1

PA – House and Human Services Committee

 

 
www.LymeDiseaseAssociation.org
Mr. Chairman, committee members:
Thank you for inviting me to testify favorably today on HB 798.
  
  • setting guidelines for quality assurance, or providing standards for reimbursement.

  • Yet, doctors are inappropriately using CDC surveillance criteria to diagnose, and insurance companies are using the criteria to deny reimbursement, thus patients are not getting diagnosed and treated.

    Further clouding the diagnostic and treatment picture are the draconian Infectious Diseases Society of America (IDSA) 2006 treatment guidelines for Lyme, which recommend

    against any long-term treatment for people who are chronically ill with Lyme,

    against entire classes of antibiotics,

    against alternative treatments,

    against some supplements and

    To date, almost 28,000 people have signed an LDA petition opposing the IDSA treatment guidelines on humanitarian grounds. (see www.LymeDiseaseAssociation.org)

    [6]

    [11] and even acne. It appears that with little outcry, animals can be fattened with antibiotics, health care workers can practice shoddy hygiene leading to resistant strains, acne sufferers can get years of treatment, but terribly sick Lyme disease patients are singled out to be left without treatment because of undocumented accusations of resistance.

    In closing, note that this legislation is about safeguarding the right of seriously ill patients to obtain treatment under one of the standards of care. Moreover, a significant body of evidence supports the persistence of the Lyme bacteria after short-term treatment and the efficacy of longer-term treatment approaches. Significantly, the Columbia University NIH-funded long term treatment study, currently in press in the journal, Neurology, found improvement in patients on longer-term therapy. (Other studies in attached table, pp.4, 5).

    2 CDC website

    3 Expert Review of Anti-infective therapy 2(1) Suppl. 2004

    4 http://www.guideline.gov/

    5 L Johnson, JD, MBA et al The Treatment of Lyme Disease: A Medico-Legal Assessment Ex. Rev. Anti-infect. ther. 2(4) 2004

    10 http://www.ucsusa.org/food_and_environment/antibiotics_and_food/myths-and-realities

    Lyme Disease Treatment Studies Table

    Controlled studies of Persistent Lyme Disease

    Study

    Treatment

    Results

    Comments

    Cameron

    (2005) [1]

    3 months treatment with amoxicillin

    Treatment effective for 2/3 of patients with the worst quality of life as measured by SF-36

    Results presented at ILADS 2005 Annual Conference.

    Fallon
    (2004) [2]

    10 weeks of IV Ceftriaxone

    Cognitive improvement

    Krupp
    (2003)[3]

    4 weeks of IV ceftriaxone

    64% showed improvement on fatigue

    No improvement on cognition

    Klempner
    (2001) [4]

    4 weeks IV ceftriaxone then 2 months of oral doxycycline

    No improvement on SF-36.

    Non-Controlled Studies Supporting Longer Treatment Approaches or Retreatment

    Study

    Comments

    Donta
    (1997) [8]

    277 patients with chronic Lyme treated for between 1 and 11 months: 20% were cured, 70% improved and 10% had treatment failure.

    Oksi
    (1998) [9]

    Fallon
    (1999) [11]

    References



     




    ME – Testimony Provided to Insurance/Finance Comm. Bill LD 1521

    LD 1521 Testimony from: Lyme Disease Association, Inc. (LDA)
    Patricia Smith, President    Jackson, New Jersey
    Maine Charity registration # CO3875
    National patient non profit dedicated to funding Lyme disease prevention, education, research, and patient support


     
     
    LD 1521 Testimony from: Lyme Disease Association, Inc. (LDA)
    Patricia Smith, President    Jackson, New Jersey
    Maine Charity registration # CO3875
    National patient non profit dedicated to funding Lyme disease prevention, education, research, and patient support
    www.LymeDiseaseAssociation.org   Lymeliter@aol.com 888 366 6611
     
     
    To Co-Chairs, Senator Nancy Sullivan and Representative John Brautigam, and Members of the Insurance and Finance Committee and Senator Bruce Bryant, Sponsor:
     
     
    I am submitting testimony today regarding Maine Bill LD 1521. While the Lyme Disease Association (LDA), a national non-profit that works with Lyme groups nationwide, is pleased that mandatory insurance coverage for and awareness of Lyme disease has been introduced in the State of Maine, the LDA’s position mirrors that of many Maine support groups− amendments must be added before considering bill passage in order to support patient interests.
     
    A history in Maine shows that patients have difficulty obtaining diagnosis and treatment for Lyme disease, a serious disease which can become chronic and attack joints, muscles, heart and the brain. The bacterium can enter the brain less than 24 hours after a tick bite.[i] Once it becomes chronic, it is difficult to control or eradicate with short-term antibiotic treatment. Patients sometimes require repeated courses of antibiotic therapy over months or years to eradicate or control symptoms.
     
    Patients and treating physicians struggle with regulations and policies from government agencies, insurance companies, and others in order for patients to receive the treatment necessary to live productive lives.  Doctors who treat the disease are already scarce due to the controversy, and patients often travel many hours to other states to obtain appropriate treatment.
    The concern here is that the language of Sec. 1. 24-A MRSA §2745H, Lyme disease coverage, is too general in nature and could easily be manipulated by insurers to the detriment of Lyme disease patients. For example, this proviso has no definition for Lyme disease contained within the language. If the insurer interprets that language to mean Lyme disease as defined by the federal Centers for Disease Control & Prevention (CDC), many Lyme patients will remain undiagnosed and untreated. The CDC indicates that its definition is for surveillance purposes only and not meant for diagnosis nor for reimbursement. That fact has not previously stopped insurers, however, from using the definition.
    If insurers interpret the language using the 2006 Infectious Diseases Society of America (IDSA) guidelines for Lyme disease treatment as a basis for definition, patients will be denied treatment, and maybe even the diagnosis of Lyme disease will be disputed. These guidelines do not recommend any doctor discretion in diagnosing, any long-term treatment, and do not recognize chronic Lyme disease as a treatable condition. This is at odds with the fact that Columbia University is poised to open the first endowed Center to study chronic Lyme disease in the world on April 30, 2007, with monies raised by the patient organizations, LDA and its Connecticut affiliate, Time for Lyme
    These IDSA guidelines have already begun to be cited by insurers, government agencies, even pharmacists, to prevent Lyme disease patients from receiving treatment necessary for their disease. These same guidelines are currently under investigation by the Connecticut State Attorney General, who has served the IDSA itself with a Civil Investigative Demand (subpoena), citing possible exclusionary conduct and monopolistic practices in the guidelines’ development process as a basis for his action.
     
    We feel that the use of these guidelines as a definition for Lyme would almost certainly result in the increase in chronic Lyme disease cases due to lack of doctor discretion in diagnosing. Chronic Lyme is more costly to patients physically, mentally, and financially. According to a 1998 study in a CDC journal, early Lyme costs* averaged $161 per patient and neurologic longstanding Lyme disease averaged $61,243.[ii] Chronic Lyme is also more costly to the state and federal government in terms of disability and other costs such as those incurred by school districts for impacted areas such as special services, home instruction, and substitute teachers. [iii]
    The LDA and its Rhode Island Chapter worked with the legislature there to develop and pass a bill into law in Rhode Island which provides mandatory insurance coverage for Lyme patients. Additionally, the legislature passed into law protection for treating physicians. These laws have more specific defined language which may be useful to the Maine legislature in crafting an amendment which will benefit Maine patients, since Rhode Island patients are currently receiving benefits under the existing law
    Maine needs an education program. In 2005, it was 10th nationally in rate of incidence (18.7/100,000 pop.). The federal CDC states that only 10% of cases that meet its narrow surveillance criteria are reported, therefore Maine’s 247 reported cases in 2005 represent about 2,470 actual cases that meet the CDC surveillance criteria. That number does NOT in any way count the number of people contracting Lyme who do not meet the CDC criteria, which are for surveillance, not diagnostic, purposes.
     
