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How a media frenzy caused incalculable damage to hormone replacement therapy worldwide
In 2002, a study by the Women’s Health Initiative (WHI), a globally leading outfit that conducts research, caused a media frenzy linking hormone replacement therapy (HRT) to breast cancer, heart conditions, and stroke. Speaking at the annual congress of the South African Menopause Society in Stellenbosch, gynaecologist Professor Alan Alperstein discussed the implications of the sensationalised media coverage, which caused HRT prescriptions to plummet and antidepressant prescriptions to soar. Alperstein explained that the media aggrandised and discussed the rise of Compounded Bio-identical Hormone Therapy (CBHT), warning of the potential risks and lack of scientific evidence associated with it. This article by health journalist Chris Bateman demonstrates how the controversy surrounding the WHI caused incalculable damage to the highly beneficial HRT worldwide. Also noteworthy is the extent to which the media is capable of bending the truth and, in turn, society’s course. This article first appeared on Med Brief Africa. – Nadya Swart
Veteran gynae unpacks HRT.
By Chris Bateman
A media-fueled frenzy linking hormone replacement therapy (HRT) to breast cancer, heart conditions and stroke in Britain in July 2002 caused incalculable harm to women’s healthcare and had no scientific basis.
Professor Alan Alperstein, a part-time obstetrician gynaecologist at the University of Cape Town and Groote Schuur Hospital, said the media reports caused inestimable damage to highly beneficial HRT worldwide.
He was speaking on Friday last week at the first live annual congress of the South African Menopause Society in Stellenbosch since the Covid outbreak in March 2020.
Reports on the controversial Compounded Bio-identical Hormone Therapy (CBHT) study by the Women’s Health Initiative (WHI) leaked in July 2002 (just before its scientific publication) and saw HRT prescriptions plummet and antidepressant prescriptions soar.
Alperstein provided a scientific perspective on the watershed controversy, which has echoed to the present day.
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He said the media sensationalised a very limited WHI study where the average age of the women was 63, a full 16% were within the last five years of their last menses and most already had a silent cardiovascular disease. Also omitted in the media reporting was that half of the women studied were current or former smokers and had an average body mass index (BMI) of 28,5 (with many of them obese), while the average participant was an older, overweight smoker – and asymptomatic.
“So, it was a study of fat, unfit, asymptomatic, older, smoking women – hardly a healthy cohort,” he quipped.
He displayed a WHI graph marked on July 17, 2002 (the date of the study publication), showing how HRT prescriptions subsequently tracked down while antidepressant prescriptions rose. Prior to this, the two tracked more evenly, with HRT prescriptions well above antidepressants.
The consequences of the initial WHI-linked controversy were that doctors and patients became fearful of HRT, many doctors advised discontinuing HT, and half of its users stopped. The pivotal media ‘event’ fueled a multi-billion dollar market in alternative and complementary products to relieve menopausal vasomotor symptoms. However, he noted that as many as 25% of those who stopped HT returned to their doctors for ‘permission’ to resume treatment.
An aggressive and highly seductive advertising campaign promoting bioidentical hormones as a ‘safer and more effective’ option and touting them as ‘exact replicas’ of those produced by the female body before menopause, rubbished synthetic versions as having ‘dangerous side effects’.
In South Africa alone, 1,7 million women googled bioidentical hormone use, and within a few years, 2,5 million women over 40 in the USA were using CBHT.
Many women thought CBHT was safe because it was touted as ‘natural.’
Alperstein said CBHT products were not FDA-approved, while ‘bioidentical’ was a marketing term by clinics punting the benefits of CBHT.
“It has been proposed by menopause specialists that rBHRT (r = regulated) should be referred to as ‘body identical’ – to distinguish regulated hormone therapy from the compounded varieties,” he said.
He explained that with bioidenticals, the dosage was adjusted according to salivary or blood hormone levels, unlike commercial HR, which was adjusted based on symptom relief.
Additionally, supposed anti-ageing, sexual vibrancy and energising effects were similar to structure/function claims made for dietary supplements rather than disease treatment/prevention claims made for drugs.
He explained that some bioidentical hormones were made by drug companies and were FDA-approved (e.g. Estradiol pills, patches, gels, sprays, vaginal rings and oral micronised progesterone).
However, compounded bioidentical hormones were custom-made by a pharmacy according to a doctor’s orders. Compounding involves ingredients being combined or altered to meet the needs of an individual. The compounded forms were not tested nor approved by the FDA.
