*Updated 28th April 2015
IDSA re-working their guidelines in a Lyme Project Plan, panel has been chosen:
More on the Lyme Project Plan (PDF):
UK charity Lyme Disease Action give their response:
*Updated 17th June 2014
Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process
This paper from a legal team examines the legality of the IDSA guidelines
Under Our Skin produced a very good comparison of IDSA v ILADS guidelines with regards to diagnosis and treatment of Lyme disease. For those new to the topic IDSA claim that short term antibiotics will clear the illness, chronic Lyme doesn’t exist and blood tests using the 2 tier system (Elisa & Western Blot) are sufficient methods for detecting Lyme. ILADS are aware that the antibody borrelia tests often miss Lyme infected patients (producing a false negative result), that Lyme if left untreated WILL lead to chronic Lyme in some cases and that longer term antibiotics are vital to give back long term sufferers the quality of life they deserve. The two opposing ideas can be found on this useful table. If you have been recently diagnosed this literature is invaluable as many doctors in Europe are led by the IDSA guidelines which means that treatment is often stopped too early resulting in incomplete eradication of the disease.
IDSA have extended their deadline on comments and the public hearing date has also been changed:
IDSA has convened a review panel to examine whether the Society’s Lyme Disease guidelines, published in 2006, should be revised or updated based on a rigorous review of the medical and scientific evidence on the diagnosis and treatment of Lyme Disease.
The Review Panel initiated a 60-day input period to allow the public to submit information to ensure that all points of view are taken into consideration. There will also be an open public hearing to offer a forum for the presentation of relevant information on the diagnosis and treatment of Lyme Disease.
The public input period has been extended to April 24. Interested individuals and organizations may submit information as follows:
Submissions* must be received by 5:00 PM Eastern, April 24, 2009 and must include
Name and contact information of the submitter
Issue(s)/concern(s) and relevance to 2006 IDSA Lyme Disease guidelines; and/or
Issue(s) not covered in the 2006 IDSA Lyme Disease guidelines
Reference list of supporting data (if available)
The Review Panel is committed to considering all points of view. The Panel respectfully requests that comments be succinct and focused into approximately 10 pages; however all written submissions, regardless of length, will be considered. Comments should identify specific recommendations from the 2006 guidelines and evidence that either supports or refutes those recommendations.
Submissions should be made to the attention of the “IDSA Lyme Disease Review Panel” at: firstname.lastname@example.org.
*Note that submissions may be posted Online by IDSA for public viewing.
Open Public Hearing
The Review Panel will hold an open public hearing in Washington, DC.
The hearing, which had been planned for April 27, is being postponed to allow potential presenters more time to prepare and make travel arrangements.
Individuals who wish to present at the hearing must download and submit the application and disclosure form.
Members of the public will be able to view the hearing live on the IDSA website. A taped archive will be available online after the hearing.
PUBLIC INPUT PERIOD NOW CLOSED.
Open Public Hearing
The Review Panel will hold an open public hearing *July 30, 2009* in Washington, DC. The hearing, which had been planned for April 27, is being postponed to allow potential presenters more time to prepare and make travel arrangements.
APPLICATION PERIOD NOW CLOSED.
Members of the public will be able to view the hearing live on the IDSA website. A taped archive will be available online after the hearing.
(For comments regarding ILADS submission please check out the discussion topic marked “ILADS”)
The UK Says No to IDSA Lyme Guidelines
Lyme Disease Action (in the UK) filed a submission with the IDSA contesting the IDSA 2006 Lyme disease guidelines. The submission points out that the presentation of Lyme disease in the UK may be different than the presentation in the US, and the application of the guidelines in the UK lead to under-diagnosis and under-treatment of patients with Lyme disease.
The submission states:
Despite the facts that Lyme disease is caused by at least two further genospecies of Borrelia burgdorferi sensu lato in Europe than in the USA and that there are clear differences in the resulting disease presentation, the IDSA guidelines are recommended for use within Europe and specifically within the UK by the UK Health Protection Agency (HPA). Lyme Disease Action believes that the IDSA guidelines should be presented with a clear delimitation of usage to the USA and a warning that other national authorities must conduct clinical trials and develop and publish independent guidelines specific to the conditions in their own regions.
Germany Says No to IDSA Lyme Guidelines
The German Society of Lyme Borreliosis submitted its objections to the IDSA Lyme disease review panel. The society protested the application of the IDSA guidelines in Germany, emphasizing the poor lab test sensitivity, persistence of the organism, and seriousness of the illness.
