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BTA Statement about Armour Thyroid [TPA Rebuttal]

In 2004 TPA wrote to the British Thyroid Foundation (BTF) regarding their position on Armour Thyroid which was to deny it was prescribable in the UK and safe to use. We sent them a number of documents, such as the letter from the MHRA, to prove this was untrue. (see A Response From the MHRA Regarding NDT)

In March 2005, the British Thyroid Association (BTA) put out this statement stating that Armour may be allowable but not preferable. This letter is a copy of our response to this statement. The BTA statement is in italics.

10th June 2005

Dear Member,

A Statement from the British Thyroid Association Executive Committee March 2005

Armour as Thyroid Hormone Replacement

British Thyroid Association (BTA)
1) The BTA recognise that the Armour preparation contains both T4 and T3 and that we are presuming that the concentrations in the preparation are carefully regulated by the manufacturer. Armour is prepared from desiccated animal thyroid and the preparation and purification of this product may not be at the same rigorous standards of more modern medications.

Thyroid Patient Advocacy (TPA)
Armour desiccated animal thyroid is manufactured in the USA by Forrest Pharmaceuticals. The manufacturers web site clearly states that Armour Thyroid Tablets, USP contain the labelled amounts of levothyroxine and liothyronine established by the United States Pharmacopoeia (USP). To meet quality standards it must also pass bacteriological testing and must meet other product quality tests. The ratio of Armour Thyroid T4 to T3 is 4.22:1 (4.22 parts of T4 to one part of T3). The manufacturers also state that the amount of thyroid hormone present in the thyroid gland may vary from animal to animal. To ensure that Armour Thyroid tablets are consistently potent from tablet to tablet and lot to lot, analytical tests are performed on the thyroid powder and on the actual tablets to measure actual T4 and T3 activity. Evidence of stability and consistency in the extracts is available from the monograph on Armour Thyroid to USP when it was tested by four US laboratories.

Medical practitioners who refuse to prescribe Armour in the belief that it has no part to play in the treatment of hypothyroidism are making judgments without studying the available evidence as to its safety and efficacy.

BTA
2) There is no evidence for favouring the prescription of Armour in the treatment of hypothyroidism over the prescription of thyroxine as supplied in the United Kingdom.

TPA
There are no trials available comparing the efficacy of Armour and thyroxine, but there is an increasing body of subjective information from patients now taking Armour about the many benefits that they have experienced on changing to this medication. At present, few practitioners are aware that there is a choice, and so no alternative treatment strategy is offered to patients who do not feel well on thyroxine. It is important that medical practitioners be given such information so they become aware that there is a choice of treatment strategies.

BTA
3) We note that Armour preparation is not on the British National Formulary but can be obtained on a named patient basis if a prescribing medical practitioner chooses to arrange this (as per advice provided by Dr Graham Matthews the Pharmaceutical Assessor of the Medicines and Health Care Products Regulatory Agency 29th June 2004).

TPA
As we pointed out to you in our previous letter, prescribing on a named patient basis no longer applies. All that is needed (by arrangement with Discord Medicines and MHRA) is that a doctor just writes on the prescription required to treat hypothyroidism.

BTA
4) We note that the cost per month of Armour is 25-30 compared to an equivalent cost of 1 per month for thyroxine. According to the DOH, hypothyroidism is a medical exemption. It does not specify a treatment so in theory Armour could be prescribed. It could also be prescribed by GP’s and dispensed by a community pharmacy despite it not being in the drug tariff. The problems may arise with a GP being asked to prescribe something they are not familiar with and a community pharmacy who may not be willing to try and source a supply of Armour. Any decision to approve this prescription will rest with the Primary Care Trust for that patient and opinion may vary.

TPA
It appears that evidence based medicine is moving from relatively simple questions about a drugs safety and effectiveness to thornier questions of relative clinical effectiveness and cost effectiveness. Your statement leads to an evaluation that is based more on cost than on effectiveness, within a framework of ethical values. Doctors are educated to prescribe the most cost effective drug for hypothyroidism (thyroxine).

TPA is in the process of ensuring that all information regarding Armour will be passed to doctors so that they will become familiar with this well-tried and successful medicine. Also community pharmacies must not deny patients such medication solely on the grounds that they may be unwilling to try and source a supply of Armour. They have only to contact Idis World Medicines to source this product.

