Vitamin B6

– in the House of Commons at 10:37 am on 24th June 1998.

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Photo of Keith Simpson Keith Simpson Shadow Spokesperson (Defence)

The Select Committee on Agriculture yesterday published a damning report on the Government's intention to limit the level of consumption of vitamin B6 to a daily dose of 10 mg. I want to pay tribute to the members of that Select Committee, which began its work in March and has completed it in a short time. It took a mass of evidence. The Committee was dominated numerically by Labour Members. I recognise that it is often difficult for members of such Committees to resist the temptation to back their own party, but the members of the Agriculture Committee unanimously concluded that the Government were wrong; that they had over-reacted; that they had made a wrong decision; that the scientific evidence on which their decision had been based was unjustified; and that, once informed of the risks, we, the consumers, should be free to take vitamin B6 as we like.

The purpose of the debate is to persuade the Minister sto withdraw his draft legislation, to admit that he made a wrong decision, and to consider his ministerial position; after all, the conclusion of the Select Committee report was in effect a total vote of no confidence in him as a Minister.

Members of Parliament are rarely lucky enough for a debate to follow so closely the publication of a Select Committee report dealing with a contemporary issue still open to consultation, and so perhaps to be able to exert real influence on the Government and persuade them to change their mind.

Some 3 million people take regular doses of vitamin B6; 80 per cent. of them are women. They have exercised their choice and they take vitamin B6 in different doses for a variety of reasons. The overwhelming majority of them are convinced that it is of great benefit. Since the Minister first signalled his intention to regulate the consumption of vitamin B6, Members of Parliament have received more than 100,000 letters of complaint, some of which have been passed on to the Minister.

In his evidence to the Select Committee, the Minister pointed out that the letters that we and he had received had come from a variety of sources. With a lightness of touch, he said: I will not even make a joke because I have not counted them but a number of men said taking 100 mg of B6 every day helped them with their PMS and they have signed the letters. No doubt that witty comment was based on some element of fact; we are all aware that a number of lobby groups write to us on great issues like this. However, most Members can distinguish quickly between a generally signed letter and one that comes from a genuine constituent. One such letter came from Diane Turner, a constituent of mine in my home town of Reepham. She runs Diane's Pantry—a combination of health shop and local store. She has not lobbied on behalf of a health food company; she is a woman of great common sense, as are her customers.

I draw the attention of the House to the origins of the proposed legislation to limit the consumption of vitamin B6. It was largely based on scientific evidence drawn from the 1987 Dalton and Dalton study, which suggested that high doses of vitamin B6, taken over prolonged periods, had been shown to be harmful. Since the Minister announced his proposal and explained the scientific basis for it, he has been widely criticised by scientific and medical opinion and has provoked disbelief, anger and dismay among millions of consumers. In the damning words of the Select Committee: It is our view that the doubts concerning the Dalton and Dalton study are so serious that it is scientifically unjustifiable to use them as the basis for establishing a lowest observed adverse effect level in relation to Vitamin B6 intake.

Everyone agrees that high doses of vitamin B6, of about 2,000 mg a day, can be dangerous and can lead to tingling in the hands and feet, loss of sensation and muscle weakness; I suspect that you and I, Mr. Deputy Speaker, would call it pins and needles. What is disputed is the level of maximum safe dose. As regulators, our American cousins are famously averse to risk, for fear of being sued, and tend to err on the side of caution. Yet, in America, vitamin B6 is a allowed to be sold over the counter in doses of 100 mg–10 times the British limit proposed by the Minister.

We are not talking only about the balance of risk; we are talking about the balance of ministerial judgment. That is something to which the Minister also drew attention in his evidence to the Select Committee. He said: It is our job as politicians, as guardians of the public interest in looking at public health, to weigh up and make a judgment. The judgment is not for ever more, it is a judgment based on best evidence we may have available at the time to make it.

Photo of Anne McIntosh Anne McIntosh Conservative, Vale of York

Is it not extraordinary that a Government who were elected on a platform of helping women have, in one fell swoop, acted to take away from them the one vitamin that can help them at certain times of their lives and on a monthly basis?

Photo of Keith Simpson Keith Simpson Shadow Spokesperson (Defence)

My hon. Friend is correct, and in a few minutes I intend to refer to the Government's hypocrisy over consumer choice.

The hon. Member for Blackpool, South (Mr. Marsden) asked the Minister: Have you personally looked at the evidence that COT looked at, in particular Dalton and Dalton and the Phillips study? The Minister replied: The answer is yes, but it is no good asking me any questions about it. I am a production engineer". On the surface, that seems very fair, but most Ministers are not experts. Indeed, most politicians, by definition, are not experts. By background, I am a military historian. Other Members have backgrounds as doctors, nurses, teachers and so on. When one becomes a Minister, one has sometimes to make judgments based on contradictory evidence. As I shall show in a few minutes, the Minister's track record in that respect is not good.

Photo of Nick Palmer Nick Palmer Labour, Broxtowe

A moment ago the hon. Gentleman agreed with the remarks of the hon. Member for Vale of York (Miss McIntosh). It therefore appears that he believes that vitamin B6, as a food additive, is effective as a treatment for pre-menstrual syndrome. Is that his belief? If it is, it contradicts the findings of the Select Committee and the belief of the vast majority of scientists, who say that the evidence is extremely inconclusive.

Photo of Keith Simpson Keith Simpson Shadow Spokesperson (Defence)

I think the hon. Gentleman is wrong in that matter.

In his draft regulatory appraisal, the Minister said that he was faced with five options: Option 1—do nothing;Option 2—address the problem simply by requiring, on a voluntary basis or, if necessary, by legislation, that supplements containing vitamin B6 products include a warning of the risks of prolonged intake of high doses;Option 3—seek agreement from industry to limit the level of Vitamin B6 in supplements and add warning labels on a voluntary basis;Option 4—introduce a higher limit than that recommended coupled with warning labels;Option 5—legislate to implement COT's and FAC's recommendations in full.

The Minister was faced with five options, ranging from do nothing to legislating. He decided to use the legislative sledgehammer—option 5—whereas most reasonable people would have concluded that the evidence pointed to option 2 or 3.

This is not the only case of ministerial misjudgment at the Ministry of Agriculture, Fisheries and Food. The Minister used the legislative sledgehammer some months ago when he decided to ban beef on the bone, to the disbelief of scientists and the majority of consumers. He is rapidly becoming the biggest nanny of them all: to consumers throughout the country, he symbolises the ultimate nanny state.

The Minister has on many occasions, including in his evidence to the Select Committee, talked about the Government putting the consumer first, but he has not done that. He has put bureaucracy and flawed judgment before scientific evidence and common sense, and he has put the consumer last—whether on the issue of beef on the bone or on vitamin B6.

Photo of Austin Mitchell Austin Mitchell Labour, Great Grimsby

I served on the Committee that conducted the inquiry. The hon. Gentleman is being irresponsible and excessively party political in placing the whole emphasis of his attack on the Minister. The Minister was faced with the report by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment saying that vitamin B6 could be damaging in doses over a certain limit. What is a responsible Minister to do in that position? Is he supposed to ignore the report and gloss over it, or do what the Minister did and propose a regulation and put it out to consultation? My hon. Friend is now considering the responses to that consultation. That seems to me a very responsible approach.

