People who suffer from the condition known as chronic fatigue syndrome are accustomed to being dismissed by health care professionals and to only occasional mentions of their condition in the media. These past few weeks have been a notable exception, but with quite different conversations going on in the United States and the United Kingdom.
Last week, the National Institutes of Health announced that it is “strengthening its efforts to advance research” on the illness, which has been known as chronic fatigue syndrome in the United States and myalgic encephalomyelitis in the UK. It’s increasingly referred to as ME/CFS.
Starting early next year, the NIH will launch an in-house study of about 40 people who fell ill suddenly after a flu-like illness and never returned to normal. This is a common, though not universal, history among patients with ME/CFS. The illness is characterized by disabling fatigue, pain, flu-like symptoms, unrefreshing sleep and other symptoms, all of which tend to worsen following even mild exertion and typically require days to weeks of recovery.
The illness is believed to affect more than 1 million Americans of all ages. Its cause — or more likely, causes — are unknown. There is currently no blood or other biological test that doctors can use to diagnose it.
Patients have long criticized the NIH for what they see as extreme underfunding of research into the illness, with the annual amount hovering around $5 million or $6 million for the past several years.
That’s about to change, according to Dr. Francis Collins, director of the NIH. “It will be substantially greater than the current five or six million a year,” he said in an interview with Shots. “We are going to ramp this up.”
Among the new measures, a newly invigorated trans-NIH working group comprising members from several of NIH’s institutes will meet soon to determine research priorities. Then the exact budget amount will be determined.
Collins said he’s ambitiously aiming for money to be disbursed in 2016. Patient advocates and researchers have been pushing NIH to start that grant process for a decade.
Within NIH, the initiative will also move ME/CFS from the auspices of the Office of Women’s Health to the National Institute of Neurological Disorders and Stroke, perhaps to be shifted to or shared with the National Institute of Allergy and Infectious Diseases in the future.
“Assigning responsibility for ME/CFS to NINDS is very significant,” says Jennifer Spotila, a patient advocate and blogger, “because it should mean that a program officer will be responsible for building an ME/CFS research portfolio. To my knowledge, that would be a first in the history of this disease, and a meaningful prerequisite for progress.”
Stanford University professor Ronald Davis, a geneticist and father of a 31-year-old son who is severely ill with ME/CFS, also hailed the announcement but also expressed caution, noting that constraints in NIH’s budget sometimes result in funding that is less than needed to solve complex biomedical problems like ME/CFS.
Davis has launched his own study of severely ill ME/CFS patients, thus far funded entirely from private donations to a foundation created for the purpose. He has tried twice to apply for NIH grants, but was turned down. “There are so many researchers out there, and the budget isn’t increasing,” he pointed out.
Nonetheless, Davis, who worked with Collins on the Human Genome Project back in the 1990s, says, “I’m optimistic. I think Francis will do a good job. He knows what he has to do. It’s just very hard to do it.”
But that’s not the only way that ME/CFS has made headlines recently. Just two days before the NIH announcement, a group of psychiatrists in the United Kingdom published the latest of a series of papers from a study that has caused huge controversy in the ME/CFS community since its first findings were released in 2011.
Funded by the UK government division that distributes disability benefits, the PACE trial was based on the theory that the symptoms of chronic fatigue syndrome are mainly due to “unhelpful interpretations of symptoms, fearful beliefs about engaging in activity, and excessive focus on symptoms” and physical deconditioning, and could therefore be treated with cognitive behavioral therapy and progressive, graded exercise. Those are the current standards of care for ME/CFS in the UK.
While the study’s results have suggested benefit for both treatments, members of the patient community have long disputed that conclusion.
Indeed, just a few days prior to the release of the latest PACE paper, David Tuller, a journalist who works as an academic coordinator at the University of California, Berkeley, published a blog series detailing what he and patient advocates say are major flaws in the way the PACE trial was conducted, including that they changed various aspects of the study design along the way, used questionable methods for scoring recovery, and didn’t disclose financial conflicts of interest.
The PACE investigators responded in the same blog, saying that other studies have supported their findings, and that they have previously addressed issues such as changes in the criteria for determining if a patient had recovered.
And the British press wrestled with the issue, too. The Telegraph had to retract a headline saying said CFS/ME “is not actually a chronic illness” after hundreds of commenters, including people with the illness, complained.
One important issue that has been raised about PACE and other studies but tends to be overlooked is that people diagnosed with ME/CFS are not all the same, and that variability can affect study outcomes.
The PACE trial, which began in 2005, recruited patients using one of the least specific “chronic fatigue syndrome” criteria, which essentially requires only six months of severe unexplained disabling fatigue to make the diagnosis.
In contrast, Davis’ study will investigate only patients who are bedbound – believed to comprise about a quarter of all ME/CFS patients – and who have not been studied before because they’re too sick to come to labs. The initial NIH intramural study is also aimed at identifying a more uniform population by focusing on those with sudden onset of illness.
Collins declined to comment on the PACE controversy directly. “The kind of study we want to focus on immediately is to try to understand at the molecular level what is actually causing the problem. We’re just feeling our way in the dark until we have that information.” He added: “We might get to a therapeutic trial at a later step, but I think right now we just need to understand this condition at a level that we don’t.”
Miriam E. Tucker is a freelance journalist specializing in medicine and health. You can follow her on Twitter @MiriamETucker.