Keep an Eye on Your Walitt: NIH Study Poses Dramatic Risk to Long-Term Disability Benefits

Many ME/CFS* sufferers are covered by employer-sponsored long-term disability (“LTD”) policies. These policies almost universally limit LTD benefits to 24 months for disability caused—or even just contributed to—by a mental/nervous disorder. The following language is taken from a current policy issued by a major LTD insurer:

“Once 24 monthly disability benefits have been paid, no further benefits will be payable for any of the following conditions:

  • Anxiety disorders
  • Delusional (paranoid) disorders
  • Depressive disorders
  • Mental illness
  • Somatoform disorders (psychosomatic illness)” [emphasis added]

Another leading disability insurance company defines mental illness as:

“a mental, nervous or emotional disease or disorder of any type.” [emphasis added]

There are variations in the language, but the gist of the mental-health limitation in most LTD policies is the same: a termination of coverage for mental-health conditions after 24 months. Somatic Symptom Disorder as well as other somatoform disorders are listed in the DSM-V and regardless of whether they are expressly mentioned in a policy, any diagnosis of a somatoform disorder will, without a doubt, be classified as falling under the mental/nervous clause.

Disability insurance companies routinely claim that ME/CFS patients are suffering from a mental/nervous disorder despite the fact that the patient’s physician did not diagnose such disorder. Nevertheless, LTD insurers are often successful in their effort to terminate benefits at 24 months by requiring that claimants undergo an “independent” medical exam (“IME”) performed by doctors who are paid by the insurance companies and, nearly without fail—in the case of a CFS diagnosis—find a mental/nervous disorder as a primary cause or at least contributing factor for the disability.

Disabled ME/CFS patients typically suffer disability for their lifetimes, in many cases for decades. Any NIH study, finding or official reference that supports, in any way, the characterization of ME/CFS as a somatoform disorder would be a dramatic boon to disability insurance companies enabling them to limit their payments to disabled ME/CFS patients to 24 months as opposed to the age of 65 (which is the typical age at which LTD benefits terminate for disabilities not caused, or contributed to, by mental/nervous disorders).

The risks regarding disability coverage extend well beyond new claims; current recipients of LTD benefits would not be grandfathered in. Disability policies universally provide for ongoing reviews as to continued eligibility as well as the ability to require an IME or otherwise to review each ongoing claim on a regular basis. Therefore, every ME/CFS patient who has been receiving disability payments beyond 24 months should expect this type of review and likely termination of their benefits should the findings or positions of any HHS agency, such as NIH, suggest a classification of ME/CFS as a somatoform (or other mental/nervous) disorder.

Enter Dr. Brian Walitt, lead clinical investigator for NIH’s intramural study of post-infectious ME/CFS. Walitt is positioned to have a key role—probably the key role—in the study. According to the study’s principal investigator, Dr. Nath, Walitt has been instrumental in the study design. As a member of the small NIH team responsible for the “final assessment of diagnostic validity” (see screen shot below taken from this link to the NIH study website), Walitt will also be involved in the ultimate selection of the 40 ME/CFS patients, one of the most critical aspects of any study. Walitt is a member of that team because he is considered by NIH a “clinical expert” on ME/CFS. His influence will undoubtedly extend to the final conclusions of the study.

(Added 3/30/16: Please see my comment in the comment section below further clarifying Walitt’s central role in the study.)

I discussed at length, in my recent blog post (“Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?”) Walitt’s views (stated only a few months ago) of fibromyalgia not being a medical entity, but merely a normal life experience. Fibromyalgia is, of course, considered to have substantial overlap with ME/CFS and clinicians and researchers who believe fibromyalgia is a somatoform disorder typically believe the same about ME/CFS. Indeed, should there be any doubt, Walitt has been unequivocal in his opinion that chronic fatigue syndrome is a somatoform illness. This is set forth expressly in the 2015 paper, “Chemobrain: A critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy,” which he co-authored and which contains the following statement:

“The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.” [emphasis added]

Many patients were incredulous when Walitt flippantly revealed his obvious disdain during NIH’s March 8, 2016 invite-only “ME Advocacy Call” about the study in response to concerns about his bias:

“If chronic fatigue syndrome/myalgic encephalomyelitis is all in your head, it’s only because your head is part of your body.”

Here is Walitt’s quote in full:

“First let me affirm by saying that chronic fatigue syndrome/myalgic encephalomyelitis are a biological disorder. Research has shown that in every system of the body that has been investigated that there have been abnormalities when compared to healthy volunteers. If chronic fatigue syndrome/myalgic encephalomyelitis is all in your head, it’s only because your head is part of your body.” [emphasis added]

As you can see, it is true that Walitt acknowledged that every bodily system of patients has shown abnormalities. But that is entirely consistent with his view that ME/CFS is somatoform, as patients with somatoform disorders are not required to lack physical abnormalities; instead, patients are said to generate thoughts, feelings or behaviors in response to their somatic symptoms that are disproportionate or excessive. Further, Walitt seems to believe that the abnormalities are being created by the patients’ own thoughts and emotions due to some kind of biochemical mechanism. The symptoms themselves do not need to be medically unexplained; they can, in fact, be associated with a biological condition. Saying that one doesn’t believe that symptoms are all in a patient’s head is not irreconcilable with believing that the patient suffers from a somatoform disorder. Therefore, Walitt’s acknowledgement of abnormalities in ME/CFS does not, in any way, negate his apparently strongly-held belief that ME/CFS is a somatoform disorder.

Walitt had to know—in light of the overwhelming criticism directed at him—that it was crucial to pull off a flawless performance during the call and yet, he could not resist making that astonishing remark, which effectively betrayed his assurances of the absence of any bias. Walitt had the perfect opportunity to let us know if he had changed his mind by 180 degrees and no longer considers ME/CFS to be a somatoform disorder, unlikely as it would have been in only a few months. He did not do so.

Given Walitt’s well-documented opinion on CFS as a somatoform illness, there is a high likelihood that the study design, the patient cohort selected for the NIH study, the day-to-day decisions made by the lead clinical investigator and the ultimate conclusions of the study will be affected by Walitt’s clear bias. The very fact that NIH appointed Walitt in the first place, as well as the agency’s in-patients-face failure to remove him from the study after an unprecedented and ongoing outcry from the patient community, is ever so revealing in terms of NIH’s objectives for the study and its recently oft-repeated assertion of a suddenly-found desire to work with patients. It is hard to imagine that NIH could have managed a more perfect middle-finger salute to ME/CFS patients than appointing Walitt as the lead clinical investigator.

As I have said before, this study—in its impact—has the potential of becoming PACE on steroids. In addition to the other dramatic risks posed by the design of the study (which are beyond the scope of this post), thousands of disabled ME/CFS patients could face the sudden loss of most, if not all, of their already modest lifetime income and, as a result, life-threatening poverty that would be impossible to navigate for many in the face of the debilitation caused by their disease—if Walitt continues to remain on the study.

*I am using the term “ME/CFS” because that is what NIH says it is studying. It is beyond the scope of this blog post to discuss the futility of combining the disease, ME, and the social construct and wastebasket diagnosis, CFS.
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51 Responses to Keep an Eye on Your Walitt: NIH Study Poses Dramatic Risk to Long-Term Disability Benefits

  1. "Flo" says:

    Jeannette,

    Perhaps you’re revealing the ultimate goal of this study.

    The claim made during the group phone call that bias could not exist at the NIH was shocking in its denial of the history of this disease at the Institutes.