Photo of Keith Simpson Keith Simpson Shadow Spokesperson (Defence)

I accept that the hon. Gentleman was on the Select Committee, but I think that any fair-minded man or woman reading the report would see that what the decision ultimately came down to was a ministerial misjudgment. A range of options were open to the Minister, and he made the wrong choice. This issue has been around the Ministry of Agriculture for some time.

I fear that millions of consumers have lost confidence in the Minister's judgment. There is a real danger that, at some future point, a clear, scientifically based, unequivocal threat to food safety will be ignored by consumers, because they will think that it is another case of beef on the bone or vitamin B6—another Rooker's folly. The Minister should accept the Select Committee's recommendations, withdraw his draft legislation on vitamin B6, and admit that he made a serious error of judgment.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East 11:12 am, 24th June 1998

I am pleased that we are having a debate on vitamin B6; indeed, I was fairly certain that there would be a debate after the consultation process finished on Friday. I am sorry that it has begun with an attack on the Minister by the Opposition. The Minister is stuck between a rock and a hard place. I would not like to be in his shoes and have to make a decision on the matter.

Opinions differ across the political parties. The controversy has generated my largest postbag to date: it is even larger than that generated by fox hunting or by my controversial views on the misuse of illicit substances. Shortly after the general election, letters from my constituents started to arrive which first alerted me to the Government's proposal on vitamin B6. Being a chemist, I was attracted to the topic, and I soon found that a factory in my constituency employing 150 people manufactures high-dose dietary supplements of the vitamin.

I want to highlight a major difficulty. The Government's proposal has been made under food law—we should not lose sight of that fact. However, hundreds of thousands of people—mainly women suffering from premenstrual stress—take these high-dose dietary supplements of vitamin B6 daily because they believe that it helps to alleviate a medical condition. We need more research to substantiate the medical claims made for vitamin B6. I hope that that research will be carried out in the not too distant future.

The major difficulty is that dietary supplements fall into a regulatory no man's land between foodstuffs and medicines. Medicines are closely regulated—as they should be— whereas food law expressly forbids medical claims to be made for foodstuffs. Unfortunately, vitamins fall between medicines on the one hand and foodstuffs on the other.

The Government propose to restrict the recommended daily intake of the vitamin to 10 mg under food law. I am sure that the Minister will stress that tablets containing 11 mg to 49 mg will still be available over the counter in pharmacies, and that general practitioners will be able to prescribe tablets containing more than 50 mg.

Photo of John Hayes John Hayes Conservative, South Holland and The Deepings

With the greatest respect to the hon. Gentleman, I must correct him. There was no previous definition of this substance in European Union or United Kingdom law. In their draft regulations, the Government have defined vitamin B6 as a "food supplement." Those are their words.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

I do not necessarily agree with the Government's definition. I stick to my point that vitamins and other substances that we take orally fall between foodstuffs and medicines. There are no proper Government regulations to control such substances. That is the point I am trying to make.

The higher-dose tablets will cost much more from pharmacists and doctors—especially if they are on prescription—than they cost in health food shops at present. GPs' surgeries will be a little fuller than at present, and I am against that. Alternatively, a consumer could buy the 10 mg tablets and take 10 in one day, which would make a mockery of any regulation that the Government propose.

Following complaints from the Consumers Association, the Ministry referred vitamin B6 to the Food Advisory Committee, which in turn asked the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment to look into the problem. In 1996, back went the advice to the Minister of the day under the previous Administration. He was not convinced by the evidence at that time, so COT and FAC were asked to re-run their inquiries. On 4 July 1997, the current Minister made a recommendation to the House. I stress again that that was under food law.

Nutritionists complain that they were not directly involved in the decision-making process. They probably have a point, because nutrition is now a highly respected subject. We must ask ourselves whether the Government have in place the right mechanisms for making such decisions. Paragraph 2.7 on page 6 of the recent White Paper "The Food Standards Agency" states: Where there are uncertainties about the scientific evidence, an element of political judgement is inevitably involved in reaching decisions on the best course of action. Let us briefly examine the scientific evidence.

Photo of Martin Smyth Martin Smyth UUP, Belfast South

Does the hon. Gentleman accept that there was a degree of concern and fear in the Department because of the BSE outbreak, so people there were bending over backwards to keep things straight, and in the process were coming to wrong judgments?

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

My hon. Friend the Minister will have to answer that question. I do not know what goes on in the Ministry. However, there have been a number of food scares, not just that relating to BSE, as a result of which the decision was taken to set up the Food Standards Agency—which I strongly support—with all that that involves. I am fully behind that. We must also bear in mind the precautionary principle, of which I am sure the Minister will also remind us. In his own way, he is taking into account consumers' best interests.

Although COT claims to have reviewed more than 100 scientific papers, two appear to have caught its eye and most influenced its conclusions. The hon. Member for Mid-Norfolk (Mr. Simpson) referred to the Dalton and Dalton work, published in 1986 and 1987, based on human toxicity studies. They claim to have observed peripheral sensory neuropathy in women using vitamin B6 to treat PMS with daily intakes as low as 50 mg over prolonged periods of 35 months.

COT stated that the work had "some methodological deficiencies", but that the study could not be ignored. The problem is that no one has managed to repeat the Dalton and Dalton work. The most comprehensive review of the safety of vitamin B6 was carried out last year by Cantox Inc. in the United States. Its report, published last year, concludes: The deficiencies of the Dalton and Dalton study of 1987 are so great that they prohibit the use of the findings in making a decision to the long-term safe upper intake of pyridoxine. Pyridoxine is another name for vitamin B6.

The deficiencies cited by the report were: a potential bias in describing the symptoms experienced and the lack of objective neurological assessment; the lack of information related to concomitant medications or concurrent medical conditions; and possible inaccuracies in reporting the actual doses of vitamin B6 taken and the duration of the treatment. There was no control group in the Dalton and Dalton study, and it relied almost completely on observation, with little accurate scientific support. For example, no neurologist was involved in the study.

Recently, at a meeting in the other place, I asked Katrina Dalton to defend those criticisms. She responded by throwing down the paper, claiming that vitamin B6 had potential teratogenic effects. There is little scientific evidence for that claim either.

On 13 February 1997, I received a letter from Damien Downing, the senior editor of the Journal of Nutritional and Environmental Medicine. He enclosed a letter from Professor Alan Gaby, which has now been published. Professor Gaby, working in the United States, has attempted to repeat the Dalton work which was carried out here in London. He has concluded: Dalton's claim that these symptoms were caused by B6 is highly questionable". Professor Gaby found that the same symptoms occurred among the control group of women who were suffering from PMS and depression but who were not being treated with vitamin B6 as among the group of women who were being treated with vitamin B6.

The lowest adverse effect level reported in animals is 50 mg per kg of body weight; that was in beagles, after administration for approximately 16 weeks. That was the work of Phillips and Munro in 1978 in Canada.

COT, in its report to the Ministry, stated: With a safety factor of 300 and assuming that an individual weighs 60 kilograms, extrapolation from the lowest observed adverse effect level in dogs would give a maximum daily safe dose for humans of 10 mg. That is where that figure of 10 mg comes from.

