Pharmaceutical industry 'rejoices' at demise of pioneering EPD allergy treatment
Enzyme Potentiated Desensitisation is a groundbreaking treatment for allergy sufferers. But the recent closure of a firm championing EPD leaves its future in doubt. Drug companies and mainstream doctors are unlikely to be mourning, says Charlotte Davis
As I lay on my back, looking up at a warm summer sky, I could hear the bees buzzing in the flowers and the gentle drone of a tractor as it criss-crossed the fields nearby. I lay where I had landed, felled by an allergic reaction. By my side was a spent epi-pen. My body ached from the excessive dose of synthetic adrenalin roaring through my system but at least I was breathing again. I was 19 and glad to be alive.
Like many others, my allergies had started innocuously enough, a little nettle-rash, occasional mysterious swellings, but now something had pushed me over the edge and I was in an anaphylactic spiral from which there seemed no way out.
According to the British Allergy Foundation, one in three people suffer from an allergy at some time in their lives. The numbers increase every year and as many as half of those affected are children. One in three UK 13-14 year olds suffer from asthma, one in four from hay fever and one in five from eczema. And allergies aren't just getting more common, they are getting more serious. Between 1990 and 2000 hospital admissions for life-threatening allergic reactions increased by 700 per cent, giving the UK one of the highest allergy rates in the world.
Allergies and intolerances have been around since the beginning of time – Otzi the frozen stone age man found in the Alps was diagnosed last month by post-mortem as being 'lactose intolerant'. But most allergies are modern - an unforeseen by-product of industrialisation and pollution. UK figures are up to ten times higher than in Eastern Europe and Asia. Yet when it comes to diagnosis and treatment, Britain has been described by the House of Lords’ Science and Technology committee as 'the laughing stock of Europe'. In 2007, the Committee reported that because of a lack of training 'a significant proportion of general practitioners are unable to diagnose and manage allergic disorders, and have nowhere to refer patients with complex allergies'.
When financial woes caused McEwen Laboratories to shut its doors earlier this year, Enzyme Potentiated Desensitisation (EPD), a ground breaking desensitisation treatment, came to an abrupt halt. Until now EPD treatment was available both on the NHS and privately, but its future is increasingly uncertain.
Developed by allergist, immunologist and pharmacologist, Dr Leonard McEwen, at St. Mary’s Hospital, Paddington, in the mid-60s, EPD works like a vaccine. Extremely small doses of allergens are injected under the skin together with an enzyme that occurs naturally in the human body to gradually desensitise a patient against his allergies.
Since the treatment exploits a natural reaction in the human body it is particularly safe - in 40 years use, over 300,000 carefully controlled doses of EPD have been given, and no patient has ever suffered a major side effect.
For many patients, including in my own experience, EPD treatment improves lives dramatically. In many cases, house-bound sufferers with no control over their symptoms became fully functioning members of society. One such person was Jon, who battled ME and multiple food intolerances.
'I was in no doubt that if I didn’t have treatment I would die,' he says. 'I was getting weaker and weaker and conventional medication wasn’t doing anything for me. My heart goes out to all those people who are stuck in the situation that I was in eight years ago.'
So with rocketing need and strong results, why has EPD foundered? The largest problems appear to have been a hostile commercial environment, excessive 'red tape' and a lack of funding for research and development.
One interest group unlikely to mourn EPD’s difficulties is the pharmaceutical industry. The over the counter allergy remedies market alone was valued at £110m in 2011 and is forecast to increase dramatically. Antihistamines, steroids and adrenalin are used to manage the symptoms of allergic disease but they do not address the underlying problem. As a result, allergies often get worse over time and sufferers tend to 'recruit' more allergies. In contrast, the problem with EPD, as Dr Len McEwen notes, is that 'patients tend to get better and stop needing treatment'. 'Drug manufacturers are aggressively anti-EPD, they would rather desensitisation didn't exist at all'.
The UK’s commercial licensing regime and manufacturing regulations also present major hurdles for EPD. The House of Lords Committee, which criticised the UK for its failure to regularly use immunotherapy treatments that have been shown to work elsewhere in Europe, found that UK regulations are 'inappropriately stringent' for allergy desensitisation treatments, reducing the scope for profitability.
Limited funding has in turn limited the amount of research and development. As a result, not only has the real potential of EPD to help people not been fully explored but many doctors remain sceptical of a treatment that has not been exhaustively trialled and unequivocally proven.
Yet a seven year study of EPD treatment in America involving over 10,000 patients reported that three quarters of patients rated the improvement in their health as good to excellent. Placebo controlled, double blind trials and follow-up studies after five years also suggest that EPD has much greater long-term success than any other method of immunotherapy.
Similarly, nine out of ten published trials into the effect of EPD on hay fever symptoms have shown that a single pre-seasonal dose of EPD gives significant protection. However, critics point out that a larger study in Southampton failed to show any benefits for hay fever sufferers, and there has not been enough funding for subsequent research to weigh in on one side or the other.
Fumes and food
Another reason that the medical establishment are sceptical is that EPD claims to treat conditions that are not yet widely accepted, such as food intolerance and adverse reactions to inhaled fumes, known as fume sensitivity, thought to be caused by anything from perfume to pesticides or smoke from anything from cigarettes to factory chimneys.
Believers in fume sensitivity suggest that scientific research may simply have failed to keep pace with allergies unheard of before industrialisation. And of course for big business and its government supporters there are huge financial reasons for remaining sceptical.
Faced with medical suspicion, industry hostility and the closure of his family-run factory, Len McEwen remains surprisingly undaunted. He says he is hopeful for the future of EPD because of the obvious and increasing need. 'There is hope because there is a need. The phone calls we are getting from patients are absolutely desperate'.
And his optimism has its own supporters. Doctors and allergists around the world who treat patients with EPD and who have been impressed by the results are pulling together in search of ways to get the treatment funded and manufactured again. Dr Franziska Meuschel, a member of the new International EPD Society, reports that a Spanish factory is poised to start production of EPD but cautions that 'If there are too few patients it will become so expensive that we can’t afford it ... but we hope with demand and some funding that we can create wider availability'. 'The NHS was the biggest user of EPD in England and we hope that they will offer it again'.
Eunice Rose, Founder of the National Society for Research into Allergy says: 'The need for intelligent, open-minded doctors and effective allergy treatment in this country is greater now that it has ever been. Now’s the time to challenge the establishment and the vested interests and to demand action in the long-term interests of our health rather than in the short term interests of big business.'
Looking back on my own experience as a teenager, lying on the ground gasping for breath and suffering from a life-threatening allergic reaction, all I can think is that I am glad there are doctors and researchers who put people before profit and that the last sound I heard was not the rhythmic chug of a crop-spraying tractor.
Conditions that have been treated successfully with EPD include:
hay fever, dusts mite allergy, perennial rhinitis, asthma, urticaria ('hives') eczema, angioedema (swelling of the face, lips, etc) anaphylactic reactions (life-threatening swelling, usually involving the airways) to most known substances, food allergy or intolerance, adverse responses to inhaled fumes (sometimes known as “multiple chemical sensitivity”), ADHD (Attention Deficit Hyperactivity disorder) autism, tourette’s syndrome, irritable bowel disorders, Crohn’s disease, ulcerative colitis and migraine. EPD also appears to be a long-lasting treatment option for autoimmune illnesses including Rheumatoid arthritis, Type 1 diabetes and multiple sclerosis, illnesses which respond poorly – or not at all – to other methods of treatment of any kind.