and lifecycle manage the brand.
But how it works for contraception, and how it works for the investigational study we’re doing for the prevention of chlamydia and gonorrhea, is incredibly simple, actually. So, a normal vaginal pH is 3.5 to 4.5. So, 3.5 to 4.5 is most women. So, what happens when semen enters, that pH goes up to 7 or 8, and you become pregnant. Same thing when chlamydia enters, gonorrhea enters, your pH rises and that’s how you get infected. Well, our product, Phexxi, is acid buffering. So, those three ingredients combined, all it does, quite simply, is help the vagina maintain it’s natural acidic level of 3.5 to 4.5, which makes the sperm immobile, which makes it kill the pathogens for chlamydia and gonorrhea.
Now, however, here’s what’s special and here’s what is the tradeoff. What’s special is that it’s on demand. So, you only use it when you have sex. You put it in right before sex or within an hour, anytime within that hour window — 30 minutes, 40 minutes, 60 minutes, or literally right before sex. The applicator is very simple, small, elegant, discreet. Many women have used tampons — you literally insert the applicator, put in the gel, take the applicator out, throw it away. It takes 10 seconds to put it in. That is the benefit.
When I say that’s the benefit, I say sex on demand. Men have had condoms forever. Men can go out with a condom in their pocket. They can protect themselves from getting a woman pregnant, protect themselves from STDs. Women have been asked, and told, and trained, “You should take a pill every day of every week of every month. Year after year after year after year. You should put an IUD in your uterus. You should have hormones be released in your body synthetically, every day.” You and I, we don’t need contraception right now when we’re talking to each other. So, why do you have to put a synthetic hormone in your body every day? And most women do not have sex every day. Market research says women have sex, on average, twice a week. So, the beauty is that this is on demand, and women have the power of not suffering from hormonal side effects.
However, the tradeoff that I say is that — and I know this is Captain Obvious — but you have to use it for it to work. It’s on demand. So, every time you have sex, you have to use it. And now, I don’t think it’s a tradeoff at all — I think it’s an amazing blessing. I think it’s absolutely wonderful. However, there are some women that say, “I want a fit-and-forget method. I don’t want to think about it.” And I say, “Okay, great. Well, this is not for you. I totally understand, no problem.”
But I can tell you that there’s 23 million women in the U.S. right now that say, “You know what, I’ve tried pills, and patches, and IUDs, and I have suffered, and the suffering is real.” And a lot of women suffer in silence, and they say, “Look, I don’t have hormones in my milk, I don’t have it in my meat, you know? If chickens can be hormone free why can’t I be hormone free?”
So, for me, I think this is the biggest innovation in decades. And I think it’s so empowering that women don’t have to suffer when they don’t even need this to save their life, right? They don’t need contraception to save their life, why would they take it every day?
Jamie DePolo: Do you have to use it before sex, or can you use it right after?
Saundra Pelletier: It has to be used before. So, it’s designed semen-to-product ratio. So, each applicator is 5 mL of product. So, it has to be used before, so then it stops the mobility of the sperm. So, if used after, it won’t be effective. It has to be used right before, within an hour.
Jamie DePolo: Okay. Now, it’s a prescription product, and I’m curious why that is? Because the ingredients — to me, a non-scientist — sound “non-prescription-y,” if I can say that. So, I am curious why it’s prescription?
Saundra Pelletier: Yeah. I agree with you. The ingredients are so safe. So, here’s really why, for two reasons. One, under the Affordable Care Act — ACA, in the United States, when Obamacare was established — what was stated is that one product in every category of contraception would get covered, and women would have zero out-of-pocket pay. Zero. So, being a prescription in the category of contraception meant, “We know we’re getting it for free.” So, over the counter, they would have to pay.
However, let me tell you the dirty little trick that’s happened to us. So, we assumed, because we had brought this incredible innovation to market — particularly for the 800,000 women that get diagnosed with cancer — we assumed that the Office of Women’s Health would definitely give us our own category, and they would do that right out of the gate. Well, it was during COVID. So, they said, “Look, we’ve got COVID. We have too many things on our plate. We can’t worry about this. It’s not like you’re saving lives, so we can’t do this. But we will, we just can’t do it right now.”