That safety factor of 300 used by COT is only ever applied to extremely dangerous substances such as the organophosphate insecticides. Such a high safety figure has never been applied to anything that is taken orally and described as a foodstuff. For example, if it applied to beer, we would be recommended to take only one teaspoonful a day. That is ridiculous. [Horn. MEMBERS: "Hear, hear.1 Well, it is for me. A more reasonable safety factor of 30 would lead to an upper daily dose of 100 mg, the higher dose level with which the industry would be happy and which all the scientific evidence suggests is acceptable.

Early-day motion 209 carried 111 signatures by 3 June, while early-day motion 1303 carried 93 signatures by 10 June. The signatories reflect the extreme concern across all the political parties represented in the House about the Ministry's proposal.

What worries me most about the proposal is the way in which the scientific evidence has been used to make the recommendation to the Minister. I must question whether the right machinery is in place for scientific evidence to be used to advise the Government. I have written to the Chairman of the Select Committee on Science and Technology, which is about to conduct an inquiry into the use of scientific evidence by the Government decision-making machinery, giving evidence on that point.

Photo of Owen Paterson Owen Paterson Conservative, North Shropshire

In a letter to me dated 28 July 1997, Professor Gaby was emphatic in dismissing the Dalton and Dalton report. He said: The report by Dalton and Dalton alleging toxicity at 50 mg per day was so replete with flaws and questionable interpretations that it cannot be taken seriously by objective scientists.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

I have seen that letter, as, I know, has the Minister, who will make his own observations on it.

Last year, a conference was held here in London on the safety of vitamin B6. It presented ample evidence to show that the 10 mg proposal was over the top. All the specialists present, and many others who have published articles and scientific papers since then, have agreed on that conclusion.

On 7 April, just a few weeks ago, the American Academy of Sciences institute of medicine published a voluminous paper on dietary reference intakes. That paper is now the most extensive and authoritative review on the safety of vitamin B6 published anywhere in the world. Its conclusion is that intake levels of 200 mg per day or less produce no adverse effects, but it recommends a tolerable upper intake level of 100 mg per day, based on human studies—the figure to which I just referred.

The question is whether all those opinions should outweigh those of a small group of people —I think three—from COT, which made the 10 mg a day proposal to the Ministry. That is the big question that the Minister will have to weigh carefully before he makes his final decision.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

I should like to conclude.

Yesterday, another important document was published, to which reference has already been made—the report of the Agriculture Committee on vitamin B6, which concludes what many of us believe, that we should not adopt the 10 mg recommendation, even under food law, until more research is available to prove that it is necessary.

When a small group of us met the Minister before Christmas to discuss the proposal, he seemed to have a genuinely open mind on the subject. I hope that he still has, and that he will keep an open mind until the consultation period concludes on Friday. Stuck as he is between a rock and a hard place, I hope that he will weigh the evidence carefully and use his best political judgment.

In conclusion, I recognise that some hon. Members have opinions different from mine on this subject. I do not see this as a political issue. I am glad that we are debating it, but I repeat that we should debate it as a matter of scientific study rather than as a way of attacking the Minister.

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Joint Committee) 11:38 am, 24th June 1998

I am very grateful to you, Mr. Deputy Speaker, for giving me the opportunity to participate in this debate. I have long taken a very keen interest in the matter. I must declare, first, that I have been an officer of the all-party alternative and complementary medicine group for the past 10 years. Secondly, I have long taken an interest specifically in diet and allergies, and went round a clinic for the first time in 1981. Thirdly, I practise what I preach—I take vitamin B6 supplements and other supplements. I was advised to take 100 mg of B6, which I think has helped me in my work and also to sleep—[Interruption.] I see one of the doctors laughing, but 3 million or more people cannot be wrong.

Photo of Nick Palmer Nick Palmer Labour, Broxtowe

Three million people voted Tory.

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Joint Committee)

We shall be pressed for time if we engage in such banter. The hon. Member for Bolton, South-East (Dr. Iddon) has just mentioned the fact that vitamin B6 is a cross-party issue. The signatures on the three early-day motions that he mentioned—one of which I initiated, and which received almost 100 signatures—show that hon. Members on both sides of the House agree on the issue.

I have consistently warned that the problem would not go away. The Minister has been guilty of tunnel vision. To use the old—some might say quite hackneyed—phrase, the light at the end of the tunnel has turned out to be the headlight of an express train, which has now raced out of the tunnel. Its passengers are not only the 3 million people who have already been mentioned—ladies with pre-menstrual tension—but elderly people with Alzheimer's disease and people with skin conditions. All sorts of deficiencies are put right by the use of vitamin supplements. Very often, doctors refer to vitamin specialists the patients they cannot cure—which is another reason why the issue must be handled so sensitively. Not only consumers but scientists are passengers on the train. As has already been said in the debate, many scientists disputed the Dalton report.

Nevertheless—a point that I shall develop in more detail later in my speech—the Minister is lucky. At the back of the train that has raced out of the tunnel and is heading for him is a Pullman coach, in the shape of the United States national academy of science and its report, which he will be able to use if he wants to.

I first raised the vitamin B6 issue on 19 February 1997, and opened my speech by quoting a letter from the British Society for Allergy, Environmental and Nutritional Medicine. It was one of the many persuasive letters that I, like other hon. Members, have received on the matter. It stated: Your ministry is planning steps which may lead to the deaths of thousands of people in the UK, and to substantial avoidable suffering for many others.

There is tremendous fear in the nation on the issue, which has generated the level of concern that we are witnessing. Very many people believe that their lives literally depend on vitamin supplements. The broader issue is that, in recent weeks, already 400 supplements or herbal medicines have been taken off the shelves.

The B6 issue is seen as a test. If B6 goes, so will vitamin C. Then another vitamin will go. There is constant pressure, all the way down the line, on alternative and complementary treatment. I believe that the situation is quite mad. Demand for such supplements, herbal medicine, homeopathy and other alternative treatments is exponential, and the Department is completely out of line with public opinion.

On 30 July 1997, in an Adjournment debate, I raised the issue with the Minister. I told him that if MAFF wanted its post room to be full, he should do nothing about the issue. Although he wrote to me after the debate—for which I am grateful—I think that he completely misunderstood what I had been saying. He stated that clogging up hon. Members' postbags was a stupid thing to do. However, that is not what I had said—I had no intention of orchestrating a campaign. I was saying that concern among the public on the issue was so great that he could not expect the situation to disappear. It will not go away.

Photo of Mr Jeff Rooker Mr Jeff Rooker Minister of State, Ministry of Agriculture, Fisheries and Food, Minister of State (Ministry of Agriculture, Fisheries and Food)

Letters to the Ministry are welcomed openly. Thousands of letters—no problem—are welcome. The point that I was making to the hon. Gentleman is that thousands of letters to my constituency secretary, who has to sort them out, clog up the process of dealing with my constituency work. That is the point that I was trying to make to the hon. Gentleman.

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Joint Committee)

We had better not get stuck in the post room. However, I think that the points have been made.

