These confidence tricksters, which is essentially what they are, motivations aside, set about creating a web of intricate, supportive lies for their concepts or products and one of their go-to tools over the last decade has become the open-access model of predatory journals.

Unlike the con that may cost you a few dollars and a sheepish grin when you recount the tale to friends, these cons can and do occasionally exact the ultimate price. Your life.

Medika Life is developing a repository of quacks and questionable, sometimes life-threatening products and devices. As the EIC, I am intimately involved in the project and over the course of the last few weeks, a clear, if highly disturbing, modus operandi has emerged for many of these medical charlatans.

To create trust among both laypeople and professionals, these con’s turn to predatory journals. These ‘scientific’ publications have become their very lifeblood and sustain everything from highly questionable new drugs to bogus medical devices, and yes, questionable papers are often co-authored by medical or scientific colleagues whose motivation will remain, for the moment, irrelevant.

The scale of fraud and deception being committed on both the public and the medical/scientific sector is mind-numbing as more and more quacks and snake oil sellers realize the potential of these predatory publications. By now you’re wondering perhaps as to the exact nature of the beast I have been describing. Allow me to explain in detail.

Sharks in the water

There are many established, and reliable journals, publishers of medical and scientific papers, authored by ethical students and professionals in their chosen fields. With numerous disciplines that each require specific knowledge, this community of publications numbers in the thousands. Science, as we all know, is a vast and complex subject.

These publications serve essentially as validatory mechanisms that rely on a system of peer review. They use other specialists in the same field to rigorously check and question the contents of any submitted paper. Rejection rates are high, and those that make it through this rigorous review process are rewarded with publication.

It is an old and time-honored system that has served the industry incredibly well. It’s effective. It weeds out fraud or points to errors in logic and research that the author/s may not have been aware of. In short, if a publisher accepts a paper, it’s a guarantee of sorts that the materials contained are both plausible, possible, and properly researched. It is validation by your peers and it means a lot in the industry. Or it used to.

As with all things, this time has now passed, thanks in no small part to the age of the internet. A large percentage of scientific publications are no longer reliable. The industry has been fundamentally changed by the introduction of open access (OA). Fraudsters and less than ethical companies and players have entered the market with profit as their only motivation.

You can now publish a paper in many predatory journals without concern for the annoyance of peer review. All you need to do is pay to get your paper published, and thousands upon thousands of authors take advantage of this on a daily basis. You can then reference your published ‘scientific’ article on pigs flying and roadrunners living underwater.

Do this multiple times across multiple journals, attend a conference or two, offered by the same journals, and suddenly you appear to the layman, and apparently a large percentage of the scientific community, to be credible.

Nothing could be further from the truth.

The serene pond that previously represented the scientific publishing community is now a shark-infested, turbulent sea of deceit and deception. The phrase predatory publication was coined to describe these sharks, whose primary goal is not the rigorous monitoring and dissemination of reliable scientific knowledge, but rather money. A pay to publish club. Checks and reviews be damned. It’s a free for all that many take advantage of.

This feeding frenzy is partly fuelled by the scientific community itself. It keeps pushing new swimmers into the water. Your reputation in your profession is broadly determined by the number of papers you have published or co-authored. The more, the better your chances of promotion, peer recognition, etc, etc. It is, in this author’s opinion, a flawed system that encourages deception and deceit and powers predatory journals.

The consequences for Science and Medicine

Before we explore these publications in more depth and I will provide numerous names and resources to enable readers to make their own evaluations of these, let’s examine why this matters so much.

It all boils down to one simple thing. Trust. It’s the biggest asset enjoyed by both science and medicine and any mechanism that eroded that trust needs to be addressed, and aggressively so.

In case you’ve forgotten, the anti-vaxers trace their origins to a 1998 paper published in The Lancet by a now-disgraced British doctor, Andrew Wakefield, and 12 of his colleagues. Despite the paper having been proven to be fraudulent and subsequently retracted, for 12 years it stood. After years of criticism and proper peer review, the Lancet retracted the paper. Wakefield was exposed as a liar, having manipulated data used in the research, but the damage was done. Vaccines have been under attack ever since.

The Lancet is a highly prestigious and respected journal. It values its reputation and goes to great lengths to ensure the validity of the papers it publishes. If Wakefield was able to intentionally evade, even if only temporarily, their quality control mechanisms in 1998, how much more simple in 2020 with a smorgasbord of dodgy and cash to publish journals touting for business.

