NIH ME Intramural Paper
The NIH continues its obstinate false portrayal of ME as a disease characterized mainly by fatigue with the publication in February 2024 by Brian Walitt et al of its infamous Intramural Paper on post-infectious Myalgic Encephalomyelitis (ME), a chronic, complex disease affecting many millions worldwide. The NIH intramural paper purports to define the ME phenotype based on a cohort of 17 ME patients.
The NIH put a new spin on its decades-old fatigue narrative; using the Effort Expenditure for Rewards Task (EEfRT) in a 15-patient sub-set, the investigators reframed fatigue as “unfavorable preference” to exert effort or an “unfavorable” “Effort Preference” which they say is the decision to avoid the harder task to be a “defining feature” of ME. According to the NIH this 'Effort preference' outcome was the study's primary objective.
According to Jeannette Burmeister, "The Effort Preference claim is an endorsement and expansion of the work of Dr. Simon Wessely, the knighted potentate of the biopsychosocial brigade, which disparages the disease and its patients. According to Wessely, ME is a disorder of the perception of effort, which is identical with NIH’s characterization of Effort Preference. NIH used Wessely’s body of work as a blueprint for the NIH intramural study."
Please see more about this in Part 1 of Jeannette Burmeister's analysis.
NIH and Effort Preference
A piece by Jeannette Burmeister from Part 4 of her analysis
"By NIH’s own admission, the intramural ME study has been first and foremost a delivery vehicle for the brand-new Effort Preference term and concept in ME, which, in essence, asserts, instead of being objectively physically limited, that ME patients falsely believe, as the result of a dysfunctional effort perception, that they are unable to exert themselves past their limits, resulting in deconditioning and functional disability. NIH had obviously decided that the fatigue label, which it has used to falsely describe ME for decades, was no longer damaging enough.
NIH invented Effort Preference as defining of ME, which is not supported by the data and which is deeply and glaringly derogatory and severely harmful. The agency then contaminated everything else in the intramural paper by relating it all to the new Effort Preference concept. By doing so, NIH formalized Wessely’s theory on ME as an issue of false perception of effort and fatigue. This is about as hostile to the ME community as one can imagine. If NIH had had even just neutral intentions, the authors would have presented the immunological findings as the primary findings instead of altered Effort Preference.
This constitutes a defamatory assault on ME patients. Since the publication of the paper, NIH has been flailing, trying to put a benign spin on the effort claim with a disingenuous, contrived re-framing that does not stand up to scrutiny. Because the alleged Effort Preference findings are tied in with the other findings of the study, the entire paper is tainted and has to be retracted. We all know that the peer-review process is broken, and this paper is an effective illustration of that.
The issues laid out in this four-part series are extremely serious. Whether or not they rise to the level of research misconduct is yet to be determined. The sheer number and the nature and severity of the issues combined with the well-documented ME agenda on the part of the agency and several of the investigators in this study suggest at the very least recklessness—that much incompetence at NIH would be shocking but not surprising in light of the absence of accountability at the agency—if not knowledge or, more likely, intent."
Call To Action
Jeannette Burmeister's four-part analysis of the NIH 2024 ME Intramural Paper is a powerful and brilliantly written criticism in which she scrutinises and dissects the Department of Health and Human Services (HHS)' shameful hijacking of the October 2012 recommendations by the Federal Advisory Committee (CFSAC)* and the deliberate and aggressive urgency at HHS to quash the Canadian Consensus Criteria (CCC) momentum that had been building due to the CFSAC recommendation and other CFSAC work, the subsequent HHS tampering of the CCC recommendation, the publication of the IOM** definition of ME, the NIH ME intramural paper and its harmful characterization for ME ( 'Effort Preference'), the study behind the paper and the authors and other NIH staff, i.e., Dr. Avindra Nath, NIH senior investigator and NINDS intramural clinical director, principal investigator of the NIH ME Intramural Study; Dr. Brian Walitt who would have a major impact on the direction of ME research at NIH and, therefore, worldwide, steering it toward the biopsychosocial narrative.
