CDC's DRAFT Strategic Research Plan

Discussion in 'Fibromyalgia and ME & Chronic Fatigue Syndrome' started by QuayMan, Apr 26, 2009.

  1. QuayMan

    QuayMan Member

    The CDC's DRAFT Strategic Research Plan can be read at:
    http://www.cdc.gov/cfs/draft_research_plan.htm

    People will be commenting on it at the teleconference today (Monday, April 27).

    People can send in comments on it till Friday, May 1. Instructions are at:
    http://www.cdc.gov/cfs/meetings/2009_04.htm

    ~~~~~~~~~~
    One person has done a critique of it with some points he is concerned about:
    "Some thoughts and observations on the CDC's DRAFT Strategic Research Plan General Outline".

    I don't post too much here so don't know if it's suitable to post (it is quite long) but it can be found at:
    http://tinyurl.com/c3qff4
    i.e.
    http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0904d&L=co-cure&T=0&F=&S=&P=3795
    [This Message was Edited on 04/27/2009]
  2. QuayMan

    QuayMan Member

    How did people think the meeting went?
    The speakers on the phone made a lot of critical comments.

    Was anybody in the room? Did all of the CDC team stay around? Could the people in the room hear what was said? Did anyone make faces in the room or react in a positive or negative way to comments in the room or on the phone? Just curious.
  3. acer2000

    acer2000 New Member

    To be quite honest, I don't know how they can be coming up for a plan to study the management of "CFS" when they can't even define it and don't even know what *it* is. It makes me nervous that they are already talking about forgoing trying to understand the etiology and come up with a treatment and are instead talking about managing and coping. I mean coping is important, but curing it more important. How about some real scientific research into the cause of CFS and then some more research into what to do about it?
  4. richvank

    richvank New Member

    Hi, QuayMan.

    I wasn't present at the meeting either, but I did offer my comments by phone.

    I would say the meeting went about the way I expected it would. The CDC is currently a bit on the hot seat with regard to CFS, I think. Now that the "bubble" in funding that they were forced to come up with as a result of the earlier misappropriation scandal has subsided, the budget is much lower than it was a few years ago. Suzanne Vernon has moved from the CDC to the CFIDS Ass'n. The CFIDS Ass'n and the IACFS/ME have both been critical of the CDC lately. An external review group called for a longer range research plan with public input. I think the CDC felt sort of compelled to hold this meeting.

    Quite a few of "the usual suspects" either showed up in person in Atlanta or
    called in by phone.

    Here are some names of "old hands" that some of you might recognize: Nancy
    Klimas (past pres. of the IACFS/ME and current member of the board), Kim
    McCleary (director of the CFIDS Assn), Wilhelmina Jenkins (formerly active in
    the CFIDS Assn.), Mary Schweitzer (former history professor and frequent
    commenter), Hillary Johnson (author of Osler's Web), Tom Kindlon (active on the
    internet), Cort Johnson (phoenix-cfs), Staci Stevens (developer of the double
    exercise test for diagnosis of CFS), Marly Silverman (of the Pandora group, in
    Florida), and Katrina Berne (on the board of the CFIDS Assn and author of books
    on CFS).

    Quite a few people offered comments, most of them critical of the CDC. Several
    advocated that the CDC adopt the Canadian definition for ME/CFS. Some urged
    that the CDC release all its data to external researchers so that they could do
    their own analyses of it. Many people told of their long-term illness or that
    of family members.

    One person accused the CDC of killing people by not doing their job of solving
    the CFS puzzle, noting that he had nearly committed suicide himself. Several
    people called for more education for the doctors, many of whom still do not
    believe that CFS is a real illness.

    There were a few comparisons with the Whittemore-Peterson Institute, which was
    said to be making more progress than the CDC with a much shorter history. There
    were calls for defining the subsets in the CFS population. Some people spoke
    against cognitive behavioral therapy and graded exercise therapy.

    Some were unhappy that the CFS case definition has been broadened to include
    more people with depression. Some called for more collaboration with external
    researchers. Several called for the removal of Bill Reeves as the head of the
    CFS research effort at the CDC. This meeting can't have been a lot of fun for Bill.

    I phoned in and got my five minutes to talk. I suggested that the CDC consider
    the methylation cycle block concept, and noted that I thought it would satisfy
    several of the items in their posted research outline, and would mesh well with
    their earlier work. I followed it up with an email to the designated email
    address, with a bunch of attachments, giving all the gory details. So if they
    are interested, there's lots for them to read.

    It's impossible to know if anything will come of it, but I gave it a shot.
    Apparently their plan now is to flesh out their 5-year plan and present it in
    more detail next month, and get more input then.
    It will be interesting to see what they do. Maybe this is one of those critical moments
    in politics where there's an opportunity to influence the direction of things.
    We shall see.

    Rich
  5. bigmama2

    bigmama2 New Member

    for this post

    thanks for the details

    bigmama2
  6. AuntTammie

    AuntTammie New Member

    I agree...thanks to all of you for the info....and a particular thanks to Rich for all the work and advocacy and for answering so many of our questions.....we need more people like you.....maybe someday i will manage to find the funds to be tested for the methylation block and then be able to try the treatment - it sure makes a lot of sense to me, & the possibility gives me some hope, but the testing cost is just way beyond what I can manage at the time being (& yes I know that you have nothing to do with that...I'm just glad that you keep working to help us)
  7. xchocoholic

    xchocoholic New Member

    thanks rich for posting about what happened at the CDC mtg.

    It's great that so many who are well versed in CFS are fighting for us ...

    Marcia

  8. QuayMan

    QuayMan Member

    Hi Rich,

    Could this be re-posted e.g. on some yahoogroups? I think it gives a good flavour of the meeting. I don't mind whether I give the name of the author or not.
  9. QuayMan

    QuayMan Member

    One thing that I just remembered (which gave me a laugh but also gives an idea that people were being given free rein to give out and many were very annoyed):

    There was a doctor who was also a patient giving out a lot (I don't know his name unfortunately). He came in for the second time and seemed to stop and be at the end and the chair, in a gentle voice, asked "are you finished, Mr/Dr <name>" and he comes back with "I'll never be finished" and then starts giving out again!
  10. AuntTammie

    AuntTammie New Member

    I'd like to be as hopeful as you sound about this, but I really tend to think that CFS is still a joke to the CDC. This meeting came about bc too many people had finally realized that the CDC is treating us terribly and wasting research dollars...basically they were backed into a corner and this is an attempt to pacify people....until they change the name and use a good definition and start looking into the subgroups, they are not going to actually be doing anyone any good - just continuing to water down the definition so that it could apply to nearly anyone, and in doing so they can also go on implying that it is really more of a mental illness. They are not studying what we really have, and they are not giving us any respect. I did write in, and it would be great if what people are writing and if what was said at the meeting does have an impact, but I am really not betting on it.
  11. outofstep

    outofstep Member

    I got the feeling that the CDC was expecting people to say "I am sick please help me" so that they could just spew more nonsense re: how CFS is a mysterious disease and they are doing all that they can blah blah. What they got was one slam after another and were basically told that everything that they are doing is completely wrong, that patients have had enough, and that the CDC should be doing a, b, and c instead. (Luckily for us we are now able to compare the CDC's progress with that of the much more productive non-profits.) I would love to know if anyone was actually at the meeting, like Quayman asked, to know how this criticism was received.
  12. QuayMan

    QuayMan Member

    Hopefully other people will post theirs in public accessible places - this was posted on Co-Cure which has a public archive.

