Undisclosed financial conflict of interest in Norwegian ME research

A Norwegian psychologist and researcher has not reported that he also owns the health care center that diagnoses and treats the same group of patients he researches.

I have previously written about a Norwegian ME-study on cognitive behavioural therapy (CBT) where the results were not as good as they were presented: Norwegian ME study: Not so important findings anyway? Read the English version of my comments to the article here.

The results of the study were recently published in the prestigious journal Frontiers in Psychiatry. The project was a collaboration between St. Olav’s University Hospital, Norwegian University of Science and Technology (NTNU) and Central Norway Regional Health Authority, (Helse Midt-Norge HF) in Norway.

One of the researchers, psychologist Tore C. Stiles, planned the study, developed the treatment manual, designed the 8-week I-CBT intervention and reviewed the text. The 8-week CBT intervention took place at the Coperio health centre. Coperio has an agreement with the Central Norway Regional Health Authority, a state-owned regional health authority, to deliver rehabilitation services for CFS/ME-patients. For several years, Coperio also had an agreement with the Norwegian Labour and Welfare Administration (NAV) for referral of patients from 7 counties to a project with the aim to get patients rapidly back to work. Patients are also referred from insurance companies and employers.

Coperio is a commercial company, solely owned by T. C. Stiles. In other words, Stiles, owner and CEO of Coperio Holding, has a financial conflict of interest in the results of the study. This is not reported in the article: “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.”

It’s an important principle in research that any possible conflict of interest is declared. It is the research institution and the individual researcher’s responsibility to ensure transparency about possible conflicts of interest.

See the National Research Ethics Committees’ general guidelines here and the Declaration of Helsinki here.

The conflict of interest was also not disclosed in the application for ethical approval in 2008.

Affiliations

Tore C. Stiles is affiliated with NTNU, St Olav’s University hospital and the University of Oslo. When asked whether the conflict of interest should have been declared in the article, Tore C. Stiles answers on email 27th May 2021 that the interpersonal cognitive therapy method used in the study has never been used in clinical practice either at the CoperioSenteret or elsewhere. «Therefore, there are no commercial interests here.».

He writes that: «Patients who are referred to the CoperioSenteret do not receive cognitive therapy, neither traditional nor interpersonal variant.»

The Coperio Center offers both diagnosing and rehabilitation of CFS/ME patients. According to Coperio’s website, the 10-week program for CFS/ME patients has key elements such as «recovery, thought patterns, movements, relaxation, personal needs, self-esteem and sleep.»

According to Stiles, on the other hand, the Coperio centre «treat CFS/ME as a disorder of the inflammatory system and the immune system». He writes that «the treatment principles are aimed at normalizing the reactivity of the inflammatory system and the immune system.».

 – CoperioSenteret does not want to be associated as a centre that works according to cognitive treatment principles, Stiles concludes.

According to a patient journal from Coperio, the rehabilitation program focuses on “symptom management through working with thought management, stress management, affect awareness, identification of needs, communication, boundaries, interpersonal challenges and self-esteem. It is taught within the framework of psychomotor physiotherapy, cognitive and metacognitive therapy and neurolinguistics.»

Lightning Process

In the study protocol, the I-CBT intervention that Stiles designed is described: «Short-term CBT has not yet been documented in CFS/ME, but there are anecdotal case studies of intensive, group-based courses with elements from CBT, so-called «Lightning Process».»

The treatment team at Coperio includes Lightning Process instructor, Ann Schifte (Osmundsen). Lightning Process is an alternative treatment based on i.a. the pseudo-scientific method of neurolinguistics. Schifte is also a member of the LP-organization Recovery Norway (RN). RN was established by i.a. a number of LP instructors and is lobbying the health authorities. Schifte is not an authorized healthcare professional.

Read more about the establishment of Recovery Norway here.

The website Karriere.no states that «CoperioSenteret is a private health company in strong growth and we are experiencing increased demand for our psychology services. We want to connect with psychologists and psychologist specialists all over the country. Our clients are referred from NAV, insurance companies or employers and our focus is rapid return to working life using cognitively oriented forms of treatment.».

Read here about ME and psychiatrists’ ties to insurance companies.

Another planned study at NTNU, where ME-patients are to be treated with LP, is also associated with conflicts of interest. It is financed by the Norwegian Research Council – via the scheme «Public PhD» – despite the fact that the PhD candidate operates via a commercial enterprise.

