Phoenix Rising: A Chronic Fatigue
Syndrome (ME/CFS) Newsletter (Nov 2008)
The NEWS EDITION
The CFIDS Association Slams the CDC
The Whittemore-Peterson
Institute Comes Out of the Closet
Is the First Drug About To Approved For
ME/CFS??? A Look at Ampligen
By Cort Johnson
Chronic Fatigue Syndrome (ME/CFS) News
New Chronic Fatigue Syndrome (ME/CFS) Physician Education Program -
The CFIDS Association of American presents the first physician education
course
created entirely by ME/CFS physicians (What a concept!). Throw the CDC
Toolkit in the trash; this is
the program you
should bring your physician to if she/he needs to learn about this
disease. This program on Medscape provides continuing education credits as well.
The Complete Symposium on Viruses in Chronic Fatigue Syndrome
(ME/CFS) is now available for
viewing on Scivee.tv. Check out Dr. Chia, Klimas, De Meirleir,
Vernon, Montoya, Komaroff and others as they present the latest info
on pathogens in ME/CFS.
The Calgary Conference didn't get alot of attention but it
featured Dr. Flor-Henry’s
talk on the Canadian Consensus Criteria, Dr. Stein's talk on
Differentiating chronic fatigue syndrome (ME/CFS) from common psychiatric conditions and Dr. Esche's
talk on Assessing Occupational Disability.
Podcasts
of the Conference are available. More podcasts are apparently
coming.
OFFER Conference Overview - Linda Milne provides an
overview of the latest OFFER conference. One of the talks covers
exciting news about a possible post-exercise biomarker from Kathleen
Light, a researcher funded recently by the CFIDS Association
of America's Research Initiative.
PANDORA Is Busy Again - The dynamic Miami organization
PANDORA has been spreading the wealth around. They've been using the funds
from their successful Golf Tournament to feed efforts elsewhere.
- With PANDORA's seed money (rewarding Dr. Friedman's
efforts there) the Vermont CFIDS Association established a five
year medical student scholarship program
- El Syndrome del Fatiga Cronica - PANDORA funded a Spanish
translation of the New Jersey Consensus Manual on the Primary Care
of CFS.
Click here to download the free manual.
New ME/CFS Website - Check out the new interactive
CFSKnowledgeCenter
website. Dr. Ken Friedman, Marly Silverman, Dr. Herbert Hyman and Dan
Moricoli created it.
ME/CFS and Pregnancy - an excellent
overview of pregnancy and ME/CFS is now available at Prohealth.
Invest in ME International Conference Overview
- thanks to Chris
for his excellent overview of the
International Conference in London featuring Dr. Chia, Dr.
Jason, Dr. Mikovits and others.
Alexandro Casparo, a graduate student at the Pacific Fatigue Lab at
the Univ. of the Pacific, is doing a nutrition study on chronic fatigue
syndrome (ME/CFS). The
Pacific Fatigue Lab is doing groundbreaking work on this disease. If you're a women
over 18 with ME/CFS please give her an hour of your time. For more on the study
click here or contact
Alexandra at CFSstudy@pacific.edu, W: (209) 946-7606, F: (209) 846-3902
Prohealth Has A New Face-
From its newsletter to its message boards and chats with physicians Prohealth delivers as much, if not more,
ME/CFS information than any organization. Prohealth was started by
Rich Carson, an ME/CFS patient, who has contributed generously to
ME/CFS causes and recently started the Campaign for a Fair Name.
Check out Prohealth's beautiful
new website.
Phoenix Rising Boo Boo Corrected - thanks to Tom Kindlon for
pointing out that the Interferons in ME/CFS page not only was
incomplete but was also inaccurate (!). It has been updated and
corrected.
Burning Bridges: The CFIDS Association of America Slams The CDC's CFS Research Program
The CFIDS Association of America has built a reputation as a highly
professional organization They do their homework, they consult
with a wide variety of players and generally end up taking a middle of the road position.
Recognizing that this is a small community they’ve preferred collaboration
over out and out confrontation.
