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TPAs Rebuttal to The Scottish Governments Submission PE1463.


TPA would point out that some statements in the Scottish Governments Submission are misleading, and other statements are incorrect:

No 1
It is our understanding that the balance of T4 and T3 at tissue level is controlled by the activity of deiodinase enzymes, and as there is no medical way of influencing the activity of deiodinase enzymes there is no discernible benefit in measuring the blood levels of hormones e.g. rT3 that cannot be altered by medication.

Tests such as clinical assessment of ankle reflex relaxation time, cholesterol, muscle enzymes, basal temperature [1] and basal metabolism rate, although not definitive, could be used to help diagnose those patients with post thyroid deficiencies and provide a viable rationale for further examination.

There is a large body of evidence to support the use of 24 hour urine testing for thyroid dysfunction.

Excellent papers are available to point out their efficacy but have been ignored. Analytical and clinical validation has been shown to anyone who will read it, or listen. The 24 hour urine thyroid function test is generally to be preferred over standard serum TFT because it shows the amount of thyroid being used, not simply how much is there and perhaps not being used (2-21).

No 2
We would expect endocrinologists to consider adrenal insufficiency in patients with on-going symptoms where they are taking thyroxine. This should be standard procedure but only if the patient appears to have appropriate symptoms.

It is accepted that endocrinology tests and treat patients with adrenal insufficiency (Addisons or Secondary Addisons disease) but what endocrinology is failing to recognise, and treat, are those patients suffering with adrenal fatigue (other names for this condition are adrenal exhaustion, non-Addison’s hypoadrenia, sub-clinical hypoadrenia, hypoadrenalism, and neurasthenia.) The simplistic nature of this label truly underestimates the complexity of the stress-response system and completely disregards the vital roles that other bodily organs and systems, hormones, and enzymes play in the overall stress response. There is always an underlying aetiology behind states of low cortisol, and clinicians who understand the complexity of the HPA axis and discover the underlying root cause of a patients hypocortisolism will succeed where others may fail.

Not only is Endocrinology ignoring adrenal fatigue and the science showing that this syndrome has global effects.[22] it is also ignoring the imbalance of other hormones, the likely presence of systemic candidiasis and dysbiosis, malabsorption, low levels of nutrients and food allergy, in those suffering symptoms of hypothyroidism etc.[23-39]

No 3
. various randomised control trials have been done comparing the use of T4 versus T3 and T4 combined. Overall the trials show no benefit to the combined treatment.

Endocrinology continues to ignore the errors perpetrated by various anti-T3 studies and meta-analysis, circa 2000-2006. The literature searches taken by three meta-analyses [40-42] considered only 11, 9, and 9 studies respectively out of more than 500 relevant studies. Thus, the investigation was reduced by 98%. Current guidelines and the RCP policy statement on hypothyroidism are based on flawed logic and imperfect evidence that bind physicians to diagnoses and treatments that fail around 15% of their patients.[43]

Quite simply, no matter what the RCP, the BTA state, they have failed to produce evidence that T4 monotherapy fully resolves every patients symptoms. The RCP must provide analytical and clinical validation to demonstrate the efficacy of their position statement on the diagnosis and treatment of primary hypothyroidism. Old testing measures have been improperly dismissed.

No 3 –
Desiccated thyroid extract has no licence for use.

This statement is misleading. Armour and several other thyroid medications have never required a license. These were ‘grandfathered’ in when Congress passed the Kefauver-Harris Drug Efficacy Amendments of 1962 to tighten control over drugs.[44.45] Before marketing a drug, manufacturers had to prove the safety and effectiveness for the product’s intended use. The requirement was applied retrospectively to 1938, when the Food, Drugs and Cosmetics (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.[44,45] 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 Thyroid and other brands of NDT continues to retain their ‘grandfathered’ status since no evidence to the contrary has developed concerning its safe and effective status.

No 3 –
there is no robust clinical evidence for its (i.e. natural desiccated thyroid extract) benefit.”.

Incorrect. Listed below are the following robust studies:

Armour Thyroid/Natural Thyroid Extract v- levothyroxine monotherapy:

Researchers reported using Armour per se in three of the studies.[46-48) Nine published reports of direct comparison of the two forms of treatment i.e. natural thyroid extract and synthetic thyroxine.[49-57] Further studies that Established the Clinical Benefits of NDT[58-79] and studies showing the therapeutic equivalence of NDT, T4, and T3.[80-83]

No. 4
In the same way as adrenal inefficiency, vitamin B12 will be checked when clinically appropriate in the very small group of patients with autoimmune polyglandular syndrome.

We are not discussing B12 deficiency in a very small group of patients with autoimmune polyglandular syndrome only. We are discussing B12 deficiency in the vast number of patients suffering with primary hypothyroidism and euthyroid hypometabolism.[84,85]

No. 4 –
Vitamin D insufficiency is an independent issue to the specific issues raised in the Petition. Although many hypothyroid patients will co -incidentally have vitamin D insufficiency, the two are not directly connected so we would require further clarification of the reasoning behind this request prior to making further informed comment.

There are several articles published over 20 years ago showing that patients with symptoms of hypothyroidism have low levels of vitamin D, especially in Scotland. Importantly, both vitamin D and thyroid hormone bind to similar receptors called steroid hormone receptors. A different gene in the Vitamin D receptor was shown to predispose people to autoimmune thyroid disease including Graves disease and Hashimotos thyroiditis. For these reasons, it is important for patients with thyroid problems to understand how the vitamin D system works.[86]

No 4 –
As noted above T4 tablets are the recommended treatment of choice by the British and European Thyroid Associations (BTA/ETA) if the thyroid gland is under active.

