Following suggestions from visitors to the website, this page has been set up to allow me to give details of items about M.E. and related issues, as well as other subjects, that will hopefully be of interest to those who visit the site. Do let me know what you think!
The Department of Health has decided to ban blood donation permanently from all prospective donors in the UK who report they have had ME/CFS from 1 November this year. The decision was announced in an email sent to The ME Association today by the Department's Director of Health Protection.
In a brief email, Clara Swinson writes:
"As of 1st November 2010, blood donors who report that they have had ME/CFS will be permanently excluded from giving blood in the UK. This change is being made on the grounds of donor safety, as ME/CFS is a relapsing condition. It brings practice for ME/CFS into line with other relapsing conditions or neurological conditions of unknown origin.
"The change to donor selection criteria is being made following a recommendation by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee (JPAC)."
The announcement has already been welcomed by contributors to ME/CFS internet forums around the world as further indication that the physical nature of the illness is being taken ever more seriously. Clara Swinson's email does not reveal the extent to which studies into the XRMV virus figured in Department of Health's thinking.
August 2010
New study results released: Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors
Chronic fatigue syndrome (CFS) is a serious systemic illness of unknown cause. A recent study identified DNA from a xenotropic murine leukemia virus-related virus (XMRV) in peripheral blood mononuclear cells (PBMCs) from 68 of 101 patients (67%) by nested PCR, as compared with 8 of 218 (3.7%) healthy controls. However, four subsequent reports failed to detect any murine leukemia virus (MLV)-related virus gene sequences in blood of CFS patients. We examined 41 PBMC-derived DNA samples from 37 patients meeting accepted diagnostic criteria for CFS and found MLV-like virus gag gene sequences in 32 of 37 (86.5%) compared with only 3 of 44 (6.8%) healthy volunteer blood donors. No evidence of mouse DNA contamination was detected in the PCR assay system or the clinical samples. Seven of 8 gag-positive patients tested again positive in a sample obtained nearly 15 y later. In contrast to the reported findings of near-genetic identity of all XMRVs, we identified a genetically diverse group of MLV-related viruses. The gag and env sequences from CFS patients were more closely related to those of polytropic mouse endogenous retroviruses than to those of XMRVs and were even less closely related to those of ecotropic MLVs. Further studies are needed to determine whether the same strong association with MLV-related viruses is found in other groups of patients with CFS, whether these viruses play a causative role in the development of CFS, and whether they represent a threat to the blood supply.
Two Reno scientists, who last year discovered a new infectious human retrovirus they linked to Chronic Fatigue Syndrome, said Monday that their findings have been replicated and confirmed by the U.S. Food and Drug Administration.
Dr. Judy Mikovits, one of the lead researchers with the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, said the FDA’s review of their findings is scheduled to be published in September.
“There has been an issue over whether anybody could replicate our study, and it will not only confirm our findings but extend our findings, which is really exciting for us,” she said.
Mikovits said they also have new, unpublished data concerning the retrovirus, XMRV, that could lead to treatment of Chronic Fatigue Syndrome.
“We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,” she said. “So we could have a diagnostic test to follow clinical treatment and show that people’s immune systems go back to normal. That’s the latest data that’s really amazing. That’s what we’re after.”
That data will be published by the end of the year, probably in a clinical immunology journal, she said.
Lombardi said clinical trials could begin soon at the Whittemore Peterson Institute, which is relocating from its tiny laboratory on the University of Nevada, Reno campus to the university’s newly opened Center for Molecular Medicine.
“Actually, we already have been contacted by people who are sending us tests, perceiving that they may be asked to be part of the clinical trials,” he said.
“I think once the (FDA) paper comes out and once the controversy is put to rest, the pharmaceutical companies will realize that this is some very low-hanging fruit for them to make the next transition,” said Lombardi. “There are so many drugs that have been developed for HIV, and it’s a retrovirus. So there’s probably a ton of HIV drugs that they can go back and re-screen that could be used.”
There also are three published drugs that work against XMRV, Mikovits said.
“We totally expect at least one clinical treatment trial before the end of the year,” she said. “That is our goal and that’s what this new facility is for.”
I have only recently come across this organisation. The following is from the front page of the website -
THYROID PATIENT ADVOCACY (TPA) is an independent user-led organisation established to ensure that all thyroid disease sufferers are given a correct diagnosis and receive effective treatment. TPA believes all patients should have access to all relevant tests and treatment, including synthetic or natural T3.
As a result, TPA campaigns for better education in diagnostics and treatment and provides extensive support and guidance for all sufferers.
TPA is managed by a group of dedicated thyroid patients who volunteer their services freely. The web site, the TPA-UK Information Pack and the Internet discussion forum is available to all and will help patients and doctors develop greater knowledge and understanding about the illness, will advise on reliable diagnostic tests, and recommend where to obtain proper, effective treatment.
Invest in ME recently received an invitation from the British Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (BACME) inviting us to apply to become an executive member of that organisation.
BACME is chaired by consultant paediatrician Dr Esther Crawley - who was recently awarded a grant to do a clinical trial on the Lightning process (funded with £164,000 from the Linbury Trust and the Ashden Trust) - a business which assumes that no matter what is causing an ME patient's illness it will help cure a patient from them.
