PHOENIX RISING

Bringing Opportunity to ME/CFS Patients

 ADVOCACY

 In Day II of the May, 2007 meeting the CFSAC got down to business regarding their next recommendations to the Secretary of Health. We hear about

• The Status of the Centers of Excellence Program Recommendation

• A Proposal to Get the Surgeon General of the U.S. Involved in CFS

• Ideas for Promoting Clinical Drug Trials for Off Label Drugs in CFS

• Seven Patients/Advocates Testify Before the Committee

Recommendations to the Secretary of Health - Except for the patient presentations, Day II was mainly about upcoming CFSAC recommendations to the Secretary of Health. Advising the Secretary how to improve the nation’s CFS program is one of the main objectives of the CFSAC. Their last package of recommendations, which was produced almost three years ago, appeared to have little effect; after sitting on them for two years, the Secretary replied that he was already complying with them. In this section, the different subcommittees provided their individual recommendations for analysis by the committee.

Research Subcommittee Report - (Dr. Jason (chair), Dr. Glaser, Dr. Hartz, Dr. Hanna, Dr. Reeves)

This subcommittee focused on (a) the Centers of Excellence proposal to form Centers combining research, treatment and education and (b) on whether to send a letter to clinicians and researchers across the country regarding the use of off-label drugs in CFS and to use the responses to influence drug companies to engage in clinical trials on CFS patients

CENTERS OF EXCELLENCE (COE) – The COE proposal was at the heart of the Committee’s last recommendations to the Secretary of Health. Many believe COEs or some other type of structure are needed to jumpstart the ailing NIH CFS research program. The program now relies on outside researchers applying for grants. COEs typically offer research, treatment and education programs at the same facility. The discussion on the COE proposal reflected some divisions in the committee.

Dr. Hartz pointed out some limitations of the COEs; clinicians who are not researchers, researchers who don’t teach (?), a different set of patients who show up at these clinics vs. elsewhere, problems finding patients. (These objections, frankly, seemed insignificant to a program that is barely functioning at all). Dr. Bateman noted that OFFER’s approach, which involves research, treatment and education and outreach to providers and university researchers, is enabling it to build momentum that a more single focused effort could not.(i.e. OFFER is a functional small Center of Excellence!).

Dr. Bateman’s response illustrates the strengths a COE could have. A COE with ties to a major University will stimulate research there and educate a new generation of physicians. The educational component should impact the way health care providers treat CFS/ME patients, leading to better and more available treatment options. The CFS/ME patients themselves will both provide a much needed research base and get treatment at less than exorbitant rates. Living in a town with a CFS COE could be a very good thing!

Dr. Hanna noted that the COEs or research center question comes up again and again in the Committee, but that there is no money for them.

Dr. Klimas later moved that the Committee recommend to the Secretary of Health that five regional COEs be created. That was seconded and the matter was opened up for discussion again. Dr. Hartz, Dr. Glaser and Dr. Jason recommended that the matter be sent back to the research subcommittee to come up with a more specific proposal.

Dr. Papernik supported Dr. Klimas’s recommendation and Dr. Reeves called the COEs a tremendous idea that would greatly further CFS research but noted that since the DHHS doesn’t have any money the appropriate thing now is to have organizations like the IACFS/ME (International Association of CFS/ME – the professional CFS organization) lobby Congress. Dr. Klimas replied (and Dr. Glaser agreed) that recommending and re-recommending the COEs is a powerful tool that communicates how important these centers are. Then she stated that the Secretary needs to hear from the CFSAC that DHHS should spending $50 million a year on a disease of this magnitude (!) (They spend about $8 million).

Dr. Hartz feared that the Centers would be developed to the exclusion of other approaches, (What other approaches????) This was just too much for Rebecca Artmann who said that’‘without a centers program the CFS field will not just stagnate it will decay”. Dr. Jason stated that a Centers program would bring “a critical mass of the best minds into the CFS field”. Dr. Hanna noted the NIH has mechanisms to produce the kinds of the Centers the Committee wants. The discussion ended with agreement that the Centers recommendation would be revisited at the next meeting.

The Committee couldn’t stay away from the COEs, however, as the chair of the CFSAC, Dr. Oleske, later turned their attention to them again. Dr. Oleske noted that five of the six patient guests made unsolicited requests for them. Rebecca Artman stated that although the Committee was asking for them again and again, it’s continuing to restate the need in new ways. Given that the Centers are the main recommendation of the Committee, Dr. Jason suggested focusing more on them rather than less.

Dr. Hanna and Dr. Willis-Finger, perhaps in some frustration, stated that the Committee has been made well aware of the funding resources available and perhaps the Committee members should read the past minutes. Dr. Newfeld asked if the Committee should request funding trends from the Secretary to see if it shows a decrease over time (?!).

