Wednesday, April 20, 2011

34 News: Institute of Medicine Releases Lyme Disease Workshop Summaries

Source link: http://www.iom.edu/Reports/2011/Critical-Needs-and-Gaps-in-Understanding-Prevention-Amelioration-and-Resolution-of-Lyme-and-Other-Tick-Borne-Diseases.aspx?utm_medium=etmail&utm_source=Institute+of+Medicine&utm_campaign=04.20.11+Report+-+Lyme+Disease+%26+Other+Tick-Borne+Diseases&utm_content=New+Reports&utm_term=Media

To read the Workshop Summaries, click on the link at the top and look in the righthand column - you'll see gray buttons that say "Download Report" or "Read Report Online For Free". If you want to download a pdf of the report, you'll need to supply your email address and other info. If you just want to view it online, click "Read Report Online For Free" and there will be no request for personal information.

Once you select "Read Report Online For Free", by the way, you have an opportunity to download a 21 page summary of the report (direct download) by clicking on a link for it on the lefthand column. Otherwise, the full report is 468 pages long.

[CO update: The 21 page summary gives the barest of outlines of what was discussed, along with a list of those who attended - you are much better off reading the 468 page report.]

One thing to note here is that this appears to be a report on what was discussed at the Institute of Medicine (IOM) workshop on tickborne diseases in October 2010 and not a final position piece stating the IOM's consensus on how Lyme disease and tickborne infections should be approached through research, prevention, or treatment.

34 comments:

  1. More stalling at taxpayers and the TBD infected citizens expense...all of this information was available online in the video. There is more useful information available on this blog (Camp Other)alone, than this 500+ page transcript--but Camp Other information does not cost the taxpayer a dime and at least gives the impression that someone is more concerned about public health than science or politics.

    If I sound frustrated, it is because I have been patiently (how fitting) waiting for this report for an indication of how I should proceed with my treatment...I get nothing.

    I recently had another Western Blot test done after two years of oral antibiotics. The test came back with yet more positive bands and stronger positives than the test prior to the antibiotics. However, still barely shy of CDC or IDSA guidelines for being Lyme positive. My physical health has dramatically improved, but my neurological symptoms have changed very little--if anything, for the worse. My stomach can no longer tolerate oral antibiotics.

    Insurance will not pay for IV antibiotics since I do not meet IDSA guidelines (close only counts in horseshoes and hand grenades), and I cannot afford the IV treatments out of pocket. I wanted to try at least 30 days of IV treatment since it is reported, by the IDSA, to be effective for neurological symptoms in late diagnosis cases such as mine, even though my doctor believes 30 days would be like pissing in the wind. Still, if the government says it is effective, I would be willing to give it a shot in the heart; but I do not quite fit the perfect IDSA model for the disease that has disabled me for three years, relieving my insurance from being obligated to pay for what I cannot afford. I am almost 54 years old and should be in the prime of my earning potential. Time is not on my side, and I have waited another year for nothing.

    Yeah, I'm frustrated.

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  2. Hi Anonymous,

    I agree that this report was pretty much what was covered in the online webcast by the IOM then put into print form. Some of the information in there is new for people who hadn't heard it before - but most of it of no immediate practical use except for knowing more about the diversity of specific tickborne infections in specific parts of the country.

    Beyond that, the list of action items for each section are pretty much the same action items the Lyme patient community has wanted fulfilled for some time: better tests and effective treatment; treatment for those of us with persisting chronic symptoms and not more vaccine development.

    And while vaccines that actually worked and were safe which would prevent Lyme disease have my support, I don't see one on the horizon any time soon. Besides - we need help now. We've needed it for a long time.

    You have my sympathy on this issue of there not being enough information on treatment and research on treatment when this is something patients need the most.

    I'm glad your physical health has improved a lot. Sorry about the neurological symptoms getting worse - that is concerning. Have you received any second opinions about your neurological symptoms just to make sure it isn't something else? I'd take advantage of having insurance to rule out any other potential causes of neurological symptoms through a primary care doctor and neurologist just to cover all your bases - even if you are pretty sure the underlying cause is infectious or immune related. If the specialist finds nothing, at least it gives you peace of mind to rule out other causes or factors.

    I am sorry insurance won't cover IV antibiotics - they won't for most people with persisting symptoms, and I am disappointed to find that even those with early disseminated neurological symptoms often get missed and don't get the 30 days of IV they should be able to get without a fight.

    Your situation is one where I think you should be able to get 30 days of IV treatment with a positive test and clinical diagnosis without a fight, based on a number of case studies and research. Even by the more conservative standard of care, I see no reason why your insurer should not cover a month of IV antibiotics for you if it's indicated. (Out of curiosity, do you know if your positive test bands are specific to Lyme or cross-reactive?)

    I agree it's frustrating. The question is: What do we as patients need to do to improve this situation? Who else do we need to work with for making changes?

    So far, individual patients take it into their own hands, and once they have a prescription, try to find the cheapest way to get on IV medication and do as much prep for themselves as they can. Which is hard when you're already sick and not up to doing much.

