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The NIH and CFS: The CFS Community’s Concerns

 

By Craig Maupin at http://cfidsreport.com

When the GAO (General Accounting Office) Report on chronic fatigue syndrome (CFS) was released in 2000, the report maintained the CFS program at the NIH was rapidly growing, becoming stronger, only lacking more “coordination” between agencies.  For the most part, the GAO based these findings on the testimony of NIH officials.   The CFS program has shifted to a "trans-NIH" system, exactly the coordinated approach that GAO report claimed would be successful.  Yet, in the years following the report, funding for CFS research at the NIH stagnated.

As the new century turned the corner, many advocates say the GAO Report missed the mark. More importantly, some advocates felt the report mischaracterized the CFS community's views and concerns. What are the CFS community’s concerns?

Concern 1: The NIH and Public attitudes toward CFS

One common concern of advocates is the social apathy and stigma toward chronic fatigue syndrome. Views as to the cause of the public apathy toward CFS differ.  However, many advocates feel that the way federal agencies  have handled CFS has reflected public attitudes and  abetted flagging public attitudes toward CFS.   Several components of the federal response to CFS -- low funding, emphasis on the brain and perception -- are commonly cited as evidence that the NIH response to CFS is a symptom of public apathy.

The Name: Common Experience of Fatigue

Many people with CFS believe the name, chronic fatigue syndrome, has contributed immensely to public indifference toward the illness, as well as confusion among the research community as to what CFS is. “Fatigue” reflects such a universal, temporal, and often insignificant human experience.

In 1991, the NIH's Dr. Steven Straus alleged the broad term "fatigue" was chosen to perform a scientific and didactic task.   According to Straus, researchers wanted to drive home the point that CFS should not be viewed as a single disease, with any known cause. “Researchers chose the name because they believe this illness is not a single disease…every time someone has tried to pinpoint a cause in the past, they've been mistaken.”

Dr. Anthony Komaroff attended the 1988 meeting in which the name, chronic fatigue syndrome, was chosen. Komaroff believes the impact and misunderstanding caused by the ubiquitous term should have been easily anticipated.  According to Komaroff, the possible effects of the term were not even discussed.

“None of the participants in creating the 1988 case definition, and the illness' name, ever expressed any concern that the name might appear to trivialize the illness.   We simply were insensitive to that possibility, and we were wrong.   Since “fatigue” is an universal human experience, I’m afraid some people have responded to the word “fatigue” in the name by thinking “I’m tired now and then like everyone, 'Why is this illness?' ”. (Maupin-Komaroff /04-05). 

In 1994, a new CDC case definition integrated CFS research and clinical care with other illnesses that cause fatigue. Many CFS advocates, however, believe the definition is too broad, and their illness has been lost in the mess.   These advocates believe the term "chronic fatigue syndrome" led to the redefinition of the illness to include many illnesses that cause fatigue.   Much of this complaint can be seen in the federal response to CFS, a response that integrates various conditions with fatigue into research samples.

Bias against women in Emerging Illnesses

CFS is one of many chronic illnesses which predominantly strike women.  Dr. Stephen Straus noted this demographic feature in 1991. “At least two-thirds of the people with chronic fatigue syndrome are women…. There appears to be risk factors among race, sex and socioeconomic status that can predispose a person to chronic fatigue syndrome. ...But what can medical science offer, besides an analysis of risk factors for the illness?”

Kate Duprey, a CFS advocate and a former journalist, says there has been a societal tendency to rationalize women's symptoms as altered perceptions or hypersensitivity. "There is a cultural attribution that we [women] are more emotional and vulnerable. There is a bias against women that causes these models [for CFS] to proliferate.”

Pat Fero heads the Wisconsin CFIDS Association. According to Fero, women’s health issues are more likely to pigeon-holed into a “coffee table psychology and hormones” mindset. Fero believes “as a woman I look at this and I think, ‘CFS is a classic example of a bias’.