Jeannette highlights both Nath and Walitt's involvement in Part 4 of her analysis.
*CFSAC
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provided advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to Myalgic Encephalomyelitis and chronic fatigue syndrome. CFSAC members included ME advocate Ms. Eileen Holderman, the late Dr. Mary Ann Fletcher, and others. Once the IOM published its redefinition of ME in 2015, it did not take long for CFSAC to be disbanded as it no longer had any usefulness for HHS. More about CFSAC
**IOM
"The Institute of Medicine, US (IOM) criteria are expressly and importantly limited to clinical diagnosis, i.e, they are not to be used for research. HHS’s purported reason for limiting the IOM contract to clinical criteria contrary to the CFSAC recommendation was that a new government research definition would follow, which, of course, never happened. " [......] "As discussed in Part 3, the IOM definition is so broad that all 17 ME patients in the NIH study satisfied it while only about half of the patients satisfied the stricter CCC, the definition ME experts and advocates had endorsed. The IOM definition is even broader than the Fukuda definition, which was satisfied by 82% of the patients in the NIH study."
In Part 4, following analysis of NIH's 'Effort Preference', Jeannette Burmeister invites the ME community worldwide and others to participate in a Call To Action asking NIH to retract the ME Intramural Paper.
Jeannette provides a Call To Action template, see below, and suggests that patients worldwide can write to the:
- NIH Director
- Director of Research Integrity & Agency Intramural research Integrity Officer
- Inspector General
The only US-specific aspect of this Call To Action is contacting US elected officials.
"I urge readers to file complaints by sharing my four-part analysis with the following authorities:
- your U.S. Senators and Representatives
- the NIH Director, Dr. Monica Bertagnolli:
- monica.bertagnolli@nih.gov
- the Director of Research Integrity and the Agency Intramural Research Integrity Officer (AIRIO), Dr. Kathy Partin (https://oir.nih.gov/sourcebook/ethical-conduct/research-misconduct):
the HHS Office of the Inspector General (OIG). OIG complaints can be filed in a variety of ways as follows:
by U.S. mail:
- U.S. Department of Health and Human Services
Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, DC 20026
- by fax: (800) 223-8164
with requests to:
- investigate the study
- with respect to potential gross misconduct and potential research misconduct, including, but not limited to, falsification of data, i.e., manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
- constituting a significant departure from accepted practices of the relevant research community and committed intentionally, knowingly, or recklessly,
- discipline any individuals involved in the foregoing improprieties, if any, and
- retract the NIH intramural study.
As we cannot know all the individuals who were involved with the EEfRT testing, the complaints should be made against:
- Dr. Avindra Nath as principal investigator of the study and
- any other individuals at NIH involved in any the EEfRT testing in any way (including, but not limited to, the design, administration, and interpretation of the EEfRT testing), including, but not limited to, Dr. Brian Walitt and Dr. Nicholas Madian."
ME Advocates Ireland (MEAI) Support the Call To Action
We at ME Advocates Ireland (MEAI) have sent the following email to NIH Director, Dr. Monica Bertagnolli and the Director of Research Integrity and the Agency Intramural Research Integrity Officer (AIRIO), Dr. Kathy Partin, calling for a retraction of the NIH ME Intramural Paper and other actions. Please see our email below which we have edited to set out under headings for an easier read.
__________________________________________________________________________
Dear NIH Director, Dr Monica Bertagnolli,
We support Jeannette Burmeister, attorney and Myalgic Encephalomyelitis (ME) advocate, and our other ME advocate colleagues along with ME patients in the US, and worldwide, in our complaint against the NIH ME Intramural Paper, 'Deep Phenotyping of Post-infectious Myalgic Encephalomyelitis/chronic fatigue syndrome, Brian Walitt et al, February 2024, and in particular against the over-generalization of the unsupported 'Effort Preference' claim to millions of ME patients worldwide based on the one-time EEfRT performance of 15 ME patients, some of whom seem to have been misdiagnosed.
