NIH Study

websiteThe Solve ME/CFS Initiative held a phone call with Vicky Whittemore, Ph.D., of the National Institutes of Health yesterday regarding our concerns over staffing of the NIH’s new intramural study on ME/CFS.

Specifically, our organization is concerned about the appointment of Dr. Brian Walitt, who is the Lead Associate Investigator on the study under the leadership of Principal Investigator Dr. Avi Nath. As other advocates have reported, Dr. Walitt has made public comments regarding his belief that ME/CFS and fibromyalgia are psychosomatic. Dr. Whittemore was very receptive to our strong opposition to Dr. Walitt’s participation in the study, but said that she has no role in the study design or staffing; that rests with Dr. Nath.

The Solve ME/CFS Initiative urged proactive patient participation in the study to avoid similar missteps and ultimately prevent bad science and the waste of taxpayer dollars. Dr. Whittemore said that the NIH is now actively exploring ways to integrate patients into the study to the full extent that it is allowable and legal. Whittemore said that they have identified three avenues for patient feedback so far:

1. Include an open period during each Trans-NIH Working Group meeting in which patients can ask questions and offer their feedback;

2. Include advocates on the smaller working groups created in conjunction with the study; and

3. Hold regular teleconferences throughout the study so that community members can receive updates on progress from the investigators themselves. The first conference call is expected to be announced this week.

In other updates, Whittemore said:

  • In a follow-up email responding to our question regarding the cost of the intramural study, Whittemore responded: “We don’t yet know what the cost will be because they are still revising the protocol.  NIH will spend whatever is necessary for this study to get answers to some basic questions about the clinical and biological characteristics of ME/CFS. Any taxpayer dollars spent on this study will be in addition to use of the unequalled resources and facilities of the NIH Clinical Center.”
  • The NIH would be providing updated responses to the Chronic Fatigue Syndrome Advisory Committee recommendations from last fall. At the time NIH responded to the CFSAC recommendations, the Trans-NIH Working Group had not yet been formed, so the NIH’s responses were based on limited information. The updated responses could be available as early as next week.
  • The NIH is developing an outline of research strategies and initiatives, which will be reviewed by Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and the entire Trans-NIH Working Group. Whittemore said the outline will be shared with the ME/CFS community as soon as it’s final. “I think you’re really going to be happy with what we’re planning,” she said.
  • The NIH is currently looking for funding for the initiatives in the Fiscal Year 2016 budget since no NIH Institute has set-aside dollars.
  • She, Dr. Koroshetz and Dr. Collins remain committed to research regarding ME/CFS.

Solve ME/CFS Initiative President Carol Head will continue to raise the concerns over Dr. Walitt when she meets with NIH officials in D.C. on March 8 along with fellow advocate Mary Dimmock.


40 comments on “NIH Study

  1. “Dr. Whittemore was very receptive to our strong opposition to Dr. Walitt’s participation in the study, but said that she has no role in the study design or staffing; that rests with Dr. Nath.”

    So does this mean she will help or you will try to speak with Dr, Nath now? Was she receptive enough to try and help make this happen?

    There seem to be 4 more individuals on staff who are on record as having been proponents of the psychosomatic theories or CBT/GET. How were they chosen? They also should be of grave concern to us and involved in any talks with Dr, Nath.

    Also, if you can have a conversation with Nath, one of the biggest concerns I didn’t see voiced was concerning the two control groups. Very controversial picks that could mess up any good findings.

    Thank you for your efforts, I hope as a community we keep fighting to make sure good science wins as we did with the IOM. This study is too important and begging to soon to leave to good faith and promises given the history of broken promises and damage done over the decades,, They want a fresh start they are going to have to do better,

    • Gowwab,
      I agree with you. Your comments were extremely well stated.

      I have had fears all along about this study and others working on ME/CFS and FM. With government and private money being given for these studies, we need the best of the best doctors who are knowledgeable and interested in finding causes and cures.

      Any doctor that even mentions the word, somatic or somatocizing, needs replaced immediately by someone else who wants to be a part of this special research.

