Meeting date: Tuesday, December 4, 2018
Meeting of the Parliament 04 December 2018
Agenda: Time for Reflection, Topical Question Time, Thyroid and Adrenal Testing, Diagnosis and Treatment, Veterans, Counter-Terrorism and Border Security Bill, Point of Order, Decision Time, Autistic Children’s Experiences of School
- Time for Reflection
- Topical Question Time
- Thyroid and Adrenal Testing, Diagnosis and Treatment
- Counter-Terrorism and Border Security Bill
- Point of Order
- Decision Time
- Autistic Children’s Experiences of School
Thyroid and Adrenal Testing, Diagnosis and Treatment
The next item of business is a debate on motion S5M-14984, in the name of Johann Lamont, on the “Report on petition PE1463: Effective thyroid and adrenal testing, diagnosis and treatment”. I call Johann Lamont to speak to and move the motion on behalf of the Public Petitions Committee.14:30
The Public Petitions Committee has been considering PE1463 since 2012. I only recently became the convener of the committee, but it is my privilege to speak to the report, which contains the understanding that the committee has accumulated over a long period.
I acknowledge a number of people who assisted in the committee’s consideration of the petition, including the petitioners, Sandra Whyte, Marian Dyer and Lorraine Cleaver; the many individuals who took time to submit evidence to the committee, many of whom are struggling with the condition; and organisations such as the British Thyroid Association, Thyroid UK and the Society for Endocrinology, which provided oral and written evidence.
Thyroid disease is known to affect millions of people, predominantly women, throughout the world. The female-to-male ratio is up to 20:1, which makes the disorder predominantly, although not exclusively, a women’s disorder.
The petition is drafted in broad terms to cover all adrenal and thyroid disorders, but the petitioners explained in evidence to the committee that it is focused on a particular subset of hypothyroid patients. As the petitioners explained to the committee:
“By definition, primary hypothyroidism is a problem within the thyroid gland, but the condition that we are talking about is not within the thyroid gland. It is about the hormone that comes from the thyroid gland that becomes inactive.”
They told the committee:
“the condition that we are talking about”
“a conversion failure of the inactive T4 thyroid hormone to cross over into the active T3 hormone.”—[Official Report, Public Petitions Committee, 5 February 2013; c 1057, 1056.]
The Public Petitions Committee’s scrutiny has therefore focused on a subset of thyroid and adrenal diseases—that is, hypothyroidism—with a focus on patients who continue to experience symptoms while undergoing the recommended standard treatment.
I will set the scene by providing some medical detail of the issues that were considered in the context of the petition. Hypothyroidism is a condition in which the thyroid gland produces insufficient amounts of thyroxine, a hormone that is important for regulating the body’s metabolism. A healthy thyroid gland normally produces the hormones triiodothyronine—or T3, which is much easier to say—and thyroxine, or T4. Low levels of thyroxine can result in symptoms such as tiredness, weight gain and depression.
Testing for hypothyroidism occurs mainly in primary care when patients present with symptoms. Once diagnosed, hypothyroidism is usually treated in primary care with a prescription of thyroxine, or T4, tablets—usually levothyroxine, which is the standard treatment. Levothyroxine is a thyroid medicine that replaces a hormone that is normally produced by the thyroid gland to regulate the body’s energy and metabolism. It is given when the thyroid does not produce enough of the hormone on its own. Patients then undergo monitoring, to ensure that their levels of thyroid stimulating hormone—TSH—and T4 are within normal limits.
Thyroid conditions can have a significant impact on the lives of the people in whom they are diagnosed. Although the majority of patients with hypothyroidism will get a diagnosis and be treated successfully through the standard treatment and testing regimes, that is not the case for a proportion of patients.
Does the convener acknowledge that even patients who are on the standard T4 treatment can have symptoms that they do not know are associated with the thyroid condition, which can be an issue?
The evidence suggests—as do constituents who have spoken to me—that there is, across the board, a fundamental lack of understanding of the impact of the condition on the people who suffer from it, on the part of not just people around the patients but the professionals.
The petition has raised the profile of that cohort of patients who either do not respond to the standard treatment or do not respond to the extent that they feel sufficiently well. The committee said in its report:
“It is important that these patients are believed when they report ongoing symptoms to clinicians.”
That is something to which I will return.
As I said, the condition that we are talking about was explained by one of the petitioners as
“a conversion failure of the inactive T4 thyroid hormone to cross over into the active T3 hormone.”
The petitioner continued:
“That does not happen in the thyroid gland at all. The Royal College of Physicians guidance seems only to cover people who can convert normally, and we agree with it that levothyroxine is the right treatment for those people. We do not convert normally”.—[Official Report, Public Petitions Committee, 5 February 2013; c 1056.]
The British Thyroid Association has acknowledged that some patients continue to experience ill health on standard treatment, and the committee welcomes that as a positive step forward in bringing the issue to the attention of clinicians in mainstream endocrinology.
I have referred to the majority of patients with hypothyroidism being diagnosed and treated successfully. The petition and the committee’s work also focused on diagnosis. A key concern of the petitioners is the recommended method of diagnosing and testing hypothyroid patients who do not respond well to standard treatment. The existing guidance recommends that, if a patient is not satisfied with their response to standard treatment, they
“should be thoroughly evaluated for other potentially modifiable conditions”.
According to the National Institute for Health and Care Excellence and the Royal College of Physicians, the starting point for diagnosing a patient with suspected hypothyroidism is to arrange blood tests for thyroid stimulating hormone, or TSH, and free thyroxine, or FT4. Thyroid UK told the committee:
“Part of the problem is that in some areas only a thyroid stimulating hormone test is done, whereas in others a free T4 test is done as well. It is very rare to get a free T3 test done.”—[Official Report, Public Petitions Committee, 1 October 2013; c 1676.]
The committee considered the consistency of testing practices across Scotland and, in particular, the issue of whether testing for T3 is required. The petitioners were of the view that it should be done as a matter of course. However, the committee heard from medical experts and the president of the British Thyroid Association, who do not currently support that view. The president of the British Thyroid Association said:
“It is very misleading to be thinking about measuring T3. I agree with Dr Toft that the optimal measurement for patients who are taking T4 and who have hypothyroidism should be the TSH and the T4. I do not think that there is a place at the moment for T3 because we do not understand enough about it.”
