[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Extensions of Remarks]
[Pages 18090-18091]
[From the U.S. Government Publishing Office, www.gpo.gov]




       ESTABLISHING AN ADVISORY COMMITTEE ON TICK-BORNE DISEASES

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                       Tuesday, December 3, 2013

  Mr. SMITH of New Jersey. Mr. Speaker, Patricia Smith, a constituent 
of mine from Jackson, New Jersey and the President of Lyme Disease 
Association, Inc., LDA, recently testified before the House Energy and 
Commerce Health Subcommittee regarding the need to establish an 
advisory committee on Tick-Borne Diseases. I would like to submit her 
compelling testimony from the hearing, entitled ``Examining Public 
Health Legislation to Help Local Communities,'' for the Record:

       Chairman Pitts and Committee Members, Thank you for 
     allowing me to testify on the need to establish an advisory 
     committee on Lyme disease to ensure that government resources 
     are being appropriately used to move forward the field of 
     science and treatment in an area that is fraught with 
     political, scientific, and medical obstacles, yet is 
     dominating discussion on the worldwide stage. In 2009, the 
     Centers for Disease Control & Prevention (CDC) indicated that 
     Lyme surpassed HIV in incidence followed by a 2013 
     announcement confirming a 10-fold under-reporting of Lyme 
     cases, estimating 300,000 Lyme cases annually. A 2001 
     National Institutes of Health (NIH) sponsored study found 
     that the impact of Lyme disease on physical health status was 
     at least equal to the disability of patients with congestive 
     heart failure or osteoarthritis, was greater than those 
     observed in type II diabetes or in recent myocardial 
     infarction, and chronic pain contributing to impairment was 
     similar to that reported by patients with osteoarthritis. 
     Couple those facts with Lyme spreading worldwide to 80 
     countries and the discovery of many newly emerging tick-borne 
     pathogens being carried by many different ticks, then the 
     passage of HR 610 is long overdue.
       The LDA just revised its comprehensive education and 
     prevention brochure, LymeR Primer, which went from featuring 
     7 tick-borne diseases (TBD) in 2009 to 15 diseases. Besides 
     Lyme disease, there are at least 15 other TBD of concern in 
     the US: anaplasmosis; babesiosis, bartonellosis; 
     ehrlichiosis; Rocky Mountain Spotted fever; Colorado tick 
     fever; Q fever; tick paralysis; tularemia; Powassan 
     encephalitis; STARI, a Lyme-like disease often with the same 
     rash, transmitted by a lone star tick bite, pathogen cause 
     unknown, but may be a bacteria similar to the Lyme bacteria; 
     Rickettsia parkeri Ricketsiosis found increasingly along the 
     Gulf Coast and in the South; Borrelia miyamotoi, a tick-borne 
     bacteria which had been producing disease outside the US, now 
     found in the US; newly found Ricketsia species 364D in the 
     Pacific Region; and a newly discovered tick-borne virus in 
     Missouri, Heartland, carried by the lone star tick. One tick-
     bite can give someone more than one disease.
       My education on Lyme began almost 30 years ago as a NJ 
     Board of Education member whose district had a large number 
     of students and staff out with Lyme disease. Then, only a few 
     US ticks were recognized as major health threats to humans. 
     Now, many ticks in the US are causing more human diseases, 
     ticks including Ixodes scapularis (deer, black legged), 
     Amblyomma americanum (lone star), Dermacentor variabilis 
     (American dog), Dermacentor andersoni (Rocky Mt. wood), 
     Ixodes pacificus (western black legged), Amblyomma maculatum 
     (Gulf Coast), and Dermacentor occidentalis (Pacific Coast).
       My Lyme work, including 17+ as president of the national 
     volunteer-run non-profit Lyme Disease Association (LDA), has 
     kept me in close contact with patients nationwide. The 
     complicated nature of Lyme disease, the difficulty in 
     diagnosis, and lack of recognition by some in the medical 
     community have exacerbated the plight of patients and their 
     families, many of which contain more than one Lyme victim. 
     Medical bills rise; jobs are lost; education is interrupted. 
     Divorce is not an uncommon result in these families, further 
     complicating the picture. Often, the families are forced to 
     seek government help, government which is already burdened 
     with more debt than it is able to handle.
       Children have always been at the highest risk of acquiring 
     Lyme disease. Based on CDC's Lyme reported cases numbers from 
     2001-2010 by age, LDA estimated that 37% of reported cases 
     were children. Using 1990-2011 CDC reported numbers adjusted 
     for 10-fold underreporting, LDA found that 1,590,449 children 
     have developed Lyme disease over that period. Many more 
     children were probably clinically diagnosed but not included 
     in the CDC surveillance figure, which uses a strict reporting 
     definition not meant for clinical diagnosis. These are 
     children who often go on to develop chronic Lyme disease--who 
     often miss months/years of school and have their childhood 
     destroyed. Showering, walking, talking, thinking can be a 
     problem, and serious pain is a daily challenge. A 1998 
     Columbia University study documents improvement in IQ of 22 
     points in a 16 year-old after IV treatment for Lyme disease.
       A 1992 CDC/NJ Department of Health study in NJ of 64 school 
     children with Lyme showed that the median duration of Lyme at 
     time of interview was 363 days; the median number of days the 
     illness was said to have significantly affected normal 
     activities was 293; the mean number of total school days lost 
     was 140; the mean duration of home instruction, 153 days. 
     Only 26% of children under study were said to have fully 
     recovered.
       The direct medical costs per case incurred by 54 case-
     patients totaled $5.2 million, $8.7 million in CPI adjusted 
     2013 dollars. The mean estimate was $96,569 ($274,412-2013); 
     and costs of $100,000 ($166,891-2013) or greater were 
     incurred by more then 1/5 of children. Some indirect costs 
     were assessed totaling

