Author: Dutch Citizens’ Initiative “Recognize ME” (Group ME-TheHague).
In the release of its much-anticipated report, the Dutch Health Council sees no reason to advise the use of Graded Exercise Therapy for people with Myalgic Encephalomyelitis / chronic fatigue syndrome. However, the report does not go as far as to provide a rebuttal of GET or CBT.
The report stated that patients must be free to decide whether or not to undergo Cognitive Behavioural Therapy (CBT) and/or GET, and that choosing to decline these treatments should not invalidate patients’ insurance or disability claims.
“The choice to refrain from CBT or GET should not lead to the judgment that the patient misses his chance of recovery, does not cooperate in his or her recovery or acts culpably,” the report stated.
Protection from being forced to undergo CBT or GET is not clear since the Dutch association of insurance physicians (NVVG) rejected the Council’s conclusions regarding CBT and GET.
In a preliminary statement, NVVG said they can only agree with recommendation 1 (more research funding); the report in its current form is not workable; its conclusions lack scientific basis and are – in their view – tainted by patients’ perceptions.
The Dutch Health Council also proposed using the IOM criteria for diagnosis, which means that post-exertional malaise (PEM) is a mandatory symptom. (The report does not discuss or recommend which criteria to use for scientific research.)
The council also said there is an urgent need for research to help patients and for new treatment options. It acknowledges that in the past decade no biomedical research has been funded by the Dutch Government (all the money after the former 2005 Health Council report went to CBT/GET research). And that it is important for the Netherlands to close that gap and become part of international biomedical research developments.
Even though the recommendations are an important step in the right direction, guarantees and concrete actions will now have to be discussed with Parliament and the Minister of Health. They will determine what to do with the report and its recommendations.

Seven Years of Activism

The Dutch Health Council advisory report released on March 19th was a direct result of seven years of advocacy work by a Dutch Citizens’ Initiative (Group ME-The Hague).
A group of 10 severely ill ME patients started a petition “Recognize ME” in 2011. Their goal: recognition of this (neurological) disease recognized by the WHO since 1969 (ICD-10 G93.3).
The ME-The Hague Group sounded the alarm because adequate diagnosis, knowledge, care and investment in biomedical research in the Netherlands has been completely lacking for decades.
It took two years to collect over 56,000 signatures. After several meetings with parliament finally, in 2015, with a unanimous vote, the entire House of Representatives asked the Dutch Health Council (which is their official advisory body) to write an advisory report about the current state of science regarding ME. A committee was installed in March 2016 and now, two years later, the report is finished and public. It was presented to Parliament in a closed session on March 13^th 2018.
An English summary of the report can be found here. When the full report becomes available in English we will post the link.

Summary of the Report

• Recognizes “ME/CFS” as a serious chronic multisystem disease and cites that scientific research shows abnormalities in the immune system, the metabolic system, the cardiovascular system, the central nervous system, the neuroendocrine system, the microbiome and the genome. The disease substantially limits the functioning and quality of life of patients.
• Proposes the IOM criteria for diagnosis (means post-exertional malaise (PEM) is mandatory symptom). (The Dutch CFS guideline from 2013 (not authorized by patient organisations for its lack of inclusion of biomedical research and overemphasis on CBT/GET, recommends Fukuda in which PEM is not mandatory).
• Sees no reason to recommend GET. It also states that there is no evidence for effectiveness of CBT/GET for home- or bedbound patients (as they were never represented in research). Both points, however, are not included in the executive summary.
• As to non home- and bedbound patients, the committee was clearly divided on CBT (remember the committee consisted of several BPS proponents, with background in CBT/GET), a small majority considered it a relevant treatment “option”, other committee members opposed it, especially the type of CBT provided to patients in the Netherlands (based on hypothesis of false illness beliefs, and its standard inclusion of gradual increase of activity).
• The committee concluded that patients must be free to decide whether to undergo CBT and/or GET. In assessments made by insurance physicians (fitness to work or assessment for medical aids or help in household), CBT and GET can not be regarded as “adequate medical treatments according to general medical standards to which patients can be obliged,” and “the choice to refrain from CBT or GET should not lead to the judgment that the patient misses his chance of recovery, does not cooperate in his or her recovery or acts culpably”.
• The report does cite publications about patients’ experiences with CBT and GET and their dissatisfaction with the lack of adequate care. The report mentions based on 0 to 10 point scale (10 being the best), that Dutch patients give the quality of care on average a 2.3 score.
• The report states that there is an urgent need for research to help patients and for new treatment options. It acknowledges that in the past decade no biomedical research has been funded by the Dutch Government (all the money after the former 2005 Health Council report went to CBT/GET research). And that it is important for the Netherlands to close that gap and become part of international biomedical research developments.
• The committee concludes by making four recommendations:
  1) The Minister of Health should commission ZonMw (government research funding organisation) for a long-term, substantial research programme on ME/CFS. The research would primarily focus on substantiation of the diagnosis, pathogenesis and treatment.
  2) Those responsible for training and further education of healthcare providers should ensure that education and training highlight the serious, chronic, multi-system disease ME/CFS and what healthcare providers can do for patients with this disease.
  3) The Federation of University Medical Centres and healthcare insurers should designate a few university medical centres that – in collaboration with patient representatives, other hospitals, GPs, rehabilitation centres, sleep centres and other healthcare providers in the region – will open an outpatient clinic for ME/CFS, with associated healthcare networks and research groups.
  4) Medical disability assessors within the context of private and social disability insurance, the Social Support and Provision Act and the Long-term Care Act should recognise that ME/CFS is a serious disease that is accompanied by substantial functional limitations, and they should not regard a patient’s decision to forego CBT or GET as inadequate recovery behaviour.