However, Dr Toft clarified his own view by saying:
“There is no reason why T3 should not, from time to time, be measured in patients who are being treated for an underactive thyroid gland.”—[Official Report, Public Petitions Committee, 1 October 2013; c 1680-1, 1678.]
The reference ranges that are used in some testing add to the potential confusion and the mass of information that patients have to grapple with. In the course of forming a diagnosis, clinicians and laboratory biochemists rely on “typical reference ranges” for “normal” thyroids to interpret the results from blood tests. However, those ranges are only a guide and will often vary according to the laboratories, because different tests or methodologies might be used.
Some respondents were critical of the process by which the reference ranges are developed and their use in diagnosis. Thyroid Patient Advocacy has noted that different ranges are used in other countries, and its view is that the range that is used in the United Kingdom should be reviewed. The Royal College of Physicians noted in its guidance:
“We recognise that different methods used for testing blood can give differing results, and we support the international initiative for greater harmonisation of reference ranges and of the units used in expressing results.”
The committee recommended in its report that
“consideration should be given to moving towards the development of a single, national protocol for testing, along with an accompanying process for issuing consistent advice to primary care practitioners for use when considering and interpreting diagnostic tests for suspected hypothyroidism.”
I intend to offer only a short summary of treatment options, as I am keen to hear from other members about their experiences and possible treatments.
According to the British Thyroid Association, the standard treatment for hypothyroidism is synthetic T4, or levothyroxine. The standard treatment appears to work for most people because they can naturally metabolise T4 into T3, which is the active form of the hormone. However, the lead petitioner argues that some patients are not able to naturally metabolise T4 into T3 and that they continue to experience symptoms despite receiving the standard treatment. The petitioners contend that such patients should have access to alternative treatments such as T3 or natural desiccated thyroid.
The committee recognises the concerns that the petitioner has raised about the supply of T3 and notes that the licensing of medication is reserved but that the Government’s action has included discussing previous supply issues with the UK Department of Health and Social Care to monitor the supply of T3 in the UK.
In relation to the production and costs of T3, the committee understands that the market for that treatment in the UK is relatively small. For the majority of the period in which the petition has been under consideration, there has been only one licensed supplier of T3. However, the committee understands that two further licences were granted in the summer of 2017. Following that development, the Scottish Government told the committee:
“The prices charged by the pharmaceutical companies for generic and branded drugs are generally competitive. However, where excessive costs on drugs are identified it would be for the independent Competition and Markets Authority to take appropriate action against those companies.”
We understand that the CMA is at an advanced stage of an investigation into the production and supply of T3.
Leaving aside the medical facts and the arguments for certain treatments, there is the issue of patients not being believed, which we have touched on before. The Public Petitions Committee considers a great many petitions that are linked to health issues, and a common and worrying theme that too often seems to emerge is that patients are not believed when they report symptoms. It is essential that the Government addresses that general experience and concern. I would be interested in that conversation with clinicians, as we are being told that, when people present with symptoms of whatever their condition is, they are not being believed and are being dismissed. That has compounded problems for people who have particular conditions.
I again thank the clerks, all the committee members and those who gave evidence on what is a complex but, for many people across our communities, a serious issue.
That the Parliament notes the conclusions in the Public Petitions Committee’s 1st Report, 2018 (Session 5), Report on Petition PE1463: Effective thyroid and adrenal testing, diagnosis and treatment (SP Paper 301).14:41
I thank the Public Petitions Committee for securing the debate, and the convener, Johann Lamont, for moving the motion.
I offer my personal thanks to the petitioner, Lorraine Cleaver, and to Elaine Smith, and I commend those who have shared their personal experiences throughout the work on the petition over a number of years.
The Scottish Government is committed to ensuring that everyone in Scotland who is living with thyroid and adrenal conditions is able to access the best possible care and support. The petition urges the Scottish Government to take action to ensure that GPs and endocrinologists are able to accurately diagnose thyroid and adrenal disorders and provide the most appropriate treatment.
The petitioner also asked for the inclusion of free tests for T3 and reverse T3 thyroid hormones, as well as tailored treatment consisting of either T4 alone, T4 in combination with T3, T3 alone or natural desiccated thyroid.
I will highlight some of the progress that has been made since the members’ business debate on hypothyroidism last November. My predecessor, Aileen Campbell, met the petitioner and Elaine Smith MSP in February this year, when it was agreed that stronger communication and a consistent approach from GPs are important. Following that meeting, the deputy chief medical officer, Dr Gregor Smith, met representatives from NHS Education Scotland to discuss the development of an endocrine learning module for GPs, which would set out helpful steps to diagnosis and pathways of care for GPs.
In response to the committee’s final report on the petition, which was published in March, the Scottish Government confirmed that the Scottish clinical biochemistry managed diagnostic network had agreed to review evidence in relation to variation in thyroid testing. I can now confirm that the network is in the process of developing a guideline, which I hope will be helpful. I am pleased that, through the hard work of the committee, Lab Tests Online-UK now also provides people with the relevant information about testing options.
The chief medical officer’s specialty adviser for endocrinology is also leading work to support a consistent approach to specialist input across the country. That includes exciting work to develop an endocrine information technology system to support the modernisation of outpatient endocrine care and to facilitate clinical audit and research.
It is imperative that accurate guidance is available to all clinicians to ensure accurate thyroid diagnosis. The leading UK body for thyroid disorders, the British Thyroid Association, set out clear recommendations in its 2015 statement on the management of primary hypothyroidism. That statement was based on a current literature review of the published positions of the European Thyroid Association and American Thyroid Association. A number of expert bodies including the British Thyroid Foundation and the Royal College of Physicians endorsed the statement.
In 2016, NICE published its clinical knowledge summary on hypothyroidism. It is also developing a guideline on thyroid disease, with an expected publication date of November 2019. I appreciate that that is a year away, but it reflects the extensive and rigorous process of guideline development, which includes wide consultation across stakeholders including—importantly—people who are living with thyroid conditions.
With regard to treatment, the British Thyroid Association’s position statement takes into account the wide-ranging international evidence base and concludes that T4 provides
“a safe, rational ... approach to the correction of hypothyroidism”
and that it improves the “physical and psychological well-being” of “the vast majority of patients”.
However—this is an important point that the convener made—healthcare professionals should recognise that a small proportion of patients do not tolerate T4. In that instance, with the expert opinion of an endocrinologist, patients can be prescribed a combination of T4 and T3 or, indeed, T3 alone when they feel that is safe and effective.
