Dr. Joan Grobstein delivered these comments to the CFS Advisory Committee at its October 3-4, 2012 meeting. She has kindly given me permission to publish them here.
Hello. I’m Dr. Joan Grobstein. I’m a physician.
My topic is responsibility.
Recently we’ve seen accomplished scientists honestly and courageously admit that their original findings about XMRV were mistaken. They took responsibility for an error. At its best, this is how science works: form a hypothesis, test the hypothesis, revise the hypothesis. We would like to see the same honesty and courage from scientists at CDC about the empiric definition. The hypothesis that the empiric definition defines the same disease as either Fukuda or the Canadian definitions has been tested and found to be wrong. Scientists at CDC must take responsibility for this error. The original paper on XMRV in ME/CFS patients has been retracted. CDC should retract all papers using the empiric definition or, at least, rename them to indicate that they are studies of Idiopathic Chronic Fatigue and major depression, not ME or CFS.
NIH must also take responsibility: fund studies that will clarify the definition controversy, as it did with XMRV. Because we saw money appear quickly to study XMRV, we know that funds are available. It’s clear that CDC’s new study about the definition is unlikely to be impartial. They are vigorously defending their position. During a recent phone contact with patients Dr. Unger said CDC could be “lumpers one day and splitters the next”. This is a remarkably unscientific statement. The scientific method demands that we rigorously define the conditions of our investigations. Without understanding this, how can Dr. Unger be trusted to undo the harm to ME and CFS patients that the definitional conflict has caused? Leaders at CDC must take responsibility and ensure that science done at CDC is impeccable. There are biomarkers for Canadian-defined ME/CFS patients. Does CDC wish to conceal that these biomarkers are not found in empiric-defined CFS patients?
Turning now to the responsibilities of the voting members of CFSAC, its staff, and its ex officio members, we’re all aware that very few recommendations made by this Committee have been implemented.
For example, CFSAC made three specific revenue-neutral recommendations which have been ignored. The first, from 2009, condemned the use of the empiric definition. Despite this recommendation, CDC continues to publish studies using the empiric. The second recommended removing the Toolkit from the CDC website. The third recommended making IACFS/ME’s Primer widely available. These last two recommendation were made 4 months ago. Today, the Toolkit remains on the CDC website. Meanwhile, CFSAC’s own website has a new link to the Toolkit and no link to the Primer.
Who’s responsible for the lack of action? Committee members have fulfilled their responsibilities. It says on the website they “asked” that these three things be done. On the contrary, they are experts, and, as such, they made recommendations to the Secretary. Yet neither the ex officio members nor the staff have apparently worked on implementation. Dr. Koh’s comments gave no indication that he is aware of the importance of these recommendations. In a letter to advocates explaining his refusal to meet, Dr. Koh said, “CFSAC provides a mechanism to ensure stakeholders are engaged and have the opportunities to offer input.” Instead, it appears that CFSAC provides a mechanism to ensure stakeholders are contained and have opportunities to offer input that will be ignored. So what is the point of CFSAC? If it cannot accomplish these small, high impact tasks how can it accomplish what we really need: significantly increased funding for research, better education and improved clinical care? CFSAC costs $235,000 annually. That sum could fund a study of natural killer cell function in Canadian-defined patients, or create a mechanism to identify an undiagnosed low-income patient, or educate a few more physicians. I’m a taxpayer. I’m concerned that we’re spending almost a quarter of a million dollars each year on a committee whose recommendations are routinely ignored by DHHS.
Here’s a suggestion. Ask ex officio members to take responsibility. Ask staff members to assign each recommendation to the agency or agencies with responsibility for implementing that recommendation. Ask each ex officio member to report on activities to implement each recommendation at every meeting. If nothing is happening ask for explanations from higher levels within the agencies.
We need to see progress.
I thought these parts from Dr Joan Grobstein’s written testimony were excellent:
“MS is estimated to affect approximately 400,000 Americans and receives $121 million per year from NIH for research. ME and CFS are estimated to affect at least 1,000,000 Americans. It therefore seems reasonable to allocate $302 million annually to ME and CFS research.”
“NIH research funding for CFS is currently $6 million per year. This level of funding is 220th out of 232 diseases. There is no funding for ME, i.e., no funding that requires using the Canadian definition. There are no centers of excellence.”
(http://cfspatientadvocate.blogspot.co.uk/2012/10/cfsac-testimony-dr-joan-grobstein-on.html)
How can the NIH find it reasonable that MS gets 20 times more money than ME/CFS, when ME/CFS in fact affects twice as many people? (so it’s 40 times more per patient) What does the NIH respond to this?
NIH’s response on the issue of funding disparity is that they don’t receive many applications for ME/CFS research.
Thanks Jennie, I’ve heard that too. But with that reasoning/excuse, they should be able to say that if they just got good enough applications, they would be willing to fund ME/CFS research at a level corresponding to, for example, that of MS, right?
In this report from the October meeting:
http://www.masscfids.org/resource-library/15/423
I read this quote:
“When many present indicated that a major increase in funding is necessary, for example $100,000,000, Susan Maier seemed to find that totally unrealistic”
So the question, I think, is: Are NIH prepared to fund ME/CFS at a level comparable to that of other similar diseases, given that they receive goood enough applications? What do they envision that a reasonable level of funding for ME/CFS would be, given that they received a large number of high-quality applications? Has anyone asked? (or could we?)
Excellent questions, Emma. I would have to rewatch the video from the meeting to see the $100,000,000 point in context. One of the reasons I asked for metrics in my testimony was to put NIH’s willingness to fund CFS research to the test. If they are receiving 50 applications and funding $6 million, what would happen if they received 100 applications? Or 200? If we knew the number of apps they were receiving every 6 months, then we could track if funding increased as the number of applications did. If we knew how many applications were “enough” to justify an RFA, we could track how well we were doing relative to that goal and report back to researchers on it as well.
Is NIH willing to fund CFS on par with MS? Not right now. And no one is identifying the levers that need to be pushed to change that.