Misinformation about Bioidentical and Compounded Hormones

The Dangerous Legacy of Suzanne Somers

Sadly, Suzanne Somers died this week from breast cancer. I struggled with how to write about this or if I should write anything at all. And yet her impact on menopause was undeniable, and unfortunately not in a good way. Under the guise of female empowerment, she used her celebrity to advocate for unproven and dangerous hormone regimens. She became an influencer on menopause before being an influencer was even a thing. Somers was the original “bioidentical” and “compounded hormones” juggernaut. If you have heard those words regarding menopause or asked for those hormones, it is almost certainly related to Somers.

Many doctors, none with real expertise, had tried and failed to popularize the concept of “bioidentical” and compounded hormones before her. It wasn’t until Somers started writing about these concepts and, more importantly, getting promoted by celebrity magazines and various major outlets, such as Oprah, Larry King, and ABC News, to talk about it that it went viral before we even knew what that meant. It wasn’t just because of her celebrity, her appearance, her use of medical terminology, or her friendly yet confident demeanor. Somers was interesting to the public because she had estrogen-receptor-positive breast cancer, and instead of following the full treatment recommendations, she took estrogen, seemingly in very high doses, something that is universally recommended against. She took the position that women are essentially nothing without hormones, which played into misogynistic tropes that got and still get the attention of the press and the public. And the press positioned her as someone who “did their own research” and might even know more than doctors. This was the dawn of the era of “doing your own research” for your health, but instead of discussing what that might actually entail, like listening to real experts and developing a strong understanding of reproductive biology, the public could buy into Somers's words and by proxy, they had done their own research too. 

Somers almost single-handedly vaulted a fringe, untested medical hypothesis into the mainstream. This is important because, according to Google Trends, searches for bioidentical hormones have spiked since the announcement of her death. Some people are paying homage to her “menopause advocacy,” and others are posting about how her “regimens” saved them. This means many people are clearly unaware of the dangerous and unproven nature of Somers’ recommendations.

Given the possible renewed interest in what she promoted and the truth behind Somers’ research and experts is often glossed over or even completely ignored, I felt it was appropriate to set the record straight.

The Suzanne Somers Effect

I often show this graph when speaking about misinformation on social media and the celebrity effect. It’s a Google Trends search for “bioidentical hormones” back to 2004 (as far back as I can search). 

Notice the three biggest spikes, which are in 2004, 2006, and 2009. Each one is linked temporally with Somers. The first spike is in March 2004 and corresponds with the release of her book. “The Sexy Years: Discover the Hormone Connection--The Secret to Fabulous Sex, Great Health, and Vitality, for Women and Men” (March 2004). The second spike (behind the label) is October 2006, when her book “Ageless: The Naked Truth About Bioidentical Hormones,” was published. The massive January 2009 spike coincides with Somers’ appearance on the Oprah Winfrey Show, where she was essentially given a free platform to promote medical disinformation about “bioidentical hormones” to Oprah’s following.

The “Research”

Somers used a variety of sources to “research” her medical care over the years, cherry-picking the ones that supported her beliefs. Still, one that seems to have had the greatest impact on her and also stands out in horror is the Wiley Protocol®, which sounds medical but is a hormone regimen designed by T.S. Wiley, a woman without medical training. The Wiley Protocol® is apparently “bio-mimetic HRT” (a nonsensical term) that was a “thought experiment” by Wiley. It involves a series of color-coded syringes with varying concentrations of compounded estradiol and progesterone that are applied to the skin and are purported to raise the serum levels of the hormones cyclically to mimic the levels seen in a twenty-year-old woman. 

Somers’ 2006 book, “Ageless: The Naked Truth About Bioidentical Hormones,” is essentially an infomercial for Wiley, who is introduced as an “anthropologist who focuses on evolutionary biology and environmental endocrinology in molecular medicine and genetics.” That sounds impressive, and Somers promotes Wiley as a scientist, but anthropologists don’t typically recommend medical protocols or instruct pharmacists about compounding hormones. After the press snooped, Wiley changed her biography to state she "Attended the B.A. Program in Anthropology, Webster University, 1970-1975." The Riverfront Times had her lack of degree confirmed by Don Morris, the school's registrar. 

The Wiley Protocol is best described as medically absurd, and it’s no shocker that someone with no medical training or expertise conceived it. A deep dive into this “protocol” was published in 2007 in the journal Menopause, and frighteningly, it was being promoted unethically to the unsuspecting public as a study. And yes, some doctors still prescribe the Wiley Protocol® today, and there are pharmacists willing to make it.

