World Thyroid Register -

ACTION 1

The following contains two items.
 
Firstly, the letter below is being sent to key colleagues who generally are Chair people of affiliated groups;
 
Dear Colleague,
 
You may be aware of the work of the World Thyroid Register (details available on the website www.worldthyroidregister.com). Its membership has increased steadily comprising registered members and affiliated groups where the Chair person of these groups has indicated their support towards our four-action strategy which has been discussed with you either in person or via correspondence.
 
The first step in the programme will be actioned in March of this year when a representative letter (draft to follow) will be sent to Governmental Regulatory and Educational organisations in Australia, China, Europe, UK and USA. This will address the following major issues in a World Forum.
 
I seek your help as a matter of urgency on the following:
 
A view on which organisations you feel appropriate for the respresentative letter.
 
The number of members in your Group whom you feel it may be possible to approach as anonymous support. This is important as the level of support will lend credence and weight to the deputation; I do not seek to overestimate this level of support but will become particularly important if and when we need to proceed to Actions 2, 3 or 4.
 
I would very much appreciate your input on the representative letter which could be by sent by email (action@worldthyroidregister.com). I would like our campaign to be totally transparent and in many ways the more public then perhaps the more effective. Our communications are all non-confidential and available for interested parties on a global level.
 
I do realise that we are all 'overworked and underpaid' but an early response would be very much appreciated as the campaign involves a considerable co-ordinated effort. I believe that our four-action strategy is the only reasonable prospect of improving the health of patients with hypothyroidism.
 
I urge your support.
 
Aye yours,
 
Gordon R B Skinner  MD, DSc, FRCOG, FRCPath
 
Enclosure: Draft of Representative Letter
 
Secondly, this a draft of the representative letter requesting a World Forum to address the issues of concern.
 
Dear Sir/Madam, 
 
The World Thyroid Register (WTR) has presently fifty thousand registered members which includes affiliated groups in Australia, China, Europe and the United States. The objective of WTR is to redress the continuing serious shortfall in the diagnosis and management of patients with hypothyroidism; WTR has no political or other agendum. 
 
Issues requiring resolution
 
i.                   Patients who are unequivocally hypothyroid on clinical evaluation are considered to be not hypothyroid if free thyroxine (FT4) and or thyroid stimulating hormone (TSH) levels lie within 95% reference intervals.  
 
ii.                 A patient who has been diagnosed as hypothyroid may never return to optimal health because the dose level is maintained at an inadequate level – or even reduced – on account of thyroid chemistry without regard to clinical status. 
 
iii.               There are patients in whom there is reasonable evidence that they would benefit from a derivative preparation of thyroxine namely Liothyronine which is the active post-cursor of thyroxine or from thyroid extract preparations usually of porcine origin. Patients are often denied this therapeutic option on quasi-academic argument; it is clear from the literature and informed clinical experience that these are reasonable therapeutic options. 
 
This preliminary note will not attempt to provide extensive evidence from the literature which is most certainly available and your Chairman (GRBS) is presently preparing a book to present cogent argument on these areas of dispute. I thought a brief summary of the present position might be useful at this juncture.
 
The most critical issue is that thyroid chemistry has never been validated in terms of the frequency of hypothyroidism or its usefulness in managing patients already diagnosed with this condition. The general contention that the 95% interval of thyroid hormone levels will somehow correlate with the frequency of the disease - which is then extrapolatable to an individual patient - has no evidential basis and would seem to have been loosely developed from an erstwhile laboratory test for hypothyroidism namely protein-bound iodine levels which itself was never thus validated.  
 
The futile quest for an ‘objective system’ of diagnosis is based on the misconception that  symptoms - which de facto arise from the subjective perception of a patient – are not ‘objective evidence’ bespeaks an ongoing misunderstanding of evidence based medicine. I regret that the excellent tenet of Professor Sir William Osler that the patient will tell you the diagnosis has degenerated into a truism only if a non-validated laboratory test confirms the matter.
 
Thyroid chemistry was never presented as a pivotal criterion of diagnosis. Professor Grasbeck who developed TSH reference intervals in 1969 definitively counselled that diagnosis should be based on clinical features with thyroid chemistry as a possibly helpful adjunct. As the years went by and the misunderstanding of evidence based medicine gathered apace, hypothyroidism which was defined by clinical features was insidiously transmuted into a biochemical disease with catastrophic outcome on a global basis. The only justification for using laboratory chemistry to define a disease is when the disease has been defined ab initio by its chemistry for example hypercholesterolemia and thus there is a family of disease conditions which are properly defined by biochemical criteria but not hypothyroidism.
 