    I am at my own sort of breaking point over treatment for similar reasons. I should be out there working now. Working and playing hard, like I used to do. I don't think I can do antibiotics forever, nor should I because my digestive system has its limits. So the question becomes: What's next?

    I have pieces of that answer, but not all of it.

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  3. Camp Other
    I have had other opinions for my neurological symptoms, in fact those were the first opinions I heard regarding chronic fatigue, poor memory, inability to focus, anxiety, etc.; several doctors all had different diagnosis from "its all in your head" and depression, to mania and natural aging...of course each doctor quite sure of their diagnosis. When a referred psychiatrist insisted I should see a sleep specialist I was sure my new CPAP was going to be a cure all--it helped with some of the chronic fatigue, but nothing else. My peace of mind moment came when my Lyme aware doctor told me Lyme's disease was the culprit, and there was a good chance it could be treated successfully.

    As for the Western Blot bands being Lyme specific. I do not remember the band numbers off hand, however there was a note on the lab report stating that two of the bands that were strong positives could be indicative of Lyme vaccination. I am not aware of ever getting a Lyme vaccination, so it seems puzzling that I would still not meet IDSA guidelines.

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  4. Hi Anonymous,

    I'm sorry you went through several doctors before this. It's not uncommon for Lyme disease patients and I wish I knew how many people are diagnosed and treated right away.

    Those of us with persistent symptoms seem to get shuffled from one doctor to another, one specialist to another to determine what's wrong. To hear that you already went through a lot of evaluation when you could have been tested and evidence found that it was Lyme disease all along is enormously frustrating.

    If you never had a vaccination - and most people did not - then those bands should have been given as evidence of an infection. Specific bands are more important. That along with your clinical picture and history would point to Lyme disease. What happened to you doesn't make sense to me either. How this disease is diagnosed and treated - and how patients are treated - has not made sense to me in a number of cases including yours.

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  5. More stalling at taxpayers and the TBD infected citizens expense..

    NatCap said first:
    The report confirmed what Lyme patients have known for years – that Lyme disease is a serious illness, and significant gaps remain in our understanding of the disease.

    Then went on to 'thank' and 'commend' the IOM for spending tax money for a useless sham of a report:

    The National Capital Lyme Disease Association (NatCapLyme) would like to thank the IOM for completing this arduous task with integrity within the guidelines they were charged to respect.

    And:

    We commend the IOM for so effectively establishing the convergence of science with real-life situations and highlighting both the need for more scientific knowledge and the serious societal challenges that need to be addressed.

    WHAT? HUH?

    I much preferred Pat Smith's comments:

    2010 Labor HHS appropriations language adopted by Congress clearly directs this IOM process. NIH assured me in discussions that the process would be one that Lyme organizations would find in compliance in every way with the intent of that language, including a guarantee that this process would be totally open and public. IOM told me that adequate time would be allotted so that all public comment would be heard. The only public comment time is 5 minutes, hardly adequate to cover crucial topics that need addressing and has even discouraged those geographically distant from attending.

    Instead of providing an unbiased panel on this most controversial topic, IOM indicates bias is not relevant thus isn’t considered in panel selection. However, balance is stressed by IOM, yet the chosen panel does not represent the diverse viewpoints that exist on selection and interpretation of existent scientific Lyme research. Several individuals are clearly associated with entities that hold preconceived ideas about Lyme, especially chronic Lyme. LDA and other organizations sent IOM recommendations for panel
    members, none of whom were selected, and later sent concerns about imbalance in the chosen panel, including recommendations to provide that balance. That issue has not been addressed to date.


    What a sham. What a waste of public money and time. However, the IOM has always clearly stated what they will/can and won't/can't do. What's amazing to me is that the people at NatCap didn't read the fine print and believed something would be solved/done? And one is an attorney!

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  6. Hey cave76,

    I hear you - and I agree, the wording at the top of your comment translates into "we're here to report that there's a problem in Lyme disease". Who hasn't known this for years, for anyone who has either gotten the disease, is close to someone to has it, or works in the field in some respect? These problems have been problems for years. It's meaningless.

    Regarding Pat's comment, a public comment time of 5 minutes is inadequate. Is 5 minutes for public comments historically typical of IOM workshops - or was this specific to last October's Lyme/tickborne workshop? In other words, was our patient population singled out or are all patients (and their allies) equally not given enough time to comment?

    Pat said, "... IOM indicates bias is not relevant thus isn’t considered in panel selection."

    The IOM really said that? That doesn't make sense. That isn't good science. If there are legitimate scientists out there with differing viewpoints and the evidence to support those viewpoints, those viewpoints should be deliberately represented. Obviously, if someone isn't a real scientist and doesn't have experience or credentials, they shouldn't be presenting - but to not even care about bias is scientifically unwise.

    Pat also said, " However, balance is stressed by IOM, yet the chosen panel does not represent the diverse viewpoints that exist on selection and interpretation of existent scientific Lyme research."

    What does the IOM think constitutes balance, versus constitutes bias?

