Please see the link below to my original letter dated 23 April 13:
thyroiduk.healthunlocked.co...
Here is the reply I received:
Dear X,
Thank you for your correspondence of 23 April to Jeremy Hunt about hypothyroidism. I have been asked to reply on the Secretary of State's behalf.
I appreciate your concerns about access to a potentially helpful treatment.
Natural desiccated thyroid products are not recommended by endocrinologists as standard thyroid hormone replacement treatment, as the amount of thyroid hormone is more variable between batches than it is in thyroxine tablets. Furthermore, the ratio of thyroxin (T4) and tri-iodothyronine (T3) in natural desiccated thyroid products is higher than is normally secreted by human thyroid tissue, resulting in potentially harmful levels of T3.
At present, it is considered good medical practice to rely upon clinical history and examination, in addition to blood tests, in the diagnosis of hypothyroidism.
As you may be aware, joint guidelines from the British Thyroid Association (BTA) and the Association of Clinical Biochemists (ACB) have been produced on the use of thyroid function tests. They are specifically written for clinicians, provide details on the use and interpretation of thyroid function tests for hypothyroidism and hyperthyroidism and support the use of thyroxine (T4), which is usually prescribed as levothyroxine.
The RCP's and BTA’s guidelines were developed in response to concerns that people were being incorrectly diagnosed and treated because of the number of unvalidated diagnostic tests and treatments offered by various private individuals and companies. The guidelines are supported by a large number of patient and professional groups.
You also asked about the licensing process of the Medicines Healthcare products Regulatory Agency (MHRA). Before any medicine or medical device can be placed on the UK market, the manufacturer must submit a request for market authorisation with the MHRA. Further details on this process can be found on the MHRA website at
mhra.gov.uk/Howweregulate/M....
I hope this reply is helpful.
Yours sincerely,
Nxxx Axxxxx
Ministerial Correspondence and Public Enquiries
Department of Health
And here is a copy of my reply:
Dear Mr Axxxxxx
Thank you for your response to my correspondence of 23 April to Jeremy Hunt which was about Liothyronine licensing, not hypothyroidism. I am disappointed that your reply has not addressed my concerns.
Firstly, my letter made no mention whatsoever of natural desiccated thyroid products, therefore, I am at a loss as to why you would mention these in your reply.
My enquiry was about synthetically manufactured Liothyronine (T3), I specifically mentioned the product Tiromel which is produced in Turkey. Currently there is only one licensed T3 product available in the UK, it is produced by Mercury Pharma and costs the NHS around £54 per pack of 30 tablets.
My question was mainly about the cost to the NHS (this is especially relevant in these austere times) because Tiromel is available for around £3.50 for a pack of 100. The other issue I am concerned about is that many patients are being denied access to T3 on the basis of cost, this is because thyroxine (T4), which as you mention is usually prescribed as Levothyroxine is available very cheaply.
I am aware of the guidelines from the British Thyroid Association (BTA) and the Association of Clinical Biochemists (ACB), however, do not see their relevance in relation to my original correspondence, my questions are not about diagnosis.
Your final paragraph mentions the licensing process of the Medicines Healthcare products Regulatory Agency (MHRA) and I have already seen the link that you provided . I have also received a reply from the MHRA to the same email I sent to Jeremy Hunt on 23 April, MHRA advise that a medicine can only become licensed if an application is made for such a licence (usually by the manufacturer), which implies that parties other than the manufacturer may apply for a licence, this is confirmed by the information on their website which I have quoted below:
Who can apply?
Applications are generally submitted by the pharmaceutical industry, but anyone with the necessary supporting data may apply for a license.
I see no reason why the Department of Health or the NHS could not apply for a license? I would like to ask a freedom of information question around licensing which is:
‘Please provide a list of all medications currently licensed in the UK where the license has been applied for by the Department of Health (including any legacy departments) or the NHS (including Trusts and PCTs).’
Finally, I return to the opening paragraphs of my original letter where I mentioned testing the notion of ‘empowering patients and listening to communities’
Thus far, I do not feel as though I have been either listened to or empowered. My concerns have not been addressed.
I am now specifically asking the Department of health to make an application to MHRA to have Tiromel licensed in the UK so that it becomes available to patients who are currently being denied the treatment on the basis of cost and also that should the application be successful that a considerable amount of taxpayer’s money will be saved by the NHS.
I would also mention that Mercury Pharma are currently experiencing problems with the supply of their product, and I understand that that they are exploring the possibility of importing unlicensed products from abroad whilst they are themselves unable to provide supplies.
I would be most interested to know how it is possible for a manufacturer to supply the NHS with an unlicensed product from another manufacturer and furthermore, if this information is accurate, whether or not the NHS is receiving this unlicensed medication at a reduced cost (which reflects the cost of the product) or if Mercury Pharma are continuing to charge a similar charge to that levied for their own product? I assume that the Department of Health will be in a position to establish the answers to these questions.
I look forward to hearing from you soon.