The irony of anti-vaxers using a paper from journals they claim to distrust to justify more attacks on the same industry is apparently lost on these misdirected souls, but that isn’t the point. They are laypeople who have been misled by a paper that was published in a respected medical journal. The author managed to fool his colleagues and in this instance, the process of peer review failed. Trust was eroded and we know in this instance what the ramifications were.

We are at a point, in a pandemic ravaged world, where trust has become a watchword and the lack of credibility enjoyed by the scientific community is gravely worrying. We are in large part to blame for this sad state of affairs.

Regulatory bodies and watchdogs have been slow to keep pace with the internet and how it has fundamentally changed the face of scientific publishing. Sadly, fraudsters on both ends of the scale, both published and publishers, have been quick to exploit the lack of regulation and literal free for all created by the worldwide web.

If we are to restore credibility in the eyes of the public, we need to clean house. Aggressively. What the scientific community does, matters, and at no point in its entire history has this become more evident than now. Covid has brought this truth home to roost.

You cannot help the public or engage with them in a meaningful way if they no longer perceive you to be reliable.

And that my friends, is why this matters so much. Why the list of companies I will highlight below need to be policed, monitored, and potentially closed if found wanting. They are a blight on the scientific landscape, insidious cancers that will destroy an old and robust patient, that was, until a few years ago, the picture of health.

OA and the birth of Predatory Journals

In principle, Open Access or OA is a good thing. Its goal is to make scientific papers more accessible. In particular, developing countries struggle to access and publish papers, costs are often restrictive, and writing one paper may require accessing thirty others in a diverse range of journals.

This process costs money and undoubtedly, OA has addressed this issue by improving access. Sadly, the very market OA sought to help is now one of the primary targets of the predatory journals.

This exceptionally lucid article on the Open Access topic from the Association of College and Research Libraries describes the problems in more depth. Entitled Beyond Beall’s List: Better understanding predatory publishers, the article is well worth reading and offers a very fair assessment of the OA model, considering the authors are supportive of the model.

Charging a fee is not itself a marker of a predatory publisher: many reputable OA journals use APCs to cover costs, especially in fields where research is often funded by grants. (Many subscription-based journals also charge authors fees, sometimes per page or illustration.) However, predatory journals are primarily fee-collecting operations — they exist for that purpose and only incidentally publish articles, generally without rigorous peer review, despite claims to the contrary.

The name Jeffrey Beall has become synonymous with predatory journals. In the last decade, Beall became the self-appointed guardian of published literature and a vocal campaigner against predatory journals. His now-infamous Blacklist (discontinued in 2017) even made it into the NYT and became a go-to resource for those wishing to filter out the scammers from legitimate publications.

Unfortunately, Beall’s tendency to link OA to predatory publishers has tarnished, unfairly so, the reputation of Open Access and it is the main reason I have tried to avoid the use of the terms together in this article. The concept of OA remains sound, it is the execution that has to date been flawed and it will now require a serious overhaul to regain credibility. Identifying and rooting out predatory journals from the global pool of scientific publishers is key to this process.

Beall was a firm and outspoken advocate of Elsevier. The quote below is lifted directly from Elsevier’s page on pricing and APC (Article Publishing Charges) and is an indicator of their adoption of Open Access.

Where an author has chosen to publish open access, which typically involves the upfront payment of an article publishing charge (APC), we will also make their article immediately and freely available upon publication on Science Direct, in perpetuity, with the author’s chosen user license attached to it. Elsevier’s APC prices are set on a per journal basis, fees range between c$150 and c$6000 US Dollars excluding tax, with prices clearly displayed on our APC price list and on journal homepages.

The Hustlers and the Watchdogs

There are a few key indicators of a journal’s acceptance and recognition within the scientific community that do not rely on Bealls List. They are important tools in sifting through the dregs to find legitimate publications. Here in no particular order are three points of reference. The first two have been guilty of accepting errant journals in the past, but are more rigorous now in vetting applicants, in particular, DOAJ.

The Directory of Open Access Journals is a watchdog that focuses on producing a trusted list or Whitelist of non-predatory publications. The CRLN article says the following about their quality control.

At the basic level, a journal must be chiefly scholarly; make the content immediately available (i.e., no embargoes); provide quality control through an editor, editorial board, and peer review; have a registered International Standard Serial Number (ISSN); and exercise transparency about APCs. Journals that meet additional requirements, such as providing external archiving and creating persistent links, are recognized with the DOAJ Seal. DOAJ receives an assist from the ISSN Centre, which in 2014 added language reserving the right to deny ISSNs to publishers that provide misleading information.

