Freedom of information: can researchers still promise control of participants’ data?
BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5053 (Published 21 September 2016) Cite this as: BMJ 2016;354:i5053
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I was disappointed to read Timothy Jordan's response to the article "Freedom of information: can researchers still promise control of participants’ data?"
While I welcome the sharing of professional opinion relating to myalgic encephalomyelitis (M.E.), I was disheartened by Dr Jordan's suggestion that M.E. is not a true illness, and that for "alleged sufferers" it is "all in their head".
Such comments propagate the long-standing myth that M.E. is not a true physical illness, and perpetuate the disbelief and stigmatisation that people with M.E. are subjected to.
For M.E. patients, who often struggle to find acceptance and support from friends, family, colleagues and social and welfare services, this can cause a great deal of harm and prevent them from accessing the medical, financial and emotional support they desperately need, which is something I hope Dr Jordan recognises.
Dr Jordan's opinion is at odds both with the research evidence that supports M.E. as a true physical illness, and with an appropriate medical stance.
Sonya Chowdhury, Chief Executive, Action for M.E.
Competing interests: I am Chief Executive of an M.E. charity
Dear Editor,
I read Nigel Hawkes' article with great interest. I suspect the issues he touched on are faced by clinical researchers with increasing frequency.[1]
Throughout my medical training, maintaining confidentiality has been held up as one of the pillars of the doctor-patient relationship. Upon entering into the realms of clinical research, I have been faced with the research ethics application for the project which will form the basis of my Phd, and have been grappling with the issues of how the data my project collects will be shared and open to public scrutiny.
On one hand, we have a duty to the patients who participate in the research we conduct to maintain their privacy. On the other hand, we have a duty to the patients who participate in the research to ensure the integrity of the science, and hence open up their data to external assessors. From yet another perspective, we have the responsibility to extract the maximum amount of utility from the data that has been collected in order to justify putting patients through the research process and the financial costs of conducting the research, which is often paid for at least in part by the taxpayer.
Throughout this process, the researcher is in the middle, and very little guidance seems to be available. The explosion of Big Open Data has happened but many parts of clinical research are only now understanding what that means for their specialist areas of research. Involving ethics committees may ultimately prove to be the best course of action, as it brings in external experts used to arguing over the conundrums presented in such situations.
Reference:
1. Hawkes Nigel. Freedom of information: can researchers still promise control of participants’ data? BMJ 2016; 354 :i5053
Competing interests: No competing interests
The action taken against the researchers appears to be a continued attempt to justify the condition as a disease entity, thereby creating an environment in which some form of personal gain may be achieved. Whether that gain is in the form of a financial incentive or to manipulate the research findings as a way of placing some distance between a possible underlying mental health or psychosomatic illness and a true physical illness is unknown. It obviously helps satisfy alleged sufferers to hear that it is not all in their head and that what symptoms are experienced must be seen as real and part of a real disease process. Arguments against the sceptics and critics must be answered with facts, according to one's own definition of the facts.
Fibromyalgia would be a more apt description of the symptoms as no amount of manipulation is able to confirm myalgic encephalomyelitis as a condition that presents with any form of brain or spinal cord inflammation.
In Alberta Canada, the condition may be used to claim illness benefits, so there is a very real advantage to having it classified as a disease.
Please note that the aforesaid is my opinion and mine alone. I cannot claim any conflict of interest but my experience in its management provides me with an insight not always available to others.
Competing interests: No competing interests
Patient confidentiality and protection of patient data should be (and is) a primary concern for clinical trials. But so too should be the principles of high quality, reproducible science that is open to re-analysis and discussion. In fact, as this landmark case shows, it is not impossible to have both.
The data is now publicly available (1) and it is clear that identification of any individual who took part in the trial would not be possible from this data set. A preliminary analysis (2), backed by statisticians is now available online and no doubt peer-reviewed publications will follow. This is how good science happens, and all credit to the patients for pursuing this goal.
The greatest danger here lies not in the vanishingly small chance of patient identification that comes from releasing anonymised data, but rather in choosing to keep clinical data closed, thus quashing scientific progress through the normal processes of discourse and debate. And if that happens, the biggest losers of all are of course, the patients themselves.
References:
1) Reference 10 in : Virology Blog http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis...
2) Virology Blog http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis...
