Lyme Wars.....

Discussion in 'Lyme Disease Archives' started by jarjar, Jan 28, 2007.

  1. jarjar

    jarjar New Member

    The National Law Journal

    Antitrust scrutiny of Lyme guidelines

    Disease treatment probe by state AG.

    Marcia Coyle/Staff reporter

    January 22, 2007

    WASHINGTON-A state attorney general's novel investigation into the development of treatment guidelines for Lyme disease should put healthcare and professional medical societies on alert to a possible new front in antitrust litigation, say antitrust lawyers and others. Connecticut Attorney General Richard Blumenthal late last year issued a subpoena to the Infectious Diseases Society of America (IDSA) for information on how it established its latest guidelines on the diagnosis and treatment of Lyme disease- guidelines that were subsequently adopted by the Centers for Disease Control and Prevention (CDC).

    While IDSA has responded to the subpoena, Blumenthal said his investigation is ongoing. "We've reached no conclusion," he said. And while some have characterized it as novel or unprecedented, Blumenthal said the inquiry involves "basic antitrust principles applied to medical care."

    The antitrust implications here, he explained, are the restraint on doctor and patient choices for treatment of the disease because of the guidelines, and particularly their effect on insurance companies' willingness to pay for treatment.

    Nineteen members of Congress recently sent a letter to the CDC requesting that agency to review the IDSA guidelines, which they said have "the potential to effectively shut down" all treatment of chronic Lyme disease. The IDSA reacted on Jan. 17 with a letter to Congress explaining its guideline process.

    State attorneys general have been very aggressive in the health care arena in recent years, say health care and antitrust practitioners, but antitrust actions involving treatment guidelines have not been common.

    "There is certainly a possibility that if a professional organization puts out a set of principles that tells you how to act, and people ac tin accordance with it, it could have an effect on competition," said Stephen P. Mahinka, a partner in the Washington office of Morgan, Lewis & Bockius, and chairman of the firm's life sciences interdisciplinary practice group.

    The federal National Guideline Clearinghouse Web site lists more than 1,800 guidelines under the heading "disease/ condition," including the IDSA guidelines.

    The backdrop to Blumenthal's investigation is an intense dispute between the IDSA and the International Lyme and Associated Diseases Society (ILADS).

    The IDSA, widely recognized as the pre-eminent authority on infectious diseases in this country, does not support a separate diagnosis of "chronic" Lyme disease, nor do its guidelines support antibiotic treatment for patients on a long-term basis-for a period of months or even years.

    The ILADS, a nonprofit, international, multidisciplinary medical society dedicated to the diagnosis and appropriate treatment of Lyme and its associated diseases, takes the opposite view.

    The ILADS and other critics, such as the Lyme Disease Association, contend that the panel that developed IDSA guidelines excluded any opposing views of chronic Lyme disease and its treatment.

    Although the IDSA says its guidelines are not mandatory, they have the effect of becoming the standard of care in the medical community, according to Lorraine Johnson, an attorney and executive director of the California Lyme Disease Association.

    The national association, she said, has received numerous complaints from patients denied reimbursement for longer-term treatment than recommended by the IDSA guidelines, and physicians who don't follow the guidelines have faced malpractice charges by medical boards. The development of treatment guidelines is analogous to standard-setting-a hot area in antitrust today, according to New York attorney Richard Wolfram, an independent antitrust specialist assisting the California Lyme Disease Association. Common principle

    Although the relevant case law has been outside of the health care field, he said, there is a common principle. Because standard-setting by competitors supplants competition, the process must be fair, open and not subject to any bias by participants with economic interests instilling competition, he explained, especially when the standard-setting is done by an association or other entity that is highly influential or dominant in the relevant market.” The fundamental antitrust claim here is an abuse of the standard-setting process by which guidelines for diagnosis and treatment of Lyme disease was articulated," said Wolfram.” We say there was at bottom a refusal to deal with certain elements of the medical community who have different points of view about treatment of the disease, particularly chronic Lyme disease, and an exclusion of treatment, particularly long-term antibiotic treatment. “Douglas A. Hastings, partner in the health care and life sciences practice in the Washington office of New York's Epstein Becker &Green, said he could see how the guidelines could be viewed as standard-setting, but, he added, an antitrust claim in this context is novel.

