From the Church Times, 8 October 2010
Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.
An impassioned online debate has arisen about the authorisation this summer of a scientifically controlled clinical trial of children by a consultant paediatrician linked to Bristol University. The trial plans to recruit children aged 12 to 18 with ME, or chronic fatigue syndrome (CFS), into a randomised controlled trial, comparing the effectiveness of the so-called Lightning Process with that of conventional medical care.
Critics argue that the Lightning Process is being promoted commercially for use across a wide range of medical conditions, even though it is as yet scientifically untested for its effectiveness or even safety, and that it should be tested on volunteer, competent adults long before it is tested on children. It is not, of course, for a theologian to pass any scientific judgement on the Lightning Process. At an ethical and theological level, however, it does raise issues that have arisen before in the context of commercially driven faith-healers. Morris Cerullo's Mission to London in 1992 raised these issues in a sharp way, for example.
The Lightning Process was developed by the Phil Parker organisation, and involves a three-day course, said to be based upon neuro-linguistic programming (which is concerned with brain-body connections) and life coaching. This programming, or coaching, seeks to make your mind influence your condition in such a way as leads to improvements in the condition. The organisation's website emphasises that the Lightning Process is thus neither a therapy nor a treatment, but a “training programme” (although clients on the site write about “becoming well”).
The website also claims that this programme can address a very wide range of conditions: ME/CFS, food/ chemical intolerances, depression, fibromyalgia/chronic pain, weight loss, phobias/anxiety/stress, multiple sclerosis, eating disorders, low self-esteem, irritable bowel syndrome/ digestive issues, obsessive-compulsive disorder, and “other conditions”.
The site runs a disclaimer: “Due to the nature of the training we cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with chronic illness.” Esther Rantzen, for instance, and her daughter (who has had ME) are both quoted giving such positive feedback.
Mr Cerullo also claimed to be able to address a wide variety of conditions. The advertising campaign for his Mission to London featured posters showing discarded white canes and overturned wheelchairs, and carried the caption (without any disclaimer): “Some will see Miracles for the First Time”.
After investigating complaints, the Advertising Standards Authority (ASA) concluded in October 1992 that the posters had been “targeted on the disabled”, and were “a source of distress”. Similarly, in June 2010, the ASA found against an advert carried by a Bournemouth company that they “did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME . . . we concluded that the claims had not been proven and were therefore misleading.” Arguably, a number of the conditions listed on the Lightning Process website are psychosomatic, and might effectively be addressed by a cognitive training programme. It will be seen, though, that multiple sclerosis is included.
The MS Society remains cautious about this. It replies to enquirers that the claims of the Lightning Process in relation to MS are not currently backed up by scientific trial evidence, and that it is therefore unable to comment on its effectiveness and/or safety.
The MS Society has good reason to be cautious. In the past few days, a doctor has been struck off for exploiting MS patients, after claiming that he could cure them with injections of cow stem-cells. The chairman of the GMC disciplinary panel told him: “You have exploited vulnerable patients. . . Your conduct has unquestionably done lasting harm.”
Critics of the Lightning Process also argue that people (especially the young) who place hopes in the ability of the Lightning Process to improve their condition, and yet find no such improvement, can become more despondent, and feel worse than they were before. They may even stop taking vital medication.
Critics of Mr Cerullo claimed that that is exactly what happened, when a vulnerable person gave up life-sustaining medication and died soon after attending one of his healing services.
The word “currently” is important in the position of the MS Society. It implies that, if the claims of the Lightning Process were based on solid evidence, instead of anecdotes, then its advice could change. This is exactly why cognitive behavioural therapy, for example, has gradually become an accepted medical procedure.
As it happens, there is also a considerable body of reliable survey evidence (some of it resulting from large population studies) that religious beliefs and practices can be a significant factor in health and longevity (as can a happy marriage).
This is certainly not to say that the specific actions of Mr Cerullo would indeed have allowed people to “See Miracles for the First Time.” Nor is it to say that doctors should prescribe churchgoing or marriage to their ill patients (faith and marriage being emphatically both personal commitments, not forms of medication). But it is to say that strong personal commitments do seem to be a part of living healthily. Perhaps that is what the Lightning Process is trying to promote as well.
There is still a problem, however. Critics of the involvement of children in the Bristol ME/CFS clinical trial are surely correct. The GMC and BMA have both insisted for some time that clinical trials should always involve competent adults wherever possible. These adults should be fully informed, and must give their explicit and uncoerced consent. If they then decide to take part in a clinical trial, that is entirely up to them.
Children and incapacitated adults should be involved only when this is not possible (such as when the particular conditions apply only to them) – and, even then, a proper assessment must be made that the clinical trial is genuinely in their best interests. The coercion of children is not an ethically acceptable option.
Canon Robin Gill is Professor of Applied Theology at the University of Kent.
e-mail adress for any letters in reply to this article: firstname.lastname@example.org