    In reference to Section 3 of the bill, the language therein should be amended to include the participation of members of the public in the process, specifically, Lyme patient advocates, who are stakeholders in the process. Government agencies often do not have the resources or manpower to be on top of every issue in their state, and patient input is key to having a balanced report which reflects reality rather than just fiscal concerns which state agencies often face. 
     
    This well-intentioned bill should have further committee discussion with stakeholders to develop amendments to ensure it will be beneficial for Maine residents. Thank you.
     
     


    [i] Steere, Allen, Mandel, Douglas, and Bennett’s Principals & Practices of Infectious Diseases, 4th ed. 1995.

    [ii]Martin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8.
    * This is in 1996 costs not adjusted to 2007. The following additional significant costs to society aren’t measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.

    [iii] Patricia Smith, Wall Township, NJ, Board of Education member NJ School District Study on Impact of Lyme Disease on School Districts presented in Washington DC Congressionally hosted meeting with CDC & NIH, March 12, 1992.

     




    MD – Senate Testimony Against Lyme Bill

    ,
    Thank you for this opportunity to testify today.

     

    ,
    Thank you for this opportunity to testify today.
     
    All that glitters is not gold, and if Shakespeare were here today, he would agree that adage applies to the well-intentioned HB 836. The appealing title, Public Health- Lyme Disease – Public Awareness, belies the danger lurking in the language—a danger which threatens all Maryland residents—those with and without Lyme disease and the doctors treating Lyme disease.
     
     
    [i]
     
    These guidelines will:
    • [ii]
    • result in patients being denied alternative treatment for Lyme disease
    • limit doctor discretion in diagnosing Lyme disease
    • result in more chronic Lyme disease and
    •  
    [iii] And the bill includes $1,334,100 of State money to distribute guidelines which may be in violation of antitrust law.
     
     
    [iv] Doctors would not be able to diagnose using their clinical discretion and many children would get missed, resulting in the tragedy of chronic disease and costing the child his/her entire childhood.
     
    Testimony of Patricia V. Smith     HB 836
    President, Lyme Disease Association, Inc.
    April 4, 2007
     
    Education, Health and Environmental Affairs Committee
    Senator Joan Carter Conway, Chair
    Roy P. Dyson,V. Chair                                  

     
     
     
     
     
     
     
     
    Lyme Disease Association, Inc.
    MD Charity # 13447
    www.LymeDiseaseAssociation,org
    888-366-6611
    Lymeliter@aol.com
     
    National all-volunteer non profit patient group dedicated to funding
    Lyme disease education, prevention, research and patient support
     
     
     
     
     
     
     
     
     
    Endnotes


    [i] Wormser, G, et al, “The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America;” Clinical Infectious Diseases 2006;43:1089-134

    [ii] Lyme Disease Association, Inc.; compilation of patient complaints on use of current IDSA guidelines and the prior version which were less restrictive, to cut of patient treatment, diagnosis, and dispensing of prescriptions

    [iii]Coyle, Marcia, “Antitrust Scrutiny of Lyme guidelines,” National Law Journal, January 22, 2007

    [iv] CDC website

     




    MD – House Lyme Bill HB836

    |
    Testimony of Patricia V. Smith
    President, Lyme Disease Association, Inc.


     
     
    Testimony of Patricia V. Smith
    President, Lyme Disease Association, Inc.
    March 13, 2007
     
      
    Health and Government Operations Committee
    Peter A. Hammen, Chair
    Marilyn R. Goldwater, V. Chair
     
     
     

     

    Lyme Disease Association, Inc.
    MD Charity # 13447
    www.LymeDiseaseAssociation,org
    888-366-6611
    mailto:Lymeliter@aol.com
     
     
     
    Mr. Chairman,
     
    I am submitting testimony today in regard to HB 836 (Montgomery). While the Lyme Disease Association (LDA), a national non-profit with affiliated groups in Maryland, is pleased that an awareness bill has been introduced, the LDA feels that amendments must be added to the bill to support patient and treating physician interests.
     
    A history in Maryland shows that patients have difficulty obtaining diagnosis and treatment for Lyme disease, a serious disease which can become chronic and attack joints, muscles, heart and the brain. Once it becomes chronic, it is difficult to control or eradicate with short-term antibiotic treatment. Patients sometimes require repeated courses of antibiotic therapy over months or years to eradicate or control symptoms.
     
    Patients and treating physicians struggle with regulations and policies from government agencies, insurance companies, and others in order to receive the treatment necessary for the patients to live productive lives.  Doctors who treat the disease are already scarce due to the controversy,and patients often travel many hours to other states to obtain appropriate treatment.
     
    The concern here is that the Maryland Department of Health and Mental Hygiene (DHMH) will follow the path it has already begun and disseminate biased information from physician organizations such as the Infectious Diseases Society of America (IDSA). These IDSA treatment guidelines recommend against physician discretion in diagnosing Lyme disease as well as against most classes of antibiotics used by treating physicians and alternative treatments and supplements–bottom line, no treatment for chronic Lyme patients.
     
    This supposition about the DHMH is based upon its already failed attempt to work with patient groups here in Maryland. A committee was formed and patients met with DHMH, but the direction of DHMH was biased toward short-term therapy, despite patient examples of positive responses to longer-term therapy. Patient representatives withdrew from the committee.
     
    Maryland needs an education program. In 2005, it was 7th nationally in total case numbers (1235) and 9th in rate of incidence (22.1/100,000 pop.). The Centers for Disease Control & Prevention (CDC) states that only 10% of cases that meet its narrow surveillance criteria are reported, therefore about 12,350 new cases of Lyme disease occurred in Maryland in 2005. That number does NOT in any way count the number of people contracting Lyme who do not meet the CDC criteria, which are for surveillance, not diagnostic, purposes. CDC statistics indicate Lyme is most common in boys ages 5-19 and combined boys & girls, ages 5-9.
     
    Maryland needs an educational program that will be beneficial to patients. At this time, I ask that you only consider favorably the passage and release of HB 836 with the following amendments to protect the physicians who treat and the patients who require treatment−amendments supported by many Maryland Lyme disease patient organizations:
     
    REPLACE existing Section A (2) line 15-17, (IV) with
    (IV) Develop and disseminate balanced educational materials to health care providers including National Guideline Clearinghouse peer-reviewed guidelines for the diagnosis and treatment of early and chronic Lyme disease;
     
    ADD in Section 2, as lines 27-28
    AND BE IT FURTHER ENACTED, That this act shall take effect October 1, 2007. It shall remain effective for a period of two years and the provisions herein shall be accomplished by October 1, 2009, and with no further action required by the General Assembly, this Act shall be abrogated and of no further force and effect.
     
    Thank you for your consideration. Do not hesitate to contact me.        Pat Smith, President, LDA



    CT – Public Health Committee

    |
    Written Testimony for the Connecticut Public Health Committee February 26, 2007

     

     


                                                                     

    LDA CONNECTICUT PARTNERS
    LDA Affiliate Time for Lyme, Inc. Greenwich, CT
    LDA Supporter Newtown Lyme Disease Task Force  Newtown, CT
     
     
    Written Testimony for the Connecticut Public Health Committee February 26, 2007
     
    Co-Chairs and Committee Members,
    Thank you for the opportunity to testify on this very important piece of Lyme disease legislation, Bill 5747 (Bartlett).
     
