The 12th Invest in ME Conference, Part 1
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I Contacted CDC re False Info on XMRV Site

Discussion in 'Action Alerts and Advocacy' started by rebecca1995, Jul 8, 2010.

  1. rebecca1995

    rebecca1995 Apple, anyone?

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    After Justin pointed out that the CDC website on the XMRV paper tries to pass off the empirical definition as the Fukuda Criteria, I wrote this letter to the CDC.

    I pasted it into the contact form on this page, http://www.cdc.gov/contact/index3.htm, and also sent it as an email to Dr. Frieden (CDC Director) and Dr. Unger (acting chief of the Chronic Viral Diseases Branch, which houses the CFS Research Program). Their addresses are ftdh@cdc.gov and eru0@cdc.gov, respectively.

    I purposely made this letter straightforward and non-accusatory. If they don’t amend the webpage, I’ll raise the rhetoric and forward the letter with a sterner preface to higher-ups at DHHS.

    Feel free to copy. Don't forget to sign your name and add your location, if you wish.

    ***

    Dear Centers for Disease Control:

    I’m writing to point out a factual error on your webpage entitled “Updates: XMRV”, located at http://www.cdc.gov/ncidod/dhqp/bp_xmrv_overview.html.

    The error concerns which case definition was used to select CFS patients for a recent CDC study on XMRV by Switzer et al. The webpage reads,

    “Patients from both groups had CFS that met the criteria of the 1994 International CFS Research Case Definition, which was established to help distinguish CFS from other illnesses that cause fatigue.”

    Several paragraphs down, the page continues,

    “The CDC-led team tested specimens collected from previous population-based studies in Kansas and in Georgia and from physician referrals in Georgia. All CFS patients received a clinical assessment and had a diagnosis that met the criteria of the 1994 International CFS Research Case Definition.”

    Both these statements imply that the patients met criteria for the case definition described in 1994 by Fukuda et al. (1) and commonly known as the Fukuda Criteria. However, the Switzer paper, which was peer-reviewed and published, makes clear that your patients were selected by different criteria. The paper reads,

    “Archived blood specimens were tested from persons with CFS defined by the revised 1994 CDC case definition and matched healthy controls from Wichita, Kansas and metropolitan, urban, and rural Georgia populations.”

    This “revised 1994 CDC case definition” was described in 2005 in a paper by Reeves et al. (2) and is commonly known as the empirical definition or Reeves Criteria.

    The difference between the empirical definition, which was used by Switzer et al., and the Fukuda Criteria, which your webpage implies were used, is significant. Work by Reyes et al. (3) in 2003 found 240 people with CFS per 100,000 in Wichita, Kansas. In 2007, Reeves et al. (4), using the empirical definition, found 2,540 people with CFS per 100,000 in Georgia. Markedly broader than its predecessor, the empirical definition diagnosed more than ten times as many people with CFS.

    The paper by Switzer et al. also notes that the CFS patients under study were administered “standardized questionnaires” to assess fatigue, functional impairment, and symptoms. The use of these questionnaires is another tip-off that the case definition employed by the study is the empirical definition, not the Fukuda Criteria.

    The error on your webpage can easily be corrected by inserting the word “revised” before the phrase “1994 International CFS Research Case Definition”, which appears twice. Doing so will reconcile the page with your published study.

    Thank you for your time. I look forward to viewing the amended page.

    Sincerely,




    References:

    (1) Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome - a comprehensive approach to its definition and study. Annals of Internal Medicine 1994, 121:953-959.

    (2) 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 Medicine 2005, 3:19.

    (3) Reyes, M., Nisenbaum, R., Hoaglin, D.C., Unger, E.R., Emmons, C., Randall, B., Stewart, G., Abbey, S., Jones, J. F., Gantz, N., Minden, S., & Reeves, W.C. Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas. Archives of Internal Medicine 2003, 163, 1530-1536.

