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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submitted to the MHRA, the company was informed that the position had not changed and, as a consequence, ALK-Abello had withdrawn its file.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
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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.
6.08 pm
Lord Lipsey: My Lords, as this debate has shown, yet again, there is no subject on which there are not a number of people in your Lordships’ House who are highly expert—many, in this case, as a result of serving on the committee so excellently chaired by the noble Baroness, Lady Finlay. I bring a different expertise, which has been shared by at least one other noble Lord, that of a sufferer.
Because one likes to excel in life, I was rather chuffed when I went into my doctor’s surgery three years ago and he said, “My God, David, that is by far the worst case of hay fever that I have ever seen in all my years of practice”, and he packed me off to the Hereford Eye Hospital. I am half-way through a course of immunotherapy which is, so far, working for grass but not for tree. In order to be in your Lordships’ House this afternoon, I am on 20 milligrams a day prednisolone steroids—nasty stuff steroids, incidentally; 180 milligrams of fexofenadine, which is a strong antihistamine; hourly doses of sodium cromoglicate eye drops; four doses a day of antihistamine eye drops; nasal steroid spray; and piriton to send me off to sleep at night. So it is obviously not trivial going through all these treatments, especially if you still look like a living monster. I mention that not only to get the sympathy of the House, although that is always nice, but more seriously to make three points.
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First, the only reason why I am here this afternoon is that I am receiving treatment at Guy’s Hospital from Professor Chris Corrigan and his wonderful specialist allergy team. They gave me new heavy-duty antihistamines, which would not be known to many GPs. My GP is excellent and he had only just heard about them. It is only because I am able to receive that specialist treatment that I am not lying down in a dark room, moaning, at this moment.
My second point is more important, goes to the heart of the debate and is about the importance we tend to attach to allergy. There is a feeling that allergy, even if you get it quite badly, does not rate highly in the league table of human suffering. It does not really matter and the health service should be concentrating on things that save people’s lives, rather than things that make their daily existence more comfortable. I make one or two points on that. A noble Lord, whom I will not mention because he is not in his place, quite often sits next to me in the allergy clinic because his life is threatened without immunotherapy. One bee sting could do for him. Therefore, he has to be there; that makes his treatment high-priority. These are, of course, terribly difficult questions of priority.
In addition, this is something that you can start having at an early age and which, without treatment, can knock you out for four months of every year, right through your lifetime, until you die. Sometimes, quite seriously, you wish when you have it that you were dead. There is a case for priority to be given to that, even over things that are life-threatening but may only be so to people who will have relatively short spans of additional life if they are treated. There is a case to be weighed there.
I pick up a point made by the noble Lord, Lord Taverne. A balance has to be struck in weighing risks. I had a first symptom-free period of eight or ten years when I was injected with immunotherapy by my GP. That was made illegal after one or two people had dropped down dead in doctors’ surgeries. Doctors’ surgeries are now much better equipped to cope if somebody keels over as a result of the treatment they are getting, and will be even more so when the Minister has finished his report. I am not quite clear, delightful though it is to be in the allergy treatment room, that sitting there for an hour after each jab is absolutely essential to my survival, and could not equally well be done in a doctor’s surgery, with greater convenience in many cases. To take another example of risk, there was a very good drug, from which many sufferers benefited, called Triludan Forte, which was banned after a few bad reactions in a million had occurred in the United States. There was a suspicion that it was associated with heart disease. It was worth the risk as far as I was concerned. We must not let risk stand in the way of important advances.
Thirdly, in my experience, everything I have seen underlines the importance of the recommendations made by the noble Baroness, Lady Finlay, and her committee in their excellent report, particularly about the availability of centres of excellence. I am at a centre of excellence. The lady sitting next to me travels for two and a half hours every week to go to that centre because it is the nearest to her. She sits there for
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Some disobliging things have been said—I understand that, having read it—about the Government’s response to the noble Baroness’s report. I did not feel that the response was wicked or dismissive so much as that the department felt that with so many things on its plate, understandably, it did not really wish to grasp this one. It was just a step too far—too much to take on. The same has clearly been true of NICE, as we have heard. No one seems to want to give this the small but decisive push that it requires to be treated properly. I say to the Minister and to the House only that there are hundreds of thousands, maybe millions, of people like me who wish that they would.
6.16 pm
Lord Colwyn: My Lords, the noble Lord, Lord Lipsey, should be congratulated. Without being too light-hearted, I must say that if he is on that cocktail of drugs, I am surprised that he managed to stay awake during his own speech today let alone others.
