Children with ME as test subjects – an ethical warning

Norwegian version

We are several ME-moms (and -dads) who for a long time have been concerned about the way our children are met at the National center of ME/CFS expertise (Department of Pediatrics, the Oslo University Hospital).  To redefine a serious physical illness as psychosomatic is a serious matter, an opinion we have expressed earlier (please use google translate to read).

We are not only concerned about the attitude toward our children’s disease at the University Hospital.  The so-called “treatment” our children are offered in line with their “sustained arousal theory”, is of great concern to us as well.  Not only trials with graded exercise, cognitive treatment (including the highly controversial “Lightning Process”), but also trials of potential “stress-reducing” drugs.  The medication now in question is Clonidine. Clonidine is a medical drug that blocks the sympathetic nervous system’s adrenergic activity and is considered to reduce bodily distress. The hypothesis is that “patients with CFS have enhanced sympathetic activity and that sympatho-inhibition by clonidine would improve symptoms and function.” 

In line with this theory, the scientists have for a long time been giving other types of blood pressure reducing drugs (beta blockers) to several children suffering from ME, with little or no positive effects as far as we have observed.  We also have reason to believe that there has been a lack of follow-up of these children, since none of them, to our knowledge, have been summoned for medical follow-up after starting on this medication.  This alone is of medical concern as far as we can see.

Regarding Clonidine – how could the scientists choose to use children when they were testing this drug, knowing that this drug has potential serious side effects (which are also the case for beta-blockers) and is generally not recommended for children at all?

Not recommended for children and adolescents. Serious side effects, even lethal, are observed when clonidine is combined with methylphenidate for children with the unapproved indication ADHD. […]
(Excerpt from The Norwegian Pharmaceutical Product Compendium 2011, my translation and highlighting.)

The fact that a drug trial is performed primarily on children without testing on adults with the same diagnosis is a highly uncommon medical practice as far as we know, a practice we consider both irresponsible and unethical. (Declaration of Helsinki) This is the reason why for instance rituximab, another, – and considerably more promising, drug now being tested on ME-patients, has to await testing on children until results are available from the testing on adults.

We have also seen speculations raised in the Norwegian medical community whether Clonidine should be used in the treatment of ME at all.  The blogger SerendipityCat quotes the neuropharmacologist  Sturla Molden (University of Oslo) who writes that this drug actually can give the opposite results from the expected by increasing an auto-immune process in the body, and that this medical trial in his opinion  is highly unethical and has no value, as discussed here (please use google translate to read).

The hypothesis that ME-patients should have a sustained bodily arousal is also highly speculative and controversial, in our opinion. Research done including «pure» ME-patients selected by strict criteria (ICC) has shown that these patients have substantial biomedical changes in their bodies. Such changes have been described by several medical experts, including prof. Anthony Komaroff (The Physical Basis of CFS) and, recently  by prof. Ian Lipkin and co-workers (only preliminary results), who in a large examination of specimens from several hundreds of ME-patients have discovered  interesting findings suggestive of a continuous stimulation of the immune system leading to an overactive immune response.

One of the major concerns in ME-research in general, and not the least in this Norwegian trial from The Oslo University Hospital, is the use of non-strict criteria in diagnosing ME;

«In agreement with clinical guidelines,2,32 we applied a broad case definition requiring 3 months of unexplained disabling, chronic/relapsing fatigue of new onset […]. We did not require that patients meet any other accompanying symptom criteria.»

This means that the research team probably included patients with several stress-related conditions in addition to those suffering from ME.  This is of concern not only ethically, but also makes the interpretation of the results difficult.  This fact has also been noted by the medical press, commenting upon the Norwegian trial (the clonidine trial in News Daily (outdated link here)). See also a discussion about diagnostic confusion by the Norwegian author Jørgen Jelstad: Diagnoseforvirringen (Google translated from Norwegian).

Despite mainly “negative” findings, the Norwegian scientists have now published the results of the Clonidine trial and an additional trial where they examined the effect of Graded Exercise (GET). Despite the chance of a highly diverse mix of patients they have not been able to confirm their hypothesis of “sustained arousal”.  (Fortunately, we must say).

The fact that a highly speculative hypothesis has lead to drug testing directly on children as we have been witnessing in this trial, is, in our opinion, frightening and alarming and we therefore find it important to shout out a warning!

By Frustrated ME mum, MD, PhD

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