      Living with ME/CFS and FM, so I’ve read is as transmittable as mononucleosis is. My husband has had FM for nearly 10 years now and now has ME/CFS.

      I don’t know about anyone in this conversation, but I am deathly afraid of the Zika virus and what it could do to people like us with weakened autoimmune systems. I am allergic to mosquito bites. Some types of mosquitoes more than others, which I carry and need to replace my eppy injectors. I have had to be treated at a hospital 3 times for severe swellings and trouble breathing. Being 63 now, I fear that the virus which also includes severe viral responses in adults and is actually transmitted by sex, is a very scary outlook. I am going to be taking a minimum of 250-300 mg. or more of Vitamin B-1 to help keep mosquitoes away from me. It is the first thing I have ever used that has been successful in keeping them away from me.

  2. I thought both the IOM and P2P reports were pretty clear on the degree to which it is inappropriate to view this disease as psychological in nature (which is what “somaticizing” is). Given one was commissioned by HHS and the other by NIH, why have they ignored that? I think I would have asked that question and would want an answer.

    • One answer is that Dr. Walitt does not view this disease as psychological. He believes its physiological in nature – as his research record suggests.

      While he does use the disturbing psychosomatic label in the Chemobrain paper – he also – which has been completely ignored – committed to finding a physiological basis for disorders like ME/CFS and FM and outlined a research protocol aimed at uncovering the immune basis of these diseases.

      He also proposed that immune treatments including monoclonal antibodies such as Rituximab be used and asserted that studies employing a physiological stressor should be able to uncover the biological mechanisms in these disease.

      Walitt has also gone on record stating that CBT doesn’t provide much help in FM.

      Maybe a deeper look at a researcher is in order before one passes judgment is in order.

        • The basis is in his research papers – a far more substantive reference than a short interview. I would add that the initial post also plucked out one negative section from a paper while ignoring sections indicating that he believes these disorders are immunologically based, that he believes immune treatments will win out for these disorders and that he and the authors hope to show that they are biologically derived.

          Of course if you want to ignore all that you can 🙂 . If you don’t want to you might check out this blog –

          • I don’t care. A researcher does not use a term like that carelessly. He knows very well what it means.

            ANYBODY who throws out the term “somaticizing” as a description of our illness is dangerous. The fancy window dressing is meaningless. Straus had his narrative of our “somaticizing” illness all dolled up as caused by hormone imbalances; Reeves and Heim in the US and the UK psychs ran with that and soon we had a narrative of (in the US) too much stress in childhood is the cause of “CFS.” All would say very sincerely that they understand this is a serious disease. Reeves in particular would go on and on about “the brain is a plastic organ” without the foggiest notion of what that phrase meant.

            But they all also disregarded the vast literature on biomedical factors in their work and in their endnotes.

            Bipolar disorder is apparently physiological, but it is also considered a psychiatric condition. Emphasizing “fatigue” and throwing around “somaticizing” will not get us anywhere positive – it’s just one more exhausting slog through the muck to have to explain what’s wrong with the research. Oh niffy. I can’t wait. (not.)

          • Except that Walitt is not a psychologist, he does not recommend CBT and he has a research agenda that you would surely agree with and be behind…if he had used a different word.

            I know I’m not gong to win this argument but in effort of fairness and completeness I think you should understand that Walitt’s research proposal has nothing to do with psychology and everything to do with physiology. He’s suggested hitting ME/CFS patients with a physical stressor and then uncovering the immune problems causing it. He’s also proposed that immune treatments such as Rituximab could be helpful in these disorders – and he stated in the Chemobrain article that his goal is to uncover the physiological causes behind them.

          • Let’s see – who could they have invited? And they pick somebody NONE of us have hear of (and we are not an ignorant or naive group), who uses the IAIYH word, and we’re supposed to hope that he didn’t really mean to use it?

          • Cort, can you please give us the references for your statements on Dr. Walitt — I.e. his academic and research orientation, papers backing his views on fibro and me, and anything else (transcripts of speeches are fine) that would demonstrate his recognition of a pathogenic or other physical cause for M.E. and his thoughts on how to research treatments for it? Thank you.

