In UK, was NDT 'grandfathered' in? Where can I find this info?

[TaraJR]

My local group is refuting a CCG document. Most of it is finished, but one section says: “Funding of unlicensed medicines e.g. Armour Thyroid for the treatment of hypothyroidism is not supported.”

So far our draft says: "This incorrectly states that Armour (Natural Desiccated Thyroid “NDT”) is unlicensed. NDT is a grandfathered product, which never lost the grandfather status, and is therefore exempt from licensing law because it pre-dates - and has proven effective use - prior to licensing in 1938. NDT was used very effectively by clinicians from the early 1890s through to mid-1970 as the preferred form of therapy for hypothyroidism."

However, someone in the group has commented:

"I have never found proof of this in the UK, it appears to only apply to America.... (the FDA were formed in 1938) In the UK the MHRA was formed in 2003, before this it was called the MCA. If a medicine is used in America, we do not automatically allow its use here. The first comprehensive licensing system for medicines in the UK was the 1968 Medicines Act"

Does anyone know any concrete evidence saying how NDT came into UK, and if it does have to be licensed? What is the status of NDT in UK now?

[helvella]

I believe that Armour Thyroid is not licensed in the UK nor in the USA:

ARMOUR THYROID - thyroid, porcine tablet

Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

dailymed.nlm.nih.gov/dailym...

Up until the early 1980s, Thyroid BP was available in the UK. I do not know its status in any detail - that is, whether it was approved, licensed or whatever.

You might find this older post here of interest:

healthunlocked.com/thyroidu...

[amala57]

STTM & Holtorf Med say ndt is FDA regulated & approved.

holtorfmed.com/is-natural-d...

[shaws]

I would like a 'freedom of information' to find out how levothyroxine became the No.1 worldwide. How was this achieved? Were doctors and Endocrinologists 'persuaded' by 'incentives' probably in the USA inititally? to prescribe levothyroxine instead of NDT etc despite people's lives being saved since 1892 - without blood tests at all. Before NDT they all died a horrible death.

So Big Pharma profits from sales of additional medications for remaining symptoms plus sales of blood tests. Before it was doctors' expertise and trial of NDT.

By 'payments in kind'?...... Doctor Lowe believed this. So Pharma Companies make money through diagnosing alone by blood test and then providing levothyroxine, T4 alone, for patients. Many who don't recover and thus are prescribed 'other medications' to try to control the symptom when, in fact, it is a whole body experience when hypo - not just one area of the body.

Dr Lowe was convinced it was due to corruption and made the Rebuttal to the appropriate UK Associations. He did three yearly reminders to both but never did get a response before his death.

thyroidscience.com/Criticis...

We don't need to be scientists to use our brains and think:-

T4 alone - provides all the hormones a healthy gland would do???? The answer is NO. It may convert to T3 but maybe not so effectively if dose is too low or patient's body cannot.

NDT alone - provides all of the hormones a healthy gland would???? Answer is yes.

Is Free T4 and Free tested frequently if patient complains - No. It is believed that TSH is sufficient and maybe T4. Ignoring the only Active Thyroid Hormone which is T3. We can live without T4 but not without T3 in our T3 receptor cells.

The majority of sufferers are women and we are being told by mainly by harsh doctors that 'put up or shut up' as levothyroxine alone will resolve our disabling symptoms. Mind you - do they think females are constant moaners about everything? - probably if we aren't on the correct dose and correct thyroid hormones for us as individuals.

If our thyroid health is restored by T3 or NDT it should not be withdrawn - it is the harshest decision made by those who we expect to be 'knowledgeable first of all' - 'sympathetic' - second - 'caring' third and be permitted to prescribe what they think will help patients without restrictions put upon them like Dr Peatfield and Dr Skinner had and the pursuit of good men - who are these invisible people who want to control - they have lost the core of whatever made them want to 'cure' patients and help humanity as a whole.

We are only asking, after all for quality thyroid hormone replacements. We are not asking for face-lifts or aesthetic operations - just to have a healthy and pain-free life which we know is achievable if on the right dose and the right hormones which suit us as individuals. It is not one size fits all.

[nightingale-56]

Jane Asher's Father, Dr Richard Asher, used NDT on his patients and information about this has been posted in the past on this site.

[helvella in reply to nightingale-56]

And here is a link:

ncbi.nlm.nih.gov/pmc/articl...

Warning: It could be distressing just looking at the photos - and then reading the text.

[nightingale-56 in reply to helvella]

Thank you for finding it helvella . It is heartbreaking to see how much these people must have suffered, but good to see that they had improved a bit by the 'after' photos.

[amala57 in reply to helvella]

What an extraordinary read. These poor poor women. NDT worked well in many of the cases. Thanks for posting. Fascinating.

[helvella]

Just thinking, in the USA, levothyroxine was "grandfathered in" until around 2000. The FDA then insisted that all levothyroxine products be submitted for approval as new medicines. The reason? The poor conformance of the actual products to the required standards. Repeated recalls due to being sub-potent.

[helvella]

The earliest use of any form of dried thyroid that I have found is from 1895:

Br Med J. 1895 Mar 30;1(1787):695-6.

A Case of Pityriasis Rubra Treated by Thyroid Tabloids.

ncbi.nlm.nih.gov/pmc/articl...

There were various liquid extracts before then.