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  • Tania Elfersy

Can we stop experimenting on women?



The medicalization of menopause started in the US as one big experiment.

For decades, and without science to back up their claims, doctors in the US led the way in convincing women that their midlife bodies were destined to malfunction. Poorly tested hormone therapy was offered as a panacea for over 25 symptoms associated with menopause, and as a strategy to prevent future disease.

With time and in the shadow of numerous HRT scandals, which revealed the false promises made around hormone therapy and brought into question its safety (especially with prolonged use), doctors became more cautious. By 2017, the North American Menopause Society (NAMS) had changed their policy statement on hormone therapy to reflect how large randomized controlled trials had only managed to show the impact of hormone therapy on a limited number of symptoms, and failed to show any impact on disease prevention.

At that time, over the pond, a new approach was emerging around the treatment of menopause in the UK.

Historically, British women had been more reluctant to turn to hormone therapy to relieve their symptoms, but something was about to change.

Despite the fact that the NAMS policy statement on hormone therapy had been endorsed by most of the menopause societies in the world, The British Menopause Society continued to claim that HRT could relieve more symptoms and prevent disease. Within a few years, a group of menopause influencers emerged and became popular guests on daytime TV. The influencers – celebrities, politicians, and media folk – declared a “menopause revolution.”

They positioned themselves as feminists but came up with some pretty strange revolutionary feminist messaging, which boiled down to:

- Fear your body

- Fear menopause

- Relate to menopause as a deficiency disease

- Save yourself with HRT – your “cure” for current and future ills

- Tie your well-being to government and corporate supply chains


With connections in influential places, there was barely a news item on menopause that didn’t promote these messages, again and again.


In addition, despite strong advertising laws in the UK, which prohibit the advertisement of prescription drugs, HRT was promoted as if these laws had vanished. Celebrities would show women how to administer HRT products, and promote them for off-label use while no official medical body seemed to care. HRT was marketed like candy, and more and more menopausal women were convinced that it was the right choice for them.


Between 2017 and 2021, the number of HRT prescriptions doubled in the UK. The behavior of British women had changed. It was an excellent test-case for pharma interests.


Meanwhile, GPs knew that HRT was not an easy medicine to prescribe. Although it can help certain women with some menopause symptoms, for others it can worsen symptoms or have no effect at all. In fact, once a doctor starts a woman on HRT, it is likely she’ll be back for a few different prescriptions until she finds a type of HRT that works for her, if she can find one at all.


So, while the media continued to market HRT as a cure-all for women at midlife, doctors remained reluctant prescribers of the drug.


In came the private clinics. For those doctors offering private menopause consulting, business started to boom. For one particular doctor who regularly appeared in the media pushing the option of HRT as a simple solution to almost all of women’s problems at midlife – from a lack of motivation to exercise to mental distress – her business would grow to accommodate a monthly client base of up to 4,000 women seeking treatment for perimenopause and menopause symptoms, in three different well-branded clinics.


Women, who were desperate to relieve their symptoms (I remember how that feels) were willing to pay a high price to get “fixed.” But after all the money they spent, they wanted results. It seems “perhaps HRT isn’t going to work for you” would not be something they wanted to hear after they had been led to believe that HRT would work like magic, no matter what. The solution? If a commonly prescribed dose of HRT wasn’t delivering relief, up the dose, regardless of medical guidelines, until some level of relief was achieved.


And for a woman with a medical history that prevented her GP from prescribing her HRT? Well, it turns out that in private clinics there were more possibilities to bend the guidelines.


Medical guidelines are in place to protect patients from unnecessary risks. Were women at private clinics being informed of the increased risks from higher doses of HRT? It seems not.


In December 2022, the Pharmaceutical Journal reported that private menopause clinics were prescribing estrogen at up to twice the recommended dose. The article quoted medical experts who were concerned that the high doses of estrogen without adequate protective amounts of progesterone were exposing women to greater risks of hyperplasia and cancer. But there was no public outcry and no visible action taken on behalf of the medical organizations that are supposed to weigh in on such practices to protect patient safety.


Then on 2 April 2023, Barney Calman at The Mail on Sunday published an exposé on a celebrity doctor “accused of putting women at risk of cancer by prescribing 'alarmingly high' doses of HRT.”


With reports of some private clinics prescribing three, four or more times the licensed maximum dose of estrogen, The Mail interviewed patients who following such high-dose prescriptions had experienced excessive bleeding, mental health issues and endometrial hyperplasia. The article triggered other women who had experienced similar problems to come forward to share their stories. I witnessed this in social media posts and Dr Jen Gunter, OB/GYN and author of The Menopause Manifesto tweeted:


The Mail article quoted Joyce Harper, professor of reproductive science at the Institute for Women’s Health at University College London, who said she was ‘horrified’ by their findings.


She explained: “You should not go against guidelines and give women higher and higher doses of a powerful drug without any real data on what it will do.


“This is not evidence-based medicine. If you do want to try a new approach then it should be done as part of a clinical trial, otherwise it could be dangerous.

“In my opinion this sort of practice is treating patients like guinea pigs and charging them for the privilege.”


When asked to comment on the practices in their clinic, “Newson Health clinical director Dr Magnus Harrison responded: ‘We are not aware of any peer-reviewed data that shows there is an increased clinical risk associated with higher doses [of oestrogen]. Informed consent is not used at Newson Health Group. We have a philosophy of shared decision-making and empowerment of the women who choose to attend.”


This shocking statement and others in The Mail on Sunday article led the British Menopause Society and relevant medical bodies to issue a joint news alert a day later. The Joint BMS FSRH RCGP RCOG SfE and RCN Women's Health Forum safety alert stated: “We are aware of increasing numbers of women being initiated on high doses of oestrogen which exceed the product licenses, not in line with any clinical guidelines. Oestrogen should not be regularly prescribed in doses higher than the upper limit listed in the individual Summary of Product Characteristics (SmPC) as these limits are informed by the results of clinical trials, to ensure patient safety. If in exceptional circumstances a higher than licensed dose is deemed necessary for symptom control, informed consent should be obtained according to good medical practice guidance and patients must be made aware that treatment falls outside of reassuring safety evidence. In addition, the dose of progestogen should be increased proportionately.”


As more women come forward with their stories of harm from high doses of estrogen, I would like to add a message of calm. While HRT can offer women benefits, just like all medicines, it also carries risks.


For women who have taken doses of HRT similar to those mentioned in the The Mail on Sunday article, it is worth remembering that even in the 1960s when women were prescribed higher doses of hormones for life, not all women experienced negative side effects.


Some did. And while it is important to understand the risks involved, stressing out about medicines that we may have taken is unlikely to promote health.


The body always tries to bring us back to our innate health and we can return to balance even after we have taken a trip off nature's path.


In addition, feeling better during perimenopause and menopause does not have to involve a medical route because despite what we have been told, the body is designed for change. There are choices that we can make that will reduce our symptoms and allow us to experience greater well-being, naturally and simply, even while our hormones are in flux.


It was clear that something had to change in the UK if women's health was going to be respected. A so-called “menopause revolution” that dragged women back to the misogynistic approach of menopause care of the 1960s was good news for pharmaceutical interests, but it was never going to serve women well.


Women deserve accurate information and true choice when it comes to understanding what can support us safely during perimenopause and menopause.


Hopefully, as we move forward, the two central pillars of medical ethics – first, do no harm, and informed consent – will be upheld.


 

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