Let us put the debate on vitamin B6 in context. The hon. Member for Bolton, South-East has already described the beer situation. However, how many hon. Members had coffee this morning? How toxic is a large quantity of coffee? What about tobacco? Figures from the Library show that, last year, 120,000 people died from smoking-related diseases. Aspirin can now be bought over the counter in any supermarket. Last year, there were 37 deaths–31 from poisoning, and six from adverse effects—in England and Wales from aspirin and related compounds.

How many deaths have been caused by vitamin B6? I tabled a parliamentary question on the matter, which was answered by the Office for National Statistics. It revealed that, since July 1997, no one has died from vitamin B6. I tabled another question, asking the number of people who had died from vitamin B6 in total—over 20, 30 and 40 years. Unfortunately, the statistics go back only to 1993. The matter cannot be researched further back without —what is the phrase?—incurring unnecessary costs. However, the answers that I received show that no one—not a single person, despite the publicity—has died from vitamin B6. I wonder how many people have died of caffeine poisoning or of having too much tea—[Interruption.] We had better not pursue that line.

I once spoke in the Chamber for three hours, and nothing would give me more pleasure than talking for three hours on vitamin B6. However, my hon. Friends will be wilting if we pursue that route. I shall therefore restrict my remarks. I can see that the Minister would not be keen on hearing a three-hour speech—perhaps that applies to all hon. Members. I assure you, Mr. Deputy Speaker, that I do not intend to filibuster, particularly on a subject of such gravity.

I am surprised that the Labour party has got itself into such a mess. One of the points stressed in the White Paper "Our Healthier Nation" is that Labour wants not only to lengthen life, but to increase the quality of life. Labour wants to ensure that people have more quality years before they die. One of the ways in which the Government can accomplish that goal at very little cost is by encouraging vitamin supplements. The Government can go through a range of supplements on the shelves. All the statistics on people with diseases of the mind and the body point to alternative treatment as one of the great freedoms of the modern age, and one of the ways in which to rectify the problems that are caused in an increasingly polluted environment. It is a way in which to overcome those problems.

I cannot imagine how the Government could be so foolish as to miss that trick. I do not think that the Minister is foolish, and I hope that he will not miss the trick later on. If he comes into line with public opinion and now science, he will be richly rewarded—[Interruption.] I must have said something wrong—[Interruption.] I do not know whether you, Mr. Deputy Speaker, are going to call the House to order. I shall continue.

An examination of the membership of the Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment reveals that 15 of the 19 members have a declared financial interest in pharmaceutical companies. I must seriously ask the Minister whether he thinks that those minds will be independent if 15 out of 19 members—if not in the pocket of pharmaceutical companies, which have a vested interest in suppressing other remedies—have such an interest.

Photo of John Hayes John Hayes Conservative, South Holland and The Deepings

I wonder whether my hon. Friend will be mindful of the contribution in the Select Committee of the hon. Member for Great Grimsby (Mr. Mitchell) on precisely that point? He said to the Minister: It shifts the whole basis of supply from health shops to pharmacies, from one set of manufacturers to another". That is the point that my hon. Friend is making, which has not been satisfactorily answered by the Minister, either in his evidence to the Select Committee or since.

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Joint Committee)

I am grateful to my hon. Friend who brings me to my next point. Consumer surveys show that, if the products were moved from health food shops to chemists, the market would be destroyed. It would not move, as many people resist going to chemists. A related issue concerns doctors, such as the hon. Member for Kirkcaldy (Dr. Moonie). How will he feel when his surgery is clogged up with people asking for prescriptions for vitamin supplements? Doctors' surgeries are overflowing in any case. That is a problem for doctors and for the Secretary of State.

Reference has been made to Dr. Dalton's report; some time ago, I attended a committee meeting on the subject. Dr. Dalton was in the audience and the focus shifted to her. Under pressure, she got up and asked why the Department had not consulted her before using her report. It was an amazing allegation to make. Dr. Dalton told the meeting—basically people who did not agree with her—that the Department had not consulted her or asked her before using her report. Is it any wonder that the Secretary of State has got himself into such a tangle?

I conclude by referring to the report by the United States national academy of science, which is very thorough and is the most recent report available. The Minister is jolly lucky because he does not have to put his hands up and say, "I made a mistake. I am going to change." He can say, "I accepted the science that was available at the time. It has now been superseded and I am going with the American science." So with one simple trick, he can get himself out of gaol and make everyone happy.

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee 11:40 am, 24th June 1998

I shall not detain the House for long, but I am grateful for the chance to make a few remarks on the subject. I have the misfortune to be the closest thing in the House to an expert on the safety of substances that we take, being medically qualified and having worked in the pharmaceutical industry for a few years, with responsibility for submissions to the Committee on Safety of Medicines and others, and an intimate knowledge of drug toxicity studies.

Unlike the hon. Member for Bosworth (Mr. Tredinnick), I do not take vitamin supplements. I suspect that my general dietary intake is quite adequate for all my nutritional requirements. However, I shall try to be as objective as I can on a subject on which there are one or two accepted facts and a great deal of opinion.

First, pyridoxine, or vitamin B6, is an essential dietary constituent; the recommended daily intake is approximately 1.2 mg. Secondly, in very high doses, pyridoxine is a poison which causes serious neurological symptoms. It is therefore quite right that the Government should decide what the safe recommended level for public sales should be.

I disagree with Opposition Members who have spoken so far. When we are considering pyridoxine as a dietary substance, it is quite proper for it to be on general sale and for people to be entitled to make up their own minds as to whether or not they take it. When it is used as a medicine, however, it enters a quite different world, and in those circumstances, it behoves us to regard it with much greater care.

The proposed limit of 10 mg a day, or 10 times the recommended daily intake, is perfectly adequate for all conceivable dietary needs.

Photo of John Hayes John Hayes Conservative, South Holland and The Deepings

The Government themselves, in their draft regulations on the subject, define the product as a food supplement. To talk about it as a medicine would be like talking about orange juice enriched with vitamin C as a medicine. Of course medical claims may be made for it, but it is not a medicine. By the Government's own definition, it is a food supplement.

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee

At present, the Government are using accepted practice in their definition of the subject. That is why a Minister from the Ministry of Agriculture, Fisheries and Food is replying to the debate rather than a Minister from the Department of Health. The Government are obliged to follow established practice until that practice is changed. It may well be that the Food Standards Agency, if it is given some say over such matters, will recommend different practice in future.

To return to the subject, 10 mg of pyridoxine is perfectly adequate to cover all dietary needs. When we start talking about the medical uses of the substance—we should not call it a drug, but we are effectively using it as one—and start indulging in self-medication, we are obliged to pay careful attention to the potential ill effects of the substance, particularly when its effects are ill defined.

The hon. Member who opened the debate—I am sorry, but I have forgotten his constituency

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee

I knew that it was somewhere in Norfolk. I am glad that the Conservatives still have at least one seat there.

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee

Good gracious! I am sure that that will not last for long.

Let me draw the hon. Gentleman's attention to the penultimate paragraph of the Agriculture Committee report: The evidence on the efficacy of vitamin B6 is inconclusive, and many consumers may experience a placebo effect rather than any actual health benefit. The hon. Gentleman denied that the Committee said that, but he must accept it as the Committee's opinion.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

Is not my hon. Friend's point about vitamin B6 being used in a medical sense also true of hundreds of substances sold in health food shops? What would he say about that?