The literature abounds with evidence providing sound academic argument against the single minded adoption of thyroid chemistry and it is worrying that in the face of this overwhelming body of evidence, a number of Endocrinologists and indeed Family Practitioners - perhaps influenced by the latter - do quite sincerely believe that you can continue to exclude this diagnosis by thyroid chemistry. Indeed many patients have reported that they have been advised by Family Practitioners who agree they are hypothyroid, ‘that it would be more than their jobs worth’ to prescribe thyroxine or other thyroid replacement; it is sad 'that ever this should be.*'
 
Critique of study by Pollock et al., (2001)**
 
It would be improper to not flag up one study which did purport to examine the fate of hypothyroid patients treated with thyroxine who had thyroid chemistry within 95% reference intervals. Considerable reliance is placed on this study by protagonists of pivotal thyroid chemistry. In fact, the study is self contradictory in that the authors identified patients according to six typical clinical features of hypothyroidism but these patients had ‘normal’ thyroid chemistry which in itself casts doubt on the security of thyroid chemistry as a pivotal criterion of hypothyroidism.
 
In this study, outcome was assessed by psychological profiling and the authors did not report an improvement in the patients treated with thyroxine. However, the study contained too few patients over a short assessment period with dose levels not exceeding 100 micrograms thyroxine per day which is unlikely to be an optimal dose level. The most curious feature of this study was the absence of outcome information on the symptoms which were adopted as entry criteria to the study.
 
It is all too easy to criticise a colleague’s research but it is necessary to critically consider this study as it is commonly quoted as evidence that thyroid replacement in patients based on their clinical features will not be of benefit. On a personal basis, this diverges from my own experience during many years of practice at the Louise Lorne Clinic in Birmingham UK which is dedicated to the diagnosis and management of hypothyroidism. I respectfully offer that in this practice, many patients deemed to be not hypothyroid on the basis of thyroid chemistry have returned to optimal health by sensible and responsible thyroid replacement.
 
Proposed Action 1; World Thyroid Forum
 
The World Thyroid Register thus seeks your support to consider and redress these issues. We propose that an international forum be arranged under the auspices of -  probably but not essentially - the World Thyroid Register and we would suggest the following key persons in the Forum.
 
Dr Gordon R B Skinner would be prepared to serve as Chairperson but welcomes suggestions of other appropriate persons.
 
Representatives from the following organisations
 
a)     The General Medical Council, UK 
 
b)     The Department of Health who have already provided useful input on these issues.
 
c)     The Royal Colleges of Physicians and General Practitioners, Society of Endocrinology and the Association of Clinical Biochemistry. This is important towards achieving a balanced view as these parties are sincere protagonists and have opined on the pivotality of thyroid chemistry in the diagnosis of hypothyroidism; an issue of particular concern is the contention which was reaffirmed by the Royal Colleges that hypothyroidism should not be diagnosed unless the TSH value is >10.0 mU/L. 
 
d)    A Professor of Endocrinology and a Consultant Endocrinologist working in the field of thyroid disease. 
 
e) The Royal Society of Medicine who will propose an experienced physician who has no specialised experience of hypothyroidism.  
 
f) Thyroid Support Organisations in particular Thyroid Patient Advocacy and Thyroid UK who have worked with commendable diligence during the last decade to stimulate debate on these critical issues. We will invite The British Thyroid Foundation who take a different view on the diagnosis and management of hypothyroidism but have given dedicated support over many years to patients suffering with hypothyroidism.
 
g) A patient from the four constituent countries of the United Kingdom who feel that they have been inadequately served in their treatment of this disease. These patients would provide an important perspective for the Forum. 
 
h) It is suggested that equivalent Representatives from our affiliated groups in Australia, China, Europe and the USA be invited to participate in this global Forum.
 
We wish to achieve a sensible balance between inclusive and relevant representation. Our present thinking would be to limit the number to around 20 participants.

We thank you for taking the time to read this note and ask that you give it your reasonable consideration. We will of course be pleased to provide any further information on the work of the WTR and its objectives.
 
Aye yours,
 
Gordon RB Skinner MD, DSc, FRCPath, FRCO
 
References
 
*S.T Coleridge, The Rime of the Ancyent Marinere. 1798; Part II
 
**M Pollock et al., BMJ. 2001 October 20; 323(7318): 891–895
 
 
The First Action will take place on 27th April 2012 where the WTR has convened a World Thyroid Forum and the relevant invitations (see above) have been sent out.
 
