October 1, 2024 • 41 mins
What is the vaginal microbiome, and why is it crucial for women's health? How does bacterial vaginosis (BV) and its treatments impact women's lives? Dr. Craig Cohen, a leading expert in obstetrics, gynecology, and reproductive sciences at UCSF, explains the importance of the vaginal microbiome and its role in women's health. Drawing from years of experience and extensive research, including his work in Kenya, Dr. Cohen discusses the challenges of treating BV, the necessity of innovative treatments like live biotherapeutics, and the urgent need for better diagnostics and widespread education. He emphasizes the importance of advocacy for research and funding to improve women's reproductive health outcomes.
Check out the shownotes to learn more!
Takeaways:
- Understanding the vaginal microbiome is essential for women's reproductive and overall health.
- Bacterial vaginosis (BV) is a common condition that many women may not be aware of.
- BV can increase the risk of preterm birth, HIV, and other sexually transmitted infections.
- Proper education and awareness about BV can help women take proactive steps for their health.
- Routine testing for the vaginal microbiome is not standard but can be requested from healthcare providers.
- Advocacy for better diagnostics and treatments for BV is crucial to improve women's health outcomes.
- The vaginal microbiome plays a significant role in maintaining optimal health and preventing infections.
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A huge thank you to Evvy for sponsoring this episode! Evvy is a women's health company that is unlocking precision healthcare for women & people with vaginas. Their mission is to close the gender health gap by discovering and leveraging overlooked female biomarkers — starting with the vaginal microbiome. Learn more about them at Evvy.com.
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Episode Transcript
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(00:02):
If you have a vagina, here's aquestion for you. Do you really know
what's going on down there? I'm serious.
As a woman with a vagina, I didn't
know what the vaginal microbiome
was. Ididn't know that not all bacteria
is badbacteria, and that there's a possibility
that some women may be living with
bacterial vaginosis and not even
know it. Hey, and welcome back to
another episode of global health
Pursuit, a podcast for beginner learners,
seasoned public health professionals,
and fanswho just love hearing inspiring stories
from leaders working to make the
world a better place. I'm Heddal
Bahman. I'm a social entrepreneur,
storyteller, and your host. Today,
we're talking about vaginas, how
itcan affect your health and even mental
wellbeing, with doctor Craig Cohen,
professor of obstetrics, gynecology,
andreproductive sciences at the University
ofCalifornia, San Francisco. Make sure
you're subscribed to the podcast,
leavea five star review, and share this
episode with someone who might find
it valuable. Your support helps me
keep this one woman show going and
makes it 1% better every single day.
This episode is proudly supported
byEvie, a women's health company that
is unlocking precision healthcare
forwomen and people with vaginas. Their
mission is to close the gender health
gap by discovering and leveraging
overlooked female biomarkers, starting
with the vaginal microbiome. Learn
more about evvy by clicking the link
in the description or visiting them
on the web@evvy.com. that's e v y.com
dot doctor Cohen, thank you so much
for being here. You know, this conversation
is something that kind of opened
myeyes up. I didn't know about any
ofthis before even reading the articles
that you wrote, as well as the articles
on resolve. So I'm very excited to
be here. Welcome.
(02:03):
Thank you, Hetal It a pleasure to be here and have this
opportunity to have this conversation,
because I think that's one of the
issues, is we need more women to
understand what the vaginal microbiome
is,why it's important for them and their
health, their partners, their children,
and just the way of life.
(02:23):
You know, you spent so much ofyour career studying bacterial vaginosis
and just, you know, the vaginal microbiome
in general. What drew you to this
field?
Yeah. Yeah, the interestingquestion, I mean, I can think back
to during my training in residency,
when Ispent my first year of residency
at theUniversity of Washington. Later on,
did my fellowship there as well.
Iremember specifically, Doctor David
Eschenbach, who later on became the
chair of the department at the University
of Washington. I remember him helping
me as an intern to take care of one
of my earliest patients who complained
ofa vaginal discharge and really just
took me through step by step, like
going what sort of questions to ask
her, and then the laboratory evaluation
with the microscopy and so forth,
andthen the treatment. And the reason
Ibring up David Eschewak is he's one
of the leaders of this field. If
you take a look at some of the earliest
publications on BV, a lot of them
emanate come from the University
ofWashington. King HolMes, David Eshvak,
two of my really amazing mentors
duringthat earlier period of my life. It
really, it came about through my
taking care of women, seeing that
the treatment that we had was okay
for getting rid of symptoms initially,
butthat the majority, in the majority
ofthese cases, women would start complaining.
They'd come back and say, Doctor
Cohen, you know, I have these symptoms
again, what can you do? And essentially
Iwould re prescribe antibiotics. And
that was just not feeling good. But
in addition, it came about as I became
interested in helping women to prevent
them from becoming infected by HIV,
but also those who are living with
HIV to improve their quality of their
lives. And that came about through
mywork, predominantly working in Kenya.
I've now worked there for almost
30years. But in doing that, understanding
theassociations of the vaginal microbiome
andHIV, preterm birth and many other
problems that can emanate from having
Bv.
(04:45):
Right. So I want to start offvery, very beginner. I guess my question
is, what is the vaginal microbiome
like?What does that mean? Like, what is
a microbiome first?
Yeah, I think there'sincreasing over the last decade or
so, been a lot in the media about
themicrobiome, mostly focused on the
gut microbiome, because it's probably
the microbiome that the scientific
community, medical community knows
most about, but also because we kind
of know how to manipulate it. But
there's been an increasing interest
justin understanding that human beings,
we're not just who we are like those
walking around, but we harbor, you
know, trillions of microbes, whether
itbe on our skin, I mean, throughout
most,not the entire body. I joke around
sometimes. I say, you know, you think
about, you know, why do human beings
exist? And you could say we, you
know, we essentially we co evolved
withthese microbes, right? But you could
say maybe we exist as an opportunity
forthe microbes to be able to live,
youknow, you can flip it, right? Instead
of being human centric, you can think
of it, you know, micro centric. And
also it's important to understand
thatthese microbial communities, that
they truly are communities, right?
Sowe talk, commonly thinks, I think
people talk about bacteria and they
say, oh, I don't want bacterial infection.
But the reality is there are bacteria
that help us to stay healthy, and
we in turn actually provide the bacteria
nutrients that keep them healthy.
We arepart of that community, if that makes
sense. Now, in the vagina, women
haveco evolved with the microbial community
that we think of as optimal, which
predominantly are dominated by a
certain species of bacteria called
lactobacillus. These aren't the lactobacillus
that you find in your yogurt. So
just to dispel that there are four
dominant lactobacilli species, probably
one is the best of the bunch, called
lactobacillus crispatus. Interestingly,
to myknowledge, humans are the only species
that have a vaginal microbe that's
dominated by lactobacillus. So the
other animals have vaginal microbiome,
butthey're distinct from the human vaginal
microbiome.
(07:22):
Okay.
The human reproductive tractis relatively unique, even amongst
primates, although there are primates
that have some similarities to the
estrus cycle, the monthly cycle that
women have. But there are unique
aspects to it. So it's so interesting
thatthese bacteria, these optimal vaginal
microbiome, they really have co evolved
with us and essentially have supported
health and well being and reproduction
andbirth. Right? I mean, that's a lot
of responsibility for these microbes.