Although these products were advertised as ‘natural choices’ because they were made from plants, they were actually altered in a laboratory.
Pharmacy compounding of BHT was now a multi-billion-dollar-a-year industry. Bio-identical HR drugs were prescription drugs, not over-the-counter, and physicians should always be part of the patient, pharmacist, doctor triad, he emphasised.
Most bioidentical hormones were made and sold without controls for safety, quality or purity, and a plethora of medical organisations had taken a stand against them. While CBHT was often touted as being safer and more effective than synthetic hormones, the FDA and most doctors cautioned that these claims were unproven in any reputable studies – and that they could even be potentially dangerous in some cases.
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Digging for reasons for the huge surge in CBHT prescriptions (beyond the initial media alarmism), Alperstein said there was a societal suspicion of traditional medicine, a dislike of pharmaceutical companies and a perception that CBHT was a safer alternative.
“Natural is equated with safer, wider and more aggressive advertising via the internet and other media plus a patient preference for alternative medicine – which begs the question of just how ‘alternative’ CBHT is,” he said.
The least likely reason was that patients were still symptomatic on properly prescribed commercial HR products.
Given the uncertainty as to whether South Africa’s Medicines Control Council (MCC) or the South Africa Health Products Regulatory Authority (SAHPRA) could effectively regulate, there was no real incentive for anyone to do randomised controlled or comparative studies locally.
“It would be great if somebody did because there’s little or no substantive data comparing BHT with commercial HT. Those that exist all have deficiencies,” he stressed.
Alperstein said almost all potential patients could obtain adequate medical therapy/symptom relief with commercial HR were they “prescribed properly and patients so inclined to take them.”
Some healthcare professionals who prescribed CBHRT claimed to be able to determine the precise requirement of each individual woman via a series of complex serum and saliva tests. However, this costly practice had never been substantiated through rigorous research and was not recommended by the menopause societies, and was ‘largely unnecessary’.
He cited the North America Menopause Society position statement that CBHT presented safety concerns, such as minimal government regulations and monitoring, overdosing and underdosing, the presence of impurities and a lack of sterility, lack of scientific and safety data and the lack of a label outlining risks.
Higher risk possible
Most experts agreed that the risks for BHRT and HRT were similar, but compounded bioidentical hormones “may carry even more risk – there’s no credible evidence that BHRT is more effective than HRT,” he said.
Alperstein said intelligent, aware women often spent an inordinate amount of time with their physician or with ‘Dr Google’, researching the efficacy and adverse events associated with the medicines they were prescribed.
Curiously, the same women were happy to take various unregistered and unregulated hormones which had not undergone controlled trials and for which there were no efficacy or safety studies.
Prescribers were often not gynaecologists or even medical practitioners but homoeopaths and compounding pharmacists, so “patients are therefore often not adequately examined or even examined at all,” he added.
Healthcare practitioners should explain to women that the efficacy and safety of unregulated CBHT were unknown, as were the quality, purity and constituents.
Those women with a history of, or at high risk of, breast cancer should be told that although there was some evidence that St John’s wort may be of benefit in the relief of vasomotor symptoms, there was uncertainty about appropriate doses, the persistence of effect, the variation in the nature and potency of preparations and potentially serious interactions with other drugs (including tamoxifen, anticoagulants and anticonvulsants).
Alperstein said physicians hurt patients by taking them off meds with known safety and efficacy to place them on BHT where these were unknown. They also wasted scarce patient financial resources on meaningless hormone level testing and more expensive BHT that offered no therapeutic advantage. Just because patients wanted this therapy and were willing to pay for it did not mean physicians had to go along with it.
“You prescribe only when it’s indicated. It’s the medical profession’s job to place real limits on this. It’s our fiduciary duty to do so,” he asserted.
The trade-off was patient autonomy versus evidence-based medicine, and you have to ask, “what do we stand for as a profession, really?” he added.
The South African Menopausal Society did not recommend the use of BHT. No hormonal preparation, or a preparation presumed to have a hormonal effect, should be prescribed for a woman without a full history and examination. This included a breast exam, periodic mammogram, and pelvic exam, which would not infrequently also require a transvaginal U/S scan of the ovaries and endometrial thickness.
“I guess to be old and wise, you first have to be young and stupid,” he quipped.
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