We will of course keep you updated on the outcome on this site.
 
 
 
 
World Thyroid Forum
 
 
Ardencote Manor Country Club, Claverdon, Warwickshire
 
 
Friday 27 April 2012
 
 
The first World Thyroid Forum under the auspices of the World Thyroid Register (WTR) was held on the 27 April 2012. There was representation from the Royal College of Obstetricians and Gynaecologists, the Private and Public medical sector, General Practice and Thyroid Support Groups within the UK and Europe.  Dr Gordon R B  Skinner chaired the Forum.
 
Apologies were received from the World Health Organisation,  Department of Health, National Institute for Health and Clinical Excellence, Medicines and Healthcare Products Regulatory Agency, General Medical Council, Royal Society of Medicine, Royal College of Physicians, Royal College of Pathologists,  Royal College of Psychiatrists, Royal College of Nursing,  Independent Doctors Federation, British Medical Association, British Medical Journal, Medical Protection Society,  Medical Defence Union and British Thyroid Foundation.
 
We regret that we did not receive the courtesy of a response from the Royal College of General Practitioners, British Thyroid Association, Society for Endocrinology, Association of Clinical Biochemists nor any Professor of Endocrinology or Consultant Endocrinologist who were invited to the Forum.
 
 
Morning session
 
This addressed the problems of hypothyroidism in identical twins, the role of thyroid chemistry in Obstetrics and Gynaecology and the usefulness of tri-iodothyronine in treatment resistant depression.
Ms Coralie Phillips and Ms Donna Roach are authors of a most interesting book ‘Hypothyroidism in childhood and adulthood’ which documents their trials and tribulations during their childhood; it is a unique account allowing comparison of differential treatments in identical twins. They also presented the results of their MSc research, Coralie’s MSc thesis entitled ‘Controversy concerning the diagnosis and treatment of hypothyroidism: Stakeholders’ views and recommendations whichindicated that a large body of public opinion including thyroid support groups, voluntary organisations and patient support groups were concerned that these patient led organisations were having too little influence on future research into the problems of hypothyroidism. Donna’s MSc thesis highlighted concerns regarding a link between artificial fluoridation of water and hypothyroidism.
 
We were pleased to welcome Dr Paul Hardiman as representative of the Royal College of Obstetrics and Gynaecology; Dr Hardiman is a Consultant and Senior Lecturer at Royal Free Hospital and University College, London. 
D
r Hardiman drew attention to the comparative paucity of literature on the relevance of hypothyroidism to obstetrical and gynaecological problems on the Royal College of Obstetrics and Gynaecology (RCOG) website in the UK in comparison to the USA. He provided an interesting account of the evolving utilisation of thyroid function tests in this discipline. Before 1994, this was routine but had gradually declined to approximately 5% of these patients towards the end of the century and reached even lower levels following an audit report which resulted in the 2004 RCOG Guidelines which did not advocate routine thyroid function tests. 
 
Dr Hardiman reminded the Forum of the (then) somewhat controversial  work of the late Dr Ginsberg who would diagnose  hypothyroidism on the basis of their clinical features notwithstanding unremarkable thyroid chemistry.  The Chairman (GRBS) also recalled enjoying professional interaction on shared patients with Dr Ginsberg; she was a wonderful character and is greatly missed by patients and colleagues alike.
 
Dr Hardiman undertook to revisit the requirement and or extent of utilisation of thyroid chemistry in Obstetrics and Gynaecology with the Royal College of Obstetrics and Gynaecology.
 
Dr Zaman from the Community Mental Health Team for Older Adults, John Black Centre, Birmingham presented a most interesting paper on the use of tri-iodothyronine in treatment resistant depression. The Star D study which was a prospective clinical trial of Major Depressive Disorder indicated moderate improvement on both lithium (maximum dose 900mg per day)  and tri-iodothyronine (maximum dose 50micrograms per day) over 9 weeks of treatment. There was no significant difference in the remission rate, mean time to response to medication and mean time to remission but there was a significant decrease in the frequency of adverse effects and continuance in the trial in patients receiving tri-iodothyronine compared to lithium. This is an important finding suggesting that tri-iodothyronine is a useful adjunctive medication for the treatment of patients with treatment resistant depression.
 