We also wish to make a complaint against Dr. Avindra Nath as principal investigator of the NIH ME Intramural Study and any other individuals at NIH involved in any the EEfRT testing in any way (including, but not limited to, the design, administration, and interpretation of the EEfRT testing), including, but not limited to, Dr. Brian Walitt and Dr. Nicholas Madian.
Further to our complaints we graciously request that you:
1. investigate the NIH Intramural study
a. with respect to potential gross misconduct and potential research misconduct, including, but not limited to, falsification of data, i.e., manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
b. constituting a significant departure from accepted practices of the relevant research community and committed intentionally, knowingly, or recklessly;
2. discipline any individuals involved in the foregoing improprieties, if any, and
3. retract the NIH intramural study.
The following is a summary of some of the potential misconduct in relation to the NIH ME Intramural Study. Please Note: this is a not an exhaustive list of potential misconduct.
1. The inclusion of a graph in the study, i.e., Figure 3. a, in order to support the 'Effort Preference' claim, that was the result of statistical manipulation resulting in a completely misleading presentation of the data, which, when graphed, present a picture that contradicts Figure 3. a;
2. The claim that ME patients chose fewer hard tasks than controls “at the start of and through the [EEfRT]” with Figure 3. a claiming that patients chose fewer hard tasks in every single trial
A. During the May 2, 2024 NIH Symposium on the study, Dr. Madian stated, “We did again see a difference at baseline, which persisted throughout the task, indicating differences in effort discounting.”
B. Out of the first four trials, ME patients and controls chose the exact same number of hard tasks per participant. For the very first trial, arguably “the start” of the EEfRT, patients chose twice as many hard trials as controls, even though the patient cohort consisted of one fewer individual than the control cohort.
C. For 34% of the trials, ME patients chose hard tasks at a higher rate than controls. For another 2% of trials, both groups chose the same percentage of hard tasks. During an additional 14% of tasks, both groups’ hard-task choices were nearly identical, and the difference was, therefore, not statistically significant.
3. The inclusion of randomly assigned tasks (hard versus easy) in the analysis of hard-task choices despite no choice having been made in those cases, which occurred substantially more often in the case of patients than controls and with a substantially higher percentage of the randomly assigned tasks being easy tasks in the case of patients compared to controls;
4. The omission of an analysis of the obvious impact of patients using a game optimization strategy and the conclusory claim (without discussion) that there was no resulting group difference in probability sensitivity despite the fact that there was a significant difference between groups for 12% and 50% probability trials but not for 88% probability trials, negating any basis for the 'Effort Preference' claim;
5. The use of an improper metric, number/ratio/probability of hard-task-trial choices, in support of the 'Effort Preference' claim, as opposed to the correct metric, the average rewards earned by both groups, for which there was no significant difference between the two groups (less than 1%), negating any basis for the 'Effort Preference' claim;
6. The failure to address or even acknowledge significant confounding factors and to attempt to control for them or at least minimize their impact, contrary to other EEfRT studies, for example:
A. the failure to exclude from the EEfRT patients taking benzodiazepines,
B. the failure to control for patients’ motoric or other physical impairment to complete hard tasks by calibrating the maximum required button-press rates to individual physical ability despite numerous prior EEfRT studies emphasizing the need to do so,
C. the failure, contrary to what prior EEfRT studies have done, to exclude five patients who were physically unable to complete hard tasks at a reasonable rate or at all (the combined hard-task completion for those five patients was less than 16%) leading to a significant group difference in the ability to complete hard tasks (96.43% for controls versus 67.07% for patients), invalidating the EEfRT data and analysis,
- During the May 2nd, 2024 NIH Symposium of the study, Dr. Madian stated, “What the [original EEfRT] paper describes is that the EEfRT was designed so that the sample of patients used within that original study could consistently complete the task. This does not mean that everyone who takes the task must be able to complete the task without issue for the administration or data to be valid or interpretable. It seems that the creators wanted to ensure that in general as many people as possible would be able to complete the task but without compromising the task’s ability to challenge participants. Furthermore, I think, it bears mentioning that although our ME participants did not complete the task at the same 96-100% rate as the participants in the original study or at the same rate as our healthy controls, they still completed the task a large majority of the time. To wrap things up, to answer the question, consistently completing the task is not a requirement for a valid EEfRT test administration, and by all accounts we believe our data is valid and is, thus, interpretable as a measure of impaired effort discounting.”