    Since Connecticut’s 2003 removal of mandatory lab reporting, Lyme disease reported case numbers have reflected a paper drop[1] which is dangerous to Connecticut residents. A drop in numbers translates into decreased awareness which often leads to a delayed diagnosis. According to an actuarial study in the journal Contingencies on Lyme disease costs, “37% of the financial costs of this disease is incurred before the correct diagnosis is made.” [2] 
     
    A delay in diagnosis also leads to more chronic disease since the Lyme bacterium can get into the brain within 24 hours of a tick bite.[3] Chronic Lyme is more costly to patients physically, mentally, and financially. According to a 1998 study in a CDC journal, early Lyme costs* averaged $161 per patient and neurologic longstanding Lyme disease averaged $61,243.[4] Chronic Lyme is also more costly to the state and federal government in terms of disability and other costs such as those incurred by school districts for impacted areas such special services, home instruction, substitute teachers. [5]
     
    Statistics drive our society, and a perceived decrease in Lyme disease cases may also result in public complacency and lack of precautions. This complacency results in a higher disease incidence. According to the CDC, Lyme disease is most common in boys ages 5-19 and combined boys & girls ages 5-9.[6] That lack of awareness has the greatest impact on our most vulnerable resource, our children.
     
    According to a CDC study of 65 children with Lyme disease in grades K-12 in a 5 township area of Monmouth & Ocean Counties in New Jersey, the median number of school days missed was 140, with median duration of home instruction,153 days. 78% of parents said their children experienced a fall in grade point average during the time of illness. 78.6% experienced a decrease in friends. “…often, patients spent large blocks of time as semi-invalids, isolated from social groups and missing out on cultural, sports and social activities….School performance of nearly all patients fell sometimes drastically, and in several instances, was said to interfere with selection by colleges and universities.”[7] A study at Columbia University demonstrated a drop in 22 points in IQ of a student with Lyme disease, later reversed with treatment.[8]
     
    Case numbers drive awareness and lessen public complacency. Without mandatory lab reporting, Connecticut’s reported cases over three years, from 2003-05, totaled 4,561. That total number is lower than total number of reported cases for the single year 2002, the last year lab reporting was mandatory−4,631 reported cases. [9]
     
    Disease funding is often predicated on case numbers. The plunge in Connecticut reported cases played a significant role in the nationwide case decline in 2004.[10] In 2004, the federal government expended $33.6 million total on Lyme disease. In 2005, the government figure dropped 3% to $32.6 million,[11] in an area already vastly under funded. It does not help that reported case numbers are only 10% of actual case numbers[12] meeting the CDC surveillance criteria and that no one tracks cases that do not meet the CDC surveillance criteria.
     
    Connecticut and Rhode Island numbers were artificially lower in 2005. Rhode Island had made some internal changes to its reporting system effective in 2005[13] but quickly understood the negative significance of its reporting changes and promptly rectified its methods.** Its reported numbers are again justifiably on the rise. California instituted mandatory lab reporting of Lyme disease in September 2005, and its case numbers went from 32 cases in 2004 to 174 cases in 2006.[14] 
     
    Facts support the reinstatement of mandatory lab reporting which should be implemented in conjunction with a two-tier reporting system for Lyme disease. LDA made this recommendation as a member of the Connecticut Lyme Disease Coalition to Commissioner Galvin and the Attorney General in an April 2004 private meeting. Currently, all cases are initially accepted and screened and those meeting the surveillance criteria are sent to the CDC for surveillance purposes. Other cases not meeting surveillance criteria are discarded. The two-tier system would require a subsequent step, the now discarded cases would be filed in a separate tier as physician diagnosed, non-surveillance cases.
     
    Benefits are that doctors would be more inclined to spend the time and money to report cases, thus there would be better tracking of cases; doctors would be more willing to diagnose and treat knowing their clinical diagnoses are accepted and not looked upon with suspicion; there would be a more widespread acceptance that the surveillance criteria are not diagnostic tools; and less chronic disease would result. If this were implemented along with reinstated mandatory lab reporting, Connecticut would have the most effective tracking system in the country for Lyme disease cases. Thank you.
    Endnotes


    [1] Centers for Disease Control & Prevention, Lyme Disease Cases by State 1993-2005 http://www.cdc.gov/ncidod/dvbid/lyme/resources/StateTable_05.pdf, last reviewed Aug. 28, 2006.

    [2] Irwin Vanderhoof, Lyme Disease the Cost to Society, Contingencies January/Februray 1993.

    [3] Steere, Allen, Mandel, Douglas, and Bennett’s Principals & Practices of Infectious Diseases, 4th ed. 1995.

    [4]Martin I. Meltzer The Cost Effectiveness of Vaccinating against Lyme Disease CDC Emerging Infectious Diseases; Vol.5, No.3; 1999 May-June;5(3)321-8.
    * This is in 1996 costs not adjusted to 2007. The following additional significant costs to society aren’t measured by this table: special education needs for children, disability, increased medical and insurance costs, and livestock losses, etc. Also, there are personal loses: friends, employment, self, esteem, domicile, and breakup of families.

    [5] Patricia Smith, Wall Township, NJ, Board of Education member NJ School District Study on Impact of Lyme Disease on School Districts presented in Washington DC Congressionally hosted meeting with CDC & NIH, March 12, 1992.

    [6] Centers for Disease Control & Prevention Average Annual Incidence of Reported Cases of Lyme Disease by Age Group & Sex http://www.cdc.gov/ncidod/dvbid/lyme/ld_MeanAnnualIncidence.htm.

    [7] CDC presented study in Wall Township, NJ, October 1992 at Congressional meeting. Study later published in Lyme Times Children’s Educational Issue, ed. CALDA, Summer 2006.

    [8] Brian Fallon MD The Underdiagnosis of Neuropsychiatric Lyme Disease in Children & Adult, The psychiatric Clinics of North America, Vol.21, No.3, Sept.1998.

    [9] Centers for Disease Control & Prevention Lyme Disease Cases by State 1993-2005

    [10]Statement based on CDC figures, see endnote 1.

    [11] Figures obtained from NIH website and from the CDC through (NJ) Congressman Christopher H. Smith’s office.

    [12] Paul Meade, Centers for Disease Control & Prevention; Jessica Adler, Lyme Disease, NJ Herald News 5-4-04

    [13] LDA phone conversation with Rhode Island DOH’s Dr. Bandy on several occasions including 2-23-07.
    ** Rhode Island did not end mandatory laboratory reporting at any time.

    [14]Department of Health Services, State of California, California Summary Monthly Report Selected Reportable Diseases, http://www.dhs.ca.gov/ps/dcdc/pdf/cdtables/CM-SEP2006.pdf, September 2006, Report Weeks 36-39 September 3- September 30, 2006.




    NJ – Assembly Health Sub Committee Bill A269

    Testimony to New Jersey Assembly Health Committee June 12, 2006
    By Pat Smith, President, Lyme Disease Association, Inc.
                                                 
    Testimony to New Jersey Assembly Health Committee June 12, 2006
    By Pat Smith, President, Lyme Disease Association, Inc.
    CDC reported case numbers nationwide for Lyme have ranged from 20,000-24,000, representing only 10% of actual cases meeting the CDC surveillance criteria[ii] so up to 240.000 new cases occur annually that do meet the CDC criteria, a number that does not even include cases that fall outside the CDC surveillance criteria. Preliminary 2005 CDC numbers show Pennsylvania (5449) New York (4031), and New Jersey (3372), 1,2,3, respectively, in reported Lyme cases, with a 25% increase in NJ cases over 2004 (2698).
    [iii] Studies published in JAMA and elsewhere show that Bb antibodies form immune complexes, limiting the ability of the ELISA screening test, since it can only detect free antibody. [iv]
    [v]
    [vi]
    Thanks to theNJ Assembly for unanimously approving AR-55 supporting these bills. 
    NASA and the NIH have a joint culturing project for bacteria including Borrelia burgdorferi, the Lyme disease causative agent, using microgravity chambers, which mimic conditions in space and in the human body. [vii]This could lead to better success culturing this organism which now is difficult to do. The NIH has just funded a study to map the genome of the deer tick, and according to one of the NIH project researchers, tick expert Dr. Stephen Wickel, the army just kicked in almost $5 million because they fear that ticks will be used to spread bio warfare agents.[viii]
    Other proposed solutions
    For the Department of Health (DOH):
    Department of Education (DOE): remind school districts that mandatory inservice is required for staff who have children with Lyme disease, keep properties maintained, post tick warnings where necessary, and develop trip policies reflecting high risk areas.


