Trial By Error: The Lightning Process Is “Effective”? Really?

They've swapped from nonsense designed to appeal to foolish members of the public to nonsense designed to appeal to foolish academics.

 

The blogpost has been updated with further email exchange. David Tuller has received a response from dr. Terry Segal, senior author of the review in Current Opinion in Pedicatrics that claimed LP is effective. He has also written a reply which is included in the update.

 

LP is being promoted by Parker and his cult as curing MS, psoriasis and a bunch of other diseases. They can't pretend they don't know this. Sharpe, Chalder and the others are fooling themselves, Parker is just a useful tool. His crap is no better or worse than "rousing reassurance".

 

Pathetic. Reckless disregard for people's lives and unable to even pretend to give a damn.

 

Maybe they did just want to send a quick reply to show that they'd received the e-mail before the authors assessed and discussed the concerns raised? It could also be a deeply irritating brush off but it's best to avoid jumping to assuming the worst imo.

 

The only comment I would make is that this is the immediate response which should have been given to the first e-mail. They have already had a week for consideration.

 

It's been a year. "We'll look into it" is way back then.

 

No it's the Crawley paper that has been a year, not the Segal paper - that has been about a week.

 

I hope not ...might be confused with where I went to college...I still call it a polytechnic though ...god I’m old

 

Nope, not just a quick e-mail, as far as I can tell. She did not respond to the letter I had sent to her previously. She only responded when I wrote to the editor of the journal and cc'd her on it, along with everyone else. It would have been appropriate to respond quickly to me after I had written to her directly.

 

Ah... I think that I've lost track of this correspondence.

 

What does it say? Facebook embeds don't always work, I think they're blocked from non-users.

 

Oh, I didn't know that. Here you go:

Today I sent the following letter to Dr Terry Segal, senior author of a recent review of pediatric "CFS/ME" in the journal Current Opinion of Pediatrics. Last week, Dr Segal promised to "consider" my concerns. I asked her to impose a deadline on herself for concluding this period of "consideration." I did not hear back--so I wrote again:

Dear Dr Segal--

As you know, I have raised questions about the fact that your recent review of pediatric CFS/ME in Current Opinion in Pediatrics called the Lightning Process an “effective” treatment for children. Given that this claim was highlighted in the abstract, your review has granted enormous credibility to an intervention created by a self-styled Tarot specialist who has also taught spiritual healers the art of using auras as a diagnostic tool.

Last week, you indicated that you and your colleagues would "consider" my concerns about the Bristol University study on which this claim of effectiveness is based. You did not provide a deadline for this period of consideration, so I wrote back asking that you impose one on yourself and your co-authors.

Since I have not heard back, I need to ask again: When do you and your co-authors intend to finish your process of consideration and resolve this matter? Further delay is unacceptable, given the serious public health issues involved and the potential that your review will not only influence the opinions of pediatricians but also those involved in developing new ME/CFS guidelines under the auspices of the National Institute for Health and Care Excellence.

Dr Segal, this is not really a complicated issue. As I documented well over a year ago, the Bristol University investigators, led by Professor Esther Crawley, violated multiple methodological and ethical principles of scientific research in conducting and writing up their trial. Archives of Disease in Childhood, which published the study, posted an obscurely located editor's note almost a year ago affirming the concerns and noting that the matter was under "editorial consideration." The journal’s inability or unwillingness to conclude this process of "editorial consideration" clearly suggests that Archives does not want to acknowledge that retraction of the paper is the only viable way in this instance to preserve the integrity of the medical literature.

So I need to ask you again: When do you intend to finish "considering" my concerns? Do you plan to take almost a year, as Archives has now done, despite my many appeals about the issue to Dr Fiona Godlee, editorial director of BMJ? As I noted in my last message, it takes about half an hour, if that, to review the relevant trial documentation and ascertain the troubling facts. I assume you have had the time to do this in the past week. Sooner or later, you will either need to remove the claim that the Lightning Process is "effective"--or introduce the many caveats about why the study on which this claim is based is invalid and cannot provide reliable data. There is no other resolution possible.

Thank you for your attention to this matter. Because of the urgency of this issue, I am again cc-ing multiple people, including: Dr Fiona Godlee, editorial director of BMJ; Sue Paterson, director of legal services at Bristol University; several doctors involved with the development of the new NICE guidance; Professor Philip Pizzo, the editor of Current Opinion in Pediatrics; and two members of Parliament who have expressed alarm at the poor quality of research in the ME/CFS domain, along with a parliamentary aide.

I look forward to your response and a quick resolution of this distressing matter.

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

 

It is actually much worse. It’s not just positive thinking, it’s being told you can’t recover if you acknowledge symptoms or tell anyone what the program is. It is positively evil.