I also thank the noble Baroness, Lady Finlay, for her chairmanship, Professor Barry Kay for his specialist advice and Sarah Jones and Cathleen Schulte for their backup on this inquiry. The key theme that has emerged from the report is that allergy in the UK has reached epidemic proportions, with more complex and sometimes life-threatening new allergies emerging almost daily. Advice to sufferers varies: should the hygiene theory, as described by the noble Lord, Lord Rea, be supported or rejected—cats and dogs and dirt—or should we take every opportunity to isolate our children from possible allergens? The noble Baroness, Lady Finlay, and the noble Lords, Lord May and Lord Rea, have already discussed peanut allergy and advice given for very young children as a good example of that.
About 20 million children and adults in the UK suffer from a form of allergy, and from April 2006 to March 2007 there were 67,077 emergency hospital admissions for people experiencing just an asthma attack, 40 per cent of whom were children under 15. A simple allergy can be an early step on the allergic march towards more serious allergies, and the critical impact of allergy on health and quality of life and its potential to cause fatalities, usually in older children and adolescents, should not be ignored. Allergic disorders are usually chronic and low-intensity but can have serious effects on quality of life for both patients and their families, and in extreme cases can even lead to death. The prospects of unexpected allergic catastrophe or anaphylactic death are real issues for many families and should not be underestimated.
Many common modalities of treatment are outdated and put sufferers at significant risk of side effects, when modern, safe treatments are more effective but
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Good health and the ability to fight off disease are a function of the immune system, and there are daily references in the media about how that can be improved. It has been suggested that pregnant women who lead a sedentary lifestyle may cause an increased risk of asthma in later life. Recent studies have shown that levels of vitamin D, found in food such as oily fish and boosted by natural sunlight, can influence the development of a child’s lungs and immune system while in the womb. There is also a possible link between asthma and obesity; the numbers of people with both problems have soared in recent decades. It has been suggested that handling rubbish that has been left out for two or more weeks before being collected can increase the risk, as the level of bacteria and fungal spores above bins that have not been emptied is more than 10 times higher than in locations where there is a weekly collection. Keeping a cat can allow the onset of allergic symptoms: a study from Imperial College found that increased exposure to cat allergen was associated with greater sensitivity of the respiratory system.
Blame has been put on the possibility of a defective gene that plays a key role in the appearance of allergic symptoms that occur when the immune system wrongly identifies allergens such as dust mites, pollen, peanuts or cat hair as being dangerous. Scientists have also identified a cold-fighting protein which asthmatics lack. The common cold triggers about 85 per cent of asthma attacks in children, and 60 per cent of those in adults. A study by US scientists has shown that sufferers of allergic rhinitis appear to be at much greater risk of the degenerative brain condition, Parkinson’s. About 5 million Britons are affected by perennial allergic rhinitis, usually triggered by indoor allergens such as dust mites, pet skin flakes and spores, causing inflammation and irritation to the delicate linings of the nose and eyes. A further 3 million suffer from a mix of perennial and seasonal rhinitis, or hay-fever.
We need accurate data, so I commend our recommendation that the Department of Health should ensure that the Systemised Nomenclature of Medicine system, supported by appropriate training, ensures efficacy as a simple, consistent classification system to record allergic disease, monitor its prevalence and inform the commissioning of allergic services.
Whatever measures are taken to minimise the risks of allergen contamination, ultimately some responsibility must lie with the allergic consumer. Social difficulties can make sufferers reluctant to take necessary precautions, and many young people take risks with foods carrying a “may contain” label, believing that food companies are covering their backs with a generalised warning. Children at school risk contact with allergens such as nut proteins, which are easily transferred between surfaces, and if their understanding of their allergy is poor, they can suffer high levels of anxiety. That sometimes leads to a panic-attack reaction. Although
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In the year to 30 September 2006, about 165,000 prescriptions were dispensed in England for Epipens, at a cost of about £8.2 million. The quick dose of adrenaline which these automatic injectors provide can be life-saving for people suffering an anaphylactic shock to food, insect stings or allergens known to the patient. We had evidence that these auto-injectors were not being used effectively. I agree with my noble friend Lady Perry that it might be a good idea for schools to have their own supply of adrenaline injectors, for use by a trained member of staff or a school nurse, rather than relying on children to carry their own medicine. The prescription of such auto-injectors requires specialist allergy knowledge that is currently lacking among many general practitioners and needs to be coupled with patient training. The establishment of allergy centres and the further education of practitioners in allergy should improve the quality of training provided to patients about administering their treatments.