Thefocus, a lot of my work is I try
tostay away from the word healthy and
use the word optimal. It's maybe
semantics, but not everyone, and
that's what we'll start talking about.
Bacterial vaginosis or vaginal dysbiosis,
essentially an aberration of the
vaginal microbiome. Not everybody
hasthat lactam cells, crispatus. And
so that's part of what our work is
about, is can we then help those
women to move their microbiome to
a more optimal vaginal microbiome?
(08:29):
So what would an optimalmicrobiome look.
Like dominated by one of thefour species of lactobacillus crispatus,
lactobacillus crispatus, lactobacillus
gasri,lactobilis jansenii. And then there's
another lactobacillus that's much,
much less common, like one or 2%
those lactobacilli an optimal vaginal
microbiome comprise of 90% of the
bacteria within the vagina. Still,
they're living within community.
They'renot living by themselves. There are
other bacteria that will be part
ofthat community, and it's thought
thatthose other bacteria, in many cases,
are supporting that community. The
lactillus are supporting the other
bacteria, and those other bacteria
mostlikely are providing nutrients which
are required for the lactobacillus
to be ableto survive and sustain in the vagina
long term. Also, if you think about
it, think about what these lactobacillus
aregoing through. Okay. You think of
the vagina. Our dinner table, by
the way. So I have teenage kids.
Actually, my daughter just turned
20.She's not a teenager any younger.
But wetalk about the vagina. We talk about
the microbiome. We talk all these
things all the time.
(09:44):
So I hope it's not like you, dad.
Absolutely not. In fact, mydaughter has educated her friends
alot. Yeah. Like the hpv vaccine,
forexample. It's a painful vaccine,
and shegot it, and she told her friend,
butmost people don't understand, like,
why do you need this vaccine? Educated
all of her friends in middle school,
and they all got it anyway, so.
(10:11):
Wow. In middle school, too.That's great. That's impressive.
Yeah. Middle school. Thevaginal microbiome. Oh, so think
about the vagina. Right? Okay. But
think of everything that the. I mean,
think about what the vagina encounters,
right? So, I mean, there's. For women
who are menstruating, there's the
menstrual cycle, right? So here,
oncea month, here comes the blood, which
obviously, we know changes the microbiome.
So at least transiently, the lactobacillus
usually decline and other bacteria
canincrease. And, in fact, when women
develop BV, it's a very common time
for them to develop. Bacterial vaginosis
is immediately after menses. So that's
something that the microbiome has
had to adjust to over time. Then
there's pregnancy. Right? And then
there's sexual intercourse as well,
and exposure to semen. Right. And
then there are other conditions that
can happen, sexually transmitted
infectionsand yeast infection and those sorts
of things as well, which the microbiome
has to contend with if it wants to
sustain itself long term, which is
usually the goal, at least, the optimal
vaginal microbiome. But oftentimes,
theseperturbations, these changes will
alter the microbiome and the lactobacillus.
Wedon't know what comes first. Do the
lactobacillus decrease and then allow
the other bacteria to then increase,
especially those associated with
bacterial vaginosis. And or is there
an exposure to this microbiome, which
is suboptimal, which then essentially
killsoff or dominates the lactobacillus?
It'sprobably both that happen, and there's
some other possibilities that may
be causing this change from optimal
tosuboptimal vaginal microbiome.
(12:07):
Okay, so what I'm hearing isthat there can be multiple ways of
a woman getting bacterial vaginosis,
right?
So, that's right. So we thinkof sexually associated causes and
non sexually associated causes. So
it's not technically a sex transmitted
infection, but it's definitely associated
with sex. Does that make sense?
(12:39):
Say more.
Okay, so, for example, therehave been studies that have shown
that among women who have sex with
women, that if one of the partners
hasBV and they share sexual toys, so
essentially they're sharing the bacteria
from one person's vagina to another,
that it's highly likely that if the
initial woman partner had Bv, that
the penis can also be a way of sharing
bacteria between vaginas. A male
partner with more than one partner
canshare the bacteria from one woman
with another. Okay, so that's a sexually
transmitted element to it. We know
that there are other factors that
also put a woman at risk of developing
BV,certainly multiple sexual partners
notusing a condom, those sorts of sexual
aspects. And then there are also
associations with hormonal contraception.
Sothe non sexual transmitted elements
thatalso increase a woman's risk. Menstruation,
as I mentioned earlier, also puts
alot of women at risk. For example,
acolleague of mine has recently completed
some really interesting work among
teenagers in Kenya. Her name's Supriya
Mehta. She's at Rush University.
So she'sdone a very interesting study among
teenagers in western Kenya using
themenstrual cup during menstruation,
and hasdemonstrated that. So, essentially,
catchingall the blood at the cervix, not
allowing very little of it, then
goes to the vagina and demonstrating
thatthose young women, those teenagers
whoare using the menstrual cup, have
asignificantly lower chance of developing
BVD. Super interesting. So it's not
related to sex, it's related to menstruation.
Right. So there are other factors
thatare associated with having the abnormal
vaginal discharge and microbiome.
(14:42):
So how does this show upwomen? Like, what are the first symptoms
that somebody might show and say,
okay, this is not normal?
Yeah. So the majority of womenwho have BV are asymptomatic. They
don't complain of symptoms. Okay,
now, if you do a detan, you know,
forthose women who do have BV. Don't
have. Are not complaining. Remember,
I'musing the word complaining of symptoms
because you may have something for
your whole life, but you think of
it as normal. You're not gonna complain
about it, right? Because everybody
hasit. And this is really an important
pointbecause. And this is also an interesting
point for your listeners, is that
BeV affects women of color in the
US much more likely than women who
identify as white. And it's also
much more common among women in sub
saharan Africa as well. It's probably
acombination of genetics, behavior,
andbehavior around menstrual hygiene
andgenital hygiene practices. So, for
example, douching or use of products
inone's vagina is a significant risk
factor. So I want your listeners
to know,do not douche. But a lot of times,
women are trying to dress. They have
a discharge that is smelly. It's
bothersome, it's embarrassing. And
so they'll go. They don't know what
to do. Maybe they've gone to the
doctor, and then they get the smell
back again. And so then they go to
the drugstore, and they see these
femme fresh, all the names of these
various products. Women spend billions
of dollars a year on these products.
Soit could be due to different genital
hygiene practices between different
ethnic and racial groups as well.
Butimagine in some communities, like
inAfrica, 35% to 50% of women can have
BV. Okay? So imagine you have it.
Your older sister has it, your mother
has it, and you've had this discharge
ever since soon after you went through
puberty. And you've had this right
almost the entire time. So it's not
something that you see as abnormal.
It'spart of what you think of as normal.
But you're not aware that it's not.
It's not optimal for you or your
family members or your friends. So
a lot of women don't complain. But
if they do have complaints, the most
common complaint is having abnormal
discharge. It can be gray or white.
It's usually thin, and then it has,
like, a. It can also oftentimes have
a fishy smell. And oftentimes, this
fishy smell is most pronounced if
a woman is having sex and has exposure
to semen immediately after ejaculation.