    [vi] Horizon Blue Cross Blue Shield letter to patient, August 24, 1999

    [viii] Shapley, Dan Speakers Hail Lyme Research Poughkeepsie Journal April 27, 2006

    MA – Combined Health Committee Hearing on Lyme Disease

    TESTIMONY TO MASSACHUSETTS COMBINED HEALTH COMMITTEE
    By Pat Smith, President, Lyme Disease Association, Inc. 10-12-05

    Personal Background: President of the Lyme Disease Association (LDA), Vice President of Political Affairs, International Lyme and Associated Diseases Society, (ILADS), a professional medical society, and former chair of the [New Jersey’] Governor’s Lyme Disease Advisory Council, and former president of the Wall Township Board of Education. I also sat on the hearing panel for this committee in Ayer this past summer.


    LDA Background: LDA is an all-volunteer national organization whose goals are education, prevention, research and patient support. LDA has supported research projects coast to coast, many published in peer review including JAMA, Infection, Neurology, and Proceedings of the National Academy of Science. LDA has five chapters (including one on the Cape, W. Barnstable), and 7 affiliates, and along with its CT affiliate, TFL, LDA is partnering with Columbia University to open an endowed chronic Lyme disease research center, the first of its kind in the world. 75% of the funds needed to open the center have been raised to date with actress Mary McDonnell, LDA’s national spokesperson, supporting the project. LDA has the LymeAid 4 Kids fund for children without insurance to be evaluated for Lyme disease and that is supported by internationally acclaimed author Amy Tan.

    Lyme is the most prevalent vector-borne disease in the US today. Research has shown the Lyme bacteria has the ability to enter the central nervous system less than a day’s time after a tick bite, yet Lyme is rarely given the weight it deserves to be given. Witness the Center’s for Disease Control & Prevention’s (CDC) recent expenditures on Lyme disease: $7M annually.

    Lack of funding and focus have lead to lack of physician education. It has also created a climate of fear for potential treating physicians who are often afraid to diagnose and treat patients due to medical board investigations nationwide of those treating chronic Lyme disease, investigations often initiated by insurers or other physicians who do not recognize chronic disease. Sanctions including supervision, fines, losing ability to treat Lyme patients, and license suspension and revocation have been imposed. This in turn has created a situation where patients are unable to obtain diagnosis, treatment, insurance reimbursement, disability, education or even understanding from their families and peers.

    The need for more treating physicians becomes apparent when one examines the CDC reported case numbers which range from 20,000-24,000 annually nationwide, numbers which represent only 10% of actual cases meeting the CDC surveillance criteria according to the CDC, thus up to 240.000 new cases actually occur annually that do meet the CDC criteria.

    That represents almost ¼ M new cases, a number that does not even include cases that fall outside the CDC surveillance criteria, incredibly, a number no one knows, because the CDC does not require record keeping on those cases. In fact, these physician-diagnosed cases are rejected by health departments if they are reported, because CDC does not accept them.

    In 2004, New York (5100), Pennsylvania (3985), New Jersey (2698), and Massachusetts (1532) ranked 1,2,3,4 respectively in reported Lyme cases with Rhode Island 10th (249), New Hampshire 11th (226), Maine 12th (225), and Vermont 17th(50). Massachusetts continues to be 4th in 2005 reported cases (758).

    Reported cases meet the surveillance criteria if the patient has a physician-diagnosed EM (bullseye) rash, or positive blood work and other system involvement. Studies have shown that the EM rash appears less than 50% of the time, and Lyme disease testing, especially the initial required screening test, the ELISA, is highly inaccurate. According to a letter from the NY DOH in 1996 to the CDC, if NY had followed the 2-tier testing requirement for 1995 cases, using first a + ELISA test requirement, 81% of non-EM cases would not have been confirmed. The CDC states that doctors should not use surveillance criteria for diagnosing Lyme, yet many physicians continue to do so.

    This creates a controversy which pits physicians primarily from academia who only diagnose based on CDC guidelines and treat short-term against primarily physicians in a clinical setting who diagnose outside the CDC guidelines and treat long-term when necessary and their patients who are experiencing symptom relief from extended treatment. Beyond that controversy is something few dispute: if diagnosed and treated early, Lyme disease can usually be treated rather successfully with a four to six week course of antibiotics. The dispute arises because the tests are not reliable, Lyme mimics other conditions such as MS, ALS, Lupus, even autism and Alzheimer’s, and Lyme is often accompanied by other tick-borne diseases, clouding the diagnostic picture further. Thus diagnosis is difficult and does not fit a text book definition, and delaying treatment or providing inappropriate treatment can lead to chronic disease, developed by an estimated 15 to 35% or more of patients.

    Patients diagnosed with chronic Lyme disease often cannot buy life insurance policies, nor can they donate blood. Red Cross blood donor guidelines distinguish between Lyme disease and chronic Lyme disease, “Accept persons with Lyme disease if they were treated, the disease resolved and at least one year has passed. Those with chronic Lyme disease are not eligible to donate blood.” The American Society of Clinical Pathologists (ASCP) blood donor guidelines state under “serious illness,” “defer indefinitely…Lyme disease.” The bacteria that cause Lyme have been shown to survive blood banking conditions, although to date, no cases of Lyme disease transmission have been reported to occur through blood donations.

    Doctors are faced with a dilemma: do they treat sick patients who do not meet the CDC surveillance criteria and patients with chronic symptoms? Besides pressure from medical boards, doctors are pressured by insurance companies who often deny coverage to anyone not meeting CDC surveillance criteria, despite CDC’s warning that the guidelines are not meant to be used as reimbursement criteria. Doctors indicate that insurance carriers strongly suggest they stop treating Lyme patients long-term or leave the plan. While a few continue to treat, some refer their patients to other long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients.

    An insurance company letter to a New Jersey patient typifies what is happening: “Unfortunately, a number of unscrupulous practitioners in this and neighboring states have held themselves out as experts in the treatment of Lyme disease. These individuals have subjected patients to improper diagnoses, excessive treatments, inordinately long courses of intravenous therapy, and other activities not supported by science or generally accepted standards of medical practice. Because our organization has been appropriately vigilant and aggressive in dealing with certain practitioners, they have chosen to leave our network.”

    While trying to solve the issue of physicians right to treat in NY several years ago, LDA was told by the NYS Office of Professional Medical Conduct (OPMC) that they get some of their best tips from insurance companies. Fortunately, the Lyme treating issue has been resolved in NY by a memo from the OPMC to its staff stating that physicians cannot be investigated by the OPMC based solely on their long-term treatment of Lyme disease.

    In order to better educate physicians and to allow treating physicians and patients to have input into Lyme disease policies at the federal level, companion bills have been introduced into the US House (HR 3427, Smith/Kelly) and US Senate (S 1479, Dodd/Santorum). They provide $100M over 5 years for Lyme disease research and education to be utilized for well delineated goals. LDA sent a letter to all senators and representatives signed by 90 nationwide groups, including several in Massachusetts, supporting the bills, which also create a patient/ physician/researcher task force with input to Health & Human Services (HHS).

    LDA has briefed HHS in DC on doctor patient issues and expects to meet with them soon for further discussion. In September, LDA met with US Army CHPPM (Centers for Health Promotion & Preventive Medicine) at Aberdeen Proving Grounds where they are testing ticks from military bases for Lyme and other tick-borne diseases such as RMSF, Ehrlichiosis, Anaplasmosis, Babesiosis, and STARI (Southern Tick-Associated Rash Illness) a Lyme-like disease carried by the Lonestar tick. The army has also developed a laptop sized testing device which can be used in the field for PCR testing of ticks so that those bitten can immediately know if the tick carries Lyme disease and can receive treatment if necessary. US Army CHPPM has patented the device and is in discussions with a private company to produce the product.

