M.E. and the ethics of testing on sick kids

This past week, two major British M.E. organisations, the Young ME Sufferers Trust and the ME Association, issued a joint statement ([1], [2]) condemning as “unethical” a study, scheduled to start in September, of the so-called Lightning Process on children with “CFS and ME”. The research team, awarded £164,000 from the Linbury Trust and the Ashden Trust and is led by Dr Esther Crawley, “Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, CFS Clinical Lead for Bath NHS FT and a Senior Lecturer, University of Bristol”. Dr Crawley is also the medical adviser to the Association of Young People with ME (AYME). (Invest in ME also commented on this study in their March/April 2010 newsletter; scroll down to “Lightning Process — the Falsehood of Magical Medicine”. Update: the 25% ME Group, which represents severely affected people and their carers, have issued this statement in .doc format; see here for views of some ME activists on this subject. Greg Crowhurst, a nurse who cares for a wife with severe ME, suggests that the study will in fact include nobody with genuine ME.)

Needless to say, this study hasn’t received an uncritical reaction in the ME community with the two organisations mentioned condemning it. What is really quite surprising about it is that they are trialling the process on children when no such study has yet been done on adults, which is the opposite of how medical trials are normally done. The ME Association’s own study revealed that a fifth of those who tried the Lightning Process were made worse, and in 2008 the Tymes Trust, in their Brief (PDF here), printed an account of someone who had tried the LP, had a brief period of improvement followed by a relapse to a worse state than they had been in before, because they started acting as if they no longer had ME and no longer had to pace themselves.

The Lightning Process periodically crops up in the media and is often touted as a miracle cure for ME — a three-day talk therapy programme supposedly based on “concepts from Neuro-Linguistic Programming, Life Coaching and Osteopathy” (however, although its originator, Phil Parker, is an osteopath, participants have noted that there was no obvious osteopathy on display). The people behind it claim it is a cure for pretty much every ill under the sun: according to a cachéd version of an LP website quoted by an Australian charity for ME and fibromyalgia, it can cure or partly relieve all of the following (I was going to count them, but it’s quicker to just cut and paste):

“ME, chronic fatigue syndrome, PVFS, adrenal fatigue, acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury, PMT, perimenopausal symptoms and menopause, clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD, low self-esteem, confidence issues, hay fever, asthma and allergies, candida, interstitial cystitis, urinary infections, bladder and bowel problems, IBS, coeliac disease, crohns disease, food intolerances and allergies, blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper / hypo thyroidism, insomnia and sleep disorders, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, weight and food issues, anorexia and eating disorders, multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”

These are pretty staggering claims, and it’s no surprise that British trading standards departments in two districts have taken action against them, and the Advertising Standards Authority in the UK have ruled that a particular advertisement containing claims of its effectiveness by one of the LP practitioners involved in this study should be removed (adjudication here). Some are straightforward physical disorders with proven drug treatments; if you have hypothyroidism (as I do), thyroid supplements are readily available. It should go without saying that, for the LP to even have the slightest chance of being effective, the participant should be physically able to get to the venue; this excludes anyone with severe ME who is bedridden and sensitive to light and noise. It helps, when undergoing talk therapy, to be able to talk (so don’t promote it in the context of coverage of the Lynn Gilderdale story, for example, because it’s not good taste, but this didn’t stop Esther Rantzen doing it earlier this year). It is pretty expensive, and sometimes referred to as the “Lightening Process” because of its effects on the participant’s wallet.

The joint press release notes that the “primary outcome measure” of the study is “school attendance after six months”. The MEA and Tymes Trust respond that children have a right to suitable education, at school or otherwise, and that the Chief Medical Officer’s Working Group had acknowledged in 2002 that children with ME would require home education for a substantial period. However, getting back to school (or work) is not the be-all-and-end-all reason for why people with ME need to get better; getting someone back to school earlier than they can deal with can cause a relapse (and people who have been on the LP have said that practitioners denied that relapses occur with ME). If an ME patient cannot sit exams at 16 but subsequently recovers, they can take them at a later date; it’s a bigger tragedy if they drop out just before their exams and remain too ill to take a class, let alone their exams, for a decade or more afterwards.

Dr Crawley has expressed some questionable views on ME in the past. In the UK at least, many ME sufferers and activists despise the term “chronic fatigue syndrome” because they find that “fatigue” doesn’t adequately describe what they experience (many sufferers say they do not feel fatigued at all, in fact). In 2007, Crawley participated in an edition of the BBC’s Case Notes programme on Radio 4 (transcript here), and she explained the issue of naming ME thus:

Yeah there’s lots of names for chronic fatigue syndrome and the patient group usually call it ME or myalgic encephalitis or myalgic encephalopathy and that is because that actually described their symptoms, so muscle aches and pains and cognitive or thinking problems. In fact doctors don’t like that because when you actually look there’s no evidence of muscle inflammation. And so doctors decided to call it chronic, which means long term, fatigue and syndrome, which means a collection of symptoms. Patients didn’t like that, so we’re now ended up with CFS/ME is the actual official terminology.

