Petition Closed

End Preferential Treatment of the IDSA Guidelines for Lyme Disease

This petition has been superseded by the new petition: Enact Rule to End Preferential Treatment of IDSA Guidelines for Lyme Disease

Click here to sign: https://www.change.org/p/cdc-enact-rule-to-end-preferential-treatment-of-idsa-guidelines-for-lyme-disease

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Citizen Petition to the Centers for Disease Control and Prevention, Bacterial Diseases Branch

Pursuant to the Administrative Procedure Act, 5 USC § 552, the Patient Centered Care Advocacy Group, a patient advocacy organization with members and supporters throughout the United States, and the undersigned individuals petition the Centers for Disease Control and Prevention Bacterial Diseases Branch to end preferential treatment it provides to the Infectious Diseases Society of America (IDSA) by endorsing and promoting IDSA’s guidelines for The Clinical Assessment, Treatment, and Prevention of Lyme Disease...

Background
The Centers for Disease Control and the Infectious Diseases Society of America worked closely to develop the IDSA guidelines for Lyme disease. These guidelines are contested by large numbers of physicians, scientists, patient advocates, and lawmakers, who maintain the IDSA guidelines misrepresent science and restrict access to care for patients with chronic illness. Despite these and other critical flaws, CDC continues to endorse and promote the IDSA guidelines, extending preferential treatment to them, while omitting information about guidelines for Lyme disease that contain information on evidence-based treatments that could improve the health of thousands of chronically ill patients throughout the world. In addition to causing harm to patients, CDC’s preferential treatment and participation in clandestine advisory meetings with authors of the IDSA guidelines violates federal law.

I Actions Requested
1. Remove references the IDSA guidelines for Lyme disease from all CDC published material, including CDC’s website and all printed publications.

2. Dispose of all material in CDC’s possession that promotes or endorses the IDSA guidelines for Lyme disease.

3. Because of ongoing harm, expedite the response to this petition and reply within 30 days.

II Statement of Grounds
The Centers for Disease Control and Prevention extends preferential treatment to the Infectious Disease Society of America (IDSA) by endorsing and promoting IDSA’s guidelines for diagnosis and treatment of Lyme disease, while failing to provide equivalent exposure for competing guidelines from the International Lyme and Associated Disease Society (ILADS).

1. CDC acknowledges preferential treatment of IDSA guidelines
In at least two places on the CDC website, in at least five printed brochures, and in at least one book, Tick-borne Diseases of the United States, CDC provides references to the 2006 IDSA guidelines for Lyme disease, which are almost a decade out of date and are non compliant with federal standards, while providing no mention about the 2014 ILADS evidence-based guidelines for Lyme, which are based on the best available science and are compliant with current standards.

CDC’s rule regarding the IDSA guidelines is published in the following statement on the CDC website, in answer to the question: “Why does CDC only link to one set of treatment guidelines?”

“CDC believes that the Infectious Disease Society of America (IDSA) guidelines currently represent the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease. The IDSA, with input from CDC experts and other doctors, has developed and published Lyme disease treatment guidelines.”

How can these outdated, critically flawed guidelines represent the best available synthesis of the medical literature?

2. CDC’s preferential treatment violates the law
CDC’s preferential treatment of IDSA violates the federal law that governs the conduct of Executive Branch employees:

“Employees shall act impartially and not give preferential treatment to any private organization or individual.”

“Employees shall endeavor to avoid any actions creating the appearance that they are violating the law or the ethical standards set forth in this part. Whether particular circumstances create an appearance that the law or these standards have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts.”

Why is the CDC giving favorable treatment to guidelines from IDSA that are a decade out of date and noncompliant with current standards, while excluding mention of the more current and fully compliant guidelines from ILADS?

3. CDC is promoting critically flawed guidelines
Since they were first published in 2000, the IDSA guidelines for Lyme disease have been the subject of intense controversy, including an antitrust investigation by the state of Connecticut and hundreds of protests.

The view enforced by IDSA is that Lyme disease is easy to diagnose and simple to treat with a limited course of antibiotics. The IDSA guidelines are followed by many physicians and used by insurers to determine limits on coverage.

