Enact Rule to End Preferential Treatment of IDSA Guidelines for Lyme Disease
Enact Rule to End Preferential Treatment of IDSA Guidelines for Lyme Disease
Enact Rule to End Preferential Treatment of Infectious Diseases Society of America (IDSA) Guidelines for Lyme Disease
Pursuant to the Administrative Procedure Act (5 USC §§ 551-559), the Patient Centered Care Advocacy Group, a patient advocacy organization with members and supporters throughout the United States, petitions the U.S. Department of Health and Human Services to enact a rule to prohibit preferential treatment of clinical practice guidelines published by private organizations.
The justification for this rule is to end preferential treatment extended by the Centers for Disease Control and Prevention (CDC) to the Infectious Diseases Society of America (IDSA) and prevent this type of preferential treatment from occurring in the future within the CDC and other HHS agencies. In addition to causing harm to patients, the preferential treatment afforded to the IDSA by the CDC and its employees violates the federal law that governs the conduct of Executive Branch employees.
Lyme disease is the most commonly reported vector-borne illness in the United States, with 329,000 new cases annually and an annual economic burden of more than $3.6 billion in increased health care and disability costs.
CDC worked closely with the IDSA to develop guidelines for the diagnosis and treatment of Lyme disease. These guidelines have been the subject of intense controversy, including an antitrust investigation by the state of Connecticut and hundreds of protests.
CDC provides preferential treatment to IDSA by endorsing and promoting IDSA’s 2006 guidelines for Lyme disease while withholding information from the medical community, the insurance industry, and the general public, about more comprehensive guidelines for Lyme disease published by the International Lyme and Associated Diseases Society (ILADS) in 2014.
CDC officials who provide the preferential treatment are also members of IDSA, the organization receiving the preferential treatment— a glaring and long-standing conflict of interest.
Unlike the ILADS guidelines, the IDSA guidelines do not comply with the National Academy of Medicine (formerly the Institute of Medicine) Standards for Developing Trustworthy Clinical Practice Guidelines or with the Grading of Recommendations Assessment, Development and Evaluation Working Group (GRADE) standard for rating the quality of evidence and recommendations.
The National Academy of Medicine report, Clinical Practice Guidelines We Can Trust, cites the 2006 IDSA Lyme guidelines to illustrate the problems of conflicts of interests, lack of transparency, and scientific bias in guidelines development.
Despite the fact that the IDSA guidelines are based on outdated science, are not compliant with current standards, and have been delisted from the National Guideline Clearinghouse, CDC continues to endorse and promote them, while withholding information about the ILADS guidelines, which contain information on evidence-based treatments that could improve the health of thousands of chronically ill patients throughout the world.
Due to restrictions imposed by the IDSA guidelines, patients are misdiagnosed, refused treatment, and denied insurance coverage. Hundreds of thousands of Lyme patients experience a greatly diminished quality of life; a tragedy compounded by financial hardships from out-of-pocket costs and lost income. The burden on individuals as well as on our economy is enormous, the suffering is widespread, and much of this is preventable.
I. Action Requested
Enact the following rule:
HHS employees, programs and agencies shall not endorse, promote, or otherwise make available to the public, government agencies, or private organizations, clinical practice guidelines that are not listed by the National Guideline Clearinghouse and are noncompliant with current standards, including the National Academy of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group system. In the event clinical practice guidelines are endorsed, promoted or referenced on any HHS agency websites or agency publications, and similar guidelines that meet the criteria of this rule are published, the agency shall remove all references to the existing guidelines or provide equivalent exposure to the newly published guidelines.
II. Statement of Grounds
CDC extends preferential treatment to IDSA by endorsing and promoting IDSA’s 2006 guidelines for Lyme disease while withholding information from the public about the more current and more comprehensive 2014 Lyme guidelines from ILADS.
For other infectious diseases, the CDC does not endorse guidelines provided by a private, non-government group—not for HIV, not for malaria, not for Ebola. No other private group’s guidelines are given preference in CDC publications and on CDC’s website except the IDSA guidelines for Lyme disease.
IDSA is a politically active 501-C6 tax-exempt organization and can receive unlimited contributions from individuals, corporations, and unions. It is unclear why this private organization is allowed to determine federal health care policy.
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, while providing no mention of the 2014 ILADS guidelines for Lyme disease.
