MOVE POST Infectious Disease Society gets what they deserve

Discussion in 'Lyme Disease Archives' started by Sharon, May 1, 2008.

  1. Sharon

    Sharon New Member

    twinofdar
    Infectious Disease Society gets what they deserve 05/01/08 03:16 PM

    Please contact your papers and ask them to publish this press release.

    FOR IMMEDIATE RELEASE May 1, 2008

    CONTACT:
    Nicole Rodgers 202-822-5200

    Settlement Announced in Landmark Investigation of Lyme Disease Diagnosis
    and Treatment Guidelines

    Patients’ Rights Groups Applaud Connecticut Attorney General
    Blumenthal’s Settlement in Anti-trust Case Against Powerful Medical Society


    Hartford, CT – Patients’ rights groups today hailed Connecticut Attorney
    General Blumenthal’s announcement of a settlement in a landmark
    antitrust investigation into the Lyme treatment guidelines of the
    Infectious Diseases Society of America (IDSA).

    “My office uncovered undisclosed financial interests held by several of
    the most powerful IDSA panelists,” said Blumenthal. “The IDSA’s
    guideline panel improperly ignored, or minimized, consideration of
    alternative medical opinion and evidence regarding chronic Lyme disease,
    potentially raising serious questions about whether the recommendations
    reflected all relevant science.”

    The groundbreaking settlement announced today forces a complete review
    of the IDSA guidelines by a new panel free from conflicts of interest,
    specifically excluding previous panel members. This panel will consider
    a range of scientific evidence in a public forum broadcast live over the
    internet and will be overseen by a specialist in financial conflicts of
    interest in medicine.

    “This settlement makes it clear that the IDSA guideline development
    process was corrupted by a commercially driven panel that excluded
    evidence supporting longer term treatment of Lyme disease,” said
    attorney Lorraine Johnson, Executive Director of the California Lyme
    Disease Association (CALDA). “This settlement allows suppressed
    scientific viewpoints and evidence to be heard, and it is promising news
    for patients.”

    This is the first-ever antitrust investigation against a medical
    society’s guidelines development process.

    “We congratulate Attorney General Blumenthal for exposing the IDSA’s
    conflicts of interest and helping reduce the suffering of Lyme patients
    everywhere,” said Pat Smith, president of the national Lyme Disease
    Association (LDA). “The IDSA guidelines are dangerous for patients who
    suffer longer-term Lyme symptoms that do not fall within the IDSA’s
    narrow disease definition.”

    The IDSA guidelines are treated as mandatory within the medical
    community. More than 50 physicians who use longer-term treatment
    approaches have been investigated or sanctioned by state medical boards.
    The guidelines can also result in financial problems for patients, since
    insurance companies refuse to reimburse for longer-term treatment and
    pharmacies may refuse to fill prescriptions.

    The majority of individuals involved in the IDSA guidelines development
    process held direct or indirect commercial interests related to Lyme
    vaccines, patents, and/or test kits, and did not take the opinions or
    experiences of the competing Lyme groups into account.
    While the announcement of a settlement comes as a huge relief to
    suffering Lyme patients, the case has much broader implications for a
    health care system that often contends with conflicts-of-interest in
    guideline processes – guidelines which are often used by insurance
    companies to limit diagnosis and treatment options.

    “Today’s settlement marks an important victory for all patients who
    suffer Lyme disease, but it is also a victory for anyone concerned about
    health care,” said Johnson. “Commercially driven guidelines that limit
    patient treatment options are a major issue today in healthcare, and
    this decision marks an important step towards addressing it.”

    The national Lyme Disease Association, (LDA), CALDA, and Time for Lyme
    are non-profit organizations that were founded by individuals who had
    personal experience with Lyme disease, in order to address the lack of
    education and support services available for this newly emerging infection.