The alternative paradigm, represented by the International Lyme and Associated Diseases Society (ILADS), maintains that Lyme disease is a serious national medical problem of epidemic proportion that needs to be researched, diagnosed, and treated aggressively and often requires long-term treatment beyond the limits set by IDSA.

Both guidelines are listed by the National Guidelines Clearinghouse, although only the ILADS guidelines comply with the Institute of Medicine (IOM) Standards for Developing Trustworthy Clinical Practice Guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group system for rating the quality of evidence and strength of recommendations.

There are now hundreds of peer-reviewed articles that support the ILADS position. Culture confirmed cases of persistent infection in humans after short term antibiotic treatment show that chronic Lyme disease is a very real and widespread problem.

One of the earliest cases of chronic Lyme was confirmed by a CDC laboratory that cultured Lyme bacteria from cerebrospinal fluid obtained from patient Vicki Logan, who had undergone intensive antibiotic treatment and ultimately died from the disease after treatment was suspended.

According to remarks at the 2013 World Wide Lyme Rally by Kenneth Liegner, MD, who treated Logan, “In 1991 the Lyme disease organism, Borrelia burgdorferi, was grown from the cerebrospinal fluid of my patient Vicki Logan at the Centers for Disease Control in Fort Collins, Colorado despite prior treatment with intravenous antibiotics.”

The April 2013 article Review of Evidence for Immune Evasion and Persistent Infection in Lyme Disease describes how Lyme can evade the immune system and survive antibiotic treatment. Mechanisms include varying its outer surface proteins to confuse the immune system and participating in biofilm communities, which protect it from antibiotics.

Pathologist Alan MacDonald, Eva Sapi and other researchers have documented biofilms of Lyme bacteria, both in the lab and in human tissue. The presence of Lyme biofilms was confirmed by atomic force microscopy and DNA probes.

A serious issue with the IDSA guidelines is the requirement that a positive test result be achieved prior to issuing a Lyme diagnosis unless other objective symptoms, such as the bulls eye rash, are present.

There is plenty of evidence that large numbers of patients never see a rash. At least eight peer-reviewed studies that show the CDC endorsed two-tier test for Lyme disease misses more than half the cases.

In a 2010 report by Dr. John Aucott of Johns Hopkins the CDC endorsed test missed 50 percent of men and 68 percent of women. Aucott’s study was based on objective information from patients who were confirmed to have Lyme by the current CDC criteria.

The poor performance of the tests is partly explained by the concept of “Seronegative Lyme,” which means some patients with active infections do not produce detectable antibodies to Lyme, even in the late stages of the disease.

Another major limitation of the two-tier test is CDC’s restrictive definition of Lyme disease. The CDC criteria does not cover all strains of Lyme and excludes the OspA and OspB (outer surface proteins) “bands” specific to Lyme, which were omitted to keep the failed LYMErix vaccine from generating false positive test results. The CDC also discourages testing and acceptance of positive results in areas it currently considers non-endemic, despite the lack of data or data collection effort in those areas.

CDC officials have made conflicting statements regarding the test. In a September 2014 letter to the Wall Street Journal, Paul Mead said “The two-step testing process recommended by CDC is accurate and was developed specifically to aid in diagnosing patients suspected of having Lyme disease.” This directly conflicts with Dr. Mead’s 2004 testimony before the Connecticut Department of Public Health.

Why does the CDC continue to defend the IDSA’s view of Lyme disease as an acute bacterial infection curable with short term antibiotics, when the preponderance of the evidence shows that position to be wrong? Why does the CDC continue to defend and promote a test that misses more than half the cases?

4. CDC’s preferential treatment harms patients
CDC’s preferential treatment of IDSA adversely impacts the health of thousands of chronically ill patients who are harmed by misdiagnosis and denial of medically necessary treatment because of restrictions imposed by the IDSA guidelines.

CDC’s failure to provide equivalent exposure for the ILADS guidelines compounds the harm by limiting access to information about evidence-based treatments that could help these severely ill patients recover from this devastating disease.

In addition to the harm to patients’ health, CDC’s actions and omissions contribute to the financial hardships of patients who must pay out of pocket for medically necessary treatment because of the CDC’s preferential treatment of the IDSA guidelines.

