Trial By Error: My Letter to Professor Chalder about the PRINCE Trial

By David Tuller, DrPH

In its efforts to save money, the National Health Service has been expanding the program known as Improving Access to Psychological Therapies (IAPT) by encouraging physicians to refer over all those with so-called “medically unexplained symptoms” (MUS). Under IAPT, the illness referred to as “chronic fatigue syndrome” falls into the MUS category. The program essentially provides CBT and related “rehabilitative” interventions.

Key PACE investigators have been among the leaders in the MUS field, and their trial served as scientific “evidence” to justify the IAPT expansion. Although citing PACE in any kind of authoritative way has become much more problematic in the last couple of years, that hasn’t stopped people like Professor Trudie Chalder from conducting additional problematic trials. The PRINCE trial proposes to investigate whether trained GPs can provide an effective rehabilitative approach to “persistent physical symptoms” (PPS), another term used to describe the phenomenon under examination.

In late July, BMJ Open published the protocol for this trial. And sure enough, smack in the first paragraph of the text, is a major factual error about the cost of MUS to the NHS. Since the beginning of this year, I have repeatedly documented how this same error has appeared in multiple papers over the last decade. I had hoped that raising awareness about it would prevent further repetitions. I was wrong.

It is important to remember that BMJ Open is the journal that obfuscated, dissembled and presented false information when confronted with the indisputable fact that it published Professor Esther Crawley’s school absence study without ethical review under the false premise that it was service evaluation. And Professor Chalder is the researcher who claimed at the PACE press conference that twice as many who received CBT and GET got “back to normal”–and has never explained or apologized for that egregious misstatement. So expecting forthright admission of error and prompt corrective action from either BMJ Open or Professor Chalder would, I think, be unwise.

In any event, I sent the following letter to Professor Chalder late last week. I cc’d several other people.


Dear Professor Chalder,

You are the senior and corresponding author of “Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial.” This protocol was recently published by BMJ Open. I am writing to point out a factual error in the first paragraph of the text.

The sentence in questions reads: “The National Health Service (NHS) in England is estimated to spend approximately £3 billion each year attempting to diagnose and treat MUS, which represented ~10% of the total NHS expenditure in 2008–2009.” This statement is incorrect. The study cited, Bermingham et al, is clear: the amount estimated to have been spent on MUS among the working-age population in England was 10% of the total amount spent on that population, not of “total NHS expenditure.” This false assertion dramatically overstates the supposed impact of MUS on the NHS budget.

I have additional issues with this protocol, but I will leave those for another time. My immediate interest is that you and your co-authors correct this misinformation in short order. As I have noted in multiple posts on Virology Blog, leaders in this domain of scientific inquiry have repeatedly managed to mangle this data point in their efforts to promote public health policy, including the expansion of the Improving Access to Psychological Therapies program. In fact, the British Journal of General Practice recently corrected an editorial that included the exact same mistake after I repeatedly requested the editor to take action.

Perhaps you can explain why you and so many of your colleagues–including the 12 co-authors of the PRINCE protocol–appear unable to accurately cite a seminal study in your claimed field of expertise. I assume you would agree that research protocols and public health policy should be based on accurate information. I look forward to seeing the corrected PRINCE protocol.

I am cc-ing BMJ Open editor Adrian Aldcroft on this letter. I am also cc-ing Sarah Bermingham, the lead author of the misquoted study. Because you and others lump ME/CFS into the categories known as MUS and PPS, I am also cc-ing members of the NICE committee currently developing new guidelines for that illness. Finally, I am cc-ing three members of Parliament who have expressed serious concerns about the poor quality of much UK research into ME/CFS, including the PACE trial. I will also post this appeal on Virology Blog.

Thank you for your attention to this matter. Please let me know when the paper has been updated. I trust the correction will be prominently noted, as is standard.


David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
University of California, Berkeley
Berkeley, California, USA

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