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[Emma]

Bio Identical HRT adverts misled women. Bioidenticals are NOT safer or more effective than HRT.

Radio 4's consumer affairs programme 'You & Yours' lead an investigation into claims that Bio Identical HRT adverts have mislead women.

Listen here:
http://www.bbc.co.uk/programmes/b092jw41

it's the first article beginning at 57 secs and lasting for 5 minutes

The Advertising Standards Authority report on Bioidenticals is here:
https://www.menopausematters.co.uk/newsitem.php?recordID=186/The-ASA-report-on-Bioidenticals

[Hurdity]

How timely is that?! Thanks for posting this Emma. I would never have known about it otherwise.

CLKD - not sure what twice means?

I listened to the clip and also to the more detailed original investigation from July 2016 which led to the ASA investigation into the claims. Breeze if you listen to the original one there is much more detail and today's is more of a recap and follow-up - along with the ASA ruling.  http://www.bbc.co.uk/programmes/b07jqqw1  (you have to register and sign-in to listen). Heather Currie is also interviewed as part of the 2016 investigation.

The main thrust of the argument is that some of the private clinics (such as the Stratford Dermatology Clinic featured in the latest investigation) are making unsubstantiated claims - specifically that BHRT that they prescribe is safer and more effective than their conventional counterparts. Independent medical experts reviewed the evidence provided by this particular clinic and found no good evidence to back-up their claims and therefore the complaint against them was upheld by the ASA and the clinic has had to change their advert.

Also a woman who had hoped for a more "natural" approach was charged around £1000 (including blood tests) and in the end didn't even get the prescription that was discussed with the doctor.

In the previous You and Yours investigation, someone from the London Specialist Pharmacy (that manufactures the various hormonal preparations - pessaries, creams etc - from the raw powdered hormones) was interviewed and said there was a body of evidence proving that these were safer - but what was missed from this was the fact that "bio-identical hormones" ie BODY-identical hormones (same molecular structure as our own) - are available as part of conventional HRT in the form of estradiol and progesterone. The evidence she was talking about actually refers to these hormones rather than the way they are prescribed and delivered via these private clinics.

Yes there is always debate about approved medicines too! However this is a case of some private very expensive clinics pulling the wool over women's eyes and making out that their treatments are more natural, safer, more effective and individualised (as a result of blood tests) than (some) conventional treatments, so good to see that some are being taken to task over this.

Hurdity x

[dazned]

As you say Trey it's quite easy to be misunderstood so best to discuss your particular wants/needs with your gp ,consultant etc. It's a real minefield.

[Dana]

I'm pleased to see the alleged "safety" of bioidentical compounded hormones has been addressed by Emma/Dr Currie. I stand by everything I wrote in my previous post on the other thread and the information I included. However every woman has the right to make her own choices. Just be aware of the ALL the facts when you do and not just the marketing spin, because that is all it is.

[Pollyanna]

Actually, my oestrogen only HRT has always been 'bio-identical' and that's on NHS.

haha....I really don't care where I get my testosterone gel from, or what it is derived from....a coconut, a banana or a chicken.

I just want my drugs!

Haha....sorry, we need to lighten up a bit. It's becoming too competitive for me and I joined to share experiences.

'Compounded' only means it's mixed together in a lab. Think we all agree on that.

Yep, (some of) the Americans still confuse the term bio-identical with compounded.

I think they always will.

I'm too tired care to right now.

Good night to you all.

[Dana]

Pollyanna please check out the below link. It explains it all fairly well. Use what works for you, but just be aware of the information and concerns about compounded hormones.

Women need to be aware that regardless of the fact that "bioidentical" gets used an awful lot on the MM forum, doctors don't use it, and it is really just a marketing term for those who advocate compounded hormones.

https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms

[Dana]

Okay. Well all I can do is post the information that is freely available on sites like NHS, FDA, North American Menopause Society,  Australasian Menopause Society and other similar organisations. It's even available right here on Menopause Matters. All that information was included in my previous post. I guess it is the case that when you research you will always find the information you want to find. 

[Cassie]

Hormones such as oestrogel are considered bio identical but so are the compounded creams etc made up in pharmacies and I think this is where the confusion comes in, those are not considered safe nor strong enough  I remember my gynae saying that if I was using oestrogel I should not use the compounded progesterone cream aka bio identical as it would  not be strong enough to oppose the oestrogel and thereby protect my uterine lining.

[Hurdity]

No problem Lil 22 x

 


Hi Analee

The title of the thread is really shorthand for the topic  so if you follow the links and listen to the programme and maybe the earlier one from last year that I linked to, you can follow the story. It is quite clear there (on the programme) what they and Emma are referring to which is BHRT as a privately marketed therapy as opposed to HRT (comprising as you say a variety of hormones - synthetics as well as bio-identical ones). There is still a lot of confusion due to the appropriation of the term "bio-identical" by the industry and which it now seems better to use the term "body-identical" for the hormones themselves even in UK as the practice is becoming more common here as well as elsewhere where it has been prevalent for some years (mainly Aus and US). If you listen to the clips form the programme it should all become clear but it really is an important ruling by the ASA.