IDSA emphasizes the guidelines are voluntary, but CDC’s endorsement is effectively an official seal of approval, so many physicians feel compelled to comply and insurance companies are supported in refusing to cover non-IDSA compliant care.

In a July 2015 article, Centers for Disease Control and Prevention: Protecting the Private Good? in the BMJ, Marcia Angell, former editor in chief of the New England Journal of Medicine, said “The CDC’s image as an independent watchdog over the public health has given it enormous prestige, and its recommendations are occasionally enforced by law. Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes, and the money it is taking.”

5. CDC participation in clandestine meetings of the Ad Hoc group violates FACA
The Ad Hoc International Lyme Disease Group was formed in 2005 by CDC and NIH employees and 14 authors of the IDSA guidelines who, according to patient advocacy groups, have been engaged in an organized propaganda campaign to discredit research that contradicts the IDSA’s position that Lyme disease is hard to catch and easy to treat.

CDC emails released in 2012, in response to a Freedom of Information Act (FOIA) request by science writer Kris Newby for the award winning documentary Under Our Skin, provide evidence the Ad Hoc Group has been covertly setting government policy on Lyme in violation of federal law.

According to Congressional testimony by Lorraine Johnson, JD, MBA of LymeDisease.org, who reviewed the emails, the Ad Hoc Group “composed of members of the Infectious Diseases Society of America (IDSA), a medical specialty society, along with members of the Centers for Disease Control & Prevention (CDC) and the National Institutes of Health (NIH), has been acting in violation of fundamental principles of ethics. This group has been covertly setting government Lyme policy, intentionally excluding other stakeholders, running afoul of government open meeting standards, and deliberately subordinating the public interests to those of a private medical society.”

According to Dr. Susan O’Connell of Britain’s National Health Service, who is a founding member of the Ad Hoc group, the goal of the group was to “counteract misinformation from groups such as ILADS, unorthodox laboratories and support groups.”

The CDC emails show that a clandestine conference of the Ad Hoc group was held in May 2005 at Westchester County Medical Center in Valhalla, NY.

According to Johnson’s testimony:

“No public notice was given and the meeting was clandestine. The participant list for the meeting, chaired by Dr. Wormser included principally IDSA researchers and CDC employees…”

Attendees included IDSA guidelines panelists Mario E. Aguero-Rosenfeld, Paul G. Auwaerter, Johan S. Bakken, Linda K. Bockenstedt, Raymond J. Dattwyler, J. Stephen Dumler, Durland Fish, John J. Halperin, Mark S. Kempler, Peter J. Krause, Robert B. Nadelman, Eugene D. Shapiro, Sunil K. Sood, Gerold Stanek, Allen C. Steere, Franc Strle, and CDC employees Barbara J.B. Johnson and Paul Mead.

According to Johnson: the Ad Hoc group, “which subsequently added two members of the NIH, Drs. Philip Baker and Edward McSweegan, to its membership ranks, proceeded to work on IDSA projects and government policy projects regarding Lyme disease. A second clandestine meeting, also chaired by Dr. Wormser, was held on January 15th and 16th, 2007 at Westchester Medical Center.”

The participation of CDC and NIH employees in clandestine meetings of the Ad Hoc group violates The Federal Advisory Committee Act (FACA), public law 92-463, which governs the “creation and operations of advisory committees in the executive branch of the Federal Government.”

According to the General Services Administration (GSA) Office of Governmentwide Policy, “Any advisory group, with limited exceptions, that is established or utilized by a federal agency and that has at least one member who is not a federal employee, must comply with the FACA.”

Sec. 10 (a) of FACA states that “Each advisory committee meeting shall be open to the public,” and “records, transcripts, minutes, appendixes, working paper, drafts, studies, agenda, of other documents shall be available for public inspection.”

Other than documents obtained via FOIA, no records have been made available for public inspection.

6. CDC’s preferential treatment violates CDC policy on scientific integrity
The CDC has high standards for scientific integrity that are described by the publication CDC Guidance on Scientific Integrity by the Office of the Associate Director of Science (OADS).

OADS “establishes and promotes standards for internal scientific clearance and evidence-based guidelines to ensure that all scientific products authored by CDC staff members or published by CDC and released for public use are of the highest quality and are scientifically sound, technically accurate, and useful to the intended audience.”