They’ve had some real successes operating this
way; it’s hard to imagine the NIH’s CFS research program, the federal
advisory committee (CFSAC), the Social Security ruling on CFS, the Media
Campaign and the new Medscape Physician Education Course coming into being
any other way.
But that's not the course they’re taking this
time.
"Research to Nowhere" - Kim Mc Cleary
didn’t pull any punches in her presentation to the CFSAC on Dr. Reeves
management of the CDC's CFS research program. By her second
paragraph she’d called Dr. Reeves leadership ‘shameful’ , she’d rated
his accountability at ‘zero’ and she’d tagged his research program
‘Research to Nowhere".
These problems she's referring to did not appear
overnight and it’s worth taking a quick look at some history.
Some Background. After the GAO documented
CDC debacle of the late 1990’s the chronic fatigue syndrome (ME/CFS)
research program at the CDC was awash (relatively speaking) in money.
Much of almost $13 million in ‘payback’ funds went to launch the
innovative and much lauded Pharmacogenomics research efforts.When the payback
period ran out in the last couple of years the programs funding level
declined precipitously.
Given this it was expected the program would
decline in productivity but the CAA was watching and felt the decline
was greater than warranted. (One must assume that Dr. Suzanne Vernon with
her intimate knowledge of the CDC's research program played a major role
in the investigation. Was her
dissatisfaction with the course of the CDC's research program one reason
she left?) Something was clearly up at
the May CFSAC meeting when the CAA came down very hard on the programs
lack of productivity and cited Dr. Reeves lack of communication. While
talking with Sheridan Group members later I was struck by the very harsh
tone they took towards Dr. Reeves.
The CAA called in some favors and got some
Congressmen to open doors and over the past couple of months they’ve
been digging into the CDC's books. Most of the problems they found
concern Dr. Reeves relationship with a research consulting firm called
Abt Associates that his CFS research team
has used for about 10 years.
Misuse of Funds The CDC, like many
organizations, appears to operate under a mandate of "use it or lose it"
with regard to funding. Dr. Reeves is given a budget at the beginning of
each year that he’s obligated to use up or be faced with a smaller
budget next year. The pattern of payments suggests that for the past few
years Dr. Reeves has had a substantial amount of money left in his
research kitty at the end of each fiscal year and that in order to
maintain his budget he’s resorted to funneling it to Abt for projects
they haven't begun to start. Kim McCleary reported that:
- For the last four years at the end of his fiscal year Dr. Reeves
has funneled a total of $1,500,000 to Abbot that they’ve simply sat
on.
Dr. Reeves also appears to have provided Abt
with other funds they’ve had no immediate use for. She stated that:
- From 2006 to 2007 he provided $3 million to Abt for a project
he waited until September of 2007 to try and get approval for. That
project was approved September 2008 – two years after he’d committed
substantial funds for it.
"Zero Accountability" – Dr. Reeves is
also accused of not holding Abt and others accountable for several
projects in which the CDC has seen little return on their money. Kim McCleary indicated that:
- Abt received over $2,000,000 since 2005 to work on a patient
registry that has enrolled one patient.
- Abt received $2,500,000 since 2005 to manage patient entry
into an Emory study that didn’t begin enrolling patients until April
2008. That $2,500,000 bought them exactly 30 ME/CFS patients and 60
controls; $30,000 to find each participant.
- Emory University has received almost two million dollars during
a similar period of time to conduct the same study.
A Cardinal Sin - Dr. Reeves is accused of
committing a cardinal sin in the research world - of not having ideas.
Researchers are expected to have more ideas than funding; they’re
expected, relatively speaking, to be idea-rich and money-poor but the
data thus far suggests Dr. Reeves has been just the opposite.
Dr. Reeve’s budget at the CDC" while small
relative to other diseases, is nevertheless huge relative to other
ME/CFS research efforts and it’s unconscionable that he hasn’t been
squeezing every last penny out of it. The situation is especially
onerous given that the field is essentially starved for federal funds
right now. The CFS program at the NIH, for
instance, is only
funding 1-3 new studies a year.
