Network asks CIHR to address the ME/CFS and FM Research Deficits

On Tuesday October 23, the Network met with two officials from the Canadian Institutes of Health Research, the federal government agency that hands out around $1 Billion in health research funding every year.  Here is our letter back to the officials following the meeting.

Introduction

We would like to thank you and ** for meeting with the National ME/FM Action Network at the CIHR offices on Tuesday Oct 23rd.

We would also like to thank you for putting forward two initiatives to improve research on ME/CFS and FM in Canada: One was an invitation to attend the workshop on skeletal muscle health on November 29 in Toronto. The second was a $5,000 scholarship targeted to FM or ME/CFS in the musculoskeletal institute's undergraduate competition to be advertised in December.

These are exactly the kinds of initiatives that the ME/FM community needs. We are, however, looking for a much larger response. The ME/FM community is suffering greatly because of lack of research and because of misinformation that needs to be countered. Research and knowledge translation are badly needed. Canadians with ME/CFS and FM have not received much research support at all. Aggressive action is required to address the research deficit around ME/CFS and FM.

Please take a look at a poster presentation put together 5 years ago by experts in the field of ME/CFS identifying the problem, proposing causes and recommending solutions (attached). The same analysis would apply to FM.

Annual per capita funding

I shared with you a table showing funding by CIHR for a selection of medical conditions.  The data was extracted from CIHR funding databases using key word searches. The table also showed the number of people diagnosed with these conditions according to the Canadian Community Health Survey 2010. Dividing the funding by the number of patients diagnosed and the number of years covered gives an estimate of research spending per patient per year for each condition.

Certain data limitations need to be considered, especially:

• key word searches pick up all studies that mention the condition whether the condition is directly targeted by the proposed study or casually referred to in the study's description.
• the CCHS does not cover Canadians living in institutions so certain conditions would be undercounted more than others.

No matter what time period was used, .the annual per capita funding ranged from several hundred dollars per patient per year for some illnesses down to pennies per patient per year for others. Here are the figures for the time period April 2010 to March 2013, updated to October 28, 2012.

Parkinsons and Alzheimers show the highest per capita funding. Even if we estimate that 75% of people with a diagnosis of Alzheimers and Parkinsons are in institutions, the range is still very broad from around $100 per patient per year to pennies. FM, CFS and Multiple Chemical Sensitives are at the bottom of the list at $1.38 (FM), 35 cents (CFS) and 1 cent (MCS) per patient per year. The disparities in research funding are shocking.

Explaining the disparity in funding

One justification for disparity might be the burden of illness. However, CFS and FM have high illness burdens and therefore should have high spending. Here are quotes from two experts concerning CFS: http://mcwpa.org/change-needed-now/our-forum/

“We’ve documented, as have others, that the level of functional impairment in people who suffer from CFS is comparable to Multiple Sclerosis, AIDS, end-stage Renal Failure, Chronic Pulmonary Disease.” – Dr. William Reeves, former CDC Chief of Viral Diseases Branch, 2006 Press Conference

“They [CFS patients] experience a level of disability equal to that of patients with late-stage AIDS and patients undergoing chemotherapy…” – Dr. Nancy Klimas, University of Miami, 2006 Press Conference

Other factors which might justify differential funding between medical conditions could include the number of people affected (economies of scale with large populations), the complexities of the illness (more complex illnesses require more research) and the unmet needs of patients. None of these factors explain why ME/CFS and FM are receiving so little research funding.

One reason for the disparity (but not a justification) could be the lack of awareness of how widespread and serious ME/CFS and FM are. While our organization had insights into the situation through our contacts with patients across the country, the figures from the Canadian Community Health Survey shocked even us. The data showed that CFS and FM are widespread and that people with the illnesses are very disabled, very disadvantaged, and very underserved. Please look at the statistics here:

http://mefmaction.com/images/stories/quest_newsletters/Quest80springsummer2009.pdf

The usual reason given for the low level of funding for ME/CFS and FM at CIHR are that few quality applications were received. The question is then becomes why researchers aren't applying. Here are three factors:

• the lack of prestige of the illnesses
• the moral unworthiness of the patient (stigma)
• the difficulty of applying when no research infrastructure is in place.

A study in Norway surveyed specialists, general practitioners and medical students on the prestige of various medical conditions. http://www.ncbi.nlm.nih.gov/pubmed/17852972. The study put fibromyalgia in 38^th and last place on all three lists. CFS and MCS were not asked but presumably would have scored very low as well. This lack of prestige has very real consequences. It is difficult to attract researchers to areas without prestige. One researcher was told that his career would be over if he took on a ME/CFS study. One has to wonder if people reviewing applications would treat proposals from un-prestigious areas with disdain.

This issue of patient worthiness and stigma was raised in an article in the American Sociological Review that I shared with you. http://asr.sagepub.com/content/77/5/780.abstract.  he researcher found that there has been a shift in recent years in US health research funding towards considering patients (rather than scientists or the public) to be the beneficiaries of the funding. She found that “[o]nce patients were viewed as beneficiaries of medical research funding, disease stigma became increasingly relevant to NIH priority setting.” She summarized the same concept in the abstract as follows: “[o]nce patients, rather than scientists or the public at large, were thought of as the primary beneficiaries of medical research funding, their perceived moral worthiness became increasingly relevant to funding decisions.”

ME/CFS and FM have a lot of undeserved stigma. In the same way that autism was attributed to “cold refrigerator mothers, ME/CFS has been attributed to “distorted illness beliefs” implying a lack of moral worthiness. Proponents of this theory have propagated the idea that the condition can be treated with cognitive behaviour therapy and graded exercise therapy. The same model can be suggested for cancer, diabetes and broken legs, but science has moved past this over-simplistic model for those conditions.