          • I want to thank Cort for giving us this gift to stay informed. In my opinion it’s a miracle the IOM report has made such a powerful impact. After they screwed us Desert Storm Vets I was certain our fate was sealed. Maybe they caught so much hell from Vets and congressional hearings it somehow opened a doorway for CFS/ME patients. I learn so much from people far more educated than me. Thank God Doc Mary, Cort Johnson, Bob Mlller and so many advocates fought so hard! You are the reason we have the IOM report, thank you! I have witnessed the CFSAC meetings in D.C. year after year in complete disbelief the horrible treatment from the government! Without Mary pushing them and Cort staying remarkably neutral so maybe just maybe the government might change its evil ways. I was so angry when I could no longer afford Ampligen because I was 60% better after a year of infusions. I’ve learned not to waste my precious energy on anger. I pray the Government will follow through. I do believe God helps those who help themselves don’t get me wrong. I’m simply saying I’m at peace with our current circumstances. Before the IOM report we had no hope in my mind whatsoever. Now there is hope and I can keep going knowing that. Before I honestly prayed to die in my sleep but I kept waking up. We just might get some real help!

        • Wow, what Dr. Walitt is saying very clearly, albeit circuitously, is
          that fibomyalgia is all in a person’s head, invalidating the disease altogether. It’s disturbing that the NIH finds this person appropriate for the investigation of CFS/ME.

      • The very term: Psychosomatic is a gravely major, and totally insulting terminology no matter what anyone says. Whomever thinks of Fibromyalgia and/or ME/CFS, shouldn’t even have been picked to do research.

        Maybe it’s time to join the other groups in the USA, Canada, the U.K and Russia. In Russia, they think some or all of the people with these diseases have had too many x-rays and too man radioactive injections before having x-rays which may result in all sorts of organ functioning and down to the cellular level of damage.

      • Nope. There is evidence of autoimmunity, and the hypothesis that Rituximab helps leans on that evidence, but it is not classified anywhere as an autoimmune disease.

        The World Health Organization (WHO) has classified ME as a neurological disease since 1969 and considers CFS to be colloquial for ME. The US classifies ME as neurological; CFS as a condition about which little is known.

        At CDC, “CFS” replaced CEBV (chronic EBV or chronic mono or chronic glandular fever) has always been housed in the division of viruses and infectious diseases (which has had different names in the past 28 years) although they also insist it is not related to viruses. In the US, the name for ME was epidemic neuromyesthenia, and that is classified under neurology, but that has not been used since the 1970s. Outbreaks in the 1980s were labeled chronic EBV, and the national “expert” on EBV was Steven Straus within NIAID (the National Institute for Allergies and Infectious Disease). Straus (who was neither a psychiatrist or psychologist) concluded the disease was a somatoform disorder (that is, psychosomatic) – a disease of upper middle class white women trying (and failing) to have it all; they could not handle the stress. Straus later went on to head CAM (the Center for Alternative Medicine) until his death in 2007. [CAM has been renamed the National Center for Complementary and Integrative Health; and by coincidence, that’s where Brian Wallit worked until late last year when he shifted over to a different institute at NIH.] Straus tried to continue to control research on CFS at NIH after moving to CAM, but members of Congress actually stepped in and it was moved to the Office for Women’s Health in the Office of the Secretary of HHS (if you’re confused by now, you wouldn’t be the only one).

        From roughly 2000 until last year, both OWH and, within NIH, the Office for Research on Women’s Health at NIH (yes, two different offices) were technically in charge of CFS research. Neither office has funding for research. So special emphasis panels (SEPs) have been created to judge whether proposals for CFS are fit for funding at NIH – but most of the researchers on the SEPs have not had anything to do with research on ME or CFS, or what the NIH now calls ME/CFS. [CFSAC, the CFS Advisory Committee to the Secretary of HHS, recommended that the US adopt the Canadian Consensus Criteria of 2003 and the name used in the CCC, ME/CFS – they adopted ME/CFS, but not the CCC – and not at CDC.] (Confused now? Welcome to Washington.)