    Most importantly, people have the chance to comment themselves on or before Friday - see
    http://www.cdc.gov/cfs/draft_research_plan.htm

    ---------
    http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0904d&L=co-cure&T=0&F=&S=&P=6445
    From: Tom Kindlon
    Subject: ACT: My testimony (or a rough idea of it) to the meeting on the CDC Draft Strategic Research Plan on CFS

    Here is a rough idea of what I said at the meeting on the CDC's draft
    research plan over the phone.

    I hope people will write reports. Or other people who provided testimony
    will share what they said or an idea of what they said.

    Background: Over the weekend, I was "talking" to somebody (by E-mail) who
    seemed to know they were going to be called so I thought I wasn't going to
    be called as I hadn't got a message and I am from the outside the US, so I
    didn't prepare anything. Then when I rang in, it said something about being
    on a listening only line so I definitely thought I wasn't going to be called
    (people from outside the US had to ring a different number). So I was
    listening along and then they say something along the lines of "and next up,
    Hilary Johnson and then Tom Kindlon"! So I can tell you those were five
    minutes of panic!

    So the first part is what I thought I said but it might not be exactly what
    I said! I made "header" notes before the second optional contribution so it
    is
    closer to what I actually said.

    [Aside: When I send it in, I will include what is visible on the petition
    http://CFSdefinitionpetition.notlong.com
    i.e.
    http://www.ipetitions.com/petition/empirical_defn_and_CFS_research
    including comments but won't close the petition down.

    People can until Friday (May 1) still send in comments on the draft plan
    http://www.cdc.gov/cfs/draft_research_plan.htm - see
    http://www.cdc.gov/cfs/meetings/2009_04.htm for details]


    ======1st Contribution=========

    I should first apologise and say that I didn't think I was going to be
    speaking today so I don't have anything prepared.


    I have been ill for 20 years since the age of 16. I got 1460 in my SATs,
    top
    percentile in both of the subjects so had a promising future ahead of me,
    but I have now been housebound for over a decade.


    I have read the CDC's research plan and am concerned that Graded Exercise
    Therapy and CBT based on Graded Exercise Therapy are going to be
    recommended. I am concerned that the CDC has been taken in by the hype of
    these conditions. Lots of people have been made worse by these treatments.
    Unfortunately, because they are not drugs, there is no easy way for patients
    or doctors to report adverse the way there is with drug treatments. So no
    one is recording that many people are being made worse by these treatments.
    About the only place this shows up is in patient surveys: patient survey
    after patient survey shows a high percentage of people have been made worse
    by Graded Exercise Therapy and CBT based on Graded Exercise Therapy.


    The draft plan uses the word "evidence based" three times. I think it is
    premature to use this term. There have only been a relatively small number
    of Randomised Controlled Trials and Controlled trials in the area. I fear
    what it means is that the CDC is going to be supporting and recommending GET
    and CBT based on GET.


    The draft plan refers to arriving at an "international consensus on
    management". But again, I think it is premature to be talking about an
    "international consensus". There are lots of views. I fear that what the
    CDC is referring to is GET and CBT based on GET especially after the
    publication of the NICE Guidelines.


    I am concerned by the phrase "prevention of CFS". This phrase isn't used
    much. One prominent person believes that one can prevent CFS by getting
    people moving and exercise soon after an infection. Many other people would
    think this is dangerous and what people actually need to do is rest. I am
    concerned that what the CDC is referring to is getting people to exercise
    after an infection which could be risky.


    When the CDC refers "intervention studies" I fear what the CDC is referring
    to is GET and CBT and GET. In other countries, these strategies have
    gobbled up a lot of the governmental money. Another study just gives these
    treatments an unfair advantage - other treatments have barely been tested at
    all.


    The whole idea of GET and CBT based on GET is to get people to do more. But
    where is the evidence that it actually achieves this? There is none. There
    is no actometer data. All they have is questionnaire data which could be
    due to factors such as placebo or time spent with a therapist. It isn't
    solid
    evidence. Indeed one CBT study by Friedberg[1] this year reported that
    people
    improved on the SF-36 physical functioning scale and on fatigue but actually
    were doing less as measured by actometer data. This intervention involved
    encouraging patients to go out walking. And yet at the end people weren't
    walking more. So there's a lot of hype about GET and CBT based on GET but
    the evidence isn't there.


    I think the empirical definition is flawed. It selects 2.54% of the
    population or 1 in 40 of the population[2]. I don't think they all have
    what is
    commonly understood to be CFS. Who knows what some of the people have. A
    study found that 38% of those who had major depression but didn't have CFS
    satisfied the empirical definition[3]. This defintion messes everything up.


    The thresholds of the 25th percentile in the empirical definition weren't
    picked statistically, they were picked out of the air[4]. There is no
    particular reason why that should be the threshold. The role emotional
    subscale isn't a suitable way to pick way to find people who are
    functionally impaired on its own - Leonard Jason and lots of others also
    don't think it is suitable[5,6]. It shouldn't be used to decide that people
    are functionally impaired.


    At this time, when we don't know who might be suitable for CBT and GET based
    on CBT, I think it is dangerous to be recommending them.


    Thank you.

    ==================
    References (these weren't said of course):

    [1] Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue
    syndrome: is improvement related to increased physical activity? J Clin
    Psychol. 2009 Apr;65(4):423-42.

    [2] Reeves WC, Jones JF, Maloney E, Heim C, Hoaglin DC, Boneva RS, Morrissey
    M, Devlin R. Prevalence of chronic fatigue syndrome in metropolitan, urban,
    and rural Georgia. Popul Health Metr. 2007 Jun 8;5:5.

    [3] Jason, L.A., Najar, N., Porter, N., Reh, C. Evaluating the Centers for
    Disease Control's empirical chronic fatigue syndrome case definition.
    Journal of Disability Policy Studies 2008, doi:10.1177/1044207308325995.

    [4] Reeves WC, Wagner D, Nisenbaum R, Jones JF, Gurbaxani B, Solomon L,
    Papanicolaou DA, Unger ER, Vernon SD, Heim C. Chronic fatigue syndrome--a
    clinically empirical approach to its definition and study. BMC Med. 2005 Dec
    15;3:19.

    [5] Jason L, Richman J. How science can stigmatize: the case of chronic
    fatigue syndrome. Journal of Chronic Fatigue Syndrome. 2007;14(4):85-103.

    [6] White PD. Reviewer comments on: Reeves WC, Jones JF, Maloney E, Heim C,
    Hoaglin DC, Boneva RS, Morrissey M, Devlin R. Prevalence of chronic fatigue
    syndrome in metropolitan, urban, and rural Georgia. Popul Health Metr. 2007
    Jun 8;5:5.
    Available at:
    http://www.biomedcentral.com/imedia/1083914155124266_comment.pdf (and
    http://tinyurl.com/dakhlz )




    =========Second contribution on the phone===================

    I just thought I'd add something as my first piece wasn't pre-planned and I
    left some information out.


