Make Sure We Speak

After a difficult few weeks in the world of ME advocacy, it’s been really heartening to see the new critique of the PACE trial and accompanying editorial on the Sense About Science USA/ American Statistical Association website. After 7000 words of searing analysis, Rebecca Goldin concludes that the flaws in the study design “were enough to doom its results from the start”, while Trevor Butterworth’s editorial pronounces “a terminal prognosis” on the study. As far as patients are concerned, this demise cannot come too soon – and it remains to be seen if the British media, who have uncritically lauded the study on so many occasions, will consider this latest development to be worth reporting.

Nevertheless, it is encouraging for patients to receive such clear validation of what we have been saying for so long from such a reliable source. It has to be another important step in the right direction.

Trevor Butterworth writes: “David Tuller may not get a Pulitzer Prize for investigating PACE trial on a blog; but his service to—and we do not exaggerate—millions of sufferers around the world make it hard for us to think of another work of journalism so deserving of commendation.” Patients – including those who produced the initial critiques which first attracted Tuller to the issue – will heartily agree with that analysis, likewise with Butterworth’s acknowledgement of the important contribution of Julie Rehmeyer in drawing attention to the flaws of the trial. Let us hope their work pays off very soon and the study is deservedly retracted. Lead PACE investigator Peter White still has his finger in the dam but sweat is breaking out on his forehead. He must be wondering how much longer he can hold back the torrent of truth.

Meanwhile, concerns continue regarding the upcoming US NIH (National Institutes of Health) Post-Infectious CFS Study. Some issues, such as the bizarre ‘functional’ movement disorders control group which I addressed in a previous post, have now been resolved but others remain, most notably the continuing presence of Dr Brian Walitt, who has described CFS as a ‘somatoform disorder’ in the post of ‘Lead Clinical Investigator’. There are also problems with three of the other so-called ‘ME experts’ involved with the selection of patients, as Mary Schweitzer explains in the supporting text of her petition (of which more in a moment):

* “Dr. Elizabeth Unger from CDC has told patients that “cognitive behavior therapy and graded exercise” are “scientific” and would remain on CDC’s website despite the IOM report;
* “Dr. Fred Gill recommends counseling and exercise in his most recent NIH/CDC educational video on the disease and seems unaware of the current literature on biomedical abnormalities in ME/CFS;
* “Dr. Leorey Saligan considers himself an expert on “fatigue” and states he is “investigating the relationship of fatigue with other behavioral symptoms including pain, sleep, depression, anxiety, and catastrophizing.” “

So four out of the five ‘experts’ on the committee have views about ME which seem very much out of alignment with the ‘new start’ which has been promised by the NIH. The Study Leader, Dr Avindra Nath, has announced that the hypothesis for the study is to be that “post-infectious ME/CFS is triggered by a viral illness that results in immune-mediated brain dysfunction” and has outlined the comprehensive series of tests which will be involved in examining this. All of which sounds very promising. But why, then, appoint so-called ‘experts’ who seem to have a very different view of the condition? How does that make sense?

There have been heated disputes among patient advocates about how best to respond to these mixed messages from the NIH. The study personnel seem to be pulling in two directions at once, so perhaps it is not surprising that the patient community has also split, with patients dividing into two camps: seeing the glass as either half full or half empty. This seems to me to be perfectly understandable. The fact is: the glass is half full and half empty. The NIH appears to be full of good intentions but some of the so-called ‘experts’ involved seem to be empty of understanding of ME.

So what are we supposed to do about it?

Many of the patient advocates I greatly respect are convinced that all is well and we should not make a fuss. Simon McGrath, to whom I am immensely grateful for his excellent lay people’s guides to the complexities of ME research, is inclined to be optimistic. He writes on the ME Action site: “the sentiments and plans are all great, and I can’t think of another ME/CFS study or research programme with anything like this level of patient engagement. The NIH deserves a good deal of credit for this work”.

He goes on to report that Dr Walitt “appeared eager to say the right thing” at the 8^th March NIH telebriefing and he seems to have been reassured about Walitt’s attitude to the condition by the latter’s explanation that “if ME/CFS is all in your head, it’s only because your head is part of your body”.