    We are seeing that that bias continues: different names, even worse aims.

  2. Reblogged this on Short Blogs for the Distracted……… and commented:
    Definitely PACE on steroids… great blog Jeannette x

  3. Ess says:

    Thank you, Jeannette, I hafta repeat this—“The very fact that NIH appointed Walitt in the first place, as well as the agency’s in-patients-face failure to remove him from the study after an unprecedented and ongoing outcry from the patient community, is ever so revealing in terms of NIH’s objectives for the study and its recently oft-repeated assertion of a suddenly-found desire to work with patients. It is hard to imagine that NIH could have managed a more perfect middle-finger salute to ME/CFS patients than appointing Walitt as the lead clinical investigator.” Here is the HHS–NIH-CDC poised and ready to pull another ‘fast one’ on the M.E. patient community. Walitt is a DISaster. Clearly, Walitt’s beliefs that M.E. or ME/CFS and Fibromyalgia are somatoform disorders are exactly why NIH has appointed him to this ridiculous study. The ‘whole study’ is set-up for yet another pre-determined outcome to the detriment of M.E. patients — attempting to relegate 17+ million patients worldwide to ‘somatoform’ — therefore, disability payments will end @ 2 years. M.E. is biomedical disease with a life sentence attached — the US government leads the way in withholding commensurate funding for BIO research and real treatments for us. Yes, and children get this disease too and suffer incredibly–their young lives robbed of living and enjoying life. Yes, and this debilitating life-robbing disease continues to spread. This all means NOthing to TPTB. The U.S. economy suffers an economic loss of $24 billion annually due to Myalgic Encephalomyelitis–yet TPTB continue to do NOthing to help us regarding real funding and BIOmedical treatments–which would enable us to regain our active lives and return to being productive members of society. UNfortunately, for persons with M.E. and our families, this is an ongoing decades-long horrific saga. HHS’ actions and inactions are based on obfuscation and malfeasance; hiding the truths of Myalgic Encephalomyelitis and putting up roadblocks to discovery at every step along the way. And now — NIH’s idea of helping a very sick patient group is to throw us even further under the bus — with their new study — with Dr. Walitt, et al — with a very small questionable cohort with patients of short duration with ME/CFS–eliminating severe M.E. patients from the NIH study. This is an NIH study — set up and designed to FAIL the M.E. patient community — and benefit big business and insurance companies. HHS-NIH-CDC are NOT looking after the health interests of M.E. patients … at all. #ACTUP4ME #CrimesAgainstHumanity

    • It seems like every time we get a step forward, it’s two steps back! Thanks again Jeanneette for your hard work, all of us have a limit on how much information we can process. Personally, just a few emails turns my head to mush. I really appreciate you going the extra mile to interpret all the double-speak these self proclaimed experts put out there.
      Keep up the good work, myself and probably thousands more rely on your thoughts. Ess also made some really interesting points! 😃 Soft hugs to all

  4. ian says:

    It’s not just Walitt. Look at the other people they deem “clinical experts” on ME . There is a great thread on PR about them and the ones listed above next to Waliitt, Gill and Saligan too.
    http://forums.phoenixrising.me/index.php?threads/investigating-the-investigators-of-the-upcoming-post-infectious-nih-study.43223/

    The nicest reason these guys are on the team is that they don’t have any clinical experts at the NIH and they don’t want to give any of our real experts a place at the table.

    Then there is the scarier explanation that they chose these people with an outcome in mind, And after this study they will be elevated to ME/CFS experts for a generation having played a key role in the only big study on us from them. They might not write anything on this study but I see papers in the future that get media attention in the mainstream press that our experts with real knowledge never seem to.

    I don’t like how they are playing word games and telling half truths in their answers to our question about whether clinical experts will be involved in patient selection and at first glance it looks like they are but as you point out that is not the case. It is also not the case they are getting all their patient from well known ME clinics. They implied that but it is not the whole story either. with only 40 patients it should be no problem to get them from well known clinics who know how to diagnose. Instead we get these yahoos making a diagnosis from a questionnaire.

    I’ve never felt more grateful to people like Klimas, Peterson, Anthony K, and the rest who took up for our cause for the pure reason that that had sick patients they wanted to help. We are not an easy bunch to treat and the rewards are few. Most others were scared away.

    I’m almost glad the government neglected us enough to gain a basic understanding from these people or else we might not have solid ground to stand on in any respect. I’ve never appreciated them more than now when they are being shut out.

  5. Sharon says:

    Important and valuable posting, Jeannette, thank you.

    I was incredulous (and disgusted) when I read Brian Walitt’s testimony: “I don’t have a bias and I don’t have the outcome that I hope to see except that we find an answer that makes people better.”

    Why would any of us believe him when he claims he has no bias – when what he has written and published, and the interview he gave SEVEN months AFTER the IOM’s ME/CFS report was published all say otherwise? His claim seemed a naked and unapologetic lie.

    To the point you made above about his quote, “If Chronic Fatigue Syndrome, Myalgic Encephalomyelitis is all in your head, it’s only because your head is part of your body.” – it seems like another of those sentences in which a different disease could easily be substituted; wouldn’t it be accurate to also say, “If depression is all in your head, it’s only because your head is part of your body”? Maybe I’m wrong about this but his statement IS really ominous – and factually incorrect. It isn’t all in anyone’s head – no one should say that, particularly after the IOM report. But Walitt did and no one at NIH will acknowledge his bias nor do anything about it.

    As for his NIH colleagues, also of interest was Dr. Koroshetz’s comment:
    “…I think the point is that the NIH is a very unusual place in that the people here try and get at the bottom of problems.

    And they have really the strictest scientific minds and I, rarely if ever, have seen what you might call a personal bias affect the study. So I think everybody here is really devoted to just getting to the bottom of the problem.

    And I really do not see any chance that this is going to be corrupted at all. It’s a very unusual place where there’s very little incentive and actually it’s a career-breaker if that ever happens.

    So I really do not feel that this is a concern that the community should worry about. But thanks very much.”

    Sadly, Dr. Koroshetz’s response was tone deaf on the bias issue. That, too, seemed an outrageous thing to say to this community, given the long history of *documented* governmental malfeasance.

    Thanks again, Jeannette 🙂

  6. Spoonseeker says:

    Walitt’s words are the same attempted old sleight of hand we always get from the psychosocial ‘researchers’, pretending that the distinction between physical and psychological conditions is really inconsequential, just the result of some sort of silly prejudice on the part of patients. This ignores the fact that the very framework of western medicine is built around this distinction – and as you point out, it has very real consequences for the lives of patients. Yes, we are aware that the head and body are joined at the neck – and we also know we need money to put food in our mouths.

  7. Sally says:

    Thank you Jeannette for clearly putting into words the problem with the new USA NIH study on ME/cfs. These are huge concerns, not just for ME patients in the USA, but also the rest of us elsewhere.

    It is incredibly sad that our patient population must always be so wary of hidden motives. Hopefully one day ME research will be entirely free of the taint of the psychosocial premise.

