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.

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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.

Best–David

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

Comments on this entry are closed.

  • Couch Turnip 16 September 2019, 3:17 pm

    Well Chalder and BMJ Open don’t have much choice here by the sounds of it. Since the British Journal of General Practice corrected this mistake then surely they must too. Let’s hope the correction doesn’t end up in Editorial Siberia.

  • Richard Vallee 16 September 2019, 6:12 pm

    Once is a mistake. Twice is a failure.

    Where we are right now is beyond failure and is indistinguishable from malice. The problem is clearly widespread as well.

    Something’s very rotten in the kingdom of Wessely, too many dubious claims made in support of a wild ideology, which ironically will not even save a penny and waste many a pound.

  • CT 17 September 2019, 5:32 am

    Indeed, the IAPT LTC/MUS Pathfinder Evaluation Project Phase 1 Final report by the University of Surrey Evaluation Team in November 2013 indicated that the MUS strategy likely wouldn’t save the NHS much or any money and yet they pressed on with the IAPT project regardless, now having a target of 2/3rds of new referrals to IAPT being made up of LTC or MUS patients. Why? I suspect because the hypothesis behind Layard and Clark’s IAPT project couldn’t be seen to be flawed, so to that end it appears that proponent/s of this strategy have suggested that commissioners or whoever consider cutting their physical healthcare spending upfront in ANTICIPATION of reductions in physical healthcare spending on LTC and MUS patients, reductions that we know weren’t seen in the Evaluation Project. How irresponsible is that? I assume this is all part of the Government’s plan to reduce secondary care services and switch to so-called ‘care in the community’. Oh, and according to Dr Rhiannon England (see pdf ‘The Two doors of mental and physical health: making it one door for both’), MUS patients don’t recover, but she still appears to be in favour of the MUS strategy. Work that one out, if you can.

  • Lady Shambles 17 September 2019, 8:16 am

    I’ve heard that someone else approached BMJ Open about this mistake and they were told that they needed to submit a response to the paper for the correction to proceed. So, even though people at BMJ Open knew that this error was there and misleading their readers, they seemingly wouldn’t do anything without the complainant jumping through their ridiculous hoops. How open and honest is that?

  • CT 19 September 2019, 8:14 am

    Apparently I’ve broken some social media convention in not making clear I was changing from ‘Couch Turnip’ to ‘CT’ above. I thought it was fairly obvious since I’ve been referred to as ‘CT’ in a reply or replies by other people before. But to make it abundantly clear, ‘Couch Turnip’ will now be commenting as ‘CT’. I heard that some people weren’t comfortable with the name ‘Couch Turnip’ and I don’t wish to offend anyone, but I will always be ‘Couch Turnip’ in my head, throwing the despicable opinions that the BPS lot appear to have of patients with ‘MUS’ back in their faces. (‘Turnip’ came from this inane paper by Stone and Carson -https://pn.bmj.com/content/17/5/417).

  • jimells 19 September 2019, 11:45 am

    Hello CT,

    For most websites, the comment software will not allow multiple names from the same internet address. This reduces spam created by other software on the internet.

  • CT 21 September 2019, 7:45 am

    Hi jimells,

    Thanks for explaining.

  • Steve Hawkins 21 September 2019, 2:10 pm

    I wish they’d do something about the Persistent Patronising Sarcasm we’ve always got from most GPs. Perhaps if they actually tried applying a logical methodology to diagnosis, they wouldn’t keep sending patients for the wrong tests with the wrong consultant speciality.