This is a misrepresentation of the what the original EEfRT study found (required task completion by “all subjects”) and what subsequent EEfRT studies have stressed. Furthermore, it is untrue that patients “completed the task a large majority of the time.”
7. The inappropriate use of a test (the EEfRT), that was designed for and has been exclusively used for mental-health issues (or in healthy individuals), in order to support a novel and newly introduced term and concept, 'Effort Preference', in a physical disease;
8. The failure to discuss the validity of the use of the EEfRT in an unprecented way, i.e., to measure alleged disrupted effort discounting as opposed to the established use of EEfRT results as an assessment of effort-based, reward-based motivation;
9. The failure to identify any limitations of the EEfRT testing contrary to what other EEfRT studies have invariably done;
10. The failure to exclude the data of four “spontaneously recovered” ME patients (about a quarter of the patient cohort), a recovery rate well above of what has been found by credible researchers, indicating that at least some of those patients were misdiagnosed;
11. The over-generalization of the unsupported 'Effort Preference' claim beyond the expending of effort for small gambling rewards, i.e., for any effort exertion by ME patients;
12. The over-generalization of the unsupported 'Effort Preference' claim to millions of ME patients worldwide based on the one-time EEfRT performance of 15 ME patients, some of whom seem to have been misdiagnosed;
13. The inclusion of data from healthy controls with diseases that have substantial symptom overlap with ME (orthostatic issues in high numbers, Chronic Lyme Disease, and Psoriasis) as well as the inclusions of two blood relatives (siblings) of ME patients in the study despite the fact that there seems to be at least an infectious component to ME;
14. The choice of a new and exceedingly prejudicial label for a patient community that has suffered grave harm from decades of misrepresentation of the disease nature and from sustained and relentless defamation, including by NIH;
15. The use of three vastly different criteria (two of which are overly broad) for patient selection, including one set of criteria, the IOM definition, that is not a research definition, which likely resulted in including individuals in the patient group who were not ME patients;
16. The claim to have established the ME phenotype based on an exploratory, hypothesis-generating study of a cohort of only 17 patients, with many tests run only on even smaller sub-subsets of patients;
17. The misrepresentation of the nature of ME by reducing it to mere fatigue, exercise intolerance, malaise, and cognitive complaints, which is a non-specific description that does not capture ME, a chronic complex multi-system disease with a variety of other disabling symptoms;
18. The assigning of a researcher to design the study and run its day-to-day activities, Dr. Brian Walitt, who is on record with his unscientific views of ME, for example, that it is merely a normal way of experiencing life and not a medical entity;
19. The hostility, derision, and unprofessional conduct by the principal investigator Dr. Avindra Nath, a high-level civil servant, toward the ME community:
A. his persistent demands of unqualified praise from the ME community,
B. his veiled threats as well as his overt intimidation with respect to future ME research in an attempt to silence criticism by advocates of the intramural study and NIH’s research and conduct, causing pain and suffering to ME patients,
C. his presenting himself as a victim of ME advocates, gravely sick patients, causing reputational harm to the ME and ME advocacy community, and
D. his relentless stressing that he and the other researchers in the study have allegedly been forced to donate their time and work without compensation for ME patients;
Analysis
We are sharing with you a four-part analysis of the NIH Intramural Study on post infectious Myalgic Encephalomyelitis (ME) and the 'Effort Preference' Claim by Jeannette Burmeister, attorney and Myalgic Encephalomyelitis (ME) advocate, which we have read in full.
We feel that Jeannette Burmeister's analysis reflects very well the horrendously inappropriate NIH actions put on the Myalgic Encephalomyelitis (ME)/Severe Myalgic Encephalomyelitis (ME) community in the US who have suffered the NIH's decades-long obfuscating characterisation of ME as merely fatiguing; its reframing of fatigue in ME as being purely subjective; and NIH’s ongoing research of an allegedly dysfunctional 'Effort Preference' in ME.
