Taking the Initiative: The Chronic Fatigue Initiative For ME/CFS Takes Off

Posted by Cort Johnson

We are focused on assembling the best team; developing a new strategy; formulating a straight-forward operating plan; and driving results.

Scott Carlson, Director of the Chronic Fatigue Initiative

There are times you can feel some momentum in the air. Yes, XMRV is in trouble and the WPI is re-evaluating their research program but other parts of the ME/CFS Community are stepping up.The International Consensus Criteria for ME came out of the blue to present a powerful call for change, the Coalition4ME/CFS jumped right into the policy arena with a proposal before a federal committee to change the ICD designation for CFS, Dr. Peterson’s Simarron research Foundation has embarked on a series of studies, Dr. Montoya began his Stanford initiative on Chronic Fatigue Syndrome and now a major new non-profit – the Chronic Fatigue Initiative – has shown up with a hearty budget and a superb slate of researchers . Things are happening…….

The Chronic Fatigue Initiative bounced onto the scene in dramatic fashion with an article in (what else?) the Wall Street Journal proclaiming that it was now applying something called ‘venture philanthropy’ – a different kind of philanthropy used in success in other underfunded disorders such as cystic fibrosis and multiple myeloma.

Venture Philanthropy – What is ‘venture philanthropy’? A query to the CFI about this approach resulted in this answer.

“CFI has created an organizational model and strategy that incorporate business principles and accountability in an attempt to accelerate medical research and development.”

OK, that’s short and sweet and more than a bit dense but it breaks down to this: venture philanthropy uses concepts and practices from venture capital and finance to accelerate philanthropic goals. To this end it focuses on new and innovative approaches, requires measurable results, funds multi-year projects and most importantly it focuses on developing foundations for future success rather than just funding programs. As we’ll see the CFI is doing all of these.

The CFI, which was incorporated in 2010, came front-loaded with a 10 million dollar stake (through 2014) making it the largest ME/CFS non-profit and, in real terms, putting it almost on par with the NIH and CDC programs in spending.

Who? The big mystery, of course, is who would do such a thing? That who is the Hutchins Family Foundation, a relatively small Foundation which Guidestar reports has about $4,000,000 in assets in the bank, almost all of it provided by Glenn Hutchins, the founder of Silver Lake, an investment firm with a hankering for technology companies (one them Skype). Why they appear to be using a large chunk of their foundation money on ME/CFS is another question. Science mag reported the Hutchins Family Foundation has an interest in ‘orphaned diseases’ (diseases the medical research establishment is essentially ignoring) and that the family has several friends with the disease.

Whatever the reasons they’re off to a great start…

Top Talent – The CFI is populated with top-notch researchers and physicians. Four of the best diagnosticians in the business, Drs. Klimas, Bateman, Peterson and Montoya will be providing 200 plus patients for the first studies. (That kind of potential study size alone makes the CFI stand out). With the creation of a comprehensive Biobank at Duke collecting almost every type of sample one can imagine plus a databank at Harvard, both of which will be open to future researchers, the Initiative is building the foundation for a long term effort at understanding ME/CFS.

Pathogens – The first project, which will look for both novel and known viruses will take advantage of Dr. Ian Lipkin’s technological expertise in pathogen detection and will be lead by Dr. Mady Hornig…. Well designed pathogen studies, of course, have been at the top of both patients and researchers wish lists for years and the CFI will bring a rigor to the field of pathogen detection that we have not seen before.

Science mag reported that ‘the technology Lipkin will use, the size and careful characterization of the cohort, the investigators involved, and the business-driven approach’ makes this study unique. CFI manager Scott Carlson rather understated the studies strong point stating “I don’t think anybody’s ever taken as comprehensive an approach.”; the truth is, with the feds essentially shutting down funding for pathogens 10 years prior to the discovery of XMRV, no pathogen study has even come close to the CFI is planning to do.