  8. Only those who *choose* to be blinkered can claim that the governance at the NIH for the ‘ME/CFS’ studies isn’t biased. A child could see through that claim. If the NIH go ahead with this debacle..and it would seem that they have every intention of doing so and I suspect Jeannette has hit the nail on the ‘vested-interest-fiscal’ head… then this won’t be bad news only for those living in the USA, but the rest of ‘us’ worldwide will be marginalised for god-knows how many more decades until someone with gumption, morality, and a sense of justice at last chucks a grenade at this scandal. And scandal it is. I have been ill since 1970, ironically the very year that Beard and McEvedy decided to rewrite history and without examining a single patient turned the epidemic Royal Free Outbreak of ME into ‘neurasthenia’: a rubric which once established set in train all that we have subsequently seen from the Institute of Psychiatry at the KCL, London; to Kaplan and Holmes; to Reeves et al at the CDC; to Per Fink and countless others who think that this neuro immune disease is somatoform.

    The thing is the NIH is going to look very silly at some point in time. When ‘we’ have people as vested as Ron Davis in finding out the answer, people who can gather together a team of multiple Nobel Laureates around them, the NIH in hanging on to this maladapted behaviour pattern only has a finite amount of time to play with it until their Luddite, flat-earth immorality is exposed. And it *is* immoral. Any person or organisation who can choose, clearly knowingly (..after all the ME community has provided a wealth of information already to counter any suggestion that a conversion disorder is playing out in this disease ..indeed the IOM has also underscored this position) to act to retain the status quo is immoral. There is no other way of looking at this.
    Wallit cannot be trusted one inch by any patient with authentic ME. The choice of cohort cannot be trusted unless or until those who oversee it themselves can be trusted. We know cohorts can be skewed.. the PACE Trial saw to it that as many people as possible with neurological ME were screened out of it and as many fulfilling the junked ‘Oxford Criteria’ were screened in. We’re not talking about skewing just 40 patients (the number suggested by the NIH) ..PACE was able to skew hundreds of patients. It’s easy if you want to. No problem at all..and Walitt’s final overview of that cohort tells ‘us’ all we need to know about that cohort: it won’t be about neuro-immune ME.

    I have made the analogy before and I will make it again: this is the equivalent to the survivors of Historic Sex Abuse in the UK choosing to reject two Chairs appointed by the Government to head up the Inquiry into that abuse. Unless those conducting Inquiries or research have the complete confidence of the population they claim to support then there can be no confidence in the eventual outcome. Does the NIH want to waste the (paltry) sum of money it has so belatedly awarded us? I suppose the notion of ‘waste’ is relative isn’t it? If the goal is to kick genuine research into this condition into the long grass to satisfy vested interest of Government and re-insurers etc then what they’ve designed ensures a lot of ‘bang for their buck’.

    As I noted above, “The thing is the NIH is going to look very silly at some point in time”… the question is ‘when?’ and ‘how much time?’. Can Francis Collins get away with it for long enough not to have to face the big question of ‘why?’ he let this happen under his watch? Will death release him from that as it did for Strauss and Reeves? My betting is that that time is shorter than he thinks. Ron Davis wants his son back to being the chap he once was: fighting fit and with a career to match. Ron Davis isn’t playing fast and loose with people’s lives.. his solitary vested interest is just to get this dastardly disease unpicked and ameliorated. That’s all any of us who have been suffering for so long also want. Maybe Davis is the man the NIH needs? I know who I’d trust with my wallet..

  9. Kimberly Deneris says:

    I find it appalling that NIH clearly wants to continue investigating whether or not ME is a “somatoform” illness. The concept of somatoform illness is itself unproven. It makes no more sense to classify ME as one than it did to classify epilepsy or MS as “nervous” or psychological conditions in the past. The inclusion of Walitt does seem like a deliberate effort on the part of the NIH to ensure that patients do not receive the support they are entitled to as a result of this severe and severely disabling illness, ME.

  10. Khaly Castle says:

    The tone (and I’d dare say policy) for research on this disease was set early on at NIH. http://cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html

    There was actually an origination point for CFS, where ME-literate doctors claimed that the illness in question had all the hallmarks of ME. Steadfast refusal on the part of ALL ME/CFS researchers to revisit the evidence of that outbreak speaks loudly to me. Compounding that with 30 years of conducting ever-escalating “biopsychosiocial” discussion seems to be culminating in this last drive home to negating this illness for good.

  11. John Gabor says:

    An excellent blog Jeannette. What most people don’t seem to realize is that there are billions of LTD dollars at stake in the USA alone. These companies are no different than the tabacco industry; they will stop at nothing to guarantee their profits. When you see unqualified people assigned to a major study and you no the money at stake, it is reasonable to suspect that the fix is in.

  12. Thank you (again) for using your limited resources to write this post, Jeannette. The implications of this study for long-term disability claimants are very worrying.

    Recent comments by Dr Walitt regarding Fibromyalgia and related conditions (as detailed in your previous post) suggest that he is not an appropriate person to act as Lead Clinical Investigator on biomedical research into any of these illnesses. I live in the UK but this study will have a significant impact on the physical and social welfare of ME patients all over the world.

    NIH should clearly be re-evaluating their whole approach to this study which seems to have been flawed from the start.

  13. Patricia Hess says:

    The proposed study by the NIH is a sham at all levels. A lead researcher who thinks ME is a somatoform illness, the Reeves definition from 1994 where they called people on the phone to ask them if they were tired. The possibility that this sham could affect the genuine ME population and the pittance that they recieive as their long-term disability payout is disgusting. We have a right to protest this ongoing negative treatment. It has literally cost me my life! going on 25 years now.

    • schweitz75 says:

      Patricia – the 1994 definition was Fukuda. The Reeves definition came a decade later. The main difference between the two is that the Reeves definition does not exclude primary psychiatric conditions – which makes it, in practice, closer to the Oxford definition used by Wessely and the PACE authors than Fukuda.

      Reeves created a set of questionnaires for his definition, but nobody was particularly interested until he renamed the questionnaires, now saying they “operationalized” the Fukuda definition – which was just plain wrong – see my somewhat frustrated blog on the subject here:

      http://slightlyalive.blogspot.com/2010/02/cdc-research-on-cfs-open-deception.html

      But that ruse did not fool researchers. It was still called the Reeves definition – and no one outside CDC used it.

      When the NIH study was first announced, they said they were going to use the Reeves definition. After an outcry from the community, they stepped back and said they were using the CCC. However, it was reported informally that the Reeves questionnaires would be used in screening.

      In a recent article by Beth Unger et al, the Georgia cohort is compared to the Wichita cohort. NOT ONCE IN THE ARTICLE IS IT MENTIONED THAT THE GEORGIA STUDY USED THE REEVES QUESTIONNAIRES – THAT IS, THE REEVES DEFINITION.

      So the Reeves definition could still be used just by not CALLING it the Reeves definition.

      We need to demand that NO ONE WITH A DIAGNOSED MENTAL DISORDER, including depression, anxiety, and somatoform disorders – in accordance with both Fukuda and IOM – be permitted in the very small patient group of 40.

      • schweitz75 says:

        That is, in accordance with Fukuda, IOM, and the CCC definition they claim they are using.

      • jimells says:

        The “study” [1] mentioned above deserves close scrutiny. Although it appears to be research, I view it as a policy statement, that is, it is a response to the IOM and P2P reports of a year ago. (Remember them? NIH and CDC have already flushed them).

        One might think that after spending a million dollars on a new definition, CDC might be interested in studying the use of the “SEID” criteria. Instead, they are *still* studying the “best” way to use the awful Fukuda criteria developed 20 freakin’ years ago. So this “study” is a giant “Up Yours” to the IOM Report and the patient community. It will likely be used to justify the questionnaires used in the proposed Clinical Center study.

