Wednesday, 26 October 2016
Karina Hansen 6: THE HOMECOMING by Valerie Eliot Smith
KARINA HANSEN, “PRISONER OF DENMARK”, IS HOME AT LAST.
On Monday 17 October 2016, after three and a half years of incarceration, Karina finally returned home to her family. The arrangement was on a trial basis but in the hope and expectation that she would be finally and permanently back where she belongs.
In recent weeks, Karina’s condition had improved slightly and her parents were able to visit her on a regular basis (more detail in my previous post). As a result, meetings took place between those in charge of the Clinic at Hammel where she had been an inmate since February 2013 (see Karina’s Story below for background) and representatives of Karina’s family. An arrangement for Karina’s return home was agreed whereby her parents would take her home within the next few days and she would remain there for a trial period. If all went well, she would stay on at home permanently.
Significantly, Karina was well enough to sign a document saying that she wanted to go home with her parents. Although she was still unable to speak, she was able to communicate via gestures that she understood the plan and wished it to happen.
The trial period has now passed without incident and so Karina and her family have decided that they want to share the news with their friends and supporters all over the world.
Karina has finally come home.
A request for privacy
It is Karina’s birthday on 7 November, the first one she will have been able to enjoy at home with her family since 2012. Her supporters all over the world will be celebrating with her. There are various groups (on Facebook, for example) with more details of how to get involved.
The Hansen family is very grateful for the huge amount of support and many good wishes which they have received over the last few years. However, this is a time of enormous re-adjustment and they would like to request that, once Karina’s birthday is over, their privacy is respected. Karina has a long way to go with her recovery and her family members need time to adapt to their new situation and reflect on how to process the traumatic events of recent years.
Regular readers of this blog will be familiar with Karina’s horrifying story (as detailed in my series of posts) and with the often appalling treatment of ME patients generally. However, for new readers, and those needing a reminder, here is a summary:
Karina (pictured top left, from her schooldays) lives in Denmark. In 2008, she was diagnosed with severe Myalgic Encephalomyelitis (ME).
[ME is a complex, multi-systemic neuro-immune disease; its controversial nature continues to cause immense patient suffering and distress. ME receives universally derisory state funding for desperately-needed biomedical research/treatment, despite having been accurately identified and described in the 1950’s and recognised as a neurological condition by the World Health Organization since 1969.
ME patients in many countries are still routinely referred to psychiatrists who use the inappropriate, and sometimes dangerous, psychosocial treatment model; patients are frequently unable to access medical treatment with a knowledgeable physician. There is still no recognized diagnostic pathway or treatment for ME – and definitely no cure, despite the claims made by some.]
Inevitably, Karina’s diagnosis became the subject of a prolonged dispute. Her family continued to care for her at home, in accordance with her express wishes. However, in February 2013, then aged 24, she was forcibly removed from her home by a large team of police, doctors and social workers. She was taken to Hammel Neurocenter, against both her own will and that of her family. Hammel is part of “The Research Clinic for Functional Disorders” at Aarhus University Hospital.
Several doctors have been involved in Karina’s case but psychiatrists Nils Balle Christensen and Per Fink were in charge of her treatment at Hammel. Shortly after her initial detention, she was classed as a “voluntary” patient, despite having been taken there against her will; she was found by a court subsequently to lack capacity to make her own decisions. As a result of that finding, the court appointed a legal guardian to take responsibility for her welfare and make decisions on her behalf. Her condition deteriorated rapidly after her admission to the Clinic.
Three years on, in February 2016, Karina remained a de facto prisoner of the state. She had been moved to a nearby rehabilitation center but allowed very little contact with her family. Her father was permitted to visit her in December 2015. Whilst she was physically clean and cared-for, she was apparently immobilized, in a wheelchair and unable to speak except for incomprehensible mumbling and grimaces. At that time, she did not appear to recognize her own father.
During the course of 2016, I have written a series of blog posts chronicling and analyzing Karina’s story from my perspective as a lawyer, a journalist and a long-time ME patient. On 12 October, I wrote a short update detailing the changes which were beginning to come about in Karina’s condition. Although she still could not speak, her ability to communicate with gestures was increasing, her mobility was improving and her parents had been able to visit on a regular basis during the preceding weeks.
