Letter to MP template Re NHS Consultation T3

Please use this template and send to your MP if you can. Dr. Sarah Wollaston has just received a copy. Sorry don't know how to do an attachment. Admin is there a better way other than copy and paste. I've got the file.

OUR NAME, ADDRESS & CONTACT DETAILS

NAME & ADDRESS OF YOUR MP:

parliament.uk/mps-lords-and...

DATE:

NHS England consultation and proposed removal of liothyronine, a life supporting medication, from the list of medications prescribed on the NHS.

I am a member of ITT - Improve Thyroid Treatment Campaign and a number of thyroid support and action groups in the UK representing thousands of patients who do not feel they get the thyroid care they need from the NHS.

At the same time there are an increasing number of patients in real fear of having their current NHS prescribed successful thyroid medication withdrawn.

I oppose the withdrawal of Liothyronine T3 medicine as proposed in the NHS England consultation “Items which should not be routinely prescribed". NHS England is currently leading a review of “low clinical value” but costly prescription items and it aims to introduce a new guidance for Clinical Commissioning Groups. Liothyronine has been listed as one of the products, which are the first under consideration to be withdrawn. It is the only one not available "over the counter" without requiring a prescription.

I am writing to you as my (elected representative in Parliament / a Member of the House of Lords) because I would like you to oppose the proposed removal of liothyronine T3 from the list of medications prescribed on the National Health Service.

The reasons I oppose the withdrawal are set out below.

1. The NHS England consultation proposes that Thyroxine or T4 is a suitable alternative for Liothyronine or T3. There are two main types of thyroid hormones: T4 and T3. T4 is biologically a prohormone, an inactive form, which has to be converted by the body into T3. T3 is a biologically active form, which is utilised by the body. T3 is different in chemical composition from T4. NHS England consultation is based on an incorrect assumption. The thyroid hormones Liothyronine T3 and Thyroxine T4 are not the same and one is not an alternative for the other.

2. While many thyroid patients do well on a T4 Thyroxine monotherapy, there are many others who require treatment with Liothyronine T3 either in the form of a combination therapy T4/T3 or T3-only therapy. There are a number of reasons why some patients cannot tolerate T4-only therapy

a. Mutation(s) in DI02 (deiodinase 2) gene, which cause a deficiency of T3

b. Decreased peripheral conversion of T4 to T3.

c. Cases of thyroxine-induced liver injury

d. Impaired sensitivity to thyroid hormone.

In addition, the use of T3/T4 combination therapy may actually be recommended “in cases where a person has a history of thyroid cancer and there’s a significant risk of it reoccurring” (NHS Choices, 2015).

It is estimated that c300,000 thyroid patients are using Liothyronine because the T4 monotherapy has proved distressingly ineffective for them. I ask that Liothyronine T3 is removed from this exclusion list because Thyroxine T4 is not a suitable effective alternative for many patients and the removal of Liothyronine T3 will adversely impact many patients.

3. The withdrawal of Liothyronine T3 violates the following two key principles of the NHS constitution, which are meant to guide the NHS in all it does:

a. “Access to NHS services is based on clinical need, not an individual’s ability to pay” and “the patient will be at the heart of everything the NHS does” (DH, 2015, p.3).

b. “You have the right to receive care and treatment that is appropriate to you, meets your needs and reflects your preferences” (DH, 2015, p.6).

The reality of the NHS T4 Thyroxine monotherapy care provided to thyroid patients could not be possibly further from what they are rightfully entitled to, according to the NHS constitution. Many patients remain highly symptomatic on T4Thyroxine only medication and a considerable minority of patients can only tolerate Liothyronine T3-only medication. For the latter group, the removal of Liothyronine T3 will be debilitating and significantly impact the quality of their lives. ‘This Morning’ interview with Sue Chippendale, a thyroid patient who could not tolerate T4-only treatment, illustrates how deeply poorly treated hypothyroidism can affect person’s daily functioning:

I attach a personal statement on the treatment I received for my hypothyroidism and how T3 has given me back my life.

4. I also ask you to note that the BMA have also issued a statement that the NHS England consultation is a fundamental shift in the approach by the NHS in regard to medical care of patients.

“This proposal to reduce the NHS provision of commonly used effective and safe medicines represents a fundamental change in the relationship between residents of England and their NHS, and a change of this magnitude should not be instigated by CCGs, but should only happen following regulatory change by politicians who can then bear the political and electoral responsibility for their actions.”

bma.org.uk/news/media-centr...

