Torrey vs. IDSA/Insurers Lawsuit Update: Cigna Third Insurance Defendant to Settle

The Lyme Disease Association is providing the most recent update regarding Torrey vs. IDSA/Insurers, the federal lawsuit filed by 24 Lyme patients against six members of the Infectious Disease Society of America (IDSA) and eight insurance companies in the U.S. District Court for the Eastern District of Texas, Texarkana Division.

According to investigative journalist Mary Beth Pfeiffer, Cigna has now become the third insurance company defendant in the case to settle following Kaiser Permanente in November 2019 and Blue Cross Blue Shield of Texas (BCBST) in January 2020. Pfeiffer reports that, as was the case with the first two, the Cigna settlement is being handled in secret with sealed documents. The public may never know what the plaintiffs received, or what was accomplished during the hearings. The remaining defendants include the IDSA, five other insurance companies, and six Medical Doctors. 

At this stage, this is all the information that has been made available. Details regarding the terms or amount of the settlements are unknown. The lawsuit was initially filed in 2017 on behalf of the group of Lyme disease patients who claim they have been denied care, as well as harmed, under existing insurance and medical protocols. The litigation proceedings will continue in the U.S. District Court in Texarkana, Texas.

LDA will provide updates when we have them. You can also continue to watch for updates on Mary Beth Pfeiffer’s website and Twitter feed

Click here to view the Notice of proposed settlement of Cigna Health and Life Insurance Company.

Click here to view the Notice of settlement of BCBS of Texas.

Click here to view the Settlement reached with Kaiser Permenente.

Referenced articles and websites:

  1. Thefirstepidemic.com. Patient lawsuit against IDSA and insurers moves forward in Texas. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  2. Thefirstepidemic.com. Amended complaint in Lyme lawsuit; battle lines are drawn. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  3. LymeDisease.org. TOUCHED BY LYME: Latest in anti-IDSA/insurers lawsuit: Kaiser settles. [Web Article]. Copyright 2019 LymeDisease.org. https://www.lymedisease.org/torrey-v-idsa-kaiser-settles/



Torrey vs. IDSA/Insurers Lawsuit Update: Proceedings Delayed ‘Till Feb.

The Lyme Disease Association is providing an update regarding Torrey vs. IDSA/Insurers, the federal lawsuit filed by 24 Lyme patients against six members of the Infectious Disease Society of America (IDSA) and eight insurance companies in the U.S. District Court for the Eastern District of Texas, Texarkana Division.

Recently, two documents were filed electronically by the suit’s mediator. The first announces that Kaiser Permanente, one of the eight insurance company Defendants, has settled with the Plaintiffs. The second stated that the mediation session, which commenced in February of this year, has been suspended, and that “the undersigned mediator will continue to work with the parties in an effort to settle”.

More recently, according to Investigative journalist and author, Mary Beth Pfeiffer, “Proceedings have again been delayed, to 2/14/20. Parties will report by 1/31/20 on ‘agreements and/or differences concerning the case schedule, the amount of time necessary to finish discovery and trial timing.'”

At this stage, this is all the information that has been released to the public. Details regarding the terms or amount of the settlement are currently unknown. The lawsuit was initially filed in 2017 on behalf of the group of Lyme disease patients who claim they have been denied care, as well as harmed, under existing insurance and medical protocols. The litigation proceedings will continue in the U.S. District Court in Texarkana, Texas.

LDA will provide updates when we have them. You can also continue to watch for updates on Mary Beth Pfeiffer’s website and Twitter feed

Referenced article:

  1. Thefirstepidemic.com. Patient lawsuit against IDSA and insurers moves forward in Texas. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  2. Thefirstepidemic.com. Amended complaint in Lyme lawsuit; battle lines are drawn. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  3. LymeDisease.org. TOUCHED BY LYME: Latest in anti-IDSA/insurers lawsuit: Kaiser settles. [Web Article]. Copyright 2019 LymeDisease.org. https://www.lymedisease.org/torrey-v-idsa-kaiser-settles/



Research Review Finds IDSA Guidelines Contribute to Mental Health Epidemic

Researchers, including Robert C. Bransfield, MD, Lyme Disease Association Professional & Medical Advisory Board Member, recently reviewed the proposed new Lyme Disease Guidelines, a 100 page document on the prevention, diagnosis, and treatment of Lyme disease drafted by the Infectious Disease Society of America (IDSA) in collaboration with the American Academy of Neurology and American Academy of Rheumatology.  The draft of the IDSA Guidelines  was released for public comment in August of 2019 and received a considerable number of responses from the Lyme community, many critical of the proposed Guidelines.