        Now look at the name of the lead author of this “study”: Elizabeth Unger, head of CDC’s “CFS” program. Dr Unger has a long history of making muddled public statements that sound an awful lot like psychobabble. Dr Unger also has her name on a very long list of junk “CFS” studies. Is this really a suitable person for screening patients in the Clinical Center study?

        And where did this study come from in the first place? Whose idea was it? Have patients taken to the streets in their beds and wheelchairs to demand “We Want A Clinical Center Study”?

        Maybe it’s time for a FOIA request to find out where this turkey was born…

        [1] http://www.ncbi.nlm.nih.gov/pubmed/26973437

  14. Jerry says:

    Excellent analysis, Jeannette. Somatoform disorders are specifically excluded by the 2003 CCC document from the ME/CFS diagnosis. There is detailed information in the section “Differences Between ME/CFS and Psychiatric Disorders” beginning on page 28 on how to differentiate between suspected somatoform disorders and CCC ME/CFS.

    http://www.mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf

    There can be a high degree of symptom overlap between CCC ME/CFS and an ostensible non-medical somatoform disorder. The CDC’s Fukuda CFS criteria, on the other hand, do allow what could be considered a somatoform disorder to be diagnosed as CFS. The CDC considers CFS symptoms to be medically “unexplained,” as are the symptoms of an alleged somatoform disorder by definition.

    As the Fukuda CFS definition states:

    “The following conditions do not exclude a patient from the diagnosis of unexplained chronic fatigue.”

    “1. Any condition defined primarily by symptoms that cannot be confirmed by diagnostic laboratory tests, including fibromyalgia, anxiety disorders, somatoform disorders, nonpsychotic or nonmelancholic depression, neurasthenia, and multiple chemical sensitivity disorder.”

    It is entirely dependent of the good faith and diligence of researchers to identify and exclude subjects with primary psychiatric disorders from use as CCC ME/CFS subjects. If both the CCC and CDC CFS criteria are used concurrently to select subjects, the medical status of the subjects labelled “ME/CFS” will be unclear.

    The hybrid condition “ME/CFS” cannot even be diagnosed in the US now following US ICD rules, in any case. Only the ill-defined condition CFS (R53.82) or the neurological disease ME (G93.3) can be diagnosed by doctors. The diagnosis “post-infectious CFS” or “post-infectious ME/CFS” is not listed in either the US ICD or WHO ICD. What is the point of doing a study on an unscientifically ambiguous condition that can have no application to any specific patient group?

    The CDC’s !994 CFS definition is a diagnosis of exclusion. The CDC has stated that it considers some patients meeting the CCC as possibly having a neurological condition that the CDC considers exclusionary for their CFS diagnosis.

    From a 2010 CDC paper:

    “The 1994 International CFS case definition [Fukuda] and the Canadian Consensus Criteria are different and do not necessarily identify similar groups of ill persons. Most notably, the Canadian Criteria include multiple abnormal physical findings such as spatial instability, ataxia, muscle weakness and fasciculation, restless leg syndrome, and tender lymphadenopathy. The physical findings in persons meeting the Canadian definition may signal the presence of a neurologic condition considered exclusionary for CFS…”

    Basically, the two sets of criteria, the CCC and the CDC CFS criteria, are incompatible. Nevertheless, the NIH study is proposing to use subjects simultaneously meeting both sets of criteria. It’s anybody’s guess what portion of the “ME/CFS” subjects, if any, will have ME, or if a significant portion of the “ME/CFS” subjects will have symptoms solely associated with psychiatric disorders.

    The muddle indicates the necessity of separating ME from the assortment of fatiguing conditions the CDC has assembled under the CFS, and now ME/CFS, labels. Good faith by the researchers in applying criteria is essential, and there is very little evidence of that here.

    Placing a radical psychogenic theorist, such as Walitt, in control of subject selection demonstrates a lack of good faith by the NIH and an overriding political agenda to discredit “ME/CFS” – and ME by implication – as a legitimate medical disease. How could a fringe researcher who believes CFS to be a somatoform disorder, contrary to the CCC definition being used in the study, be included by the NIH? This hopelessly biased study, unfortunately, will have far-reaching consequences for obtaining disability status and appropriate medical treatment by both ME and CFS patients.

    Even if Walitt is removed, the anti-ME institutional bias at the NIH and CDC will remain. How can there be progress in research when the two major US governmental medical research organizations are controlled by biased disease deniers? It’s a tragic situation for people with ME.

  15. I was circumspect, to put it mildly, when a new NIH study on what they continue to lump together as ‘ME/CFS’, but what really seems to be a study of idiopathic fatigue, was announced. Anyone familiar with the disastrous history of the federal response to this epidemic would have been concerned about the possible bias of a new research effort.

    The appointment of Dr. Brian Walitt confirmed my worst fears about the purpose of the study. Most knowledgeable doctors and scientists have long recognized that ME is an infectious illness, probably of viral origin. As Dr. Harvey Alter said, ‘I’m absolutely convinced that when you define this disease by proper criteria, this is a very serious and significant medical disease, and not a psychological disease. It has the characteristics of a viral disease.’ By contrast, Dr. Walitt, a rheumatologist, has been adamant that what he throws together as ‘fibromyalgia and chronic fatigue’ are psychosomatic conditions. His undisguised dislike of patients suffering from the very disease he has chosen to treat comes through in interviews and his published medical papers, one of which concludes, ‘Fibromyalgia patients are those that physicians don’t want to see. They are ‘heartsink’ patients…’We think they are all crazy,’ a distinguished rheumatology division head and Professor of Medicine told us, reflecting a not uncommon view’.

    It is beyond me that the NIH can, with a straight face, present Dr. Walitt as an expert on ME. Ignoring the abundant evidence of cardiac and circulatory problems, the NK cell deficiency and numerous other immune abnormalities, and evidence of inflammation of the brain and spinal cord, Dr. Walitt continues to insist that there are no empirical findings that support patients’ claims of severe illness. His statements about the mind/body relationship are on the level of the maunderings I hear in the local health food store, pretentious and utterly devoid of basic common sense.

    One would have to be very naive to miss the potential enormous favor to insurance companies, elaborated above by Ms. Burmeister. Since the NIH and CDC have neglected this epidemic for more than 30 years, allowing it to spread unchecked, leaving the disease’s victims to suffer and die, the costs of fulfilling the obligations of insurance contracts have been and remain huge. I agree that the study is shaping up to be a gift to the insurance industry. I wish I could see it differently.

    • You are so right, the insurance companies are going to be able to throw all sufferers of ME/CFS and Fibromyalgia under the bus! This is after they got all Americans required to buy health insurance, it’s all a money game to them. Can you imagine the billions they will make? I’m right back to feeling helpless again, just where the AMA wants us to be! Shame on all those that make a name for themselves while patients suffer.

  16. Annunziata says:

    I was circumspect, to put it mildly, when a new NIH study on what they continue to lump together as ‘ME/CFS’, but what seems to be a study of idiopathic fatigue, was announced. Anyone familiar with the disastrous history of the federal response to this epidemic would have been concerned about the possible bias of a new research effort.

    The appointment of Dr. Brian Walitt confirmed my worst fears about the purpose of the study. Most knowledgeable doctors and scientists have long recognized that ME is an infectious illness, probably of viral origin. As Dr. Harvey Alter said, ‘I’m absolutely convinced that when you define this disease by proper criteria, this is a very serious and significant medical disease, and not a psychological disease. It has the characteristics of a viral disease.’ By contrast, Dr. Walitt, a rheumatologist, has been adamant that what he throws together as ‘fibromyalgia and chronic fatigue’ are psychosomatic conditions. His undisguised dislike of patients suffering from the very disease he has chosen to treat comes through in interviews and his published medical papers, one of which concludes, ‘Fibromyalgia patients are those that physicians don’t want to see. They are ‘heartsink’ patients…’We think they are all crazy,’ a distinguished rheumatology division head and Professor of Medicine told us, reflecting a not uncommon view’.

