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>> Nancy Lee: So, let's call this to order. I want to thank
everybody for coming. We're going to do this a little bit out of order because our first
speaker is in two places at once this morning, right. And she has to leave and get to Baltimore
for a meeting she's going to be late for. And we really appreciate her being here. So,
instead of having the usual welcoming and going around the room, we're going to let
Donna Pickett -- well, I think we should -- I think we should go. Oh, okay, well, then we
will do that. Okay, thank you. So, we'll go around the room and introduce ourselves and
then Donna will start. And then we'll do some of the other issues that we would like
to do later.
This should not be turned on right now. Thank you. We'll turn it on when -- at 10:00, 10:00.
So, just to let people know, my name is Nancy Lee. I am the new designated federal officer
for the Chronic Fatigue Syndrome Advisory Committee. I am also the deputy assistant
secretary for women's health at the Department of Health and Human Services.
And I am very glad you're here.
Dane, why don't we start with you? And we'll go around. And Dane, just to remind everyone,
this is being audio-streamed to anybody who wants to call in, so we have to speak into
these mics. And perhaps if somebody could tell us how we know it's on.
>> Dane Cook: The little red light right here.
>> Nancy Lee: I don't see a little red -- oh, there is it.
There's a little red light here. So make sure your little red light is on.
>> Dane Cook: [laughs] Good morning. Dane Cook. I'm one
of the committee members from the University of Wisconsin. I do research on exercise and
functional brain imaging in chronic fatigue syndrome.
>> Steve Krafchick: My name's Steve Krafchick. I'm an attorney,
and I represent people with chronic fatigue syndrome particularly trying to get them their
long-term disability benefits through private policies.
>> Ann Vincent: Ann Vincent. I'm a general internist from
Mayo Clinic. And I currently study fatigue and fibromyalgia.
>> Leonard Jason: Lenny Jason. I'm a psychologist at DePaul
University, particularly interested in diagnostic issues, epidemiology, and particularly case
definition.
>> Susan Levine: Susan Levine, New York City. I see a lot of
chronic fatigue syndrome patients and fibromyalgia patients.
>> Theresa Michele: Hi, I'm Theresa Michele. I'm in the Division
of Pulmonary, Allergy, and Rheumatology Products at the Center for New Drugs at the FDA.
>> Martha Bond: Good morning. Marty Bond, senior public health
advisor with the Office on Women's Health and alternate DFO [spelled phonetically].
>> Christopher Snell: Christopher Snell, I'm a professor at University
of the Pacific in Stockton, California. I'm interested in functional aspects of chronic
fatigue syndrome. I'm also the current chair of CFSAC.
>> Beth Collins Sharp: Good morning. I'm Beth Collins Sharp. I'm
from the Agency for Health Care Research and Quality where I'm senior advisor for [inaudible].
>> Ermias Belay: Good morning. Sorry. My name is Ermias Belay
[spelled phonetically], I am from the Centers for Disease Control and Prevention. I'm the
ex-officio for CDC to CFSAC.
>> Nancy Klimas: I'm Nancy Klimas from the University of Miami.
I'm a investigator and clinician. I care for patients with chronic fatigue syndrome.
>> Gailen Marshall: I'm Gailen Marshall from the University of
Mississippi. I'm a clinical immunologist interested in biomarkers for chronic fatigue syndrome.
>> Jordan Dimitrakoff: I'm Jordan Dimitrakoff from Harvard Medical
School. I'm interested in chronic pelvic pain syndrome, [unintelligible] and its overlap
with chronic fatigue syndrome.
>> Eileen Holderman: Thank you. Good morning. I'm Eileen Holderman.
I am the patient advocate.
>> Nancy Lee: Thank you very much. So, Donna Pickett is
going to give a presentation to us about ICD. Donna is with the National Center for Health
Statistics in Hyattsville, Maryland, which is part of CDC. And she is going to, I think,
give us a bit of an overview and also answer some of the questions that she has received
from the committee. Thank you very much, Donna, for coming here.
>> Donna Pickett: Red light. [laughs] Thank you all. Again,
my name is Donna Pickett. I'm with the National Center for Health Statistics. My specific
responsibilities at NCHS is team lead for classification activities, specifically ICD
and ICF. And my remarks today will focus on ICD.
Are they going to advance the slides or I'm -- I can work without them if they all have
copies.
[off-mic discussion]
Well, if all the committee members actually have copies of the slides, while they try
to work the wonders with technology, I can just walk through this -- okay.
[off-mic discussion]
For those of you who are not familiar with the ICD, though I think many people probably
are, the International Classification of Diseases has been in existence for about 100 years.
The current version that is being used in the United States is ICD-9-CM, which is a
clinical modification of the WHO classification. I'll apologize in advance. [laughs] The ICD
is used for a variety of purposes. Its primary function started out as being used for classifying
causes of mortality for death registration, but more recently, many countries also use
it for the capture of morbidity statistics in-patient hospital, physicians' offices,
out-patient clinics, home health, rehab, a variety of health care settings. Also, it
is used for reimbursement, as many of you know, particularly the providers that have
to send in claims. In order to submit a claim, you need an ICD-9-CM code. Next slide, please.
Again, ICD-9-CM is a clinical modification of the WHO classification. ICD-9 as published
by the World Health Organization was published in 1974. The U.S. in agreement with the World
Health Organization created a clinical modification of the ICD which has more detail than the
WHO classification. ICD-9-CM has been updated annually since 1985. Prior to ICD-10, WHO
did not have an update process. So, for those countries that had clinical modifications,
it was very important to try to keep the classification as current as possible. So, again, we've been
updating ICD-9-CM in the U.S. since 1985. We have a public process, the ICD-9-CM Coordination
and Maintenance Committee. Currently, it meets twice a year, in March and September of each
year. Proposals to modify the classification can come from a variety of stakeholders and
users of the classification, including hospitals, specialty groups, subspecialty groups. It
also can come from an individual provider.
I know one of the questions of interest was specifically related to the coding of chronic
fatigue syndrome in ICD-9-CM. On this slide, I show you the first request to have information
about chronic fatigue syndrome was requested in 1990. Excuse me. And an alphabetic index
entry was created for chronic fatigue syndrome, referring the coder to code 780.7. A second
request and this time a unique request for a new code for chronic fatigue syndrome was
requested in 1997. That request was brought to the C and M Committee, and a new code was
approved and implemented October of 1998. That code, 780.71, is titled chronic fatigue
syndrome. So, that code has been used in the U.S. for the last 13 years to capture chronic
fatigue syndrome.
ICD-10, which is the classification that basically is being used worldwide except for here in
the U.S. for morbidity purposes -- ICD-10 was approved by the international conference
for the 10th revision of the ICD in 1989. It was adopted by the World Health Assembly
in 1990. The tabular list, which is the bulk of the book, was published in 1992. However,
WHO was not able to publish the alphabetic index until a couple of years later. The key
issue about that -- and you're probably wondering why do I have that on the screen -- well,
you can have a tabular list, but you can't do anything with it unless you have an alphabetic
index because the alphabetic index is what guides you toward the use of the classification.
So, the full classification and coding rules were not available completely until 1995.
Next slide.
Once the U.S. had all of the components of the ICD, we began a process of evaluating
ICD-10 for use in the U.S. for morbidity purposes specifically. On the mortality side, which
is the coding of death certificates, the U.S. has used ICD-10, plain vanilla, as published
by WHO since 1999. As part of the review process, one of the aspects that was looked at was
whether or not ICD-10 actually addressed all of the concepts that had actually been added
to ICD-9 CM since the annual update process for 9-CM began in 1985. We did the review
in consultation with a large number of physician groups, clinical coders from the in-patient
and out-patient settings, and other users of ICD-9-CM, which includes researchers, epidemiologists,
and others. There were three phases of development, the first phase from 1994 to 1995. And, again,
that was dependent upon having all parts of the classification available from WHO. Phase
two, from 1995 to 1996, we opened up a comment period for users to tell us specifically what
issues, if any, they had with ICD-10 and where it may have been lacking. Again, as I showed
you in the previous slide, the World Health Assembly approved ICD-10 in 1990.
So, fast-forward to 1995, 1996, and, as you might guess, there's probably a lot of new
information that had come about since WHO had approved ICD-10. Phase three -- well,
and we're sort of in phase three now, in 1997, we had a public comment period. We posted
the entire ICD-10-CM on the Internet and invited public comment. Following that comment period,
we incorporated a number of changes into ICD-10-CM to enhance its utility for a number of purposes.
There was a pilot test conducted by the American Hospital Association in conjunction with the
American Health Information Management Association in 2003. And there were further modifications
to ICD-10-CM based on the results of the pilot test. From there on, we've been actually updating
ICD-10-CM every year simultaneously with updates to ICD-9-CM. Again, ICD-9-CM, while it has
its limitations, we were able to incorporate a number of new concepts into ICD-9-CM, sometimes
not very well, but, again, to try to capture some data is sometimes better than capturing
no data at all. So, bird flu, SARS, all of those things have been added to the classification.
But, again, it came a time where I think the U.S. realized that we could no longer update
ICD-9-CM because we had run out of space. There were no opportunities in some chapters
to add one single new code. And so, ICD-10-CM became an important focus. Next slide, please.
For ICD-10-CM, we will continue to use the process that we currently use to update ICD-9-CM.
Many of you may not know, but ICD-9-CM, we are only doing minimal updates to ICD-9-CM
leading up to October 1, 2013 when ICD-10-CM and ICD-10-PCS, which is the procedure coding
system that will be used in the in-patient setting, will be implemented. But again, we've
been maintaining 9-CM and 10-CM side-by-side, and we've been doing it through our public
process. Proposals to add new information to ICD-10-CM need to be sent to NCHS two months
in advance of a meeting. Meetings are open to the public. A tentative agenda is published
in the Federal Register approximately one month in advance of the meeting. And the tentative
agenda is also published on the NCHS website. Comments are encouraged during the meeting,
but we also ask that people submit their comments in writing so that we have a public record
of those comments.
As I mentioned earlier, ICD-10-CM will be implemented October 1, 2013. And the implementation
of ICD-10-CM is tied to the standards adoption process specified under HIPAA, the Health
Insurance Portability and Accountability Act. There were multiple hearings about migrating
from ICD-9-CM to the ICD-10 code sets. The National Committee on Vital and Health Statistics,
which is also a federal advisory committee, held public hearings -- approximately eight
hearings over the course of 1997 to 2003, and ultimately a letter to the secretary was
issued November 2003 recommending moving to the ICD-10 code sets. A notice of proposed
rulemaking was published August 2008, and a final rule was published January of 2009.
Next slide, please.
One of the things that I know of interest was the placement of ICD -- in ICD-10 for
chronic fatigue syndrome. The WHO version has post-viral fatigue syndrome, G93.3, which
is in the nervous system chapter. Also included there in the WHO version is benign myalgic
encephalomyelitis. Next slide.
Chronic fatigue syndrome in ICD-10-CM, the current version, is at R5382, but the code
post-viral fatigue syndrome still stands as well. In July of this year, we received a
proposal from the Coalition for ME and CFS -- next slide, please -- asking that ICD-10-CM
be modified and move chronic fatigue syndrome into G93.3, the post-viral fatigue syndrome.