Official comments on Karina’s case
Regular readers may recall from earlier articles in this series that I contacted (via an academic colleague who is an expert on Open Justice in European countries) the Danish Ministers for Health and Justice and Hammel Neurocenter. These requests for comment were made in February 2016.
* The Minister for Health replied two months after the original request and refused to comment on the basis of patient confidentiality (although the request was worded as a general inquiry rather than for specific information about Karina).
* The Minister for Justice sent standard acknowledgments and eventually responded in July (nearly six months after the original request). The reply simply referred the inquiry back to the Minister for Health.
* Per Fink replied within two days on behalf of himself and Hammel. In summary, he stated that all patients are there on a voluntary basis and that the clinic is very popular
The Clinic has been contacted again for comment about Karina’s return home. I will update this article when I receive a response.
Where are we now?
The status of Karina’s legal guardian will need to be resolved formally by the Court. Whether or not his role in these proceedings (see previous posts) is subjected to any further scrutiny is another matter. Only time will tell. And there are other issues such as ongoing medical treatment which will still need to be addressed so the story is not necessarily over yet.
However, the question which I asked in Karina Hansen 3: Update March 2016 remains unanswered: “In the absence of any clear explanation, the inevitable question arises: [was] her condition the direct result of a state-orchestrated plan which went horribly wrong?” Perhaps this question will be addressed if there are any further legal proceedings in relation to these events.
How much damage has been done to Karina and her family remains to be seen. After three and a half years in an institutional environment, there will be considerable adjustments and adaptations to be made. It is to be hoped that plans have been put in place and that appropriate support will be made available to them.
Significance of Karina’s story for the future
Karina’s story is horrifying. It is a story which should be of the utmost international concern, as a salutary reminder not only of a shocking breach of one young woman’s rights but also of the continuing scandal of the appalling treatment and stigmatization of ME patients all over the world.
It is also of supreme importance that a permanent record of these events is publicly available as reference material for the future. That is why I have invested so much time and effort into researching and writing this series of articles (always whilst battling through my own brain-fog, one of the hallmark symptoms of ME and, for me, the most difficult of all to live with).
But, for now, the international ME community can celebrate the fact that Karina is free at last.
I would like to thank Bente Stenfalk of Borgerretsbevægelsen (Civil Rights Movement Group in Denmark) for keeping me up to date with the Group’s work in assisting Karina and her family.
I would also like to thank Rob Wijbenga from the Netherlands for his support and assistance.
I have lived with the illness ME since 1981. For more information see About.
Saturday, 15 October 2016
Professor Fred Friedberg asks why cognitive behavioural therapy (CBT) is so vilified in the chronic fatigue syndrome community.
Professor Fred Friedberg asks why cognitive behavioural therapy (CBT) is so vilified in the chronic fatigue syndrome community.
He opens his Editorial by stating: “Cognitive behaviour therapy (CBT) is a well-established psychosocial intervention for psychiatric disorders, pain management and stress related to medical conditions” (Editorial: Cognitive-behavior therapy: why is it so vilified in the chronic fatigue syndrome community? Fatigue, Biomedicine, Health & Behavior 2016:vol 4: no:3:127-131) but ME/CFS is not, and never has been, a psychiatric disorder and CBT has no more role in its management than in the management of multiple sclerosis, MND, Parkinson’s Disease, malignancies or other autoimmune disorders such as lupus or RA.
CBT is not mandated as the primary management approach in those other disorders, so why in ME/CFS?
Patients with ME/CFS do not summarily reject any intervention that would help them: what they reject is a psychosocial intervention that is used with the intention of changing their correct perception that they are very sick with an organic disease, not with a behavioural disorder that is curable by “cognitive re-structuring” if they would only co-operate.
Friedberg appears to assume that, where there is stress related to a medical disorder, CBT supports patients to help them cope better with their disease.
However, a key consideration which he fails to mention is the significant difference between supportive CBT and directive CBT.
