By David Tuller, DrPH
The National Institute for Health and Care Excellence, the U.K. organization that develops clinical guidelines for medical conditions, has rejected my freedom-of-information request for the names of the experts involved in the reassessment of the guidance for the illness it calls CFS/ME. This isn’t surprising, since the agency also recently rejected similar requests from the Countess of Mar and the ME Association. However, NICE’s response to the FOI request, which I received on Friday, contains some useful information and clarifies the decision-making process. I have included the NICE response below, but here are some key observations.
The 2007 guidance, called CG53, endorsed cognitive behavior therapy and graded exercise therapy as the treatments of choice. According to the FOI response, the surveillance team that drew up the recently published “consultation document,” which recommends no change in this guidance, includes four NICE staffers: a technical analyst, a technical adviser, a clinical adviser and an associate director. In developing their proposal, they consulted with seven “topic experts”–three psychiatrists, two neurologists, a pediatrician and a patient representative. The surveillance team’s provisional decision to leave the guidance as is triggered this month’s two-week period for receiving comments from stakeholders. The final call will now be made by a group of eight top NICE employees, collectively called the “guidance executive.” Among the eight are Sir Andrew Dillon, NICE’s chief executive; Mark Baker, director of the Centre for Clinical Practice; and communications director Jane Gizbert.
According to the FOI response, four of the topic experts consulted were members of the committee that developed the guidance in 2007. That list included Professor Esther Crawley of Bristol University, who could presumably be the pediatrician among the topic experts. (For those who have not followed this saga closely, Professor Crawley falsely accused me of libeling her in two high-profile lectures this year—her inaugural address at her own institution and a talk to the British Renal Society. Despite my multiple efforts to extract an explanation from her, she has failed to provide any documentation for this ridiculous allegation.)
It is inappropriate and unsatisfactory that psychiatrists were the largest group represented among the topic experts. Apparently NICE still fails to recognize that the disease in question is most emphatically not a psychiatric or psychological disorder; the agency apparently accepts without question the specious perspective of the cabal of U.K. psychiatrists, psychologists and others who have hijacked the debate for the last three decades. The 2015 reports from the U.S. National Institutes of Health and the Institute of Medicine (now the National Academy of Medicine) authoritatively documented that ME/CFS, as American government agencies now generally call the illness, is an actual organic disease and not a figment of patients’ fevered imaginations.
The PACE/CBT/GET counter-narrative—that deconditioning alone accounts for the perpetuation of the symptoms, and that patients harbor “unhelpful beliefs” about having a medical condition—is not grounded in legitimate scientific research. Despite the desperate attempts by the PACE investigators to defend their pet theoretical framework, it is now clear to the international scientific community that the study’s reported findings in The Lancet (2011) and Psychological Medicine (2013) were wildly inflated—the result of rampant outcome-switching and other egregious methodological lapses.
In addition to PACE and other Oxford criteria studies, the NICE document cites the Cochrane reviews of CBT and GET in support of its conclusion. First of all, Cochrane includes the illness it calls CFS in its mental health disorders section, which immediately raises questions about the organization’s biased perspective. Moreover, given the inclusion of PACE and other studies using overly broad case definitions in the Cochrane analyses, the NICE consultation document is seriously misguided to cite these reviews as reliable evidence. After all, the Cochrane analyses cannot be legitimate and accurate when the studies they include are not. (I plan to take on Cochrane in an upcoming post.)
Both CBT and GET involve telling patients that these approaches will help them get better—an obvious method of biasing the results, especially given that the study was not blinded. The treatments appear to provide modest boosts in subjective measures but no long-term benefits over other treatment or management approaches. Neither PACE nor other studies from this group of researchers have documented objective improvements to match these subjective results; indeed, objective measures have consistently failed to support the claims of improvement and recovery. The significance of these salient facts appears lost on the NICE surveillance review team, which apparently suffers from the same “dysfunctional cognitions” as the PACE investigators about the efficacy of their strategy.