    (4) Reeves, W.C., Jones, J.J., Maloney, E., Heim, C., Hoaglin, D.C., Boneva, R., Morrissey, M., & Devlin, R. New study on the prevalence of CFS in metro, urban and rural Georgia populations. Population Health Metrics 2007, 5:5.
     
  2. George

    George waitin' fer rabbits

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    Fantastic letter Rebecca!
     
  3. rebecca1995

    rebecca1995 Apple, anyone?

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    Thank you, George! I hope it does something!
     
  4. ixchelkali

    ixchelkali Senior Member

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    Rebecca, may I suggest posting your letter (or a version of it) to the Retrovirology journal website, as a comment on the Switzer et al study? That way the differences in criteria can be read by scientists and other interested parties who read the paper. I think it's a point worth making to a larger audience than the CDC.
     
  5. capemark

    capemark

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    Great work!

    I was unaware that Reeves had pulled this sneaky little trick!
    I guess this paper is his parting shot before being forced into another line of work (hopefully where he can't do as much harm!)

    Keep us informed of their reply!

    Mark Elliott
     
  6. taniaaust1

    taniaaust1

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    great letter :) , im really struggling to get my head around what is what right now, so im glad that some of us are.
     
  7. leelaplay

    leelaplay member

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    fantastic letter Rebecca!

    And I second ixcelkali's request that you also submit this to Retroviriology so any scientist reading the CDC's paper will be clear about the problems witht he definition.
     
  8. parvofighter

    parvofighter Senior Member

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    Thank you Rebecca!

    GREAT letter, and thank you so much for advocating on behalf of us. Am having to pass the torch on these days - hope to be better soon.

    FYI here is the Retrovirology link for Comments: http://www.retrovirology.com/content/7/1/57/comments
    so that your excellent analysis is front-and-centre for those CDC louts.

    Thanks again!

    parvo
     
  9. glenp

    glenp "and this too shall pass"

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    Great letter - Will he reply??

    glen
     
  10. rebecca1995

    rebecca1995 Apple, anyone?

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    Thanks everyone! I'll have to tweak it some to post on Retrovirology...maybe add a reference to the Jason study that found a high percentage of those with major depressive disorder fit the empiric definition. I'm on the burnout bench/beach at the mo--but hopefully next week. :Retro wink:

    Glen--I don't care if no one responds, as long as the CDC corrects their da@n website!
     
  11. rebecca1995

    rebecca1995 Apple, anyone?

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    Second Letter to CDC re XMRV Error on Webpage

    Because the CDC hasn’t corrected its webpage--surprise, surprise!--to clarify that Switzer used the empirical definition, I wrote another letter, below. I borrowed some material from Jerry’s revision of my first letter (thanks, J.!).

    I pasted it into http://www.cdc.gov/contact/index3.htm to reach CDC and also sent an email addressed as follows:

    To: ftdh@cdc.gov
    Cc: eru0@cdc.gov, kathleen.sebelius@hhs.gov, howard.koh@hhs.gov, francis.collins@nih.gov, margaret.hamburg@fda.hhs.gov, wanda.jones@hhs.gov, jdwallace@ajc.com, insideajc@ajc.com, newstips@ajc.com, health@washpost.com, health-science@washpost.com, national@nytimes.com, news-tips@nytimes.com, newseditors@wsj.com, a.murray@wsj.com, Tami.Dennis@latimes.com, Davan.Maharaj@latimes.com

    Plus, I forwarded it to Amy Marcus.

    Feel free to copy this letter, tweak it, etc. If you send it, don’t forget to sign your name and include contact information.