Well, our product was approved a year ago. So, now, we’ve activated senators, we’ve activated congresspeople, we’ve activated advocacy groups, we’ve activated Erin Brockovich. Seriously, Erin Brockovich — her daughter is on Phexxi. And we now are saying, “Look, you are preventing vulnerable women from getting access to the only nonhormonal product that they use on demand. This no longer makes sense. Enough of this, right? COVID is dissipating.”
So, it’s prescription because once we get our own category, every woman will get it at zero copay. Right now, only 55% of the women get it because we have only 55% coverage through managed care. However, we do have a patient assistance program that gets women to only pay up to $30. So, we offer that now. But the reason it was prescription is because of the Affordable Care Act.
And the FDA really believed that because it’s on demand… So in the study, one of the number one reasons for failure was a failure to reapply with the second act of sex. So, if women used it at 8 o’clock at night and had sex, they believed, well, they already had some there. So, if they had sex 2 hours later, they didn’t reapply. And just like a condom, every time you have sex, you have to use it. So, they believed — as we agree — that the interface with the doctor would help women understand the protocol: “You have to use it every time. It’s on demand, just like a condom.”
So, that was the other reason why we wanted it to be prescription, at first. Now, do I eventually think it will be over the counter? Yes, I really do. I think it will eventually go to over the counter because it’s so safe, there’s no reason that it shouldn’t. But I do think for the first 3 to 5 years — maybe less than that — but at least 3 or 4 years, it will stay prescription because of that.
Jamie DePolo: Okay. So, it’s interesting to me that the office said, “Well, you’re not saving lives.” Because, as you well know — and we talked about the irony before — anybody who’s been diagnosed with breast cancer is told to use nonhormonal birth control. That could be very detrimental to someone’s life, if they use hormonal birth control and they’ve had breast cancer. That blows my mind, first of all — and I guess I’m wondering — can you confirm, if somebody’s been diagnosed with breast cancer, can you just tell me, this is truly safe?
Saundra Pelletier: Yes. I can tell you it is truly safe. And I can tell you this: we just did a partnership with a group called NCODA. NCODA, their whole purposeful design is to educate pharmacy groups and oncologists on what are the right products that can be used concomitantly with whatever therapy they’re on. Whether they’re in active treatment and chemo, whether they’re on post-treatment medications, right? You want to make sure you can feel good about using something that’s not going to interact with these other medications that these women are on.
And we purposely put together this whole protocol and explanation about why this is the right and the safe product to use for your cancer patients. And so, I feel like you do — and of course you would think I am because I’m the CEO of this company, but as a woman, as a human — I’m confounded that a group called the Office of Women’s Health is not going to give a category. And then I said, “Okay, even if you don’t do it for the other women, do it for the cancer patients, the 800,000 cancer patients.” And then I said, “But then again, if they have daughters, they don’t want their daughters using hormones, either.” It seems so hard to understand that they won’t just do it.
So, we tried the civilized way, by the way, to appeal to them. And now — I’m not going to lie — I said, “Listen, the civilized way is not working. We’re going to have to scream from the rooftops.” That’s why I say we need to get activists, like an Erin Brockovich, because what I’m hoping is that they say, “Okay, fine, fine, white flag — we don’t want to deal with this!” And I think, you know what, that’s what you have to do to get women access, and that’s what we’re going to do. It’s too bad we’ve got to do it, but that’s where we’re at, truthfully.
Jamie DePolo: Okay. Now, we talked a little bit about some of the other things: condoms, diaphragms. What is the effectiveness rate of Phexxi versus some of these other nonhormonal things? And I know, too, like with a diaphragm, you’re always told you should use it with spermicide. Condoms are better if you use them with spermicide. So, how does it rank in terms of effectiveness?
Saundra Pelletier: So, in the clinical study we did because of the FDA, our effectiveness is 93%. However, here’s what I want to say: in the study design that we agreed to with the FDA, when women did not use the product at all, it was counted as a failure. When women used the product after intercourse, it was counted as a failure. So, why I’m saying that is that, that’s why it’s 93%. I believe if we only counted the women who actually used it safely and correctly, our efficacy would be far higher than that. But the way that the protocol’s designed with the FDA, a failure is a failure, regardless.