In relation to ME/CFS, in the UK PACE trial CBT was not supportive but directive: Professor Sir Simon Wessely, currently President of the Royal College of Psychiatrists, has publicly stated: “CBT is directive – it is not enough to be kind or supportive” (New Statesman, 1st May 2008).
No amount of directive “cognitive re-structuring” can result in “recovery” from such a multi-system inflammatory disease process as has been demonstrated in ME/CFS.
The Centres for Disease Control (CDC) has archived its toolkit that recommended CBT and GET as interventions for ME/CFS (http://www.cdc.gov/cfs/toolkit/archived.html) and the National Institutes for Health (NIH) has produced a report which acknowledges the harm done to patients (http://annals.org/article.aspx?articleid=2322804); their conclusions were based on comprehensive reviews of over 9000 peer-reviewed research papers and testimony from expert researchers and clinicians.
Does this not provide the answer to Friedberg’s question as to why CBT is so vilified in the ME/CFS community?
Diverting scarce resources from biomedical research by funding psychosocial interventions that have been conclusively proven to be ineffective can only harm patients further.
Money must now urgently be made available by institutions such as the MRC for research that is relevant to the disorder; for example, Professor Faisal Khan (recently appointed to the Chair of Cardiovascular Sciences, Division of Molecular and Clinical Medicine at the University of Dundee) is working on NRF2 (nuclear receptor factor 2) in ME/CFS patients and his work ties in with the study by Japanese researchers who looked at index markers in ME/CFS patients with dysfunction of TCA (the tricarboxylic acid cycle, also known as the Krebs cycle, which is the biochemical pathway used to generate energy) and urea cycles (http://www.nature.com/articles/srep34990).
Behavioural researchers who for over 30 years have shown disregard for the scientific process should have no influence on future research.
Patients with ME/CFS do not need “behavioural” guidance from a profession which has visited such harm upon them.
To spell it out: directive CBT does not work for patients with ME/CFS and it is time that those psychologists and psychiatrists who insist that it does returned to reality.
Professor Malcolm Hooper
15th October 2016
Friday, 14 October 2016
By Dr Mercola
A widespread and silent killer that’s worse for your health than alcohol, nicotine and many drugs is likely lurking in your kitchen cabinets right now.
“It” is monosodium glutamate (MSG), a flavor enhancer that’s known widely as an addition to Chinese food, but that’s actually added to thousands of the foods you and your family regularly eat, especially if you are like most Americans and eat the majority of your food as processed foods or in restaurants.
MSG is one of the worst food additives on the market and is used in canned soups, crackers, meats, salad dressings, frozen dinners and much more. It’s found in your local supermarket and restaurants, in your child’s school cafeteria and, amazingly, even in baby food and infant formula.
MSG is more than just a seasoning like salt and pepper, it actually enhances the flavor of foods, making processed meats and frozen dinners taste fresher and smell better, salad dressings more tasty, and canned foods less tinny.
While MSG’s benefits to the food industry are quite clear, this food additive could be slowly and silently doing major damage to your health.
What Exactly is MSG?
You may remember when the MSG powder called “Accent” first hit the U.S. market. Well, it was many decades prior to this, in 1908, that monosodium glutamate was invented. The inventor was Kikunae Ikeda, a Japanese man who identified the natural flavor enhancing substance of seaweed.
Taking a hint from this substance, they were able to create the man-made additive MSG, and he and a partner went on to form Ajinomoto, which is now the world’s largest producer of MSG (and interestingly also a drug manufacturer).
Chemically speaking, MSG is approximately 78 percent free glutamic acid, 21 percent sodium, and up to 1 percent contaminants.
It’s a misconception that MSG is a flavor or “meat tenderizer.” In reality, MSG has very little taste at all, yet when you eat MSG, you think the food you’re eating has more protein and tastes better. It does this by tricking your tongue, using a little-known fifth basic taste: umami.
Umami is the taste of glutamate, which is a savory flavor found in many Japanese foods, bacon and also in the toxic food additive MSG. It is because of umami that foods with MSG taste heartier, more robust and generally better to a lot of people than foods without it.
The ingredient didn’t become widespread in the United States until after World War II, when the U.S. military realized Japanese rations were much tastier than the U.S. versions because of MSG.
