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What Do I Need to Know About Lyme Transmission Time?

Published on May 24, 2017 by ContagionLive (4th of 9 segments)
Patricia Smith, President of the Lyme Disease Association, Inc, explains what you need to know about the time it takes for Lyme to be transmitted from tick to host.

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Are Patients Facing Difficulties in Accessing Treatment for Lyme?

Published on May 24, 2017 by ConagionLive (5th of 9 segments)
Patricia Smith, President of the Lyme Disease Association, Inc, shares thoughts on the difficulties many patients face in accessing treatment for Lyme disease.

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Why is May Lyme Disease Awareness Month?

Published on May 25, 2017 by ConagionLive (6th of 9 segments)
Patricia Smith, President of the Lyme Disease Association, Inc, explains why May is Lyme Disease Awareness Month.

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How Does Government Acknowledgement of Lyme Affect Patient Care?

Published on May 25, 2017 by ContagionLive (7th of 9 segments)
Patricia Smith, President of the Lyme Disease Association, Inc, shares her thoughts on how government acknowledgement of Lyme disease affects patient care.

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The Current State of Lyme Disease Prevention

Published on May 25, 2017 by ConagionLive (8th of 9 segments)
Patricia Smith, President of the Lyme disease Association Inc., discusses Lyme disease infection prevention.

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Lyme Disease Legislation May Advance Patient-Centered Research

Published on May 25, 2017 (9th of 9 segments)
Patricia Smith, President of the Lyme disease Association Inc., explains what it means that Lyme disease has been incorporated into CDMRP legislation as well as the 21st Century Cures Act.

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

 

FOR IMMEDIATE RELEASE
CONTACT: Melissa Chefec, 203-968-6625 or Nicole Rodgers, 202-822-5200, ext. 249/226 

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, May 1, 2008
– 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 adds, “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.




IDSA Violates Lyme Antitrust Settlement Agreement with Connecticut Attorney General

IDSA Violates Lyme Antitrust Settlement Agreement with Connecticut Attorney General
Greenwich, CT, February 4, 2010 – On Monday, February 1, 2010, the Connecticut Attorney General Richard Blumenthal sent a letter to the IDSA expressing “concern” over “improper voting procedures” used by the IDSA in the Lyme guidelines review voting process. The IDSA may soon approve hearing determinations based on this improper voting procedure. The Attorney General requested that the IDSA redo the vote to comply with the Settlement Agreement. 
“First, the IDSA stacked the panel by excluding our physicians and now they’re stacking the ballot box. The IDSA needs to comply with the settlement agreement and place the interest of patients’ paramount,” commented Attorney Lorraine Johnson, Executive Director of the California Lyme Disease Association. 
The four-page Attorney General letter was released in response to a Freedom of Information Request made on behalf of patient groups for information regarding the IDSA’s compliance with the Settlement Agreement. 
“Attorney General Blumenthal continues his fine work ensuring that agencies such as the IDSA take the legal settlement process seriously. If not for his oversight, the IDSA would once again violate a process that could medically impact hundreds of thousands of patients,” said Debbie Siciliano, Co-President of Time for Lyme. 
What happened? The IDSA used an “improper voting procedure,” based on a process of its own design, which blatantly violates the Settlement Agreement and undermines the integrity of the voting process. The IDSA consented to the voting procedure in the Settlement Agreement and confirmed its understanding of the required voting procedure in an internal memo from the IDSA to the panel before the panel met. The Attorney General’s letter and the IDSA internal memo to the panel are attached to this release.
What voting process was required and how was it violated? The Settlement Agreement requires a two step voting procedure, with each step requiring a supermajority vote (6 of 8 panelists). The first vote asks the question whether each of the contested guideline recommendations is “medically/ scientifically justified in light of all of the evidence and information provided.” This vote requires a supermajority of the panel (6 of 8) in order for a guideline recommendation to stand. In essence, it asks “did the panel that adopted the 2006 guidelines get it right”? The second vote, also by supermajority, determines whether the guidelines require no changes, partial revision or complete revision. 
The IDSA’s flawed voting procedure combined the two voting steps into one. First, the panel failed to conduct the vote to determine whether the science was sufficient to support the guideline recommendations. Next, the panel substituted its own procedure for the second step in the voting and required a supermajority for any change. This process effectively flipped the supermajority requirement to favor no change to the guidelines. 
From the get-go, two significant points stand out: 
The IDSA failed to voluntarily comply with the Settlement Agreement in good faith. 
Absent oversight by the AG pursuant to the Settlement Agreement, the IDSA would have carried out a corrupted process that blatantly violates the agreement—and it might never have been discovered. 
Patient groups are appalled that so far the IDSA, which should conduct an honest review and assessment of the evidence supporting the IDSA recommendations, has chosen to manipulate the voting requirement to influence the outcome, in clear violation of the Settlement Agreement and the scientifically based review and voting process which it provides. This turns evidence-based medicine on its head.
“It is unconscionable that IDSA professionals would so little value patient health. By manipulating the vote, they continue to subvert the scientific truths about the devastating effects of Lyme and refuse to allow patients to be diagnosed and treated. They can’t face the truth,” adds Pat Smith, President of the national Lyme Disease Association.
Can the process be saved? Patient groups, along with the public at large, expected that the IDSA would comply with the Settlement Agreement in good faith. It is, after all, a settlement agreement with the Attorney General of the State of Connecticut. When the IDSA panel so deliberately violates the voting procedures, as expressly confirmed by the words of the IDSA’s own internal memo, and refuses to comply with the Attorney General’s request, there can be only one conclusion: The ability of the IDSA to run this process with integrity is extremely suspect and any outcome must be viewed critically.
Other examples of abuse by IDSA of settlement process: This is not the first time legitimate questions have been raised regarding the IDSA’s willingness and reliability in performing its obligations with integrity under the settlement process. For instance, the IDSA was charged with selecting the panel and chose to exclude divergent viewpoints (including physicians who treat chronic Lyme disease). One panelist was removed by the panel after patients complained because he had served on another Lyme guidelines’ panel− a direct violation of the settlement agreement. Another panelist had also served on a previous Lyme guidelines’ panel, but despite patient complaints, was not removed. 
Patient organizations call upon the IDSA to hold an individual vote on whether each of the guidelines’ recommendations is medically/scientifically justified in light of all the evidence as requested by the Attorney General. If IDSA fails to do so in good faith, patients continue to rely upon the Attorney General to continue to enforce the Settlement Agreement.
Time for Lyme, www.timeforlyme.org, the national Lyme Disease Association, www.LymeDiseaseAssocation.org, and California Lyme Disease Association, www.lymedisease.org, are non-profit organizations that were founded by individuals who had personal experience with Lyme disease, in order to address the lack of research, education and support services available for this emerging infection. 
[An example of the IDSA manipulation of the voting procedure. 