The Dubbo project provides a notable example
of how the funding woes have hit good programs. Initially funded by the
CDC the program was cut off at the very time Dr. Reeves was apparently
funneling money to Abt and Emory for projects that existed on paper
only. Dubbo researchers may very well have recently identified a key
component in the progression of this illness but funding woes have
caused them to cut back their project severely and it could disappear
altogether.
Dr. Reeves, of course, will have his say but
it doesn't appear that it will be to the patient community. The notes of the CFSAC meeting
suggested that for the first time in memory he was either not present or
didn’t deliver an address.
Good-bye Dr. Reeves?
It appears that the CAA wants Dr.
Reeves gone. Kim McCleary didn't ask for oversight or for Dr. Reeves to
explain himself, she asked for the CDC's leadership to "decisively
address" the situation – a request that, if fulfilled, would seem to
have only one outcome. Dr. Reeves vaulted to the head of the CFS
research program on the heels of an accounting scandal - how ironic that
he could be leaving the program on the downside of another one.
The CDC’s CFS program is undergoing review right now and it’s hard to
imagine they won’t be taking a very hard look at a researcher who has, for the past
few years, apparently not been doing much
research.
Dig Deeper!
For Kim McCleary’s presentation to
the CFSAC
Kudos to the CFIDS Association of America
- This is the kind of investigative work that national organizations
excel at it and the CAA deserves to be acknowledged for doing.
Individual advocates simply don’t have the energy or resources to
undertake an investigation of this scope. Without the CAA stepping in
this problem would have never been uncovered. This is another reason it’s imperative
that we have strong, professional, national organizations working for
us.
The CAA is in the midst of its annual
fundraising campaign – not an easy task in such a difficult economic
climate. This has been quite a year for the group; their successful
Research Initiative greatly expanded their research program, they (once
again) exposed deep problems at the CDC, they backed out of an
unsuccessful CDC physician educational campaign and in its place created
a dynamic new educational program on Medscape that should reach many
more physicians (see above). Please do what you can to support them.
The Whittemore-Peterson Institute (WPI) Comes
Out of the Closet.
I believe that the Whittemore Peterson
Institute is the beginning of new hope for the millions who suffer from
neuro-immune diseases such as ME/CFS, fibromyalgia, atypical MS and
other similar diseases that have a life long impact on both the immune
system and the brain of those afflicted."
Annette Whittemore, President of the
Whittemore Peterson Institute For Neuro-Immune Diseases
They said they’d be different, that they’d be
filling in gaps in the research agenda and that it was time for a fresh
approach to this disease …and they weren’t blowing smoke. The WPI
website is up and this organization is different..
ME/CFS - The first hint of something new
came in the ‘About Us’ section. Chronic fatigue syndrome is gone!
Instead there’s this disease called ‘ME/CFS’ and what a change that is;
instead of that fatigue word staring you in the face there's just ME/CFS
- a symbol for a difficult disease, nothing more.
It’s actually a bit jolting to see ME/CFS dot
a professional organizations website and it’s probably intended that
way; the WPI, after all, is not focusing on chronic fatigue
syndrome. The disease they’re studying – called ‘ME/CFS’ – appears to bear
little resemblance to the chronic fatigue syndrome our federal agencies
are studying.
Frequently Asked Questions: Very Different
Answers – The WPI’s conception of this disease really begins to
emerge in the FAQ’s.
A Different Definition
- The diagnosis
section refers not to the CDC produced International Definition but to
the Canadian Consensus Definition (CCD) – a startling change for an
organization of this prominence. The CCD with its tighter diagnostic
parameters and its emphasis on post-exertional malaise been a big hit
with many researchers but the WPI is the first prominent Research
Institute to specifically endorse it.
A Contagious Disease- Similarly it’s
almost become dogma that ME/CFS is not infectious but the researchers at
the WPI aren’t so sure. When asked if the disease is contagious the WPI,
citing various ‘outbreaks’ and several pathogens that may be associated
with the disease, simply says "Quite possibly’.
New Prevalence Figures
- How many people
does this possibly contagious disease with a new name and definition
strike? In what appears to be a dig at the CDC’s latest figure of 4
million Americans with CFS - which was based on their
controversial Empirical Definition - the WPI states 4 million people
worldwide have ME/CFS.
Dig deeper!