Ifthe discharge can have a real malodorous
smell, very fishy smell. So that's
usually the most common. It can also
be associated with general itching
andburning sensation as well. But the
majority of individuals who have
BV,majority of women have BVD, don't
have any symptoms.
(18:00):
So I could have it and Iwouldn't even know. Wow.
(19:36):
You wouldn't know. And why. Sowhy is that important? I think it's
truly important. In fact, I wouldn't
be.I would be doing this work, but not
with the same urgency, if it wasn't
for these. That bvs associated with
poor reproductive health outcomes.
Right.So if a woman has BV, she's more
likely to have a preterm delivery.
If shehas BV, she's more likely. If she's
exposed to HIV, she's more likely
tobecome HIV infected. And if she's
living with HIV, she's more likely
totransmit HIV to an uninfected partner,
and she's also more likely to be
infected by other sexually transmitted
infections like Goddarin, chlamydia
andherpes. So there are many reasons
whythere's a real need, I believe, I
think an urgency to help women to
understand the importance of knowing
about their vaginal microbiome. We
haven't talked about testing much
yet, but knowing about the vaginal
microbiome and then working with
their medical professionals to work
towards optimizing the vaginal microbiome.
And then a lot of my work is the
research to develop new products
thatcan help women to optimize a vaginal
microbiome and that we call the field
called live by therapeutics. It's
separate from probiotics. It's similar,
but separate. Probiotics are usually
comprised of bacteria, but they can't
have any medical claims because they
have not been rigorously tested in
clinical trials. Live by therapeutics,
essentially are bacteria as well,
butare going through very rigorous testing,
both for how well they work to prevent
the recurrence of bacterial vaginosis
andalso safety, which is of utmost importance,
too.
(21:36):
So now I want to go into thetesting part, right? So when we go
to see our Ob Gyn for our annual
checkup and all of that, is that
included in the annual checkup? Like,
what do we have to ask for that?
Orwhat does that look like? I mean,
weusually just, like, we just go and
trust our physician and then, okay,
we're good, and then we just move
on. Right.
(22:08):
So usually most of thatcheckup with your gynecologist or
primary care physician or provider
isgoing to be symptoms based. Right?
Soif you don't complain of a vaginal
discharge, the clinician is probably
notgoing to look now, if, when your
clinician does an exam and sees copious
discharge that has a smell, they
maytake some swabs and do a test, which
would help to identify if you have
BV or yeast or whatever, even if
you don't have complaints. Again,
based on what I told you earlier,
someone may not complain of things
because they don't see it as not
being normal, because they've had
it most of their life since puberty.
So,yeah, this is a kind of interesting
area.So it's really been symptoms based.
The other part is, and this is a
little technical, but I hope your
listeners will understand, the treatments
are good. The antibiotics usually
usemetronidazole, also known as flag
orclindamycin. They're good at taking
care of reducing symptoms initially.
Firstmonth or so, they're relatively good.
Anywhere from 70% to 90% of women
will have a cure. Up to 70% to 80%
of women will have a recurrence within
a year. So the treatments are not
great. Right. So you can get rid
ofyour symptoms initially. That's good,
but it's a high likelihood that this
is going to come back. The reason
isthat the antibiotics are decreasing
thebacteria that are causing the BV.
But remember, I told you about the
lactobacillus species, it's not bringing
back the optimal vaginal microbiome.
Andthat's why I'm working on the development
of live by therapeutics. So you would
use them in conjunction with antibiotics.
Soyou would take the antibiotics, get
rid of the bad bacteria, and then
you immediately bring in the good
bacteria to hopefully replace an
optimized vaginal microbiome. So
the part of the reason why the diagnostics
are the way they are is because the
treatment is suboptimal until we
get these new treatments approved
by theFood and Drug Administration.
(24:26):
From your research, I do wantto mention this, though, because
in theresolve paper, well, you say that
the way that I take care of a woman
with BV is the same way I was trained
30 years ago. In most cases, we use
these inexpensive antibiotics from
1980s, and it recurs in anywhere
from50% to 70% of women in a year. So
that's, you know, speaking to what
you just said. And now kind of building
on that, can you just speak a little
bit more about like, or the wins
orlike, the things that you're seeing
inthe research that could really improve
the state of BV?
(25:05):
Yeah, yeah, exactly. Becauseit really hurts me when I'm taking
care of, I do work clinically in
San Francisco. So when I take care
of my patients and they had me, I
diagnosed with BV, I tell everything.
I'mtelling you. I tell them, like, I'm
going to give you antibiotics. It's
very highly likelihood that it's
going to get rid of your symptoms,
butit's also very high likelihood you're
going to get this again, and you're
going to come back. And this is what
I can offer. This is what I can offer
you right now. And so, yeah, it's
definitely problematic from that
perspective. So because of that,
I'vebeen, you know, I've been working
inothers as well to develop, we call
them these live biotherapeutics.
So the idea is,if a woman has BV, she has a lot
ofaberrant bacteria that are growing
instead of the optimal vaginal microbiome.
And so we use antibiotics to get
rid of those, really decrease those
bacteria, and either you can use
the antibiotics in the vagina once
nightly for five nights, or you can
take a pill twice a day for a week,
and then immediately after. The idea
is that we give the live biotherapeutic,
thelactam crispatus, live by therapeutic,
toreplace and replenish the optimal
vaginal microbiome. I think conceptually
itmakes a lot of sense. So what did
we find? We completed in 2019. We
published our results in May of 2020
in the New England Journal of Medicine.
You might remember what else was
happening early part of 2020. So
the world wasn't very focused on
BV right at that time.
(26:46):
All of that is just like, youknow, I've just blanked our paper.
I mean, I was happy the NewEngland Journal, of course, New England
Journal published, but when I was
very happy, we were one of the very
few manuscripts, papers that were
published that were not Covid related
during that period of time. So, but
in that study, we enrolled 228 women
from four different locations in
the US. San Francisco, San Diego,
St.Louis, and Chicago. We chose our
sites on purpose so that we could
have a large proportion of our population
which identifies african american
and orhispanic. These are two groups in
the US that have a higher chance
ofhaving BV than other populations.
So, andthen we randomized them. So, like
throwing a dice. But we did it two
to one. So there was two time chance
you would get lactin V and a one
time chance you would get a placebo.
Allthe women got treated with the five
days of the topical metronidazole,
and thenthey got treated then for eleven
weeksof either lactin v or placebo. And
what we found is that the twelve
weekvisit, that the recurrence of BV
happened in 45% of the placebo arm
and in only 30% in those who got
lactin V. So we significantly reduced
the risk of the recurrence of BV.
It was essentially the first study
ofthe live bar therapeutic to show
that. And then we followed these
women for additional 13 weeks. Some
additional women got BV in both arms
of the trial, but we saw a significant
reduction of recurrent BVD in the
lactin V arm in comparison to placebo
arm. So that's fantastic, right?
And alot of interest in our study and
inthe field, but it's not sufficient
to getthe product to the market. Remember,
Iwas trying to explain the difference
between a probiotic, which you can
go to your whole foods or your pharmacy,
or you can Amazon, you can buy lots
of probiotics, but live biotherapeutics
with anindication to prevent recurrent BVA,
you can't have, because the FDA at
this point in time, is requiring
additional, what's called phase three
trials. So phase three trials essentially
demonstrate, confirm that the product
works, it reduces recurrence of pv.