Correct. Those patients who have a deficiency in secretion of hormone by the thyroid gland (primary hypothyroidism) can usually be treated successfully with levothyroxine-monotherapy. However, this position is refuted by the existence of euthyroid hypometabolism (EH) [87,88] and is an over-simplification and a suppression of evidence.[89]

Neither the Association of Clinical Biochemists (ACB) Thyroid Function Test Guidelines [90 nor the Royal College of Physicians position statements [91] stipulate definitions, nor do they provide logical consistency. Both their statements are about the thyroid gland, not other physiology, which includes peripheral metabolism, reception and mitochondrial energy production, which are being ignored and which should be treated with the active thyroid hormone triiodothyronine (T3) and NOT T4.

Numerous studies have been passed to the RCP and the BTA on many occasions pointing out that their Thyroid Function Testing Guideline and Position Statement go beyond primary hypothyroidism but they continue to ignore these studies. WHY?

No 4
The committee members may wish to note that it is our view that the quotes and information presented by the petitioners do not represent the full scope of views based on the overall scientific evidence.

The views presented here by the Scottish Government do not represent the full scope of views based on the overall scientific evidence.

During the writing of this document examination of the evidence available was undertaken and at least two patient representative bodies were included in the creation of the document.

The RCP selected ONLY those 2 patient groups connected with the BTA (the British Thyroid Foundation) and their own patient group, the RCP Patient and Carer Network. The RCP failed to consult those patient representative bodies in diametric opposition to their policy statement in the UK, i.e. the Charities Thyroid Patient Advocacy (TPA) [92] and Thyroid-UK (TUK)[93] who represent tens of thousands of UK patients who are being left to suffer under the present NHS diagnosis and treatment protocol.

The RCP has, in fact, tried to discredit and denigrate those very people who oppose them, first, by silence, then by riding roughshod over their desperate need for a cure, and to use their ‘collective’ power to terrorise doctors into submission, even when these doctors know that the suggested protocol is wrong.

In the creation of new guidelines, all, not selected, evidence must be considered. The policy statement does not meet the goals of the RCP to serve patients well by setting high standards, neither do they champion the values or ethics of the medical profession with respect to the post thyroid deficient patient. With respect of these patients, it makes diagnosis and treatment worse, it is not patient centred and does not support ethical doctors. With respect of the post thyroid patient, it is a stain on the name of the Royal College of Physicians and the Scottish Government.

The Scottish Government should be open minded and take into account all the factors operating when a doctor is in the position of deciding whether or not a patient with symptoms of hypothyroidism should be diagnosed as having failure of the greater thyroid system and treated appropriately including thyroxine, a combination of thyroxine and Liothyronine or desiccated thyroid.

On this decision hangs, not just the health of the patient, but a major part of the profits of the drug industry.

If the diagnosis is not made (as in the case of the petitioners), alternative patent medicines are proposed for a variety of ensuing conditions. These conditions, actually complications of thyroid system failure, are diagnosed as anything but thyroid. The current system of failing to diagnose symptoms of hypothyroidism means that the drug industry has to spend a good deal of misplaced resources for the ineffective treatment of these emerging symptoms.

In contrast, if the attending doctor does make a true diagnosis of T3 deficiency in the face of misleading tests for symptoms of hypothyroidism, they are liable to be prosecuted by the GMC (as happened in the case of the petitioners doctor).

This state of affairs is unacceptable. Whilst TPA is not saying that the system is driven by the marketing strategies and profit of the drug industry, there are those that hold that view, based partly on the $Billions of fines levied by the U.S. Department of Justice on US and UK drug companies for the criminal mis-selling of drugs, partly on the reluctance of some medical advisors to face facts and partly on the basis of Cui Bono and Res ipsa loquitur.

This petition to the Scottish parliament is not the only protest reaching representative government about what is, in effect, the control of healthcare by the drug industry that does a disservice to patients. In November 2012, the president of U.S. C.P. (Political platform: Seeking to end the corruption in medicine that is harming human health) was heard at The Congressional Oversight and Government Reform Committee. Although the specific topics raised at Congress were different from those being raised in the Scottish Parliament, they both share the basic concern; that the sale of patent medicines has been allowed to override concern for patients welfare, increasingly so over the past half century.

The Scottish Government has made much of questionable research which would appear to undermine the case which the petitioners are making . For the government to base their response on research would appear to be sensible. But what are we to make of that research?

The US Department of Justice has fined drug companies an aggregate of about $10 Billion over the past ten years for criminal mis-selling of drugs (Including bribery and falsification of research), UK companies (GSK and Astrazeneca) account for about a quarter of the total fines 2003-2012 [94]

Is it therefore wise of the government to place reliance on research which would appear to discredit the petitioners and flies in the face of the recovery of tens of thousands of patients which has been based on remedies that do not find favour with the RCP and GMC?

The experience of the petitioners illustrates the price which the public pays for the folly and criminality of the drug industry. This criminality must stop.

The people of Scotland would be nobly served if the present paradigm of endocrinology was replaced by that advocated by Dr Henry Lindner, whose opinion the Petitions Committee sought in this matter.

Sheila Turner (Chair Thyroid Patient Advocacy)


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