In normal circumstances, it might be appropriate to include committee members who worked on previous guidance as topic experts in the review process. But these are not normal circumstances. With this illness, relying on these committee members is a bad move. It stands to reason that those who developed the utterly inadequate and potentially dangerous 2007 guidance would be unwilling to challenge their own past perspective that GET and CBT are effective. This is especially true given that the PACE authors and other adherents of the biopsychosocial approach have consistently demonstrated their unwillingness to accept any criticism that challenges their viewpoint. They refuse to acknowledge, for example, that any study in which participants can meet outcome thresholds at baseline, before any treatment at all, has no place in the scientific literature, as many dozens of well-known experts have made clear in open letters to The Lancet and Psychological Medicine.
In Professor Crawley’s case, her research on the prevalence of the illness among children consistently conflates the symptom of “chronic fatigue” with “chronic fatigue syndrome.” This conflation serves to dramatically inflate the numbers of those purported to be afflicted. Her work, such as her proposal for the FITNET-NHS study of online CBT for kids, also misrepresents the NICE guidance that she herself was involved in developing, in ways that appear to render post-exertional malaise as an optional symptom rather than a required one. When called to account for these distortions, she chooses to insult her critics rather than provide satisfactory explanations of her flawed methodological choices. It is therefore highly troubling that the NICE consultation document cites FITNET-NHS as important new research that will inform future guidance.
The NICE response to my FOI request indicates that the agency reached out to the topic experts seeking their opinions on being identified. Three of them expressed concerns about having their names made public; a fourth could not be reached. The response does not indicate the answer, if any, from the remaining three; perhaps they didn’t object at all. Nevertheless, based on the responses from the three who objected, NICE has decided to keep all the names secret.
According to the NICE response, here’s why the three topic experts objected: “Reasons given include their experience, and that of other experts in the field, of being connected with this topic area. These included concerns about personal harassment, previous abuse and threats they have been subjected to when involved in work on this topic.”
It needs to be stated clearly that the PACE authors have routinely wielded this overhyped claim as a way of discrediting critics. However, the tribunal decision last summer that ordered Queen Mary University of London to release the raw trial data dismissed the claims as unfounded. The tribunal decision noted pointedly that the only reliable evidence presented to the court about such behavior involved an incident in which Professor Trudie Chalder, one of the three main PACE investigators, was heckled at a lecture. Professor Chalder herself acknowledged in her testimony at the tribunal that none of the investigators had received death threats, despite their habit of hyperventilating about the issue of abuse from patients. As has been previously documented, the wave of news stories about these purported death threats was a public relations stunt organized by the Science Media Centre.
So have some CBT/GET investigators received offensive e-mails or other communications that have upset them? I have no reason to doubt it. Perhaps some of these messages have even contained what could be construed as threats. But Professor Crawley and her colleagues have routinely deflected attention from the defects of their research by wrapping themselves in martyrdom, complaining vociferously that even the filing of freedom-of-information requests constitutes harassment—a preposterous argument, given that patients have a legal right to seek key information about publicly funded trials. And these researchers also frame accurate criticism as vexatious and illegitimate. That’s what Professor Crawley did earlier this year when she accused me of “libelous blogging” in a slide shown during her two speeches.
So despite its claims of valuing an open and transparent process, NICE is allowing the topic experts involved—including four whose names are already public as part of the 2007 guidance committee–to cloak themselves in anonymity. That is not acceptable. Given the enormous importance of this reassessment of CG53 and the huge public interest in understanding how the decisions are being made, NICE should reconsider this rejection of my request.
I am appealing to the agency to overturn its initial decision. Following the agency’s expected rejection of my appeal, I will then appeal to the Information Commissioner’s Office. Whatever the ultimate outcome of my request, the FOI response suggests that it is critical that the members of the guidance executive recognize that a pro forma ratification of the 2007 guidance will be a public relations disaster. More than 15,000 people signed the ME Association petition protesting the NICE provisional decision; that’s a lot of very, very unhappy patients. With PACE now exposed as a dishonest and even fraudulent piece of research, the ground in the debate has shifted. It is no longer time for business as usual.