This proposal was discussed, presented and discussed at the September 14th Coordination
and Maintenance Committee meeting. In addition to the option proposed by the coalition, NCHS
also put forward an option which was to move chronic fatigue syndrome into G93.3 but also
to expand the code so that a unique code would be created for chronic fatigue syndrome under
G93.3 to ensure that data captured for the last 13 years with the current chronic fatigue
syndrome code in ICD-9-CM would not disappear. So we submitted that as an option for public
discussion.
The public comment period is still open. It does not close until November 18. So I really
unfortunately don't have anything to share with the committee about the results of what
has come in thus far, but I wanted to mention that, that we are still in an open comment
period. Next slide.
The last slide is just the websites for the Coordination and the Maintenance Committee
where you will find the actual proposal and a summary of the discussions regarding that
proposal and the other proposals that were discussed on that day. And also, if one is
interested in looking at ICD-10-CM as a whole, there is the website for all of the files
and coding guidelines and relevant material related to ICD-10-CM. And again, I didn't
want to have too much down in the details so we could allow time for questions relative
to the C and M process or any other issues related to the classification. So thank you
and I hope I'll be able to respond to your questions.
>> Christopher Snell: Thank you, Donna. I've been reminded that
we've been a little remiss and I haven't -- we haven't formally opened the meeting.
>> Nancy Lee: We're learning.
>> Christopher Snell: Yeah, you can forgive me on that, and then
we won't have to ask Donna to repeat the presentation, so. The meeting is now formally opened. Thank
you. Call to order. And I open the floor for questions. Nancy?
>> Nancy Lee: So when this public open comment session's
over, what is the process to make that decision, option one, option two, or deny both options?
>> Donna Pickett: Well, we'll evaluate the comments, so it's
kind of hard to say, you know, exactly what would happen with this particular proposal.
But I can give you by way of example some of the options that have occurred with other
proposals. Yes, one of the options -- well, in reviewing the comments that come in, there
may be overwhelming support for the proposal, so obviously that would make it quite easy
to move forward. But also, an option could be that there is a divided opinion about the
proposal. And the other thing about the proposal, there are two issues related to the proposals.
As I had mentioned previously, ICD-9-CM and ICD-10-CM are currently in a partial freeze.
What that means is we would not be implementing any new codes for 9-CM and 10-CM to keep the
classifications stable while the industry prepares its systems, et cetera, to use ICD-10-CM.
The industry requested that we do this. So, the only new codes that would be created at
this point in time would be related to new diseases and new technology. And, again, that
relates to the procedure side.
So, in commenting, submitters will have to comment on whether or not they agree with
one of the two options presented, or they could actually submit an alternative, which
would have to be discussed at a future meeting. But the other thing they'll be asked to do
is to indicate whether or not they agree that this does or doesn't meet the criteria for
making a change during this partial freeze. So we'll have two issues to deal with as part
of the comment period.
But, again, by way of example, again, one could have complete support for a proposal.
There could be partial support, or there could be issues raised that would require clarification
which likely would mean possibly coming back with a revised proposal to a subsequent public
meeting. Or it could be totally rejected with no support for the proposal. And, again, we'd
have to look at the comments to see how that would work. In the past, we've had some proposals
that were not fully supported. However, based on the total of comments, sometimes a proposal
can be revised and still brought back to a future meeting. So, again, a lot has to do
with the proposal itself and the comments that are received.
>> Female Speaker: If this advisory committee in these two days
discusses this and adds its thoughts to this discourse, how do we best provide that to
your process?
>> Donna Pickett: Generally speaking, advisory committees don't
often weigh in as a committee. They generally will weigh in as individuals. But again, you
know, we're open to all comments. So, how you choose to conduct your business and come
forward with a proposal or comments, we would be open to receiving those in any fashion
that you deem appropriate for your body. Because I know the FACA [spelled phonetically] committees
have specific requirements, so.
>> Christopher Snell: Lenny -- I would just ask anybody that's asking
a question, we had a request as this is audiotaped but not videotaped live at the moment, if
you could just state your name and your affiliation so that people know who you are. Lenny.
>> Leonard Jason: Thank you, Donna, for coming to this meeting.
We certainly appreciate you making --
[off-mic comments]
>> Leonard Jason: Lenny Jason, DePaul University. It takes me
awhile to learn. Thank you, Chris. So, we really appreciate you coming to this meeting,
and I know that it took time to be able to make this part of your busy agenda because
I know you had some other appointments.
You had mentioned before that we should make comments individually to your group. Because
we're an advisory committee and we make recommendations to the secretary of Health and Human Services,
if we were make a recommendation to the secretary of Health and Human Services concerning our
preference for possibly option one or option two, might that have some weight in terms
of your deliberations as a recommendation to the secretary of which the secretary of
Health and Human Services might then give you their preference. That's question one.
And question two has to do with option one versus option two, which I know that a couple
months ago, Pandora, ME/CFS Coalition, and others, Marly Silverman [spelled phonetically]
had made a presentation to you, and they have had a comment about option one versus option
two with a strong preference for option one. And I'm wondering if you might be willing
for this committee to articulate some of the reasons that they felt option one was superior
to option two. Thank you.
>> Donna Pickett: Let me try to start with your last question
first. The difference between option one and option two, option two attempts to recognize
the fact that there has been a unique code for chronic fatigue syndrome in ICD-9-CM for
the last 13 years. And there are a number of researchers and others who use that code.
So for option one, which was basically to take the term, chronic fatigue syndrome, and
add it back into G93.3 with no further specification, some researchers and others felt that to be
extremely problematic. They did not want to see the data disappear for that code. So,
that was the reason we put forward an option two which was in recognition of the fact that
there has been a unique code for 13 years. Now, the other issue regarding -- [clears
throat] excuse me -- submission of a recommendation to the secretary, I really can't speak to
that. We've not had a circumstance like that in the past. The way the public comments work
for us is generally we receive individual comments either from hospitals, medical groups.
I don't recall in recent history that we've actually received a comment letter related
to a coding issue from a federal advisory committee.
>> Leonard Jason: Okay, just a follow-up question too, just
a procedural question to Nancy because this is new terrain that we're on particularly.
I'm wondering if you can give our clarification to our committee. At least in the past, we
have had recommendations that we've made to issues like this and others, and I'm wondering
whether this would be appropriate to make a recommendation even though it has not been
done before, to the secretary. And once again, this is Lenny Jason at DePaul University.
>> Nancy Lee: And this is Nancy Lee, DFO. I know that last
May we did have this recommendation, right. And it went to the secretary. We encouraged
at the time for the individuals around the room to make sure that they sent it through
the normal channels that NCHS has. And we can certainly, if you all make some sort of
recommendation in this regard, we can get it to Donna through either directly to her
or through the channels that Donna showed us on the weblink before November 18th, because
that's -- we need to make sure it's made by that date. I don't know because I'm new and
I'd have to look into it other -- the more subtle response to your question.
>> Leonard Jason: And, just again, a quick follow-up question
because -- this is, again, Lenny Jason at DePaul -- because we have made a recommendation
as a formal body, in my understanding it was unanimous to make this change, is it possible
for us to find out what the reaction to the secretary was to that recommendation made
six months ago?
>> Nancy Lee: We can look into that.
>> Christopher Snell: Susan? Levine.
>> Susan Levine: Yeah, hi. It's Sue Levine from New York. I'm
curious to know -- I mean, I think it makes sense for instead of each of us weighing in
separately on this recommendation that perhaps we can come to a conclusion based on the discussion
of our committee regarding any changes. But what I want to know is more procedurally what
occurs if we disagree with the final decision, is there a chance to appeal it or who really
decides whether this recommendation is made and is approved. And if we disagree with it,
can we appeal?
>> Donna Pickett: Susan, I'm not clear on what you mean "appeal."
>> Susan Levine: Well, you know, let's say you decide as a
group not to go forward with what we want to do in terms of changing the existing coding
system. Is -- are we stuck with it for another year or is there a chance to readdress this
in a shorter period of time?
>> Donna Pickett: Again, a lot would depend on not just a comment
made by this group but other users of the classification as well. So, again, without
seeing the totality of what those comments might be, it's hard for me to say what the
next steps would be. Again, you know, comments could be fully supportive, could be partially
supportive, or not supportive at all, which would lead to other discussions. And again,
many times when things are not fully supported, we try to work with the different groups to
come up with an option that might be a consensus option that would then be represented at a
public meeting because it all has to go back to a public meeting.
>> Susan Levine: I see. Thank you.
>> Christopher Snell: Nancy.
>> Nancy Lee: And when there's the "we" thing, who's actually
-- who makes the decision? Are there -- who's the committee that decides to weigh these
different comments? And how much are professionals or physicians or researchers weighted compared
to, say, the general public?
>> Donna Pickett: Well, again, the comment letters come in from
a variety of groups. And again, I can't say who might be commenting on this. But again,
it could be medical groups. It could be other provider organization types. It could be like
the hospital association. We try to look at all the comments as they come in, and we don't
weight them in any one direction or another, but one of the key things we are looking at
is whether or not the comments really relate to the classification and placement of conditions
within the classification and the appropriateness of comments related to the need for instructional
notes and things of that nature. One of the things that we don't do as part of the public
process for updating the classification, we do not look at reimbursement issues just because
that's a whole different tract. What we're looking to do is ensure that what is being
added to the classification or modified within the classification is clinically accurate
and is consistent with the structure and conventions of the ICD. But we look at all the comments
to look for those particular issues.
Oh, and I think the other thing you were asking, who ultimately makes the decisions. As is
noted on our website, the final decision makers is the director for NCHS and the center administrator
for the Centers for Medicare and Medicaid Services, and the reason being those two organizations
have responsibility for the classification as a whole. But we do reach out to others
and, again, people will reach out to us as well because we do get a lot of input from
the medical groups.
>> Christopher Snell: Lenny.
>> Leonard Jason: Lenny Jason, and again, a couple questions.
My understanding is that your agency is under the HHS rubric so that the secretary would
be the person overseeing your particular agency, or am I incorrect on that assumption? Again,
this is Lenny Jason. That's question one. Question two is because we made a recommendation
six months ago very specifically, I'm wondering whether that recommendation got to your office
and whether you have considered it and have any comment on it. And the third question
really has to do with option one versus two. You were very eloquent in talking about some
of the rationale for option two. I'm wondering if you'd be willing to also speak about the
arguments you've heard that were given to you in September for option one. Thank you.
>> Donna Pickett: Well, I think the rationale for option one
is included in the background information that was presented with the proposal, so I
don't know whether there is more that I could actually contribute to that discussion. Again,
the concern about moving chronic fatigue syndrome into G93.3 with no further expansion of that
category means that, again, statistics, data for 13 years disappears. And that was a major
concern from other stakeholders. But in terms of what the coalition was requesting which
was just to move the condition into that G93.3, I think that speaks to the fact that they
were hoping to have [clears throat] chronic fatigue align itself the way it is in ICD-10.
But again, the issue there is ICD-10 did not have a breakout for chronic fatigue syndrome,
and it did not exist in the WHO ICD-9. So we're having to deal with transitioning from
ICD-9-CM to ICD-10-CM and the best way to accomplish that. And I hope that answers your
question. I'm not sure it did.