    Pat continued, "Several individuals are clearly associated with entities that hold preconceived ideas about Lyme, especially chronic Lyme. LDA and other organizations sent IOM recommendations for panel
    members, none of whom were selected, and later sent concerns about imbalance in the chosen panel, including recommendations to provide that balance."

    cave76, do you know who those recommended panel members were?

    What did you think of the presenters who did speak? I know some of them have preconceived ideas about the Chronic Lyme Disease diagnosis - but I think some of them sidestepped the issue and presented research that at least left the issue of chronicity open to doubt, and a few mentioned persistence directly.

    There were presenters there who were also clearly cut and dry about being against CLD's existence - and the most damning for me was not Wormser and his presentation (it was predictable; I'd heard it before) it was Afton L. Hassett, Psy. D.'s presentation on somatic and psychological disorders associated with Post Lyme Disease Syndrome that bothered me. Not that chronic illness can't make anyone get depressed - but the emphasis on how big a role somatic and psychological disorders plays in the Lyme disease process concerns me. This is not particular to Hassett but to a number of researchers including Steere, who has made outrageous statements about female patients with Lyme disease.

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  7. ***cave76, do you know who those recommended panel members were?***

    I'll find more of the answers to your questions later.

    For now:
    Four of the 6 IOM panel members are IDSA members.

    10 of the 14 physician speakers were authors on the IDSA guidelines or the copycat guidelines issued by members of the IDSA panel or members of the IDSA.

    Zero ILADS physicians have been chosen to speak.


    From
    http://www.lymedisease.org/news/lymepolicywonk/550.html

    (sorry, lost my cheat sheet for how to make a live url)

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  8. To:
    Dr. Francis S. Collins, M.D., Ph.D.
    Director, National Institutes of Health
    1 Center Drive, MSC 0148 (Room 126)
    Bethesda, MD 20892-0148

    On Jun. 25 2010

    We are writing to express our concerns regarding NIH's implementation of Congress'
    request for the Agency to sponsor a scientific workshop on Lyme and other tick-borne diseases.
    We have particular concerns with the statement of work on the project issued by NIH and the
    open session of the planning meeting on April 29, 2010. Specifically, the language calling upon
    NIH to sponsor a scientific workshop on Lyme and other tick-borne diseases was included in the
    House and Senate Appropriations Committee reports accompanying their respective versions of
    the Fiscal 2010 Labor, Health and Human Services, Education and Related Agencies
    Appropriations bills. Additionally, we have comments regarding the Office of Medical
    Applications of Research (OMAR) in the office of the Director ofNIH.

    During the study charge presentation at the April 29 open session, Jill Harper, Public
    Health Analyst, ODINIAID, stated that NIHINIAID decided to "step back" from this process.
    Before stepping back, NIH issued a statement of work (SOW) or study charge that directs the
    study and the panel with what look to be biased statements that are central to the controversies
    surrounding Lyme disease.

    Page 3 ofthe SOW states "In a few individuals, signs and symptoms of infection may
    continue or recur, .... " This statement seems a simplistic, over-generalization of a myriad of
    complex issues and patients. What does NIAID consider "a few" and what is the basis for that
    conclusion of only "a few"? Does this statement apply to individuals who have advanced
    disease before they are first treated? Does NIAID have good data on the number of infected
    individuals who may not receive early treatment for innumerable reasons, including the lack of
    sensitivity oftests or who were never tested for Lyme? According to the US Army Center for
    Health Promotion and Preventive Medicine (now the US Army Public Health Command, in
    provisional status), "in advanced disease, treatment failures may occur and retreatment may be
    necessary. "

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  9. In discussing chronic Lyme disease, NIAID states, "the term sometimes [emphasis
    added] is used to describe illness in patients who have had Lyme disease or are actively infected
    with the disease, in many occasions [emphasis added] it has been used to describe symptoms in
    individuals who have no evidence of a current or past B. burgdorferi infection." Could it not be
    true to say that on "many occasions" chronic Lyme is used to describe illness in patients who
    have had or are actively infected with the disease (otherwise would be to marginalize the
    category of post-Lyme syndrome - a condition often cited as being significant by some members
    of the IDSA although it's actual prevalence seems to be mainly based on conjecture) and that
    "sometimes" it is used to describe symptoms in individuals who have no evidence of a current or
    past Lyme infection? It could be viewed that NIAID is implying to the panel that the majority of
    chronic Lyme patients have never had the disease and is making judgments regarding chronic
    Lyme that remain unsubstantiated and frequently based on circular arguments incorporating
    questionable evidence.

    NIAID also states, "Some experimental, evidence suggests that B. burgorferi may persist
    after antibiotic treatment in animal model studies. The results of these studies are challenging to
    interpret broadly because only some of the tissues in each study are positive by sensitive
    molecular tests and are nearly uniformly culture negative." Could it be seen that NIAID is
    giving the panel a signal to not give too much weight to animal studies showing persistence of
    infection after treatment? Animal model studies are used in most other diseases as powerful
    indicators of what occurs in humans, requiring that the studies' findings be fully explained.