Here is the substantive part of the NICE response to my FOI request:
Thank you for your request for information under the Freedom of Information Act (FOIA), received at this office on 07 July 2017. You requested the following information about the review of the CFS/ME guideline (CG53):
1. The number of people on the expert panel who will review input from stakeholders
2. The number, if any, of these people who are the same as those who were on the panel that developed the 2007 guidelines
3. The names of the people on the expert panel reviewing the CFS/ME guidelines, those currently serving and those who have served in the past year.
There is no expert panel which reviews input from stakeholders in our review process. You can read more about how we check that published guidelines are current and accurate in our guidelines manual.
For this review we followed the process for the 4 and 8 year checks. It includes extensive searches to identify any new primary and secondary studies, including any economic studies. The focus is on the scope of the published guideline, but any additional areas or changes in practice that are identified are also considered if they fall within the referral of the published guideline. A literature search is conducted across a range of sources. These may vary from topic to topic. They are selected according to their relevance to the topic and are based on those used in the published guideline.
Topic experts and members of the original guideline committee are asked for their opinion, in their personal capacity, on the relevance of the published guideline, recent developments in the topic area and their knowledge of any new important evidence since publication of the guideline. Guideline committees are responsible for the recommendations made and we publish the membership of them. We do not routinely publish the identities of topic experts because while they may express an opinion they are not part of the decision making body.
NICE’s surveillance review team summarises the relevant evidence and highlights any studies that may have an important impact on our recommendations. The main themes of new, relevant evidence across the guideline are also summarised, along with any other identified information (such as changes in licensing indications for a medicine or updated national policy). The surveillance team is made up of NICE employees – a Technical Analyst, Technical Adviser, Clinical Adviser and Associate Director.
The information identified as part of the surveillance review forms the basis of a review proposal for NICE’s Guidance Executive. In this case the review proposal was a public consultation document. When the information summarised in the review indicates that a ‘no update’ decision should be considered there is a 2‑week consultation with stakeholders who are registered for the published guideline.
The final decision about whether an update is need is based on a balanced assessment of new relevant evidence published since guideline publication, the views of the topic experts, feedback during consultation and other sources of information on the continued relevance of the guideline. The findings of the check on the need for an update are discussed with topic experts. All proposals go through an internal validation process (including sign‑off by the Associate Director and Director) before submission to NICE’s Guidance Executive. It is Guidance Executive that takes the decision to update the guideline or not.
Response to your request under the FOIA
Given the background above, in responding to your request, I have assumed that by ‘expert panel’ you mean the topic experts who were asked for their opinion on the relevance of the published guideline.
1. The number of people on the expert panel who will review input from stakeholders.
Seven topic experts were asked for their opinion on the relevance of the published guideline.
2. The number, if any, of these people who are the same as those who were on the panel that developed the 2007 guidelines.
Four of these people were also members of the original guideline committee.
3. The names of the people on the expert panel reviewing the CFS/ME guidelines, those currently serving and those who have served in the past year.
We hold the names of the topic experts who were asked for their opinion on the relevance of the published guideline. For your information the topic experts are from the following fields: neurology (2), psychiatry (3), paediatrics (1), patient representative (1). However, we consider that the names are exempt from disclosure under 2 sections of the FOIA. We explain these exemptions and why we have applied them below.
Section 40 – personal information
Section 40 provides an exemption from the right to know where the information requested is personal data protected by the Data Protection Act. Personal data is data that relates to a living individual who can be identified from that data. The names of these individuals is clearly personal data.
Under section 40(2) we are withholding the names of the topic experts because we consider that to release it would contravene the principles of the Data Protection Act. In reaching this decision we considered whether disclosure would be fair to the individuals concerned, the consequences of disclosure, the reasonable expectations of the individuals and any legitimate public interest in disclosing the information.
NICE does not routinely publish the names of topic experts who contribute to the review process therefore the individuals had no expectation that this information would be made public. We wrote to the topic experts to ask them if they had any objections to their identities being disclosed to the public, and if so, what those objections were. Three of them were strongly opposed to their identities being made public in this context and one could not be contacted within the time available.