Many CFS patients feel government agencies have shifted to a more tactful manner of communicating this bias.  The 2003 conference sponsored by the CFS working group choose two chairs who propound this "perception" theory for CFS.   In 2001, Stephen Straus drew fire from patient advocates for his comments that CFS patients fail to achieve health because they "become so focused and phobic". By 2004, Straus was delivering his views on CFS in a different manner. In addressing famous author Laura Hillenbrand's testimony on CFS, he said, "We don't understand, what fully goes wrong with a person neurochemically that leads to what Ms. Hillenbrand had." (Diane Reihm Show, 3-2004).

Who the NIH decides to fund?

Many advocates feel federal funding patterns have played a key role in perpetuating public apathy.   In the May issue of Psychology Today, the University of Washington’s Dr. Wayne Katon explained his model for CFS. “In our modern society, for people who have driven themselves, fatigue becomes a palatable way out of a difficult existence. Whatever caused this impairment is probably not what is keeping it going. What is keeping it going, to a large extent, are the misbeliefs about getting back to an active lifestyle.”

Katon's research was funded by the NIH through grants to a University of Washington CFSCRC headed by Dedra Buchwald. Many advocates believe that such funding simply constitutes federal support for work that is purely speculative, rather than scientific, in nature.  Even worse, it plays into stereoptypes of women's illnesses and poor information about CFS.

Shared Responsibility

Altogether, most advocates feel the causes of public apathy toward CFS are multifaceted. One of the most profound statements about the stigma of CFS came from Dr. Donna Dean. Dean's comments appeared to sum up the feeling of many in the CFS community.

“There is a significant stigma attached to it [CFS]. I think the scientific and research community bears some of the responsibility for that stigma. I think the medical community bears some of the responsibility for that stigma -- by invalidating as a real condition. And, I think the patient advocacy, or some segment of the patient community (or individuals in the patient community), bear some responsibility for sometimes working at cross-purposes, even amongst themselves.”

Concerns About Internal NIH Preferences for CFS Research

NIH conferences for CFS have been watched closely as a barometer of the NIH's internal feelings about CFS. Conferences are often an indication of NIH efforts to “inform” and direct research funding. In 2000, advocate Dr. Mary Schweitzer was one of many CFS advocates who protested an original slate of speakers chosen for the February 2000 State of the Science conference at the NIH. At the time, NIAID officials and the CFS advocacy community squared off. At issue was the NIAID's original insistence that researchers who supported organic models for CFS should be excluded from the conference.

Schweitzer explains, “…By choosing only these four, the narrow perspective voiced by Straus, Demitrack, Wessely and Sharpe can only harden the existing, biased picture of CFS/M.E within the NIH.” When Dr. Donna Dean took over the responsibility for the CFS program, she worked to incorporate a broader array of views in a new conference later that year.   But many advocates felt the conference was a display of widespread attitudes toward CFS and women's illnesses within the NIH.

Some advocates have expressed concern about the output generated by the 2003 Neuro-Immune conference as well. Two proponents of a psychiatric model for CFS were chosen to chair the conference, Dedra Buchwald (U. of Washington) and Leslie Crofford (U. of Michigan).

Advocates felt the choice of the two chairs, and the final output of the conference, was simply indicative of bias within the NIH. John Herd, a CFS advocate from southern California explains. “Why wouldn’t the choosing of both Buchwald and Crofford lead one to believe that the Trans-NIH workgroup (and the ORWH) are leaning toward a psychiatric, rather than truly systemic, model?”

While the title of the conference suggested a “neuro-immune” focus, common themes of the psychiatric model for CFS were featured.

“…the brain is the organ that controls and regulates all action and interaction between the diverse body systems affected in CFS as well as the input from the external environment. Thus, it could prove an integrative model in which to explain female predominance, acute onset, uniformity of symptoms, absence of prominent findings on physical examination, substantial disability, and altered perception that exist in CFS and the multiple conditions with which it overlaps, e.g. Temporomandibular Muscle and Joint Disorders (TMJ), chronic pain, Fibromyalgia (FM), Irritable Bowel Syndrome (IBS). “

Kate Duprey has watched NIH conferences for CFS closely. Duprey says, “This was not a truly ‘integrative’ or ‘multidisciplinary’ approach. It simply reflects the psychiatric, 'perception-based' model at Washington [Center] headed by Buchwald.”   Duprey feels that for the NIH, “to support research using a model that continues to attribute to women that they misperceive their symptoms is, regardless of the intention, counterproductive.”