Here’s where I find myself disagreeing with Simon. For Dr Walitt to try to explain away his theory about ‘somatisation’ with “your head is part of your body” is another example of the obfuscating tactic we so often get from Prof Wessely and the psychosocial lobby.  They try to pretend that the distinction between physical and psychological conditions is inconsequential and just the result of some sort of silly prejudice on the part of patients. They claim we are only concerned about it because we don’t want the supposed stigma of mental illness – as if we didn’t have enough stigma already from having ME. This argument flies in the face of the inarguable reality that, as nonsensical as this distinction is, it derives not from patients but from the medical profession itself,  where mental health issues are dealt with in separate departments from other conditions, where mental health patients are treated dismissively by many health professionals (loath though they might be to admit such a thing), and where conditions such as ME go under-researched and under-investigated because of this mistaken classification. On top of which , there are the consequences for health insurance payments and social support, both of which – in the real world – can make so much difference to the wellbeing of patients.

Not only is this argument misleading, it is deliberately misleading. It is a conscious attempt to produce a smokescreen. Far from reassuring me about Dr Walitt, it makes me all the more convinced that he should not be involved in this important study. He had a chance to sort things out by saying clearly and distinctly at that telebriefing that he does not believe ME/CFS is a ‘somatoform disorder’. He chose not to take it.

The ‘half full’ faction are rightly concerned that patients should not be seen as unreasonable: that we should not be banging and shouting at Francis Collins’ open door. Well fair enough. But surely it’s important that we should make use of that (supposedly) open door?

On that same teleconference, NIH Director Dr Collins emphasised that his organisation wanted to work together with the patient community. “We want to hear from you,” he said. “We’re listening carefully to the comments and suggestions you might have about how best to move this effort forward.”

So I think we should make full use of that invitation. We should let them know – politely – what we think.  We should consider the situation entirely objectively – setting aside any fears we may have about being seen as ungrateful – and ask ourselves a question. After all that has happened, after all the years of neglect and trivialisation by the US government agencies, after the admission in the IOM Report that patients have suffered from “the misconception that (ME/CFS) is a psychogenic illness or even a figment of the patient’s imagination”, after the P2P Report’s finding that “both society and the medical profession have contributed to ME/CFS patients feeling disrespected and rejected” and furthermore that “(ME/CFS) is not a primary psychological disease in etiology”, after all of that, is it even remotely reasonable that not only the ‘Lead Clinical Investigator’ but the majority of the so-called ‘experts’ involved in the final selection of patients for the study appear to have made statements suggesting a psychogenic interpretation of ME? How can that be right? How can that he helpful? How can the NIH believe that is even remotely acceptable?

It seems to me that we have to leave them in no doubt what we think about it. It serves us (and all concerned) to be polite, but they said they want to know what we think. We should make sure we tell them: not only about the so-called ‘experts’ but also about the other remaining issues concerning the study.

There are two very easy ways to do this.

Mary Schweitzer has produced a very good petition which focuses on the vital importance of selecting a cohort of patients who actually have ME – and the imperative of having ME experts who genuinely understand the condition to ensure this happens.

Another petition (from ME Action) emphasises the importance of placing patients at the centre of the study design process. There has been a lot of lip service paid to this by the NIH and the teleconference was reassuring to some, but all this time into the planning, there is still nothing formal in place. The NIH have said that they want to be partners with patients. They need to work out how to put an arrangement in place to achieve this as soon as possible. This petition also summarises the various other issues which need to be addressed, including the Lyme Cohort, another strange choice of control group considering the difficulty in diagnosing Lyme and the controversy concerning Chronic Lyme, a condition often confused with ME yet whose very existence is in dispute. ME itself is complex and controversial enough. Why make things more difficult by adding in yet another controversial condition? The Lyme cohort has been explained on the grounds of ‘convenience’. But how is it convenient to add in another – entirely unnecessary – element of controversy and complexity?

If you haven’t already signed these petitions, please consider doing so. If you’ve already signed one, please consider also signing the other. Between them, they’ve got most things covered. The more who sign them, the louder our voices become.

In his editorial on the PACE Trial, Trevor Butterworth observes: “Patients need to be much more closely involved in the research process. You would think, following the transformational role played by patient groups in changing the way HIV/AIDS trials were designed, that patients would be seen as partners in research: they have, after all, an inside knowledge of their own suffering—histories that can be richly mined by researchers who are not lifetime experts in the disease. Patients come to research with a fundamentally different perspective to scientists; as Julie Rehmeyer puts it, their question is, “How does this new research fit or fail to fit with my experience?” Reaction to PACE from patients was that it did not—and that kind of reaction should not have been summarily dismissed.”

What was true for PACE is equally true for the NIH Study. The last thing any of us want is another PACE debacle. It is time for researchers to listen to patients – and for us to make sure we put our voices out there. They say they want to listen. We need to make sure we speak.

Note: There’s also a very detailed summary of the numerous problems with the NIH study in this post by ME Advocacy.

Update: This post has been slightly amended to clarify Dr Walitt’s job title and the role of the ‘experts’ mentioned.