Congress acts to improve CDC and NIH Lyme disease programs
The following article is submitted by Bruce Fries, of the Patient Centered Care Advocacy Group:
Congress has stepped up efforts to improve the federal government’s response to the rapidly growing epidemic of Lyme disease.
The FY 2018 Congressional Appropriations bill signed into law on March 23, 2018 was accompanied by House and Senate Appropriations Committee reports that include more than a dozen directives for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to improve their programs for surveillance, prevention, diagnosis, and treatment of Lyme disease.
These directives also require CDC and NIH to submit detailed reports to help Congress gauge program effectiveness and determine future funding levels. In addition, CDC has been directed to establish performance indicators for Lyme disease and to justify funding disparities between Lyme disease and other less common vector-borne diseases, such as West Nile virus and Zika.
Complementing these actions, a Department of Health and Human Services (HHS) Tick-Borne Disease Working Group, encompassing a diversity of scientific disciplines and views and including patients and representatives from key stakeholder organizations, will issue its first report in December 2018. The group was created in November 2017 under the 21st Century Cures Act, which was signed into law in December 2016. The working group will “provide expertise to review agency efforts related to tick-borne diseases to help ensure interagency coordination, minimize overlap, and examine research priorities.”
Rapid Growth of Lyme Unchecked
Since Lyme disease was identified in 1975 by Dr. Allen Steere when he was investigating a cluster of cases of rheumatoid arthritis in children in Lyme, Connecticut, it has become the most common vector-borne disease in the United States with 380,690 new cases in 2015 alone at a cost of more than $4.2 billion. Lyme disease has been reported in all 50 U.S. states, and the number of high-risk counties has increased 320% over the past two decades.
Lyme disease is called “The Great Imitator” because it can mimic many other diseases. It is common for patients with Lyme to be misdiagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, psychiatric illnesses, and neurodegenerative diseases such as Multiple Sclerosis, Parkinson’s, and Alzheimer’s.
Undiagnosed, untreated, and inadequately treated 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.
Formidable obstacles have hampered the federal government’s response to the Lyme epidemic. Unreliable tests and lack of awareness among healthcare providers contribute to widespread misdiagnosis and lack of medically necessary treatment. Conflicts of interest and entrenched biases influence policy decisions. Lack of transparency and accountability make it difficult to assess agency performance.
Compounding these problems is inadequate federal funding for prevention and research. While CDC and NIH consider Lyme a priority vector-borne disease, they don’t give it the same attention and resources as other priority vector-borne diseases, such as West Nile virus and Zika, which are far less common with a dramatically lower burden of disease. For example, NIH’s FY 2015 Lyme disease program funding was $24 million, or $63 per case. By contrast, funding for West Nile virus with 2,062 cases in 2015 was $40 million, or $19,627 per case.
Unfortunately, CDC and NIH have fallen short in their mission to fight the Lyme epidemic. The number of cases continues to grow, the geographic range continues to expand, the CDC endorsed two-tier test is highly unreliable, CDC and NIH sanctioned treatment options fail up to 36% of the time, and no human vaccines are available.
Congressional Oversight Ramps Up
A key responsibility of Congress is to provide oversight of federal agencies to monitor performance and ensure that taxpayer money is used wisely.
Appropriations bills and accompanying committee reports are a common vehicle for congressional oversight. This is referred to as “power of the purse.” Appropriations Committees provide instructions for the use of appropriated funds in the bills and in the reports for each bill. These instructions are commonly referred to as “directives.”
Yet federal agency performance does not always match congressional expectations. For example, CDC and NIH have done little to fulfill past appropriations directives that “encouraged” them to “include a broad range of scientific viewpoints in their Lyme disease planning and execution efforts.” Instead, they adopted a narrow view of Lyme disease promoted by a group of academic physicians with myriad conflicts of interest related to tests and vaccines.
However, even though only directives included in the law itself are legally binding, there can be consequences if agencies fail to comply with directives in committee reports. In his book, The Power of the Purse: Appropriations Politics in Congress, congressional scholar Richard Fenno, Jr. says:
“The criticisms and suggestions carried in the reports accompanying each bill are expected to influence the subsequent behavior of the agency. Committee reports are not the law, but it is expected that they be regarded almost as seriously.”
In December 2016, Congress addressed noncompliance by directing HHS to form the Tick-Borne Disease Working Group, which broadens input by including a diversity of scientific views as well as the voices of patients and representatives from key stakeholder organizations.
Development of Lyme Directives for FY 2018
To strengthen CDC and NIH Lyme disease programs in face of the burgeoning Lyme epidemic, the House and Senate Appropriations Committees issued a comprehensive set of directives for FY 2018 appropriations.
House Report 115-244 and Senate Report 115-150 include directives to increase accountability, improve diagnostics, correct misuse of the case definition for Lyme disease, ensure better transparency, increase stakeholder involvement, improve surveillance and prevention, and expand research—including for chronic Lyme, which has not been officially recognized by CDC or NIH. Also included are directives that require CDC and NIH to submit reports to Congress for evaluation and monitoring.
The Patient Centered Care Advocacy Group worked with other stakeholder organizations to develop a portion of the proposed report language, which was submitted to the House and Senate Appropriations Committees via letters from individual members of Congress. Committee staff reviewed the input and drafted the final language for approval.
