Tina J. Garcia

544 South Solomon

Mesa, Arizona  85204

480-570-5178

March 1, 2006

Victorio Vaz, Ph.D., Office Chief

Office of Infectious Disease Services

Arizona Department of Health Services

150 North 18^th Avenue, Suite 140

Phoenix, Arizona  85007

            Re:      Pertinent Issues Effecting Diagnosis and Treatment

                        of Lyme Disease / Borreliosis in Arizona

Dear Dr. Vaz:

            I am writing in follow-up to our telephone conversation of February 2, 2006 and your correspondence dated February 8, 2006.  I am certain you are quite busy and I appreciate your taking the time to speak and correspond with me regarding issues related to Lyme disease in Arizona.

CASE I

            A patient sees an infectious disease specialist and provides a written history of symptoms indicative of Lyme disease, including erythema migrans.  The patient states that he was bitten by a tick in a state other than Arizona.  The physician orders an ELISA test based upon the CDC’s recommendation of two-tiered testing, laboratory criteria established in conjunction with the development of the first Lyme vaccine.  Since 1994, the serologic testing criteria has not changed, most likely due to the fact that the individuals who promoted that “business model” testing criteria are still marketing their “business model” test kits to the laboratories utilizing the “business model test kit” criteria and are thereby continually reaping financial profits.

            The inaccurate ELISA test will be returned to the physician with a negative result and no western Blot test will be ordered.  The negative ELISA is possibly the result of antigenic variation:

Victorio Vaz, Ph.D.

March 1, 2006

Page Two

Molecular biology of antigenic variation in Lyme borreliosis and relapsing fever: a comparative analysis.

 

·         Barbour AG.

Department of Microbiology, University of Texas Health Science Center, San Antonio 78284.

Lyme borreliosis and relapsing fever are human diseases caused by different members of the genus Borrelia. Antigenic variation has been a well-known feature of the pathogenesis of relapsing fever for decades. More recently it has been recognized that Borrelia burgdorferi, the agent of Lyme borreliosis, also can vary its surface antigens. In this review the biology and molecular biology of antigenic variation of the pathogens in these two disorders are compared.

PMID: 1947817 [PubMed - indexed for MEDLINE]

            The physician will inform the patient that his test is negative for Lyme borreliosis and will refer him to a rheumatologist and neurologist for the musculoskeletal and neurological symptoms.  The other specialists rule out rheumatoid arthritis and brain lesions and the patient receives no antibiotic therapy from any of the physicians.

CASE 2:

            A patient sees an infectious disease specialist and provides a written history of symptoms indicative of Lyme disease, including erythema migrans.  The patient states that she was bitten by a tick in Arizona.  The physician informs the patient there has not been one documented case of Lyme disease reported to the Arizona Department of Health Services, and therefore, the patient could not have been bitten by a tick in Arizona and have Lyme disease.  The physician states that he is a “Lyme expert” and that he has seen many Lyme disease patients and reputed Lyme disease patients.  Yet  he has not been able to document a case of Lyme disease originating in Arizona.  The doctor informs the patient that Lyme disease does not cause neurological problems.  The patient asks why her ankles could be so swollen and painful, and he responds by telling her she could have syphilis or rheumatoid arthritis.  Due to the fact that the patient has already received 6 weeks of antibiotic treatment elsewhere, the physician informs her, “You’ve had enough antibiotic to kill any bug in your body.”  The physician suspects syphilis and rheumatoid arthritis, so he recommends the patient have a psychological examination for the hallucinatory tick bite and residual debilitating

Victorio Vaz, Ph.D.

March 1, 2006

Page Three

symptoms.  The patient does not receive additional antibiotic therapy from the physician despite ongoing symptoms.

            This is an abstract from a published article co-written by Alan C. Steere in the New England Journal of Medicine, Nov 22; 323(21):1438-44, which refers to a study of Borrelia burgdorferi:

“These chronic neurologic abnormalities began months to years after the onset of infection, sometimes after long periods of latency, as in neurosyphilis…The typical response of our patients to antibiotic therapy supports the role of spirochetal infection in the pathogenesis of each of the syndromes described here…The likely reason for relapse is failure to eradicate the spirochete…This last article is one of many studies that show continuing symptoms are most likely due to persistence of the spirochete.”