Twenty-two years after the American College of Rheumatology published its definition for FM, the authors of the proposed Canadian guidelines felt it necessary to say that FM was real, but then they did not acknowledge that FM could actually affect functioning. A recent survey of Canadian general practitioners found that many thought of FM patients as malingerers.

It is very frustrating for Canadians with ME/CFS and FM to be very sick and disabled and yet not be taken seriously. Canadian science needs to adopt more complex models for ME/CFS and FM but is missing in action. Canadians with ME/CFS and FM feel abandoned by science.

One of the complaints we hear is the difficulty applying for grants. It takes a specialized insider skill set to navigate the system. Our organization has tried for funding, once for knowledge translation and once for funding of the very important international patient and professional conferences held in Ottawa in September 2011. We don't know how we scored on the knowledge translation grant but we did not get funding even though the proposal was very important to us. We did not score well on the conference applications. We believe we deserved funding for the conferences. These were very valuable events for research and knowledge translation. (Both the US CDC and the NIH sent strong delegations, and the next conferences will be hosted by Stanford University.) We see CIHR grant system as hopeless and we have talked to researchers who share that view. To use an analogy, the CIHR research train left the station a decade ago without ME/CFS and FM on board, and there doesn't seem to be any way to get on board.

An equitable level of funding

Returning to the annual per capita funding table, the National ME/FM Action Network suggests that funding of around $50 per patient would be reasonable and equitable considering the burden and complexity of the illness and the unmet research needs of patients. As noted earlier, the figures include all studies in which keywords are mentioned whether or not the study is directly relevant. Assuming that half the funding is directly relevant (and the other half is casual mentions), this would convert to $25 per patient per year of directly relevant funding. Multiplying this by the number of patients, we suggest $10M each is the approximate amount of directly relevant funding that ME/CFS and FM should be receiving this year. This doesn't consider the issue of retroactivity to compensate for the research that didn't take place in the past.

Are there enough possible studies to justify $20M in annual funding. The answer is a resounding yes. Let me refer you to the abstracts at the IACFS/ME's biennial conference on ME/CFS, FM and related diseases that was held in Ottawa in September 2011which was hosted by the National ME/FM Action Network: http://iacfsme.org/LinkClick.aspx?fileticket=%2bG6GTkbP33I%3d&tabid=499 These abstracts show the range of issues that need to be addressed. Let me also point to the recent proposed Canadian guidelines on FM. 33 or the 46 recommendations were given the lowest grade of evidence, showing the need for research in a broad range of areas around FM.

Are there enough Canadian researchers familiar with ME/CFS and FM to use $20M right away? The answer is no. There are major capacity issues around ME/CFS and FM. What is needed is a strategy to build capacity quickly and responsibly. You mentioned that a strategy had been developed and implemented to build research capacity around First Nations health issues.  That could provide an useful model for what is needed here.

CIHR's mandate to help

We have identified several barriers to funding – lack of prestige, patient stigmatization and lack of insider skills. The solutions would include affirmative action type strategies. It must be emphasized that the purpose of these strategies is not to give patients an undeserved advantage but rather to overcome the discrimination they have experienced and bring them up to equal status.

Does CIHR have the authority to implement such strategies? The issue boils down to the interpretation of Section 4 of the CIHR Act http://laws-lois.justice.gc.ca/eng/acts/C-18.1/FullText.html. Section 4 says that that the objective of CIHR is to excel by, among other things, (f) addressing emerging health challenges and (h) disseminating knowledge. This is what we are asking. Section 4, however, qualifies the statement by saying that the objective of CIHR is to excel “according to internationally accepted standards of scientific excellence”. CIHR seems to be interpreting this phrase to mean that it must use the peer review open competition process throughout. To counter that argument, we note that the peer review process is mentioned in subsection (b) which refers to a mature research environment, but not in subsection (f) which deals with emerging research environments. We would argue that the peer review open competition process is a goal and not a barrier. If, however, CIHR does not think it has the legislative authority to go outside the process in order to provide effective help in emerging areas, please let us and your Minister know.

Fortunately, no-one at the meeting put forward the argument that ME/CFS and FM couldn't receive additional funding because other illnesses are already using the available funds. This would be equivalent to saying that girls can't attend school because the educational funds are needed for the boys. The challenge funders face is to distribute resources in a non-discriminatory manner.

Multi-system illnesses

As multi-system illnesses, ME/CFS and FM touch on many of the CIHR's thirteen institutes but have not been adopted by any. This has been a barrier to progress. There seems to be a current desire to assign them to the Institute of Musculoskeletal Health. While we appreciate the value in having a home, it is somewhat ironic that this is the institute has been chosen just after the Canadian Rheumatology Association voted to disown FM, partly based on the argument that FM is not a musculoskeletal issue. We really need to have a discussion of where the illnesses belong. Meanwhile, we were assured that attending the November workshop would not preclude the wider discussion of belonging.

Moving forward

The National ME/FM Action Network spearheaded the development of clinical diagnostic and treatment protocols for ME/CFS and FM. We have been involved in distributing information to health professionals, social services and the public. We analysed and published statistics from the Canadian Community Health Survey. We hosted the international association's biennial conference in Ottawa in 2011which attracted hundreds of leading researchers from around the world. We have established a scholarship fund for medical students. We provided advice on the development of the clinic for complex chronic diseases that is opening in BC and we are fundraising for that clinic. We are doing a lot to encourage research.

We hope that CIHR will recognize the inadequate levels of support that ME/CFS and FM have received in the past and will work diligently to develop robust research programs that address the legitimate healthcare needs of Canadians with ME/CFS and FM.

Margaret Parlor
President
National ME/FM Action Network