Letter to MHRA, Duncan Selbie (Public Health En... - Thyroid UK

Thyroid UK

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Letter to MHRA, Duncan Selbie (Public Health England)& Rt Hon. Jeremy Hunt asking for Tiromel to be licensed in the UK.

T4_malcontent profile image
5 Replies

Dear All

Please find below a copy of an email sent yesterday to the above named people. I'm new to this site and have been trying to find out more about T3, as I am not doing very well on T4. I know that T3 is expensive so have written to ask for Tiromel (from Turkey) to be licensed in the UK. In view of the blogs I have just read about a nationwide shortage of T3, this letter now seems even more relevant. I think I will send another email to inform the recipients of this additional issue.

If other members feel that I have raised a valid point, then I would have no objection whatsoever topeople copying the text below into an email and sending it to the same recipients.

------------------------------------------------------------------------------------------------------------------------------------------------

Sent: 22 April 2013 23:06

To: 'RIS.NA@mhra.gsi.gov.uk'; 'duncan.selbie@dh.gsi.gov.uk'; 'huntj@parliament.uk'

Subject: Liothyronine - licensing

Dear MHRA, Duncan Selbie & Rt Hon Jeremy Hunt MP

I have been reading on the Department of Health website how a new healthcare system is designed to empower patients and local communities, the website says the new system is designed to deliver better health, better care and better value for money. healthandcare.dh.gov.uk/gui...

I would like to test this notion of ‘empowering patients and listening to communities’ and in the spirit of that concept would like to bring to your attention an issue which I believe may save the NHS a significant amount of money.

I have been viewing the MHRA website in my quest to learn more about Liothyronine (T3) as I am researching alternative therapies for use when the prescribing of Levothyroxine (T4) is having little effect.

It is my belief, and the belief of many other Hypothyroid patients that Liothyronine may provide a more effective alternative therapy for Hypothyroidism, for patients who do not readily convert T4 into T3. thyroiduk.healthunlocked.com/ (for views of an on-line community of thyroid patients, please see tags on this website listed under the Tags A-Z for T3, Liothyronine, t4 to t3 conversion).

Many patients have asked their GPs and Endocrinologists to prescribe Liothyronine, however, many requests are met with barriers in the form of a) the current guidance from the Royal College of Physicians which states: ‘ The College does not support the use of thyroid extracts or thyroxine and T3 combinations without further validated research published in peer-reviewed journals. Therefore, the inclusion of T3 in the treatment of hypothyroidism should be reserved for use by accredited endocrinologists in individual patients’ and b) the issue of cost, although I am not aware of the actual cost to the NHS, I have seen the current licensed product made by Pharma for sale at an on line chemist for £2.50 PER TABLET, so my assumption is that a box of 28 tablets must be fairly costly. chemistdirect.co.uk/liothyr...

As mentioned above, I am researching Liothyronine as an alternative therapy, and I am aware that there is already a considerable amount of research and clinical trials which conclude that there is no benefit in T3 monotherapy or T3/T4 combined therapy over the existing recommended T4 monotherapy as recommended by RCP, the clinical trials being based largely on double blind testing where some patients reported improvements on T4 monotherapy and others were said to prefer T4/T3 combined, and a third group reported no preference. An example of such research was conducted by Simona Grozinsky-Glasberg et al (2006) in the form of a review of a number of studies, jcem.endojournals.org/conte... this review concluded that there was conclusive evidence to support the continuation of T4 monotherapy as the standard treatment for hypothyroidism.

Although I do not yet have conclusive evidence, my assertion is that the subjects of these clinical trials were drawn from the general hypothyroid community, and that perhaps the majority of subjects were already stable on T4 monotherapy, suggesting that a large number of the subject DID NOT have a problem converting T4 to T3, so the whole question of a preference of T3/T4 combined over T4 monotherapy for such a group, is in itself rather ‘academic’. It is my belief that a clinical trial/further research needs to be conducted with a group of patients who have reported a lack of improvement on T4 monotherapy, indicating a problem with conversion. A trial could then be conducted to determine if there are any benefits from T3/T4 combined over T4 monotherapy and perhaps T3 monotherapy as well?

Apologies for the length of this email and for my unorthodox approach, however, having mentioned the above need for further clinical trials, I will now return to the issue of the cost of the current licensed product made by Pharma and would like to bring to your attention an alternative product which is made by Adbi Ibrahim a pharmaceutical company in Turkey, with a London office. This company produced a product named Tiromel which is available in 25 mcg tablets (100 tablets per pack) at a cost of £3.50 per pack abdiibrahim.com.tr/en/produ... If this product were to be licensed and doctors less worried about the cost, then vast numbers of hypothyroid patients would gain access to an alternative therapy which is likely to produce positive effects (T3 being the active hormone, whereas T4 is only the ‘raw material’ and in itself of little use, if not converted to T3).

Therefore, I am respectfully asking what steps need to be taken to get Tiromel licensed by MHRA?

I look forward to hearing from you soon.

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5 Replies
greygoose profile image
greygoose

Good email! Very well written.

Hugs, Grey

T4_malcontent profile image
T4_malcontent

I have just sent the email below to follow up on the unavailability of T3.

pjonline.com/supply_issues_0

Dear Sirs

Further to my email of 22 April (below). I am now writing to bring to your attention a problem with the existing supply of Liothyronine – please see link above and the following quote from PJ Online (Royal Pharmaceutical Society) as you will see the sole licensed product is unavailable until June. This is likely to cause considerable health problems for patients reliant upon this medication as without t3 a myxedema coma can result. I cannot imagine a scenario where insulin stocks were allowed to become depleted! The company which manufactures the licensed product are called Mercury Pharma (not Pharma, as mentioned in my email below).

In view of these supply issues I believe this matter is now rather urgent, as is the problem with the existing supply which needs an urgent resolution – please forward this email to the relevant person in DH or NHS who is able to take action to deal with the supply problems.

Thank you

13 April 2013

Liothyronine

Liothyronine BP tablets 20µg are out of stock from Mercury Pharma. The product will be available again in June 2013. Further information on 020 8588 9441 020 8588 9441 FREE . Medical information on 08700 703033.

Totoro profile image
Totoro in reply to T4_malcontent

They should also license Unipharma liothyronine. It's used in Greece so must conform to EU standards. A packet of 30 x 25mcg tablets costs 2 euros.

ravenhex profile image
ravenhex

Consider it sent.

happyeverafter profile image
happyeverafter

Cynomel is France costs 3 euros for a box of 30 x 25mcg.

We are being fobbed with the "high cost" of T3!

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