    Also in the SOW, why did NIH specify that 10M solicit panel nominations from 10M
    membership, National Research Council membership, and 10M Boards? Without knowing the
    composition of members of those entities and how such membership compares to Lyme experts
    from across the spectrum of scientific viewpoints, we are concerned with the possibility that such
    direction could influence the overall composition of the panel as to their views regarding Lyme
    disease, despite the inclusion of reference to "other experts." As the sponsor, did NIH make
    nominations for the committee?

    The appropriations report language in both the House and Senate Committee reports
    states that the conference should represent the broad spectrum of scientific views on Lyme
    disease and should include input from individuals with Lyme disease.

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  10. Public input is encouraged in other disease reviews, thus it is important to provide the
    public a voice in Lyme disease despite inherent difficulties with public participation. The public
    includes very well informed advocates who have worked for more than 20 years with scores of
    patients, researchers, and treating physicians, and who in some cases, have funded millions of
    dollars in research. Experienced advocates may provide some assistance in identifying patients
    that would provide useful perspectives. The public also includes individual patients or parents of
    patients, who mayor may not be well informed. Many parents of patients have compelling and
    revealing stories of their quest to get medical help for their children.

    It is critical not to allow the challenges of including public participation to distract from
    consideration of the broaq spectrum of scientific views. A frequent misrepresentation is to
    postulate that there is only one consistent and homogeneous scientific view regarding Lyme
    disease and that divergent views are attributable not to scientists but to an "uninformed" public.
    On the contrary, we have heard from many eminent researchers and physicians at prestigious
    institutions who hold what may be considered divergent perspectives or who, at a minimum, are
    driven to find the answers as to why so many patients are sick and do not fit into established
    paradigms. Certainly, one of our intents in requesting a scientific conference under the auspices
    ofNIH was to open the scientific debate and to hear from the broad spectrum of highly
    creditable researchers and physicians focusing on tick-borne diseases.

    We are extremely concerned by the presentations selected for the open session of the
    planning meeting on April 29. 10M states, "The open session will provide an opportunity to
    hear from federal agencies, researchers, and other organizations and individuals interested in
    tick-borne diseases on the scientific issues that the committee could consider while planning the
    workshop."

    Ofthe presentations by federal agencies and researchers, only two presentations - Susan
    O'Connell, Southampton Hospital, and Sally Hojvat, CDRH, FDA, addressed issues of diagnosis
    and treatment of Lyme disease, the latter only briefly touching upon current diagnostics for
    Lyme. Ms. O'Connell's was the single presentation that broadly covered Lyme disease
    diagnostics and treatments - a major focus ofthe appropriations language.

    Excepting the limited FDA presentation, six additional speakers from five federal
    agencies provided material primarily on tick habitats. CDC, a major player in diagnostics and
    influential in treatments and guidelines, addressed prevention through tools such as bait boxes.
    The presentations were fascinating based on the content, however, we question the relevance of
    the material to the direction of the 10M workshop, why the open planning session was so
    different from the SOW, and what the panel was able to glean from the all afternoon session.
    Minus the discussions on tick habitat, the panel heard one perspective from one person in the UK
    on issues germane to the appropriations language.

    Based on the content of the open planning session, one would be led to believe that 10M
    intended that the focus of the workshop would be on tick-habitats.

    We strongly believe that NIH should have utilized its own internal organization which
    appears better matched than any external body to conduct a conference on Lyme disease
    considering the nature of the controversies. NIH's state of the science conference under the
    Consensus Development Program (CDP) seems tailor made to comply with the appropriations
    language. Under this mechanism, NIH organizes major conferences to address "controversial
    issues in medicine important to health care providers, patients, and the general public."

    ReplyDelete
  11. According to NIH's OMAR, for an issue to qualify as a topic under the CDP, "three main
    criteria must be met: (1) Public health importance (2) Controversy or a gap between current
    knowledge and practice (3) An adequately defined and available base of scientific information."
    Lyme disease would appear ideally suited for such a conference, but more relevant to our
    concerns, the CDP and its "State-of-the-Science Conference" seems uniquely suited for
    consideration of the extremely controversial issues surrounding Lyme disease - including
    unusual efforts to protect against institutional bias, i.e., keeping the sponsoring NIH Institute or
    Center separated from the panel during the process to avoid the potential influence of the IC and
    thus maintain the panel independence.

    OMAR's unique positioning to address controversial issues is further illustrated by their
    program, "Medicine: Mind the Gap," which "explores a wide range of issues at the intersection
    of research evidence and clinical practice - especially areas in which conventional wisdom may
    lead us astray ... to engage the NIH community in thought-provoking discussions to challenge
    what we think we know to think critically about our role in today's research environment."
    The SOW for the Lyme and other tick-borne diseases scientific conference states that "4.

