My Take on the FDA Panel on MHT

I just listened to the FDA panel on MHT (sorry Marty Makary, we call it MHT in this house), and wanted to give you my take.

Makary spouted the disinformation from his book chapter for the first 10 or 15 minutes. Read my previous post so you can see my extensive fact checking.

I thought the information on removing the Black Box warning was solid. Dr. Simon especially. He explained that the estradiol levels with the lower doses of vaginal estradiol are the same as with vaginal DHEA (Intrarosa), and yet vaginal DHEA doesn’t need a black box warning. Two of the speakers felt it would be appropriate to remove the black box, but add a warning about vaginal bleeding and and for women with estrogen receptor positive breast cancer, who should discuss with their medical providers before starting.

The presentations on MHT were more all over the place, with some being more solid than others. Some of the presenters stuck with safety, but others oversold the benefits. And this is something that bothers me, because when the public is watching how do they know the difference?

Another big issue I had was the lack of representation from the WHI, especially as some of the presenters seemed to cherry pick some of the data, and at times it was hard to know if they meant the estrogen arm or the estrogen progestin arm. Also, some presenters were clear we can’t translate WHI data to other hormones, and others were not. Some were clear when the data was observational and some less so.

Another HUGE oversight was not having a methodologist, an epidemiologist, or an oncologist.

I wish they had confined the panel to vaginal estrogen. And who knows, maybe this will spur more funding to do some more research. But if we are building on what Makary believe’s to be true, that will be an issue. Remember, he’s a forced birther who doesn’t believe in putting fluoride in water.

Correction:

I mistakenly referred to intravaginal DHEA as Imvexxy, it’s Intrarosa. To be clear: the low dose intravaginal estrogen has the black box warning, and the DHEA product does not, but they achieve the same estradiol levels.