In 1959, the U.S. Food and Drug Administration labeled MSG as “Generally Recognized as Safe” (GRAS), and it has remained that way ever since. Yet, it was a telling sign when just 10 years later a condition known as “Chinese Restaurant Syndrome” entered the medical literature, describing the numerous side effects, from numbness to heart palpitations, that people experienced after eating MSG.
Today that syndrome is more appropriately called “MSG Symptom Complex,” which the Food and Drug Administration (FDA) identifies as “short-term reactions” to MSG. More on those “reactions” to come.
Why MSG is so Dangerous
One of the best overviews of the very real dangers of MSG comes from Dr. Russell Blaylock, a board-certified neurosurgeon and author of “Excitotoxins: The Taste that Kills.” In it he explains that MSG is an excitotoxin, which means it overexcites your cells to the point of damage or death, causing brain damage to varying degrees — and potentially even triggering or worsening learning disabilities, Alzheimer’s disease, Parkinson’s disease, Lou Gehrig’s disease and more.
Part of the problem also is that free glutamic acid is the same neurotransmitter that your brain, nervous system, eyes, pancreas and other organs use to initiate certain processes in your body.4 Even the FDA states:
“Studies have shown that the body uses glutamate, an amino acid, as a nerve impulse transmitter in the brain and that there are glutamate-responsive tissues in other parts of the body, as well.
Abnormal function of glutamate receptors has been linked with certain neurological diseases, such as Alzheimer’s disease and Huntington’s chorea. Injections of glutamate in laboratory animals have resulted in damage to nerve cells in the brain.”
Although the FDA continues to claim that consuming MSG in food does not cause these ill effects, many other experts say otherwise.
According to Dr. Blaylock, numerous glutamate receptors have been found both within your heart’s electrical conduction system and the heart muscle itself. This can be damaging to your heart, and may even explain the sudden deaths sometimes seen among young athletes.
“When an excess of food-borne excitotoxins, such as MSG, hydrolyzed protein soy protein isolate and concentrate, natural flavoring, sodium caseinate and aspartate from aspartame, are consumed, these glutamate receptors are over-stimulated, producing cardiac arrhythmias.
When magnesium stores are low, as we see in athletes, the glutamate receptors are so sensitive that even low levels of these excitotoxins can result in cardiac arrhythmias and death.”
Many other adverse effects have also been linked to regular consumption of MSG, including:
Fatigue and disorientation
Further, even the FDA admits that “short-term reactions” known as MSG Symptom Complex can occur in certain groups of people, namely those who have eaten “large doses” of MSG or those who have asthma.
According to the FDA, MSG Symptom Complex can involve symptoms such as:
Facial pressure or tightness
Chest pain or difficulty breathing
No one knows for sure just how many people may be “sensitive” to MSG, but studies from the 1970s suggested that 25 percent to 30 percent of the U.S. population was intolerant of MSG — at levels then found in food. Since the use of MSG has expanded dramatically since that time, it’s been estimated that up to 40 percent of the population may be impacted.
How to Determine if MSG is in Your Food
Food manufacturers are not stupid, and they’ve caught on to the fact that people like you want to avoid eating this nasty food additive. As a result, do you think they responded by removing MSG from their products? Well, a few may have, but most of them just tried to “clean” their labels. In other words, they tried to hide the fact that MSG is an ingredient. How do they do this? By using names that you would never associate with MSG.
You see, it’s required by the FDA that food manufacturers list the ingredient “monosodium glutamate” on food labels, but they do not have to label ingredients that contain free glutamic acid, even though it’s the main component of MSG. There are over 40 labeled ingredients that contain glutamic acid, but you’d never know it just from their names alone. Further, in some foods glutamic acid is formed during processing and, again, food labels give you no way of knowing for sure.
