PLOS One allows authors of experimercial undeclared conflicts of interest, restrictions on access to data

  • While checking what PLOS One had done to address my complaints about authors’ repeated undeclared conflicts of interest, I made some troubling discoveries.
  • The PLOS One Academic Editor for one of the papers  was from Harvard Medical School, the same as the offending authors.
  • PLOS One had agreed to absurd restrictions on the availability of data,  essentially protecting these authors from independent investigation of their claims.
  • The agreement with these authors serves as a model for others’  defiant refusal to share data as a condition for publishing in PLOS One, including, obviously, the PACE investigators.
  • As a modest and symbolic protest, I am suspending activities as a PLOS One Academic Editor until a reasonable response to all of these issues is received, including my request for the PACE, which has been languishing for over 100 days.

plos one upside downBackground to the story

On October 25, 2015 I tweeted

October 25 tweet COI

PLOS picked up immediately and emailed me that they would investigate. I elaborated my concerns in a reply:

Publication of the PLOS article was coordinated with advertisements for the resiliency program. The PLOS article which is not a randomized trial, but a observational study misinterpreted in places as if it is a controlled RCT. it is effectively an experimercial [1, go to bottom of post for footnote] for the program and exploited as such in the advertisements.

My previously raising the issue about triple P parenting programs in another context elicited over 50 corrections and errata notices and changes in some journal policies. BMC medicine has offered an opportunity me to write about conflicts of interest in nonpharmacological trials. I intend to cite this paper has an example.

I believe that if reviewers and readers were prominently warned about a potential conflict of interest, they would be more vigilant to overinterpretation of an observational study with serious selection bias and would qualify their own independent evaluation of the study.

On February 5, 2016 PLOS sent me an email informing me results of their preliminary investigation, assuring me that conflict of interest statements would be attached to the articles in question and providing some preliminary wording.

On March 3, 2015, I checked the articles and found no conflict of interest statements had been attached yet, but whatI saw was truly alarming and suggested more serious problems. Hence, this blog post.

One of the articles

Gotink RA, Chu P, Busschbach JJV, Benson H, Fricchione GL, et al. (2015) Standardised Mindfulness-Based Interventions in Healthcare: An Overview of Systematic Reviews and Meta-Analyses of RCTs. PLOS ONE 10(4): e0124344. doi: 10.1371/journal.pone.0124344

“Overviews” of systematic reviews and meta-analyses are often less than the sum of their parts.They are subject to bias, particularly when their authors have products to sell. I have previously discussed this. I have been an activist for systematic reviews conducted by authors with conflicts of interest to be treated quite skeptically, particularly undisclosedconflict. This particular review concluded with a rousing and unjustified endorsement of the products that it offered to patients and other healthcare systems and providers. Big bucks are involved.

The evidence supports the use of MBSR and MBCT to alleviate symptoms, both mental and physical, in the adjunct treatment of cancer, cardiovascular disease, chronic pain, depression, anxiety disorders and in prevention in healthy adults and children.

The authors have declared that no competing interests exist, but one of the authors profits from an Institute that bears his name at Harvard.

Herbert Benson Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, United States of America

The following declaration of conflict of interest would be a modest and incomplete acknowledgment that these authors have big bucks at stake.

The following authors hold or have held positions at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital, which is paid by patients and their insurers for running the SMART-3RP and related relaxation/mindfulness clinical programs, markets related products such as books, DVDs, CDs and the like, and holds a patent pending (PCT/US2012/049539 filed August 3, 2012) entitled “Quantitative Genomics of the Relaxation Response”

I went to the article at the PLOS One website check what is now corrected. I found nothing. I noticed that the Academic Editor for this article was also at Harvard. I believe he should have been excluded. I can’t believe that he did not know about the undisclosed conflict of interest. But the basic issue is that he should not have been reviewing a manuscript from his own institution in the first place.