>> Leonard Jason: Once again, Lenny Jason at DePaul University.
The first two questions really had to do with whether your agency falls within the mandate
of the secretary of Health and Human Services and what any implication of that might be
or whether you're outside of that particular kind of mandate. And then the second thing
has to do with our recommendation from our committee and whether you have actually seen
it, considered it, reflected on it, and made any decisions about the worthwhileness [sic]
of that particular motion.
>> Donna Pickett: I've been made aware of the recommendation.
However, what the recommendation did not do, it did not fully specify what modifications
you wanted in the classification. And so, kind of hard to react to a recommendation
that just says move this when you actually need to have -- and I don't know if you're
familiar with how the proposals are done, but you have to show the proposal as it relates
to what it looks like in the tabular list and how you are modifying it according to
the structure and conventions of the classification. So, having a recommendation that says move
something but actually having a proposal that can be brought to the public for full discussion,
we need to have a full proposal for discussion, which is what the coalition brought forward
as part of their submission in July.
>> Christopher Snell: Steve Krafchick.
>> Steven Krafchick: Thank you. I'm an attorney and I represent
a lot of people who have chronic fatigue syndrome and other conditions. And the ICD-9 often
weighs heavily in reimbursement questions and disability questions. And I didn't realize
that that wasn't considered as your modifying the classification because, for instance,
if you would classify it under something that would lean more to a mental health condition,
say, than a physical condition, that would have great implications for whether people
at Microsoft or Weyerhaeuser [spelled phonetically] or any major corporation can get disability
benefits beyond 24 months, something very, very critical to a lot of people in the country.
And also, it has great implications for providers being able to get reimbursement for care they
render. And if those aren't factored in, how does the jump get made? I mean, we know they're
used -- I mean, and the most common use of the ICD-9 now is in your health insurance
reimbursement. So anyway, could you comment on that?
>> Donna Pickett: The reimbursement issues, again, are outside
how and why we update the classification. Business decisions, yes, are made by the insurers
relative to the codes, but we do not interact with them at all on those business decisions.
And yes, there are some conditions that reside in certain chapters -- for instance, mental
health -- but again, the placement of those things is generally based on where WHO has
placed them. And so, we just build upon what WHO has done in many instances. But again,
I do understand that there are reimbursement and coverage implications, but that is not
factored into the discussions of updating the classification.
>> Christopher Snell: Ann and then Susan.
>> Ann Vincent: Donna, thanks for the very informative presentation.
I have a question on chronic fatigue versus chronic --
>> Nancy Lee: Please identify yourself.
>> Ann Vincent: Ann Vincent, Mayo Clinic. So my -- chronic
fatigue is present in many medical conditions. So did I hear you say that option two is going
to fold chronic fatigue into -- so is -- how is chronic fatigue going to be separated from
chronic fatigue syndrome? That's my question.
>> Donna Pickett: Okay. The only thing that would be removed
from the R5382 would be the term "chronic fatigue syndrome." That was what was being
proposed to be moved into the G93.3. The code for chronic fatigue would remain in the signs
and symptoms chapter. So, if the provider has documented chronic fatigue, not chronic
fatigue syndrome, there would still be a unique code to identify that particular case. And
chronic fatigue syndrome would be moved out and grouped with the G93.3.
>> Christopher Snell: Susan Levine, CFSAC member.
>> Susan Levine: Hi, Sue Levine, CFSAC member. What -- yeah,
this concerns me that the reimbursement issues are not taken into account. I mean, it seems
to me that ICD-9 codes have been primarily used by providers and for purposes of reimbursement
and I don't see the point of changing it if we're not going to take into account reimbursement
issues. I mean, this -- who are you changing it for? What group of -- for researchers and
you're concerned about the loss of data for the last 13 years.
>> Donna Pickett: Well, it's not just researchers. It's providers.
I mean, it's all users of data. And let me just address the issue of reimbursement. The
ICD-9-CM has been used long before it was used for reimbursement purposes. Medicare
didn't start using the codes for reimbursement for DRGs until 1983. The classification was
in use since 1979, so there are a number of other reasons that the classification is used.
But trying to incorporate reimbursement use cases which vary by payer is next to impossible.
What we are doing is modifying the classification to be consistent more or less with the WHO
classification. And again, it's clinical, it's accuracy, but it is not reimbursement,
because there are too many variations on a theme to try to sort out the reimbursement
issues.
But yes, we're aware that reimbursement is a use case, but it is, again, there are multiple
use cases. So reimbursement is not the only one. But historically, we do not modify the
classification for reimbursement purposes. And, in fact, at the C and M meetings, that
announcement is made at every meeting. So, that's historical since I can remember, and
I've been doing this for about 16 years. But even as attending as an outsider, reimbursement
issues are not discussed as part of the meeting.
>> Eileen Holderman: Eileen Holderman, CFSAC member.
>> Eileen Holderman: I couldn't have said it better. Thank you.
I was wondering -- I know that public comment plays a role in changing codes. How much of
a role does consulting other agencies such as the CDC and looking at their medical literature
play a role?
>> Donna Pickett: We -- literature is submitted to us many times
with proposals, but also in terms of people commenting, many of the medical groups will
also provide a literature review. And if we are having difficulty sorting out the variations
in what is being presented, we will reach out to other medical groups to try to help
sort out the issues, so it's not just within the CDC family. We have established links
with other external groups that we work with frequently to help us sort out the issues.
But, of course, we would also look toward CDC, AHRQ and others in trying to sort out
the issues related to a particular proposal.
>> Eileen Holderman: Does one agency have more prominence, or do
you give more weight to one agency over another?
>> Donna Pickett: No.
>> Christopher Snell: Leonard Jason, CFSAC member.
>> Leonard Jason: This issue has generated a tremendous amount
of controversy over the last few months in terms of our members in our group getting
emails and phone calls and other types of interactions with the larger patient and physician
community. I'm wondering whether your office has also gotten a lot of communications with
outside individuals concerning this issue. That's the first question.
Second question is do you have a sense of why this is such a important and pressing
issue for the patient community which possibly has generated for us and possibly for you
the amount of attention. And number three, do you have a sense of the difference between
what chronic fatigue is versus chronic fatigue syndrome?
>> Donna Pickett: The generation of email -- currently all comments
are going into a general C and M inbox. Staff and I are not reviewing those comments at
this point, though I realize my -- that inbox is filling up rapidly. But again, because
the comment period doesn't close until the 18th, we're not looking at any of the comments
at this point, but yes, we can see that there's a lot of activity and emails going into the
inbox. But we've not made any attempt -- and this is normal practice. We wait until the
end of the comment period to start sorting through the comment letters. It's a much better
process when you do it that way because this way you're not getting an early view of one
sort or the other. We sort them out at the end and then we try to review them and figure
out what's actually going on rather than doing this on a daily basis. [coughs] Excuse me.
You're mentioning something about like definitions. Again, definitions aren't in the classification.
We'd look to the provider community to help us with those definitions. But again, at the
end of the day, if a provider has diagnosed a patient with any disease -- doesn't matter
whether it's chronic fatigue syndrome or appendicitis -- they are using their clinical judgment
in making that diagnosis determination. And that's what we go with. So, again, we're not
looking at the definitions or, you know, even the case definitions of which I know there
are several because -- in preparing for the C and M meeting in September, we were made
aware that there were, you know, conflicting or varying definitions out there, but again,
definitions are not in the classification. So, while we are aware of them, it's not how
we update the classification.
>> Leonard Jason: Just a follow-up question. I mean, the process
by which you elicit feedback through comments seems to be appropriate for things that you
have to do as an agency. I'm just kind of wondering whether there is particular expertise
in this Chronic Fatigue Syndrome Advisory Committee which represents kind of scientists,
patient organizations, patients, practitioners, whether there are -- have been times in the
past history when particularly organizations that are as multidisciplinary as we are are
sought out for some type of specific kind of consultation or advice when particularly
controversial and difficult decisions have to be made in the classification effort by
your agency.
>> Donna Pickett: Generally, in trying to sort out issues, we
would go back to subject matter experts, and by that, I mean the medical community, so
it could be the AMA. And again, it depends on the issue. I'm not talking chronic fatigue
syndrome specifically. It could be the AMA. It could be the Academy of Urology. It could
be orthopedic surgeons. So we reach back to external groups to work with us to help us
sort out those issues. And we do have established links for that. As an advisory committee,
normally we would not have reached back to an entire advisory committee. We would be
focusing in on specific subject matter experts.
>> Christopher Snell: Nancy just wanted to make a comment.
>> Nancy Lee: Or ask a question, actually. Yes, I know.
Thank you. Donna, I -- just to put this process for ICD-10 and ICD-9 in context, about how
many conditions are covered under ICD-10? I know it's thousands.
>> Donna Pickett: Yes. Exactly how many thousands I couldn't
tell you, but --
>> Nancy Lee: But in the order of magnitude.
>> Donna Pickett: Well, again, it would depend on if you're
talking just total number of codes versus number of conditions. We really haven't had
a count of how many conditions. But needless to say, I think we pretty much cover from
A to Z. But there are approximately 160,000 codes in ICD-10-CM, some with varying degrees
of granularity versus not, but --
>> Nancy Lee: So you are responsible for assuring 160,000
codes.
>> Donna Pickett: Yes.
>> Nancy Lee: Okay.
>> Christopher Snell: Susan Levine.
>> Susan Levine: Hi, thanks. I'm still trying to understand
the process of how the committee for ICD-9, ICD-10 coding works. And I guess a little
following up on Lenny Jason's question and Steve's question regarding, for instance,
disability issues, do you ever have people from Social Security disability, or representatives
from private disability companies weight in on your choice of whether or not to update
the coding process?
>> Donna Pickett: It's been rare that an insurance company will
actually weigh in. We have had attendance by some representatives, but in terms of actually
submitting formal comment letters on a given clinical entity, no. Generally, they defer
to the clinical subject matter experts for that clinical expertise. How they handle a
code after it's created or how they handle current codes is their business decision.
>> Christopher Snell: We have public comment in one minute, so I'll
just take Lenny's question and then we'll wrap things up.
>> Leonard Jason: It's very good to hear that you occasionally
under controversial times reach out to very important scientific and other advocacy and
legal arenas to basically be able to make these types of difficult decisions. In this
area of CFS, there is an international scientific organization that represents the science of
this particular field. The question I have is, are you aware of that scientific organization?
Would it be appropriate in any way to reach out to that scientific organization that covers
the realm of chronic fatigue syndrome? And could some consultation with some of the officers
of that particular body be instructive at this time, given the controversy that you're
dealing with?
>> Donna Pickett: Well, let me just clarify one thing. We reach
out to external bodies on all issues, whether or not they are controversial. That is just
a standard way of how we conduct the process. So even if it appears to be something that
isn't controversial, we still do that reach back, because you never know when something
is controversial. So we want to make sure that we're talking to everybody as possible.
In terms of reaching out to the international groups, we've not don't that often because
we have within the U.S. which is where the clinical modification is used. We'd look to
U.S. experts. But we have had international experts reach out to us as well on other issues.