The full text of FY 2018 directives for tick-borne diseases can be viewed at: https://tinyurl.com/FY2018LymeDirectives
The Patient Centered Care Advocacy Group also submitted outside witness testimony to the Senate Appropriations Committee to express concerns about CDC’s management of the Lyme epidemic. Specific concerns included lack of accountability, lack of transparency, poor performance, and CDC’s failure to comply with prior Committee directives.
Performance Indicators
Despite the fact that Lyme disease is the most common vector-borne disease and costs billions of dollars annually, CDC has no indicators by which to measure the performance of its Lyme disease program. In addition, the absence of appropriate performance indicators conflicts with federal laws regarding government accountability and performance, including the Government Performance Results Act (GPRA) of 1993 and the GPRA Modernization Act of 2010.
Currently, the only performance indicator for preventing and controlling vector-borne diseases in general is the “cumulative number of tests performed worldwide to diagnose infections transmitted by mosquitoes, ticks, and fleas using CDC-produced reagents.” Yet the number of tests performed using CDC reagents not only is a poor measure of the agency’s effectiveness in preventing and controlling disease, it also represents a conflict of interest since various CDC employees hold patents on some of those reagents and receive more royalties when more tests are performed.
House Report 115-244 recognizes that “Vector-borne diseases, such as Lyme disease, West Nile Virus, and Zika, have high human consequences and are a growing threat to public health.” To better monitor CDC’s efforts, it “directs CDC to include goals and performance indicators for each priority vector-borne disease in its annual Congressional Justification.”
Appropriate performance indicators will help Congress better understand the impacts of Lyme disease and other priority vector-borne diseases, as well as the effectiveness of agency programs for surveillance, prevention, and control. The resulting information will aid in future budget considerations. Most importantly, these indicators will improve health outcomes for patients impacted by this rapidly growing epidemic, thereby reducing the burden on our nation’s economy by reducing health care and disability costs.
Reports to Congress
Both the House and Senate reports direct CDC and NIH to submit reports that will help Congress evaluate each agency’s Lyme disease program. These reports also will help Congress monitor compliance with appropriations directives.
House Report 115-244 directs CDC to submit a report to the House and Senate Appropriations Committees that investigates funding disparities between Lyme disease and other priority vector-borne diseases, which include West Nile virus and Zika. The report must compare “funding for high priority vector-borne diseases to the burden of disease as defined by Disability Adjusted Life Years (DALYs)” and include “estimates for the burden of each high-priority vector-borne disease on the U.S. economy, including direct medical costs, indirect medical costs, nonmedical costs, and productivity losses.”
This report should show Congress the glaring disparity in resources between Lyme disease and other less common vector-borne diseases with far lower burdens of disease and economic impact.
Senate Report 115-150 requests that NIH provide a detailed report on its program for Lyme disease. The report is to include a summary of efforts to advance more accurate tests including an analysis of obstacles hindering adoption of direct detection tests currently available or in the pipeline, an assessment of the current science on persistent infection, a summary of NIH research on prevention of Lyme and related tick-borne illnesses, information on the effectiveness of currently available prevention methods, a description of prevention methods that NIH plans to investigate further, and details on progress achieving NIH strategic objectives relevant to Lyme as well as plans to address any shortfalls in meeting goals.
Collectively, these reports will help Congress better understand the impact of the tick-borne disease epidemic and better evaluate CDC’s and NIH’s performance.
Diagnostics
The poor accuracy of the CDC-sanctioned two-tier serology test for Lyme disease (ELISA and Western Blot) has been a point of contention for years. This test is an indirect assay that measures the immune response but does not confirm the presence of an infection.
According to CDC, the two-tier test is inaccurate in the early stages of the disease and should not be relied upon for at least 6 weeks after a tick bite. CDC asserts that this test is highly accurate later in the disease, but a systematic meta-analysis of 20 years of published data showed a mean sensitivity of only 35.4% in the acute stage and 64.5% in the convalescent stage, with an overall sensitivity of only 59.5%. By comparison, the sensitivity for the HIV/AIDS antibody test is greater than 99%.
Patients with Lyme who test negative remain undiagnosed and untreated. Untreated Lyme disease can cause neurological and cardiac damage and, occasionally, death.
Rather than advance the development and use of direct detection tests that can confirm the presence of an infection, CDC continues to promote outdated serology. In addition to being highly unreliable, the two-tier test does not detect most strains and species of Borrelia that are known to cause disease. This further contributes to misdiagnosis and underreporting.
To help address the issue, House Report 115-244 includes a directive encouraging CDC to “expand activities related to developing sensitive and more accurate diagnostic tests for Lyme disease.” This report also includes a directive encouraging NIH to intensify research efforts focused on developing “more sensitive and accurate diagnostic tests for Lyme and tick-borne diseases, including next-generation polymerase chain reaction and new testing methodologies such as proteomics and metabolomics.”
Senate Report 115-150 includes a similar directive urging the National Institute of Allergy and Infectious Diseases (NIAID) to “evaluate the effectiveness of laboratory tests designed to detect Borrelia burgdorferi in order to diagnose Lyme disease early, which can improve the treatment of patients suffering from chronic Lyme disease.”
Several next-generation direct detection tests for Lyme disease are either commercially available or in the pipeline for FDA clearance. These tests, which include urine antigen, nested PCR/16S rRNA sequencing, and RNA reverse transcription, are significantly more sensitive than the two-tier test and can confirm the presence of infection. They also work in the early stages of disease before antibodies have a chance to develop.
