By David Tuller, DrPH
*Two corrections had been made in the text below. The NEM committee has 12 members, not nine, as I originally wrote. And when Dr Flottorp wrote her letter, it was not while the NEM committee was considering the proposed Lightning Process trial, as I originally wrote, but before it had progressed that far. The letter was written in expectation that the matter could be forwarded to the NEM committee, which it then was.
Dr Signe Flottorp is a promoter of the Lightning Process for ME/CFS as well as the research director at the Norwegian Institute of Public Health. That’s a scary combination! Dr Flottorp, a general practitioner, is also a fervent member of the Scandinavian arm of the CBT/GET ideological brigades. She and two colleagues recently wrote an ill-informed opinion piece promoting GET and CBT called “Facts and myths about ME” for Aftenposten, a major news organization. Aftenposten also published my rebuttal–with an appealing photo!–in which I declared their unfounded arguments to be “tullprat.” (“Nonsense,” for non-Norwegians.)
It recently became known that Dr Flottorp engaged in some private lobbying last April on behalf of a controversial proposed LP study being reviewed by NEM–a national research ethics body for medicine and health sciences. In 2021, NEM rejected a previous version of the proposed LP study, although the 12-person decision-making committee has since had a partial turnover of membership. The committee approved the new version of the LP study earlier this year.
As revealed online, Dr Flottorp sent an e-mail–on her private rather than government account–to a new member of the NEM committee. In the e-mail, she derided the previous decision to reject the LP study, criticized ME “activists,” and urged approval this time around if it came before the committee again. This communication, which emerged through a freedom-of-information request, occurred before the matter had actually come before the committee. It is unknown whether Dr Flottorp contacted other committee members as well.
I have no idea if this contravenes any of NEM’s ethics policies about studies under review, or if the organization has such policies. Maybe this sort of intervention from a prominent government health official is considered perfectly kosher, but it certainly has the appearance of a possibly inappropriate effort to influence internal committee deliberations. (I plan to write to NEM and seek answers to a couple of questions about the situation.)
Nina Steinkopf, a Norwegian ME patient who chronicles domestic ME shenanigans on her invaluable blog, MElivet, has posted an article about this particular matter. I am re-posting it in full below, with her permission. [The text has been through google translate.]
The head of research at FHI engages in unethical lobbying for alternative treatment
Research manager at FHI, Signe Flottorp conducts private lobbying for the alternative method Lightning Process as a treatment for ME. She uses her position to influence public authorities and the outcome of a complaint. This is done based on anecdotes and with grave language in the mention of a patient group and of dissenters.
The complaint about the project where 100 ME sufferers are to be treated with the alternative method Lightning Process was dealt with in the National Research Ethics Committee for Medicine and Health Sciences (NEM). On 13 July 2022, it became known that NEM had decided – by dissent – to let the project retain the ethical pre-approval .
A minority, NEM leader Kari Milch Agledahl, deputy leader Anne Kjersti Befring and member Steven Blackman voted against the project retaining the ethical pre-approval. 9 voted for.
Now it appears that the head of research at FHI, Signe Flottorp, has contacted at least one of the members of the committee and tried to influence the voting. On 31 March 2022, she sent an SMS to Jo Røislien – with whom she is on a first name basis:
Røislien asked Flottorp to send an email about what was involved. Flottorp sent an e-mail on April 5 from her private e-mail address and writes that she is strongly committed to NEM not repeating what she believes was a completely hopeless decision when they overturned the Regional Committees for Medical and Health Research Ethics, REK Amid its approval decision in the first round of applications in 2021. She is convinced that LP is potentially very effective. Those who complained about REK’s approval decision are referred to as “the ME activists” who she claims “harass former patients who have recovered, and they also harass researchers and others who do not support their strategy.”. Read the email on Twitter .
Røislien informed the head of the secretariat in NEM about the correspondence in connection with a request for access in November this year and writes that he did not reply to the email. It is not clear whether he and Flottorp talked about the matter on the phone.
Røislien was one of the 9 who voted for the project to retain approval. It is currently unknown whether Flottorp contacted others in the NEM committee in connection with the complaint.