    Since the late 80’s, CHPPM has mapped all the major military installations in the country for tick populations and has created risk assessments for Lyme disease at each installation. Now CHPPM is doing the same for tick infectivity rates. The information can be beamed to satellites and then eventually to handheld receivers to be carried in the field, advising the troops where the population and infectivity rates of ticks are high, so they may maneuver troops around high risk areas. CHPPM has recently used the GIS tick data on its Virginia Ft. A.P. Hill installation which hosts the Boy Scout jamboree to determine where ticks were located so they could map and spray those areas for ticks before the Scouts arrived. (map)

    Obviously, prevention is the best practice, but that does not solve the problems of those already infected and those with chronic disease which is why we are here today. The physicians’ right to freely practice medicine without vested-interest interference and the patients’ right to receive timely diagnosis and appropriate treatment need to be considered in the context of a quote from CDC spokesman Paul Meade in Sunday’s NH Union Leader. "Can I say chronic infection never, ever occurs? No, of course I can’t, and that’s where one has to not be dogmatic about these things," says Meade. These are the reasons why today’s hearings are necessary and not unprecedented. Connecticut, Rhode Island, and New York have held two hearings and Texas and California, one. Officials in other states such as Pennsylvania, New Jersey, and Maryland have met with LDA to discuss these issues, and New Hampshire Governor Lynch invited me to speak there at a May press conference.

    Legislative and policy solutions to Lyme problems include RI’s mandatory insurance coverage and doctor protection, CT’s insurance coverage with some limitations, California’s and NY’s Lyme treating physician protection based on existing protections for doctors using non-conventional treatments, NJ’s addition of Lyme-literate doctors to its State Board of Medical Examiners Review Board, NJ’s mandatory teacher in-services for educators who have students with Lyme disease, and the creation of advisory councils in a half dozen states.

    The Lyme Disease Association offers the following relatively low cost easy to implement ideas for consideration by Massachusetts officials. (Full chart distributed) For the Department of Health (DOH):
    • send letters to all licensed physicians in the state explaining that CDC surveillance criteria are not to be used for diagnosis and that Lyme is a mandatory reportable disease.
    • send a letter to family care agency telling them not to use Munchausen by proxy label against parents who are having children treated long-term for Lyme disease.
    • require Lyme disease continuing medical education (CME) credits for state-licensed physicians. Alert physicians about available conferences including those that cover chronic Lyme disease such as LDA/Columbia University conference and the ILADS conference to be held October 28 and the 29th/30th, respectively, in Philadelphia.
    • develop a system to track physician-diagnosed cases that do not meet CDC criteria to determine the true incidence of the disease. The DOH already has these reports from physicians.
    Department of insurance (DOI):
    • alert insurers that they cannot deny Lyme disease treatment based on the CDC . . surveillance criteria.
    Department of Education (DOE)
    • encourage schools in endemic areas to provide educational forums on Lyme disease . for staff and students, to keep properties maintained, post tick warnings where . .. …necessary, and develop trip policies reflecting high risk areas.

    The legislature should consider introducing doctor protection measures and mandatory insurance coverage for doctor-recommended treatment like RI has adopted. The adoption of such measures will ensure that patients receive necessary diagnosis and treatment, cutting costs long-term by reducing disability, special education costs, and the other costs associated with chronic Lyme disease. You have the rare opportunity to save thousands of people untold suffering, many of whom may be our children and grandchildren, who run some of the highest risk of acquiring the disease. Playing outdoors, petting the dog, rolling in the leaves, and sitting on a log are all risky behaviors for the development of Lyme disease, yet are all activities enjoyed by children. Keep that in mind while listening to patient stories today. Thank you.

     1 Dr. Paul Meade, CDC epidemiologist, Lyme: Battles with Illness, Emotions, Insurers, Jessica Adler, (NJ) Herald News 5-4-04

    2 Horizon Blue Cross Blue Shield letter to patient, August 24, 1999




    NH – Senate Health & Human Services Comm.

    Click here for printable pdf

    March 29, 2005

    Testimony of Pat Smith, Lyme Disease Association, to the New Hampshire Senate Health & Human Services Committee


    I want to thank Senator Kenney for introducing the bill and for requesting LDA testimony and the Committee for their time and consideration of the bill.

    Lyme is the most prevalent vector-borne disease (insect & tick-borne) in the US and the most prevalent vector-borne bacterial disease in the world.(1) Different ticks are now carrying Lyme or a Lyme-like illness called STARI, southern tick associated rash illness.(2) The range of these ticks appears to be spreading with the lone star, which 15-20 years ago only was found far north as central New Jersey, now found as far north as Maine.

    With one tick bite, you may contract one or more tick-borne diseases (TBD) some of which include Lyme, babesiosis, anaplasmosis, Ehrlichiosis, bartonella, tick paralysis, STARI, and tularemia, complicating an already difficult diagnostic process and treatment regimen.

    From poppy-seed to sesame seed size, deer ticks, the main Lyme disease tick vector, can transmit bacteria that can wreak untold havoc on the infected individual and family. Dozens of doctors, years of treatment, lost income, and piles of unpaid medical bills are only part of the scenario; the lack of emphasis placed on Lyme disease by many in the medical and governmental communities is another. To help address that education issue, LDA and Columbia University will jointly present LDA’s 6th Lyme & Other Tick-borne Diseases conference this year in Philadelphia in October for physicians and health care providers and the public.

    Lyme disease is serious. The bacterium can enter the central nervous system within hours of a tick bite (3) ; it can hide in your cells: a Sept 2004 article in The American Journal of Pathology presents research that confirms that the bacterium is able to hide in certain places in the body (skin & Joints) and evade the immune system. Also, it can mutate, change into forms unrecognizable to conventional antibiotics, and can go in and kill cells that are supposed to kill it (see photo at end). It can even perform a Star Wars maneuver: it can enter your cell and come out cloaked in the body’s own membrane, (4) unrecognized as the enemy it is. It can cross the placenta, it can cause birth defects and death of the fetus, and it can kill those infected.

    Lyme can attack every system in the body and is called the great imitator since it can mimic many other conditions including MS, ALS, CFS, FM, lupus, Parkinson’s, Alzheimer’s, and even autism.

    Research has shown that the bacteria can survive in blood under blood banking conditions, (5) and the Red Cross has changed blood donor guidelines now prohibiting those diagnosed with chronic Lyme disease from giving blood.

    Our children are at the greatest risk of acquiring the disease, and they may spend years out of school due to effects of the disease. Columbia University research has demonstrated a 22 pt. IQ drop in a Lyme patient, reversed with treatment. (6)

    LDA and its CT affiliate Time for Lyme are partnering with Columbia University to open an endowed research center there for studying chronic Lyme disease. LDA is also supporting research mapping genomes of different strains of the Lyme bacteria. The first phase of that research was published in The Proceedings of the National Academy of Science, Sept 2004, initially funded by LDA and later joined by NIH funding. That research showed that different strains of Borrelia can quickly exchange genetic material among themselves enabling them to better survive and confound testing procedures.

    Unfortunately, the monies our organizations can provide are relatively small, but research requires a concrete monetary commitment commensurate with Lyme’s status. Based on Centers for Disease Control reported case numbers which it says are only 10% of cases that meet its criteria, about 220-240,000 new cases of Lyme disease develop each year, and research studies have shown a prevalence of persistence of 34-62% of Lyme patients. (7)

    The Society of Actuaries conducted a study of over 500 patients and found the average reported costs of the difficult cases was over $60,0000 patient. (8) A CDC 1992 NJ school district study showed median total direct medical costs at $48,000/child in a study where the mean was 103 days out of school, and the mean duration of illness was 753 days. (9)

    Yet the government, particularly the CDC, is expending relatively small amounts of monies to research the disease. In 2003, LDA took a team of 14 to Washington DC to present to the Health & Human Services office of Tommy Thompson the issues surrounding Lyme disease─one issue the lack of funding. The CDC, for example, from 99-2003, shows its LD funding was constant at $7 million, totaling $35 million over the period, while West Nile went from $0 to $38 million, totaling $119 million over the same period.

