Coyne of the Realm’s open letter to the National Health and Research Medical Centre (NHMRC) of Australia

I received the  message below from Australia. I attempted a timely response to the National Health and Research Medical Centre (NHMRC) concerning their convening of an Advisory Committee to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). [Please don’t let this establish an expectation that I can respond to such requests in the future, but this time I did.]

If you have any time to write to the NHMRC at me_cfs@nhmrc.gov.au before Thursday  I’d appreciate it enormously. As you know, professionals hold much more sway with government than us patients.

kangaroo_600_600My assessment of the situation in Australia:

To put it bluntly:  Detection and diagnosis, as well as research and public policy concerning Myalgic Encephalomyelitis (ME) in Australia are a disaster. There is a high likelihood of the situation becoming worse.

The letter to NHMRC

To whom it may concern:

I understand that an Advisory Committee is being established to provide advice on research, funding and treatment of Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). I am told that it will convene on December 7 and that you are open to input from the international scientific community. I hope these comments reach you in time or that you otherwise will consider them.

By way of introduction, I am a Professor Emeritus of Psychology in Psychiatry at the Perelman School of Medicine of the University Of Pennsylvania. I have had a visiting professorship in the School of Psychology at Australian National University. I regularly come to Australia. In the past, I have given keynote addresses at the Australian Behavioural and Cognitive Therapy Association in Sydney, presentations at the World Congress of Behavioral and Cognitive Therapies meeting in Melbourne, a keynote at the Australian Skeptics National Convention in Brisbane and numerous talks and workshops on critical thinking and science writing throughout Australia. I particularly enjoy presenting to Australian audiences, because I feel so free to speak directly with a candor that does not always go over well elsewhere. I write here in that spirit and with that candor.

I have no financial conflicts of interest to declare with respect to myalgic encephalomyelitis a.k.a. chronic fatigue syndrome in terms of receiving any financial support from anyone for my opinions.

To put it bluntly:  detection and diagnosis, as well as research and public policy concerning ME in Australia are a disaster and there is a high likelihood of the situation becoming worse.

Epidemiologic data suggest that Australian GPs employ loose criteria for detection and diagnosis, seemingly considering a serious medical condition as simply being a highly prevalent “chronic fatigue”. The risk is that substantial numbers of patients may be denied treatment for treatable medical and physical conditions, whether already diagnosed or not yet diagnosed. Accurate diagnosis of these conditions may be delayed. Much of the treatment research similarly employs loose criteria. The combined failure of some Australian treatment studies to exclude minor common mental problems, the reliance on subjective self-report outcomes and the unblinded designs would lead to even homeopathy appearing effective. Generalizations are being made from patients who do not have the cardinal symptom of postexertional malaise (PEM) to patients who do not participate in the trials, but who have PEM and are at risk risk of harm from receiving these treatments.  In the United States, with stricter diagnostic criteria have now been adopted, Australian treatment studies are not admissible evidence. I’m not at all suggesting blindly following the Americans, but I think their extensive documentation empirical evidence for this position should be considered in the own right. RACP Chronic Fatigue Syndrome Clinical Practice Guidelines have rightly been criticized by patient groups as leading to misdiagnosis, unrealistic expectations for psychological approaches to ME, and and for ignoring accumulating evidence of biological parameters to properly and strictly diagnosed ME.

A planned RCT of online continuing education for health professionals funded by the Mason foundation would likely ensure the bad guidelines potentially leading to ineffective treatment and harm to some patients are going to be more consistently applied.

Australia is convening an advisory committee concerning research, funding, and treatment at a time when the Americans have already begun such a reevaluation, the Dutch are about to, and the British have announced a reconsideration of NICE guidelines. It is important to achieve a balance of viewpoints in the makeup of that advisory committee in terms of general practitioners, consumer/patients/advocates, and researchers. The risk is that glaring problems in the status quo will be perpetuated and emerging research in re-evaluations will be ignored.

To understand how some of these issues can be dealt with, I recommend a summary of a meeting held at the UK House of Lords in September 2017 between Professor Mark Baker, Director of Guidelines, NICE, and, Mr P Boorman, Communications, NICE and patient representatives for a summary of some of the issues involved in assembling committees reevaluating guidelines on myalgic encephalomyelitis.

I’ve examined a recently updated list of the membership of the advisory committee. It’s laudable that there are representatives of advocacy groups are members. However, there should be some concern about such groups that stand out from other advocacy groups in supporting treatments the other groups consider potentially ineffective or harmful. Similarly, it is laudable that Professor Andrew Lloyd is among the members. However, he has passionately and emphatically spoken out in favor of cognitive behaviour therapy and graded exercise therapy, which, for good reason, are no longer recommended by the American Agency for Healthcare Quality Research or Center for Disease Control. I’m particularly concerned by statements attributed to Professor Lloyd in a recent letter from Professor Rodney Phillips, Dean of NSW Medicine. They are almost verbatim from what I get when I submit statements from a member of the Dutch Health Council to Google translator. Perhaps they are drawing on the same talking points. I would hope that the presence of Professor Lloyd would be balanced with the presence of academics from MCRI, the ANU and Melbourne University who hold decidedly different points of view.

I am a member of the Cochrane Collaboration. I shared in one of their Bill Silverman Prize awards for my alerting the collaboration to conflict of interest as a risk of bias. In raising issues about balancing competing interests on the advisory committee, I’m not suggesting financial conflicts of interest, but that clear, strongly held beliefs that might be resistant to contrary evidence.

Finally, my own non-financial declaration of interests: I requested data that the PACE trial investigators had promised would be available as a condition for publishing in PLOS One, the megajournal where I am an Academic Editor. I had thought there would be a timely response to a straightforward request. Two years later, the investigators continue to refuse produce the data, and the Journal has taken the extraordinary step of placing an Expression of Concern on their article, which many interpret as the first step before a retraction.

Similarly, I have raised issues and dueling blogs with David Tovey, a senior administrator at the Cochrane concerning financial conflict of interest and switched outcomes in Cochrane reviews of graded exercise therapy. I was very surprised and disappointed when Dr. Tovey refused my request for individual participant level (IPL) for independent-re-review of a systematic review and meta-analysis in which the PACE investigators were directly involved. These experiences leave me with seriously concerns about the validity of the PACE trial and the Cochrane reviews that depended on studies with similarly coordinated switching of outcomes. So, do take these intellectual and scientific commitments of mine into account, but also consider the need for balance in the membership in the advisory committee for similar intellectual and scientific commitments.

Thank you for your consideration and do not hesitate to contact me if I can be of further assistance.

Sincerely,

James C Coyne, PhD