Topic: From CALDA! From AG Blumenthal! EMAIL SUGGESTIONS!
daise
Unregistered
posted
I saw the thread that was already posted about this and it is an historic, breaking news event: IDSA brought to its knees over Lyme!
Here's more. This was emailed to me by Colleen Nicholson, Military Lyme Support (Yahoo Groups.) It's from CALDA (California Lyme Disease Association) and Connecticut Attorney General Blumenthal's office.
I sent copies of both to the following 3 politicians (and you can too!):
1.) Email: The Honorable Senator Edward Kennedy, Chairman Senate Health, Education, Labor and Pensions Committee U.S. Congress
Dear Senator Kennedy:
(As I sent a previous letter, I sent a short text this time. Bill S 1708. He can't cosponsor it because he is the Chairman. However, we can ask for his support of the bill to bring it up for a hearing. This is when the LDA and ILADS doctors educate members of the Senate!)
Note: In the following email address there is an underline between "help" and "comments." This is Senator Kennedy's email address at the Committee.
help_comments@ help.senate.gov
2.) The Honorable Congressman Frank Pallone, Chairman Committee of Energy And Commerce, Health Subcommitee U.S. Congress
Dear Representative Pallone,
(As I sent a previous letter, I sent a short text this time. Bill HR 741. He is Chairman of the Subcommittee and therefore can't cosponsor it, but he can be asked to support it and to bring it up for a hearing.)
On the top left DON'T click "Who We Are," but bring the mouse over it to pull down the small menu underneath and click "Contact Us." I copied my short letter along with a copy of the 2 announcements, directly into the box.
3.) The Honorable Congressman Dingell, Chairman Committee of Energy And Commerce U.S. Congress
Dear Representative Dingell,
(As I sent a previous letter, I sent a short text this time. Bill HR 741. He is Chairman of the Committee and therefore can't cosponsor it, but he can be asked to support it and to bring it up for a hearing.)
On the top left DON'T click "Who We Are," but bring the mouse over it to pull down the small menu underneath and click "Contact Us." I copied my short letter along with a copy of the 2 announcements, directly into the box.
Happy May Day everyone!
_________________________________________________
California Lyme Disease Association
News alert, May 1, 2008
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). Diane Blanchard, co-president of Time for Lyme in Connecticut agrees. "The IDSA guidelines are dangerous for patients who suffer longer-term Lyme symptoms that do not fall within the IDSA's narrow disease definition," Ms. Blanchard added.
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.
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.
To view the entire IDSA agreement, go to the Attorney General's website.
sometimesdilly
Frequent Contributor (1K+ posts)
Member # 9982
posted
daise-
could you please also copy this into the main on-going thread about B's decision?
too many threads on the same topic and this info will be missed by some (or many) of us...
Posts: 2507 | From lost in the maze | Registered: Aug 2006
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bettyg
Unregistered
posted
dilly and daise,
[/B]I ALREADY BROKE UP THE 3 MAIN EVENTS TODAY AND POSTED IN "MAIN" BLUMENTHAL ANNOUNCEMENT TODAY... so you don't need to repost it there; thanks! it's confusing enough with all the posts an reposts in there! [/b]
... blumenthal's complete statement
.. press relese from lda/calda
.. IDSA's letter to its member saying they did no wrong.
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posted
"If I wasn't on a anti-yeast diet, I would invite you all over for cheesecake."
Well put!
This is huge.
-------------------- "We must be willing to get rid of the life we've planned, so as to have the life that is waiting for us" - e.m. forster Posts: 921 | From PA | Registered: Jan 2004
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Tracy9
Frequent Contributor (1K+ posts)
Member # 7521
posted
Look at all those who WON'T be allowed to participate on the new panel:
Gary P. Wormser Raymond J. Dattwyler Eugene D. Shapiro John J. Halperin Allen C. Steere Mark S. Klempner Peter J. Krause Johan S. Bakken Franc Strle Gerold Stanek Linda Bockenstedt Durland Fish J. Stephen Dumler Robert B. Nadelman1
13 years Lyme & Co.; Small Fiber Neuropathy; Myasthenia Gravis, Adrenal Insufficiency. On chemo for 2 1/2 years as experimental treatment for MG. Posts: 4480 | From Northeastern Connecticut | Registered: Jun 2005
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bettyg
Unregistered
posted
kudos TRACY
by showing the names of the 14 people responsible for the 2006 idsa lyme guidelines HOG WASH!
i do wish blumenthal would have named them all in his report!!! they deserve to be named for the CONFLICT OF INTERESTS $$$ !!!
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daise
Unregistered
posted
Hi Tracy,
Now there is a useful list. I'm already emailing it out to many places where it will do some good.
The Lyme Disease Network is a non-profit organization funded by individual donations. If you would like to support the Network and the LymeNet system of Web services, please send your donations to:
The
Lyme Disease Network of New Jersey 907 Pebble Creek Court,
Pennington,
NJ08534USA http://www.lymenet.org/
UBBFriend: Email this page to someone!
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