Academic Editor: Aristidis Veves, Harvard Medical School, UNITED STATES

The second conflicted article

Stahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, et al. (2015) Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLOS ONE 10(10): e0140212. doi: 10.1371/journal.pone.0140212

This is the article that originally aroused my attention because it is a methodologically poor study with improbable results. But publication of the article in PLOS One does an excellent job of promoting the authors’ products and services, especially when publication is coordinated with advertisements, including notifications on their websites 

The abstract states

Background

Poor psychological and physical resilience in response to stress drives a great deal of health care utilization. Mind-body interventions can reduce stress and build resiliency. The rationale for this study is therefore to estimate the effect of mind-body interventions on healthcare utilization.

Design

Retrospective controlled cohort observational study. Setting: Major US Academic Health Network. Sample: All patients receiving 3RP at the MGH Benson-Henry Institute from 1/12/2006 to 7/1/2014 (n = 4452), controls (n = 13149) followed for a median of 4.2 years (.85–8.4 yrs). Measurements: Utilization as measured by billable encounters/year (be/yr) stratified by encounter type: clinical, imaging, laboratory and procedural, by class of chief complaint: e.g., Cardiovascular, and by site of care delivery, e.g., Emergency Department. Subgroup analysis by propensity score matched pre-intervention utilization rate.

Results

At one year, total utilization for the intervention group decreased by 43% [53.5 to 30.5 be/yr] (p <0.0001). Clinical encounters decreased by 41.9% [40 to 23.2 be/yr], imaging by 50.3% [11.5 to 5.7 be/yr], lab encounters by 43.5% [9.8 to 5.6], and procedures by 21.4% [2.2 to 1.7 be/yr], all p < 0.01. The intervention group’s Emergency department (ED) visits decreased from 3.6 to 1.7/year (p<0.0001) and Hospital and Urgent care visits converged with the controls. Subgroup analysis (identically matched initial utilization rates—Intervention group: high utilizing controls) showed the intervention group significantly reduced utilization relative to the control group by: 18.3% across all functional categories, 24.7% across all site categories and 25.3% across all clinical categories.

plos upside 2The abstract ends with a rousing advertisement for products and services, aimed at gaining referrals and  dissemination to other settings, from which the authors would profit..

Conclusion

Mind body interventions such as 3RP have the potential to substantially reduce healthcare utilization at relatively low cost and thus can serve as key components in any population health and health care delivery system.

But then I noticed the data availability statement:

Data Availability: Data from this study are available through the MGH Institute for Technology Assessment for researchers who meet the criteria for access to confidential data, such as having internal review board approval to access the data as part of their research request. Access to data from this study is subject to review as noted as it contains potentially identifiable patient information. Authors from this study may be contacted through the MGH Institute for Technology Assessment or the MGH Benson.

Give me a break! The authors are restricting access to their their data with the excuse that someone seeking it might conceivably identify one of the over 17,000 participants. These authors were granted this restriction by PLOS One. Their rationale could serve as a model for other authors with conflicts of interest trying to the strict scrutiny of exaggerated and false claims, like the PACE investigators.

I am in the upper end of the distribution of PLOS One Academic Editors in terms of the number of manuscripts that I process. I actively try to recruit new academic editors when I give talks around the world, in an effort to increase the diversity of the editorial board in terms of both geographic location and expertise. I do this for free. But I do it because I love open access, data sharing, and post publication peer review. Immediately upon publication of this blog post, I am taking a leave from my editorial responsibilities for PLOS One. There are number of editorial decisions pending. I want to get back to work, if that’s what you call you what you do for free, but PLOS One has some problems to fix including, but not limited to the refusal of the PACE authors to to provide me the data has promised. Now that we have these other issues on the table before us, I’m adding this one. I hope to hear from PLOS soon.

citizen scientists try this at home

I invite citizen scientists to get to their computers, exploit the open access of PLOS One, search, and bring other such undisclosed data sharing atrocities to the attention of the administration.

  1. I learn a lot from Barney Carroll. I borrowed his invented term experimercial from a comment left on the Retraction Watch blog

Bernard Carroll September 17, 2015 at 12:50 pm

In the New York Times yesterday, Study 329 was described as an experiment. Actually, the study has all the hallmarks of an experimercial, a cost-is-no-object exercise driven by a corporate sponsor to create positive publicity for its product in a market niche. This is not clinical science… this is product placement. And if they had to put lipstick on the pig to get what they wanted, well… Meanwhile, the continued stonewalling by AACAP is misguided.