And then we always continue to follow
safety. So we have never seen any
sort of safety problems with this
product at all. But that additional
testing, and this is what, hopefully
yourlisteners can be part of the solution.
Wereally need to create an advocate.
Notwe, not me, but women need to rise
up and create an advocacy movement
thatreally moves forward with educating
womenand providers and partners about
theimportance of the vaginal microbiome
anddiseases associated with it, and
why we need to move forward with
research and funding of that research
todevelop new therapeutic options so
that I'm not taking care of a woman
in 2025 the way that I have. I was
trained in 1990.
(29:58):
That's crazy.
That makes sense. There's notan advocate, but there's not an advocacy
group like, name the advocacy group
for around BV or the vaginal microbiome.
Some of these new diagnostic companies
are trying to fill that void. Like
Eby, they're trying to fill that
void, but they're trying to educate
women and they have a educational
missionand research mission as part of their
company, which is fantastic. Ideally,
this would be a grassroots sort of
advocacy, because there's just a
lack of investment a lot. Most of
the funding that we've had to date
to develop Lactin V, that's the name
of the product, has been public money
through the national, US national
institutes of health companies are
not investing at this point in time,
have chosen, at least at this point
in time to invest at least in Lactin
V. They may be funding their own
research, but if we had the proper
funding for Lactin V, if we had it
today, like you said, craig, I'm
giving you, I'm not going to give
you the amount, but I'm giving you
this amount of money. Our listeners
havecontributed this. I'm sounding like
a politician, and we had all the
money today. Within three years,
theproduct is on the market. So we have
a plan in place. We just need the
resources. But really there's not.
Ithink advocacy is definitely one
ofthe missing ingredients because at
least so far, I'm not finding that
the pharmaceutical industry has been
fully vested in this field for a
variety of reasons. Maybe they'll
change when we get our new president,
theUS at least.
(31:34):
Who knows?
We'll see.
This year has been crazy. Letme just tell you that.
Although I have to say it'sexciting to them.
(33:25):
Well, yeah, there's two. Yeah,you could describe it two different
ways.Why do you think there hasn't been
much investment in this, in this
field? I just learned about BV literally
like a month ago, so I had no idea.
And it feels like for me, what else?
Like, what else is out there that
Idon't know about?
(33:50):
Yeah.
As a woman and trying to, youknow, be healthy and take care of
her body, there are a lot of.
These diseases that women, Imean, people don't talk very much
about. Again, I told you, our dinner
table, we talk about the vagina and
diseases and health and so forth,
butthat's not every dinner table in
America. It's good also, I have a
teenage son, too. It's good for him
to learn about these things to, and
ask questions. So I think there's
alack of awareness. I also think your
providers as well, are not necessarily
verywell trained in how to take care.
That's part of what I do in our medical
school with our residents and our
students is train the next generation.
Butit takes a lot of individuals to
be able to do that, to really raise
awareness and then to discuss it
with our patients. Part of it's around
time and other interests that people
have again. Over the last four years,
people been focused on health, but
mainly, like, on Covid and those
sorts of things, and not as much
onreproductive health. I hope that's
changing. So people say, well, I
have a vagal discharge, but it really
does. I know this is one of the,
youwrote this in the email. How does
this affect women's lives? I mean,
ithas, it may have really negative
consequences for women's lives, not
even the preterm birth and HIV and
sexually transmitted infections,
but theembarrassment, the quality of life.
Imagine if when you have sex, if
you have BV, you have this fishy
smell and how that might be off putting
to your partner, right? And you might
be afraid to be intimate with your
partner because you're afraid of
how your partner is going to react,
whether it's a male partner or female
partner. So I think that's that.
Weknow that BV is associated with poor
quality of life. So in regards to
get back to your question around
investment, I mean, overall, and
there's quite a bit written on this,
there's just, there's a lack of investment
in women and reproductive healthcare,
period. Right. There's just a lack
of investment. And I've been learning,
asI've been working on lact v now for
15 years, doing four clinical trials
now. We just finished our last clinical
trial outside of Durban in South
Africa. That was great study as well,
is that I'm learning that you have
to, essentially, you have to work
through the regulatory agency. So
in the US, that's the FTA, every
country has their own regulatory
agency.You have to also get support of providers.
They have to see that, okay, if your
product does what you say it's going
to do, then I'm going to prescribe
itlike the result will be better than
the current standard of care. You
also need to get patients, in this
case, women, who are going to desire
this additional treatment. Because
imagine right now you're taking a
pill twice a day for a week or using
something in your vagina for five
days. Now we're asking you to take
eleven additional weeks of using
avaginal applicator, which looks like
a tampon applicator, and apply the
product twice weekly. Okay? I mean,
that takes some commitment. You have
to know that you're going to benefit
from using this product. And then
the last one, and this is particularly
unique to the US situation because
of.It's the role that third party payers,
so you mentioned your history working
the pharmaceutical industry. I'm
sure you understand the role then
ofthird party payers. And so they have
to see there's going to be a value
tothem because you're getting extra
treatment to spend the extra money
inorder to justify you developing this
product.
(37:29):
Right.
Right. The benefit to thenthat the patients are going to end
up with a better outcome and I guess,
I mean, I don't want to speak for
third party payers, but maybe that
it's going to save them money because
now your patient is less likely,
that'sbeing covered by your insurance,
is lesslikely to come back to the provider
forcare because now she has an optimal
vaginal microbiome. All right, well,
that's going to save us money because
they're going to have fewer clinic
visits. All right, we'll spend the
extra dollars for this additional
treatment, but if you're the pharmaceutical
industry trying to decide are you
going to invest money here on some
other product, you have to look at
all of those factors. So it's not
just the research that drives us.
That's why when I mentioned your
listeners can play a very important
rolehere in developing like an advocacy
network to understand more about
thevaginal microbiome and demand better
diagnostics and treatment, what would.
(38:28):
Be a call to action for ourlisteners here? Y'all? Listen to
this episode. What's the next step?
The one little next step. Theone little next step would be to
see if, I don't know if there's already
an established organization, but
essentially to establish a advocacy
group that could use this podcast
butalso could have other speakers come
to educate themselves and then to
start advocating at the national
level,global level as well. I mean, I mentioned
the BV is more common in Africa than
it is in any other region in the
world. So it's really an equity issue.
Health equity, reproductive health
equity issue as well. So combining
efforts with the global health community
and with women's health community,
reproductive health community, I
think finding affiliations with like
the March of Dimes, which advocates
fornew treatments prevent preterm birth,
for example. So finding the other
groups that might be aligned with
your interests, but really pushing
forward, because to me, it all comes
down to optimization of agile microbiome.
If we can do that, we can prevent
preterm birth. Not all, but a lot.
And we can prevent HIV acquisition,
STIacquisition, we can improve the quality
reproductive health for women. I
mean, we get it all.
(39:54):
We get it all.
That would be my ask.
And then also I think my askto my listeners is to ask more questions
to your physician.
I use the word clinicianbecause not all clinicians are physicians.
