The FDA Panel on Hormone Therapy was a Trojan Horse for Disinformation

Marty Makary is gunning for Feminine Forever 2.0

ilbusca/Getty Images

For those who don’t know, Feminine Forever was the secretly Pharma-funded book from the 1960’s that introduced the concept that women in menopause are gross castrates that are unappealing to men. However, through the magic of estrogen, women can once again regain the only currency they have – looking hot in a tennis skirt. It is slick Pharma marketing meets misogyny.

I gave my rundown of the FDA panel on menopause hormone therapy, or MHT, yesterday. The panelists who adhered to the plan of addressing the issue of the black box warning for vaginal estrogen presented the evidence fairly and effectively, in my opinion. However, the science was limited, as each speaker had only five minutes to present their findings. The presenters who spoke about systemic MHT ranged from accurate to not in line with the recommendations from the Menopause Society, and there was a fair amount of cherry-picking about the supposed benefits of MHT for the heart and brain.

Once I heard that there had been three months of discussions in the lead-up, and yet the panel was missing key stakeholders (like a methodologist, an epidemiologist, an oncologist, and someone from the WHI), but had managed to include menopause influencers, I was left wondering if the motive were really the black box warning on vaginal estrogen, or perhaps something else. Something like using the legitimate concerns about access to vaginal estrogen and a panel of experts as a Trojan horse to introduce a Feminine Forever 2.0, agenda where MHT would be promoted as the answer for almost everything, which is the narrative of his scientifically-dubious chapter on hormones in his aptly titled book, Blind Spots (read more about his cherry picking and false claims here).

My other worry was how Makary and the Trump Administration might use removing the black box warning on vaginal estrogen and the accompanying PR as part of their strategy to ban or restrict mifepristone. Typically, to remove a black box warning, the FDA convenes a scientific advisory committee, not a panel, to specifically look at new safety data. The scientific advisory committee then takes that information to the FDA. Unlike a panel, these committees have a specific makeup and follow a particular process. For example, public commentary is required, but it is not at a panel. Additionally, there is a specific agenda for a scientific advisory committee that includes the representation of new data; however, we were informed at the start that this was a “Tell us what you think” panel, and unfortunately misinformation was presented alongside accurate information and that misinformation has now has the appearance of having the FDA’s stamp of approval.

There is another, potentially even more serious concern. Dr. Lauren Streicher, an OB/GYN and menopause expert (you should follow her Substack, Menopause: The Inside Info), was initially involved in preliminary discussions for the panel and then backed out because, as she explains in a video on her Substack:

“At one of the preliminary meetings, when I'd asked, well, are we going to have that scientific meeting? Are we going to go through the normal process in order to get that label off? I was told, well, that's really not planned. We're just doing this public, public thing to just let the public know what's going on in terms of hormone therapy.”

Dr. Streicher was concerned, and rightly so, that Makary might take the expert opinions of the panel, change the label for vaginal estrogen, and disregard the actual process altogether. It doesn’t matter that the Menopause Society and the American College of OB/GYN support removing the black box warning on vaginal estrogen. It doesn't matter that Dr. Simon presented a summary of new data regarding the endometrial safety of vaginal estrogen; the data needs to explained appropriately at a Scientific Advisory Committee. Process matters.

Suppose Makary decides the panel is sufficient enough to give him the illusion of due process to change the label for vaginal estrogen. I share Dr Streicher’s concern that nothing would stop him from doing the same with mifepristone and restricting it to seven weeks or making some other unscientific, forced-birth change. Once he sets the precedent that he can make the change after “listening to experts” that he chose to support his pre-established bias, he can simply repeat it.

Am I being paranoid? That’s what people said 20 years ago when I started warning people that doctor’s wouldn’t be able to do abortions for women with serious medical conditions under the new wave of forced-birth laws, and look where we are now all those years later.

My fears are valid, considering a post-panel interview that Makary gave on NewsNation, a right-leaning media organization that has apparently quite a niche in covering stories about UFOs (yes, you read that correctly). In Makary-world, MHT is almost as good as antibiotics. What does that even mean? But the public will take away that MHT should be given to every woman. What dose? What formulation? And based on what data that is not-cherry-picked? Just little things that those of us who actually treat women with hormone therapy think about. Things that matter when you care about science and transparency and using evidence to help your patients.

Since the panel, Makary had persisted in using the incorrect term, hormone replacement therapy or HRT, a term you should know was invented by Pharma to position estrogen as the fountain of youth. The Menopause Society has been working since at least 2003 to eliminate the use of that term.

In his interview on NewsNation (don’t make me listen to Megyn Kelly), Makary continues to lump all MHT together, as if vaginal, oral, and transdermal are all the same thing. They are not. Oral Premarin is not the same as transdermal estradiol, oral medroxyprogesterone acetate is not the same as oral progesterone or a levonorgestrel IUD. If you are treating actual patients or making governmental policy about hormones, you better understand the differences. The importance of being specific was explicitly addressed on the panel, so it’s super clear he was paying attention (read that in sarcasm font). This error, for which I would chastise a medical student, only reinforces how little I think of Makary’s understanding of MHT. For a doctor who has written a chapter on hormones and who attended a panel he organized himself on this topic to then go on TV the next day and promote hormones used in menopause as if they are a single intervention leaves me thinking that he is either incapable of learning anything outside of his surgical field, he is fully committed to Feminine Forever 2.0, or both.

