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Volume 572: debated on Tuesday 17 December 2013

I am very grateful to have the opportunity to raise this subject in Parliament. It was first brought to my attention by a constituent; I will obviously keep her name confidential, but she is content for me to discuss her experiences, which are not unusual. Hypothyroidism is not a small or niche illness; it is estimated that up to 3.5 million people in the UK may have a thyroid problem. It disproportionately affects women compared with men, by a power of 10, and the effects of the disease can be really debilitating, with the many symptoms including tiredness, aches, weight change, coldness, memory loss and depression. Even more seriously, the disease can impact on the functioning of the heart. The problem is that many of these symptoms are not unique indicators, and therefore they may be hard to pinpoint or describe.

When someone is suspected of having an underactive thyroid, or hypothyroidism as it is known, their GP will usually do a blood test to check the levels of the thyroid-stimulating hormone, or TSH. This test is called the TSH or FT4 test. In the UK, an abnormal test result will only come back for someone who is above the “over” levels of the TSH bell curve for the population. That means that some people may have sub-clinical levels of hypothyroidism but they are not flagged up for treatment. Once again, there is a disparity between the number of men and women with sub-clinical levels of hypothyroidism; three times as many women as men suffer from those sub-clinical levels. The opposite can also be true. Doctors have to consider how to treat patients with abnormal results who otherwise show no clinical signs of hypothyroidism. Therefore, it is accepted that GPs might face many different problems when trying to treat a patient with hypothyroidism.

However, my constituents know exactly how difficult and frustrating it can be to live without effective treatment of their condition. I expect that all of us know someone who has suffered from hypothyroidism, and I think that we are all aware of the impact it can have on someone’s quality of life.

In her introduction, the right hon. Lady mentioned that about one in 50 women and about one in 1,000 men develop the disease in their lifetime. Does she agree that if someone has a family history of the disease, perhaps at a certain stage of life there should be a check carried out on them to see if they have it?

I thank the hon. Gentleman for his intervention, because that is an excellent suggestion; it is what I would describe as a no-brainer. If someone has a family history of the disease, surely that should be a very strong indication for the GP to be proactive in monitoring the possibility of it appearing in subsequent generations within the family. The Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), is responding to the debate and perhaps she could respond to that point.

The constituent who first brought this issue to my attention a couple of years ago is, in fact, director of the charity Thyroid UK, which has been contacted by 19,000 thyroid sufferers. There was recently a petition with more than 5,000 signatures from sufferers who wish to see this matter debated and this disease being better dealt with. Therefore, I want to take this opportunity to raise awareness of this serious disease, the methods of diagnosing it and the ways of treating it. I also want to question the broad range of GP responses to diagnosis. More training is required to ensure that GPs respond consistently and are ready to test a patient fully for thyroid problems, so that a quick and full diagnosis can be made. That should include checking someone who has a family history of the disease, which was the excellent point made earlier.

If hypothyroidism is left undiagnosed, it can affect heart health, as I said before. It can also be a risk in pregnancy for a younger woman. If they are undiagnosed, sufferers have to live with unabated symptoms. Wrongly diagnosed patients spend time and money on visiting different specialists, as they try to find an answer to the symptoms they know they have. That is obviously a waste of both the patient’s time and the doctor’s time, as well as a waste of precious resources within the NHS. Effective and quick diagnosis is needed. There are many stories of misdiagnosis, for example where depression or fibromyalgia is diagnosed, and therefore the patient is given the wrong prescription, which can include anti-depressants and other hormone-altering drugs.

There is also an argument that in the long term correct diagnosis and treatment will cost the NHS less. In addition, a healthy, active working patient will cost the state less in benefits. My constituent had to give up work during a period of five years, and she very much regrets that her symptoms necessitated her having to do that. The disease obviously has a huge impact on someone’s life and on their overall earning capacity within their working lifetime.

