Trial By Error: The View From Norway

By David Tuller, DrPH

I spent the last week of November in Oslo. The Norwegian ME Association invited me to give a couple of talks and have some meetings with public health officials. The city was charming, even if dark and overcast at this time of year.

Not surprisingly, the same tussle taking place over this illness everywhere–between the biopsychosocial forces and the proponents of biomedical approaches–is also occurring in Norway. The country has its own branch of the GET/CBT ideological brigades and a small but vocal group of Lighting Process proponents. Yet Norwegian scientists have also been on the forefront of efforts to seek biomedical answers, with the prime example being the research into rituximab as a possible treatment.

In my talks and meetings I made sure to issue sharp criticism of the Cochrane review of exercise therapies for what it has called chronic fatigue syndrome. The lead author of that review is Norwegian and works for a key health institute, so the document’s ultimate fate was of particular interest to everyone.

Since my visit, in fact, the fortunes of the exercise review and related research have taken a downturn. Cochrane recently rejected a revision of the exercise review. Cochrane has also just withdrawn a protocol–with the same lead author–for a more in-depth “individual patient data” exercise review. That means that Cochrane will not publish the actual IPD exercise review, which was written based on the protocol.

For anyone who hasn’t seen some version of my basic spiel, here it is yet again. This talk–“The PACE Trial: ‘Thing of Beauty’ or Piece of Crap?”–was in Drammen, a small city outside Oslo:

https://www.facebook.com/MEBuskerud/videos/559624284459761/

And below is a Q-and-A about what’s going on in Norway that I conducted with Trude Schei, the Norwegian ME Association’s assistant secretary general (sort of like a deputy director).

Q: What are the estimates of numbers of ME patients in Norway?

We often hear about 10.000 and 20.000, but nobody really knows.
I believe it may be higher than that, since numbers from the Norwegian patient register show that there have been an average of 2000 new diagnoses each year in 2014, 2015 and 2016. We have seen a sharp increase in diagnoses the last few years.

Q: What is the current situation for people with ME in Norway?

In 2011, a Norwegian research institute documented a profound lack of knowledge about ME at all levels of the health service in Norway. As a result of the report, the government set up a National Competence Service, whose aim is to raise the level of knowledge about ME in the health services, and among patients and the population. The Health Directorate, which implements government health policy, also produced a guideline for diagnosis and treatment. These guidelines were published in 2013.

The ME Association is not entirely enthusiastic about the guidelines, but we are pleased that they recommend the Canadian criteria for diagnosis and include PEM. While the guidelines mention CBT and GET as possible interventions for ME, they stop short of actually recommending them. There is also a good section about care of the severely ill. After the guidelines were first published, there were some complaints about the section on care of the severely ill and requests that some advice be taken out, such as about shielding patients from sound and light. Although the guidelines were revised in 2014, the advice about care of the severely ill was kept.

The ME Association is less happy with the National Competence Service (Nasjonal Kompetansetjeneste) for CFS/ME. This service has a biopsychosocial approach to ME. They may not say much in public that is completely wrong, but they fail to say a lot that is right. Among other things, they fail completely to inform health care professionals or patients about PEM, or the report from the Institute of Medicine. They publish pamphlets that say thing like “moderate worsening of symptoms is normal with activity, and the patient should be encouraged to view symptom exacerbation as a normal part of activity.”

The service is currently being evaluated, but the results are not in yet. The ME Association submitted an evaluation in which we essentially said that we do not think the Competence Service for CFS/ME is doing its job, and that it is probably doing more harm than good.

Q: How are patients viewed?

How ME patients are viewed depends on who you meet. Many patients report that they are not taken seriously, and that they do not get the help they need–and that they should have had, according to Norwegian law. How well you are treated by the system seems to be a bit like Russian roulette. We see that it is possible for ME patients to be greatly helped in dealing with symptoms and other aspects of their illness within the system, if they meet the right person–but the wrong person can make their life hell.

There are some very knowledgeable people–that includes GPs, people in social services, and some of the local authorities. There are also some terrible ones. The ME Association has done several surveys of how ME patients are met by the health services and social services. The good thing is that things are better than we expected–the bad thing is that our expectations were pretty low to begin with.

Here are some of the findings:

*Around 50% of patients think that the contact with NAV [Norwegian Labour and Welfare Association, a government agency that deals with employment and benefit issues] made them sicker.

*Around 20% of parents with children with ME reported that messages of concern had been sent to child protection services about their care for their children.

