CFSAC Meeting / Cracking the National Institutes of Health / Exercise Studies Come Through by Cort Johnson
Not a Good Time To Skip The Biology: The Centers For
Disease Control – Dr. Reeves’ testimony was taken up addressing the
effects of the media and outreach campaign. I’d assumed he’d been asked to
do this but it turned out that the CDC’s media officer had come to DC to
give got up to give his presentation on the same subject.
I rather enjoyed Dr. Reeves’ presentation - it was well organized and well
presented – but this apparently was not a good time for him to skip the
biology. Falling publication rates and other considerations have caused
concern in the CAA about the direction of the program, but attempts to get
information on the status of the program from Dr. Reeves have been rebuffed.
Further meetings suggested that the problem is not at the top but at the
bottom. The director of the CDC has apparently acknowledged that at the very
least there is ‘a problem’ with communication. One of the goals of our small
Lobby day was to get Congressional pressure on the CDC to open up on what’s
going on in their program. So eyes rolled when Dr. Reeves chose this of all
moments to ignore the biology.
One can only wonder what effect Dr. Vernon’s departure has had. The head of
the CDC’s CFS lab, she was the guiding force behind the complex
Pharmacogenomics effort that created such a splash. Now she’s gone and has
not been replaced and one wonders (a) if the group is floundering to some
extent and (b) if there was some resentment.
The CDC’s CFS research program was recently given an in-house review, and
will in the next year or so undergo an extensive external review (standard
procedure). Most of their research money is spent on pathophysiology – i.e.
laboratory work. Dr. Reeves stunned me at one point, though, when he said
they would be looking at whether they should be funding the laboratory
component as much as they had. Prioritizing where the money should go is in
fact part of the review process but it was still shocking to hear Dr. Reeves
explicitly refer to the research component. Was Dr. Reeves just covering all
the bases or did his statement suggest the CDC was considering pulling back
on the research?
The NIH 
Dr. Hanna’s Presentation – Dr. Hanna is clearly trying. Nothing big
is on the horizon but she is opening up small opportunities where she can.
The Mental Health Institute (NIMH) is willing to look at CFS in relation to
mental disorders. Not very exciting news for most ME/CFS patients but my
experience with ME/CFS suggests that along with cognition, fatigue, etc.
this disease does affect mood and we know it affects mental ability. Check
out the upcoming overview of Dr. Baraniuk’s Georgetown Study for his ideas
on the intersection between neurology, ‘mood’ and ME/CFS.
She is trying to get the Aging Institute (????) interested in the question
of fatigue and aging and she has apparently found a place for CFS in the
Chronic Pelvic Pain Syndrome Initiative.
A Fellowship for Chronic Fatigue Syndrome (ME/CFS) –
the only 'big' news Dr. Hanna had was the possibility of a privately funded
Fellowship for ME/CFS studies in the NIH. She got a call last December from
someone who is apparently interested in creating one if the money can be
raised. She’s got a commitment from two researchers, Esther Sternberg and
David Goldstein, to start up some sort of program on CFS.
Given Dr. Goldstein’s background with ME/CFS one wonders how good this news
is. The Neuro-Immune Conference on Chronic Fatigue Syndrome in 2003 birthed
an intramural program that Dr. Goldstein leads which turned out to have no
interest in ME/CFS. According to NIH statistics, this program has received
more ‘CFS funds’ than any other CFS project since 2000 but he has yet to
publish a single paper on the disease and it was barely mentioned in a book
he just wrote. He’s a well-known respected researcher and if he is actually
interested in ME/CFS he could be a big asset.
Actually getting the NIH to focus on CFS is a huge, huge problem. NIH
projects that start out on CFS almost invariably seem to go south over time.
This is because when the NIH turns to its own researchers it turns to people
who, for the most part, know little about ME/CFS. This is why advocates are
so adamant about getting CFS researchers and physicians into Centers of
Excellence or research centers that they can control. It’s also why its so
critical to attract more researchers to CFS.
No new funding is on the horizon, the Centers of Excellence are still a pipe
dream and if the program expands it will do so very, very slowly.
Hanging Tough - I got to talk to Dr. Hanna later
but first I watched as she endured an absolute harangue for a good 10
minutes from a couple with ME/CFS who were irate at the abysmal rate of
funding. Her willingness to hang in there as voices rose and tempers mounted
was impressive.
My jaw dropped when she said she
hoped to re-open the pathogen question in ME/CFS given the advances in
pathogen detection since the 1990s. If this is true it’s quite a turnaround
for an NIH program that has written off this area for at least the last six
years.
Dr. Hanna has repeatedly said that success rates for chronic fatigue
syndrome grants are at
normal levels. Yet a Freedom of
Information Act (FOIA) recently revealed that ME/CFS researchers had only an eight percent success rate when
using the Program Announcement mechanism (the only one currently available
to them). I asked her about this – she clearly didn’t believe that was so –
and one wonders at times how much information she has about her own program.
