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2005 Letter Sent to the British Thyroid Foundation from TPA

Mrs. Janis Hickey
[LEFT] British Thyroid Foundation
PO Box 97
Clifford
Wetherby
LS23 6XD
Yorkshire
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[LEFT]
1 January 2005
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[LEFT]
CC to ALL PATRONS, TRUSTEES AND MEDICAL ADVISERS
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Dear Mrs. Hickey,

Subject: Evidence-based information about Armour

Thank you for your letter of 13th December. We are disappointed that owing to the differing views of your Trustees concerning Armour, you have decided not to allow the information which Thyroid Patient Advocacy-UK (TPA-UK) sent you on your web site, not even a link to the TPA-UK web site.

It says in your Mission Statement (1991), that your aims are (i) “to provide support for those with thyroid disorders and (ii) to provide information to those with thyroid disorders and to the medical profession”. As someone with thyroid disorders, I have these questions for you:

BTF web site and case histories

In your letter dated 10 th August 2004, you state:

The development of the BTF web site is an ongoing process and we are always interested in the views of our members. Therefore we hope to, at some point in the future, include on the web site case histories and articles of interest which have been sent in to BTF by members”.

Does this mean that case histories of members who previously remained unwell on thyroxine but who regained their normal health on Armour will be included? Will the many articles of interest about desiccated porcine thyroid extract also be included?

Research on the efficacy of thyroid replacement therapy:

On your web site, you state that you “encourage the highest standards in patient care and research, that you are a team committed to helping thyroid disease sufferers, that you will provide support and clear information to sufferers, and that you wish to promote a greater awareness of these disorders amongst the general public and the medical profession”. With this in mind, we would be grateful for your comment on the following.

In ‘What’s New under Research Award 2003 Important Update, it says that you “will be doing research into whether thyroid deiodinase polymorphisms alter the efficacy of thyroid replacement therapy, on the basis that they affect the conversion of T4 to T3″. You say:

“A previous study has shown that after administration of 100mcg thyroxine there was a significantly lower level of the active hormone T3 in people who were symptomatic of hypothyroidism despite normal thyroid biochemistry. It is not known whether this is due to a problem with the deiodinase enzymes in this group”.

Could you take the study one step further and include undiagnosed patients with symptoms of hypothyroidism but normal blood tests?

Information about Armour at the BTF web site:

In the FAQ’s under the section ‘Hypothyroidism (Underactive thyroid)‘, one question is, Can Natural Thyroxine (Armour) be used to treat hypothyroidism? Some of the details in the response are not accurate. Could you please correct them so that readers will have up-to-date information? Ive interspersed correct information (fact, not opinion) with the web site response:

Your Statement “There are no advantages of taking natural thyroid extract over synthetic thyroxine. There are other known (unmeasured) hormones in Armour, including Calcitonin”. The disadvantages are that because it is made from pooled thyroid glands from animals, which vary from batch to batch in their thyroxine levels, the exact dose of thyroxine cannot be estimated precisely. Therefore one dose from one batch of tablets may well create different thyroxine levels to the same dose from a second batch of tablets.

The dose of thyroxine and liothyronine can be and is estimated precisely in Armour. From the manufacturers. web site 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 (raw material) and on the actual tablets (finished product) to measure actual T4 and T3 activity. Different lots of thyroid powder are mixed together and analyzed to achieve the desired ratio of T4 to T3 in each lot of tablets. This method ensures that each strength of Armour Thyroid will be consistent with the United States Pharmacopoeia (USP) official standards and specifications for desiccated thyroid lot-to-lot consistency.

TPA sent you further evidence regarding this proof of stability in every batch of Armour in a letter on 18 August 2004 (which has never been acknowledged by you). TPA also included extracts from the Monograph on Armour Thyroid when it was tested:

. . . As determined by Armour Pharmaceutical Company and other participating laboratories, the liothyronine and levothyroxine content in Armour thyroid is well within the specifications set by the U.S. Pharmacopoeia. The precision of the assay procedure as determined by Armour, Eli Lilly, and the FDA is considerably better than that reported by Pharmaceutical Basics
. (US Pharmacopoeia., 21st rev.; U.S. Pharmacopoeia Convention: Rockville, MD, 1985; pp 1893-1895 Richheimer, S. L.; Jensen, C. B. J. Pharm. Sci. 1986, 75, 215-21.)