    - The draft plan refers to "international consensus on management",
    "intervention studies" and "evidence based .. management of CFS". I fear
    that these will not include strategies such as pacing and the "envelope
    theory".


    Leonard Jason in 2007 published a study, "non-pharmaceutical interventions
    for CFS"[1], from money from an NIH Grant.
    It found that pacing came out better than CBT, an exercise program and a
    relaxation intervention.


    There is also some evidence that a similar strategy, the "envelope theory",
    is useful.


    These strategies have excellent safety records.


    These strategies involve listening to your body. This is very different
    from the rationale of Graded Exercise Therapy and CBT based on Graded
    Exercise Therapy.


    So I am not sure how there can be any consensus at this time. It is
    premature to have consensus at this time. However I fear what is being
    talked about is to recommend Graded Exercise Therapy and CBT based on Graded
    Exercise Therapy.


    - There is a lot of hype about GET and CBT based on GET. I fear that the
    CDC may have been taken in by this hype. Often the words "evidence based"
    and "effective" for example are used with regard to these treatments.
    However, reviews of the treatments do not show them to be that effective.


    Malouff in 2008 published a meta-analysis of cognitive behavioural therapy
    Trials[2] (this included some studies on Graded Exercise Therapy). They
    calculated a Cohen's d effect size to be an average of 0.48 for the outcome
    measures. For those who don't know, an effect size is a measure of how
    effective a treatment is - some treatments can help a little, some
    treatments can help a lot. 0.48 is below the threshold for a treatment to
    be seen as having a moderate effect size.


    So the hype of cognitive behavioural therapeutic interventions isn't
    justified.


    A Cochrane Review of CBT studies[3] found that at the end of treatment, 40%
    of people in the CBT group showed clinical improvement in contrst to only
    26%
    in the control group (usual care) but at follow-up, 1-7 after the treatment
    end, when drop-outs were included, there was no difference.


    In Belgium[4], they set up five rehabilitation clinics that used GET and
    CBT. If you look at the questionnaire data, yes, it looks like the patients
    were
    helped like with other published literature.
    However, on the exercise studies, there was no difference. And on the
    hours worked, patients were
    actually working less hours than before they did the CBT and GET.


    So as I say, many questions remain about GET and CBT based on GET.


    - With regard to the empirical definition, I forgot to say in my first
    submission that I set up a petition on the issue on the 15th of April.
    Already 250 people have signed it. It calls for the CDC to stop using the
    empirical definition, also called the Reeves definition, for its research.
    It's on ipetitions.com [5] - if
    people go there they can see the many points people have made on the issue
    [I am copying it below. I did not get a chance to say that other people
    also added comments but for some reason they did not show up]


    - I forgot to say that I have a personal reason that I am so concerned about
    exercise programs. My own health was ruined by an exercise program. Before
    I did the exercise program I was only mildly affected but now I have been
    housebound for over a decade.


    - A final point is to say that there are many problems with the philosophy
    surrounding GET and CBT based on GET. Many of the proponents say patients
    with CFS shouldn't be entitled to disabiliy benefits. They also say that
    people shouldn't get home help as this can get in the way of the
    rehabilitation. Also that family and relatives should be helpful for the
    same reason. They can also recommend against people getting disability aids
    and parking badges.


    And this is for an illness where at the very least we don't know what is
    causing it. But there is plenty of evidence to suggest it's "physical". As
    one person said to me once, the attitude (of those promoting the CBT/GET
    model) is medieval.

    =======================

    References (these weren't said of course):

    [1] Jason LA, Torres-Harding S, Friedberg F, Corradi K, Njoku MG,
    Donalek J, et al.Non-pharmacologic interventions for CFS: A randomized
    trial. Journal of Clinical Psychology inMedical Settings 2007;
    14:275-96.

    [2] Malouff JM, Thorsteinsson EB, Rooke SE, Bhullar N, Schutte NS. Efficacy
    of cognitive behavioral therapy for chronic fatigue syndrome: a
    meta-analysis. Clin Psychol Rev. 2008 Jun;28(5):736-45.

    [3] Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for
    chronic fatigue syndrome in adults. Cochrane Database Syst Rev. 2008 Jul
    16;(3):CD001027.

    [4] Rapport d'evaluation (2002-2004) portant sur l'execution des conventions
    de re-education entre le Comite de l'assurance soins de sante (INAMI) et les
    Centres de reference pour le Syndrome de fatigue chronique (SFC). 2006.
    http://tinyurl.com/d48t7u i.e.
    http://www.inami.fgov.be/care/FR/revalidatie/general-information/studies/stu
    dy-sfc-cvs/index.htm

    [5] "CDC CFS research should not involve the empirical definition (2005)"
    http://www.ipetitions.com/petition/empirical_defn_and_CFS_research/
  13. QuayMan

    QuayMan Member

    [Make sure to press "more". Hillary is the writer of Osler's Web and writes very well]

    Copied from a Co-Cure message:
    NOTICE: Hillary Johnson's Blog on the CDC Meeting

    I wrote a "blog" about the CDC meeting on Monday and posted it to my Web site.

    the Link is: http://oslersweb.com/sb/page.php?ID=74147

    It's on the blog page of the website, which is www.oslersweb.com

    Best wishes,

    Hillary Johnson
  14. mezombie

    mezombie New Member

    Comments made by the president and two board members from the the CAA can be read here:

    http://www.facebook.com/pages/The-CFIDS-Association-of-America/47921632107
    [This Message was Edited on 04/29/2009]
  15. mezombie

    mezombie New Member

    To Whom it May Concern:

    My name is Craig Maupin. For several years, I have run a popular
    website on chronic fatigue syndrome (CFS), The CFS Report
    (http://www.cfidsreport.com) . Like many people with CFS, I want to see the
    CDC's research program succeed.

    However, the CDC's CFS Research Program has failed to garner my
    support. And given that I interact with CFS sufferers on a regular basis,
    I can say with confidence that the CDC's efforts does not have the support
    of the CFS community. Though the CFS community is diverse, currently I
    know of no CFS sufferers who feel that the leadership of the CFS program is
    effective or capable.


    Investment decisions at the CDC program have been narrow and
    restrictive. Some of those decisions are as follows:

    1. In 2006, the CDC research program held a news conference that touted
    "groundbreaking findings" regarding the pathology of CFS. Such an
    announcement from the Centers for Disease Control will steer the direction
    of future research and clinical care. How is it responsible
    decision-making to base such an announcement on a "pathology-specific" study
    that discarded any findings outside of the HPA axis?

