| Medicines for Human Use (Kava-Kava) (Prohibition) Order 2002
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The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears): I thank all hon. Members for the thoughtful and challenging contributions that they made in our previous debate on this issue. In my contribution, I shall try to respond not only to Column Number: 007 questions asked this morning, but to issues raised in the earlier debate.I do not want to cover too much old ground, but it is important to emphasise the key point: we have acted on the clear and consistent expert advice that there is a risk of liver toxicity which, although rare, is unpredictable—the phrase that I used in the last debate was ''an idiosyncratic reaction''. Incidentally, Professor Waller also agreed with that finding in his report. The reaction, despite being unpredictable, can be very serious and is associated with kava-kava consumption. The Committee on the Safety of Medicines has reviewed the matter on five separate occasions, so there is a good evidence base for the step that we are taking. I acknowledge that it is a serious step, but I am confident that it is being taken on the basis of good evidence and expert advice. We now have some updated figures for the case reports. The number of cases of liver damage suspected to be associated with the consumption of kava-kava has risen from 70, which was the position when we last debated this matter, to 77. Seven new cases have been reported in Germany, Spain and America. The five cases from Germany all involved patients who had developed hepatitis or liver failure. Four of the individuals had been taking kava-kava for between one and three months, but the fifth had been taking it long term. The case from Spain relates to a 55-year-old man who developed hepatitis after three months of treatment with kava-kava. That treatment was stopped and the patient recovered after two weeks. He was not taking any other medication. No other risk factors for liver disease were identified. Blood tests for hepatitis virus were negative and a liver biopsy revealed a pattern of liver damage. Tim Loughton: I am grateful for the updated figures, but can the Minister confirm that the 77 cases did not happen only in the past year or so but go back to 1990? We are discussing 77 cases that developed over 12 to 13 years from countries with a combined population of more than 500 million people. Ms Blears: The hon. Gentleman is correct. Such cases have arisen over a long time. However, there may be under-reporting. For example, people seeing their GPs about liver problems may not have reported the fact that they had been taking kava-kava because they would not necessarily make the connection. Although the cases have arisen over a long time, it does not mean that that is the full extent of the problem. The problem is so serious that action is needed. The right hon. Member for Wokingham (Mr. Redwood) referred to the association with drinking. One of the cases reported from America relates to a 14-year-old girl who had been taking kava-kava for approximately five months before she developed nausea, fatigue, jaundice and hepatitis. She was on no other medication. Investigation for other causes including liver biopsy showed no other Column Number: 008 identifiable causes. The patient required a liver transplant and she has since recovered.I refer to the overall position. The case reports originate from Switzerland, Germany, Australia, Canada, France, Spain, the UK and America. Four are from the UK. Of the overall total, seven patients suffered irreversible liver failure and required a liver transplant. Four patients have died, including two of the patients who received liver transplants. Those fatal reports were received by worldwide regulatory authorities between 1998 and 2002. The four UK cases involved two males and two females. In three of those cases, the individuals had been taking kava-kava for only a few months before developing symptoms of hepatotoxicity, including jaundice, nose bleeds and abnormal liver enzyme levels. The fourth case related to someone who had been taking kava-kava intermittently during the past eight years and throughout that period had raised liver enzymes. Mr. Tredinnick: Can the Minister reassure the Committee that those people had been taking only kava-kava, and not other drugs at the same time? Ms Blears: I have said that in some of the reported cases no other drugs were being taken at the same time. The 14-year-old girl from America was taking no other medication. I come now to the issues raised by members of the Committee, especially about Professor Waller's report. We examined that report at some length at our previous sitting. It was issued over a year ago in February 2002, when significant numbers of case reports were still emerging. The report reviewed 34 cases of suspected hepatotoxicity which had been assessed by independent expert scientific committees. It included a further 22 reports of adverse effects associated with kava-kava which were not related to liver damage, although it dealt only with 34 of the cases connected with liver damage. The data concerning those 34 cases was limited. It did not