[Congressional Record (Bound Edition), Volume 156 (2010), Part 12]
[Extensions of Remarks]
[Pages 17456-17457]
[From the U.S. Government Publishing Office, www.gpo.gov]



                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                     Wednesday, September 29, 2010

  Mr. SMITH of New Jersey. Madam Speaker, as chair of the congressional 
Lyme Disease Caucus and a person who has been closely involved in Lyme 
disease issues for over twenty years, I want to bring to your attention 
extremely troubling issues regarding Lyme disease.
  Lyme disease is the most common of all vector-borne infections in the 
U.S., with approximately 290,000 new cases in 2008. With the increase 
in Lyme cases, problems due to poor diagnostics and ineffective 
treatments for Lyme disease have become almost overwhelming--affecting 
larger numbers of people over longer periods of time.
  Many patients are angry because progress in addressing Lyme disease 
has been impeded by entrenched bias and a lack of accountability in the 
science of tick borne diseases. It is critical that we identify biases 
and impediments that are constraining the science on Lyme and to open 
up the dialogue to honest and transparent debate. The scientists who 
have long been marginalized, the treating physicians who have felt 
intimidated and threatened, and most importantly the sick patients and 
their families need our help.
  My main purpose here today is to introduce for inclusion in the 
Congressional Record the following statement ``The Patient Perspectives 
on the Research Gaps in Tick Borne Diseases,'' written by three of the 
Nation's largest Lyme disease advocacy organizations, who represent 
tens of thousands of patients. I believe that this statement provides 
important perspectives that need to be heard and taken to heart.

    Patient Perspectives on the Research Gaps in Tick Borne Diseases

(Submitted by Time for Lyme, the national Lyme Disease Association, and 
   the California Lyme Disease Association on behalf of our patients 
                       across the United States)