They've not necessarily done that with chronic fatigue syndrome. But again, the option is
there. But ICD-10-CM, as was ICD-9-CM, was developed for use in the U.S., so we are definitely
looking to make sure that the U.S. perspective on something is handled correctly, which also
is its own challenge on some occasions.
>> Nancy Klimas: I think a follow-up, though -- this is Nancy
Klimas -- to Lenny's question is that there actually is only one organization, and it
represents the United States. There is no American Association -- in fact, it use to
be the AACFS, and it turned into the IACFS, so it's really the only group of experts to
go to.
>> Christopher Snell: Donna has to be somewhere else, so I'd like
to thank her for attending, some very useful information, and I'm sure we can feed that
into our discussions. And if we have any further questions, can we get in touch with you before
the 18th, Donna? Thank you. Thank you very much.
>> Nancy Lee: And thank you very much, Donna.
>> Donna Pickett: My pleasure. Thank you.
>> Christopher Snell: We just have to do roll call now just to make
sure that nobody's missing in action, and then we'll move onto public comment.
[off-mic discussion]
>> Nancy Lee: So we have three people -- or four -- three
who weren't before. So --
>> Christopher Snell: So we're just doing [unintelligible] now.
>> Nancy Lee: Yes, please. Make it fun. You're standing
out.
>> Deborah Willis-Fillinger: Nice to stand out. Deborah Willis-Fillinger
from HRSA. Thank you.
>> Nancy Lee: And for the people who didn't know, there's
a button on your left to make sure that there's a little red light here.
>> Alaine Perry: Alaine Perry, Centers for Medicare and Medicaid
Services.
>> Charles Wells: Charles Wells, National Institutes of Health.
>> Nancy Lee: I think that's -- so we have everyone up here
from ex-officios and committee members. Let me just give a couple of quick housekeeping,
and then we will start public comment. There is a message board at the back. If people
want to leave messages and get in touch with people. So we have a message board at the
back. The restrooms, you go past the FEMA desk and to the left out here. And just for
the committee members, we will be taking lunch orders at the break. So, let us begin with
public comment.
[off-mic discussion]
She has to tell me what to do here. Okay, so our first person for public comment, and
we will have the people sit at the desk, remember, making sure that the red light is on, is Chris
Williams [spelled phonetically] .
>> Leonard Jason: Just a quick point of order, Nancy. Have we
approved the minutes for last time? And are we going to do that at some point?
>> Nancy Lee: We'll do that. We're -- we had a special issue
this morning because we needed to make sure that we could get Donna here. Well, I think
we should go because we have limited time for our public comment.
>> Christine Williams: Okay. Good morning. Thank you for the opportunity
to provide public testimony today. My name is Christine Williams, and I was privileged
to have served as an ex officio to the CFSAC for the Agency for Health Care Research and
Quality until my retirement from the federal government in June of this year after 30 years
of service. I'm pleased to see my successor, Beth Collins Sharp, is ably taking my place
on the dais today. I spent my career in health policy and health services research, about
half of the time on Capitol Hill as a senior health policy staff to the Senate majority
leader, George Mitchell, and the balance at the Agency for Health Care Research and Quality.
In August of 2008, I had a sudden onset of flu-like symptoms that never went away. I
spent seven frustrating months having doctors tell me there was nothing wrong with me or
that I wasn't tired enough to have CFS/ME. Through my persistent online searching, I
found a practicing physician with expertise in CFS/ME who determined that I had seven
of the eight symptoms established by the CDC. My illness significantly affected my personal
and professional lives. I was no longer able to travel for business, needed to work at
home on a regular basis, and too often, did not have the energy to attend meetings to
develop partnerships for the agency, which was my primary job. Because I was determined
to complete the remaining two-and-a-half years of federal service so I could retire, I spent
most of my limited energy working. I had to decline most after-work activities with my
husband or friends. I spent evenings and weekends on the couch, trying to rest so I'd have the
energy to go back to work. And so, I was very relieved when I was able to retire in June.
I spent my career in government and I believe it can be a force for good and can make an
important difference in people's lives. I've witnessed that positive impact both on Capitol
Hill and in the executive branch. The Department of Health and Human Services has the opportunity
and the ability to make an enormous difference in the lives of people with CFS/ME, but that
opportunity has not been fully realized. I'd like to make a few suggestions about how the
department might move forward towards maximizing that opportunity.
First, the department must provide public and active leadership to move the debate forward.
The secretary, assistant secretary for health, Drs. Collins, Jones, and Lee, have all exhibited
their commitment to this issue, but the commitment needs to extend to all levels in the department
and the agencies. And the leadership must be backed up with action.
Secondly, the department through NIH, ARHQ, and other research agencies and divisions
needs to be a leader in CFS/ME research, making it a priority, building on new studies and
partnering with academic institutions and others in the field. Reverse translational
research from clinical experience must be part of this effort.
Thirdly, HHS needs to be part of the dialogue around the recently developed international
consensus criteria which demonstrates progress towards sharpening the case definition for
CFS/ME. A more refined case definition could be the basis of improvements in focused research,
patient registries, et cetera. The existing babble and broadness of case definitions is
a barrier to meaningful research and other critical efforts to find answers to this complex
illness.
Fourth, HHS can convene stakeholders. The 2011 State of the Knowledge Conference at
NIH was an important start. Some of the researchers at the table had never connected before. HHS
can create and facilitate an ongoing learning network with these researchers and clinicians
to help them connect the dots across disciplines.
And finally, the department must beef up its efforts to coordinate activities and initiatives
across its agencies through this committee or through another group. Agencies should
not duplicate efforts, and they need to know what others are doing. They need to partner
to maximize resources and initiatives. And they must be a source of current scientific
information on all of their websites.
Finally, don't let difficult fiscal times and bureaucratic red tape be a barrier to
progress. There are actions this department can take now. Move forward on the name change
and other existing recommendations from this committee, which have been pending for some
time. When the AIDS epidemic hit in the '80s, HHS rose to the challenge to find treatments
for people who were dying. Patients with CFS/ME have lives that have died. They're in beds
and on couches watching the world pass them by. This department needs to be a real leader
in the search for effective treatments so that people can recover. And I know this great
department of the people can rise to the challenge. Thank you.
[applause]
>> Christopher Snell: Thank you, Chris. Your input is appreciated
as always.
>> Nancy Lee: The next speaker is Mary Dimmick [spelled
phonetically].
>> Mary Dimmick: I'm sorry. I thought it was this afternoon.
>> Nancy Lee: We apologize. We are having last minute changes
>> Mary Dimmick: Not a problem.
>> Nancy Lee: You know what I could do? Let me just quickly
list the next few so that people know they're -- what's the order.
>> Mary Dimmick: That's a good idea.
>> Nancy Lee: So after Mary, we will have someone from the phone who will get through,
then Andrew Bokelman [spelled phonetically], Mary Schweitzer [spelled phonetically], Pat
Fero [spelled phonetically], Kim McCleary [spelled phonetically]. Thank you.
>> Mary Dimmick: Thank you. Let me know if you can't hear me.
I talk softly. Thank you for this opportunity to talk to you today and for all that you
do for the ME/CFS community. I am the mother of a 24-year-old man who came down with ME/CFS
in 2010. Since then, I've had to come face to face with a harsh reality, that my son
is sick with a disease that others have suffered from for almost 30 years, 30 years during
which our government has neglected patients by seriously underfunding research and diddling
around with studies focused on psychiatric issues, decades during which government mislabeling
and inadequate definitions have led to the devastating disease being hopelessly confounded
with general fatigue and depression. Breathe.
I wake up every morning thinking that this really can't be happening to my son. What
parallel universe have we just entered? I am here to ask you today for two things that
are critical to getting us out of this mess: the reclassification of CFS in the ICD-10-CM
and the replacement of Fukuda [spelled phonetically].
Regarding the CFS reclassification, first let me state the obvious. CFS is a terrible
name. It needs to be abolished, but CFS, not ME, is the term that we have to deal with
in this country right now and other places as well, and it's not going to change overnight.
Until CFS is replaced with the term "ME," it's critical that CFS be properly defined
and classified.
Regarding the presentation that Donna had made, I give you a couple quick notes. CFS
is already listed in ICD-10 under neurological. It wasn't indicated in her presentation, but
it already is there. Regarding option two, the concern with option two was that, as stated,
the intent was the use CFS for non-viral cases and PVFS and ME for viral cases. The best
case definitions in the world did not discriminate this on the nature of the trigger, and it's
not appropriate for it to do so in the classification. It's also not appropriate to continue to list
chronic fatigue syndrome underneath chronic fatigue. I'm a lay person, and if I can go
in and survey this literature, figure out that it's a neurological disease, it certainly
shouldn't be listed under chronic fatigue.
Given the CFSAC role to advise HHS on the science and definition of ME/CFS, I call on
NCHS to partner with you to ensure that the final classification decision reflects the
best option for both NCHS and this community. And it must be done in an expedited fashion
before ICD-10-CM rolls out in 2013. Donna indicated that that was an option. It has
to be done before roll out.
Reclassifying ICD-10-CM is not enough on its own. It's important but not enough. It also
brings me to my second request, and that's it's time to ditch Fukuda. It has to go. Patients,
when this proposal came out, voiced a legitimate concern that we're reclassifying CFS as neurological,
and we have a case definition that doesn't support that. The concern is that Fukuda does
not describe a neurological illness. It does not adequately describe all of the facets
of the disease or even require the hallmark post-exertional neuroimmune exhaustion as
a necessary condition. What have we gotten instead with Fukuda? And I quote, "a conceptual
framework to study fatiguing illnesses and a Chinese menu of optional symptoms." No wonder
ME/CFS has become so confounded with depression and chronic fatigue. No wonder we have such
paltry and potentially harmful information on diagnosis and treatment on the CDC website.
God help the patients if the latest CDC educational efforts are still using this same foundation.
With its focus on fatigue, Fukuda is incapable of reflecting what is known today about ME/CFS,
but we have choices. We all know about the Canadian consensus criteria. We all know about
the ME international consensus criteria that's just come out. These case definitions have
been shaped by ME/CFS experts that people in this room, working with real patients over
the last 30 years, they reflect the specific nature of ME/CFS and accommodate the evolving
science and resulting standards that will come from that in a way that Fukuda will never
be able to. Given your role as experts on the science and definition of ME/CFS and advising
the HHS on this, I call on the CDC to partner with you to take the reclassification recommendation
to its logical conclusion, get rid of Fukuda, and replace it with MEICC [spelled phonetically],
a case definition that is grounded in the science of today, not the misperceptions of
1994.
Until both of these things happen, a million sons and daughters are going to continue to
suffer and die in their parallel universe. And I hope for your sake that the next one
is not yours. Thank you.
[applause]
>> Nancy Lee: Thank you very much. Our next speaker will
be by phone and has requested to remain anonymous, so we will not identify this speaker.
[off-mic discussion]
>> Nancy Lee: Excuse us while we figure this out.
[off-mic discussion]
>> Female Speaker: Hello.
>> Nancy Lee: Yes, this is Dr. Nancy Lee at the CFSAC committee,
and you requested to provide testimony for our committee.
>> Female Speaker: Yes, I did, Dr. Lee. Thank you.
>> Nancy Lee: So I think you're very quiet right now. Let's
>> Nancy Lee: Well, no, it's not your problem. We have to
get the mic.