*Around 80% of those who had been to rehabilitation centres (usually a four-week stay) disagreed or strongly disagreed that they had improved.

Q: How much does treatment in Norway focus on CBT and GET?

The national guidelines only say that CBT “might be beneficial” and stops short of actually recommending it as a therapy. However, the idea that “cognitive therapy” is good for ME is prevalent. Health professionals do not generally know that CBT for ME is a very different animal than CBT for cancer, for example. NAV often requires that CBT should be tried before disability benefits can be considered, even though they legally cannot do so.

The guidelines also cite GET as an option without actually recommending it. We also see that some patients are asked by NAV to do GET, but this is less prevalent than CBT.

Q: Is there a big push for MUS [medically unexplained symptoms] or MUPS [medically unexplained physical symptoms] here?

There are a number of health professionals who seem to like to use the term MUPS about what they cannot explain, and to lump everything they cannot explain into the same bag. We see diseases like fibromyalgia, IBS, interstitial cystitis and so on put into this bag. Of course, the proponents of the Lightning Process love the MUPS idea–and support the notion that ME is “all in the mind.”

The focus of the debate in Norway is often not so much on treatment as on the cause of the disease–is it physical, or is it in the mind? There are those who would like to see ME defined as MUPS–and of course if it is defined that way, CBT and GET are the obvious treatments. The line we often hear is: “Yes, we think your symptoms are real (according to those who believe in MUPS it is important to gain the patient’s trust!) but serious problems can be caused by thought processes, have you considered that?”

Q: What is the situation with the Lightning Process? Why does there seem to be an LP movement in Norway?

Live Landmark is a journalist who was diagnosed with ME, did LP and got well-ish. She then trained as a coach and started selling LP in Norway. She is extremely good at marketing her product, and at getting in to talk to anyone in a position to make decisions about ME. She can be extremely charming. She knows the press in and out, and knows how to plug articles where patients give glowing testimonials. That is the main reason LP has become such a big thing–clever marketing.

Unfortunately, all the publicity around LP has harmed patients. Many people–even health professionals and politicians–have come to think that it is possible to get well quickly if you only want to. This makes it hard for ME patients to be taken seriously in many cases.

The marketing has changed over the years. First LP was presented as a cure for ME. But as advertising rules became stricter, it became “stress management” and a “training course,” not a “treatment.” NAFKAM is an organisation that keeps an eye on alternative therapies. It classes LP as an alternative treatment, as does the Health Directorate. A number of patients have reported severe adverse effects of LP to NAFKAM.

Recently, when the rules for advertising alternative treatments were tightened again, Recovery Norway was founded. This is an organization for those who say they have recovered from ME and other diseases with the help of “mental techniques.” They claim that their stories of recovery are more worth listening to than the stories of those who are still ill. They claim to give hope–at the same time accusing the ME Association of crushing hope when we give patients realistic information on prognosis.

Those from Recovery Norway also perpetuate the myth that ME patients are “difficult” and claim that those who talk about their own recovery are persecuted. It seems that people like to believe in simple solutions – and that taking a three-day course where you are told not to “do ME” can cure serious illness.

I am very happy that some people have recovered from ME, and I can sympathise with the wish to communicate how you got well. What I find hard to understand is that this group does not seem to grasp that even if something helped them, it may not help others, and that their experience is not necessarily universal. As it is, I feel that this group is doing a lot of damage to how ME patients are perceived, and to how both the public and health professional perceive ME.

Q: What has changed in the last 2-3 years, if anything? Has support for PACE and the GET/CBT paradigm weakened, stayed the same or gotten stronger?

The ME Association has shared most of your blogs, and most patients seem to know about the problems with the PACE trial. We saw a big change with the Rituximab trial, with more attention and more people believing ME was an organic disease – but during the last year the National Competence Service and Recovery Norway have done a lot of damage.

On the other hand, we also see more awareness of the symptom of PEM and that ME patients should not be pushed to do too much. We find that it is easier for the ME Association to get to talk to politicians and health officials.

Q: What is currently happening with rituximab and/or other biomedical research, if anything?

There are number of big projects going on. A few years ago, the Norwegian Research Council wanted to change how grants were given, after new legislation asked for more involvement from consumers/patients. They wanted to pilot a new model, and ME was chosen as the area to do so. A committee of patients, carers, administrators and health professionals helped write the invitation for proposals and conduct the first round of screening applications.

There was an application for an LP study from Live Landmark and a well-known professor who supports the biopsychosocial approach, Vegard Bruun Wyller. It did not pass the first round. That caused acrimonious debate in the media, where as usual it was claimed the denial was because of undue pressure from angry patients.