    2. Since 2002, the majority of the CDC's funds have gone to two
    contractors. One is ABT Associates, and the other contractor is a small
    group of researchers at the Emory University Department of Psychiatry. The
    question is whether the current CFS program is pursuing a personal interest
    in stress and anxiety, rather than the broader interest in CFS shown by the
    scientific community. The budgeting of resources with these two contractors
    does not correlate well with the following:

    a. A lack of any appreciable progress from the investments in ABT
    Associates.

    b. Researchers with a diverse set of interests have been privately funded.
    These researchers are seen in the efforts of the Whittemore Institute and
    the CFS Research Foundation. More diversity in CFS research was seen at a
    recent HHV-6 Foundation conference and the IACFS/ME Conference in Reno.
    These conferences are evidence that there is strong interest in CFS beyond
    the HPA axis, stress, and anxiety.

    c. In 1998, Dr. William Reeves (Congressional hearing on the Gulf War)
    stated that CFS was attributable to "multiple major lifetime stresses in the
    year before one becomes ill." Dr. Reeve's views toward CFS were
    established publicly before he chose to invest heavily in the psychiatry
    department at Emory.

    d. There are no women represented in the leadership of the CDC's CFS
    Research Program. As stated earlier, decisions have been made to restrict
    much of the research investments for CFS research at the CDC to stress,
    anxiety, and the HPA axis. These restrictions are often associated with
    societal biases toward women's illnesses. Has the CDC done enough to
    assure the public that the questionable decisions cited above are based on
    science, and not traditional societal or gender attitudes toward women's
    reactions to stress or anxiety, especially given the lack of female
    leadership within the program?


    3. Emory University's recently publicized problems with conflict of
    interests at the psychiatry department have done nothing to shore up
    confidence in the CFS research program. The congressional probes into
    conflicts of interest are causing questions in the CFS community to fester,
    questions such as whether or not there was compensation to Dr. Reeves for
    teaching classes in stress response and fatigue at Emory. Though Emory has
    decided not to address those questions, I believe that Dr. Reeves would not
    take salary from his own contractor. However, clearing up the speculation
    would be helpful.

    4. The largest contributor to the lack of confidence in the CDC's CFS
    Research program comes from its highly controversial research definition.
    The average research subject of the Wichita dataset was capable of 31 hours
    or work and 17 hours of chores and activities a week. This level of
    activity does not represent me or my clinical symptoms. It also does not
    reflect an accurate clinical picture of CFS patients. In addition, a recent
    study found that the current "empirical definition" captures subjects with
    emotional disorders.
    Whether this clinical picture is accurate or not, it will greatly
    impact the advice that my caregivers receive from the CDC as to how to treat
    and manage my illness. The truth is that most CFS sufferers and many
    doctors no longer believe that the CDC program is researching their illness.



    For fifteen years, Dr. William Reeves has shown a commendable interest
    in stress disorders. He has worked diligently with the military on studies
    on these disorders - working with the Air Force in 1998 and with the Army at
    Fort Benning in 2006. However, despite Dr. Reeve's deep passion for
    learning more about post-traumatic stress, he does not have the confidence
    of the CFS community.

    The CDC's CFS program needs to recapture the CFS community's support.
    To do this, the CDC's needs to address the concerns raised above. And to
    address those concerns, they will need to change the leadership at the CDC's
    CFS research program. One through a change in leadership will the program
    begin to more accurately reflect the breadth of current CFS research.




    Sincerely,


    Craig Maupin
  16. mezombie

    mezombie New Member

    To the CDC, regarding the proposed 5-year 'CFS' research plan:

    Whatever happened to the CDC's National Enterovirus Surveillance System (NESS)? From what I've been able to find through the internet, it was running from 1961 through 2005. Through NESS, private laboratories voluntarily reported findings of enteroviruses. http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5508a1.htm

    Given increased reports of enterovirus infection in people diagnosed with 'CFS', why not resurrect this program?

    And, considering the number of patients describing an "infectious-type" onset who, after testing, are found to harbor a number of other viruses (see, for example, http://vicd.info.research.html), why not expand the program to include these?

    Doing this is entirely in line with the CDC's historic role in monitoring emerging diseases and is highly appropriate for the agency's future involvement in 'CFS'.

    Sincerely,
    Liz Willow

  17. QuayMan

    QuayMan Member

    Don't forget, folks, comments on the draft plan have to be in on or before Friday, May 1st.

    See:
    http://www.cdc.gov/cfs/meetings/2009_04.htm
    (and http://www.cdc.gov/cfs/draft_research_plan.htm)

    Even a few lines would be useful - it might back up what other people have said.
    Also the more submissions there are, the more it reminds everyone in the CDC that people are interested and also that they are being watched.
    [This Message was Edited on 04/30/2009]
  18. mezombie

    mezombie New Member

    I am sure I did not stick rigorously to the text I wrote in advance - testifying by phone was much more exhausting than I had expected. If you don't mind, I'll put down what I intended to say. Thank you.

    Thank you for allowing me time to speak.

    I have too little time to get across so much, so I’m going to cut to the chase:.

    * A completely new group should be created to operate and run the CDC’s program on CFS. In the 25 years since the CDC was first contacted about the mid-1980s cluster outbreaks, the agency has done absolutely nothing to help a single patient, and done much that has harmed patients.
    At least one million American adults have this disease. CDC admits that at least 85% of patients do not have a diagnosis at all, and half of all patients cannot work because of the severity of the disease. That’s a failing grade by anybody’s scale.
    This is a travesty. This is a disease that is as severe as multiple sclerosis. The CDC’s behavior over the past quarter-century towards these patients is completely unacceptable.

    * CDC should immediately adopt the Canadian consensus diagnosis for clinical work. It a bit outdated now, but it paints a much more accurate picture of this complex and baffling illness. U.S. Drs. Dan Peterson, Nancy Klimas, and Martin Lerner were on the committee. And it does not rest on the theories of the narrow “biopsychosocial” school of British psychiatry. A summary of the Canadian consensus document can be downloaded here:
    http://www.mefmaction.net/Portals/0/docs//ME-Overview.pdf

    * In 1994, The Annals of Internal Medicine published what has come to be called the Fukuda Definition for research into the disease Chronic Fatigue Syndrome. Almost all the useful research on CFS was done using this definition. [Fukuda et al, “The chronic fatigue syndrome: a comprehensive approach to its definition and study.” Annals of Internal Medicine, (1994) 121:953-959.]
    However, in 2005-2006 the CDC shifted to the Reeves “international empirical” definition. The main difference between the Reeves definition and the Fukuda definition is that the Fukuda definition did not admit patients who had a diagnosis of depression for research purposes. Dr. Reeves lifted that constraint, with the proviso that the bout of depression have resolved at least FIVE YEARS before the ONSET of fatigue. [Reeves et al. “Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution.” BMC Health Services Research (2003) 3:25. <http://www.biomedcentral.com/1472-6963/3/25>]
    The “empirical” part of the definition refers to a set of questionnaires. Unfortunately, the questionnaires do not achieve the goals of the international committee to revise the Fukuda definition. The questionnaires were verified during a two-day hospital stay in Wichita, Kansas, where unfortunately only 6 patients identified with CFS during the 3-year community study conducted earlier by CDC were diagnosed with CFS with the questionnaires. The questionnaires identified 43 patients as having CFS, and at most only 10 could have been categorized as “CFS” using the Fukuda definition. That is a slim basis for a new definition, and a very slim basis on which to market a set of questionnaires. [Reeves et al. “Chronic fatigue syndrome - a clinically empirical approach to its definition and study.” BMC Medicine (2005) 3:19. <http://www.biomedcentral.com/1741-7015/3/19>]

    DePaul psychologist Leonard Jason demonstrated recently that, when applied to a set of patients in Chicago diagnosed using Fukuda, the questionnaires missed the sickest of the CFS patients, and a third or more of the patients now included had a major depressive disorder. Setting aside the depression, they still would not have met the Fukuda definition. [Jason et al, “Evaluating the Centers for Disease Control’s Empirical Chronic Fatigue Syndrome Case Definition,” Journal of Disability Policy Statistics (online first 10/21/08).]
    Clearly this new definition represents not improvement but regression. I wonder just who will be helped by it – because patients with depression who are misdiagnosed as CFS are not going to be helped either, just as the worst cases of CFS will be left behind.
    Therefore, I join with other patients in calling for a GAO investigation into the inequitable treatment CFS patients have received from CDC regarding both the allocation of funds, and their creation of a definition that ignores the sickest of the patients (who had been included in the Fukuda definition), and brings in patients with a professional diagnosis of major melancholic depression.