>> Nancy Lee: There, now that's better. Go ahead.
>> Female Speaker: Should I just talk for a little bit until
you get the volume calibrated?
>> Nancy Lee: I think we're -- I think it's good now. Can
we -- people back at the back here? Yes, we're good. Go right ahead. And you have five minutes.
>> Female Speaker: Okay, thank you very much. Today I'm going
to talk about money and death, show you why many patients with ME are dying from microvascular
cardiac disease, and introduce you to the Women's Ischemia Syndrome Evaluation, or WISE,
an NIH initiative which presents a huge opportunity for research synergy and funding on heart
disease and ME. I'm asking you to follow the money, follow the debt.
First of all, definitions. The endothelium is the inner lining of blood vessels. Microvascular
refers to the smallest vessels. Ischemia is when your tissues are oxygen starved. And
atypical angina is when you get ischemia but have unobstructed coronary arteries. Persistent
undiagnosed chest pain is rampant among ME patients, yet patients presenting with atypical
angina receive rote cardiac tests focused on blocked coronary arteries which routinely
miss microvascular disease. WISE researchers don't fully understand the mechanism of ischemia
and their patients, but they know that patients with clear-as-a-bell coronary arteries can
still have deadly ischemia. They might have coronary artery vasospasm, tightening the
coronary arteries, reducing blood flow to the heart. They might have inflammatory narrowing
of the lumen of the microcirculation. What WISE researchers do know is that microvascular
and endothelial dysfunctions can and do kill. If ever there were a research direction for
CFSAC to recommend, it's into the causes of premature death in ME. The NIH must learn
that ME for many is fatal and invest accordingly.
The WISE research is strategically funded in continuing NIH initiatives with which CFSAC-sponsored
researchers could dovetail. The profile of WISE patients is uncannily similar to that
in ME. There are many unanswered questions by WISE teams, which ME researchers could
help answer. It's a win-win. The WISE research erodes because, contrary to popular myth,
women die far more often than men from cardiovascular causes. In studying 80,000 men and women,
cardiac mortality was 12-fold higher for middle-aged women than men. Women with crystal clear coronary
arteries are dropping dead prematurely after years of atypical angina and neglect. The
WISE research look for novel markers for women's cardiovascular risk. And they found a pattern
that should be eerily familiar.
I submit WISE researchers are studying a population with significant representation by ME patients.
Here's why. WISE teams found their patients had an inflammatory cytokine signature including
IL6 in celiac [spelled phonetically] of protein and that generalized inflammation predicted
higher cardiovascular risk. They found comorbid conditions like IBS and FM and other signs
of microvascular disease like [unintelligible] and migraine. They found abnormal lactaid
production, abnormal metabolism, and that exercise stress shifted reliance to anaerobic
metabolism. They found abnormal pain perception and overlap with metabolic syndrome. They
found high oxidative stress. And it was predictive of endothelial dysfunction and of cardiac
prognosis. They found low functional capacity and early mortality from heart disease. They
found harm avoidance, or was this post-exertional relapse? They found abnormal autonomic perception,
or was this undiagnosed orthostatic intolerance? And they found a high frequency of past treatment
for depressive symptoms. And most ME patients have, at one point or another, been mislabeled
with depression.
Given the many parallels between WISE and ME patients, research into microvascular endothelial
pathology could prove pivotal for both groups. Bottom line, atypical angina is a condition
in which the NIH is pouring money and attention into. WISE researchers found that smaller
anatomy, different hormones, and predisposition to vascular pathology prime women for microvascular
dysfunction. If so, then many women with ME with their high oxidative and [unintelligible]
stress, inflammatory cytokine cascades, and prevalence of vasculitic symptoms should be
sitting ducks for microvascular dysfunction. Atypical angina is not restricted to women,
and I'm not the only one pointing to microvascular risk in ME.
Thanks Drs. Mikovits [spelled phonetically], Mason, Broderick [spelled phonetically] and
the University of Dundee [spelled phonetically]. But as a first step, overt collaboration with
WISE teams could supercharge funding and foster recognition of the seriousness of ME. We could
help WISE researchers differentiate depression and anhedonia from OI and PEM. But this won't
happen if magnified CFS cohorts such as Fukuda are used.
So, please, follow the deaths. Follow the money. Set CFSAC priorities that show recognition
that ME can and does kill. And use robust ME criteria such as the CCC or ICC that require
PEM. Additional information recommendations, WISE team contact information and references
are in the appendix. And shame on CFSAC for not making this meeting accessible to disabled
and housebound ME patients through live video streaming. Thank you.
>> Christopher Snell: Thank you.
[applause]
>> Nancy Lee: The next speaker is another person by phone,
Andrew Bokelman [spelled phonetically]. So I will make that call.
>> Andrew Bokelman: Hello.
>> Nancy Lee: Yes. Mr. Bokelman?
>> Andrew Bokelman: Speaking.
>> Nancy Lee: Yes, this is Dr. Nancy Lee at the CFSAC meeting.
Are you ready to give your testimony?
>> Andrew Bokelman: Yes, I think I am.
>> Nancy Lee: Thank you. You have five minutes, sir. And
I think people can hear at the back of the room -- yes, we're getting a nod. So go right
ahead.
>> Andrew Bokelman: Okay. Thank you to the CFSAC for allowing
me to speak. My name is Andrew Bokelman. Before I became ill with chronic fatigue syndrome,
I didn't take it seriously, but now I can tell you just how serious it is.
In 2005, I was hit with chronic fatigue syndrome. In January 2008, I was diagnosed with prostate
cancer. Three months later, I was diagnosed with squamous-cell carcinoma in my tongue.
And now I also suffer collateral damage from cancer treatment. And after all of this, I
can honestly say that having chronic fatigue syndrome has been much worse than dealing
with two cancers, because it is not cancer that keeps me from working and visiting friends.
It's not cancer that makes me so sick I need help with basic personal care. It is actually
chronic fatigue syndrome that has destroyed my life as I used to know it.
Some people dismiss CFS because many of us don't look sick. But I also didn't look sick
when I was diagnosed with cancer. And nobody used this to dismiss cancer. Other people
dismissed CFS because some of us can articulate with the same strength and focus as healthy
people. But I also articulated okay with a cancer tumor in my tongue. And I still can
despite scar tissue from radiation treatment. And nobody uses this to dismiss cancer. With
most illnesses, people are seen as heroic for all they accomplish despite being sick.
But with CFS, our accomplishments are used to dismiss us. They are used to discredit
us.
So what is causing this dismissing attitude? I think one problem is with the [unintelligible]-centric
model. The illness name is misleading. The description is misleading. Most doctors who
know the full description still think in terms of fatigue. They look only for energizing
solutions. They ignore inflammation, immunity, and neurocognitive issues. In my opinion,
part of this problem could be solved if the name and description were changed according
to the international consensus criteria. But I also think the available information about
CFS is a problem.
Imagine, if you would, that someone did a study on subjects who have chronic coughing
and gave them sugar lozenges and found moderate improvement in some subjects. And then I took
this study and claimed sugar lozenges treat asthma while ignoring that the subjects were
not evaluated for asthma, only for chronic coughing. Sounds crazy, doesn't it? Yet, this
is the type of thing that's being done with CFS. For example, on the Centers for Disease
Control website, there is treatment information that cites Oxford criteria studies. These
criteria define a different syndrome that only requires physical and mental fatigue.
No sore throat, no tender lymph nodes, no post-exertion malaise. So it is not chronic
fatigue syndrome as defined in the United States. It only has the same name.
And using different syndromes as if they are interchangeable is bad science no matter what
you name them. Yet, the CDC and others have been doing this for years. Do you think the
Department of Health and Human Services would be complacent if their divisions used generic
coughing studies to evaluate treatments for asthma, pertussis, or lung cancer? Would you
like this approach used with medical care of your family?
In my opinion, the DHHS should stop condoning this. And instead, they should explain to
people how this corrupts the understanding of CFS. Further, the clinical section of the
CDC website is missing important information about medications. Now, I realize that pharmaceutical
research is very limited. But it is more reliable than treatment models based on the wrong syndrome.
So why not include the better medications but also explain the limitations? There is
new leadership in key positions at the DHHS and CDC, so finally, the possibility exists
for ending the practice of misrepresentation and selective omission of CFS information.
I've seen some positive change already. I hope this is a sign for more to come and not
just a brief flurry of activity. Thank you for letting me speak.
>> Nancy Lee: Thank you, sir.
[applause]
>> Nancy Lee: Okay, so Mary Schweitzer [spelled phonetically]
is the next speaker, and we're going to distribute her testimony while she's getting up to the
microphone. And just a minute, Mary, let's finish the distribution. Thank you very much.
Okay, you may begin. Thank you, ma'am.
>> Mary Schweitzer: Good morning. My name is Mary Schweitzer.
I have been sick with this disease for 16 years, probably for 20 years, but I know for
16 years. I was a rising professor of history when I was struck down with it. Most people
here know my history. If you don't know my history, I'll be glad to explain it to you.
I don't want to waste time doing that now.
The only reason I am here able to talk to you is because I'm on the experimental immune
modulator, Ampligen, which I have been on, on and off, since 1999. When I am not on it,
I relapse. I get too sick to be very coherent. I don't understand much of what's said to
me. I'm in severe pain behind my eyes, back of my neck, severe headaches. I can't handle
light. Obviously, I get to the point where I shuffle. I have to lean on walls and things
to walk. According to my doctor, I have viral encephalitis. Dr. Inlander [spelled phonetically]
calls that encephalitis, so I have viral encephalitis. I also have significant CNS damage, which
would -- and I have a lot of muscle pain. Together that is myalgic encephalomyelitis,
or encephalomyelitis, as he would say. And that is what I have, pretty much by definition.
That's my symptoms.
Now what else do I have? I am positive for a lot of immune defects, and I am positive
for a toxic stew of viruses, some of which are in my spinal fluid. I have HHV-6 variant
A, HHV-7, cytomegalovirus, [unintelligible] EB, and I have -- I just got over another
round of EBV. I've been diagnosed seven times in the last 20 years with EBV. All of these
are -- two of these are in my spinal fluid. The rest we're getting out of my blood. It's
disingenuous to think there's no relationship between the viruses that are in my spinal
fluid and my encephalitic symptoms. One would think they were connected. But if you go to
CDC's website, you would have no idea they were connected at all because CDC doesn't
mention them.
Now, I was going to -- and that's what I wanted to talk about today which is the discussion
du jour tomorrow, which is CDC's website. I was going to talk about the paragraph, D
paragraph that says do not test for viruses unless you want to say a person does not have
CFS. And I just noticed that the paragraph has changed. So that's very nice. The paragraph
has changed on the website like in the last two days. It is better. But it still says
if I am positive for Epstein-Barr virus, I don't have CFS. Now that's fine with me. I
don't really want CFS. I hate it. Is that true? If I don't have -- if I'm positive for
Epstein-Barr virus, I don't have CFS? On the other hand, in the recent press release about
EBV vaccine, EBV's a very nasty disease. If I am positive for it at least seven times
in the last 20 years, is there a danger I could get cancer? CDC doesn't have any information
on this, but Dan Peterson does. And I suggest you listen to it.