5. The withdrawal of T3 medication from NHS prescription based on cost factors is strongly advised against by the BTA (British Thyroid Association which provides clinical guidance to practitioners) in its December 2016 guidelines.

“The BTA Executive Committee have been made aware of recent difficulties encountered by patients in obtaining Liothyronine (L-T3). In some instances, patients who have long been established on T3 have had their treatment abruptly withdrawn and some clinicians have received requests from local health authorities to switch patients from T3 to Levothyroxine T4. We are concerned that these actions are driven by cost considerations rather than clinical need…. The BTA does not support the sudden withdrawal of T3 therapy.”

www.british-thyroid association.org/sandbox/bta2016/information_for_endocrinologists.pdf

6. The present vastly increased high cost of Liothyronine T3 is the main reason for its inclusion on this NHS England list. Liothyronine T3 is essentially subject to a single supplier monopoly in the UK. Until 2007, the price of the Liothyronine brand Tertroxin remained stable at £15.92 for 100 tablets. However, the brand name was removed by the present owner Concordia and the product is now marketed as generic Liothyronine. In March 2016, the prescription cost of Liothyronine had risen to a staggering £922.44 monthly (based on 28 tablets at £256.20). The same Liothyronine can be bought in Europe for approximately £20 for 100 tablets. You might find the comparative low cost in other major countries very interesting!

Country Price of liothyronine (T3)

Australia 100 tablets 20mcg each = £21.25 = 37.00 AUD

Sweden 100 tablets 25mcg each = £21.10

Finland 100 tablets 25mcg each = £15.81

Norway 100 tablets 25mcg each = £21.65 = 254.50 NOK = 27.51€

Denmark 100 tablets 20mcg each = £20.09 = 190 DKK= 25.53€

Germany 100 tablets 20mcg each = £25.46 = 30.15€

Turkey 100 tablets 25mcg each = £1.25

Greece 100 tablets 25mcg each = £3.24 = 3.83€

France 100 tablets 25mcg each = £2.94 = 3.48€

UK 100 tablets 20mcg each = £922.44

The Competitions and Markets Agency is already reviewing the cost in its case Pharmaceutical sector: anti-competitive conduct. The CMA is investigating suspected unfair pricing in the supply of certain pharmaceutical products under Chapter II CA98/Article 102 TFEU. The inclusion of T3 on the NHS England list pre-empts the outcome of this review. The CMA should be allowed to conduct its review and NHS England should await the outcome of the case and Liothyronine T3 should not be included in the consultation.

7. NHS England has the power to reduce the high cost of Liothyronine. In the austerity drive the Secretary of State and NHS seem to be taking the easy option of removing Liothyronine T3 from the list of NHS prescribed medicines.

a. Firstly, the high cost of T3 to the NHS should be addressed through the National Health Service 2006 Act. The Act was recently amended by the Health Service Medical Supplies (Costs) Bill to enable the Secretary of State to require companies to reduce the price of an unbranded generic medicine, or impose other controls on that company’s unbranded generic medicines, even if the company is in the voluntary scheme for their branded medicines. The government's own website states;

"The government intends to use this power to limit the price of unbranded generic medicines where competition in the market fails and companies charge the NHS unreasonably high prices for these products. Patients should not be denied access to medicine they need because of cost." gov.uk/government/publicati...

I believe NHS England’s inclusion of Liothyronine in the consultation contravenes this statement.

b. Secondly, NHS England has the power to introduce competition into the supply of Liothyronine T3. Morningside Health Care has recently applied to supply T3 to the NHS. The Secretary of State should be encouraging competition in its supply chain to reduce the cost to the NHS.

Liothyronine should be removed from the consultation and the Secretary of State and NHS England should use the power vested in them through the Act to bring down the cost of Liothyronine T3.

8. I would also like you to be aware that to the considerable distress of patients already receiving T3 medication on NHS prescription some local CCGs (Clinical Commissioning Groups) are already stopping patient access to T3 on a cost/benefit basis despite the National consultation being open until 21 October. The CCGs have singled out Liothyronine and have not stopped the prescribing of other items under consultation. The stopping of access to Liothyronine is resulting in a postcode lottery effect for current patients prescribed T3 and appears to indicate that there is a foregone conclusion of the consultation. The impact is many patients are driven to self medicating and obtaining Liothyronine from suppliers on the internet. This exposes patients to the risk of harm from tainted or counterfeit medicines or fraud. Also, by self medicating many patients are not under medical supervision and put their health at risk. Thyroid treatment in the UK lags woefully behind the rest of the world and the imposition of T4 monotherapy by NHS England driven by what must be seen as a most unfortunate but temporary vast increase in the price is a backward move. In these circumstances some patients recognise the NHS may not support them but ask for the NHS to provide a prescription so that they can purchase at their own cost Liothyronine from a safe and reliable alternative overseas source.