CDC’s policy to extend preferential treatment to IDSA has been confirmed in correspondence from CDC officials and 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[s] 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 decade-old, critically flawed guidelines, which are noncompliant with current standards, 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 Standards of Ethical Conduct for Employees of the Executive Branch, which states:
“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 providing preferential 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 refuses to end preferential treatment 
On June 11, 2013, CDC’s Division of Vector-Borne Diseases hosted a meeting in Fort Collins, Colorado with Lyme support group leaders to discuss the concerns of Lyme patients and advocacy groups. Encouraged by CDC’s outreach, the group leaders presented a list of priorities they wanted CDC to address. The number one issue was “Treatment Information and Guidelines.” Support group leaders specifically wanted CDC to end its preferential treatment of the IDSA guidelines and provide equivalent exposure for the ILADS guidelines.
On November 13, 2015, a support group leader who had attended the June 11 meeting sent an email to Dr. Charles (Ben) Beard, Chief of CDC’s Bacterial Diseases Branch, that asked CDC to end its preferential treatment of the IDSA guidelines and list the ILADS guidelines wherever the IDSA guidelines were mentioned.
On December 2, 2015, the support group leader received a response from Lyle Peterson, MD, Director of CDC’s Division of Vector-Borne Diseases. The response confirmed CDC’s preferential treatment of the IDSA guidelines, with the implication that the favoritism would continue. Dr. Peterson is a member of IDSA.
Independent of the support group leader’s correspondence, on October 14, 2015, the Patient Centered Care Advocacy Group filed a citizen petition, End Preferential Treatment of the IDSA Guidelines for Lyme Disease, with the CDC Bacterial Diseases Branch.
On November 30, 2015 a response was received from Beth P. Bell, MD, Director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). The response included a statement that “CDC believes that IDSA guidelines currently represent the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease.” Dr. Bell is also a member of IDSA.
It is wholly unacceptable that, when presented with evidence of improprieties, a federal government agency’s official response is to confirm the improprieties and indicate they will continue.
4. CDC is promoting critically flawed guidelines based on poor quality evidence
At the center of the controversy surrounding Lyme disease is the existence of chronic Lyme disease, also referred to as “persistent infection,” which means that some Lyme bacteria can tolerate and survive antibiotic treatment. Other areas of controversy are the accuracy of the CDC/IDSA endorsed two-tier test, and the efficacy of long term antibiotic treatment.
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 maintain that chronic Lyme disease does not exist, the two-tier test is accurate, and that long term treatment is not warranted.
The alternative paradigm represented by ILADS maintains that Lyme disease is a serious national medical problem of epidemic proportion that needs to be researched, diagnosed, and treated aggressively. The ILADS guidelines recognize chronic Lyme and recommend that the duration of therapy be guided by clinical response, rather than by an arbitrary treatment course.
There are now hundreds of peer-reviewed articles that support the ILADS position. Lyme bacteria are called spirochetes because of their spiral shape. Spirochetes can drill through tissue to reach immunoprivileged sites (with less immune activity), including the central nervous system (brain and nerves) and collagen dense tissues, such as tendons and cartilage (joints) and the heart.
When conditions are unfavorable for growth, such as when the spirochetes are under attack by antibiotics, they can evade treatment by changing into dormant forms that remain viable but do not cause inflammation unless they receive signals to reactivate. With little or no metabolic activity, such as protein synthesis or replication, there is nothing for an antibiotic to disrupt. Bacteria that are capable of surviving targeted antibiotic therapy for any reason are referred to as “persisters.”
According to an article in Emerging Microbes & Infections, “Frontline drugs such as doxycycline and amoxicillin kill the replicating spirochetal form of B. burgdorferi quite effectively, but they exhibit little activity against non-replicating persisters ...”
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 confirmed cases of chronic Lyme was verified in 1993 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.
More recently, a study published in the December 2015 issue of Clinical Microbiology and Infection provided culture confirmation of chronic Lyme disease in 24 patients from North Carolina, Georgia, and Florida. All 24 had undergone previous antibiotic treatment.
Biofilms are colonies of bacteria bound together by a DNA-containing gel of nutrients and protected by a polysaccharide (type of carbohydrate) shell. Biofilms protect the bacteria and provide up to 1000-fold higher tolerance to antibiotics compared to free floating bacteria.
