Thank you for your request for funding armour thyroid for the above patient to treat acquired hypothyroidism; this was considered by the Exceptional Clinical Circumstances panel at their recent meeting.
The panel considered the information provided in the proforma and also the information provided by the patient. They also took into consideration the most recent UKMI review dated November 11, which states the following:
“A combination of levothyroxine and liothyronine, in both non- and physiological proportions, has not consistently been shown to be more beneficial than levothyroxine alone with respect to cognitive function, social functioning and wellbeing. Use of dried thyroid hormone extracts, such as Armour® Thyroid, is therefore not recommended. The variation in hormonal content and large amounts of liothyronine may lead to increased serum concentrations of T3 and subsequent thyrotoxic symptoms, such as palpitations and tremor”
The panel also noted:
•Armour Thyroid is not a not a licensed product in the UK, and is only available as an unlicensed special.
•The British Thyroid Association Executive Committee does not recommend the use of combined thyroxine (T4) and tri-iodothyronine (T3).
•There is insufficient clinical evidence of effectiveness to support the use of Armour thyroid, and potential side effects, quality and cost concerns.
In view of all of the above the panel were unable to support the request for Armour Thyroid.
The normal concentration of these hormones in the human thyroid is, however, at a ratio of 14 to 1. In other words, Armour thyroid extract contains excessive amounts of T3 relative to T4 when used to replace thyroid hormone in man.
I see NO logic in comparing the ratio of T4 and T3 in the thyroid against that in the Armour tablet. There are so many ways in which this is inappropriate. You could consider dissolution and absorption from the gut as a starter in one direction. And that the AMOUNTS present in the human thyroid are not necessarily closely related to the RATES at which the hormones are released.
Moreover, as pig thyroid contains other substances apart from T4 and T3, Armour Thyroid is not a pure preparation of thyroid hormones. Historically, extracts of animal thyroid glands were the only way to treat thyroid underactivity, but since the 1950s pure synthetic thyroid hormones have been available in tablet form (thyroxine sodium [T4] and liothyronine [T3]).
NO UK-available levothyroxine or liothyronine product is pure either. They contain all sorts of things like magnesium stearate, lactose, acacia powder, maize starch, and others. Further, the impacts of these have never been fully tested and this was behind the withdrawal of a whole product (Teva levothyroxine). Worse, it is absolutely known that a significant percentage of the UK population is lactose intolerant and yet all these products contain lactose.
The nearest you can get in oral products to "pure" is arguably Tirosint - which, despite many positive reports in the literature and from patients, is also not licensed in the UK.
Despite this, there have been significant problems with the stability of Armour Thyroid in recent years, prompting a massive recall of tablets.
Surely the withdrawal of Teva levothyroxine due to its failing to deliver, the unavailability of Mercury Pharma liothyronine due to manufacturing difficulties, unavailability of Mercury Pharma Eltroxin, the wholesale withdrawal of the USA number two brand Levoxyl, and numerous reports of inconsistency in levothyroxine all go to prove that synthetic products have stability problems? Further, I am not aware of any proved stability issues in any of the major desiccated thyroid products since before 2007. (This needs to be checked out - I might have missed something.)
C.There is no evidence to favour the prescription of Armour Thyroid in the treatment of hypothyroidism over the prescription of thyroxine sodium, as supplied in the United Kingdom. There has never been a direct comparison of these two treatments.
There most assuredly HAS been a comparison - at the Walter Reed army hospital in the USA. That the BTAEC have shown themselves unable to update their documents in line with published research is an indictment of their accuracy. We cannot rely on papers that are never maintained. And that comparison was moderately favourable towards Armour despite many people questioning whether the Armour doses used were comparable - many here thought they were a little too low.
With the experience of using desiccated thyroid within the UK from its inception to around 1980, what was the evidence of "thyrotoxic symptoms, such as palpitations and tremor” over that time? Are the BTAEC able to answer that? Do bear in mind that the products in use for most of a century were relatively variable because the assay methods were not nearly as good as those now available. Please provide some evidence of the claimed "variation in hormonal content". All we seem to have is proof by assertion.
