Public Petitions Committee

Meeting date: Thursday, May 25, 2017

Official Report 586KB pdf

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Continued Petition

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Pernicious Anaemia and Vitamin B12 Deficiency (Understanding and Treatment) (PE1408)

I welcome everyone to the 11th meeting in 2017 of the Public Petitions Committee. I remind members and others in the room to switch phones and other devices to silent.

I understand that a minute’s silence will be observed in the Parliament at 11 o’clock today as a mark of respect for those who have been affected by the events in Manchester on Monday night. If we are still considering petitions at that time, I intend to suspend the meeting for a brief period before 11 o’clock so that we are able to show our respect for all those affected, particularly those who died or were injured and their families and friends.

Agenda item 1 is consideration of petition PE1408, by Andrea MacArthur, on the updating of pernicious anaemia and vitamin B12 deficiency understanding and treatment. We are joined by the Minister for Public Health and Sport, Aileen Campbell MSP, who is accompanied by Elizabeth Sadler, deputy director of planning and quality, Scottish Government, and Dr Padmini Mishra, senior medical officer in the office of the chief medical officer for Scotland. Thank you for joining us.

I understand that the minister would like to make an opening statement. I shall allow time for that before we move to members’ questions.

Good morning, convener, and thank you. Pernicious anaemia can have a significant impact on the lives of those with the condition. People can be unwell for some time, having experienced difficulties in obtaining diagnosis and appropriate treatment. That is why I commend Mrs MacArthur for her determination and work to support all those who are living with the condition in Scotland.

I recognise that the committee might ask questions of a more clinical nature. That is why I am accompanied by Dr Padmini Mishra, one of the senior medical advisers in the CMO’s office, and Liz Sadler, who is the deputy director of planning and quality.

The petition was lodged in 2011, and I understand that at that time Mrs MacArthur hoped that the guidelines that were then available for general practitioners would be overhauled and updated. That was achieved by the publication in 2014 of the British Committee for Standards in Haematology guidelines.

The petition made several requests, and I will outline how they have been met. First, on the request for greater awareness of common sets of symptoms experienced by people suffering from a deficiency in vitamin B12, the GP training curriculum includes investigation related to all types of anaemia, including pernicious anaemia, and GPs are expected to be able to address the signs and symptoms of a patient presenting with pernicious anaemia. The British Society for Haematology guidelines further support healthcare professionals in the assessment and diagnosis of pernicious anaemia.

The second request was for an overhaul of the diagnostic tests that are used and to adopt the active B12 test, and for homocysteine and methylmalonic acid tests to be used regularly. I understand that there is no definitive test for diagnosing vitamin B12 deficiency, which is an area for experts in haematology that is addressed in the guidelines. The committee will understand that it is not appropriate for Scottish ministers or their policy officials to intervene in or contradict the evidence-based guidance that is produced by specialists in the field.

The next request was for patients displaying advanced symptoms to be automatically offered trial injections of vitamin B12. Again, the BSH guidelines state that that could be considered. The petitioner also asked that folate and ferritin be checked for, along with other coexisting conditions. The BSH guidelines also provide advice on folate deficiency, coexisting conditions and the provision of folic acid.

Lastly, the petitioner asked for patients to be able to self-inject vitamin B12 as and when they need it. All matters of treatment are for discussion and agreement between the individual and clinician concerned, and that is not and cannot be a matter for Scottish ministers to become involved in. However, I have been advised that self-administration can be challenging as it requires an intramuscular injection that has risks associated with it. As a result, some patients might not wish to self-inject, so that would have to be a matter for discussion between the individual and a clinician.

The BSH guidelines address the majority of the issues that were raised in the petition. However, at the time of their publication, Scottish Government advisers felt that the guidelines were not in a suitable format for use in GP practices—that is, they were not in a format that GPs were familiar with, such as the Scottish intercollegiate guidelines network or National Institute for Health and Care Excellence guidelines. As a result, the Scottish Haematology Society was asked to prepare a draft summary document of the guidelines. An initial draft was prepared but the SHS advised the committee that, because of the level of work required to complete the document, it had taken the decision to withdraw from the process, leaving the document in draft.

Committee members will be well aware that it is not the Scottish Government’s role to publish clinical guidelines or summary documents derived from them. However, I make clear that the content of the BSH’s guidelines was considered relevant and appropriate for adoption by Scottish clinicians, and that view is extant.