With cases of people with ME being made worse from this business the recent Norwegian film by Paal Winsents ("Make Me Well") illustrates the danger of people with no medical training attempting to treat a neurological illness such as ME. A telling quote from a LP practitioner in that film says it all -
".... It does not matter how it started. Sometimes people had a bacterial infection, sometimes people had a viral infection. It does not matter how it started. The Lightning Process works equally well".
Such uninformed, non-clinical and dangerous statements being used by people promoting businesses without any medical training, at a time when the need for more funding for biomedical research into ME and the evidence to support that funding requirement is overwhelming, is symptomatic of the problems on a non-strategic, non-biomedical approach to diagnosing and treating people with ME. Meanwhile ME patients and their families have to witness this absurd waste of money.
Dr. Crawley's views on ME aren't those of Invest in ME's and we have serious concerns about her position as chair of an organisation such as this.
The Assistant Chair of BACME is Alison Wearden, who is Reader in Psychology at the University of Manchester, Chair Elect of British Psychological Society's Division of Health Psychology and Associate Editor of British Journal of Health Psychology and whose studies include "Illness cognitions and diabetes - how the beliefs which patients hold about their diabetes impact on their attempts to manage it, their adjustment and well-being". Wearden was head of the FINE trials (click here) - a waste of taxpayers' money which resulted in nothing of value for people with ME.
BACME has a constitution to which members have to sign up. In this constitution, which BACME requires its members to support, it includes the following -
2.2 Objectives
2.2.1 To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the NICE guidelines
2.2.4 To support the delivery of services and to enable services to maintain standards of care in the treatment of CFS/ME as set out in the NICE guidelines
4. The Executive
4.1.4 The BACME Executive will invite no more than four people drawn from National UK CFS/ME organisations which explicitly support the aims and constitution of the organisation to sit on the Executive committee as either observers or members
Invest in ME rejected the NICE Guidelines and therefore cannot agree to endorse a constitution which lists among other things the above objectives.
Invest in ME endorse the critique set out by Twisk FNM, Maes M. in their review of CBT/GET in which they state
"So, it can be concluded that the efficacy claim for CBT/GET is false. But what is more important, is the fact that numerous studies support the thesis that exertion, and thus GET, can physically harm the majority of the ME/CFS patients.
This assertion is confirmed by the outcomes of two large patient surveys in the UK and Norway, and two smaller surveys in Scotland and the Netherlands."
(A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009 Aug 26;30(3):284-299.) click here
The NICE guidelines need complete revision as their current version is far from evidence-based.
The NICE guidelines have been shown to be ineffectual, biased, unusable, with ME patients eventually taking NICE to a judicial review.
For an organisation to support NICE, and require members to abide by them, let alone "champion" them illustrates a flawed and damaging basis for any claim to represent people with ME and their families. Such an organisation is likely to continue to force a continuing approach of going round in circles, obfuscating the true requirements for ME patients and achieving little of real value for people with ME and their families.
With BACME maintaining its present structure, current chairman and constitution then Invest in ME will decline any offer to apply for membership of this organisation.
It would be unethical of Invest in ME to sign up to such a constitution and Invest in ME's aim remains to find ways other than those set out in the NICE guidelines to treat patients diagnosed with ME according to the Canadian Clinical Consensus guidelines.
Further Reading:
Magical Medicine: How to Make a Disease Disappear - click here
Lightning Process - The Falsehood of Magical Medicine - IiME Newsletter March 2010 - click here
As you may have heard via the Christian Institute, or even on the news, the Christian owners of the Chymorvah Hotel in Marazion, Cornwall, Pete and Hazelmary Bull (who are friends of ours), are currently in the process of being sued by a gay couple for not allowing them to stay in a double room at their hotel. Pete and Hazelmary were recently interviewed by the Christian Broadcasting Network; to watch the video click on - http://www.cbn.com/cbnnews/world/2010/July/Gay-Couple-Sues-Bed-and-Breakfast-for-Moral-Stance/
July 2010
MSG Myth - http://www.msgmyth.com/ I recently came across another website that will be of help to those who already know that they have problems when eating anything containing monosodium glutamate, as well as for those who are currently looking for further information on the subject.
The front page of the website includes the following -
You have reached us because you or someone you care about is suffering from puzzling chronic conditions such as headaches, stomach disorders, fatigue, depression, and many other problems. Tests have come up negative and you want answers.
What you will find out at this time will most likely be the missing piece of the puzzle. What we discovered helped our family and thousands of others. Some skeptics will think, "It's too simple an explanation", but the truth is, most of us are suffering needlessly because of so-called "safe" food additives, namely excitatory neuro-transmitters (nicknamed excitotoxins). The main ones are monosodium glutamate (MSG), aspartame, and L-cysteine. You may think that you are actually avoiding MSG if you avoid Chinese restaurants, but this factory created flavor enhancer is in almost every bottled, bagged, frozen, or canned processed food on super market shelves. But since MSG is often a component of a formulation, it is not labeled as such. You've seen words like autolyzed yeast, hydrolyzed protein, and whey protein. Each of these substances contain a percentage of glutamate, the harmful component of MSG.
I didn't correlate my headaches and diarrhea to the food I was eating for years. Most of us don't because reactions to these excitatory substances can occur from ten minutes to 48 hours after ingestion. But when my 19 year old son began to develop debilitating headaches, my search for answers led me to the culprit: MSG. See if you suffer from any of these commonly reported symptoms and disorders.