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    femmdange



    AWESOME! 05/01/08 03:43 PM

    this _should_ totally discredit that letter the IDSA wrote to Kennedy, trying to kill those bills in senate and congress.

    my sis just told me there was a show in public tv she was watching (i don't have tv) ... on lyme. they had people call in and speak to this "expert", who was IDSA brainwashed, and a caller phoned in, and for about 10 minutes went into a very educated (cited studies, articles etc) speech about the damaging effects of chronic lyme, and how short term therapy did NOT HELP him, and how he's been sick very long. he mentioned people who have died, and the many symptoms it can cause, and illnesses it can mimic. This health expert/(don't know her title) sat with a screwed-up face and then just hung up on him, and said he was disconnected, and they were taking another call. She couldn't even answer him.

    doctors are so uneducated, because they've just been brainwashed. let's hope that will end in this decade.

    we should include mention of this in our letters to senate/congress asking them to pass the bill. victoria has the links posted on the lyme board.

    this man deserves a medal for doing that.
    [This Message was Edited on 05/01/2008]


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    ladybugmandy



    good news! 05/01/08 03:44 PM

    it's about time someone gave a chit about the way new diseases are handled.

    health care should NOT be FOR PROFIT!!!!!


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    liesandmorelies



    Great News for ppl with LD/FM/CFS etc...... 05/01/08 04:16 PM

    This is incredibly good news for all of us!!!!!

    We should all be rejoicing....

    Health care should never be about profit. Not ever!!!!!!!

    What an appropriate thing to come out today!!!!!

    I'm so happy for all of us!!!!!

    Share The Good News!!!!!

    Blessings to all,
    LAML


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    liesandmorelies



    Femmdange not just a medal 05/01/08 04:38 PM

    Femmdange,

    I'd like you to give him the medal and I will savor the finest bottle of Champagne with you guys......

    This is so wonderful. I can't believe the timing of this! With everything I have found out in my own life this week this is incredible. I know I have moved in the right direction. This is just extra confirmation.

    Couldn't be sweeter!!!

    I'm seeing my Dr. tommorrow.....I'm going to print this for him..

    Just wonderful!


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    tansy



    twinofdar this is great news 05/01/08 04:44 PM

    and proves that determined advocacy can work. I hope everyone is inspired by this. It can seem an uphill struggle until some progress is made.

    Two requests for a judicial review of the NICE guidelines for CFS (ME) in the UK are progessing. Many similar cases are thrown out at the first stage.

    Once objective third parties see the evidence they quickly become aware of the vested interests.

    This is definitely a day for celebration.

    tc, Tansy

    [This Message was Edited on 05/01/2008]


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    Victoria



    more info - 05/01/08 04:46 PM

    And Conn. state's official release:

    http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284

    Connecticut Attorney General's Office

    Press Release

    Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter

    May 1, 2008
    Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.

    The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.

    Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.

    "This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said. "My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.

    "The IDSA's Lyme guideline process lacked important procedural safeguards requiring complete reevaluation of the 2006 Lyme disease guidelines -- in effect a comprehensive reassessment through a new panel. The new panel will accept and analyze all evidence, including divergent opinion. An independent neutral ombudsman -- expert in medical ethics and conflicts of interest, selected by both the IDSA and my office -- will assess the new panel for conflicts of interests and ensure its integrity."

    Blumenthal's findings include the following:

    * The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;

    * Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;

    * The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;

    * The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";

    * The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;

    * The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.

    IDSA has reached an agreement with Blumenthal's office calling for creation of a review panel to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary. The panel -- comprised of individuals without conflicts of interest -- will comprehensively review medical and scientific evidence and hold a scientific hearing to provide a forum for additional evidence. It will then determine whether each recommendation in the 2006 Lyme disease guidelines is justified by the evidence or needs revision or updating.

    Blumenthal added, "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.

    "Our investigation was always about the IDSA's guidelines process -- not the science. IDSA should be recognized for its cooperation and agreement to address the serious concerns raised by my office. Our agreement with IDSA ensures that a new, conflicts-free panel will collect and review all pertinent information, reassess each recommendation and make necessary changes.