Pathologist Alan MacDonald, MD, Eva Sapi, PhD, 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 imaging.
A serious problem with the IDSA guidelines is the requirement that a positive test result be achieved prior to issuing a Lyme diagnosis unless objective symptoms, such as a bull’s-eye rash, are present.
Unfortunately, most patients never see a rash. At least eight peer-reviewed studies show the CDC endorsed two-tier test for Lyme disease misses more than half the cases, even in the late stages of the disease. 
Physicians and insurers who require a positive test, according to CDC/IDSA criteria, ensure that large numbers of patients are denied treatment and insurance coverage.
The dismal accuracy of the CDC/IDSA-sanctioned test has been a point of contention for many years. A 2010 report by Dr. John Aucott of Johns Hopkins University, found that 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 test is an indirect assay that detects antibodies that indicate past exposure to a single genospecies of Borrelia burgdorferi. It does not detect other species and strains of Borrelia that are known to cause disease, including B. bissettii, B. hermsii, B. lonestari, and B. miyamotoi.
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 efforts in those areas.
CDC and IDSA cite NIH-funded, double-blind, randomized, placebo-controlled trials in claiming, “There is substantial risk, with little or no benefit, associated with additional antibiotic treatment for patients who have long-standing subjective symptoms.”
However, a rigorous biostatistical review of the NIH trials, published in November 2012 in Contemporary Clinical Trials, determined that “long term treatment can be beneficial” and explains that “significant findings and errors may arise when disagreement and uncertainty exists in the medical community, as is the case with Lyme disease.”
It is also likely that the method of antibiotic treatment can play a role in successful treatment. For example, using pulse dosing to eliminate persister cells needs further inquiry. Equally likely is that new drug combinations need to be investigated, just as tuberculosis requires a mixture of drugs, rather than monotherapy, when it has become an entrenched infection. All of these possibilities, if proven effective, would cut costs for insurers and patients alike because the bacteria would be eradicated and patients would return to good health.
While standard antibiotics help some patients with persistent symptoms, they don’t work for everyone. Patients need individualized treatment that takes into account complications, such as co-infections, compromised immune systems, and the fact that patients who do not receive timely diagnosis and treatment require a much more aggressive and comprehensive approach than patients who are treated in the early stages of the disease when it is most curable.
An authoritative, point-by-point refutation of the contested elements of the 2006 IDSA guidelines is included in the paper, “Active Infection: Clinical Definitions and Evidence of Persistence in Lyme Disease—Contesting the Underlying Basis for Treatment Limitations for Early and Late Lyme Disease, as well as Chronic Lyme Disease, Alternately Known as “Post Treatment Lyme Disease Syndrome,”  The author, Yale-trained Dr. Steven Phillips has treated more than 20,000 Lyme patients and his work is well-published in the peer-reviewed medical literature.
The CDC/IDSA concept of Lyme disease fails to take into account peer-reviewed literature on the microbiology and immunology of the Lyme bacterial infection. Lyme disease is not a planktonic infection like strep. It is an immune evasive, persistent infection like tuberculosis, capable of reactivating. CDC explanations of Lyme disease dismiss these peer-reviewed findings. Good science produced by prestigious academic institutions is ignored by CDC officials and IDSA guidelines panelists.
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?
5. 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.
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.
When treatment goes beyond the IDSA guidelines, doctors risk becoming the focus of medical board investigations. Physicians who provide patients with evidence-based treatments are targeted, while doctors who follow the IDSA guidelines and deny treatment to patients who are later proven to have Lyme face little or no repercussions.
Because of these attacks many doctors refuse to provide treatment to patients with persistent symptoms. This creates a critical shortage and forces many patients to travel long distances at great expense to receive treatment. Patients who cannot afford the travel either remain sick or are forced to seek out alternative treatments.
Due to restrictions imposed by the IDSA guidelines, most insurers refuse to pay for long-term treatment. This creates an enormous financial burden because patients must pay out-of-pocket for necessary treatment. With the help of IDSA reviewers, insurance denials often include the message, “There is no evidence that this patient ever had Lyme disease,” regardless of medical evidence. In this context, the phrase “no evidence” is used rhetorically to justify the denial; however, “no evidence” as asserted in these circumstances refers specifically to a negative result on the “two-tier” serological tests as interpreted by the IDSA/CDC standards, which has a rate of false negative results approaching 50%.