       In December 2009, Labor HHS 2010 appropriations language, 
     signed into law by President Obama, encouraged the National 
     Institutes of Health (NIH) to ``sponsor a scientific 
     conference on Lyme and tick-borne diseases . . . the 
     conference should represent the broad spectrum of scientific 
     views . . . and should provide a forum for public 
     participation and input from individuals with Lyme disease.'' 
     The language also requires NIH to identify research gaps to 
     understand the ``mechanisms of persistent infection.'' The 
     passage of this language represents a significant opportunity 
     to summarize and solidify the issues that prevent scientific 
     progress for a disease recognized here for 35 years, if, and 
     only if, this process occurs without bias. Progress can be 
     accomplished if the stewards commit to the elimination of 
     predisposition by key decision makers.
       It is not clear why the NIH elected to subcontract this 
     issue to the Institute of Medicine (IOM), given that the 
     existing NIH conference structure contains the best process 
     to address the appropriations language requirements. 
     According to the NIH Consensus Development Program, which 
     explains the two relevant types of conferences offered by 
     NIH, ``when the available evidence is weak or contradictory, 
     or when a common practice is not supported by high-quality 
     evidence, the State-of-the-Science label is chosen.'' This 
     conference format would appropriately address the research 
     gaps that exist for Lyme and tick-borne diseases as it 
     provides a ``snapshot in time'' of the state of knowledge on 
     the conference rather than a policy statement of the NIH or 
     the Federal Government.
       In Lyme disease, there are two distinct disease paradigms, 
     each providing science to support its claims. One paradigm 
     views the disease as ``hard to catch and easy to cure'' and 
     denies the existence of chronic Lyme disease--persistent 
     infection with Borrelia burgdorferi, the spirochete that 
     causes the disease. Under this paradigm, the state of the 
     science for patients with chronic Lyme disease is closed. Any 
     treatment is considered too risky because practitioners are 
     unable to determine the cause or extent of patient symptoms, 
     or they view the symptoms as insignificant and write off the 
     patients' complaints as psychiatric in nature. This leaves 
     seriously ill patients without any viable therapeutic 
     avenues. It also shuts the door on future research necessary 
     to get patients to a state of wellness.
       The alternative paradigm says that the science is too 
     unsettled to be definitive and there can be one or more 
     causes of persistent symptoms after initial treatment in an 
     individual who has been infected with the agent of Lyme 
     disease. These causes include the possibility of persistent 
     infection, or a post-infectious process, or a combination of 
     both, with the Lyme bacterium itself driving the autoimmune 
     process. This paradigm allows doctors the ability to exercise 
     their clinical judgment and provide therapies that are 
     helping their patients.
       Patients with Lyme disease need a research agenda that 
     reflects outcomes that matter to patients, namely effective 
     diagnostic tools and effective treatments that restore them 
     to health. The reason there are two disease paradigms in Lyme 
     disease is because central pieces of the puzzle are missing 
     or are inadequate. The first area of concern involves 
       There are no reliable biomarkers of the disease.\1\ Current 
     diagnostic tests commonly used do not detect the spirochete 
     that causes Lyme disease, rather, they detect only whether 
     the patient has developed antibodies to the pathogen. 
     Antibody production, if it registers on the tests at all, 
     takes weeks to appear, thus rendering the current tests 
     ineffective in the earlier and more easily addressed stage. 
     Additionally, the Lyme antibody has been shown to form a 
     ``complex'' with the bacterium itself--and tests cannot 
     detect ``complex'' antibodies. Once triggered, antibody 
     reactions may remain long after an infection has been 
     treated, also clouding the diagnostic and treatment picture.
       The two-tier testing system endorsed by the Centers for 
     Disease Control and Prevention (CDC) is very specific for 
     Lyme disease (99%), so it gives few false positives. But the 
     tests have a uniformly low sensitivity (56%)--missing 88 of 
     every 200 patients with Lyme disease. By comparison, AIDS 
     tests have a sensitivity of 99.5%--missing only one of every 
     200 infected patients.\2\ Sensitive AIDS tests were developed 
     less than 10 years into the disease, while archaic Lyme tests 
     remain unreliable 35 years later. There is a critical need 
     for research exploring newer technologies such as polymerase 
     chain reaction (PCR), which is used with many other diseases, 
     and cutting-edge proteomics. Strain variations and co-
     infections with other organisms, often transmitted by the 
     same tick bite, obscure the diagnostic picture further.
       A vast number of strains of Borrelia burgdorferi have been 
     identified. Variation in strain may cause differing symptoms 
     or severity of symptoms as well as determine the appropriate 
     antibiotics and duration of treatment needed to clear the 
     infection.\3\ Different strains may also express different 
     proteins. Preliminary research shows that proteins need to be 
     examined to find the ones most often expressed, then using 
     microarray technology, doctors may be able to diagnose 
     patients using a chip which contains the proteins.
       Research is needed concerning the role of mutation on 
     persistence. Some research indicates that bacteria can 
     exchange genetic material, probably contributing to its 
     ability to invade different systems in the body--some may 
     have a proclivity for the heart muscle, others for the brain, 
     and some for muscles and joints. By exchanging genetic 
     material, bacteria may be able to form a symbiotic 
     relationship to avoid detection by the immune response or to 
     further invade the body.
       To date, every NIH-funded treatment research study has been 
     designed using the inaccurate diagnostic test results as part 
     of the entry criteria. The entry criterion in these studies 
     excluded the vast majority of Lyme patients and created 
     sample sizes too small (less than 220 patients to date) to 
     detect clinically important treatment effects or generalize 
     to the clinical population. Moreover, Lyme has not attracted 
     industry funding for treatment approaches, which places the 
     disease at a considerable research disadvantage. To detect 
     clinically relevant treatment effects requires much larger 
     treatment trials with sample populations that reflect those 
     seen in clinical practice.\4\
       One thing that past research has demonstrated is that 
     patients with Lyme are a heterogeneous population. Hence, the 
     course of illness and responsiveness to treatment may vary 
     depending on the duration of onset of the disease to its 
     diagnosis and treatment, the presence of co-infections, 
     comorbid factors, other genetic characteristics of the 
     patients, and the virulence of the strain(s) with which the 
     patient is infected. Research sample populations must reflect 
     those seen in clinical practice to yield clinically relevant 
       As advised by the Appropriations language, research on the 
     pathophysiology of Lyme disease is necessary. Research 
     projects need to be designed which determine the course of 
     the disease from inception, and which utilize treatments that 
     effectively interfere with the mechanisms that allow the 
     infection to persist. Little to no government sponsored

[[Page 17457]]