Original Press Release from the Netherlands: FDA and NIH confirm 'XMRV findings'
Gendringen, NL (MMD Newswire) June 22, 2010 - The FDA and the NIH have independently confirmed the XMRV findings as published in Science, October last. This confirmation was issued by Dr. Harvey Alter of the NIH during a closed workshop on blood transfusion held on May 26-27 in Zagreb. Two journalists from the Dutch magazine for health professionals, ORTHO, who have been working on XMRV stories for several months, were able to obtain a copy of the Alter lecture.
In the October 8, 2009 issue of Science Express, the Lombardi-Mikovits group at the Whittemore Peterson Institute (WPI), the Cleveland Clinic and the National Cancer Institute (NCI) reported that 67% of 101 chronic fatigue syndrome (CFS) patients tested positive for infection with xenotropic murine retrovirus (XMRV). Only 3.7% of 218 healthy subjects tested were positive for this gammaretrovirus. Since that time, a number of research groups have proved unable to independently confirm these findings.
On Friday last, the AABB released an Association Bulletin recommending that its member blood collectors actively discourage potential donors who have been diagnosed with CFS from donating blood or blood components. This interim measure was proposed by the AABB Interorganizational Task Force on XMRV. This Task Force includes representatives from several government agencies, including the Center for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
The fact that the measure was introduced suggests the presence of information not yet published. The ORTHO journalists were able to obtain a pdf document of the lecture given by Harvey Alter at the IPFA/PEI 17th Workshop on 'Surveillance and screening of Blood Borne Pathogens' in Zagreb. The International Plasma Fractionation Association (IPFA) represents the not-for-profit organizations around the world involved in plasma fractionation. The IPFA is based in Amsterdam, the Netherlands.
The highly-experienced Dr. Harvey Alter is Clinical Studies Chief at the Infectious Diseases and Immunogenetics Section of the Department of Transfusion Medicine at the NIH Clinical Center in Bethesda. "The data in the Lombardi, et al Science manuscript are extremely strong and likely true, despite the controversy", was one comment on the XMRV findings reported by Alter in Zagreb. "Although blood transmission to humans has not been proved, it is probable. The association with CFS is very strong, but causality not proved. XMRV and related MLVs are in the donor supply with an early prevalence estimate of 3% to 7%. We (FDA & NIH) have independently confirmed the Lombardi group findings."
ORTHO contacted Dr. Harvey Alter today for a reaction. He did not want to comment, but confirmed that a paper is soon to be published.
ORTHO is a Dutch magazine for health professionals focusing on nutrition and dietary supplements. ORTHO has been publishing reports on CFS since 1988. Editor-in-chief: Gert E. Schuitemaker (PhD). Tel: / E-mail: ortho@orthoeurope.com
Callous Disregard: Autism and Vaccines - The Truth Behind A Tragedy by Dr Andrew Wakefield.
From the website -
The subject is autism; the suspect is childhood vaccines. This is the account of how a doctor confronted first a disease, and then the medical system that sought and still seeks to deny that disease, leaving millions of children to suffer and a world at risk.
In 1995 Wakefield came to a fork in the road. As an academic gastroenterologist at the Royal Free School of Medicine and the University of London, Wakefield was presented with a professional challenge and confronted by a moral choice. Previously normal children were, according to their parents, regressing into autism and developing intestinal problems - many parents blamed the MMR vaccine. Trusting in his medical training, parental narrative, and above all, the instinct of mothers for their children’s wellbeing, he chose the hard road.
Walk that road now, here; some already have - the parents of affected children. Many will, either as parents or grandparents, as the worldwide tsunami of childhood developmental disorders break hearts and bankrupts educational and healthcare infrastructures.
Wakefield provides the facts, an explanation of the problem that confronted him and his colleagues 15 years ago. He does this in a detailed forensic analysis of the lies, obfuscation, cover ups, and the dystopian science and medicine that panders to commercial interest at the expense of your children.
The above article by Sarah Boseley appeared in the Guardian newspaper on Thursday 13th May to mark M.E. awareness week. Malcolm Hooper has written a response to the article, pointing out a couple of inaccuracies in it; his response can be found at - http://www.meactionuk.org.uk/Boseley-response-final.htm
Second Opinions, Exposing Dietary Misinformation, is the website of Dr Barry Groves, author of books such as "Trick and Treat - How 'healthy eating' is making us ill" and "Natural Health and Weight Loss". Much of what is said on the website is the opposite to what we are told via the media, but it is certainly worth reading and thinking about!
Please help us in raising funds for biomedical research and for performing activities related to biomedical research. By buying an Invest in M.E. wristband you will be helping IiME in its work as well as promoting the message that biomedical research into M.E. is the only way to make real progress in finding treatments and cures for this illness.
Sell them to friends, family, work colleagues - even in your local library, GP surgery or hospital.
Funds raised will be used for the following -
Biomedical Research into M.E.
Education Regarding M.E.
Conferences related to M.E.
Expenses in Sponsoring Presenters to Speak at Conferences
Cost of sponsoring PhD students performing biomedical research into M.E.
Set up and running of M.E. Clinic treating severely affected patients with M.E.
Assisting with equipment and other costs of researchers performing purely biomedical research into M.E.