Because of the insurance quagmire, patients are unable to easily find doctors who will diagnose or treat Lyme disease, particularly when the bacterium has become entrenched. Without medical help, patients are left to wander endlessly from one specialist to another or fend for themselves outside of insurance networks just as HIV/AIDS patients did during the early years of the HIV/AIDS crisis. To add to the burden of illness, Lyme disease patients are also saddled with financial hardship.
The consequences—both physical and psychological —are outlined in the 2015 Johns Hopkins study, “Living in Limbo: Contested Narratives of Patients with Chronic Symptoms Following Lyme Disease.” The study describes the consequences of medical neglect, as well as long-term patient bitterness, when there is an inability to locate care and treatment when desperately ill. All of these consequences can be traced to the CDC/IDSA guidelines that lock patients out of the medical system and out of insurance coverage.
6. Serious conflicts of interest influence CDC policy on Lyme
CDC is allowing IDSA, a private organization, to determine federal policy on Lyme disease by endorsing critically flawed guidelines that have been adversely influenced by well-documented conflicts of interest and biases. As stated previously, the CDC officials who provide and endorse the preferential treatment are also members of IDSA.
Members of the IDSA guidelines panel are awarded a disproportionate share of CDC and National Institutes of Health (NIH) research grants for Lyme disease. Two institutions, Yale University and New York Medical College, have received over $52 million over the past 17 years, with few tangible benefits to patients.
From 1998 to 2015, CDC/NIH awarded a total of $510 million in grants for Lyme disease. Some of this funding went to scientists with impeccable credentials, whose discoveries contradicted IDSA dogma. Yet their groundbreaking work—particularly findings related to persistent infection—has been ignored or dismissed by the CDC and IDSA.
In addition, members of the IDSA Guidelines Review Panel profit through their conflicts of interest.  These conflicts include patents on Lyme test kits, accepting payments from vaccine manufacturers, and consulting for health insurance companies that rely on the IDSA guidelines to restrict coverage for long-term treatment.
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 report, Conflicts of Interest in Lyme Disease: Laboratory Testing, Vaccination and Treatment Guidelines, by the Lyme Disease Association shows that a handful of academic physicians with serious conflicts of interest and biases are allowed to dictate a standard of care that supports their interests and misrepresents science.
The CDC’s narrow definition of Lyme disease is designed to support vaccine development. If the definition is expanded to include the increasing number of Borrelia genospecies known to cause “Lyme disease” or “Lyme-like” disease, as well as the other tick-borne microorganisms that fall under the umbrella of Lyme disease, the patents filed by IDSA guidelines panelists and CDC employees would become worthless.
In a July 2015 article, Centers for Disease Control and Prevention: Protecting the Private Good?, 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.”
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?
These irregularities have created distrust and have damaged the credibility of the CDC among patients, healthcare providers, and the research community.
7. CDC’s preferential treatment includes secret meetings that violate rules on open government
The Ad Hoc International Lyme Disease Group was formed in 2005 by CDC and NIH employees and 14 authors of the IDSA guidelines.
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.”
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. [Gary P.] 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 “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.
8. 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 noncompliant with the National Academy of Medicine 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.
9. 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 2006 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.
CDC’s Lyme Corps program, which should be disseminating accurate information about up to date science, instead only distributes information that is consistent with the outdated, critically flawed, noncompliant 2006 IDSA guidelines for Lyme disease.
10. 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 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.
CDC has repeatedly ignored directives from Congress to address the situation, and in many cases has taken actions that have made matters worse.
The Senate report for fiscal year 2002 appropriations for HHS includes the following directive:
“The Committee recognizes that the current state of laboratory testing for Lyme disease is very poor. The situation has led many people to be misdiagnosed and delayed proper treatment. The vaccine clinical trial has documented that more than one third (36 percent) of the people with Lyme disease did not test positive on the most sophisticated tests available. The ramifications of this deficit in terms of unnecessary pain, suffering and cost is staggering.
The Committee directs CDC to work closely with the Food and Drug Administration to develop an unequivocal test for Lyme disease.”
Similar directives for CDC and NIH were included in subsequent reports for HHS appropriations bills.
Fourteen years later, CDC continues to promote the highly unreliable two-tier test for Lyme disease, despite the fact that technology for more accurate tests exists and several tests that can confirm persistent infection are commercially available.