     science has been dedicated to the effects on persistence of 
     the different forms of the Lyme bacterium (cyst vs. 
     flagellar), the role, if any, of biofilms, sequestration of 
     the organism from the immune system, the exchange and 
     mutation of genetic material of the spirochete, and the role 
     that components of the bacterial genome may play in 
     protecting it from eradication by the immune system or 
     antibiotics. Understanding the pathology of the organism can 
     greatly enhance targeted diagnostics and treatment 
       Patients also need studies that explore a range of 
     treatment options. The ideal antibiotics, route of 
     administration, and duration of treatment for any stage of 
     Lyme disease are not established. No single antibiotic or 
     combination of antibiotics appears to be capable of 
     completely eradicating the infection in all patients, and 
     treatment failures or relapses are reported with all current 
     regimens, although they are less common with early aggressive 
     treatment.\5\ Treatment failure rates suggest the need to re-
     examine the effectiveness of the currently recommended 
     monotherapy as a treatment approach. Studies need to explore 
     combination treatments and longer term treatment regimens, 
     which have been critical to the successful treatment of AIDS 
     and tuberculosis.
       Patients need the type of outcomes research advocated by 
     the IOM to examine how well treatments are working in actual 
     clinical practice.\6\ While not all patients with chronic 
     Lyme disease have returned to a state of wellness, many have, 
     and we need to find out how and why. This information can 
     then be applied to other patients and used to establish a 
     research agenda for treatment that has a likelihood of 
     success, rather than abandoning patients based on limited 
     treatment trials.
       The IOM process does not allow these research ideas to be 
     heard in an unbiased and transparent fashion with balanced 
     divergent viewpoints. While the NIH process precludes bias on 
     the part of panel members, the IOM does not. Four of the six 
     members of the IOM panel that have been selected belong to 
     IDSA, a medical society that has a known bias against chronic 
     Lyme disease diagnosis and treatment. Rather than providing 
     curative treatments that restore health, the IDSA would 
     provide costly and long term palliative treatments, 
     presumably for life. While the NIH requires participation by 
     major stakeholders (including patients and treating 
     physicians), the IOM does not.
       The summary of the IOM proceedings will reflect this 
     pervasive lack of objectivity, undermining its integrity and 
     credibility. Additionally, much IOM deliberation is done 
     behind closed doors and an anonymous panel will be permitted 
     to comment on the written record. Because of such flaws in 
     the IOM proceedings, the three largest patient interest 
     groups who were offered a brief opportunity to speak (TFL) at 
     the IOM October 2010 meeting and an opportunity to provide a 
     commissioned paper--CALDA, the LDA and TFL--pulled out of the 
     conference in protest.
       From a research perspective, strongly held paradigms can 
     create a closed loop, and experiments may be designed, 
     implemented and interpreted to support a particular 
     viewpoint.\7\ The antidote to bias is to balance scientific 
     perspectives and to ensure that all scientific viewpoints are 
     being heard and explored. Given the extraordinary stream of 
     federal funding granted to researchers who support the closed 
     paradigm which was created and is supported by the Infectious 
     Diseases Society of America (IDSA) and their vested interest 
     in maintaining the status quo, it is not reasonable to expect 
     this group of researchers to serve as neutral arbiters of 
     scientific debates over competing scientific paradigms. For 
     example, Lyme related panels dominated by IDSA have time and 
     time again excluded opposing viewpoints from participating or 
     controlled the review process to ensure outcomes that 
     reinforce the IDSA paradigm. If past is prologue, it is 
     obvious what the future holds for panels dominated by one 
       Worse, the small treatment trials that have been conducted 
     have been given an undue amount of weight by IDSA researchers 
     and in its guidelines and used to apply a degree of certainty 
     on the science that far exceeds the limitations of the small 
     sample sizes of the studies. Further, they claim that the 
     state of the science is sufficient to determine with 
     certainty that chronic Lyme disease does not exist, is not 
     treatable with antibiotics, and that no further research on 
     this topic is needed. Sample size affects the strength of the 
     conclusions that may be drawn from them: ``Providing 
     definitive answers in the face of low event rates and small-
     to-moderate treatment effects necessitates sample sizes in 
     the thousands or tens of thousands. . . . Funding for such 
     mega-trials is very limited, and is often restricted to 
     industry sources.''\8\
       For that reason, the Connecticut Attorney General antitrust 
     investigation into the development process of IDSA Lyme 
     guidelines found exclusionary practices and suppression of 
     divergent viewpoints on the part of IDSA panels that crafted 
     IDSA 2000 and the 2006 Lyme disease guidelines. Although IDSA 
     settled the investigation with the Attorney General by 
     agreeing to review its guidelines with a panel without 
     conflicts of interest, the control of the process was in the 
     hands of IDSA, which again selected a panel consisting almost 
     exclusively of IDSA members and excluding treating physicians 
     who held divergent viewpoints.
       It was patients who pressed for the language in the 
     Appropriations bill that called for a review of the state of 
     the science of Lyme disease. However, patients need that 
     process to occur in a transparent manner, without bias, and 
     with the participation of all stakeholders. Albert Einstein 
     defined insanity as ``doing the same thing over and over 
     again and expecting different results.'' This process is a 
     perfect example of that insanity.
       Patients want research which will restore their health. 
     Their voice and the voice of the clinicians must be given the 
     necessary weight to legitimize the research agenda and the 
     research process. Truth in science can be achieved through 
     open debate in an independent process free from bias and 
     conflicts of interest. The scientific process fails when one 
     side of a debate controls the arena and sets the rules to 
     ensure that its viewpoint prevails.
       Lorraine Johnson, JD, MBA, Chief Executive Officer, 
     California Lyme Disease Association.
       Patricia V. Smith, President, Lyme Disease Association, 
       Diane Blanchard/Deb Siciliano, Co-Presidents, Time for 
     Lyme, Inc.


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