So, I’m a little bit on a soapbox about that because, it’s that if you use it correctly, the product is going to work. You should not use it after sex, right? So when I say 93%, it’s still amazing because 23 million women are doing nothing. They’re literally not using anything. Now, there is a misnomer, most people think that condoms are 99% effective, when in fact the truth of it is condoms are 85% effective.
And the tough thing about diaphragms — I will be candid — is that I know some people love their diaphragms and I think, “Great!” I really do. I’m an advocate for women taking control of what makes themselves work. However, the tough part is that right now, spermicides on the market all have an ingredient called nonoxynol-9. And that ingredient has a black box warning, and in most of the world it’s banned completely because that ingredient is a detergent. It doesn’t have the same safe ingredients like Phexxi. That detergent tears at the epithelial lining of the vaginal cavity. It’s banned in most of the world because that tearing increases transmission of HIV. Now, some women can tolerate it in the U.S., but over time it thins the vaginal wall, and it increases infection. It’s just not great for women to use that long term, frankly.
So, that’s why we feel so good about Phexxi. If you’re going to use something nonhormonal, one, women don’t control condoms. And most of the women I talk to say that even if they want to, sometimes they don’t win the condom negotiation. And these aren’t kittens, these are powerful women. And women say they don’t really like condoms either, their male partner doesn’t like condoms. And so, the condom part is always tough for me, because it’s not in control of the woman’s hands, you know? That’s why Phexxi, I think, is a much better choice for women, because they’re empowered with their own control.
But to your point — I mean, diaphragms are there and if women want to use them…. But we have found a lot of diaphragm users that have tried Phexxi and have basically said, “This is quicker and easier, and I put a little Phexxi applicator in my purse and I don’t have to walk around with my diaphragm.” And not that these women are ashamed of their diaphragm — they’re not — but it’s just easier and discreet to have a little applicator in their pocket.
Jamie DePolo: Sure. Sure. Well, yeah, and as you said, too, women aren’t in control of condoms and the Phexxi just sounds so much easier, quicker, faster, like, “Oh, let me run out and do this and I’ll be right back.”
Saundra Pelletier: Yeah.
Jamie DePolo: Okay. So, now I want to ask a little bit, too, about the Phexxi preventing chlamydia and gonorrhea. That sounds like a great added feature — like, what other birth control can do that? And I believe I read that the product is being tested for that right now — it’s in trials for that now, is that right?
Saundra Pelletier: It is. So, we’re doing this investigational phase III study, by the way. So, this isn’t a concept — it’s not phase I, it’s not phase II — we are already enrolling patients in a phase III study. Our enrollment will be done at the end of this year, 2021. We will be able to have top-line data to read out in the second quarter of 2022.
And what’s so important is the CDC has said, for the sixth year in a row, both chlamydia and gonorrhea are on the rise. Chlamydia is 1.8 million cases in the U.S., and it’s the number one diagnosed and prescribed infectious disease — not just sexually — infectious disease in the United States. And gonorrhea is antibiotic resistant and there’s 600,000 cases.
We’re the only product that will have the indications for prevention of chlamydia and gonorrhea. So, the FDA gave us a fast-track review, 6-month review. So, instead of 12 months, it will be 6 months. And they’ve given us something called Qualified Infectious Disease Prevention — QIDP — which gives us 5 additional years exclusivity in the marketplace. So, no competitors will be able to come out for 5 additional years.
So, those two indications — I have to tell you — to me, it’s really going to change the quality of life for women. Because when women get infected with chlamydia, 30% of the time it recurs. And if it’s not treated, it causes a lot of issues. I mean, it can cause pelvic inflammatory disease. It can eventually cause infertility. They’re serious.
So, we’re excited that we’re doing — and no other company is doing this. Because, truthfully, for some big pharma companies, a billion-dollar opportunity isn’t even that big — as crazy as that sounds — it’s really not that big, you know? For us, it’s incredible because we want to be the company that says, “Innovation matters.” And it’s not just that women are half of this population, it’s that women are the access for all of these humans. We make the world go round, with men, with children, and everybody in our life. Why shouldn’t we have innovation? So, that’s why I’m excited to be part of this.
