12th February 2010
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.
The Report can be accessed at http://www.meactionuk.org.uk/magical-medicine.pdf
File Size 6Mb Adobe Acrobat format
(Please see also: http://www.meactionuk.org.uk/magical-medicine.htm and http://magical-medicine.blogspot.com/)
Letter of complaint to the Rt Hon The Lord Drayson
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.