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New TPA Corrections to the BTA Statement on Armour Thyroid and Combination T4/T3 Treatment

[SIZE=4]On 28 August 2007, TPA-UK sent a response to Professor Weetman (President) and Dr. Abraham (Secretary) to the BTA. The aim of TPA-UK is to secure an appropriate amendment to the BTA Executive Committee Statement on Armour Thyroid and T4/T3 combination therapy. After a meeting, the BTA Executive Committee found no reason to change their statement through “lack of evidence”. TPA-UK has now resubmitted their response to BTA with the required ‘evidence’ on 6th April 2008 and now look forward to receiving confirmation that they will amend both their statements and that this will be carried out in the very near future.[/SIZE]

[LEFT]Please print off the TPA-UK’s responses and take them to your GP/Endocrinologist if they refuse to give you a trial of combination therapy, either synthetic or natural Armour Thyroid because of the BTA’s Executive Committee’s previously misleading and incorrect statements.

The TPA-UK’s corrections to the BTA’s Executive Committee “Statement on Armour Thyroid and Synthetic T4/T3 Combination Therapy”- March 2008 are as follows:

The Thyroid Patient Advocacy-UK (TPA-UK) response to: A Statement from the British Thyroid Association Executive Committee on Armour Thyroid

The Thyroid Patient AdvocacyUK (TPA-UK) response to the British Thyroid Associations (BTA) Statement on the Use of Combination Thyroxine/Triiodothyronine
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PREVIOUS CORRECTIONS (August 2007)
[LEFT]On 28 August 2007, TPA-UK sent a response to Professor Weetman (President) and Dr. Abraham (Secretary) to the BTA. Our aim is to secure an appropriate amendment to the above BTA Executive Committee Statement on Armour Thyroid and we look forward to receiving confirmation that this will be carried out in the very near future. Please print this off and take it to your GP/Endocrinologist if they refuse to give you a trial of Armour Thyroid because of the BTA’s Executive Committee’s misleading and incorrect statement. Corrections to the British Thyroid Association’s Executive Committee “Statement on Armour Thyroid” August 2007 are as follows:
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BTA Statement A:
[LEFT]“Armour Thyroid contains both thyroxine (T4) and tri-iodothyronine (T3) extracted from the thyroid gland of pigs. One grain, about 60 mg, of desiccated pig thyroid extract contains about 38mcg of T4 and 9mcg of T3, a ratio of around 4 to 1. 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. 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]).”
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TPA Correction:
[LEFT]The United States Pharmacopoeia (USP) web site states: “Federal law requires prescription and non-prescription medicines sold in the U.S. to meet USP standards, if such standards are available. Manufacturers independently ensure that their products conform to USP standards, where applicable. When medicines meet USP standards, it means that they are pure, consistent in ingredients and strength, and properly labelled and stored. The Food and Drugs Administration (FDA) approves drugs based on manufacturers’ own standards. USP sets public standards for products already approved by the FDA. Once USP standards become official, manufacturers must comply with them and the FDA can enforce the standards.

The human thyroid secretes T4 and T3 in a ratio of about 10 to 1. A similar ratio can be obtained by prescribing both Armour and thyroxine, although clinical response should take precedence over a theoretical ideal. Armour Thyroid contains other substances apart from T4 and T3 and is thus a priori the preferred option for patients with little or no residual thyroid function.
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BTA Statement B:
[LEFT]“The concentration of thyroid hormones in Armour Thyroid USP is regulated by the manufacturer to United States Food and Drug Administration (FDA) standards. Despite this, there have been significant problems with the stability of Armour Thyroid in recent years, prompting a massive recall of tablets.1 Because of these stability problems with Armour Thyroid, there is potential for fluctuations in thyroid hormone levels in the blood of patients treated with Armour Thyroid. These fluctuations may be unpredictable and have adverse effects on patients’ health.”
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TPA Correction:
[LEFT]There have NOT been “significant problems” with the stability of Armour Thyroid in recent years. On the contrary, Thyroxine has a very poor track record in the USA with many recalls. Goldshield recalled injectable Tertroxin last year.

Supplies of Tertroxin in tablet form were unavailable for a number of weeks earlier this year. Armour Thyroid has an excellent track record of stability and conformity. Thyroxine, in particular generic preparations, can yield wide fluctuations from the nominal dosage. Most thyroxine preparations contain lactose, causing thyroxine malabsorption in patients who are lactose intolerant. Whenever a batch of any drug is made, the manufacturer holds back a small number of tablets from that batch. These samples are periodically tested for quality. If a quality, potency, or other problem is found, the manufacturer recalls that batch. In a 2005 sample testing of several batches of Armour, it was found they were not maintaining full potency. These were manufactured between March and August 2003, and were set to expire between March and August of 2005. To avoid potential problems, they decided they would recall ALL the Armour made during that timeframe in 2003. According to the spokesperson at Forest Pharmaceuticals, very little product from these batches was in distribution at that time. Most of the recalled product had been sold long ago, leaving very little of the recalled Armour actually unused and in the market.

