Hutchins Family Foundation is providing “over $10 million” to hunt for the causes of ME/CFS

By Amy Dockser Marcus, SEPTEMBER 15, 2011, WSJ's blog on health:


Venture philanthropy — the model used to accelerate research and drug development in diseases such as multiple myeloma and cystic fibrosis — is now being applied to a new arena: chronic fatigue syndrome.

Scott A. Carlson, executive director of the newly launched Chronic Fatigue Initiative, tells the Health Blog the Hutchins Family Foundation is providing “over $10 million” in funding for projects through 2014, with the possibility of more depending on the findings.

The initiative wants to fund projects that hunt for the causes of the illness, the creation of a central bio-bank for blood and other biological specimens and the development of a cohort of 200 patients and 200 healthy controls for studies.

The concept that large sums of private money can be used to drive specific scientific projects in an overlooked disease has proven successful in the past. The Cystic Fibrosis Foundation, the Multiple Myeloma Research Foundation and the Myelin Repair Foundation are all high-profile examples that have used venture philanthropy to jump-start research projects and drug development in diseases that previously languished because they were less common and therefore didn’t attract pharmaceutical company or academic research interest.

Chronic fatigue syndrome affects more than a million Americans according to CDC estimates, but has had trouble attracting significant funding from either government or private resources. The cause is not known and there is no diagnostic test; diagnosis is usually made by excluding other conditions. There is often a social stigma too, says Carlson, since CFS is still “a disease that hadn’t been considered a disease in many places,” he says.

The first group of funded projects includes the enrollment of 200 CFS patients at different sites around the country. Researchers will use “very specific criteria to ensure we have representation of many of the aspects of CFS that may increase chances of finding a pathogen if it is still present in blood samples or other samples we will be acquiring,’’ says Mady Hornig of Columbia University, who is a co-director of the pathogen discovery piece.

In addition to blood,
the researchers are collecting patients’ saliva, tears, urine — even a rectal swab. “You are trying to get a sense of what is different about them,” says Nancy Klimas of the University of Miami, who is in charge of the cohort recruitment project.

Samples will be stored in a central bio-bank, along with material from matched healthy controls, who are being recruited with help from the Red Cross.

Another funded project involves a large epidemiological study using data from over 250,000 people who are part of three long-running Harvard School of Public Health studies, including two groups of female nurses who have been providing information and health data for decades.

Alberto Ascherio, a Harvard professor who is leading this project, says researchers will try to identify people who have chronic fatigue syndrome and then study biological samples in addition to lifestyle, environmental, and other information to get a better estimate on the prevalence of the disease and its risk factors.

The new venture philanthropy approach comes at a time when the most promising recent lead, a possible link between CFS and the retrovirus XMRV, has come under serious fire. The editors of Science, where the 2009 finding was published, have asked the authors to retract their paper because of concerns about the validity of the findings. The authors have refused.

Ironically, one of the key players in the new venture philanthropy effort has a lead role in the effort to determine if XMRV is linked to CFS. Virus hunter Ian Lipkin of Columbia, who is co-leading the pathogen discovery effort as part of the Chronic Fatigue Initiative, was appointed by NIH to direct a major study to determine whether or not the XMRV link exists. (Lipkin tells the Health Blog that the NIH study has not yet started collecting samples from patients and healthy controls but hopes to get underway soon.)

Some of the same sites participating in the NIH’s XMRV study will also help enroll patients in the Chronic Fatigue Initiative’s bio-bank and cohort recruitment project. Once samples start coming in to the bio-bank, Lipkin says they plan to do an initial search for 20-30 infectious agents implicated in the past to be connected to CFS, including the herpes and Epstein-Barr viruses.

XMRV won’t be one of them, Lipkin says. “This should not be taken as bias one way or another,” he adds. “Given we are already doing that in another context, it doesn’t make sense to invest twice.”