Sunday, October 2, 2011

Q & A with Scott Carlson of
Chronic Fatigue Initiative

Scott Carlson, the executive director of the newly launched Chronic Fatigue Initiativewhich has already pledged $10 million to get to the bottom of ME/CFSagreed to an email interview with CFS Central:

CFS Central:  The Chronic Fatigue Initiative website states, “CFI will offer grants to fund new research guided by five or six general hypotheses formed by a scientific advisory board of leading scientists and clinicians.” Will this research be started immediately or down the road?  Have these hypotheses been decided on?  If so, what are they?

Chronic Fatigue Initiative: Now that the epidemiology study, the cohort recruitment and the pathogen discovery programs have been organized, we are beginning the recruitment of leading scientists and clinicians for the scientific advisory board, which will be funded through the CFI Mechanism of Illness grant program. We plan to finalize appointments and have our first meetings to develop some general hypotheses over the next six to nine months. We expect to publish requests for proposals shortly thereafter. All of this work will be funded through the Mechanism of Illness grant program.

CFS Central:  On the CFI website it says that the “Pathogen Discovery and Pathogenesis Study” will begin following cohort recruitment, creation of the bio-bank and population of the database.  Can you give me an idea how long recruitment and creation of the bio-bank and database will take?  Can you give a ballpark figure on how long the pathogen study will take?

Chronic Fatigue Initiative:  We expect to recruit cohort subjects over the next 12 months. The pathogen discovery project will begin within three months following completion of recruitment, as the first bio-samples are processed. We plan to have results from the pathogen discovery project within the next 18 months.

CFS Central: Would you explain what other research the CFI will undertake over the next year to two years?

Chronic Fatigue Initiative:  We will focus future research efforts through the Mechanism of Illness grant program described above.

CFS Central:  What are the short-term goals of the CFI?  What are the long-term goals? And what’s the time frame for both?

Chronic Fatigue Initiative:  CFI’s goal for the next three years is for the CFI-sponsored researchers to complete and publish the results of the epidemiology study, the cohort recruitment program, the pathogen discovery program, and the various studies funded by the Mechanism of Illness program. We expect that the results of this comprehensive strategy will attract attention and greater funding from larger research foundations and philanthropic organizations.

CFS Central:  Figuring out the cause of the disease is crucial for treatment but has proved elusive. Another piece of the puzzle that’s probably easier to figure out and could potentially lead to treatments quickly is an understanding of the cellular pathophysiology of post-exertional malaise (PEM).  For many patients, crashing after activity is the most problematic aspect to the disease.

There has been some research on ME/CFS patients’ diminished VO2 max levels—the threshold at which the body goes from aerobic to anaerobic—as well as gene-expression changes after exercise.  But researchers still don’t understand what exactly happens to patients 24 to 48 hours after activity, and beyond. Do the muscle enzymes, for instance, become abnormal?  Does the body produce too much lactic acid?  Or is glucose not reaching the muscles? That kind of thing.  Will the CF Initiative examine the PEM problem?

Chronic Fatigue Initiative:  PEM is a medical issue that we are aware of. At the recent IACFSME [International Association for CFS/ME] conference, Dr. Betsy Keller and Dr. Christopher Snell made compelling presentations of PEM. The scientific advisory board of the Mechanism of Illness grant program will consider PEM among other issues in determining the four or five general hypotheses on which to focus.

CFS Central:  Dr. Joe DeRisi of the University of California, San Francisco, has devised a ViroChip.  It’s a DNA microarray on a slide that includes every virus ever discovered—about 22,000 altogether. It works like this: DNA and RNA from a patient are tagged with a fluorescent dye and placed on the chip. If there’s a match between what’s on the chip and the patient’s sample, a particular spot on the chip glows. Using computers, DeRisi can look for thousands of viruses at one time. What’s the difference between Columbia University’s techniques to uncover viruses and DeRisi’s?  Why has the CFI decided to use Columbia’s technique?

Chronic Fatigue Initiative:  Representatives of CFI met with a number of virologists when we were establishing the pathogen discovery study. Dr. Lipkin was selected based on his unquestioned expertise, high-quality team and superior track-record of pathogen discovery.

CFS Central:  What’s your relationship to the Hutchins family? How did the Hutchins family become interested in ME/CFS?

Chronic Fatigue Initiative:  The Hutchins family approached Scott Carlson 18 months ago about organizing and implementing CFI’s comprehensive strategy using business principles and accountability to accelerate medical research. The Hutchins family has several friends who suffer from CFS.