    * The Fukuda model does not just set a definition for “chronic fatigue syndrome.” Fukuda assumed that the patients diagnosed using this definition would represent a heterogeneous set, and that the next order of business was to go about identifying subgroups making use of biomarkers and objective measures.
    That the CDC has steadfastly refused to do – instead turning to the new Reeves definition that actually makes the population even more heterogeneous than it was.

    ---------------------------------
    *My own history with ME/CFS:

    I have had CFS since 1994, when I suffered a blackout in my office. When I came to, I could not understand a single work of the bluebooks in front of me. I was a tenured professor – you could say I made my living reading, analyzing, and giving lectures. But now I could not read, could not think, and could not express myself.

    I prefer to use the designation M.E. for myself because I fit the Ramsay 1988 description of Myalgic Encephalomyelitis (M.E.), the Hyde descriptions (1992, 2006), and the technical definition in Stedman's medical dictionary. I also meet the Canadian consensus document's criteria for ME/CFS. M.E. and CFS are classified together under neurology in WHO's ICD-10 at G93.3. However, since the CDC does not recognize M.E., I will use "CFS" for the purposes of this essay.

    The next four years I went downhill very quickly. By the fall of 1998 I had severe cognitive dysfunction, including expressive dysphasia, poor short-term memory, dyslexia, ataxia, and severe confusion. I could not pass a simple Romberg test. As an example of the severity of the cognitive dysfunction, I once poured a pot of coffee into a silverware drawer absolutely convinced it was a cup.

    I had constant pain behind my eyes and in the back of my neck, headaches that sometimes reached the level of migraines, muscle aches, and sore, swollen glands. On a bad pain day all I could do was lie in the dark, listening to my favorite movies.

    In the fall of 1998 I was diagnosed for the 37kDa Rnase-L defect, yet another bout of active Epstein-Barr Virus, and active Human Herpesvirus 6, Variant A.

    In February 1999 I began treatment with the experimental drug Ampligen, an immune modulator that also works as an effective antiviral. Within six months my symptoms had improved dramatically, and the three biomarkers disappeared. I could drive, I could walk, I could read a newspaper. I danced with my son at his wedding.

    I went off Ampligen for a year, and then relapsed severely. So when I went back on Ampligen I was determined to stay on it, even though it cost my family out-of-pocket $20,000 a year.

    [Note: Most patients don’t make enough to afford $20,000 for a single medication. Many of my friends live alone on less than $12,000 a year; many of them have no health insurance – public or private – at all.]

    A year ago February I lost Ampligen, and my symptoms returned. It is supposed to be reviewed by FDA in May, unfortunately before the new FDA head will be in place. I have not been able to get it back, even paying for it - and I fear I will lose it forever.

    By September I was in relapse. I have suffered from a low-grade fever for months, the severe pain in the back of my neck and behind my eyes is back, with the headaches. I have returned to the wheelchair. I cannot drive.

    We can now add cytomegalovirus to the list of diseases. I scored 16 on a VO2 MAX stress test, which by itself would categorize me as disabled according to social security. A SPECT scan showed “decreased activity in left lateral temporal lobe and occipital lobes,” and we can add a low natural killer cell count and function to the list of immune problems. We tried Vistide for the cytomegalovirus, but my liver rejected it.

    I do not have a single day without pain. I do not have a single day without confusion.

    I have testified to the CFSAC for ten years about these biomarkers, symptoms, and treatment. Did the CDC respond with interest in a possible subgroup? No. With deeply flawed statistical analysis that must have Popper whirling in the grave, and a complete misrepresentation of Occam’s Razor, they take each possible biomarker and test it on a sample of CFS patients, then report back that everybody didn’t have it, so it’s not worthy of further study.

    Well, yes. Everyone didn’t have it. That is what you would expect out of a subgroup, isn’t it?

    ------------------------------
    *We do not have a “fatiguing” illness.

    We were assured when the Holmes committee came up with the name “chronic fatigue syndrome” in 1987 that it did NOT mean fatigue writ large, that clinicians, researchers, and the public would understand it was a discrete illness, different from "fatigue."

    Now the CDC has even betrayed that promise, creating the category of “fatiguing illnesses” and plopping CFS down in it as the poster child. I don’t see leukemia there, or congestive heart failure. Just other poorly understood illness that - frankly – impact women far more often than men.

    The current group’s insistence that CFS is primarily a “fatiguing illness” shows the absence of any real knowledge of – or interest in – the disease as it exists for us out here, as we have it. We can’t find doctors. Nobody understands what this is. That Reeves himself would dally with the concept of “fatiguing illnesses,” especially in concert with British psychiatrists, shows that he either does not understand the disease – although surely he knows everything I know about it- or he does not really care. If you look at the pamphlets that CDC sends out to medical personnel who request information on CFS, you will find that they state starkly “There are no tests and there are no treatments.” That is simply not true. They devote an inordinate amount of print to “CBT” (Cognitive Behaviour Therapy) – a type of analysis developed by British psychiatrists, using a different definition entirely for CFS, who claim that they need to “learn better illness beliefs,” “GET” (Graded Exercise Therapy), which claims to be able to return patients to work with graded exercise, no matter how sick they start out, and the omniscient SSRIs.

    Imagine telling a roomful of patients with MS they would be fine if they just forgot to “play the sick role” and began to exercise again. What must Dr. Reeves think of us?

    The name chronic fatigue syndrome was created in response to requests for attention to a number of cluster outbreaks, perhaps the best known of which occurred in north Lake Tahoe, on both the Nevada and California sides.

    After 25 years, many of those patients remain severely ill, and others are doing okay only because they are on medicines that are either targeted at viruses or the immune system.

    NONE of them would fit in the new Reeves definition.

    Shouldn’t the definition at least fit the patients it was commissioned to describe?

    As I descend into Hades for the third time in my life, I beg you to please start over with this disease, and this time take Dr. Fukuda’s imperative seriously – cooperate with the independent research centers that are already creating subgroups with biomarkers that also relate to a proposed etiology.

    As I sat on the phone waiting for the chance to testify, imagine how I felt to have you segue into swine flu, and away from us. If the patients with swine flu end up with chronic viral infections or immune disorders like the one we have, will they also be completely abandoned by CDC?

    There are good private research centers already out there, often in concert with a clinic –as examples, Dr. Nancy Klimas’ CFS study group in Miami, and the new Whittemore-Peterson Institute (WPI) in Reno, Nevada. The WPI does not even have a building, but they are already producing cutting edge research into the viruses and immune dysfunctions surrounding this disease, using new tools made available for the study of molecular medicine. So there is reason for patients to be hopeful.

