Positive Health Online

General Medical Council (GMC) Clears Dr Jayne Donegan of Professional Misconduct
On 24th August 2007 the panel of the General Medical Panel in Manchester cleared Dr Jayne LM Donegan MBBS DRCOG DFFP DCH MRCGP MFHom of all charges of serious professional misconduct.
They said, contrary to the charges levelled by the GMC that:
“The panel were sure that at no stage did you allow any views that you held to overrule your duty to the court and the litigants.”
“The panel is sure that in the reports you provided you did not fail to be objective, independent and unbiased.”
“Accordingly the panel found that you are not guilty of serious professional misconduct.”

Further Information

Reader’s Feelings about Positive Health (PH)
I have been reading Positive Health for over 12 years now. As someone interested in my own health and in my profession (Massage) I find Positive Health to be head ands shoulders above all other publications. It simply oozes integrity and good academic standards. This is because it’s chief editor, Sandra Goodman has stamped these aspects of her personality upon the magazine.

These days, so many magazines are either just glorified advertorials, or they are overly academic treatises – not so Positive Health. Sandra’s editorial touch steers the magazine through the middle way, one that avoids both crass commercialism and overly technical detail. It’s style is easy and interesting.
Simply put: If I want to find the latest research – I go to Positive Health; If I want to read up about the latest news and developments in the world of healing – I go to Positive Health; If I want to learn more about nutrition, herbs or anything in complementary medicine – I  go to Positive Health;
The book reviews are outstanding and the tone is always thoughtful and measured – without being stuffy. In my professional capacity I read over twenty trade journals: if there was just one magazine that I could subscribe to then Positive Health would win hands down. No question.


The Editor Comments
It is always very moving to realize that the work of PH is appreciated and valued; these are dark days of dirty tricks on the part of commercial interests to limit our access to Nutritional and Herbal Supplements, to rubbish Complementary Medicine (see Response to Enemies of Reason, Letters (page 46-7) and to deny appropriate treatment and research for ME/CFS patients (see Letters page 44-46). Much of the work done in PH is completely unfunded, in particular the Research Updates, Book Reviews, and the PH website.

Without attempting to be overly melodramatic, I can’t stress enough that the only way that tiny, independent publications such as PH can survive is by readers purchasing or subscribing to the magazine and practitioners and suppliers supporting our work through promoting their products and services in PH. I realize that everyone is trying to survive, and that one economy can be made by cutting down on expenses such as subscriptions and advertising.

We can only continue to make a difference to people’s knowledge about their health and to promote understanding of the inter-relatedness of all the healing therapeutic modalities of integrated medicine if we can continue to publish. Otherwise, yet another light will go out.


Correspondence re CFS/ME between Nancy Blake and Dept of Health
Dear Ms Blake
Thank you for your recent emails to the Department of Health about Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Your emails have been passed to me for reply.

The World Health Organisation (WHO) classifies CFS/ME as a neurological disease and the Government has long recognised the WHO classification.

You are concerned about Graded Exercise Therapy and Cognitive Behaviour Therapy (CBT), which are included in a current research trial. PACE (Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation), is a large scale UK-wide trial that will evaluate the value of adding specific therapies to patients’ usual medical care provided in specialist clinics.

These approaches have been shown to benefit some people, but previous trials have been criticised for being too small or selective to definitively evaluate their effectiveness. It is important that this research is done, as while some patients have been helped back to a more normal life, it is the case that some have reported a worsening of symptoms when these treatments have been applied outside of research settings.
CBT, which is often – wrongly – described as Psychotherapy, is in fact a form of psychological rehabilitation and there is good research evidence for its effectiveness in other physical illnesses such as heart disease and chronic low back pain.

The methodologies that NICE uses to develop its guidance are based on the best available evidence and are a matter for the Institute. NICE has a world class reputation and its appraisal process has been reviewed by the WHO, which made a number of positive comments in its report, stating that NICE has developed a well-deserved reputation for innovation and methodological developments that represent an important model for technology appraisals internationally.