Effort Preference
'Effort Preference' is an overwhelmingly prejudicial label. Even when the term 'preference' is viewed as a liking or favouring as opposed to a choice, it is a tremendously stigmatizing label when it comes to preferring something undesirable, such as preferring to perform easy instead of hard tasks, and the authors would have been keenly aware of that. In fact, they characterized the 'Effort Preference' of ME patients as “unfavorable" and have managed to take the defaming of ME patients to a new level.
How NIH Views Myalgic Encephalomyelitis
Having followed the NIH's handling of Myalgic Encephalomyelitis (ME) over years, and considering how the NIH views ME patients and treats advocates, i.e., with a deeply entrenched institutional bias against ME that pervades the agency, we believe that:
- the NIH has pathologised pacing and has branded Myalgic Encephalomyelitis (ME) with a highly prejudicial malingerers’ label.
- the NIH view ME as 'poorly understood', conflating their refusal to accept the findings of many thousands of peer-reviewed, published papers by ME researchers documenting the biomedical abnormalities of the disease with a lack of understanding of the disease.
- the NIH 'Effort Preference' claim is an endorsement and expansion of the work of Dr. Simon Wessely, the knighted potentate of the biopsychosocial brigade, which disparages the disease and its patients. According to Dr Simon Wessely, Myalgic Encephalomyelitis (ME) is a disorder of the perception of effort, which is identical with NIH’s characterization of 'Effort Preference'. NIH used Simon Wessely’s body of work as a blueprint for the NIH ME intramural study, a 'textbook case of the breathtaking power of statistics in the hands of researchers inclined to reverse-engineer their desired outcome'.
- the NIH staffing of their ME intramural study and its alleged findings were guaranteed to be extremely prejudicial and harmful for ME patients.
Advocates had protested Dr Leorey Saligan’s involvement with the intramural study to no avail; Dr Saligan co-authored, while at NIH, a literature review on Chronic Fatigue Syndrome (or what he calls “chronic fatigue”) and catastrophizing, “Association of catastropizing and fatigue: A systematic review,” which promotes cognitive-behavioral therapy for ME patients.
And Dr Brian Walitt does not believe that ME is a medical entity despite the fact that (i) ME is an illness classified by WHO as a neurological illness; (ii) is defined by the International Consensus Criteria as ' a complex disease involving profound dysregulation of the central nervous system (CNS) and immune system, dysfunction of cellular energy metabolism and ion transport and cardiovascular abnormalities. The underlying pathophysiology produces measurable abnormalities in physical and cognitive function and provides a basis for understanding the symptomatology.' and (iii) the non-exhaustive list of physical features and symptoms which highlight the pathophysiological nature of ME, available in the International Consensus Primer.
Dr Walitt is an acolyte of the biopsychosocial school; he asserts that patients gravitate towards an ME diagnoses because it is a more desirable diagnosis than a psych diagnosis as it is more socially acceptable. A ten-minute interview in 2015 by Walitt leaves no doubt where the NIH study would inevitably lead under Walitt’s direction.
Attorney and ME Advocate Jeannette Bermeister's four-part analysis of the intramural study
We paid particularly close attention to part 2 of the four-part analysis where Jeannette analyzes the EEfRT data to show that they do not support the claim that ME patients’ symptoms are caused by dysfunctional effort discounting (overestimating of effort and underestimating of rewards and capacity), which is what NIH calls an altered Effort Preference.
The authors of the study included a graph, Figure 3. a, which is the main illustration of the false 'Effort Preference' claim, that completely misrepresents the EEfRT data and, in short, presents an entirely false picture of the EEfRT results. Jeannette also shows that the recorded EEfRT data is unreliable as at least some of it is false.
In addition, Jeannette identifies a large number of careless mistakes in the paper with respect to the EEfRT, demonstrating that NIH’s work on ME was phoned in.