The 2002 Senate report also directed CDC to correct the misuse of its surveillance case definition for Lyme disease:
“The Committee is distressed in hearing of the widespread misuse of the current Lyme disease surveillance case definition. While the CDC does state that “this surveillance case definition was developed for national reporting of Lyme disease: it is NOT appropriate for clinical diagnosis,” the definition is reportedly misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases. The CDC is encouraged to aggressively pursue and correct the misuse of this definition. This includes issuing an alert to the public and physicians, as well as actively issuing letters to places misusing this definition.”
Fourteen years later, the case definition is still widely misused by physicians as a requirement for a diagnosis and by insurance companies to deny coverage to patients with valid cases of Lyme.
Instead of complying with this directive, officials in charge of CDC’s Lyme disease program regularly make public statements and publish articles that claim a positive test by CDC criteria is required for a diagnosis.
For example, 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 is in direct contradiction to the CDC’s often-repeated assertion that the test was developed for surveillance purposes only.
A July 2016 article in CDC’s Emerging Infectious Diseases journal says “laboratory testing is necessary to confirm the diagnosis” for patients who do not present with the erythema migrans (bull’s-eye) rash. The article was co-authored by Paul Mead, and by Christina Nelson, who is in charge of CDC’s Lyme Corps program.
CDC has had 40 years to address this epidemic. The limited progress made has been significantly outpaced by the harm to patients from CDC’s preferential treatment of the critically flawed IDSA guidelines, CDC’s dissemination of inaccurate information, and CDC’s noncompliance with congressional directives.
We cannot let the CDC Lyme group operate above the law to the benefit of a private medical society at the expense of chronically ill patients who are discriminated against because IDSA, a private organization, has been allowed to dictate federal policy on Lyme disease.
11. Economic impact
Undiagnosed and untreated Lyme disease patients represent an enormous social and economic burden with lifelong costs for unemployment, Medicaid, Medicare, disability, and welfare for people who can no longer work or manage everyday activities.
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 article, Economic Impact of Lyme Disease, published in April 2006 in Emerging Infectious Diseases shows the direct and indirect costs of Lyme disease average $8,172 per patient, or $10,769 when adjusted for inflation. With 329,000 new cases per year as of 2014, this works out to an economic burden of more than $3.6 billion annually.
When misdiagnosis and underreporting are factored in, the economic burden of this epidemic is likely to be much greater as undiagnosed and untreated Lyme disease patients advance to the costly specialties of neurology, rheumatology, orthopedics, and cardiology.
The true economic impact is difficult to accurately estimate, but CDC’s preferential treatment could be costing our economy billions 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/IDSA guidelines refuse to pay.
12. Information adverse to petition
As noted throughout this petition, CDC has a well-documented track record of conflicts of interest, entrenched biases, and mismanagement related to its programs for Lyme disease.
The IDSA guidelines are in the process of being revised. The petitioners 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.
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 …”
However, there have been no indications from IDSA indicating that any significant changes will be considered in the new guidelines revision. To the contrary, guidelines panelists have recently published a series of articles that strongly suggest the past IDSA position on the diagnosis and treatment of Lyme disease will not change.
The National Academy of Medicine standard 2.4 for clinical practice guidelines states “Members with COIs should represent not more than a minority of the Guideline Development Group.” In a clear violation of this rule, most of the current panel members have significant intellectual and institutional COIs, and many have significant financial COIs as well.
The National Academy of Medicine publication Conflict of Interest in Medical Research, Education, and Practice defines 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.” The report explains that COIs can be financial, intellectual, or institutional.
Intellectual COI “includes authoring a publication or acting as an investigator on a peer-reviewed grant directly related to recommendations under consideration.” Intellectual COIs specific to clinical practice guidelines 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).”
All of the current IDSA panel members chosen for expertise with Lyme disease have significant intellectual COIs as described above. These include Linda Bockenstedt, MD; John J. Halperin, MD; Peter J. Krause, MD; Allen C. Steere, Jr., MD; Franc Strle, MD, PhD; Gary Wormser, MD, all who co-authored the 2006 IDSA guidelines, and Paul Lantos, MD, who led the internal IDSA review of the 2006 guidelines after the 2008 Connecticut antitrust investigation.
