Health: Allergy (Science and Technology Committee Report)

My Lords, much of the fundamental research on allergy and its management has been done in the United Kingdom, and yet with allergy reaching epidemic proportions, this report of the sub-committee so ably chaired by the noble Baroness, Lady Finlay of Llandaff, and guided by our expert adviser, Professor Barry Kay, identifies major deficiencies in allergy services in the country, including a shortage of specialists, lack of training and deficiencies in management when compared, for example, with the continent of Europe. I wish to focus on immunotherapy in allergy. Immunotherapy, or desensitisation, can lead to a potential cure for an allergy rather than merely alleviating the symptoms with drugs. Immunotherapy has been found to be highly effective in numerous rigorously controlled clinical trials. Importantly, desensitisation treatment has scored well at the highest level of scrutiny such as meta-analysis using the Cochrane database. The treatment, which consists of administering graded increasing doses of whatever the person is allergic to, such as pollen, dust mites, bee and wasp venom, is a specialist procedure that is best undertaken by a specialist. Immunotherapy, given either by subcutaneous injection or drops under the tongue, is the standard treatment for common allergies in virtually every country in the developed world with the exception of the United Kingdom. We found that it is hardly used at all, and there appear to be two reasons for this. The first is simply a lack of UK allergy specialists. The second seems to be reluctance bordering on obstruction by the Commission on Human Medicines to approve licence applications for allergen immunotherapy given by injection, bearing in mind that, world-wide, immunotherapy is still mainly given by injection, and at present most allergy products are only available in injectable form. The sub-committee was informed in written evidence from the Medicines and Healthcare Products Regulatory Agency that the UK uses the mutual recognition procedure for immunotherapy products in the same manner as other treatments. Yet we were told on our visit to a Danish vaccine company, ALK-Abello, that this appears to be far from the case. For example, one of that company’s products, Alutard SQ, used to treat grass, tree, cat, dog and house dust mite allergies, has been licensed for use in many European countries for decades. The company told us that in December 2005, Sweden as the reference member state approved Alutard SQ for grass allergy and submitted the file to six European member countries for approval, including the United Kingdom and Ireland. All the countries approved Alutard for use in hay fever with the exception of the United Kingdom. Furthermore, when a revised application was submitted to the MHRA, the company was informed that the position had not changed and, as a consequence, ALK-Abello had withdrawn its file. In other words, this company and no doubt other allergy product companies think it simply not worth their while trying to get an allergen immunotherapy product licensed in this country. So one might ask why the bar for approval of these products in the UK as opposed to all other European countries is set so high. Is it still the mindset of the 1980s when deaths occurred because this specialist treatment was being administered by untrained personnel to poorly selected patients using crude vaccines in GP surgeries? That is possible, but we have moved on. We must now remove the obstructions to effective allergy practice by making immunotherapy to a range of allergens widely available for UK allergy sufferers. The obvious place for immunotherapy clinics is at our proposed allergy centres. Perhaps MRHA would be more flexible in granting licences for a wider range of allergy products when they are administered by experts in these centres of excellence, rather than continuing with the present unsatisfactory situation in which most products are imported on a named-patient basis. We also urge NICE, the National Institute for Health and Clinical Excellence, to evaluate those products currently on the UK market which have been subjected to thorough, controlled clinical trials. For example, bee and wasp sting anaphylaxis accounts for several deaths a year and remains often undiagnosed. For these patients, venom immunotherapy by injection can give life-saving protection, but few centres have the facilities for offering this treatment. Endorsement by NICE of bee and wasp venom vaccines would go some way to raising the profile of allergen injection immunotherapy. Finally, there is the question of oral immunotherapy, in which the allergen is given under the tongue as sublingual drops or tablets. This is safe and effective treatment which can be self-administered by the hay fever sufferer at home. Mr Andrew Dillon, the chief executive of NICE, said in evidence that he had no plans to evaluate the oral hay fever vaccine Grazax. Why is this? The popularity of sublingual immunotherapy is growing year on year, especially among European and American allergists. Why do we have such a negative response to a treatment which has been subject to a Cochrane review and evaluated by numerous robust clinical trials? The Government’s response to our submission on immunotherapy occupied five lines and concluded: "““If immunotherapy is given sufficient priority by the Department of Health, Ministers will consider it for referral to NICE””." This in a situation where, as the noble Baroness, Lady Finlay, said, we are the laughing stock of the European Union with respect to allergy treatment. The irony is that although allergy immunotherapy was pioneered in the United Kingdom more than 100 years ago and many of the landmark clinical trials have been performed in this country, it seems to be the rest of the world, not us, which have benefited from that research.