Misuse of Case Definition
Another problem related to the two-tier serology test is use of the CDC case definition for Lyme disease to interpret results, even though CDC’s official policy is that the case definition for Lyme disease is intended for surveillance only and should not be relied upon as the primary criteria for diagnosis. Despite this policy, the CDC case definition for Lyme disease is widely misused by physicians as a requirement for diagnosis and by insurance companies to deny coverage to patients with valid cases of Lyme.
The continued and widespread misuse of CDC’s case definition results in large numbers of patients being misdiagnosed and denied medically necessary treatment. Many who do obtain treatment are refused insurance coverage and face financial hardship from out-of-pocket expenses.
A directive from Senate Report 115-150 requests that CDC issue a report to Congress that addresses misuse of the Lyme disease case definition. The directive also requests an update on work being done to advance more sensitive tests and details of how funds for Lyme disease were spent in FY 2017.
Scientific Integrity
Intense controversy over Lyme disease has resulted in two competing standards of care that disagree on most aspects of the disease. Key issues are the existence of chronic Lyme disease (persistent infection following antibiotic treatment), the accuracy of the two-tier serology test, and the efficacy of long-term treatment.
The mainstream view represented by the Infectious Diseases Society of America (IDSA) regards Lyme disease as difficult to catch and easy to cure with 2-4 weeks of antibiotics. The IDSA guidelines for treatment of Lyme disease maintain there is no credible evidence for chronic Lyme disease, and long-term treatment provides no benefit. For a patient to be diagnosed with Lyme, the IDSA guidelines require a positive result on the unreliable two-tier test, according to the narrow CDC case definition.
The alternative view 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. 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.
Hundreds of peer-reviewed articles 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.
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, 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.”
Unfortunately, CDC and NIH ignore the growing evidence and continue to endorse the IDSA viewpoint that Lyme disease is difficult to get and easy to treat, and they continue to promote the IDSA guidelines, which require a positive result on the unreliable two-tier test for patient diagnosis.
House Report 115-244 addresses preferential treatment of the IDSA guidelines with a directive that “encourages CDC to provide a written rationale for the selection of Lyme and tick-borne disease treatment guidelines it displays on its website” and “to ensure transparency on its website of its physician education programs regarding Lyme disease, including scientific resources and schedules…”
In an encouraging move, in December 2017, CDC removed references to the IDSA guidelines from its website, although the IDSA guidelines still appear in CDC’s published materials.
CDC’s removal of references to the IDSA guidelines from its website took place after a group of patients filed a federal antitrust and Racketeer Influenced and Corrupt Organizations Act (RICO) lawsuit in November 2017 against IDSA, eight health insurance companies, and seven IDSA guidelines panelists. The suit alleges that the defendants conspired to develop treatment guidelines that allowed the insurers to deny coverage for long-term antibiotic treatment for patients with chronic Lyme disease.
Surveillance and Prevention
CDC is responsible for promoting the “health and quality of life by preventing and controlling disease, injury, and disability.”
In testimony before the Connecticut Department of Public Health and the Connecticut Attorney General’s Office in 2004, Dr. Paul Mead, chief of epidemiology and surveillance for 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, the number of cases reported annually continues to grow, and associated costs continue to rise. Even CDC’s pledge to develop a safe, effective vaccine has not been fulfilled. The only vaccine that made it to market, LYMErix™ in 1998, was withdrawn after a flood of lawsuits were filed due to adverse events.
To improve surveillance and prevention, Senate Report 115-150 “encourages CDC to support surveillance and prevention of Lyme disease and other high-consequence tick-borne diseases in endemic areas as well as areas not yet considered endemic.” The report also says that “CDC should work closely with States to advance the use of Integrated Pest Management for prevention and control of tick-borne diseases.”
In addition, the report refers to Lyme cases as being under-reported and “encourages CDC to re-evaluate surveillance criteria used to track cases of the disease while assisting States to more accurately evaluate prevalence.”
House Report 115-244 includes a directive for CDC to “intensify surveillance of Borrelia infections in non-endemic/non-high incidence areas.”
Improving surveillance will require CDC to acknowledge that Lyme disease is increasingly common in non-endemic areas. CDC must also abandon its narrow view of Lyme as an acute disease with limited geographic distribution and broaden its definition of Lyme to include all strains and species of Borrelia known to cause disease.
Research Priorities
In addition to significant increases in research funding, more research is needed that provides tangible, near-term benefits to patients, and chronic Lyme needs to be better understood.
When interviewed by the director of the award-winning documentary Under Our Skin, Willy Burgdorfer, discoverer of the bacteria that causes Lyme said:
“The controversy in 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.”
Senate Report 115-150 “encourages NIH to issue requests for grant applications for research to investigate causes of all forms and manifestations of Lyme disease, including post-treatment symptoms, as well as research to develop diagnostics, preventions, and treatments for those conditions and for complications caused by co-infection by other tick-transmitted bacteria, viruses, and parasites.”
The report also “urges the NIAID, in coordination with CDC, to study the long-term effects on patients suffering from post-treatment Lyme disease syndrome, or ‘chronic Lyme disease.’”
Another directive encourages the National Library of Medicine (part of NIH), in coordination with NIAID, to “update its terminology to reflect new research on chronic Lyme disease.”
In addition, House Report 115-244 includes a directive encouraging NIH to intensify research on Lyme and other tick-borne diseases, including the mechanisms of persistent infection (chronic Lyme disease) and potential treatment protocols.
Links to Mental Illness
Lyme disease is known to cause a wide range of psychiatric manifestations. Neurological Lyme disease can mimic or trigger depression, agitation, anxiety, mania, panic disorder, and many other common psychiatric illnesses. Other tick-borne diseases, such as Bartonella, have also been reported to cause neurological and neurocognitive dysfunction, as well as causing agitation, panic disorder, and treatment-resistant depression.