Next up is the Open Access Scholarly Publishing Association. Again, according to CRLN

Members must apply and pledge to adhere to a code of conduct that disallows any form of predatory behavior. OASPA has made errors in vetting applicants, though: it admitted some publishers that it later had to reject (e.g., Dove Medical Press).

Private individuals, similarly driven to rid the industry of charlatans, have also created websites that identify charlatans and fraudulent or predatory journals head-on. Sarah Beaubien and Max Eckard have created a rubric of sorts called Open Access Journal Quality Indicators to assist authors in identifying reliable journals. This list is worthwhile repeating and is shown in full below.

POSITIVE INDICATORS

• Scope of the journal is well-defined and clearly stated
• Journal’s primary audience is researchers/practitioners
• Editor, editorial board are recognized experts in the field
• Journal is affiliated with or sponsored by an established scholarly society or academic institution
• Articles are within the scope of the journal and meet the standards of the discipline
• Any fees or charges for publishing in the journal are easily found on the journal website and clearly explained
• Articles have DOIs (Digital Object Identifier, e.g., doi:10.1111/j.1742–9544.2011.00054.x)
• Journal clearly indicates rights for use and re-use of content at article level (e.g., Creative Commons CC BY license)
• Journal has an ISSN (International Standard Serial Number, e.g., 1234–5678)
• Publisher is a member of Open Access Scholarly Publishers Association
• Journal is registered in Ulrichsweb.com, Global Serials Directory
• Journal is listed in the Directory of Open Access Journals
• Journal is included in subject databases and/or indexes

NEGATIVE INDICATORS

• Journal website is difficult to locate or identify
• Publisher “About” information is absent on the journal’s website
• Publisher direct marketing (i.e., spamming) or other advertising is obtrusive
• Instructions to authors information is not available
• Information on peer review and copyright is absent or unclear on the journal website
• Journal scope statement is absent or extremely vague
• No information is provided about the publisher, or the information provided does not clearly indicate a relationship to a mission to disseminate research content
• Repeat lead authors in same issue
• Publisher has a negative reputation (e.g., documented examples in Chronicle of Higher Education, listservs, etc.)

It may be worthwhile adding two more telling aspects for identifying a predatory journal. Business registered to mailboxes with foreign owners is a clear indicator accompanied by a noticeable absence of information on the parent or company that clearly identifies who you are dealing with.

A cursory check on the editors and editorial staff will often expose non-existent individuals, qualifications, or people who are not even aware of the fact they have been added to the pages of the journal.

Two additional open resources that list actual journals and publishers known to be predatory can be found here. This link will take you to the homepage listing of actual predatory journals. If it’s publishers you’re interested in they offer this resource on a separate page. You can simply tweet to notify them of any journal that does not appear on their comprehensive list.

Now we’ve dealt with a few of the self-imposed industry regulators, let’s examine the big players in the predatory journal market.

The Hustlers

Let me introduce you to OMICS and its subsidiary company called Pulsus. Omics acquired the Candian based Pulsus Group in 2016 and has rapidly established itself as the king of the hill when it comes to predatory journals. Based in India with offices in the UK and Canada, the company aggressively pursues authors and couples its publications with an aggressive conference schedule to extend their “sales” beyond simple publication.

According to a Wikipedia entry on the company;

OMICS Publishing Group is a predatory publisher of open access academic journals. It started publishing its first journal in 2008. By 2015, it claimed over 700 journals, although about half of them were defunct. Its subsidiaries include iMedPub LTD and Conference Series LLC LTD. Other organizations linked to OMICS are EuroSciCon Ltd, Allied Academies, Trade Science Inc, and Meetings International.

OMICS is a slick, well-oiled machine built to intentionally exploit the Open Access model of publishing within the scientific community for the purposes of financial gain. This fact was acknowledged by the US Courts when they handed down a fine to OMICS International in excess of $50 million in 2019 for misleading practices.

This was after the U.S. National Institutes of Health sent a cease-and-desist letter to OMICS in 2013, demanding it to discontinue with false claims of affiliation with U.S. government entities or employees.

According to an article in the Scientist, which covered the 2019 case;

US District of Nevada Judge Gloria M. Navarro has ordered OMICS International to pay the US government fines to the amount of over $50 million, according to a court report released March 29.