 

I sent the following earlier today to the FOI office at Bristol University.

Dear Freedom of Information Office--

I am requesting information related to the trial of the Lightning Process as a treatment for pediatric CFS/ME, which was conducted by investigators from the University of Bristol (UoB) and published in Archives of Disease in Childhood (ADC) in 2017.

In January 2018, ADC received a letter signed by multiple experts expressing concerns about the conduct and reporting of the trial. In response, ADC promised to review the matter. In June 2018, ADC posted an editor’s note about the trial that referred to “clarifications” the investigators provided in response to the concerns raised.

So:

1. Did the investigators notify UoB that ADC had raised concerns about the conduct and reporting of their trial? If so, on what date did the investigators notify the university?

2. Have the investigators provided UoB with the formal responses they gave ADC—“clarifications,” per the editor’s note--to the concerns raised about the conduct and reporting of their trial? If so, can you provide a copy of the formal responses or “clarifications” that were given to ADC?

3. Given the nature of the concerns raised by ADC, did UoB set up a review or investigation into the conduct and reporting of the trial? If so, can you provide a copy of the results of this review or investigation?

I would be happy to receive this information in electronic format.

Thank you.

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

 

Thanks!

Sometimes it works, but most Facebook embeds are blank for me. Though maybe it's the forum software. Oh well.

 

This morning, I sent the following e-mail to Dr Nick Brown, editor-in-chief of Archives of Disease in Childhood:

Dear Dr Brown—

On June 3, 2018--that is, a year ago--you responded to a letter I had sent to people involved in the development of new ME/CFS guidelines under the auspices of the National Institute for Health and Care Excellence. In my letter, I had alerted them to serious methodological and ethical violations in a high-profile 2017 paper in Archives of Disease in Childhood, a BMJ journal. The paper, from investigators at the University of Bristol, was called "Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial."

Along with people involved in the NICE process, I had cc-d Dr Fiona Godlee, BMJ's editorial director. You indicated in your e-mail that Dr Godlee had passed on my letter to you. You assured the various recipients that Archives would "respond fully when ready” to the concerns I had raised.

Later that month, Archives posted an “editor’s note" that acknowledged the concerns, explained that the investigators had provided “clarifications,” and indicated that the matter was under “editorial consideration.” The editor's note was clearly intended as an interim response, not the promised full response. For unexplained reasons, it was not visible from the paper itself but was posted somewhere in what I have referred to as the editorial equivalent of Siberia.

In April of this year, Current Opinion in Pediatrics published a review called "Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis: where are we now?" This review highlighted the Lightning Process as “effective,” based solely on the Archives paper. Presumably, the review authors did not notice the obscurely located editor’s note.

(I presume the review authors did not notice the editor's note because anyone reading it would likely have become alarmed about the validity and reliability of the paper's reported findings. Certainly such readers would likely have recognized that a decision to cite the Archives findings authoritatively could come back to haunt them.)

The new review in Current Opinion in Pediatrics could impact ongoing public health policy decision-making involving a highly vulnerable population--children with a debilitating and stigmatizing illness. It is therefore urgent to finally address the situation in order to safeguard the medical literature and prevent further dissemination of information based on flawed science. While Archives continues to deliberate the fate of the published paper, the now-appointed NICE committee has been holding meetings to debate and develop the new ME/CFS guidelines.

I have noted repeatedly that it takes half an hour, if that, to examine the relevant trial documents and ascertain what happened. Let's recap. The investigators recruited more than half the participants before registration, in the process violating a strict policy that BMJ professes to observe. They then swapped outcome measures based on data from these early participants, which allowed them to present positive rather than null results for their reported primary outcome. Then they failed to mention the pre-registration recruitment and the mid-trial outcome-swapping in the paper itself; of course, including these details would have likely doomed the chances of publication in a major journal.

Dr Brown, to those who have been waiting patiently on your year-old promise to “respond fully when ready,” can you explain why Archives is not yet ready to respond fully, given the prolonged period of editorial consideration? Will you now commit to a deadline by which Archives can be ready to respond fully to the plain set of facts outlined above?

In seeking to expedite resolution of this public health issue and protect children from exposure to recommendations arising from this unacceptable piece of research, I have cc’d the following: Four physicians involved with the NICE committee, along with two patient representatives; Dr Godlee; Dr Terry Segal, the senior author of the review that, to its misfortune, cited the Archives paper uncritically; Sue Paterson, director of legal services at University of Bristol; two members of Parliament who have expressed concerns about the poor quality of much ME/CFS research, along with a parliamentary aide; and Professor Chris Ponting, vice chair of the UK CFS/ME Research Collaborative, a position he assumed following the tenure of the Lightning Process trial's lead investigator.

Thank you for your attention to this matter.

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