The review was published in Healthcare Scientific Journal and scrutinizes specific sections of the guidelines that are most relevant to psychiatry including the disclaimer, laboratory testing, and adult and pediatric psychiatric sections. The researchers have outlined many issues with the IDSA Guideline draft, most notably, the failure to outline the causal association between Lyme disease and psychiatric illnesses throughout, despite the vast amount of well-founded supporting evidence.

The Disclaimer

According to the researchers, the proposed disclaimer, which was more extensive than the one on past IDSA  guidelines, contained many issues, including failure to state that the guidelines cannot be used to establish a standard of care. The analysis found that the disclaimer offered no type of warranty of accuracy or reliability with the methods outlined and that the institutions responsible for creating the guidelines held themselves harmless from any potential losses that may occur when practicing physicians use the guidelines to treat patients. The seriousness of the guidelines issue came to the attention of the US Health and Human Services Tick-Borne Disease Working Group (TBDWG), of which LDA President Pat Smith is a member, and discussion was included in the group’s 2018 Report to Congress.

Diagnostic Testing

According to the researchers, one of the most central flaws contained within the guidelines was the recommended use of the scientifically unfounded surveillance case definition as diagnostic criteria. The IDSA Guidelines make the incorrect assessment that patients who do not meet the surveillance case definition for Lyme disease do not meet clinical diagnostic criteria either, and therefore, do not have Lyme disease. Additionally, the review calls attention to issues with the IDSA’s arbitrary focus on 2-tiered testing as a reliable method of diagnosis.

Testing Adults with Psychiatric Illness for Lyme Disease

The IDSA Guidelines advise against testing for Lyme disease in adults with diagnosed psychiatric illness, yet a number of studies show a causal relationship between Lyme disease and certain kinds of psychiatric illnesses. Prior research has shown that a low prevalence of mental illness may exist prior to infection while the presence of psychiatric illnesses and comorbidities is more significant post-infection.

The researchers were able to identify 377 unique citations on the ILADS website, supporting an association between Lyme disease and psychiatric illness. However, the IDSA Guidelines include only a small number of articles limited to epidemiologic studies that selectively reported outcomes

Testing Children with Developmental, Behavioral, or Psychiatric Disorders for Lyme Disease

The IDSA Guidelines also recommend against standard testing for Lyme disease in children with developmental, behavioral, or psychiatric disorders, referencing that there is no data to support a causal association between tick-borne infections and behavioral disorders or developmental delays in children. However, as the researchers who analyzed the IDSA Guidelines state, the IDSA included no references to support these claims and in fact, numerous articles demonstrating the causal relationship between Lyme disease and developmental, behavioral, and psychiatric disorders in childhood do exist.

References:
1. Bransfield RC, Cook MJ, Bransfield DR. Proposed Lyme disease guidelines and psychiatric illnesses. Healthcare. 2019;7(3):105.

2. Rheumatologyadvisor.com. Review Indicates Inclusion of Psychiatric Illness Association in Proposed Lyme Disease Guidelines. [Web Article]. Copyright 2019 Rheumatology Advisor. https://www.rheumatologyadvisor.com/home/topics/lyme-disease/review-indicates-inclusion-of-psychiatric-illness-association-in-proposed-lyme-disease-guidelines/




Lyme Patients File Civil Suit Against Insurers/IDSA/IDSA Panelists

The Lyme Disease Association (LDA) has announced that on November 10, 2017, twenty-three Lyme patients/estates of patients filed Civil Action No. 17-cv-190 in the US District Court for the Eastern District of Texas, Texarkana Division─4 counts under Racketeer Influenced and Corrupt Organizations Act (RICO) and one count of antitrust violations of the Sherman Act. The plaintiffs are asking for actual damages, treble damages, reasonable attorney’s fees, and court costs and have demanded a jury trial. The defendants are:

• Infectious Diseases Society of America (IDSA)
• Blue Cross and Blue Shield Association
• Blue Cross and Blue Shield of Texas
• Anthem Inc.
• Aetna Inc.
• Cigna Corp.
• Kaiser Permanente Inc.
• United HealthCare Services Inc.
• UnitedHealth Group Inc.
• IDSA Panelists: doctors Gary P. Wormser, Raymond J. Dattwyler, Eugene Shapiro, John J. Halperin, Robert B. Nadelman, Leonard Sigal, & Allen Steere.

