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Good Evening. My name is Gregg Skall. I am a member of the law firm Womble Carlyle Sandridge and Rice, PLLC and serve as counsel to the National Capital Lyme & Tick-Borne Disease Association, also known as NatCapLyme.  NatCapLyme, formed in 2001, serves approximately 1800 members and has Virginia chapters in Northern Virginia, the Shenandoah Valley, Central Virginia and Hampton Roads.

I will discuss the development of the “Late-Stage” Lyme disease problem later in this testimony, but first, I wish to dispel a significant misunderstanding.  

Contrary to some critics, H.B. 512 does not legislate or mandate care! It simply gives doctors the freedom to treat based on their medical training and clinical judgment.  Some say it is not needed; doctors have that freedom.  To the contrary, it is needed! As we will show, a decision to pass up this opportunity is not an abstention.  A vote to do nothing is a vote against Lyme treatment and physician clinical judgment, and will be perceived as such by many practicing physicians.

H.B 512 does not protect negligent physicians.  H.B. 512 simply provides that a licensed physician may not be investigated or subjected to disciplinary action by the Board of Medicine solely for prescribing, administering, or dispensing long-term antibiotic therapy.  The physician is still subject to all the standards of proper practice and must be able to defend his or her clinical diagnosis.  

I would now like to turn to a statement of the facts which gave rise to the problem addressed by HB 512.

Late-Stage Lyme Disease

Thanks to a mother’s persistence, Lyme disease came to public consciousness in Old Lyme, Connecticut back in the mid-seventies due to the illnesses of her children being dismissed as simple childhood arthritis. Amazingly, a generation later, it is still a very misunderstood disease.  Most people know all about early stage Lyme disease and the signs and symptoms to look for including a bulls-eye rash, joint pain, stiff neck and flu-like symptoms. Most doctors know that the standard treatment regimen for early stage Lyme is three to four weeks of antibiotics. On these points, there is general universal understanding and agreement. Disagreement comes when the illness moves beyond this initial stage and into the secondary and tertiary stages of the disease. If not properly diagnosed and treated in the initial stage, Lyme can become a highly debilitating illness.

That late-stage Lyme disease exists and is growing exponentially is unquestioned.  Lyme disease is regarded as the fastest-spreading vector-borne infection in the United States.  The CDC states that only 10 percent of cases which meet its strict surveillance criteria are reported.  In 2007, 27,444 cases of Lyme disease were reported yielding a national average of 9.1 cases per 100,000 persons and a total of over 270,000 cases.  Due to the limitations of the CDC case definition, some believe the real annual incidence of Lyme disease may be as much as 40 times the reported number of cases.   Virginia experienced a 169% increase in CDC-reportable Lyme cases from 2006 to 2007; an increase from 357 to 959 cases.  From 1993 to 2007, Virginia has seen a 909% increase in reported cases.  A 1990 Army study detected the causative agent of Lyme disease, Borrelia burgdorferi (Bb), in 37 percent of Ixodes ticks collected in York County, Virginia.

In a 2008 study, researchers at Columbia University in New York City concluded that the fatigue level in chronic Lyme disease patients is equal to that of multiple sclerosis.   Other studies have described the fatigue as “profound, notable, unusual, debilitating, and extreme, not as a vague symptom of tiredness.”    Two earlier articles in the Annals of Internal Medicine attributed “long-term impairment of functional status”  to exposure to Lyme disease, including “more musculoskeletal impairment and a higher prevalence of verbal memory impairment when compared with those without a history of Lyme disease.  Our findings suggest that disseminated Lyme disease may be associated with long-term morbidity.”   Two more researchers conducted a meta-analysis of papers on the subject in 2005 and concluded that “some patients with LB [Borrelia burgdorferi] have fatigue, musculoskeletal pain, and neurocognitive difficulties that may last for years despite antibiotic treatment.  

Medical Practice – Two Standards of Care

Current practice, in response to the recommendations of the 2006 Infectious Disease Society of America (IDSA) Guidelines, is for physicians to rule out Lyme disease based on the authors’ narrow views that the disease is easily cured.  If a patient previously had treatment and is negative by today’s faulty tests, it could not be Lyme disease.  The Guidelines recommend this approach despite ample peer-reviewed literature demonstrating the persistence of Bb following antibiotic treatment   and documented presence of active borreliosis despite seronegativity.   This practice and application of the Guidelines leads to many patients developing serious and deeply entrenched infection by Bb and other pathogens due to misdiagnosis or under-treatment.