     2005-03-29 NH SenateHlthHumanServCommGrph

    Resolutions such as your can make a difference in the funding area. Note the reference to increased public/political attention to disease resulting in separate accounting below from the CDC:

    In addition, separately tracking diseases in the accounting system usually occurs when: new money is appropriated from Congress for the first time for a specific disease; when there is an outbreak of a new disease; and when there is increased public/political attention to a disease. (10)

    Remember that Lyme disease does not discriminate, nor does it confer immunity. Risky behavior includes walking the dog, jogging, or playing in the backyard. The only thing standing between you, your family, and Lyme disease may be the power of new government research monies to unlock the secrets of Borrelia burgdorferi, a bacterium causing Lyme disease.

     2005-03-29 NH SenateHlthHumanServCommPic

    A scanning electron microscope image of Borrelia burgdorferi penetrating a human B cell at a magnification of ~13,700
    Courtesy: David Dorward, PhD Rocky Mountain Labs MT

     

     

     

    2005-03-29 NH PatSmithSignature

    I will be available for speaker phone questions if necessary after 10am Tuesday March 30 at 732 938 4834.

     


    End Notes:

    1CDC website
    2CDC website
    3Steere A et al Bennett’s Principles & Practices of infectious Diseases 1995
    4David Dorward, PhD, NIH Rocky Mt Labs
    5Johnson SE et al J Infec Dis 1990 Aug;162(2):557-9
    6Fallon B et al The Psychiatric Clinics of NA Sept. 98
    7Shadick NA et al Annals of Internal Med. 94. Asch ES et al Rheumatol. 94.
    8Vanderhoof et al Contingincies, 93.
    9CDC & NJDOH field study 1992 unpub. Presented at Congressional Lyme Forum Wall NJ 1992
    10Information presented by LDA Team to HHS in DC meeting, Nov. 2003

     




    RI – Assembly Committee Hearing

    By Pat Smith, President, Lyme Disease Association, Inc. 6-26-03

     

     

     

    By Pat Smith, President, Lyme Disease Association, Inc. 6-26-03
    NASA and the NIH have a joint culturing project for Lyme disease and other bacteria using microgravity chambers, which mimic conditions in space and in the human body. [1]This work is showing how complicated relationships are from bacteria to bacteria and how they may communicate to evade body defenses and perhaps even treatment.
    New York has the highest reported case numbers, although CDC data from 1990-1999 lists Rhode Island with an annual Lyme disease incidence rate of 39 per 100,000 of population, behind only Connecticut.[3] Interestingly, Maine recently reported an upsurge in both tick populations and the disease itself.[4]
    [7]Excerpts from Lyme disease protocols used by insurance companies seem to support that the insurers improperly use the surveillance criteria to deny treatment to Lyme patients.
     
    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.”
     
    Doctors will try to support their diagnosis of Lyme disease by ordering direct detection tests such as PCR, which doctors feel are more accurate. Insurance companies often do not accept PCR for a Lyme disease diagnosis, although PCR is accepted for other diseases such as HIV, hepatitis, and TB. Insurers also may limit treatment to 28 days and/or substitute orals for IV medications, when doctors often prescribe IV treatment for Lyme disease that has invaded the central nervous system.
     
     Several studies have been done with oral versus IV medications including one published called “Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borelliosis” by J. Oksi, et al.[8] Two treatment regimens for disseminated Lyme (mainly neurologic and musculoskeletal manifestations) were compared. A group of 30 patients received orals for 100 days. Another group of 30 patients received intravenous ceftriaxone for 14 days followed by orals for 100 days. The total number of patients with relapses or no response at all and the number of positive polymerase chain reaction findings after therapy were greater in the oral group. The general outcomes of infection in patients with disseminated Lyme after 3-4 months of therapy indicate that prolonged courses of antibiotics may be beneficial.
     
    Dr Brian Fallon, Columbia University, also published that a repeated course of intravenous antibiotic therapy results in marked improvement in memory, attention, and overall functioning.[9] 23 patients with complaints of persistent memory problems who had previously received 4-16 weeks of intravenous antibiotic therapy were given either IV, orals or intramuscular injections. Patients given intravenous antibiotics showed the greatest functional improvement (pain, physical functioning, energy) and the most cognitive improvement even when controlling for differences in cognition at baseline between the groups. The results of this preliminary study were given to the NIH as a basis for applying for and receiving the $4.7 million NIH grant for the treatment study now underway.
     
    We have heard from physicians throughout the country that their insurance carriers strongly suggested they either leave the plan or stop treating Lyme patients long term. A few continue to treat, some refer their patients to long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients. In some states, physicians have been subject to investigations by licensing boards for treating Lyme patients long-term. Sometimes, it has been insurance companies who have filed the complaints against the treating physicians simply for treating long term.
     
    The treatment of Lyme disease is mired in a scientific controversy. The controversy pits academic-based physicians who feel Lyme is cured with 28 days of treatment against physicians in the trenches who are treating Lyme cases and their patients who are experiencing symptom relief from extended treatment. The heart of the argument is that if Lyme is diagnosed and treated early, it can be treated rather successfully with a four to six week course of antibiotics; however, because of a lack of a definitive test, its ability to mimic other diseases, and the presence of co infections with other tick-borne diseases, diagnosis and treatment are often delayed which may cause chronic disease. Research has also shown that the Lyme disease spirochete, similar to the one that causes syphilis, can enter the central nervous system less than a week after a tick bite. Neuroborreliosis, Lyme disease in the central nervous system, can be very difficult to eradicate.
     
    OSHA, Occupational Health & Safety Administration, recognizes the seriousness of Lyme disease. Their Hazardous Information Bulletin discusses the dangers of Lyme disease and the importance of early diagnosis and treatment and states “Lyme disease in a later stage is more difficult to diagnose, and treatment may become prolonged and costly.”[10]
     
    New Red Cross blood donor guidelines distinguish between Lyme disease and chronic Lyme disease, “Accept persons with Lyme disease if they were treated, the disease resolved and at least one year has passed. Those with chronic Lyme disease are not eligible to donate blood.” The American Society of Clinical Pathologists (ASCP) blood donor guidelines state under “serious illness,” “defer indefinitely… Lyme disease.”[11]
     
    Clinical physicians and researchers provide many theories based on published research to explain how the spirochete can persist in the body after treatment. Research performed by Dr. David Dorward, NIH, has shown that the spirochete that causes Lyme disease can enter a cell and come out the other side cloaked in the cell’s membrane, thus eluding the body’s immune system, which no longer recognizes the spirochete as a foreign invader. The spirochete has also been shown to persist within macrophages by Montgomery et al.[12] and in Nanagara, Duray and Schumacher,[13] spirochetal antigens have been found to persist in the joint in chronic Lyme disease, both intracellularly and extracellularly in deep connective tissue, suggesting the ability to elude host response and antibiotic treatment. Also, research by Brorson & Brorson[14] shows that the spirochete, in vitro, is able to change itself into different forms. The change in form may occur in vivo under conditions unfavorable to the spirochete. The work of Alban et al[15] indicates that the spirochete reacts to conditions of serum starvation by changing cell morphology. This can explain how the spirochete is able to survive periods of nutrient deprivation in host tissues.   Some of these new forms may lack a cell wall, thus eluding cell-wall targeting antibiotics. When the climate gets better, the cell wall-less forms may change back into the spirochete, and the disease may become active again.
     