    It is beyond me that the NIH can, with a straight face, present Dr. Walitt as an expert on ME. Ignoring the abundant evidence of cardiac and circulatory problems, the NK cell deficiency and numerous other immune abnormalities, and evidence of inflammation of the brain and spinal cord, Dr. Walitt continues to insist that there are no empirical findings that support patients’ claims of severe illness. His statements about the mind/body relationship are on the level of the maunderings I hear in the local health food store, pretentious and utterly devoid of basic common sense.

    One would have to be very naive to miss the potential enormous favor to insurance companies, elaborated above by Ms. Burmeister. Since the NIH and CDC have neglected this epidemic for more than 30 years, allowing it to spread unchecked, leaving the disease’s victims to suffer and die, the costs of fulfilling the obligations of insurance contracts have been and remain huge. I agree that the study is shaping up to be a gift to the insurance industry. I wish I could see it differently.

  17. Mary Avery says:

    Thank you for this! As an aside, Multicare, one of three big medical agencies where I live has said to me that they do not, nor will they ever treat ME/CFS. This plays directly into their hands.

  18. Keith says:

    The more things change the more they stay the same.
    The insurance companies and the government are in bed together.
    Not to get too political but I think the only chance things change in this country is if Bernie Sanders gets the presidency.

  19. wildaisyfl says:

    I have been sick with M.E. for 30 years now, and I continue to be surprised that even after falling for NIH and CDC lies again and again, when those lies are promoted by the same phony
    “advocates” and fake “patient” organizations, ME patients continue to fall for the NIH and CDC lies. Of course the NIH toadies are out in force promoting this NINDS study. They always do whatever the NIH and CDC tell them to do; and then later when the government lies become obvious, those toadies go into hiding, and other ME patients never hold them to account for supporting the lies. What will it take to awaken the ME patient community? Isn’t 30 years of ridicule and mistreatment enough?

    Patient desires and needs are being overridden by the selfish goals of the phony “advocates” and fake “patient” organizations who are promoting this study. If ME patients want progress in ME research and treatment, now is the time to make our desires known. Rather than sheepishly following the dictates of the phony “advocates” and fake “patient” organizations, we, as M.E. patients, need to get loud and make our desires known. When this bogus NINDS study is under way , it will be too late. The time to act is now! If we do not do something now, this NINDS study will be PACE on steroids and it will affect ME patients all over the world.

    Patricia Carter

  20. schweitz75 says:

    Thank you again for another powerful essay.

    • Gabby says:

      Thank you Jeannette for pointing out the risks and the very real harm that ME patients are facing with this NIH intramural study.

      It’s the same old, same old at NIH.

      If Collins and others at NIH were really interested in studying the biomedical disease, ME, they would have created a completely different protocol and design of the study.

      The choice of Walitt as a lead associate investigator is but one of the many problems with this study.

      The design is leading to a preconceived result of showing that it is a somatoform disease.

      The patient community needs to wake up and forcefully fight this before it is too late.

  21. Utting Wolff says:

    When I introduced your powerful blog post in which you gave a detailed analysis of Walitt’s interview and his research history, I wrote about his and his colleagues’ power to destroy lives. What they say and do has devastating and far reaching consequences re insurance, disability allowance, benefits and, ultimately, for patients’ possibilities to survive. Those who suffer from ME (and other comparable illnesses such as FM) experience on a daily basis, year after year, what it is like to be at the receiving end of stigmatisation and prejudice. Dr. Walitt, and many with him, know that their words and actions have serious implications. Thank you, Jeannette, for not letting anyone silence you. I know how much this important blog post has cost you. May others feel inspired and encouraged to speak up, too.

  22. Carrie says:

    NIH is still mining their old playbook.

    Remember the early 80s? Stephen Straus’ interviews and press releases? That’s where AIYH (All in Your Head) began—and where ME research stalled.

    Now 2016, enter Dr. Brian Walitt. Somatoform…false illness beliefs—sound familiar?

    Keep in mind that in the future, Dr. Walitt’s views about ME that are so readily available on the internet are now the views of the lead investigator of a major NIH ME study.

    Insurance companies won’t be looking for cytokine or exercise studies. They’ll be looking for this guy—the new Dr. Peter Manu.

    It’s tempting to say NIH just hasn’t learned from the past or that these are all new people so the past doesn’t matter, but the facts speak for themselves. History is repeating here, and there’s no reason to believe NIH decision makers don’t know exactly what they are doing.

    NIH can’t legitimately claim a desire to work with patients when they steadfastly refuse to address patients’ legitimate concerns regarding Dr. Walitt.

    The NIH is clearly putting patients at risk all over again.

    Unapologetic middle finger salute, indeed.

  23. Phyllis Griffiths says:

    The NIH appears to be carrying on as it always has when it comes to the subject of M.E./CFS; as if it is a cover-up or one big joke. Dr. Walitt appears to be talking out of both sides of his face when it comes to M.E. How can any illness be both somataform and one with biological abnormalities in every system looked at? One thing precluded the other. Making statements such as that and letting both stand makes the man look either incompetent or corrupt. People who rely on LTD benefits from insurance companies have need to worry when someone such as Dr.Walitt is named as a researched, let alone the head of the team. Articles such as this one bring such conflict to the notice of those who will be affected by it. In this case lives are at risk, as well as great suffering. The NIH must be kept on notice- and people speaking up and speaking out is the way to do it.

  24. Colleen S says:

    Thank you for sharing this important information. The flaws we are seeing in the protocol of this study are alarming. This blog is a reminder that any NIH study will have long reaching consequences.

  25. Dave Olson says:

    very good Wallitt wallop, let us not forget to focus on the two other biased co workers Gill and Saligan, as was pointed out above..They seem to be building a very destructive team at the NIH..It is sad they missed the point that what was needed was OUTSIDE research using those who already have a good start on discovery, NOT an internal, and now seemingly wrongheaded and seriously damaging study using their brand of “science” are they actually exempt from liability for the damage they will do?

  26. M.E. has been on the insurance companies radar for over 80 years now, ever since that multi million dollar payout was made in the wake of the outbreak in LA during the 30’s ( a HUGE sum in those days). That’s a very long time to dig in and strategize as to how NOT to payout.

    It’s mindboggling to me that some people are unaware as to just how much clout the insurance companies have in terms of policy, especially post Citizen’s United.

  27. Laurie says:

    In case people haven’t seen this, here is a 2 hour NIH video with Brian Walitt, “Demystifying Medicine 2013 – Pain: How It Happens and What Can Be Done?” The whole video is important. I’m sorry I’m not well enough to write about it; others will have to do that. Thank you. https://www.youtube.com/watch?v=1DTwkooHUF8

  28. sharonkramer says:

    Somatization and her sister, Malingering, frequently appear in courtrooms. They are brought in by well-paid “medical experts” in toxic torts and head injury cases. The purpose for their frequent court appearances is to cast doubt on insurers’ liability for their insureds’ roles in causation of physical disability. To my knowledge, Dorothy Sims, Esq, in Florida is the foremost expert in the US on the subject. She’s a published author on the subject and assists other law firms to debunk the somatization/malingering schtick of white-coated-causation-doubt-sellers. http://dorothyclaysims.com/

    Dr. Walitt’s frequent co-author, Dr. Wolfe, has written “courtroom science” that is used by the defense. It’s used to project that plaintiffs’ experts cannot meet a standard of proof that an injury caused fibro/chronic pain, and thus the defense attorneys’ clients cannot be held liable for causation of fibro/chronic pain from injury sustained.

