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386888
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Amyloidosis more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government which of the four phase 2 or 3 clinical trials for systemic amyloidosis approved since 2004 are still ongoing; and whether any of the trials have produced sufficient positive outcomes to encourage commercial development. more like this
star this property tabling member printed
Lord Willis of Knaresborough more like this
star this property uin HL997 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.</p><p> </p><p> </p><p> </p><p>Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register</p><p> </p><p> </p><p> </p><p>The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:</p><p> </p><p><a href="http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf" target="_blank">http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf</a>.</p><p> </p><p> </p><p> </p><p>We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL995 more like this
HL996 more like this
star this property question first answered
less than 2015-07-14T15:34:29.553Zmore like thismore than 2015-07-14T15:34:29.553Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf more like this
star this property title 2013-14 Annual Report more like this
star this property tabling member
4151
unstar this property label Biography information for Lord Willis of Knaresborough more like this
386887
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Amyloidosis more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government whether there are currently any trials for systemic amyloidosis in humans being conducted by the National Institute of Health Research charities or the commercial sector. more like this
star this property tabling member printed
Lord Willis of Knaresborough more like this
star this property uin HL996 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.</p><p> </p><p> </p><p> </p><p>Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register</p><p> </p><p> </p><p> </p><p>The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:</p><p> </p><p><a href="http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf" target="_blank">http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf</a>.</p><p> </p><p> </p><p> </p><p>We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL995 more like this
HL997 more like this
star this property question first answered
less than 2015-07-14T15:34:29.297Zmore like thismore than 2015-07-14T15:34:29.297Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf more like this
star this property title 2013-14 Annual Report more like this
star this property tabling member
4151
unstar this property label Biography information for Lord Willis of Knaresborough more like this
386886
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Amyloidosis and Multiple Myeloma more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government whether they will place in the Library of the House any publications resulting from the phase 3 clinical trials approved for the potential treatment of systemic amyloidosis or multiple myeloma; and what is the National Institute of Health Research’s assessment of progress in these areas. more like this
star this property tabling member printed
Lord Willis of Knaresborough more like this
star this property uin HL995 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.</p><p> </p><p> </p><p> </p><p>Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register</p><p> </p><p> </p><p> </p><p>The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:</p><p> </p><p><a href="http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf" target="_blank">http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf</a>.</p><p> </p><p> </p><p> </p><p>We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL996 more like this
HL997 more like this
star this property question first answered
less than 2015-07-14T15:34:29.197Zmore like thismore than 2015-07-14T15:34:29.197Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf more like this
star this property title 2013-14 Annual Report more like this
star this property tabling member
4151
unstar this property label Biography information for Lord Willis of Knaresborough more like this
386885
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Multiple Myeloma more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government when they expect the National Institute of Health Research Technology Assessment programme to publish initial findings from its assessment of the benefits of antibiotic prophylaxis and its effect on healthcare associated infections in myeloma patients. more like this
star this property tabling member printed
Lord Willis of Knaresborough more like this
star this property uin HL994 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-09more like thismore than 2015-07-09
star this property answer text <p>This trial is led by the University of Birmingham. The project is recruiting ahead of schedule and expects to reach its target of 800 in the near future. The target was to do so by the end of November 2015. Publication of initial findings is expected in 2017.</p><p> </p> more like this
star this property answering member printed Lord Prior of Brampton more like this
star this property question first answered
less than 2015-07-09T13:00:57.7Zmore like thismore than 2015-07-09T13:00:57.7Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property tabling member
4151
unstar this property label Biography information for Lord Willis of Knaresborough more like this
386884
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Amyloidosis more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government what progress has been made on setting up a study to image amyloid deposition in systemic amyloidosis using hybrid positron emission tomography-magnetic resonance imaging; where the study is located; how many patients have been recruited; when the study is expected to complete its initial work; and where the results will be published. more like this
star this property tabling member printed
Lord Willis of Knaresborough more like this
star this property uin HL993 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>This is a single centre study at University College London Hospital. It has now been set up and one patient has been recruited and scanned. The current planned date for end of recruitment is 1 October 2016. It is anticipated that the data will be analysed and submitted for publication in a peer reviewed journal within a year of the end of recruitment.</p><p> </p> more like this
star this property answering member printed Lord Prior of Brampton more like this
star this property question first answered
less than 2015-07-14T15:36:20.96Zmore like thismore than 2015-07-14T15:36:20.96Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property tabling member
4151
unstar this property label Biography information for Lord Willis of Knaresborough more like this
386927
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Vitamin B12 more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government whether they have assessed the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies; and, if so, what they consider them to be. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1036 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL1032 more like this
HL1033 more like this
