Oral Testimony to the Chronic Fatigue Syndrome Advisory Committee to the
U.S. Department of Health and Human Services
October 3, 2012
Peanuts cartoon [courtesy of the Charles M. Schultz Museum, Santa Rosa, California] -
Charlie Brown is watching Lucy and Linus.
Lucy: OK, Linus. Now we put on our dark glasses and we look at the sun.
Charlie Brown: ?
Lucy: Do you see it? It's eclipsing! It's eclipsing! Isn't that marvelous?
Charlie Brown: Oh good grief!
Lucy: Now, when you take off your glasses, the eclipse stops. See?
Charlie Brown, turing away: I can't stand it!
Lucy: Now put 'em on again … See? It's eclipsing! It's eclipsing!
Charlie Brown to Patty: Poor Linus. He'll have to go to school twice as long as everybody else. It'll take him twelve years to UNLEARN everything Lucy's been teaching him!
Thank you for allowing me time to testify.
[I also want to thank FDA for the meetings they are holding on developing pharmaceutical treatments for ME and CFS. I have been on Ampligen since 1999, except for three or four years. Please don't take it away from me again. (Added in oral testimony.)]
I want to point out several issues that have come up since the last meeting of CFSAC.
FIRST, I'm glad that CFS is going to be coded in G93.3 in ICD-10-CM, but why is NCHS determined to add "NOS" to CFS in ICD-10-CM?
At the last meeting of NCHS, Donna Pickett stated that in this case, we should take NOS to signify the default designation for the code. That doesn't make sense – NOS would be expected to appear in every code if that were true. And it most certainly doesn't.
Accompanying material for ICD-9-CM tells us that NOS (not otherwise specified) stands for cases where there is not enough evidence to give a more specific diagnosis. That makes more sense – but it leaves us even more confused as to what NCHS intends by the designation "CFS NOS" - because if there's not enough evidence for a CFS diagnosis, the CDC website says to use CF, or chronic fatigue, which is coded at R53.8 (where they wanted to code CFS).
ICD-10 has been out for two decades. It is in use by over 100 nations. Several use clinical modifications, like we do, but they adopted theirs a decade ago.
"CFS NOS" does not occur in any other nation's version of ICD-10. Period. Why has it suddenly appeared in ours? Get rid of it.
[There was more on this subject in the version handed in to the committee.]
SECOND, do something about CDC. Shut down the website, throw away the "toolkit" and the pamphlet, and while you're at it, shut down the studies in conjunction with Emory Universities section on factitious illnesses within their department of psychiatry.
It's funny - I find the Emory studies laughable - the entire idea of a million Americans having a "factitious" illness is laughable - but your people find them convincing. At the same time, the virus studies seem to come much closer to fitting the symptoms we actually have, but you find the virus studies laughable.
I don't want to be rude, but let's look at the institutions involved. CDC is infatuated with Emory University (because it's nearby, I guess) and, in particular, Emory's unit on factitious illness. The virus studies are being conducted by Ivy League institutions and others, such as Stanford and Mt. Sinai, that are of that stature. Please. Get us somebody to deal with this disease who knows what they are doing. Factitious illness is – frankly – a crackpot idea. You've spent enough time on it, and since Dr. Reeves is no longer with us to defend it, let's move on.
If CDC refuses to move on, then I turn to Secretary Sebelius and ask that the entire section on CFS at CDC be shut down now, along with the website and current publications.
As Charlie Brown observed, poor Linus would have to go to school twice as long to unlearn everything Lucy had taught him. Those new to the disease CFS who have turned to CDC for information, including family doctors and anyone in the media, will have to re-learn everything they think they know after having read what's been on that website for 25 years.
THIRD, I have explained at length in other testimony and in an essay on my blogsite how the Wichita study that supposedly verified the accuracy of the "empirical definition" by the late William Reeves of CDC for CFS was a sham. I think that article should be retracted, but that is probably a subject for another day. In the meantime, return to Fukuda (1994) and dispense with any references to the Reeves definition, which also means get rid of the questionnaires and any studies conducted with them.