Mr Paul Robinson whose book ‘Recovering with T3’  gives a challenging account of his personal experience of treatment failure with thyroxine- containing preparations, described his return to health using tri-iodothyronine in tune with the circadian rhythm of cortisol production. Difficulties in thyroxine administration which - as indicated by the Chairman – tend to be the exception rather than the rule were revisited by three case presentations later in the afternoon session.   
Mr Robinson also emphasised that a laboratory test which measured not the concentration of thyroid hormones in the serum but the efficacy of these hormones at the cellular level would clearly impart a higher level of precision to the diagnosis and management of hypothyroidism.
 
 
Afternoon session
 
This focussed on reports from three Thyroid Support Groups in the UK and Sweden.
 
We were very pleased that Ms Ewa Berthagen who is the Chairperson for one of the two Thyroid Support Group in Sweden attended the Forum and provided an update of the delivery of care to hypothyroid patients in Sweden. Ms Berthagen drew attention to two serious problems in Sweden namely the non-recognition of hypothyroidism pursuant to thyroid chemistry within 95% reference intervals and the virtual impossibility of providing thyroid medication by an unlicensed medication in Sweden. A petition containing 1000 signatures did not engender any movement in regulatory strategy.  It is necessary for patients to travel to Norway or Finland to obtain their medical care; this would seem an even more difficult situation than can obtain in the UK.
 
Ms Sheila Turner, Chairperson of Thyroid Patient Advocacy outlined four important initiatives of her Support Group and stressed the importance of all patient help groups working together. Firstly the Group have prepared detailed documentation for presentation to the Royal College of Physicians with copies being sent to the General Medical Council, the Secretary of State for Justice, the Treasury Solicitor, the Secretary of State for Health and Shadow Secretary of State for Health, the Royal College of General Practitioners, the Association for Clinical Biochemistry; the Society for Endocrinology; the British Thyroid Association; the British Society of Paediatric Endocrinology and Diabetes, the Deans of all UK Medical Schools and all NHS Endocrinologists. The document presents argument that the medical curriculum is not providing a balanced education on the diagnosis, management and therapeutic strategy for hypothyroidism with greater focus on the physiology of peripheral thyroid utilisation and tissue resistance.
 
Secondly, the serious problems caused by the two physiologically different definitions of 'hypothyroidism'. 
 
Thirdly, the registry of counterexamples has reached 2000 in number and is providing critical evidence on the importance of acceptance by the medical profession that there are patients who unequivocally cannot return to optimal health on thyroxine replacement alone; three interesting case reports which relate to this problem were presented later in the afternoon session.
 
Fourthly, Ms Turner has opened discussion with a member of the Scottish Parliament and there will be formal debate with a balanced group of colleagues in the near future to explore these possible shortfalls in healthcare. Thyroid Patient Advocacy also runs a very successful and active Internet Thyroid Support forum.
Ms Susan Chippendale represented Thyroid UK and presented an interesting overview of the ongoing activities of this organisation. Ms Chippendale emphasised the importance of working with the Department of Health and the medical profession and was pleased to report that an increasing number of medical practitioners, pharmacists and of course patients make contact with Thyroid UK for information on various aspects of hypothyroidism. They also have a researcher who is involved in a study comparing blood and urine tests.
 
Thyroid UK have initiated a petition to request investigation into the relative efficacy of tri-iodothyronine and natural desiccated thyroid preparations. The petition has presently 3314 signatories. They have also initiated a new membership scheme with a related new publication which is intended to reach a wider base of patients who need help.
 
Ms Chippendale introduced the ‘Health Unlocked’ site which has 4500 members and provides advice to patients and this will clearly complement the latter initiatives.
 
The Thyroid Tracker is due to be launched in London; patients can input their health data to monitor their and view other member’s data with their permission. The information can be printed off by patients who can then present their symptoms to the Family Practitioner. They are also starting Webinars in September/October 2012.
Thyroid UK are working with the NHS Sustainability Unit to investigate ways of saving the environment and money for the NHS and are also asking for prescriptions to be re-issued at six monthly rather than one or three monthly intervals.
On behalf of the World Thyroid Register, the Chairman gave thanks to the representatives of the thyroid support groups and offered the unqualified support of the WTR to these important projects.
 
 
Final session
 
This examined three case reports wherein two of the patients were present at the Forum and answered questions on their medical problems; the patients kindly waived any concerns over confidentiality.
 
The first patient was unable to take thyroxine over many years and was only returned to optimal health using a T3 containing preparation. It was also notable that this patient had diabetes and hypothyroidism was not diagnosed for some 8 years. This is a critical point; the Chairman emphasised that the presence of another condition most particularly a patient who is deemed by questionnaire to have depression should not be excluded from a diagnosis of hypothyroidism which in his view was not an unusual occurrence in present day medicine.
 