For more on the Empirical
Definition
Prognosis - Most ME/CFS experts say full
recovery is rare and the WPI agrees but the general consensus seems to
be that many if not most ME/CFS patients do get better over time. Here
the WPI goes its own way, rather startlingly stating that the vast
majority of ME/CFS patients, fully 80% of them, "do not get better" over
time.
A New Emphasis Indeed- A possibly
contagious disease with a different definition, a different name,
different prevalence figures and different outcomes? The WPI has not
pulled their punches on their website; this disease – this ‘ME/CFS’- is different from what we’re used to seeing portrayed by
professional organizations.
A True Research Center - The rubber really
meets the road with the research component. In order for the WPI to make
the difference they want to make they’re going to have to do research
and lots of it. Building a building is one thing but raising money for a
strong research program is a much more nebulous enterprise. Could they
do it?
The answer appears to be an emphatic yes. The
WPI lists 14 ongoing research projects – the same number as the NIH did
in 2007 - suggesting that their effort may be on par money wise with the
NIH, CDC and Japanese efforts. It clearly dwarfs any other research
programs on ME/CFS.
These aren’t your ordinary bag of research
projects either; for one thing they’re completely focused on the immune
system (no ‘neuro’ projects yet). Not surprisingly a significant number
of projects focus at better elucidating the pathogenic component of
ME/CFS (HHV-6, enterovirus, HCMV) but the biggest focus is on
elucidating the immune problems (cytokines, RNase L, NK & T cells)
these researchers clearly believe play a big role in this disease.
One particularly interesting study will try to
determine why some patients respond to Valcyte and other anti-virals and
others do not. Another seeks to uncover the immune imbalances that may
be allowing chronic infections to persist. Another involving
enteroviruses with its emphasis on ‘leaky gut’ appears to be piggybacking
on Dr. Chia’s work. Two are examining a possible cancer (T-cell
lymphoma) subset. Two more are searching for biomarkers.
A New Player in Town
- Thus far everything
we’ve heard from Annette Whittemore about the WPI is true. With it’s
focus on a new name, a different definition and a different research
slant – the WPI clearly aims to shake up the CFS research world. ME/CFS
is a complex disease that has not yielded its secrets easily and it’ll
take time to tell if their new approach will pay off. In the meantime
one can only admire and applaud the Whittemores' and Dr. Peterson’s
determination to bring this facility to fruition. As federal programs
decline its nothing short of astonishing to see an Institute of this
size (focused on this disease!) spring up almost overnight. A future
edition of Phoenix Rising will examine the WPI in greater detail.
Dig Deeper!
Check out the WPI's new website
The First Federally Approved Drug For Chronic
Fatigue Syndrome (ME/CFS)?
Ampligen: There can’t be many more frustrating subjects than Ampligen.
Chronic fatigue syndrome (ME/CFS) advocates hoped that the FDA‘ would
fast-track’ Ampligen twenty years ago and yet its fate is still in limbo. At the
2007 IACFS/ME conference Ampligen representatives seemed excited over their
chances at the upcoming FDA review. Ampligen did not, however, pass muster and
the FDA, citing numerous problems, kicked the application back to the company.
What is it with Ampligen? We know Ampligen works very well and has even been
something of a lifesaver for some patients. Federal advisory committee (CFSAC)
members were recently treated to impassioned testimony from a father with CFS
and his wife regarding his decline after he had to stop Ampligen. Annette
Whittemore’s daughter and Mary Schweitzer are two prominent figures who’ve
benefited greatly from Ampligen. Yet here we are 20 years later and this drug is
still available only to study participants. What’s going on here? Is it the FDA?
Is it the company? Is it the drug?
It’s probably everything but in this case we are indeed unlucky in our
friends. Hemispherx has been embroiled in financial intrigues and lawsuits for
much of its existence. The founder of the company is a hard working but at times
very contentious eighty-something figure who some believe might have done the
drug better by remaining more in the background. The drug may be good but you hear
little good about its maker.