The 5th Invest in M.E. conference is due to take place on Monday 24th May. It has as it's slogan "A New Era of ME/CFS research" and as it's theme "Education of healthcare staff in ME/CFS". The line up of speakers this year includes Prof Leonard Jason, Dr John Chia, Dr Paul Cheney, Dr Jonathan Kerr, Dr Nancy Klimas and Dr Judy Mikovits, with Prof Malcolm Hooper as conference chairman.
The number of weeks in the time from 8th February 1991 until the 9th April 2010 is one thousand. Why the interest in one thousand weeks? It was at the start of those one thousand weeks, on Friday 8th February 1991, that my illness started. It is also the title of an article I have written looking back over those one thousand weeks. To read more, please click on the link above.
For it's School of Theology from 6th - 8th July this year, the Metropolitan Tabernacle has as the theme "Winning and Keeping Souls from the World". I have wanted to attend this annual event for some years but with being housebound I am simply unable to do so. However, recordings of all the talks can be purchased afterwards on CDs and DVDs. For further details, click on the link above for the PDF brochure.
To: Professor Malcolm Hooper
2 Nursery Close
Sunderland
SR3 1PA
02 March 2010
Dear Malcolm,
Thank you for your letter and for enclosing "Magical Medicine: How to Make Disease Disappear".
You are obviously aware that NICE has, in the recent past, been involved in defending an action for Judicial Review over the ME/CFS guideline we published a couple of years ago. Although judge found in favour of the Institute the legal costs were considerable. I am afraid, therefore, that I am not prepared to enter into any correspondence on this matter.
From: Malcolm Hooper Ph.D.,B.Pharm.,C.Chem.,MRIC
Emeritus Professor of Medicinal Chemistry
School of Sciences
Fleming Building
Wharncliffe Street
University of Sunderland
SUNDERLAND SR2 3SD
Thank you for your letter and the returned copy of Magical Medicine which I found very disappointing and disconcerting.
To be faced, yet again, with the denial and dismissal of the comprehensive amount of biomedical evidence about ME that has been presented in some 5000 published and peer-reviewed papers is disturbing and has sinister connotations devoid of any compassion.
Failure to consider this evidence means that any policy towards people with ME will be "built upon sand" in defiance of the basic principles of scientific inquiry and any consideration for very sick people, their families and carers
As a fellow medical scientist I find the continuing denial and unwillingness to face the biomedical evidence both puzzling and incomprehensible.
We know Government is committed to funding research that is perceived to support policy, an attitude that has, in this case, lead to lack of scientific rigour, integrity and humanity in order to avoid developing a policy based on the biomedical evidence available in this complex and difficult area of medicine.
I am a ‘blast from your past’. I was at Sunderland School of Pharmacy and you were at Newcastle in Clinical Pharmacology when the M.Pharm course in Pharmacokinetics was developed. Congratulations on your eminent status and knighthood.
Since 1997, when I retired as Professor of Medicinal Chemistry, I have been involved with the emerging and widespread complex chronic multi-system illnesses (Gulf War Syndrome/Illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, ME/CFS, multiple chemical sensitivity, MCS, Aerotoxic Syndrome, organophosphate and other pesticide poisonings) that are of growing concern and are medically challenging - writing and lecturing, locally, nationally and internationally.
This letter is linked to my concerns about ME which involves some 240,000 people in the UK with varying degress of disability. Some 25% are housebound or bed bound and have formed their own group, www.25megroup.org/.
The 442 page report “Magical Medicine, how to make a disease disappear”, copy attached with the press release, together with a copy of my letter to the Minister, Lord Drayson, currently the Minister responsible for the MRC, brings together an extensive and fully referenced review of the literature on ME.
It provides the evidence supporting my complaint about the MRC PACE Trial to Lord Drayson.
The entire report, the press release and the letter of complaint have now been circulated worldwide on the internet and have received much acclaim and support from the major ME organisations in various countries and numerous individuals, as well as academic institutions. The report is to be discussed by the International Association of CFS/ME at its next board meeting in early March, as confirmed by the President, Professor Fred Friedberg from the US.
Despite the vast amount of biomedical literature (some 5000 papers) going back to 1934 and the classification of ME as a neurological illness by the WHO (ICD-10 G93.3) since 1969, the official UK attitudes as demonstrated by the MRC, DWP, Department of Health, and to some extent your own organisation NICE:
a.ignore all this evidence
b.show an ideological commitment to a psychosomatic/behavioural model of the illness which is no longer tenable
c.recommend only cognitive restructuring techniques (CBT and GET) that are "not remotely curative" and have been shown to be of no lasting value and in the case of GET to be positively harmful (Peter White's assertion that this is because the interventions have been incorrectly administered has been shown to lack credibility)
d.proscribe any investigative tests to identify the disorder, leading to missed diagnoses and misdiagnosies
e.support cruel, even vicious, actions that lead to patients being wrongly sectioned and parents, particularly mothers, accused of Munchausens’-Syndrome-by-Proxy, MSBP.
f. the result is that essential benefits and insurance payments to support patients and their families have not been paid or have been granted only after protracted and expensive legal action. All this adds to the burden of the illness for patients and for those who care for them.
The psychiatrists’ argument that what they refer to as “CFS/ME” is substantially different from past epidemics of ME does not withstand scrutiny in the light of current knowledge. It is beyond question that ME is associated with a severely disrupted immune system which renders patients more susceptible to both further viral and chemical challenge and reactivation of latent viruses and persistent viral-specific symptoms.