The submission states:
The Deutsche Borreliose-Gesellschaft (German Society of Lyme-Borreliosis) raises objections to the IDSA Lyme Guidelines published in 2006. The fundamental basis for our objections is that the implementation of the IDSA guidelines extends beyond the United States and into Europe. Accordingly, our ability to diagnose and treat patients with Lyme disease is being severely restricted by these guidelines, and we believe that the guidelines must be revised to provide greater flexibility in the diagnosis and treatment of Lyme disease given the poor laboratory test sensitivity, the persistence of the organism despite adherence to IDSA protocols, and the seriousness of this illness.
Why was the IDSA asked to review their guidelines I hear you ask?
Here’s some snippets from a very good article – website link for full extract:
(link now broken but have kept details below for reference….
Patients’ Rights Groups Applaud Connecticut Attorney General Blumenthal’s Settlement in Anti-trust Case Against Powerful Medical Society
Attorney General’s Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter
May 1, 2008 Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America’s (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.
The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions.
Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent.
“This agreement vindicates my investigation — finding undisclosed financial interests and forcing a reassessment of IDSA guidelines,” Blumenthal said. “My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.
“The IDSA’s Lyme guideline process lacked important procedural safeguards requiring complete reevaluation of the 2006 Lyme disease guidelines — in effect a comprehensive reassessment through a new panel. The new panel will accept and analyze all evidence, including divergent opinion. An independent neutral ombudsman — expert in medical ethics and conflicts of interest, selected by both the IDSA and my office — will assess the new panel for conflicts of interests and ensure its integrity.”
Blumenthal’s findings include the following:
* The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
* Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
* The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA’s oversight committee;
* The IDSA’s 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group’s position on chronic Lyme disease to achieve “consensus”;
* The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
* The IDSA portrayed another medical association’s Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.
IDSA has reached an agreement with Blumenthal’s office calling for creation of a review panel to thoroughly scrutinize the 2006 Lyme disease guidelines and update or revise them if necessary. The panel — comprised of individuals without conflicts of interest — will comprehensively review medical and scientific evidence and hold a scientific hearing to provide a forum for additional evidence. It will then determine whether each recommendation in the 2006 Lyme disease guidelines is justified by the evidence or needs revision or updating.
IDSA announces presenters and order of presentation
The Infectious Diseases Society of America has selected presenters to speak before its Lyme disease guidelines review panel on July 30. (This is part of the guidelines review process mandated by the IDSA’s settlement with the Attorney General of Connecticut.) The speakers representing patient advocates are Tina Garcia, of the Lyme Education and Awareness Program (LEAP) and me. Three researchers that are not affiliated with either ILADS or IDSA will speak: Drs. Brian Fallon from Columbia, Ben Luft from Stony Brook, and David Volkman, previously from the National Institute of Health (NIH). The following members of ILADS will be presenting: Drs. Daniel Cameron, Ken Liegner, Steven Phillips and Raphael Stricker. In addition, Allison Delong, MS, of Brown University, and Dr. Donta, a member of IDSA, will present. Those advocating for the IDSA guidelines include Drs. Phillip Baker (President of the American Lyme Disease Foundation and previously with NIH), Barbara Johnson (Centers for Disease Control), Eugene Shapiro, Sunil Sood, Allen Steere, Art Weinstein and Gary Wormser.
Below is the final order of presenters:
1. Tina Garcia (patient advocate )
2. Lorraine Johnson (patient advocate)
3. Daniel Cameron (physician-scientist)
4. Phillip Baker (physician-scientist)
5. Ben Luft (physician-scientist)
6. Allison Delong (scientist)
7. Barbara Johnson (physician-scientist)
8. David Volkman (physician-scientist)
9. Sam Donta (physician-scientist)
10. Eugene Shapiro (physician-scientist)
11. Brian Fallon (physician-scientist)
12. Sunil Sood (physician-scientist)
13. Ken Liegner (physician-scientist)
14. Allen Steere (physician-scientist)
15. Steven Phillips (physician-scientist)
16. Art Weinstein (physician-scientist)
17. Raphael Stricker (physician-scientist)
18. Gary Wormser (physician-scientist)
On July 30, the Infectious Diseases Society of America (IDSA) will hold a one-day hearing in Washington DC to review its controversial 2006 Lyme disease treatment guidelines. The hearing will be streamed live over the internet via the IDSA website. At the same time, CALDA will provide up-to-the-minute summaries of the testimony on this new blog, along with an open discussion forum.
