HI Jen! There are a couple times where you say "Vaginal DHEA which is Imvexxy, but Imvexxy doesn't have to have that same warning label because they are not estrogen, they are DHEA." I think you might be mixing Imvexxy (TM) and Intrarosa (TM)? Time: 4:53 and 6:25 approximately. My understanding is Imvexxy IS estradiol and DOES have a black box warning (ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER); while Intrarosa is DHEA/prastrone and only has a warning of "if you have vaginal bleeding only." Did I hear you right, or is this what you meant? (Sorry I DM'ed you on Instagram as I didn't yet know how a LIVE here on Substack works!)
So much time and energy is placed on the risks of using any form of estrogen (black box warnings). There are so many medications that women are prescribed duirng peri and menopause that have a multitude of side effects and possibly harmful effects.
Again, thank you for taking the time to do this —very appreciated! I'm abroad and couldn't join you live, so was able to listen to in my car this morning like a podcast which was perfect. I did watch the FDA Roundtable, but was interested to hear your perspective. Many quality arguments as you highlighted. Others a bit more suspect. I felt similarly about the brain and cognitive data presented. Seemed curious. In general, was deeply surprised to hear so much discussion about MHT and not just vaginal estrogen as expected.
On a side note, are you still doing The Dodge? And if so, how does one catch it?
Thank you so much for sharing! Agreed that they should have had WHI researchers there to help with the data. I have come to appreciate some aspects of the study given the way that we were using hormone therapy in the 90's. When will they make the decision regarding the vaginal estrogen black box warning? I discuss this with every new prescription I give for this med. I have had many folks read it and decide not to use it.
It must be at least 20-25 yrs ago, I was at a Women's Health NP conference & one of the lecturers railed about the need to get rid of the black box warning on vag. estrogen -- and here we are...
I also thought (more recently) about Intrarosa -- it's DHEA, but then it's converted into estrogen; but because it didn't *start out that way* it didn't get the black box.
Hi Dr. Jen. I'll never know for sure....but one year I had a clear Mammogram. Had been on Vagifem full tablet twice a week for a couple years. I started Intrarosa 5 days a week and Vagifem (1/2 tab) the other 2. Mammogram exactly one year later: estrogen-positive DCIS. Coincidental, maybe. Or maybe not.
Either way, I've never returned to the vaginal products, strictly out of fear and unknown.
I've come to really respect your commentary and information. Being Canadian is a bonus to me! Can I ask your opinion on the Menopause Society in general? You mention them at times. Do they keep up with what is currently being understood or still tow the old (maybe outdated) party lines? I'm a pharmacist, considering their certified practitioner exam, etc but am leery to attach my studies or future efforts without their training keeping up with what is"current", as you often present. Thanks.
Thank you so much for diving into Substack Live! I apprecate your expert overveiw of this panel, which I also watched in full. Makary sucked much of the oxygen out of the room with his opening, but I was grateful that the panelists moved forward and presented information to remove the black box warning. I'd appreciate an additional post on this panel if you can do so.
As someone who leads conversations around evidence-based women’s health, I can’t overstate how critical your voice is right now.
So does vaginal estrogen have a risk of bleeding (you mention in the discussion about removing the black box warning but keeping something about bleeding etc) I didn't know that it could cause that and did experience some when I started and my doctor made me have the ultrasound etc.
It’s a complicated answer, because many studies have good points and some have flaws. The gold standard for a medication is a randomized double blinded placebo controlled trial, like the WHI. There are many kinds of observational studies. The observational studies I am referring to here look at medical records or people and outcomes and try to look for signals. For example, the information about progesterone being a lower risk for breast cancer is from an observational study. One issue with an observational study is we don’t know if the groups are really the same. What if women who took progesterone had fewer risk factors for breast cancer, for example. Most observational studies with hormones show the women who take them are generally healthier and wealthier, so that is a big confounder. All the literature has to be put in context as well. Sometimes all we can have are observational studies, for example when the incidence of a condition is too low for a clinical trial. It’s hard to be definitive and say “we know for sure” about a drug having a true benefit with an observational study. This is a gross generalization and there is a lot of “it depends.” But people should be honestly, in my opinion, when it’s observational data.
Thank you so much. I will go review that now. I was thinking of what you said in the piece here about starting a 65-year-old woman on MHT specifically for bone health. I’ve been on it on and off and went through menopause at age 57. recently broke a bone in my foot. Gyno said “why aren’t you on systemic?“ And put me on it.
HI Jen! There are a couple times where you say "Vaginal DHEA which is Imvexxy, but Imvexxy doesn't have to have that same warning label because they are not estrogen, they are DHEA." I think you might be mixing Imvexxy (TM) and Intrarosa (TM)? Time: 4:53 and 6:25 approximately. My understanding is Imvexxy IS estradiol and DOES have a black box warning (ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER); while Intrarosa is DHEA/prastrone and only has a warning of "if you have vaginal bleeding only." Did I hear you right, or is this what you meant? (Sorry I DM'ed you on Instagram as I didn't yet know how a LIVE here on Substack works!)