    When a department or agency of the executive branch of the Government determines that the
    Academy, because of its unique qualifications, is the only source that can provide the measure of
    expertise, independence, objectivity, and audience acceptance necessary to meet the
    department's or agency's program requirements, acquisition of services by the Academy may be
    obtained on a noncompetitive basis if otherwise in accordance with applicable law and
    regulations." A sole source agreement with 10M does not appear justified because OMAR is
    not only well qualified, but given the nature of the controversies, is the best positioned to provide
    "the measure of expertise, independence, objectivity, and audience acceptance necessary .... "
    through the state-of-the science conference.

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  12. We recommend that NIH use its own in-house mechanism, specifically the state-of-the
    science conference to satisfy the requirements of the house and senate committee report
    language. Should the study continue with the 10M, we request that NIH issue a new SOW to the
    10M and the panel, as the existing statement contains leading and biased statements that are
    central to scientific controversies rather than being consensus views of the broad spectrum of
    creditable scientists. Furthermore, as NIH is the sponsor of this workshop, it is important that
    when any products are issued that explanations are provided of the distinctions between NIH
    state-of-the-science conferences and 10M independent workshops, as NIH itself in the SOW
    refers to the 10M charge as "THE STATE OF THE SCIENCE."

    To a very significant portion of Lyme stakeholders, including researchers and physicians,
    as well as advocates and patients, what has been most lacking and has greatly contributed to the
    lack of progress and common purposes is the lack of transparency. We request that NIH foster
    transparency to the greatest extent possible regarding this scientific workshop, including in its
    communications with 10M, and in all of its Lyme disease activities. In their brochure, 10M says
    that the names and affiliations of the report reviewers are made public when the report is
    released. It is important that information be made public, including the identity of all reviewers,
    and that transparency exist to the maximum extent possible throughout the process.

    CHRISTOPHER H. SMITH
    and Frank Wolf signed this

    ReplyDelete
  13. Thanks for sharing all this, cave76. It certainly does sound like the statement of work requested was not fulfilled, based on my review thus far of the summaries, either.

    What do you think the IOM workshop should have looked like, in terms of representation of differing viewpoints? Obviously fewer IDSA panel associates (but do Donta and Volkman work as candidates?) would be welcome, and ILADS doctors need to be included - but who specifically do you think would be the best people to give presentations?

    ReplyDelete
  14. *****It certainly does sound like the statement of work requested was not fulfilled, based on my review thus far of the summaries, either.*****

    You betcha!

    ****What do you think the IOM workshop should have looked like, in terms of representation of differing viewpoints?****

    That would be a difficult decision for me to make. But I'd start out by insisting that all the members, committees and anyone associated with the IOM issue statement of conflicts.

    Insist on transparency. Yeah, right!

    Tell us where the money comes from.

    Here is what the IOM said (in 2005 when I first because suspicious about the IOM and their 'reports'. This was on the IOM web site but I'd have to go back and see if they're still saying this.

    Quote:
    Is IOM part of the government or quasi-government? Who does IOM work for; where does your funding come from?

    The National Academy of Sciences was created by the federal government to be an adviser on scientific and technological matters. However, the Academy and its associated organizations (e.g., the Institute of Medicine) are private, non-governmental, organizations and do not receive direct federal appropriations for their work. Studies undertaken for the government by the Academy complex usually are funded out of appropriations made available to federal agencies. Most of the studies carried out by the Academy complex are at the request of government agencies


    Note the word 'direct'. (grin) and (smirk)

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  15. All of the following are/were from the IOM's web site:

    ****8. With the advice of the Finance Committee, the President shall prepare and submit to the
    Council at least once a year a budget for the Institute. The Institute shall forward its budget to the
    National Academy of Sciences for approval.****

    [cave note: If the IOM is not funded by a government agency, why would have have to forward their budget to the NAS?]

    ****The Institute of Medicine has been established as a separate membership organization within the
    National Academy of Sciences.****

    ***In particular, although many meetings are open to the public, the committee may deliberate among themselves, and is not obligated to conduct all their work in a public forum.****

    [cave note: If I had MY wish, which I don't, ALL their work would be in a public forum.]

    In recognition of foundations, corporations, and other organizations that have supported the IOM
    between September 1, 2008 and August 31, 2009.

    Corporations
    Abbott Laboratories
    Aetna Inc.
    Amgen, Inc.
    Arch Chemicals, Inc.
    AstraZeneca Pharmaceuticals LP
    Blue Cross and Blue Shield Association
    Blue Shield of California Foundation
    Bristol-Myers Squibb Company


    From the IOM's study methods--- a direct quote:

    The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization.

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  16. Good job investigating this, cave76. Everyone should know this information! Does the LDA and other Lyme advocacy groups know about this?

    You posted, "[...] ( e.g., the Institute of Medicine) are private, non-governmental, organizations and do not receive direct federal appropriations for their work. Studies undertaken for the government by the Academy complex usually are funded out of appropriations made available to federal agencies. Most of the studies carried out by the Academy complex are at the request of government agencies."

    So how do we follow this money? Private donations from individuals and corporations -> NSF and IOM, but the NSF and IOM may perform studies that are a) not government requested studies, although those are in the minority, and b) government requested studies, which were funded by appropriations to federal agencies.