It is imperative that all GPs are trained in identifying this condition, and that they are reminded to consider that certain symptoms might indicate hypothyroidism even if someone’s TSH test comes back as normal. For example, could it be that the patient is still affected by sub-clinical hypothyroidism? Should the range for those considered “normal” be reduced to bring in these borderline and sub-clinical patients? In the UK, the test considers anything above 10 ml of TSH in serum in the blood as abnormal. However, given that 10 ml is an average figure, there will be individuals who may be hypothyroid with TSH levels below the 10 ml figure. So there may be an argument for reviewing the 10 ml level. At the very least, there should be assurances that the tests are standardised, with reproducible performance in different laboratories. I have discovered that in Germany the threshold is, in fact, 3 ml, but I have to say that it is measured in a slightly different way from the way that we measure it here. However, one question that I put to the Minister is this: why does there seem to be a more sensitive threshold in another well-developed country such as Germany, which might allow a doctor to be alerted sooner than might be the case here?

When a normal result is shown but symptoms are present, why is it not regular practice to carry out a T3 test, in case the problem is caused by a malfunction of the pituitary gland rather than a malfunction of the thyroid gland, or a lack of conversion from T4 to T3? A consistent and sympathetic approach to hypothyroid diagnosis by GPs and specialists is necessary, putting the needs, experience and concerns of patients first.

There is also an inconsistency in the prescription medicines that are offered. Guidelines from the National Institute for Health and Care Excellence clearly state that levothyroxine should be prescribed in the case of overt hypothyroidism, and that might be why the 10 ml level is required by the test. NICE also states that T3 should not be used in conjunction with levothyroxine.

First, it should be made clear that the test to see if the disease is present should not be set at a level solely for identifying the level needed for prescription and a curative drug. The threshold perhaps needs to be different to ensure that there is early and correct diagnosis. People need to know with certainty what illness they might have, in order to give them at least the ease of mind that they have the answers to their health questions.

Recently, the Medicines and Healthcare products Regulatory Agency called into question levothyroxine tablets made by a company called Teva. The agency recognised that levothyroxine is now far more controlled in its production and sale here in the UK. Levothyroxine is licensed in the UK, and I am not suggesting that those problems have not been dealt with; they have been. However, in the minds of patients, doubts were of course raised at the time.

Levothyroxine is not a drug as such, but is a naturally occurring thyroid hormone made to replace the missing hormone in someone who suffers from hypothyroidism. NHS Choices is clear that the drug does not usually have any side effects, unless too much of it is taken. Levothyroxine sodium can also be used.

A naturally desiccated thyroid treatment, or NDT, is a medication made from dried porcine thyroid glands. Before artificial thyroxine existed, this product tended to be used. I do not know at what date it ceased to be licensed, but presumably it was licensed in the 1960s, when it was the only product available. It is not now licensed in the UK, as the hormone levels in the naturally desiccated thyroid treatment can be inconsistent and both T4 and T3 hormones are present. However, my constituent is anxious that sufferers such as herself, who do not respond well to the artificial thyroxine product, should be able to be prescribed NDT treatment as an alternative.

The Royal College of Physicians advises against the use of the hormones T3 and T4 together, as that is inconsistent with normal physiology and high risks of long-term harm may outweigh the considered short-term benefits to the patient. However, NDT is prescribable by GPs, on their own direct responsibility, in respect of their patient’s health. Therefore they are rightly under no obligation to prescribe it. The Minister might like to reflect on the fact that, within the NHS, such variation can be a cause of concern among patients, some of whom do not have access to a GP who will prescribe it for them.

This inconsistent approach by doctors has caused distress among patients, some of whom have received the drug from GPs although others have not. Patients do, of course, compare notes. This inconsistency needs to be addressed. Combination and NDT drugs probably do not yet meet the clinical requirements to be licensed in the UK. However, it is surely time that a T3 replacement medicine or a combination medicine that meets the requirements is researched and produced. There is official recognition of some patients’ preference for such medicines, although it was understood, when studying patients who were unaware that they were taking a combination drug, that there is no clinical benefit. There is guidance to GPs on explaining the possible benefits and dangers in full to their patients.

There may be sufficient justification for a reappraisal of the treatment of hypothyroidism in the UK by such bodies as NICE and the Society for Endocrinology. Such a professional reappraisal would also benefit from the involvement of patients. The results of any reappraisal should be communicated clearly to patients, health care professionals and prescribers, and we parliamentarians, who take up individual cases.