9. You may also wish to consider that the impact of the withdrawal of Liothyronine T3 and imposition of a Thyroxine T4 monotherapy is enormously disproportionate on women. Approximately 95% of Thyroid patients are women. Given the above statistics, the vast majority of the patients affected by this proposal, by the NHS England, to withdraw liothyronine are women. This is an example of discriminatory practice, which contradicts the following right guaranteed by the NHS constitution: “you have the right not to be unlawfully discriminated against in the provision of NHS services including on grounds of gender” (DH, 2015, p.6). I strongly feel that inadequate treatment of thyroid patients in the UK, including the withdrawal of liothyronine from the NHS prescriptions, is an act of discrimination against the patients on the basis of gender.

10. The NHS England consultation does not take into account the cost of the failure of T4 Thyroxine monotherapy. Those patients who will be denied access to Liothyronine T3 will become highly symptomatic again. This will result in an additional cost to public funds when poorly treated thyroid patients become too unwell to work and remain on sick pay or on benefits. The consultation does not consider the cost of additional GP surgery time from patients who remain symptomatic including the cost of prescriptions (typically for anti-depressants, diabetes, stomach complaints) or hospitalisation.

As a thyroid patient, who requires T3 hormone I strongly oppose the proposal to remove liothyronine from the NHS prescriptions. I am writing to you as I trust that, as a/my representative in the Parliament, you will support me and other thyroid patients.

Personal statement - The impact of T4 Thyroxine only treatment and why I need T3 Liothyronine

The impact of removing T3 on me is:

Further background information on Hypothyroidism and T3

There are two types of thyroid hormones: T4 and T3. T4 is biologically a prohormone, an inactive form, which has to be converted into T3. T3 is a biologically active form, which is utilised by the body. T3 is different in chemical composition from T4. They are not the same and one is not an alternative for the other.

Liothyronine is a synthetic form of thyroid T3 hormone. Liothyronine (T3) is used to treat an underactive thyroid (hypothyroidism) of any aetiology. This includes primary hypothyroidism resulting from Hashimoto’s disease (autoimmune disorder), secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, primary atrophy, partial or total absence of thyroid gland, or the effects of medical interventions (surgery, radiation, or drugs) used to treat Graves disease (autoimmune disorder) and thyroid cancer. Liothyronine is also used to treat people with rare metabolic disorder called thyroid hormone resistance syndrome. All the above diseases effectively make substitution with thyroid hormones for the rest of patients’ lives an absolute necessity. Without thyroid hormones, we, thyroid patients, die.

Many thyroid patients do well on the synthetic version of T4 called thyroxine. However, there are also many others who require treatment with synthetic T3 hormone (liothyronine) either in form of a combination therapy T4/T3 or T3-only (liothyronine-only) therapy.

The Charity, Thyroid UK carried out a survey on hypothyroid patient experiences (Mynott, 2015), which included responses of 4,299 participants. In the survey report, it is recommended that if the hypothyroid symptoms do not abate a patient should be tested for the DIO2 polymorphism (Mynott, 2015, p.12). In spite of those recommendations, DIO2 polymorphism testing is not available on the NHS. Some patients do carry out the test privately but such data is not being collected in a rigorous manner, which would enable a statistical analysis. There is no data on how many hypothyroid patients have DIO2 polymorphism or other genetic mutations, which affect their ability to gain benefit from T4-only medication. As some patients take desperate measures and buy their medication abroad, it is unclear how many thyroid patient in the UK are self-medicating with synthetic T3 or dissected thyroid extracts (combination of T3/T4 hormones from swine thyroid).

In addition, the use of T3/T4 combination therapy may sometimes be recommended “in cases where a person has a history of thyroid cancer and there’s a significant risk of it reoccurring” (NHS Choices, 2015). Furthermore, Chernow and their colleagues (1983) state that, in cases of critically ill patients with myxedema coma T3 may be a better medication than T4 because T3 crosses more rapidly and more completely from serum to cerebrospinal fluid (CSF). T3 is the biologically active and fast acting hormone.