In 2015, the National Institute for Health and Care Excellence produced a clinical knowledge summary “Anaemia—B12 and folate deficiency”. Clinical knowledge summaries are designed to be concise, accessible summaries of current evidence for primary care professionals and are in a format that GPs are familiar with.

Our position is that the petitioner’s requests have been met. The chief scientist office within the Scottish Government, which has responsibility for the funding of clinical research in Scotland, would welcome applications for research projects aimed at the diagnosis and treatment of people with pernicious anaemia. The petitioner may want to consider that route, aided by the Pernicious Anaemia Society to identify researchers willing to move that forward.

I hope that my statement has addressed the substantive points in the petition and illustrated the progress that has been made. I am happy to take questions from the committee.

Thank you very much. As you said, the petition has been under consideration since 2011, as the committee had been waiting for the development of suitable clinical guidance. First, we were waiting for the publication of the British Society for Haematology’s guidelines, which were published in 2014. More recently, we have been waiting for the Scottish Government to publish a summary of the guidelines, which the Scottish Haematology Society was asked to produce.

Why was the summary document commissioned, what did it cost and what outcomes did it hope to achieve?

As I outlined, the considered opinion at the time was that the guidance from the BSH was in a format that GPs might not have been used to. There was no question about the content or the guidelines themselves; rather, the issue was about the format. Therefore, the SHS was asked to produce a summary but that has not happened. The summary has not been completed; it remains in draft format. However, since then, NICE has produced a clinical knowledge summary, which is in a format that GPs are used to.

GPs have a plethora of information to access on the condition.

You said that the format was not considered to be appropriate “at the time”. Does that mean that you now think that the BSH’s guidelines are appropriate?

You said that the question was about the format. However, the advice on the BSH’s guidelines was about more than the format—indeed, the Government view was that the BSH’s guidance was not suitable for the Scottish practice setting and it raised concerns that the second-line testing that was recommended by the BSH guidelines was not standard in Scottish laboratories. Do you agree that it was not just the format that was the issue, or has that opinion changed?

The issue was about the format. There was never any question about the content.

With respect, minister, the committee’s briefing says that the Scottish Government

“raised concerns that the second-line testing recommended by the BSH guidelines is not standard in Scottish laboratories and the format”

was an issue. There are two separate matters.

The other point to remember is that NICE has published guidelines, which are taken from the BSH’s guidelines. Those are complementary; they do not contradict one another. The issue was the way in which information was presented; there was never any question about its content or the guidance.

That is not the evidence that we were given before. I am asking whether you have changed your opinion.

I ask Dr Mishra to comment.

The opinion has been the same. The British Society for Haematology’s guidelines took two years to develop. Scottish clinicians, including GPs, never questioned those guidelines. The issue was that they were not used to reading the society’s guidelines. They are much more used to reading the frequent guidelines that they get from the General Medical Council, SIGN and NICE, and so on.

There has not been a change of opinion on what is recommended in the guidelines. It remains the case that no definitive test is available for pernicious anaemia. First and foremost, a person’s clinical condition must be taken into account. If required, empirical treatment should be tried, even if the tests are negative—because the tests could be negative and that is the issue.

That still does not explain why, at the time, the guidance was deemed to be not suitable. If it was just a question of the format, I presume that that would have been a relatively straightforward thing to sort out. If it did not really matter that much, you would not have asked the Scottish Haematology Society to do more work for you, and if it mattered, I would have thought that you would have found somebody else to do the work that the society was unable to do.

Maybe my colleagues will ask—

It is important to recognise that, in 2015, NICE produced a clinical knowledge summary in a format that GPs could use, which does not contradict anything in the original BSH guidelines. There is that concise summary for GPs to use, and there is also the much more in-depth format that is produced—

With respect—

With respect, I am saying that there is that format for GPs to use, which has been produced since the petition was lodged.

We would maybe need to test some of that, because there seems to be a contradiction. You seem to be saying that there was a problem and now there is not a problem, but that, anyway, even if there was a problem, it is okay because NICE has produced information. Anyway, I call Angus MacDonald.

Good morning, minister. You touched on this in your opening remarks, but the submission from the Scottish Government dated 12 October 2016 explained that it has

“no plans to publish any draft/incomplete adaptation undertaken by SHS.”

Can you clarify the extent to which the SHS’s work is incomplete? You have told us why the Scottish Government decided not to publish it, but what aspect of it was incomplete?

There has to be a set of processes that are gone through. Ms Lamont said that the process would be straightforward, but it requires a lot of discipline to make a concise document out of something that is in depth. A lot of work and effort is required to make sure that nothing is missed or omitted and that nothing is included that overstates a particular way in which a system should be approached.