It’s been evident for some time that some members of the CFSAC are not fully aware of the declines in CFS research funding at the NIH. This question has come up before. Some Committee members are very aware of this problem and others don’t have a clue. Why does the CFSAC not require each agency to prepare an annual report on CFS expenditures?

There’s obviously a lot of support for the Centers and the Committee is willing to argue strongly for them. Oddly enough, given all this attention, we didn’t hear anything about Dr. Hanna’s proposal at the last CFSAC meeting to meet with the CFSWG to propose a Centers program under the Roadmap Initiative.

Promoting Clinical Drug Trials For Off-label Drugs in CFS – A suggestion was made that the Committee recommend the NIH query physicians regarding their use of off-label drugs in CFS and use their responses to push drug companies to carry out clinical trials.

Dr. Hartz believed that not enough is known on CFS treatment to begin this effort. A further complication is that CFS physicians engage in complex therapies that are difficult to present to drug companies. While he agreed that it would be good to survey clinicians on the effectiveness of the off-label drugs they are using, clinical trials are very expensive and he believes that the ‘field is not there yet.’

Dr. Klimas disagreed, noting that many physicians are treating CFS patients with off-label drugs that they can’t get reimbursed for. She said physicians have been working on CFS for 20 years now and its time to hammer out what’s successful and what’s not. Dr. Hartz stated that he supported gathering information on this subject but stated again that he doesn’t think randomized clinical trials are possible. Dr. Reeves interjected that while he thinks a clinical trials network is vital, the mandate of the CFSAC did not allow it to set one up. Dr. Klimas agreed that it might not be reasonable for the Committee to survey physicians, but she volunteered to have the IACFS/ME send a questionnaire to its members.

Patients/Quality of Life Subcommittee - Rebecca Artmann (chair), Mr. Newfield, Dr Snell

This subcommittee has a lot on its plate: CFS diagnostic codes, long term disability and social security disability concerns, low physician availability for CFS patients. They are mulling over requesting that third party players such as the Centers for Medicare and Medical Services (CMS), Signa and Aetna appear before the Committee to report on disability issues so that the CFSAC can assist CFS patients using these systems.

Veterans Administration. There was a discussion regarding making a Veterans Administration official a permanent member (‘ex officio’) member of the committee. Various committee members agreed but then Dr. Reeves noted that the CFSAC was established to advise the Secretary of the Department of Health and Human Services on CFS issues and the Veterans Administration is not a part of the DHHS. He also recommended against focusing on Gulf War Illness despite its similarities to CFS suggesting that the CFSAC would dilute its focus by doing so.

This is a rather common pattern. Apparently after spending many years in the government Dr. Reeves knows his organizational mandates well. He frequently points out when he believes the committee starts to move beyond its stated capabilities.

Dr. Klimas and Dr. Hanna jumped in noting the VA’s great experience in many areas of relevance to the committee and Dr. Reeves agreed that having a VA representative speak would be helpful.

Dr. Jason made the first motion to add the VA as an ex-officio member and then made another one adding the Agency for Healthcare Research and Quality which was seconded but the vote was tabled until later.

The subcommittee has also drafted a letter that it wishes the DHHS to send to third party providers regarding incidence of CFS, drug coverage and costs. The committee was worried about how confrontational it should get. Dr. Jason inquired whether a letter asking about the success rate for CFS applications to these companies, etc. would be appropriate. Apparently these companies are under no obligation to reply to such a request. The committee appears to want to word this request in such a way as to get a meaningful reply.

Education Subcommittee - Dr. Lucinda Bateman, Dr Klimas, Dr. Papernik, Ms. Healy (chair), Dr. Hanna, Dr. Reeves, Dr. Willis-Finger

Surgeon General and CFS: The Education Subcommittee suggested that a letter from the Surgeon General to state health departments and others informing them about the information available at the CDC including the CDC toolkit and CME health provider course would help spread the word about CFS. Dr. Reeves noted that “‘many modifications” of the CDC’s research program had grown out of CFSAC committee discussions and that they were of “tremendous benefit”.

The committee mulled over the politics of drafting such a letter; would it be too aggressive for them to give to the SG to send out? Or should they ask him to produce it? Or should they give him the Surgeon General the choice of writing it himself or not? Dr. Bateman cleverly noted that the recommendation to the Surgeon General should contain much of what they wanted in the letter. Dr. Reeves stepped in and said that while he thought the letter would be read he didn’t think such a letter would accomplish much. He believed having the CDC go to an annual meeting of epidemiologists would accomplish more. He also stated that the CDC is going to annual meetings of several of the organizations noted and giving them information on the CDC toolkit.