HL1034 more like this
HL1035 more like this
HL1042 more like this
star this property question first answered
less than 2015-07-14T15:00:42.183Zmore like thismore than 2015-07-14T15:00:42.183Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name colbalamin and folate disorders.pdf more like this
star this property title BSCH Guidance more like this
star this property tabling member
1861
unstar this property label Biography information for The Countess of Mar more like this
386926
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Vitamin B12 more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government what assessment they have made of the frequency at which patients with pernicious anaemia require vitamin B12 replacement therapy by injection; whether they have any evidence that patients are purchasing additional supplies from unregulated sources; and whether they will review current guidance. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1035 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL1032 more like this
HL1033 more like this
HL1034 more like this
HL1036 more like this
HL1042 more like this
star this property question first answered
less than 2015-07-14T15:00:42.073Zmore like thismore than 2015-07-14T15:00:42.073Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name colbalamin and folate disorders.pdf more like this
star this property title BSCH Guidance more like this
star this property tabling member
1861
unstar this property label Biography information for The Countess of Mar more like this
386925
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Vitamin B12 more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government what steps they are taking to ensure that a reliable test to assess the vitamin B12 status of the United Kingdom population is made available as a means to prevent serious and irreversible neurological damage before any mandatory fortification of flour with folic acid is introduced. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1034 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL1032 more like this
HL1033 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
star this property question first answered
less than 2015-07-14T15:00:41.947Zmore like thismore than 2015-07-14T15:00:41.947Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name colbalamin and folate disorders.pdf more like this
star this property title BSCH Guidance more like this
star this property tabling member
1861
unstar this property label Biography information for The Countess of Mar more like this
386924
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Vitamin B12 more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government whether they plan to review how pernicious anaemia and other symptoms of vitamin B12 deficiency in the United Kingdom population are diagnosed and treated, particularly taking into account the neurological and mental health impact of any failure to diagnose quickly and accurately; and, if not, why not. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1033 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL1032 more like this
HL1034 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
star this property question first answered
less than 2015-07-14T15:00:41.81Zmore like thismore than 2015-07-14T15:00:41.81Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name colbalamin and folate disorders.pdf more like this
star this property title BSCH Guidance more like this
star this property tabling member
1861
unstar this property label Biography information for The Countess of Mar more like this
386923
star this property registered interest false more like this
star this property date remove filter
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Department of Health more like this
star this property answering dept id 17 remove filter
unstar this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Vitamin B12 more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government what steps they are taking to find an alternative and reliable test to assess the vitamin B12 status of the population; and what level of false high results the current test provides. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1032 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2015-07-14more like thismore than 2015-07-14
star this property answer text <p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12 (cobalamin) deficiency, is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014. A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates independently of the Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, in the diagnosis and treatment of patients with pernicious anaemia were needed, including whether any new or additional tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that cobalamin status is the recommended first line diagnostic test. The Department has no data relating to false positive results in relation to the test. The guidance also states that clinical picture is the most important factor in assessing the significance of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most patients respond well to treatment through quarterly intramuscular injection of vitamin B12. Whilst some patients with pernicious anaemia might prefer to have more frequent injections, or for other forms of vitamin B12 to be self-administered, these are matters for individual patients to discuss with their general practitioners.</p><p> </p><p> </p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently reviewing claims made by some clinics that are administering vitamins and minerals intravenously for nutritional therapy purposes, the agency has not encountered any clinics making claims to treat pernicious anaemia. In addition, the Department does not have any information regarding patients purchasing additional supplies of B12 from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended a number of measures to ensure monitoring and surveillance of the impact of fortification of flour, should it be implemented. This included appropriate systems to monitor any potential adverse effects, including cancer and a review of the evidence on benefits and postulated risks after five years. The National Diet and Nutrition Survey monitors folate intakes and the most recent data, which was published earlier this year, will be carefully considered alongside other information sources before any decision is made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has made no assessment of the social and economic costs of misdiagnosis or late diagnosis of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
star this property answering member printed Lord Prior of Brampton more like this
star this property grouped question UIN
HL1033 more like this
HL1034 more like this
HL1035 more like this
HL1036 more like this
HL1042 more like this
star this property question first answered
less than 2015-07-14T15:00:41.673Zmore like thismore than 2015-07-14T15:00:41.673Z
star this property answering member
127
star this property label Biography information for Lord Prior of Brampton more like this
star this property attachment
1
unstar this property file name colbalamin and folate disorders.pdf more like this
star this property title BSCH Guidance more like this
star this property tabling member
1861
unstar this property label Biography information for The Countess of Mar more like this