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Vitamin B6 Supplements: Adverse Reactions

Earl Kitchener asked Her Majesty's Government:

Lord Donoughue: The Government have no information concerning the number of British people who take higher dose vitamin B6 supplements, nor is there any established reporting procedure for adverse effects arising from consumption of dietary supplements sold under food law. However, the UK Yellow Card Adverse Drug Reaction (ADR) reporting scheme administered by the Medicines Control Agency has reports associated with medicinal products. These are provided voluntarily by doctors, dentists and pharmacists and indirectly by pharmaceutical companies and are not a complete record of the ADR's occurring in the population.

From 1964 to date there have been a total of 649 reports of 1,181 spontaneously reported adverse reactions associated with products containing vitamin B6, of which 16 were fatal. The majority (63 per cent.) of reactions are associated with products containing a number of constituents, 410 reactions being associated with products containing only vitamin B6, most at doses below 100mg daily.

A summary of reactions reported with single constituent products containing vitamin B6 in each of the last 10 years is given in the table below.

Table of Yellow Card Reports from 1987 to 1996 for Vitamin B6

YearTotal reactionsSeriousFatal
1987730
1988410
1989830
1990220
1991320
1992640
1993521
1994100
1995550
1996110
Total 1987-9642231

The inclusion of any one reaction in the table does not necessarily mean that vitamin B6 caused the reaction. Other factors such as the temporal relationship between medicine and reaction, any concomitant medication and the possibility of underlying disease must also be considered.

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Vitamin B6: Limit in Dietary Supplements

Earl Kitchener asked Her Majesty's Government:

    What recent representations about the ban on higher dose vitamin B6 they have received from Dr. John Hathcock or other former directors of the United States Food and Drug Administration; and whether any such representations supported or opposed the introduction of the ban.

Lord Donoughue: The Government have no intention of introducing a ban on higher dose vitamin B6 products. It has accepted advice from the independent Food Advisory Committee that the level of vitamin B6 in dietary supplements sold under food law should be limited to a maximum of 10mg per daily dose. However, higher dose products licensed as medicines for the treatment of specific clinical conditions will continue to be available from pharmacies and on prescription.

On 23 July my honourable friends the Minister of State at the Ministry of Agriculture, Fisheries and Food and the Minister for Public Health met with representatives of organisations who were unhappy with the proposed limit in order to listen to their concerns. Dr. John Hathcock was present at that meeting as part of a delegation from the National Association of Healthfood Stores. He also met with officials from the Ministry of Agriculture, Fisheries and Food earlier on the same day. On both occasions he questioned the validity of the scientific evidence upon which the proposed limit is based.

Vitamin B6: Scientific Evidence for Limiting Supplementation

Baroness Wharton asked Her Majesty's Government:

    What recent representations about the ban on higher dose vitamin B6 they have received from Professor Alan Gaby or others who have reviewed the published literature relating to supplementation with such vitamins; and whether any such representations supported or opposed the introduction of the ban.

Lord Donoughue: The Government have no intention of introducing a ban on higher dose vitamin B6 products. They have accepted advice from the independent Food Advisory Committee that the level of vitamin B6 in dietary supplements sold under food should be limited to a maximum of 10mg per daily dose. However, higher dose products licensed as medicines for the treatment of specific clinical conditions will continue to be available from pharmacies and on prescription.

On 23 July my honourable friends the Minister of State at the Ministry of Agriculture, Fisheries and Food and the Minister for Public Health met with representatives of organisations who were unhappy with the proposed limit in order to listen to their concerns. Professor Alan Gaby was present at that meeting as part of a delegation from Consumers for Health Choice. He

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also met with officials from the Ministry of Agriculture, Fisheries and Food earlier on the same day. On both occasions he questioned the validity of the scientific evidence upon which the proposed limit is based.

Veterinary Laboratories Agency: Annual Report and Accounts

Lord Rea asked Her Majesty's Government:

    When the annual report and accounts for the Veterinary Laboratories Agency is due to be published.

Lord Donoughue: The Veterinary Laboratories Agency's annual report and accounts was published on 29 July 1997. Copies are available in the Library of the House. The report demonstrates the continuing progress and success of the organisation as a "Next Steps" Agency.

BSE Selective Cull

Baroness Smith of Gilmorehill asked Her Majesty's Government:

    What progress has been made on the BSE selective cull.

Lord Donoughue: Since 1 May progress with the selective cull has substantially improved. In Northern Ireland the cull is complete except for six animals and any which have been imported from Great Britain. In GB we have completed nearly half of the natal herd visits; in Scotland we have completed all of them. In England and Wales all but a few of the visits have been made to farms with animals in the compulsory years. We have now slaughtered 15,000 animals in the UK: 10 times the number that had been slaughtered when we came into office. This is good progress, but we need to do better still.

We have looked at all our procedures to see what more can be done to speed up. We have recently reached agreement with the Commission that farmers can choose a valuer from a list of valuers drawn up by the Ministry, where the valuation is for 10 or fewer animals. Up to now, many owners are opting to have two valuers, which has created problems in arranging valuations, and thus slowed down progress with the cull. This new procedure is already being put into practice.

Now that owners can choose the valuer, my honourable friend the Minister of State for Agriculture, Fisheries and Food does not consider it necessary to have two valuers for 10 or fewer animals. We therefore propose to amend the BSE Compensation Order 1996 so that the option of having two valuers for 10 animals or fewer is no longer available. We regard this as necessary in particular to ensure that we make maximum progress with animals which have moved away from their herd of birth and will mainly be dealt with as single animals. Farming and valuers' organisations will be consulted on the draft amendments to the order which, in the interests of making speedy progress on the cull,

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my honourable friend the Minister of State for Agriculture, Fisheries and Food proposes to lay and bring into force during the Recess.

Intervention Board: Performance and Key Targets

Baroness Smith of Gilmorehill asked Her Majesty's Government:

    How the Intervention Board performed against its targets for 1996-97; and what key performance targets have been set for 1997-98.

Lord Donoughue: The Intervention Board's performance against its key targets in 1996-97 was as follows:

Target PercentagePerformance
Percentage of claims processed within deadlines99.085.0
Percentage of claims processed correctly98.599.5*
Cumulative running cost efficiency gains2.55.3
Improvement in index of productivity6.03.0
Ratio of disallowance to EAGGF funds handled0.40Not yet known
To maintain expenditure within vote provision, cash and running cost limits--Met
New value for money savings in procurement of goods6.06.8
Yield: cost ratio of anti-fraud activities3.0:1.01.2:1.0

In agreement with my right honourable friends the Secretaries of State for Scotland, Wales and Northern Ireland, my right honourable friend the Minister of Agriculture, Fisheries and Food has set the following targets for 1997-98:

Target percentage
Percentage of claims processed within deadlines99.0
Percentage of claims processed correctly98.5
Cumulative running cost efficiency gains2.5
Improvement in index of productivity6.0
Ratio of disallowance to EAGGF funds handled0.40
To maintain expenditure within vote provision, cash and running cost limits
New value for money savings in procurement of goods and services 6.5
Yield: cost ratio of anti-fraud activities3.0:1.0

*Results for BSE-related schemes were based on a smaller sample of processed claims, because monitoring on the same basis began later in the year.


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