Feel free to use any or all of the above. Or ignore it!
Thank you Rod... I will be using...at the moment I am so very very angry with regards to this reply. My appeal letter was sent in September but only just got a reply. I sent a letter on how it has changed my life and the fact I am now on no meds from the NHS compared to before.
Just a question...if anyone knows...can you appeal against an appeal?- where do I go from here??- any advise as to my next move.
thank you Rod-thought it would be a good idea to show you my letter- I am not sure where I got it...but hunted on the net..but tailored it for me as an individual...then also added my ongoing pointers of how I am feeling 6months on of NDT.......CAN YOU suggest my next route...?- is there one..to take a step further?????
£55 private consultations plus bloods of £250 then mileage to go onto the appoitment... plus NDT £45 for 100 tablets is popping me in debt
I am applying for funding of my Armour Thyroid prescription on an “Exceptional Basis” and ‘Letter of Clinical Need” on a “ Named Patient Basis” as an exception to MIMS within the terms of the CCG’s guidance on the grounds of the further information I have set out below.
The information includes the results of a large UK study showing that between 9 and 15% of patients prescribed T4-monotherapy continued to suffer symptoms that might, in some way, be related to T4 therapy.
Approximately 300,000 patients in the UK do not benefit from the RCP recommended therapy of T4-only. Peripheral thyroid hormone physiology exists and patients should not be given a diagnosis of ‘Hypothyroidism’ or treated with T4-only. (2,3,4,5).
I am one such patient who needs natural thyroid extract and not the synthetic preparations – which could be because the synthetic thyroxine is biologically different to the natural thyroxine.- (1)
My body needs natural thyroid extract that includes all thyroid hormones T4, T3,T2, T1 plus calcitonin, which are not found in synthetic T4 and T3. I am benefiting greatly within 2 months of the treatment of Armour with many side effect disappearing as the weeks and months go by.
The view that hypothyroidism is best treated by T4-only is not, and never has been, based on solid scientific evidence. To this end, the effectiveness of whole thyroid extract versus synthetics should be compared in further clinical trials, especially involving problematic patients, (I am one such problematic patient that only stays well on NDT) as was first shown in a 1932 study comparing levothyroxine and desiccated thyroid extract in hypothyroid patients. (6)
It is not possible to replace natural thyroid extract with synthetic T4 - only, as T4 is a pro-hormone and has little to no effect on its own. Natural thyroid extract contains not only T4, but the active thyroid hormone T3, T2, T1 plus calcitonin.
The MHRA Review of Unlicensed Medicines‟ makes the point that: “Clinicians should have the ability in appropriate circumstances to exercise their professional judgement to commission the supply of an unlicensed medicine to meet the special needs of an individual patient”. (7)
Armour® Thyroid does have a higher amount of T3 compared to T4 than the relative amounts of T3 to T4 secreted by the human thyroid gland, however it is well documented that Armour® is often more effective and is better tolerated than synthetic preparations of T4, T3 and T4/T3 combination. (8,9) This is because the T3 in natural thyroid extract is absorbed more slowly than synthetic (purified, unbound) T3.
(10) -There has been no research or studies to show that levothyroxine has consistently been shown to be more beneficial than natural thyroid extract, and those studies showing T4 alone works better than synthetic combination of T4/T3 have been shown to be flawed.
I am one such patient that benefits greatly from Armour Thyroid. There is increasing anecdotal evidence that Armour Thyroid and other brands of natural thyroid extract, or combination synthetic T4/T3 benefit over the use of levothyroxine only therapy. Already, TPA has registered over 2420 counterexamples to T4-only therapy – all of whom do better on some form of T3.