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee

I regret to say that the hon. Member for Bosworth was quite right. A great many preparations taken as so-called dietary supplements are being used as medicines and, if they are found to be toxic, they should be subjected to exactly the same standards as any other allopathic medication. This is the first of many instances in which we shall look a bit more closely at so-called folk remedies, and discover that they are much more toxic that we thought and should be subjected to the same standards. So 10 mg of vitamin B6 is safe, or 50 mg for prescription by a pharmacist, is a reasonable limit. Above that, the substance should be controlled. In my opinion, those are reasonable precautions for the Government to take.

Opposition Members made great play of beef on the bone as another example of the Government acting unwisely. As the matter has been raised by the hon. Member for Mid-Norfolk (Mr. Simpson), and it is an important analogy, let me digress for a moment.

The Government are in possession of evidence in respect of the potential effect on the human diet of consuming BSE-infected material. We are not at present able to identify with certainty what the risks are. The Government have a study that says that the upper limit for cases of CJD as a result of consuming BSE-infected material is 8 million. I do not for a moment believe that there will be that many deaths, but given that the Government have such a paper before them, they have to be careful how they behave.

In the case of pyridoxine, excessive use has been shown to be harmful and the basic dietary needs are very low, so again the Government are obliged to be extremely careful about the action that they recommend. Let us make no mistake about it, if the study on BSE is proved right and if evidence eventually proves that pyridoxine is harmful, Opposition Members will be demanding the head of the Minister for exactly the opposite reason to the one for which they are demanding it today.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 11:47 am, 24th June 1998

The subject of today's debate has attracted a great deal of attention from hon. Members of all parties. My hon. Friend the Member for North Cornwall (Mr. Tyler), the Liberal Democrat spokesman on food safety, who unfortunately cannot be here this morning, and my hon. Friends the Members for Taunton (Jackie Ballard) and for Weston-super-Mare (Mr. Cotter) have taken an interest in the subject from the beginning. Some of the key questions in the debate are the balance between safety and liberty, between safety and the commercial aims of those who manufacture the medicines, and between safety and the efficacy of any substance that is ingested or applied, whether for a nutritional purpose or for a purported medicinal purpose.

However, it is inappropriate to weigh safety against political considerations. Ministers acting on scientific advice should not make political decisions to win votes, but rather political judgments based on scientific evidence. For the same reason, the hon. Member for Mid-Norfolk (Mr. Simpson) was unwise to call for ministerial resignations. It is inappropriate to try to make the issue a party political one. We heard much of control groups for comparison in the debate so far, but the only control group for the Minister to base his decision about his future is the record of the Conservatives, in which case he can feel confident about his decision. It is unwise for hon. Members on either side to engage in such a debate. The hon. Member for Bolton, South-East (Dr. Iddon) adopted a more measured, persuasive and well-thought-out approach. I would correct the hon. Member on one point, however,

The Dalton and Dalton study did have a control group, but it was the wrong control group. The study suffered from being retrospective, with a control group that was not untreated and therefore not a pure control. Most scientists who write papers on such issues recognise the difficulty of obtaining good control groups. Hearing the criticism that the Dalton study has received, many will think, "There but for the grace of God go I," because of the great cost, time and practical difficulties of getting such studies perfect.

Photo of Dr Lewis Moonie Dr Lewis Moonie Chair, Finance and Services Committee, Chair, Finance and Services Committee

I accept that retrospective studies are generally flawed. When some evidence has been produced to suggest that the drug is harmful, should not a prospective study be carried out with proper controls?

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

Absolutely. I was going to come to that. A great deal of parliamentary time and parliamentary Clerks' time has been expended on this controversial issue, where a line has to be drawn. Government money might be made available through existing research budgets, if not new ones, for a proper study, not just to remove difficulties in this case, but as an example of how a good study can be conducted into food supplements. It is very difficult to conduct good research, which is so important, into medicines. I hope that the Minister will make representations to the Secretary of State for Health about the underfunding of research into many treatments. The NHS research and development budget has shrunk in the past two years, when issues of quality, as we have seen from tragic events in Bristol, and the proposal for a national institute for clinical excellence have pressed on the health service the need for good evidence for existing and proposed treatments. There but for the grace of God go all those who practise medicine. Again, that is open to criticism. Many medical treatments might not stand up to such scrutiny .

Photo of John Hayes John Hayes Conservative, South Holland and The Deepings

The hon. Gentleman talks about taking further evidence. That option was available to the Minister and to COT. They chose not to commission further investigation or study, but to act on the existing study, which, as the hon. Gentleman has acknowledged, was limited. I am disappointed that he has not picked up on that, and that his hon. Friends who he claims feel so strongly about the issue have not bothered to come today.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

There has been a succession of Liberal Democrat Members on the Benches throughout the debate. They signed the early-day motions early, before others who felt that they ought to sign because of weight of numbers.

I do not know whether COT has the right or the funds to commission further research. I should be interested in the Minister's reply on that. The consultation phase might be extended to give time for a prospective study, which would not have the problems of the published studies.

It is difficult for a scientist such as Dr. Katharina Dalton to complain that her study is being looked at and ask to be consulted beforehand. Anyone who publishes in a scientific journal accepts, by virtue of their submission and peer review, that anyone can refer to it, as long as they do so fairly and accurately. It would not be right if people had to overcome the further hurdle of seeking permission before quoting such work.

The balance between safety and liberty is important. An assessment of the safety issues has to be made. This case is rather different from BSE, because here any adverse effects are recognised as reversible, certainly in terms of peripheral neuropathy. There would be time to reassess the issue later without inadvertently exposing fellow citizens to the risk of permanent damage from using a substance—I do not suggest that any Minister would do so deliberately. There would be time for further representations if reversible symptoms were found.

The difficulty of assessing the balance between safety and efficacy taxes the pharmaceutical industry every day. One reason why the price of many drugs is so high is that so much research has to be done to show efficacy because of the hurdles put in the way of marketing a drug for medical reasons rather than as a food additive. It is incumbent on those who make medical claims for what are currently recognised as food additives to ensure that there is evidence on safety. If I was a manufacturer of a food additive, I would be reluctant to make medical claims, because I might then have to provide research data, including possible animal studies and safety and efficacy studies—which are prospective and have to be controlled—as the pharmaceutical industry has to do.

I did not sign early-day motion 209 in the name of the hon. Member for Congleton (Mrs. Winterton), because it makes claims that cannot be substantiated. It says that vitamin B6 supplements are widely believed to be efficacious in a wide range of conditions"— believed to be, but not proven to be, which is correct— including, according to the Royal College of Obstetricians and Gynaecologists, helping with the effects of pre-menstrual tension". I was interested in that, because I had never heard of it as a treatment for pre-menstrual syndrome in my clinical years.