    ------------------------------
    *What should the CDC be doing?

    I see the role of the CDC not as primary researcher, but rather as the center that can pull in information from top researchers, in this case coordinate with the international research organization IACFS/ME to establish clinical definitions and identify subgroups, and then use the strength of the federal government to require the reporting of cases nationwide.

    Currently you will not find a single article on the CDC’s website for CFS that has not been authored by a person who was a member of CDC at the time. Most of the CDC’s “bibliography” has Dr. Reeves’ name on it. The CDC should not be someone’s personal resume. Compare the CDC's bibliography on CFS with the bibliography on the back page of the Canadian Consensus Document (see above). The second bibliography ranges over a number of specialties and many authors. It is not a platform for a single person, or single point of view. THAT should be what doctors see when we go to CDC's website.

    Rather than trying to do everything themselves, the CDC needs to go off-campus and make use of what’s already there. As one example, there has recently been a lot of research, ignored by CDC, into what happens when more than one virus is activated at the same time. It would have been nice if CDC had funded more of that research, then paid attention to the results, BEFORE this new epidemic, wouldn’t it?

    As was suggested by the CFSAC (Chronic Fatigue Syndrome Advisory Committee to DHHS) in 2003, CDC should adopt the ICD-10 classification of CFS under neurology, together with Myalgic Encephalomyelitis (M.E.). The Canadian Consensus Document, recommended above, was written in response to ICD-10.

    Finally, there is evidence that at some point in its lifetime “CFS” is contagious. Again, the CDC has ignored that – but they never really considered it. Hopefully they will do so before another 25 years has passed.

    Please be aware that many of us have serious immune defects and are therefore more endangered by the possibility of a swine flu epidemic than the average citizen. We are especially concerned that there will be patients left damaged by this new flu strain who will, like us, still be sick 20 years from now.

    In December I joined with a group of online ME/CFS patients to “meet” to discuss health care reform for the Obama-Biden transition team. The team chose a report from each state to publish on their website; ours represents my home state of Delaware. While the report was intended for the DHHS, the CDC obviously plays a prominent role. You can read the report at:
    <http://healthreform.gov/communityreports/delaware/delaware_19711.html>

    Mary M. Schweitzer, Ph.D.

  19. QuayMan

    QuayMan Member

    From the CFIDS Assoc. Facebook page-
    http://www.facebook.com/pages/The-CFIDS-Association-of-America/47921632107

    Comments by Katrina Berne- Board of Directors, Jennifer Spotila- Chairman of
    the Board of Directors, and Kim McCleary- President & CEO, CFIDS Assoc. of
    America

    *********************************************************************************

    Katrina Berne, PhD's Presentation at the CDC Meeting on April 27,
    2009<http://www.facebook.com/note.php?note_id=100228655538>

    *STATEMENT FOR THE APRIL 27, 2009 CDC MEETING
    REGARDING THE CHRONIC FATIGUE SYNDROME RESEARCH PLAN*
    I appreciate the opportunity to address the CDC regarding my views on its
    proposed research program.

    I serve on the Board of Directors of The CFIDS Association of America. I am
    a Clinical Psychologist specializing in the treatment of people with CFS and
    their families and author of the book Chronic Fatigue Syndrome, Fibromyalgia
    and Other Invisible Illnesses. I have served on panels to develop
    educational curricula for physicians and for behavioral health
    professionals.

    In addition I am a CFS patient who became ill in late 1984 – now in my 25th
    year of illness, having declined over the years and ultimately having become
    disabled in 2001. In fact I have been ill for approximately the same length
    of time as the CDC’s involved in CFS. This represents a sad silver
    anniversary; as I reflect on my years with the illness and the CDC’s
    inadequate efforts over that time, it would be accurate to say neither of us
    has made any significant progress.

    The history of the CDC in regard to CFS is dismal, beginning with assigning
    a name both trivializing and inaccurate, an inadequate and inaccurate case
    definition, misappropriation of funds and poor-quality research, in terms of
    both the focus of its studies and its methodology. The CDC has not had a
    meaningful or significant impact on our understanding of the illness or how
    to treat it.

    Along with quite a few people from the CDC, I served on a committee whose
    purpose was to develop an educational curriculum for professionals. To my
    disappointment, those from the CDC were ill-prepared to make a meaningful
    contribution and did not seem to have an accurate understanding of the
    illness.

    The CDC has acknowledged that CFS is a complex, chronic illness that affects
    millions of Americans, one that costs our nation a considerable amount of
    money in lost productivity and wages, medical costs and disability benefits
    and that it therefore merits immediate action and rigorous study. However
    the CDC, although in a unique position to make progress in the understanding
    and treatment of CFS, has continually failed to do so.

    The CDC has invited comments regarding its five-year research program for
    discussion at its May 27, 2009 meeting but on short notice and without prior
    release of the details regarding this program. Unfortunately this seems to
    be consistent with CDC’s slipshod approach to the study of CFS over the
    years – lip service without evidence of any real planning or commitment
    behind it.

    The CDC and others have conducted an abundance of studies of psychological
    and psychosocial aspects of CFS and epidemiological studies with continual
    revision of the estimated number of persons with CFS. Given the large number
    of people with the disorder, I am dismayed with the relative paucity of
    attention to the pathophysiology, cause(s), biomarker(s) and treatment of
    CFS, obviously not a priority to the CDC.

    The lack of shared data from previous CDC studies another roadblock to
    progress. Researchers operating in a vacuum rather than cooperatively will
    not solve the puzzle that is CFS. I urge the CDC to share their data – not
    just their findings but their raw data - and to work collaboratively with
    non-CDC researchers to get the answers we need.

    Sadly, the CDC has not appeared to be very interested in delving into CFS
    with the necessary rigor to make significant progress and I fear that the
    program currently under discussion will be more lip service that results in
    little participation by the CDC in meaningful CFS research.

    It is my understanding that no one in the CDC attended the March, 2009
    symposium presented by the International Association for ME/CFS in Reno,
    Nevada. This is a strong indicator of the CDC’s lack of desire to keep
    abreast of recent research developments, hardly a good sign of interest in
    moving forward by building on existing knowledge.

    To summarize, my suggestions for the CDC’s 5-year plan for future research
    is as follows:

    - Adoption of an accurate case definition, e.g., the Canadian case
    definition.
    - Shared Data: The CDC should allow open access to all research-related
    data. Cooperation and collaboration with researchers in the public and
    private sectors are vital to assembling the puzzle pieces of CFS without
    unnecessarily duplicating research efforts.
    - Rigorous Science: The CFS Research Program should be directed toward
    the meaningful study of CFS – its pathophysiology, cause(s), marker(s),
    treatment and ultimately its cure. A purposeful effort and timely,
    well-focused research, rather than a scattered, half-hearted approach, is
    necessary to achieve this goal.
    - Spending and accountability: Curtail excess spending to delegate funds
    to a focused and relevant research program.

    The CDC’s consistent lack of meaningful involvement, wanton spending
    practices and lack of progress have been a continuing, dismal disappointment
    to those of us who have CFS and/or assist and advocate for those who have
    CFS. We need to see a definitive plan and steps to implement that plan to
    know that the CDC is dedicated to progress in CFS research.

