Tuesday, April 12, 2011

NIH SoK: The Good, the Bad, and the Ugly

In  the mid-1990s, I attended a conference organized by the International Association for Chronic Fatigue Syndrome (IACFS, now IACFS/ME).  It was my very first and I found myself excited and energized by the presentations and discussions.

Fast-forward to April 7 and 8, 2011, when the NIH held its most recent ME/CFS State of Knowledge Workshop.
With the passage of fifteen years, wouldn’t it be reasonable to expect an even more exciting event?  Yet I felt I was time traveling -- and in the wrong direction.  In 2011, two years after the discovery of XMRV and other HGRVs in a majority of  ME/CFS blood samples, most presentations covered pathophysiology and potential biomarkers.  There was more discussion of potential causation at the earlier conference than at this “State of the Science” workshop.  
Things got bad after that IACFS conference.  DeFreitas’s research was killed and no researcher dared to go near infectious agents.  Psychoneuroimmunology was in vogue and heavily applied to ME/CFS research.  Fauci, director of the large and powerful National Institute of Allergies and Infectious Diseases (NIAID) stated publicly that he didn’t understand why people with “CFS” couldn’t accept that they had a new psychological illness. Backward we slid. 
Our nemesis, Straus, left NIAID and with that there was no interest in CFS at all.   The Office of Research on Women’s Health offered us a supposedly temporary home which now has become permanent. The amount of research sponsored by NIH from the time CFS was moved to ORWH to date has been abysmal.  And what has been funded is often only tangentially related to CFS.
So what’s this NIH State of the Knowledge Workshop?
NIH is supposed to hold these type of workshops or conferences on a regular basis.  This is just the most recent.  One was held in 2000 and another in 2003.  The previous State of Science conferences were heavy on psychological factors.  There was much less mind-body talk at the April workshop, yet the idea that psychology plays a role in ME/CFS still came up.
Did this Workshop change anything?
Yes and no.   
The NIH Workshop was well-organized, packed with presentations, and attracted staffers from all over the U.S. Public Health Service. We now have people in influential positions who get that we are very sick.  They understand the devastation CFS has created. 

And yet, while we may have people at NIH and other parts of the U.S. Public Health Service who finally recognize that we have a “real” biomedical illness, I still feel we have progressed from the Dark Ages to the Middle Ages, with no one seeming to recognize we are in the Twenty-first century.
The only real progress I noted was the impact of new technology and measurement tools on what we patients already knew.  I’m not saying that’s not helpful; it is.  Objective and quantifiable means of presenting data on our symptoms is welcome.
But the elephant in the room remains.  And it is XMRV and other members of the HGRV family of retroviruses that could explain the symptoms studied by the presenters.
Mikovits was the sole proponent of HGRVs role in ME/CFS.  As usual, she did a terrific job explaining her research and attempting to educate her critics.  But why weren’t Ruscetti and Lo there?  And why was Alter put in the position of moderating?  Instead he only had a few minutes to explain his MLV study with Lo, which meticulously ruled out contamination.  Coffin’s statement that XMRV should be left behind said more about the politics than the science. 
I spoke with a number of people at the workshop. Several researchers expressed interest in studying XMRV/MLVs but felt strongly no such research will be funded by the NIH until the Ian Lipkin study is completed.  Lipkin’s study will take at least eighteen months to complete.
In the meantime?
We were told that the researchers at the table would be collaborating more, sharing their data, and standardizing their research.
Which brings us the patient cohort issue, something that still is not agreed on. Thankfully, NIH Director Collins mentioned the need for a new definition (albeit with subsets) and several presenters informed me that the Canadian Consensus Document is in the process of being updated. 
What’s next?
Funding, funding, funding is what everyone wants to know about.  The two NIH grant mechanisms for ME/CFS will run out in September.  While we were told that NIH was “looking to move on with other initiatives", it turns out that the funding opportunity announcements will simply be rewritten and renewed.  So much for any earth-shaking changes, such as a Manhattan Project for this disease as suggested by presenter Baraniuk, who is quite familiar with the ins and outs of NIH having worked there for years before moving on.
My prediction? 
The “new initiatives” will use the now more sophisticated research on what we knew years ago to educate the people in the various NIH Institutes and Centers and hopefully “stimulate more research”.  Perhaps researchers will share data and collaborate more; perhaps not.  Scientists are not known for sharing as they fear being scooped on a discovery.
Of concern to me was the cozy relationship between CFIDS Association (CAA) CEO McCleary and Mangan, Chairman of the Trans-NIH ME/CFS Working Group. McCleary was not on the planning committee for this conference, yet she hovered near Mangan toward the end, asking if there was anything else she could do.
How helpful is McCleary making herself?  The funding opportunity announcements are significant for researchers who are trying to move the science forward.   Will McCleary have a role in rewriting them?  If so, brace yourselves for more denials of any research applications proposing infectious etiology, especially retroviral. 
Where to from here?
The inter-disciplinary research NIH favors spreads scarce resources too thin.  Funding should go to the most promising areas.  Why make everyone sit on their hands while Lipkin finishes his study? Why not focus on the infectious characteristics seen in many ME/CFS patients and connect them to pathogens, such as retroviruses, that could explain most if not all symptoms?
Well-designed and funded clinical trials are needed now, not years from now.  Already practitioners are using combinations of immune modulators, antivirals,  antibiotics and antiretrovirals on their patients.  It is the only way to get to the bottom of the core question raised by the research -- are infectious agents causing this disease?
Baraniuk is correct.  We need to look outside the confines of the current system of funding ME/CFS research if we want cutting-edge research to move forward. Major restructuring is called for. NIH can move mountains if it wants to; it just takes guts.  