    Dr. Reinhard Straubinger, a world renown Lyme researcher with famous dog studies at Cornell, wrote to the NY State Department of Health that he was able to culture spirochetes from 3/23 30-day antibiotically-treated dogs (human dosage comparable), detect spirochetal DNA in 20, and quantify spirochetal DNA in 12. “In contrast to many human studies we could show persistent infection, because a lengthy time period separated the phase of treatment and the phase of testing. …the spirochetes may need sufficient time after antibiotic treatment in order to recover and multiply to sufficient numbers so we can detect them with the techniques we have currently available.[16]
     
    The jury is still out. Controversy over Lyme swirls while patients continue to be denied treatment. Last year, Rhode Island took the lead and passed a most important piece of legislation to protect physicians who treat. That was the first step in helping patients receive the medication they need to help them live rather than exist. 
     
    Risky behavior for acquiring Lyme disease can be walking your dog, jogging through the park, your child playing in a sandbox. Everyone has the potential to become a Lyme victim, and without appropriate treatment, chances are increased that early Lyme can turn to chronic Lyme. Without continued treatment to resolve symptoms, the heart, eyes and brain, can become infected producing heart block, blindness, and memory loss and seizures. Chronic Lyme disease patients are not going away. Their numbers are increasing and will continue to increase without appropriate treatment regimens.
     
    Chronic Lyme patients do require extended treatment but are often able to remain productive members of society, working and being educated. Rhode Island has the opportunity to take the lead in this issue by introducing and passing the strongest protection anywhere for patients’ rights to be treated and reimbursed for Lyme disease treatment. Remember, you could be the next victim.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   


    [1]Lyme & Other Tick-borne Diseases: A 21st Century View, LDA Princeton medical conference brochure, November 10, 2001

    [2] Roberts, David M., et.al., “The bdr Gene Families of the Lyme Disease and Relapsing Fever Spirochetes,” Emerging infectious Diseases, 6(2), 2000. Centers for Disease Control

    [3] CDC LD Chart: LD Cases reported by State Health Departments 1990-1999 www.cdc.gov/ncidod/dvbid/lyme/ldcases90-99.htm

    [4] Bangor Daily News 3/30/02 as reported by Maine’s Bureau of Health

    [5] Dept of Labor, Health, and Human Services, and education, and related Agencies Appropriations Act 2002

    [6] Aetna guidelines http://www.aetnaushc.com/cpb/data/CPBA0215.html, Oxford Health, Medical Policy Manual

    [7] NYSDOH to CDC April 15, 1996

    [8] Eur J Clin Microbiol Infect Dis. 1998 Oct;17(10):715-9.

    [9] Fall 1999 issue of the Journal of Spirochetal and Tick Borne Diseases

    [10] OSHA Hazardous Information Bulletin April 20, 2000

    [11] Press release American Society of Clinical Pathologists

    [12] Journal of Immunology 1993 Feb1;150(3):909-15

    [13]Human Pathology, 1996 Oct;27(10)1025-34

    [14]Infection 1997Jul-Aug;25(4):240-6

    [15] Microbiology 2000Jan;146 (Pt 1):119-27

    [16] Dr. Straubinger’s letter to NYSDOH, November 22, 2001




    RI – Senate Commerce, Housing & Municipal Govt. Committee

     
     

    TESTIMONY TO RHODE ISLAND STATE SENATE COMMERCE, HOUSING & MUNICIPAL GOVERNMENT COMMITTEE 
    House Bill #H6136 Substitute A


      

     
     
    TESTIMONY TO RHODE ISLAND STATE SENATE COMMERCE, HOUSING & MUNICIPAL GOVERNMENT COMMITTEE 
    House Bill #H6136 Substitute A
     
    By Pat Smith, President, Lyme Disease Association, Inc. 6-26-03
     
    I am President of the Lyme Disease Association, LDA, and sit on the board of directors of International Lyme and Associated Diseases Society, ILADS, a professional medical society, and am former chair of the [New Jersey] Governor’s Lyme Disease Advisory Council.
     
    LDA is an all-volunteer national organization providing Lyme disease education and funding for research projects coast to coast, including a past grant to URI for tick control. The LDA has acquired five national affiliates and four state chapters (of which RI is one) and recently along with its CT affiliate, partnered with Columbia University College of Physician & Surgeons to open an endowed chronic Lyme disease research center to be housed at Columbia. The LDA is also poised to announce the creation of a fund to be used for payment to help children suspected of having Lyme obtain a proper diagnosis. Internationally acclaimed author Amy Tan, Joy Luck Club, Bonesetter’s Daughter, is supporting the fund. 
     
    Lyme is the most prevalent vector-borne disease in the U.S. and the most prevalent vector-borne bacterial disease in the world according to the World Health Organization Coordinating Committee. Actions occurring at the federal level relating to Lyme disease are often not well known. For example, The US Army Centers for Health Promotion and Preventive Medicine (CHPPM) has developed a prototype pocket-sized lab to test ticks in the field using sophisticated PCR technology. LDA saw this prototype on our visit there a few years ago. Soldiers may receive immediate treatment in the field if bitten by ticks that test positive for Lyme.
     
    CHPPM has performed risk assessments on military bases in this country since the late 80s/early 90s. Tick populations and infectivity rates from the bases are being stored, now in GPS satellites. While we were there, CHPPM showed us the plan for the development of a prototype helmet to be worn by a soldier in the field with a heads up display. Satellites will beam the tick data to the special helmet worn by a soldier in the field, allowing armies to maneuver around heavy tick concentrations.
     
    NASA and the NIH have a joint culturing project for Lyme disease and other bacteria using microgravity chambers, which mimic conditions in space and in the human body. [1]This work is showing how complicated relationships are from bacteria to bacteria and how they may communicate to evade body defenses and perhaps even treatment.
     
    In 2002, the US Senate thought Lyme was so serious is passed a federal bill providing $50 million for Lyme disease research, physician education, and prevention, with one of the goals a definitive diagnostic test. LDA and its CT affiliate worked with the Senators and Congressmen on the bill. Unfortunately, the session ended before the House took up the bill, but it will be reintroduced this session.
     
    The problems of patients not being able to receive treatment stems in part from Lyme disease case reporting at the federal level. Lyme disease cases nationwide are reported to the Centers for Disease Control & Prevention, CDC. The actual number of Lyme cases meeting the CDC criteria is estimated to be 10 times higher than reported cases.[2] The average number of reported cases nationwide is 18,000, thus about 180,000 actual cases occur each year that meet the CDC criteria.
     
    New York has the highest reported case numbers, although CDC data from 1990-1999 lists Rhode Island with an annual Lyme disease incidence rate of 39 per 100,000 of population, behind only Connecticut.[3] Interestingly, Maine recently reported an upsurge in both tick populations and the disease itself.[4]
     
    Reported cases in the US must meet the Centers for Disease Control & Prevention, CDC, surveillance criteria: a physician diagnosed EM (bullseye) rash, or positive blood work and other system involvement.  One of the problems inherent in the criteria is the fact that studies have shown that the EM rash appears less than 50% of the time, and another problems lies in the inaccuracies of Lyme disease testing. Antibody response testing such as the ELISA and the Western Blot are not very reliable diagnostic tests for Lyme disease if the CDC 2 step protocol is followed and the 5-band CDC criteria are used. According to a document from the NY Department of Health to the CDC, if they followed the 2-tier testing requirement for 1995 cases (positive ELISA followed by Western Blot), 81% of non-EM cases would not have been confirmed.[5]
     
    The CDC warns on its website that doctors should not use its surveillance criteria for diagnosing Lyme. Despite CDC warnings, many physicians do use the surveillance guidelines to diagnose, instead of making a clinical diagnosis based on symptoms and history as the CDC recommends.
     
    Public Law 107-116 signed by President Bush January 10, 2002[6] states under CDC “The Committee [Senate appropriations] 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.”
     