Critics of Late-Stage Lyme disease would have you believe that Lyme disease is easily diagnosed and treated.  An example is the recent letter to Virginia legislators from Dr. Phillip Baker, Executive Director of the American Lyme Disease Foundation, to which NatCapLyme responded on January 23, 2010.  This view has been widely contradicted by noted researchers.  Borrelia burgdorferi is considered by many to be one of the most complex bacteria ever studied, with five times as many functioning genes as T. pallidum, the causative agent of syphilis.  It is considered, even by those involved with the IDSA Guidelines to be the new “Great Imitator” of other medical conditions, following in the footsteps of its spirochetal “cousin” syphilis, about which it has been said, “To know syphilis is to know medicine.”   In vitro studies of Borrelia burgdorferi have documented survival techniques such as Antigenic variation, intracellular sequestration, polymorphism and drug resistance.  It is the first spirochete known to show resistance to penicillins and other antibiotics.  Researchers are exploring the possible role of borellial colonies and biofilms.

Perhaps most tragic, is the refusal to seriously consider the staggering accrual of anecdotal evidence of late-stage Lyme disease.  Anecdotal evidence is important because it breaks our paradigms.  President John Adams said, “Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.” When facts present in the form of clinical experience, and do not conform to a current paradigm, that leads to questioning.  The questioning and honest investigating lead to new understandings of the world, or in this case, a disease process.  There is a large and quickly growing body of anecdotal evidence worldwide, including the evidence among our own members, that complex chronic illness can have underlying infectious bases that frequently give way to long-term antibiotic treatment.  There is an extraordinary mass of clinical observation and patient experience that is dismissed as anecdotal evidence, implying it has no value.  

It is on these issues of ease of detection, diagnosis and treatment of later stage Lyme disease that the medical community is fiercely divided. This disagreement has led to two standards of care fostered by two groups of doctors.  The Infectious Disease Society of America (IDSA) has one standard of care which limits treatment to that initial four weeks of antibiotics. The International Lyme and Associated Diseases Society (ILADS) recognizes that the Borrelia burgdorferi bacteria that causes Lyme disease can persist well beyond the initial treatment phase and calls for more open-ended, long-term antibiotic treatment, if supported by clinical evaluation.  Both viewpoints are reflected in peer-reviewed, evidence-based guidelines. Some physicians treat patients for 30 days only and assume that remaining symptoms reflect a self-perpetuating autoimmune response. Other physicians assume that the persistent symptoms reflect on-going infection and gauge the duration of treatment by the patient's individual clinical response. These physicians believe that there is insufficient evidence at this point to adopt standardized treatment protocols."  Many people have greatly benefited from this standard of care. Both guidelines are registered with the National Guidelines Clearinghouse, an initiative of the U.S. Department of Health and Human Services.

Doctor Intimidation and H.B. 512

Doctors who treat Lyme disease more aggressively than the IDSA guidelines protocol often face professional intimidation and persecution.  Since the 1980s, more than thirty doctors have faced investigation by their state medical licensing boards for providing Lyme disease treatments not recommended by the IDSA’s treatment guidelines.  Although, in writing to Senator Ted Kennedy, the IDSA declared physician compliance with its 2006 guidelines to be voluntary, state health boards have sanctioned a number of dissenting physicians based on the IDSA’s strict short-term antibiotic treatment protocols.  In so doing, the 2006 IDSA Guidelines often hurt the patients whose welfare they purport to protect by insufficiently treating the infection, allowing it to further disseminate and more deeply sequester in the patient’s tissues,   often suppressing the immune system  and invading the central nervous system, where it is far more difficult to treat.

That physicians in the US and specifically in Virginia have been intimidated in this way is not seriously in question.  This was recognized by Governor McDonnell in his letter of last July, where he said that we must “. . . examine ways to provide our physicians the ability to meet the treatment needs of their patients without undue liability threats.”  HB 512 is designed to accomplish that purpose.

Contrary to some critics, HB 512 does not legislate treatment. It only provides doctors the right to diagnose and treat clinically, as they have been taught in medical school, without fear of facing charges just for treating Lyme patients with long-term antibiotics. We have seen this happen in Virginia.  That case concluded without sanctions, but the time, money and energy required to produce that result was wasteful and costly to the physician and that physicians patients.  