Jamie DePolo: That’s pretty amazing. Thank you, so much, for sharing all this. I guess to wrap up, my last question is: Do you have any advice for women who’ve just been diagnosed with breast cancer, and they’re worried about their jobs, their loved ones, their lives? What would you say to them?
Saundra Pelletier: I would say, it’s a moment in time when you look inside of your core and really get comfortable with your core values. And your core values, not obvious things — my family, my God, my health — the un-obvious core values that are: Why do I matter on the planet? Why, really? What are the contributions that I need to make, whether it is as a caregiver, whether it’s as a contributor to your community, to your kids? But really, take the moment to say, “I need to become a priority on my own priority list. I need to put myself first because it’s not selfish, because when I put myself first, everybody else benefits.”
And when you get that diagnosis, I believe it’s an opportunity to put yourself first and to know that you’ve got to invest in yourself in a way that many women have never done. And there are only two things that we can control: What we feed our mind, and what we feed our body. So, it’s either garbage in and garbage out, or it’s amazing aspirational in and amazing aspirational out.
And it has to not just be feeding yourself well and walking to be healthy, it has to be the rhetoric you feed your brain. It has to be your ability to really challenge all the negativity that society says, the odds that people put on your survival and your ability to beat it — even the doctors. You have to get square with your own head — however powerful you think you are, or strong you think you are, or however un-powerful or not strong you think are — that you have to sit down with yourself and say, “Look, I owe it to this vessel that I’ve been given on this planet to do everything I can to fight because I’m worth it.” It is the one chance for women to really love themselves in ways that... we always put ourselves second, right? We’re raised to be pleasers, and mediators, and martyrs, and so, one: It’s that personal justification to put yourself first, and it’s so hard for women to do it.
But from a job standpoint, the one thing that I would encourage women to do — and I think a lot of people don’t agree with me; in fact, I know a lot of people don’t agree with me. I was radically transparent and direct with my chairman right away, out of the gate, and I told him everything. Everything. Instead of hiding it, and instead of waiting, instead of worrying, and instead of thinking, “Oh my goodness, what’s going to happen? What’s going to happen?” I eliminated all of that. I didn’t want any negative worrying, right? I already had enough negative cells and energy in my body because of cancer. So, I literally called him up and said, “I need to meet with you in person. I’ve been diagnosed with cancer. Here’s what’s happening, here’s my treatment.” And I was very business-like. Now, I was sad, but I was very business-like. “I’ve identified I’m going to get three opinions, I’m going to choose the right opinion for me, I’m going to fight this, I’m going to get to the other side, I intend to continue working, I may need to adjust my schedule, I’d like to know that you have my back.”
And I can tell you, it’s really hard for people. When you’re telling them you’ve got this diagnosis and you say, “I’d like to know you have my back,” what kind of a monster is going to say, “Well, I’m not so sure that I do.” If you make them part of the solution, you make them part of the equation, you make them part of your team and your tribe — even if, by the way, you never would do that otherwise, and you don’t even think they want to be in your tribe or your team — humanity prevails and you should use it to your advantage. And you should tell them everything and make them stand up and be good human beings, because 99% of the time it works.
Now, there may be some women — which is unfortunate, and we should make a voodoo doll of their bosses — and their boss isn’t a human that’s going to get behind them. But I believe being unbelievably candid and transparent, and say all of it — right down to once you know the medication, “Here’s the chemo that I’m on.” And by the way, they probably don’t want to know that, but you tell them anyway because then you’re eliminating all of that doubt and all of those secrets. It’s so much better because then you’ve unburdened yourself and you can worry about fighting cancer, not about what you’re worrying about what they’re thinking, right? I just think it was the best approach, and the women who I’ve known who have done it, they’ve unburdened themselves from this secret, and it seems to be better.
Jamie DePolo: I personally agree with you, because I think otherwise it just leaves all this opportunity for people to imagine things.
Saundra Pelletier: Yes.
Jamie DePolo: They can imagine what’s going on with you, and in most cases it’s wrong and it’s much worse than reality. So, I think that’s brilliant. Yeah.
Saundra, thank you, so much. I really appreciate your time, your insights, your outlook. I wish you much success with this, because I believe something like this has been needed on the market for a long time.
Saundra Pelletier: Thank you. Thank you for having me. It’s been really lovely. I really appreciate the opportunity.
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