This is clearly not the case with IDSA’s guidelines, which are based primarily on expert opinion and low quality evidence, and are non compliant with the IOM standards and GRADE.

The Office of Management and Budget publication Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies states: “…if an agency, an institution disseminates information prepared by an outside party that reasonably suggests that the agency agrees with the information, this appearance of having the information represent agency views makes agency dissemination of the information subject to these guidelines.”

Rather than helping patients and physicians make better informed decisions, CDC is publishing, distributing, endorsing and promoting information that harms patients by restricting access to care, while omitting information on evidence-based treatments that could help these patients restore their health.

CDC’s Guidance on Scientific Integrity states that:

“In accordance with CDC policy for Peer Review or Research and Scientific Programs, CDC research and science programs will be subject to periodic, independent, external peer reviews, which address quality, integrity, direction, and impact, and help ensure informed decisions and effective public health research and programs.”

CDC’s Guidance on Scientific Integrity further points out that OMB:

 “...requires peer review for influential scientific information publications before they are disseminated to the public (OMB Final Information Quality Bulletin for Peer Review). Issues that must be considered include transparency of the review process, conflicts of interest, and appropriateness and independence of reviewers.

It’s time for an independent, external peer review of CDC’s science program for Lyme disease.

7. The dissemination of incomplete, inaccurate and biased information violates HHS and CDC information quality guidelines
CDC’s Pledge to the American People includes the commitment to: “Base all public health decisions on the highest quality scientific data that is derived openly and objectively.”

CDC’s endorsement and promotion of the IDSA guidelines directly conflicts with required practices regarding the quality, objectivity, utility, and integrity of information disseminated by federal agencies.

According to the Department of Health and Human Services (HHS) Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public:

“It is CDC’s policy to ensure and maximize the quality, objectivity, utility, and integrity of information that it disseminates to the public. We strive to provide information that is accurate, reliable, clear, complete, unbiased, and useful”

 “To the degree that the agency action is based on science, the agency shall use … the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices...”

Instead, CDC is ignoring the best available peer-reviewed science and disseminating incomplete, heavily biased, and inaccurate information.

8. Serious conflicts of interest influence CDC policy on Lyme
CDC is allowing IDSA, a private organization, to determine federal policy on Lyme disease, and endorsing critically flawed guidelines that have been adversely influenced by well-documented conflicts of interest and biases.

In testimony for an August 1993 Senate oversight hearing, Lyme Disease: A Diagnostic and Treatment Dilemma, Dr, Joseph J. Burrascano, Jr., MD, described the issue in detail:

“There is a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight. Unfortunately many of them act unscientifically and unethically. They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. They exert strong ethically questionable influence on medical journals, which enables them to publish and promote articles that are badly flawed. They work with government agencies to bias the agenda of consensus meetings, and have worked to exclude from these meetings and scientific seminars those with alternate opinions. They behave this way for reasons of personal or professional gain, and are involved in obvious conflicts of interest.

This group promotes the idea that Lyme is a simple, rare illness that is easy to avoid, difficult to acquire, simple to diagnose, and easily treated and cured with 30 days or less of antibiotics.

The truth is that Lyme is the fastest growing infectious illness in this country after AIDS, with a cost to society measured in the billions of dollars. It can be acquired by anyone who goes outdoors, very often goes undiagnosed for months, years, or forever in some patients, and can render a patient chronically ill and even totally disabled despite what this core group refers to as ‘adequate’ therapy. There have been deaths from Lyme disease.

They feel that when the patient fails to respond to their treatment regimens it is because the patient developed what they named ‘the post Lyme syndrome’. They claim that this is not an infectious problem, but a rheumatologic or arthritic malady due to activation of the immune system.”

In 2008 Connecticut Attorney General Richard Blumenthal, now a U.S. Senator (D-Conn), conducted an antitrust investigation of IDSA based on allegations of abuses of monopoly power and exclusionary conduct. In a May 2008 press release, Blumenthal said:

“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.”

The IDSA guidelines are now up for revision and the health of thousands of chronically ill patients depends on IDSA getting it right this time around. Patients and advocates are gravely concerned that given CDC and IDSA’s track record and the makeup of the review panel, history will be repeated and untold numbers of Lyme patients will continue to suffer unnecessarily from injury and death.