The negative/what Dutch Patients worry about
Although the assignment from Parliament was a report on ME (ICD G 93.3), the Dutch Health Council decided (not part of their charge) not to use the term ME, but ME/CFS, which does not exist in the WHO classification (ICD-10). This could lead to misdiagnosis and misclassifications.
One of the Dutch Citizens’ Initiative’s goal has always been taking ME out of the broad “CFS” umbrella that was created by broadening the original ME criteria into a heterogeneous group of “fatigued” patients (especially by psychologists). Research shows that the IOM criteria recommended by the report is still broader than ME criteria (such as Ramsay or ICC criteria), which select a sicker group of patients with more functional limitations. The report does not discuss or recommend which criteria to use for scientific research.
With the conclusion that this is a serious chronic multi-system disease and the biomedical research presented (even though this could have been far more comprehensive), there should be no discussion about the nature of this disease.
Irrelevant labels given by (bio)psychosocial (BPS) proponents, like MU(P)S (medically unexplained physical symptoms), somatoform disorder, neurasthenia, somatic symptom disorder, functional somatic syndrome, bodily distress syndrome/disorder, ideopatic fatigue etc, have harmed patients, and are no longer appropriate.
However, this BPS paradigm dominates care in the Netherlands. Even members within the Dutch Health Council committee openly continue to use these terms. There is a strong movement within UK and elsewhere in Europe to rebrand/relabel the disease. Given the fact that the report does not explicitly say what the disease is NOT, this remains a problem. In a reaction to the report in a Dutch journal for physicians, several well known CBT/GET proponents vented their frustration with the report, stating that the “label” multi-system disease, strengthens “somatic attributions” and places the disease outside the cluster of “MUS”.
Not a Rebuttal of GET
Concluding that patients cannot be forced to undergo CBT or GET is important but gives no guarantees. Currently, Dutch patients are almost always, as a condition for receiving benefits, obliged to follow CBT/GET. This also applies to obtaining medical aids, etc.
In a preliminary statement the Dutch association of insurance physicians (NVVG) said they can only agree with recommendation 1 (more research funding); the report in its current form is not workable; its conclusions lack scientific basis and are – in their view – tainted by patients’ perceptions.
Where does that leave patients when faced with assessments by insurance physicians in the future?
In addition, parents of young patients are regularly classified as “perpetuating factors” for the physical chronic illness of their child. Children with ME in the Netherlands are still regularly confronted with child protective services when their child does not follow CBT or doctors do not recognize the disease as “real”.
The Council’s report also takes a too positive stance towards the flawed PACE trial that has been the undergirding of GET and CBT for people with ME and CFS.
Although the report states, in accordance with the NIH, that the Oxford criteria are not suitable, the report references the Oxford studies in its report and conclusions.
The Agency for Healthcare Research and Quality (AHRQ) in their review separated results from the Oxford criteria studies versus other studies in an addendum in 2016, concluding that there is no evidence for the effectiveness of CBT/GET in patients who meet CFS, ME/CFS or ME criteria. The Dutch Health Council ignores this conclusion, instead citing older reviews that did not make this distinction.
The report also cites the PACE longterm follow-up conclusion (already shown to be incorrect).
The independent PACE reanalysis papers are not mentioned at all in the advisory text let alone are the results taken into account in the conclusions. The Health Council wrote an appendix about international developments that briefly mentions PACE and the controversy, but none of the peer reviewed published reanalysis papers are cited.
There is also no discussion about the different definitions (cut-off scores) used in research to define subjective improvement and recovery. Objective recovery (resumption of work, increasing activities, physical condition) has never been demonstrated in CBT/GET studies. The Dutch Health council fails to address this. The text often talks about an “effect” (of CBT/GET) without clearly specifying it.
Although the committee seems to distance itself from GET (sees no reason to recommend it), they fail to stress what this means for CBT, as in the Netherlands GET is a standard part of CBT, which they still consider to be a treatment option. A discussion about the lack of evidence for the underlying hypothesis for these treatments (false illness beliefs, deconditioning, fear of exercise etc) is absent in the report. This leaves room for an unproven (bio)psychosocial model to be perpetuated and patients can still be told (as they are now) through CBT that they might have had a virus, but that they are not ill anymore, that thoughts and behavior are perpetuating their symptoms – that increasing activity and ignoring symptoms is a way to get better.
What’s Next?
Even though the recommendations are an important step in the right direction, guarantees and concrete actions will now have to be discussed with Parliament and the Minister of Health. They will determine what to do with the report and its recommendations.
For the Dutch Citizens’ initiative, it’s important that the focus should remain solely on ME patients. A long term research program will only succeed and be meaningful for ME patients if the Minister of Health frees up substantial funding AND when it funds biomedical research only. The Dutch Citizens’ Initiative advocated for this from the start. The Dutch will not accept funding of any other type of research (CBT/GET) and be extra cautious about conflicts of interests in ZonMW committees, that determine where research money will go (after a 2005 debacle, where most money ended up in the hand of those on the committee and their CBT/GET colleagues).
Cooperation between international biomedical research initiatives should be a prerequisite for receiving funding. Foreign biomedical expertise is required for training of health care professionals (as ME expertise is lacking in the Netherlands, and a false paradigm still dominates).
When setting up outpatient clinics, it must be ensured that the care provided also reaches the patients (adults and adolescents) who are home/bedbound and that the outpatient clinics are not converted into “MUS” clinics or centers for ‘chronic fatigue”, that ME patients have been subjected to for decades.
Patient involvement in directing research (funding), education, a new guideline (for ME!) and care that meets their needs, will be essential to achieve a much needed paradigm shift.
Much work ahead!