There are actually patients in many countries who do identify with the term CFS or ME/CFS. In this country (the UK), the illness was identified as myalgic encephalomyelitis in the 1950s following the Royal Free outbreak. It’s not a theory which was picked up by patients because it fit their symptoms; it was a name reached by examination of patients who had fallen ill during the outbreaks of the mid-20th century, particularly Royal Free, by some of this country’s most distinguished physicians and microbiologists. Other names included epidemic neuromyesthenia and atypical polio, as a polio-like enterovirus was linked to most of these outbreaks. Chronic Fatigue Syndrome is a much later invention, and its definitions were always much wider than those of ME. Indeed, many of those being put forward for this trial may meet some definition of CFS but may actually not have ME.

AYME’s website, no doubt under influence from Crawley, states that ME stands for “myalgic encephalopathy” while the term, “myalgic encephalomyelitis” is “technically incorrect because the term ‘myelitis’ means inflammation of the brain and there is no inflammation found in the brain of ME patients”. Myelitis actually means inflammation of the spinal cord (from Greek myelos) and that has, in fact, been found in the spinal cords of at least three ME sufferers who died in the last five years or so (Sophia Mirza, Lynn Gilderdale, and an unnamed male who committed suicide and was referred to in a presentation by Dr Abhijit Chaudhuri at the 2007 Invest in ME Conference). As another example, the name “transverse myelitis” refers to the inflammation of one section of the spinal cord. Leading Canadian ME expert, Dr Byron Hyde, noted that “the critics of this term have no problem with the Myalgic part referring to muscle pain” — i.e. evidence of inflammation of the muscles themselves is not necessary — and that “in the epidemic situation with patients falling acutely ill and in some cases dying, autopsies were performed and the diffuse inflammatory brain changes are on record”. (Hyde, 2006; PDF here).

In the 2007 BBC programme, Crawley makes a couple of other claims that need to be answered:

If you actually look in the population in children under 12 it’s equally common in boys and girls and - in children and in adults it’s a bit more common in girls than boys. But in specialist clinics you’re much more likely to be seen if you’re actually female. And the same is true for ethnic groups as well, so in a specialist clinic you’re much more likely to be seen if you’re white. But in the population the most common ethnic group is actually Bangladeshis. In specialist clinics you’re most likely to be seen if you’re social class one and two, so if you’re relatively wealthy, in the population it’s actually most common in social class five, it’s common in poor socially deprived groups.

ME is not “slightly more common” in adult women than men; it’s much more common. A study of cases in schools by Dowsett & Colby from 1997 (PDF here) noted that, among pupils, the male:female ratio was 1:2 (among staff it was 1:4, but more school staff tend to be female anyway). They also noted that historical surveys, going back 60 years, noted “female preponderance of cases” and “peak incidence at puberty”. This is borne out by any examination of communities of ME sufferers; the majority of participants do seem to be female although there are a sizeable minority of males. Men and boys can get severe ME just as women and girls can.

The claim about Bangladeshis is extraordinary! Does she mean that there are more Bangladeshis with ME or “CFS” than whites, or just that it is more common, proportionally, among Bangladeshis than any other group? If the former, one would expect the Bangladeshi community in the east end of London to be noticeably ravaged by the illness and for it to have been news long before now. A brief perusal of the names of participants in online ME communities won’t reveal a single identifiable Bangladeshi name (and I can tell). Most Bangladeshis are Muslims, and having participated in various online Muslim forums for years, and seen prayer requests for every eventuality (surgery, one illness or another, car crashes, deaths in the family and so on), I have never seen one related to ME. If anyone out there knows where all these Bangladeshis with ME are, I’d like to know.

There have been some explanations as to why some people who supposedly have ME do well out of the Lightning Process, one of them being that it helps people who are recovering from ME or who have been unable to move on, but another is simply that not all of them had genuine ME but had some sort of psychological fatigue state which was mistaken for ME or ME/CFS; given the confusion that has built up regarding what is and what is not ME, it would not be surprising to learn that ME charities were partly representing those affected by something other than ME, but even so, when research like this is being conducted, it ought to be made clear who is involved. The explanation of LP based on an “adrenaline, nor-adrenaline and cortisol loop” goes against decades of research which states that it’s an inflammatory illness of the brain and spinal cord, so it’s quite amazing that a therapy which sells itself on the basis of clearly unscientific claims is being trialled on children in this country.

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