At the June 2012 CFS Advisory Committee meeting, Dr. Susan Maier from the NIH Office of Research on Women’s Health reported that NIH funding of CFS research in 2011 totaled $6.3 million. In the past, advocates have questioned whether studies characterized as CFS research were actually related to CFS. Let’s take a look at the 2011 studies.
Twenty different studies are listed for 2011 (several grants are listed more than once because funding came from more than one institute):
- Four studies are related to XMRV: Dr. Maureen Hanson’s investigation of Dr. Bell’s New York cohort, the Lipkin study, Dr. Frank Malderelli’s study on detection of mouse retroviruses in humans, and Dr. Monica Roth’s study on the integration of murine retroviral vectors.
- Three studies examine aspects of orthostatic intolerance: Dr. Julian Stewart’s examination of vascular dysfunction, Dr. Roy Freeman’s study of the role of nitric oxide, and Dr. Anthony Ocon’s study of nitric oxide splanchnic hyperemia.
- Two studies examine cognitive treatment strategies: Dr. Fred Friedberg’s self-management study and Dr. Michael Antoni’s stress management study.
- One clinical trial looks at using Viagra to alter fatigue, but it is a tiny piece of a $3.6 million grant to Accelerate Excellence in Translational Science, and it is not clear to me that the study examines CFS patients.
- The remaining ten grants examine neurological, endocrine, and immune aspects of CFS. The investigators include many well-known to the CFS community: Dr. Mary Ann Fletcher, Dr. Steven Schutzer, Dr. Theoharis Theoharides, Dr. Brigitte Huber, Dr. Nancy Klimas, Dr. Vince Lombardi, Dr. Benjamin Natelson, and Dr. Kathleen Light. Dr. Leorey Saligan is examining samples from Dr. Baraniuk for relationships between reported symptoms and gene and protein expression. A study on HHV-6 inhibition by Dr. Shawn Spencer is a sub-project of a $2.3 million grant to a Pharmaceutical Research Center.
Twelve of the twenty grants were reviewed by the CFS Special Emphasis Panel. This panel is convened with different rosters of reviewers. Compare the June 2011 roster to the November 2010 roster, and you will see that only two members overlap (Drs. Broderick and Friedberg). The November 2010 roster is also larger than June 2011. The CFS SEP was last convened on June 25-26, 2012, and that roster should be available at the end of the month. Of the eight grants not reviewed by the CFS SEP, two (Maldarelli and Saligan) were intramural grants at NIH and do not have a review panel listed. The remaining six grants were reviewed by a variety of study sections and special emphasis panels.
The total expenditures for these 20 grants totals $6,346,148, According to NIH categorical spending data, the same amount was spent in 2010 and projected spending in 2012 and 2013 is also estimated at $6 million. This puts CFS at 218th out of 233 research and disease areas. The allocation of funding among the grants in the CFS category is striking:
- XMRV Spending: The Lipkin study received $1,043,040, by far the largest grant and representing 16.4% of the total. Other XMRV related studies totaled $700,736, bringing the total funding for XMRV related studies to $1,743,776 or 27.5% of the total spending in 2011. Given what we now know about XMRV and CFS, this investment represents a huge opportunity cost for CFS research. XMRV funding did not actually increase the overall spending on CFS compared to 2010. It is unknown whether this funding might have been spent on other worthy CFS proposals, or if absent XMRV, CFS funding would have dropped below the 2010 level.
- Psychological studies: After the Lipkin study, the next largest line item is the $530,892 grant to Dr. Antoni examining the impact of stress management therapy. Combined with Dr. Fred Friedberg’s grant to test his self-management protocol, the total spending on psychological treatment studies is $857,397, or 13.5% of total 2011 spending.
- Orthostatic intolerance: Spending on the three orthostatic intolerance studies in 2011 totaled $856,346.
- Neuroendocrine Immune Studies: The ten studies examining pathogens, immune dysfunction, and gene and protein expression received a total of $2,852,225 in funding in 2011. The mysterious Viagra study received $36,404, bringing the total for these ten studies to $2,888,629 or 45.5% of the total.
It is difficult to apply hindsight to grant decisions. The Lipkin study was announced in 2010, several months before the presentation of data showing that XMRV was a lab recombinant. Obviously, the CFS community wanted a thorough and well-funded effort to investigate the role of XMRV in CFS. Once funding commitments are made, such as for the Lipkin study, I don’t even know if there is a procedure for pulling that money back. For many diseases, less than $2 million to investigate the role of a pathogen might be insignificant, but for us it represented 27.5% of the total NIH investment in CFS research. Not only that, but the single largest grant on any CFS subject was the Lipkin study, and that money was appropriated outside the usual peer review process. This may have been a good decision at the time, but it was a huge investment that still has not reported any results.
The large investment in psychological treatment studies – 13.5% of the total for 2011 – also must be carefully examined. I don’t know if Dr. Friedberg’s and Dr. Antoni’s treatment protocols are helpful to patients, and in the absence of other treatments the argument can be made that it’s better than nothing. But I think we need to consider the chilling effect of these kinds of decisions on funding research. If I want to propose a study to measure the utility of post-extertional malaise as a diagnostic marker, what conclusion will I draw from recent NIH funding decisions? My idea is not related to XMRV or psychology, but 41% of 2011 funding went to those two areas. So my proposal is not competing against others for a share of $6.3 million. My proposal will be competing for a share of just under $3.7 million. Will it be worth my while to submit my proposal?
NIH keeps insisting that they do not receive enough proposals to justify a Request for Applications with dedicated money attached, but they refuse to acknowledge the impact of their funding decisions on future applications. If the review panels, including the CFS SEP, score psychological grants highly enough, then it quickly becomes a disproportionate amount of overall funding. This, in turn, further discourages researchers from submitting proposals on other aspects of the disease. Given that the pool of money is so small, it does not take much imbalance to establish a self-fulfilling cycle of few applications, no money, fewer applications, and so on.
It’s just saddening and maddening how little research money this illness still gets. I always have this tiny glimmering hope that maybe the number will start climbing up, but no. And in many countries the number is and has always been 0, like in Finland.
At least the amount of studies that seem potentially fairly useful is relatively high, though of course it would be nice to get more treatment studies.
@Maija Haavisto (and others): I think it’s important that all countries try to raise money to support research even if there are no researchers in that country to do the research. In the Rep. of Ireland, there’s nobody interested in doing research so we have given money to research funds in other countries. There is a shortage of money in the field and we need as many countries as possible raising money.
I’m sure the disagreement will viurfeoocs, but the initial quotes posted do not prove your case. The first quote is scientifically accurate and taken out of context.The second is a rather off, CBT is offered everywhere so that seemed silly, but not evil with a capital E.The third is medically sound. Spinal taps are medically very invasive and most doctors avoid them because of the chance of infection. And general practitioners, which is where most people start when they become ill, don’t do them at all. Most aren’t willing to risk a malpractice suit if something goes wrong. It is understandable that most patients do not have enough of a science or medical background to understand why those quotes are accurate, but misusing them to stir people up because they don’t have that awareness could be considered manipulative. Patients who do not care for the way the CAA or Gail’s group work should start their own. The petition asks the government not to listen to the CAA, but offers nothing in its place. If you are actually serious stop whining, get your act together, raise the money and start your own association. Complaining doesn’t accomplish much.