Look at this chyron from his interview. This is disinformation, we do not have this data, and yet it is presented as a “breakthrough.” Makary is doing exactly what he blamed the WHI lead investigator for doing with the press many years ago, twisting words for a specific outcome to sell fear. I just can’t even.

In the interview on NewsNation, Makary spoke about removing the black box as if it applied to all forms of menopause hormone therapy, not just vaginal estrogen, but experts only support removing it for vaginal therapies. His quote:

“First of all, removing the black box warning, and we haven't officially decided to do that yet. Let me be clear, the FDA is taking a look at this as one of my top priorities.”

He should have said, “I will be convening a scientific advisory committee on the black box warning for vaginal estrogen.” To me, “we haven't officially decided to do that yet” sounds like he thinks that removing the black box warning is something that doesn’t need a scientific advisory committee, and it’s just up to him. But conflating vaginal estrogen and systemic menopause hormone therapy this way is useful if he plans on corrupting the science, and promote MHT for heart and brain health, something for which we do not have the data. I’m already getting trolled by menopause influencers who I guess now feel emboldened to make false statements about MHT being better than statins. I can only guess it is because Makary has been making this claim. For those who want to know more, I have written and MHT and statins for heart health here and here. And the Menopause Society issued this statement about misinformation and MHT last year:

Based on existing science and clinical evidence, estrogen-containing hormone therapy is not recommended for primary prevention of cardiovascular disease or dementia in women who experience menopause at the average age.

What is undoubtedly going to happen going forward is there will be a lot of propaganda about menopause hormone therapy from Makary, which will be repeated by a variety of influencers who have successfully commercialized menopause. All of the thoughtful work of the Menopause Society will be pushed aside in favor of cherry-picking, and I expect many news organizations to get it wrong. For example, about the panel, The New York Times reported that Dr. Pinkerton was pleading for the FDA to remove the black box warning, but the article did not make it clear that she was explicitly referring to vaginal estrogen. In science and medicine, the specifics matter, and communicating those specifics is not difficult in this case. Any reader could easily have thought Dr. Pinkerton meant all estrogen.

We have excellent, evidence-based recommendations from the Menopause Society and other reputable medical organizations, a fact that Makary, nor any panelist that I can remember, mentioned at the meeting. Makary also never mentioned the guidelines in his chapter or in the press. This does not mean that we know all there is to know, but it does mean experts have spent a lot of time sifting through the data to come up with as unbiased guidelines as possible. We can always use more research about heart health, brain health, and many other aspects of menopause, and it’s clear we need more data on how best to recommend menopause hormone therapy for osteoporosis. However, what is very concerning is the growing lack of respect for the quality evidence that we actually have, and dismissing randomized controlled trials that show no benefit for heart health for combination menopause hormone therapy for women in their 50s, like KEEPS, and the WHI, over lower quality shorter trials and observational studies that support preconceived conclusions is a worrying trend. While the ELITE study showed a benefit in reducing atherosclerosis in the carotid artery, there was no impact on cardiac calcium levels. ELITE contradicts KEEPs, but ELITE is oral and KEEPS includes a transdermal arm, which is the most common estrogen used. Fear mongering, oversimplifying, cherry-picking, and offering a solution that is a panacea appears to be profitable for many influencers, and it seems Makary has glommed onto that tactic.

Women deserve evidence, transparency, and due process—because when those are ignored, the consequences are real. Also, ignoring higher-quality data is misogyny, because it means that women don’t need science, opinion is sufficient. If Dr. Makary were serious about improving women’s health, he’d call for a scientific advisory panel on the black box warning for vaginal estrogen and commit to funding meaningful research. Instead, he’s using his book chapter on hormones as a springboard for policy and attention.

Though Makary clearly misunderstands the science behind menopausal hormone therapy, he knows how to play the PR game. By presenting himself as an MHT advocate, he’s gained positive press and a network of meno-influencers who amplify his message—often to mutual benefit.

It is true that many women have been scared to use vaginal estrogen or denied it based on the black box warning. It is also true that many women have suffered without access to menopause hormone therapy because their health care providers couldn’t be bothered to read the guidelines. And finally, it is true that menopause is underfunded and understudied.

None of these important issues are appropriately fixed by the erosion of science and process, because science is all about process. Using Makary’s cherry-picked Feminine Forever 2.0 beliefs as a blueprint for menopause care will be harmful in many ways, and not just for menopause, for the scientific process itself.

Ask yourself, do you trust a forced birther like Makary with the power to decide what drugs are safe for women? And do you deserve the scientific process, or would you prefer that we cherry-pick the literature to find articles that support a specific narrative?