For the psychiatrists to amalgamate 25 different disorders (Holgate, RSM July 2009) and to focus on “medically unexplained fatigue” whilst ignoring cardinal symptoms of ME is a travesty of medical science.
Of special concern and relevance are the legal and ethical requirements facing doctors today, in particular, the legal requirement for doctors to keep up to date with developments in medicine and medical science (as clearly set out in “Good Medical Practice: Duties of a doctor. The duties of a doctor registered with the General Medical Council: 'Keep your professional knowledge and skills up to date' and 'Never abuse your patients' trust in you or the public's trust in the profession' (http://www.gmc-uk.org/guidance/good_medical_practice/duties_of_a_doctor.asp).
Ignoring vast swathes of evidence is not keeping up to date. For any registered medical practitioner – consultant or GP - to dismiss or ignore this widely available evidence which invalidates the behavioural model of “CFS/ME”, together with the prescription of inappropriate interventions, is in clear breach of the GMC regulations and consequently raises issues of medical indemnity.
As noted in the report: “since the general body of knowledge known about by other clinicians and researchers working in the field of ME/CFS is now so great, the question repeatedly asked is: at what point will that body of scientific knowledge be so great that it will be considered serious professional misconduct to ignore it and to continue to deceive patients by pretending that it does not exist?”.
The recommendation not to carry out appropriate investigative tests is inconsistent with the Hippocratic Oath in its ancient or modern form.
The offering of treatment that is known even by its proponents to be ineffective is a betrayal of doctors’ responsibility to their patients. Merely to pronounce that the onus is on the individual doctor, when adherence to NICE Guidelines is to become compulsory, is unacceptable.
Inappropriate sectioning of patients and false diagnoses such as MSBP represents a further betrayal.
To rely on only a few studies, showing very modest efficacy, all of which having been shown to have very serious flaws (as is the case with the PACE Trial) and enshrine this inadequate information in official directions, publications and statements from authorised bodies, including NICE, is utterly unacceptable and dishonours the name of medicine as well as being destructive of lives of sick people and those who care for them.
I draw to your attention the commissioned editorial in last week’s BMJ by Alistair Santhouse, who you will be aware was a member of the CG53 GDG. Please read the attached eBMJ response submitted by Horace Reid, a former long-serving NHS clinician. It was rejected for publication, a fact that is revealing in itself, given that it is impeccably accurate.
I would ask you in your role as Chairman of NICE to engage fully with our report and act accordingly to right the long standing wrongs that people with ME have suffered for the last 20 years.
A formal complaint has been lodged by Professor Malcolm Hooper with the Rt. Hon The Lord Drayson, Minister of State with responsibility for the Medical Research Council (Science and Innovation) about the "PACE" Clinical Trial of behavioural modification interventions for people with Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS).
PACE is the acronym for Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation, interventions that, according to one of the Principal Investigators, are without theoretical foundation.
The MRC's PACE Trial seemingly inhabits a unique and unenviable position in the history of medicine. It is believed to be the first and only clinical trial that patients and the charities that support them have tried to stop before a single patient could be recruited and is the only clinical trial that the Department for Work and Pensions (DWP) has ever funded.
Since 1993, the giant US permanent health insurance company UNUMProvident has been advising the UK DWP about the most effective ways of curtailing sickness benefit payments. The PACE Trial is run by psychiatrists of the Wessely School, most of whom work for the medical and permanent health insurance industry, including UNUMProvident. These psychiatrists insist - in defiance of both the World Health Organisation and the significant biomedical evidence about the nature of it - that "CFS/ME" is a behavioural disorder, into which they have subsumed ME, a classified neurological disorder whose separate existence they deny. Their beliefs have been repudiated in writing by the World Health Organisation.
In 1992, the Wessely School gave directions that in cases of ME/CFS, the first duty of the doctor is to avoid legitimisation of symptoms; in 1994, ME was described by Professor Simon Wessely as merely "a belief"; in 1996 recommendations were made that no investigations should be performed to confirm the diagnosis and in 1999 patients with ME/CFS were referred to as "the undeserving sick".
The complaint is supported by a 442 page Report which addresses areas of major concern about the PACE Trial.
These include apparent coercion and exploitation of patients, flawed methodology, apparent lack of scientific rigour, apparent failure to adhere to the Declaration of Helsinki, the unusual personal financial interest of the Chief Investigator, the vested financial interests of the Principal Investigators and others involved with the trial and the underlying non-clinical purpose of the trial.
The psychiatrists' unproven beliefs and assumptions are presented as fact and trial therapists have been trained to provide participants with misinformation; therapists have also been trained to advise participants to ignore symptoms, a situation that may in some cases result in death.
There are some extremely disquieting issues surrounding the MRC PACE Trial and documents obtained under the Freedom of Information Act allow the full story to be told for the first time.
People with ME/CFS do not seek any special consideration; they simply wish to be treated equally to those who suffer from other classified neurological disorders. As shown in the Report that accompanies the complaint, the MRC PACE Trial clearly demonstrates that people with ME/CFS are not treated equally to those with other chronic neurological disorders.