    "This Action Plan -- incorporating a conflicts screen by an independent neutral expert and a public hearing to receive additional evidence -- can serve as a model for all medical organizations and societies that publish medical guidelines. This review should strengthen the public's confidence in such critical standards."

    THE GUIDELINE REVIEW PROCESS

    Under its agreement with the Attorney General's Office, the IDSA will create a review panel of eight to 12 members, none of whom served on the 2006 IDSA guideline panel. The IDSA must conduct an open application process and consider all applicants.

    The agreement calls for the ombudsman selected by Blumenthal's office and the IDSA to ensure that the review panel and its chairperson are free of conflicts of interest.

    Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody as the ombudsman. Dr. Brody is a recognized expert and author on medical ethics and conflicts of interest and the director of the Institute for Medical Humanities at the University of Texas Medical Branch. Brody authored the book, "Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry."

    To assure that the review panel obtains divergent information, the panel will conduct an open scientific hearing at which it will hear scientific and medical presentations from interested parties. The agreement requires the hearing to be broadcast live to the public on the Internet via the IDSA's website. The Attorney General's Office, Dr. Brody and the review panel will together finalize the list of presenters at the hearing.

    Once it has collected information from its review and open hearing, the panel will assess the information and determine whether the data and evidence supports each of the recommendations in the 2006 Lyme disease guidelines.

    The panel will then vote on each recommendation in the IDSA's 2006 Lyme disease guidelines on whether it is supported by the scientific evidence. At least 75 percent of panel members must vote to sustain each recommendation or it will be revised.

    Once the panel has acted on each recommendation, it will have three options: make no changes, modify the guidelines in part or replace them entirely.

    The panel's final report will be published on the IDSA's website.

    ADDITIONAL FINDINGS OF BLUMENTHAL'S INVESTIGATION

    IDSA convened panels in 2000 and 2006 to research and publish guidelines for the diagnosis and treatment of Lyme disease. Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists. The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.

    IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines a the same time -- a violation of IDSA's conflicts of interest policy.

    The resulting IDSA and AAN guidelines not only reached the same conclusions regarding the non-existence of chronic Lyme disease, their reasoning at times used strikingly similar language. Both entities, for example, dubbed symptoms persisting after treatment "Post-Lyme Syndrome" and defined it the same way.

    When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact. The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.

    The two entities sought to portray each other's guidelines as separate and independent when the facts call into question that contention.

    The IDSA subsequently cited AAN's supposed independent corroboration of its findings as part of its attempts to defeat federal legislation to create a Lyme disease advisory committee and state legislation supporting antibiotic therapy for chronic Lyme disease.

    In a step that the British Medical Journal deemed "unusual," the IDSA included in its Lyme guidelines a statement calling them "voluntary" with "the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances." In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.

    Blumenthal thanked members his office who worked on the investigation -- Assistant Attorney General Thomas Ryan, former Assistant Attorney General Steven Rutstein and Paralegal Lorraine Measer under the direction of Assistant Attorney General Michael Cole, Chief of the Attorney General's Antitrust Department.

    View the entire IDSA agreement - (PDF-2,532KB)


    Content Last Modified on 5/1/2008 1:51:01 PM

    ---------

    Sigh, I cannot access PDF documents due to ongoing computer bug...


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    mollystwin



    Its about time!!! 05/01/08 04:54 PM

    Thank goodness for this. It's a victory for all of us with these strange dd's.

    dar


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    nimzovich76



    not really 05/01/08 05:09 PM

    NEWS RELEASE

    For Release: Thursday, May 01, 2008
    Contact Information

    Contact Name: Steve Baragona
    Contact E-mail: sbaragona@idsociety.org
    Contact Phone: (703) 299-0412

    Contact Name: Monica Charleston
    Contact E-mail: mcharleston@pcipr.com
    Contact Phone: (312) 558-1770

    Agreement Ends Lyme Disease Investigation By Connecticut Attorney General

    Medical Validity of IDSA Guidelines Not Challenged

    The Infectious Diseases Society of America (IDSA) has entered into an agreement with the Attorney General of Connecticut ending his investigation of the Society’s Lyme disease guidelines.