(10)-Evidence is presented in the Empirical use of Armour thyroid by Gaby that many people have a thyroid or thyroid hormone disorder undetected by laboratory thyroid-function tests, and cases are reported to support the empirical use of Armour Thyroid. Clinical evaluation can identify individuals with sub-clinical hypothyroidism that is likely to benefit from thyroid-replacement therapy. In a significant proportion of cases, treatment with thyroid hormone has resulted in marked improvement in chronic symptoms that had failed to respond to a wide array of conventional and alternative treatments. In some cases, treatment with desiccated thyroid has produced better clinical results than levothyroxine.
Research supporting the existence of sub-clinical hypothyroidism is reviewed, and the author's clinical approach to the diagnosis and treatment of this condition is described.
Because of the relevant clinical information I have provided in the above, I have set out the basis upon which I consider my request to have Armour Thyroid, should you, my GP be willing to prescribe it using the additional supporting test and results from Dr Liam Chapman who has initialised Armour privately.
(2,3,4,5)-Saravanan P, Chau F, Roberts N, et al: Psychologi¬cal well-being in patients on ‘adequate’ doses of L-thyroxine. results of a large, controlled community-based questionnaire study. Clin Endocrinol, 2002; 57: 577-585
'Understanding Thyroid Hormone Action and the Effects of Thyroid Hormone Replacement – Just the Beginning Not the End'. P Saravanan, C M Dayan, Integrative Neuroscience and Endocrinology, University of Bristol: hotthyroidology.com/editori...
CHOPRA IJ: Euthyroid sick syndrome: is it a misnomer? J Clin Endocrinol Metab 82: 329-334, 1997.
Gross J, Pitt-Rivers R. 3:5:3'-triiodothyronine. 2. Physiological activity. Biochem J. 1953 Mar;53 (4):652-7
(6)- Gautam Das, Shweta Anand & Parijat De. Diabetes & Endocrine Unit, City Hospital, Birmingham, United Kingdom Endocrine Abstracts (2007)13 P316
(8,9,10)-Steven L. Richheimer, Charlotte B. Jensen. Response to “Liothyronine and Levothyroxine in Armour Thyroid?”: 1987.Journal of Pharmaceutical Sciences. Volume 76, Issue 4. Pages 346-347
Rees-Jones RW, Larsen PR. Triiodothyronine and thyroxine content of desiccated thyroid tablets”. Metabolism. 1977 Nov;26
(11):1213-8
Alan R. Gaby, MD “Alternative Medicine Review” Volume 9, Number 2, 2004
May I politely suggest that you edit your post and remove your NHS no., date of birth, names of people involved. For your security obviously.
They are changed to all 9s on the actual post but the alert emails, activity, etc. show them as posted. There is nothing I can do about them, I am afraid.
So sorry to cause you problems admin wise..I had not really thought about my persona details just wanted to share with you my reply in the hope somebody would help in a way forward or some suggestions. Sorry once again.x
What a long convoluted reply-you just knew the answer was going to be no before you reached the bottom. I thought I had recently won my GP over until my last visit-not the same probs but in the light of that I started looking at Understanding Thyroid Disorders published in association with the BMA. Not got it with me at the moment but sure I read something along the lines of if Levo not working well try taking some additional T3. However it did say NOT to take the combined T3/4 tablet as shown not to be successful which sort of follows as we known we don't all conform to the same doses so I combined tablet isn't a one size fits all as it never would.
Thank you for your reply- I had a trial of T4/T3 and had a terrible response via my GP/consultants guidance...hence me then looking elsewhere. I feel amazingly well on the NDT but my bank balance climbs in debt!
Thank you..interesting...I am unsure has to how and who to take my appeal, if I can a step further...and how to progress here...
Just a small point, can anyone tell me who decided the British Thyroid Association was speaking for all the thyroid patients. And if they are not speaking on our behalf what is the panel even noting their opinion for.
I know I joined the BTA years ago and after a short time left the group and spent years without any contact with other patients, which negatively impacted on my health as After reading their literature I was convinced that my thyroid was not causing the terrible effects of the fatigue. I have lost years on the advice given by the BTA.
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Could I get feedback on my thyroid blood test please
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Feedback on the results please