Jeannette has shown that the intramural study does not provide a basis for the further study of effort or of any “valuation-network damage or dysfunction” in ME patients. In fact, the EEfRT testing demonstrated clearly that there there is no such damage or dysfunction.
We would like to signpost vital analysis in Part 3 where Jeannette Burmeister addresses the EEfRT as a psychological measure, NIH’s desperate attempts to justify their EEfRT conclusions, the agency’s history of falsely reducing ME to fatigue and its pivot to Effort Preference, the investigators’ denial of established CPET science, and the ongoing inquiry by NIH into Effort Preference.
Links to Part 1, 2, 3 & 4
In our email body above we refer to:
- the ME Symposium on Thursday May 2nd, 2024 during which the NIH ME Intramural study authors explained their 'Effort Preference' claim: NIH VideoCast - ME/CFS Symposium
People with ME and Severe ME have endured a persistent politico economic culture for a long time, have been denied the healthcare, social care, welfare, recognition and respect afforded to other chronic illnesses. The decades long obfuscating characterisation of ME as merely fatiguing by the NIH, and their reframing of fatigue in ME as being purely subjective has undeniably led to the suffering of a community of patients who have been denied care appropriate to their needs, to unacceptable outcomes including deterioration and death.
We are against the over-generalization of the unsupported 'Effort Preference' claim to millions of ME patients worldwide, including those in the ME community in Ireland; we request that you urgently:
1. investigate the NIH Intramural study
a. with respect to potential gross misconduct and potential research misconduct, including, but not limited to, falsification of data, i.e., manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
b. constituting a significant departure from accepted practices of the relevant research community and committed intentionally, knowingly, or recklessly;
2. discipline any individuals involved in the foregoing improprieties, if any, and
3. retract the NIH intramural study.
Yours Sincerely,
M. Dillon
Advocate, Patient Rep & Cofounder of ME Advocates Ireland (MEAI) on behalf of ME Advocates Ireland (MEAI)
__________________________________________________________________________________
With Thanks
Our thanks to Attorney and ME Advocate Jeannette Burmeister for her excellent four-part analysis of the NIH 2024 ME Intramural Paper on which much of our email is based. Please follow and support Jeannette on Twitter/X; her handle is @JKBurmeister
Our thanks also to ME Advocate and former Federal Committee Advisor, Department of Health and Human Services, US, Eileen Holderman for her contribution to the 4-part analysis, for her continued work in support of ME patients in the US and worldwide, for highlighting NIH actions against the ME community and the work of advocates such as Jeannette Burmeister. Please follow and support Eileen on Twitter/X; her handle is @TurnItUP4ME
Thanks to others also involved in the ongoing vital advocacy in the US; we have no intention of excluding anyone; names like Gabby Klein and Colleen Steckel come to mind.
The combined efforts of Jeannette, Eileen, Gabby, Colleen and others have contributed to many campaigns to ensure HHS and NIH do right by ME patients in the US and in turn by millions of others worldwide.
Thank you all.
Further Information
According to Jeannette Burmeister, in July 2024, "NIH's Agency Intramural Research Integrity Officer (AIRIO) began assessing research-conduct complaints made by ME advocates against NIH investigators involved in NIH ME Intramural sudy, the first in a 4-step process. The second step will be an inquiry, the third step an investigation, and the fourth step a determination by the Deciding Officer whether NIH accepts investigation report's findings and recommended actions."
Jeannette stated that she felt "optimistic that the requirements of the Public Health Service Policies on Research Misconduct (2 CFR Part 93) and NIH policy will be satisfied for stages 1-3; that the investigation report will, consequently, find research misconduct, and that the Deciding Officer will concur."
Further Reading
- Read advocate Colleen Steckel's article which shows how the NIH ME Intramural Study is not a study for Myalgic Encephalomyelitis (ME) here
- It will be interesting to see how NIH respond, sadly health agencies always find a way to defend their actions and stance with regards to ME. This is what the NHS replied with in response to requests to retract the PACE Trial (UK) here
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