Hope this helps

Hurdity x

[jmj]

Hormones such as oestrogel are considered bio identical but so are the compounded creams etc made up in pharmacies and I think this is where the confusion comes in, those are not considered safe nor strong enough  I remember my gynae saying that if I was using oestrogel I should not use the compounded progesterone cream aka bio identical as it would  not be strong enough to oppose the oestrogel and thereby protect my uterine lining.

That's how I see it too. Bioidenticals not as compounded only, but also estradiol and progesterone in all forms.

[dangermouse]

Surely yam-based estradiol is estradiol and progesterone is progesterone? The difference between pharma and compounded are the ratios and method of delivery and the only safety issues I've seen on the latest NICE/Body Identical spiel on doctors' websites are about compounded DHEA and prednisolone as they aren't usually prescribed to women.

Presumably if a pharmaceutical company wanted to combine Vitamin D with a drug to aid delivery then this would become a body identical pharmaceutical that could have millions spent on research studies, thus sending Vit D supplements to the bottom of the pile with no backed up research to support them, making them perceived as dangerous by comparison?

I'd understand if we were seeing a significant number of women being harmed by compounded hormones but I've not heard about a single case, apart from transient side effects, compared to the acceptable amount of deaths and serious damage done by pharmaceuticals.

I hope that these Government organisations have our best interests at heart but you can't help but wonder when things just don't add up.

[Dana]

That would be the same for you too Dana.

We are all experts in our own health and nobody else's.

Well I guess the difference is that the information I linked is from legitimate medical and scientific sites like Menopause Matters and NHS (UK), FDA and Nth American Menopause Society (USA), Australasian Menopause Society and Therapeutic Goods Administration (Australia). These are only a few of the international medical sites I get my information from. I've already had somewhat snarky comments about providing TOO much information, so could you imagine what would happen if I gave even more?

However it's yours and everyone else's individual choice.

[Dana]

Hormones such as oestrogel are considered bio identical but so are the compounded creams etc made up in pharmacies and I think this is where the confusion comes in, those are not considered safe nor strong enough  I remember my gynae saying that if I was using oestrogel I should not use the compounded progesterone cream aka bio identical as it would  not be strong enough to oppose the oestrogel and thereby protect my uterine lining.

This is very correct. Using compounded progesterone cream along with any kind of estrogen is of great concern to medical experts.

[dangermouse]

Hi CLKD,

Compounded (in pharmaceuticals) according to US-FDA: 'In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.'

and it goes...

'Why do some patients need compounded drugs?
Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For example:
 
if a patient has an allergy and needs a medication to be made without a certain dye; or
if an elderly patient or a child can't swallow a pill and needs a medicine in a liquid form that is not otherwise available.'

You can see the whole thing here
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm#what

Of course, this is FDA, I'm aware that NHS/NICE might be a slight different but I like the way they put it.


Compounded Progesterone: I think its safety/efficacy depends on the amount, delivery method and, MAINLY, on what is it being prescribed for... this is an on-going debate and sometimes people get confused by an overabundance of medical and cosmetics advertising/counselling/prescribing.

Sorry for the long post, won't happen again! Menobrains don't deserve them! 

Yes, that's a good point about what compounded progesterone is prescribed for. Some on here may not be aware that it's has therapeutic and bone-saving properties and can help women with hot flushes and for perimenopause to offset unopposed oestrogen. Left unopposed it can be very dangerous.

Women on NHS ERT need a more potent form like Utrogestan to keep the strong oestrogen opposed which is a completely different situation.

[dahliagirl]

Wot I understand about compounding/bioidenticals 

Compounding bioidentical hrt is something that is made for a particular patient in a private pharmacy.  Women go to a private practitioner they do tests and stuff and prescribe something that the compounding pharmacy makes up.  You sometimes read about this in glossy magazines when celebrities talk about their menopause.  It seems fashionable in the states.  It is all very expensive and out of my range 

Bioidentical means the hormone prescribed is like our own.  Oestrodiol is usually made from Yams.  It is found in compounded stuff, but it is also in a lot of tablets/pessaries/patches gel etc that come from pharmaceutical preparations such as vagifem estrodot and oestrogel and elleste/femoston.  Older preparations contained Conjugated (Equine) Estrogens (CE or CEE) which does the same job but is not quite the same.  There are also preparations like Estrodiol valerate used in one hrt and Ethinylestradiol which is a potent form used in contraceptives (where the purpose is to provide a negative feed back look to stop FSH and therefore ovulation)

There is also bioidentical progesterone - called micronized progesterone.  Micronized means that it is in very small particles.  This is to stop it being broken down in the liver before it circulates.  Progesterone is very prone to this, so there are a lot of synthesised ones that are not bioidentical that were made to get past this problem.  These are known as progestogens in the UK and progestins in the US to differentiate them from the natural progesterone.  They attach to some receptors better than others. One is norithisterone which is very good at reducing the womb lining.  Others are a bit more like the bioidentical ones, such as the one used in Femeston.

Progestogens are not as good transdermally.  There is one patch with levenorgestrel in it and one with norithisterone.  Micronised progestogen seems to work in the vagina where it is close to where it is needed.  Non-prescription creams do not work well enough.  Not sure about other cream type things .....

Someone is in trouble for advertising their compounded hrt as safer    There is no evidence that it is better the the pharmaceutical preparations.  These are well tested before they are allowed to sell them and are perfectly safe when used properly.

Hope that helps.  Otherwise, this thread has made my head explode