[[Page 18091]]

     about $15,000 ($ 25,034-2013) due to lost time caring for 
     patient and parents' lost time transporting children to 
     medical treatment.
       A 2001 Columbia study showed children with Lyme disease had 
     significantly more cognitive and psychiatric disturbances. 
     Cognitive deficits were still found after controlling for 
     anxiety, depression, and fatigue. Lyme disease in children 
     may be accompanied by long-term neuropsychiatric 
     disturbances, resulting in psychosocial and academic 
     impairments. Regarding depression, parents indicated that 41% 
     of children with LD had suicidal thoughts, 11% had made a 
     suicide gesture.
       Early intervention and appropriate treatment are the 
     answers for patients with Lyme to prevent the development of 
     chronic Lyme disease, aka, Post Treatment Lyme Disease, late 
     disseminated Lyme, persistent Lyme, Post Lyme Disease 
     Syndrome, etc. While discussions continue on the 
     justifications for the various terms used for chronic Lyme 
     disease, we cannot allow the semantics to eclipse the need 
     for research on chronic Lyme, the area producing the most 
     human suffering and receiving the least research funding. 
     According to a new Columbia University Lyme study, based upon 
     10-fold underreporting and on 10% of newly infected and 
     treated patients developing symptoms that persist for more 
     than 6 months, ``the actual incidence of new chronic cases 
     (PTLS) is . . . 30,000.''
       Currently, many major health threats including chronic 
     fatigue have an advisory committee. Lyme disease does not, 
     placing its patients and advocates at a great disadvantage. 
     We have lobbied for a research agenda which includes more 
     effective treatments for Lyme and other TBD and better 
     diagnostics, including detection of active infection. B. 
     burgdorferi was recognized in 1981 to cause Lyme, almost 33 
     years ago, yet the two-tier testing system endorsed by CDC is 
     very specific for Lyme disease (99%), so it gives few false 
     positives, but according to some sources, the tests have a 
     uniformly low sensitivity (56%)--missing 88 of every 200 
     patients with Lyme disease. Yet HIV was identified as the 
     cause of AIDS in 1984, and tests were developed within a few 
     years after and are 99% sensitive and specific. Moreover, 
     Lyme has not attracted industry funding for treatment 
     approaches, which has allowed patients to develop severe 
     mental and physical disabilities from the disease without 
     help from science. There is also a need for educating doctors 
     and the public about the state of the science regarding these 
     diseases.
       The above agenda requires the establishment of a venue 
     where government agencies working on diverse aspects of tick-
     borne diseases (e.g., CDC surveillance, testing; NIH research 
     funding-clinical trials, as well as basic and translational 
     research; FDA drug, vaccine and device approvals; USDA 
     research into natural tick prevention strategies; EPA tick 
     prevention strategies) can present their activities, submit 
     their proposed TBD agenda, and receive input from committee 
     members who represent a wide variety of stakeholders with 
     diverse scientific viewpoints on development of new 
     diagnostics, treatment methods, and prevention strategies. 
     Utilizing this format, government would ensure its agencies 
     were providing the most judicious use of human and financial 
     resources for Lyme and TBD. Using an already established 
     federal advisory committee format ensures that the committee 
     is only advisory in nature--committee members would not 
     control nor dictate agency agendas, a concern that has been 
     expressed by an outside group in the past. However, those 
     agencies should not be insulated from the public input and 
     diverse scientific viewpoints this committee would provide in 
     shaping an agenda and ensuring the wise use of tight federal 
     dollars, which are provided by taxpayers. Another concern 
     might be whether an advisory committee is worth the costs, 
     including time, to support the operation of the committee. In 
     the case of Lyme disease, the history of the past decades 
     should lead to an easy yes.
       One does not have to be a scientist to realize that it is 
     premature and unwise to preclude further clinical trials 
     studying a broader range of treatment regimens when there are 
     numerous major and significant aspects of the bacteria's 
     known pathophysiology which have not been accounted for in 
     studies conducted to date, when there are still many unknowns 
     in that pathophysiology, and when we are learning more every 
     day. While our knowledge of the pathophysiology of the 
     bacteria continues to evolve, we must be open to additional 
     clinical trials to document and establish better treatment 
     regimens. There is preliminary evidence for more effective 
     regimens, and a specific forum for open dialogue can help 
     ensure we move forward and don't get waylaid.
       An open dialogue also could only improve the process of 
     utilizing the pool of competent researchers--not in any 
     manner that would interfere with established fair and open 
     processes for grant-making, but only to increase awareness. 
     It's a fact that a small number--a handful--of Lyme 
     researchers have individually received many millions of 
     federal research dollars, many of whom shared the same set of 
     biases and perspectives. Common biases and perspectives are 
     not objectionable if they are based upon the best scientific 
     evidence; open dialogue, information sharing, and 
     transparency can help safeguard the process and the 
     taxpayers' money.
       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 discussion with diverse viewpoints 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.