    Efforts to date have merely compounded the loud and clear message that the
    CDC does not take CFS seriously and has no organized approach to
    investigating this complex and devastating disorder. I would like to believe
    that the CDC takes CFS seriously and is willing to dedicate the necessary
    funding, concerted effort and rigorous, high-quality research necessary to
    achieving real progress, although I have serious doubts that this is the
    case. I have little to be optimistic about when I examine past lack of
    performance. By the CDC’s own count, millions of lives rest upon its
    decisions and follow-through. I would like to believe that this time will be
    different.

    Katrina Berne, Ph.D.

    http://www.facebook.com/notes.php?id=47921632107

    ********************************************************************

    Jennie Spotila's Presentation at the April 27, 2009 CDC Meeting


    My name is Jennifer Spotila, and it is my honor to serve as Chairman of the
    Board of Directors for the CFIDS Association of America.

    In November 2006, I sat in a room at the National Press Club and
    participated in the launch of the CDC’s public awareness campaign for CFS.
    Then-Director Dr. Julie Gerberding called CFS an "urgent reality," on par
    with avian flu. Swine flu might be a better choice today. And then-Assistant
    Secretary for Health Admiral John Agwunobi announced 7 new NIH grants,
    saying, “There's so much more research that needs to occur. We're pleased to
    announce this work, but we also commit to doing more as time goes on.” The
    promises made that day in November 2006 have faded away.

    Today, you have requested input only "on the CFS strategic research plan,
    not on CDC’s overall CFS program." Strategic plans are forward-looking, but
    not to the exclusion of looking back. In order to draft a strategic plan,
    CDC must consider its overall CFS program, including the ways in which the
    program has fallen short or failed. Given the narrow invitation you have
    extended to stakeholders today, asking us to comment only on the plan and
    not the overall program, I wonder whether your internal planning process has
    been similarly myopic.

    Your "Draft Strategic Research Plan General Outline" (
    http://cdc.gov/cfs/draft_research_plan.htm) was made available for
    stakeholder review only five days ago. This outline is so devoid of
    specifics that the only input I can offer is to point out what is missing.

    What is the priority order of the four goals? What funding needs have been
    identified? How will funding be allocated among the goals? What are the
    milestones and performance measures? Will you continue the use of
    third-party contractors for research studies? What are your plans and
    timeline for data sharing? How will you engage extramural researchers? Does
    the absence of any reference in the draft outline to patient registries or
    sample repositories mean that those initiatives will be abandoned? How,
    exactly, do you propose to develop international consensus on the management
    of CFS? Will you continue the use of the empiric criteria for CFS? What
    efforts will be made to expand use of those criteria by other researchers? I
    could go on.

    Your general outline could have been written two years ago, or ten. "Refine
    understanding of the etiologic pathways," "improve clinical management,"
    "move CFS into the mainstream.”" Yes, yes, of course. There is nothing new
    in this list of objectives. There is no specificity, no measurable
    commitments, and no accountability. There is no acknowledgement of the many
    problems in the CFS program, and no plan to fix them.

    I offer my own list of immediate priorities:

    1. Move quickly to utilize systems already in place to release the
    program’s research data to other investigators.
    2. Conduct a thorough audit of the program’s use of funds and failures in
    oversight. This review should be conducted by personnel outside the program,
    and should include an examination of the program’s practice of obligating
    funds to third-party contracts despite their lack of performance.
    3. Focus on defining and diagnosing CFS through a multidisciplinary
    effort to identify objective biomarkers.


    CDC may be an institution committed to excellence, but the CFS research
    program is losing its vigor and relevance, however excellent individual
    program personnel may be. If CDC fails to address the systemic problems
    within the CFS program, if corrective measures are not undertaken to address
    the wasteful spending and lack of accountability, then any five-year
    strategic plan will not be worth the paper it is printed on. Moreover, the
    opportunity costs of allowing these conditions to continue are incalculable.

    My input is this: CDC is uniquely positioned to have enormous impact on the
    state of CFS research, but the CFS program is falling behind and failing its
    mission. Until you fix that problem, until the program is reinvigorated by
    accountability and purpose, you will be a barrier to success instead of
    being a part of it. Fix that problem, and you can truly create a new
    landscape for CFS.
    http://www.facebook.com/note.php?note_id=100225615538&ref=mf

    *********************************************************************

    Kim McCleary's Presentation at CDC Meeting on April 27, 2009

    *CDC Stakeholder Meeting on the 5-year Strategic Research Plan*
    **
    My name is Kim McCleary and I am the president & CEO of the CFIDS
    Association of America, the nation’s largest and most active organization
    working to make CFS widely understood, diagnosable, curable and preventable.
    This is my 19th year of service to the organization, and in all that time, I
    have missed just one public meeting on CFS. I am deeply familiar with the
    CDC’s research program and CDC staff is quite familiar with me. I’ve got
    just 5 minutes so I’ll cut to the chase and focus on five areas of concern
    as the CDC develops its 5 year strategic plan for CFS research.

    The 4 goals CDC has provided us (http://cdc.gov/cfs/draft_research_plan.htm)
    are certainly worthy and closely match our organization’s goals. If that was
    all we had to discuss, we could end the meeting early and be on our way. But
    a strategic plan requires more than that. (Dr.) Steve (Monroe) has just told
    us that the swine flu cases in the U.S. make it a national “public health
    emergency.” With 4 million cases of CFS in the United States alone, what
    does it take to have CFS declared a public health emergency?

    I will agree with the four peer reviewers who met in November of last year
    that at one time, this program was doing good work and contributing to the
    field and to our understanding of CFS. But the CFS research group has lost
    its mojo. The CDC’s CFS research group receives half of the (meager amount
    of) money that the U.S. spends on CFS. Half. CDC has provided extensive
    financial information on its CFS spending between FY2005-2008, during which
    time expenditures totaled about $23 million. Since 2000, CDC has spent about
    $71 million on CFS and it has published 115 peer-reviewed articles in the
    same time. I doubt most academics could survive with that record. There is a
    tremendous amount of data housed in this program that needs to be widely
    shared so we as taxpayers and as advocates yield a better return on our
    investment than CDC can produce on its own.

    Second, by virtue of the plan outline posted on the CDC’s website for a CDC
    RESEARCH plan, it does not seem that three of the four goals are consistent
    with a research plan for a branch housed in the Coordinating Center for
    Infectious Diseases. Using organizational information contained in the CDC’s
    2008 Congressional Justification document, Goal 2 of the research plan,
    clearly an education-related activity, appears much better suited to either
    the National Center for Health Marketing or the National Center for Chronic
    Disease Prevention and Health Promotion. The same is true of goal 4. But
    these tasks are not logically part of a research strategic plan and are not
    well-suited to the individuals and leadership currently working in the
    Chronic Viral Diseases Branch. Even Goal 3 seems an odd fit. This group has
    become increasing isolated and insular and is not currently collaborating
    with any clinical investigators, yet it proposes to develop international
    consensus on the management of CFS. Note that its clinical recommendations
    on the web site focus on UK guidelines that are very controversial in that
    country. How does CDC expect to replicate the success of the clinics in Bibb
    County, Georgia, that Dr. Royal (from Abt Associates) described? Educating
    health care professionals is necessary and worthwhile, but it’s cost
    prohibitive to go town to town with the approach used in Macon. How will CDC
    address that?