NICE processes are open and transparent, inviting comments from a wide range of stakeholders in the development of its guidance. NICE’s Technology Appraisal process also allows stakeholders to appeal against the guidance if they feel that the Institute has failed to act fairly and in accordance with its published procedures as set out in the Institute’s Guide to the Technology Appraisal Process. Stakeholders can also appeal if they consider that NICE has exceeded its powers or prepared a Final Appraisal Determination (FAD) that is perverse in the light of the evidence submitted. If a stakeholder has concerns about technical aspects of a NICE appraisal, then the appropriate course of action is to approach the Institute directly.
The Department expects NICE to take on board the comments received from stakeholders and to give proper credence to all issues raised. NICE makes a particular effort to include patients and the public in the development of all its guidance and consults to ensure that the evidence presented is accurately represented.
I hope this reply is helpful.


Nancy Blake’s Reply
Dear Mr Shanahan
Thank you for your reply to my letter, which was (and remains, along with this reply) intended for the attention of the Minister for Health.

Myalgic encephalitis is a distinct disease entity, which has been the subject of a great deal of research. It begins with a viral infection, affects the brain stem and hence many neurological functions. Because it affects many different systems, it has a variety of symptoms, but experts who have studied patients with ME agree that a defining characteristic is that, due to faulty muscle metabolism, any form of exercise (including mental exertion, but particularly physical exercise) is not tolerated, and can make the illness worse, up to and including permanent disability and death. It is therefore essential that a diagnosis and a prescription of a regime including rest and bed rest is made as early as possible.

Chronic Fatigue Syndrome is a category cobbled together on the basis of fatigue as a symptom, and covers patients who may suffer fatigue from a number of different causes ranging from depression to cancer. One of the conditions specified in the list of symptoms is that it cannot be diagnosed until the fatigue has lasted at least six months. This label has no scientific basis; it is not a diagnosis, and effectively can prevent a diagnosis being made, particularly as proponents of this category insist that it is a psychiatric disorder.

Graded Exercise Therapy (GET), for the reasons given above, is known to be potentially extremely damaging to people who have ME, and CBT at best, if the physical nature of the illness is acknowledged, can be supportive, in the same way that it may be supportive for any physical disorder with major consequences. If it is based on the idea that ME is purely psychiatric, it is abusive.

You refer to a current research trial (PACE) which “will evaluate the value of adding specific therapies to patients usual medical care provided in specialist clinics”.

Which patients? If ME patients are mixed in with a large group of patients with miscellaneous illnesses, then the fact that these ‘specific therapies’ make them worse could be lost among figures for a large number of individuals suffering from other conditions. And why is a large amount of money being spent on researching treatments which are already known to be either worthless or positively harmful to ME patients? Research money should be being allocated to the Neurologists, Endocrinologists, Immunologists and other specialists who are trying to learn more about the causes, effects, and potential treatments which might be helpful. How and why have funds specifically earmarked for the study of ME been diverted in this way?

You mention “specialist clinics”. Are there “specialist clinics” for people with ME which are offering them “medical care”, to which these specific therapies may be “added”? Or are patients with ME being denied clinics staffed by specialists in the complex physiology of ME, and offered nothing but these unhelpful and destructive treatments?

It seems that rather than researching the illness, vested interests are being given diverted funds to support a form of treatment in which various Government advisors have a stake. I refer specifically to Dr Simon Wessely and his colleagues, who seem to have a grip on Government policy. He is very popular with the MOD and the US equivalent, for giving ‘expert’ testimony that Gulf War Syndrome is purely a psychiatric condition. Obviously this would save the MOD a great deal of money.

Likewise, he and his colleagues profit from connections with major insurers, who also save money if ME is classified as a psychiatric, rather than a physical condition. He is also a member of the supervisory board of PRISMA – would this be the company that is doing the research on PACE? This company, according to my source, is being paid millions of pounds to provide “‘rehabilitation’ programs (such as CBT and GET) to the NHS for use on ‘CFS’ patients”. And the government can save quite a bit of money by taking ME sufferers off Incapacity Benefit and insisting they go back to work, on the basis that they have refused to ‘cooperate’ with these treatments.

So ME patients have had money for research into their illness diverted into research on unhelpful therapies. When unable, through their disability, to attend or participate in these therapies, they can be labelled as uncooperative, and lose any means of income, as well as being denied medical care. In sum, it seems that NICE is being influenced by a small group of corrupt and self-serving psychiatrists, and the thousands of people suffering from a serious, debilitating and potentially fatal illness are being denied the benefits of research and proper medical care.