Also, there has also been no consultation on the document and there has not been the required level of peer review and research to look at the guidance, so it would not be appropriate or responsible for the Government—or anybody—to publish the summary document at this point.

I point out again that, since then, NICE has published a knowledge summary in a format that GPs can use, which does not contradict the existing guidance from the BSH but complements it. Therefore, a significant amount of information is to hand and ready to be used by GPs and clinicians across the country.

Have you had any indication from GPs that they are not satisfied with the NICE advice?

I am not aware of any. I am not even aware that GPs have raised any issues with the BSH guidelines. Nothing has been raised with us by clinicians.

With respect, even if GPs have not raised concerns, the Scottish Government itself has said that there are problems with the BSH guidelines. That was the considered view of the Scottish Government in evidence to the committee.

However, it is still helpful to know whether there has been any feedback from GPs, and there does not seem to have been any.

Precisely.

Good morning, minister. The Scottish Government explained in its submission of 26 November 2015 that it would share the draft version of the SHS’s summary document with the Public Petitions Committee

“only once the”

diagnostic steering group

“were satisfied with the draft”.

The committee received a copy of the draft summary document after it was approved by the diagnostic steering group.

Can you clarify whether the group’s view on the summary document has changed? If it has not, can you clarify why, in those circumstances, the Scottish Government will not publish it?

The summary document has not been approved, so it is not going to be published.

I add that the summary document went to the diagnostic steering group—that was the version that the committee has seen. The committee asked Mrs MacArthur whether she had any comments on the draft, and she had a number of comments, which she made to the SHS. It responded to those comments, and that was the point at which it withdrew from the process, because it felt that it was being asked to change the content of the guidance, rather than just summarising it. The document was never finalised, therefore, and it has not been back to the diagnostic steering group since the version that the committee has seen.

09:15  

Does that mean that the diagnostic steering group’s view of the summary document has actually changed?

No, because the purpose of the document was to give a summary of the original guidelines; it was not about changing the guidelines. The clinical consensus is that the original guidelines remain valid. As the SHS removed itself from the process before it could finalise the document, the Government is not in a position to publish that document.

I am sorry but, just for my benefit, does that mean that the summary document does not reflect the original document?

It reflects the original document, but it has not been finalised. The SHS did not formally sign it off and therefore did not give the Government a final version that could go to the diagnostic steering group. The SHS withdrew before it did that.

Yes—the SHS summary document has not been approved, but it is not contradictory to the original BSH guidelines that were issued. The SHS was not asked to change the guidelines. The aim of the process was to change the format to ensure that the guidelines were accessible for GPs. To go back to an earlier point, NICE has since produced a clinical knowledge summary, so there is a concise, usable and understandable summary for GPs in a format that they are used to. The request of the SHS was never to change anything in the guidelines, which were set by the BSH.

If nothing in the summary document contradicts the NICE document, I still do not get why we cannot publish it.

It has not been approved.

So it cannot be approved if the SHS is not involved any more. Is that what you are saying?

There is no need for it now. There is the NICE clinical knowledge summary, which presents the information to GPs. As I said in response to Angus MacDonald, no GP has raised any concern over that. The clinical knowledge summary follows on and flows from the original BSH guidance, which at that time was considered to be in a format that GPs were not used to. Since then, NICE has produced a clinical knowledge summary, and there is plenty of information for GPs to use. Furthermore, much more authority is attached to the NICE guidelines. Despite the considerable work and effort that the SHS has put in, the summary is no longer deemed to be as necessary as it was when the BSH published its guidelines.

Thank you.

At the risk of repeating ourselves, I want to clarify that, regardless of what has happened over the publication or non-publication of documents, you and the GPs are satisfied that there is enough information in the NICE document and the BSH document to provide comprehensive guidelines and there is no ambiguity about any of it.

There is nothing contradictory in the NICE clinical knowledge summary and the BSH guidelines. The clinical knowledge summary is in a format that GPs are used to and, as far as I am aware, no GP has contacted us to raise questions about the guidelines or request additional information.

What has been the demand for second-line testing in Scotland since the BSH’s guidelines were introduced and how is it being met?

We have no evidence on how much the demand has increased or decreased as a result of the guidelines. However, the guidelines suggest that the diagnosis is not clear cut. If required, clinicians can access the second-line test. It is not universally available in Scottish laboratories, but it is available to them from elsewhere.

Why is it not universally available in Scotland?