Many patients turn to complementary therapy to diagnose and treat their allergy, usually because they are unable to obtain proper diagnosis from their GP or stand no chance of being referred to a specialist. Many patients are worried about the side effects of conventional drugs. As president of the All-Party Group for Integrated and Complementary Healthcare, I was disappointed by the lack of response from complementary practitioners to this enquiry. Homeopathy, herbalism, acupuncture, cranial osteopathy, applied kinesiology and methods of self-testing, including Vega hair and blood testing, were dismissed as having no scientific evidence or mechanistic base to suggest that those treatments and tests could be remotely effective. Although I know that that is not true and I have sent patients for these treatments with success for many years, there was little evidence to present to the Committee to back up my belief.
We heard the argument that complementary practices may delay accurate, valid and pressing diagnosis, leading to medical harm. I regret that the lack of evidence did not enable us to assess the beneficial effects of complementary therapies, which are harmless when compared to those of conventional drugs on the thousands of people who are harmed or die needlessly as a result of idiopathic reaction.
I am delighted that the Government accept that research into the effectiveness of complementary treatment should address the outcomes that we have identified, and I hope that the Minister will give serious consideration to the points made today.
6.24 pm
Viscount Simon: My Lords, as I am the last Back-Bencher to speak, what is there left for me to say? Not a lot, unless I repeat matters raised by other noble Lords, and I shall do that occasionally.
The Select Committee of which I was a co-opted member, chaired very efficiently by the noble Baroness, Lady Finlay, investigated the subject before it with
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In response to a question last week in another place about the small number of allergy specialists, the Minister listed the large numbers of consultants in dermatology and respiratory medicine and of GPs. The stark reality is that very few of these treat allergy. The services they offer are complementary to allergy but cannot be a substitute for allergy treatment. These doctors do not make an allergy diagnosis or identify an allergic trigger; they diagnose only the single, specialised area covered by them.
Of course, the key problem in providing allergy care is a lack of doctors trained in allergy, and the fact that there are only a few allergy specialists. Currently, only a few doctors are being trained as allergists—a specialty in which it takes some years to become fully trained—and few places are available for those interested in this specialty. More posts for doctors to train in allergy need to be created and funded and there need to be more posts for consultant allergists.
I believe that existing allergy centres are somewhat fragile because most operate on academic funding and there is insufficient NHS funding. This means that when the head of department retires or leaves, the service can disappear. A small amount of NHS funding is needed in these centres to secure them long term. The cost need not be great—two extra consultants, a trainee in allergy, two half-time allergy specialist nurses and a part-time dietician. This would produce trained staff who could then be seeded out to set up centres in areas of the country where there are poor allergy services.
In relation to the large patient need these costs are extremely small. In addition, improved services would result in cost savings for the NHS. Identifying allergic triggers will stop further allergy such as episodes of anaphylaxis, severe asthma and many other conditions. This, in turn, would result in reduced use of health service resources; for example, fewer A&E attendances, hospital admissions, GP consultations and a reduced need for drugs. I very much hope that the Minister will acknowledge that.
Last week I was invited to a reception hosted by the Spinal Injuries Association. I spoke with a senior consultant about the specific areas she covered and about many other matters. When I raised the subject of allergy her immediate response was that there are not enough trained allergists around—I am almost inclined to use that old-fashioned cliché “north of Watford”—with most of the country being without any at all. I found her knowledge refreshing and, at the same time, sad. She knew that there is little happening to alleviate the problems caused by the epidemic of people with allergies.
But at least there is a start in addressing the problem. A new regional allergy centre is being created in Manchester. If this is adequately funded and if those
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The report of our Select Committee has, I hope, highlighted the requirements of those suffering from allergic conditions. I am one of them. Fortunately, I am being tended by a consultant allergist nearby but many are not, and that is what concerns us all.
6.29 pm
Baroness Barker: My Lords, when the hunting legislation was going through your Lordships' House I was asked by another Peer whether I had ever hunted. When I said no, that Peer was rather disparaging. I redeemed myself only by saying that I had not done so because I am severely allergic to horses. The one and only time in my life I have been on a horse I looked about as good as the noble Lord, Lord Lipsey, does today. As I have that very common battery of allergies, I was delighted to spend last weekend reading the noble Baroness’s excellent and thorough report.
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