The CFS program at the NIH – Past, present, and future
By Craig Maupin at http://www.cfidsreport.com
(Sept 2005) For years, the National Institutes of Health (NIH) placed chronic fatigue syndrome (CFS) under the NIAID (National Institute of Allergy and Infection Diseases). During a meeting between Anthony Fauci and Harold Varmus, then director the NIH, it was decided the CFS program should be moved from the NIAID. In late 1999, Dr. Donna Dean assumed control of the CFS program from the Office of the Director. This was the beginning of a transition period, and it placed Dean in the unenviable position of handling CFS at both the NIH and the Department of Health and Human Services (DHHS).
According to Eleanor Hanna, current director of the CFS program at the Office of Research on Women’s Health (ORWH), “…housing it in one institute wasn’t accomplishing what was needed to get the answers we were looking for. And, that is why it was decided to put it into the Office of the Director."
"All of the programs would be developed and proposed by a Trans-NIH working group [for CFS] that worked out of the Office of the Director. People from each institute would have to work collaboratively. So, every institute wasn’t developing its own special piece of the whole in a vacuum, but that we would work together to develop a cohesive interdisciplinary approach across all ICs.”
In 2002, CFS was transferred to the Office of Research on Women's Health (ORWH). It was Dr. Donna Dean who weighed the options of which institute would be the most effective at overseeing the CFS program.
“The responsibility that I had been given by NIH and DHHS involved the policy function of trying to straighten out, as much as I could, the mess that the NIH had gotten into with CFS (and the mess that DHHS had gotten into). I was wearing two hats, one of taking the lead for NIH in coordinating CFS research activities at NIH and the other hat of administratively managing the DHHS level CFS Coordinating Committee."
"My goal was to get both NIH and DHHS back into taking an objective research and health-care-delivery-focused approach. It was important to get the NIH CFS program leadership somewhere where people were focusing on scientific kinds of issues, on a scientific approach to medical conditions, without the encumbrances and biases of the past. The one entity that was really talking and thinking in these complex and multidisciplinary approaches to health was the Office of Research on Women’s Health, under Vivian’s Pinn’s leadership. “
Dr. Dean says that although CFS is an illness which predominantly affects women, gender predominance was a secondary factor in her decision. Dr. Dean believed the ORWH was the best-equipped to study CFS as a chronic, multisystemic disease. Over time, Dean had developed a close working relationship with Dr. Pinn. “I know Vivian Pinn is a passionate advocate of all issues related to women’s health (and that includes areas of men’s health). I knew that, because she cares so passionately about this area.”
A major concern of CFS sufferers has been the tendency of society to quickly classify emerging illnesses which predominantly affect women as psychiatric, stress-related, behavioral, or emotional dysfunction. Dean believes the CFS program resides in an office which has a clear stake in how the illness is addressed. “I think there is a safety factor and a perspective that the ORWH promotes, to ensure that illnesses such as CFS are not trivialized in the minds of researchers and the broader CFS community. It was the right venue then, and I still think ORWH continues to be the right venue to leverage that approach and philosophy.”
The Trans-NIH Workgroup for CFS is a trans-agency committee charged with oversight of the CFS research program at the NIH. Each member of the committee is chosen by their institute's leadership. The members of the Trans-NIH Workgroup then act as liaisons for CFS within their individual institutes, petitioning their institutes for funds for requests for applications (RFAs), centers, or other collaborative projects.
The ORWH, and ultimately its director, Dr. Vivian Pinn, has final say on CFS projects. However, it is common for the director of the ORWH (Pinn) to accede to the wishes of the Trans-NIH Workgroup for CFS. Dr. Eleanor Hanna, has been chosen by Dr. Pinn to chair the Trans-NIH Workgroup on CFS.
How is CFS funded?
There are two different factors that determine the funding level for CFS at the NIH. The level of institute commitment is the first factor. The funding of research/clinical centers, RFAs (Request for Applications) and the percentage of grants funded are key benchmarks of that commitment.
Funding for conferences, program announcements, website development, and the salaries of the chair of the Trans-NIH workgroup (Dr. Eleanor Hanna) come out of budget of the Office of Research on Women’s Health. The ORWH also co-funds several research grants, as well contributing to the CFS RFA. Individual institutes can choose to fund a research center or intramural research. The NIAID did just that between 1997 and 2002, funding three “cooperative research” centers which worked on varied models for CFS.