I pay tribute to the work of the charity, Thyroid UK, which provides important support to the large number of sufferers, and families, affected by this disease.

It is a pleasure to serve under your chairmanship, Sir Roger. I congratulate my right hon. Friend the Member for Meriden (Mrs Spelman) on securing a debate on this issue. This is, as she says, an opportunity to highlight something that we do not discuss often in Parliament. I hope that the debate will prove informative for those who wish to learn more about the condition, and will be useful to those who are affected in the way that she so ably described. I will mention the help and support that is available and will try to respond to the points that she made. If I am not able to respond to each point, I will write to her.

As my right hon. Friend said, hypothyroidism describes the general effects of a severely underactive thyroid gland, where not enough hormones are produced to keep the body functioning properly. The condition can be congenital, but most commonly occurs as a result of an autoimmune disease that attacks the thyroid gland and impairs its function. The condition is not uncommon, as she said. In the UK, the annual incidence of primary hypothyroidism is 3.5 cases per 1,000 women, and 0.6 per 1,000 men, so there is, as she said, a disparity between men and women.

The effects of hypothyroidism can be pronounced and debilitating, as my right hon. Friend said. Often, the condition goes untreated, because symptoms are frequently subtle and non-specific—she highlighted some—and may be wrongly attributed to other illnesses. Fatigue, weight gain, dry skin, lethargy, memory impairment and tiredness are all likely to be present. In elderly populations, symptoms such as memory disturbance, impaired mental state and depression may also be seen. However, the good news is that, for the vast majority of patients, once the right dose of hormone replacement treatment is given, they will return to a healthy state. Continuous medication is usually required to maintain that correct balance, and patients needing it are entitled to receive their prescriptions free of charge.

However, to get the right treatment and to restore the balance of health and well-being, a prompt diagnosis is, of course, crucial. My right hon. Friend focused on that. A range of guidance is available to improve awareness of the condition among both members of the public and health professionals. NHS Choices provides comprehensive advice on the causes, symptoms and treatment of the disease, and more detailed clinical guidance is available on the NHS clinical evidence website.

Best practice on the identification and management of hypothyroidism has been set out by the Royal College of Physicians in its guidance, “The Diagnosis and Management of Primary Hypothyroidism”, which was developed on behalf of key organisations, including the British Thyroid Association, the British Thyroid Foundation and the Society for Endocrinology. The guidance is endorsed by the Royal College of General Practitioners.

Clinical symptoms and signs alone are insufficient to make a diagnosis of hypothyroidism, so the RCP guidance makes it clear that the only validated method of testing thyroid function is blood testing, which must include measurement of the thyroid-stimulating hormone—TSH—and free thyroxine, or FT4, in serum. There is no evidence to support either the use of body fluids or the measurement of basal body temperature as a means of testing thyroid function. However, the guidance recognises that different methods of testing blood can give differing results, as my right hon. Friend mentioned. Highlighting in Parliament the RCP’s support for a helpful international initiative for greater harmonisation of reference ranges, and of the units used in expressing results of thyroid function tests, reinforces its thinking in that regard. My right hon. Friend is right to highlight that.

Once patients have been diagnosed with hypothyroidism, the vast majority can achieve successful management of their condition with a synthetic hormone replacement treatment. My right hon. Friend focused on the fact that some people do not get on with that treatment. The RCP guidance sets out that overwhelming evidence supports the use of thyroxine T4 hormone replacement—usually prescribed as levothyroxine tablets—alone in the treatment of hypothyroidism. The guidance does not recommend prescribing additional T3 hormone in any presently available form, including natural desiccated thyroid treatments, such as Armour Thyroid. This is because it has not been definitively proven to be of any benefit to patients and may be harmful. However, that does not prevent clinicians from considering other forms of thyroid hormone replacement, if appropriate.

For some patients, as my right hon. Friend highlighted, the wider availability of NDTs is a concern. It is worth making it clear that although this treatment remains unlicensed in this country, because the evidence base for its efficacy is unclear, GPs may prescribe it on a named-patient basis. I appreciate the push-back on inconsistency, but that is probably because it is unlicensed, so people have to find a GP willing to prescribe it on that basis.