The guidelines mandate that Lyme cannot be diagnosed without a confirming diagnostic test. The tests are known to be insensitive and flawed. Requiring a positive test means that many patients with Lyme disease will fail to be diagnosed. One panel vote described in the AG’s letter was whether this recommendation should be revised. Four of the eight panel members voted for change, without the panel first having voted to determine whether the recommendation was supported by the science. As the AG’s letter points out, this clearly means that had the panel voted in accordance with the Settlement Agreement, this recommendation would have failed as not properly supported by the medical/scientific evidence. Why? A vote to uphold this recommendation would have required 6 votes; however, the 4 votes calling for revision (even though predicated on a flawed procedure) plainly indicates insufficient evidence to support the recommendation. Thus, (a) the IDSA failed to vote to determine whether the science supported the recommendation, (b) substituted its own procedure regarding revision (requiring a supermajority vote to revise), and (c) thereby manipulated the voting requirements to achieve a result in its favor.] 

 

 
 



Congress Calls for Removal of Outdated Lyme Disease Guidelines / Sign Petition Here!

January 21, 2012- Congressman Christopher Smith (NJ) with co-signers Congressmen Gibson (NY), and Wolf (VA) recently sent a letter to the National Guideline Clearing House (NGC), Agency for Healthcare Review & Quality (AHRQ) requesting the removal of the highly controversial Infectious Diseases Society of America’s (IDSA) Lyme Disease Treatment Guidelines from the NGC website, since NGC policy mandates removal after 5 years of “stale” guidelines unless a specific review process is followed.

For treatment guidelines to remain on the NGC site more than five years, they must be reviewed and updated to reflect current science, with a designated review panel responsible for that duty. IDSA failed to convene such a panel, indicating that its current Lyme guidelines were reviewed already, thus do not require another review, and are then eligible to remain on the NGC until 2015.

IDSA claims are based on a review convened as a one-time legal remedy to comply with an anti-trust settlement IDSA reached with then CT Attorney General, now US Senator, Richard Blumenthal. He initiated an investigation after input from CALDA, TFL, and LDA, Lyme organizations, which have been working to ensure patients can obtain treatment for chronic Lyme disease, demonstrated to Blumenthal how the Guidelines were hurting patients.