But four projects got grants in the end:

Karl Johan Tronstad in Bergen, who had studied the possible role of the citric cycle-pyruvate dehydrogenase, is looking further into cellular energy production.

A team in Harstad is doing a project on fecal transplant as a possible treatment.

Benedicte Lie in Oslo is looking into associations between HLA genes and possible auto-immunity.

Fluge and Mella are still working on some results they have not published yet, and we are curious to see them. They have built a large biobank. The big question is whether they will be able to say anything about why some responded and others did not – in both the Rituximab and the placebo group. I think that a lot of interesting things could still come out of the trial.

Q: And a final question. Given that the lead author of the Cochrane exercise review is Norwegian and employed at a Norwegian government institute, do Norway public health officials have a special role to play in getting rid of it?

I would certainly hope that Norwegian authorities play in part in getting rid of flawed research when and if they have the power to do so!

Comments on this entry are closed.

  • Sten Helmfrid 12 December 2018, 4:53 pm

    Thanks for a yet another nice blog entry, David. I am a bit puzzled by the stated number of patients. Norway has about 5.3 million inhabitants. The published prevalence rates for the Fukuda criteria are in the interval 0.19–0.42% and for CCC about 0.11%. That means that the number of patients in Norway should be somewhere in the interval 10000–22000 if they are diagnosed according to the Fukuda criteria and around 6000 if they are diagnosed according to the CCC criteria.

    If there are 2000 new diagnoses every year, that is a lot. Are the stated numbers from the Norwegian patient register confirmed? Have they been published somewhere? There have been claims in newspapers that there is an ME epidemic in Norway. I have been very skeptical to these claims, as the published incidence of ME in the UK agrees with what can be expected from the known prevalence rates. But if the number 2000 new diagnoses each year really is true, that would indicate extremely high prevalence rates in Norway—or an inadequate diagnostic process.

    Does anyone of our Norwegian friends know anything about this?

  • Trude Schei 12 December 2018, 5:38 pm

    These numbers were, as far as I know, produced by the Patient Register on request from the Norwegian Health directorate as part of their work, not as part of a study. They have not been published in a study, but got some attention in the press in 2015:

    https://www.nrk.no/norge/fem-ganger-sa-mange-me-diagnoser-som-i-2008-1.12422139

  • B 12 December 2018, 7:45 pm

    Helmfrid: is there not also more MS and autoimmune disease in general in the North vs the World in general?

  • Sten Helmfrid 13 December 2018, 3:48 am

    @ B. That is true, but the prevalence of 0.11% for CCC was quoted from a British study. So, there shouldn’t be that big difference as compared to Norway. I am still puzzled …

  • Peter 13 December 2018, 4:26 am

    Thanks David.

    Sten: Cant give you the source here and now, but I think the estimation of 10.000-20.000 patients in Norway are based on the assumption that the prevalence of ME (CCC) are somewhere between 0,1-0,2% of population.

    The 2000 per year and the the “epidemic” bogus is out of this world, often used by Landmark. All these numbers really only says how little knowledge there is. Numbers of diagnosis of ME have complex factors. There are several reasons that could explain a rise from previous years. Knowledge is somewhat a little better, could be more people actually getting ill. These factors would result in a slight increase, no way like this. What we never can forget, is that there for years have been and probably still also are a significant rise in misdiagnosis. One thing is primary care, where there are a lot of doctors not knowing of ME and misdiagnosing. But knowledge is so bad, that even a diagnosis from specialist care may be fundamentally wrong.

    The diagnosis process is really bad. The National Competence Service (Nasjonal Kompetansetjeneste) for CFS/ME has not contributed in any meaningful way raising knowledge in Norway.

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  • Sissel Sunde 13 December 2018, 1:46 pm

    I’m a Norwegian patient (Postviral fatiguesyndrom G93.3 triggered by severe Denguefever) who has some additional information related to the number of patients as well as approved ME-treatment and Research in my country.

    DIAGNOSIS

    In the West of Norway there’s a Stress Management Clinic who focuses on ME/CFS. http://www.stressmedisin.us/Stressmedisin/Klinikk_for_stressmedisin.html

    In 2016 they were given a special agreement with “Helse Fonna” to examine all patients above 18 years for ME/CFS in a certain part of the country. https://praksisnytt.wordpress.com/2016/07/20/klinikk-for-stressmedisin-forst-ute-med-ny-samarbeidsavtale/

    I’m not diagnosed by them, but I’ve attended their 4 days treatment-program for ME/CFS. I’ve listened to the Clinic’s Director and Psychatrist Dr. Bjarte Stubhaug, call people who were able to work 40-50 hrs/week and be active in sports for ME-patients. I’ve heard him say ME is just going through a bad phase, or have a bad day, and that you can get ME in your relationships and s*xlife too….