Letter of complaint to the Rt Hon The Lord Drayson
Professor Malcolm Hooper Ph.D.,B.Pharm.,C.Chem.,MRIC
Sunderland SR3
11th February 2010
The Rt Hon The Lord Drayson
Minister of State (Science and Innovation)
1, Victoria Street
London
SW1H 0ET
Dear Minister
re: Complaint about the Medical Research Council
It is with deep concern that I lodge this formal complaint about the Medical Research Council with you in your capacity as Minister with responsibility for the MRC.
You will doubtless be aware of the serious problems at the MRC that were documented in the 2003 Report of the House of Commons Select Committee on Science and Technology (HC 132) in which MPs issued a damning judgment on the MRC, lambasting it for wasting funds and for introducing misguided strategies for its research. MPs found evidence of poor planning and of focusing on “politically-driven” projects that have diverted money away from top-quality proposals. The unprecedented attack was the result of a detailed probe into the workings of the MRC.
Sadly, very serious problems continue to exist at the MRC, with disastrous results for patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
The attached 442 page Report addresses the background to the MRC “PACE” Trial on “CFS/ME”, the biomedical evidence that disproves the assumptions of the MRC trial Principal Investigators, the many extremely disturbing issues surrounding the PACE Trial, and illustrations from the Manuals used in the trial.
The unproven beliefs and assumptions of the MRC Investigators are presented as fact; trial therapists have been trained to provide participants with misinformation, and therapists have also been trained to advise participants to ignore symptoms arising from the interventions, a situation that may in some cases result in death.
Patients with ME/CFS do not seek any special consideration; they simply wish to be treated equally to those with other classified neurological disorders. As shown in the commissioned Report that accompanies this complaint (a bound copy of which will follow), the MRC Trial clearly demonstrates that people with ME/CFS are not treated equally to those with other chronic neurological disorders.
Given the long-standing recognition that at least one of the interventions used in the trial is contra-indicated for people with ME/CFS, an intervention that is already known to have adverse effects on 50% of those who have already undertaken it, there is international concern about the MRC PACE Trial.
I urge you to read the attached Report and to respond to it with due attention and alacrity. You may wish to know that the Report is already on international academic websites.
This new book by Dr E S Williams looks at the increasingly popular Christian counselling movement which has spread throughout many churches in the UK. The book examines the ideas and assumptions behind the counselling movement, addressing two questions: Is counselling, as practised by the Christian counselling movement, a legitimate part of Christian ministry? Does the church benefit from integrating psychological truth and Scripture? I would recommend this book; it will certainly be an eye-opener for some.
You may have seen in the media reports of a study carried out in the UK which appears to cast doubt on the research published in October last year that found evidence of the XMRV retrovirus in ME patients. The UK study has already been criticised by many, including those who carried out the original research at the Whittemore Peterson Institute in the USA. They have released a press statement as follows -
Official Statement from the Whittemore Peterson Institute Regarding UK Study
The Whittemore Peterson Institute (WPI) has reviewed the paper entitled “Failure to Detect the Novel Retrovirus XMRV in Chronic Fatigue Syndrome.” This study did not duplicate the rigorous scientific techniques used by WPI, the National Cancer Institute and the Cleveland Clinic, therefore it cannot be considered a replication study nor can the results claim to be anything other than a failure not just to detect XMRV, but also a failure to suggest meaningful results.
The scientific methods used by WPI are very exact and require specific techniques to ensure accuracy. Differences in techniques employed by Erlwein et al. not only explain their failure to replicate the WPI study, but also render the conclusions meaningless. These differences include, but are not limited to the following:
1) blood sample volumes and processing;
2) patient criteria/population differences;
3) number and type of tests done to assure accurate results, including white blood cell culture;
4) use of a molecular plasmid control in water versus a positive blood sample; and
5) different primer sequences and amplification protocol used to find the virus, which were not validated by a clinical control.
The WPI study was published after six months of rigorous review and three independent lab confirmations, proving that contamination had not taken place and that infectious XMRV was present in 67 percent of CFS patients diagnosed according to the Canadian and Fukuda criteria. In contrast, this latest study was published online after only three days of review. Significant and critical questions remain as to the status of patient samples used in the UK study as those samples may have been confused with fatigued psychiatric patients, since the UK has relegated “CFS” patients to psychiatric care and not traditional medical practices.
“Little is known about the prevalence of XMRV world-wide, much less the incidence of XMRV in ME/CFS or prostate cancer” emphasizes Dr. Judy Mikovits. “WPI and its NCI collaborators are actively engaged with international research teams to investigate these important questions.”
WPI does not recommend the use of anti-retroviral drugs that have yet to be proven to be effective in treating XMRV infection. However, several large pharmaceutical companies have expressed interest in developing anti-retroviral and immune modulating drugs that will effectively treat XMRV associated diseases.
WPI looks forward to the results of other scientific groups around the world, serious about replicating its scientific results, by using the same techniques as WPI and its collaborators. The fact that XMRV was detected in 67 percent of the CFS samples in the U.S. study determined a significant association between XMRV and CFS, demanding a much more serious inquiry by responsible health agencies around the world as to the cause of this debilitating disease.
Whittemore Peterson Institute
The Whittemore Peterson Institute for Neuro-Immune Disease exists to bring discovery, knowledge, and effective treatments to patients with illnesses that are caused by acquired dysregulation of the immune system and the nervous system, often results in lifelong disease and disability. The WPI is the first institute in the world dedicated to X associated neuro-immune disease (XAND), and other X associated diseases, integrating patient treatment, basic and clinical research and medical education.