You state, by the way, that CBT is not a Psychotherapy. I am a Psychotherapist, and understand that Cognitive Behaviour Therapy (CBT) is a Psychotherapeutic modality. You state that there is “good research evidence for its effectiveness in other physical illnesses such as heart disease and chronic low back pain.” Does this mean that patients suffering from heart disease will have research funding into physical causes diverted into studying the effectiveness of CBT, and that physical care is now going to be replaced by CBT and graded exercise?

Or that bodies invited to formulate policies in relation to heart disease will consist largely of Psychiatrists, with specialists in heart disease excluded on the basis that they are too involved in thinking it is a physical condition? This has happened in relation to ME. I would really be interested to see the “good research evidence for its effectiveness in… heart disease”.

NICE may have a good reputation and have inspired positive comments, but the guidelines which are currently under consideration in relation to ‘ME/CFS’ have not taken into account the view of patients (I assume they are considered to be among the ‘stakeholders’) – they have in fact gone completely against what these patients have had to say, as well as the large amount of research evidence concerning the physical nature of ME and in particular that rest, and bed-rest, and severe limitation of physical exercise are the most helpful forms of treatment.

There is a strong case that if the recommendations I have seen are included in the Final Appraisal Determination, it will be “perverse in the light of the evidence submitted”. If NICE ignores the evidence of medical researchers into ME, and the evidence of 3,000 patients, and allows the guidelines to be dictated by a group of individuals who have a major financial interest in the prescriptions suggested, it can hardly deserve unlimited praise.

I have written to the Minister of Health hoping that the new government, Gordon Brown, and his new appointees, would be interested in wiping the slate clean of this sort of corruption.



Comments from Dr Derek Pheby, Project Coordinator, National ME Observatory
I found the exchange of emails between Nancy Blake and the department of Health very illuminating. A number of issues are raised, viz:
1.    The definitions of ME and CFS.
2.    Graded exercise, cognitive behaviour therapy, and the PACE trial
3.    The development of the NICE guidelines on CFS/ME.
Definitions of ME and CFS
 I agree with Ms. Blake about the nature of ME. However, she asserts that CFS “…is a category cobbled together on the basis of fatigue as a symptom, and covers patients who may suffer fatigue from a number of different causes ranging from depression to cancer.” This is incorrect. CFS is a diagnosis made by exclusion, i.e. it should not be made in the presence of other illnesses which may explain the patient’s fatigue. When she asserts that the diagnosis cannot be made until the fatigue has lasted at least six months, she is referring to the various clinical research definitions in current use, in particular to the Fukuda definition (Fukuda et al, 1994).

The point is that these definitions were devised to enable relatively homogeneous groups of well-characterised subjects to be identified for clinical trials. They were not designed as diagnostic tools, though they are frequently misused as such, and Ms Blake makes the important point that this may artificially delay diagnosis, which can be very serious, as it is clear that failure to implement appropriate management in the early stages of illness is a major factor leading to severe and prolonged disease. As she states, there is some evidence that ME may be a different disease from CFS, but this is unlikely to be true in all cases, as many people who, on the basis of their current illness, would be labelled as CFS, have had episodes of severe disease in the course of their illness which would put them clearly in the ME category.

Graded Exercise, Cognitive Behaviour Therapy, and the PACE Trial
I have serious misgivings about Graded Exercise Training (GET), which may be very damaging, and also about the over-interpretation of the results of clinical trials, which, because they were conducted on unrepresentative groups of clinic attendees, cannot be generalised to the whole population with CFS or ME. CBT, I agree, can be very helpful in enabling people to develop a coping strategy. That is why it is used in indisputably physical conditions such as cancer. When it is used for other purposes in CFS/ME, e.g. to persuade people to abandon their belief in the physical nature of their illness, this is thought control, and in unacceptable. In any case, in my view, scientific knowledge has moved forward so quickly that the so-called ‘Psychiatric paradigm’ of CFS/ME should now be consigned to history (Pheby, 2007), though inevitably there are those with vested interests who will never accept this.

As regards the PACE trial, I am aware that many people are unhappy about this. However, it is important that pacing, which I consider a far more sensible approach to management for most people than either GET or CBT, should be properly scientifically evaluated. Of course there is concern about the representativeness of the participants, and it should also be recognized that some management approaches may benefit certain subgroups but not others. There is therefore going to have to be a very careful and sophisticated approach to analysing the data generated by the study, and care will need to be taken to avoid sweeping claims and generalisations in interpreting the results. We won’t know whether this approach is going to be adopted until we see the results, but the trial could provide one more useful piece in the jigsaw. At the end of the day, though, it is one research project, and, until its results are corroborated and confirmed by subsequent independent research studies, it should not be regarded as the last word on the matter. Whether the PACE trial justifies the amount of money that has been poured into it is, of course, another question altogether.

