Date: Sat May 15, 2004 10:10 pm Subject: The FINE Experience Courtesy of Dr. Alison Wearden - An ME/CFS Patient Speaks PERMISSION TO REPOST The FINE Experience Courtesy of Dr. Alison Wearden - An ME/CFS Patient Speaks -------------------------------------------------------------- Dr. Alison Wearden has written today to The Independent national newspaper UK in defence of these psychosocial PACE and FINE trials. ME/CFS patients have experienced the so-called 'treatments' offered by Dr. Wearden and her colleagues before and published on One Click and Co-Cure on the 9 January 2004. Please see the story of one brave young woman treated by Dr. Wearden. This is what Dr. Wearden and her team did to her. This is what Dr. Wearden and her colleagues want to do to you. Read on. Jane Bryant THE ONE CLICK GROUP http://health.groups.yahoo.com/group/THEONECLICKPROTEST/ 15 May 2004 ---------------------------------------------------------------------- 9 JANUARY 2004 Published in Message No. 1277 in The One Click Group Archives and available at: http://listserv.nodak.edu/scripts/wa.exe?A2=ind0401B&L=co-cure&P=R6916 The FINE / Wearden Experience ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Funded Once More By The Medical Research Council (UK) ------------------------------------------------------ FOR INTERNET PUBLICATION ONLY A young person has written to me and asked me to publish their verbatim account of what happened to them and what they endured at the hands of a FINE trial carried out in Manchester in the 1990's. This person is a young adult who has been ill for 14 years. They have asked to remain anonymous for significant personal and legal reasons. New FINE trials are soon to be carried out the UK under the auspices of the Medical Research Council UK. These will cost over £1,000,000. FINE stands for Fatigue Intervention by Nurses Evaluation and will be headed by Dr. Alison Wearden at the University of Manchester. This is the same woman who treated the young ME sufferer whose Case History is below. FINE: "The approach involves helping patients to understand the symptoms they are experiencing and working together to agree a plan of rehabilitation." http://www.psy.man.ac.uk/staff/weardena.htm Dr. Wearden said: "There is clearly a pressing need to help the estimated 240,000 people in the UK suffering from CFS/ME and in particular those who are severely ill and cannot attend specialist clinics. We've been sufficiently encouraged by some of our previous results, to test whether or not his treatment programme, which we've found is acceptable to patients, can fill a gap in the primary care. It could provide a viable, effective treatment option for patients and GPs as it can be easily taught to qualified nurses without the need for lengthy, expensive training and delivered in the home, which has got be good news for everyone." This has not unfortunately been the experience of quite a few ME/CFS sufferers treated by Dr. Wearden and colleagues to date. Jane Bryant THE ONE CLICK GROUP http://health.groups.yahoo.com/group/THEONECLICKPROTEST/ 9 January 2004 "The history of medicine is built on examples of mindset that delayed recognition or evolution of most illness concepts." http://health.groups.yahoo.com/group/THEONECLICKPROTEST/ ---------------------------------------------------------------------- ------- 9 January, 2004 CASE HISTORY ­ THE FINE / WEARDEN EXPERIENCE "I was in the prime of my young life when I became ill. I had a successful career, relationship, active social and sporting life. It was all lost at a promising point in my life. Now over 14 years later I am still too ill to regain any of it. I was referred to take part in the CFS clinical trial (they didn't believe in the term ME, or that a distinct illness of ME existed) at Withington hospital in the early 1990's after I had experienced almost two years of continuing ill health following a sudden viral illness. I first saw Dr. Richard Morriss (who was a senior registrar in psychiatry at that time - now a Professor at Liverpool University I think) who took my history and a number of blood tests. He was very interested in the 'mental' symptoms and dismissed others that I felt were important which he obviously did not. I was subsequently enrolled in their study of antidepressants and Graded Exercise Therapy (GET). Dr. Pearson passed through the room during this initial consultation and was very derisory about Clare Francis, the ME charities and the term ME itself. (Clare Francis is the Round The World Woman Yachtsman, an ME sufferer herself.) This was the only time I saw or had any contact with Dr. Pearson. I was led to believe that fluoxetine was a drug that would only be available to me if I took part in the study. I was never told at that time that I could have it (Prozac!) from my G.P. on ordinary prescription if I so wished at any time. Because of this, I agreed to take part in the trial. I attended the clinic for 5 months at weekly and then monthly intervals. During this time I only ever saw Ricky Mullis (physiotherapist) and Alison Wearden (psychology post-graduate student). I was given what I eventually discovered was a placebo and I was 'encouraged' to do more than I felt well enough to do. At each assessment I was required to go on an exercise bike for as long as I could. This did nothing for my state of health! Over three months I deteriorated considerably, became very frightened and eventually depressed (I wasn't when I entered the study!). I expressed this to Alison Wearden each time I saw her yet I was never referred to see any of the doctors despite my repeated requests for this to happen. Eventually a relative of mine demanded we see a doctor and I said I no longer wished to participate in the study, as I was getting worse not better. Ricky Mullis (physiotherapist) vigorously tried to persuade me to stay on the trial regardless of my deteriorating physical and mental condition. I refused to do this and again demanded to see a doctor. I eventually saw a senior registrar in medicine. Only the second medical consultation I had received since initially attending. I felt so ill and was so frightened and depressed that I was admitted to the hospital. The ward staff told me that only I