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Baroness Jay of Paddington: I assume the noble Lord refers to the criteria for withdrawing food and fluids drawn up by an international working party and published by the Royal Hospital for Neuro-Disability in February 1996. However, I understand that these were not referred to in the judgment in the case of Miss D. Whether the criteria should be revised is a matter for the Royal Hospital.
The noble Lord may be aware that following a recommendation of the House of Lords Select Committee on Medical Ethics the Royal College of Physicians published guidelines in March 1996 entitled "The Permanent Vegetative State".
Baroness Jay of Paddington: The Government have no information on either the numbers of women who experience debilitation as a result of pre-menstrual tension or the total number of women supplementing their diet with high dose vitamin B6 preparations. Figures for prescribed medicines may be obtained but the number of women using vitamin B6 products without a prescription in unknown.
In the years 1987-96 the UK yellow card adverse drug reaction (ADR) reporting scheme administered by the Medicines Control Agency has received a total of 42 reactions associated with products containing only vitamin B6. Of these, for five women the indication for
Adverse reaction data from the UK's Yellow Card adverse drug reaction reporting scheme are provided voluntarily by doctors, dentists and pharmacists and indirectly by pharmaceutical companies. ADR reports relate to suspected adverse reactions associated with medicinal products. Officials have no information on the use of vitamin B6 as a food supplement. The inclusion of a reaction on the ADR database is not considered evidence that the medicine caused the reaction. Other factors such as the temporal relationship between medicine and reaction, any concomitant medication and the possibility of underlying disease should also be considered.
Baroness Jay of Paddington: Higher doses of vitamin B6 have not been banned. The MAFF independent Food Advisory Committee (FAC) recommended, on the basis of advice from the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), that the level of vitamin B6 in dietary supplements sold under food law should be limited to 10 mg. per daily dose. In addition, on the basis of the COT's advice, the Medicines Control Agency's Committee on Safety of Medicines reviewed vitamin B6 medicinal products and recommended that those vitamin B6 preparations sold on the General Sales List (GSL, i.e. those freely available to the public) should be limited to 10 mg., while those above 10 mg. but below 50 mg. should be available under the supervision of a pharmacist. Those of 50 mg. and above should be available under the supervision of a doctor (prescription only medicines).
The COT has considered the toxicity of vitamin B6 on two occasions. Before the second occasion, representatives of industry and nutritional therapy/alternative medicine groups were asked to submit information giving evidence of the safety of vitamin B6 for consideration. Neither Dr. Ian Munro nor any of the other scientists who participated in recent trials involving high dose supplementation of dogs were specifically consulted.
Baroness Jay of Paddington: The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) has considered the toxicity of vitamin B6 on two occasions. A list of the scientific papers published in national and international journals which it considered on the first occasion has already been placed in the Library and a further list of the scientific papers considered on the second occasion has now been lodged in the Library. The COT considered the totality of the literature on vitamin B6 toxicity, in excess of over 100 papers, and its conclusions were passed to the Food Advisory Committee. Although the COT was aware of specific instances where conclusions of scientific papers have been challenged, it is not possible to give a list of all such papers.
Baroness Jay of Paddington: Data are only held centrally on those "water tower" hospitals which had more than 100 beds which are open. We do not collect centrally information on which psychiatric hospitals and psychiatric wings of hospitals are currently disused and empty.
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