Notice from Prof Malcolm Hooper and Margaret Williams, both of whom are well know in the ME World (you can access many of their documents on the MEActionUK website http://www.meactionuk.org.uk/) -
Prior to the publication of the MRC PACE Trial results in the Spring of 2010, Professor Malcolm Hooper and Margaret Williams will be releasing a series of linked documents addressing central flaws in the PACE Trial.
These documents form part of a more substantial document that has the provisional title Magical Medicine: How to make a disease disappear.
This webpage will contain an easily accessible Contents page so that people can surf and then select whatever section (or part of a section) they may wish to look at.
Although he and Margaret Williams have previously addressed some of the issues contained in the substantial document, Professor Hooper thinks it is essential for there to be a single, comprehensive narrative of events and information leading up to and involving the PACE Trial.
Following on from the disappointment of the unsuccessful Judicial Review brought in February by two ME sufferers against NICE (see further articles listed at the bottom of this page), the above article by Margaret Williams contains statements that were provided by ME experts to the lawyers but which were sadly not used during the JR. They clearly provide further evidence that the usual recommendations of Graded Exercise Therapy and Cognitive Behavioural Therapy are at best unhelpful and can be positively harmful for those suffering from ME, a neurological disorder.
December 2009
Wedding photos!
On Thursday 26th November my brother Tim married Lois. I was not well enough to be at the wedding, but was kept up-to-date with all that happened via phone calls, text messages and email. If you would like to see some wedding photos please go to my blog at http://oneagleswingsme.blogspot.com/
"A review on Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)" by Frank Twisk and Dr Michael Maes. This review shows that CBT/GET is not only ineffective and not evidence-based but also potentially harmful for many patients with ME/CFS. Click on the above link on the Invest in ME website for further details.
The CFIDS Association of America have a write-up on their website of the recent research regarding the XMRV virus, including a links to a number of related articles.
Following the news of the recent discovery of the XMRV retrovirus the European ME Alliance wish to issue this statement -
"The European ME Alliance (EMEA) wish to congratulate the Whittemore-Peterson Institute for the painstaking, professional and groundbreaking work which its staff have performed, along with the National Cancer Institute and the Cleveland Clinic, which has resulted in the publication of the findings of a novel virus XMRV in causing or influencing ME.
"The members of EMEA recognise that the staff at WPI are performing research of the highest quality.
"The publication of this research in Science magazine is itself an amazing achievement.
"This work has been achieved in an amazingly short period of time and the tenacity, dedication and sheer excellence of the WPI has brought hope to millions of people, patients, carers and friends, in Europe and further afield.
"EMEA announces its continued full support for WPI and hopes to be able to become a stronger partner in the future."
Signed by all members of the European ME Alliance -
Belgium ME/CFS Association (Nieuwrode, Belgium)
Denmark ME-NetDK
Ireland Irish ME Trust
Germany Fatigatio e.V.
Norway Norges ME-forening
Spain Liga SFC
Sweden Riksföreningen för ME-patienter
UK Invest in ME
9th October 2009
Retrovirus associated with ME
This encouraging research news has broken in the last 24 hours; apart from anything else, it further shows how mistaken it is to offer psychological "treatments" such as Graded Exercise Therapy and Cognitive Behavioural Therapy to those with ME! There is a lot of information about the research available on the internet already, with links to many of the articles on the following website which states - http://www.meactionuk.org.uk/XMRV_News.html "News and scientific websites are publishing details of a groundbreaking scientific research study that for the first time links a normally dormant retrovirus called XMRV to patients with a diagnosis of Chronic Fatigue Syndrome or Myalgic Encephalomyelitis. This virus is also related to a subset of patients with Prostate Cancer. You can read an overview of XMRV in relation to CFS/ME here. "
Much of the research is linked with the Whittemore Peterson Institute (WPI) in the USA. Their press release, which includes the following, can be found at -
WPI Press release http://www.wpinstitute.org/xmrv/docs/wpi_pressrel_100809.pdf
Whittemore Peterson Institute Scientists Discover Significant link between XMRV and ME/CFS
"RENO, NV – A recently identified retrovirus called XMRV has been linked to a debilitating neuroimmune disease that affects more than one million people in the United States.
"Scientists from the Whittemore Peterson Institute (WPI), located at the University of Nevada, Reno, and their collaborators from the National Cancer Institute and the Cleveland Clinic, have discovered a retroviral link to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). "
XMRV research http://wpinstitute.org/xmrv/index.html
Overview
"The spectrum of neuro-immune diseases including: Myalgic Encephalomyelitis (ME/CFS), Atypical MS, Fibromyalgia and Gulf War Syndrome, share common abnormalities in the innate immune response inc, which result in chronic immune activation and immune deficiency.
"We have detected the retroviral infection XMRV is greater than 95% of the more than 200 ME/CFS, Fibromylagia, Atypical MS patients tested. The current working hypothesis is that XMRV infection of B, T, NK and other cells of the innate immune response causes the chronic inflammation and immune deficiency resulting in an inability to mount an effective immune response to opportunistic infections.
"This discovery opens an entire new avenue of Neuro-Immune Disease related research and our discovery has brought to this field world-renown immunologists and retrovirologists building our team of collaborators to translate our discoveries into new treatments as soon as possible.