OMICS is a publisher and conference organizer, and has been reported to engage in predatory publishing. According to the OMICS website, they publish over 700 journals and organize over 3,000 conferences globally. Topics covered include medicine, pharma, engineering, science, technology, and business.

OMICS also claims to have over 50,000 leading experts as editors for their journals. Scientists who were listed have reported they never received manuscripts to review or were not aware of their names being on the editors list, Ars Technicareports.

“I am neither on the rolls of OMICS nor am I the editor of any of those journals. I didn’t even know that they were using my name on their website. In fact, my affiliation on the site is not accurate. It was possibly lifted from the cover of one of my earlier books,” Rajesh Malhotra of AIIMS-Delhi tells Indian Express.

Pulsus, who owns and runs various journals, enjoyed a relatively reasonable reputation prior to being bought out by OMICS. It has since degenerated into a model that replicates the business practices of OMICS. I checked in on some of the publications, and as a simple example, chose this English journal based in the UK, (according to a mailbox address) called the International Journal of Clinical Skills (IJOCS).

It is a textbook example of a predatory journal, you don’t even need to look into the journal, just follow their Twitter feed or peruse their articles. A list of Editors and editorial staff has been made available and I have reached out to each individual member to confirm their association with the journal. Further evidence is provided by their APC page which states the following completely unethical bull.

If authors wish to retract their paper after 7 days of submission, he/she will be labelled to pay 50% of the total expenses on their article as a fee for withdrawal charges. Since, the publication process requires input of Editors, Reviewers, Associate Managing Editors, Editorial Assistants, Content Writers, Editorial Managing System & other online tracking system to ensure that the published article is of good quality and is in its best possible form.

Sorry, but isn’t that purpose behind the APC charge you levy upfront on the authors? Charging authors to edit or remove papers from a journal is unethical and not conducive to encouraging the correction of errors after publication. It is a commonly employed tactic of a predatory journal.

Similarly, the Scopus registration they boast on their front page is no longer valid. Here is the Scopus report on the journal. Yet more bull.

International Journal of Clinical Skills

• Scopus coverage years: from 2012 to 2013, from 2016 to 2017(coverage discontinued in Scopus)
• Publisher: SkillsClinic Ltd.
• ISSN:1753–0431E-ISSN:1753–044X

It is important to remember that many of the current predatory journals were once well-respected publications that have been bought out to simply exploit their reputations and these journals may retain a semblance of respectability for some time. It’s a thin veneer and although organizations like SCOPUS may have terminated the journal, other organizations may be slower to respond to the change in ownership and ethics.

An imposing mountain

That’s probably the easiest way to refer to the problem. How many publications are we talking about? To get an idea of the scale of the problem, here are two lists of the journals operated by Pulsus and OMICS respectively. The lists are maintained by Wikipedia and cumulatively total well over 800 journals.

OMICS has added a new trick to the predatory repertoire in the form of conferences. In addition to publishing journals, OMICS also organizes conferences. In 2017, about 3,000 such conferences were organized. The conference arm makes up about 60% of OMICS’ revenue.

A Bloomberg News investigation in 2017 noted a tendency of pharmaceutical companies to publish in these journals, which might have stemmed from a self-interest in skipping rigorous review procedures. They were also the major sponsors of OMICS conferences.

Where to now?

I don’t have to point out the obvious dangers posed by OMICS and other predatory journals and publishers out there. Danger to public health and danger to the professions in general. How much of the disinformation spread during the covid pandemic was and still is being enabled by these confidence tricksters?

The public is most susceptible to this sea of misinformation and often, the information is designed and published specifically to mislead them about a product, service, or idea. It is the most dangerous and destructive marketing tool we could have unleashed on the scientific community and an unwary public at a time when we can least afford it.

Stopping it now from within the industry appears to be forlorn hope and regulation may be the only alternative. If the FDA can sanction companies and businesses for misrepresenting information about Covid, they may not be too far off entering the fray. Whatever happens, let’s hope it is timeous.

In the meantime, do what you can to rid us of these insidious journals. Use common sense when selecting a journal to publish into, take due care for the future, your reputation, and your credibility as an ethical member of the scientific community. Report the tricksters when you cross their path. Electing to use these less restrictive journals now could well prove to be career-changing in the future, and not in a good way.

The post How OMICS and Other Predatory Publishers Enable Scientific Fraudsters appeared first on Medika Life.

Because all claims about treatments affecting human health and well-being should be subject to robust review. That review requires someone to facilitate criticism, locate qualified critics, and bring them into the discussion.