I wrote to the Royal College of Obstetricians and Gynaecologists, which found no policy supporting the claim. It sent me a copy of a letter from the college to Mr. Masterson-Smith, the chairman of Consumers for Health Choice, which said: You state in a letter dated 17 July 1997 to a Member of Parliament"— that is me— that 'The Royal College of Obstetricians and Gynaecologists says that B6 supplements can help with conditions like pre-menstrual tension'. The RCOG has never said that. The college supposed that the claim referred to a publication, "The Wellbeing of Women" by WellBeing, a charity that raises money for research into obstetrics and gynaecology. Even that publication, in a section entitled "What you can do to help yourself', said only: Try a vitamin B6 supplement". Those who make medical claims must take care, or those claims will be judged against medical criteria of safety and efficacy.

What lessons does the Minister feel should be learned? I was interested to hear from the hon. Member for Bolton, South-East that a Select Committee will consider how the Government take scientific advice. I myself have learnt lessons. My instinct as a clinician was not to sign any early-day motion that made claims on medical grounds and showed scepticism about scientific advice. Having read the report of the Agriculture Committee, I do now think that the wrong decision was made in the initial consultation. I believe that the majority of Liberal Democrat Members join me in hoping that the Government will change their opinion, taking into account the criticisms that have been made.

I want to deal with one or two of the comments made by the hon. Member for Bosworth (Mr. Tredinnick), because many of them were spurious. One cannot use an analogy with tobacco. If that was a new substance coming into use, it would be banned in any quantity. We want to see greater efforts directed towards preventing new users of the substance. Representations are being made by all parties to the Secretary of State for Health on that matter.

Aspirin is a different issue also because it is a medicine and there are clear warnings about its use. There have been deaths from aspirin and it is a serious issue. The problem of iatrogenic illnesses and deaths from drug treatments is serious and has been raised on the Floor of the House during other debates. It does not help to draw spurious analogies with non-supplements.

It is not valid to claim that high-dose food supplements help the NHS by reducing the use of GPs so that they can be reserved for people with serious medical syndromes or symptoms, or serious medical concerns. I believe that the role of members of the medical profession is to treat whatever comes before them and to reassure where necessary. There is a role for alternative treatments, if only as a placebo effect. That should not be denigrated, because it is a critical and helpful effect in medication. However, it should not be advertised as anything other than something that can help and can make people feel better without treating the cause.

I hope that the Minister will pay attention to the level of safety and risk versus people's right and freedom to make informed choices—all Liberal Democrats feel strongly about that. I hope that the Minister will bear in mind the fact that any Government announcement will have an impact on small businesses, which must be weighed in the balance. Also weighed in the balance must be the efficacy versus the likely risk. Party political considerations should not arise in the decision. I look forward to the Minister's reply.

Photo of Nick Palmer Nick Palmer Labour, Broxtowe 12:01 pm, 24th June 1998

I should begin by making a general declaration of interest. I advise Novartis UK, which sells pharmaceutical products. However, as far as I am aware, it has no corporate position on vitamin B6.

It is clear from the Library briefing—which is as helpful as always—and from the Consumers Association survey that the overwhelming majority of consumers of vitamin B6 as a food supplement have been encouraged to believe that the product is helpful in dealing with pre-menstrual syndrome and some other problems.

The difficulty faced by the manufacturers and vendors of vitamin B6 is that repeated attempts by clinical trials to prove those effects have failed. Therefore, they are not able to market the substance with the claim that it is effective against PMS. However, they are dependent on the belief that it works to reach the level of sales that they do.

On the face of it, people suffering from PMS would do just as well by eating the Select Committee report. There is no clear evidence that vitamin B6 helps PMS at all. If that is true—it is accepted by the Select Committee—vitamin B6 should not be sold as a food additive if there is any significant risk of side effects. Since the Committee on the Toxicity of Chemicals in Food, Consumer Products and the Environment has advised the Minister that that is the case at dosages above 50 mg, he would have been failing in his duty if he had allowed such dosages to be freely available. The criticisms made by Opposition Members, who are seeking to make a party political point, are entirely misplaced.

The lobby to counter that straightforward argument has deployed a barrage of specious arguments, some of which have, unfortunately, persuaded the Select Committee to launch an attack on Government scientists. The Chairman of the Select Committee broadened that last night on BBC television into an attack on the judgment of all scientists. Perhaps we shall have the pleasure of seeing the Chairman on the "X-Files" in the near future.

Photo of John Hayes John Hayes Conservative, South Holland and The Deepings

I am sure that the hon. Gentleman is aware that I am the only member of the Select Committee in the Chamber. Other members would have liked to be here, but they are taking part in an investigation today. The Select Committee took a balanced view and produced a unanimous report. There was none of the extremism that he suggests and there was no party political malice because the majority of the Select Committee were Government Members.

Photo of Nick Palmer Nick Palmer Labour, Broxtowe

I accept entirely that that is true of the Select Committee report. However, the hon. Gentleman might agree that that has not characterised the speeches that we have heard today.

What claims has the lobby been making to make up for the lack of efficacy in dealing with PMS? First, the lobby said that many consumers say that the pills make them feel good. Well, whenever I hear a speech from my hon. Friend the Member for Bolton, South-East (Dr. Iddon), I always feel good. The lucidity and logic of his arguments always makes me feel that life is worth living, even when he may be mistaken on a particular point. However, that does not mean that he should be taken in unlimited doses. We cannot base licensing policy on subjective impressions or anecdotal evidence. Any serious people working in this area accept that.

The lobby argues that, in a free society, consumers should be able to buy any product if the warnings are adequate. That belief is pushed by libertarian groups, which are widespread in the United States. They argue that even heroin or cocaine should be freely available as long as there is a clear warning. That belief is not accepted in that extreme form by hon. Members in the House of Commons, with the possible exception of the junior Opposition health spokesman, the hon. Member for Rutland and Melton (Mr. Duncan). Most hon. Members accept that we have to weigh up the ratio of efficacy to risk. In this case, there is no proven efficacy. The ratio of efficacy to risk is zero.

If we are fair, we have to say that the evidence on both efficacy and risk is open to dispute. That is probably the fairest way of summarising the evidence so far. The most reasonable policy is to suspend judgment until we have further evidence. For as long as we have no evidence that it works and there is suspicion that it does not work, the balance of the judgment must go against licensing.

The lobby's third line of attack has been to abuse members of COT and the Food Advisory Committee. We have all had letters attacking individual members of those committees — they have great difficulty in answering back—merely because, at some stage in their career, they have advised some company or group with which the letter writer did not agree. That is a weak point. The lobby needs to address the arguments, not individuals.

We have also seen the manipulation of public opinion. I have a copy of yesterday's Evening Standard. Paragraph two of its front page story says that the Government have proposed to ban the sale of vitamin B6 over 10 mg and that Members of Parliament have received 110,000 letters on the subject in recent months.

As we know, the Government are not planning to ban the sale of vitamin B6, but are planning to put dosages over 10 mg on prescription. Previous speakers have mentioned the 110,000 letters. I wonder who counted those letters. Does the post office steam open letters in the hope of finding a reference to vitamin B6? Are we seeing a count of constituents' letters coming in spontaneously? I cannot speak for other hon. Members, but I have received just two letters from constituents—rather than those written by others—on this subject. What we are really seeing is the lobby's count based on the form letters that it has been pushing through health food shops. I concede that I have had such a package. I received 60 in one envelope—some were unsigned, some illegibly signed, some addressed to the wrong Member of Parliament, some to no Member at all and some were entirely blank, presumably just to make up the numbers. It is easy to reach 110,000 or 150,000 letters when one prints them all oneself and pushes them on customers.

