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Fifth Standing Committee
on Delegated Legislation
Thursday 20 March 2003
[Miss Ann Widdecombe in the Chair]
Medicines for Human Use (Kava-kava) (Prohibition) Order 2002
Motion made, and Question proposed [30 January],
That the Committee has considered the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 (S.I., 2002, No. 3170).—[Tim Loughton.]
Question again proposed.
Mr. David Tredinnick (Bosworth): I seek your guidance, Miss Widdecombe. The clock has stopped, and I wonder whether that means that we are on European Commission time, which would mean that the Committee is open-ended and can run for ever. The Minister looks aghast.
I open by saying that we should spare a thought for our troops in the Gulf and on the borders of Iraq, and we should wish them well—whatever we think about the war politically—on what is almost certain to be the first day of the war.
I have given the Minister notice of every point that I intend to raise. I ask her to withdraw the order for four reasons. First, the Government's evidence is flawed, as it was when vitamin B6 regulations were withdrawn years ago, because the German report on which it is based is flawed. Secondly, there is no certain link to liver toxicity, and that link was the main thrust of their argument. Thirdly, the noble Lord Hunt, who has now resigned, refused in our exchange of letters to discuss my main point, which was that the Government's case had been destroyed by the Illinois university study. Fourthly, the Government's conclusion was effectively rubbished by the report of Professor Ernst of Exeter university's school of postgraduate medicine and health sciences.
Kava-kava is a natural remedy that has been used by 2 million people for over 2,000 years. In my researches, I discovered that it is so dangerous that it is the national drink of Tonga and Fiji. We should bear that in mind.
Mr. Mark Field (Cities of London and Westminster): It is a somewhat mischievous question, but does my hon. Friend have any statistics on the life expectancy of people in places such as Tonga? If so, are there any lessons that we should draw from those statistics?
Mr. Tredinnick: Well, their life expectancy is good, and their rugby teams are very powerful. I thank my hon. Friend for his intervention.
Some 250 million doses of kava-kava extract have been sold in the past decade, and several placebo-controlled trials on its efficacy have been conducted. The case to ban it is inconclusive, even according to the Government's evidence. In his letter to me, Lord Hunt said:
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''To date, 70 cases of liver damage, suspected to be associated with the consumption of Kava-Kava, have been reported worldwide . . . Each case of suspected hepatotoxicity associated with Kava Kava has been assessed for causality . . . no case''—
not a single one—
''has been identified with a causality of 'certain' ''.
Does not the Minister believe that the Government should be able to show a certain causal link between kava-kava and liver damage before implementing such a draconian ban?
The Government's case is further weakened by the fact that the safety record of kava-kava is far superior to that of many pharmaceutical drugs on sale. Paracetamol, for example, accounted for 2,564 deaths between 1995 and 1999, but it has not been banned.
Mr. John Redwood (Wokingham): Has my hon. Friend noticed that in the 70 cases of liver damage mentioned by Lord Hunt there is usually a pattern of drinking? Yet the Government are not proposing to ban all alcoholic beverages. They could make a better case for doing that than for banning kava-kava. I hasten to add that I would ban neither, because I think that wine in moderation is one of the pleasures of life. Many of the medical cases put forward in evidence by the Government clearly involve drinkers, and all doctors believe that excess drinking can cause liver damage.
Mr. Tredinnick: I am very pleased to hear the wisdom of the former Secretary of State for Wales, under whom I had the honour of serving as a Parliamentary Private Secretary. He is absolutely right.
Lord Hunt's letter went on to say that ''both the CSM''—that is, the Committee on Safety of Medicines—
''and Medicines Commission considered the toxic effect of Kava Kava to be unpredictable. Therefore there are no means for the public to determine whether they were at risk of an unpredictable reaction to Kava Kava.''
Does not the Minister think that argument nonsense? Peanuts, aspirin and paracetamol are dangerous to some people—indeed, anything can be dangerous—but they are on the market, so why ban kava-kava?
The Medicines Control Agency set great store by the so-called German report. In a letter to herbal interest groups dated 14 February 2002, Richard Woodfield, the MCA's chairman, when asked why there was a delay in making a decision on kava-kava, said:
''The principal reason for this was the risk/benefit review of Kava Kava being carried out in Germany has taken longer than was originally estimated. Our current expectation is that the German regulatory authorities will have reached a conclusion on this issue by the end of February.''
He went on to say that the report
''is expected to be a key source of data''.
When that report, by BfArM, was published, an expert in the field, Dr. Schmidt, produced a widely available review, and several glaring errors were found. It was judged that the causality between kava-kava intake and liver reactions was unproven. The report presented to the MCA was five pages long,
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but the original German report had 25 pages. There was duplication in the cases, and in not a single case was a patient shown to have ingested only kava-kava; most had been either drinking alcohol, abusing kava-kava, or taking it with other drugs. There was no way that any case could be proven. It was judged that the causality of any liver reaction was unproven because in most reported cases concomitant drugs were used which have been proved to be responsible for liver toxicity.