Tips for Keeping MSG Out of Your Diet
In general, if a food is processed you can assume it contains MSG (or one of its pseudo-ingredients). So if you stick to a whole, fresh foods diet, you can pretty much guarantee that you’ll avoid this toxin. The other place where you’ll need to watch out for MSG is in restaurants. You can ask your server which menu items are MSG-free, and request that no MSG be added to your meal, but of course the only place where you can be entirely sure of what’s added to your food is in your own kitchen. To be on the safe side, you should also know what ingredients to watch out for on packaged foods. Here is a list of ingredients that ALWAYS contain MSG:
These ingredients OFTEN contain MSG or create MSG during processing:
Flavors and Flavorings
Natural Flavors and Flavorings
Natural Pork Flavoring
Natural Beef Flavoring
Natural Chicken Flavoring
Soy Protein Isolate
Anything Enzyme Modified
Anything Protein Fortified
So if you do eat processed foods, please remember to be on the lookout for these many hidden names for MSG.
Choosing to be MSG-Free
Making a decision to avoid MSG in your diet as much as possible is a wise choice for nearly everyone. Admittedly, it does take a bit more planning and time in the kitchen to prepare food at home, using fresh, locally grown ingredients. But knowing that your food is pure and free of toxic additives like MSG will make it well worth it. Plus, choosing whole foods will ultimately give you better flavor and more health value than any MSG-laden processed food you could buy at your supermarket.
Tuesday, 11 October 2016
To whom it may concern,
ME (Myalgic Encephalomyelitis) has long been recognised as a serious physical/neurological illness by the World Health Organisation, International Classification of Diseases, Tenth Revision: ICD-10-G93.3. The WHO ICD-10 separates ME from idiopathic/psychiatric fatigue syndrome, which it lists in section F.48: ICD-10-F.48. The WHO have emphatically stated that different disease classifications should not be conflated. If only the medical establishment and media would properly recognise this fact a lot of trouble, suffering, money and litigation would have been saved.
Unfortunately, the controversy over the 'PACE trial' recommendations of cognitive behavioural therapy and graded exercise therapy (CBT/GET) for "CFS/ME" patients, based upon the alleged fear of activity/deconditioning hypotheses, continues. If there were any justice, Ireland's Tom Kindlon and ME activist associates around the world would be given an official public honour in the new year for services to the sick and vulnerable. Kindlon et al have exposed what has been publicly called the PACE trial "fraud" and "scientific misconduct". Alas, in my experience of campaigning for ME justice since 2004, no such justice is ever GIVEN by the medical and political establishment in ME circles, it has to be FOUGHT for. The recent forced release of raw PACE data is a case in point. I therefore fear that the recent ME community "Plea for decency to White, Chalder and Sharpe", requesting retraction of their published PACE results, is akin to a mouse begging a cat to stop chasing it. I do hope that I am proved wrong, but I seriously doubt that there will be an early retraction of the PACE trial paper in the Lancet by the authors. Moreover, the controversial, and internationally influential, UK NICE Clinical Guideline 53 on "CFS/ME" recommended CBT/GET treatments for NHS patients long before the PACE study was even published. It is unlikely therefore that NICE CG 53 will be retracted or amended on the basis of the unlikely event of said PACE trial paper being withdrawn from the Lancet.
A recent ME community forum posting stated that "Protests and petitions shouldn't be [the] only activism tools, fundraising for biomedical research [is] important". I agree, but we also need to be realistic about the fact that biomedical ME research is starved of funds as an ongoing act of intergovernmental POLITICAL POLICY. Policy that is informed by an insurance-industry-linked psychiatric lobby. Taxpayers who fall ill with ME have a right to expect genuine science-based public health/welfare policy, and a right to expect that a fair proportion of government medical research funds are allocated to biomedical ME studies. Official ME political policy needs to be changed. Political activism is therefore absolutely vital to securing funding for biomedical research and securing genuine science-based health policy. Activism therefore has to be a priority.
Mere blogs and protests will not however achieve ME justice on their own. I am therefore deeply concerned that a strategic opportunity in the wake of the recent raw PACE data release may be missed. It is absolutely imperative in my view, that the ME community now urgently works to persuade a number of respected and well-known specialist biomedical ME clinicians/researchers from various countries, along with non-specialist academics who have recently taken an interest in PACE, to collaborate to produce a joint scientific overview paper on ME/PACE. They should then attempt to publish the paper in a respected peer-reviewed journal. Such a paper must do two things: firstly, it should draw attention to the flawed PACE trial methodology and to the flaws in CBT/GET for ME generally; secondly, it should set out an updated overview of existing biomedical evidence, indicating known disease processes and setting out WHY CBT/GET may be contraindicated as treatments (as earlier authors have attempted to do).