In Connecticut, the home state of the community for which the disease has been named, both legislative bodies unanimously voted for a similar bill and Connecticut Governor Jody Rell signed it into law last summer.  Here in Virginia, and elsewhere, many doctors are reluctant to treat beyond the four week IDSA standard for fear that they might face repercussions for exceeding the four week limit.  From the statistics cited above, it is apparent that we do not have the answers, and freedom to exercise their clinical judgment is something we desperately need in Virginia. Again, this bill does not legislate or mandate care! It gives doctors the freedom to treat based on their medical training and clinical judgment.  A decision to pass up this opportunity is not an abstention.  A vote to do nothing is a vote against Lyme treatment, physician clinical judgment and will be perceived so by many practicing physicians.

Some medical societies opposing this bill, continue to advance the belief that Lyme disease is easily diagnosed, easily treated disease and that in the vast majority of cases the infection cannot persist after four weeks of antibiotics.  They have alleged that the bill will mandate a standard of care requiring long-term antibiotic treatment and prevents the Board of Medicine from effectively policing the profession by protecting negligent or fraudulent doctors who might abuse the system.  That argument overreaches; it does not properly reflect H.B. 512,

H.B. 512 simply provides that a licensed physician may not be investigated or subjected to disciplinary action by the Board of Medicine solely for prescribing, administering, or dispensing long-term antibiotic therapy.  For the new section to be applicable, the physician must have made a clinical diagnosis, document it and include that documentation in the patient's medical record.  The physician is subject to disciplinary action if an appropriate clinical diagnosis cannot, or has not been made, and normal standards of maintaining a clinical record still apply.  The bill simply allows a licensed physician to treat according to their professional training as a clinician, even as the IDSA has said should be done, without fear of intimidation, reprisal or prosecution, provided all standards of clinical practice are met.

Implications of Failure to Approve HB 512

The implications of HB 512 for Lyme infected patients are great.  If not diagnosed and treated soon after onset of the infection, Lyme and many of its confections often become a far more debilitating, more entrenched infection that can impact a patient both physically and neurologically.  As Dr .Shor explains in his testimony, there are many studies that support the position that the Lyme bacteria, Borrelia burgdorferi, can persist despite weeks or even months of antibiotics. We are quickly reaching the point where nearly everyone you know has either experienced Lyme disease in their own family or in the family of a good friend.  Many have all too familiar stories to tell about disabled victims who have had their lives stolen from them by this disease, and how some have been able to return to useful and fulfilling lives with long-term antibiotic therapy.  The establishment medical research community strongly conveys the idea that this is “microbiologically implausible” and attempts to portray the Lyme treating community as non-evidence-based and out on the fringe. Yet, there is a lot of science supporting extended treatment that is being ignored by the IDSA and the ALDA.

The IDSA Lyme Disease Guidelines are the predominant guidelines followed by most of the medical establishment.  However, the fact is that the IDSA guidelines are so narrow and so extreme that the Attorney General of Connecticut was compelled to launch an antitrust investigation regarding the IDSA guideline development process.  His staff concluded that the IDSA Lyme Guidelines panel was rife with extensive conflicts of interest.  In a settlement agreement, the IDSA agreed to convene a new panel to review the current guidelines. On July 30th 2009, presenters from all sides made their arguments. ILADS physicians submitted more than 1300 pages of peer-reviewed research in support of their analysis. In the view of many observers, they submitted substantial and compelling evidence opposing the guideline recommendations, much of which was ignored by the 2006 IDSA Guideline panel.

Conclusion

Time permitting; you will hear testimony from people who have lived the horrors of this terrible disease. You will see from their testimonies that Lyme can cause serious physical and mental disability as well as economic hardship. You will see that what many of the patients will describe here is nothing remotely close to the IDSA’s description of lingering symptoms as the fatigue, aches & pains of everyday life. Without more doctors who feel free to follow their own medical best judgment and treat Lyme patients beyond the IDSA four week limit, we will continue to see the numbers of chronically ill Virginia residents rise dramatically. We desperately need this bill so more doctors will feel comfortable doing what they believe is right by their patients, using their best clinical judgment, without fear of disciplinary action.

Now, I would like to ask that every Virginia resident here in this room who is here to support a family member who has Lyme disease, please stand if they are able to do so. Please support HB 512. These people are counting on you. Thank you.