Promoting an unstudied, dangerous hormone protocol from a completely unqualified person as science-based is not advocacy. 

The Wiley Protocol® is so DANGEROUS that not even Dr. Christianne Northrup would recommend it! Northrup and several other doctors wrote an open letter to Somers’ publisher about the harm involved in the Wiley Protocol. In truth, these doctors might have viewed the Wiley Protocol as competition for their own compounded hormone practices. But still, imagine being too out there for Northrup.

Another of Somers’ experts was Dr. Prudence Hall, who wrote the foreword for Somers’ 2013 book, “I’m Too Young for This!” Dr. Hall was placed on four-year probation by the Medical Board of California in 2018, charged with “gross negligence, repeated negligent acts, and failure to maintain adequate and accurate medical records in the care and treatment of two patients” related to her prescribing of hormones. It is extremely difficult to get suspended by a medical board, so there’s that. 

Somers clearly believed deeply in the Wiley Protocol®, in the “miracle” of compounded hormones, and in the doctors who apparently told her what she wanted to hear: that high doses of hormones were healing when what she was taking was not supported by science and was medically concerning. The charitable take here is that she was misled, like so many other women, by medical grifters, and the success of her books and all the media attention just reinforced her idea that she was helping women and had “the answer.” 

The Oprah Connection

Somers appeared on Oprah in 2009, where she was positioned as an expert. Here’s Oprah holding up Somers’ recently published book immediately after Somers gave this quote, “The synthetic hormone business is a 20 billion dollar a year business.” There is no mention of how much money T.S. Wiley had made from her patented, yet unstudied, Wiley Protocol®.

The implication from Somers was Pharma wants to harm you and that she has a safe gateway to the fountain of youth. Somers and Winfrey successfully rebranded every misogynistic trope about hormones as feminism, and the absence of medical evidence was not presented as a concern; rather, it was advocacy. 

This is why I am also cynical about Oprah’s current foray into menopause education. Allowing Somers to promote an unstudied hormone protocol designed by someone without a college degree doesn’t scream menopause advocacy. And if Oprah didn’t research those things and just elevated Somers because menopause makes bank, then again, that too suggests to me a lack of judgment needed to take the lead on menopause. 

Then again, when it comes to health, Oprah has always leaned into the “what they are keeping from you” conspiracy theory aspects, never asking any important questions, just providing the illusion of investigation. For example, the fact that  Suzanne Somers developed her breast cancer and precancer of the uterus while taking her “bioidentical hormones” should have been worth discussing but was ignored. 

Oprah did give Somers space to discuss her precancer of the endometrium by way of an excerpt from one of her books on Oprah.com. Somers never considered that her cancer could have been caused by high doses of unregulated estrogen and topical progesterone (essentially a recipe for causing endometrial cancer). No, the cause was a medication she received to dry up her milk postpartum, the birth control pill, and not “cycling” her hormones, none of which is biologically plausible. The birth control pill actually reduces the risk of endometrial cancer. Oprah, the menopause champion she is, still has that misinformation up on Oprah.com (or at least she did as of my writing this piece).

The Truth about “Synthetic Hormones”

“Bioidentical hormones” can only be good if “synthetic hormones” are bad. So Somers’ promotion of “bioidentical hormones” included a campaign of disinformation about tested pharmaceuticals, labeling them “synthetic,” when in reality she was also taking “synthetic” hormones. The word synthetic was useful to her as it’s a devil term, meaning a word we automatically think negatively about; it is commonly abused to scare people unnecessarily. Whether something is synthetic or natural is irrelevant. What matters is whether or not a medication has been tested to be safe in humans. Synthetic can mean one of two things:

• Made in a lab

• A novel compound, for example, levonorgestrel, a hormone used in birth control pills, or bazedoxifene, a selective estrogen receptor modulator.

The hormones Somers was taking were made in a lab, just like the safe, tested, and regulated Pharma hormones that I prescribe.

To add to the confusion, the process of making hormones also uses similar words, synthesis and semi-synthesis.  Semi-synthesis means the starting compound was found in nature and then converted in a lab to another substance. Hormones can also be made by synthesis, meaning from smaller molecules not found in nature. Estradiol made by semi-synthesis and synthesis are identical. The estradiol we prescribe today and have always prescribed is made by semi-synthesis. 

If you want natural estradiol, that would have to be extracted from animal or human ovaries, placenta, or urine from pregnant animals or humans. There is no natural estradiol to prescribe because the process of extracting it requires far too much raw material (animal ovaries, placenta, or urine) to make it feasible to scale. 