I will come to this issue again in my own speech. Would the minister expect health boards to get in line with that approach and not stop people getting T3 or prevent their starting to take it?
What people are experiencing on the ground is really important. The guidelines make it clear that, if T4 is not working for an individual, the endocrinologist is able to prescribe T3.
That brings me to the accessibility of T3. In 2017, the Scottish Government’s effective prescribing programme board looked at medication for a wide range of conditions and at best practice in the management of hypothyroidism, concluding that there is currently insufficient clinical evidence of effectiveness to support the use of T3, either alone or in combination, as the first line of treatment of hypothyroidism. That reflects the current best practice that T4 is the preferred first-line treatment for the vast majority of patients. NHS boards were therefore asked to review the position of T3 in their formularies to ensure that T3 is initiated only on the advice of an endocrinologist, who is a specialist.
That review must be carried out in a person-centred manner, which means that face-to-face consultations are essential before any change is made. An assurance should be given that the individual can return to the original treatment if mutually agreed outcomes are not achieved. I am referring specifically to someone who is currently on T3. The Scottish Government is clear that an endocrinologist can prescribe T3 for an individual patient if their symptoms are not adequately controlled with T4. Nevertheless, I recognise Elaine Smith’s point.
The diagnosis and management of hypothyroidism should also not rely solely on the results of biochemical tests, and it should take account of the individual’s circumstances, experiences and goals. That is in line with the realistic medicine approach, which emphasises that the making of decisions about an individual’s healthcare should be focused on the individual and discussed and agreed between them, their family or carer and the clinician.
Time has rushed by. I have a few more points to make, which I may be able to cover in my closing remarks.
I thank the Public Petitions Committee for the huge amount of work that it has done. I also thank the petitioner, Sandra Whyte, and others in the public gallery, and Elaine Smith, who has put a huge amount of effort into this.14:48
As Johann Lamont said, this particular petition has exercised the Public Petitions Committee for some time. I would like to thank the petitioner, Sandra Whyte, for lodging the petition and to mention the work that Elaine Smith has done over the period of the consideration of this petition and in keeping the committee in line.
In discussions about the disparity in healthcare provision, we regularly hear the term “postcode lottery”. What became clear during the committee’s investigation is that when it comes to the diagnosis and, in particular, the treatment of thyroid conditions, it is often not a question of postcode but of individual medical practitioners. While I recognise that the conventional T4-only treatment is successful in the majority of cases of hypothyroidism, I am concerned that when the conventional treatment is not effective, the options that are available to patients seem to be driven more by the individual opinions of treating physicians than by any clear guidance.
Both inside and outside the committee’s investigation, I have had the opportunity to speak with a number of thyroid patients about their experiences. What struck me most was the vast range of experiences that they had, from those who received faultless treatment to some who are now having to pay for their own T3. To me, that level of inconsistency in treatment is a real cause for concern.
To give you an idea, I will read out a description that one hypothyroid patient gave me of their path through diagnosis and treatment. In their own words:
“T3 changed my life. It’s as simple as that. At least, it should be as simple as that. But before T3 could change my life, I had to get it, and that was more difficult than I believe it should be.
Luck played an enormous role in my experience. Hypothyroidism is less common in men, so when I went to see my GP suffering from depression, low energy and other symptoms, hypothyroidism was never really considered. That’s why it was years of different ineffective medications, some with fairly unpleasant side effects, before I received a diagnosis. Even then, it was pure luck—a consultant looking into an unrelated issue ran a blood test that diagnosed me.
When I was put on T4, and ever-higher doses were having little or no effect, it was luck that my GP at the time suggested I ask my consultant about taking T3 as well. Then it was even more luck that my consultant was willing to try using T3. It was only later that I discovered he was the only consultant in that health board who would have prescribed it.
I understand that the medical profession has mixed views on the use of T3, but when there are so many people like me, who rely on it to function, it’s unfair that so much is left to chance. T3 works for me. Most people with hypothyroidism may not need it, but that’s not an argument to say it shouldn’t be available to those who do.
When I was diagnosed with depression, I went through various different combinations of medications. When the most commonly effective combination didn’t work, my GP knew they had other options and they tried them. When it comes to T3, the options are there, but it’s up to the doctor to decide whether they’re worth trying or not. That’s simply wrong. The effectiveness of a treatment may always have an element of luck. Whether or not someone can get a prescription for a treatment shouldn’t.
T3 changed everything for me. Without it, I don’t believe I’d have the job, the friends or the life that I have now. Without it, I really don’t know where I’d be. I hope Parliament can do more to ensure that it can change the lives of others.”
That is by no means an isolated case in the evidence that we took. Although it is not our remit in this place to make any kind of medical recommendations, the pervasive inconsistency and lack of clarity shown by the healthcare profession on this issue cannot be allowed.
Because healthcare is not an exact science, there will always be differing opinions on treatment options. Our healthcare professionals are trained to make those decisions and, in the vast majority of cases, I assume that that is in line with what we would all expect. However, when the medical profession is so split on a treatment, especially for a condition that can have such a devastating effect on a person’s quality of life, I think that it is incumbent on the Scottish Government and specifically the cabinet secretary to call for strong guidance to be given to healthcare professionals on the treatment of hypothyroidism, especially on when the prescription of T3 may be appropriate.
We cannot allow a situation where patients are left to order their own medicines—medicines that they know are making a difference and are making a significant contribution to their quality of life—to continue. We need a clear direction from the Scottish Government to the medical profession that guidance needs to be given to the front line where appropriate.14:53
I have made many speeches in this chamber over 20 years but this is one of the most important. It is quite literally a matter of life and death, including my own.
I am not sure how I can address six years of evidence in around six minutes, but I must start by thanking the lead petitioner, Lorraine Cleaver, who resolutely stuck with the process during that time and who is in the public gallery, along with other thyroid sufferers.
I would also like to thank the convener of the committee, the committee members, the clerks, the Government and the many witnesses who gave evidence, including 50 who gave personal stories.