According to Senate Report 115-150, it is “plausible that a certain number of severe psychiatric presentations are due to underlying infection” The report includes a directive urging the National Institute of Mental Health (NIMH) to review published literature on links between tick-borne diseases and psychiatric illnesses and report the results in NIH’s FY 2019 Congressional Justification. The literature review and report to Congress should help elevate awareness and guide further research.
Ensuring Compliance
Congressional committee reports for appropriations bills from FY 1998 to FY 2017 include more than 90 directives for Lyme disease and other tick-borne diseases. Unfortunately, many of these directives have not been fulfilled, and there has been minimal oversight to ensure compliance.
In April 2016, the Patient Centered Care Advocacy Group sent a letter to HHS Secretary Sylvia Mathews Burwell expressing concerns about CDC’s noncompliance with directives for Lyme disease in reports for FY 2002 appropriations. In reply, CDC Principal Deputy Director Dr. Anne Schuchat defended CDC noncompliance, saying:
“Although committee reports may include language that encourages agencies to work on programmatic activities…there were no directives specific to Lyme disease in the FY 2002 Labor, Health and Human Services, and Education appropriations bill.”
While technically true, noncompliance with congressional directives can have political consequences for agencies that depend on Congress for funding. In the 1993 Supreme Court case, Lincoln v. Vigil, (508 U.S. 182), Justice David Souter summarized congressional authority to direct appropriations:
“Congress may always circumscribe agency discretion to allocate resources by putting restrictions in the operative statutes (though not, as we have seen, just in the legislative history). And, of course, we hardly need to note that an agency’s decision to ignore congressional expectations may expose it to grave political consequences.”
Now that congressional oversight has been strengthened, thanks in large part to efforts by stakeholder organizations, excuses for noncompliance will no longer work.
By Bruce Fries, President, Patient Centered Care Advocacy Group
About the Patient Centered Care Advocacy Group
The Patient Centered Care Advocacy Group advocates for improved prevention, diagnostics, treatments, and access to care for chronically ill patients who are underserved and marginalized by the medical establishment.
For more information visit www.facebook.com/PCCGroup
Congress has stepped up efforts to improve the federal government’s response to the rapidly growing epidemic of Lyme disease.
The FY 2018 Congressional Appropriations bill signed into law on March 23, 2018 was accompanied by House and Senate Appropriations Committee reports that include more than a dozen directives for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to improve their programs for surveillance, prevention, diagnosis, and treatment of Lyme disease.
These directives also require CDC and NIH to submit detailed reports to help Congress gauge program effectiveness and determine future funding levels. In addition, CDC has been directed to establish performance indicators for Lyme disease and to justify funding disparities between Lyme disease and other less common vector-borne diseases, such as West Nile virus and Zika.
Complementing these actions, a Department of Health and Human Services (HHS) Tick-Borne Disease Working Group, encompassing a diversity of scientific disciplines and views and including patients and representatives from key stakeholder organizations, will issue its first report in December 2018. The group was created in November 2017 under the 21st Century Cures Act, which was signed into law in December 2016. The working group will “provide expertise to review agency efforts related to tick-borne diseases to help ensure interagency coordination, minimize overlap, and examine research priorities.”
Rapid Growth of Lyme Unchecked
Since Lyme disease was identified in 1975 by Dr. Allen Steere when he was investigating a cluster of cases of rheumatoid arthritis in children in Lyme, Connecticut, it has become the most common vector-borne disease in the United States with 380,690 new cases in 2015 alone at a cost of more than $4.2 billion. Lyme disease has been reported in all 50 U.S. states, and the number of high-risk counties has increased 320% over the past two decades.
Lyme disease is called “The Great Imitator” because it can mimic many other diseases. It is common for patients with Lyme to be misdiagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, psychiatric illnesses, and neurodegenerative diseases such as Multiple Sclerosis, Parkinson’s, and Alzheimer’s.
Undiagnosed, untreated, and inadequately treated 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.
Formidable obstacles have hampered the federal government’s response to the Lyme epidemic. Unreliable tests and lack of awareness among healthcare providers contribute to widespread misdiagnosis and lack of medically necessary treatment. Conflicts of interest and entrenched biases influence policy decisions. Lack of transparency and accountability make it difficult to assess agency performance.
Compounding these problems is inadequate federal funding for prevention and research. While CDC and NIH consider Lyme a priority vector-borne disease, they don’t give it the same attention and resources as other priority vector-borne diseases, such as West Nile virus and Zika, which are far less common with a dramatically lower burden of disease. For example, NIH’s FY 2015 Lyme disease program funding was $24 million, or $63 per case. By contrast, funding for West Nile virus with 2,062 cases in 2015 was $40 million, or $19,627 per case.
Unfortunately, CDC and NIH have fallen short in their mission to fight the Lyme epidemic. The number of cases continues to grow, the geographic range continues to expand, the CDC endorsed two-tier test is highly unreliable, CDC and NIH sanctioned treatment options fail up to 36% of the time, and no human vaccines are available.
Congressional Oversight Ramps Up
A key responsibility of Congress is to provide oversight of federal agencies to monitor performance and ensure that taxpayer money is used wisely.
Appropriations bills and accompanying committee reports are a common vehicle for congressional oversight. This is referred to as “power of the purse.” Appropriations Committees provide instructions for the use of appropriated funds in the bills and in the reports for each bill. These instructions are commonly referred to as “directives.”