So just to be mindful of that, we
have excellent nurse practitioners,
physiciansassistants and other providers. I
use the more generic term, and sometimes
it's a physician, sometimes it's
not.
(40:23):
Yeah, your healthcareproviders, healthcare providers.
Exactly. Ask more questionsand that will push them to learn
moreand be more educated and hopefully
educate their patients more as well
about this very important topic.
Amazing. Well, thank you somuch for being here.
My pleasure.
(40:44):
Thank you for listening tothis episode. If you'd like to learn
more about today's topic and guest,
head over to the show notes linked
inthe description of this episode.
Thereyou can get access to resources,
links,and ways you can get involved in
the pursuit for global health. And
if you loved this episode, don't
forget to write me a review on Apple
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ofmore people just like you and continues
to elevate the causes we are so passionate
about. I'll see you in the next one.
If you have a vagina, here's aquestion for you. Do you really know
what's going on down there? I'm serious.
As a woman with a vagina, I didn't
know what the vaginal microbiome
was. Ididn't know that not all bacteria
is badbacteria, and that there's a possibility
that some women may be living with
bacterial vaginosis and not even
know it. Hey, and welcome back to
another episode of global health
Pursuit, a podcast for beginner learners,
seasoned public health professionals,
and fanswho just love hearing inspiring stories
from leaders working to make the
world a better place. I'm Heddal
Bahman. I'm a social entrepreneur,
storyteller, and your host. Today,
we're talking about vaginas, how
itcan affect your health and even mental
wellbeing, with doctor Craig Cohen,
professor of obstetrics, gynecology,
andreproductive sciences at the University
ofCalifornia, San Francisco. Make sure
you're subscribed to the podcast,
leavea five star review, and share this
episode with someone who might find
it valuable. Your support helps me
keep this one woman show going and
makes it 1% better every single day.
This episode is proudly supported
byEvie, a women's health company that
is unlocking precision healthcare
forwomen and people with vaginas. Their
mission is to close the gender health
gap by discovering and leveraging
overlooked female biomarkers, starting
with the vaginal microbiome. Learn
more about evvy by clicking the link
in the description or visiting them
on the web@evvy.com. that's e v y.com
dot doctor Cohen, thank you so much
for being here. You know, this conversation
is something that kind of opened
myeyes up. I didn't know about any
ofthis before even reading the articles
that you wrote, as well as the articles
on resolve. So I'm very excited to
be here. Welcome.
(02:03):
Thank you, Hetal It a pleasure to be here and have this
opportunity to have this conversation,
because I think that's one of the
issues, is we need more women to
understand what the vaginal microbiome
is,why it's important for them and their
health, their partners, their children,
and just the way of life.
(02:23):
You know, you spent so much ofyour career studying bacterial vaginosis
and just, you know, the vaginal microbiome
in general. What drew you to this
field?
Yeah. Yeah, the interestingquestion, I mean, I can think back
to during my training in residency,
when Ispent my first year of residency
at theUniversity of Washington. Later on,
did my fellowship there as well.
Iremember specifically, Doctor David
Eschenbach, who later on became the
chair of the department at the University
of Washington. I remember him helping
me as an intern to take care of one
of my earliest patients who complained
ofa vaginal discharge and really just
took me through step by step, like
going what sort of questions to ask
her, and then the laboratory evaluation
with the microscopy and so forth,
andthen the treatment. And the reason
Ibring up David Eschewak is he's one
of the leaders of this field. If
you take a look at some of the earliest
publications on BV, a lot of them
emanate come from the University
ofWashington. King HolMes, David Eshvak,
two of my really amazing mentors
duringthat earlier period of my life. It
really, it came about through my
taking care of women, seeing that
the treatment that we had was okay
for getting rid of symptoms initially,
butthat the majority, in the majority
ofthese cases, women would start complaining.
They'd come back and say, Doctor
Cohen, you know, I have these symptoms
again, what can you do? And essentially
Iwould re prescribe antibiotics. And
that was just not feeling good. But
in addition, it came about as I became
interested in helping women to prevent
them from becoming infected by HIV,
but also those who are living with
HIV to improve their quality of their
lives. And that came about through
mywork, predominantly working in Kenya.
I've now worked there for almost
30years. But in doing that, understanding
theassociations of the vaginal microbiome
andHIV, preterm birth and many other
problems that can emanate from having
Bv.
(04:45):
Right. So I want to start offvery, very beginner. I guess my question
is, what is the vaginal microbiome
like?What does that mean? Like, what is
a microbiome first?
Yeah, I think there'sincreasing over the last decade or
so, been a lot in the media about
themicrobiome, mostly focused on the
gut microbiome, because it's probably
the microbiome that the scientific
community, medical community knows
most about, but also because we kind
of know how to manipulate it. But
there's been an increasing interest
justin understanding that human beings,
we're not just who we are like those
walking around, but we harbor, you
know, trillions of microbes, whether
itbe on our skin, I mean, throughout
most,not the entire body. I joke around
sometimes. I say, you know, you think
about, you know, why do human beings
exist? And you could say we, you
know, we essentially we co evolved
withthese microbes, right? But you could
say maybe we exist as an opportunity
forthe microbes to be able to live,
youknow, you can flip it, right? Instead
of being human centric, you can think
of it, you know, micro centric. And
also it's important to understand
thatthese microbial communities, that
they truly are communities, right?
Sowe talk, commonly thinks, I think
people talk about bacteria and they
say, oh, I don't want bacterial infection.
But the reality is there are bacteria
that help us to stay healthy, and
we in turn actually provide the bacteria
nutrients that keep them healthy.
We arepart of that community, if that makes
sense. Now, in the vagina, women
haveco evolved with the microbial community
that we think of as optimal, which
predominantly are dominated by a
certain species of bacteria called
lactobacillus. These aren't the lactobacillus
that you find in your yogurt. So
just to dispel that there are four
dominant lactobacilli species, probably
one is the best of the bunch, called
lactobacillus crispatus. Interestingly,
to myknowledge, humans are the only species
that have a vaginal microbe that's
dominated by lactobacillus. So the
other animals have vaginal microbiome,
butthey're distinct from the human vaginal
microbiome.
(07:22):
Okay.
The human reproductive tractis relatively unique, even amongst
primates, although there are primates
that have some similarities to the
estrus cycle, the monthly cycle that
women have. But there are unique
aspects to it. So it's so interesting
thatthese bacteria, these optimal vaginal
microbiome, they really have co evolved
with us and essentially have supported
health and well being and reproduction
andbirth. Right? I mean, that's a lot
of responsibility for these microbes.
Thefocus, a lot of my work is I try
tostay away from the word healthy and
use the word optimal. It's maybe
semantics, but not everyone, and
that's what we'll start talking about.
Bacterial vaginosis or vaginal dysbiosis,
essentially an aberration of the
vaginal microbiome. Not everybody
hasthat lactam cells, crispatus. And
so that's part of what our work is
about, is can we then help those
women to move their microbiome to
a more optimal vaginal microbiome?
(08:29):
So what would an optimalmicrobiome look.
Like dominated by one of thefour species of lactobacillus crispatus,
lactobacillus crispatus, lactobacillus
gasri,lactobilis jansenii. And then there's
another lactobacillus that's much,
much less common, like one or 2%
those lactobacilli an optimal vaginal
microbiome comprise of 90% of the
bacteria within the vagina. Still,
they're living within community.