The hearing is part of the antitrust settlement that the Connecticut Attorney General negotiated to address “serious flaws” in the IDSA guidelines process.
Eighteen speakers–representing patients, physicians, and research scientists–will testify. The public will not be allowed into the hearing room. However, as mandated by the settlement, the proceedings will be streamed live via the IDSA website.
For anyone who missed the IDSA hearing I have typed up an 8 page summary with occasional screen shots of the day’s proceedings. If anyone is interested in a copy feel free to drop me a line!
The IDSA panel list has been revised to reflect the fact that Dr. Paul Duray has resigned from the panel. The IDSA does not post this type of information as a stand-alone announcement. Instead, they revise their prior notices. So you have to keep a close watch on their website for changes. What they did was add to his listing the following: Resigned from the Panel on October 7, 2009, due to a family illness. I am sure that everyone’s heart goes out to Dr. Duray and we wish him and his family the best during this trying time. Let’s light a candle for Dr. Duray and his family.
In terms of the panel, this means that there are now only 8 members. It seems likely this will delay the process and that a decision will not be reached by the end of December as anticipated. The IDSA has acknowledged that the decision will not occur until sometime after the new year , but the specific timeframe is unknown.
More delays in Lyme guideline revisions
The Infectious Diseases Society of America (IDSA) has missed its target date of December 31, 2009 for rendering a decision on whether it will rewrite its Lyme disease medical guidelines, which according to a group of leading Lyme disease specialists, “mislead clinicians and result in poor patient care.”
Diana Olson, IDSA VP of Communications, said that the medical evidence review panel, which has met over a dozen times in 2009, is aiming to release recommendations “as early as possible in the new year.” If a rewrite is called for, the IDSA revision would be completed in “several months to a year or more”, leaving suffering Lyme patients in treatment purgatory for four years since the scientific integrity of the guidelines was first questioned.
The reevaluation of the IDSA Lyme guidelines was driven by an antitrust investigation led by Connecticut Attorney General Richard Blumenthal. During his 17-month investigation, Blumenthal found substantial conflicts of interest among the 2006 guidelines authors, who held commercial interests in Lyme-related diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and excluded opposing views.
In December, Senator Chuck Grassley launched an investigation into the conflicts of interest of 30 other medical societies, saying in a press release, “These organizations have a lot of influence over public policy, and people rely on their leadership. There’s a strong case for disclosure and the accountability that results.”
During the 2.7 years since the IDSA Lyme guidelines investigation began, IDSA leadership has shown a consistent lack of concern, remorse or urgency in correcting possible inaccuracies and biases in the 2006 Lyme guidelines.
As soon as Blumenthal’s investigation was announced, IDSA’s conflict-riddled panel launched a far-reaching campaign to disseminate their 2006 recommendations across the U.S. medical information network through physician continuing education (CME), medical textbooks, infectious disease board certification courses, online resources, and medical school lectures. So, even if the IDSA guidelines are revised immediately, it could take a year or more to remove flawed diagnosis and treatment recommendations from the system.
Furthermore, rather than censuring the guidelines chairman, Gary Wormser, M.D., for violating the IDSA’s conflicts-of-interest policies by holding “a bias regarding the existence of chronic Lyme” and handpicking “a likeminded panel without scrutiny by or formal approval of the IDSA’s oversight committee,” the IDSA leadership awarded Wormser the IDSA’s 2007 Society Citation for being “a bold champion for rational, evidence-based medicine.”
To add insult to injury, three days after the mandated evidence hearing, which according to many observers was an evidence-based victory for Lyme patient advocates, former IDSA president Anne Gershon IDSA denied any IDSA wrongdoing, saying, “IDSA’s signing the agreement was not, as [Blumenthal] alleges, an admission of guilt, but an effort to end a fruitless investigation.”
Gershon went on to say, “The notion that the authors had financial conflicts of interest is absurd to anyone who has read the guidelines, which recommend generic tests and a short course of generic drugs.”
Lyme disease policy expert, Lorraine Johnson, J.D., M.B.A., explained why this IDSA statement is misleading: “People in the Lyme disease community know that conflicts of interest were a big issue in the Lyme vaccine. We also know that the narrow disease definitions that suited the vaccine trials the best, hurt patients by denying and delaying diagnosis to patients with Lyme.”