    BRIEF OF AMICUS CURIAE, FLORIDA DEFENSE LAWYERS ASSOCIATION IN SUPPORT OF RESPONDENTS…The Florida Defense Lawyers’ Association (“FDLA”) is a statewide organization of defense attorneys with over 1,000 members…

    (pg 7) “Prominent scholar and medical doctor Frederick Wolfe1 wrote in 2000 that the causal link between trauma and fibromyalgia syndrome (FMS) is “certainly not agreed upon by the scientific community. Frederick Wolfe, ‘For Example Is Not Evidence: Fibromyalgia and the Law’, 27 The Journal of Rheumatology 1115 (2000)…..

    (pg 8) Another study noted that “adverse psychosocial factors, aspects of health beliefs and behavior, and a history of reporting somatic symptoms” have been predictive factors in the onset of chronic pain http://archive.law.fsu.edu/…/sc06-118/06-118ACFDLA.pdf

    There are several papers by Dr. Walitt that are not listed on his NIH promo page, but can be found on PubMed. Here’s a good example of one co-published with Wolfe titled “Fibromyalgia and physical trauma, the concepts we invent”. Read the abstract. It acknowledges that Dr. Wolfe serves as an expert witness. http://www.ncbi.nlm.nih.gov/pubmed/25086080

    “somatization” is a term that can and does get used to cast doubt on causation of physical illness with the potential for conflicts of interests muddling the outcome of this ME/CFS study. I have no idea if Dr. Walitt’s intents are honorable/dishonorable or if his reputation-staked-somatization-theory-bias will influence the outcome. But the clear appearance alone of bias should make the NIH rethink their choice of involving him with this study.

  29. leelaplay says:

    Thanks again Jeannette for focusing your energy on publicizing key concerns with the trial. You highlight 2 of the key problems
    1. Having Walitt and Gill (i haven;t checked into Saligan but others have said he too considers ME a psychosomatic disorder) in positions of power on this study is like having climate-change deniers as the clinical lead and key team members on research into the cause of and treatment for climate change.
    2. Insurance companies only provide LTD for 2 yrs for psychological problems where they pay to 65 for biomedical conditions. Should Walitt and the other psychosomatic promoters be successful in subverting the study and getting any psychological language regarding the physical disease, ME, millions of people worldwide would be left penniless.

    • schweitz75 says:

      Saligan is into the “catastrophising” theory – that is, he’s done research that shows a correlation between experiencing pain and thinking about pain, so obviously thinking about pain CAUSES pain – right? (This was actually published.) Now he has shifted more into fatigue studies, and – you guessed it – thinking about fatigue makes you … fatigued. So yeah, his views on the disease run a bit towards the psychosomatic theory.

  30. Anja Jott says:

    Thank you so much for your clear analysis and your hard work, Jeannette!

    The problem is surely not only Wallit, but also the criteria of the sample, together with the small number of cases are highest cause for concern.
    To differentiate ME from somatoform disorders must be explicit in a ME study, otherwise the consequences of the resulting Psychiatrization are devastating for all of us. Not only in relation to the insurance, but also for our treatment and especially for our ME-suffering children. Another biopsychosocial psychogenic explanation is a real danger for every single child.

    The results of this study will make a worldwide impact for a long time on all of our lives. Therefore, it is so important, to fokus the attention on Wallit and the study design to raise a critical awareness. I’m convinced, that the team around Dr. Nath will remain not entirely unimpressed, that we arme keeping an sharp eye on them.

  31. Utting Wolff says:

    Reblogged this on Utting-Wolff Spouts and commented:
    Irrespective of what people think of the scientific value and validity of the proposed intramural NIH study, Jeannette raises some very important points in her most recent blog post. There are serious legal aspects to Dr. Walitt’s terminology, for instance

    “There are variations in the language, but the gist of the mental-health limitation in most LTD policies is the same: a termination of coverage for mental-health conditions after 24 months. Somatic Symptom Disorder as well as other somatoform disorders are listed in the DSM-V and regardless of whether they are expressly mentioned in a policy, any diagnosis of a somatoform disorder will, without a doubt, be classified as falling under the mental/nervous clause.”

    Please do not be intimidated by silencing techniques and sustained ad hominem attacks on advocates who contribute with invaluable knowledge and insight to the field of ME. While we all are desperate for scientific studies and solid findings in the hopes of adequate treatment in the future, uncritical or overly optimistic acceptance of what is on offer is not the way forward if we also want sufferers to live in relative safety. Being stripped of all payments and benefits is not what I would want for anyone, but we need to understand that this is exactly what will happen if we choose to look the other way out of gratitude to the NIH for ‘something’ after so many years of total neglect. Jeannette gives of her considerable legal expertise to this cause, expertise that would be very expensive if we had to pay for it. I suggest we listen to her advice and act on it before it is too late. We all want to get better, we all want to collaborate, but we must pay attention to questions of sustainability for all of us. It is possible to produce sound science and take ethical responsibility for those who are supposed to benefit from such research.

  32. Laurie says:

    From PubPDF I found 46 search results for Brian Walitt. There were at least 5 results for 2016.
    http://www.pubpdf.com/search/author/Brian+Walitt

    I’m very ill and only looked at the first result. All I did was search the document for chronic fatigue syndrome and read the conclusion http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761650/

    Characterizing “fibrofog”: Subjective appraisal, objective performance, and task-related brain activity during a working memory task.

    Neuroimage Clin 2016 2;11:173-80. Epub 2016 Feb 2.
    Brian Walitt, Marta Čeko, Manish Khatiwada, John L Gracely, Rakib Rayhan, John W VanMeter, Richard H Gracely

    From pg. 178 of the PDF:

    In this way, the dyscognition of fibromyalgia appears similar to the “brain
    fog” described in Gulf War Illness and other war-related illnesses,
    (Binder et al., 1999; Hyams et al., 1996; Wallin et al., 2009) chronic
    fatigue syndrome, (Capuron et al., 2006; Ocon, 2013) post-Lyme disease
    syndrome, (Hassett et al., 2009) postural orthostatic tachycardia
    syndrome, (Freeman et al., 2011) the “chemobrain” in cancer survivors,
    (Tannock et al., 2004; Wang et al., 2015) the “brain fag” historically
    described in neurasthenia, (Ross, 2004) and (perhaps) the ethnographic
    illness “brain fag” documented in male African teenagers (Ola et al.,
    2009). These disorders are characterized by distressing subjective
    cognitive impairment without clinically obvious cognitive deficits.

    This discordance is in contradistinction to neuropsychiatric
    dementias with demonstrable pathology such as Alzheimer’s disease,
    Parkinson’s disease, Wernicke’s encephalopathy, Korsakoff Syndrome,
    and vascular dementia, where the cognitive impairment is clinically
    obvious. In these disorders, cognitive impairment is measured easily
    using objective tests and ratings from relatives (McGlone et al., 1990).
    In fact, a common clinical scenario in neuropsychiatric dementia is the
    reverse of what is seen in fibromyalgia: clearly discernible cognitive
    deficits accompanied by minimization, confabulation, or outright denial
    of these cognitive deficits by the afflicted (Weinstein et al., 1994).
    Unlike fibromyalgia, these progressive dementias are associated
    also with obvious physical disability and early mortality (Wolfe et al.,
    2013). The dyscognition of fibromyalgia appears to be more a
    problem of subjective cognitive appraisal – the privileged homeostatic
    sensation that accompanies cognitive tasks – than of actual cognitive
    performance.