Professor (MD/PhD) and specialist in general practice and psychiatry Egil Fors was project manager for CBT-study. At that time, he was employed at St Olav’s Hospital. He now works at the Coperio Centre. He is also part of the project team in the planned LP-study.

Research articles

Since the Coperio Center was established in 2002, T. C. Stiles has co-authored at least 79 published research articles, of which 21 are clinical studies. Most articles are with topics and treatment related to Coperio’s healthcare services. Frontiers has published 10 of these. None of them disclose a conflict of interest.

Written by Nina E. Steinkopf

Former HSEQ Chief Executive

Now: ME-patient and writer

References

  1. Gotaas ME, Stiles TC, Bjørngaard JH, Borchgrevink PC, Fors EA.: 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. Front Psychiatry. 2021 Apr 12;12:580924. doi: 10.3389/fpsyt.2021.580924.
  2. Vethe D, Kallestad H, Jacobsen HB, Landrø NI, Borchgrevink PC, Stiles TC. The Relationship Between Improvement in Insomnia Severity and Long-Term Outcomes in the Treatment of Chronic Fatigue. Front Psychol. 2018 Sep 21;9:1764. doi: 10.3389/fpsyg.2018.01764. eCollection 2018.PMID: 30298037 
  3. Jacobsen HB, Glette M, Hara KW, Stiles TC. Metacognitive Beliefs as Predictors of Return to Work After Intensive Return-to-Work Rehabilitation in Patients With Chronic Pain, Chronic Fatigue and Common Psychological Disorders: Results From a Prospective Trial. Front Psychol. 2020 Feb 6;11:70. doi: 10.3389/fpsyg.2020.00070. eCollection 2020.PMID: 32116900 
  4. Jacobsen HB, Aasvik JK, Borchgrevink PC, Landrø NI, Stiles TC. Metacognitions Are Associated with Subjective Memory Problems in Individuals on Sick Leave due to Chronic Fatigue. Front Psychol. 2016 May 13;7:729. doi: 10.3389/fpsyg.2016.00729. eCollection 2016.PMID: 27242634 
  5. Aasvik JK, Woodhouse A, Jacobsen HB, Borchgrevink PC, Stiles TC, Landrø NI. Subjective memory complaints among patients on sick leave are associated with symptoms of fatigue and anxiety. Front Psychol. 2015 Sep 8;6:1338. doi: 10.3389/fpsyg.2015.01338. eCollection 2015.PMID: 26441716 
  6. Brage, Jonassen Rune, Stiles Tore C., Landrø Nils. I. Dysfunctional Metacognitive Beliefs Are Associated with Decreased Executive Control Front Psychol. 2017  doi: 10.3389/fpsyg.2017.00593   
  7. Jacobsen HB, Klungsøyr O, Landrø NI, Stiles TC, Roche BT. MINDflex Training for Cognitive Flexibility in Chronic Pain: A Randomized, Controlled Cross-Over Trial. Front Psychol. 2020 Dec 21;11:604832. doi: 10.3389/fpsyg.2020.604832. eCollection 2020.PMID: 33408670 
  8. Østergaard T, Lundgren T, Rosendahl I, Zettle RD, Jonassen R, Harmer CJ, Stiles TC, Landrø NI, Haaland VØ. Acceptance and Commitment Therapy Preceded by Attention Bias Modification on Residual Symptoms in Depression: A 12-Month Follow-Up. Front Psychol. 2019 Aug 29;10:1995. doi: 10.3389/fpsyg.2019.01995. eCollection 2019.PMID: 31555180 
  9. Aasvik JK, Woodhouse A, Stiles TC, Jacobsen HB, Landmark T, Glette M, Borchgrevink PC, Landrø NI. Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. Front Psychol. 2017 Jan 6;7:2003. doi:10.3389/fpsyg.2016.02003. eCollection 2016.PMID: 28111555 
  10. Lyche P, Jonassen R, Stiles TC, Ulleberg P, Landrø NI. Cognitive Control Functions in Unipolar Major Depression with and without Co-Morbid Anxiety Disorder. Front Psychiatry. 2010 Dec 21;1:149. doi:10.3389/fpsyt.2010.00149. eCollection 2010. PMID: 21423456 

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