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Mr. Deputy Speaker (Mr. Michael Morris): Order. There is no one in the Gallery that the hon. Member and I are aware of.
Ms Corston: I apologise to you, Mr. Deputy Speaker. I am grateful to you for drawing that to my attention. It may be that people who have an interest in that matter will be listening intently to the debate.
These people have suffered terrible side effects and ill health after taking that drug, which they took in all good faith and on the basis of advice, sometimes for a very long time. Many of them are young, high-achieving people, who feel that their lives have been destroyed. They have suffered denial and, at times, disbelief. They have suffered the isolation of serious illness. They have been very brave in overcoming such adversity, and have joined to fight one of the giants of the pharmaceutical world.
The Parliamentary Under-Secretary of State for Health (Mr. John Horam):
I congratulate the hon. Member for Bristol, East (Ms Corston) on raising this matter, because it enables us to discuss two very important public health issues: the prevention of malaria and the safe use of medicines. Lariam--which is otherwise known by its approved name, mefloquine--is one of several medicines used in the prevention and treatment of malaria.
The starting point for this debate should be a recognition that malaria is a serious disease that can lead to death. It is a major cause of ill health and death in many parts of the tropics and sub-tropics, and effective prevention of malaria is a concern to anyone who travels to areas where it is endemic. Malaria is a parasitic disease, which is transmitted by the bite of an infected mosquito. Of the four types of human malaria, falciparum malaria is the most serious.
The symptoms of malaria may include fever, chills, sweats, coughs, diarrhoea, respiratory distress and delirium. However, these can be very varied, and malaria can easily go unrecognised and be misdiagnosed. Falciparum malaria leads to bleeding disorders and failure of various organs. It may also involve the brain, leading to coma and death. Prompt treatment of malaria is essential, even in mild cases, since irreversible complications may develop rapidly.
In the United Kingdom, malaria is an imported disease. About 2,000 cases a year are reported to the public health laboratory service malaria reference laboratory, and, as the hon. Lady said, between four and 12 people a year have died of it in recent years. An increasing proportion of cases is due to the more severe falciparum malaria, which currently accounts for about 60 per cent. of the total.
The Government have long recommended that all travellers to malarious areas take appropriate measures to protect themselves against malaria. Travellers to the tropics and sub-tropics should consult a doctor before travelling. We issue recommendations on malaria and its prevention, both to the general public and to doctors.
Advice for the public is contained in the free booklet, "Health Advice for Travellers" and in a new leaflet on malaria, both produced by the Department of Health. That advice is kept up to date, and is also available on Prestel and Ceefax. The United Kingdom Health Department's book "Health Information For Overseas Travel", which every general practitioner receives, contains more detailed information for doctors. Additionally, the malaria reference laboratory has pre-recorded information on malaria prophylaxis for travellers, and provides advice on specific problems to healthcare professionals.
Prevention of malaria in travellers consists of four components: first, awareness of the risk in the area visited; secondly, preventing mosquito bites by the use of insect repellants, protective clothing after dark and sleeping under bed nets; thirdly, taking an appropriate medicine regularly throughout the stay and for four weeks after returning; and, finally, remembering that malaria can still occur despite all these precautions, and seeing a doctor urgently in the event of fever or flu-like symptoms for up to a year after returning.
As the hon. Lady said, there are several medicines available that protect against malaria, and a range of alternatives is needed, because the disease varies from one part of the world to another. This depends on the type of malaria that is predominant, and on whether local malaria parasites are resistant to particular medicines--a problem that has increased in recent years. In many countries, falciparum malaria is now resistant to chloroquine, which has been the mainstay of malaria prevention for many years.
Advice on the prevention and treatment of malaria has been provided by an ad hoc committee convened by the malaria reference laboratory. The committee's guidelines, which are aimed at health professionals, were last published in the British Medical Journal in 1995, where they are available to all those interested in the subject. Its report includes advice on the use of mefloquine.
The committee is presently producing a new set of guidelines. When consultation has been completed, its advice will be published and the Government will review the implications fully. I heard clearly the hon. Lady's impatience with the procedure. I take her comments seriously, and I shall determine when the committee intends to conduct a further review or publish work on the subject.