To ensure that patients with the most severe and complex endocrine problems receive appropriate care and support, NHS England has published a service specification for complex endocrinology, setting out clearly what NHS England expects to be in place in order for providers to offer evidence-based, safe and effective care. That has been developed by clinicians and commissioners, with expert patient input. Certain patient groups have been calling for specialised training for endocrinologists and general practitioners in diagnosis and treatment. My right hon. Friend rightly focused many of her remarks on that.

Health Education England has responsibility for promoting high-quality education and training that is responsive to the changing needs of patients and local communities, and works with key stakeholders to influence training curriculums as appropriate. The curriculums of the Joint Royal Colleges of Physicians’ Training Board, which is responsible for the specialty of endocrinology, and the Royal College of General Practitioners, are both subject to regular review. As such, there are regular opportunities for stakeholders and interested parties, including parliamentarians, to express their views and influence the training of these clinicians. In light of the issues raised today by my right hon. Friend, I will write to the Royal College of General Practitioners, asking for its opinion on the guidance available to support its members in the diagnosis and treatment of hypothyroidism.

My hon. Friend the Minister is coming towards the end of her remarks. Perhaps when she writes to the Royal College of General Practitioners, she will mention the excellent point raised by the hon. Member for Strangford (Jim Shannon). Where there is a family history of hypothyroidism, we should be thinking a bit more about prevention. When a patient presents with an ill-defined collection of symptoms, such a family history might set off an alarm bell in a GP’s head and precipitate a test, so that the hypothyroidism does not go undetected for so long.

That is a good point. There is some information on the NHS website, but I will certainly include that point in my letter, and hopefully I will get a response from the royal college, which I will pass on. The hon. Member for Strangford (Jim Shannon) takes a fantastic interest in health issues and, as ever, is here in his place.

I hope that the Chamber is pleased to hear that the National Institute for Health Research is funding a £164,000 study on whether people aged 80 or older with hypothyroidism would benefit from lower doses of hormone treatment. Older people often have the condition in a mild form, and may not have symptoms with adverse outcomes, so the current treatment might not be beneficial.

I always make the point in these health debates that the NIHR welcomes high-quality funding applications for research on any aspect of human health. My right hon. Friend the Member for Meriden highlighted some areas that she feels would benefit from further research, and I can only say that the NIHR’s door is open to high-quality bids in any of those areas. That might be worth passing back to the charities and experts working in this field.

As I come to my conclusion, I reassure the Chamber more generally about the Government’s commitment to improving outcomes for the 15 million-plus people living in England with long-term conditions, including hypothyroidism. Through the NHS mandate, we have asked NHS England to make measurable progress towards making the NHS among the best in Europe at supporting people with ongoing health problems. We want such people to be able to live healthily and independently, with much better control over the care they receive. Of course, that feeds into many other priorities, such as ensuring that people do not present at accident and emergency because the management of a long-term condition has gone wrong. We want to ensure that such people can be healthy, well and looking after themselves without getting to that stage.

The various improvement areas mirrored in the NHS outcomes framework—this is relevant to the point on local doctors—are also in the clinical commissioning group outcomes indicator set, so CCGs are also held to account for, and are asked to provide information to the public on, the quality of the services and health outcomes that they achieve through commissioning for people with long-term conditions.

At a service level, the new NHS improvement body, NHS Improving Quality, has made the development of evidence-based tools for the management of long-term conditions the subject of a key improvement programme for 2013-14. The interventions under consideration include care plans, care co-ordination, the use of technology, self-care and the role of carers. That work will be evaluated, with best practice identified, to help us drive improvement across a range of long-term conditions. I am sure that some of the conclusions reached and evidence gathered by NHS Improving Quality will be relevant to hypothyroidism.

In conclusion, I thank my right hon. Friend once more for securing today’s debate. I hope this discussion has been helpful in providing some reassurance on our commitment to improving the quality of life for all those with long-term conditions such as hypothyroidism. I will, of course, write to her to follow up on this debate, which I hope will both help her to reassure her constituent and add to the wider debate.

Sitting suspended.