Johnson provided details on the author conflicts in a recent article in the Journal of Medical Ethics:
“The most influential panelists on the IDSA guidelines panel had commercial interests related to Lyme vaccines, diagnostic tests, and insurance. Some of the panelists had been involved in the development of the first Lyme vaccines—had run the clinical trials for these vaccines–vaccines which were withdrawn from the market after patients reported serious neurologic side effects. Some had been sued as part of a class action lawsuit or served as expert witnesses for the vaccine manufacturer. Some of the panelists acknowledged they owned Lyme diagnostic tests or were working on the second generation of Lyme vaccines, which are still under development.”
In the meantime, as the number of U.S. Lyme cases grows by about 30% per year, Lyme patients are trapped between a broken health care system and biased medical guidelines that are being used by insurance companies to deny treatment.
Here’s to hoping that Senator Grassley and CT Attorney General Blumenthal (who is now running for the Senate) will put some legislative teeth into making “non-profit” medical societies like the IDSA more accountable for patient welfare and less beholden to vaccine and drug manufacturers.
Photo caption: At the July 30, 2009 Lyme evidence hearing, ILADs submitted 300 pages of analysis and 1,300 pages of peer-reviewed research contesting the IDSA Lyme Guidelines recommendations.
For an overview of the Lyme controversy, watch the UNDER OUR SKIN trailer:
For a detailed timeline of the IDSA Lyme Guidelines investigation:
IDSA Violates Settlement Agreement Voting Procedures
During an antitrust investigation of the IDSA guidelines development process for the 2006 Lyme disease treatment guidelines, AG Blumenthal’s office uncovered significant procedural deficiencies, including conflicts of interests of the panel members. A settlement was reached, and the IDSA is breaching it. The IDSA is manipulating the voting process to favor no change in the guidelines. The AG has sent the IDSA a letter requesting that they redo the vote in compliance with the agreement.
On Monday, February 1, 2010, the Connecticut Attorney General 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. 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.
More can be found at CALDA:
Review Panel Says Lyme Treatment Guidelines Don’t Need To Change
By ARIELLE LEVIN BECKER The Hartford Courant
April 23, 2010
The Infectious Diseases Society of America will continue to recommend short-term antibiotic treatment for Lyme disease and advise against long-term antibiotic therapy for people with lingering symptoms.
A review panel, established under an agreement with Connecticut Attorney General Richard Blumenthal, decided after more than a year of study to support the society’s existing, and controversial, guidelines.
“In the case of Lyme disease, there has yet to be a single high-quality clinical study that demonstrates comparable benefit to prolonging antibiotic therapy beyond one month,” the panel said in its report, released Thursday. “[I]n the case of Lyme disease, inherent risks of long-term antibiotic therapy were not justified by clinical benefit.”
The report also noted that “there is no convincing biologic evidence” of the existence of chronic Lyme disease.
Since they were developed in 2006, the society’s guidelines have drawn criticism from people who believe Lyme disease can be a chronic condition that may require long-term antibiotic treatment.
Blumenthal also raised concerns after finding that some members of the panel that originally developed the guidelines had conflicts of interest, such as financial stakes in companies involved in Lyme disease tests or treatments.
Representatives of the infectious diseases society said the panelists had nothing to gain by recommending short-term treatment. But under an agreement with Blumenthal, they consented to a special review of the guidelines.
In a written statement, Blumenthal said his office was reviewing the report. “We will carefully and comprehensively assess the final report and the review process leading to that report to determine whether the IDSA fulfilled the requirements of our settlement,” he said.
The findings are unlikely to end the controversy over Lyme disease. Even before the report was released Thursday, some chronic Lyme advocates raised concerns about the process, including the composition of the review panel, which did not include any doctors who earned more than $10,000 a year treating Lyme disease.
Dr. Daniel Cameron, the immediate past president of the International Lyme and Associated Diseases Society, which acknowledges the existence of chronic Lyme disease, said he was disappointed but not surprised. Insurance companies may use the guidelines to deny coverage for long-term treatment, he said, but doctors will continue to see patients with chronic problems that require treatment.
“I don’t think the IDSA is going to continue to offer much leadership in terms of solving the chronic Lyme disease problem,” he said. “I don’t see them welcoming the challenges of somebody that’s been sick for months or years.”
Dr. Carol J. Baker, the review panel chairwoman and a pediatric infectious diseases specialist at Baylor College of Medicine in Houston, said panel members had “tremendous compassion” for Lyme disease patients who said they had chronic cases.
