Despite evidence of a financial conflict of interest; after nearly two years the journal Frontiers has decided to believe in the authors and publish a worthless corrigendum. What happened to their high standard of research integrity?

On May 22^nd, 2021, I made Frontiers aware of a financial conflict of interest that had not been disclosed in a number of articles published in the journal.

I had discovered this lack of disclosure when this article was published in April 2021: «Cognitive Behavioral Therapy Improves Physical Function and Fatigue in Mild and Moderate Chronic Fatigue Syndrome: A Consecutive Randomized Controlled Trial of Standard and Short Interventions», https://doi.org/10.3389/fpsyt.2021.580924. The article states that “The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.».

This is simply not correct.

The project, which started in 2008, was a collaboration between St. Olav’s University Hospital, Norwegian University of Science and Technology (NTNU), Central Norway Regional Health Authority, (Helse Midt-Norge HF) and the Coperio Health Centre in Trondheim, Norway. Two versions of Cognitive Behavioral Therapy, CBT were compared: one standard 16-week and one short 8-week version.

Financial conflict of interest

The 8-week version was developed by one of the researchers, psychology professor Tore C. Stiles and took place at the Coperio Health Centre. This is a private, commercial company. Stiles is the founder of – and was the sole owner of Coperio where the 8-week version of the intervention took place.

I raised this issue with Frontiers. During Frontier’s discussion with the authors, they have responded to the allegations. At one point they claimed that: “The Pain clinic at the hospital had a lack of offices to conduct the treatment so they borrowed offices at Coperio” … “And no patients admitted to Coperio participated in the study.”. The information leaflet that was given to the study participants clearly states otherwise: «In the project, we collaborate with the Coperio Centre, and patients can be admitted there for treatment. The patient relationship with St. Olav’s Hospital then ends before the Coperio Center takes over the treatment.»

«Both the examination and the treatment trial are carried out in collaboration with Coperiosenteret AS. They participate in the collection of data and will have an active role in relation to the treatment offered to the patients.» (my translation)

Obviously, this was not just «borrowed offices».

List of vendors

The authors also claim that Coperio is part of the public health system.

This is also not true.

Coperio is a vendor, a private, commercial company with an agreement with a regional health authority to deliver certain services, including rehabilitation services for ME/CFS patients. Coperio is on the Central Norway Regional Health Authority’s (Helse Midt) list of private vendors of rehabilitation services.

This means that Stiles has invoiced the health authorities for his services from 2005 to 2022 when he sold Coperio to Unicare. Coperio is a stock-based company. Their business is commercial by nature regardless of who they invoice.

Similar treatment

According to the article, the 8-week CBT trial intervention was: “individual, interpersonal and personality-oriented”. Coperio has offered this type of treatment to ME/CFS patients for many years and still does. Coperio’s current 10-week rehabilitation programme is very similar to the 8-week CBT-intervention in the study. The following keywords are from the article published in 2021 on the left and from Coperio’s home page and information given to recent patients on the right:

See Coperio’s homepage from April 2021: “Rehabilitering for CFS/ME” and also the information given to Coperio’s patients (2021):

The information about the content of the rehab programme was removed from Coperio’s homepage in June 2021, when it became publicly known that the financial conflict of interest was undisclosed. See my article “Undisclosed financial conflict of interest in Norwegian ME research”.

There are several methodological issues with the study also. In 2021 Frontiers published my “rapid comment” but later removed it for reasons not told. Read my comment here: Rapid Comment by Nina Steinkopf.

Similar to current treatment

In addition to developing the 8-week CBT and having study participants treated at Coperio, Stiles also planned the study, developed the treatment manual and reviewed the article text. He had a financial interest in the results of the study which is not disclosed in the article. It was also not disclosed in the application for ethical approval in 2008.

See also my article with additional information from august 2022: Silence from Frontiers on financial conflict of interest in publications.

Since May 2021, I have supplied Frontiers with a long list of evidence for my claims, and also provided contact information to public bodies that can verify the correctness of the information. Frontiers has however, decided to believe in the authors’ current claims rather than the evidence and the information they provided to the participants at the time of the study.

Corrigendum

In December 2022 Frontiers published a preliminary corrigendum: https://www.frontiersin.org/articles/10.3389/fpsyt.2022.1122220/full 

The corrigendum says that Stiles claims that “the Coperio Health Centre is part of the public health system and does not treat patients commercially”. Furthermore, the corrigendum states that “After investigation, the journal has no reason to believe that the scientific conclusions of the article are affected in any way.” This is unlikely.

On February 27^th, 2023, Frontiers informed me that they have received a confirmation from the authors that:

«At the time of publication of the article, Coperio delivered specialized day treatment in groups (both physical and online) for patients with CFS/ME as part of the public health system and did not treat patients with CFS/ME commercially. The Coperio rehabilitation program was complex with multiple approaches and very different from the therapy offered in the study. There was, among other things, focus on diet, sleep, relaxation, body awareness and physical movement. The individual, interpersonal I-CBT offered in the study was developed specifically for the RCT and has not been used either prior to or after the study.».

Frontiers also informed me that “From our perspective as a publisher this response is satisfactory and there is no further action we can take. Our intention is to proceed with publication of the Correction and updated Conflict of Interest statement in its current form to avoid further delay.”

Retraction

Since the establishment of Coperio in 2002, T.C. Stiles has co-authored at least 79 published scientific articles, thereof 21 clinical trials. A majority of these articles are on subjects and treatment methods related to his (former) company’s services.

Frontiers has published at least nine other relevant articles co-authored by Stiles where the conflict of interest has not been disclosed.

The omission of declaring any financial conflicts of interest is a breach of the ethical standards of scientific publications. It may justify a retraction of an article. If Frontiers did, they would demonstrate that they adhere to the high standards of research integrity.

It will be a sad day for science if Frontiers proceeds with publication of the proposed Corrigendum and updated the Conflict of Interest statement in its current form. By doing that they accept something that is obviously wrong.

This fits into a pattern where many studies on CBT for ME sufferers are carried out by people with commercial interests, and that are often not disclosed.

Update, March 7th 2023: Frontiers has applied the corrigendum to the original article.

Written by

Nina E. Steinkopf

Former HSEQ Chief Executive

Now; ME-patient advocate