    "Antitrust requires independent parties conspiring to do certain things to violate antitrust law and is anti-competitive," said Hastings.

    "That is not something typically raised around development of practice guidelines."

    The IDSA's attorney, antitrust litigator Alvin Dunn, counsel to the Washington office of Pillsbury Winthrop Shaw Pittman, said: "Our view is this is not a matter for antitrust laws or courts generally, but this is a medical question and one that doctors and scientists should be addressing if there is an issue as to whether the guidelines are proper."

    The IDSA's critics challenge the guidelines' positions that there is no such thing as chronic Lyme disease and that long-term antibiotic treatment should not be given, Dunn said. "IDSA is saying that would be over treating and clinical evidence studies don't support that. The challengers want much more treatment and reimbursement. There's no economic benefit to IDSA members getting together here.” Dunn said other professional societies that develop guidelines should find this investigation troubling.

    "Today, guideline development is very common; its use is encouraged, and people think the quality of care improves if doctors and other follow these guidelines," he said. "They should be very concerned about the possibility of legal challenges if they do what they think improves patient health and safety
  2. klutzo

    klutzo New Member

    As usual there is no mention of the conflicts of interest on the part of members of the IDSA....all those nice consulting fees they get.

    They don't care if people die as long as they maintain their incomes and reputations. It's disgusting.

    I already know people whose ABX have been cut off due to the new guidelines. One good friend is very, very sick due to this and I fear she may not make it. She has 4 kids and a husband who also has Lyme and no more ABX.

    These arrogant doctors of the IDSA will have a lot to answer for some day to a higher authority.

  3. victoria

    victoria New Member

    there was an article not too long ago about this where one of the head doctors of the IDSA was quoted as saying to the effect that the studies they used to review treatment options consisted of many research papers written by its own members.

    That statement to me says SO much... gotta find it again, I hope I saved it as I meant to post it here...

    all the best,

  4. victoria

    victoria New Member

    in the interest of fairness, I am printing the whole article here...

    Jan 18, 2007
    Medical experts weigh in on Lyme disease
    By Laura Kenyon Hersam Acorn newspapers

    Amidst the start of an unprecedented investigation by Connecticut Attorney General Richard Blumenthal into Lyme disease treatment guidelines, victims of and experts on the disease are speaking out about its precarious place in the medical world.

    In the second of two articles about Lyme disease, the Advertiser considers the varying opinions medical professionals hold regarding such guidelines, the existence of chronic Lyme disease, and long-term antibiotic treatment. The previous article, published in last week's issue, focused on local victims.


    According to the Centers for Disease Control, 1,810 cases of Lyme disease were reported in Connecticut in 2005, more than any other state besides Massachusetts, New Jersey, New York and Pennsylvania.

    In October, the Infectious Diseases Society of America (IDSA) released an updated version of its 2000 Lyme treatment guidelines, which are often used by doctors and insurance companies to determine treatment.

    Prompting national contention from many organizations, doctors and sufferers, the guidelines discourage the prolonged use of antibiotics to treat lingering symptoms, saying it "has not proven to be useful."

    They also conclude that there is no "convincing biologic evidence" for the existence of "chronic" or "post-Lyme syndrome."

    These particular findings prompted Mr. Blumenthal, he told the Advertiser, to worry that treatment choices and coverage for long-term Lyme sufferers would be determined by government officials or insurance companies rather than patients and their physicians.

    In November, he filed a Civil Investigative Demand to look into possible anti-trust violations by the IDSA during the development of its new guidelines.

    The Lyme Disease Association (LDA), a nonprofit organization "representing more Lyme disease patients than any organization in the United States," quickly issued a press release applauding his move as "vitally necessary to protect the welfare of chronic Lyme patients nationwide."