However, the primary component of overall funding levels at the NIH is grant submission, grant approval, and the scientific review process. Externally-funded grants will increase only if several factors exist: grant submissions rise, grants for CFS are scored highly, or the institutes decide to fund a growing percentage of grants.
The amount budgeted for most illnesses, is determined by the amount that was funded in the previous year. If 6 million dollars of research were funded for CFS last year, and grants submissions were growing by 10 percent a year, the NIH would likely budget 6 million plus for CFS research the next year.
Centers of Clinical Excellence
The NIAID chose to fund three CFS Cooperative Research Centers from 1998-2002. Each center proposed a different model for CFS. A University of Washington Center led by Dr. Dedra Buchwald, adhered to a psychiatric, perception-based model. A New Jersey Clinic, headed by Dr. Ben Natelson researched neurological, autonomic nervous system dysfunction. A Miami center headed by Dr. Nancy Klimas favored a systemic and organic model, focusing on immunology, circulatory dysfunction, and coping strategies. In concert, the three models provided the NIAID with a multidisciplinary approach to CFS. Yet by 2002, the NIAID decided to not renew the funding for the three centers. That money was sent back into the NIAID budget to be spent on other issues.
According to Dr. Hanna, there is not enough commitment from individual institutes to fund new centers. However, she says the Trans-NIH workgroup is leaving the door open to discussing the possibility of funding centers in the future.
“They take a lot of money…. This is not off the table. It is just that it doesn’t look like anything that is going to happen in the near future, primarily because of funding. You can’t have a center for less than a million dollars. To support the centers, then you would not be able to have any individual research projects.”
If the NIH, the ORWH, or the Trans-NIH Workgroup has a direction they deem more important to steer CFS research, a sponsored conference would be a place to observe those tendencies. A February 2000, State of the Science consultation generated controversy and backlash. CFS advocates objected to the exclusion of researchers who proposed an organic approach -- the NIAID/NIH only issued invitations to a group of researchers favoring a psychiatric model. In response to advocate concerns, Dr. Dean worked to get a broader-based State of the Science research conference in October 2000.
In 2003, the Trans-NIH Workgroup and the ORWH sponsored a new conference, titled ‘Neuro-immune Mechanisms in CFS’. This conference led to the revised program announcement, PA-05-030 and the newly issued (request for applications) RFA OD-06-002. A detailed `NIH sponsored publication on the conference is now available for download on the ORWH website.
The Trans-NIH Workgroup chose researchers Dr. Dedra Buchwald and Dr. Leslie Crofford to chair the conference. Buchwald headed a CFSCRC Center at the University of Washington. She proposed a perception-based model for CFS by emphasizing brain, central nervous system, neuroendocrine, and HPA axis findings common to a wide variety of psychiatric disorders that cause fatigue. Crofford, from the University of Michigan Pain and Fatigue Clinic under Dr. Daniel Claaw, proposed similar model. She has worked as a consultant for pharmaceutical companies that hope to develop a new class of neuroendocrine drugs to work in concert with behavioral therapy on patients with Fibromyalgia.
The NIH also has the option of funding intramural research using internal researchers. The foundation for a new intramural program for CFS is currently being laid at the NIH. Hanna says the focus will be on chronic, systemic illnesses, and she hopes the program will pique the interest of internal NIH scientists in CFS. “It [CFS] involves so many different systems. And, that is why I am so excited about this new interest group. This new intramural interest group on scientific integrative medicine because that really allows you to look at things in that way…. most of these illnesses results in a breakdown of one or more homeostatic regulators.”
Dr. David Goldstein is heading up the intramural efforts at the NIH. He is widely known as an expert on circulatory dysfunction, primarily orthostatic intolerance. Goldstein has also written a text on a concept he refers to as “scientific-integrative” medicine. Attempts to contact Dr. Goldstein for comments about his plans for the intramural program were unsuccessful.
Scientific Review - the CFS SEP
The vast majority research funded by the NIH is through external grants to universities, researchers, and even private industry. In the case of CFS, grant proposals are sent to the CFS Special Emphasis Panel at the Center for Scientific Review.