Yet federal agency performance does not always match congressional expectations. For example, CDC and NIH have done little to fulfill past appropriations directives that “encouraged” them to “include a broad range of scientific viewpoints in their Lyme disease planning and execution efforts.” Instead, they adopted a narrow view of Lyme disease promoted by a group of academic physicians with myriad conflicts of interest related to tests and vaccines.
However, even though only directives included in the law itself are legally binding, there can be consequences if agencies fail to comply with directives in committee reports. In his book, The Power of the Purse: Appropriations Politics in Congress, congressional scholar Richard Fenno, Jr. says:
“The criticisms and suggestions carried in the reports accompanying each bill are expected to influence the subsequent behavior of the agency. Committee reports are not the law, but it is expected that they be regarded almost as seriously.”
In December 2016, Congress addressed noncompliance by directing HHS to form the Tick-Borne Disease Working Group, which broadens input by including a diversity of scientific views as well as the voices of patients and representatives from key stakeholder organizations.
Development of Lyme Directives for FY 2018
To strengthen CDC and NIH Lyme disease programs in face of the burgeoning Lyme epidemic, the House and Senate Appropriations Committees issued a comprehensive set of directives for FY 2018 appropriations.
House Report 115-244 and Senate Report 115-150 include directives to increase accountability, improve diagnostics, correct misuse of the case definition for Lyme disease, ensure better transparency, increase stakeholder involvement, improve surveillance and prevention, and expand research—including for chronic Lyme, which has not been officially recognized by CDC or NIH. Also included are directives that require CDC and NIH to submit reports to Congress for evaluation and monitoring.
The Patient Centered Care Advocacy Group worked with other stakeholder organizations to develop a portion of the proposed report language, which was submitted to the House and Senate Appropriations Committees via letters from individual members of Congress. Committee staff reviewed the input and drafted the final language for approval.
The full text of FY 2018 directives for tick-borne diseases can be viewed at: https://tinyurl.com/FY2018LymeDirectives
The Patient Centered Care Advocacy Group also submitted outside witness testimony to the Senate Appropriations Committee to express concerns about CDC’s management of the Lyme epidemic. Specific concerns included lack of accountability, lack of transparency, poor performance, and CDC’s failure to comply with prior Committee directives.
Performance Indicators
Despite the fact that Lyme disease is the most common vector-borne disease and costs billions of dollars annually, CDC has no indicators by which to measure the performance of its Lyme disease program. In addition, the absence of appropriate performance indicators conflicts with federal laws regarding government accountability and performance, including the Government Performance Results Act (GPRA) of 1993 and the GPRA Modernization Act of 2010.
Currently, the only performance indicator for preventing and controlling vector-borne diseases in general is the “cumulative number of tests performed worldwide to diagnose infections transmitted by mosquitoes, ticks, and fleas using CDC-produced reagents.” Yet the number of tests performed using CDC reagents not only is a poor measure of the agency’s effectiveness in preventing and controlling disease, it also represents a conflict of interest since various CDC employees hold patents on some of those reagents and receive more royalties when more tests are performed.
House Report 115-244 recognizes that “Vector-borne diseases, such as Lyme disease, West Nile Virus, and Zika, have high human consequences and are a growing threat to public health.” To better monitor CDC’s efforts, it “directs CDC to include goals and performance indicators for each priority vector-borne disease in its annual Congressional Justification.”
Appropriate performance indicators will help Congress better understand the impacts of Lyme disease and other priority vector-borne diseases, as well as the effectiveness of agency programs for surveillance, prevention, and control. The resulting information will aid in future budget considerations. Most importantly, these indicators will improve health outcomes for patients impacted by this rapidly growing epidemic, thereby reducing the burden on our nation’s economy by reducing health care and disability costs.
Reports to Congress
Both the House and Senate reports direct CDC and NIH to submit reports that will help Congress evaluate each agency’s Lyme disease program. These reports also will help Congress monitor compliance with appropriations directives.
House Report 115-244 directs CDC to submit a report to the House and Senate Appropriations Committees that investigates funding disparities between Lyme disease and other priority vector-borne diseases, which include West Nile virus and Zika. The report must compare “funding for high priority vector-borne diseases to the burden of disease as defined by Disability Adjusted Life Years (DALYs)” and include “estimates for the burden of each high-priority vector-borne disease on the U.S. economy, including direct medical costs, indirect medical costs, nonmedical costs, and productivity losses.”
This report should show Congress the glaring disparity in resources between Lyme disease and other less common vector-borne diseases with far lower burdens of disease and economic impact.
Senate Report 115-150 requests that NIH provide a detailed report on its program for Lyme disease. The report is to include a summary of efforts to advance more accurate tests including an analysis of obstacles hindering adoption of direct detection tests currently available or in the pipeline, an assessment of the current science on persistent infection, a summary of NIH research on prevention of Lyme and related tick-borne illnesses, information on the effectiveness of currently available prevention methods, a description of prevention methods that NIH plans to investigate further, and details on progress achieving NIH strategic objectives relevant to Lyme as well as plans to address any shortfalls in meeting goals.
Collectively, these reports will help Congress better understand the impact of the tick-borne disease epidemic and better evaluate CDC’s and NIH’s performance.
Diagnostics
The poor accuracy of the CDC-sanctioned two-tier serology test for Lyme disease (ELISA and Western Blot) has been a point of contention for years. This test is an indirect assay that measures the immune response but does not confirm the presence of an infection.