    I’ve argued with him after becoming bedridden for 24 hrs with severe worsening of symptoms during the program, and yet been told there’s no difference between me and a stressed person. He said all fatige were ME/CFS, regardless if it’s caused by physical or psychological triggers, regardless of additional symptoms and reaction to activity.

    Me meeting the Canada Criteria had no value as people could read them online, he said. Nor did he acknowledge the Norwegian study “Metabolic profiling indicates impaired pyruvate dehydrogenase function in ME/CFS” which just had been published at the time. https://insight.jci.org/articles/view/89376

    He also asked me to make a choice, if I belived in him or the ME Assocciation.

    Based on this experience I think it’s fair to question how many stressed and depressed people are getting the diagnosis here..?

    TREATMENT

    The clinic treats the patients with stressmanagement (regular sleep and meals, Mindfulness and 1 hour daily hiking). Basically, you spend 4 days being told you’re not sick and can recover if you want to. The key is to ignore your body and symptoms, withstand the discomfort, have a strong mind and stay motivated.

    The premises are in Dr. Stubhaug’s private house/childhood home, 5-600 meters away, uphill from the hotel we stayed in. The Norwegian government payed for everything; the 4 days program, accommodation, food and travel.

    RESEARCH

    According to their website, the clinic is approved for doing research on their own treatment by REC (Regional Committees for Medical and Health Research Ethics) and General Data Protection Regulation.
    https://helseforskning.etikkom.no/
    https://www.datatilsynet.no/en/

    The results so far are very positive for treating ME/CFS and will be published, according to their website.

    This is my experience with their research:
    Every participant on their ME/CFS treatment-programs, regardless of diagnosis, symptoms and level of function, are invited to attend the study. 6 out of 8 participants on my program did not have ME/CFS-diagnosis, yet they were enrolled in the study. Personally I was enrolled without been given any information about the study, nor ever signing the form of consent.

    The study consists of 4 similar forms to be filled out within a year. The same form is being used by the Dead Sea Clinic, which is a clinic for all kinds of health issues. No questions are related to ME-symptoms, PEM or level of function.

    Several from my course, incl. myself, did not receive the 4th and last form. Additional tests, mentioned on their website as being part of the study, were not offered. Such as psychophysiological and cognitive tests, and measure of the stresshormon cortisol.

    Dr. Stubhaug is also represented in the “Regional Competence Service for CFS/ME, Region West” and was involved in creating the report for “Diagnosis, treatment and follow-up of ME/CFS-patients, Region West” in 2013.
    https://helse-bergen.no/regionalt-kompetansesenter-for-habilitering-og-rehabilitering/regionalt-kompetansenettverk-for-cfs-me-i-helse-vest#nettverkets-representantar

    MEDIA

    A few weeks ago, one of the biggest newspapers in Norway (Bergens Tidende), published a very positive article about Dr. Stubhaug and his ME/CFS-treatment. It has pictures of people knitting and drawing, being motivated and committed to change their lives and no longer worry about their symptoms. The heading says: “I don’t provide support to people who feel sorry for them selves.” https://www.bt.no/btmagasinet/i/VRvOgW/-Eg-driv-lite-med-stakkars-deg-og-troyst

    I’ve reached out to the newspaper twice afterwards, as well as to another major paper, but unfortunately they don’t seem interested in the information and documentation I’ve provided. Yet.

    So in Norway a person can be given the power to both examine, treat and research on a disesease he don’t acknowdge – but side with worries and bad relationships. Be fully supported by the government – and the media – despite patients getting worse and the progress made in biomedical research.

    If you want to support the Norwegian patients, please consider signing the ongoing poll which claims to dissmiss today’s leadership at the National Competence Service for CFS/ME. It’s currently signed by more than 6 100 people and will soon end. English version here:

    https://melivet.com/2018/08/25/petition-to-help-norwegian-me-patients/

    Thank you!

  • Lois Addy 15 December 2018, 8:05 am

    i’m confused. about the guidelines for the severely affected people. it’s not clear to me why advice to sheild severely affected from light and noise would be a bad thing? we often have trouble with those. so why would that be wanted to be taken out?