Discussion of the investigation of the IDSA by then Attorney General Richard Blumenthal (now Senator) is presented, testimonies before governing bodies of an advocate and a doctor are included, and cases of defendant patients are presented as well as cases of some physicians who were charged by state medical boards.

One excerpt from the Factual Allegations Common to All Counts & Claims is below: (p.23-4)

The acts of the defendants form a ‘pattern of racketeering’

99. The IDSA, Insurance Defendants, and the IDSA Panelists, acting through their officers, agents, employees and affiliates, committed numerous predicate acts of “racketeering activity,” as defined in 18 U.S.C. §1961(5), prior to and during the period made the basis of this suit, and continues to commit such predicate acts, in furtherance of their scheme to prevent treatment of chronic Lyme disease and to prevent the proper testing of potential Lyme disease patients, including including (a) mail fraud, in violation of 18 U.S.C. §1341, and (b) wire fraud, in violation of 18 U.S.C. §1343. Such predicate acts include the following: mailing, causing to be mailed, knowingly agreeing to the mailing of various materials and information, and/or wiring information including, but not limited to, correspondence regarding the following: fraudulently and wrongfully claiming lack of insurance coverage for chronic Lyme disease; fraudulently and wrongfully denying insurance coverage to people with chronic Lyme disease; issuing false and misleading EOB’s to patients with Lyme disease; fraudulently and wrongfully claiming all Lyme disease patients can be easily treated and cured with short-term antibiotics; fraudulently and wrongfully claiming Lyme disease patients only have Lyme disease if they exhibit an EM rash or test positive with a two-tier serology test; wrongfully and illegally reporting doctors to their medical boards for treating chronic Lyme disease; fraudulently and wrongfully misleading people with Lyme disease, and their doctors, by classifying their chronic Lyme disease as a mental disorder; fraudulently and wrongfully misleading people with Lyme disease, and their doctors, by classifying their chronic Lyme disease as a different physical condition such as chronic fatigue syndrome or fibromyalgia; and fraudulently and wrongfully enforcing the IDSA guidelines even when doctors determine a patient requires long-term antibiotic treatment.

Click here for a news release on suit

Click here for complete lawsuit




Lyme Comm. Unites: Protect Patient Rights

UPDATE 5-6-15: Click here for LDA/LDo Press release on IDSA guidelines process

In a move designed to spotlight concerns about the Infectious Diseases Society of America (IDSA) guidelines’ development process, groups in the Lyme community nationwide have come together to make their voices heard. The effort to date consists of three different letters which were signed on by multiple groups representing dozens of states across the U.S. and were then sent to the US House of Representatives Lyme Disease Caucus, the US House of Representatives Energy & Commerce Committee, and the IDSA itself, which requested input into its newly structured guidelines development process.2009-10 LDA Aff Meeting 148kb2009 LDA file photo depicts Lyme leaders from across the U.S. at an LDA Affiliate Meeting in Maryland.*

Citing concerns about the lack of patient representation− a concept the Institute of Medicine (IOM) has endorsed for guidelines’ development in general− and also the lack of clinicians in the trenches who are treating not only Lyme but the often concurrent tick-borne diseases seen in many patients, the groups have requested specific actions to be taken by each letter recipient.

Further actions may be forthcoming by the Lyme Community. As other actions occur, we will post them.

 

NOTE: The IDSA has just extended its Lyme Guidelines Process Comments until April 24th. Anyone who has not replied to the IDSA directly can go to their website and register their comments. Click here for IDSA website.

_______________________________________________________________________________________

VIEW LETTERS RESULTING FROM LYME GROUP LETTERS

Click here for Letter from US House of Representatives Lyme Disease Caucus to the IDSA

_______________________________________________________________________________________

VIEW LETTERS FROM THE LYME GROUPS

Click here for Letter to US House of Representatives Lyme Disease Caucus on the proposed new IDSA Guidelines process from 57 Groups

Click here for Letter to US House of Representatives Energy & Commerce Committee asking for a hearing on issues surrounding the IDSA Guidelines process from 57 Groups

Click here for LymeDisease.org and Lyme Disease Association Letter of Comments to IDSA Guidelines process from 67 Groups

Click here for LymeQuest Submission on behalf of 22 groups & 67 groups #

# NOTE: IDSA extended its filing time but would not permit LDA/LDo to submit additional comments with additional groups signed on. So LymeQuest submitted the additional comments to IDSA on behalf of all the groups, total of 89 (22 + 67).