    Under the agreement, the guidelines remain in effect; but in an effort to clear the air, IDSA is voluntarily agreeing to an extra step: a one-time special review of the Lyme disease guidelines.

    The agreement ends the investigation of IDSA and its volunteer guideline panel members without the filing of a complaint or the entry by a court of factual or legal findings,

    without IDSA paying any fines or penalties, and without imposing on IDSA any restrictions on its right to promulgate guidelines for Lyme disease or any other disease or condition in the manner it believes best serves public health.

    “IDSA has agreed to this unique, singular review of our guidelines because the panel will consist solely of physicians and scientists,” said IDSA President Donald Poretz, MD.

    “We are confident that our guidelines for the diagnosis and treatment of Lyme disease represent the best advice that medicine currently has to offer, as is the case with all of the medical guidelines issued by the Society, and we look forward to the opportunity to put to rest any questions about them.”

    The IDSA Lyme disease guidelines recommend against long-term antibiotic therapy, an unproven and potentially dangerous treatment.

    A small group of physicians outside the medical mainstream and their patients endorse such long-term treatment, despite the compelling medical evidence that it is ineffective and can have serious, life-threatening complications—and, furthermore, is extremely expensive.

    This agreement does not change the medical advice to patients: The 2006 Lyme disease guidelines remain in place.

    Under the terms of the agreement announced today, IDSA will convene a review panel to conduct a comprehensive review of the Lyme-related literature to determine whether the 2006 guidelines should be revised or updated.

    While IDSA periodically reviews all of its treatment guidelines in order to keep them current, the agreement allows for an expanded process that includes an opportunity for public presentation and submission of information to ensure that all points of view are presented to and considered by the review panel.

    IDSA is voluntarily agreeing to this extra scrutiny in the hope that it will help put to rest assertions that have been made – all of them unfounded – that IDSA has ignored divergent opinions in developing its Lyme disease guidelines.

    This expanded review process is pertinent to this unique case only. IDSA has not agreed to use it as a model for other IDSA guidelines, nor is IDSA urging other medical organizations and societies to use it.

    The main actions of the agreement include:

    *
    Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.
    *
    The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.
    *
    IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest.

    The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.

    IDSA strongly disagrees with the Attorney General’s assertion that panel members had significant conflicts of interest.

    Panel members had no financial interests that would have affected, or been affected by, recommendations in the guidelines.

    The guidelines recommend generic drugs and generic diagnostic tests. Panel members do not stand to profit from any recommendation in the guidelines.

    In fact, the panel members denied themselves and their colleagues an opportunity to generate a significant amount of revenue when they recommended against expensive, repeated, long-term antibiotic therapy.

    IDSA also strongly disagrees with the Attorney General’s allegation that the Lyme disease guideline panel excluded competing viewpoints.

    In fact, the panel offered an opportunity for other organizations and individuals to submit additional evidence and carefully considered all information provided.

    In 2000, a single member of the panel voluntarily stopped participating. He was not removed from the panel, as the Attorney General has alleged.

    Furthermore, all IDSA guidelines are subjected to a rigorous, multi-level review and approval process before they are published, which allows other clinicians who did not serve on the panel that developed the guidelines to ensure that the guidelines are relevant, accurate, useable, and balanced.

    IDSA’s guidelines—like all medical societies’ guidelines—are voluntary. They are for the benefit of physicians seeking the best possible advice from experts in the field.

    Medical societies do not have the authority or the desire to dictate to physicians how to practice medicine. Nor do they have the ability to dictate to insurance companies how to reimburse for services. No ties exist between IDSA and any insurance company.