Development of the NICE Guidelines on CFS/ME.
Despite the assertion of the Department of Health, the development of the NICE guidelines on CFS/ME has not been sufficiently open and transparent. If it had been, given the extent to which the draft guidelines were rubbished by the entire ME community, what is to be published this month (August 2007) should be another draft for consultation, not the final document. However, this is not the position. NICE’s procedures may be fine in circumstances where the evidence base is extensive, and a systematic means of evaluating it is clearly necessary. The problem with CFS/ME is that the evidence is inadequate, and the NICE procedures are not designed to cope with this situation. The only sensible solution would be to abandon the project for now, and undertake it in three to four years time, when the results will be available from a lot of research currently under way.


Response to The Enemies of Reason – The Irrational Health Service
Channel 4, Monday 20 August    
The Faculty of Homeopathy and British Homeopathic Association support an easily understood approach to difficult scientific issues. However, Professor Richard Dawkins’ Channel 4 programme The Irrational Health Service presented an unbalanced and biased picture of the facts and evidence about Homeopathy.

Contrary to the impression given by the programme, there has never been more evidence for the effectiveness of Homeopathy than now: www.trusthomeopathy.org/pdf/Summaryofresearchevidence.pdf This comes from audits and outcome studies, cost effectiveness studies, narrative medicine and statistical overviews (or meta-analyses). Four out of five meta-analyses of Homeopathy as a whole show positive effect for Homeopathy, as do several focusing on specific conditions.

There is also an increasing body of work about the scientific properties of highly diluted substances, which Professor Dawkins dismissed. The most recent issue of the Faculty of Homeopathy’s journal Homeopathy contains articles by scientists from around the world, which are a timely reminder about how much there is still to learn about the science of these dilutions. The outright dismissal of any potential activity of these substances is increasingly untenable.

Far from being Enemies of Reason, Homeopathic doctors are highly trained physicians who choose to integrate homeopathic treatment when appropriate for their patients, often when other treatments have not been helpful or have produced side effects. They use Homeopathy because it is effective, safe and encourages patients’ responsibility for their own health. This is what most patients hope for from their health service.

Patients who attend one of the five homeopathic hospitals in the UK are referred there by their GP or specialist, typically for health problems that are complex, chronic and have defied treatment with conventional medicine such as rheumatic diseases, chronic fatigue or ME, fibromyalgia, irritable bowel syndrome, allergies and serious skin conditions.

In questioning the public money spent on refurbishing the Royal London Homeopathic Hospital, the largest centre for complementary health care in this country, Professor Dawkins omitted to mention that the building on Great Ormond Street is also shared with Great Ormond Street Hospital, the National Hospital for Neurology and Neurosurgery and the Eastman Dental Hospital, and that there is an increasing integration of homeopathy and other forms of complementary medicine between the hospitals. With an acknowledged 500 million people worldwide using homeopathy, can they all be wrong and Dawkins right?

Further Information

Homeopathy has been available on the NHS since it started in 1948 through the NHS Homeopathic hospitals in Bristol, Glasgow, Liverpool, London and Tunbridge Wells. Patients are referred by their GP or specialist in the normal way and treated by doctors trained in Homeopathy and other Complementary Therapies. Homeopathic medicines are regulated by the British Government via the Medicine and Healthcare Products Regulatory Authority (MHRA).

The Faculty of Homeopathy

The Faculty of Homeopathy was incorporated by Act of Parliament in 1950 to provide education and training in homeopathy for statutorily regulated healthcare professionals. The Faculty’s membership includes Doctors, Vets, Dentists, Nurses, Pharmacists, Podiatrists and a number of other healthcare professionals who integrate Homeopathy into their practice.

The British Homeopathic Association

The British Homeopathic Association (BHA) is a registered charity, which aims to ensure high-quality Homeopathy is an integral part of health care. The BHA provides information to the public, promotes access to treatment and supports the Homeopathic education of health care professionals and research. A list of health care professionals qualified in homeopathy can be obtained by calling Tel: 0870 444 3950 www.trusthomeopathy.org

Source

Sarah Buckingham SBuckingham@TrustHomeopathy.org