But she said the panel was concerned about the safety of some treatments, including extended antibiotic therapy, which can go on for years and may be delivered through an intravenous catheter. That approach can involve considerable costs, she said, and leave a patient susceptible to bloodstream infections from the catheter.
“We don’t want our patients to be exposed to those kinds of risks when there was no credible medical or scientific evidence that these kinds of therapies improved their illness,” she said.
Copyright © 2010, The Hartford Courant
A list of some possible changes in the next IDSA review!
Review Panel Vote on Overall Guidelines (April 2010)
Based on its review of all the evidence and information provided, the Review Panel determined that no changes to the 2006 Lyme disease guideline are necessary at this time (8-0).
The Review Panel suggests consideration of the following when the 2006 Lyme Guidelines are next updated:
* Expansion of the background section to include an overview of the currently available diagnostic tests for Lyme disease, including the advantages and limitations of the currently recommended 2-tier serological tests. Formal recommendations about the utility and appropriate use of alternative tests should be added, with accompanying discussion and references. Such alternative tests should include the following:
o Cerebrospinal fluid (CSF) serology
o PCR of blood, CSF, and synovial fluid
o Serum C6 peptide
o Inclusion of the VIsE band in the IgG Western blot
* A discussion of the effect of antibiotic exposure (particularly for patients previously treated with suboptimal regimens) on the development or persistence of seropositivity.
* Directly addressing whether some patients with late Lyme disease may be seronegative before treatment.
* A discussion of the Southern Tick-Associated Rash Illness (STARI), how its geographic distribution compares with that of human Lyme disease cases, and recommendations as to how an EM-like rash should be managed in geographic areas where STARI has been described.
* A discussion about non-antimicrobial modalities that have been explored for patients who attribute chronic symptoms to persistent Lyme disease.
ILADS response to the IDSA:
Lyme Disease Action’s response to the IDSA:
The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about development of clinical practice guidelines
Lorraine Johnson and Raphael B. Stricker
Published: 9 June 2010
Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.
For full PDF paper go to http://www.peh-med.com/content/5/1/9
TOUCHED BY LYME: Those controlled studies cited by the IDSA Lyme guidelines included only 221 patients
The Institute of Medicine, part of the National Academy of Sciences, is examining the “state of the science” regarding Lyme disease. In April (2010), the IOM heard from various scientists. Recently, the IOM committee held the second of several “listening sessions” via telephone conference call, which allowed Lyme patients and advocates to give input.
Lyme Times Associate Editor Pam Cocks, the mother of two adult children with Lyme, points out that all of the controlled trials cited by the IDSA guidelines involved a mere 221 patients.
My name is Pam Cocks. I have a Masters of Library Science and a Masters of Public Health. I have worked in health policy and planning, and served many years on a children’s hospital board during which time I chaired the Quality Assurance Committee. I serve as associate editor of the Lyme Times, the quarterly journal of CALDA (the California Lyme Disease Association).
To read more go to:
TOUCHED BY LYME:
“Under Our Skin” producer says cronyism and conflicts of interest have stymied Lyme research (21 June, 2010)
Kris Newby, senior producer of the awarding-winning Lyme disease documentary, recently addressed the Institute of Medicine’s listening session for “The State of the Science” of Lyme and other tick-borne infections. She observed that Lyme research has been tightly controlled by the same lead IDSA Lyme guidelines authors for the last 20 years–while we still have no reliable testing and no effective treatments for patients who fail the IDSA protocols.
The Institute of Medicine, part of the National Academy of Sciences, is examining the “state of the science” regarding Lyme disease. In April, the IOM heard from various scientists. Recently, the IOM committee held the second of several “listening sessions” via telephone conference call, which allowed Lyme patients and advocates to give input.
What follows are remarks from Open Eye Pictures Senior Producer Kris Newby.
My name is Kris Newby, and I’m the Senior Producer of the award-winning documentary on Lyme disease, UNDER OUR SKIN. I am a science writer by profession, with a BS in engineering/premed from the Univ. of Utah and a Masters in engineering from Stanford.
While filming UNDER OUR SKIN, I spent four years trying to understand how and why Lyme disease research went off track. My investigation involved hundreds of interviews with researchers, clinicians and patients, as well as an extensive analysis of grants and the conflicts of interest of the researchers receiving those grants.
In my three-minute slot, I’ll suggest some science areas for the committee to pursue as it sets the course for research.