According to CDC, the two-tier test is inaccurate in the early stages of the disease and should not be relied upon for at least 6 weeks after a tick bite. CDC asserts that this test is highly accurate later in the disease, but a systematic meta-analysis of 20 years of published data showed a mean sensitivity of only 35.4% in the acute stage and 64.5% in the convalescent stage, with an overall sensitivity of only 59.5%. By comparison, the sensitivity for the HIV/AIDS antibody test is greater than 99%.
Patients with Lyme who test negative remain undiagnosed and untreated. Untreated Lyme disease can cause neurological and cardiac damage and, occasionally, death.
Rather than advance the development and use of direct detection tests that can confirm the presence of an infection, CDC continues to promote outdated serology. In addition to being highly unreliable, the two-tier test does not detect most strains and species of Borrelia that are known to cause disease. This further contributes to misdiagnosis and underreporting.
To help address the issue, House Report 115-244 includes a directive encouraging CDC to “expand activities related to developing sensitive and more accurate diagnostic tests for Lyme disease.” This report also includes a directive encouraging NIH to intensify research efforts focused on developing “more sensitive and accurate diagnostic tests for Lyme and tick-borne diseases, including next-generation polymerase chain reaction and new testing methodologies such as proteomics and metabolomics.”
Senate Report 115-150 includes a similar directive urging the National Institute of Allergy and Infectious Diseases (NIAID) to “evaluate the effectiveness of laboratory tests designed to detect Borrelia burgdorferi in order to diagnose Lyme disease early, which can improve the treatment of patients suffering from chronic Lyme disease.”
Several next-generation direct detection tests for Lyme disease are either commercially available or in the pipeline for FDA clearance. These tests, which include urine antigen, nested PCR/16S rRNA sequencing, and RNA reverse transcription, are significantly more sensitive than the two-tier test and can confirm the presence of infection. They also work in the early stages of disease before antibodies have a chance to develop.
Misuse of Case Definition
Another problem related to the two-tier serology test is use of the CDC case definition for Lyme disease to interpret results, even though CDC’s official policy is that the case definition for Lyme disease is intended for surveillance only and should not be relied upon as the primary criteria for diagnosis. Despite this policy, the CDC case definition for Lyme disease is widely misused by physicians as a requirement for diagnosis and by insurance companies to deny coverage to patients with valid cases of Lyme.
The continued and widespread misuse of CDC’s case definition results in large numbers of patients being misdiagnosed and denied medically necessary treatment. Many who do obtain treatment are refused insurance coverage and face financial hardship from out-of-pocket expenses.
A directive from Senate Report 115-150 requests that CDC issue a report to Congress that addresses misuse of the Lyme disease case definition. The directive also requests an update on work being done to advance more sensitive tests and details of how funds for Lyme disease were spent in FY 2017.
Scientific Integrity
Intense controversy over Lyme disease has resulted in two competing standards of care that disagree on most aspects of the disease. Key issues are the existence of chronic Lyme disease (persistent infection following antibiotic treatment), the accuracy of the two-tier serology test, and the efficacy of long-term treatment.
The mainstream view represented by the Infectious Diseases Society of America (IDSA) regards Lyme disease as difficult to catch and easy to cure with 2-4 weeks of antibiotics. The IDSA guidelines for treatment of Lyme disease maintain there is no credible evidence for chronic Lyme disease, and long-term treatment provides no benefit. For a patient to be diagnosed with Lyme, the IDSA guidelines require a positive result on the unreliable two-tier test, according to the narrow CDC case definition.
The alternative view 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. 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.
Hundreds of peer-reviewed articles 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.
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, 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.”
Unfortunately, CDC and NIH ignore the growing evidence and continue to endorse the IDSA viewpoint that Lyme disease is difficult to get and easy to treat, and they continue to promote the IDSA guidelines, which require a positive result on the unreliable two-tier test for patient diagnosis.
House Report 115-244 addresses preferential treatment of the IDSA guidelines with a directive that “encourages CDC to provide a written rationale for the selection of Lyme and tick-borne disease treatment guidelines it displays on its website” and “to ensure transparency on its website of its physician education programs regarding Lyme disease, including scientific resources and schedules…”
In an encouraging move, in December 2017, CDC removed references to the IDSA guidelines from its website, although the IDSA guidelines still appear in CDC’s published materials.
CDC’s removal of references to the IDSA guidelines from its website took place after a group of patients filed a federal antitrust and Racketeer Influenced and Corrupt Organizations Act (RICO) lawsuit in November 2017 against IDSA, eight health insurance companies, and seven IDSA guidelines panelists. The suit alleges that the defendants conspired to develop treatment guidelines that allowed the insurers to deny coverage for long-term antibiotic treatment for patients with chronic Lyme disease.
Surveillance and Prevention
CDC is responsible for promoting the “health and quality of life by preventing and controlling disease, injury, and disability.”
In testimony before the Connecticut Department of Public Health and the Connecticut Attorney General’s Office in 2004, Dr. Paul Mead, chief of epidemiology and surveillance for 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, the number of cases reported annually continues to grow, and associated costs continue to rise. Even CDC’s pledge to develop a safe, effective vaccine has not been fulfilled. The only vaccine that made it to market, LYMErix™ in 1998, was withdrawn after a flood of lawsuits were filed due to adverse events.