These panelists have no incentive to publish new guidelines that refute their entrenched positions on Lyme, which are contradicted by a growing body of evidence that they have so far chosen to ignore.
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.
The Patient Centered Care Advocacy Group certifies to the best of its knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which are unfavorable to the petition.
 Standards of Ethical Conduct for Employees of the Executive-Branch
 CDC statistics for infectious diseases
 Incidence of Clinician-Diagnosed Lyme Disease, United States, 2005–2010
 Economic Impact of Lyme Disease
The Infectious Diseases Society of America Lyme guidelines: A Cautionary Tale about the Development of Clinical Practice Guidelines
 Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter
 Why we protest against the IDSA
 IDSA: The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis
 ILADS: Evidence Assessments and Guideline Recommendations in Lyme disease: The Clinical Management of Known Tick Bites, Erythema Migrans Rashes and Persistent Disease
 Standards for Developing Trustworthy Clinical Practice Guidelines
 GRADE Working Group
 Clinical Practice Guidelines We Can Trust
 National Guideline Clearinghouse
 Severity of chronic Lyme disease compared to other chronic conditions: a quality of life survey
 CDC resources for Lyme disease
 CDC educational materials for Lyme disease
 Tick-borne Diseases of the United States
 November 2015 letter from Beth Bell
 CDC: Lyme Disease Frequently Asked Questions
 Standards of Ethical Conduct for Employees of the Executive-Branch
 CDC Refuses to End Preferential Treatment of IDSA Lyme Guidelines in Response to Citizen Petition
 Petition to End Preferential Treatment of the IDSA Guidelines for Lyme Disease
 List of 700 Articles Citing Chronic Infection Associated with Tick-Borne Disease
 Morphological and biochemical features of Borrelia burgdorferi pleomorphic forms
 Drug Combinations against Borrelia burgdorferi Persisters In Vitro
 Lyme Disease: Does It Really Linger?
 Isolation of live Borrelia burgdorferi sensu lato spirochaetes from patients with undefined disorders and symptoms not typical for Lyme borreliosis
 Biofilm-Associated Infections
 Characterization of Biofilm Formation by Borrelia burgdorferi In Vitro
 Evidence of in vivo existence of Borrelia biofilm in borrelial lymphocytomas
 Lyme Disease Diagnosis
 Hard Science on Lyme: Let’s get real – the testing is no better than a coin toss
 Sex Differences in the Clinical and Serologic Presentation of Early Lyme Disease: Results From a Retrospective Review
 Antibiotic retreatment of Lyme disease in patients with persistent symptoms: a biostatistical review of randomized, placebo-controlled, clinical trials
 Active Infection: Clinical Definitions and Evidence of Persistence in Lyme Disease—Contesting the Underlying Basis for Treatment Limitations for Early and Late Lyme Disease, as well as Chronic Lyme Disease, Alternately Known as “Post Lyme Disease Syndrome
 Living in Limbo: Contested Narratives of Patients with Chronic Symptoms Following Lyme Disease
 Conflicts of Interest in Lyme Disease: Laboratory Testing, Vaccination and Treatment Guidelines
 LDO Congressional Testimony Submission For 2012 Senate Hearing
 Federal Advisory Committee Act
 Federal Advisory Committee Act (FACA) Brochure
 CDC Guidance on Scientific Integrity
 OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies
 CDC Mission, Role and Pledge
 HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public
 Secretive and Harmful Sums Up the CDC Lyme Corps Program
 Paul Mead testimony for Connecticut Department of Public Health and the Connecticut Attorney General's Office
 Geographic Distribution and Expansion of Human Lyme Disease, United States
 CDC: How many people get Lyme disease?
 Lyme Disease Costs Up to $1.3 Billion Per Year to Treat, Study Finds
 The Lyme vaccine: a cautionary tale
 Senate Report 107-84 to Accompany S. 1536 for FY 2002
 Congressional directives for Lyme disease 1998 - 2016
 CDC 2011 Lyme disease case definition
 CDC Lyme Test Is the One You Want to Use
 Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States
 Health Care Costs, Utilization and Patterns of Care following Lyme Disease
 Economic Impact of Lyme Disease
 IDSA project plan for updating guidelines for Lyme disease
 Standards for Developing Trustworthy Clinical Practice Guidelines
 Conflict of Interest in Medical Research, Education, and Practice