World Thyroid Register -
            Gordon Skinner was born in Glasgow in 1942 and attended Kelvinside Academy Grammar School where he was duxproxima accessit. Dr Skinner is widowed with a daughter Fiona and two sons Niall and David; his wife Janet was a school teacher who sadly passed away in December 2003. 
 
            He graduated in Medicine at the University of Glasgow in 1965 and following house jobs in Glasgow and Midlands of England specialised in Obstetrics and Gynaecology and later in Virology and in 1976 became Senior Lecturer in Medical Microbiology at the University of Birmingham with Consultant status at the Queen Elizabeth Hospital in Birmingham. Dr Skinner’s research portfolio for which he was awarded the prestigious Doctorate of Science by the University of Birmingham can be found in his CV.
 
           His research has also extended to the clinical arena. Some fifteen years ago he was asked by colleagues to see patients who were considered to have myalgic encephalopathy or chronic fatigue syndrome or post viral syndrome or post viral fatigue on account of his interest in virus disease. He noted that a number of these patients had clinical features of hypothyroidism but had ‘normal’ levels of thyroid hormones which would lead most workers in the field to reject a diagnosis of hypothyroidism. Dr Skinner has since treated and returned to health many patients who were clinically hypothyroid but had normal thyroid chemistry and has reported these results in a preliminary paper entitled “Clinical response to thyroxine sodium in clinically hypothyroid but biochemically euthyroid patients”. He is disappointed that many doctors have little enthusiasm or will to examine this critical shortfall in patient care which in part motivated his book “Diagnosis and Management of Hypothyroidism”.
 
         This book was written to draw attention of the medical profession to a major faux pas in the care of patients with hypothyroidism. This arises from the inexplicable refusal of the medical profession to recognise that patients can suffer from hypothyroidism when the thyroid chemistry is deemed to be ‘normal’ if the free thyroxine or the thyroid stimulating hormone lie between 95% reference intervals. There is a further problem that when a patient is diagnosed as hypothyroid many patients receive too low level of thyroid replacement through servile reliance on thyroid chemistry with (often) cavalier disregard of how the patient feels accompanied by an implicit and bizarre belief that a level of thyroid hormone is a better index of wellbeing than the patient’s own view of his/her wellbeing.
 
         This situation has arisen from the mindless deification of ‘evidence-based medicine’ which usually means laboratory-based-medicine where one chooses the evidence which suits and ignores evidence which doesn’t suit. There is no evidence that the efficacy of thyroid replacement  is better correlated with levels of thyroid chemistry than with the initial clinical picture nor clinical outcome and in a small pilot study the author has provided preliminary evidence of this assertion.
 
         A second issue concerns use of a porcine thyroid extract (Armour Thyroid) which was used extensively in the United Kingdom until introduction of synthetic hormones but was removed from the British National Formulary for reasons which remain unclear. Dr Skinner argues that there is a place for this preparation in a number of patients and practitioners who use all three thyroid preparations namely thyroxine, triiodothyronine and natural thyroid extract  (Armour Thyroid) have all seen patients who benefit from Armour Thyroid. It is often posited that the matter has not been put to placebo controlled trial which is true and there has never been a clinical trial comprising different preparations; it is therefore nothing short of presumptuous to proclaim blanket condemnation for a product on the bizarre assumption that if a comparison between this product and another product has never been made the more recently developed synthetic products are de facto more efficacious; proposition that the composition of recent batches of Armour Thyroid is not known seems unlikely given that the product has been under scruitiny for many years in both the United Kingdom and The United States.
 
Ms Mary Shomon has kindly provided updated information on Armour Thyroid and contrary to my previous assertion, it has not a product license in the USA nor (more bad news I'm afraid) grandfather status or GRAS/E which stands for 'generally recognised as safe and effective'; this was publicly annouced by the FDA in 2009.
 
It seems likely that the FDA will call for approval and requirement for New Drug Application (NDA) or the less costly approval known as Abbreviated New Drug Application (ANDA) which will allow the product to be sold but I am not clear how this will interact on the present facility to legally prescribe the drug on a named patient basis; I am seeking clarification.
 
In summary, the problem is presently not regulatory but educational. The regulatory authorities in the USA (FDA) and UK (MHRA) seem to be taking a sensible position on this product which has of course stood the test of time. Part of the problem relates to the present uncritical declamation of Armour Thyroid by Endocrinologists notwithstanding there has been no formal comparitive evaluation of synthetic versus other thyroid preparations - a somewhat wayward application of evidence based medicine.
 
The unfortunate sequela is that Family Practitioners (quite correctly) fear that prescription of Armour Thyroid will incur disapprobrium from Consultant Endocrinologists and (mistakenly) from the General Medical Council (GMC) albeit they are prescribing responsibly and with diligent consideration of the patient; they also fear (again mistakenly) that prescription of an unlicensed product on a compassionate basis will engender vunerability to litigious process.
 
I will try to keep you updated with future developments vis-a-vis Armour Thyroid.
 
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