could make myself better and 'to get a grip'. On the ward I saw a senior registrar in psychiatry who prescribed a tricyclic anti-depressant, which he assured me gave me great hope of a recovery. Whilst staying on this ward, I met two other people who had been diagnosed as having ME prior to attending the hospital, and they were told that if they did not take part in the trial, they would receive no other treatment, and so felt they had to take part to be able to do anything to feel better. It was at this point I began to question the ethics and motivation of the study. After a few days in the ward, I had seen and heard enough and decided to go home! A close friend at that time said all along the doctors and students running the trial were more interested in their research than they were in the welfare of the patients. I had not been depressed before I was ill or during the time; I was ill until I attended the Manchester hospital. My own doctors would confirm this. I took the anti-depressants still believing that they would make me better. I returned to the outpatient clinic 6 weeks later, waited three and a half hours to see a house officer, who told me all my tests were normal and that there was nothing wrong with me. As you can imagine, I was rather taken aback by this. I asked to see Dr. Pearson or one of the senior doctors. The house officer went off presumably to confer with someone else (Dr. Pearson I presumed), and returned to say that I could not see anyone else as I had chosen to withdraw from the study, so no further treatment was available to me. I was given no further appointments, despite my insistence of how ill I still felt. The antidepressants did eventually lift the depression, but all my ME symptoms still remained. (I have not had any need for anti-depressants since this time and actually feel much better without them!) In fact, my mobility was much reduced after attending this trial. Previously my mobility had been better than it was subsequent to my treatment in this Manchester Hospital and this condition continued for many years. (I now practice "pacing" proper and manage much better!) So their 'treatment' left me worse and more debilitated than I was before I entered the study! I felt there was no concern for me as a human being and there was no further contact with me to see how I was doing, except a request some years later for me to take part in further research, which as you can imagine I quickly declined! After this I began to hear from others their experiences of this same research team and became increasingly alarmed about what was occurring. I began to see many flaws in their trial. People enrolled in the trial were allowed to continue to take other treatments and to have other therapies, such as acupuncture and homeopathy independently, during the trial period. The doctors knew about the patients having other treatments independently during the trial period and yet these patients still remained in and were part of the trial and its results. This negates the whole purpose and the validity of a randomised, double-blind, placebo controlled trial and therefore the results. I am therefore astonished when I see that the results have been published in a reputable journal * and are frequently quoted in other work. I also became aware that there were a broad range of patients and conditions being enrolled in the study. It was clear that people with ME were being enrolled, but also others with other "fatigue" states of a variety of aetiologies. The CFS trial appeared to be an 'umbrella' including anyone who reported "unexplained fatigue" or "an absence of any signs of physical illness" (their words not mine). I became aware of people with ME who were being prescribed 20 minutes exercise three times a week and who were also getting worse not better. My own doctor was amazed at what I reported to him about what was happening at this Centre. He stated that if he had known, he would never have referred others there. My own doctor was outraged at what had occurred. He has remained adamant that I had a genuine physical illness and that I was never ill through psychological problems or depression. I never complained at the time, as I was so ill. It is only with hindsight that I can see what was happening was not helpful or useful and indeed damaging to some people including myself. This was a teaching hospital and a so-called Centre of Excellence. It is therefore a scandal that this trial was conducted as it was and that the results were published and taken seriously by others in the medical profession when there was so many flaws within it and extremely poor and disrespectful treatment of patients. It was poor scientific research with no concern for the patients involved. As patients, many people place their trust in doctors to help them recover. They do not expect disrespect or for the treatments to make them worse. A sick patient probably never contemplates that a doctor or their prescribed treatments will do them more harm than good! As a result of this trial, I would be reluctant to take part in any other clinical trials and would advice others to proceed with caution. This trial has done a disservice to medicine as a whole and to patients. I am therefore annoyed every time I see this trial quoted as published research as I know that what went on was not good quality research. It had many flaws. With regard to their published findings, so much for their commentary (regarding high drop-out rates) that "Of the 21 drop-outs assessed at 26 weeks, there was no worsening of fatigue, functional work capacity, MOS health perception or depression" and "graded activity may provide patients with reassurance that exercise at a controlled rate need not exacerbate fatigue"! I know of at least three others who were in the exercise group that were made so much worse!" * Reference: Wearden, AJ., Morriss, RK., Mullis, R., Strickland, PL., Pearson, DJ., Appleby, L., Campbell, IT and Morriss, JA. Randomised, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. British Journal of Psychiatry, 1998, 172, 485-490. --------------------------------------------- Too much mail? Try a digest version. 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