    Clinical guidelines currently drive the standard of care, it said, and are sometimes used to deny treatment reimbursement. The IDSA guidelines list as "not recommended" "most of the conventional medical treatments prescribed by physicians as well as alternative treatments often chosen by patients for any Lyme manifestation."

    Dr. David Reed, New Canaan's assistant director of health, does not believe IDSA had "ulterior motives" or "some sort of political agenda." Calling the attorney general's move "highly unusual," he said it will have "repercussions."

    "These are nonprofit organizations. They don't have, in my opinion, profit motives," said Dr. Reed, who declined the opportunity to speak about chronic Lyme or long-term antibiotics.

    First Selectman Judy Neville, who battled the disease for seven years in the 1990s, said treatment choices should be made only by patients and their doctors and Mr. Blumenthal is "doing what is necessary to protect Lyme patients."

    The Lyme Disease Association contends that the guidelines will negatively affect the number of treating physicians "since clinical discretion is not recommended by the guidelines" - a statement that Dr. Raymond Dattwyler, chief of Allergy, Immunology and Rheumatology at Westchester Medical Center and one of the authors of the IDSA guidelines, said is false.

    "I think that one should really read the guidelines first before they should really make any judgments," he told the Advertiser Friday. "They're guidelines. They're not cast in stone, and ultimately it states that that they allow individuals' physicians to make their own judgments."


    <b>Dr. Steven Phillips of Wilton, who served as president of the International Lyme and Associated Diseases Society (ILADS) from 2003-05, estimates that more than 25 percent of Lyme victims develop chronic symptoms and finds it "unsettling" the IDSA would exclude "a significant percentage of the Lyme disease population" in its findings. </b>

    "A great number of patients derive benefits from long-term antibiotics," he told the Advertiser.

    Chronic Lyme has been documented in thousands of medical journals, he said, but in composing its guidelines the IDSA referred to just 400 of more than 10,000 studies, many of which support the existence of chronic Lyme.

    "If they're going to pick a random sample," he said, "it has to be random." They should have taken a "more even stance," he added.

    Dr. Dattwyler said between everyone who worked on the IDSA guidelines, "we probably read the overwhelming majority of stuff that's ever been published on Lyme disease."

    The guidelines cited 405 papers. They were chosen, Dr. Dattwyler said, based on criteria including study design and the quality of the publishing journal. The group primarily choose articles in the "premier" journals, as rated by the National Library of Medicine, such as the New England Journal of Medicine, Nature and Annals of Internal Medicine.

    <b>"It's really just a review of the literature published in respected medical journals," he said, adding that there are "some really bizarre papers" out there.

    "Most of us wrote a lot of these papers," he said, citing one of his own published in the New England Journal of Medicine. </b>

    Both ILADS and IDSA offer guidelines for Lyme disease, and both differ in their findings.

    While IDSA concludes that long-term antibiotic treatment "is not proven to be effective and may be dangerous," and that there is no "convincing" evidence for the existence of "so-called 'chronic' Lyme disease," ILADS believes antibiotic treatment should be "tailored to the individual" and cites chronic Lyme as "a growing epidemic."

    The 30-year-old daughter of New Canaan resident Judy Larson, who has battled Lyme since age 12 and was featured in last week's Advertiser, initially improved while on intravenous antibiotics, but suffered "toxic" side effects - one forcing the removal of her gall bladder.

    On the other side, New Canaan Director of Human Services Cheryl Jones was on intravenous antibiotics for four months in 2000 and oral antibiotics for more than a year, and said "for me, (they) were the only choice."

    Ms. Jones was initially diagnosed with Multiple Sclerosis in 1990 and believes the Lyme was overlooked during the next 10 years - not a rare story in either direction, according to Dr. Dattwyler.

    Many people - "80 percent or more," he said - are misdiagnosed with Lyme disease when they really have something else. That is why IDSA states that patients who believe they have "chronic" Lyme symptoms should ensure they do not in reality have another affliction, such as Multiple Sclerosis or cancer.

