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386923

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Vitamin B12
	house id	2
	legislature	25277 pref label House of Lords
	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.
	tabling member printed	The Countess of Mar
	uin	HL1032
	answer	answer is ministerial correction date of answer 14/07/2015 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> answering member printed Lord Prior of Brampton grouped question UIN HL1033 HL1034 HL1035 HL1036 HL1042 question first answered 14/07/2015 15:00:41 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name colbalamin and folate disorders.pdf title BSCH Guidance
	tabling member	1861 label Biography information for The Countess of Mar

386925

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Vitamin B12
	house id	2
	legislature	25277 pref label House of Lords
	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.
	tabling member printed	The Countess of Mar
	uin	HL1034
	answer	answer is ministerial correction date of answer 14/07/2015 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> answering member printed Lord Prior of Brampton grouped question UIN HL1032 HL1033 HL1035 HL1036 HL1042 question first answered 14/07/2015 15:00:41 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name colbalamin and folate disorders.pdf title BSCH Guidance
	tabling member	1861 label Biography information for The Countess of Mar

386926

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Vitamin B12
	house id	2
	legislature	25277 pref label House of Lords
	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.
	tabling member printed	The Countess of Mar
	uin	HL1035
	answer	answer is ministerial correction date of answer 14/07/2015 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> answering member printed Lord Prior of Brampton grouped question UIN HL1032 HL1033 HL1034 HL1036 HL1042 question first answered 14/07/2015 15:00:42 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name colbalamin and folate disorders.pdf title BSCH Guidance
	tabling member	1861 label Biography information for The Countess of Mar

386927

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Vitamin B12
	house id	2
	legislature	25277 pref label House of Lords
	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.
	tabling member printed	The Countess of Mar
	uin	HL1036
	answer	answer is ministerial correction date of answer 14/07/2015 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> answering member printed Lord Prior of Brampton grouped question UIN HL1032 HL1033 HL1034 HL1035 HL1042 question first answered 14/07/2015 15:00:42 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name colbalamin and folate disorders.pdf title BSCH Guidance
	tabling member	1861 label Biography information for The Countess of Mar

387206

	registered interest
	date	02/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Vitamin B12
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government whether they plan to replace the current test for human vitamin B12 status with the Active B12 (holotranscobalamin) test; and if not, why not.
	tabling member printed	The Countess of Mar
	uin	HL1042
	answer	answer is ministerial correction date of answer 14/07/2015 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> answering member printed Lord Prior of Brampton grouped question UIN HL1032 HL1033 HL1034 HL1035 HL1036 question first answered 14/07/2015 15:00:42 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name colbalamin and folate disorders.pdf title BSCH Guidance
	tabling member	1861 label Biography information for The Countess of Mar