PACE Trial: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Baroness Meacher Excerpts

Wednesday 6th February 2013 Grand Committee

[Baroness Meacher]

My Lords, I thank my noble friend Lady Mar for tabling this Question for Short Debate concerning the PACE trial. I must declare an interest as former chair of East London NHS Foundation Trust. Professor White, a leading researcher in the PACE trial, works as a consultant in that trust in addition to his research post at Queen Mary, University of London.

CFS/ME can be a seriously disabling syndrome. I like to refer to it as a syndrome because it seems to be not one but a number of diseases. NICE compares the physical symptoms of CFS/ME with those of multiple sclerosis, systemic lupus erythematosus—if I can pronounce that correctly—and rheumatoid arthritis, probably three of the most fearsome illnesses one can think of. To make matters worse for sufferers, as the noble Lord, Lord Alderdice, so rightly said, the causes and disease processes of CFS/ME are not yet understood. That must be a deeply frightening thing for any patient.

Doctors can misdiagnose sufferers or, worse still, dismiss them as not really physically ill at all. I understand that for some, some psychological aspects may be important and for others they may not. I am aware of people who have had major viruses and suddenly been struck down, having led very active lives, getting on with things and being fine. We have to be very careful about any assumptions, whether physical, psychological or whatever.

CFS/ME is all too real. Of course we need much more research. I await the outcome of Professor White’s cytokine research later this year, for example. We look to the MRC and others to prioritise this distressing syndrome. Thankfully, the MRC has two boards—it probably has others, too. One funds studies such as PACE and the other funds studies into the immune system, and viral and genetic considerations. The PACE study did not in any way affect funding for organic CFS/ME research. That is terribly important because there are fears that it may have done.

As the noble Lord said, the experts believe that in time a number of distinct diseases will be identified that currently fall within the CFS/ME label. In the mean time, NICE recommends CBT and/or graded exercise therapy for people with mild or moderate CFS/ME because these are the interventions for which there is the clearest evidence of benefit to patients. No doubt in time treatments that attack the causes and achieve better and faster results will be developed but in the mean time it is a great step forward that, as in the PACE trial, 22% of patients recover—I agree that there is debate about the word “recovery”—after only 13 sessions of CBT or graded exercise.

Meanwhile, 60% of patients achieve significant improvements in both fatigue and exercise levels after the same period, according to the PACE study, which certainly fits with my experience of the limited number of people—about half a dozen—who I know. A meta-analysis showed a 50% recovery rate after one year. These results are very significantly better than spontaneous recovery rates or those following alternative available treatments. From our most helpful discussion on Monday, I understand that my noble friend Lady Mar respects the PACE study but, very reasonably in my view, has grave concerns about the spin put upon the results. People have to be very careful. We all know what happens once things get into the media but the spin that is put on these things is really important for patients. Things can be very hurtful.

I understand that the DWP may treat people as workshy if they have not undergone a CBT/GET treatment regime. At least a quarter of PCT areas do not have any specialist services for these patients. Others have nothing but grossly inadequate services at a pathetic level. It is essential that the DWP and, indeed, insurance companies take account of the non-availability of such services in many areas. Will the Minister pass on this concern to the noble Lord, Lord Freud? The DWP also needs to be aware that CFS/ME patients can take time to improve. I am not an expert but out of the people I know, several have needed much longer than one year to recover acceptable levels of functioning.

In terms of returning to work, the PACE trial had no effect whatever on the numbers of CFS/ME patients in work. I would not expect it to have done. These people have been, on average, out of work for two and a half years before they entered the trial, and from all the work that numbers of us have done over many years, we know that it is incredibly difficult to get people back into work if they have been out of work for two and a half or three and a half years. However, the social care costs and the need for family support were reduced. People were much better—not necessarily completely better but an awful lot of them were much better.

I now want to address a few other issues arising from the PACE study, including the fact that 10% of patients deteriorated during the trial. I understand that all these deteriorations resulted from life events or other infections during the trial period. We know well that serious life events or further infections do—or can—cause relapses in this horrible set of illnesses or this syndrome. Secondly, there is the question of whether ME patients benefited from the PACE trial. I am reliably informed that 51% of the patients in the PACE trial had been defined as having ME. I know there are all sorts of debates about that definition, but there was no significant difference in the outcome of treatment for patients who had been deemed to be suffering from ME relative to patients who had been given the CFS label.

Concerns have been expressed about the 11 serious adverse reactions to treatment. The 10 “possible” adverse reactions were equally distributed across the four treatment types. There is no indication that CBT or GET caused any problems. There was one “probable” serious adverse reaction, which was in the medical treatment group and was a reaction to an anti-depressant. Some of us are very familiar with the fact that people can have reactions to anti-depressants, but there is no evidence that CBT or GET can be dangerous.

The PACE trial is the largest ever trial of treatments of this debilitating set of conditions and has received acclaim from clinicians and scientists across the world. Some have wanted to criticise it for changes to the protocol, but those were made before the analysis and were approved by the independent trial steering committee; they were not fixes. The changes were minor and did not affect the results or conclusions in any significant way. Any potential conflicts of interest were published alongside all the papers, and none applied to the statisticians who did the analysis.

It is very encouraging that the Association of Young People with ME accepts that the NICE guidelines are useful for patients and healthcare practitioners. They are right. In conclusion, will the Minister give the Committee an assurance that the Commissioning Board will, in future, give equal priority to the specialist services needed for CFS/ME to that which they give for rheumatoid arthritis and MS?