    A year-long study at the Yale University Lyme Disease Clinic that studied 209 patients with a "presumptive diagnosis" (by their physicians, themselves or both) - published in the March 1, 1998, Annals of Internal Medicine and cited by Dr. Dattwyler - found that only 21 percent met the criteria for active Lyme disease, 19 percent were previously but no longer infected, and
    60 percent had no evidence of current or previous infection.

    A study published in the June 24, 2003, issue of Neurology, cited by Dr. Phillips, found that patients given 28 days of antibiotic treatment (ceftriaxone) showed improvement in "disabling fatigue." The study also found adverse side effects and little or no improvement in cognitive or persistent function, however, and concluded that it "does not support the use of additional antibiotic therapy with parental ceftriaxone in post-treatment."

    The study was penned by Stony Brook University Medical Center doctors, including Dr. Dattwyler.

    Authors of an April 15, 2004, Journal of Clinical Investigation article explored both sides, stating that a small percentage of patients with "well-documented Lyme disease" may develop post-Lyme disease syndrome symptoms (including musculoskeletal pain and fatigue) for months or years after antibiotic treatment, but that prolonged antibiotic therapy "may be harmful." When treating those with chronic Lyme, they advocated following the guidelines for chronic fatigue syndrome or fibromyalgia, a "similar" affliction.


    "The biggest problem," Ms. Larson said, "is nobody really knows what the answer is and it's a very elusive thing that can take many forms. There needs to be a lot more research on it. I think it's an epidemic that people haven't really recognized in the medical community."

    Many diseases, "not only tick-borne infectious diseases," are in need of further study, Dr. Dattwyler said, but organizations such as the National Institutes of Health and the Center for Infectious Disease need more funding in order to do so.

    While its existence may be controversial, he said that the pain felt by those diagnosed with chronic Lyme disease is real and modern medicine does not always provide them with the answers they are seeking.

    The bottom line on both sides, Dr. Phillips said, is that patients must become educated about Lyme and other diseases, and become "their own advocates."


  5. klutzo

    klutzo New Member

    I love how they say there are legions of people who have been told they have Lyme when they really have something else like MS!

    The truth is the opposite way around. I was told I had MS for 4 years when it was really Lyme, and I know plenty of others in the same boat.

    The tragedy of all this, is that the current treatment for MS will make Lyme much worse.....No wonder MS is so progressive.

    I am looking forward to the ABC Primetime Live show about the connection between MS and Lyme ,which is supposed to be on for an entire hour in February sometime, if the network isn't ordered to kill it by it's corporate owners. They've already postponed it once. Whatever happened to the free press?

    ABC's The View spent the whole hour on autism yesteday,and never once mentioned the connection to Lyme, or the possible connection to thimerosol in vaccines. They played it safe, and as a result, the only treatments put forth were behavioral.

    Let's not forget the other most common things Lyme either imitates or actually causes,dependng upon your viewpoint: ALS, Parkinsons, AZD, CFS, FMS.

    I wish we could get Michael J. Fox to have an Igenex Lyme test, so he would realize he was never cured of his Lyme, and that his Parkinson's is just late-stage Lyme, not a separate illness. I am sure someone must have told him about this possibility, so he must still be placing his faith in conventional doctors. How sad.

    Mis-diganosis of Lyme as ALS is a real crime, since those people will all die, when some who really have Lyme could possibly be saved with agressive antibiotics.

  6. victoria

    victoria New Member

    Huh! I didn't know that Michael J. Fox had had Lyme!!!!!!

    Verrrry interesting...

    wouldn't that be something if he'd consent to be tested and was found positive and/or responded to treatment of ANY kind for lyme!!!


  7. jarjar

    jarjar New Member

    I don't have to time to go research it but there have been report that have surfaced in the last year or two that indicate Parkinson is often caused by lyme.
    As patients are testing positive for it.
  8. Kimelia

    Kimelia New Member

    is it just me or does a lot of this stuff go over your heads? My brain feels so foggy. I was in the top of my classes in college... I know I'm not stupid.
  9. mollystwin

    mollystwin New Member

    I am intelligent as well, but on brain fog days, it goes right over my head!