Commitment from Institute Leadership

A 2004 report by the CFIDS of Association of America claimed CFS funding had fallen since 2000, and much of what was being funded as CFS research was misclassified. Another concern of the CFS community is that internal commitment from institute leadership to fund biomedical research for CFS has been tepid.   The Trans-NIH Workgroup has worked diligently to make petitions to their institutes for CFS funds.   However, securing money for RFA’s and centers has been a struggle, taking years to finalize.

Advocate John Herd says the amount of time is telling. "It took two years to officially release the conference writeup, and it took three years to get an RFA out."   Herd believes "that kind of time lag is too slow". He also says the wait yielded "a convoluted, yet tactful, presentation of mind/body medicine."

In 2002, the NIAID’s David Morens attempted to convince institute leadership to foot a portion of the bill for CFS research.   Morens reported back to the DMID (Division of Microbiology and Infectious Diseases) subcommittee that few institutes were interested in chipping in. Many advocates say that the response of the NIH institutes to Moren's appeal reflects an unwillingness of institute leadership to commit resources to CFS.

Three CFS Cooperative Research Centers (CFSCRC) funded by the NIAID were closed in 2002 -- a controversial decision made by NIAID head, Anthony Fauci, and NIH executive, Harold Varmus. The money freed from the closings was returned to the NIAID budget.

Many advocates feel that if the NIH was going to show a commitment to CFS, that moment would have been a good time. Jill McLaughlin has attended meetings at the DHHS CFS advisory committee. “When the centers closed, agreeing to send some money back into CFS research at the appropriate institutes would have been done, if the NIH felt CFS was important or severe.”  According to McLaughlin, "NIH officials showed they cared little for CFS by sending the money elsewhere"

Dr. Donna Dean said she had hoped that conferences and program announcements would stimulate interest in CFS research. In hindsight she says, that simply didn’t happen.

“I would have hoped that the institutes would have seen a resurgence of interest and been able to make the arguments to have more money to be set aside for funding projects in this area. That was my hope, and now we are almost five years later. I think in hindsight now we know that resurgence didn’t happen..."

Dean continues, "With all the benefit that hindsight gives, had I known then what I know now, I would have negotiated some sort of plan to have some portion of that money (that was in the CFS centers) that I knew was going to lapse, to…have been available in some way.   It would not have been easy, because the individual institutes at the NIH cannot just pick up and move their money from one institute to another."

Concern 3: Scientific Review and CFS

As long as there is disagreement over the cause of CFS, peer review is likely receive more attention. There is a widespread concern among advocates that the CFS SEP may reflect either traditional societal attitudes toward women's illnesses, or even internal NIH bias.

Several courts have upheld a privacy exemption from the FOIA (Freedom of Information Act) in regard to NIH grant proposals. However, in 2001, clinician Dr. Wayne Kurzon (Kurzon/NIH 2001) sued the NIH and won a precedent right to secure researcher names who submit grant proposals. Since then, the FOIA has applied only to the patented research information in grant proposals.

Two advocacy groups, the CFIDS Association of America and the Wisconsin CFS Association, have expressed concern about the review process. Since the CFS program was moved to the Office of the Director in 2000, CFS funding has stagnated. The NIH’s version of the story is that researchers are not submitting “good grants” based on solid science or a "testable hypothesis".

However, many advocates are skeptical. Perceptions persist that a small group of researchers who prefer hypothesis for CFS outside of neurobiology or behavior of psychiatry, are faring poorly. Research into low molecular weight Rnase L has not been funded for years, as well as other unique markers for CFS.

According to Elsie Owings, who has run a Western Michigan CFIDS Support Group, the recently-issued 2005 RFA (Request for Applications) appears to "be asking for a broad range of multidisciplinary approaches, but then makes it clear that stress hormone function is the primary focus." While Owings is waiting to see what research the RFA will fund, she wonders if the NIH will accept past research findings that go beyond "...this RFA's constant emphasis on stress responses."