  1. One observation at this time. The CFS researchers, are, themselves, fragmented. They need a format, a platform WITH NIH scientists to cozy up and to grow the science. As I watched NIH attendees, I believe that this is the first time MANY of them understood the very serious nature of CFS. This understanding does not dent a budget with other priorities, but NIH could conduct a workshop follow up with the scientists, both extramural and intramural for the purpose of scientific cozy, cozy. I do not mean to trivialize this. In any occupation, people form alliances based on human selection of common interests. Why not here? I do not believe that the NIH people are against us. Face to face meetings on building the science could include the CFS SEP review officer as well as other NIH employees. THIS was an introduction. When do our researchers meet? At conferences they spend a bit of time, but then fly off in different directions. CFS science needs a functioning collaborative.

  2. I think your statement "from the dark ages to the middle ages" really captures it well!

    "As I watched the NIH attendees, I believe this is the first time many of them understood the serious nature(...)"

    --I agree with that, most of the NIH people seemed like they were coming from a state just not knowing much at all about it previously--from a state of ignorance if you will. It remains to be seen how much they will do.

    Wasn't impressed that this was the case with the CDC, though, from the snippets I saw they still seem intent on it being "mind-body". It feels to me like we should just try to leave behind the CDC's CFS research or, drag them along kicking and screaming...

  3. Excellent article! Thank you for taking the time and energy to review the recent NIH SoK for those of us who were unable to attend and too ill to watch the videos.

  4. I just finished reading my spring issue of the newsletter from the National CFIDS Foundation. They reminded me that Dr. DeFreitas' retroviruses was replicted with their funding many years ago and the results shared at a medical conference. It was not causative. I found little proven science even alluded to at the recent NIH conference. Was it really done to merely soothe the patient community?


  5. Thanks for putting this all into perspective for us. It was interesting to hear the take of someone who attended this conference and the IACFS conference nearly 20 years ago. Remarkable how little we have moved forward. It seems like it would require more work to stagnate to this degree than it would to just move forward.

  6. Thank you for attending, and thank you for reporting. You pointed out several things I had not read in any of the other reports, such as: "McCleary was not on the planning committee for this conference, yet she hovered near Mangan toward the end."

  7. ME patients need to keep pushing for ME to be recognized. The reaction to this - from dead silence to censorship to overt hostility - is telling. We go on with these pronouncements and talk about "our illness" or "this illness," yet never say what it is nor seem to realize it does matter.

    We have sites/resource centers with info, articles on CFS, ME/CFS, ME, whatever anyone uses or means... Within the same article it will say "CFS research" "ME/CFS patients," "ME studies" and even flip back and forth. Definitions are critical and we ignore it. Or perhaps may occasionaly revisit the "we need subsets" debate. Of - CFS. It's time to divide and conquer.

  8. "Thankfully, NIH Director Collins mentioned the need for a new definition (albeit with subsets)"

    Why 'albeit'? That there are subsets within this illness would seem rational and sensible to me. There is real danger in trying to create a 'purist' definition of ME as being the only subset worth having.

    If the ME purists want to retain the support of the rest of the CFS/ME community in pushing through the science, then they need to acknowledge that the community includes a number of different viral onset strands which have just as much right to science and services.

  9. Very good essay here. I would say more but my CFIDS is acting up, and I can't write more.

    I read the CFIDS Association website's updates for May, research updates and information, and there was much there.

    There seems to be much more research going on than ever before.

    Judy Mikovits is a hero in my opinion, and she has stood up to vitriol and ridicule and maintained her scientific discoveries.

    Scientists at Harvard Medical School (rah to Kamaroff), NIH and FDA seem to be finding retroviral evidence, too.

    I hope that soon the naysayers and "psychological causes" types will all be set back with scientific evidence of this very debilitating disease.