"Because retroviruses are known to cause inflammatory diseases, neurological disease immune deficiency and cancer the discovery of XMRV has far reaching implications for the prevention and treatment of not only lymphoma, one of the potentially devastating complications of ME/CFS but prostate cancer and perhaps many others.
"As National Academy of Sciences member and expert retrovirologist, John Coffin wrote in the commentary accompanying our landmark publication in Science "One New Virus-How many Old Diseases". We look forward to translating this discovery into treatment options!" The WPI has also put together a webpage of questions and answers about the research at: http://wpinstitute.org/xmrv/xmrv_qa.html One of the questions is as follows -
Question:
"Does this latest information prove once and for all that ME/CFS is not a psychological or psychosomatic illness as described by those who don't understand the disease?
Answer:
"Absolutely! Actually, there are thousands of research articles showing the very real biological problems that ME/CFS patient's experience such as low NK cell count and function, MRI and SPEC scan changes, and repeated chronic infections, to mention just a few. Only the most stubborn and misinformed individuals refuse to believe that this disease is real and serious. The process of placing poorly understood illnesses into a psychological category is very similar to what happened in the early days of MS and epilepsy before the advent of technologies which proved the illnesses were "real." Unfortunately, many in the scientific and medical fields have not learned from their past mistakes."
Set up earlier this year, the Mission of European Society for M.E. states:
"Our mission is to create a Think Tank where top scientists from relevant fields can discuss current M.E. knowledge in order to determine the most crucial direction of future research, and to provide a reliable source of cutting-edge M.E. information that E.S.M.E. will incorporate in the education of medical professionals."
Statement from E.S.M.E. - http://esme-eu.com/home/statement-from-esme-european-society-for-me-article52-6.html
More Biomedical Research Needed
"M.E./C.F.S. (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) is a physical disease. It is not a product of the patients’ imagination and is not a psychological problem. Funds have been used for research into the hypothetical psychiatric nature of the disease at the expense of biomedical research. Future research needs to be interdisciplinary and focused on the causes, early diagnosis and treatment of M.E./C.F.S.
"The British National Health Service has published N.I.C.E. guidelines for this disorder which, according to E.S.M.E., are not helpful and might even induce relapse in some cases.
"E.S.M.E. will encourage research leading to the accumulation of new knowledge and to a better understanding of the disease, and will endeavour to raise funding for biomedical research in, and education about, M.E./C.F.S."
An article by Dr Peter Masters "The Cycle of Grace: Pressures – Prayer – Encouragement - Thanksgiving". Taken from the Sword and Trowel, issue No 1 2008.
The Sword and Trowel, a Christian magazine, was started by C H Spurgeon in 1865 and is still going strong today. It is designed to "stress the doctrines of grace coupled with the need for vigorous evangelism". I would recommend the following articles from the recent Sword and Trowel magazine, issue No 1 2009 -
This Christian website, which I have only recently come across, contains numerous articles, audio and video files. Run by a former Roman Catholic priest, the Berean Beacon, as it says on the site, is "primarily an evangelistic ministry promoting the Gospel of Jesus Christ wherever possible. The ministry places particular emphasis on the evangelization and conversion of Catholics. The other main thrust of the ministry is to inform evangelical Christians about Catholicism through speaking engagements, distribution of literature, tapes, CDs, and DVDs".
I would recommend this new book by Canadian M.E. expert Dr Byron Hyde. He gives information about the differences between M.E. and C.F.S., as well as looking at tests that can be done which show up some of the physical abnormalities that exist in M.E. patients. The book includes the Nightingale Definition of M.E.
The Invest in M.E. organisation ran a conference in May of this year, "Management, Treatments and Latest Advances in Research into M.E./C.F.S". The speakers, who came from a number of countries, included Mrs Annette Whittemore, Prof Garth Nicolson, Dr Jonathan Kerr, Dr Barbara Baugarten, Dr John Chia, Prof Kenny De Meirleir, Prof Harald Nyland, Dr Daniel Peterson, Dr Judy Mikovits and Prof Basant Puri - most of those names being familiar to many in the M.E. World. The talks were all recorded and are available on DVD.
July 2009
Judicial Review of the NICE Guideline on C.F.S./M.E. In February of this year two M.E. sufferers brought a Judicial Review against the Guideline on "C.F.S./M.E." produced in August 2007 by the National Institute for Health and Clinical Excellence (N.I.C.E.). The Judicial Review was not successful, but some of the documents provided by the two claimants for their lawyers are available to read online and may be of interest and help to those with M.E., their families and friends. Some of those documents are as follows -
Evidence that the Guideline Development Group that produced the NICE Guideline on CFS/ME (CG53) failed to fulfil its remit (particularly in relation to the potential dangers of graded exercise therapy) http://www.meactionuk.org.uk/FACTS_re_GET.htm
Immunological, neuroendocrine and neurological evidence (including evidence of CNS inflammation) documented in ME/CFS that NICE chose to ignore in the production of its Clinical Guideline 53 http://www.meactionuk.org.uk/Immunol_and_neuroendo.htm
This new book by Dr E S Williams looks at the increasingly popular Christian counselling movement which has spread throughout many churches in the UK. The book examines the ideas and assumptions behind the counselling movement, addressing two questions: Is counselling, as practised by the Christian counselling movement, a legitimate part of Christian ministry? Does the church benefit from integrating psychological truth and Scripture? I would recommend this book; it will certainly be an eye-opener for some. 