Prof Susan Davis was shocked to see her name on the website of an Australian telehealth menopause clinic offering a product she believes “is frankly reprehensible” and “misleading women”.
Davis, the director of Monash University’s Women’s Health Research Program, was concerned that the unauthorised use of her name and accompanying quotes suggested she backed the custom-made menopause hormone therapy (MHT) being sold.
Known as “compounded bioidentical” MHT, the treatments are custom-mixed by pharmacists and often promoted as a personalised and “natural” way to manage menopause symptoms.
While MHT sold in ordinary pharmacies contain known quantities of hormones and are approved by drugs regulator the Therapeutic Goods Administration, therapies made by a compounding pharmacist are not subject to the same dosing, quality or safety standards.
The website removed Davis’s name and quotes after she complained . The company was also using her name on advertisements recruiting doctors.
However, Davis said the problem of companies selling compounded MHT by misleading women to believe it was more “natural” and therefore safer than regular MHT had “really come to a head” as industries sought to profit from the menopause moment, especially on social media.
Davis said she frequently had patients come to her with “all sorts of problems” because they were using a compounded product containing either too much or too little of specific hormones.
Davis, an endocrinologist, said women did not realise the compounded formulations were an unregulated prescription.
Compounded bioidentical hormones have been associated with endometrial cancer, the Australian Menopause Society (AMS) has warned.
On its own, oestrogen – used to treat hot flashes and night sweats and prevent bone loss – may increase the risk of endometrial cancer.
Ensuring the correct dose of the progesterone hormone to balance this is important to protect the lining of the uterus against thickening, which is what increases the cancer risk.
Dr Amie Hanlon, an obstetrician-gynaecologist and member of the AMS’s board of directors, said one of the greatest concerns with the use of compounded hormones was that “it can’t be guaranteed that, if women are using oestrogen, that there’s enough progesterone in their products for safety of the uterine lining”.
“There have been some cases of endometrial cancer arise from the use of compounded hormones,” Hanlon said.
Davis said that as well as patients who had required surgical management due to complications from thickening of the lining of the uterus, she had also seen patients with issues arising from “massive” oestrogen doses.
“The Australasian Menopause Society would be aligned with the other national and international societies in that we would all strongly advise against the use of compounded bioidentical hormone therapy,” Hanlon said.
The Pharmacy Board of Australia’s guidelines state that pharmacists should only compound products if there is not an appropriate commercial product available, or if a commercial product is unsuitable for a patient; for example, if someone is allergic to an ingredient in a manufactured product.
In May the federal government banned compounding pharmacies from creating replicas of Ozempic and other weight loss drugs due to safety concerns.
Davis said she did not support a total ban on compounded therapies “as these are sometimes the only option in quite unique circumstances”.
“But the circumstances in which compounded hormones can be prescribed need to be tightly regulated,” she said. “There should also be the requirement that patients be provided with written information that the treatment is not TGA approved or regulated.”
Why do women buy compounded MHT?
Prof Martha Hickey, the chair of obstetrics and gynaecology at the University of Melbourne and the lead author of the Lancet clinical series on menopause published in March, said she was concerned by the increasing promotion of compounded MHT, particularly on social media.
The companies selling these products claim the customised compounding can be better suited to an individual’s specific hormone levels, which they will often test based on biological samples. However, Hickey said there was no evidence that the tests, or the customised formulas, can better manage symptoms and hormone levels, which can change frequently during the menopause transition.
“We all love the idea of something being individualised – it makes it sound more special, that it’s being tailored to our needs – but there isn’t evidence that these kinds of compounds can provide that individualised care,” Hickey said.
Davis said the websites of companies – including the one which appropriated her quotes – are rife with misinformation. She has seen “pseudo-scientific” claims that bioidentical hormones are more natural than synthetic hormones because they are derived from the Mexican yam root.
Davis said the TGA-approved hormones doctors commonly prescribe were equally natural, given they were also derived from the Mexican yam. The difference is that the TGA-approved products meet regulatory standards.
“Most hormone production is from the Mexican yam – including the oral contraceptive pill,” Davis said.
“It is no different to many of the therapies approved by the TGA, our national regulator of drugs, [which are] equally as bioidentical as what they’re offering.
“There’s absolutely no need for a woman to go first to a compounded hormone when we have these available.”
The cost of compounded HRT is also considerably higher than conventional HRT. “Supplements are also a money pit for women, but they’re probably not going to hurt you,” Davis said. “The compounded hormones have the potential for harm.”
Hickey said women might be turning to compounded hormone therapy when they hadn’t received the solutions they were hoping for from conventional menopausal HRT.
“All the industries are trying to profit off the menopause moment … This is not just about the unregulated products, it’s also about heavy marketing of the regulated products,” Hickey said.
Many symptoms commonly cited – like brain fog and rage – have not been shown to improve with any kind of menopausal hormone therapy and may not be due to menopause, Hickey said.
“Say you have rage or brain fog, and you went to your doctor, and you were given menopausal hormone therapy, and it didn’t get better… But you can read on social media that it is a menopause symptom, then you might be seeking something else to try and help you deal with that,” she said.
“Our problem in Australia is that these products are not regulated, and how they’re advertised is not well regulated, so I think it makes women very vulnerable.”