Competing interests: No competing interests
I disagree with Nigel Hawkes' opinion that the 2011 PACE trial, which included 641 patients is the most important research to date into treatment for chronic fatigue syndrome or myalgic encephalomyelitis.1,2
The most important research to date is the discovery by John McLaren-Howard, Sarah Myhill and Norman Booth that chronic fatigue syndrome is due to mitochondrial dysfunction. The more severe the disability - the more severe the mitochondrial dysfunction. 3-5
Dr Sarah Myhill’s book "Chronic Fatigue Syndrome “It’s mitochondria, not hypochondria” is helpful.6 Like migraine patients, chronic fatigue syndrome patients benefit from following low allergy diets, taking general and specific nutritional supplements, and detoxification of toxic metals such as nickel from jewelry and cadmium from tobacco smoking. Patients also need to avoid alcohol and the use of contraceptive or menopausal hormones as the female/male sex ratio in chronic fatigue syndrome is about three to one.
It is unfortunate to worry patients suffering from chronic fatigue about the merits of either behaviour or exercise therapy without first attempting to investigating and treating important biochemical reasons for their condition. No good mechanic would try to accelerate a car which has a faulty engine needing repair.
Freedom of information should include the most helpful information for patients.
1 Hawkes N. Freedom of information: can researchers still promise control of participants’ data? BMJ 2016;354:i5053.
2 White PD, Goldsmith KA, Johnson AL, et al. PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet2011;377:823-36.. doi:10.1016/S0140-6736(11)
3 Myhill S, Booth NE, McLaren-Howard J. Chronic fatigue syndrome and mitochondrial dysfunction. Int J Clin Exp Med. 2009;2:1-16.
4 Booth NE, Myhill S, McLaren-Howard J. Mitochondrial dysfunction and the pathophysiology of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Int J Clin Exp Med. 2012;5(3):208-20.
5 Myhill S, Booth NE, McLaren-Howard J. Targeting mitochondrial dysfunction in the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - a clinical audit. Int J Clin Exp Med. 2013;6:1-15.
6 Myhill S. In "Chronic Fatigue Syndrome It’s mitochondria, not hypochondria.” 2014 Hammersmith Health Books, London PP 44-72.
Competing interests: No competing interests
Re: Freedom of information: can researchers still promise control of participants’ data?
In response to Dr Timothy Jordan I would like to mention the following:
1) Canada's CIHR (Canadian Insitutes for Health Research) has contributed an average of 11 cents per patient per year for the last 12 years in research, compared to an average of 158$ per pt per year for other chronic diseases similar in disability. This means that the average canadian physician is not relying on science in order to make teir own opinion, but rely on now crumbling Cochrane reviews to make their minds about ME.
2) The very reputable Institute of Medicine declared ME a biological disease, featuring a set of symptoms which is common to all patients and discriminates from other groups of patients who do not have the disease. (1)
3) University of Columbia Institute of Infection and Immunity found distinct cytokine patterns depending on phases of illness that patients went through, an inflammatory phase for up to 3 years after infectious onset, and a subsequent period of immune depletion (2)
4) Recently Dr Naviaux et al published a landmark paper on a distinct metabolomic signature in patients with ME. They found difference in metabolome in males and females but similar in suggesting a 'daur state'.(3)
5) Lastly the PACE trial which was highly pushed by the media as truth, now uncovers the many fatal flaws of what a rigorous clinical trial should be like. The authors changed the recovery requirements mid trial to declare more patients 'recovered'. This change resulted in 12% of the patients entering the trial being already classified as recovered. I invite you to read the compelling body of work from Dr David Tuller in this regard, much more eloquent than mine. (4)
Many say that medicine is both art and science. What you are providing us here in your comment is an opinion, not based on science, but based on what knowledge and experience you have, but this does not represent the opinion of the experts who have worked with ME patients on a daily basis.
The same kind of opinion has obstructed the medical judgement for decades for other diseases, for instance with Parkinson's disease, epilepsy, multiple sclerosis, and stomach ulcers. It takes curious and brave scientists to uncover the truth, facing disproval from their peers, facing government grant refusal, facing publication refusal. The science behind ME is rapidely unfolding, thanks to the current technology and advances in science and medicine, which will make current opinions in regards to this disease rather embarrassing.
Lastly, do not believe one minute that living on insurance or government benefits is an enviable position to be in. Too many patients had to leave behind a career, a life, and family members they loved, and would rather have their lives back instead of living with a disease that so few understand and so few physicians are willing to help with.
(1) http://www.nationalacademies.org/hmd/Reports/2015/ME-CFS.aspx
(2) http://advances.sciencemag.org/content/1/1/e1400121
(3) http://www.pnas.org/content/113/37/E5472.full
(4) http://www.virology.ws/2015/10/21/trial-by-error-i/
Competing interests: No competing interests