Friday, November 27, 2020

James COYNE's COLUMN

Retraction! A Chirping Sound Treatment for Fibromyalgia Finally Gets Flagged

You can add your voice to this article. Scroll to the footer to comment

Why did I have to complain and troll the Senior Editor of mega-journal PLOS One to get this article retracted?

An academic editor should have rejected outright an article that was aimed at promoting an unproven medical treatment directly to consumers. With PLOS One somehow having let such an article slip through peer review, the Senior Editor should have been more responsive to my complaint.

Getting the article retracted took over a year and — as always — some trolling* of PLOS.

A lot of us have concluded that we must embarrass a publisher in social media to get a retraction, based on past experience.

Even the eagle-eyed Retraction Watch missed the retraction when it finally came. Without any fanfare, PLOS One posted a retraction notice on the journal’s website. Months later, it would also notify me.

I had presented my case for retraction at Science-Based Medicine, Infomercial in PLOS One links to a website selling unproven treatments for fibromyalgia and dementia.

The mega journals like PLOS One and Nature Publishing’s Scientific Reports seem to have grown too big to care about the integrity of scientific publications. There is too little oversight by senior editors to keep out bad science or to take swift action to retract it when it somehow gets published.

Nonscientist laypersons perk up when “supported by clinical studies” appears in direct-to-consumer pitches for unproven medications and medical devices.

Consumers are particularly vulnerable to promotions of quack medicines and devices that cite findings in a prestigious peer-reviewed journal — and in an open-access article that they can access themselves

I see little evidence that stopping the exploitation of these vulnerabilities to misinformation is given the priority in scientific publishing that it deserves.

I believe journal reviewer forms should have click-box for reviewers to express concern about the effects of an article being published on the larger community’s perception of what is and what is not scientifically credible information relevant to their health care decision-making.

When an academic scientist (an academic editor of PLOS One, in my case) calls attention to an article intended to exploit lay persons, there should be a timely investigation and action. Usually, there is not — or it flounders for reasons we are not told.

The original open-access article [click to view or download]

Janzen TB, Paneduro D, Picard L, Gordon A, Bartel LR. “A parallel randomized controlled trial examining the effects of rhythmic sensory stimulation on fibromyalgia symptoms.” PLOS One. 2019 Mar 1;14(3):e0212021.

The abstract gives the basic rationale and design for the study:

We were interested in whether rhythmic sensory stimulation would promote significant changes in fibromyalgia and associated symptoms, and whether treatment effects would differ between two distinct treatment parameters.

A double-blind, two-arm parallel randomized controlled trial investigated the effects of gamma-frequency rhythmic sensory stimulation on fibromyalgia.

“Gamma-frequency rhythmic sensory stimulation” sounds awesomely scientific. Don’t be intimidated. Actually, you can listen to the 40hz tone right here. Having done so, are you changed yet? I doubt listening will soothe any pain or fatigue you might have, whether or not you suffer from fibromyalgia. listen to the sound here.

Patients randomized to the active treatment:

Received vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with usual care.

The comparison/control group received

The same treatment protocol but received a different stimulation, consisting of random and intermittent complex wave gamma-range vibrotactile stimulation.

The outcomes were self-reports of fibromyalgia symptoms, pain severity and interference, depression symptoms, quality of life, and sleep quality were assessed at baseline and post-intervention.

The authors concluded

These findings provide preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation may decrease fibromyalgia symptoms and ease associated comorbidities, opening new avenues for further investigation of the effects of rhythmic sensory stimulation on chronic pain conditions.

Why the article should never have been published

There is no plausible mechanism by which a 40z tone would be expected to influence chronic physical health conditions. The authors admitted as much in the article.

Researchers should not be able to blithely subject people to a five-week treatment procedure that lacks any sound scientific rationale, especially when they are physically ill patients who are fatigued and in pain.

Where was the hospital’s Internal Review Board (IRB), a.k.a. the Committee for the Protection of Human Subjects, when these patients needed protection? I believe that there was complicity on the part of a Canadian institution in allowing this research to be approved and then in resisting retraction.

The study found no differences between the treatment and a sham treatment over time. Of course not. There was no scientific reason to expect a difference. Yet, authors then ignored this crucial finding and instead focused on differences that occurred over time within the group of patients receiving the intervention.

The authors were ignoring the embarrassing finding that the patients who randomized to the sham treatment experienced the same improvement as patients using the device the authors were promoting for sale in direct-to-consumer ads.

Focusing on this isolated finding defeated the purpose of the authors having conducted a randomized trial. One goal of an RCT is to provide a comparison group that controls for the simple passage of time.

Worse, clicking on one of the links in the PLOS One article took you to the product page for the VTS-1000 Vibroacoustic Therapy System. The “therapy system is just as it was pictured in the PLOS One article, but with pricing (currently $995.00) and a full range of accessories. [My complaint got the picture in the article removed, and before the article was retracted. However, there was no notice at the journal website, simply a disappearance.]

“I discovered the principle of entrainment in physics, how one rhythmic vibrating object will synchronize with another and so I used that idea and started creating music to affect your brainwaves music…”

An infomercial to create hype.