include the subsequently updated and more detailed information received by the Medicines Control Agency. Professor Waller's report therefore does not cover a substantial proportion of the data that was available to the advisory committee that considered the kava-kava on several occasions and advised the Government about the risks. In addition, Professor Waller acknowledged that kava-kava may cause rare causes of hypersensitivity or idiosyncratic responses. It is the view of the independent expert committees that the idiosyncratic reactions represent an unacceptable level of risk. Dr. Evan Harris (Oxford, West and Abingdon): The Minister will know that Liberal Democrat Members consider her wish to ban kava-kava as a food as a complete over-reaction. Does she agree that the issue is whether there is a negative risk-benefit ratio for the product as a medicine? If there is, it seems reasonable to ban it, because there is no clear evidence of its being efficacious. There is, however, some suggestion that it may be harmful. Column Number: 009 Does the Minister agree that in a Committee sitting of half an hour, and with very little of that time left, it is not possible to go over all the detail and find out why the Medicines Commission felt that there was a negative risk-benefit ratio? Would she consider withdrawing the order and returning to the Committee when we have had time to look at the wodges of information on the issue which were belatedly placed in the Library? Ms Blears: We have not only had half an hour to discuss the matter; we set aside three hours originally in which to discuss the food order and the medicine regulations. I do not think that it is appropriate to withdraw the order. The situation is serious; the regulations are necessary to protect public health; and I intend to proceed today. Dr. Harris: Does the Minister accept that some of the information used by the Medicines Commission, the Committee on Safety of Medicines and the MCA has been available to us only since the previous two and a half hours of debate? She cannot argue that we have already had two and a half hours in which to consider that information. She accepted during the last sitting that we would not have had adequate time to consider information that was placed in the Library on the day of the debate. Ms Blears: Since the previous debate, there has been an extended opportunity for Committee members to consider the information and to raise issues, as I understand the hon. Member for Bosworth (Mr. Tredinnick) did with Lord Hunt. To deal with the important point on risk-benefit analysis which was raised by the hon. Member for Oxford, West and Abingdon (Dr. Harris), where a case is proven, proportionate measures must be taken on efficacious medicines that could have a clear therapeutic effect. It is fair to say that the evidence of the efficacy of kava-kava is not of the standard that we would get, for example, for a drug that had a proven benefit in dealing with a condition as serious as cancer. The risk-benefit analysis is, therefore, a crucial action that we would take. If there were a clear therapeutic role for kava-kava, judged on the proper measures in relation to medicines, the point would be better made—but there is not. Similar action has been taken to remove conventional medicines from the UK after incidents of idiosyncratic hepatotoxicity. It is not a matter of treating herbals in a discriminatory fashion, or differently, from how we treat conventional medicines. The licensed medicines troglitazone and tolcapone are conventional medicines that have been withdrawn on a similar basis. We are not in the business of saying that herbal medicines should be treated less seriously or without proper consideration. We are concerned, and we should act with a consistent set of proportionate principles when dealing with medicines of any kind. Mr. Tredinnick: The Minister has to accept that we still sell peanuts, although we know that they can kill certain children if they consume them. We can still buy aspirin, which can kill us too if we overdose on it. There is no logic to the argument. Column Number: 010 Ms Blears: Yes, I was just coming to peanuts—the hon. Gentleman has intervened at an appropriate point. That matter was raised during the last sitting. People who are allergic to peanuts know that they are allergic, because they have suffered an acute reaction linked to exposure to peanuts and they know that they will suffer adverse effects from any future exposure. The medical advice to those people is to avoid consuming peanuts. Proper label warnings, comprehensive ingredient lists and medical advice enable affected consumers to avoid foods containing peanuts. Banning peanuts would be disproportionate and unnecessary. People with a family history of peanut allergy have an increased risk of allergic reaction, and they, too, may choose to avoid foods containing peanuts. The information enables them to do that. It is not possible to put information on labels for kava-kava, because we do not know how it interacts with other drugs and we do not know what dosage may produce idiosyncratic and rare, but very serious, effects.
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