    The physicians who wrote IDSA’s 2006 guidelines concluded that, for nearly all patients, a short course of antibiotics is an effective treatment for Lyme disease.

    Studies have proven that long-term antibiotic treatment, which is usually given through a needle and a catheter, is ineffective, expensive, and potentially harmful.

    The overuse of antibiotics also contributes to an important public health threat: the development of drug-resistant infections that are difficult if not impossible to treat.

    “We recognize that medicine is always evolving, and we welcome the opportunity that the review panel provides to examine any new evidence and vet our earlier findings,” said Dr. Poretz.

    “We are pleased that under this agreement, the proper diagnosis and treatment for Lyme disease will be decided in a medical forum, not a courtroom.

    We hope this special review of the guidelines will help quell the unfortunate controversy surrounding the treatment of Lyme disease and ensure that patients receive advice and treatment based on the best available scientific and medical evidence.”

    IDSA is an organization of physicians, scientists, and other health
    care professionals dedicated to promoting health through excellence in
    infectious diseases research, education, prevention, and patient care.
    The Society, which has more than 8,000 members, was founded in 1963
    and is based in Arlington, VA. For more information, visit www.idsociety.org.

    [This Message was Edited on 05/01/2008]


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    femmdange



    nimzovich's article 05/01/08 05:33 PM

    this article is from the infection disease society. oh, we're surprised.

    and apparently they felt they had need for some damage control on this. do you know what pcipr does?

    Public Communications (PCI) + PR = pcipr.com

    I wrote a post about this kind of bunk just yesterday. This is a damage control/pr/image firm that creates lies and sells a facade.

    check out a post if you can handle the read. this is exactly what they do. Thanks for the timing of the post, nimzovich. this is a perfect example! (and below I'll copy and paste from pcipr.com, to show you what they do.

    http://www.immunesupport.com/chat/forums/message.cfm?id=1268207&B=FM#1268207


    "How industry manipulates public opinion
    Why you believe what you believe

    PR (public relations) was created to manipulate public opinion. More and more of what we hear, see and read as "news" is actually PR content. On any given day much of what the media broadcasts or prints as news is provided by the PR industry.

    "Trust Us We're Experts" a new book co-authored by John Stauber and Sheldon Rampton of the Center for Media and Democracy, shows how the world's richest and most powerful corporations do this."

    (more in the post)

    and PCIPR.com is ...

    (from their home page)

    Public Communications Inc. (PCI) provides thoughtful, strategic counsel to our clients, whether we're dealing with the most serious and complex crisis or the splashiest of events - and we've been doing so for 44 years.

    Our job is to guard our clients' reputations, to be truthtellers and trusted counselors, and to find the right way for clients to communicate what they have to say so it is heard and believed.

    Our clients trust us and stay with us, and our business has grown primarily through referrals and positive word of mouth. More than half of our clients have been with us 10 years or more; 15 and 20+ year relationships are common (and valued).

    Our size and the depth of our staff enable us to manage the most sophisticated of client assignments while allowing us to move quickly, be flexible and change course when it makes sense to do so.

    We love what we do.


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    twinofdar



    Thanks for the additional info guys and dolls! 05/01/08 05:54 PM

    This is a great day for the chronically ill!!!


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    liesandmorelies



    NOONE ON ORIGINAL PANEL CAN SERVE ON NEW PANEL!!!!! 05/01/08 06:10 PM

    So much will change now.....We know what it means when ppl are willing to settle out of court correct?

    What I love about the new agreement is that not one person from the old panel can be on the new panel.....

    Why would anyone say this is not really a good day for everyone with chronic illnesses????????

    Hold onto your seats Ladies and Gentlemen, were in for a bumpy ride! YEE-HAW!!!

    Stay positive - It's our day to celebrate

    Cheers to All!!!
    LAML