My sorely missed, departed skeptic friend, Professor Bernard “Barney” Carroll coined the term “infomercial” to label an article published in a biomedical journal not to advance science and human welfare, but to promote a product elsewhere.

I agree with Barney that infomercials corrupted medicine and medical journals.

Worse, this was not an infomercial to attract start-up capital or boost stock prices, this infomercial was cited in a website offering direct-to-consumer advertisements with wondrous claims.

The authors cited this paper in PLOS One inclaims at the website that the tone has been used to treat pain, dementia, Parkinson’s disease, and more with dramatic success.

But, hold on. In the abstract to the PLOS One acknowledged that these were preliminary findings (They were non-findings, but let’s ignore that for now.), Why market devices directly to ill patients and people who care for them?

“Surprise, Uncle Baba. Happy Birthday. I got you a thousand dollar revolutionary Vibroacoustic Therapy System that your physician has not even bothered to tell you about.”

The website with a link in the PLOS One article makes the claim:

Clinically Proven, Doctor Developed Sounds…The revolutionary Vibroacoustic Therapy System uses clinically proven, doctor developed sounds and vibration to help you sleep, relax and renew your body — naturally! Vibroacoustic therapy systems, costing several thousands of dollars, have been successfully used in hospitals and clinics around the world. Now you can enjoy this same therapeutic technology at a fraction of the price. Sound therapy provides soothing music with clinically proven brainwave entrainment for effective stress reduction, relaxation and healing.

The website also has a prominently displayed video of a TED X talk with the bait:

Dr. Lee Bartel’s TEDx talk at Collingwood, Ontario gives an excellent overview of the current state of vibroacoustic medical research. Dr. Bartel explains how scientifically developed sound played through Vibroacoustic devices can help reduces the symptoms of Fibromyalgia pain, Alzheimer’s Disease, Parkinson’s Disease, Depression, and increases blood flow.

The TEDx Talk video, Music Medicine: Sound at a cellular level” describes Lee Bartel’s moment of epiphany as extracting honey on a farm in western Canada. Honey sticking to belts made them:

Go squeak squeak squeak to drive me nuts and just as inevitably a cricket would walk into the honey house and would go chirp chirp chirp… it didn’t take very long before what started as a sort of a random chirp would synchronize with the squeak on the belt. Why this was happening was a question that lingered in my head for very many years until I discovered the principle of entrainment in physics, how one rhythmic vibrating object will synchronize with another and so I used that idea and started creating music to affect your brainwaves music…

Image for post
Screenshot of device captured from TEDx. The PLOS One article originally had the image on the left as Supplementary Material, along with a link to the website where it was for sale. The image and link were discretely removed after my complaint was received by the Senior Editor.

The reasons given for retracting the article

Even when calls for retractions get an institutional response, the official statement typically involves a cover-up of what actually happened.

This PLOS One retraction notice misrepresented the problem with the paper as that the clinical trial lacking a control group. That was not true and avoided mentioning the other serious problems with the article.

The lack of a placebo group was raised during pre-publication peer review and was acknowledged as a limitation in the article’s Discussion. However, after further consideration and post-publication input from a member of our Editorial Board, we concluded that the claims made in the article are not adequately supported by the results given the lack of the control group and the implications of this issue for the interpretation of the data. Therefore, the article does not meet PLOS ONE’s publication criteria, and so the PLOS ONE Editors retract this article. We regret that this issue in the study design was not fully addressed during the pre-publication peer review process.

TBJ and LRB did not agree with the retraction. DP, LP, and AG either did not respond directly or could not be reached.

It may come as a surprise that authors are asked to agree with a retraction of their paper. I suspect that not PLOS One being able to secure an agreement with these authors delayed the retraction. Who knows, the whole matter may have buried if I had not been such a pain to the senior editor.

No credit, no respect

Retraction notices do not acknowledge who did the work of documenting a problem and filing a complaint. There is no open science badge for securing a retraction.

I once considered a responsibility to get flawed articles retracted from PLOS One because I took seriously the idea of PLOS as a Public Library of Science that belonged to its volunteers and its readership.

In the early days, of PLOS One was run by an activist group in a couple of small rooms in San Francisco and London.

I was a passionate booster, but I would get into public spats about a seemingly independent administrative structure that refused to grant fee waivers without asking authors to furnish their pay stubs and would not correct errors in articles introduced during their production.

I would complain through social media when my emails were ignored. The folks in the small rooms in San Francisco and I would make up. They would cheerfully send me tee shirts and coffee mugs that I would give away at conferences.

I would promote PLOS One with tweets like “No journal is perfect, but PLOS One fixes its mistakes,” which PLOS would retweet.

I recruited early-career women and men, academic editors, and editors with expertise in neglected areas like qualitative research, telling them about how you could kick the journal in the shins and the editors would pay attention.

Then PLOS One got big, very big, and corporate.

Rather than imagining myself as an activist promoting open science, I realized that I was one of over 5,000 academic editors at a journal publishing, at one point, 27,000 articles per year, with obvious breakdowns in quality control that did not get promptly fixed.