Grants sent to the CFS SEP are often received in response to solicitations from the NIH. There are two types of solicitation: program announcements (PA) and request for applications (RFA). Both appear similar; however, requests for applications (RFA) come with guaranteed "set aside" money attached. For CFS, a new RFA has been released this summer. The RFA was a collaborative effort between of the Trans-NIH Working Group for CFS.
In recent years the CFS Special Emphasis Panel has been under increased scrutiny from the advocacy community. This topic will be covered in more detail in the next section.
How the NIH plans to build the CFS program
The CFIDS Report spoke with Dr. Eleanor Hanna, who chairs the CFS Workgroup at the NIH. Dr. Hanna believes the NIH will build a solid program for CFS. She says the plan the Trans-NIH Workgroup has laid out simply requires time and patience.
“We’ve sort of had a plan in mind and we’ve been acting on it through these years; although, it probably didn’t look so obvious to the [advocacy] community from the beginning. After putting out the PA (program announcement in 2002), the next thing we did was to decide on having a symposium that could then inform future research initiatives -- for example the RFA that will be coming out very soon -- as well as help create interest in the NIH intramural community. That was the scientific workshop on 'Neuro-immune Mechanisms and Chronic Fatigue Syndrome'. ”
Hanna said a Request for Applications based on the 2003 conference, issued on July 14 of this year, is part of that plan. “The RFA is coming out of that…. It should be out this fiscal year… That will come with dollars attached to it. That is hard work through this committee because each member has to go to his/her institute for approval of the scientific content and for additional (over their anticipated projected amount) financial support for CFS research.”
Dr. Hanna also addressed the lack of growth in externally funded grants for CFS. Since 2000, externally funded CFS research has dropped from 7 million (GAO 2000) to 6 million dollars per year (CFSAC testimony 2005). Conversely, the coffers of the NIH were doubled by Congress during a five years stretch from 1998-2002.
Hanna cited two external problems she claims are contributing to the drop in funding. The first is an alleged lack of external interest from the scientific community, hindering growth in funding. Dr. Hanna also cites a scarcity of good fundable grants as another culprit. Hanna points to the fact that CFS funding has remained stable.
“The idea of just getting more money isn’t going to be enough, because you have to have the grant proposals too. Putting in more money is not going to mean we are going to get good fundable grants. You have to build up an interest among promising researchers. Someone has to have their interest piqued to want to study the condition. It is unlikely that you would get any significantly different kinds of research than what is already out there, unless you attracted a new group. [You do this] by doing the things like the conferences and planning conference initiatives from those newer ideas.”
In recent years, many CFS advocates have been concerned that a core group of researchers who proposed a systemic, rather than a psychiatric model for CFS, have failed to secure NIH funding. Researchers affiliated with CFSCRC research centers that preferred a systemic, rather than psychiatric model for CFS, have struggled. Growing knowledge about low molecular weight Rnase L, previously funded by the NIAID, has also ground to a halt. Dr. Hanna says the ORWH and NIH are looking for projects based she says is "good" science.
“If it is good science, if it is a testable hypothesis, and if the science is good -- the more innovative it is -- the better it will fare. It is all judged on whether or not the reviewers feel the way the study is designed is going to let the researchers answer their proposed questions.”
Dr. Hanna claims the NIH and the Trans-NIH Workgroup want researchers to be persistent and resubmit proposals. She says researchers should pay attention to the criticisms of reviewers.
“And that is why many times, people will get discouraged by their reviews. Then, they will go home and lick their wounds, and they don't do anything about it again. I always encourage people to take to heart the criticisms that are made and resubmit, because getting an NIH grant is a hard thing to do. There is a lot of competition and you get useful feedback from these reviewers. They really work hard at it.”
Dr. Hanna expressed enthusiasm about the new intramural program at the NIH. The program will be headed by Dr. David Goldstein. Dr. Hanna understands skepticism in the CFS community about the NIH’s commitment to CFS. She believes that, given time, the Office of Research on Women’s Health and the Trans-NIH Working Group can turn that skepticism into support.
“I just know that the group (Trans-NIH Workgroup) is trying to do the best job possible and we really are all committed. And, Dr. Pinn is extremely supportive and committed with resources. Give us a chance.”
Next - The NIH and CFS - Scientific Review
Craig Maupin can be reached at firstname.lastname@example.org
References at http://cfidsreport.com/Articles/NIH/References.htm