Authors want to be heard, praised, loved, paid handsomely, not criticized — even scientists.

That is why, as a counterbalance, scientific publications get peer reviewers involved to evaluate their claims.

Science journalism should be a key part of the independent, post-publication peer-review process. But how often have you seen journalists taking on that responsibility?

When it comes to psychedelics as treatments, the critics presumably, won’t be the only ones having a say. What they say can be disputed by the advocates of these drugs.

After all, there is an all too familiar situation across all of science, not just biomedicine or psychiatry: Initial claims about breakthroughs so often turn out exaggerated, premature, or simply false.

Ioannidis JP. Contradicted and initially stronger effects in highly cited clinical research. JAMA. 2005 Jul 13;294(2):218–28.

Having critics ready to point out that breakthrough findings might just not be what they seem can save time, resources, and maybe lives.

The critics come in with some advantage because of this strong past pattern of decline effects in science and biomedicine. Reliably critics have been met with resistance, often fierce because of what is at stake for advocates: prestige, reputation, and money.

Of course, critics, like advocates can prove biased or wrong, but it takes debate involving outsiders to decide that.

So, why do we have such wild enthusiasm and so little criticism of a recent RCT of psilocybin as an antidepressant in JAMA Psychiatry?

Or the past research cited to justify these studies?

Across peer-reviewed journals and the media we are witnessing an extraordinarily coordinated campaign for psychedelics as antidepressants that makes extraordinary claims:

The claim is that psychedelics administered in the context of relatively long term psychotherapy will have rapid, profound, and lasting effects on depression.

This campaign is funded and coordinated by advocates of the use of psychedelics for recreational and performance enhancers, not just as mental health treatments. The advocates include venture capitalists such as Tim Ferriss, one of the leading podcasters American entrepreneur, investor, author, and podcaster Tim Ferriss.

Where else do you see substances Pharma proposes as mental health treatment being discussed by leading psychiatrists as “expanding minds.” yet ‘advancing science’? Mental health professionals are letting their guard done, They are tolerating screaming conflicts of interest in a merging of the shouting of advertisements with the more, cautious, rigorous, skeptical talk of scientists.

I am not sure that is a good idea.

The unique claim for psychedelics as antidepressants is that they change the brain long-term, maybe permanently, yet they do absolutely no damage to the brain. Wherever have you seen such claims in psychiatry that did not have to be revised?

The claim is not being made that psychedelics can be shown to be effective antidepressants, but rather that psychedelics administered in the context of 8 months of psychotherapy can prove extraordinarily effective.

Skeptics who are accepted for their expertise in psychopharmacology may be hesitant to weigh in on matters requiring expertise in psychotherapy. They are concerned about being greeted with “Please don’t speak about things outside your expertise.”

Skeptics who are accepted for their expertise in psychotherapy may be hesitant to weigh in on matters requiring expertise in psychopharmacology for similar reasons.

Sure, experts in psychopharmacology may feel comfortable about combining evidence-based drug treatment with evidence-based psychotherapy, particularly when they have the advice of those who know more about psychotherapy research than they do. The assumption is that the effect might be not simply additive but interactive.

An analogous statement could be made for psychotherapy researchers needing to weigh in on combining evidence-based drug and therapy treatments.

So, who am I, the notorious CoyneoftheRealm, to try to stir the pot when so many others sniff the aroma and taste the success of a breakthrough treatment for depression?

Good question, but don’t ask me, I am biased.

Maybe you can decide that I can safely be ignored. All I can do in my defense is point out some serious flaws in the studies being discussed as clinical trials. I am trying to make the case as clearly and transparently as I can.

Psilocybin as an Antidepressant for Cancer Patients Who Are Not Depressed

Powerful Placebo in a Psilocybin for Depression Study

I don’t think any one person has all the expertise for a final word on whether psychedelics are great anti-depressants. We would seem to need breakthroughs, all the available antidepressants are not all that impressive.

There have been so many disappointments in past promising candidate drugs, that a lot of the smart money in Pharma has moved away from the search for new psychiatric drugs to cancer and cardiovascular disease.

Maybe I can make enough fuss so that experts with the full range of needed expertise step in and talk to each other. And I would be pleased if they showed me my skepticism was misplaced.

The post How Dare You Criticize Psychiatrists Who Praise Studies of Psychedelics As Antidepressants? appeared first on Medika Life.

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…

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.]

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….?”

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