A PACE-critique-inclusive peer-reviewed paper is now timely and would be extremely useful. It could be properly cited when interacting with politicians, medical/research professionals, media and lawyers. I reiterate: blogs, supplicatory letters and protests are not enough. Citing a blog will never command the authority that citing a scientific paper will. True, a peer-reviewed paper (as described) will not GUARANTEE international ME justice, but I believe I can guarantee that justice will not come without such a paper. In my view the ME community needs to help assemble a clinical and academic collaboration and encourage them to publish on PACE etc as a matter of strategic urgency. Such a collaboration occurred with the setting up of the International Consensus Panel under Dr Bruce Carruthers et al, leading to publication of the International Consensus Criteria (ICC) in 2011. The time is now ripe for a similar action on PACE.
ANGLIA ME ACTION. 10 October 2016.
 See: World Health Organisation, International Classification of Diseases 10th Revision, Section G93.3, Diseases of the Nervous System (WHO ICD-10-G93.3):
- International Statistical Classification of Diseases and Related Health Problems - Tenth Revision – Second Edition: Volume 1 – Tabular List – ISBN: 92 4 154649 2.
- International Statistical Classification of Diseases and Related Health Problems - Tenth Revision – Second Edition: Volume 2 – Instruction Manual – ISBN: 92 4 154653 0.
- International Statistical Classification of Diseases and Related Health Problems - Tenth Revision – Second Edition: Volume 3 – Alphabetical Index – ISBN: 92 4 154654 9.
 Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialis medical care for chronic fatigue syndrome (PACE): a randomised trial. P D White et al, The Lancet, 2011:
 Trial By Error, Continued: The Real Data. David Tuller, DrPH, 22 September 2016:
PROOF POSITIVE ? (REVISITED). M Williams, September 2016:
The PACE Trial did not go Unchallenged. M Williams, March 2016:
 Plea for decency to White, Chalder and Sharpe. meaction.net October 2016:
 Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management Clinical guideline [CG53]. National Institute for Health and Care Excellence (NICE), published August 2007:
 High Court Witness Statement of Dr Neil C Abbot, 2007:
 Protests & petitions shouldn't be only activism tools. Fundraising for biomedical research important. Phoenix Rising, October 2016:
 The UK Government’s three-pronged strategy for “CFS/ME” [AMEA – Corrected Version]. Margaret Williams, 15th July 2014:
CORPORATE COLLUSION? Professor Malcolm Hooper, Eileen Marshall, Margaret Williams. September 2007:
 Myalgic encephalomyelitis: International Consensus Criteria. B M Carruthers et al, 2011:
Myalgic encephalomyelitis: a review with emphasis on key findings in biomedical research. Professor Malcolm Hooper, 2007:
 Myalgic encephalomyelitis: International Consensus Criteria. B M Carruthers et al, 2011:
MESSAGE ENDS - - PERMISSION TO REPOST.
Monday, 10 October 2016
By Jerome Burne
Trust me I’m a doctor has become a knowing, cynical catch-phrase but the underlying truth is that we do need to trust our doctors, not only because trusted doctors exert a beneficial healing effect but also because we are entrusting them with something precious – our health.
Several recent events however suggest that we would do well to keep our cynical streak on high alert when visiting. Unquestioning trust can have dangerous consequences, as some patients taking statins have found along with those with ME/CFS.
A reasonable summary of a recent HIUK post about statins would be: ‘You can’t trust claims about statins because they are based on secret data’. While a summary of last week’s post might be: ‘You can’t trust claims about the benefits of psychological treatment for ME/CFS because they have been wildly exaggerated’. Not only that but the authorities involved fought hard and expensively to prevent the facts emerging.
I do think there may be a way out of this long-running conflict between patients and authorities which I will come to later but what happened initially in the wake of these two posts caused my trustometer to plunge even lower.