A Frustrated Official. The dissatisfaction
towards the NIH cuts both ways. I got the sense Dr. Hanna feels considerable
frustration at the unwillingness of CFS researchers to knuckle down and
skillfully apply themselves to the opportunities that are present. She
certainly has reason to feel disappointment with the outcome of her latest
effort: the Grantsmanship Workshop for CFS.
The Workshop was designed to make researchers aware of grant opportunities
outside the ME/CFS grant program. The NIH made a good showing but the CFS researchers
simply didn’t show. Their attendance was charitably described as ‘sparse’
but it would be more accurate to call it ‘embarrassing. I wondered if the
presenters outnumbered the researchers. Why in an era of diminishing
opportunities did ME/CFS researchers not show up?
Perhaps the opportunity was not perceived to be very high. Perhaps a
research community with an 8% grant approval rate inside the program didn’t
think it had much of a chance outside the program. Whatever the reason the
poor response to the only NIH initiative of the last two years obviously
didn’t help our chances and only underscores Dr. Vernon’s assertion that it
is critically important to attract new researchers to the field.
Cracking the National Institutes of Health -
Cracking the NIH is absolutely critical for ME/CFS patients’ hopes. Pumping
about $26 billion a year (yes that’s billion) into the medical research,
field the NIH is the premier research institution in the world. Given the
statistics surrounding this disease - up to 4 million Americans affected,
$25 billion dollars a year in economic losses, high rates of disability,
etc. - this disease could eventually be receiving $100s of millions a year
(instead of 4). Those kinds of numbers will only show up though after
researchers are applying for and receiving grants on a very large scale..
Why the Low Numbers? A recent Freedom of Information Act response indicates
that CFS researchers apply for very few grants and when they do they have
miserably poor success rates. With regard to the first issue – researcher
interest - Dr. Vernon reported that the CFS study section has the lowest
rate of grant proposals in the entire system(!). Put low researcher
participation and low success rates together and you have a stagnant
program.
The NIH and ME/CFS appear to be locked into a cycle of dysfunction but the
NIH is where the money is; in a bad year they still spend 10 to 20 x’s what
our largest private research funder (the CAA) does on CFS. It’s a complex
situation which calls for a concentrated focus and in that regard it’s good
to have Dr. Vernon on our side.
Dr. Vernon, the CAA’s Research Director and our liaison with the federal
research establishment, has many years of experience in the research field.
She’s been busy meeting with NIH officials in her efforts to jumpstart the
ME/CFS research program. Most recently she met with Dr. Cheryl Kitt, of the
Center for Scientific Review (CSR), which is responsible for reviewing grant
applications and has become something of a death zone for CFS research
proposals.
They Have A Plan. How to crack the NIH? The
CFIDS Association’s Research Initiative appears to have been driven in part
by a realization that with the declines in federal research funding they
have to do more. The good news is – (to paraphrase one of my favorite shows
- Battlestar Galactica) – that it appears that they have a plan.
The Plan - Their plan is to fund small
studies which will be so promising that the NIH will turn them into big,
full fledged studies. They have two major problems to deal with; getting the
research community interested and improving their grant success rates.
Getting the Research Community Interested -
The CAA advertised its new grant program in research journals, etc. and it
worked: they received about 35 grant applications from researchers around
the world; the research community is interested (at least in the CAA’s
research program).
Getting Those Grants Funded - Many ME/CFS
researchers trying to navigate the labyrinthine mazes of the NIH start off
with one big problem: they need data.
The NIH demands that researchers give them preliminary data before they give
out one of their big grants. These RO1 grants typically run at least
$750,000 and last for several years. The rigor Dr. Vernon brings with her
years of experience will ensure that when the CAA funds projects they will
be the kind of statistically rigorous projects that can make it through the
NIH minefields.
.
Tiptoeing Through the Minefield. Each grant has
to pass muster before a review panel – a devastating process for CFS study
proposals in the past. Here too hopefully some change is in the air. Dr.
Vernon came back from meeting Dr. Kitt enthusiastic about ways ME/CFS
researchers can increase their chances of success at this critical juncture.
Dr. Hoffeld, the review panel leader, has been castigated again and again
for creating review panels short in ME/CFS expertise. He certainly has done
that but there is a catch. Dr. Hoffeld’s job is to produce review panels
that have the expertise to assess the grants before them. If only one or two
CFS grants (and 20 fibromyalgia grants) appear, then the review panels will
always be low in CFS specialists. (The panel reviews both CFS and FM
grants).
This is not to excuse Dr. Hoffeld; his review panel for a grant package
specifically focusing on ME/CFS still had very few CFS specialists on it but
it does illustrate the need we have to have more CFS researchers apply for
grants. The take away message is that ‘simply’ growing the field will solve
many of the problems in it. This is message the Dr. Vernon gives again and
again; we need to attract more researchers to the field.