    *****

    To: Thomas R. Frieden, MD, MPH, Director, Centers for Disease Control and Prevention

    Cc: Suzanne Unger, MD, Acting Chief of Chronic Viral Diseases
    Branch; Kathleen Sebelius, Secretary of Health and Human Services; Howard Koh, MD, MPH, Assistant Secretary for Health; Francis Collins, MD, PhD, NIH Director; Margaret Hamburg, MD, Commissioner of Food and Drugs; Wanda Jones, PhD, Designated Federal Officer for CFSAC; The Atlanta Journal-Constitution; The Washington Post; The New York Times; The Wall Street Journal; The LA Times

    Dear Dr. Frieden:

    On July 8, I emailed you regarding a significant factual error on your webpage about the recently-discovered human retrovirus, XMRV (see my email, pasted below). I also sent a copy of this email to Dr. Suzanne Unger and transmitted it to the CDC via the form on your contact page.

    As I pointed out in that email, your webpage at http://www.cdc.gov/ncidod/dhqp/bp_xmrv_overview.html falsely states that the CFS cohort in the CDC study by Switzer et al. (1) was selected by the 1994 Fukuda Criteria, when in fact it was selected by the 2005 empirical definition.

    Yet you have neither corrected your webpage nor responded to my email.

    It is beyond the scope of this letter to detail the flaws in the empirical definition, including low specificity and sensitivity, which were summarized by Jason et al. (2) this year. The purpose of this letter is to ask you, again, to amend your webpage to reflect the true facts regarding Switzer’s cohort.

    As scientists attempt to explain the discrepant results of XMRV studies, it’s critical for them to understand variations among studies, including how cohorts were selected. Switzer et al. failed to detect XMRV in CFS patients while Lombardi et al. (3) found the virus in two-thirds of CFS patients. Differences in cohort selection may help explain the papers’ conflicting conclusions. The Lombardi patients met both the Fukuda Criteria and the Canadian Consensus Criteria (4); the Switzer patients met neither of those definitions. Instead, they fulfilled the empirical definition, which is dramatically more inclusive.

    Without a doubt, the “1994 International CFS Research Case Definition” referred to by your webpage is the Fukuda Criteria. The “REVISED 1994 CDC case definition” (capitalization mine), referred to by both Switzer’s published paper and the abstract on Retrovirology.com, is the empirical definition.

    Why does the wording of your webpage depart from the wording of Switzer’s paper and abstract? Is it your intention, Dr. Frieden, to mask the disparity between the Switzer and Lombardi CFS cohorts by erroneously suggesting that the former met the Fukuda Criteria? If not, you should have no objection to correcting your webpage by inserting the word “revised” before the phrase “1994 International CFS Research Case Definition”. Alternatively, you could use the exact phrase from the paper and abstract: “revised 1994 CDC case definition”.

    If you fail to rectify the page, you will leave the CDC open to charges of deliberately misleading the public about data concerning an infectious AIDS-like retrovirus that has already been associated with two diseases--CFS and aggressive prostate cancer. Due to the serious nature of your error, I suggest that you point out on the corrected webpage both the initial error and the correction made.

    Because misrepresenting XMRV data is a public health issue, I’m sending carbon copies of this email to several newspapers.

    I look forward to your notification that the webpage has been corrected. Feel free to contact me by email, phone, or surface mail. Thank you.

    Sincerely,


    References:

    (1) William M Switzer, Hongwei Jia, Oliver Hohn, HaoQiang Zheng, Shaohua Tang, Anupama Shankar, Norbert Bannert, Graham Simmons, R Michael Hendry, Virginia R Falkenberg, William C Reeves and Walid Heneine. Absence of evidence of Xenotropic Murine Leukemia Virus-related virus infection in persons with Chronic Fatigue Syndrome and healthy controls in the United States. Retrovirology 2010, 7:57.

    (2) Jason LA, Evans M, Brown A, Brown M, Porter N, Hunnell J,
    Anderson V, Lerch A. Sensitivity and Specificity of the CDC Empirical Chronic Fatigue Syndrome Case Definition. Psychology, 2010, 1:9-16.

    (3) Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA. Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Science, Oct 23 2009, 326(5952):585-9. Epub Oct 8 2009.