    [7] Insurers also may limit treatment to 28 days and/or substitute orals for IV medications, when doctors often prescribe IV treatment for Lyme disease that has invaded the central nervous system.Doctors will try to support their diagnosis of Lyme disease by ordering direct detection tests such as PCR, which doctors feel are more accurate than an ELISA or western blot. Insurance companies often do not accept PCR for a Lyme disease diagnosis, although PCR is accepted for other diseases such as HIV, hepatitis, and TB. Excerpts from Lyme disease protocols used by insurance companies seem to support that the insurers improperly use the surveillance criteria to deny treatment to Lyme patients.
     
    We have heard from physicians throughout the country that their insurance carriers strongly suggested they either leave the plan or stop treating Lyme patients long term. A few continue to treat, some refer their patients to long-term treating physicians, while others, fearing reprisals or facing economic hardship, stop seeing Lyme patients. In some states, physicians have been subject to investigations by licensing boards for treating Lyme patients long-term. Sometimes, it has been insurance companies who have filed the complaints against the treating physicians simply for treating long term.
     
    The treatment of Lyme disease is mired in a scientific controversy. The controversy pits academic-based physicians who feel Lyme is cured with 28 days of treatment against physicians in the trenches who are treating Lyme cases and their patients who are experiencing symptom relief from extended treatment. The heart of the argument is that if Lyme is diagnosed and treated early, it can be treated rather successfully with a four to six week course of antibiotics; however, because of a lack of a definitive test, its ability to mimic other diseases, and the presence of co infections with other tick-borne diseases, diagnosis and treatment are often delayed which may cause chronic disease in 10-15% of Lyme patients.
     
     Research has also shown that the Lyme disease spirochete, similar to the one that causes syphilis, can enter the central nervous system less than a week after a tick bite. Neuroborreliosis, Lyme disease in the central nervous system, can be very difficult to eradicate. OSHA, Occupational Health & Safety Administration in their Hazardous Information Bulletin discusses the dangers of Lyme disease and the importance of early diagnosis and treatment and states “Lyme disease in a later stage is more difficult to diagnose, and treatment may become prolonged and costly.”[8]
     
    Several studies have been done with oral versus IV medications including one published called “Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borelliosis” by J. Oksi, et al.[9] Two treatment regimens for disseminated Lyme (mainly neurologic and musculoskeletal manifestations) were compared. A group of 30 patients received orals for 100 days. Another group of 30 patients received intravenous ceftriaxone for 14 days followed by orals for 100 days. The total number of patients with relapses or no response at all and the number of positive polymerase chain reaction findings after therapy were greater in the oral group. The general outcomes of infection in patients with disseminated Lyme after 3-4 months of therapy indicate that prolonged courses of antibiotics may be beneficial.
     
    Dr Brian Fallon, Columbia University, also published that a repeated course of intravenous antibiotic therapy results in marked improvement in memory, attention, and overall functioning.[10]
     
    L.B. Krupp, MD et al., Stony Brook University Medical Center, just published a treatment study, which appeared this week.[11] 55 patients with Lyme disease who had already been treated but who still suffered with extreme disabling fatigue were given four weeks of IV. Those on IV improved, those on placebo did not. 
     
    If doubt about the persistence of the bacteria in the body remains, look at the new Red Cross blood donor guidelines which distinguish between Lyme disease and chronic Lyme disease, “Accept persons with Lyme disease if they were treated, the disease resolved and at least one year has passed. Those with chronic Lyme disease are not eligible to donate blood.” The American Society of Clinical Pathologists (ASCP) blood donor guidelines state under “serious illness,” “defer indefinitely… Lyme disease.”[12]
     
    Clinical physicians and researchers provide many theories based on published research to explain how the spirochete can persist in the body after treatment. Research performed by Dr. David Dorward, NIH, has shown that the spirochete that causes Lyme disease can enter a cell and come out the other side cloaked in the cell’s membrane, thus eluding the body’s immune system, which no longer recognizes the spirochete as a foreign invader. The spirochete has also been shown to persist within macrophages by Montgomery et al.[13] and in Nanagara, Duray and Schumacher,[14] spirochetal antigens have been found to persist in the joint in chronic Lyme disease, both intracellularly and extracellularly in deep connective tissue, suggesting the ability to elude host response and antibiotic treatment. Also, research by Brorson & Brorson[15] shows that the spirochete, in vitro, is able to change itself into different forms. The change in form may occur in vivo under conditions unfavorable to the spirochete. The work of Alban et al[16] indicates that the spirochete reacts to conditions of serum starvation by changing cell morphology. This can explain how the spirochete is able to survive periods of nutrient deprivation in host tissues.   Some of these new forms may lack a cell wall, thus eluding cell-wall targeting antibiotics. When the climate gets better, the cell wall-less forms may change back into the spirochete, and the disease may become active again.
     
    Dr. Reinhard Straubinger, a world renown Lyme researcher with famous dog studies at Cornell, wrote to the NY State Department of Health that he was able to culture spirochetes from 3/23 30-day antibiotically-treated dogs (human dosage comparable), detect spirochetal DNA in 20, and quantify spirochetal DNA in 12. “In contrast to many human studies we could show persistent infection, because a lengthy time period separated the phase of treatment and the phase of testing. …the spirochetes may need sufficient time after antibiotic treatment in order to recover and multiply to sufficient numbers so we can detect them with the techniques we have currently available.[17]
     
    You can see by the above, that although the jury is still out, controversy over Lyme swirls while patients continue to be denied treatment. Last year, Rhode Island took the lead and passed a most important piece of legislation to protect physicians who treat. That was the first step in helping patients receive the medication they need to help them live rather than exist. Rhode Island now has the opportunity again assume leadership in this issue by introducing and passing the strongest protection anywhere for patients’ rights to be treated and reimbursed for Lyme disease treatment. 
     
    Everyone has the potential to become a Lyme victim. Risky behavior for acquiring Lyme disease can be walking your dog, jogging through the park, your child playing in a sandbox. Without appropriate treatment, chances are increased that early Lyme can turn to chronic Lyme. Without continued treatment to resolve symptoms, the heart, eyes and brain, can become infected producing heart block, blindness, and memory loss and seizures. Chronic Lyme disease patients are not going away. Without appropriate treatment, their numbers will increase and their condition will deteriorate. With extended treatment, many are able to remain productive members of society, working and being educated. You hold their fate and perhaps the future fate of one of your family members in your hands.
     
     
     

     


    [1]Lyme & Other Tick-borne Diseases: A 21st Century View, LDA Princeton medical conference brochure, November 10, 2001
    [2] Roberts, David M., et.al., “The bdr Gene Families of the Lyme Disease and Relapsing Fever Spirochetes,” Emerging infectious Diseases, 6(2), 2000. Centers for Disease Control
    [3] CDC LD Chart: LD Cases reported by State Health Departments 1990-1999 www.cdc.gov/ncidod/dvbid/lyme/ldcases90-99.htm
    [4] Bangor Daily News 3/30/02 as reported by Maine’s Bureau of Health
    [5] NYSDOH to CDC April 15, 1996
    [6] Dept of Labor, Health, and Human Services, and education, and related Agencies Appropriations Act 2002
    [7] Aetna guidelines http://www.aetnaushc.com/cpb/data/CPBA0215.html, Oxford Health, Medical Policy Manual
    [8] OSHA Hazardous Information Bulletin April 20, 2000
    [9] Eur J Clin Microbiol Infect Dis. 1998 Oct;17(10):715-9.
    [10] Fall 1999 issue of the Journal of Spirochetal and Tick Borne Diseases
    [11] Neurology June 2003
    [12] Press release American Society of Clinical Pathologists
    [13] Journal of Immunology 1993 Feb1;150(3):909-15
    [14]Human Pathology, 1996 Oct;27(10)1025-34
    [15]Infection 1997Jul-Aug;25(4):240-6
    [16] Microbiology 2000Jan;146 (Pt 1):119-27
    [17] Dr. Straubinger’s letter to NYSDOH, November 22, 2001