Moreover, liothyronine (T3) is also used to treat Treatment Resistant Depression (Matekovic, Baldwin, Bleakley, 2015). Rosenthal, Goldner and O'Reardon point out that “augmentation of antidepressants with T3 is one of the oldest evidence-based treatments for major depressive disorder” (2011, p.1035). The American Psychiatric Association (APA) guidelines agree that there is good evidence for the use of T3 in depressive syndromes (APA, 2010). According to Philip and his colleagues, the advantage of liothyronine is “that it generally tends to be well tolerated and has a favourable side effect profile.” (2010, p.5). Rack and Makela (2000) state that in hypothyroid patients suffering from depression on T4-only medication, T3 should be added. Depression kills. According to the Samaritans Suicide Statistics Report, there were 6,639 suicides in the UK and Republic of Ireland in 2015 only (Scowcroft, 2017).

Several research studies indicate that the combination T3/T4 therapy is superior to T4-only therapy even when offered to patients who were stable on T4-only substitution. For instance, Nygaard and their colleagues (2009) found that patients felt better on T3/T4 combination therapy, than on T4-only therapy. In addition, 49% of patients preferred combination T3/T4 therapy, compared with 15% who preferred T4-only therapy. In the randomized double-blind crossover study by Celi and their colleagues (2011) T3-only treatment was associated with reduced body weight and an improved lipid profile, when compared with T4-only treatment. A large scale retrospective study was carried out by Gullo and his colleagues (2011). They discovered that more than 20% of the patients on T4-only medication did not maintain Free T3 or Free T4 values in the reference range, which reflected the inadequacy of peripheral deiodination to compensate for the absent T3 secretion. As the authors stated, “the long-term effects of chronic tissue exposure to abnormal T3/T4 ratio were unknown” (p.1). They recommend that a more physiological treatment than T4-only may be required in some hypothyroid patients. Similarly, Midgley and his colleagues (2015) carried out a prospective observational study on a sample of 353 patients on T4-only replacement. People with the poorest T4 to T3 conversion showed the lowest Free T3 levels in spite of the highest dose and circulating Free T4. The authors concluded that thyroid hormone conversion efficiency is an important modulator of the biochemical response to T4-only therapy. In some patients, increasing the dose of T4-only medication fails to raise Free T3 appropriately. This, again, explains why some people remain symptomatic and very unwell on T4-only medication. Peterson and her colleagues have just published a large population study (2017), which included 9981 participants. Patients who were using T4-only medication exhibited lower serum T3:T4 ratios than healthy or matched controls and differed in 12/52 objective and subjective measures. In comparison to matched controls, participants on T4-only had higher body mass index despite report of consuming fewer calories/day/kg; were more likely to be taking beta-blockers, statins, and antidepressants; and reported lower total metabolic equivalents. This is how This is how Dr Antonio Bianco, President of the American Thyroid Association, commented on the outcome of the above research project:

“we have documentation that supports the patients' complaints, demonstrating that…[this] was not only in their minds, as some have suggested” (Melville, 2016).

It is possible that slow-release T3 medication, which is formulated to mimic the normal physiological profile, may have even better outcomes than normal T3. Hennemann and their colleagues (2004) have demonstrated the biochemical efficacy of a combination of slow-release T3 and T4 on the T4/T3 ratio and TSH over T4-only therapy. Slow-release T3 has never been available to the NHS patients.

Although the above studies have identified numerous reasons why some people require T3 medication, it is likely that there are other causes, which are yet to be discovered. British Thyroid Association Executive Committee in its recent statement on the management of primary hypothyroidism admitted that “more controlled confirmatory studies are needed” (Okosieme et al., 2016, p.84).

The evidence-based practice is a golden standard, which medical science is striving for. However, the practice-based evidence, which reflects “hands-on” experiences of clinicians working with their patients in clinical settings and first-hand experiences of patients, cannot be ignored whilst making crucial decisions about the accessibility of life-sustaining medication. The recent proposal by NHS England to remove liothyronine, from medications prescribed on the NHS, ignores the voice and personal experiences of vulnerable patients and their doctors. As one of the participants of the Thyroid UK survey has put it:

“My quality of life has been decimated by this condition which remains woefully untreated. I am complying with NHS Endo as cannot afford to continue privately, and despite a previous record of improvement on Levo and T3, he is refusing to prescribe. Feel so ill have contemplated suicide more than once, have been made to feel foolish, and ignored and dismissed by my former GP“ (Mynott, 2015, p. 96).