In summary, we are talking about a food additive which has no proven worth for the uses to which it is being put, is dangerous at high doses and controversial at medium doses. The Government should confirm the scientific recommendations and reject the unscrupulous campaign, not only because of the dangers of vitamin B6 but because of the precedent. We must not create a grey area of risky and useless quasi-medicines sold as food additives. If a food additive does any good, let its manufacturers do what the manufacturers of vitamin B6 have signally failed to do—prove it.

Photo of Angela Browning Angela Browning Conservative, Tiverton and Honiton 12:10 pm, 24th June 1998

A few months before the Minister of State, the hon. Member for Birmingham, Perry Barr (Mr. Rooker), took responsibility for this matter, it was my responsibility as the Minister at the time. A few months before the general election, officials at the Ministry of Agriculture, Fisheries and Food together with officials at the Department of Health suggested to me and my colleague the then Minister of State at the Department of Health that we should take the action that the Minister announced in his draft regulations. We rejected the advice. It was a matter for ministerial judgment, and we did so because exactly the same science was put in front of us as has been put in front of him.

We instructed officials to ask COT to do further work and seek more up-to-date information, because there was clear evidence in the scientific community—evidence of which we were aware even as laymen, not as Ministers—that for such action to be taken it would require a lot more than the Dalton and Dalton research of 1987. We studied the papers and the advice.

I cannot help but think that, when the Minister sat down at his ministerial desk on 2 May, that issue was at the top of his heap of papers to be dealt with. I see that he smiles —he acknowledges it. I can tell him in all sympathy that, for ages, officials, particularly those in the Department of Health and not those in his Department—the Department of Health, where we find the last vestiges of the politically correct official —have been trying desperately to get Ministers to accept that package. I have some sympathy with him because, frankly, he was set up—I am sure of it. It was early days for him in a Ministry, and by 4 July he had issued his ministerial press release saying that he intended to take the official advice.

Although time is limited, I thought it important to put on the record the fact that that set of Ministers, presented with the same information as another set, took a different decision from that which the present Minister has taken. It is a matter of political judgment. Where there is conflicting scientific evidence I know only too well that it is difficult, but that is the job of a Minister—to sort out and to take professional advice. When we were Ministers, we rightly demanded that further investigations be undertaken and further scientific evidence produced to support the case.

Interestingly, the report published yesterday by the Select Committee on Agriculture makes it clear that officials did not carry out the instructions of the former Administration. Written in the report for all to see, the paper identifies that COT did not query the result of Dr. Dalton's research, but used the exact same multiplier and formula that the hon. Member for Bolton, South-East (Dr. Iddon) so expertly described as flawed. They challenged and questioned nothing. With an election coming and the slight possibility of a Labour Government, they knew that, if they sat it out, they could present a new Minister with the same proposal and he would accept it.

The Minister is carrying out a consultation. Never mind COT and the officials at the Department of Health, as an Agriculture Minister he must by now have had the opportunity to study the scientific evidence available to him. A full page editorial in The Lancet on the subject stigmatises COT's 10 mg recommendation as seeming to be based on the slimmest of evidence. Dr. Virginia Murray at the national poisons unit, who recently conducted a large study on the toxicity of vitamin supplements, said that it had not had a single report of side effects from vitamin B6, and that if there was a problem the unit would have expected to hear about it. When such people make open scientific statements, the Minister—COT or no COT—has a duty to call for more science before he takes a decision.

As has already been pointed out in the debate, if the Minister merely accepts without challenge or query what his officials or those at the Department of Health in particular put in front of him to sign, as has happened in this case, he will undermine public confidence in Government decision making. As a former Minister who sat at that desk for three years, I can tell him that he has until Friday for the end of his consultation to take place, and although he may not want to make that statement at the Dispatch Box this morning—I would be delighted if he did—I hope that he will use this as a valuable lesson in his early days as a Minister not merely to accept what is put at the top of his pile by officials who for years have been desperate to persuade Ministers to do something that is patently flawed as far as the science is concerned.

Photo of James Paice James Paice Shadow Spokesperson (Environment, Food and Rural Affairs) 12:15 pm, 24th June 1998

First, I must congratulate my hon. Friend the Member for Mid-Norfolk (Mr. Simpson) on his good fortune in securing this debate, and the even greater fortune that it happened to follow the publication of the Agriculture Select Committee report.

This debate is about not merely science or the alleged benefits of vitamin B6—I do not know whether it works and, for the purposes of this debate, I do not really care—but about the role of Government in decision making, and particularly about this Minister. It has been suggested that we are using it as a party political issue, but it is not that; it is an issue of ministerial judgment. Of course, the Minister will say in his reply that he cannot allow unsafe foods on the market, yet he allows salt, peanuts and many other foods that are well known to cause negative reactions in some people.

We are discussing a vitamin supplement that has been taken regularly by, it is believed, up to 3 million people for many years, none of whom have died. There is ample scientific evidence that significant levels of B6 can be taken, and, apart from one study, there is a consensus that up to 200 mg a day causes no harm—indeed, some people say up to 500 mg. Even if there is a reaction, as my hon. Friend the Member for Mid-Norfolk reported, it is what most of us would describe as pins and needles. More importantly, the reaction is totally reversible if the individual stops taking the tablets. Generally it seems that it requires a daily intake in the order of 2,000 mg before the symptoms become irreversible, so we are not considering an item with major health risks or one that could cause death.

The assessment of risk is critical. As we have discussed before in the Chamber, we all take risks. We get up, cross the road, and eat a wide range of foods. That is a part of life. We know that there is a possibility of injury or disease, but as individuals we judge whether it is an acceptable risk compared with the perceived benefits. The Government think otherwise. They seem to know best and people are not to be trusted with their own lives—we should rely on the nanny state to decide for us.

Why did the Government ignore the barrage of conflicting evidence, such as that from Professor Andre McLean, a former member of COT and former chairman of the British Toxicological Society? He said in his evidence: COT … have raised issues of toxicity which seem to me to be entirely spurious. Instead, they have relied on this 11-year-old study, which by their own admission uses flawed methodology and imposes a limit of 10 mg on foodstuffs. Apparently, they did not consider merely providing information about possible side effects. Indeed, the Minister had to write to the Committee and apologise for saying that the voluntary scheme had been rejected by the industry.

If the Government believed in choice, they could have opted for a compulsory labelling scheme, but they obviously do not. Perhaps the Minister will tell us why not. Will he also tell us what is to stop people taking two or more 10 mg tablets, which means it will be an unenforceable law, and that is bad law?

Photo of James Paice James Paice Shadow Spokesperson (Environment, Food and Rural Affairs)

If my hon. Friend will forgive me, I shall not, as we are pushed for time.

The Minister has refused time and again—in written answers and, on 18 November, in response to my formal request on behalf of the Opposition—to ask for a further review of the issue. That obstinacy would be excusable if he had taken the trouble to obtain further advice or had reviewed the evidence himself, but he did not. Indeed, he told the Select Committee that he was a production engineer. He went on to say: What I did read was the document assembled by the COT secretariat on the evidence". He said that he was asked

if I had read any of the hundred papers that COT had looked at. The answer to that is yes I had read more than two or three, but no more than …six. That is a clear example of the Minister saying, "Don't confuse me with the facts—I have made up my mind on this subject."