Whilst the price of Armour may look expensive compared to that of thyroxine it should not be looked at in isolation. Many patients who are still symptomatic on apparently adequate doses of thyroxine find a vast improvement in their health when taking Armour. They very often no longer need other drugs such as Statins, painkillers, NSAIDs, anti-depressants etc. This will result in an overall saving on drug expenditure, not to mention fewer consultations with health professionals, thus effecting considerable savings both in time and money. Furthermore, if Armour were to be more widely prescribed within the UK then the NHS may well be able to negotiate a lower price with the supplier. Additionally, there is growing evidence that an increasing number of patients who are taking desiccated thyroid have been able to return to full health and paid employment, thus relinquishing the need for benefits or allowances paid by the State.

BTA
5) We are concerned about the substantial fluctuations in T3 levels in blood of patients treated with Armour and the potentially harmful effects on the heart and bones. We are also concerned about the difficulties of monitoring such treatment due to the widely fluctuating levels of T3 (which are not encountered with thyroxine treatment).

TPA
We do not understand this statement. It happens that, on thyroid extract, there is a tendency for the T3 to rise sometimes this could occur because of other components within Armour, but the rise is minor, and it does NOT fluctuate like you state. However, we would be glad to receive any references you may have about this. Like many assertions in medicine, if a statement is made often enough, eventually it is taken as gospel and there may be no evidence whatsoever. It is true that natural desiccated T4/T3 products (such as Armour and Naturethroid) have a higher percentage of T3 than that used by the researchers in their study; but Tertroxin, a T3-only drug, was and is readily available, and compounding pharmacies almost anywhere can easily prepare time-released T3. Furthermore, any fluctuations that may occur with T3 can be minimised by taking such preparations at regular intervals.

BTA
6) As an update, there have been several well-conducted studies of combination therapy of T4 and T3 some of which have been published in the Journal of Clinical Endocrinology and Metabolism; the foremost peer reviewed endocrine journal in the field of Endocrinology and the Journal of the American Medical Association. The overall conclusion from these recent studies is that there is no evidence of a beneficial effect of the combination therapy compared to unitary therapy with thyroxine, indeed a detrimental effect on psychological function was noted in some of the studies.

TPA
The studies referred to contradict other studies and, in any event, are not relevant to the use of Armour. No studies of Armour compared with thyroxine, with or without T3 have been made available. Many patients have reported marked improvement in mood using Armour, not to mention resolution of many other debilitating symptoms.

We are unclear as to who funded the research projects or what the affiliations of the authors of the editorial are. Did they accept funding from, serve in a major capacity with any professional organisations that receive funding from, or have any financial ties to pharmaceutical companies? If so, which companies/drugs? We would also be interested to learn what type of T3 was used to test the patients and would like sight of the actual articles, as we have access only to the press releases.

BTA
7) The BTA believe that patients have every right to receive a treatment that they wish to try as long as that treatment is legally available in the United Kingdom. This is certainly true for Armour. We would recognise that some patients who do not feel well on thyroxine seek other treatment options as they are entitled to do. However, we must base our recommendations on evidence and be guided by the principle of not exposing patients to potential harm as a result of our treatments

TPA
There are, as stated above, no studies available comparing Armour with Thyroxine or combination therapies, and since the grandfather principle inevitably applies to natural desiccated porcine thyroid extract available for over a century it is quite incorrect to suggest the possibility of potential harm.

BTA
8) It is accepted by the BTA that clinicians and clinician scientists must keep an open mind about any medical question. However, as evidence based medicine is in practice in this country, we believe that the findings so far do not offer any advantage to a combination of T4 and T3 over T4.

TPA
There is a sufficiency of evidence that some patients benefit from natural desiccated thyroid (Armour) and it is the experience of a growing body of practitioners that it is much preferred by their patients for the relief of thyroid symptoms. Patients should, where appropriate, be offered a trial of treatment with Armour.

The authorship of your statement is unclear; the decision making process is unclear. Please could you tell us if this was reviewed, by whom, and in what way?

We would also be pleased if you would let us have references to all of your statements.

Finally, BTF stated in the Spring 2005 Newsletter that they are offering 10,000 to enable medical researchers to supplement existing projects or for pump-priming existing research ideas. Could this be used towards a clinical trial of T4 v T4/T3 v Armour for those patients unable to regain normal health on thyroxine?

Yours sincerely,

Sheila Turner
(Chair) Thyroid Patient Advocate
www.tpauk.com

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