HL Deb 18 November 2004 vol 666 cc211-3WA
The Countess of Mar

asked Her Majesty's Government:

Whether they will give an assurance that patients who are to take part in the Medical Research Council PACE trials on chronic fatigue syndrome (CFS), myalgic encephalomyelitis (ME) and fibromyalgia (FM), or who are to be referred to any of the centres for CFS, ME or FM, will not, as a consequence of the psychiatric intervention involved, suffer a foreseeable deterioration in their medical condition; and [HL4829]

Whether patients who enrol for the Medical Research Council PACE trials are required to sign a statement giving consent and waiving their rights to sue for damages should any harm flow from the graded exercise component of the trials. [HL4830]

Lord Sainsbury of Turville

The Medical Research Council-funded PACE trial is designed to test treatments for patients who have CFS/ME. Patients with fibromyalgia alone would be excluded unless they also have CFS/ME. The treatments being tested are not primarily psychiatric treatments, with the arguable exception of cognitive behaviour therapy, which is a form of rehabilitative psychotherapy. None of the treatments being tested is likely to cause "a foreseeable deterioration in their medical condition", and were designed with the opposite effect in mind.

In common with all clinical trials, all patients recruited to the PACE trial will receive detailed patient information literature and will sign a consent form to confirm that they understand the full details and implications involved in taking part in the trial. Because the trial participants will have provided informed consent, they will receive no compensation if they become more ill (whether or not as a result of the particular treatment). However, they would retain the right to sue for negligent damage.

As with any trial, it is accepted that some people may not respond to the treatment(s), or may indeed become iller (whether or not as a consequence of the treatment). If patients do get worse, they will be reassessed earlier than planned in collaboration with their own specialist and general practitioner. A decision will be made by the patient and the doctor as to whether they should stay on their study treatment (or not), and what further help should be given.

An independent data monitoring and ethics committee will closely monitor progress of the study, including any adverse events that may occur and have the power to advise the independent trial steering committee to change or stop the study if necessary.

The new specialist centres will offer patients a multidisciplinary based approach to the treatment of their illness. It will be for the clinicians involved to decide what treatment to offer patients referred to them. Their decision will be taken in consultation with the patient, will be informed by the patient's medical history, and will take account of a range of factors, including the ability of the patient to benefit from the treatment proposed.