Q & A with Scott Carlson ofChronic Fatigue Initiative

Scott Carlson, the executive director of the newly launched Chronic Fatigue Initiative—which has already pledged $10 million to get to the bottom of ME/CFS—agreed 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.