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
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.
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T4_malcontent
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Oh for gods sake, who ever answered your letter should be sacked. And before he is sacked he should be put in the stocks and we should be allowed to pelt him with anything we like.
I wonder how lonely his one brain cell is.
Well done for not just marching round there and belting him one.....
All I can say to that is that he is a politician. Have you ever heard a politician give a direct answer to a direct question lol. My MP was just as useless when I wrote to him about it.
Thanks for doing this, because if you were to be successful we would all benefit. Your enquiry has been answered in true political style. Meaning, it has not been answered at all ! Please post the outcome of your second letter, it will be interesting to see what they say this time. I would like to know how many members of the government and nhs topnobs have shares, or are even on the boards, of these big pharma companies and how much money they are raking in from them ?
''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''.
This was the best bit of all for me. For those of us who are told we are not hypothyroid based on blood tests alone we should show our GPs his letter and point to this bit saying that even the Rt Hon Jeremy Hunt says its not good medical practice to diagnose us based on blood tests alone.
Excellent reply T4_malcontent. Well done.
T4Malcontent.. thanks for posting this brilliant letter and I echo all comments so far.
It reminds me of the initial response I got from Mercury & Actavis answering a totally different question. In poor english.
These were followed up later with a qualified persons response in a professional tone however the main question (about advice in patient leaflet) was side lined and instead emphasis put on their product.
Last week an Endo told me that 'they' had not found T3 not to have very good results and led off another subject.
My GP had advised me he can prescribe but in time the PCT would question and likely question him and refuse permission! He said if a Consultant prescribed that would accepted.
he therefore referred me unfortunately although we asked for a particular Endocrinologist known to prescribe T3 I was given an appointment with another. This was inspite of speaking to the Secretary of chosen man and being assured he would see me.
I e mailed J Hunt some months ago and am still waiting for a reply (not as well put together as your letter posted here)maybe you got the reply to my ramble
It makes you despair, either the respondent did not read the letter you wrote, or he/she is so illiterate and ignorant that reading it was a waste of time.
I also cannot believe that Mercury Pharma are allowed to profiteer like that. Of course, having a monopoly in this country IS very useful when it comes to profit.
Brilliant letter. A pity it didn't elicit the response it deserved, however it did confirm what most of us have known/feared for some time...that politicians are largely ignorant, platitude-spouting morons!
Absolutely Brilliant - I love the style in which you have replied, its clear, to the point and very intelligently written. If some sort of high powered job in the NHS came up promise us all that you would apply as you seem the type of person who gets things done.
absolutely terrific letter--espescially your follow up reply---just remember whenever you look in the mirror don't ever let that wasp out of the bulldog's teeth.....WE are all rooting for you .....incidentaly I think that the reply you received MUST have been written by ' HUMPHREY APPLEBY'......jim hacker has a lot to answer for !!!!!!!!!! alan
just shows, doesn't it. He hadn't even read the letter properly. I dont know if you have any plans to reply to what he was referring to re NDT and diagnosis and treatment guidelines. I think he should be put right regarding the notion that hormone levels vary btwn batches and that there diagnostic tools that are not used by endos.
Well don you! As usual, just like the endos and docs they hedge around things and don't actually answer the questions we ask. Perhaps we need to get together and go to number 10 Downing St. They are all so patronising and will never admit they got it wrong. Don't they realise it is not just the cost of T3 meds but all the folk like me that have to be on benefits. I'll stop before I really start ranting.
This planet needs more people like you,I'm new to this sight,have shut up put up and suffered for years,you truly are an inspiration,at away to go.....hugs n xxxxxxxxx from us all.
It will be very interesting to see what response they come up with. A disgraceful 'sloped shoulder' attitude so far... He probably handed your original letter over to the BTA and they came up with the response, thinking it was just another case of the NDT brigade trying to get their pet project approved. What arrogance!!! Please publish the reply you get this time and if it's still this stupid, please send the whole lot to Anne Robinson on Watchdog! I'm sure she'd take up the baton, especially if she puts it in Matt Awright's hands on the 'Rogue Trader' feature!!!
Well done for addressing these issues. Sadly as many know Poilticians very rarely answer directly to questions ( watch question time every week ). Does your doctors have a patient participation group? . My doctors have just started one so am hoping to bring this up at one of the group discussions, can't hurt to try.
Have belonged to our GP's PPG for about the past 6 months and our group, run by the Practice Manager, do not want to hear this kind of question and I leave many a meeting with a sore tongue. I feel these groups are only 'lip service' to the public because the Government have said they are to be put in place.
T4-malcontent, A brilliant and intelligent letter, neatly side-stepped by another useless Politician. Janet.
"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."
MPs always bring this up (and I know it wasn't even a question in your letter to Hunt), but they are incorrect, they just repeat what they are told by the BTA and we all know that thyroxine is much more variable than NDT, but can we get the message over to them, NO!!! It's sort of Chinese whispers, where the message changes along the way, except this message is coming from a so called responsible group.
Yes...it makes me cross when their so called 'reliable' Levothyroxine supplied by TEVA made me extremely ill and the review on Levothyroxine showed there was a 50% difference between some formulations of Levothyroxine, where's the consistency in that compared with NDT???? grrrrrrrrrrr.
Oh how fabulous. Keep going - this could be enlightening. I wonder if he has any idea just how stupid that reply made him look.
I am about to write to my own MP. Not about T3, as I don't take it, but about the fake diagnosis of ME. I've written the letter, but am still refining it.
Excellent letter you deserve a medal.I am in awe..I wonder if you will get an answer as it might be too difficult for them to find one. Just wonder how many palms are greased to keep the status quo.. It makes me really angry !!!!
Thank you to everyone for all the lovely comments.
I'm happy for any of my emails to be re-used by the community, hopefully someone somewhere might pay attention if they become inundated with emails all raising this issue!
I'm very pleased to see your letter and read the informative facts. Too bad that the respondent misunderstood the point you were making. I hope that you are successful in getting the information you requested and will be interested to hear the outcome.
I don't understand why there is so much resistance to patients taking T3 as our bodies produce some anyway.
The MHRA licensed Levothyroxine T4, but it was incorrectly classified as a stable drug so the testing applied to the drug for the purposes of approving a license was inadequate. As a result Levothyroxine varied in strength between manufacturers and has not been satisfactorily regulated.
Now Mercury Pharma has a shortage of Eltroxin meaning that patients have had to switch to other generic medicine. It seems like a constant battle to get a satisfactory supply of the prescription drugs that we need.
"The guidelines are supported by a large number of patient and professional groups."
I would disagree strongly that they are supported by a large number of patient groups. ThyroidUK and the Thyroid Patient Advocacy do not support them and even the British Thyroid Foundation who helped create it have a "share your story" on their website where someone only got better when T3 was added to their T4.
I'm brand new to the community as a result this morning of trying to pick up my normal T3 and T4 prescription, and very quickly reaslising there's a major problem! Without T3 I'm bed-bound and have to call in someone to take care of my kids. With it, I'm 'normal'.
Anyway, great letters. Have you thought of contacting something like Radio 4's You and Yours?
Good on you for persevering on this matter, should like to read what they reply to this. It's a shame this sort of issue isn't the kind that Watchdog would take on - sometimes it feels like progress only gets made on things when public pressure is applied.
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