One of those stories is my own. I have Hashimoto’s thyroiditis, which is an underactive thyroid. I started on T4 in my twenties, but I became very ill 10 years ago. I would have told my whole story today, but we are short of time, so I will just say that after I was wrongly diagnosed with ME, I managed to persuade my GP to refer me to Dr Anthony Toft, who put me on T3 and I came back from the dead. Many thyroid sufferers have similar stories—in fact, the story that Brian Whittle told is similar to my own—but many more sufferers are not here to tell their stories because, sadly, some have committed suicide and others have died of associated medical complications.
The diagnosis and treatment of what is primarily a women’s health issue is, quite frankly, a scandal, and many are disbelieved by the medical profession. It is accepted that 5 to 10 per cent of patients do not do well on T4, although the real figure is thought to be much higher. Those people must be helped. As the convener pointed out, the Public Petitions Committee report concludes:
“It is important that these patients are believed when they report ongoing symptoms to clinicians.”
It is also important that they get the right treatment. The Government’s response to the committee’s report recognises
“that stronger links of communication and consistency of approach between GPs, in both the diagnosis and ... referral ... could be developed.”
The minister referred to that in his opening speech and also acknowledged
“that an endocrine learning module has ... been produced”.
I think that Dr Gregor Smith is arranging for that to be reviewed and I am pleased that that is happening. The Government’s response also says that it
“expects all clinicians to demonstrate a person centred approach”.
That would certainly help because, again, as the Government response acknowledges, symptoms must be taken into account and not just test results. That is hugely important.
In The Scotsman recently, Dr Catherine Calderwood, the chief medical officer, said:
“I want us to move away from the ‘doctor knows best’ culture to ensure a more equal partnership with people.”
However, shared decision making does not seem to apply at the moment to endocrine patients, because they are not told of all the available treatments and GPs are not working with them to reach the best treatment decisions. That is the reality.
Unfortunately, six years after the petition was lodged, the situation got worse, when T3 was withdrawn. When I first started to help with the petition, I thought that I was doing it for others and not myself, because I thought that my situation was sorted. However, due to the withdrawal of T3, and to the Scottish Government having admitted that the previous listening exercise did not meet its objectives, I wonder whether the Government would now consider undertaking a proper listening exercise to hear directly from thyroid sufferers here in Scotland. I put that to the minister.
It is appalling that thyroid patients have to buy natural desiccated thyroid hormone, or T3, from abroad, rather than just lie down and die, but many of the them do that because there is no other choice. The medical establishment is not listening to them. If I had had time, I would have addressed the issue of desiccated thyroid, which was a perfectly good treatment before synthetic thyroid was invented. People started using it around the 1980s and it is still widely used abroad, but I really have to limit my remarks to T3.
The Scottish Government’s response on T3 is the most important aspect for those needing it to survive:
“The Scottish Government’s position is that treatment for Hypothyroidism in Scotland should be consistent with the BTA guidance in relation to Liothyronine (T3) and clinicians in Scotland can prescribe T3 where it is safe and clinically appropriate, on the advice of a consultant in endocrinology.”
The minister backed that up in his speech.
The most pressing, life-saving and immediate task for the Scottish Government is to instruct health boards that they cannot stop prescribing T3 to existing patients or stop new patients from accessing it. It is neither safe nor clinically appropriate for health boards to take patients who are functioning well on T3 off it and put them on T4. That is a death sentence. They are completely different medicines. The Medicines and Healthcare products Regulatory Agency says that the products are not considered interchangeable and states:
“Levothyroxine and Liothyronine are not substitutes for each other.”
In a letter dated 31 July to my colleague Lewis Macdonald MSP, who has given me permission to quote it, NHS Grampian says:
“No new patients should be prescribed ... T3 or Armour thyroid products regardless of the source of the recommendation.”
That means regardless of the clinician. It goes on to say that
“patients currently prescribed ... T3 or Armour Thyroid should be reviewed by their GP and where possible switched to Levothyroxine therapy (T4).”
It claims that
“this advice is evidence based”
“reflects the view of the British Thyroid Association.”
No, it is not, and no, it does not. There are peer-reviewed studies showing that T3 works and there are many patients like me who can bear witness to that. The BTA says:
“The BTA position statement on hypothyroidism should not be interpreted as a recommendation to not use Liothyronine or as an endorsement for its discontinuation.”
Of course, when T3 cost very little, no NHS boards were stopping it.
What is the cost to human life, not to mention our economy, of taking women off their life-saving treatment? To put it in context, it is like taking insulin away from diabetics and no one would dream of doing that. It would be helpful if the Health and Sport Committee would consider undertaking a short inquiry into the issue, with direct evidence from the women who are taking T3 and the endocrinologists who are prescribing it. That would add to the work that the Public Petitions Committee has done.
The Parliamentary Under Secretary of State for Health, Lord O’Shaughnessy, recently commissioned evidence from thyroid organisations, including the British Thyroid Foundation and Thyroid UK. In that report, Professor Chatterjee, the BTA president, says:
“The current uncertainty, with liothyronine-treated individuals either being denied ongoing prescriptions or needing to source the treatment themselves at their own cost, seems very much against patients’ interests.”
The report also shows that prescriptions for T3 have fallen most dramatically in areas where the levels of deprivation are greatest, therefore the poorest patients are being hit the hardest.
Every MSP in the chamber will have constituents or relatives who have a thyroid disorder and who are being badly let down by our health service. I hope that the Government can stop the harm that is being done to those people.
In conclusion, I remind those in the chamber that hypothyroidism affects 2 per cent of the population and that 95 per cent of sufferers are women. Therefore, it is a huge issue of gender discrimination. Most clinicians are men, which led thyroid patient, Clare Pullar, to say that it is
“a male-dominated profession actively silencing a female-dominated patient group.”
That group of women will no longer be silenced and, as their representatives, we must listen and act on their behalf. On behalf of Scottish Labour, I say that we are on the side of patients—mainly women—who are suffering and dying due to the scandal of thyroid diagnosis and treatment in this country. This debate, the Public Petitions Committee’s report and the Government’s response to that report should be a start in getting thyroid justice for them.
Thank you. We turn now to the open debate.15:00
I am extremely pleased to have the opportunity to speak today, because I was on the Public Petitions Committee when the petition was lodged in 2012. Since then, an extraordinary amount of time and work have been contributed to consideration of the petition, which allowed the committee to reach its conclusions and to make recommendations.
Thanks must be given to the petitioners—Sandra Whyte, Marian Dyer and Lorraine Cleaver—to my colleague Elaine Smith MSP, to the committee clerks and to the witnesses who took time to give evidence to the committee. Only by listening to the voices of people whose lives have been affected can we begin to learn and understand the challenges that must be tackled.