Synthetic thyroxine, on the other hand, has had numerous recalls because of stability and sub-potency problems. Details are at the FDA web site.

Your statement: As a result, endocrinologists have abandoned using this in favour of the pure form of thyroxine which is chemically exactly the same as that which is made by the normal thyroid gland.

Endocrinologists abandoned using desiccated thyroid extract because until around 1970, the hormone concentrations of thyroid medications were titrated based on iodine content. This was where the problems about potency started, but since then, all hypothyroidism medications including desiccated thyroid have been assayed by their hormone content.

Your statement: “Natural Thyroid Extract is not licensed in this country. However our licensing records show that the pure compounds, thyroxine and triiodothyronine, are stable and of consistent potency.”

The prescribing of Armour IS covered by the NHS as stated in both the letter from the MHRA and TPA that was sent to you on 18th July 2004. From the MHRA letter: “Armour Thyroid can be prescribed within the NHS for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable. Consequently, Armour Thyroid to USP can be made available to those people who need it, subject to being prescribed by a doctor.” (see A Response From the MHRA Regarding NDT)

The letter from TPA stated:

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 products 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 of them was generally recognised as safe and effective, so the levothyroxine products lost their grand fathered privilege and had to go through the NDA process. Armour retains its grand fathered status since no evidence to the contrary has developed concerning its safe and effective status.

Your statement: It is also important to remember that Armour is only obtainable in this country through your GP, if he agrees, but it is not covered by the NHS and therefore prescriptions will have to be paid for.

Armour is not only available in the UK through private medical practitioners, it is available through NHS GPs. Many pharmacies hold stocks of Armour for patients who have been prescribed this medication with a private prescription or a prescription within the NHS. In fact, it is being made available under the NHS in growing numbers because the relevant PCT’s have been requested to do so by forward-looking GP’s. and endocrinologists. According to these doctors, there are compelling clinical reasons for prescribing Armour, as the patients had not improved with thyroxine. Ultimately, the best testimony for efficacy is the recovery of well-being and the repeat prescriptions requested for them. We would be grateful if your web site could be updated with the current correct information. Thank you.

Your statement: “Evidence-based medicine: research showing no measurable benefit of Armour”

You said that current evidence appears to suggest that there is no measurable benefit from taking Armour over and above taking thyroxine alone. Will you please let TPA-UK have a copy of such research showing current evidence that suggests this?

If, as many doctors say, we are in the age of evidence-based medicine, surely that evidence encompasses not only clear research findings that pave the way to a treatment but also patients who find that their therapy (T4, T3, Armour) is not working or that it is working. We believe there is sufficient evidence to start thinking of choices beyond synthetic T4 alone to relieve those patients and to practice evidence based medicine.

Conclusion:

There is mounting evidence of unsatisfactory treatment with only T4, and a significant number of patients are having to resort to either private medicine or (worse) self-treatment. Patients are becoming aware that with inadequate treatment, they stand to miss years of their natural lives . Diabetic patients have a choice of human or natural insulin, even menopausal women using HRT have a choice of individual or combined, natural or synthetic hormone tablets, patches, creams, gels, and implants. Why, therefore, are hypothyroid patients treated so differently?

Medicine evolves. Desiccated thyroid hormone has been a safe and satisfactory treatment for hypothyroidism for a century now, and it has been more stable than synthetic T4 for over 30 years. With correct information, doctors and patients can work together to choose what each patient needs to return to health.

I look forward to your responses to my questions, and I thank you for your time.

Yours sincerely,

Sheila Turner
Thyroid Patient Advocate

CCs to All Patrons, Trustees and Medical Advisers of BTF

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