The second case concerned a patient who unequivocally developed an exacerbation in hypothyroid symptomatology with increasing levels of thyroxine. While there is controversy over the reality and significance of Wilson’s syndrome, this patient history certainly points in this direction and we are awaiting the outcome of T3 therapy in this patient.
 
The third case concerned a patient who reported three serious bouts of acute discomfort particularly relating to muscle cramps and pains within one hour of receiving 25 micrograms of thyroxine two in tablet and one in liquid form. It was particularly interesting that this patient had a high level of thyroid peroxidase antibodies encouraging a hypothesis that the patient was suffering from a form of immune complex shock and there is evidence in the literature that high thyroid antibody levels are in general associated with fibromyalgic type symptomatology.
 
The final session opened with a general discussion on the context of the proceedings and the delegates were invited to vote on the following.
 
1.      Do you think the usefulness of thyroid chemistry towards the diagnosis of hypothyroidism should be investigated by formal clinical trial?
 
2.      In a patient under treatment, do you think that the role of thyroid chemistry in deciding the optimal level of thyroid replacement should be investigated by formal clinical trial?
 
3.      Do you think that the relative efficacy of the two synthetic hormone preparations and the desiccated preparations Armour and Erfa should be compared by formal clinical trial?
 
 
The results are shown below:
Written responses to the Forum questionnaire
 
 
 Question Response Option
 
 
Do you think the usefulness of thyroid chemistry towards the diagnosis of hypothyroidism should be investigated by formal clinical trial?
 
Yes Response  40/41
 
In a patient under treatment, do you think that the role of thyroid chemistry in deciding the optimal level of thyroid replacement should be investigated by formal clinical trial?
 
Yes Response 39/41 (one abstension)
 
Do you think that the relative efficacy of the two synthetic hormone preparations and the desiccated preparations Armour and Erfa Thyroid should be compared by formal clinical trial? 
 
Yes Response 41/41
 
These results provide a clear mandate to the WTR to seek definitive resolution of these three issues.
 
The WTR feel that it is now critical to convene an academic Forum of medical practitioners and scientists who have been engaged in practice and research into these areas. We invite colleagues with relevant clinical and/or research interests to make contact with the WTR towards preparation of this Forum. We have provisionally scheduled this meeting for November 2012 at the Ardencote Manor Country Club in Claverdon.
 
The meeting concluded with thanks from the Chairman to the delegates who attended the Forum and particularly the patients who co-presented their case histories in person.  
 
We were oversubscribed with 41 attendees and are grateful to Dr Ahmad and Ms Siddiqui for their assistance in organising this Forum and to Mr and Mrs Taylor for technical back up; additional thanks to the Staff of the Ardencote Country Club who accommodated extra numbers at short notice and provided a very tasty lunch. 
 
 
 ACTION 2
 
There are two components following the mandate from the World Thyroid Forum.
 
Firstly, we will convene an Academic Forum towards the end of this year where we will have an in depth discussion with serious research workers in the field and we welcome any colleagues who might wish to attend this Forum.
 
Secondly, if there is sufficient consensus we will make deputation to both Governmental and Regulatory Authorities to seek formal trial of the three items on the Mandate.
 
It was pleasing that one of the WTR members who is based in Bulgaria will extend the register to Eastern Europe. I will be bringing together the diverse national groupings within the next two months to allow a concerted drive on the issues. I am afraid to say that this is more essential than ever and there is a increasing reluctance amongst practioners to precribe even Sodium Thyroxine to patients unless there is wayward thyroid chemistry notwithstanding unequivocal clinical features of hypothyriodism.
 
We are now preparing for Action 2 which is to make global deputation on the three serious shortfalls on the care of patients with hypothyroidism. These are
 
1. Failure to diagnose the condition from uncritical reliance on thyroid chemistry.
 
2. Failure to provide an adequate level of thyroid replacement or to introduce li-iodothyronine or a dessicated porcine thyroid extract.
 
3. Non-delivery of necessary medically indicated thyroid preparations to patients.
 
We are now putting together registered members and affiliated groups in the UK, USA, Europe and Scandanavia to prepare a global position and solicitation to the relevant bodies in these territories. I will provide more information in the very near future on the detailed strategy.
 
I am starting to organise Action 2 and at this point in time I am asking if anyone beyone The United Kingdom is worth talking to assist with the co-ordination of this next action in their respective countries. If you are interested please contact us at;
 
 
 
 
 
 
 
 
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