Hypothyroidism is a lifelong and debilitating chronic health condition that can, if it is undiagnosed or misdiagnosed, cause much greater health problems including high cholesterol, carpal tunnel syndrome, hearing loss and cardiac issues. Therefore, timely diagnosis and provision of appropriate treatment are vital.
The evidence that was presented to the committee showed that many people—mostly women—have endured many years of suffering due to prescribing of the wrong medication or misdiagnosis. Around 4.5 million people in the UK have thyroid problems, and it is a condition that disproportionately affects women—20 in every 1,000 women, compared with one in every 1,000 men. The condition is most common in women who are aged between 40 and 50, which can contribute to tell-tale symptoms being missed or simply ignored because they are wrongly attributed to the menopause.
It is important to note that most cases are diagnosed and treated successfully. However, for those that are not, the consequences can be life changing; they can cause untold misery and detrimentally affect family life and personal relationships. It is now widely understood that it can be problematic for general practitioners and endocrinologists to diagnose accurately and treat hypothyroidism, due to the often vague and non-specific nature of the symptoms that are described by patients. GPs and endocrinologists are faced with making decisions on management of patients who display few or no clinical signs of thyroid dysfunction, but return abnormal tests.
An estimated 2 million people are believed to have undiagnosed thyroid problems. Therefore, the case for consistent and effective testing, diagnosis and treatment of thyroid disease and adrenal disorders is clear. The process must be reliable and must ensure that GPs and endocrinologists are given the best possible support to allow them to provide dependable treatment.
Some harrowing accounts have been brought to light as a direct result of the petition, and those personal stories have provided greater awareness and understanding of the issue. It has been shocking to learn that some patients have suffered symptoms for many years and that their condition has gone untreated, either due to the absence of a diagnosis, or because the patient belongs to the subset of hypothyroidism patients who do not respond to the standard treatment. It is crucial to have a better understanding of the issue and clear diagnostic guidelines in order to prevent the needless suffering of any more people.
The very personal stories illustrate the adverse effects that misdiagnosis or ineffective treatment can have. The condition being untreated has frequently plunged people into extreme despair, which has resulted in inability to participate in everyday life and has often acted as a barrier to employment. Such things serve only to intensify an already miserable situation and to compound it with financial uncertainty and additional stress. The importance of the increase in general awareness of the guidelines, and developments in professional guidance and public information since the petition was lodged in 2012 cannot be overstated.
I highlight the National Institute for Health and Clinical Excellence’s clinical knowledge summary on hypothyroidism, which is in line with both the British Thyroid Association position statement and guidelines of the Royal College of Physicians. I welcome its work to develop new guidelines on assessment and management of thyroid disease, which is due for completion by 2019. I also welcome the Scottish Government’s commitment to improve diagnosis and access to appropriate treatments for thyroid disorders.
Debates such as this are extremely important in helping to raise awareness and improve people’s understanding of such complex issues. I once again offer my heartfelt thanks to everyone who has contributed to the process since 2012, and allowed us to reach where we are today.
I welcome the continuation of discussions on development of future clinical guidance and public policy, and I look forward to further consideration being given to development of a single national protocol for testing. [Applause.]
I remind people in the gallery that we do not permit applause in the public area. Thank you very much.15:06
I thank Sandra Whyte for highlighting the importance of thyroid-related conditions and for working so hard to get us to this point. I also thank Elaine Smith MSP for her hard work and for bringing her story to Parliament. Consideration of the petition has spanned nearly six years. In that time, a significant range and volume of evidence has been gathered, by way of submissions and oral evidence to the committee. I thank those who have made such valuable contributions.
According to the NHS website, thyroid underactivity in the UK affects 15 in every 1,000 women and one in 1,000 men. Although most sufferers are diagnosed effectively, many people live with the mental and physical problems that arise from being undiagnosed. Back in December 2012, petition PE1463 called on Parliament to urge the Scottish Government to take action to ensure that GPs and endocrinologists are able to diagnose thyroid and adrenal disorders accurately, and to provide the most appropriate treatment. Many years later, we are still learning of people who live with thyroid conditions and are still negatively impacted daily.
This morning, I spoke to a friend from my constituency who is a GP who told me how hard it is to diagnose thyroid conditions because they can mimic other conditions. The petition highlighted four main concerns about the need for tests for free T3 and reverse T3 thyroid hormones; for medical professionals to acknowledge the existence of adrenal insufficiency; and for the adrenal stress index test to be incorporated in NHS thyroid-testing procedures. There are lots of big words to use today. I am eating my own tongue trying to say them so I apologise for that.
Moreover, the petition called on medical professionals to acknowledge and take account of variations in individual biochemistry and to tailor treatment accordingly. We have heard a lot of members speak about that. Treatment might consist primarily of T4 only, T4/T3, T3 only or natural desiccated thyroid. The petition raised concerns that NHS procedures do not include testing of autoimmune status, minerals, enzymes or vitamins.
I will speak about the experiences of people with thyroid conditions. People live day in and day out with thyroid conditions. Their experiences of living with them range from weight gain to lethargy and depression. I am grateful to all the brave people who contributed to the committee’s evidence sessions by telling their stories.
In The Daily Telegraph yesterday, I read about a remarkable woman, Fiona McGowan, who lives with hypothyroidism. She realised that she was putting on weight and blamed her mother’s death, despite living a very healthy and active lifestyle. Eventually, a nutritionist realised that she had an endocrine issue. Although she then obtained the correct medicine to help to treat her condition, the price of her medication became an issue. People self-medicate and purchase medicines on the internet from other countries, due to high costs and lack of availability in this country.
We know from today’s speeches and from accounts of people with thyroid conditions that the problems have significant impacts on peoples’ lives. Elaine Smith’s suggestion that the Health and Sport Committee conduct an inquiry and take evidence from such people is a great idea.
Although the majority of patients with thyroid conditions are diagnosed and treated successfully, that is not the case for a proportion of patients. Members must support them, and the Scottish Government must take note of the issues. A review is needed into how professionals deal with thyroid conditions, whether through guidelines that are developed by independent experts, including health authorities and clinical bodies, or through peer-reviewed research on patient treatment.