In the March 2015 announcement of a project plan to update the Lyme guidelines, IDSA said “… the societies will make every effort to develop the guideline in accordance with the Standards for Developing Trustworthy Clinical Practice Guidelines developed by the Institute of Medicine …”

The IOM publication Conflict of Interest in Medical Research, Education, and Practice defined COI as “set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” (IOM, 2009, p. 46). The report explains that COIs can be financial, intellectual, or institutional.

Intellectual COIs specific to clinical practice guidelines, such as the IDSA guidelines for Lyme disease, are defined as “academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual’s judgment about a specific recommendation (Guyatt et al., 2010, p. 739).”

The same IOM publication states that “Intellectual COI also includes authoring a publication or acting as an investigator on a peer-reviewed grant directly related to recommendations under consideration.”

Members of the current guidelines review panel with significant intellectual conflicts of interests, according to the IOM criteria, include: Linda K. Bockenstedt, John J. Halperin, Peter J. Krause, Paul M. Lantos, Allen C. Steere, Franc Strle, and Gary P. Wormser. All were chosen for expertise on Lyme disease and have staked their reputations on the IDSA position that Lyme disease is hard to catch and easy to treat with short term antibiotics.

All of the above mentioned individuals have authored publications that are likely to be included in the systematic review of literature to determine recommendations under consideration in the updated IDSA guidelines.

In its unilateral support of the IDSA guidelines as the sole standard of care for Lyme disease, the CDC has elevated the guidelines to the status of national healthcare policy.

Why does the CDC, a public agency tasked with protecting the health of US taxpayers, promulgate the IDSA guidelines as policy, particularly when it can be demonstrated that the guidelines authors disallow, ignore, or reject a very large body of scientific evidence that contradicts their narrow view of this disease?

9. CDC has failed in its duty to protect the public health
The Centers for Disease Control and Prevention is responsible for promoting the “health and quality of life by preventing and controlling disease, injury, and disability.”

In testimony before Connecticut Department of Public Health and the Connecticut Attorney General’s Office in 2004, Dr. Paul Mead, chief of epidemiology and surveillance for the CDC’s Lyme disease program, outlined a strategy to address the rapidly growing epidemic of Lyme disease. Dr. Mead’s testimony included plans to improve awareness, prevention, diagnostics and treatment.

By all accounts CDC has failed miserably in these key areas.

Lyme disease continues to rapidly spread, with a 320% increase in the number of high risk counties from 1992 to 2012. The number of new cases annually acknowledged by CDC has increased dramatically from just 10,000 in 1995 to more than 300,000 in 2013 when CDC updated its figures to reflect new studies. Treatment regimens endorsed by CDC and IDSA leave up to 36 percent with persistent symptoms.

Even CDC’s pledge to develop a safe, effective vaccine has not been fulfilled. The only vaccine that made it to the market, LYMErix, was withdrawn after a flood of lawsuits because of adverse events.

Despite abundant evidence that Lyme disease can persist despite short term antibiotic treatment, CDC clings to the IDSA position that Lyme is difficult to catch and easy treat with 2 – 4 weeks of antibiotics.

CDC has had 40 years to address this epidemic. It’s now 22 years after the 1993 Senate hearing and 11 years after Dr. Mead’s 2004 testimony. The limited progress made has been  significantly outpaced by the harm to patients from CDC’s preferential treatment of the critically flawed IDSA guidelines.

10. Economic impact
A 2015 study published by the Johns Hopkins Bloomberg School of Public Health shows that Lyme disease costs up to $1.3 billion per year to treat. The study says the “prolonged impact of the tick-borne illness in some patients is greater and more widespread than previously understood.”

The researchers found that, “on average, people with Lyme disease cost the system $2,968 more than matched controls. They had 87 percent more visits to the doctor and 71 percent more visits to the emergency room within the year following diagnosis.”

The true economic impact is difficult to accurately estimate, but CDC’s preferential treatment could be costing our economy hundreds of millions in increased health care and disability costs, in addition to contributing to the injury and lost income of thousands of chronically ill patients who are discriminated against because of CDC’s actions and omissions. Those who cannot afford to pay out of pocket for treatment beyond the IDSA recommended treatment regimen are particularly discriminated against because insurance companies, citing the CDC Lyme treatment recommendations, refuse to pay.