               Patricia V. Smith Lyme Disease Association


                          MAJOR POINTS SUMMARY

       1. Lyme disease is increasing in numbers and range 
     worldwide, with CDC announcing U.S. cases are 300,000 
     annually. It is found in about 80 countries worldwide.
       2. A government study has indicated the impact of Lyme 
     disease on patients is as severe as disability of patients 
     with congestive heart failure or osteoarthritis, is greater 
     than those observed in type II diabetes or in recent 
     myocardial infarction, and chronic pain contributing to 
     impairment is similar to that reported by patients with 
     osteoarthritis.
       3. Other tick-borne diseases are being discovered with 
     greater frequency and people are becoming co-infected with a 
     number of diseases.
       4. More ticks are spreading different diseases to humans.
       5. My work with the Lyme Disease Association has put me in 
     close contact with patients who are sick and have other 
     family members with the disease, which is costly to them 
     financially and also impacts education and family structure.
       6. Children are at the highest risk of acquiring Lyme 
     disease. They often miss long periods of school and 
     experience cognitive difficulties, severe pain, and may 
     attempt suicide related to their Lyme disease.
       7. There is a need for HR 610 creating an advisory 
     committee which will permit all stakeholder input, including 
     treating physicians, patients, and advocates, to be presented 
     to government agencies. Currently patients have no voice.
       8. The Committee would ensure that all sides of the science 
     would be factored into the decision making process.
       9. Government agencies need to interact with other 
     government agencies, each bringing different perspectives and 
     priorities to the table.
       10. Having diverse stakeholders at the table ensures all 
     perspectives are heard to develop a comprehensive coordinated 
     approach to tick-borne diseases, helping ensure that 
     government funding is used widely.
       11. Truth in science can be achieved through open 
     discussion with diverse viewpoints in an independent process 
     free from bias and conflicts of interest.

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