_______________________________________________________________________________________

VIEW LDo’s PATIENT SURVEY RESULTS

Click here for LymeDisease.org’s IDSA Guidelines Patient Survey Results

_______________________________________________________________________________________

VIEW LETTERS+ FROM LDA/LDo TO IDSA PARTNER ORGANIZATIONS INVOLVED IN GUIDELINES’ DEVELOPMENT PROCESS

Click here for AAFP President
Click here for AAN President
Click here for AAP President
Click here for ACR President
Click here for AMMI-CA President
Click here for CNS President
Click here for ESA President
Click here for ESCMID President
Click here for PIDS President
Click here for ACP President
Click here for IDSA President

+NOTE: Each mailing contained the cover letters shown above and copy of the two group submissions to IDSA.

_______________________________________________________________________________________

VIEW LETTERS FROM OTHER COUNTRIES

Click here for comment letter to IDSA from the UK

Click here for comment letter to IDSA from Deutsche Borreliose Gesellschaft e.V. (German Society of Lyme Borreliosis)

_______________________________________________________________________________________

VIEW HISTORY OF LYME GROUP ACTIONS AND IDSA PROJECT PLAN

Click here for history of Lyme Group actions

Click here for IDSA Project Plan: Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease by the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology (Note: By clicking this link, you will leave the LDA website and be on the IDSA website)

 

*The groups represented in photo above may or may not be signed on to one or more of the letters

 

 

 

 




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.

 

 




AG’s Investigation: Flawed Lyme Guidelines

May 1, 2008, Atty. Gen. Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Iinfectious Diseases Society of America’s (IDSA) process for writing it’s 2006 Lyme disease guidelines and the IDSA has agreed to reassess them what the assess assistance of an outside arbiter.  

Click here for press release.




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
 




IDSA Guidelines Panel Decision 4-22-10

STATEMENT OF THE NATIONAL NON PROFIT LYME DISEASE ASSOCIATION, INC. ON THE IDSA GUIDELINES PANEL DECISION 4-22-10

We are not surprised by the conclusions reached by the IDSA review panel but are certainly disappointed. It is certainly suspect that in considering a disease with numbers on the rise (250% increase from 1993-2008), one which is so highly controversial and with unsettled and “undone” science, that the panel would vote “lockstep” (8-0) except for one dissenting vote to uphold all of the original recommendations. The national Lyme disease Association (LDA) and its 35 associated organizations publicly expressed their concerns about bias in the panel selection throughout the process, including the selection of the chair, who is a former president of the IDSA, and the pronounced lack of community treating physicians.

We note with interest that IDSA separated out the only real area of contention among its panel, a 4-4 vote, and because it did not fit the required voting process, IDSA alleged that this was NOT a recommendation they needed to review, but only a statement in their Guidelines executive summary that the Attorney General asked them to review. It is a crucial statement on testing, the essence of which appears throughout the guidelines and is most often used by doctors and insurers to prevent patients receiving diagnosis and treatment. The panel’s apparently improper first vote on this issue was uncovered by a FOIA, (freedom of information act) on the panel voting process. The vote was 4-4, not meeting the supermajority required to pass it, so they characterized the testing issue as a non recommendation, which they claim, does not require a supermajority.

The IDSA’s empty “political” rhetoric, adherence to these guidelines is only voluntary, certainly we support clinical judgment, is belied by their statement “Based on current research for patients with non specific symptoms that may be seen in may illnesses…it would be a deviation from “best fit” [association between illness and likely diagnosis established by medical evidence] to attribute such symptoms to Lyme disease in the absence of more specific clinical features or laboratory results…All Lyme disease clinical findings including erythema migrans can be seen in diseases other than Lyme…It would thus be clinically imprudent to make this diagnosis of Lyme disease using these non specific findings alone.”