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Hodzic E, Feng S, Holden K, Freet KJ, Barthold SW. Persistence of Borrelia burgdorferi following antibiotic treatment in mice. Antimicrob Agents Chemother. 2008;52:1728-36.   Keller TL, Halperin JJ, Whitman M. PCR detection of Borrelia burgdorferi DNA in cerebrospinal fluid of Lyme neuroborreliosis patients. Neurology 1992;42(1):32-42.  Hunfeld KP, Ruzic-Sabljic E, Norris DE, Kraiczy P, Strie F. In Vitro Susceptibility Testing of Borrelia burgdorferi Sensu Lato Isolates Cultured from Patients with Erythema Migrans before and after Antimicrobial Chemotherapy. 2005, Antimicro Agents Chemother, 49(4):1294-1301.  Cabello FC, Godfrey HP, Newman SA.  Hidden in plain sight: Borrelia burgdorferi and the extracelluar matrix. Trends Microbiol 2007 Aug, 15(8):350-4.   Steere AC, Hutchinson GJ, Rahn DW, et al. Treatment of the early manifestations of Lyme disease. Ann Intern Med 1983;99:22-6.   Oksi J, Marjamaki M, Nikoskelainen J, Viljanen MK. Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann Med. 1999 Jun;31(3):225-32.  Nanagara R, Duray PH, Schumacher HR Jr. Ultrastructural demonstration of spirochetal antigens in synovial fluid and synovial membrane in chronic Lyme disease: possible factors contributing to persistence of organisms. Hum Pathol. 1996 Oct;27(10):1025-34.  Häupl T, Hahn G, Rittig M, Krause A, Schoerner C, Schonherr U, Kalden JR, Burmester GR. Persistence of Borrelia burgdorferi in ligamentous tissue from a patient with chronic Lyme borreliosis. Arthritis Rheum. 1993 Nov;36(11):1621-6.   Preac-Mursic V, Pfister HW, Spiegel H, Burk R, Wilske B, Reinhardt S, Böhmer R. First isolation of Borrelia burgdorferi from an iris biopsy.  J Clin Neuroophthalmol. 1993 Sep;13(3):155-61; discussion 162.  Georgilis K, Peacocke M, Klempner MS. Fibroblasts protect the Lyme disease spirochete, Borrelia burgdorferi, from ceftriaxone in vitro. J Infect Dis. 1992 Aug;166(2):440-4.
Dattwyler RJ, Volkman DJ, Luft BJ, Halperin JJ, Thomas J, Golightly MG. Seronegative late Lyme borreliosis: dissociation of Borrelia burgdorferi specific T and B lymphocyte responses following early antibiotic therapy. N Engl J Med 1988;319:1441–6.  Lawrence C, Lipton RB, Lowy FD, Coyle PK. Seronegative chronic relapsing neuroborreliosis. Eur Neurol 1995;35(2):113-7.  Breier F, Khanakah G, Stanek G, Kunz G, Aberer E, Schmidt B, Tappeiner G. Isolation and polymerase chain reaction typing of Borrelia afzelii from a skin lesion in a seronegative patient with generalized ulcerating bullous lichen sclerosus et atrophicus. Br J Dermatol. 2001 Feb;144(2):387-92.  Holl-Wieden A, Suerbaum S, Girschick HJ. Seronegative Lyme arthritis. Rhuematol Int. 2007;27:1091-3.   Oksi J, Uksita J, Marjamaki M, Tylewska-Wierzbanowska S. Improvement in the laboratory recognition of Lyme borreliosis with the combination of culture and PCR methods. Mol Diagn. 2003;7(3-4):155-62
See Duray PH Clinical Pathologic Correlations of Lyme Disease.  Rev Inf Dis 1989; 11 (Suppl. 6): S1487-S1493; Steere AC. Lyme disease. New England Journal of Medicine 1989; 321:586-596; and Cooke WD; Dattwyler RJ. Complications of Lyme borreliosis. Annual Review of Medicine 1992;43:93-103
See:  Lyme Disease: Two Standards of Care, ww.lymedisease.org/calda/pdf/TwoStandards%207.2006.pdf Last viewed January 31, 2010.  This article has been widely cited in the U.S. and around the world.  e.g.: Canada, www.canlyme.com/two_standards.html;the Netherlands ,www.lymemed.nl/discussie/johnson.pdf
http://www.guideline.gov/search/searchresults.aspx?Type=3&txtSearch=Lyme+disease&num=20
Nanagara R, Duray PH, Schumacher HR Jr. Ultrastructural demonstration of spirochetal antigens in synovial fluid and synovial membrane in chronic Lyme disease: possible factors contributing to persistence of organisms. Hum Pathol. 1996 Oct;27(10):1025-34
Embers ME, Ramamoorthy R, Phillip MT, Survival Strategies of Borrelia burgdorferi, the etiologic agent of Lyme disease. Microbes and Infection 6 (2004)312-318
Trieb J, Frenandez A, Haass A, Grauer MT, Holzer G, Woessner R. Clinical and serologic follow-up in patients with neuroborreliosis. Neurology. 1998 Nov;51(5):1489-91.