PLOS One corrects undeclared conflicts of interest for 5 articles from Bensen-Henry Institute for Mind Body Medicine

PLOS One has issued corrections declaring conflicts of interest for five articles from the Bensen-Henry Institute for Mind Body Medicine  associated with Massachusetts General Hospital and Harvard Medical School. The articles previously explicitly indicated that the authors had no conflicts of interest to declare.

Each of the articles now has a correction which states:

The Competing Interests statement is incorrect. The correct Competing Interests statement is: 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.”

The five corrections differ only with respect to the initials of the particular authors now declaring conflicts of interest.

The articles are:

Stahl, James E., Dossett, Michelle L., LaJoie, A. Scott, Denninger, John W., Mehta, Darshan H., Goldman, Roberta, Fricchione, Gregory L., Benson, Herbert.  Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization.  PLOS One.  2015 October 13; 10.1371

Kuo, B., Bhasin, M., Jacquart, J., Scult, M. A., Slipp, L., Riklin, E. I. K., … & Rosenblum, J. (2015). Genomic and clinical effects associated with a relaxation response mind-body intervention in patients with irritable bowel syndrome and inflammatory bowel disease. PLOS One, 10(4), e0123861. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123861

Bhasin, M.K., Dusek, J.A., Chang, B.H., Joseph, M.G., Denninger, J.W., Fricchione, G.L., Benson, H. and Libermann, T.A., 2013. Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLOS One, 8(5), p.e62817.

Hoch, D.B., Watson, A.J., Linton, D.A., Bello, H.E., Senelly, M., Milik, M.T., Baim, M.A., Jethwani, K., Fricchione, G.L., Benson, H. and Kvedar, J.C., 2012. The feasibility and impact of delivering a mind-body intervention in a virtual world. PLOS One, 7(3), p.e33843. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0172863

Dusek, J.A., Otu, H.H., Wohlhueter, A.L., Bhasin, M., Zerbini, L.F., Joseph, M.G., Benson, H. and Libermann, T.A., 2008. Genomic counter-stress changes induced by the relaxation response. PLOS One, 3(7), p.e2576.

The long process of obtaining corrections began with an October 28, 2015  email from PLOS One:

Dear Dr. Coyne,

I am writing to follow up on your recent tweet (https://twitter.com/CoyneoftheRealm/status/655142190625099776) in which you mention the lack of competing interests declared by the authors of a PLOS ONE paper, “Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization” (http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140212).

We would like to follow up on your concerns. We understand that at least one of the authors may receive funding from pharmaceutical companies for unrelated work. We also note that the Benson-Henry Relaxation Response Resiliency Program that is studied in the paper is a program run by the Benson-Henry Institute for Mind Body Medicine, with participants paying for sessions, some of which may be reimbursed by insurers, and may be related to their trademarked “SMART” program.

Do the potential issues that we have identified above accurately describe your concerns regarding the competing interests involved in this work? If you are able to provide any further details or let me know about any potential issues we may have missed, I would be very grateful.

Once I have confirmed my understanding of your concerns, we will be able to take appropriate steps to follow up. Thanks for bringing this to our attention.

Best wishes,

Sarah Bangs

To which I immediately replied:

To: Sarah Bangs <plosone@plos.org>

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 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 I received an email from PLOS One indicating the issues I had raised had been investigated for a number of articles associated with this Institute. The email provided the draft of a correction with the conflict of interest statement that was eventually posted these five articles almost a year later.

In the interim, I had repeated communications with PLOS One in which I tried and failed to get an explanation of why nothing had been posted.

Finally, in late December 2016,  the incoming Joerg Heber, Senior Editor for PLOS One indicated in a telephone conversation that he would investigate the matter.

There is one other article from this group that should also have a correction issued from undeclared conflicts of interest. It is a meta-analysis. I complained in October 2015, but apparently the complaint got lost.

To <plosone@plos.org>

As you may have noticed, I have more than a handful going on at Mind the Brain and won’t be blogging about this any time soon.

However, a related interesting issue: Should meta analyses of mindfulness conducted by head of institute providing mindfulness declare potential conflict of interest?  I say yes and let the readers decide.

http://www.plosone.org/article/Authors/info:doi/10.1371/journal.pone.0124344

Note Benson.

The article that concerned me was:

Gotink, R.A., Chu, P., Busschbach, J.J., Benson, H., Fricchione, G.L. and Hunink, M.M., 2015. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLOS One, 10(4), p.e0124344.

I will be blogging about the article shortly. It is consistent of a mishmash of narrative reviews and meta-analyses of mindfulness interventions that makes glowing statements about the health benefits of mindfulness. It avoids the best quality, most comprehensive review, which gives a conflicting evaluation, but it does cite it in passing.

bensen-henry-logo

On the website of the Bensen-Henry Institute for Mind Body Medicine, links to research papers are interspersed with recruitment of fee-paying patients to clinical services and solicitations to other institutions from mindfulness-interventions. Much of the research is of poor quality but serves to advertise that the services and training being offered are evidence- and science-based.

resiliency-youth

Cheaper for companies to promote their products with publications in Open-access journals than paywalled journals.

Links at the institute’s website allows direct access to the PLOS One papers. Publishing such infomercials in open access journals is a lot cheaper than publishing in pay walled prestigious medical journals where reprints have to purchased for distribution.

Richard Smith estimated that Merck paid New England Journal of Medicine $836,000 for reprints of an article with two employees of Merck as authors concerning a randomized trial of  rofecoxib (Vioxx). The drug was ultimately found to be ineffective and to have more adverse events than reported. NEJM was slow to respond when notified of the problems with the drug.

The journal is no doubt embarrassed by this further twist. It was a failure of peer review, but peer review is an empty gun anyway—as I have argued in this journal before.17 More worrying is the anxiety that the drug company has used the prominent pulpit of the New England Journal of Medicine to advance a message that was very much in its interest—but ultimately incorrect. It fits with the argument that medical journals are an extension of the marketing arm of pharmaceutical companies and that the full data of trials should be published not in medical journals, where an incomplete story is advanced, but on the web.6,18

Jeffery Drazen  Editor-in-Chief of the NEJM replied:

The tale Smith tells is riddled with distortions and unsubstantiated opinions. These inaccuracies seem designed to serve an agenda he already has put forth: that journals are information-laundering vehicles for industry, a cynical view that we do not share.

ebook_mindfulness_345x550I will soon be offering e-books providing skeptical looks at mindfulness and positive psychology, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my new website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites.  Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.