In a letter to hon. Members on 21 August 1997, the Minister prayed in aid the fact that he had received support from an organisation called PMS Help, but he ignored the fact that the organisation is run by the daughter of Dr. Dalton, and that Dr. Dalton is, I understand, its patron. Worse still, he said: The Committee reviewed over 100 publications from the scientific literature… The Government has every confidence in the rigour with which COT reviewed the data". However, Professor Woods told the Committee, in his reply to the hon. Member for Great Grimsby (Mr. Mitchell), who is no longer in the Chamber:

what we looked upon as being the two key studies in this regard and that is the Dalton and Dalton paper … and also the dog study that Phillips and colleagues undertook. When the hon. Member for Braintree (Mr. Hurst) put to him that Your committee says the only human evidence that was relied upon was that contained in the Dalton and Dalton study", Professor Woods answered, Yes. I submit that the Minister is, at the very least, confused. It is clear that the Dalton and Dalton study was the only human study to be taken into account. He will say that he must follow scientific advice—so he should. However, when he hears a barrage of criticism from many scientists, both in the United Kingdom and America, about the advice, I submit that it was his duty to question that advice, not only by asking COT to look again at the matter—which he refused to do—but by seeking a second opinion of the evidence. Instead, he displayed a cavalier attitude towards the facts.

The Minister must now reply. He stands damned by the Select Committee, which is, of course, dominated by Labour Members. Will he now withdraw the draft regulations? Will he invite Professor Woods, who also stands severely criticised by the Select Committee, to consider his position as chairman not only of COT, but of the newly appointed expert group on minerals and vitamins? In the light of the Minister's total failure to understand the depth of concern about his decision, does he realise that what is at stake is not only his integrity and reputation, but the reputation of the whole Government? Will he now consider his position?

Photo of Mr Jeff Rooker Mr Jeff Rooker Minister of State, Ministry of Agriculture, Fisheries and Food, Minister of State (Ministry of Agriculture, Fisheries and Food) 12:22 pm, 24th June 1998

Notwithstanding the criticisms that hon. Members have felt it legitimate to make, no one has yet questioned my personal integrity on this matter, and I reject that allegation absolutely and without qualification.

This has been an interesting debate, and I was pleased to curtail my remarks to allow the hon. Member for Tiverton and Honiton (Mrs. Browning) a few minutes in which to speak. As one of my predecessors, she was right to point to the interesting background to the case. That background was glossed over by the hon. Member for Bosworth (Mr. Tredinnick), who quoted from a letter dated February 1997 about what the Government was allegedly doing to the health food industry without mentioning that that Government were the previous one.

Photo of Mr Jeff Rooker Mr Jeff Rooker Minister of State, Ministry of Agriculture, Fisheries and Food, Minister of State (Ministry of Agriculture, Fisheries and Food)

No, I shall not give way, as I do not have enough time. The issue has been around for a long time. The hon. Member for Tiverton and Honiton rightly said that it was not a top-of-the-tray issue, and that remains the case. The consultation process will continue until Friday. I told the Select Committee that I had an open mind, but not an empty mind, on the issue—that, too, remains the case. If I had to put food safety and public health issues as they are currently considered by the Ministry of Agriculture, Fisheries and Food on a scale of one to 10, I would put bovine tuberculosis—the most serious animal health issue after BSE—at 10, and this issue at one.

COT did more work at the request of the hon. Member for Tiverton and Honiton, although she could, of course, have killed the matter stone dead and not resubmitted it to COT. It was then reconsidered by the Food Advisory Committee, and has since been considered by the Committee on Safety of Medicines. As I understand it, the Committee on Safety of Medicines has never agreed 100 per cent. with COT on any issue—indeed, even on issues of substance, it has taken a wholly different view; it is not a rubber-stamping body.

In this case, the Committee on Safety of Medicines went through a consultation process, as the draft regulations are proposed jointly by MAFF and the Department of Health. Products sold over the chemist's counter at dosages of more than 10 mg and up to 49 mg, such as my hay fever tablets, are perfectly okay but nevertheless have to be reclassified; at higher dosages, they have to be obtained through a doctor's prescription. I was interested that, in the story in yesterday's Evening Standard, a lady was quoted as saying that she wanted to be told what to take by her doctor, not by a bureaucrat. I think that she is absolutely right—as she has a health need, she needs to be dealing with her doctor.

As has been said, we are talking about food law, not medicine law. I freely admit that there is a gap in the regulatory system—food and diet supplements fall between the two stools—which is one reason why we set up the new expert group. The group will not rush to judgment—as we said when we set it up, we do not expect it to report for between 18 months and two years.

Photo of Mr Jeff Rooker Mr Jeff Rooker Minister of State, Ministry of Agriculture, Fisheries and Food, Minister of State (Ministry of Agriculture, Fisheries and Food)

No, I do not have time to give way.

There is an interesting cocktail of interests. As I told the Chairman of the Select Committee, Madam Speaker and the Leader of the House last Tuesday morning, I received a draft press release for issue yesterday from our American cousins in the dietary supplement industry—going under the name the Council for Responsible Nutrition—the day after the Committee finished its work but before its report was published. In other words, the Committee's conclusions had travelled across the Atlantic and back again before the report was printed; embargoed like everyone else, MAFF saw the report only on Monday.

The cocktail of vested interests includes manufacturers and US scientists, and everyone seems to be citing those American scientists—no one has referred to the European Union scientists. In fact, we are being told by three of our European partners that our proposal for 10 mg is too liberal; they believe that we have the most liberal regime in Europe with the exception of the Netherlands. There are different scientific views within this country and between Europe and America. The Select Committee report comes down on one side of the argument—I do not say that as a criticism or that the report is one-sided.

As I said, there is a cocktail of interests and views, and our scientists are being abused left, right and centre—their integrity has been questioned again in this debate. As I said to the Select Committee, some of the scientists involved in the American work would not have been allowed in the room during the COT or Food Advisory Committee discussions, as their interests were so clear and specific that they could not have been party to the discussion.

In that context, I defend our regulatory system. Our use of scientific advice in policy making has been considered and okayed. Notwithstanding that fact, I still say, as I did to the Select Committee, that its report is a valuable contribution to proceedings. It is a useful report after a long inquiry; although the inquiry lasted only one day, much of that day was obviously spent on this matter, and I would not be so churlish as to say that only one day was spent in thinking about it.

Other reports may yet become available. On the last day of the Ministry of Agriculture's last big consultation, the number of doubled. I am not inviting the same on Friday, but we do not know whether that will happen. It would be churlish to make the announcement that hon. Members have invited me to make. That would go against all that I said to the Select Committee when I was asked what we would do at the end of consultation. I know that it is difficult for Ministers to be believed when they say that consultation on draft regulations is genuine, but it is the reality. Our consultation is genuine, and I cannot tell the House how we will proceed when it ends. We will deal with the cocktail of interests that has been assembled, and we will make our decision and announce it to the House as quickly as possible.