I should have given up the faith when PLOS One let everyone down, when it failed to release to me the data from the PACE Chronic Fatigue Syndrome Trial that authors had promised would be available as a condition for publishing in PLOS One.

The PACE investigators successfully lobbied the PLOS senior management to ban me from discussing any further the struggle to get the trial data released in my Mind the Brain PLOS blog.

Not everyone at PLOS Blog agreed with the censorship. My original post detailing the flaws in the PACE trial was included in a list of the most popular blog posts in a network that received over 2.3 million visitors reading more than 600 new posts.

Retaliation followed a few days later. My blog with PLOS blogs was shut down altogether and I had to hastily migrate to an independent website.

I stayed on with PLOS One because senior administrative staff assured me that the data would soon be released. PLOS One attached an Expression of Concern to the article, which usually precedes a retraction. None followed.

An incoming Senior Editor apologized to me in a telephone call for delays in releasing the data that he could not explain or defend. He said lots of reassuring things.

Years later, the data have not been released, but all legal barriers to doing so have been cleared.

Fast forward.

I got no tee shirt for bagging this shameful paper about humming treatments for fibromyalgia. I cannot even be sure that the retraction will be reflected in any fewer naïve sick persons wasting their money on useless medical devices.

I just do this kind of thing as a habit I can’t seem to break. Maybe out of a misplaced sense that consumers need protection from bad shit in peer-reviewed scientific journals.

Postscript: Trolling as activism

At the outset of this article, I admitted to trolling PLOS One and its senior editor.

*Trolling can be an excellent means to draw attention to a neglected, but just cause.”

I was not cyber mobbing PLOS One. I offered no existential threat to the journal. I made no bad faith false accusations such as the Senior Editor encouraged adult sexual abuse of children or that he sniffed strangers’ bicycle seats. [A crazy thought? No, actually, as someone who has routinely called out bad science and bad publications practices, this is the kind of bizarre blowback I have come to expect from those who cybermob and do not merely troll.]

My heavily visited Mind the Brain blog post concerning assessing Adverse Child Experiences (ACEs) attracted this kind of nasty commentary and worse.

Instead, when any tweets about PLOS showed up in my newsfeed, I replied with a reminder about a matter deserving of attention, “Yo, brother Joerg, did you happen to get to….?”

Patient Advisory

Medika Life has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by Medika Life

James Coynehttp://www.coyneoftherealm.com
James C. Coyne is Professor Emeritus of Psychology in Psychiatry at the University of Pennsylvania where he was Director of Behavioral Oncology at the Abramson Family Cancer Center and Senior Fellow, Leonard Davis Institute of Health Economics. He also was Professor of Health Psychology at the University of Groningen, the Netherlands, and has been on the faculties of University of Michigan School of Medicine and University of California, Berkeley. He received a BA in Psychology from Carnegie Mellon in 1969 and a Ph.D. in Clinical Psychology from Indiana University in 1975. Professor Coyne was the 2015 Carnegie Centenary Visiting Professor at the University of Stirling. He is the author of over 400 articles and chapters and has been designated one of the most influential psychologists of the second half of the twentieth century. His diverse interests have included clinical health psychology, mental health services research, and evaluation of depression screening and suicide prevention programs. As a blogger at Science-Based Medicine and Mind the Brain, Dr. Coyne is known for skeptical appraisals of advice gurus misleading consumers with hype and hokum. His activism with colleagues concerning undisclosed conflicts of interest has yielded dozens of corrections to published papers, a few retractions, and the Bill Silverman Prize from the Cochrane Collaboration.

JAMES COYNE, PHD

James C. Coyne is Professor Emeritus of Psychology in Psychiatry at University of Pennsylvania where he was Director of Behavioral Oncology at the Abramson Family Cancer Center and Senior Fellow, Leonard Davis Institute of Health Economics. He also was Professor of Health Psychology at University of Groningen, the Netherlands and has been on the faculties of University of Michigan School of Medicine and University of California, Berkeley. He received a BA in Psychology from Carnegie Mellon in 1969 and a PhD in Clinical Psychology from Indiana University in 1975.

Professor Coyne was the 2015 Carnegie Centenary Visiting Professor at the University of Stirling. He is the author of over 400 articles and chapters and has been designated one of the most influential psychologists of the second half of the twentieth century. His diverse interests have included clinical health psychology, mental health services research, and evaluation of depression screening and suicide prevention programs. As a blogger at Science-Based Medicine and Mind the Brain,

Dr. Coyne is known for skeptical appraisals of advice gurus misleading consumers with hype and hokum. His activism with colleagues concerning undisclosed conflicts of interest has yielded dozens of corrections to published papers, a few retractions, and the Bill Sliverman Prize from the Cochrane Collaboration.

CONNECT WITH JAMES

Website

Facebook

Twitter

LinkedIn

All articles, information and publications featured by the author on thees pages remain the property of the author. Creative Commons does not apply and should you wish to syndicate, copy or reproduce, in part or in full, any of the content from this author, please contact Medika directly.

If you'd like to keep up to date with James's latest articles on Medika why not subscribe to our newsletter below.

GET THE MEDIKA NEWSLETTER