UK drugs regulator and media industry self-regulator unite to wipe out supplements and bioidentical hormone alternatives to HRT
Nine days ago the UK media industry self-regulator, the Advertising Standards Authority (ASA), classified menopause as “a serious medical condition”.* This prepares the way for the prosecution of any seller or prescriber of food supplements or bioidentical hormone alternatives targeting this life stage of women.
This decision wasn’t made from thin air. It’s been in the making for several years.
Between February and June 2016, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) classified 3 food supplement products aimed at supporting menopause as unlicensed drugs. The products, which included the herbs black cohosh or Agnus castus, had to be removed from the market so the manufacturers would avoid criminal prosecution.
One company in particular vigorously defended its right to sell the products as food supplements using the statutory procedure. Central to any defence is the notion that the menopause is a natural life stage that marks the end of menstruation in a woman. Dictionary definitions make this abundantly clear, as does the prime health authority guiding medical practice, NICE, the National Institute for Health and Care Excellence.
Then there’s the question of the activity of the herbs themselves. Here we see the testing of the central tenet of the EU definition of medicinal product which declares any product a medicine if it is either presented to treat or prevent disease, or if it’s function is to correct, modify or restore physiological functions by exerting a pharmacological, immunological function.
Screengrab from Advertising Standards Authority (ASA) website
As early as 2003, we had foreseen this type of problem with national regulators acting arbitrarily particularly where food supplements competed with drugs. The competition that doesn’t like these food supplements that have sold safely for years, is of course the drug companies selling HRT.
Cementing these decisions is the latest advisory issued on 18 September 2017 from the UK’s media industry self-regulator watchdog, the Advertising Standards Agency (ASA). The ASA has long been a controversial private entity that behaves more like a government regulator. In December 2016, ASA issued guidance that pre-empted the notion of menopause as a disease.
But now – the ASA has classified menopause as “a serious medical condition”. We’re not talking here of the treatment of, or reference to, symptoms, we’re talking about any reference to the term ‘menopause’ by an advertiser!
In effect, the ASA’s new edict means not only does the MHRA now have a media industry body doing its dirty work – and let’s not forget that the media is heavily funded by Big Pharma – Big Pharma has eliminated significant competition from any company selling a natural alterative to HRT.
ANH-Intl friend and supporter, Alyssa Burns-Hill, who has for some time been in the cross-hairs of the ASA, tells it straight in her latest blog.
Find out more about the ASA
Action plan initiated
This initiative is aimed fairly and squarely at those using bioidentical hormones and herbal products. Both have proven very popular among women of a certain age wishing to avoid the side effects of HRT which include an increased risk of cancer.
This is not something that we can sit and allow to happen. We are looking at various ways of effecting change – and stay tuned – because sitting on the sidelines is just not an option when it comes to government regulators and media industry self-regulators twisting rules for their own benefit, to the detriment of tens of thousands of older women who will soon have no option but to go their doctor’s and be prescribed HRT.
*Update 20/11/17 - The ASA have amended their wording as follows: "Whilst the menopause itself is obviously not a medical condition, the ASA is likely to consider the symptoms of the menopause to be conditions for which medical supervision should be sought. Claims to treat those symptoms are likely to discourage essential treatment, unless that treatment is carried out under the supervision of a suitably qualified health professional"