The IDSA’s position at the onset of this investigation and settlement process has been that the Attorney General of Connecticut’s investigation was interfering in medical practice rather than the guidelines formation process. To apply logic to their way of thinking, any changes in the Guidelines would admit wrongdoing on their part and set a precedent for future government actions in creation and development of their many guidelines. So instead, the IDSA panel upheld all the recommendations, failed to provide after each recommendation the specific references that were considered and used to justify upholding each recommendation (the resources are lumped at the end of the paper). We consider it striking that they provides lists of items that need to be considered in the “next” upgrade of their guidelines, thereby relieving themselves of responsibility of acknowledging that changes are needed to these current guidelines.

The IDSA admits to receiving a large volume of case reports & case series that attested to “PERCEIVED” clinical improvement with long term treatment. One would assume that in most cases, doctors were perceiving the improvement in patients, and thus their years of clinical judgment would carry significant weight. Yet the IDSA excluded all of that evidence as not justified. IDSA also discounted the controlled studies which did indicate improvement after long term antibiotics

Patients cannot wait for the entrenched medical establishment to address the problems with this disease. They need treatment and relief now. The ratification of these guidelines by IDSA becomes another nail in the coffin for those afflicted with Lyme disease. We call upon the Attorney General of Connecticut to examine the entire process to determine compliance with his stated requirements and to take further action should grounds be found to do so.

Pat Smith Presidentwww.LymeDiseaseAssociation.org




Analysis: Why Klempner Study is Not Useful to Rule Out Benefits of Long-Term Treatment

Analysis: Why Klempner Study is Not Useful to Rule Out Benefits of Long-Term Treatment
Allison DeLong, Brown University
 
I. The clinical trial by Klempner et al. cannot be used to assess the effectiveness of re-treatment of Lyme disease in patients with continued symptoms following standard treatment
 
A. The trial was poorly designed
 
1.   The sample sizes were too small to detect clinically meaningful treatment effects (the study was underpowered).
a.   Determined by examining the ability of Klempner’s study to detect levels of improvement that were found to be of value in studies of other chronic illnesses.
2.   The (Klempner) presumed treatment effect for sample size calculation was so large for one of the two primary outcomes (mental score) that Lyme patients would have been forced to perform better than the general U.S. population at follow-up.
a.       E.g.− The trial was terminated early because it was unlikely that the presumed treatment effects would be statistically significant.
1)   Since people were not going to achieve Klempner’s unreasonable requirement for improvement (see #2), then this poorly designed trial should have been terminated.
 
3.      Lack of statistical significance cannot be used to infer ineffectiveness in a poorly designed study. This is especially true here since Klempner’s confidence intervals for the treatment effects contain clinically meaningful values.
a.   Because meaningful values are in the confidence intervals, you can’t say treatment is ineffective.
 
      B. The trial data were poorly analyzed (summarized rather than analyzed)
 
1.   The statistical method used was less likely to obtain a statistically significant result than recommended methods for analyzing clinical trials (e.g. omitted ½ the data, categorized the outcomes leading to loss of information).
      a.  30 day, 90 day measures of outcome were not included in the analysis
      b.   If a longitudinal analysis of uncategorized data was done (all data included), it would have increased the ability to detect a significant treatment effect.           
 
2.      Klempner’s treatment effects cannot be interpreted for clinical meaning. Patients with Lyme have symptoms that wax and wane. For example, patients classified as “improved” could have unchanged health status, patients classified as “unchanged” could have improved.
                   a.   They categorized people rather than examining individual scores− it is unknown how treatment affected the mean outcomes in the placebo vs. antibiotic groups.
 
3.      The findings are likely biased (i.e. wrong) because the analysis didn’t adjust for baseline, and baseline scores differed by arm, and there was an inadequate presentation and analysis of participants lost to follow-up. Klempner does not say how many were lost to follow-up, and they were simply placed in a “worsened” category.
 
Allison DeLong, MS Biostatistician Brown University Center for Statistical Sciences Providence, RI, provided an in-depth analysis of the Klempner study at the IDSA hearings in Washington, DC on July 30, 2009. A video of that presentation can be found on www.IDSociety.org. The Lyme Disease Association thanks Ms. Delong for working with LDA to provide this shortened simplified analysis.

© 2009 Lyme Disease Association, Inc.
PO Box 1438
Jackson, NJ 08527 www.LymeDiseaseAssociation.org