What about the other viruses I have? What are they doing to my body? That's why I have
to stay on this medicine, but it costs my family an arm and a leg and our firstborn
child. We're paying $20,000 a year at least in medicine and testing alone. That brings
to me what I was not pleased with which is the CDC's toolkit for professionals. There's
two new ones, which somebody [unintelligible] alerted me to. I wasn't aware of it. There's
one that has a red cover and it's 8.5-by-11. And there's a pretty tri-fold with all sorts
of multi-colors and it's very nice. Both of them do the same thing. They emphasize cognitive
behavior therapy and graded exercise as the treatment of choice for patients with my disease.
Now CDC has always said, "Oh, you know, you'll do better with some kind of psychotherapy
if you have a chronic illness, and exercise is good for you." Hm, that again is disingenuous
because there are hundreds, if not thousands, of research articles with a very specific
type of CBT and GET for people with my disease, and that's what's being talked about. And
if you don't think that's what's being talked about, then why is there a link on the website
to St. Bartholomew's Hospital in London, which is British National Health Service and has
graded exercise therapy and cognitive behavior therapy? The theory behind this is that we
have inappropriate illness beliefs. We aren't really sick any more. We can learn to be well
by having appropriate illness beliefs. What looks like sickness is really deconditioning,
so graded exercise will make us normal. And that's the theory behind it, and that is what
your website links to.
It's not a surprise because Peter White has been a frequent advisor to this board. And
Peter White is a psychiatrist at St. Bartholomew's Hospital. In fact, that's his psychiatric
practice that you've linked to. Peter White is also chief medical officer of two insurance
companies, as there's also insurance links with the two other British psychiatrists you
people have used as advisors, Simon Wessely [spelled phonetically] and Michael Sharpe
[spelled phonetically]. Now, the cognitive behavior therapy, we're going to pass on that.
That's just sort of silly to think that you can cure somebody from HHV-6 and EBV and myalgia
encephalomyelitis with cognitive behavior therapy.
What I'm worried about is the graded exercise part. We have on this committee, the chair
of this committee in fact is a gentleman named Christopher Snell who has done some excellent
research on what is called post-exertional fatigue, which is a major symptom of my disease.
I prefer to call if post-exertional relapse. What he's done is he, Staci Stevens, and others
at Pacific Labs did VO2 max stress tests of patients with this disease. And I've got to
say high-functioning patients, because I score 15 on the first day. You wouldn't let me do
a second day, I'm sure. But high-functioning patients and couch potatoes, people who are
deconditioned. They scored the same on the first day. But you bring them back the second
day, the couch potatoes do a little bit better because they're more used to the test. The
patients with my disease scored half what they did. It plummets. That's not a good thing.
The VO2 max test is something used for cardiac patients. And not scoring well on the VO2
max test means that you're not using oxygen properly in your body, and you're not dispensing
carbon dioxide properly. We can't do aerobic exercise. We can't physically.
That test shows it.
So what you are advocating is, one, cruel. Cognitive behavior therapy for a person who
is really sick is cruel. Would you do that to a cancer patient? "Hi. You have lung cancer.
"Step over here, and we'll discuss your illness beliefs." Would you do that? Well, that's
what they do to us.
Second oh, I forgot. Blue Cross Blue Shield of New York Empire Blue Cross Blue Shield
is refusing to reimburse me and, therefore, my Delaware Blue Cross Blue Shield won't reimburse
me because they want me to go for 10 weeks of cognitive behavior therapy first. So it
has snuck into the United States insurance system thanks to the CDC, and thanks to these
insurance psychiatrists.
The second is it is not only cruel. It is dangerous to have people do graded exercise
if you do not know what's going on with their systems. Dangerous. It's got to stop. And
where it's really dangerous is in the hands of bureaucrats and when teenagers are involved
because they're going to kill them.
Thank you very much. Glad I had a chance to speak. Good luck tomorrow.
[applause]
>> Nancy Lee: And thanks for observing our time limit. I
appreciate that. The next speaker is Pat Fero. And you have five minutes. Pat?
>> Pat Fero: I don't do gadgets well. I'm sure [inaudible]
[talking simultaneously]
>> Nancy Lee: It's on right now. You're fine. I see the
red light; so go for it.
>> Pat Fero: Go on red, all right. My testimony is on potential
misuse of funds, NIH grants.
>> Nancy Lee: Oh, oh.
>> Pat Fero: What you have --
>> Nancy Lee: Just one moment, Pat. We're --
>> Pat Fero: Yes.
>> Nancy Lee: We're handing out the -- does everyone have
it now? I'm sorry. Go right ahead.
>> Pat Fero: Thank you. The testimony that you have right
now is what I sent in, minus a list of names and grants, individual expenses and so on.
You don't have that part. So and I hadn't intended to read any names anyway. I think
that just sort of [unintelligible] and rude to be talking about people and not having
a basis for that. At any rate, this committee has always been concerned about misuse of
funds. I want to make it perfectly clear that I believe after nine years of talking with
NIH people, I've met some gracious, wonderful people over the phone, in person, that there's
no one in this room that's responsible for misuse of funds.
I took a tutorial recently, July 2011, made by the grants.gov. You can go there. It's
on the first page. It's wonderful. Defining "misuse of funds," I'm not talking about embezzlement,
but there are different kinds of misuse of funds. So based on that and my background
knowledge, I recruited a miracle woman Charlotte Vonsails [spelled phonetically] to help me
go through all the information I had, highlight those folks where I was concerned, and then
we went through a process, a process that started in where the GAO report went off left
off in 2000. We went to 2010 because that's the area where I'm most familiar, highlight
those people where we thought there was some question because we're not familiar with them
like who's Caldwell [spelled phonetically]? You know, our group is fairly limited.
And then we had criteria. You won't find this much of this. I did some change at the end
of your testimony. I said I reserve the right to change those. Went through the criteria.
We took the grant number, the researcher's name, anything we could find about that person.
Let's take [unintelligible] Caldwell, for example.
We went to the NIH RePORTER, looked at all tabs and took went to every link from those
tabs to find anything about chronic fatigue syndrome or anything related to chronic fatigue
syndrome. We looked at the PI's affiliation. Oftentimes on an academic website, you'll
see a team a picture you'll see something where the researcher has published the researcher
has an interest in it's there. For every Dr. Snell, Dr. Jason, Dr. Cook I mean, it's there's
information on CFS. We followed and it could be a mouse. It could be blood. It could be
questionnaires. It could be anything, something to indicate that this person had actually
done worked with chronic fatigue syndrome.
We went to PubMed, looking for any stray publications. We went to clinicaltrials.gov, looking for
any past recruitment or current recruitment for clinical trials and, last of all, Google
you can find much on Google and followed all the links. So it's a two to three hour process
per person. We started out with 47 researchers. We had concerns about our goal was to eliminate
as many as possible. We're not out to get anyone. That's not the point. There's two
kinds of misuse of funds that are on those lists. I'm just going to give some examples
at the end.
One is where first of all, misuse of funds. And I lost my spot. A little tough. Let's
see. I have to find it. This is important. It's misuse of funds to materially deviate
from the intent of the grant. Now, if a grant says "orthostatic intolerance in CFS" but,
actually, the person's starting "orthostatic intolerance in diabetics" or in something
that's unrelated, and you simply can't find anything on CFS or there's no publications
et cetera, then that materially deviates from the abstract or what the research was renewed
for or got the order for. The other kind is where the grant has nothing at all to do with
CFS. [laughs] There's a little one on here called "CFS computers." We left it because
it was kind of funny. We had a good time trying to do this. It's a small grant but, nonetheless,
CFS computers that's probably a clerical error.
Using CFS funds on the last RFA, there was one grant. It was called human spinal cord
glial cytokines and pain and chronic pain. I have been watching this one since 2007 thank
you 2007. The total now is $1,000,310 [spelled phonetically] and one million 310 [spelled
phonetically] is that 840? Numbers a problem [spelled phonetically]. I've been watching
it, looking at the website. I'm doing done everything I can with that grant. Finally,
I called Sun City [spelled phonetically], Arizona, to find out if indeed the purpose
of the grant was to set up a biobank. First researcher left. Second researcher is in the
process of leaving. The department is shut down. There was never an FM [spelled phonetically]
biobank there. There was no intention of setting up an FM biobank.
I have done everything I can to look at this grant. It's a million, three. That's a lot
of money. Dr. Klimas or Dr. Jason could use that money. So there are people that's one
kind. Another kind is a person who says children of CFS patients, the offspring no. Patients
with or parents well the effect of parental CFS on offspring. I scoured these, trying
to find anything to clear the names off the list. So you don't have a list of those. It's
not probably important that you do have them, but what you need to know is that I used the
best source material I could come up with. I used FOIA requests to get basic information.
Charlotte and I combed everything, if someone is using CFS money that's in the CFS budget
-- because these were all FOIAs, Dr. Lee. This came from the NIH; so I used those figures.
I didn't, you know, add them up on my own.
So the -- we intend to file this with the Office of Inspector General and we very I'm
hoping that we're wrong, but $18.65 million is a whole lot of money, and that was the
total.
Lastly, I do have one it's a request for you, Dr. Lee, or
>> Nancy Lee: Well, would you give it to me after the meeting?
>> Pat Fero: Oh, good. All right.
>> Nancy Lee: [inaudible] fine.
>> Pat Fero: Okay. Thanks.
>> Nancy Lee: Thank you.
[applause]
>> Nancy Lee: The next speaker is Kim McCleary [spelled
phonetically], and then after that we're going to have another phone call. Yes. And let's
just have one minute, Kim, while they pass out your testimony.
Okay. Go ahead.
>> Kim McCleary: Thank you. Name is Kim McCleary. I'm president
and CEO of the CFIDS Association of America. Thank you for the opportunity.
Two years ago when this committee met in October 2009, the session held in the great hall of
the Humphrey Building had star power, the main attraction, XMRV. Called there to speak,
retrovirology expert John Coffin, pioneering CFS experts Daniel Peterson and David Bell,
and DHHS blood safety expert Jerry Holmberg. Testimony from patients and their advocates
pleaded for you to investigate the finding published in Science Magazine just days earlier.
You did. DHHS mobilized resources across its agencies: the National Institutes of Health,
the Centers for Disease Control and Prevention, Food and Drug Administration.
The blood safety community was rapidly engaged in these efforts through two, then three task
forces. The Blood XMRV Scientific Research Working Group commenced a four phase multi-lab
study to evaluate testing methods and measure the threat that XMRV posed to the blood supply.
Several intramural programs within the National Cancer Institute, the CDC's retrovirology
group and at the FDA, developed testing methods to look for XMRV and close cousins. When publications
from CDC and FDA/NIH groups were at odds, the National Institute of Allergy and Infectious
Diseases recruited renowned virus hunter of Ian Lipkin of Columbia University to design
and coordinate a multi-center study that would draw patient samples from expert physicians'
practices across the U.S. and utilize the various labs' own test to look for evidence
of this family of retroviruses.
The NIH Clinical Center recruited a new cohort of CFS patients and completed detailed work-ups
at the nation's largest research hospital facility. The FDA's Blood Products Advisory
Committee dedicated substantial segments at two of its meetings to hear from safety experts
about the risks these agents posed. The Red Cross and America's Blood Centers instituted
new policies to educate every potential donor, millions of people, about CFS and to defer
any potential donor with a past or present history of CFS. Other countries applied similar
policies. That's what action looks like.