Reasons given include their experience, and that of other experts in the field, of being connected with this topic area. These included concerns about personal harassment, previous abuse and threats they have been subjected to when involved in work on this topic. We were sent a link to a news story from the Guardian describing threats and abuse directed at researchers and professionals in this field.
NICE is also concerned that disclosing the identities of the topic experts would have a significant impact on our ability to get experts to contribute to our work on this topic in the future. This point was supported by Mr Justice Simon in the judicial review that followed the publication of the original guideline. While Mr Simon was referring to guideline committee members in his judgement we consider that the impact would be the same if the identities of the topic experts asked for their opinion in the review process were made public.
When individuals are members of a guideline development group (also known as a guideline committee) their identities are publicly available on our website because the membership, as a whole, is responsible for the recommendations made. As described above, in the review process, the topic experts are asked for their opinion but the review decision is taken by NICE’s Guidance Executive whose membership is publicly available on our website.
As 3 of the topic experts expressed concerns over their identities being made public and 1 could not be contacted we consider that it would not be fair to make the remaining names public as this could have the effect of unreasonably focusing activity on these individuals.
We recognise the public interest in ensuring public authorities remain transparent, accountable and open to scrutiny. We also recognise that disclosure would enable individuals to understand decisions made by public authorities in more detail, however on balance we do not consider the public interest in disclosure overrides the interest in maintaining these individuals’ privacy.
We therefore conclude it would not be fair to disclose the information under section 40(2) of the FOIA.
Section 38 – health and safety
Section 38 states that information is exempt from disclosure if its disclosure would, or would be likely to
(a) endanger the physical or mental health of any individual, or
(b) endanger the safety of any individual
The topic experts, and other experts in the same field, have specifically referenced threats and harassment they have been subject to in the past, as described above.
We have also considered if some of this information is already in the public domain because of the individuals previous work in this or other fields. As 4 of the topic experts were also on the guideline committee, their interest in this field is already in the public domain. However, in the context of the review, consultation and the campaigning activity around NICE’s proposal, we consider that releasing the information at this time would create a direct link between the experts and the review proposal and would raise their profile. Therefore disclosure at this time is likely to increase the risk that these individuals would be targeted and that this could lead to additional harm.
Mr Justice Simon also referenced unfounded allegations made against guideline committee members and his judgement stated that ‘unfounded as they were, the allegations were damaging to those against whom they were made; and were such as may cause health professionals to hesitate before they involve themselves in this area of medicine. A perception that this is an area of medicine where contrary views are not to be voiced, and where scientific enquiry is to be limited, is damaging to science and harmful to patients.’
Given the volume and nature of the correspondence (enquiries, petitions, letters, activity on message boards, Freedom of Information requests) we have received to date we are concerned that the experts may be targeted individually by any campaign and that such activity would impact on experts’ wellbeing and on their and others’ willingness to contribute to the work of NICE in the future, especially when they are not part of the decision making body.
We can’t be certain that the release of the withheld information would put the individuals at risk but we consider that there is sufficient evidence to conclude that they would be singled out for harassment, intimidation and possibly threats of violence.
This exemption is subject to the public interest test. We accept that there is significant public interest in being accountable and transparent for the decisions we take and for individuals under understand how we make our decisions. However, NICE also has a duty to protect the physical and mental wellbeing of the individuals concerned.
In this case the makeup of the decision making body, Guidance Executive, is already in the public domain. The review proposal is also publicly available and contains comprehensive discussion of the evidence including the feedback from the topic experts.
NICE operates openly and transparently. All of our guidance development processes are published in detail on the website. We believe the process and information on which the proposal is based is publicly available and subject to consultation. We consider that those with an interest in this guideline have sufficient information to be able to understand both the process and consideration of the evidence.
Given the concerns raised by the individuals and other evidence of previous incidents of experts in this field being targeted for harassment, including threats of violence, in the past we conclude that the public interest in disclosing the information does not outweigh the interest in maintaining the exemption in light of the likely risks to the health and safety of the individuals.
We therefore conclude it would not be fair to disclose the information under section 38 of the FOIA.