The tests themselves are not dependable. What can be surmised from a result, whether positive or negative, might not help with the management of a case. It is difficult to interpret the tests. Therefore, more research is required so that we have standardisation of the tests and cut-off points, so that people know what is a low level and what is a sub-clinical level. Those are not available yet, so it is difficult for clinicians. At present, that is in the realm not of GPs, but of specialists and researchers.

What is the Government doing about that?

As I said in my opening remarks, the chief scientist office is willing and able to take on research proposals from researchers, so there is an opportunity to progress that if a suitable submission is made to the CSO.

Are you actively seeking submissions on the carrying out of such work as opposed to saying, “If someone has a research proposal, we would consider it”, albeit that that is helpful?

Submissions can be made by patients, the public or clinicians; it is not up to the Government to ask the CSO to look at research proposals. We have asked the CSO to look positively at any proposal that is made in this area. That is all that we can do—encourage the CSO to keep an open mind and make it aware that this is an area of need. We cannot set up the proposals; a researcher must approach the CSO.

I understand that, but Governments often create projects and actively say, “We want a researcher to do this job.” Clearly, Government ministers do not have the technical or the clinical expertise to do that, but they can identify that there is a need and actively create an option and ask people to bid for that work.

The national network management service has pursued the establishment of a short-life working group on haematology, which will be able to pursue some of the issues that the petition has raised, as well as the issues of research.

There is the short-life working group on haematology, and there is the keenness of the CSO to receive any submission on further research.

Could it not be the other way round? Could you not say that there is a job to be done, on which you would like bids to be made? I appreciate that there might be technicalities that I am not aware of, and I know that people make research bids all the time, but given that you recognise that there is a need for such work to be done, can you not create a project that invites bids to do the work?

Work is being taken forward by the short-life working group, which can consider all those elements. In addition, the chief scientist office can accept bids from researchers to progress other areas of research. There are two very clear routes forward to further enhance the research, knowledge and capacity on the issue.

I have a question for Dr Mishra. You said that, at the moment, it comes down to clinicians’ judgment, because there is no standardised diagnostic testing. Is any pattern emerging on that? Do you have any data that shows the most likely outcome of those decisions?

There is no readily available data. The British Society for Haematology acknowledged that there are no randomised controlled trials in this area. It recommended a pragmatic approach.

Because every patient starts from a different level, it is very difficult to compare the journeys that people make from the beginning of the process to the end. It also depends on patient preference—some patients would like a lot of testing to be done, some would just like to get the treatment, and some would like to wait and see. Therefore, it is extremely difficult to find any data on the issue.

Thank you.

I find that slightly staggering. If there is a need for second-line testing, the Government should take the lead and fire the gun to start the research.

We have the short-life working group, which has been established.

The group has not come to a conclusion yet about what it is doing.

It is in the process of being established.

Is looking at the gap around second-line testing part of the group’s remit?

The group intends to look at the management of vitamin B12 deficiency in the totality. Once the group is set up, it will decide its remit. If looking at the gaps requires more guidance and research work, that will be the group’s aim. The group is keen to do some work in this area, but not exclusively on testing; its remit is the general management of vitamin B12 deficiency.

The Government has set up the short-life working group, and the membership—

No; the national services division has set up the group.

What is the national services division?

The national services division is part of NHS National Services Scotland—NSS. It runs managed networks across a range of disorders. Its managed diagnostic network has set up the short-life working group on haematology, which is looking at B12 deficiency.

It would be useful to have a note on the membership of the group and its remit. I assume that the Government will have input into the remit and will say that it actively encourages research on this issue to be part of the remit.

We can get you that information and we will ensure that the network and the short-life working group understand the committee’s particular interest.

If the short-life working group is being established partly in recognition of the work that is being done, will its remit include—

Forgive me; I am trying to be helpful. We can let you know the membership and ensure that the group knows the committee’s interest.

What about the timescale? I am genuinely interested in the extent to which the Government has recognised the gap in the research and whether it will actively ensure that the research takes place. That could be included in the information that you provide to the committee about the working group.

The committee asked the Scottish Government to consult the petitioner on the development of the draft summary document from the outset. In that regard, when the SHS withdrew from the process, it commented:

“the very considered responses we have received from the petitioner in response to the draft guidelines indicate the limitation our small society has in trying to produce specific Scottish guidelines”.