Now, with more than 20 studies that have failed to confirm that initial finding, new information
about the recombinant origin of XMRV, in recognition that it is a common laboratory contaminant,
it appears the specific threat, the sound of the alarm bells has mostly passed. The
agencies' emergency management systems got through the drill. Thank you.
But guess what? CFS is still here. CFS is still wreaking damage on the lives of at least
one million Americans and millions more around the globe. CFS still presents a threat because
we don't know who will get it or why. We can't easily diagnosis it, and treatment is still
a patchwork of relatively unsatisfactory symptomatic band-aids. So out of the small country of
Norway, on October 19, again, just a few days before this meeting, comes news about a small
phase two study of Rituxan that showed tremendous promise for 67 percent of the patients who
received just two doses. Now the hunt is on for better clues as to why this therapy worked
and how to make it better through follow up studies, but right now that hunt is only going
on in Norway.
I see tremendous opportunity to leverage many of the resources that were assembled to address
XMRV, a well characterized CFS cohort already identified by physicians at the NIH Clinical
Center, where there's tremendous experience with the use of monoclonal antibody therapies,
I might add. The NIH Undiagnosed Diseases Program reported a few weeks ago that in its
first two years of operation, one of the most common diagnoses it made was CFS, another
source of patients for study.
The NIAID has invested in a multi-center network through the Lipkin study to collect samples,
and CDC will convene a collaborative group of CFS experts later this month to talk about
patient issues. This could be the beginning infrastructure to support a long needed clinical
trials group that could be activated to pursue findings such as the one from Norway.
I hope I leave this meeting with a stronger sense that the emergency alert system that
responded so effectively to XMRV will not go dormant. The main attraction that draws
us here today, CFS, is still here. We need you to mobilize as urgently as you did two
years ago to disarm it. Thank you.
[applause]
[off-mic discussion]
>> Nancy Lee: So the next person is somebody who is going
to have a proxy read his, her -- his testimony. And so I'm going to make that phone call now.
Yes. Tina Tidmore [spelled phonetically] is going to be reading the testimony of Toby
Volkel [spelled phonetically].
>> Tina Tidmore: Hello?
>> Nancy Lee: Yes. Is this Tina Tidmore?
>> Tina Tidmore: Yes, it is.
>> Nancy Lee: Yes. My name is Dr. Nancy Lee. I'm the DFO
for the CFSAC Committee, and I understand you are going to read the testimony for Toby
Volkel?
>> Tina Tidmore: Right.
>> Nancy Lee: Okay. You may go. You have five minutes.
>> Tina Tidmore: Thank you.
>> Nancy Lee: Thank you.
>> Tina Tidmore: In our society, being a man is associated
with emotional strength, physical strength and a strong character. I would like to ask
the man on this committee, how would you feel if your physical strength was taken from you
at age 18, as it was for me?
Remember how manly you felt at 18? How would you feel if you tried to live on your own,
but ended up living with your mother at age 34 because you cannot care for yourself? How
would you feel if you could do none of the things that attract a woman, that is, get
a job, provide housing or a car or even have the strength to carry her over the threshold?
How would you feel if a woman has to hold the heavy door open for you and your mother
has to open the jars you can't open? I have lost not just my vitality, recreation and
the hope for a career. I have also lost much of my manhood, or really, I never got it.
However, I have not lost the strength of my character. And so with courage, I am using
my strength, my courage, to hold you, the government agencies, accountable to the American
public, including me.
In the last meeting, a CDC ex officio agreed to have some committee members advise the
CDC on making changes to website. Have you dropped the ball or is the CDC resisting to
changes? We have a right to know. Do you have the courage to show more loyalty to the patients
instead of your fellow committee members or government employees and openly tell us why
this has not been done in six months? I expect the CDC to correct the misleading and outdated
information on their website or take it down within the next month. I also expect the CFSAC
to provide live video stream of the meeting in recognition of the cognitive limitations
we have. Do you really expect our patients to be able to hold a phone to their ear for
five straight hours, two days in a row, and try to take notes? This would be difficult
for a healthy person, much less the physically and cognitively disabled patients. I also
expect this committee to create a more fair system for public comment such as simply first
come, first served.
And who put CFS in a different code in the United States than every other country and
on what basis? And why is there continued resistance to the fact that the illness in
the United States, the one of the outbreaks at Lyndonville and Incline Village, the one
labeled CFS, is the same disease of the outbreaks in the United Kingdom at the Royal Free Hospital?
It is one disease. Just as there are varying forms of lung cancer with many different causes,
such as asbestos and smoking, in our case, there may be subgroups and different triggers,
but we all have one disease.
The NCH option two contradicts the World Health Organization's ICD-10 coding in the clinical
code manuals used in Canada, England, Germany and Australia. It contradicts the research
studies that show CFS often has a trigger; and I'll point out, this is the CFS labeled
studies. It is the Fukuda criteria. Also the CDC shows that CFS often does have viral triggers.
The option two will make it so physicians are confused as to what research to apply
to their patients. Do they have to determine the trigger, which is hard to do six months
after the fact? And if it is a virus, do they only look at ME research and say that CFS
research doesn't apply because it is a different illness with a different code?
Option two makes it so my illness has two codes, and it will classify myalgic encephalomyelitis
and post-viral fatigue syndrome as, quote, other chronic fatigue syndrome, which makes
it the lead term for the disease; however, option one, with ME, PVFS and CFS in the same
code, corrects all those problems and puts it in the chapter for neurological diseases
where it should be, and it brings us closer to doing away with the CFS term by showing
there is one code for the one disease, so I expect you to recommend adopting option
one.
Do you have a strong enough character to take a stand for what is right and do your duty
to the American public? Will you courageously do the right thing, or will you allow the
system to turn you into a wimp? I am a man. Are you?
[applause]
>> Nancy Lee: Thank you very much.
[off-mic discussion]
>> Nancy Lee: Okay. So we have -- I think we have time for
one more speaker. Nancy McRory Richardson [spelled phonetically]? And we're passing
out her testimony. Now, Ms. Richardson, if you'd -- wait a minute.
And after this, we'll have a 15 minute break.
Okay. Ms. McRory.
>> Nancy McRory Richardson: Thank you. It's -- I'm the education and outreach
director for Hemispherx Biopharma, and thank you for letting me speak.
Let me bring you up to date on our progress with Chronix Biomedical with whom in March
2011, we filed a provisional U.S. patent application on a blood test for chronic fatigue syndrome,
CFS. The Chronix experimental approach analyzes fragments of DNA often released into the bloodstream
during the process of apoptosis or programmed cell death. Chronix is using its proprietary
technology and advanced DNA sequencing platforms to measure alterations in specific regions
[spelled phonetically] of the chromosome which can be detected as distinctive signatures
in cell free blood borne DNA. By focusing on these signatures, Chronix's technology
can detect the presence of disease damaged cells and simple blood samples without needing
to biopsy disease -- excuse me -- diseased cells or tissues.
We believe the patented unique signatures captured by Chronix technologies have the
potential to be useful as a companion diagnostic for CFS. In designing and implementing any
new CFS trials, it was suggested by the FDA in their complete response letter to our new
drug application, NDA, it would be valuable to first have a capability of utilizing a
reliable diagnostic test to better identify potential participants. Once we have the confidence
the Chronix diagnostic test is predictive, it will be appropriate to meet with the FDA
to discuss the protocol for a phase three clinical trial. As there is no diagnostic
test available at this time, the Chronix test may provide such a diagnostic, and further
studies may also be able to predict differences in how individuals may respond to Hemispherx's
experimental drug, Ampligen.
During IACFS/ME biannual conference held on September 22 to 25, 2011, in Ottawa, Hemispherix
presented initial findings of our studies of the potential CFS markers. The aim of this
recent CFS study was to find signature DNA sequences from patients with CFS, compared
to healthy controls with respect to their diagnostic predictive value as well as potentially
to provide new insight to CFS biology. DNA extracted from serum samples of CFS subjects
and normal health controls were sequenced and compared to human genome. A total of about
10,000 high quality sequence read were generated from each serum sample, and four genes were
identified that separated CFS patients from the normal control group. These results support
additional studies with the larger CFS cohort, using more powerful sequencing platform and
the aim of establishing predictive clinical assays for diagnosis and evaluation of CFS.
The initial findings from more powerful platform are encouraging and consistent with previous
results; therefore, we plan to accelerate this line of investigation with Chronix. In
our original request to the FDA for an extension of time in response to their complete response
letter to our NDA, we submitted a protocol to prospectively analyze samples from our
phase three study, AMP 516 [spelled phonetically], for markers of a retrovirus called XMRV. During
the course of this past year, the results of the number of studies by experts in this
area have been unable to duplicate the original findings of Dr. Mikovits. Our current understanding
of the science is that there may be a detection of some type of gamma retrovirus; however,
the assays are too complicated and costly and, therefore, it is a route we will not
continue to pursue at this time. As with many in the CFS community, there's been the sense
of disappointment; however, it does not change the positive effects of Ampligen in many CFS
patients.
Based on the initial findings of -- initial findings with Chronix, we've recently drafted
a letter to request an extension to our NDA in accordance of the Code of Federal Regulations.
Those regulations state that failure to take any action would be considered a withdrawal
of the application unless the applicant has requested extension of time to resubmit the
application. The regulations specifically state that the FDA will grant reasonable requests
for any such extension. We anticipate that the letter will be submitted to the FDA by
November 25, and request -- and the request will be granted in due course.
In February of this year, we reported it would take approximately eight months to three years
to complete an Ampligen clinical trial from the date the study is commenced, three to
six months to close out the study and file the necessary documents to the FDA. The actual
duration to complete a clinical trial may be different based on studies when the study
commences, the final FDA acceptance of design, the availability of participants, availability
of qualified clinical sites. Other factors could also impact the implementation of a
study of analysis or requirements of the FDA or other governmental organizations.
Some of you are aware that the FDA released on the news on the assignment of drugs developed
to treat chronic fatigue syndrome which states applicants for the products being developed
to treat chronic fatigue syndrome had previously been assigned to at least six different divisions
with OND [spelled phonetically] and the Office of New Drugs. It went on to say that, effectively,
that all applications for the drug and therapeutic biologic products for CFS regardless of the
proposed mechanism, therapeutic product or primary endpoint, will be designed to the
Division of Pulmonary, Allergy, and Rheumatology Products.
On April 19, we were informed of the transfer of Ampligen to the DPARP. Over the course
of the history with FDA, CFS, this will be our fifth division to which Ampligen has been
assigned. It has been our experience that each transfer involves familiarization that
consumes additional time. We are currently taking steps to try to ensure that the way
forward is not impacted by -- negatively impacted by this change. Thank you very much.
>> Nancy Lee: Thank you.