Although I acknowledge that the licensing of medication is reserved, better dialogue would be beneficial in ensuring that T3 supply issues are dealt with in order to avoid increases in the cost of medicines, which ultimately lead to people making internet purchases. I look forward to the Scottish Government supporting sufferers, and I again thank everybody who contributed.15:10
It has been more than a year since we last debated access to T3 for people who suffer from thyroid conditions. That begs the question: what has changed? I fear that all the changes that have been described are not matched by reality. I welcome the opportunity that has been given to members by the Public Petitions Committee bringing the subject to Parliament for debate once again, because the problem has not yet been fixed.
As Elaine Smith said, the problem is an issue of women’s health equality. Some 3 million people in the UK suffer from a thyroid problem: 95 per cent of them are women. Hypothyroidism is a crippling illness. Many people are being failed by poor diagnosis and poor treatment, and some are left with no diagnosis and no treatment at all.
On average, patients in the UK wait three times longer for treatment than patients in the United States, and because the condition progresses slowly, it can be many months, if not years, before treatment begins. T4 is the standard treatment for patients, although some patients get no benefit from T4 at all, but thrive on T3. There is no clinical reason for not prescribing T3: it is simply a matter of cost.
I have no doubt that the drug company that is responsible for the manufacture of T3—Concordia International—is engaged in excessive profiteering. The Competition and Markets Authority found that Concordia had abused its dominant position by increasing the charge to the NHS by 6,000 per cent in the last decade. Concordia should be ashamed.
When we last debated the subject, the cost of 100 T3 tablets in the UK could be as much as £900. In Turkey, they cost the equivalent of £1.25 and in Greece, they cost the equivalent of £3.24. That is a shocking difference. I know that the pricing of medicines is reserved, but it has been more than two years since the Competition and Markets Authority expressed that view. We still do not have a final decision and little has changed on the ground.
As we have heard from numerous members, there are very real and serious physical and mental health challenges for women who cannot access T3. However, despite that knowledge, as well as guidance from the Scottish Government, health boards are withdrawing T3 because of the cost. There is little regard for the consequences for individuals: that is simply not good enough. I want to know, in practical terms, what the Scottish Government will do now.
When we last debated the issue, I spoke about a constituent who was on a combination of T4 and T3. She is watching the debate from the gallery. She has a genetic condition that makes T4 largely ineffective. Her consultant knew that, but tried to increase the dose of T4, although there was no clinical reason for doing so. Her condition worsened and she had to give up her job as a university lecturer. After a long fight, she is now on T3, but her consultant is trying to reduce the dosage. Again, the decision is based on cost, rather than on clinical need.
The cabinet secretary is aware of all that, because I wrote to her about it, just as I wrote to her predecessor. In a rather formulaic response, she said that it is a matter for health boards. That is an abdication of responsibility. How can it be right that people in the NHS Grampian area cannot get T3, but people in the NHS Greater Glasgow and Clyde area can? Where is the fairness and equity in that? I am sure that the minister is not suggesting that women should move to another health board area, or perhaps book a flight to Turkey or Greece. Although it would be ludicrous, it would undoubtedly be cheaper to prescribe T3 with a dose of sunshine.
The minister set out some actions that are being taken, but what he set out is not matched by experience on the ground. The Scottish Government cannot stand by and watch health boards do their own thing. Will the minister write to health boards this week to tell them to allow T3 to be prescribed? Will he monitor what happens afterwards? It is not enough to issue guidance and hope that the health boards follow it. The minister needs to be robust.
The NHS was founded on the principles of meeting everyone’s needs, being free at the point of delivery, and being based on clinical need and not the ability to pay. It is time for the Scottish Government to deliver on those principles and to stop presiding over the postcode lottery in care, which has such dreadful consequences for the women who are affected.15:15
This has been an excellent and well-informed debate. I thank the Public Petitions Committee for its hard work. I particularly acknowledge the contribution of Elaine Smith; she has been a fantastic campaigner and has made a huge difference in the campaign. I warmly thank the campaigners in the gallery for their courage, patience and dedication. They should be applauded for the hard work that they have done over many years. [Applause.]
I was pleased to be the convener of the Public Petitions Committee when the petition was first received. I notice that there are a couple of survivors from those days here, in the shape of Angus MacDonald and David Torrance, who were involved in the evidence sessions. Some people might feel that the subject is very technical—undoubtedly, it is—but the key issue is crucial, particularly for women’s health. As Jackie Baillie said, 95 per cent of the people who are affected are women. As Elaine Smith said, given that at least 2 per cent of the population suffer from thyroid disease, it is clear that many parliamentary colleagues and their neighbours, friends and constituents will be in that patient cohort.
It is obvious from the evidence and the report that thyroid diagnosis and treatment have lagged behind other areas of endocrinology, for example diabetes. Specialists cover conditions including metabolic disorders, some cancers and excessive or insufficient production of hormones. As other members have found, it is interesting to quote the British Thyroid Association, which has expressed concern about patients being taken off T3 due to cost rather than clinical need. I will quote the association’s words in its guidelines of December 2016:
“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 L-T3 have had their treatment abruptly withdrawn and some clinicians have received requests from local health authorities to switch patients from L-T3 to levothyroxine (L-T4). We are concerned that these actions are driven by cost considerations rather than clinical need and that the BTA position statement on the management of hypothyroidism is being inappropriately cited to support these requests.”
In its response to the committee, the Scottish Government has made it clear that T3 prescribing must continue. It said:
“The Scottish Government’s position is that the treatment should be consistent with the BTA guidance in relation to Liothyronine (T3)”.
However, as Jackie Baillie suggested, when the minister winds up, could he make it very clear that, where appropriate, there should be no postcode lottery and that patients wherever should be able to get necessary medications. That is vital.
When I was convener of the Public Petitions Committee during consideration of the petition, a dossier of more than 50 patients with different stories was issued to us. I do not have time to do them all justice, but I will quote one—Lee-Anne—who said:
“Prior to my diagnosis, I was slipping into such a black hole, reacting very badly to antidepressants, which caused panic attacks, full-body spasms, insomnia, clenching jaw, suicidal thoughts and the list goes on. When I reported this reaction to my GP, her answer was to double the dose.”