Mady Hornig – There is a distinct neurological component to the researcher lineup. Mady Hornig specializes in pathogenic, immune and genetic triggers for neuropsychiatric illnesses (read autism, ADHD, schizophrenia, depression). You and I may not think of ME/CFS as a ‘neuropsychiatric disorder’ but a good subset of the research community does think of it that way and given that having someone whose career has been focused on searching out the pathophysiological (as opposed to the psychological) roots of these disorders working on ME/CFS is a big plus.

Among Hornig’s more interesting and relevant studies involves the role Borna virus, a virus associated with some people with ME/CFS, plays in producing mood disorders. Hornig has not just been looking at viruses, though, she has also studying how immune problems, neurotoxins, chemicals and stress can cause central nervous system disorders and her and Dr. Lipkin’s leadership roles in the Austism Birth Cohort studies means both are well acquainted with complex neurological disease processes.

Ian Lipkin, of course, is the great virus hunter who has developed several new technologies for finding obscure and/or unknown pathogens. (Two of his technologies, MassTag PCR and Greenechip technology have been used to identify more than 400 viruses). He is best known to the ME/CFS community for his oversight of the big NIH study on XMRV. (Alas, Amy Dockser Marcus reports the Lipkin XMRV study, due to end by the end of the year, has not yet begun collecting samples).

Lipkin is a world class scientist whose level of commitment is almost dizzying. He serves as the co-chair of the Steering Committee of the National Biosurveillance Advisory Subcommittee, the Director of the Northeast Biodefense Center and the World Health Organization (WHO) Center on Emerging Infectious and Zoonotic Diseases and has ongoing projects with the Centers for Disease Control, National Institutes of Health, USAID PREDICT, US Department of Agriculture, US Food and Drug Administration, Agilent Technologies, Pfizer, Roche 454 Life Sciences, the Bill and Melinda Gates Foundation, Google.org, Institut Pasteur, and OneHealth Alliance (whew!). His lab has produced over 25 research papers thus far this year.

Even with all that on his plate he has maintained an interest in ME/CFS; besides the two ME/CFS studies he allowed the CFIDS Association of America to nominate him to serve on the federal advisory panel on CFS (CFSAC).

What does this mean? Besides the fact that he’s very busy it means he’s extremely well connected and people – lots of people – trust him and his work; if he and Dr. Hornig find pathogens in ME/CFS – it’s going to count, and that can make all the difference.

Dr. Lipkin and Dr. Hornig will start with a search for multiple known pathogens and then start looking for novel viruses. The study will get off the ground quickly with CFI manager Carlson reporting that patient recruitment will begin this fall and the study could take up to 18 months.

Dr. Aschiero – The next major player in the CFI’s research plank, Dr. Aschiero, from the Harvard School of Public Health, is conducting an epidemiological. Since 1997 Dr. Aschiero has developed and been gathering biological data on very large cohorts to try and tease out factors that increase ones risk for neurodegenerative disorders. His work has illuminated several intriguing risk factors such as Epstein-Barr Virus infection in MS and high blood urate in Parkinsons. He, too, runs a very busy lab with over 20 research citations in 2011. Now he is looking at risk factors for ME/CFS using a similar approach.

Dr. Aschiero will be identifying and intensively investigating people in these immense cohorts who came down with ME/CFS. Aschiero will be able to go back and pinpoint the time each person got ME/CFS and then test the samples he’s been collecting– a very powerful tool to determine what happens as a person comes down with ME/CFS. Given his interest in Epstein-Barr Virus in MS he will surely be looking at herpes and other virus levels as well as other factors.

Dr. Scott Hammer – The last major player, Scott Hammer (MD), will be overseeing the development of hypotheses the Initiative will test over time in it’s ‘Mechanism of Illness’ program. Another Columbia connection, Dr. Hammer, also comes with a packed resume. Currently chief of the Division of Infectious Diseases at Columbia University Medical Center, he is also the chief investigator of the Columbia Collaborative HIV/AIDS Clinical Trials Unit. Dr. Hammer’s forte is ‘unraveling the mysteries of persistent viral infections, the symptoms (e.g., fatigue) and diseases they cause, and defining the best ways to treat and prevent them.’