    What is the relevance of saying "do not receive direct federal appropriations" here? What is the difference between getting direct funding from the government versus funding from government agencies? Is there one or not?

    You wrote, "From the IOM's study methods--- a direct quote: The committee’s task is developed in collaboration with the study’s sponsor, which may be a government agency, a foundation, or an independent organization."

    Note the word may in there... Because Aetna, Inc. (the private health insurance company, for our foreign readers) and AstraZeneca Pharmaceuticals are not government agencies or foundations - would they be thought of as independent organizations? I guess by someone's definition as corporations they are. Wow

    Following the money here is like playing 3D Labyrinth with mercury beads: I don't know where it all went, and it divided and re-merged together.

    Whose interests are at stake here, and why?

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  17. "Does the LDA and other Lyme advocacy groups know about this?"

    I'm sure they do. I'm also sure that NatCap does too. If they don't----- well, shame on them.:)

    "So how do we follow this money?"

    It's difficult for the public to do that, although I'm pretty sure that the info has to be buried somewhere in the morass of words.

    W.C. Fields said:
    If you can't dazzle them with brilliance, baffle them with bull.

    Government agencies (and other agencies) have changed that a bit:

    If you don't want the unwashed to know the truth, bury them in words, preferrably words of more than 2 syllables.

    The bald facts are sometimes buried in 'sections' that don't seem to have any relationship to what is being looked for. Can't remember any specific instance off the top of my head.

    Then you have to look for synonyms, parables.

    Funding might be called all sorts of things. Just look them up. "Appropriations" has it's own set of synonyms.

    It's rather like a treasure hunt.

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  18. What is the relevance of saying "do not receive direct federal appropriations" here? What is the difference between getting direct funding from the government versus funding from government agencies? Is there one or not?

    None. It's a Silly Buggers game.

    (not to say they're 'bugger's' at least not necessarily the original meaning. Or not 'directly')

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  19. In my continuing effort to use the actual words of a person or agency to prove MY points:

    About the IOM

    The Institute of Medicine (IOM) is an independent, nonprofit organization that works ,outside of government to provide unbiased and authoritative advice to decision makers and the public.
    **************************

    Does 'outside' mean in a separate building or that they don't receive any funding from the government?

    Or is it another synonym that is so prevalent in government agencies to obfuscate and obscure the facts?

    ReplyDelete
  20. Hi cave76 - thanks for more comments. Language is a tool, isn't it?

    You wrote,

    "Government agencies (and other agencies) have changed that a bit:

    If you don't want the unwashed to know the truth, bury them in words, preferrably words of more than 2 syllables.

    The bald facts are sometimes buried in 'sections' that don't seem to have any relationship to what is being looked for. Can't remember any specific instance off the top of my head."


    The funny thing about your statement is that is how I also feel about scientific publications and the public.

    If the public can't understand it, then they can't understand the scope of the problem - and they will be looking to others to 'translate' what's written for them so it makes sense in their own terms.

    The trouble is, to really begin to grasp what's written, you have to make the effort. You have to learn, because those details your untrained brain would rather gloss over turn out to be important.

    It's easier for many people to understand the concept of a so-called "cyst" form that protects spirochetes and allows them to persist in the host than it is for many people to understand the significance of antigenic variation and its role in various immune factors. One is a statement and the other is a process, and it takes longer to understand the process because it requires knowing more terminology (and often diagrams or pictures) to follow it.

    If both much of the public and most of the media lacks the knowledge about this terminology and the process, then the focus will be on the statements because those are more easily grasped. But in doing so, they can miss points that are relevant to supporting the argument for Borrelia's persistence after antibiotic treatment.

    I want to make this information more accessible, and help people understand what's being written... because they should know, in order to inform themselves just what Borrelia does - they should know in order to be able to know when they're being lied to by others, mislead, or their concerns being treated dismissively.

    If you understand more about the details, too - it makes for a stronger position to stand from when stating your own case. You have something objective and empirical to point to that others have a hard time arguing against.

    ReplyDelete
  21. cave76 quoted,

    "The Institute of Medicine (IOM) is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public."

    I don't know what it means either. I can take a guess that it receives money from both private benefactors (as stated) for specific projects for which those benefactors set the goals, and then it receives money from federal agencies who set tasks for them.

    Would this constitute the funding structure of most thinktanks?

    The IOM works with the National Academy of Science. Described as "private, non-governmental, organizations and do not receive direct federal appropriations for their work". Which gets indirect federal funding and donations.

    Ah, let's not beat around this bush.

    http://www.nationalacademies.org/about/sponsors.html

    From http://www.nationalacademies.org/about/faq.html:

    "The National Academy of Sciences (NAS) was created in 1863 by a congressional charter approved by President Abraham Lincoln. Under this charter, the National Research Council was established in 1916, the National Academy of Engineering (NAE) in 1964, and the Institute of Medicine (IOM) in 1970. These private, nonprofit organizations share in the responsibility for advising the federal government, upon request and without fee, on questions of science, technology, and health policy. The NAS, NAE, and IOM are honorific organizations; new members are elected annually, and membership is considered a high honor."