Yes, I said Imvexxy when I meant Intrarosa, thanks!
Well done. And I agree, lots
good information.
So much time and energy is placed on the risks of using any form of estrogen (black box warnings). There are so many medications that women are prescribed duirng peri and menopause that have a multitude of side effects and possibly harmful effects.
Again, thank you for taking the time to do this —very appreciated! I'm abroad and couldn't join you live, so was able to listen to in my car this morning like a podcast which was perfect. I did watch the FDA Roundtable, but was interested to hear your perspective. Many quality arguments as you highlighted. Others a bit more suspect. I felt similarly about the brain and cognitive data presented. Seemed curious. In general, was deeply surprised to hear so much discussion about MHT and not just vaginal estrogen as expected.
On a side note, are you still doing The Dodge? And if so, how does one catch it?
Thank you so much for sharing! Agreed that they should have had WHI researchers there to help with the data. I have come to appreciate some aspects of the study given the way that we were using hormone therapy in the 90's. When will they make the decision regarding the vaginal estrogen black box warning? I discuss this with every new prescription I give for this med. I have had many folks read it and decide not to use it.
It must be at least 20-25 yrs ago, I was at a Women's Health NP conference & one of the lecturers railed about the need to get rid of the black box warning on vag. estrogen -- and here we are...
I also thought (more recently) about Intrarosa -- it's DHEA, but then it's converted into estrogen; but because it didn't *start out that way* it didn't get the black box.
Hi Jen,
Great review, BUT a mistake, vaginal DHEA (prasterone) is called Intrarosa NOT Imvexxy. Imvexxy 4mcg E2 and 10 mcg E2 both have a box warning.
Yes, I made the correction above.
Hi Dr. Jen. I'll never know for sure....but one year I had a clear Mammogram. Had been on Vagifem full tablet twice a week for a couple years. I started Intrarosa 5 days a week and Vagifem (1/2 tab) the other 2. Mammogram exactly one year later: estrogen-positive DCIS. Coincidental, maybe. Or maybe not.
Either way, I've never returned to the vaginal products, strictly out of fear and unknown.
I've come to really respect your commentary and information. Being Canadian is a bonus to me! Can I ask your opinion on the Menopause Society in general? You mention them at times. Do they keep up with what is currently being understood or still tow the old (maybe outdated) party lines? I'm a pharmacist, considering their certified practitioner exam, etc but am leery to attach my studies or future efforts without their training keeping up with what is"current", as you often present. Thanks.
Thank you so much for diving into Substack Live! I apprecate your expert overveiw of this panel, which I also watched in full. Makary sucked much of the oxygen out of the room with his opening, but I was grateful that the panelists moved forward and presented information to remove the black box warning. I'd appreciate an additional post on this panel if you can do so.
As someone who leads conversations around evidence-based women’s health, I can’t overstate how critical your voice is right now.
Katie
So does vaginal estrogen have a risk of bleeding (you mention in the discussion about removing the black box warning but keeping something about bleeding etc) I didn't know that it could cause that and did experience some when I started and my doctor made me have the ultrasound etc.
Bleeding can be a sign of endometrial cancer, so that is why it should be listed
But if vaginal estrogen isn’t systemic shouldn’t it not cause a thickening of the lining and/or bleeding? Or can it still affect the lining?
Thank you!!!
Thank you for keeping us informed!
Can you please explain the difference between a clinical trial and an observational study? Are both evidence-based?
It’s a complicated answer, because many studies have good points and some have flaws. The gold standard for a medication is a randomized double blinded placebo controlled trial, like the WHI. There are many kinds of observational studies. The observational studies I am referring to here look at medical records or people and outcomes and try to look for signals. For example, the information about progesterone being a lower risk for breast cancer is from an observational study. One issue with an observational study is we don’t know if the groups are really the same. What if women who took progesterone had fewer risk factors for breast cancer, for example. Most observational studies with hormones show the women who take them are generally healthier and wealthier, so that is a big confounder. All the literature has to be put in context as well. Sometimes all we can have are observational studies, for example when the incidence of a condition is too low for a clinical trial. It’s hard to be definitive and say “we know for sure” about a drug having a true benefit with an observational study. This is a gross generalization and there is a lot of “it depends.” But people should be honestly, in my opinion, when it’s observational data.
Thanks so much for this thorough and thoughtful answer! Appreciate you and all your work!
My doctor started me on estrogen patch this week for bone density. I would love for you to talk more about that exclamation.
I have written about it in my hormone therapy guide
Thank you so much. I will go review that now. I was thinking of what you said in the piece here about starting a 65-year-old woman on MHT specifically for bone health. I’ve been on it on and off and went through menopause at age 57. recently broke a bone in my foot. Gyno said “why aren’t you on systemic?“ And put me on it.