CFS Central: There are many definitions of ME/CFS, which results in confusion and causes a huge problem because researchers aren’t studying the same cohorts. Dr. Leonard Jason of DePaul University has studied the definitions and found that CDC’s definition results in a cohort of mostly depressed patients, not patients with the neuroimmune profile of ME/CFS.
The three most commonly used ME/CFS definitions are the Fukuda definition; the revised Fukuda (AKA Empirical) used by CDC; and the Canadian Consensus Criteria, which is what most patients and ME/CFS-literate physicians endorse.  The newest definition, Carruthers ME International Consensus Criteria, is basically a revise of the Canadian Consensus Criteria. What ME/CFS definition will CFI use in its studies?

Chronic Fatigue Initiative:  The CFI-sponsored cohort recruitment protocol uses the updated CDC definition and the Canadian Consensus Criteria to identify well-characterized subjects. We also noted the new definition presented at the recent IACFSME conference.

CFS Central: On the forums, some patients have voiced concerns about the CF Initiative because the website includes the Centers for Disease Control’s treatment protocol of cognitive behavioral therapy (CBT) and graded exercise therapy (GET). In reality, CBT is not significantly effective for patients with bona fide Chronic Fatigue Syndrome, and GET can be very harmful, resulting in relapses that last for days, weeks, months or even years.

In addition, the CFI website states that according to the National Institutes of Health, “the main symptom of CFS is extreme tiredness (fatigue).”  Seabiscuit and Unbroken author Laura Hillenbrand characterized it this way, “This illness is to fatigue what a nuclear bomb is to a match. It’s an absurd mischaracterization.”  Profound exhaustion is closer to it. Unfortunately, CDC and parts of the NIH have perpetuated the “tiredness” misinformation for decades.  Moreover, other symptoms of ME/CFS are just as problematic, if not more so, particularly the neurocognitive problems, as well as pain, PEM, and autonomic dysfunction, which makes it difficult or even impossible to sit or stand. Would the Chronic Fatigue Initiative consider amending the CBT/GET information and the description of ME/CFS on its website?

Chronic Fatigue Initiative:  CFI will continue to update its website as the science develops, including the definitions of the disease.

CFS Central: The other concern patients have is the name Chronic Fatigue. The patients contend that the name Chronic Fatigue promotes the misrepresentation of the disease—i.e., studying patients who are only tired and/or depressed but who don’t have ME/CFS. Examining the wrong cohort has been a big problem over the years, particularly with the psychiatric school headed up by psychiatrist Simon Wessely in England, and at CDC here in the U.S. This muddying of the cohorts often results in findings that are meaningless.  It’s like doing a study on Alzheimer’s disease but recruiting patients who are tired and depressed.

Patients and researchers had the opportunity to change Chronic Fatigue Syndrome’s name about 10 years ago, but CDC and the CFIDS Association nixed it.  Treatments and research have suffered as a result, and the social stigma of having a terrible disease with a trivial name has continued. The largest patient discussion groups, Phoenix Rising and ME/CFS Forums, have discussed that they’re unhappy with the name Chronic Fatigue Initiative. They’d prefer the ME Initiative. Would you be open to dialoguing with patient groups about the name?

Chronic Fatigue Initiative:  Like many organizations, Chronic Fatigue Initiative developed its name based on common usage among the scientific, clinical, and patient communities, as well as the general public. We decided not to use the word “syndrome” because we believe the illness to be a disease—far beyond a syndrome. Through the CFI-sponsored research, we hope to clearly define the causes of the disease.


  1. I so very much wanted to like this.

    But it isn't looking a gift horse in the mouth if it isn't even a horse.

    Why not study the multisystem, AIDS-like neuroimmune disease that people are dying from?

    What are they afraid of?

  2. When will the CFI do a replication study of the human gammaretroviruses the WPI and NCI discovered in Lombardi et al? No one else has tried and the negative papers all went looking for a clone not found in nature, so they cannot be included in that research.

  3. The CFI sounds exactly like the CDC. Won't get anyone anywhere ever but into the mental health manual. Totally stupid.

    If they are not applying the CCC first, then there will be no ME patients in the study.

    PEM is also not a hypothesis but a symptom. There is no other hypothesis for ME but HGRVs.

    A hypothesis must account for all observations and be testable. If you don't know why or what you are testing for, it is not a hypothesis, which is why there only exists one.

  4. Thank you for asking the questions we all want answers to. As the CFI is just starting up its programs, I suppose we will have to wait and see what it actually does.