    They are nonprofit, private, and do not take a fee. A fee being different from receiving donations and funding from federal agencies.

    It continues:

    "The National Academy of Engineering sponsors engineering studies and other activities designed to assess and meet national needs, encourages engineering education and research, explores means for promoting cooperation in engineering in the United States and abroad, and recognizes the superior achievements of engineers. The National Academy of Engineering also supports study projects carried out through the National Research Council.

    The Institute of Medicine identifies concerns in medical care, research, and education and secures the services of members of appropriate professions to examine policy matters relating to public health. Although the Institute of Medicine is not a part of the formal structure of the National Research Council, it follows the same quality assurance procedures as the Research Council.

    The National Research Council operates under the auspices of the NAS, NAE, and IOM. Most consensus studies are conducted by committees convened by the Research Council and the IOM."

    So there's something to understand their structure/purpose more.

    Read the rest of the FAQ. The vast majority of IOM staff doesn't get paid by the gov't to do this work. It is mostly pro bono except for a handful of people, and they will cover travel and subsistence expenses during travel. Sounds like that's it.

    ReplyDelete
  22. They are nonprofit, private, and do not take a fee. A fee being different from receiving donations and funding from federal agencies.

    And that, Virginia, is the key to learning a new language----- Governmentese which is the jargon held to be characteristic of government officials.

    ReplyDelete
  23. I'm taking it the universities and corporations have to pay for IOM staff salaries. Everyone there has to be working for someone else if the IOM is a voluntary organization...

    ReplyDelete
  24. Lo, the internet has spoken.

    Here's where to look for conflict of interest information at the National Academy of Science web site:
    http://www8.nationalacademies.org/cp/information.aspx?key=Conflict_of_Interest

    Warning: There is more than one downloadable file at that link and not a general statement - I have to look through them myself.

    ReplyDelete
  25. C.O. said:
    I'm taking it the universities and corporations have to pay for IOM staff salaries. Everyone there has to be working for someone else if the IOM is a voluntary organization...

    Oh, no. All these guys work for nothing for the benefit of society!!!!!! But---remember NO FEES! Just perks.

    To the subject of conflict of interest.
    OH BROTHER!!!!!
    Talk about Govermentese!
    But--- valiantly trying to make some kind of sense of it---- I'd like to pick this point:

    Public Statements and Positions
    An individual may have become committed to a fixed position on a particular issue through public
    statements (e.g., testimony, speeches, interviews, etc.), through
    publications (e.g., articles, books, etc.), through close identification
    or association with the positions or perspectives of a
    particular group, or through other personal or professional activities.

    This would ordinarily constitute a potential source of bias but not a conflict of interest.

    However, in situations where there is some significant, directly related interest
    or duty of the individual -- e.g., where the individual is currently president
    of a professional society that espouses the same fixed position on
    the issue -- the situation may constitute a conflict of interest.

    Does that give ANY CLEAR direction? I don't think so----- there are so
    many loopholes there a horse and buggy could be driven through it.


    I could save myself the trouble and just assume that that whole mess is comprised of loopholes.

    ReplyDelete
  26. Any idea of just why no LLMDs were included? I can't see how they could be excluded because of this comment:

    the term "conflict of
    interest" means any financial or other interest which conflicts with the service of the
    individual because it
    (1) could significantly impair the individual's objectivity or
    (2) could create an unfair competitive advantage for any person or organization.


    unless all member of the IDSA were excluded also, for that same reason. So there must be another reason. ???

    ReplyDelete
  27. The IOM lists the National Institute of Health as it's sponsor for the report on Lyme, 2010
    The NIH is within the government, right?

    To what extent does the IOM have to 'listen' to it's sponsor?

    Interestingly---- the IOM has .edu as it's domain extension. Hmmm.

    ReplyDelete
  28. Is it possible that the IOM is considered Extramural Research?

    Web definitions of extramural research:

    This research is proposed and conducted by non-government scientists in laboratories and clinical facilities throughout the country. About two thirds of the NCI budget is devoted to extramural research project funding.
    www.abta.org/index.cfm

    ***************************
    Office of Extramural Research. With .gov domain name.

    National Institutes of Health (NIH), (http://www.nih.gov)

    This notice provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards (referred to here as grants). On March 19, 2009, NIH published Fiscal Year (FY) 2009 information on the salary limitation in the NIH Guide for Grants and Contracts (NOT-OD-09-069).

    http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-041.html

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

    "Extramural Awards

    Funds provided by the NIH to researchers and organizations outside the NIH."