    Third, this group named the “Chronic Viral Diseases Branch” is currently
    doing little if any research on viral (or other biological triggers) of CFS.
    Although they supported the landmark Austrialian Dubbo Infection Outcomes
    Study, there is no current work to evaluate EBV, HHV-6, enteroviruses and
    other agents as triggers of CFS, despite the finding that 10% of these and
    other acute infections do not successfully resolve and result in a CFS-like
    state. Instead, the group is focused on early life psychological stressors,
    a risk factor in most chronic illness, and proposes to study whether the
    economic crisis will result in a higher rate of CFS among respondents in the
    next phase of the Georgia surveillance study. So, why is this psychosocial
    dimension the focus of research in the NCVZED and the CVDB? So much
    opportunity has been lost to study the rates of CFS occurring in the wake of
    outbreaks of West Nile Virus, avian flu and now swine flu, and other acute
    infections or chronic exposures like toxins and molds. There is great
    opportunity cost to the choices that branch leadership has already made in
    an apparent vacuum within its own center.

    Fourth, you can’t build a sustainable structure on a weak foundation. Yet,
    it is the strong belief of many in the CFS community – researchers and
    patients alike (with all due respect to the four individuals who served as
    peer reviewers in November) – that the empiric criteria is a weak
    foundation. It is used only by CDC and defines a different patient
    population and make its studies difficult – if not impossible – to compare
    to all other studies. So how much of the $25 million or so that will be
    dedicated to CDC over the next 5 years will be wasted as a result of this
    shaky methodological foundation?

    Last, the clear consensus message at the two most recent international
    research conferences on CFS has been the need to establish CFS subsets to
    facilitate research, objective diagnostics markers and more effective
    treatments. Yet the research outline makes no reference to this need and
    focuses on the need to identify biomarkers only for “incident CFS” which may
    leave out all longer duration periods of illness, and most of the patients
    who are already ill. This is an unacceptable goal for our nation’s public
    health agency.

    CDC alone has the resources and infrastructure to understand the long-term
    health consequences of CFS and we underscore the importance of CDC
    conducting longitudinal follow-up studies to track patients for several
    years. However, this is not included in the research plan. Right now we
    don’t know what happens to patients with long-term illness. I can tell you
    from having known many patients over almost 20 years now that there are some
    strange and troubling things that occur. We don’t know whether this is due
    to an acceleration of aging, consequences of long-term disability, or
    aspects of CFS that are exacerbated over time in some patients. CDC is the
    only agency that can adequately study it.

    Finally, for any strategic plan it is necessary to address performance
    milestones, accountability measures and transparency, especially since
    President Obama made these priorities in the earliest days of his
    presidency. I know that these values are held by CDC more broadly and hope
    they will be enforced at the branch level through this plan.
    http://www.facebook.com/note.php?note_id=100223710538&ref=mf
  20. mezombie

    mezombie New Member

    CFS Strategic Research Plan Testimony


    Over the past to decades I have been involved in CFS advocacy. It had
    been my hope that all CFS stake holders could be encouraged to
    cooperatively work together, thereby accelerating advancement in the
    understanding of the illness.

    Towards that goal I have sat on several Department of Health and Human
    Services (DHHS) committees, worked with many patient organizations,
    participated in related conferences, and worked extensively behind the
    scene.

    Observing the process of medical investigation was not new to me when
    I became involved with CFS advocacy; I came from a career of working
    with medical researchers and educators.

    For the past 20 years I have observed that the CDC's CFS program has
    not sincerely worked at investigating the broad range of multi-system
    pathologic dysfunctions involved in the illness, nor microbes and
    pathogens that may be potentially involved in CFS.

    Since the CDC's first involvement with CFS the agency has allowed
    internal agendas and opinions drive their investigations rather than
    allowing objective science to drive the research. This is a corruption
    of the scientific process.

    All too often we have seen narrowly focused and poorly designed CDC
    investigations conducted in such a fashion that they would assure that
    outcomes matched the opinions of the CDC's chief investigator.

    Repeatedly the CDC's CFS department has ignored the majority of the
    world's independent CFS investigators and their research findings.
    Instead the CDC's CFS department has surrounded itself with a small
    group of like minded narrowly focused investigators, then claiming it
    to be "an international panel of CFS research experts."

    In their committees that have shaped their research diagnostic
    criteria, they have formed their own narrow criteria proposals while
    ignoring input that conflicts with the CDC's opinions about the
    illness. The CDC's CFS department has then deceptively claimed their
    diagnostic criteria proposals to be the product of "international
    consensus." It is easy to reach consensus amongst like minded people.
    It is akin to playing poker with marked cards.

    Now the CDC's CFS department has created what it calls their
    "Empirical case definition" of the illness when in fact it is far from
    empirical. For their observations are only focused upon a narrow
    portion of symptomatology that may be present in a narrow subgroup of
    patients they define as having CFS. It is not just independent
    investigators that find significant flaws and shortcomings in the
    CDC's work. When looking at the symptomatology of patients in the
    CDC's studies, the vast majority of patients afflicted with CFS make
    comments like, "those patients don't have the same illness I have," or
    "I couldn't function on the level of those patients." And now the CDC
    is redefining CFS to be a stress disorder, again ignoring the bulk of
    the objective physiologic symptomatology of the illness and the
    majority of independent CFS investigators. The corruption of science
    goes on.

    Most of the important advancements in CFS research have come not from
    investigators who have received help and/or funding from DHHS, but
    rather from investigators who have conducted their work despite the
    biased actions and inactions of DHHS in regard to CFS.

    Most medical investigators are not apt to be entirely candid about the
    views of DHHS activities pertaining to CFS. They rely on research
    funding and are hesitant to bite the hand that feeds them, or may feed
    them down the road. The CDC's "Chronic Fatigue Research Program
    External Peer Review" was not a sincere external peer review unless
    "peer' means like minded or unlikely to be candid. Only a few doctors
    even took part.

    If the CDC wishes to conduct an honesty objective and forward thinking
    review of its CFS program it would request the input of a broader
    range of CFS investigators from around the world that represent the
    many fields of investigation that are needed. Without that the process
    is little more than a white wash, a token public relations gesture to
    look good.

    There is no point in developing a long term strategic plan if true
    experts' opinions and recommendations are not honestly taken into
    account. We need a plan the will be in the spirit of the founding
    principles of the CDC, to truly attempt to investigate and gain
    understanding of illnesses, to develop treatments for those illnesses
    and to keep the public informed about true empirical information; in
    essence to protect the public. The CDC's CFS department has not and is
    not doing that. If anything they have inflicted more harm upon the CFS
    patient sector with their actions and lack there of.

    Until an honest sincere review and reevaluation of the CDC's CFS
    department is conducted, and new investigators are brought in who will
    conduct the kinds of scientific inquiry need, most stakeholders will
    not support continuation of the CDC's CFS department as it has been
    functioning. If the CDC is unwilling to bring this about then it is
    time for Congress to conduct its own investigation into the CDC's
    response to the illness.


    Very sincerely,

    John Herd