            The story becomes a soap opera when you realize that many physicians refer to the CDC website for treatment guidelines.  The only treatment guidelines provided on the CDC website are those which currently stand as an “edict” from the Infectious Diseases Society of America, Practice Guidelines for the Treatment of Lyme Disease.  The drama becomes evident when one reviews the affiliations of the IDSA committee members who authored the IDSA Guidelines in 2000.  The following is from another published article by Allen C. Steere, one of the authors,

.  Steere, AC., 1995, Musculoskeletal manifestations of Lyme disease.  American

       Journal of Medicine, 1995, 88:4A-44S-51S.

“…a 1-month course of oral antibiotics may not always eradicate viable spirochetes.”

Also from Steere:

Steere, AC., et al., 1994, The long-term clinical outcomes of lyme disease.  A

       population-based retrospective cohort study.  Annals of Internal medicine, 121(8):

       560-7.

“Ten of the 38 patients with Lyme disease reported relapses within 1 year of treatment…and had had repeated antibiotic treatment (5 patients with intravenous ceftriaxone). …Patient 4, in addition, had had second degree atrioventricular block with acute Lyme disease that resolved with penicillin treatment.  Her irregular rhythm recurred 2 years later, resolved temporarily with ceftriaxone treatment, but progressed to complete heart block requiring a pacemaker. …Patient 12…was treated with 2 weeks of parenteral penicillin.  She later developed a progressive speech disorder, bradykinesia, and abnormal ocular motor function.  Magnetic resonance imaging of the brain showed scattered white matter lesions in the hemispheres and pons…she was re-treated with 2 weeks of parenteral ceftriaxone in 1989 that had no effect on her neurologic symptoms.  During the time of observation, this patient died.  At autopsy…[using] Dieterle silver stain, a spirochete was present in the cortex and another was exterior to a leptomeningeal vessel.”

Victorio Vaz, Ph.D.

March 1, 2006

Page Four

From Raymond J. Dattwyler, another author of the 2000 IDSA Treatment Guidelines:

Dattwyler, RJ., et al., 1988, Seronegative Lyme disease.  Dissociation of specific

       T-and B-lymphocyte responses to Borrelia burgdorferi.  New England Journal of

       Medicine, 1988, 319(22):1441-6.

[From the abstract:]  “We studied 17 patients who had presented with acute Lyme disease and received prompt treatment with oral antibiotics, but in whom chronic Lyme disease subsequently developed.”

            How interesting!  The 2000 IDSA Treatment Guidelines, partially authored by Allen C. Steere and Raymond J. Dattwyler, promote an extremely short course of antibiotics.  The published IDSA Treatment Guidelines are contradictory to published research, some of that research performed by the very individuals who authored the biased IDSA Guidelines!  To make matters worse, a review of several of the authors’ affiliations will reveal some blatant potential conflicts of interest. 

IMPORTANT-Please see:   http://www.lymediseaseassociation.org/Conflicts.doc

            Here is one more abstract.  This is authored by Dr. Mark Klempner, who conducted a study on long-term antibiotic therapy in association with IGeneX Laboratory.  Dr. Klempner provided IGeneX with compromised specimens which were refrigerated instead of being frozen, and when Dr. Nick Harris of IGeneX objected to the compromised specimens and offered to pay for uncompromised specimens to ensure the validity of the study (see enclosure), Dr. Klempner insisted upon utilizing the compromised specimens for the study.  Dr. Klempner then had the audacity to publish the results of the skewed study.  It is distressing to learn that Dr. Klempner, who has exhibited compromised standards in the past, will be holding a very high position at a new biowarfare laboratory.

Klempner, MS., et al., 1993, Invasion of human skin fibroblasts by the Lyme

       disease spirochetes, borrelia burgdorferi.  Journal of Infectious diseases, 1993,

       167:1074-1081.

This study found that B. burgdorferi spirochetes can survive antibiotic treatment through intracellular sequestion within firbroblasts.  “In these experiments, we demonstrated that fibroblasts and keratinocytes were able to protect B. burgdorferi from the action of this B-lactam antibiotic [ceftriaxone] even at antibiotic concentrations > or = 10 times the MBC of the antibiotic.  The protective effect was sustained for , or = 14 days and required viable fibroblast monolayers…We have demonstrated the presence of intracellular B. burgdorferi within HF [human fibroblasts] using laser scanning confocal microscopy…The observation of viable spirochetes within fibroblasts coupled to protection of B. burgdorferi from extracellular microbicidal antibiotics by fibroblasts [19] suggests that B. burgdorferi may be among the small number of bacteria that can cause chronic infection by localizing within host cells where they remain sequestered from some antimicrobial agents and the host humoral immune response.”

