Trial By Error: My Letter to Senior Author of Norway’s CBT-Music Therapy Study

By David Tuller, DrPH

In the past week, I have written three posts about a Norwegian study of cognitive behavior therapy plus music therapy for adolescents with chronic fatigue after acute Epstein-Barr virus infection–an illness known as mononucleosis in the US and glandular fever in the UK. The corresponding author of the study is Vegard Bruun Wyller, a professor at the University of Oslo’s Institute of Clinical Medicine.

Professor Wyller is also involved with a planned Norwegian trial of the Lightning Process, which has stirred up controversy and led to misinformed coverage in Dagbladet, a major news organization. On Thursday, I sent a letter to Professor Wyller inviting him to respond to my concerns on Virology Blog.I have posted the first letter below.

I also sent a letter to Dagbladet in which I noted, among other things, that the reporter forgot to include my Berkeley position and academic credentials. I will give the news organization a bit of time to publish the letter before posting it myself.

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Dear Professor Wyller–

I am an investigative journalist and an academic fellow at the School of Public Health at the University of California, Berkeley. I frequently write about research in the domains of CFS, ME and other so-called medically unexplained symptoms. Much of my work appears on Virology Blog, a science site hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. (I have cc’d Professor Racaniello on this e-mail.)

I have now written three Virology Blog posts that are critical of a recently published study on cognitive behavior therapy combined with music therapy as a treatment for adolescents with chronic fatigue following acute Epstein-Barr virus infection. Since you are the corresponding author, I wanted to offer you an opportunity to respond to my concerns. If you send me your comments, at any length you choose, I will post them in full on Virology Blog, without editorial interruption from me. (I will likely respond to your comments, but in a completely separate post.)

The three Virology Blog posts about the study are herehere and here.

As mentioned, I will post whatever you care to send. However, I’d be particularly interested in answers to the following questions:

  1. Why did the paper describe the research as a feasibility study without disclosing that it started as a small but fully powered randomized trial?
  1. Why did the conclusions in the abstract and full text not mention the poor results for the primary outcome?
  1. Why was PEM presented as an outcome when it wasn’t mentioned in the protocol, registration, and statistical analysis plan?
  1. Why was the outcome of “recovery” not mentioned in the registration and statistical analysis plan?
  1. Why was it possible for participants to get worse on the objective primary outcome but still be deemed to have achieved “recovery” in the trial based on results for a subjective secondary outcome?
  1. Given the high attrition rate in the intervention group, why did the paper highlight the per protocol analysis of “recovery” while providing intention-to-treat analyses of other outcomes?
  1. Were you concerned that one reviewer read only the abstract, and were you surprised the editors chose not to obtain a review of the actual paper instead?
  1. Do you know if the editors and/or peer reviewers checked the trial protocol, registration and statistical analysis plan?

Thank you, Professor Wyller. I look forward to hearing from you.

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

{ 12 comments… add one }
  • CT 22 May 2020, 8:27 am

    I like how you go overboard to be fair and transparent.

  • Joanne Bruce 22 May 2020, 12:58 pm

    What I find most disturbing in all of this is the BMJ’s conduct in publishing the paper at all, given that one ‘reviewer’ had not actually done the job of reviewing the paper and associated documents to ensure appropriate methodology was followed. It is, at best, lazy and at worst, negligent.

    I find it concerning that a certain few appear to have a privilege that exempts them from conducting their research to the standard required.

    Why is it always these same few, in this particular area of study? Why are the methodological lapses always of the same type? Is this happening as a matter of course in other disease research?

    What responsibility does the BMJ feel it bears in upholding the reputation and credibility of research (as a whole) in the heart and mind of the public?

    At a time when we need science to cut through rampant misinformation, do they not see that allowing poor quality science into the public domain does terrible damage to trust in the process as a whole?

  • Frøydis Hauge 22 May 2020, 1:00 pm

    Thank You for working so hard to reveal factors not ok, and for giving voice to bedbound patients worldwide

  • Elisabeth Lykke 22 May 2020, 2:25 pm

    Thank you David Tuller your work is very important, and very appreciated

  • Lene Christiansen 22 May 2020, 3:06 pm

    Thank you, David, for asking these questions. Hopefully professor Wyller will be glad to answer.

  • Christine Fenton 22 May 2020, 3:11 pm

    ‘5. Why was it possible for participants to get worse on the objective primary outcome but still be deemed to have achieved “recovery” in the trial based on results for a subjective secondary outcome?’

    Have we been here before?!

    Surely not learning from methodological mistakes previously made by ‘researchers’ in their own field is a massive professional failing – or are they confident that their colleagues have lowered their standards so ‘anything goes.’

    It also questions the respect the ‘researchers’ have for the oversight of the publishers – they either have none or are confident the publisher will ignore their poor methodology & are therefore complicit in lowering standards.

    There’s a certain result, confidence in ‘science’ is fast diminishing as is confidence in the guardians of quality, the publishers.

  • Gry Halvorsen 22 May 2020, 3:29 pm

    Thank you for fighting for us.

  • Tine Esseth 22 May 2020, 4:51 pm

    Dear David Tuller. May you always be there making sure that crapy science, is not getting published without a real gaslighting. Thank you.

  • Alicia Butcher Ehrhardt, PhD 22 May 2020, 6:40 pm

    I assume she has a boss? The next step is to go up the chain of command, and ask why she is not responding to carefully formulated reasonable requests for information.

    I wouldn’t have done this three times; you have more patience than I would display.

    Sick people don’t have a lot of spare energy for patience.

  • Charles 23 May 2020, 9:27 am

    Another interesting fact that wasn’t discussed is this:

    Over half of the possible eligible participants chose not to participate in this trial. They have no treatment alternative and still chose not to participate. And of the less than half who were positive enough towards this approach to choose to participate, 38% of the participants in the treatment group withdrew from the study. In the control group only one participant withdrew.

    Shouldn’t those numbers be discussed in a feasibility study? These aren’t patients who have a wide variety of treatments to chose from, yet they chose no treatment over this treatment. That’s a pretty strong statement, even if it doesn’t contain any words.

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