NAFKAM’s risk assessment of LP
The LP study received ethical approval for the first time in November 2020. The decision was appealed and in January 2021 it was stated that REK Midt found no grounds for changing the decision. The case was therefore forwarded to NEM for final assessment. In June 2021, NEM informed that the complaints had been upheld and that the approval decision had been reversed.
In advance of this – in March 2020, the National Research Center for Complementary and Alternative Medicine (NAFKAM) issued a new risk assessment of LP: NAFKAM’s risk assessment of LP consists of . The risk assessment shows, among other things, to a notice of negative course of CFS/ME linked to the Lightning Process from NAFKAM to the Directorate of Health dated 23.12.11.
This was bad news for the then planned LP study. In an email to NAFKAM in April 2020, Flottorp urged NAFKAM to withdraw and apologize for the warning about LP from 2011, and at the same time update the risk assessment “based on recent research”.
NAFKAM’s dialogue meeting on LP
In September 2020, NAFKAM invited a number of stakeholders to a dialogue meeting about LP and CFS/ME. In connection with the planning, NAKFAM sent out a survey to potential participants and asked what they thought were important elements in such a meeting. Flottorp didn’t like that. After a dialogue about this, she wrote to NAFKAM that “I have to say that I am surprised. As you know, I have little trust in NAFKAM, and this message strengthens my opinion that NAFKAM should have no role regarding LP – neither to make a report, nor a conference.” (my translation). She claims it is a waste of taxpayers’ money:
In February 2021, Flottorp communicated with professor of health services research at the University of Tromsø Olav Helge Førde and professor emeritus Roar Johnsen at NTNU about the dialogue meeting and writes that NAFKAM has messed it up quite badly. She is concerned about Live Landmark’s LP study and asks for advice on how UiT can “stop this nonsense”. At the time, Johnsen was part of the LP study’s “preparedness group”.
In May 2021 , NAFKAM informed that they had chosen to end the planning of the expert dialogue meeting.
Anne Kjersti Befring is a lawyer, lawyer and associate professor of jurisprudence at the Faculty of Law at the University of Oslo. She is responsible for the subject health law at UiO. Befring is also deputy chairman of NEM. I have asked Befring for a statement and she states – by virtue of her role as a researcher at the Faculty of Law and not as a NEM member, in an email on 5 December 2022:
“I am surprised by the temperature in the debate about ME and how ME can be treated, and by how the patient group is discussed by key researchers in this field. As researchers, we must be open to different views and explanatory models. It is obvious that neither the ME diagnosis nor the patient group is heterogeneous.
Researchers and practitioners must listen and learn from patients’ experiences with their own illness and with how they are met in the health service, by NAV and other service providers. The responsiveness cannot be selective in the sense that only those who agree with the researchers’ hypotheses are listened to. Opposing views must be listened to and international research must be followed.
There are several dilemmas that need to be taken seriously. The researchers must have a critical eye on the method used to obtain knowledge, as well as the selection and how the reporting takes place. Researcher Anne Kielland in FAFO has addressed the challenges with NAV benefits. If ME sufferers are almost forced to carry out undocumented therapy or research in order to receive NAV benefits, there is no valid consent. If there is a likelihood that the therapy will lead to a worsening – or prolongation of the condition, or an experience of loss of coping, the form of therapy could be considered unjustified.
We have received documentation that a central person in FHI has actively tried to influence decisions by personal mail to decision-makers, that is, in “channels” that are not open. An email has been sent from Flottorp in FHI to a member of NEM and to managers in Helse-Nord to stop NAFKAMS work processes. This is at best unprofessional and an isolated failure. It can also be an expression that there are major challenges in the governance system with attempts at network governance outside the ordinary arenas for debate and governance. We would not have known about this form of work if access had not been requested.
Flottorp describes NAFKAM’s decision that there should be an “expert dialogue” about LP as having “messed it up quite badly” and also demands an apology from NAFKAM. This despite the fact that NAFKAM’s task is to assess new undocumented methods with the aim of giving the population more knowledge. This email shows that the head of FHI does not accept this mandate given by the Storting. The email also shows that a network of managers is used to influence the work process without this being known to others.