A Very Strong Bench – all this adds up to a very strong bench. The CFI has enlisted the top diagnosticians in the ME/CFS field and leaders in pathogen detection, brain disorders and epidemiology. Their current slate of studies promises to reveal much and more are on tap. With a virologist leading their Mechanisms of Illness branch their choice of future studies will be intriguing.

The CFI is taking a methodical approach towards this complex illness. Over the next year or so the scientific advisory board will develop the hypotheses they wish to test. Once that’s done they’ll issue requests for proposals, decide on which ones they wish to fund and then fund them. How many grants will they ultimately fund? That depends on the types of studies they end up funding. However many they fund they’re going to be ploughing a nice chunk of money into the ME/CFS field Scott Carlson stated

CFI has created a multi-million dollar grant program to be implemented over the next three years. The absolute number of grants will depend upon the scale of the studies presented.

The Director – Managing all this is Scott Carlson, a self described turn-around specialist with expertise in ‘improving the performance of distressed small and middle-market private companies”. Substitute ‘underfunded illnesses’ for ‘small and middle-market companies’ and you would have a nice fit for ME/CFS. CFS research funding, after all, is definitely ‘distressed’ – some would say hardly functional – relative to the needs of the large community. On the other hand, as with the distressed companies Carlson has worked with, there is clearly potential for improvement for ME/CFS; this is after all a large community with high rates of disability and a high economic burden which should, by all rights, be receiving a great deal of funding. The CFI recognizes and appears eager to be a leader in transforming the perception of ME/CFS in the research community and elsewhere. From their website

“By simultaneously seeking the causes and treatment of CFS and leading research to understand the breadth of the affected population, CFI aims to build awareness, reduce social stigma connected to the disease, and ultimately improve patient lives in a comprehensive way. CFI believes that as more policy makers and industry experts grasp the full scale of CFS, they will more likely respond in kind and increase efforts to promote research surrounding the disease.”

The Hutchings Foundation with its emphasis on business driven philanthropy sought Scott Carlson out. Articulate and knowledgeable about ME/CFS he was present throughout the IACFS/ME conference in Ottawa. The Chronic Fatigue Initiative is a start up but hopefully Carlson with his focus on rigor, producing results and building a foundation for success will help turn around the CFS field. The CFI may be a start up but a turn-around specialist might be just what the Initiative and CFS needs.

A Feeling in the Air – with the Whittemore Peterson Institute, Dr. Montoya’s Chronic Infectious Illness Initiative, Dr. Peterson’s Simmaron Foundation and the Chronic Fatigue Initiative popping up in the past couple of years and the CFIDS Association’s renewed emphasis on research, we are seeing more major commitments from the private/non-profit sector to understanding ME/CFS than ever before. A particularly encouraging development is the focus on examining the role pathogens play in this disorder with the WPI, Dr. Montoya, the CFI, Dr. Peterson and the CAA all funding studies/doing trials examining the pathogenic contribution to ME/CFS. It’s clear that a significant amount of light will be shed on this important area over the next couple of years.

Another promising development is the willingness to buck the status quo the research community demonstrated when it banded together to combat the stranglehold the Fukuda definition has had on the CFS research field.

Even with these developments CFS is still a very poorly funded disorder that is missing a critical partner – the federal government. The federal government did pump a good deal of money into XMRV research but the rest of the field remains in tatters. (Thankfully Dr. Light did just receive a large grant for her gene expression studies.)

WPI and CAA funded studies, however, have shown that small innovative research programs can make a difference at the federal level; the WPI’s discovery of XMRV, of course, catapulted ME/CFS into the media and research limelight and CAA funded researchers (Dr. Broderick, the Lights and Dr. Shungu) have gotten major NIH grants. With its slate of top researchers and its hearty budget (at least for this field) the CFI’s emergence into the ME/CFS field promises much for the future…

Dig Deeperthe Chronic Fatigue Initiative Website

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