Dr Ray Moore, Endocrinologist, shared his experiences on the use of T3 (liothyronine) in his clinical practice (2016):

“I see many patients with Hypothyroidism who do not come completely asymptomatic on l-throxine therapy alone. I have also noted relatively low T3 levels in these patients and their symptoms greatly improve with the addition of T3 therapy”.

Dr Childs, a specialist in Functional Medicine, presents the benefits of T3 medication in his blog: restartmed.com/t3-medication/ Using jargon-free, easy to understand for a layperson language, Dr Childs explains some of the reasons why some people require T3. One of the readers commented on his article: “

“After 22 years of suffering on Synthroid (T4), T3 has changed my life.” (Pat, 03/05/17)

The safety of T3 medication has been documented in two large scale population-based studies, which were carried out over the period of 17 years (Leese, Soto-Pedre & Donnelly, 2016) and 20 years (Soto-Pedre & Leese, 2015). Furthermore, 13 incidents of patient deaths have been reported in the UK as a result of administration of T4 hormone (Medicines and Healthcare products Regulatory Agency, MHRA, 2017). There have been no reports of any deaths caused by T3 hormone in the UK (MHRA, 2017).

Patients with hypothyroidism are entitled to medical exemption certificate, (MedEx): they have a right to free prescriptions. The medical exemption certificate was introduced in 1968 for conditions, which required long-term life-saving medication. Untreated hypothyroidism is simply a slow death: it leads to myxodema coma, which, if left untreated, is fatal. Medical exemption certificates were introduced because it was felt that the access to life sustaining thyroid medication could not be dependent on patients’ financial ability to purchase their medication. The concern that some people wouldn’t be able to afford their life-sustaining medication is still valid: a survey conducted by Ipsos Mori found that prescription cost was a significant barrier to healthcare: as many as 800,000 people failed to collect a prescription during 2007 due to cost (2007).

Due to recent cost cutting, in some part of the UK, liothyronine is, already, only available via a private prescription from an Endocrinologist at a cost of £516.00 for a month’s supply. High cost makes it, effectively, unavailable to the vast majority of patients. They are the same patients, who have been issued medical exemption certificate in order to ensure that they will always, regardless of their own financial circumstances, have access to their life-sustaining thyroid medication.

In summary

• ​Liothyronine is a synthetic form of T3 hormone: the biologically active thyroid hormone, which is ready to be used by the human body.

• ​Liothyronine (T3) is necessary to sustain life and health of patients who do not feel well on T4-only therapy or, is some cases, are unable to tolerate T4 hormone, the biologically inactive packaging hormone, at all. Without T3 medication many people will be extremely ill..

• ​Rigorous scientific studies, some of which I have mentioned in this letter, indicate that liothyronine is both safe and effective form of thyroid medication.

• The need for the use of T3 has been confirmed in numerous studies as resulting from various abnormalities, including genetic mutations, and it does not exist merely in ‘patients’ heads’.

• We do not know how many people require T3 medication. More research in this area is needed together with DI02 testing on the NHS and systematic collection of data. The scale of the problem is potentially underestimated.

• The voice of thyroid patients, who do not feel well on T4-only medication, is being ignored.

​The voice of endocrinologists and GPs, who know that their patients benefit from T3 medication, is being ignored.

• By proposing to withdraw prescriptions of liothyronine (T3) the NHS England fails to fulfil its duty of care towards its vulnerable patients. It breaches three out of seven principles of the NHS constitution and unlawfully discriminates against thyroid patients on the grounds of their gender.

• By proposing to withdraw prescriptions of liothyronine (T3) the NHS England breaches the Article 3 and Article 7 of the Universal Declaration of Human Rights.

• By allowing Concordia to abuse its dominant position, the NHS England violated the following key principle of the NHS constitution: “the NHS is committed to providing best value for taxpayers’ money” (DH, 2015, p.4).

• NHS England has acted unethically by allowing Concordia to abuse its position as a monopolist, and then attempting to reduce public spending by withdrawing life-sustaining medication.

2 Replies
oldestnewest

Brilliant. Thanks for sharing. I'm off to see my MP on friday and I am using this FAB letter to brief her before my visit.

I have contacted my mp Jonnie merca am awaiting a reply will contact again if l havent heard by end of week

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