NAFKAM notified the health authorities about negative CFS/ME courses linked to the self-help technique Lightning Process (LP) and possible risks associated with this already in 2011. The Norwegian Directorate of Health asked NAFKAM to carry out assessments of this method after criticism had been raised of LP courses for children and young people with an ME diagnosis, as well as from research carried out at LP. NAFKAM has also itself received complaints from patients who have undergone LP. Reports to the Registry for Exceptional Disease Courses (RESF) from three CFS/ME patients who had experienced worsening following courses in the Lightning Process. It is part of NAFKAM’s social mission to evaluate LP and other alternative treatment methods.
Flottorp wrote an email to a member of NEM before the research project at ME was to be assessed and describes the previous decision from NEM as “a hopeless decision” and asks that NEM not do the same again, despite the fact that she says she does not know the details of the case. The criticism from the ME association, the patient group and relatives is referred to as “activism”, despite the fact that the project is controversial.
Such statements from FHI’s employees should take place in open spaces as part of the public debate and not in personal emails. The review is tendentious. It is necessary for researchers and FHI’s employees to tolerate counter-arguments and debate without characterizing dissenters.
I was not in NEM when they made the first decision not to approve the project. I am deputy chairman of NEM and was part of the minority who did not want to approve the project in a new decision in 2022, together with the chairman and the user representative. The reasoning is the same as in the previous NEM decision. We believe that sufficient changes have not been made to fulfill the law’s requirements for health research. The majority is of a different opinion.
Health research must be trusted by the population. Influencing decision-making processes by e-mail to decision-makers and describing dissenters as activists is neither confidence-inspiring nor constructive. It can be perceived as stigmatizing with the aim of stopping necessary objections from those who are strongly affected by the disease and by the treatment methods being tried. Therapists and researchers must listen to patients’ experiences, even if they do not always agree with their own theses.”
Read also: Anne Kielland and Arne Backer Grønningsæter, Psykologisk, 2022: It’s not the Lightning Process that ME sufferers are afraid of, it’s NAV .
Flottorp has strong opinions about LP and ME and expresses them diligently. In the autumn of 2021, British health authorities, The National Institute for Health and Care Excellence (NICE), published new guidelines for ME/CFS in which there is a specific warning against offering the Lightning Process to ME sufferers. NICE is an independent British institution that prepares research-based guidelines on how the healthcare system should follow up different patient groups.
In February this year, Flottorp criticized NICE in the journal The Lancet and speculates whether the guidelines are based on ideology rather than science .
In a reader’s post in Aftenposten on 25 October 2022 , Flottorp and two project members in the LP study Vegard BB Wyller and Silje Endresen criticize Reme Fafo’s research project The service and MEg. They refer to the LP organization Recovery Norway (which Landmark co-founded) and claim that “you can get better and also completely recover from ME with the help of cognitive techniques.”.
In Morgenbladet in November 2022 , Fafo researcher Anne Kielland tells about the findings in the project der Tjesenten and MEg where they have looked at the experiences of ME patients with public services. Kielland talks about ME sufferers’ enormous vulnerability in the encounter with, among other things, NAV. In the NAV system, ME patients can be forced to undergo treatment methods that worsen the disease as a condition for receiving benefits.
Flottorp says: – The project seems activist to me, as if they are closely allied with the ME association and in a way are their mouthpiece.
It is NAV that will recruit participants for the LP study.
Thank you to those of you who have sought access to these emails. They document that Flottorp engages in private lobbying for the alternative method Lightning Process as a treatment for ME. She uses her position to influence the outcome of a complaint in NEM. This is done from a position that is difficult to justify academically: not on research, but on individual stories and one case from own practice. Flottorp behaves unethically with grave language in the mention of a patient group and of dissenters.
Now the question is: Does FHI support Flottorp’s opinions and behaviour?
Disclosure: My academic position at UC Berkeley is supported largely by crowdfunded donations to the university from patients with ME/CFS, long Covid and other complex conditions.