The Committee later passed this recommendation unanimously.

The subcommittee pondered about how to convey the information on CFS most efficiently and cheaply. They brought up HRSA e-mails to health agencies, an HIV model of educational and clinical outreach, expanding the one hour CME program at the CDC to three hours, and ways to provide incentives for health care providers to train in the area of CFS.

Refining Past Recommendations to the Secretary of Health

The Committee then revisited some recommendations produced during the Nov. 6th meeting. They wanted the CDC’s ‘remarkable momentum’ to be sustained and that another Request For Applications (grant opportunity) be produced.

1. The Committee recommends that the FY08 and 09 CDC budgets for research be restored to or increased beyond the FY05 level in order to sustain the CDC’s remarkable momentum including the ability to finish the Georgia Study.

2. Based on the positive response to the NIH’s Request for Applications (RFA) issued in July 2005 (funded in 2006) the Committee recommends equivalent funding for a second RFA.

Dr. Oleske noted that instead of increasing CFS funding the NIH has reduced it by half (!). Dr. Hanna noted that ‘without new money there isn’t going to be anything new’( i.e an RFA).

Here we see the Committee again and again pounding its head against the NIH’s refusal (?) or inability (?) to increase CFS funding. It is true that budgets are flat or declining across the NIH but the decline in funding for most diseases has been minimal – a few percentage points at most. The NIH's own figures indicate a fifty percent decline in funding from 2003 to 2008.  It's not true that RFAs are not being produced – one just was, on chronic pain – or that COEs are no longer being created – Marly Silverman just reported one just was on cancer.  Just five years ago the NIH was funding three CFS Cooperative Research Centers and a fairly active external research grant program. Now the best it can do is fund a couple of new studies a year.

Even with the slight declines of the past few years the coffers of the NIH are – at least in historical terms - flush. If the NIH had simply kept the funding levels for CFS flat over the past five years they could have paid for one or two COEs simply out of the money saved from the lower number of studies they are funding. Aside from Dr. Hanna and Dr. Pinn and probably Dr. Agwunobi, the NIH appears to have virtually no commitment to producing a successful CFS research program - hence Dr. Reeves belief that what is needed is more political advocacy rather than more Committee requests.

The Committee voted to accept the first recommendation (8-1). Dr. Hartz voted against it. Oddly enough this may have been the only recommendation that Dr. Hartz didn’t argue against – so we don’t know his reasons why.

The Committee then discussed recommending that the DHHS Secretary use the CFS grant review panel (CFS SEP) as a basis for the Roadmap’s new grant review procedures. Again this suggested that the Committee is not up to snuff with some of the more onerous problems at the NIH. The CFS SEP’s inability to ‘pass’ more CFS grants has been an area of contention for at least the past five years with the CAA going so far as to request that a new panel be convened for the last RFA. Thankfully this recommendation was tabled.

Dr. Jason then requested something that I, at least, think has been lacking – asking the CDC (but not the NIH?) to specify what they are spending their money on and what will be cut under the future budgets.

Patient Testimony. Five patient/advocates testified.

Mary Schweitzer (Ph.D) pointed out the costs having a well respected organization like the CDC state “There are no tests and no treatments for CFS’. She then went on to enumerate the very positive effects several treatments have had for her.

Marly Silverman , the founder of PANDORA –called for a Centers of Excellence program including a center in Florida, expressed hope regarding the Roadmap Initiative, and called for an FDA approved drug for CFS.

Barbara Soliday of the Miami CFIDS Support Group – Barbara Soliday’s daughter used to stay up at night doing calculus before she came down with CFS nine years ago and now the scientific community has lost a fine physicist. She called for a movement to increase physician awareness and to build Centers of Excellence to provide treatment, education and research. She said her nightmare was that something would to Dr. Klimas, her daughter’s physician.

Angela Linford, OFFER Member – was training for a marathon when she came down with CFS. A recent college graduate, Angela lost her job and had to move back with her mother. Her medical bills are $700 a month and she has no health insurance. Her chances of getting disability benefits appear to be remote.

Eileen Holderman, CFIDS Association of America – spoke of her experience with the recent Lobby and its objective, to increase NIH funding of CFS under the Roadmap Initiative.

Pat Fero of the Wisconsin CFIDS Association – talked of a low-cost national CO-OP campaign to find undiagnosed CFS patients and suggested the CFSAC find innovative ways to get CFS information into doctors’ offices.

Cort Johnson of Phoenix Rising – talked of the disconnect between the increasingly promising research findings and the dramatic reduction in NIH spending on CFS over the past five years. He recommended that the NIH employ a COE program to rejuvenate CFS research.

To Day One of the CFSAC Meeting