They'renot living by themselves. There are
other bacteria that will be part
ofthat community, and it's thought
thatthose other bacteria, in many cases,
are supporting that community. The
lactillus are supporting the other
bacteria, and those other bacteria
mostlikely are providing nutrients which
are required for the lactobacillus
to be ableto survive and sustain in the vagina
long term. Also, if you think about
it, think about what these lactobacillus
aregoing through. Okay. You think of
the vagina. Our dinner table, by
the way. So I have teenage kids.
Actually, my daughter just turned
20.She's not a teenager any younger.
But wetalk about the vagina. We talk about
the microbiome. We talk all these
things all the time.
(09:44):
So I hope it's not like you, dad.
Absolutely not. In fact, mydaughter has educated her friends
alot. Yeah. Like the hpv vaccine,
forexample. It's a painful vaccine,
and shegot it, and she told her friend,
butmost people don't understand, like,
why do you need this vaccine? Educated
all of her friends in middle school,
and they all got it anyway, so.
(10:11):
Wow. In middle school, too.That's great. That's impressive.
Yeah. Middle school. Thevaginal microbiome. Oh, so think
about the vagina. Right? Okay. But
think of everything that the. I mean,
think about what the vagina encounters,
right? So, I mean, there's. For women
who are menstruating, there's the
menstrual cycle, right? So here,
oncea month, here comes the blood, which
obviously, we know changes the microbiome.
So at least transiently, the lactobacillus
usually decline and other bacteria
canincrease. And, in fact, when women
develop BV, it's a very common time
for them to develop. Bacterial vaginosis
is immediately after menses. So that's
something that the microbiome has
had to adjust to over time. Then
there's pregnancy. Right? And then
there's sexual intercourse as well,
and exposure to semen. Right. And
then there are other conditions that
can happen, sexually transmitted
infectionsand yeast infection and those sorts
of things as well, which the microbiome
has to contend with if it wants to
sustain itself long term, which is
usually the goal, at least, the optimal
vaginal microbiome. But oftentimes,
theseperturbations, these changes will
alter the microbiome and the lactobacillus.
Wedon't know what comes first. Do the
lactobacillus decrease and then allow
the other bacteria to then increase,
especially those associated with
bacterial vaginosis. And or is there
an exposure to this microbiome, which
is suboptimal, which then essentially
killsoff or dominates the lactobacillus?
It'sprobably both that happen, and there's
some other possibilities that may
be causing this change from optimal
tosuboptimal vaginal microbiome.
(12:07):
Okay, so what I'm hearing isthat there can be multiple ways of
a woman getting bacterial vaginosis,
right?
So, that's right. So we thinkof sexually associated causes and
non sexually associated causes. So
it's not technically a sex transmitted
infection, but it's definitely associated
with sex. Does that make sense?
(12:39):
Say more.
Okay, so, for example, therehave been studies that have shown
that among women who have sex with
women, that if one of the partners
hasBV and they share sexual toys, so
essentially they're sharing the bacteria
from one person's vagina to another,
that it's highly likely that if the
initial woman partner had Bv, that
the penis can also be a way of sharing
bacteria between vaginas. A male
partner with more than one partner
canshare the bacteria from one woman
with another. Okay, so that's a sexually
transmitted element to it. We know
that there are other factors that
also put a woman at risk of developing
BV,certainly multiple sexual partners
notusing a condom, those sorts of sexual
aspects. And then there are also
associations with hormonal contraception.
Sothe non sexual transmitted elements
thatalso increase a woman's risk. Menstruation,
as I mentioned earlier, also puts
alot of women at risk. For example,
acolleague of mine has recently completed
some really interesting work among
teenagers in Kenya. Her name's Supriya
Mehta. She's at Rush University.
So she'sdone a very interesting study among
teenagers in western Kenya using
themenstrual cup during menstruation,
and hasdemonstrated that. So, essentially,
catchingall the blood at the cervix, not
allowing very little of it, then
goes to the vagina and demonstrating
thatthose young women, those teenagers
whoare using the menstrual cup, have
asignificantly lower chance of developing
BVD. Super interesting. So it's not
related to sex, it's related to menstruation.
Right. So there are other factors
thatare associated with having the abnormal
vaginal discharge and microbiome.
(14:42):
So how does this show upwomen? Like, what are the first symptoms
that somebody might show and say,
okay, this is not normal?
Yeah. So the majority of womenwho have BV are asymptomatic. They
don't complain of symptoms. Okay,
now, if you do a detan, you know,
forthose women who do have BV. Don't
have. Are not complaining. Remember,
I'musing the word complaining of symptoms
because you may have something for
your whole life, but you think of
it as normal. You're not gonna complain
about it, right? Because everybody
hasit. And this is really an important
pointbecause. And this is also an interesting
point for your listeners, is that
BeV affects women of color in the
US much more likely than women who
identify as white. And it's also
much more common among women in sub
saharan Africa as well. It's probably
acombination of genetics, behavior,
andbehavior around menstrual hygiene
andgenital hygiene practices. So, for
example, douching or use of products
inone's vagina is a significant risk
factor. So I want your listeners
to know,do not douche. But a lot of times,
women are trying to dress. They have
a discharge that is smelly. It's
bothersome, it's embarrassing. And
so they'll go. They don't know what
to do. Maybe they've gone to the
doctor, and then they get the smell
back again. And so then they go to
the drugstore, and they see these
femme fresh, all the names of these
various products. Women spend billions
of dollars a year on these products.
Soit could be due to different genital
hygiene practices between different
ethnic and racial groups as well.
Butimagine in some communities, like
inAfrica, 35% to 50% of women can have
BV. Okay? So imagine you have it.
Your older sister has it, your mother
has it, and you've had this discharge
ever since soon after you went through
puberty. And you've had this right
almost the entire time. So it's not
something that you see as abnormal.
It'spart of what you think of as normal.
But you're not aware that it's not.
It's not optimal for you or your
family members or your friends. So
a lot of women don't complain. But
if they do have complaints, the most
common complaint is having abnormal
discharge. It can be gray or white.
It's usually thin, and then it has,
like, a. It can also oftentimes have
a fishy smell. And oftentimes, this
fishy smell is most pronounced if
a woman is having sex and has exposure
to semen immediately after ejaculation.
Ifthe discharge can have a real malodorous
smell, very fishy smell. So that's
usually the most common. It can also
be associated with general itching
andburning sensation as well. But the
majority of individuals who have
BV,majority of women have BVD, don't
have any symptoms.
(18:00):
So I could have it and Iwouldn't even know. Wow.
(19:36):
You wouldn't know. And why. Sowhy is that important? I think it's
truly important. In fact, I wouldn't
be.I would be doing this work, but not
with the same urgency, if it wasn't
for these. That bvs associated with
poor reproductive health outcomes.
Right.So if a woman has BV, she's more
likely to have a preterm delivery.