11. Information adverse to petition
The IDSA guidelines for Lyme disease are in the process of being updated. IDSA has agreed to provide a period for public comment before the new guidelines are published.

There have been no indications from IDSA indicating that any significant changes will be considered in the new guidelines revision. To the contrary, the IDSA and some of the panelists have recently published a book and several articles that strongly suggest the past IDSA position on the diagnosis and treatment of Lyme disease will not change.

Even if the new guidelines reflect current science and are fully compliant with federal standards, preferential treatment would still be illegal. In the interim, the preferential treatment is much more serious, because of the harm to large numbers of patients.

III Timely Action Required
We insist that CDC respond to this petition in a timely manner as required by law. The harm to patients from the preferential treatment of IDSA has gone on far too long.

Appendix A – Joseph Burrascano Senate Testimony

Oversight Hearing
Lyme Disease: A Diagnostic and Treatment Dilemma
Senate Committee on Labor and Human Resources
August 5, 1993
430 Dirksen, 10:00 AM to 12:00 PM

Testimony of Joseph J. Burrascano, Jr., M.D.

There is a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight. Unfortunately many of them act unscientifically and unethically. They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. They exert strong ethically questionable influence on medical journals, which enables them to publish and promote articles that are badly flawed. They work with government agencies to bias the agenda of consensus meetings, and have worked to exclude from these meetings and scientific seminars those with alternate opinions. They behave this way for reasons of personal or professional gain, and are involved in obvious conflicts of interest.

This group promotes the idea that Lyme is a simple, rare illness that is easy to avoid, difficult to acquire, simple to diagnose, and easily treated and cured with 30 days or less of antibiotics.

The truth is that Lyme is the fastest growing infectious illness in this country after AIDS, with a cost to society measured in the billions of dollars. It can be acquired by anyone who goes outdoors, very often goes undiagnosed for months, years, or forever in some patients, and can render a patient chronically ill and even totally disabled despite what this core group refers to as "adequate" therapy. There have been deaths from Lyme disease.

They feel that when the patient fails to respond to their treatment regimens it is because the patient developed what they named "the post Lyme syndrome". They claim that this is not an infectious problem, but a rheumatologic or arthritic malady due to activation of the immune system.

The fact is, this cannot be related to any consistent abnormality other than persistent infection. As further proof, vaccinated animals whose immune system has been activated by Lyme have never developed this syndrome. On the other hand, there is proof that persistent infection can exist in these patients because the one month treatment did not eradicate the infection.

Indeed, many chronically ill patients, whom these physicians dismissed, have gone on to respond positively and even recover, when additional antibiotics are given.

It is interesting that these individuals who promote this so called "post-Lyme syndrome" as a form of arthritis, depend on funding from arthritis groups and agencies to earn their livelihood. Some of them are known to have received large consulting fees from insurance companies to advise them to curtail coverage for any antibiotic therapy beyond this arbitrary 30 day cutoff, even if the patient will suffer. This is despite the fact that additional therapy may be beneficial, and despite the fact that such practices never occur in treating other diseases.

Following the lead of this group of physicians, a few state health departments have even begun to investigate, in a very threatening way, physicians who have more liberal views on Lyme disease diagnosis and treatment than they do. Indeed, I must confess that I feel that I am taking a large personal risk here today by publicly stating these views, for fear that I may suffer some negative repercussions, despite the fact that many hundreds of physicians and many thousands of patients all over the world agree with what I am saying here. Because of this bias by this inner circle, Lyme disease is both underdiagnosed and undertreated, to the great detriment to many of our citizens. Let me address these points in more detail.

UNDERDIAGNOSIS
1. Under reporting: The current reporting criteria for Lyme are inadequate and miss an estimated 30 to 50% of patients. Some states curtailed their active surveillance programs and saw an artificial drop in reported cases of nearly 40%, leading the uninformed to believe incorrectly that the number of new cases of Lyme is on the decline. The reporting procedure is often so cumbersome, many physicians never bother to report cases. Some physicians have found themselves the target of state health department investigators. Finally, to many physicians and government agents rely on the notoriously unreliable serologic blood test to confirm the diagnosis.