However, the makeup of review panels is not proof of bias. The makeup of review panels could be indicative of societal views on how to categorize women’s emerging illnesses, or even simple economic supply and demand factors.

According to Dr. Donna Dean, ” it is possible that if a significant portion of any review panel’s membership is from the behavioral side the inference, the inference is the vast majority of applicants would be proposing a behavioral approach.” A similar idea was repeated by Dr. Hoffeld, who administrates the CFS SEP.   But despite this possiblity, before 2000 much of the research at the NIH included researchers who favored a systemic and biological model for CFS.   Since then, almost all these researchers have failed to receive any funding.

Dr. Dean believes the Trans-NIH CFS Workgroup should assess the reliability of scientific review for CFS periodically, making certain that researchers proposing differing models for CFS have confidence in objectivity of the system.

“…maybe that would be an appropriate venue for that group to look at all of the projects that may have been submitted to the NIH for potential funding over the last couple of years. And say, ‘What were all of the projects that were submitted? What were all of the review outcomes? Do we, as an informal and internal working group, see patterns that concern us? Is it that really truly state of the art grant proposals are coming in and not being funded? Or, are we seeing a few case-by-case PI’s who are not being funded? Or, are we seeing a generic systems problem? Until you look at the whole picture, it is hard to tease it out.”

However, several advocacy groups believe it is the Department of Health and Human Services who should look into the issue. If so, there are a few questions that need to be broached in terms of scientific review for CFS.

- Is there an appropriate balance of competing research interests/expertise on review panels?

- Is there appropriate CFS expertise on the panels?

-What would explain why for Fibromyalgia proposals have apparently fared better since 2000? (see chart)

- How have the set of researchers who have seen CFS as organic (rather than psychiatric) fared under the current scientific review system for the last 6 years since the program administration changed?

- Is review panel makeup (CFS SEP) reflecting the NIH's solicitations or external economic demand?

- What is the feedback of reviewers on the grant proposals?

The practice of dismissing research findings that may fall outside one’s preferred model for CFS has been common in CFS research. This makes scientific review for CFS more challenging.

A Final Word

A vague implication that CFS patients were against any and all funding of behavioral research was made in the GAO 2000 report on CFS. The vast majority of patients I spoke with did not share that alleged viewpoint.

When CFS patients complain of bias, they are NOT referring to amounts of biological research vs. amounts of behavioral research. After all, both the systemic/biomedical model for CFS and the psychiatric model each feature behavioral and biological research findings.

In the past few years, there have been two competing models proposed for CFS. The first, a psychiatric model, is focuses on altered perceptions, maladaptive behaviors, hypersensitivity, illness beliefs, and demographic/gender/genetic characteristics these researchers allege perpetuate and create CFS symptoms (Buchwald, Crofford, Schmaling, P. White). The second approach, an organic model, emphasizes coping and adapting to CFS as one would with any disabling, long-term illness. (Jason, Hurwitz, Taylor). 

There are also two very distinct, and contrasting, biological approaches seen in CFS research. The first, the psychiatric model, emphasizes psychiatric biology (mainly focusing on stress hormones, interactions of neuroendocrine, HPA axis, and immune correlates that are said to respond to stress and cognitive processes (Crofford, Claaw, Buchwald, White). The other approach (organic) emphasizes recent and very exclusive microbiological, circulatory, and metabolic research findings in CFS (Rnase L, metabolism, hematological, immune, and autonomic nervous system dysfunction -Suhadolnik, Klimas, Rowe, Kerr.)

There has been, and there will continue to be, a struggle between these two approaches played out within society, and possibly within federal agencies as well. However, it is important to realize that ‘biological vs. behavioral research’ is not the key concern of the CFS advocacy community. The key concern is whether research findings (both behavioral and biological) that fall outside the psychiatric model (for CFS and other women's illnesses) will be embraced with an open mind, and funded, by federal agencies such as the NIH.

Sept 2005

Craig Maupin writes for The CFIDS Report (email: editor@cfidsreport.com)