        Early last year, the IOM (commissioned by HHS) and P2P (commissioned by NIH) reports came out – both strongly urging NIH to increase funding and explicitly stating that ME/CFS was not psychiatric in etiology. The disease has apparently now shifted to NINDS (the National Institute of Neurological Disorders and Stroke), which many of us have taken as a hopeful sign.

        However, there were no “experts” on CFS or ME at NINDS. Nor did they know anybody who was. That is probably where Beth Unger at CDC helped out. Or perhaps Dr. Gill, retired, from NIH, who is person number 2 on the study “expert committee.” (We’re back to the study again). Even though he labeled it a somatoform disorder, Dr. Walitt apparently is one of the few CFS “experts’ within NIH, and Dr. Saligan is a “fatiguing disorders” expert. Saligan has worked with fatigue in chemotherapy – but he has also worked with “behavioral” fatigue and fatigue as a “catastrophising” disorder. (That means that you feel fatigue because you think about it a lot – that is, you’re a catastrophiser.) Aside from the reduction to “fatigue” as the essential characteristic of the disease (which means this is about CFS and not ME), the literature on “catastrophising” and pain does not suggest anything good about applying it to “fatigue.” So I am no more pleased with Saligan being on the “expert” committee than “Walitt.”

        Dr. Gill, retired from NIH but apparently the resident expert at NIAID after Straus left the building (in more ways than one), considers psychotherapy and graded exercise good treatments for “CFS.” So I’m not particularly happy with HIM as one of the five “experts” on “ME/CFS” in this venture.

        This very long post, which started out explaining that NO, neither ME nor CFS is classified as “autoimmune” anywhere, ended up saying once again that the “expert committee,” consisting of Beth Unger of CDC, Dr. Gill of NIH, Dr. Walitt and Dr. Saligan of NIH, and Ian Lipkin (who is an expert on virology but not a clinician), has a rather strange makeup. The website of FAQs for the study states the expert committee will have final say on the 40 patients selected. That website is here:

  3. Dr Whittemore passes the buck. Walitts continued participation is a blatant effort to contaminate this study.

  4. I share gowwab’s concerns precisely. They reflect what has become largely a consensus on Phoenix Rising, in my view. About the controls, how can it be determined how people with ME/CFS depart from normal, if matched healthy controls are not used? Long term Lyme patients and those with Functional Movement Disorder aren’t, biologically speaking, fully known. There are rather assumptions made about them, that they are “just” psychosomatically ill, in my understanding. If they wanted one set of controls to be a group they believe to be psychosomatically ill, whether they are or not, that would make a lot more sense to me than having two such groups. How will they know what their results actually mean?

    • allenius,

      I really liked you comments. Well said.

      There’s not just long term Lyme patients, but I have found, just through Google, that our Vietnam War Veterans, who ended up with malaria, despite taking the pills that were “supposed” to keep them sage, are 50 years afterwards exhibiting signs of malaria returning, just like polio patients are havin post polio disease. They are not going to have results that are repeatable and verifiable and will end ip saying it’s somatic or somatocizing.

  5. Thank you for the update, I loved to read ” NIH will spend whatever is necessary for this study to get answers to some basic questions about the clinical and biological characteristics of ME/CFS. Any taxpayer dollars spent on this study will be in addition to use of the unequalled resources and facilities of the NIH Clinical Center.”

    • I feel like the NIH needs a complete weaning out of incompetent doctors, but especially Dr. Wallit. To think that put him in the position he is in, makes me wonder what, if any, trust I now have in answers to our sometimes decades long illnesses. I am angry, disappointed, and feeling sorry for all of us who are suffering from REAL DISEASES. Whatever made pick this doctor, who thinks our promblems are somatic and psychological, I have lost the hope I once had. It’s gone. I feel like someone kicked me in the stomach and said, “It’s not real it’s your imagination.”

      Didn’t Laura Hillenbrand donate the proceeds from the first book she wrote, “Secretariat” to this organization? If so, can you imagine how badly she feels about this?

      She is a wonderful, intelligent and kind woman. I met her online a couple of decades ago when we had a Fibromyalgia chat room. One day, when I was in the room, she said that she would not be returning for a real long time because she had a great idea about writing a book. We missed her wisdom and kindness, but were so proud of her accomplishments.