2. Poor Lyme disease diagnostic testing: It is very well-known that the serologic blood test for Lyme is insensitive, inaccurate, not standardized, and misses up to 40 percent of cases, yet many physicians, including many of those referred to above, and the senior staff at CDC and NIH, insist that if the blood test is negative, then the patient could not possibly have Lyme. This view is not supported by the facts. Lyme is diagnosed clinically, and can exist even when the blood test is negative.

The Rocky Mountain Lab of the NIH, which is the country's best government laboratory for Lyme research had developed an excellent diagnostic test for this illness nearly 4 years ago, yet further work on it has been stalled due to lack of funding. Incredibly, if not for private donations of just $5,000 from the non-profit National Lyme Disease Foundation headquartered in Connecticut, then this research would have had to be abandoned. An additional $30,000 was donated by this organization to allow them to continue other valuable projects relating to vaccine development and disease pathogenesis. Yet, many physicians believe that thousands of dollars of grant moneys awarded by the government to other, outside researchers is poorly directed, supporting work of low relevance and low priority to those sick with Lyme. In spite of this, their funding continues, and the Rocky Mountain Lab is still underfunded.

3. The university and Government based Lyme establishment deny the existence of atypical presentations of Lyme and patients in this category are not being diagnosed or treated, and have no place to go for proper care.

RESULTS: Some Lyme patients have had to see, as many as 42 different physicians often over several years, and at tremendous cost, before being properly diagnosed. Unfortunately, the disease was left to progress during that time, and patients were left forever ill, for by that time, their illness was not able to be cured. Even more disturbing, these hard line physicians have tried to dismiss these patients as having "Lyme Hysteria" and tried to claim they all were suffering from psychiatric problems!

UNDERTREATMENT
1. Because the diagnosis is not being made, for reasons partly outlined above.

2. University based and government endorsed treatment protocols are empiric, insufficient, refer to studies involving inadequate animal models, and are ignorant of basic pharmacology. They are not based on honest systematic studies or on the results of newer information.

3. After short courses of treatment, patients with advanced disease rarely return to normal, yet many can be proven to still be infected and can often respond to further antibiotic therapy. Unfortunately, Lyme patients are being denied such therapy for political reasons and/or because insurance companies refuse to pay for longer treatment, upon the arbitrary and uninformed advice of these physicians, who are on the insurance company's payroll.

4. Long term studies on patients who were untreated or undertreated demonstrated the occurrence of severe illness more than a decade later, reminiscent of the findings of the notorious Tuskegee Study, in which intentionally untreated syphilis patients were allowed to suffer permanent and in some cases fatal sequelae.

5. The Lyme bacterium spreads to areas of the body that render this organism resistant to being killed by the immune system and by antibiotics, such as in the eye, deep within tendons, and within cells. The Lyme bacterium also has a very complex life cycle that renders it resistant to simple treatment strategies. Therefore, to be effective, antibiotics must be given in generous doses over several months, until signs of active infection have cleared. Because relapses have appeared long after seemingly adequate therapy, long term followup, measured in years or decades, is required before any treatment regimen is deemed adequate or curative.

6. When administered by skilled clinicians, the safety of long term antibiotic therapy has been firmly established.

The very existence of hundreds of Lyme support groups in this country, and the tens of thousands of dissatisfied, mistreated and ill patients whom these groups represent, underscores the many problems that exist out in the real world of Lyme disease. I ask and plead with you to hear their voices, listen to their stories, and work in an honest and unbiased way to help and protect the many Americans whose health is at risk from what now has become a political disease.

Thank you. -

Joseph J. Burrascano, Jr., M.D.
139 Springs Fireplace Road
East Hampton, NY 11937


References

Legal / Ethical
Administrative Procedure Act
www.gpo.gov/fdsys/pkg/USCODE-2011-title5/pdf/USCODE-2011-title5-partI-chap5-subchapII.pdf

Standards of Ethical Conduct for Employees of the Executive-Branch
www.oge.gov/Laws-and-Regulations/Employee-Standards-of-Conduct/Standards-of-Ethical-Conduct-for-Employees-of-the-Executive-Branch-(PDF)

The Federal Advisory Committee Act (FACA)
www.gsa.gov/portal/content/101010
CDC Guidance on Scientific Integrity
www.cdc.gov/od/science/docs/CDCSIGuide_021612.pdf

Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies
www.whitehouse.gov/omb/fedreg_final_information_quality_guidelines

HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public
http://aspe.hhs.gov/report/hhs-guidelines-ensuring-and-maximizing-quality-objectivity-utility-and-integrity-information-disseminated-public

OMB Final Information Quality Bulletin for Peer Review
www.whitehouse.gov/sites/default/files/omb/memoranda/fy2005/m05-03.pdf

Findings of Richard Blumenthal’s Anti-Trust Investigation of IDSA
www.ct.gov/ag/cwp/view.asp?a=2795&q=414284

Conflicts of Interest in Lyme Disease: Laboratory Testing, Vaccination and Treatment Guidelines
www.lymediseaseassociation.org/images/pdf/ConflictReport.pdf

Conflicts of Interest in Vaccine Policy Making
www.vaccineinfo.net/issues/conflictofinterest/conflicts_of_interest.shtml

IDSA Guidelines
The Infectious Diseases Society of America Lyme guidelines: A Cautionary Tale about the Development of Clinical Practice Guidelines
www.ncbi.nlm.nih.gov/pmc/articles/PMC2901226

Lyme Retreatment Guidance May be Flawed
http://news.brown.edu/pressreleases/2012/08/lyme

Lyme Disease: The Next Decade
www.ncbi.nlm.nih.gov/pmc/articles/PMC3108755

Science
Characterization of Biofilm Formation by Borrelia Burgdorferi in Vitro www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0048277&representation=PDF

Morphological and Biochemical Features of Borrelia Burgdorferi Pleomorphic Forms
www.ncbi.nlm.nih.gov/pmc/articles/PMC4339653

Identification of Novel Activity Against Borrelia Burgdorferi Persisters Using an FDA Approved Drug Library
www.nature.com/emi/journal/v3/n7/full/emi201453a.html

Review of Evidence for Immune Evasion and Persistent Infection in Lyme Disease
www.ncbi.nlm.nih.gov/pmc/articles/PMC3636972

Intracellular Persistence of Borrelia Burgdorferi in Human Synovial Cells
www.ncbi.nlm.nih.gov/pubmed/8893378

Antibiotic Retreatment of Lyme Disease in Patients with Persistent Symptoms: A Biostatistical Review of Randomized, Placebo-Controlled, Clinical Trials
www.ncbi.nlm.nih.gov/pubmed/22922244

Biology of Lyme Disease: An Expert’s Perspective
www.youtube.com/watch?v=r8tESJVvM88

Lyme Disease: The Sensible Pursuit of Answers
www.ncbi.nlm.nih.gov/pmc/articles/PMC265679

Diagnosis and Prevention
Lyme Disease Diagnosis
www.lymedisease.org/lyme-basics/lyme-disease/diagnosis

Seronegativity in Lyme Borreliosis: 103 Peer-Reviewed Studies
www.lymeinfo.net/medical/LDSeronegativity.pdf

Two-Tiered Lab Testing for Lyme Disease—No Better Than a Coin Toss. Time for Change?
www.lymedisease.org/lymepolicywonk-two-tiered-lab-testing-for-lyme-disease-no-better-than-a-coin-toss-time-for-change-2

Critical Needs and Gaps in Understanding Prevention, Amelioration, and Resolution of Lyme and Other Tick-Borne Diseases:
www.nap.edu/catalog/13134/critical-needs-and-gaps-in-understanding-prevention-amelioration-and-resolution-of-lyme-and-other-tick-borne-diseases

The Lyme Vaccine: A Cautionary Tale
www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/

Social & Economic Impact
Severity of Chronic Lyme Disease Compared to Other Chronic Conditions: A Quality of Life Survey
https://peerj.com/articles/322

Lyme Disease Costs Up to $1.3 Billion Per Year to Treat, Study Finds
www.jhsph.edu/news/news-releases/2015/lyme-disease-costs-more-than-one-billion-dollars-per-year-to-treat-study-finds.html

Outcomes Important to Lyme Patients: Results of a LymeDisease.org patient survey conducted in 2015
www.lymedisease.org/wp-content/uploads/2015/04/lymedisease.org-patient-survey-20151.pdf

 

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