Once licensed, the Government closely monitor the use and adverse effects of medicines to ensure that experience from widespread use is appropriately acted upon. This work, which is called pharmacovigilance, is a top priority for the Medicines Control Agency, and an area where the UK is a recognised world leader. Our record in identifying unexpected drug safety hazards, investigating them thoroughly and taking effective and prompt action is second to none.
The yellow card scheme encourages doctors to submit reports of adverse effects to medicines to the MCA through one of the best supported reporting schemes in the world, underpinned by a purpose-designed, state-of-the-art computer system. This scheme enables us to identify important hazards as early as possible.
The Government also use a range of other methods to assess adverse drug reactions, so that effective preventive measures may be put in place. The UK has taken a lead by developing the methodology of, and guidelines for, formal post-marketing surveillance studies, and by using databases such as the general practice research database for the investigation of possible drug safety hazards.
Mefloquine is an anti-malarial drug derived from quinine, which was first authorised in the UK in 1989. It has a high level of effectiveness--between 90 and 100 per cent.--in both preventing and treating malaria. Mefloquine is an important anti-malarial drug because it is useful in areas where the parasite is resistant to other drugs, notably chloroquine.
As with any medicine, the safety of mefloquine depends on appropriate use, but adverse effects may occur even when it is used as recommended. The authorised product information for mefloquine describes the recommended uses, provides dosage schedules, indicates who should not use it, and sets out the precautions necessary for safer use, and lists the recognised adverse reactions. This is available to both doctors and patients, in the latter case supplied with the medicine in lay language. Perhaps it is not plain English, but it is understandable lay language.
The most important adverse reactions to mefloquine are those affecting the nervous system--the so-called neuro-psychiatric reactions. The most common are depression, headache, anxiety and panic reactions. When relatively mild, these reactions are distressing to the user and his or her companions, and may curtail their trip abroad. Fortunately, most such reactions are mild and short-lived, and do not lead to serious consequences or a need for hospitalisation. Rarely, neuro-psychiatric
reactions are serious or more prolonged, and no one is underestimating the consequences of such reactions for the individuals concerned.
We must see the problem in its proper context. First, travellers to tropical and sub-tropical regions face an important risk of malaria, which is an illness with significant morbidity and mortality. Secondly, used correctly, mefloquine is highly effective in preventing malaria, and where there is resistance to chloroquine, it is the best treatment available. Finally, alternative anti-malarials are also associated with adverse effects, and these may also be serious on rare occasions. Overall, the balance of risks and benefits for mefloquine is favourable, and similar to alternative treatments.
Adverse reactions to mefloquine have received considerable publicity in the media, and it is right that the public should be aware that medicines may have important side effects. It is unfortunate, however, if the messages provided are not well balanced, as this may unjustifiably scare the public and lead them to take inappropriate action, such as stopping medication needed to prevent malaria. For travellers to endemic areas who do not use preventive medicines, the risks and consequences of contracting malaria are much greater than the risks of serious adverse reactions occurring with mefloquine.
The hon. Lady mentioned the number of adverse reactions. About 1,200 people are reporting possible adverse reactions in any one year. It is probable that 700,000 have taken the drug. The MCA and the committee on the safety of medicines have carefully monitored the safety of mefloquine since it was authorised in 1989. In the light of accumulating experience, product information has been amended on no fewer than five separate occasions to make 16 significant changes to the recommendations on its use and safety. That should ensure that doctors and patients are fully aware of the adverse effects of mefloquine, and know that appropriate action can be taken to minimise them.
An important further change is currently being made to recommend that people start a course of mefloquine up to two to three weeks before travelling. The effect will be that most patients who do not tolerate it will be aware of the problem before they travel, and will not experience difficulties in unfamiliar surroundings.
We have also provided doctors and pharmacists with information and guidance about neuro-psychiatric adverse reactions, in an article published in the bulletin "Current Problems in Pharmacovigilance" in July 1996. That followed a review initiated by the Committee on Safety of Medicines. Safety monitoring is a continuous process, and, as with any medicine, further action will be taken as and when new evidence becomes available that has an impact on the risks and benefits of the drug.
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