In summary, I acknowledge the fantastic work of the Public Petitions Committee, which shows the innovative role that it can play in Parliament. I thank the committee and the campaigners for their sterling work. As a member of the Health and Sport Committee—I cannot speak for the rest of the members—I support a full inquiry by the Health and Sport Committee. My colleagues on the committee and in the chamber might wish to support me in that.15:19
I, too, think that it is important that we pay tribute to the petitioners and thank the Public Petitions Committee for giving Parliament the opportunity to again debate this important issue. It is particularly important to pay tribute to Lorraine Cleaver for her relentless campaigning on the issue, as well as to past and present members of the committee for their work since 2012 to highlight the serious concerns about the quality of patient care for and treatment of hypothyroidism.
It is also important to note Elaine Smith’s personal interest and consistent work in the Parliament on this issue. It is important that we take up the concerns of individual constituents, but the passion that Elaine Smith has brought to the issue, and to all members across the political spectrum, is important to highlight, too.
As other members have done, I welcome and commend the work of the British Thyroid Foundation, which provides advice and support to people with thyroid conditions throughout the UK. A number of my constituents asked me to make that point.
Hypothyroidism affects hundreds of people in every constituency in Scotland, and they have been waiting too long for action. As David Torrance and Rachael Hamilton mentioned, the risk of initial misdiagnosis can be significant, because some of the common symptoms mirror those of numerous other conditions.
The petition urged the Scottish Government
“to take action to ensure GPs ... are able to accurately diagnose thyroid and adrenal disorders and provide the most appropriate”
care. We all share that aim, but as Jackie Baillie has stated, I do not think that we have seen enough action and the progress that is needed.
Early access to accurate blood tests is vital, and I welcome the minister’s points about the report. It is important that that is taken forward. The lack of specific and formal Scottish guidelines on the diagnosis and management of hypothyroidism is a key issue that was raised by many patients ahead of the members’ business debate and this debate. Indeed, I received emails from constituents on the issue ahead of this debate.
I welcome what the minister said about the development of care pathways, but we need to see the timescales for that and hold the minister to his word on what the Scottish Government has said that it will do.
I will touch on the cost of drugs, which was mentioned by the committee convener and Jackie Baillie. The Competition and Markets Authority’s work on the cost to the NHS is important. Where companies have been found to breach competition law, the NHS should seek damages and invest that money in patient care and front-line services. Most recently, the manufacturer Concordia has been provisionally found to have abused its position in order to overcharge our NHS. Where companies have been conclusively found to have breached competition law, the Government should seek damages and invest that money in our NHS.
Will the member take an intervention?
The member is in his last minute. If he does not mind losing a little time, he can give way.
Unfortunately, although two other companies produce the drug, the price is not coming down.
I note that point. Given that I have 30 seconds left, we will perhaps discuss that outside the chamber.
I support Elaine Smith’s important ask that the Health and Sport Committee undertake a short inquiry. It would be important to use that to follow up the conclusions and recommendations in the Public Petitions Committee’s report.
Today’s debate is an important step forward, and the Public Petitions Committee has been helpful in moving the debate forward. For the sake of all the people whom we represent, we must see real progress on the implementation of the recommendations.15:23
I am very grateful to members who have shared their experiences this afternoon, and I appreciate the work that members have put into advancing the issue on behalf of their constituents.
The Scottish Government has striven, and will continue to strive, to ensure that everyone in Scotland who is living with thyroid and adrenal conditions can access the best possible care and support.
I acknowledge the passion that we have heard from across the chamber as members have made their points. Everyone here recognises that T4 is not an appropriate treatment for a small minority of people. For those people, I understand, particularly from hearing the personal accounts that members have given and from reading the accounts that have been submitted as part of the petition, that the journey to diagnosis and then to treatment is sometimes longer than we would expect.
We must ensure that people receive the timeliest diagnosis and correct treatment. In line with our realistic medicine approach, all discussions should be about an individual’s health and care. The focus should be on the individual and matters should be discussed and agreed with them by their clinician.
It is unfortunate that, in some cases, there has been miscommunication about prescribing T3. As we heard from Rachael Hamilton and Brian Whittle, that has led to some patients buying medication, such as NDT, online. We want patients to access safe treatment options, so we urge them to discuss options with their healthcare professional. Patient safety is paramount.
In the debate, the useful point has been made that there is a postcode lottery across Scotland. As Jackie Baillie suggested, will the minister commit to writing to all health boards to ensure that the guidance is being followed?
I will come to that point.
I re-emphasise that the Scottish Government’s position is that T3 can be prescribed by an endocrinologist if it is considered to be the safest and most effective course of treatment for an individual. Elaine Smith and Jackie Baillie raised that point—Elaine Smith asked whether I would instruct health boards, and Jackie Baillie got to the form of words that ministers need to use. I absolutely will write to health boards to confirm that patients who need access to T3 under an endocrinologist can obtain it. That is important.
I very much welcome the minister’s confirmation, but will he monitor whether boards pay attention to him?
I suspect that, if boards are not paying attention to me, many members will ensure that I am aware of that. If people cannot access the treatment that we all think and their endocrinologist says that they should get, I ask members to please write to me. We will chase that up, because some of the stories and experiences that we have heard about are unacceptable.
As Rachael Hamilton and Johann Lamont said, the pricing of medicines is reserved to the UK Government. Scottish Government officials have worked with the Department of Health and Social Care in preparation for introduction of the UK-wide Health Service Medical Supplies (Costs) Act, which received royal assent in April 2017. The act sets out a range of measures to control the cost of drugs, including a power to limit the price of unbranded medicines—generics—when competition in the market fails and companies charge the NHS unreasonably high prices. Jackie Baillie made a good point about one example of that.
We will continue to liaise with our counterparts at the Department of Health and Social Care on those issues when Scotland’s interests are affected. I urge anyone who is unhappy with their prescribed treatment to talk to the healthcare practitioner who is responsible for their care.
In my opening speech, I did not manage to cover research, which has been raised. The Scottish Government’s chief scientist office is responsible for funding high-quality research projects to build capacity in the NHS and ensure that research in the NHS is carried out to a high standard. The chief scientist would welcome applications for research projects that are aimed at the management of hypothyroidism, which would be subject to the same independent rigorous review as other applications are. We would look to academic institutions to lead on well-designed research to address the evidence gaps, particularly on whether co-prescribing of T3 and T4 might be helpful. I understand that the endocrinology community in Scotland would be happy to consider and assist with such proposals.