    I must admit I'm a bit underwhelmed by the vague answers. Clearly a public relations person responded for Scott Carlson (the answer "The Hutchins family approached Scott Carlson..." is a dead give-away).

    Still, you found out quite a lot. Knowing that the CCC will be used to define patient cohorts sets my mind at ease a bit.

  5. That last answer was the worst. Presuming 200 patients and controls are enough to study 5 hypotheses... and run an "epidemiology study"... I'm not so concerned about patient selection as what those hypotheses are. What organ transplants have to do with us is unclear, as is the input our physicians will make toward those hypotheses. Nor is it clear who's really in charge beyond doling out the money.

  6. We have a good definition to study the correct people now, the (updated) CCC, I wish that the research would stop focussing so much on finding The Cause, as they may never find it, or it may be a number of causes, and instead shift energetically to understanding the dynamics and parameters of this illness. There are a number of diseases which still have unknown first causes, yet the dynamics of them are known and treatments are known. Of course we'd ideally like to know The Cause, or Causes, but meanwhile years are passing and patients are being denied and inadequately, incorrectly, treated. How does this disease work; what does it affect; how can it be ameliorated or treated? Science can progress along these lines, and at some point, The Cause or Causes will emerge. But even then, knowing The Cause or Causes may not provide all the necessary indications for treatment and prevention. Essentials first, and in this case, I feel strongly that How It Works and How To Treat It come first.

  7. Why are they going to such lengths to avoid studying the multisystem neuroimmune disease that people are dying from?

    That is not rhetorical.

  8. The name Chronic Fatigue Initiative is absolutely unacceptable. CFI's answer makes no sense whatsoever and is totally incredible. CFI must change its name to something which does not harm patients, such as MEI.

    "Chronic Fatigue Initiative: Like many organizations, Chronic Fatigue Initiative developed its name based on common usage among the scientific, clinical, and patient communities, as well as the general public. We decided not to use the word “syndrome” because we believe the illness to be a disease—far beyond a syndrome. Through the CFI-sponsored research, we hope to clearly define the causes of the disease."

  9. They are using a definition by the CDC that has nothing to do whatsoever with the disease most people reading this blog are concerned with.

    That's a dead giveaway too, I think.

  10. This looks like to me, that these studies are going to exclude M.E. patients altogether.

    What are they going to do, study CFS patients as the government did with the 400 African American Syphilis patients in Tuskagee, or the mentally ill syphilis patients in Guadalajara, while recommending treatments that actually hasten the progression of our illness???

    If they really want to make a difference and find a treatment and cure, then why aren't they studying M.E. since the disease is really M.E. not CFS..

    I do believe we will continue with our idea to raise money for a legal fund so that we can fight for our rights to adequate medical care and security

  11. Thank you so much for addressing the concerns of the patient community to Mr. Carlson!! This is extremely important.

    I am very thankful that the Hutchins family is going to be spending millions of it's own money on ME research.

    However, I am very disappointed in the evasion of critical questions such as will Mr. Carlson be willing to speak to patients about the name "CFI" and when will the misinformation from and links to anti-ME-science websites like CDC's be dropped.

    I am also disappointed that Mr. Carlson apparently didn't review his 'interview' responses written by a staffer, as evidenced by the phrase pointed out by Liz Willow, "The Hutchins family approached Scott Carlson..."

    CFI says it will use CCC and 'the updated CDC definition.' I hope that does not mean the Reeves "empirical" criteria!

    "Chronic Fatigue Initiative: The CFI-sponsored cohort recruitment protocol uses the updated CDC definition and the Canadian Consensus Criteria to identify well-characterized subjects. We also noted the new definition presented at the recent IACFSME conference."

  12. Wow I'm pretty dizzy from the spin

  13. great job with the questions, mindy! i am hoping that they realize that the questions you asked were an attempt to "school" them on the main issues we patients see going on.


  14. @Anonymous- this is in regards to the criticism that says that CFI is calling PEM a hypothesis. I have seen this comment in several places, and I think it's an unfair criticism. Scott (or really his PR person) is saying that PEM is a symptom that needs to be considered in the hypotheses. I think it is very good news that they appear to be considering PEM a hallmark symptom that potential hypotheses should cover.
    That said, there is a lot of equivocation in these answers, and the explanation for why the initiative is named "CFI" is particularly poor. But I am happy that we finally have some real funding given to some top-notch researchers, so hopefully the horrible name will turn out to be an irrelevant misstep.

  15. Sara, I agree. I think it is very appropriate to consider PENE/PEM as it is a hallmark effect of the disease.


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