On the positive risk-benefit ratio, in 2002, special Commission E, the German committee responsible for the evaluation of herbal medicine products at BfArM, published its opinion on the withdrawal of kava-kava. It thought that its scientific competence had been ignored and, contrary to the BfArM decision, it considered the risk-benefit ratio for patients to be positive; that is, it judged that kava-kava should remain on the German market.
I have already said that the BfArM study was cut from 25 pages to five. Why was that? Dr. Schmidt, an eminent German expert in the field, said that the new report
''is . . . a (very) short version, the original text is much longer, albeit in identical structure . . . A problem with the short version is that you cannot see the origins of erroneous judgments . . . which in the German long version is already scientifical nonsense, but looks much more credible in the short version as the prose is missing. This shortening of the information in some cases also led to the introduction of additional ambiguities, like in the case of the 60 year old woman. Here, the German text clearly states that according to Kraft et al. 'The intake of piretanide might have contributed to the incident', however the BfArM denied the potential hepatotoxicity of piretanide and thus consequently left this piece of information out of the short version. This is not a scientifically based arguing, this is pure and simple politics.''
Why does the five-page summary of the detailed German paper make no mention of the role that may have been played by piretanide in producing liver failure? Dr. Schmidt is one of the world's leading experts. He and Professor Donald Waller from Illinois university clearly demonstrate that little weight can be given to the vast majority of adverse drug reactions that purportedly relate to the ingestion of kava-kava. The Government need to reconsider the evidence. Professor Waller's report, which analyses cases related to toxicity of kava-kava, concludes:
''It is my opinion, based on currently available information, that kava when taken in appropriate doses for reasonable periods of time has no scientifically established potential for causing liver damage.''
Mr. Redwood: My hon. Friend makes a powerful point. The Government's position is absurd. Would they say that because one can get lead poisoning from sucking pencils they should be banned? That would be as sensible as what they are suggesting for kava-kava. There would probably be better evidence for banning pencils than there is for what they are doing. My hon. Friend is successfully making the point that the Government are crazy to want to ban a perfectly good substance that many people enjoy using.
Mr. Tredinnick: I am grateful to my right hon. Friend for that comment.
Lord Hunt's letter repeats the same evidence over four pages; he did not answer my questions.
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Mrs. Cheryl Gillan (Chesham and Amersham): He never will.
Mr. Tredinnick: No, he has gone the way of Jeff Rooker—hon. Members will know what I mean—a Minister who was the victim of the Government debacle over vitamin B6. I realise that I must not go down that route; I shall return to the main issue.
Angela Eagle (Wallasey): The hon. Gentleman is not being fair, especially after offering his thoughts—which we all appreciated—on the position of the troops in the Gulf this morning. He should not imply that Lord Hunt went the way of a previous Minister when the noble Lord resigned on a matter of principle about the war. We may not agree with him, but we should respect his decision.
The Chairman: Order. The Committee will go no further down that route. We shall discuss the matter before us, which is kava-kava, not the war.
Mr. Tredinnick: The Australian research, to which I have not yet referred, also contradicts the Government's position. Ongoing research in the northern territories has monitored the effects of traditional preparations on consumers taking very high doses for the purposes of intoxication; they are taking far too much. Regular liver function tests found no evidence of liver toxicity in the large study brief, even at very high doses of kava-kava. Do the Government dispute that research?
The UK herb sector argues that few adverse effects have arisen from the pharmocopoeial drug as used in the UK and similar traditional preparations used in Australia and the Pacific for over a century. More work is needed to establish the difference between the whole rhizome preparation and the standardised product. There are too many questions unanswered to implement a ban on kava-kava, which is an effective herbal remedy, when labelling would be adequate.
Professor Ernst of Exeter university, speaking at a symposium held at the university in December, said:
''Kava is proven to be effective in treating anxiety and, looking at the total risk, it is safer than synthetic drugs . . . If we are going to ban kava today, then we should have banned Valium 20 years ago.''
''The public is entitled to protection from dangerous and toxic treatments whether they are complementary or conventional, and we need to investigate these recent reports of liver damage associated with kava. But it may be counter-productive to ban an efficacious medicine on the basis of criteria that seem to be harsher than those used to licence conventional, artificial drugs.''
The Minister may be sincere, but in trying to ban this product, the Government are adopting a course that is far too draconian. I hope that the Minister will be able to answer our questions today. If we do not get some satisfaction, we will return to the issue in Westminster Hall or on a Supply day in the main Chamber.