    From pg. 180 of the PDF:

    It is also possible that the poor association between subjective symptom
    reporting and objective cognitive performance is related to the influence
    of psychiatric variables, such as anxiety and depression.
    However, psychological issues are such an essential part of the clinical
    phenomenon of fibromyalgia that they cannot be meaningfully separated.
    In the National Health Interview Survey, 62.7% of persons meeting
    fibromyalgia criteria self-report a diagnosis of depression and 64.8%
    report being “often anxious” (Walitt et al., 2015). In recognition that
    fibromyalgia cannot be readily disassociated from psychiatric comorbidity,
    feeling depressed was added to the ACR diagnostic definition in
    2011 (Wolfe et al., 2011).

    5. Conclusion
    In summary, these results suggest that “fibrofog” is better characterized
    by subjective rather than objective cognitive impairment. This
    difference in cognitive appraisal appears to have neurologic correlates.
    We opine that these differences reflect both the sensory and behavioral
    aspects of task performance rather than a singular deficit in cognitive
    ability in fibromyalgia patients.

  33. T says:

    Thank you for this article. I met Dr. Walitt years ago when he opened the Fibromyalgia Center at Georgetown University Hospital and was recruiting patients for his research. I was referred over from my rheumatologist at the time and very excited to be a part of the research. Then I went to the first day, which involved interviews, an exam, and a lecture. I couldn’t wait to leave and never went back. I was not impressed with the doctor or the program. Mostly I was offended by the continuous lecturing from Dr. Walitt which can be summed up as “you probably did too much and caused fatigue and pain and now you’re depressed and anxious and can’t ever get better because your depression and anxiety make you think you’re sicker than you are.” He was cold, direct, and impatient. I was exhausted, confused, and upset by the whole experience and cried the whole way home. It baffles me that he’s involved at the NIH level and frustrates me to no end to know that he’s involved in anything at all related to CFS/ME and FM.

    • ian says:

      You should tell your story to Dr Nath and others who are in a position to change things. One of the main jobs of Lead Investigator is the well being of the patients. Klimas did a study and found that ME patients actually got PTSD from doctors like him.

      Thanks for sharing your 1st hand knowledge. It’s invaluable.

  34. Sharon says:

    Here is more information on Leorey Saligan’s work:
    1. “Association of catastrophizing and fatigue: a systematic review.”
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3553502/
    J Psychosom Res. 2013 Feb;74(2):100-9. doi: 10.1016/j.jpsychores.2012.11.006. Epub 2012 Dec 2.
    Authors: Lukkahatai N1, Saligan LN.

    Objective: Catastrophizing is an exaggerated negative evaluation and attention to specific symptoms such as pain or fatigue. A number of studies consistently support the significant role of catastrophizing in pain. However, the role of catastrophizing in fatigue is less frequently investigated. This article provides a critical review of published studies investigating this association.

    Conclusion: In spite the differences of its definition and the measurements used, a similar significant association between catastrophizing and fatigue was reported. Because this observation was based on 14 studies with limited types of patients, further studies are recommended to examine the role of catastrophizing in fatigue from other clinical populations and to investigate its utility as a behavioral marker for central fatigue.
    ================
    2. Saligan was a co-author with Walitt of “Chemobrain: a critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy.”
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750385/
    Cytokine. 2015 Mar;72(1):86-96. doi: 10.1016/j.cyto.2014.12.006. Epub 2015 Jan 5.
    Wang XM1, Walitt B2, Saligan L2, Tiwari AF3, Cheung CW4, Zhang ZJ5.
    Published in March of 2015, mind you… a month after the IOM report was published…

    “…measurements of objective neuropsychologic function frequently fail to demonstrate impairment and what is seen in positive studies is of small clinical magnitude…” – this is not true in ME!
    “Both of these illnesses have disputed causal triggers, such as… infection in chronic fatigue syndrome, whose validity is also not answered by the scientific literature to date.” – Disputed by whom? Validity not answered – by the IOM report published a month before the Chemo brain paper was published?
    “The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.”
    “Illnesses such as fibromyalgia and chronic fatigue syndrome are typically recognized after the clinical symptoms are already present and attempts to understand the contribution of discrete triggering events are subject to recall bias.”

  35. Shirley says:

    Thank you so much Jeannette for another brilliant and powerful piece of essay. This conflict of interest by the NIH influenced by LTD and insurers needs to be called out and you do it so succinctly and powerfully. This latest reearch could have very dangerous outcomes for patients and the fact that some support the researchers and NIH research as outlined is frightening. To hire someone like Wallit is a clear message of what is to be expected. And from T’s response above, “you probably did too much and caused fatigue and pain and now you’re depressed and anxious and can’t ever get better because your depression and anxiety make you think you’re sicker than you are.”, it sounds even more likely. Just sickening.

  36. sharonkramer says:

    I wonder how many times and by whom, these papers have been cited in toxic torts, personal injury lawsuits and workcomp claims handling practices? There is a TON of money to be made for expert witnesses. But first, they have to “peer review” publish and cite from peer reviewed published liitrature b/f any weight is given to their testimonies. Would love to know if and how these papers have been used in court.

  37. Karena says:

    Thank you for another well-reasoned blog. One of my (many) concerns regarding Walitt is that his participation in the study may legitimize him and his views. He obviously likes the spotlight. In a few years, we may see him on the talk-show circuit offering his interpretation of the NIH study. Regardless of the findings, he can always claim patients are exaggerating their symptoms and disability. I’m afraid he’ll spin the results so they conform to his theories about diseases like ME/CFS.

  38. sharonkramer says:

    Dear All,

    I’m posting this here b/c I can’t take this on right now on my own blog, Katy’s Exposure. I’m study you ME/CFSers for a related matter of conflicts of interest in gov’t and “nonprofit medical associations/journals” causing false policy and poor treatment of the environmentally disabled.

    So..the below paper came to my attention today about you all. Took me all of about 10 minutes to see that they are promoting that what they are doing is “evidence-based” founded upon “assumption”. Huh?

    HOW CAN A MEDICAL ASSOCIATION PAPER THAT IS BASED ON A ASSUMPTION “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?

    Direct quotes from “Prescribing exercise interventions for patients with chronic conditions” Canadian Medical Association Journal, March 2016 (early release subject to revision)
    http://www.cmaj.ca/content/early/2016/03/14/cmaj.150684

    “Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed….To help clinicians prescribe evidence-based exercise interventions”

    On page 2 it states, “To help clinicians prescribe evidence-based exercise interventions, we provide practical details for some conditions in Boxes 2–4 (low-back pain, COPD, diabetes) and Appendices 3–6 (osteoarthritis,falls prevention, chronic fatigue syndrome, heart disease; available at http://www.cmaj.ca/lookup/suppl/doi/10.1503/cmaj.150684/-/DC1).9–19

    Reference 18 in support of the above is: “White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377:823-36.”