The committee understands from the petitioner’s submissions that she is particularly concerned about gastric parietal cell antibody testing—I apologise for my pronunciation—and she does not agree with the way that the issue is addressed in the BSH’s guidelines. The SHS does not appear to have the capacity to address those concerns, and the petitioner considers that she has not been listened to for that reason. Will you commit your officials to meet the petitioner to discuss her concerns about the testing procedures for pernicious anaemia and vitamin B12 deficiency?

If the petitioner wishes to meet officials, we will happily arrange that to make sure that we understand fully any outstanding concerns, following our responses to each point in her petition. It is important to recognise that my officials are not in a position to change clinical guidelines or clinical guidance on the knowledge summaries, because of the robust processes to create that evidence base and to bring to bear peer research. They can look at avenues to ensure that the short-life working group understands her continued concerns, but there are parameters around and restrictions on changing such guidelines.

The Scottish Government took a view that the BSH guidelines were inadequate and asked the Scottish Haematology Society to produce a summary. I do not think that anyone suggests that Government ministers have to sit down and write clinical guidance, but there must be capacity within the system to meet requests by the Scottish Government for things to be done. Nobody is pretending that you, as a Government minister, are capable of making clinical decisions—none of us can do that—but the Government is capable of saying, “We think there’s a gap here. Can you look at it?” That is where a lot of this has emerged from. Can I ask—

09:30  

Sorry, but I want to respond to that because it is important to be clear about the position. Although we are absolutely happy to engage with the petitioner and we recognise the huge amount of work that she has put into the petition, it is important to put on the record that such engagement will not result in a change to the existing clinical guidelines. I reiterate that there was never any doubt as to the veracity or accuracy of what the guidelines said; the issue was the format.

With respect, we have already heard that it was about more than that and that it was also about the fact that second-line testing is not available in Scotland, and the Scottish Government itself—

That was never a part of it—

—recognised the need to do more than simply format the guidelines. However, I recognise what you said about the NICE advice—

With respect, I think that you are downplaying the summary, which is important work.

I am sorry, but can I finish the point? We recognise the work that has been done, but the question is how proactive the Government has been in recognising that the work that it asked to be done was not completed and how that work is to be completed.

Will the short-life working group have patient representation? Would it be possible for that group to meet the petitioner?

As I said, we will explore with officials where we can ensure that the petitioner’s views and voice can be heard; we will also explore whether a meeting would be appropriate for the short-life working group. I reiterate that we will get back to the committee on the membership of the group.

Okay. Obviously, the petitioner will have heard this evidence and will respond to it. We will ensure that her comments to us are conveyed to you.

I thank you very much for your evidence. We recognise that the petition has been on-going for some time and that it is about clinical technicalities that probably not one person in here, with the honourable exception of Dr Mishra, understands. However, everyone recognises the petitioner’s role in pursuing the issue.

I do not know what suggestions the committee has for taking the petition forward. I certainly think that it would be useful for us to reflect on all the information that we have had on the petition, including the information about the short-life working group and the NICE guidance. We can maybe reflect on that and what the minister has said in this evidence session, give the petitioner an opportunity to respond and then come to a view. Do members have any other comments or suggestions?

I thank the minister for her evidence this morning, which has certainly helped to clarify the situation in my mind. There are a couple of salient points in the evidence that has been given this morning, one of which is the fact that the NICE clinical knowledge summary has superseded any work by the SHS. Another salient point is the fact that there has been no negative feedback from GPs on how the matter has been dealt with up to now. I am happy to reflect on the other evidence that has been given, but I think that those two salient points have to be stressed.

Okay. That is helpful.

The niggling problem that I have is the fact that the Government initiated the work that was done by the SHS, which produced draft guidelines. There must be a way of bringing out collaborative guidelines. If the SHS guidelines do not contradict anything in the NICE guidelines, I do not see why they cannot be published as well. It seems to me that the more guidance that we have on the issue, the better.

The issue for the Scottish Haematology Society is that it felt that it did not have the capacity, as a small organisation, to do what you suggest. The question really is whether any work remains to be done, given the new guidance—that is, the work that was done was useful, but does it need to be pursued further? Obviously, we hope that the short-life working group might consider that.

I think that all those avenues have been covered. The minister has clarified that she and the GPs are happy with the SHS guidelines, which have now been superseded. I am content with that and do not think that there is any need for alarm in that respect.

Okay. I suggest that we reflect on the evidence, give the petitioner an opportunity to respond and record our thanks to the minister for her evidence and for the update on the information around the NICE guidance. We also look forward to hearing more about the short-life working group.

I thank the minister and those with her for their attendance. I suspend the meeting briefly.

09:35 Meeting suspended.  

09:38 On resuming—