In a 1980 study, a number of generic versions of desiccated thyroid were found to be unreliable in potency. The amounts of T4 and T3 in Armour Thyroid, USP, on the other hand, were found to be constant ( Rees-Jones RW, Rolla AR, Larsen PR. Hormonal content of thyroid replacement preparations. JAMA 1980;243:549-550.). Moreover, two-year old tablets of Armour Thyroid contained similar amounts of T4 and T3, as did fresh tablets.
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BTA Statement C:
[LEFT]“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.”
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TPA Correction:
[LEFT]Thyroxine was introduced without any comparison with Armour Thyroid being published. Given levothyroxine is the cheaper medication, one has to question why the manufacturers would not wish to demonstrate equal effectiveness. Natural desiccated porcine thyroid extract has been making patients better since 1894, long before the introduction of synthetic thyroxine. Thus, the burden of proof lies with the synthetic product to demonstrate it is safe, effective and as consistent as Armour.
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BTA Statement D:
[LEFT]“The BTA committee cannot recommend a treatment with possible side effects, when a safe and equally well-established treatment exists.”
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TPA Correction:
[LEFT]There can be side effects with any treatment. Possible side effects of thyroxine can include angina chest pain, arrhythmia, palpitations, rapid heart rate, muscle cramps, stomach upset, tremor, insomnia, headache, flushing, weight loss, heat intolerance. Source: Medic8 Family Health Guide

We are aware that over-dosage with T4 and T3 is undesirable, but Armour is no more likely to cause such problems than is a combination of synthetic T4 and T3. Splitting the daily dose would obviate any potential concern about transient elevations of T3 levels.
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BTA Statement E:
[LEFT]“Armour Thyroid is not on the British National Formulary and is not a licensed therapy in the UK.”
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TPA Correction:
[LEFT]Armour and several other thyroid medications were ‘grandfathered’ in when Congress passed the Kefauver-Harris Drug Efficacy Amendments of 1962, to tighten control over drugs. Before marketing a drug, firms had to prove safety and effectiveness for the product’s intended use. The requirement was applied retroactively to 1938, when the FDC Act was passed. Pre-1938 drugs were allowed because they were generally recognised as safe and effective, provided no evidence to the contrary developed. Too much evidence to the contrary developed concerning the levothyroxine products and the FDA decided none was generally recognised as safe and effective, so these synthetic products lost their ‘grandfathered’ privilege and had to go through the NDA process. Armour retains its’ grandfathered’ status since no evidence to the contrary has developed concerning its safe and effective status.
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BTA Statement F:
[LEFT]”Mr. G. Matthews, the Pharmaceutical Assessor of the Medicines and Health Care Products Regulatory Agency, in a letter sent to BTA dated 19 October 2005, has clarified that “The regulations on medicine allow doctors to prescribe an unlicensed medicine for a patient to meet such a special clinical need, on their own direct personal responsibility. Where these unlicensed medicines are not available in the UK they can be imported by appropriately licensed medicines wholesalers, for supply to a doctor or pharmacy, to meet these needs.”
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BTA Statement G:
[LEFT]“The cost of Armour Thyroid may be up to 20 per month, compared to an equivalent cost of 1 per month for thyroxine.”
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TPA Correction:
[LEFT]Although Armour Thyroid costs a little more than thyroxine and liothyronine, it is not an expensive drug. Especially when you consider that the average cost of prescriptions per person, per calendar month, is 20. Critically, some patients do not recover on thyroxine. These patients may be unable to resume work. They receive unnecessary investigations and treatments leading to an increased burden on health care resources and risk of harm.
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BTA Statement H:
[LEFT]“Furthermore, Armour Thyroid is not eligible to be claimed on the prescription exemption certificate (FP10).”
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TPA Correction:
[LEFT]According to the MHRA, doctors in the UK are allowed to prescribe Armour Thyroid within the NHS or privately to anybody diagnosed with hypothyroidism. Armour Thyroid is eligible to be claimed on the prescription exemption certificate (FP10) in the same way as other thyroid hormones. A GP can prescribe Armour using a normal green prescription form (FP10) and s/he should write “Armour Thyroid”, the dose required and also writes “For the treatment of hypothyroidism”. The pharmacy will contact Idis World Medicines and they will fulfil the order. Tel: 020 8410 0700/ Fax: 020 8410 0800. Email: prodinfo@idis.co.uk or idis@idis.co.uk for orders. Web site: http://www.idis.co.uk
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Annex 1:
[LEFT] Armour Ingredients Active Ingredients: Armour Thyroid Tablets, USP contain the labelled amounts of levothyroxine and liothyronine as established by the USP. The ratio of Armour Thyroid T4 to T3 is 4.22:1 (4.22 parts of T4 to one part of T3).

Inactive Ingredients:
1.Thyroid Powder, USP
2. Dextrose, Anhydrous
3. Microcrystalline Cellulose, NF
4. Sodium Starch Glycolate, NF
5. Calcium Stearate, NF
6. Opadry White (titanium dioxide used as a whitening agent)
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Armour Thyroid, USP does not contain gluten or lactose. You can find confirmation of their ingredients and their quality control procedures on the manufacturer’s web site:

Annex 2
[LEFT]The U.S. Federal Food, Drug, and Cosmetics Act designates the USP-NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP-NF to avoid possible charges of adulteration and misbranding. The USP-NF is also widely used by manufacturers wishing to market therapeutic products worldwide. Meeting USP-NF standards is accepted globally as assurance of high quality.

As Armour thyroid is labelled USP it would be expected to meet the requirements of the USP monograph throughout its shelf life. The current USP monograph for thyroid tablets has an Assay to measure the quantities of liothyronine and levothyroxine, a content uniformity test, a disintegration test and microbial limits. Standards are set by an expert committee with open public comment. Copies of these papers as well as copies of the USP monograph on Thyroid, Thyroid Tablets can be seen at any medical or pharmacy school library. The onus is on Idis, as importer and supplier, to prove that Armour is being supplied for the permitted indication, and a spokesperson for Idis has agreed that doctors now only need to write on the prescription “Armour Thyroid required for the treatment of hypothyroidism” and the dosage.
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