    Appendix 5 in the link above is: “Appendix 5 (as supplied by the authors): Exercise for people with Chronic Fatigue Syndrome” It states, “Rationale for exercise: To reverse the physical deconditioning, exercise intolerance and avoidance that has been caused by inactivity and to gradually re-engage the person in physical activity. Based on the assumption that chronic fatigue syndrome is maintained by physiological changes of deconditioning and activity avoidance – which can be reversed.”

    Reference for Appendix 5 is “White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive
    pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823–36.”

    1. HOW CAN A MEDICAL ASSOCIATION PAPER BASED ON AN ASSUMPTION “HELP CLINICIANS PRESCRIBE EVIDENCE-BASED” anything?

    2. Why can they only cite one reference in support of the assumptive-evidence-based physician education?

    3. Have you read about Evidence Based Medicine being hijacked? 3/16/2016 Retraction Watch: “Evidence-based medicine has been hijacked:” A confession from John Ioannidis

    “John Ioannidis is perhaps best known for a 2005 paper ‘Why Most Published Research Findings Are False.’ One of the most highly cited researchers in the world, Ioannidis, a professor at Stanford, has built a career in the field of meta-research. Earlier this month, he published a heartfelt and provocative essay in the the Journal of Clinical Epidemiology titled ‘Evidence-Based Medicine Has Been Hijacked: A Report to David Sackett.’ In it, he carries on a conversation begun in 2004 with Sackett, who died last May and was widely considered the father of evidence-based medicine. We asked Ioannidis to expand on his comments in the essay, including why he believes he is a ‘failure.’

    Retraction Watch: You write that as evidence-based medicine ‘became more influential, it was also hijacked to serve agendas different from what it originally aimed for.’ Can you elaborate?

    John Ioannidis: As I describe in the paper, ‘evidence-based medicine’ has become a very common term that is misused and abused by eminence-based experts and conflicted stakeholders who want to support their views and their products, without caring much about the integrity, transparency, and unbiasedness of science.”

    Read the entire article at Retraction Watch: http://retractionwatch.com/2016/03/16/evidence-based-medicine-has-been-hijacked-a-confession-from-john-ioannidis/

    4. The “nonprofit” medical association CMA’s journal, CMAJ, which just published this assumptive-evidenced-based paper just had a changing of the guard in late Feb 2016. From the tone of their announcement, it does not appear to me to have been amicable transition. http://www.cmaj.ca/content/early/2016/03/02/cmaj.160283

    5. In some circles of research, medicine and policy-setting; Evidence-Based-Medicine is jokingly referred to as “Iffy Based Medicine”. Not such a funny joke when your life is the butt of it, eh?

  39. I left the following comment further clarifying that Walitt will have a central role in the study on MEadvocacy’s must-read blog post, “NIH Sidesteps Critical Problems with the ME/CFS Study,” here:

    http://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study

    “Mary, I agree that if Walitt’s role were not crucial, as some want us to believe, then why not have somebody less controversial take over his job?

    However, it is overwhelmingly unlikely that Walitt’s role is limited to paper pushing. He, after all, got a special shout-out by Dr. Nath during the CDC Grand Rounds presentation for his “valuable advice” in refining the study. Nath didn’t mention any of the other 26 or so investigators who are part of the study.

    In the recent tele-briefing on the study, NIH trotted out Collins, Koroshetz, Whittemore, Nath and Walitt who was prominently featured on the call. Aside from Nath, the PI, and Walitt, none of the other investigators were on the call.

    Walitt’s initial title was that of “lead clinical investigator,” which interestingly later, after a huge outcry by patients, was apparently changed to “lead associate investigator”—a downgraded title that seems designed to imply less authority and, hence, less of a threat to the patient community.

    Most important, however, is the following. This is how Walitt’s role at NCCIH was described on its website:

    “As Director of Clinical Pain Research for the NCCIH Intramural Laboratory of Clinical Investigations, Dr. Walitt will provide his medical and scientific expertise to the development and oversight of intramural clinical protocols. He will help identify patient populations for pain studies …”

    So, Walitt’s role at NCCIH has been as follows:

    * providing medical and scientific expertise to develop and oversee intramural clinical protocols

    * identifying patient populations for studies

    That quite clearly is a central role as an investigator that goes far beyond that of a paper pusher with merely administrative duties.

    If you add up Walitt’s special title in the “ME/CFS” study (even the downgraded one), the special acknowledgment by Nath of Walitt’s role in developing this study, Walitt’s prominent participation in the recent tele-briefing and his NCCIH responsibilities, it simply leads to the unavoidable conclusion that Walitt is going to have a major and critical role in the “ME/CFS” study.

    I copied the above NCCIH website language from the following link:

    https://nccih.nih.gov/research/intramural/laboratory-clinical-investigations-branch/staff/walittb

    This was a working link only three days ago; it no longer is. Now, the URL returns “Page Not Found.” It incorrectly states that the page was last modified on February 12, 2015. I suppose it is possible that Walitt is no longer with NCCIH and that that is why his bio was removed, so recently.

    Walitt’s position at NCCIH (National Center for Complementary and Integrative Health) is, of course, of huge concern. NCCIH was originally NCCAM (National Center for Complementary and Alternative Medicine). NCCAM’s first director (in 1999) was Straus!

    You may want to say more about Straus and NCCAM, Mary.”

  40. Tracey Smith says:

    Another excellent commentary Jeannette. So glad that you thought of the ramifications this NIH study design would have on long term disability.

    The NIH has put us in a very precarious situation, only implementing one small phase 1 research study while at the same time denying the importance of the study. A study that will set precedence for years to come. It may be a puzzle piece, but it is positioned to be a cornerstone piece in the dogma that NIH has created for ME and CFS. In fact, it will fit neatly into the same puzzle in which NIH’s Dr. Stephen Straus’ research fits, as one of the other cornerstones. So what picture will develop once NIH follows this path and fills in the rest of the puzzle? It sure will not look like myalgic encephalomyelitis.

    Blog excerpt: “The very fact that NIH appointed Walitt in the first place, as well as the agency’s in-patients-face failure to remove him from the study after an unprecedented and ongoing outcry from the patient community, is ever so revealing in terms of NIH’s objectives for the study and its recently oft-repeated assertion of a suddenly-found desire to work with patients.” I will also say that the inclusion of Dr. Gill and Dr. Saligan as clinical experts further supports this conclusion.

    For those patients and advocates ignoring these concerns, and even trying to intimidate other patients and advocates from voicing concerns about the study; step back and really think about what those actions will accomplish. Don’t keep distracting yourself with the slew of biomedical tests that will be taken. They will be worthless if done wrong.

    Promoting the positives of the NIH’s recent efforts, while ignoring the weaknesses, further propagates an imbalance of power the government has with the patient community.

    I understand how the saying goes; you catch more flies with honey than you do vinegar. And there are those that feel that the little steps of progress via promises and an obscenely small increase in budget and research, has only resulted because they cultivated relationships with the government by spoon feeding honey with thank you notes and private meetings and phone calls offering help and sympathy for the government officials having to deal with the critical patients. Even if that honey was mixed with a little medicine of teaching why the patients view the government as biased, it doesn’t cure the bias. The honey insidiously counteracts the medicine.

    Don’t think the blood can easily wash off one’s’ hands that assist in the imbalance.

    *[I am using both of these terms ME and CFS since the CDC has been referring all searches of ME to their CFS website, and at times the government wrongfully uses these terms interchangeably when they have different diagnostic definition and criteria and ICD codes, where the CFS definition is so wide the majority of ME patients are shrouded in it, a living death sentence.]

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