If shehas BV, she's more likely. If she's
exposed to HIV, she's more likely
tobecome HIV infected. And if she's
living with HIV, she's more likely
totransmit HIV to an uninfected partner,
and she's also more likely to be
infected by other sexually transmitted
infections like Goddarin, chlamydia
andherpes. So there are many reasons
whythere's a real need, I believe, I
think an urgency to help women to
understand the importance of knowing
about their vaginal microbiome. We
haven't talked about testing much
yet, but knowing about the vaginal
microbiome and then working with
their medical professionals to work
towards optimizing the vaginal microbiome.
And then a lot of my work is the
research to develop new products
thatcan help women to optimize a vaginal
microbiome and that we call the field
called live by therapeutics. It's
separate from probiotics. It's similar,
but separate. Probiotics are usually
comprised of bacteria, but they can't
have any medical claims because they
have not been rigorously tested in
clinical trials. Live by therapeutics,
essentially are bacteria as well,
butare going through very rigorous testing,
both for how well they work to prevent
the recurrence of bacterial vaginosis
andalso safety, which is of utmost importance,
too.
(21:36):
So now I want to go into thetesting part, right? So when we go
to see our Ob Gyn for our annual
checkup and all of that, is that
included in the annual checkup? Like,
what do we have to ask for that?
Orwhat does that look like? I mean,
weusually just, like, we just go and
trust our physician and then, okay,
we're good, and then we just move
on. Right.
(22:08):
So usually most of thatcheckup with your gynecologist or
primary care physician or provider
isgoing to be symptoms based. Right?
Soif you don't complain of a vaginal
discharge, the clinician is probably
notgoing to look now, if, when your
clinician does an exam and sees copious
discharge that has a smell, they
maytake some swabs and do a test, which
would help to identify if you have
BV or yeast or whatever, even if
you don't have complaints. Again,
based on what I told you earlier,
someone may not complain of things
because they don't see it as not
being normal, because they've had
it most of their life since puberty.
So,yeah, this is a kind of interesting
area.So it's really been symptoms based.
The other part is, and this is a
little technical, but I hope your
listeners will understand, the treatments
are good. The antibiotics usually
usemetronidazole, also known as flag
orclindamycin. They're good at taking
care of reducing symptoms initially.
Firstmonth or so, they're relatively good.
Anywhere from 70% to 90% of women
will have a cure. Up to 70% to 80%
of women will have a recurrence within
a year. So the treatments are not
great. Right. So you can get rid
ofyour symptoms initially. That's good,
but it's a high likelihood that this
is going to come back. The reason
isthat the antibiotics are decreasing
thebacteria that are causing the BV.
But remember, I told you about the
lactobacillus species, it's not bringing
back the optimal vaginal microbiome.
Andthat's why I'm working on the development
of live by therapeutics. So you would
use them in conjunction with antibiotics.
Soyou would take the antibiotics, get
rid of the bad bacteria, and then
you immediately bring in the good
bacteria to hopefully replace an
optimized vaginal microbiome. So
the part of the reason why the diagnostics
are the way they are is because the
treatment is suboptimal until we
get these new treatments approved
by theFood and Drug Administration.
(24:26):
From your research, I do wantto mention this, though, because
in theresolve paper, well, you say that
the way that I take care of a woman
with BV is the same way I was trained
30 years ago. In most cases, we use
these inexpensive antibiotics from
1980s, and it recurs in anywhere
from50% to 70% of women in a year. So
that's, you know, speaking to what
you just said. And now kind of building
on that, can you just speak a little
bit more about like, or the wins
orlike, the things that you're seeing
inthe research that could really improve
the state of BV?
(25:05):
Yeah, yeah, exactly. Becauseit really hurts me when I'm taking
care of, I do work clinically in
San Francisco. So when I take care
of my patients and they had me, I
diagnosed with BV, I tell everything.
I'mtelling you. I tell them, like, I'm
going to give you antibiotics. It's
very highly likelihood that it's
going to get rid of your symptoms,
butit's also very high likelihood you're
going to get this again, and you're
going to come back. And this is what
I can offer. This is what I can offer
you right now. And so, yeah, it's
definitely problematic from that
perspective. So because of that,
I'vebeen, you know, I've been working
inothers as well to develop, we call
them these live biotherapeutics.
So the idea is,if a woman has BV, she has a lot
ofaberrant bacteria that are growing
instead of the optimal vaginal microbiome.
And so we use antibiotics to get
rid of those, really decrease those
bacteria, and either you can use
the antibiotics in the vagina once
nightly for five nights, or you can
take a pill twice a day for a week,
and then immediately after. The idea
is that we give the live biotherapeutic,
thelactam crispatus, live by therapeutic,
toreplace and replenish the optimal
vaginal microbiome. I think conceptually
itmakes a lot of sense. So what did
we find? We completed in 2019. We
published our results in May of 2020
in the New England Journal of Medicine.
You might remember what else was
happening early part of 2020. So
the world wasn't very focused on
BV right at that time.
(26:46):
All of that is just like, youknow, I've just blanked our paper.
I mean, I was happy the NewEngland Journal, of course, New England
Journal published, but when I was
very happy, we were one of the very
few manuscripts, papers that were
published that were not Covid related
during that period of time. So, but
in that study, we enrolled 228 women
from four different locations in
the US. San Francisco, San Diego,
St.Louis, and Chicago. We chose our
sites on purpose so that we could
have a large proportion of our population
which identifies african american
and orhispanic. These are two groups in
the US that have a higher chance
ofhaving BV than other populations.
So, andthen we randomized them. So, like
throwing a dice. But we did it two
to one. So there was two time chance
you would get lactin V and a one
time chance you would get a placebo.
Allthe women got treated with the five
days of the topical metronidazole,
and thenthey got treated then for eleven
weeksof either lactin v or placebo. And
what we found is that the twelve
weekvisit, that the recurrence of BV
happened in 45% of the placebo arm
and in only 30% in those who got
lactin V. So we significantly reduced
the risk of the recurrence of BV.
It was essentially the first study
ofthe live bar therapeutic to show
that. And then we followed these
women for additional 13 weeks. Some
additional women got BV in both arms
of the trial, but we saw a significant
reduction of recurrent BVD in the
lactin V arm in comparison to placebo
arm. So that's fantastic, right?
And alot of interest in our study and
inthe field, but it's not sufficient
to getthe product to the market. Remember,
Iwas trying to explain the difference
between a probiotic, which you can
go to your whole foods or your pharmacy,
or you can Amazon, you can buy lots
of probiotics, but live biotherapeutics
with anindication to prevent recurrent BVA,
you can't have, because the FDA at
this point in time, is requiring
additional, what's called phase three
trials. So phase three trials essentially
demonstrate, confirm that the product
works, it reduces recurrence of pv.
And then we always continue to follow
safety. So we have never seen any
sort of safety problems with this
product at all. But that additional
testing, and this is what, hopefully
yourlisteners can be part of the solution.
Wereally need to create an advocate.
Notwe, not me, but women need to rise
up and create an advocacy movement
thatreally moves forward with educating
womenand providers and partners about
theimportance of the vaginal microbiome
anddiseases associated with it, and
why we need to move forward with
research and funding of that research
todevelop new therapeutic options so
that I'm not taking care of a woman
in 2025 the way that I have. I was
trained in 1990.
(29:58):
That's crazy.
That makes sense. There's notan advocate, but there's not an advocacy
group like, name the advocacy group
for around BV or the vaginal microbiome.