It’s a nasty tough environment. Very good researchers have applied for CFS
grants and come away dismayed at their reception. One researcher recently
suggested to me that the federal government has not just ignored CFS but has
actively shut down avenues for CFS research. This person felt that private
research foundations would have to carry the load. With an environment like
that its no wonder we’ve had such difficulties.
It’s encouraging, therefore, that Dr. Kitt, the Deputy Director of the
Center for Scientific Review, appears to acknowledge ME/CFS researchers have
a real problem; she has met with Dr. Vernon and appeared several times
before the CFSAC. With a new review panel leader appearing and some
indication that the CSR is attentive to our concerns there is hope we’ll
start to catch a break in the review arena.
Starting the Ball Rolling. If the CAA’s Research
Initiative works out the NIH should be confronted with a bevy of well
prepared grant applications over the next few years. With a better review
panel leader and a better environment overall one wonders if the stars are
aligning for us a bit finally.
At the rate of 1-4 new grants being funded a year an increase of 4 or 5
major grants through better grant writing procedures, a better review panel,
more collaboration between researchers, etc. would be a considerable
achievement. This is particularly true since grants seem to build on each
other; once a researcher is in the system they seem to have a better chance
of getting the funded again.
The CAA was recently successful in turning one of their mini-grants into a
major NIH grant; a real accomplishment give the NIH’s scrooge-like behavior
towards ME/CFS recently.
Little Gains/Big Gains. It’s a good start but
consider if the CAA had 10 million dollars to work with. This number may
seem fantastic right now but other disease groups are able to create this
kind of revenue. Consider CAA funded researchers hitting the NIH with 50
grant proposals a year instead of 5 or 10; that’s a research base that can
really produce breakthroughs, that can really build the field. The ME/CFS
community has responded to the CAA Research Initiative – the Initiative
appears to be doing well. The word was that they aimed high but one wonders
if their aim could have higher still.
Exercise, the Pacific Fatigue Lab and Dr. Snell: a
Breakthrough on the Horizon?
The ability of chronic fatigue syndrome (ME/CFS) patients to pass exercise
tests has been a problem; if ME/CFS patients can generate normal or near
normal amounts of energy during exercise –as they often can - then how can
they be so fatigued?
Dr. Snell and the Pacific Fatigue Lab has shown that repeat exercise
testing; i.e. two aerobic tests done a day apart show a different story –
with most CFS patients failing the second test. He said the declines in
performance for the CFS subjects were very significant and that, with the
exception of overtraining syndrome, the post-exertional abnormalities he
sees in ME/CFS patients are not found in any other disease.
Dr. Snell has completed a larger repeat exercise study that largely
replicated the last study’s results – a very important step given the
difficulties researchers have had in replicating results in this disease.
Researchers have recognized the potential importance of these tests; not
only do they validate ME/CFS patients claims but they point a big arrow at
the post-exercise period - a largely unexplored aspect of ME/CFS. They bring
into question recent definitions of ME/CFS as well. Other repeat exercise
studies are underway in Canada and Europe. Dr. Snell’s study was co-funded
by the CFIDS Association of American.
I asked Dr. Snell how he got interested in ME/CFS. Not surprisingly, he has
a personal connection in his case involving a graduate student with the
disease. We see this scenario – professionals with a personal connection to
this disease again and again. It’s heartening but it’s not good. Of course
people with a personal connection to this disease tend to be its most
tenacious advocates but we want to see just the opposite ––a field dominated
by professionals excited by the opportunities the field offers. The fact
that we don’t see that tells us a lot about the overall health of the field.
How to Take An Exercise Test - Josh, an
ME/CFS patient asked Dr. Snell a very interesting question: since repeat
exercise tests show abnormalities but single exercise tests do not wouldn’t
it make sense for ME/CFS patients to exercise the day before they do their
single aerobic test for disability? Dr. Snell laughed and said “Yes!” In
fact, he said, patients tend to do precisely the wrong thing; since they
know the test is going to affect them they rest up before the test. He said
disability lawyers are already using his results in their cases. The problem
is cost; aerobic tests are very expensive to do; $1000 for each session –
too much for many patients.
Coming Up: Focus on the Pacific Fatigue Lab
More Exercise Good News. Good news came from Dr.
Bateman on another exercise study. Dr. Bateman has been involved or at least
in touch with University of Utah researchers who are looking at sympathetic
nervous system functioning, the endocrine system and immune activity in the
post-exercise period. I asked if they were finding what they hoped to find
and her eyes brightened up and she said ‘Yes!’. A successful result from
this study would be a big step for us. Dr. Light has a nice sized NIH grant.
For more on Light study click here.
Bad News - Losing a Researcher – After 20 years
Dr. Glaser’s work with ME/CFS is over – not because he’s not interested in
the subject anymore, or because his studies have failed but because it was
became too frustrating to have his grant applications dismissed again and
again by ignorant reviewers. He noted that not one reviewer on the last
panel knew anything about his subject – the immune system.