Dig Deeper:
Twisted History: Ampligen and Chronic Fatigue Syndrome (ME/CFS
) Part II
Why was Ampligen’s latest (last?) bid rejected? The FDA said it was missing
information. Apparently the information was there but it was in an unusual
format that the FDA had trouble understanding; Ampligen has been in the works long
enough that Hemispherx has been stuck using an old statistical package the FDA
was not familiar with. Due to the long time frame, Hemispherx is also reportedly
stuck using the old Holmes definition chronic fatigue syndrome (ME/CFS).
Questions have also been raised whether they’re measuring the right endpoints
and why different study sites reportedly had very different success
rates….Despite all these questions Hemispherx appears to remain quite
optimistic about Ampligen’s future.
Good News – Dr. Carter almost oozed confidence in a recent conference
call on Ampligen’s prospects. The FDA accepted Hemispherx’s revision and will
make a determination on the drug’s suitableness for chronic fatigue syndrome
(ME/CFS) probably in the first half of 2009.
According to Dr. Carter, just getting past the first round with FDA was a
huge step. The FDA is now taking a very hard look at drug applications early in
the process – if a drug survives that scrutiny, Dr. Carter reported, it has an
80 percent chance of approval.
Filling a Hole. Ampligen also gains points with the FDA because it is
categorized as filling an ‘unmet need’. (Yes ‘need’ does seem to register with
at least one government agency – would that it would with others.) The FDA does
care enough about underserved diseases to give drug companies something of a
break when they build a drug for one. That ‘unmet need’ reportedly gives
Ampligen another 10-15% boost. (Could we really be talking a 90-95% chance of
approval?)
Dig Deeper!
Ampligen and Chronic Fatigue Syndrome (ME/CFS) Treatment
A Safe Drug. Dr. Carter believes Ampligen has some other aces up its
sleeves. The FDA is very interested in immune stimulation but is scared to death
of approving an immune enhancing drug that pushes immune performance to the
point where a monster – an autoimmune disease – is created.
The Fading Question of Legitimacy – Another point in Ampligen’s favor is
the increasing legitimization of the disease. Having the head of the Centers For
Disease Control (CDC) stand up at a national press conference and publicly state
that this is a real, serious disease apparently
really did open many people’s eyes. The CAA’s media campaign also provided a
substantial boost. (Indeed it’s difficult now to find a mainstream website that
does not treat this disease respectfully).
The federal advisory committee on CFS (CFSAC) gives Ampligen another arrow in
its quiver. It’s been stated before but it's true (and rather startling) that
while the NIH has over a hundred advisory committees only a handful are focused
specifically on one disease and CFS is one of them. (How did that
happen??). An FDA representative sits on the CFSAC panel and he interacts with
ME/CFS physicians on the panel, some of whom have been involved in the Ampligen
trials. He also hears the patients' stories - some of which have concerned
their relapses after being deprived on Ampligen. His presence on the panel can only help.
Insurance. Ampligen is expensive, expensive enough that one wonders if
insurance companies would be willing to pay for it. But even here Dr. Carter had
good news. He reported that Hemispherx has studies showing that because chronic
fatigue syndrome (ME/CFS) patients on the drug require fewer doctor’s visits,
hospitalizations, etc. that if insurance companies commit to this drug their
costs should go down, not up; i.e. ME/CFS patients on Ampligen will cost their
insurance companies less.
Length of treatment.Dr. Carter said they were working very closely with
the FDA about ‘labeling’. Despite having done studies of all sorts of different
lengths (6, 20, 40, 75 weeks) he couldn’t give a hard and fast time about how
long a patient would have to be on the drug. Patients with a more severe illness
or who’ve had the disease longer might need to take it for longer periods. He
said the length of treatment would be a ‘doctor-patient’ decision.
Approval? Only 16 drugs were approved in all of 2007. Will Ampligen join
that select club? Will the first FDA approved drug for ME/CFS be an immune
modulator? FDA approval of an immune enhancing drug would cause many in the
medical establishment to reassess their ideas about the disease and, of course,
help ME/CFS’s legitimacy. Have the stars aligned for both Ampligen and
chronic fatigue syndrome (ME/CFS)? We’ll know within the next six months.
Dig Deeper! Ampligen and
chronic fatigue syndrome (ME/CFS)
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