The Truth About “Bioidentical” Hormones

Bioidentical is simply a marketing term that is medically meaningless. Bioidentical implies that the hormones are identical to what your body makes, so people assume they are safer, which is not the case. Here’s what you need to know about them:

• No hormone made in a lab can truly be identical to what your body makes, and that’s okay because your body doesn’t know the difference and doesn’t care. It treats estradiol as estradiol, be it lab-made or ovary-made.

• If you are stuck on using the term bioidentical, all estradiol and progesterone is bioidentical.

• I can kill you with enough estrogen from your ovaries, meaning exactly identical estrogen, by giving it to you in high doses over a long period of time so that you get cancer. Being similar or even identical to a hormone does not make a hormone safe.  

You need to know that transdermal estradiol is the first-line therapy for MHT and that conjugated equine estrogens definitely have their place as an option. 

Compounded Hormones are Not “Special,” and they are Less Safe

The estradiol in a compounded product is the same as the raw hormone that becomes estradiol in a pharmaceutical product. There is no compounded hormone estradiol tree. Yes, the raw estradiol that was eventually made into the cream Somers used came from the same place as the estradiol used by pharmaceutical companies.

Estradiol from a pharmaceutical company is measured, prepared, and dosed with precision. These products have been rigorously studied so doctors know how much is absorbed in our patients’ bodies. Making a hormone that a human can use with controlled dosing takes years, if not decades, of research; this cannot be safely whipped up on the fly. Compounded products, like those used and promoted by Somers, do not have this research on which to base their recipes, and they don’t have the quality control of Pharma.

All the safety data we have on hormones is with appropriately dosed pharmaceuticals. With compounded hormones, we don’t know if you are getting far more estradiol than has been studied, so we can’t know your risk of cancer or stroke. And if you are getting far less, you risk not getting the estrogen's benefit. The dosing and absorption of these products is erratic. And topical progesterone just doesn’t work because it isn’t absorbed.  

It’s Complicated…and It Isn’t

Nothing Somers recommended was evidence-based. EVERY professional medical society recommends against compounded products, and the National Academies of Sciences, Engineering, and Medicine also recommends against compounded hormones. And as you’ve learned, bioidentical is medically meaningless marketing.

There will likely be people claiming that Somers lived longer because of the compounded hormones that she took. To anyone thinking that it’s equally possible that she would never have had breast cancer recurrence if she had followed her doctors’ advice. The answer isn’t possible to know, so we shouldn’t presume one way or another or rely on anecdotes. 

I know that Suzanne Somers was beloved. I have great memories of watching her on Three’s Company, which is why, as a doctor, I was really taken aback by her claims about hormones. My fond memories were replaced by anger as she leveraged her privilege and used it to promote harmful ideas. Ideas that have harmed my patients and countless others. There was no more effective champion for unsafe hormones in menopause than Somers. She almost single-handedly made the lie of bioidenticals being “safer” a thing and vaulted unsafe, unregulated compounded hormones into the daily lexicon. She also paved the way for the second generation of untested, unsafe compounded hormones: pellets.

And doctors like me are still undoing this harm every day. 

References

Rosenthal MS. The Wiley Protocol: an analysis of ethical issues. Menopause. 2007;15:1041-1022.

Open letter to Suzanne Somers and publisher https://drerika.typepad.com/notepad/2006/10/letter_to_suzan.html

Riverfront Times https://www.riverfronttimes.com/news/weird-and-wiley-science-2574568

Book excerpt from Ageless, the Naked Truth about Bioidentical Hormones, oprah,com https://www.oprah.com/health/excerpt-from-ageless-the-naked-truth-about-bioidentical-hormones-by-suzanne-somers/all

Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. Menopause. 2015 Sep;22(9):926-36. doi: 10.1097/GME.0000000000000420. PMID: 25692877; PMCID: PMC4547729.

The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020). The National Academies Press. ISBN 978-0-309-67712-7.

FDA actions against compounding pharmacies https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions

Jiang X, Bossert A, Parthasarathy N, et. al. Safety assessment of compounded non-FDA-approved hormonal therapy versus FDA-approved hormonal therapy in treating postmenopausal women. Menopause 28, 8. DOI: 10.1097/GME.0000000000001782

Dohm J, Kim J, Woodcock J. Improving Adverse Event Reporting for Compounded Drugs. JAMA Intern Med. 2019;179(11):1461–1462.