Impenetrable mathematical wizardry
First was a post on another blog which explained that a trial of the great and good Mediterranean diet had arrived at its impressive conclusion with the aid of the sort of impenetrable statistical workings that has given a shine to statins. I knew that a similar form of mathematical wizardry had created things called ‘collateralised debt obligations’ that set off the banking crash but I’d never actually seen one at work.
Now I have and this is what it looks like:
We calculated PAF [Population Attributable Fraction] based on the formula of rate difference: PAF = (I0 − Ii)/I0, equivalent to I0 − HR × dMDS/I0, where HR was estimated continuously with adjustment for potential confounders as aforementioned, I0 is observed incidence per 10,000 person-years, and Ii represents a hypothetical, ideal incidence if the population achieved high MDS (95th percentile) (dMDS=MDSideal – MDSobserved). The CI of the PAF was derived from bootstrapping to estimate HR and PAF iteratively (n resampling = 100, after confirming no difference in results between n = 100 and 1000).”
Remarkable isn’t it? This one was found in a large nutrition trial published last week extolling the benefits of the Mediterranean diet (the comment originates from the blog). I’m prepared to bet that no more than a handful of BMJ or Lancet readers could assess whether the answer it produced was right or wrong or how the conclusion was arrived at. You just have to take it on trust.
It might be described as a “statistical McGuffin” (A McGuffin is a term used in movie circles to describe something that propels the plot without having any further function.) Its purpose in the trial was to produce a result that would generate the impressive headline: ‘Mediterranean Diet could prevent 20,000 heart disease deaths per year.’
What you need to know about McGufIins
I’m grateful to the indefatigable Dr Zoe Harcombe, a hugely well-informed nutritionist with a clear grip on bio-medical statistics, for this explanation. She cheerfully admitted she didn’t understand the workings of this particular McGuffin, but that didn’t matter. She knew what its underlying assumptions were and what it was designed to do.
Its purpose was to translate the key finding of the research –that following the diet closely made you less likely to die from a heart attack – into the number of lives that would save in the UK as a whole.
The problem isn’t with the mathematical processes but, as with the financial statistical McGuffins, with the assumptions it was set to work on. Firstly, that the result of a study of a 24,000 people with an average age of 59 would be directly applicable to people of the average age in the UK which is 40. Secondly that 12.5% of the total number of heart attack deaths could be prevented with the diet. As Dr Harcombe explains there are good reasons why both are unfounded.
Without independent and informed experts like her, national dietary policy and drug guidelines can presented as objective and scientific when they are actually based on questionable assumptions.
Patients take unusual steps
But there is no need to reach for a McGuffin to give statistics a highly misleading spin. A quick change to the criteria for success can also do it effectively. This move was central to last week’s blog about the remarkable events in the world of ME/CFS where the issue of how best to treat patients is bitterly contested.
For those starting here the story centred round a standard clinical trial that, five years ago, had found that the official treatment –psychotherapy and graded exercise – was effective in improving many patients’ lives and helping a significant number to recover.
When it was published something unusual happened. Not only did a considerable number of patients not believe the results but they wrote letters and compiled reports setting out their reasons and demanding to see the original data. Last month five years of campaigning produced two totally unexpected results. The psychologists who ran the trial were forced to release the data and when it was analysed the patients concerns appeared justified.
What triggered a further drop in my trustometer was the response to this bombshell. Serious questions had been raised about the accuracy of the data underpinning a NICE approved treatment which affects around 200,000 patients. And nothing happened. No TV coverage, no headlines just an uneasy silence like a car crash in slow motion.
The curve ball here was that the re-analysis had been driven by the patients rather than the regulator. That’s unheard of, although there is no reason why the results shouldn’t be correct. In fact there is obviously a case for involving patients in any such re-assessment. They are certainly stakeholders in the business here and I describe a way it might happen below.
Nothing to do with me guv.
The BMJ covered this dramatic story in a misleadingly low-key way. It didn’t spell out the long campaign to get the data or convey how damning was the dismissal of the reasons given for not releasing the data. This was especially curious because the journal has been campaigning for the release of hidden statin data for at least two years. Surely a patient’s successful use of Freedom of Information could have been hailed as a significant victory and maybe a strategy to try?