It is clear that we can still work to improve some areas, but I hope that this short debate and the Government’s response to the petition have shown people that the Government sees the subject as important. We very much appreciate the work that the committee, the petitioner—Lorraine Cleaver—and those who are in the public gallery have done to get us to this point. We will continue to work together across the Government and health and social care services to make the difference that we all want for people who are impacted by thyroid conditions.
I call Angus MacDonald to close the debate on behalf of the committee. You have a tight seven minutes, Mr MacDonald.15:29
When the Parliament last debated this issue, and the petition, in Elaine Smith’s members’ business debate, I gave her an assurance that the Public Petitions Committee would bring the subject back to the chamber to allow it to be debated more widely. I am pleased that we have been able to honour that commitment, albeit with a shorter time slot than some would have preferred.
I am also pleased that, thanks to your generosity, Presiding Officer, we have heard more about the issue from Elaine Smith than would normally be the case in a debate of this length. It was right that we did so, given the strong interest in and backing for the petition that Ms Smith has shown from day 1. In fact, as I said in the previous debate, I, too, have followed the petition from day 1, having been a member of the committee since 2012. As we have heard, although the petition was drafted in broad terms, it focused on hypothyroidism and patients who continue to experience symptoms when undergoing the recommended standard treatment.
The issue is clearly complex, and the committee has rightly taken its time to explore it and to examine all sides of the arguments that have been put before us. It is clear that while there is no one-size-fits-all solution, there is the chance to listen to patients’ experiences as well as to introduce a clear single protocol for the whole of Scotland. I am pleased to hear from the minister that the Scottish Government is committed to improving diagnosis and access to appropriate treatments for thyroid disorders. It is good to know that the chief medical officer’s speciality adviser for endocrinology is leading work to support a consistent approach to specialist input across Scotland.
Before I go any further, I thank all members who have taken part in the debate. We have had informed and passionate contributions from everyone who contributed—not least from Elaine Smith, who, as I mentioned earlier, knows and understands the complexities of the issue inside out. There were salient contributions from others, too. Brian Whittle highlighted a situation that he likened to a postcode lottery. He spoke of the differences in patients’ experiences of diagnosis depending on who had undertaken them, and highlighted the case of a patient in his constituency who had been lucky enough to be prescribed T3. David Torrance highlighted the need for effective testing and clear diagnostic guidelines.
Elaine Smith told us of her own heartfelt experience and highlighted the intervention of Dr Toft, from whom the committee was pleased to take evidence in its consideration of the petition. Ms Smith also rightly highlighted the ludicrous situation in which patients have to source desiccated thyroid from abroad. Rachael Hamilton highlighted concerns regarding the various types of treatment and the lack of proper diagnosis, leading to self-medication. Most speakers, including David Stewart, raised the issue of there being a fundamental lack of understanding by many GPs.
Jackie Baillie brought to our attention the fact that, a year down the line since our last debate, the problem has still not been fixed. I share her frustration, as I am sure do all members of the committee, along with the petitioners. Ms Baillie also highlighted the scandal of Concordia’s charges and the postcode lottery regarding diagnosis. David Stewart, too, sought an end to the postcode lottery and supported calls for a full inquiry by the Health and Sport Committee. Miles Briggs joined the calls for early diagnosis and highlighted the cost of drugs, especially through Concordia. However, there was welcome clarification from Elaine Smith that costs are coming down.
Of course, the minister’s commitment to contact health boards regarding the supply of T3 is extremely welcome. The Public Petitions Committee is aware that the then Minister for Public Health and Sport met Elaine Smith and the petitioner Lorraine Cleaver in March of this year, which was shortly before the committee published its report on the issues raised in the petition, and it has been extremely helpful to hear the views of the current minister today.
Throughout consideration of the petition, it has been very clear to the committee that clinicians have an important independent role in diagnosing and treating patients. In performing that duty, they are guided by evidence-based guidelines, which have been developed by independent experts and are informed by the available peer-reviewed research on patient treatment. The committee welcomes the fact that the profile raising that has been brought about by the petition appears to have been influential in key sources of clinical guidance being produced or updated by professional bodies and national health authorities. The Scottish Government has acknowledged that work in raising awareness of hypothyroidism and the challenges that are experienced by patients, and the influence that those have brought to the additional sources of guidance that have been produced during the life of the petition.
The committee welcomes the minister’s confirmation that NICE intends to develop a guideline on thyroid disease, with publication expected in November 2019. It hopes very much that the petitioners and others with an interest in the petition will engage in the development of such a guideline.
We also welcome the work that is being done to develop stronger links between GPs on communication and consistency of approach in the diagnosis and primary care referral of people with thyroid conditions, and we note that the deputy chief medical officer met representatives from NHS Education for Scotland to develop an endocrine learning module for GPs. That development is very welcome indeed. The committee understands that the chief medical officer’s speciality adviser on endocrinology, whom I mentioned earlier, has been asked to review that in light of the issues raised through the petition.
Although there seems to be an acknowledgement that the standard treatment is not a one-size-fits-all and does not work for everyone, the convener touched on the fact that, too often when the committee considers a health-related petition, a theme that seems to emerge is that patients are often not listened to. That must change, which is why, in the committee’s view, better means of capturing patient experience need to be developed so that clinicians can deliver the Scottish Government’s aim of promoting realistic medicine that ensures that the most appropriate treatment is given to patients. That is why the committee has recommended that the Scottish Government should develop guidance for listening exercises to ensure that they are designed in an impactful way.
Listening exercises should also be designed to capture anecdotal evidence in a way that can meaningfully inform the development of future clinical studies, clinical guidance and public policy. In that regard, the committee was pleased about the fact that, in its written response to the committee’s report, the Scottish Government said that it was encouraging anyone with an interest in thyroid conditions to engage in the development of the NICE guideline.
The committee recognises that there are differing views on the evidential basis for the current system of diagnosis, testing and treatment and the changes that are called for in the petition, and we recognise that discussions about those differing views will, and should, continue.
On behalf of the committee, I thank the petitioners for raising this important topic, and I thank all the public bodies, clinical representatives and thyroid patient representatives who have engaged with the committee in its consideration of the petition.
On a point of order, Presiding Officer. I think that the deputy convener might have misheard me, because I said earlier that the price does not seem to have come down at all. It is important to set the record straight on that point.
As a former Deputy Presiding Officer, Elaine Smith knows that that is not a point of order, but I will let it pass—I am in a good mood.