FINALLY, when is something going to be done about the absence of funding for our disease by NIH? At the most, NIH has allocated $6 million a year to this disease, which is $6 per person. All we ask for is parity. Multiple Sclerosis, hardly an overfunded disease, has allocated an average of $350 a year per person since 2000 to a disease with half as many patients. By that standard, NIH should be spending at least $700 million a year on CFS.
I was on the planning committee for NIH's CFS State of the Knowledge Workshop, and thought it went off very well. However, I was a little concerned by a statement Dr. Coffin made towards the end of his presentation. He said that too much time and money had already been wasted on the connection between [the apparent lab contaminant] XMRV and CFS.
Too much money?? Too much money had been spent trying to determine whether a retrovirus was present in a disease that could affect at least one million adult Americans?
Is that the attitude of NIH?
For years, NIH has stated that the reason there is not more funding for CFS research is that CFS researchers do not turn in good enough proposals. Aside from the overt insult to researchers around the nation, many connected with top research departments, who have ventured into the CFS arena, with such a disparity in funding it would seem that NIH would do a better job of finding the projects instead of clearing itself of an obligation to fund the projects that are out there.
When I was at the NIH workshop, during a break I had planned to ask Dr. Coffin what he thought of the question of whether chromosomally integrated HHV-6A actually has been found. It had sparked a heated debate at the HHV-6 Research Conference held in Reston, VA, a month earlier. But I foolishly began by saying I fought for years a persistent infection with HHV-6A. Coffin chuckled and told me I did not have HHV-6A. Having been in a published study conducted by Dr. Dharam Ablashi, I was fairly certain I did have HHV-6A. The only thing that held it back was that I was on Ampligen most of the past 14 years.
I never got to ask Dr. Coffin about ciHHV-6. He walked off chuckling at the absurdity of my remark.
Later, during another break, I turned to Dr. Stephen Collins of CDC. I wanted to discuss the other viruses associated with CFS. I began with EBV, and again, I made the mistake of starting by commenting that I had problems with recurring Epstein-Barr. He did not chuckle. He put his hand up (as in "talk to the hand") and said, simply, "No you don't. It's a problem with your testing. It's a false echo." Then he turned and walked away.
So twice I had asked a question having to do with a research program of which I was a part, and twice I had ended up staring at a man's back as he walked away from me.
[Then, at today's meeting of CFSAC, the topic was biomarkers. Apparently unaware that researchers have been working on a number of biomarkers in this disease for almost thirty years, they brought in someone from a different disease. Once again, the biomarkers I have weren't mentioned.]
What concerns me here is that Dr. Colllins is in charge of the division at CDC where CFS resides. And Dr. Coffin is a highly respected virologist who might well be asked to review a research proposal for NIH.
Apparently the new narrative we are supposed to accept is that CFS is an autoimmune disease. It just LOOKS like we have viruses because our immune systems are hyper-activated.
I had the same EBV testing that college students get. Nobody says they don't have EBV when the tests show them positive for active EBV. I had the same CMV and HHV-6 testing that AIDS patients get. Nobody says they don't have active CMV or HHV-6 when the tests show them positive for those viruses.
Why is it different for me?
And that brings us back to the basic problem: lack of funding.
If these gentlemen thought the very idea of persistent infections with HHV-6A or recurring infections with EBV was ridiculous, how would they judge a research program on that very subject?
What must their reaction be to Dr. Montoya, who has been studying EBV and beta herpesviruses in CFS at Stanford University for at least six years? Are they funding studies of the types of testing for natural killer cell function used by Dr. Klimas or Dr. Peterson? What of Dr. Lipkin's promise to look at the other viruses (besides retroviruses) implicated in CFS? What about the Mt. Siniai initiative, and projects at Cornell, Harvard, USC, and many other reputable research institutions that at this very moment are studying the interrelationship of a number of viruses, including not only the herpesviruses, but also enteroviruses?
Could this prejudice account for the denial of research funding by NIH? Could this problem – that there are people in a position of power over who receives funding think it is ridiculous that we could actually be suffering from long-term viral infections, that we could be immune deficient – could that have something to do with the paucity of NIH funding? It's not the research PROPOSALS - it is the research TOPICS that are "unacceptable" - unacceptable because they refute the current pet theory at CDC and most likely at NIH.