Some of these new diagnostic companies
are trying to fill that void. Like
Eby, they're trying to fill that
void, but they're trying to educate
women and they have a educational
missionand research mission as part of their
company, which is fantastic. Ideally,
this would be a grassroots sort of
advocacy, because there's just a
lack of investment a lot. Most of
the funding that we've had to date
to develop Lactin V, that's the name
of the product, has been public money
through the national, US national
institutes of health companies are
not investing at this point in time,
have chosen, at least at this point
in time to invest at least in Lactin
V. They may be funding their own
research, but if we had the proper
funding for Lactin V, if we had it
today, like you said, craig, I'm
giving you, I'm not going to give
you the amount, but I'm giving you
this amount of money. Our listeners
havecontributed this. I'm sounding like
a politician, and we had all the
money today. Within three years,
theproduct is on the market. So we have
a plan in place. We just need the
resources. But really there's not.
Ithink advocacy is definitely one
ofthe missing ingredients because at
least so far, I'm not finding that
the pharmaceutical industry has been
fully vested in this field for a
variety of reasons. Maybe they'll
change when we get our new president,
theUS at least.
(31:34):
Who knows?
We'll see.
This year has been crazy. Letme just tell you that.
Although I have to say it'sexciting to them.
(33:25):
Well, yeah, there's two. Yeah,you could describe it two different
ways.Why do you think there hasn't been
much investment in this, in this
field? I just learned about BV literally
like a month ago, so I had no idea.
And it feels like for me, what else?
Like, what else is out there that
Idon't know about?
(33:50):
Yeah.
As a woman and trying to, youknow, be healthy and take care of
her body, there are a lot of.
These diseases that women, Imean, people don't talk very much
about. Again, I told you, our dinner
table, we talk about the vagina and
diseases and health and so forth,
butthat's not every dinner table in
America. It's good also, I have a
teenage son, too. It's good for him
to learn about these things to, and
ask questions. So I think there's
alack of awareness. I also think your
providers as well, are not necessarily
verywell trained in how to take care.
That's part of what I do in our medical
school with our residents and our
students is train the next generation.
Butit takes a lot of individuals to
be able to do that, to really raise
awareness and then to discuss it
with our patients. Part of it's around
time and other interests that people
have again. Over the last four years,
people been focused on health, but
mainly, like, on Covid and those
sorts of things, and not as much
onreproductive health. I hope that's
changing. So people say, well, I
have a vagal discharge, but it really
does. I know this is one of the,
youwrote this in the email. How does
this affect women's lives? I mean,
ithas, it may have really negative
consequences for women's lives, not
even the preterm birth and HIV and
sexually transmitted infections,
but theembarrassment, the quality of life.
Imagine if when you have sex, if
you have BV, you have this fishy
smell and how that might be off putting
to your partner, right? And you might
be afraid to be intimate with your
partner because you're afraid of
how your partner is going to react,
whether it's a male partner or female
partner. So I think that's that.
Weknow that BV is associated with poor
quality of life. So in regards to
get back to your question around
investment, I mean, overall, and
there's quite a bit written on this,
there's just, there's a lack of investment
in women and reproductive healthcare,
period. Right. There's just a lack
of investment. And I've been learning,
asI've been working on lact v now for
15 years, doing four clinical trials
now. We just finished our last clinical
trial outside of Durban in South
Africa. That was great study as well,
is that I'm learning that you have
to, essentially, you have to work
through the regulatory agency. So
in the US, that's the FTA, every
country has their own regulatory
agency.You have to also get support of providers.
They have to see that, okay, if your
product does what you say it's going
to do, then I'm going to prescribe
itlike the result will be better than
the current standard of care. You
also need to get patients, in this
case, women, who are going to desire
this additional treatment. Because
imagine right now you're taking a
pill twice a day for a week or using
something in your vagina for five
days. Now we're asking you to take
eleven additional weeks of using
avaginal applicator, which looks like
a tampon applicator, and apply the
product twice weekly. Okay? I mean,
that takes some commitment. You have
to know that you're going to benefit
from using this product. And then
the last one, and this is particularly
unique to the US situation because
of.It's the role that third party payers,
so you mentioned your history working
the pharmaceutical industry. I'm
sure you understand the role then
ofthird party payers. And so they have
to see there's going to be a value
tothem because you're getting extra
treatment to spend the extra money
inorder to justify you developing this
product.
(37:29):
Right.
Right. The benefit to thenthat the patients are going to end
up with a better outcome and I guess,
I mean, I don't want to speak for
third party payers, but maybe that
it's going to save them money because
now your patient is less likely,
that'sbeing covered by your insurance,
is lesslikely to come back to the provider
forcare because now she has an optimal
vaginal microbiome. All right, well,
that's going to save us money because
they're going to have fewer clinic
visits. All right, we'll spend the
extra dollars for this additional
treatment, but if you're the pharmaceutical
industry trying to decide are you
going to invest money here on some
other product, you have to look at
all of those factors. So it's not
just the research that drives us.
That's why when I mentioned your
listeners can play a very important
rolehere in developing like an advocacy
network to understand more about
thevaginal microbiome and demand better
diagnostics and treatment, what would.
(38:28):
Be a call to action for ourlisteners here? Y'all? Listen to
this episode. What's the next step?
The one little next step. Theone little next step would be to
see if, I don't know if there's already
an established organization, but
essentially to establish a advocacy
group that could use this podcast
butalso could have other speakers come
to educate themselves and then to
start advocating at the national
level,global level as well. I mean, I mentioned
the BV is more common in Africa than
it is in any other region in the
world. So it's really an equity issue.
Health equity, reproductive health
equity issue as well. So combining
efforts with the global health community
and with women's health community,
reproductive health community, I
think finding affiliations with like
the March of Dimes, which advocates
fornew treatments prevent preterm birth,
for example. So finding the other
groups that might be aligned with
your interests, but really pushing
forward, because to me, it all comes
down to optimization of agile microbiome.
If we can do that, we can prevent
preterm birth. Not all, but a lot.
And we can prevent HIV acquisition,
STIacquisition, we can improve the quality
reproductive health for women. I
mean, we get it all.
(39:54):
We get it all.
That would be my ask.
And then also I think my askto my listeners is to ask more questions
to your physician.
I use the word clinicianbecause not all clinicians are physicians.
So just to be mindful of that, we
have excellent nurse practitioners,
physiciansassistants and other providers. I
use the more generic term, and sometimes
it's a physician, sometimes it's
not.
(40:23):
Yeah, your healthcareproviders, healthcare providers.
Exactly. Ask more questionsand that will push them to learn
moreand be more educated and hopefully
educate their patients more as well
about this very important topic.
Amazing. Well, thank you somuch for being here.
My pleasure.
(40:44):
Thank you for listening tothis episode. If you'd like to learn
more about today's topic and guest,
head over to the show notes linked
inthe description of this episode.
Thereyou can get access to resources,
links,and ways you can get involved in
the pursuit for global health. And
if you loved this episode, don't
forget to write me a review on Apple
podcasts and rate the podcast on
Spotify. It helps me get in front
ofmore people just like you and continues
to elevate the causes we are so passionate
about. I'll see you in the next one.
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