      Most of her books she has been bedridden doing them. I think I recently read her husband is going to or has already divorced her.

  6. Well, if NIH intentionally wanted to alienate and anger people who have ME/CFS and skew research results at the same time, this was a great way to do it. Put someone in charge of a research study who already has his mind made up that it’s all in our heads.

    • Nita, I am in 100% agreement with you. This is unbelievable! Are you kidding me?? This type of thing is what has set us back so far and still we have people in higher positions who don’t believe it’s a real disease. Wow! What next??

    • I honestly think we will have to wait until the UK, Australia, and I can’t remember the 3rd country, it might be Canada, that are all studying ME/CFS and FM causes and working on cures. At least, is not the only study being conducted.

  7. What I want the most is for NIH to fund Dr. Ron Davis’s research study. When will see progress on that? Is that something that Solve ME/CFS is willing to work on with NIH? In light of the comments Cheryl Kitt, Ph.D. made in the August 2015 CFSAC meeting, it seems something that we need to fight for, rather than ask for.

  8. Thank you for sharing this information with us. “Dr. Whittemore… said that she has no role in the study design or staffing; that rests with Dr. Nath.” That being the case, will Solve ME/CFS change strategy and contact Dr. Nath with concerns about Dr. Walitt’s participation? Also, what about Dr. Gill, who recommended CBT and GET in 2011? One other fine point: Not only did Dr. Walitt make public comments, his scientific publications explicitly state his position that CFS is a somatic illness. See: Quote: “The discordance between the severity of subjective experience and that
    of objective impairment is the hallmark of somatoform illnesses, such as… chronic fatigue syndrome.”

  9. Thrilled to see Mary Dimmock’s name as an advocate alongside Carol Head.
    I have complete confidence in Mary’s knowledge and political acumen.
    Thank you, Mary!

  10. Why those of us who have been ill with ME for
    decades and have long memories feel deeply disturbed by this trial proposal.

    To illustrate:
    In 2002 in England, a Chief Medical Officers report
    was published after a hard fought battle by patients, experts and charities to
    get ME recognised for the severely disabling biomedical disease that it is. The
    biomedical campaigners had to fight against a powerful psychiatric/psychologist
    lobby, known to us as the Wessely school. Several of whom walked out in the end
    without signing the report outraged they had lost ground on some important
    points, mainly that for the first time since Melvyn Ramsey described ME in the
    1950s children with ME and the severely affected had been officially recognised.
    One compromise reached with the psychiatrist/psychological lobby was that the
    name ME should now be changed to ME/CFS to reflect their views, on the
    condition of a promise that the CFS title was only for research purposes.

    Although delighted by some aspects of the report when
    it appeared there was also dismay in the ME community and charities at the
    heavy overtones of psychiatry/psychology permeating the report. However
    recommendations in the report stated that there was a great need for funding
    and research into ME. The ME community waited with bated breath, patients and
    charities lobbied for funding but when the news came it was devastating, 8
    million pounds to psychiatry to set up clinics.

    Our fate was signed, sealed and set in stone that
    day. ME was to be treated as a psychological disorder an illness belief. NICE
    guidelines were changed outlawing any treatment or research other than CBT and
    GET. Although clinics were not set up in psychiatric departments and the lead
    consultants were not psychiatrists but rheumatologists, neurologists etc. all
    were under psychiatric/psychology control and design. Patients had no other
    options than these clinics and new patients were duped into thinking that they
    were genuine biomedical clinics where their ME would be treated. Over the years
    physicians with other approaches to ME have been systematically tracked down
    and removed, struck off or funding withdrawn and today patients in the UK are
    only diagnosed with CFS. Patients have been routinely stigmatised, neglected
    and isolated, our voice has been stolen, hope crushed. The PACE trial was a further
    heavy blow to us all but is now rocked with scandal and refusal to share data.