    We will be smart once again when we conquer this illness!
  10. victoria

    victoria New Member

    this time I'm not printing out the whole article, I've tried to abbreviate it some, and put in all caps what I thought was important and/or 'verrrrrrrrry interesting'. The llink for it is below-

    The Scientist February 7, 2007
    By Susan Warner

    State official subpoenas infectious disease group

    Connecticut's attorney general has launched an antitrust investigation into The Infectious Disease Society of America's (IDSA) new guidelines for the treatment of Lyme disease, an unprecedented move that raises questions about the government's role in scientific consensus.

    .......The attorney general's decision to weigh in on medical consensus has ruffled a few feathers. "We're complying with the subpoena, but we're unhappy to see this kind of political interference with what are very normal and routine guidelines," Martin Blaser, chairman of the department of medicine at NYU Medical Center and president of the IDSA when the guidelines were published late last year, told The Scientist.

    Blaser added that clinical guidelines have to be based on science, not economics, " ... adding that the IDSA makes it clear the guidelines are voluntary...

    Blumenthal countered that even with disclaimers, the guidelines have a significant impact on the clinic.

    "The question is whether there is a denial of coverage to patients and doctors as a result of INFLEXIBLE STANDARDS that are then ADOPTED BY INSURANCE COMPANIES," Blumenthal told The Scientist, adding his office has not ruled out extending the inquiry to insurers. (YAY!!!)


    Raphael Sticker, pres. of ILADS, which supports the view that chronic Lyme exists and has published its own guidelines, said researchers should welcome the challenge to the power of a large, prestigious society.

    "When the IDSA guidelines say that there is no chronic Lyme disease (ie no persistent infection with the Lyme spirochete), that stifles scientific inquiry," he said... Sticker and others who believe chronic lyme exists point to references that suggest the opposite conclusion (that the IDSA came to).

    Blumenthal's investigation is warranted, contended Lorraine Johnson, a healthcare lawyer and member of the advisory board of the Lyme Disease Association, Inc, because members of the IDSA panel which wrote the new guidelines HAD TIES TO LYME PRODUCT MFRS THAT BENEFIT FROM A LIMITED DEFINITION OF LYME DISEASE, WHICH MAKES IT EASIER TO PROVE EFFICACY IN CLINICAL TRIALS.


    Tom File, who chairs IDSA's practice guidelines committee, defended the organization. "We are very strict in making sure there is full compliance and disclosure of conflict of interests," he said, noting corporations are most likely to turn to scientists with strong expertise for help in developing products. Blaser, for his part, noted that many doctors have their own financial conflicts of interest in arguing chronic Lyme exists, since if the IDSA recognized chronic Lyme, insurers would be more likely to pay for it.

    As it stands now, the small group of Lyme specialists who treat chronic Lyme are getting rich from patients who pay out-of-pocket, said Karen Vanderhoof, chairwoman of the Lyme Disease Foundation. "But if the IDSA guidelines provided some flexibility then patients could go to any doctor. Now there's no competition for the chronic patient. IDSA throws them out of the office."

    Susan Warner

    Links within this article

    Lyme Disease Association

    Lyme Disease Foundation

    International Lyme and Associated Diseases Society

    ILADS guidelines

    CDC: Lyme disease

    Martin Blaser

    I Oransky, "Hate ticks? Save deer," The Scientist, January 1, 2007.

    America's Health Insurance Plans

    GP Wormser et al, "The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the infectious diseases society of America," Clinical Infectious Diseases 2006;43:1089-1134.

    M Frey et al, "Detection of Borrelia burgdorferi DNA in muscle of patients with chronic myalgia related to lyme disease," Am J Med 1998;104, 591-594.

    RB Stricker et al, "Lyme disease: Point/Counterpoint," Expert Rev Anti Infect Ther. 2005 Apr;3(2):155-65

    R. Lewis, "Vaccines: Victims of their own success?" The Scientist, July 19, 2004.