To improve surveillance and prevention, Senate Report 115-150 “encourages CDC to support surveillance and prevention of Lyme disease and other high-consequence tick-borne diseases in endemic areas as well as areas not yet considered endemic.” The report also says that “CDC should work closely with States to advance the use of Integrated Pest Management for prevention and control of tick-borne diseases.”
In addition, the report refers to Lyme cases as being under-reported and “encourages CDC to re-evaluate surveillance criteria used to track cases of the disease while assisting States to more accurately evaluate prevalence.”
House Report 115-244 includes a directive for CDC to “intensify surveillance of Borrelia infections in non-endemic/non-high incidence areas.”
Improving surveillance will require CDC to acknowledge that Lyme disease is increasingly common in non-endemic areas. CDC must also abandon its narrow view of Lyme as an acute disease with limited geographic distribution and broaden its definition of Lyme to include all strains and species of Borrelia known to cause disease.
Research Priorities
In addition to significant increases in research funding, more research is needed that provides tangible, near-term benefits to patients, and chronic Lyme needs to be better understood.
When interviewed by the director of the award-winning documentary Under Our Skin, Willy Burgdorfer, discoverer of the bacteria that causes Lyme said:
“The controversy in 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.”
Senate Report 115-150 “encourages NIH to issue requests for grant applications for research to investigate causes of all forms and manifestations of Lyme disease, including post-treatment symptoms, as well as research to develop diagnostics, preventions, and treatments for those conditions and for complications caused by co-infection by other tick-transmitted bacteria, viruses, and parasites.”
The report also “urges the NIAID, in coordination with CDC, to study the long-term effects on patients suffering from post-treatment Lyme disease syndrome, or ‘chronic Lyme disease.’”
Another directive encourages the National Library of Medicine (part of NIH), in coordination with NIAID, to “update its terminology to reflect new research on chronic Lyme disease.”
In addition, House Report 115-244 includes a directive encouraging NIH to intensify research on Lyme and other tick-borne diseases, including the mechanisms of persistent infection (chronic Lyme disease) and potential treatment protocols.
Links to Mental Illness
Lyme disease is known to cause a wide range of psychiatric manifestations. Neurological Lyme disease can mimic or trigger depression, agitation, anxiety, mania, panic disorder, and many other common psychiatric illnesses. Other tick-borne diseases, such as Bartonella, have also been reported to cause neurological and neurocognitive dysfunction, as well as causing agitation, panic disorder, and treatment-resistant depression.
According to Senate Report 115-150, it is “plausible that a certain number of severe psychiatric presentations are due to underlying infection” The report includes a directive urging the National Institute of Mental Health (NIMH) to review published literature on links between tick-borne diseases and psychiatric illnesses and report the results in NIH’s FY 2019 Congressional Justification. The literature review and report to Congress should help elevate awareness and guide further research.
Ensuring Compliance
Congressional committee reports for appropriations bills from FY 1998 to FY 2017 include more than 90 directives for Lyme disease and other tick-borne diseases. Unfortunately, many of these directives have not been fulfilled, and there has been minimal oversight to ensure compliance.
In April 2016, the Patient Centered Care Advocacy Group sent a letter to HHS Secretary Sylvia Mathews Burwell expressing concerns about CDC’s noncompliance with directives for Lyme disease in reports for FY 2002 appropriations. In reply, CDC Principal Deputy Director Dr. Anne Schuchat defended CDC noncompliance, saying:
“Although committee reports may include language that encourages agencies to work on programmatic activities…there were no directives specific to Lyme disease in the FY 2002 Labor, Health and Human Services, and Education appropriations bill.”
While technically true, noncompliance with congressional directives can have political consequences for agencies that depend on Congress for funding. In the 1993 Supreme Court case, Lincoln v. Vigil, (508 U.S. 182), Justice David Souter summarized congressional authority to direct appropriations:
“Congress may always circumscribe agency discretion to allocate resources by putting restrictions in the operative statutes (though not, as we have seen, just in the legislative history). And, of course, we hardly need to note that an agency’s decision to ignore congressional expectations may expose it to grave political consequences.”
Now that congressional oversight has been strengthened, thanks in large part to efforts by stakeholder organizations, excuses for noncompliance will no longer work.
By Bruce Fries, President, Patient Centered Care Advocacy Group
About the Patient Centered Care Advocacy Group
The Patient Centered Care Advocacy Group advocates for improved prevention, diagnostics, treatments, and access to care for chronically ill patients who are underserved and marginalized by the medical establishment.
For more information visit www.facebook.com/PCCGroup
a suggestion for nih research
analyze by pcr and culture- tumours, cysts, nodules removed from thyroid, kidney, liver, brain, adrenal and pituitary glands, breast, and prostate
for TBD, including at least 2 in development diagnostic tests for TBD, in each case different tests to allow openness to innovation, rather than catering to current patent holders.