    Our story in the UK is a warning from history that
    you must be vigilant and not take anything for granted. It may be incidental
    but this trial design bears all the hallmarks of a psychiatry/psychology coup d’état
    but the questions are many. Who designed it where did it come from, who were
    the advisors, why is the trial design so odd and out of kilter with the
    direction research has recently been going in, why is there a man with such
    outrageous views of ME and Fibromyalgia in such a prominent position, why are
    there a group of psychiatrists/psychologists involved and waiting in the wings,
    is Simon Wessely involved at all?

    Dr Nath knows nothing of ME, therefore he would not
    be alert to any dangers to the integrity of the research.

    • I could not agree more. In ways, that are mean and nasty and vindictive, how I wish that people who have been studying (if that’s even believable now) would get ME/CFS and FM. I would bet that they would be singing a different tune other than somatic, psychiatric, and other terms used to denigrate and try to tell us that it’s all in our heads, would take away the insulting terms, and would be more responsible for research and finding both cause (s) and cures for our illnesses.

  11. Solve appears to be reacting to patient concerns rather than taking the initiative here. Where is the concern about the pseudo-science control groups, which represent much more of a threat than Dr Walitt?

  12. Why didn’t anyone listen to Dr. Whittemore? Instead of finding an advocate who “recently” called ME/CFS as psychosomatic, he surely hasn’t changed his colirs so easily with the exception of the need for a paycheck at our expense physically and emotionally. No matter how much you put into explaining his so-called views now, I fear that he is in this to prove his opinion of ME/CFS being psychosomatic. Even Dr. Whittemore didn’t think Dr. Wallit should be on the team. Why is and the NIH and CDC going to do about this problem. You stand to lose a lot of future funding by having Dr. Wallit on this team. Also, it’s a matter of time, if it hasn’t been done yet, that the funding you had is going to be redirected to the study of Zika virus and NOT on ME/CFS.

    I am so dissapointed.

  13. I was diagnosed with CFS/ME at the Cleveland Clinic in 1994(was an RN working with Aids patients). Do you suppose they still have blood samples? I heard they are kept rather than discarded as medical waste after testing done. And if they do still have samples of my blood, could they do some tests on it now?

  14. Has anyone heard about Dr. Judy Mikovits? Is the Dr. Whittemore you’re referring to the doctor that Judy Mikovits used to work for?

    • No, she is not related to the Whittemores of the old Whittemore-Peterson Institute at the University of Nevada, Reno (which I thought was renamed recently but perhaps not).

      • thanks. By the way, do you think there is any merit to the hypothesis that XMRV is related to ME? I think that it was announced in2009, but I haven’t heard any more about it.

  15. Thanks for the detailed response. Now my brain hurts. As far as it being a psychological or somatiform disorder, I would disagree- but, after all, it’s mostly women who are affected, and everyone knows we have “issues”. I personally developed it in 1986. I was working as an RN at Cleveland Clinic in the department of Orthopedics, Rheumatology and Immunology. Around 1981 or 1982 we began seeing patients with immune disorders- HIV hadn’t been coined yet. They were calling it Aids related complex I think. All of our patients died. In 1986, I cared for a patient who came in very ill and died that night. Within a week, I developed a severe Strep B infection which led to a prolonged episode of guttate psoriasis lasting several months. within the year, I was suffering with low grade fevers, axillary lymph node enlargement and tenderness- basically it was like a chronic flu that lasted for about a year. I then moved to Outpatient Surgery at the clinic.As an example,I helped to created all of the post-op instruction sheets for about 100 different surgical procedures- It got to the point that I had to read the instruction sheets because I couldn’t remember what I had written.Lots of other weird symptoms as well. I was evaluated to see if I had M.S.(my dad died from primary progressive M.S. in 1976). M.S. was ruled out, but the MRI showed brain atrophy and unidentified bright objects. I was diagnosed by a Rheumatologist at the Clinic by the name of Dr. Cash(an appropriate name for a doctor, eh?) I’m a lot better now, but I’ve never regained my prior cognitive ability and still suffer from PEM if not careful. I have always thought that there was an infectious etiology. And I also wonder what impact mercury or other toxic metals have on the disease. I submitted to the Hepatitis B series because we were told that while it was less likely that we would contract AIDS from our patients, we were at high risk of contracting Hep B from them.

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