Victorio Vaz, Ph.D.

March 1, 2006

Page Five

INFORMED CONSENT -- TWO PUBLISHED STANDARDS OF CARE

            There are two (2) published standards of care for the treatment of Lyme disease.  They are both published in the National Guideline Clearinghouse.

1.  Guidelines from the Infectious Diseases Society of America (IDSA)

     Practice Guidelines for the Treatment of Lyme Disease (2000)

     Summary:  Short-term antibiotic treatment, disease easily cured, relapses attributed to

     inflammatory autoimmune causes, written by committee members with experience in

     product clinical trials, owning patents and having financial interests in Lyme disease test

     kits and vaccine development.

2.  International Lyme and Associated Diseases Society (ILADS)

     Evidence-Based Guidelines for the Management of Lyme Disease (2004)

     Summary:  Long-term antibiotic and nutritional therapy, repeated chronic disease relapse,

     repeated therapy, relapses attributed to chronic bacterial infection, written by committee

     members who are Lyme-literate physicians with ongoing experience treating chronically-ill,

     relapsing patients.

This is an excerpt from the AMA Informed Consent, prepared by the American Medical Association, Office of the General Counsel, Division of Health Law, 1998.

“Informed consent is more than simply getting a patient to sign a written consent form.  It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.

In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:

            ● The patient’s diagnosis, if known;

            ● The nature and purpose of a proposed treatment or procedure;

            ● The risks and benefits of a proposed treatment or procedure;

            ● Alternatives (regardless of their cost or the extent to which the treatment options are

                covered by health insurance);

            ● The risks and benefits of the alternative treatment or procedure; and

            ● The risks and benefits of not receiving or undergoing a treatment or procedure.

In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.

This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states.  (For more information about ethical obligations, see the AMA’s code of Medical Ethics, contained in the AMA PolicyFinder. 

Providing the patient relevant information has long been a physician’s ethical obligation, but the legal concept of informed consent itself is recent.

Victorio Vaz, Ph.D.

March 1, 2006

Page Six

The first case defining informed consent appeared in the late 1950’s.  Earlier consent cases were based in the tort of battery, under which liability is imposed for unpermitted touching.   Though battery claims occasionally occur when treatment is provided without consent, most consent cases generally center around whether the consent was “informed”, i.e., whether the patient was given sufficient information to make a decision regarding his or her body and health care.  Because informed consent claims, unlike battery claims, are based in negligence, they generally are covered by liability insurance.”

            Physicians will not be able to provide informed consent to their patients according to American Medical Association informed consent guidelines if they are not made aware of BOTH published standards of care.  Due to the fact that the CDC has recently increased its presence on the Internet on the subject of Lyme disease, I expect their website to abide by informed consent guidelines by providing BOTH standards of care for physicians to utilize in their practices.  This will greatly reduce exposure to legal liability for not providing informed consent to Lyme disease patients.

            As you can see by the examples above, having a case reported to the ADHS is many times an exercise in futility.  I understand that the ADHS is not the policing agency for Arizona physicians.  However, I do want to inform you of the issues responsible for the disregard for diagnosis and treatment of Lyme disease in Arizona.

            Ignorance enjoys bliss and complacency; knowledge requires accountability.  I am aware that your agency has an association with the CDC, and I would like to know if you have any thoughts as to how the ADHS and the CDC can immediately rectify these orchestrated problems with diagnosis and treatment.

            Thank you for providing information regarding the tick and rodent studies conducted during the 1980’s and 1990’s.  You informed me in our telephone conversation of February 6, 2006 that, due to the fact that the tick and vector studies conducted were negative, the ADHS did not “save the test reports.”  You did inform me that there are “summaries” of these studies; however, you did not provide me with copies per my request.  Also, the information you provided left off at studies conducted in 1992.  You supplied me with some specific information and I would like to have copies of the following to substantiate that information.

-All test reports and summaries conducted for Borrelia burgdorferi in all vectors and ticks throughout the State of Arizona from 1980 to the present.

            Thank you in advance for your prompt response to this request.

                                                                                    Sincerely,

                                                                                    Tina J. Garcia

TJG

Enclosure