I have a concern over the popular use of “antibiotic treatment” used as a one size fits all answer for those who suffer from Late Stage or Chronic Lyme Disease. It is known there are many, unknown numbers, of strains in both Lyme and commonly coinciding co-infections, that even when someone with the ability to pay out of pocket for long term antibiotic treatment, can still become ill or relapse at a later time. Recently it was reported that a woman with late stage cancer was cured with Hyberbaric therapy. Is this type of treatment, that would directly inject red blood cells with oxygen to not only kill the bacteria itself if used at a proper amount of pressure, but heal the damage caused by untreated or under treated pathogens, that know all to well how to evade the treatments we may not be aware are still persisting, waiting for the next chance for the immune system to be weakened enough by something else that happens for it’s chance to come out, repopulate and once again spread our body’s ability to fight it off once again. I tried to explain what I had learned with the time I have mostly spent in my bedroom, to my internal medicine doctor and he quite frankly interrupted me twice to say that the science I was talking about was “above his pay grade” Obviously the education shouldn’t be put on the shoulders of the sick and dying. I asked my infectious disease Dr. who has the reputation of being world renowned if I would get better, “it is unknown” how long? “could be a long time” I jokingly asked my neurologist earlier on when my CRP was at 67, if “why, does it me I’m going to die or something?” He didn’t speak but shrugged his shoulders indicating another “unknown” response. The TBD group has until Dec. 2018 to give their first report, how many of us will die or become permanently harmed, physically, mentally, financially and for many, extremely emotionally by the time something actually gets done. Reports aren’t going to help me NOW. I don’t know if I have that kind of time or not because …well..it is “unknown” I certainly don’t have the financial ability to restore what has already been lost and to maintain a life for myself and my family much longer. I now understand why suicide is the most common cause of death from Lyme. It’s a crime in so many ways. Sadly, I think this all comes down to money. Now and for decades. Who will have the guts to admit to that and help those of us that may succumb before anything is done? I guess we’ll have to wait…and with nothing else left, have faith, because when there is nothing left, you find that is all there is.
Catherine, I share your illness, pain, and the emotional distress of being dismissed by our medical system, our government, and for me, most of my family and friends. Hang on to your family as best you can. It can get worse.
Sadly, in Feb, a dear friend who had TBD’s finally succumbed to the diseases. It’s too late for him, and it’s probably too late for a lot of us. I think that you have many of the same symptoms as I, severe fatigue, weakness, cognitive problems, MCAS, chronic viral illnesses, etc., that make it impossible to advocate for ourselves, and really, to even take care of our basic needs. We need a hero.
My heart goes out to you.
Best wishes,
Martha
Right now, ALL I WANT is my insurance to pay for my treatment, my relatives’ treatment, and my friends’ treatment for this insidious disease! We have paid into our health insurance our entire lives. Medicare does not pay, Medicaid does not pay! Now when we need it, insurance does not pay? I want all our lives returned to what they were before this disease stuck and turned our lives into living hell! Our politicians and their families have terrific insurance on our tax dimes. They can afford to talk, and talk, and talk! Why aren’t we afforded the same?? I have lost my Mother, and friends to TBD’s! I have other family and friends suffering from TBDs. ENOUGH LIVES DESTROYED! When will 300,000 plus people finally unite and say ENOUGH!!??? Rather than whine and complain??
I agree with your frustration over having paid into a system and then being denied medical care. And i resent certain politicians referring to SS, disability, Medicare as “entitlements” like it’s a dirty word. YES, I worked all my life until it was destroyed by Lyme AND paid into SS so YES I am entitled to my benefits that I paid for!
“when will 300,000+ unite…rather than whine and complain?” We are uniting! The ones of us whose brains aren’t too muddled to keep trying, fighting. We are making progress! I don’t consider it whining; our remarks, experiences and efforts are FINALLY drawing attention to how the CDC has failed! I am extremely upset, though – yet another survey, research blah blah! ALL this information has been available, some of it for years. I FAIL to UNDERSTAND how ANY doctor in this year can NOT know about Lyme, and how to treat it!!! I think any doctor or treatment facility should be forwarded the New treatment standards/how to diagnose AND the CDC should immediately update their website. Many of us don’t have time to wait anymore!
@Catherine I totally relate to your pain and frustrations. Before I knew I had Lyme, I had gotten carbon monoxide poisoning. I had read that oxygen therapy could help. Doc refused. Then I found out about Lyme and how Bartonella especially invades RBC. Then the breathing problems/Central Sleep Apnea…prescribed CPAP machine but even showing the doctor about how the bacteria invades RBC and how people benefit from oxygen, he won’t do it even for a short time.
I would say the only thing worse than having Lyme, is having to argue with the doctors on how to treat it. They HATE it when I bring in “new” treatment research from Columbia University, or Horowitz’s book…They have NO Answers, yet when the patient provides the answers from credible sources, they still refuse to treat.
Ok good read but it does not say anything about when things will change. So I guess those of us that need treatment but can’t afford it will just keep on suffering.
My husband just had a nervous breakdown from caring for me for so long. Is there ever going to be any relief for him?
My medical practitioner just re ordered the EBV test and it was positive. I had one done back in 1992 when I came down with 3 different viruses. Its so hard to say when I had this…maybe from childhood or childbirth. I should have my mother tested for it.
I read that now, nearly 3/4 of people have been exposed to EBV. Many don’t get sick from it. It is the same virus that can cause mono. I also read that because of how Lyme weakens the immune system, a person’s body may succumb/reactivate an earlier EBV. So it’s kind of irrelevant when you got it or how; if your mother is sick, or mislabeled with “chronic fatigue syndrome” yeah testing to find out what is causing the problem might be a good idea. It is discouraging to find that has reactivated, because (for me when that happened) it added even more fatigue onto the Lyme fatigue. If you or your husband hasn’t read Dr. Horowitz’s book “Why can’t I get Better?” you might check it out. It addresses how to deal with all complications of Lyme, including when EBV reactivates. And YES, there will be relief for your husband! You will at least establish an equilibrium with your illness; you will recognize your patterns; for example maybe “oh here I am oxygen starved again” and instead of panicking and heading to the emergency room (only to be disrespected) you’ll learn how to ride it out. And eventually you’ll start feeling better!