    "Extramural Research Research supported by NIH through a grant, contract, or cooperative agreement."
    From
    http://grants.nih.gov/grants/glossary.htm

    ReplyDelete
  29. cave76,

    I found the list of people that were cited as being people who were wanted to speak at the IOM workshop, but didn't (it's near the end of the paper):

    • Raphael Stricker (ILADS)
    • Benjamin Luft (SUNY-Stony Brook)
    • Steven Schutzer (University of Medicine and Dentistry, NJ)
    • Steven Phillips
    • Brian Fallon (Columbia University)
    • David Cadavid (Biogen Idec)
    • Allison Delong (Brown University)
    • Kerry Clark (University of North Florida)
    • Reinhard Strubinger (Ludwig-Maximilians Universitat)
    • Elizabeth Maloney
    • Dave Martz
    • Eugene Davidson (Georgetown University Medical Center)
    • Joseph Burrascano
    • David Volkman (SUNY-Stony Brook)
    • Steven Barthold (University of California Davis)
    • Mario Phillip (Tulane University)
    • Sam Donta
    • Robert Lane (University of California Berkley)
    • Ellen Stromdahl (US Army Center for Health Promotion and Preventive Medicine)
    • Judith Miklossy (University of British Columbia)
    • Kenneth Leigner
    • Eva Sapi (University of New Haven)
    • Karen Newell (Texas A&M)
    • Cheryl Koopman (Stanford University)
    • Dan Cameron (International Lyme and Associated Disease Society)
    • James Oliver (Georgia Southern University)
    • John Aucott (Johns Hopkins)
    • Joseph G. Jemsek (Washington, DC)
    • Norton L. Fishman (Rockville, MD)

    ReplyDelete
  30. I saw the page you copied from the PDF on page 463.
    Then I saw on page 476 the speaker bio sketches.

    I seems that some of those listed on p. 463 actually did wind up speaking. What am I missing here? Were those bio sketches 'penciled in' and they didn't actually wind up speaking? Some of those names also appear in the Workshop Agenda.

    And then there's always the chance that I'm looking at a different report than you are.
    Mine is "PREPUBLICATION COPY: UNCORRECTED PROOFS" and is 485 pages long.

    ReplyDelete
  31. cave76,

    No, you are correct, I just found the list, posted it in lieu of not getting a copy of whatever list you mentioned the LDA had sent to the IOM but I didn't have yet.

    My mistake, I spoke too soon, in other words. I should have caught it especially since I did see Barthold's presentation and found it interesting.

    So to anyone reading, I submit a correction: I amend my above statement to "I found the list of people that were cited as being people who were wanted to speak at the IOM workshop, some of whom did not (it's near the end of the paper):"

    ReplyDelete
  32. Like I said at the beginning of this thread:

    (More stalling at taxpayers and the TBD infected citizens expense...all of this information was available online in the video. There is more useful information available on this blog (Camp Other)alone, than this 500+ page transcript--but Camp Other information does not cost the taxpayer a dime and at least gives the impression that someone is more concerned about public health than science or politics.)

    The National Capital Lyme's Association must have low expectations if this report was considered to be anything but lip service, come to think of it...their response sounds of nothing more than lip service.

    Nice work Camp Other, Cave76, and any other open minded educators like you who are taking the time to inform us uninformed. Now, if only these organizations with influence would apply the available facts, we could be reading actual progress reports instead of bureaucratic transcripts stating the obvious.

    ReplyDelete
  33. Thanks, Anonymous, for your compliment. Please feel free to pass on my blog address to other people - we could use more people participating in discussion. While traffic to Camp Other has been growing, few people seem to want to comment here - maybe getting more people viewing on top of this will lead to more conversation and perspectives.

    Yes, this is absolutely free, nothing paid for by taxpayers. It would be nice if I could earn a little spare cash for it, come to think of it... I could use it. But I'm not here for the money. I'm here because I've been hurting, my medical situation has been classified as a mystery (and worse, depending on who you ask), and I have the drive to find out what is happening with tickborne infections.

    I am learning what I'm learning and sharing it here because I care, and I hope what I learn helps me and helps others. I can't guarantee that I will know the answers for everything - I don't, and this site is exploratory in nature - but I hope to begin with asking the right questions.

    I'm still going to be pulling some material out of this huge summary report from the IOM workshop - some of which readers new to the Lyme/TBD scene may not know about. But as you pointed out, the summary doesn't seem to have any mention of actionable items - and it claimed up front on the web page where it was posted that it was not an action item report - it's not even a consensus report.

    Does anyone know when we get a report from the IOM about any consensus they reached as to how to address the questions raised in discussion at the workshop? And how action items will be addressed if budget cuts are on the horizon?

    ReplyDelete
  34. Anon said:
    The National Capital Lyme's Association must have low expectations if this report was considered to be anything but lip service, come to think of it...their response sounds of nothing more than lip service.

    I'm sure NatCap will have an explanation why the IOM report is 'important'.

    I can't agree with it's importance----- and view it as a waste of tax payer's money. But it gives the impression of something being done, to by-standers.

    Most groups will start out with the highest of intentions and I'm sure that NatCap did also. But politics (low and high) always means a lowering of high intentions under the guise 'negotiating' 'quid pro quo' and all other things that allow a group and it's leaders to stray.

    ReplyDelete

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