But first, I’d like to start off with a quote from Dr. Willy Burgdorfer, the NIH Scientist Emeritus who discovered the organism behind Lyme disease. While we were filming at his home in Hamilton, Montana, he told our film crew:
“The controversy in the Lyme disease research is a shameful affair, and I say that because the whole thing is politically tainted. Money goes to people who have for the past 30 years produced the same thing — nothing.”
I believe the top priority of this committee should be to enlist a greater diversity of researchers and Lyme-treating clinicians to help set research priorities.
Lyme disease serves as an excellent case study on how cronyism and conflicts of interest can lead to stagnation in medical research.
This research has been tightly controlled by the same lead IDSA Lyme guidelines authors for the last two decades.
Collectively, their university labs have received over $130 million dollars in government grants since 1990. Over half of these grants have gone to only two universities, New York Medical College and Yale, and a disproportionate amount of the grants have been used to support these researchers’ personal interests in tick-borne disease vaccines and tests. For example, New York Medical College researchers alone have founded 5 test/vaccine companies in the last few years.
Looking at the state of Lyme disease today, 20 years later, we still have no reliable testing and no effective treatments for the large percentage of Lyme patients who fail the IDSA protocols.
So, for your workshop on Lyme science, I say you urgently need to bring new ideas to the table, by enlisting the following researchers:
Dr. John Aucott of Johns Hopkins, who is identifying early Lyme disease serum markers to help develop tests that will work during the first month of infection.
Dr. Ben Luft of Stony Brook, who is working to identify which Lyme strains are the most virulent in different geographic regions, because our current FDA-approved Lyme tests only look for one of 120 known strains.
Dr. Eva Sapi of the University of New Haven, who is investigating the role of biofilms in allowing Borrelia to create persistent illness.
Dr. Karen Newell of Texas A&M, who is working on a novel genomic strategy for overriding Lyme’s ability to disrupt the immune system.
Dr. Brian Fallon of Columbia University, who is developing new criteria for diagnosing late Lyme.
Dr. Cheryl Koopman of Stanford University, who is working to define symptom clusters to aid in the diagnosis of Lyme disease.
And finally, I feel it’s important to get input from the many community-based Lyme clinicians who are on the bleeding edge of treating the chronic manifestations of the disease.
Thank you for listening.
Patent by IDSA author: Treatment is often delayed due to improper diagnosis with the deleterious effect that the infection proceeds to a chronic condition, where treatment with antibiotics is often not useful. One of the factors contributing to delayed treatment is the lack of effective diagnostic tools.
Link to Patent:
Persistence & seronegativity:
Are the IDSA correct in saying chronic Lyme doesn’t exist? Click here to find out!
IDSA authors become editorial panel on new Tick-Borne Disease Journal
What are we to make of the recently launched journal “Ticks and Tick-Borne Diseases” that includes on its editorial board five members of the IDSA Lyme guidelines panel? Dr. Wormser, who chaired the IDSA Lyme guidelines panel, is an associate editor of the journal. Do you think that they might have a bias or might exclude others points of view? If so, is this peer review or is it censorship?
The Ticks and Tick-Borne Diseases was just recently launched. All told the following IDSA Lyme guidelines panelists serve in editorial functions for the journal:
Dr. G. Wormser (Associate Editor) Previous Chair of the IDSA Lyme guidelines panel
Dr. D. Fish (Editorial Board)
G. Stanek (Editorial Board)
Dr. A. Steere (Editorial Board)
Dr. F. Strle (Associate Editor)
To learn more go to:
Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines
Dong Heun Lee, MD; Ole Vielemeyer, MD
Arch Intern Med. 2011;171(1):18-22. doi:10.1001/archinternmed.2010.482
Background Clinical practice guidelines are developed to assist in patient care. Physicians may assume that following such guidelines means practicing evidence-based medicine. However, the quality of supporting literature can vary greatly.
Methods We analyzed the strength of recommendation and overall quality of evidence behind 41 Infectious Diseases Society of America (IDSA) guidelines released between January 1994 and May 2010. Individual recommendations were classified based on their strength of recommendation (levels A through C) and quality of evidence (levels I through III). Guidelines not following this format were excluded from further analysis. Evolution of IDSA guidelines was assessed by comparing 5 recently updated guidelines with their earlier versions.
Results In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I (≥1 randomized controlled trial) and 37% were based on expert opinion only (level III). Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence.
Conclusions More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.