I watched the FDA announcement about removing the black box warning on estrogen…and it turns out it was not just on vaginal estrogen, but on all estrogen. In addition, both RFK Jr, and Dr. Makary spewed misinformation about menopause and menopause hormone therapy. I covered it all in the live. I also suggested resources and answered some questions. I hope you listen/watch.
To recap:
I agree with removing the black box warning on vaginal estrogen, but I do not agree with the way it was done. This did not follow the appropriate process. There was an opportunity to do it right and to fund some needed studies, but Makary and RFK Jr don’t actually care about women, so we didn’t get that. Click here for a deep dive into my opinion on the black box warning and the information that we need. And here is a deeper dive into vaginal estrogens.
I do not agree with removing the black box warning from systemic estrogen. Again, we could have had an appropriate process where we reviewed the data and decided if changes were needed, but that did not happen. The label needs updating, but not like this.
When HHS and the FDA act on whims instead of science, that means they can act on any whim. They alluded to the amazing (that is sarcasm from me) panel on SSRIs in pregnancy, so yes, I am very worried we’re going to see more proclamations. You should be worried about SSRIs in pregnancy, mifepristone and birth control.
RFK Jr and Makary both claimed they were using evidence-based medicine, and then proceeded to ignore that evidence in favor of data that was cherry picked from ancient studies, most of which are observational, and some things that sounded completely made up. They made false claims about MHT reducing the risk of cardiovascular disease by 50% and Alzheimer’s disease by 35%. WE DO NOT HAVE THAT DATA. I mean, fund the studies! Some of the choice nuggets:
Menopause is a disease that causes women to die early. Not sure how women live longer than men, but hey, who cares about data right? Here is the table of life expectancy for women vs men. Pretty hard to say that menopause is shortening lives. I mean, i could say that the lack of menopause is killing men!
Without MHT, women get divorced (I don’t like to assume, but here I believe they are talking about heterosexual marriages). Oh, so if a woman is struggling her man leaves and that’s somehow the woman’s fault? To me, that means she has a shitty husband. How come I never hear how Viagra saves marriages? Also, I have yet to see any robust data on menopause causes divorce. Some men are just assholes and sometimes it takes a while to extricate yourself.
Trump is restoring our trust in public health (no really, that was said).
Dr. Jackson, who is the former CEO of the menopause telemedicine company Evernow, is now at HHS and she said, “Menopause is cascade of disease and aging.” I wonder if claiming menopause is a disease and everyone needs hormone therapy is good for business at telemedicine companies?
RFK Jr said that MHT extends lives by 10 years (wouldn’t that be in the guidelines if it were true?) and then someone else said hormone therapy is a “longevity intervention,” and I am not sure who said that last part because my soul had temporarily left my body because it needed a break from the bullshit.
In my opinion, anyone who considers this a win for women, doesn’t think women deserve science or transparency and is fine with RFLK Jr/Makary led proclamations on health.
I’m glad the black box warning on vaginal estrogen has gone, but the misinformation that was presented alongside was tragic. These talking points will spawn a decade of misinformation. RFK Jr and Makary have just done exactly what they accused the WHI researchers of doing: spread misinformation.
I promised some resources:
My review of Marty Makary’s chapter on menopause, which covers most of the disinformation spewed at the meeting: click here
The lack of data for MHT as primary prevention for cardiovascular disease: click here
MHT is not recommended for primary prevention of dementia: click here and here
The WHI Investigators respond to misinformation about MHT from HHS: click here
Brain fog in menopause: a health-care professional’s guide for decision-making and counseling on cognition, International Menopause Society: click here
2022 Menopause Society Position Statement on Hormone therapy: click here
Australasian Menopause Society Provider toolkit (for menopause for medical professionals but an easy read: click here
Also, I recommend the podcast Ovary Active