    (4) Carruthers BM, Jain AK, De Meirleir KL, Peterson DL, Klimas NG, Lerner AM, Bested AC, Flor-Henry P, Joshi P, Powles ACP, Sherkey JA, van de Sande MI. Myalgic encephalomyalitis/chronic fatigue syndrome: Clinical working definition, diagnostic and treatment protocols. Journal of Chronic Fatigue Syndrome, 2003, 11(1): 7–97.

    _____________________

    EMAIL SENT JULY 8, 2010:

    Dear Centers for Disease Control:

    I’m writing to point out a factual error on your webpage entitled “Updates: XMRV”, located at http://www.cdc.gov/ncidod/dhqp/bp_xmrv_overview.html.

    The error concerns which case definition was used to select CFS patients for a recent CDC study on XMRV by Switzer et al. The webpage reads,

    “Patients from both groups had CFS that met the criteria of the 1994 International CFS Research Case Definition, which was established to help distinguish CFS from other illnesses that cause fatigue.”

    Several paragraphs down, the page continues,

    “The CDC-led team tested specimens collected from previous population-based studies in Kansas and in Georgia and from physician referrals in Georgia. All CFS patients received a clinical assessment and had a diagnosis that met the criteria of the 1994 International CFS Research Case Definition.”

    Both these statements imply that the patients met criteria for the case definition described in 1994 by Fukuda et al. (1) and commonly known as the Fukuda Criteria. However, the Switzer paper, which was peer-reviewed and published, makes clear that your patients were selected by different criteria. The paper reads,

    “Archived blood specimens were tested from persons with CFS defined by the revised 1994 CDC case definition and matched healthy controls from Wichita, Kansas and metropolitan, urban, and rural Georgia populations.”

    This “revised 1994 CDC case definition” was described in 2005 in a paper by Reeves et al. (2) and is commonly known as the empirical definition or Reeves Criteria.

    The difference between the empirical definition, which was used by Switzer et al., and the Fukuda Criteria, which your webpage implies were used, is significant. Work by Reyes et al. (3) in 2003 found 240 people with CFS per 100,000 in Wichita, Kansas. In 2007, Reeves et al. (4), using the empirical definition, found 2,540 people with CFS per 100,000 in Georgia. Markedly broader than its predecessor, the empirical definition diagnosed more than ten times as many people with CFS.

    The paper by Switzer et al. also notes that the CFS patients under study were administered “standardized questionnaires” to assess fatigue, functional impairment, and symptoms. The use of these questionnaires is another tip-off that the case definition employed by the study is the empirical definition, not the Fukuda Criteria.

    The error on your webpage can easily be corrected by inserting the word “revised” before the phrase “1994 International CFS Research Case Definition”, which appears twice. Doing so will reconcile the page with your published study.

    Thank you for your time. I look forward to viewing the amended page.

    Sincerely,



    References:

    (1) Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome - a comprehensive approach to its
    definition and study. Annals of Internal Medicine 1994, 121:953-959.

    (2) 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 Medicine 2005, 3:19.

    (3) Reyes, M., Nisenbaum, R., Hoaglin, D.C., Unger, E.R., Emmons, C., Randall, B., Stewart, G., Abbey, S., Jones, J. F., Gantz, N., Minden, S., & Reeves, W.C. Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas. Archives of Internal Medicine 2003, 163, 1530-1536.

    (4) Reeves, W.C., Jones, J.J., Maloney, E., Heim, C., Hoaglin, D.C., Boneva, R., Morrissey, M., & Devlin, R. New study on the prevalence of CFS in metro, urban and rural Georgia populations. Population Health Metrics 2007, 5:5.
     
  12. xrayspex

    xrayspex Senior Member

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    excellent! thx
     
  13. leela

    leela Slow But Hopeful

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    Fantastic, rebecca! Heartfelt thanks for all the work that went into that!
     
  14. rebecca1995

    rebecca1995 Apple, anyone?