Let me suggest that if researchers at Ivy League and comparable institutions are working on these projects, they deserve funding by NIH. The problem is with the evaluators, not the researchers.
And we certainly don't deserve ridicule for bringing the subject up.
Mary M. Schweitzer, Ph.D.
* * *
to attach to the post.
Fall 2012 Testimony CFSAC
For almost 10 years, I have tracking NIH CFS funding patterns. What I
will present today is evidence that patients
are worse off in 2012 than in 1993. I expect you to look at these
graphs. I expect you to walk away with some
history of NIH activity. My hope is to further your understanding of
the need for fundamental change within the NIH.
1. General Accounting Office,(GAO) graph This graph shows intramural
and extramural funding as well as
cooperative agreements. On pages 46 – 52 of the GAO report,
investigators present a rationale for why some
projects were excluded from CFS expenditures and why other projects
should have been included.
Overall, the GAO concluded that the NIH was actively pursuing CFS
research despite near flat line spending from
1996 though 1999. In addition, investigators state, "Despite its
varied efforts, the intramural program on CFS in
NIAID is currently inactive. NIAID's primary CFS investigator has
recently moved elsewhere in the agency, and we
were told that no one else has yet indicated an interest in developing
work in this area." (Pg. 22)
2. Line graph two The blue line indicates NIH reported levels of CFS
expenditures from 2000 through 2010. In
1999, GAO reports research funding close to 7 million dollars. Within
the next 11 years, funding spiraled downward
to a low of 3.5 million dollars in 2008. From 2002 through 2008 with
no intramural CFS expenditures, it appears
that the CFS intramural program remained inactive. The bounce in 2009
to over 6 million is due to intramural and
extramural research on pathogens to include XMRV.
The black line shows NIH levels of CFS expenditures once adjusted
through FOIA data. I DID EVERYTHING
HUMANLY POSSIBLE TO MEET THE STANDARDS OF THE GAO. If CFS was not the
primary focus of the grant,
the GAO investigators did not include it in their report and I did not
include it in this report either.
On May 30, 2002, the National Advisory Allergy and Infectious Disease
Council (NAAIDC) voted to "not renew
CFS research centers and to give the money that NIAID had set aside
for their concept to the NIH ORWH which
coordinates CFS research for the entire NIH…" (5.30.02 NAAIDC meeting
minutes) Note: Intramural funding for
CFS stopped in 2002. Note: From 2002 through 2005, six renewed
unrelated projects show as CFS expenditures.
(FOIA 32335 ) NOTE: 2002 – 2007 gap between reported and actual CFS. I
do not blame ORWH.
3. Bar graph three Blue bars show NIH reported CFS spending. Red bars
have a number inside showing the
number of new grants funded. Again, look at 2002 through 2005. The
problem is arithmetic )), but illusive.
2010. Under ME/CFS categorical spending, the NIH REPORTER excludes at
least one CFS primary research
grant - $700,000 a year, 5 year, to a PI from Ohio State. This grant
shows under the search terms "chronic fatigue
syndrome." In 2010, an NIH FOIA officer said that the NIH Reporter is
an accurate reporting of CFS spending. Is it?
4. NIH Activities This chart is copied the GAO report page 56 and 57.
The NIH reported a long list of ongoing
Congressionally Requested CFS projects. What Happened?
There is a pattern in NIH CFS funding. Despite the development of
extraordinary research techniques and
technology, patients are on the curb. We have no evidence from the NIH
that we, the people, are being taken
seriously. We MUST continue to promote fairness. We must continue to
ask for fundamental change. I want all of
us to look at the truth. Do not sugar coat this NIH "lack of interest"
in CFS as poor grant writing, a systems error,
misstatements, and lack of funds. I may be sick, but I am not stupid.
We need a strategic and fully funded 5 year
plan. Don't be selling me a bill of goods about planning "new action,
if it does not cost anything." I am a human
being. These sick adults, and our sick children will show you we matter.