The Guardian was the only national paper to cover it but it didn’t even attempt to set out the details or provide any context. Instead of dishing out the forensic treatment given to wealthy tax dodgers or regulation busting banks, it handed over half a page to the lead author of the disputed trial to explain how hard he worked to help patients – most likely true –but which he followed with a curious use of the passive tense:
‘There are claims of foul play,’ he wrote ‘with issues over freedom of information and sharing of trial data.’ The fact that he is one of the central figures in these issues doesn’t really come across. It would certainly leave the casual reader no wiser as to what had been happening.
What this limited and downbeat response highlighted was that once a treatment is out there approved and being used, it is virtually impossible to get any kind of reassessment until people start dying as with Vioxx. And that even evidence based critiques are unwelcome.
Cholesterol data fiddling goes back a long way
Resisting any kind of challenge and dismissing critics is also the way the current statin debate has been handled. What I hadn’t appreciated until I started reading a remarkable new book this week, was just how far back the fiddling of statin data and refusal to engage with critics goes.
It has one of those does-what-it-says-on-the-tin titles: ‘Fat And Cholesterol Don’t Cause Heart Attacks And Statins Are Not The Solution’ and contains contributions from 22 leading clinical and academic critics of the widespread use of these drugs.
It builds a detailed case for the way evidence has long been ignored or twisted, detailing, for example, the early shenanigans around the long running Framingham study investigating the links between diet and heart disease. One influential paper claimed that for every 1% reduction in cholesterol there was a 2% reduction in the risk of heart disease. This was seriously misleading. Years later when the study was re-examined it emerged that the study had actually found that for every 1% drop in cholesterol there was an 11% increase in coronary and other causes of death.
The book details other long, large scale trials such as MRFIT (Multiple Risk Factor Intervention Trial) and WHI (Women’s Health Initiative) both of which found that a drop in cholesterol had no effect on CHD. There’s a description of a randomised controlled trial of a cholesterol lowering drug called Cholestryramine, which claimed to have found the same 1% reduction leading to a 2% reduction in CHD events. Again, a subsequent review found no difference between the placebo and drug groups.
Critics warned off having a meeting
But the failed trials were not enough to counter the major PR offensives against cholesterol and the facts about the unreliable ones came out later. Persistent and informed critics were ruthlessly treated. One of these was George Mann, a professor of Medicine and Biochemistry who had done research in 1960 which failed to find a link between lower cholesterol and heart disease rates, which was never published at the time.
When he attempted to organise a conference to discuss flaws in the cholesterol hypothesis only 12 delegates turned up. The rest had been either fooled by false announcements saying it had been cancelled or warned their funding would be cancelled if they attended.
A big difference between then and now is the internet, which makes it far harder to stifle criticism as both ‘Statins Are Not The Solution’ and the ME/CFS re-analysis shows. The opportunities it throws up are leading to more formal involvement by cancer patients, for example, in their treatment under the mantra: ‘Nothing about us without us’. This could be expanded to other diseases.
Patient representatives have long had a place on committees run by companies and organisations but the latest idea, dubbed ‘evidence based advocacy’, is that they should be more involved, informed and proactive. The sorts of things being suggested include ‘conducting online surveys though software such as Survey Monkey, gathering opinions at conferences and conducting Facebook polls.’ Might some such formal feedback system have made action on the demands of ME/CFS patient less of a frustrating battle for both sides?
One organisation called Europa Donna, which involves breast cancer patients, is now being asked to serve on the committees that run clinical trials. Since these can involve highly technical decisions, Europa Donna is providing training, particularly in the research field. ‘The result,’ a spokesperson is quoted as saying ‘is they can do an effective job and not just rubber-stamp what is handed to them by the scientific investigators.’
Is it wildly optimistic to imagine patients sitting across a table from researchers discussing the release of the full data on statins- maybe some had been in the original trials – or making informed critiques of the trial of a new treatment for ME/CFS. Certainly something needs to change.