After the antitrust settlement review was completed, recommended changes to future IDSA Lyme guidelines made by the IDSA’s own settlement review panel members were not incorporated anywhere.

The NGC uses the definition of clinical practice guidelines developed by the Institute of Medicine (IOM) in 1990: clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.

IDSA Lyme disease treatment guidelines, instead of being used to assist practitioners and help patients, have been used as a weapon to prosecute physicians who refuse to follow the guidelines “recommendations” and to give insurers carte blanch in denying reimbursement for treatment beyond a few weeks.

Thanks to Congressman Christopher Smith for spearheading the congressional communication to National Guidelines Clearing House and to the Congressional co-signers, Congressmen Wolfe and Gibson. In addition, thanks to LymeDisease.org, an LDA affiliate, for doing the coordination and leg work on this issue.

The NGC’s response will determine the fate of hundreds of thousands of patients. Go to http://www.lymedisease.org/news/lymepolicywonk/898.html for further details.  You can also register your opinion on how the guidelines are preventing your Lyme treatment with your Congressman.

Sign Petition To Remove Outdated IDSA Guidelines From NGC!!



click for pdf of below letter

January 18, 2012

Vivian H. Coates, MBA
Vice President, Information Services and Health Technology Assessment
ECRI Institute
5200 Butler Pike
Plymouth Meeting, PA 19462-1298

Dear Ms. Coates:

As your organization is currently contracted by the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) to maintain the National Guidelines Clearinghouse (NGC), we write to you as representatives of areas that have a large and growing Lyme disease problem. Our constituents have again contacted us about an issue that needs immediate attention to protect their welfare.

As you no doubt know, the Lyme disease guidelines of the Infectious Diseases Society of America (IDS A) have been highly controversial and have been responsible for insurance company denials of Lyme disease treatments. We have recently been informed that these guidelines have been re-instated on the NGC Web site, notwithstanding the fact that they are more than 5 years old and, hence, are no longer current. Our constituents are concerned that these guidelines have not been subject to a complete review for currency and that the methodology of any review has not been disclosed as required by the NGC’s guidelines.

Our understanding is that the recently re-submitted guidelines are based on the July 2010
Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America, which specifically was “not charged with updating or rewriting the 2006 Lyme disease guidelines. “This aforementioned review panel was convened pursuant to an agreement between the Connecticut Attorney General and the IDS A to end the Attorney General’s antitrust investigation into the IDSA’s 2006 Lyme disease guidelines. The 2010 panel recommended more than 25 revisions to the guidelines, which have not been addressed. We have been presented with considerable evidence that the NGC process, which requires that guidelines be reviewed for currency and disclosure of the methodology for the process, was not complied with before reinstating the guidelines until 2015.

We urge you to follow NGC currency compliance procedure and remove the guidelines until they have been fully reviewed and revised. The mission of the NGC is “to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, purchasers, and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.” Only a careful and transparent procedure will remove the cloud that has hung over these guidelines.

Thank you for your serious consideration. We look forward to your reply.

CHRISTOPHER H. SMITH, Member of Congress
FRANK WOLF, Member of Congress
CHRIS GIBSON, Member of Congress
 




Statistical Review Refutes Studies Used as Basis of  IDSA Guidelines

Allison DeLong   Allison DeLongA just published statistical review in Contemporary Clinical Trials, August 19, 2012, has cast doubt on the NIH funded studies which have been used as a basis for Lyme disease guidelines most often used by treating physicians for diagnosis and treatment and by insurers to determine reimbursement, i.e. Infectious Diseases Society of America (IDSA) and American Academy of Neurology (AAN) guidelines. The review by Brown statistician, Allison DeLong, and co-authors has reported “flaws in design, analysis, and interpretation that call into question the strength of the evidence against retreatment.” (see Brown release) The most detrimental of those studies to patients has been Klempner et al, which has been shown in this review to have significant statistical issues.

Ms. DeLong is an LDA Scientific and Professional Advisory Board Member. Other authors are statistics graduate Barbara Blossom, Dr. Elizabeth Maloney, and Dr. Steven Phillips.

Visit below link for Brown Press Release on the study:

http://news.brown.edu/pressreleases/2012/08/lyme

Click here for abstract

 

Click here for short analysis done by Ms. DeLong in 2009 for LDA Analysis:  Why Klempner Study is Not Useful to Rule Out Benefits of Long-Term Treatment.