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    Thanks, guys! If nothing else, the email will make clear to reporters and editors that readers are interested in stories about XMRV. And with any luck, reporters will think twice before assuming that the "CFS" patient populations of various studies are equivalent.
     
  15. leaves

    leaves Senior Member

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    You Go Girl!!
     
  16. Revday

    Revday

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    Did It.

    I've sent this letter as well as the first (tweaked) ;) to the email recipients you've suggested. Thank you for your work.
     
  17. rebecca1995

    rebecca1995 Apple, anyone?

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    Great! Thanks, Revday!
     
  18. leelaplay

    leelaplay member

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    Hey Rebecca

    Anika posted this in another thread. Looks like it'd be a great addition to your references! Jason showing yet another problem with "reeves" criteria

    Jason's Latest Paper on the Reeves / Empiric Criteria: Use of SF-36 Subsets

    [Note to moderator: I didn't see this abstract posted elsewhere so if it is, please let me know or move my comment to the right thread and I'll edit it.]

    Leonard Jason and his team keep plugging away at the problems with the CDC Reeves / empirical definition and the cohorts it produces, a la Wichita and Georgia cohorts used in the CDC's XMRV paper.

    Some of the major criticisms related to the Reeves definition concern its choice of subscales of the SF-36, and cutoff scores on those subscales, to determine whether a person has the substantial reduction in activity to be characterized as CFS. It uses a score relating to emotions (versus physical or social functioning, for example) as one of the relevant subscales, and uses arbitrary cutoffs, among other things.

    In the abstract cited below, Jason says the Role Emotional subscale had the least sensitivity and specificity of all the subscales. Other findings also sound interesting.

    Does anyone have access to the whole paper? I'd be interested in how else their findings differ from what the CDC is doing.

    The problem is, the CDC should have done something like this before it published any results using the Reeves criteria.

    http://www.ncbi.nlm.nih.gov/pubmed/20617920
    Disabil Rehabil. 2010 Jul 9. [Epub ahead of print]

    Measuring substantial reductions in functioning in patients with chronic fatigue syndrome.
    Jason L, Brown M, Evans M, Anderson V, Lerch A, Brown A, Hunnell J, Porter N.

    Center for Community Research, DePaul University, Chicago, IL 60614, USA.

    Abstract
    Purpose. All the major current case definitions for chronic fatigue syndrome (CFS) specify substantial reductions in previous levels of occupational, educational, social, or personal activities to meet criteria. Difficulties have been encountered in operationalizing 'substantial reductions.' For example, the Medical Outcomes Study Short Form-36 Health Survey (SF-36) has been used to determine whether individuals met the CFS disability criterion. However, previous methods of using the SF-36 have been prone to including people without substantial reductions in key areas of physical functioning when diagnosing CFS. This study sought to empirically identify the most appropriate SF-36 subscales for measuring substantial reductions in patients with CFS. Method. The SF-36 was administered to two samples of patients with CFS: one recruited from tertiary care and the other a community-based sample; as well as a non-fatigued control group. Receiver operating characteristics were used to determine the optimal cutoff scores for identifying patients with CFS. Results. The SF-36 Role-Emotional subscale had the worst sensitivity and specificity, whereas the Vitality, Role-Physical, and Social Functioning subscales had the best sensitivity and specificity. Conclusion. Based on the evidence from this study, the potential criteria for defining substantial reductions in functioning and diagnosing CFS is provided.

    PMID: 20617920 [PubMed - as supplied by publisher]
     
  19. rebecca1995

    rebecca1995 Apple, anyone?

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    Good point, shrews! Leonard Jason is truly one of our best allies...
     
  20. Cloud

    Cloud Guest

    Thank you Rebecca, this is some of the best advocacy work I have seen. Very well written. I think you'll get a response now......it may be the usual generic CYA bull, but at least your calling them to the carpet on their attempts to smokescreen the facts.
     

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