[applause]
And we're going to -- we're going to take one more person. We are working to get as
many people who have requested to speak to be able to speak. So the -- next we will have
Beth Shipper [spelled phonetically]. Beth, I don't know if we told you [laughs] a few
moments ago, but we are --
>> Beth Shipper: Could I [inaudible] --
>> Nancy Lee: You may. Absolutely. While she's getting ready,
the reason there's such a lot of confusion here is because -- well, there is a bit. I
feel confused -- is because two things. Some people requested to speak and did not provide
their written testimony to give to the committee. We are under FACA rules. We are required to
have written testimony, and so we suddenly had to rearrange the schedule because we could
not have those people speak.
And secondly, we're having to do a lot of photocopying. So that's the issues we're having
here. So just -- for future meetings, remember you'll have to provide written testimony to
speak.
>> Christopher Snell: Just to echo Nancy's comments. Chris Snell,
CFSAC chair. This is an important part of what we do, and we make every effort to allow
as many people to speak as possible. So if you do want to make a comment during this
session or future CFSAC meetings, get your testimony in early so that the agenda can
be organized and so that we can set up the conference calls ahead of time and get the
live speakers ready to go. So thank you very much.
>> Nancy Lee: And we do appreciate your flexibility and
willingness to speak.
>> Laurie Kroger: Okay [unintelligible] still missing -- okay.
Okay.
>> Nancy Lee: Thank you.
>> Laurie Kroger: Thank you. Yes. I'm Laurie Kroger [spelled
phonetically], and I'm speaking on behalf of Beth Skipper [spelled phonetically]. And
in her testimony that you were just handed, in the very last sentence -- paragraph, it
says, "Words cannot convey how desperate patients are for basic compassionate care, let alone,
educated, knowledgeable and proactive treatment protocols. It is hard to believe that this
level of barbaric treatment continues to be practiced by some in the medical professions
towards ME/CFS patients unless you witness this in person and firsthand. So Bob Miller
[spelled phonetically] and I are going to show you what happens in the emergency rooms.
And these are based on true stories." I am the emergency room doctor. Bob is the patient.
>> Patient: Hi, doctor. Nice to meet you. I've got an
awful pain at the base of my skull, and it runs down my spine. It's a headache that feels
like a knife has been jammed into my head. I'm nauseous. I can't eat. Noise and light
kills me. I'm dazed and forgetful and, when I stand, I'm weak and dizzy. It's hard for
me to even get to my bathroom. I'm wiped out all the time no matter how much I sleep.
Something really is wrong. I'm missing a lot of work, and I worry about my job. This has
been going on for over six months now. I've seen three doctors, including a cancer specialist
as cancer runs in my family, but they keep passing me on. The pain and weakness is brutal.
I looked on the Web, and my symptoms mirror several different illnesses: MS, lupus, Sjogren's
[spelled phonetically] and ME/CFS.
>> ER Doctor: ME/CFS? What's ME/CFS?
>> Patient: Yeah, well, my health, my job has got me stressed
out. The constant pain -- I really need something for the pain, the migraines.
>> ER Doctor: Hmm...let me see. So you've been stressed
out lately?
>> Patient: Yes. I'm worried about my job.
>> ER Doctor: Okay. Well, tell me what this ME/CFS is. I
have never heard of ME.
>> Patient: Well, they don't understand it. And when I
say "they" -- the doctors that I've been to. You know, I just seem to get so sick so fast
overnight. It was like I had the flu, and it just never went away.
>> ER Doctor: Now, are you saying chronic fatigue syndrome?
And you've been stressed lately? Hmm. Let me go check the CDC website and see what it
has to say on CFS.
>> Patient: Okay.
>> ER Doctor: I have here the tool kit right from the CDC
website. Hmm...let's see. We need -- it resembles a sight [spelled phonetically] condition.
We need mental health screening, cognitive behavioral therapy, need a team of health
professionals -- rehab, PT. There's no other therapies in here. Hmm. I think I know what
to do with this one.
>> Laurie Kroger: So the doctor comes back in the room; but
as the patient is sitting there in the room, they hear remarks from the staff in the back.
>> Staff: They're crazy.
>> Laurie Kroger: And so the --
>> Staff: [inaudible]
>> Laurie Kroger: [affirmative]
>> Staff: They're depressed.
>> ER Doctor: Okay. I know what we're going to do. We're
going to -- we're going to help you. We're going to get some tests. We're going to do
some evaluation.
>> Patient: Okay.
>> ER Doctor: We're going to do -- we really need to do
this to help you out. It says in the CDC book that we need to do a psych valuation; so we're
going to take you to the psych ward for 48 hours and do an evaluation, and this is really
going to help you.
>> Patient: Okay. Well, that [unintelligible].
>> ER Doctor: So you're going to go to the psych ward for
48 hours. So here. He's going to come take you away right now.
>> Patient: Okay. Wait, wait, wait, wait.
>> Male Speaker: Let's talk to someone who understands.
>> Patient: No. Wait, wait, wait, wait, wait. Wait a second.
I thought somebody was going to help me.
>> ER Doctor: No. We are. This is -- this is --
>> Male Speaker: We're helping you.
>> ER Doctor: This is what the --
>> Patient: No. I'm not --
>> ER Doctor: This is exactly --
>> Patient: I'm not crazy. Right?
>> ER Doctor: This is --
>> Patient: I've had this illness for, you know, over
six months now.
>> ER Doctor: Well, we have to see if you have an underlying
condition. We have to see if you have depression, and we have to do some graded exercise [inaudible]
[talking simultaneously]
>> Patient: I'm not depressed.
>> ER Doctor: Well, this is the best for you; so go ahead.
Take him up to the psych ward, please.
>> Male Speaker: Let's go.
>> ER Doctor: Just take him.
>> Patient: This is not going to help.
>> ER Doctor: Just go ahead.
>> Patient: This is not going to help me. This is the
same stuff everybody else is doing [inaudible].
>> Laurie Kroger: This has happened over and over again. I have
a patient organization, and this has happened with four people that I have known of in the
last year. People are afraid to go to the emergency room because of what is on the CDC
website and what the tool kit tells them. There are no treatments in here, and we are
treated barbarically, and it has to stop.
So we are asking you to stop doing us harm and to, please, change the CDC website. And
this is also why CFS needs to be reclassified in the ICD-10-CM in other disorders of the
brain under the same subcode as ME because it is a neurological condition. It's not psychiatric.
Thank you.
[applause]
>> Nancy Lee: Thank you very much. So we will have more
patient -- I'm sorry -- more public testimony this afternoon. And again, thank you for your
patience as we rearrange the schedule a bit. We are going to first --
>> Christopher Snell: Okay. We should get the minutes of the last
meeting approved. Oh, I apologize. My voice is loud enough without a microphone anyway,
I think. So if we have no objection to approval of the minutes --
>> Leonard Jason: Point to order. I got an email from Megan
[spelled phonetically], who indicated that there was an error in one of her minutes.
She might have emailed a couple other people. I just would like to suggest that, if it's
possible, for us to make that correction. I think you have a copy of it.
>> Nancy Lee: Yes. She sent -- I've received several emails,
and the one I got yesterday, she inadvertently included two, the same thing. So we are -- we
will correct it, but it may not be corrected until after this meeting over because I have
to go back through --
>> Female Speaker: [inaudible]
>> Nancy Lee: Okay. Thank you. No. I -- she had -- her email
to me yesterday.
>> Female Speaker: [inaudible]
>> Nancy Lee: So we will -- we will work on that, but we
have to make sure that we have the right copy. But I commit to getting that done.
>> Leonard Jason: Good. Thank you. And once again, this was
Lenny Jason from DePaul.
>> Nancy Lee: Go ahead.
>> Christopher Snell: So I'll accept a motion to approve the minutes.
>> Male Speaker: [inaudible]
>> Gailen Marshall: Gailen Marshall, Mississippi. So move.
>> Christopher Snell: Is there a second?
>> Steve Krafchick: I'll second [inaudible].
>> Christopher Snell: Steve Krafchick.
>> Steve Krafchick: Seattle [spelled phonetically].
>> Christopher Snell: So all in favor?
Opposed?
Abstentions?
Minutes are approved unanimously.
>> Nancy Lee: So --
>> Christopher Snell: With the changes.
>> Nancy Lee: Yes. I would like to do something that I would
normally do earlier in the meeting and that is to read a Conflict of Interest Disclosure
Statement.
We are convening this meeting of the Chronic Fatigue Syndrome Advisory Committee under
the authority of the Federal Advisory Committee Act of 1972. All participants of the committee
are special government employees or regular federal employees from other agencies and
are subject to the federal conflict of interest laws and regulations. The following information
on the status of this advisory committee's compliance with Federal ethics and conflict
of interest laws are being provided to participants at this meeting and to the public. We have
determined that all members of this advisory committee are in compliance with Federal ethics
and conflict of interest laws. Related to the discussions at this meeting, members of
this committee have been screened for potential financial conflicts of interest of their own
as well as those of their spouses or minor children and their employers. These interests
may include investments, consulting, expert witness testimony, contracts and grants, teaching,
speaking, writing, patents, royalties and primary employments.
We want to -- let's see. I think -- do you want to go over the agenda now? I don't think
we need to go [inaudible] --
>> Female Speaker: [inaudible] committee did not receive it in
advance.
>> Nancy Lee: Okay. All right. All right. So thank you.
So we have -- I think you now have the agenda in your notebook, and I just want to see if
anyone has a concern or an addition to the agenda.
>> Female Speaker: I just have one comment.
>> Nancy Lee: Yes.
>> Female Speaker: I -- Kim mentioned the Rituxan [spelled phonetically]
study in her public testimony. I know that one of the members of the research team will
be attending our meeting later today and tomorrow, so if there might be an opportunity to ask
about that in the context of the research discussions, that would be a lovely opportunity.
>> Nancy Lee: Say that --
>> Female Speaker: The Norwegian study that Kim referred to -- the
Rituxan study. One of the investigators is going to be joining us if he's not here yet.
He's not here yet, but he said he would be attending this afternoon --
>> Nancy Lee: Okay.
>> Female Speaker: -- and tomorrow morning. Just to know we have
that opportunity.
>> Nancy Lee: Okay.
>> Female Speaker: It's a very exciting study, and I think it's
raised a lot of interest in the community.
>> Nancy Lee: Thank you.
>> Male Speaker: I would second an interest in that if the
gentleman is here.
>> Nancy Lee: Okay. Certainly. Anything else? Thank you
for bringing that to our attention.
Okay. The -- we will break for -- until Dr. Koh is to be here at 11:30. If we have -- we
would like to take orders for lunch. And so, Marty [spelled phonetically], why don't you
tell us how to [inaudible] --
[off-mic discussion]
>> Nancy Lee: Okay.
Okay.
>> Female Speaker: [inaudible]
>> Nancy Lee: It's okay. So there --
>> Female Speaker: You received it in your notebook, in your
binder. So if you just want to take a minute now -- and the committee can certainly return
to the Jupiter [spelled phonetically] room, and we'll come and get you at 11:30.
>> Nancy Lee: And this -- as I said, we have -- are facing
severe budget crises, and we have not been allowed to provide food at this meeting, but
this should -- well, it should be more than adequately covered through your per diem.
>> Christopher Snell: So we're now officially on break. If people
want to order lunch, you could stay behind. The public -- need to take a break, then now's
the time to do it. We'll reconvene promptly at 11:30 when we should be graced by the presence
of the assistant secretary for health, Dr. Howard Koh.
Thank you.