Tina J. Garcia

544 South Solomon

Mesa, Arizona  85204

480-570-5178

                                                                                    March 1, 2006

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Julie Louise Gerberding, M.D., M.P.H.

Director

Centers for Disease Control and Prevention

Atlanta, Georgia  30333

            Re:      Conflicts of Interest, Two Standards of Care and Informed Consent

                        in the Diagnosis and Treatment of Lyme Disease

Dear Dr. Gerberding:

            I appreciate your responding to my previous letters sent to you in May and July of 2005.  I also thank you for providing the research papers included with your correspondence dated August 26, 2005.

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 laboratory criteria established in conjunction with the CDC’s recommended two-tiered testing and the development of the first Lyme vaccine. 

            The inaccurate ELISA test more often than not will be returned to the physician with a negative result, and due to the two-tiered testing approach, no Western Blot test will be ordered.  The negative ELISA is possibly the result of antigenic variation, shown in the published research below.

            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.

Julie Gerberding, M.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]

            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.

            In reference to the removal of OspA and OspB from the laboratory testing criteria, you stated in your letter, “It has been recognized for more than a decade by many investigators that these two antigens are expressed late in the course of disease, at a time when a patient’s immune system has had ample time to develop antibodies to the many other antigens present in the organism.  This means that Lyme disease patients do not characteristically have antibodies to the OspA and OspB proteins without also scoring positive by the criteria that CDC recommends.”

            The CDC certainly has a flippant attitude when it comes to including OspA and OspB, two of the most highly-specific antigens, in its recommended criteria.  So, as long as you THINK that patients are scoring positive for the antigens the CDC has hand-picked, it’s acceptable to eliminate other highly-specific antigens?  This is flawed thinking.  How do you account for the fact that OspA and OspB are continually being utilized in the development of vaccines?  It is due to the desire of the patent-holding, financial-interest-bearing individuals associated with the CDC and the Infectious Diseases Society of America (IDSA) who are allowed to continually “mold” the testing criteria to accommodate their potential money-making vaccines.  If OspA and OspB were included in the testing criteria, it would skew the vaccine results, due to the fact that the vaccines are based on the most important and highly-specific OspA and OspB antigens!

Julie Gerberding, M.D.
March 1, 2006
Page Three

VMP-like sequences of pathogenic Borrelia

Abstract

The present invention relates to DNA sequences encoding Vmp-like polypeptides of pathogenic Borrelia, the use of the DNA sequences in recombinant vectors to express polypeptides, the encoded amino acid sequences, application of the DNA and amino acid sequences to the production of polypeptides as antigens for immunoprophylaxis, immunotherapy, and immunodiagnosis. Also disclosed are the use of the nucleic acid sequences as probes or primers for the detection of organisms causing Lyme disease, relapsing fever, or related disorders, and kits designed to facilitate methods of using the described polypeptides, DNA segments and antibodies.

2.1 Methods of Treatment

An important aspect of the invention is the recognition that Borrelia VMP-like sequences recombine at the vls site, with the result that antigenic variation is virtually limitless. Multiclonal populations therefore can exist in an infected patient so that immunological defenses are severely tested if not totally overwhelmed.

            As you can see by the research published in 1991 by Alan G. Barbour and the United States Patent, one of the inventors again being Alan G. Barbour, antigenic variation can preclude a person from developing antibodies to the many antigens presented by the organism.

Julie Gerberding, M.D.

March 1, 2006

Page Four

            The CDC’s recommended diagnostic and two-tiered laboratory criteria are based upon antigens without antigenic variation.  Yet, published research and patents show that Borrelia do display antigenic variation.  The CDC’s diagnostic and laboratory criteria are contradictory to published research.  If science shows that “multiclonal populations therefore can exist in an infected patient so that immunological defenses are severely tested if not totally overwhelmed,” how can you reasonably state that “a patient’s immune system has had ample time to develop antibodies to the many other antigens present in the organism?”  I am certain you are aware by the “frequent calls from patients and family members who are confused and upset by false and misleading information they have read on the Internet”  that many people are NOT testing positive by the CDC’s carefully-designed criteria.

            Including all known antigens in the diagnostic and laboratory criteria would certainly assist more Lyme disease patients in receiving a diagnosis based upon blood tests, which despite your magnificent efforts at informing physicians that the surveillance case definition is for epidemiological purposes only, the majority of doctors follow the CDC’s recommended two-tier testing approach and order inaccurate ELISA’s which are based upon the carefully-crafted, limited laboratory and test-kit criteria and then rely only upon the lab’s notation of a positive or negative result.

            If Lyme disease patients had any cooperation at all from the CDC, we would see the CDC and the other entities involved revise the laboratory criteria to include ALL KNOWN ANTIGENS.  This could only assist in proper diagnosis.  The CDC’s selective picking and choosing of antigens to include in the laboratory criteria excludes a large number of patients from receiving diagnosis and treatment.

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.  (Lyme expert?)  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.” 

            This is false information, per your own publication.  See Questions and Answers About TB, U.S. Department of Health and Human Services, Public Health Service, CDC, 1994:

Julie Gerberding, M.D.

March 1, 2006

Page Five

“Why Do I Need to Take TB Medicine Regularly?

TB bacteria die very slowly.  It takes at least 6 months for the medicine to kill all the TB bacteria.  You will probably start feeling well after only a few weeks of treatment.  But beware!  The TB bacteria are still alive in your body.  You must continue to take your medicine until all the TB bacteria are dead, even though you may feel better and have no more symptoms of TB disease.

            If you don’t continue taking your medicine after you feel better or you aren’t taking your

            medicine regularly, this can be very dangerous.  The TB bacteria will grow again and you will

            remain sick for a longer time.  The bacteria may also become resistant to the drugs you are

            taking.  You may need new, different drugs to kill the TB bacteria if the old drugs no longer

            work.  These new drugs must be taken for a longer time and usually have more serious side

            effects.”

            The physician suspects syphilis and rheumatoid arthritis, so he recommends the patient have a psychological examination for the hallucinatory tick bite and residual debilitating 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, one of the authors of the IDSA Treatment Guidelines, 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 quite dramatic 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 following is from another published article by Allen C. Steere, one of the authors of the IDSA Guidelines:

.

 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.”

Julie Gerberding, M.D.

March 1, 2006

Page Six

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.”

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.”

            The drama becomes evident when one reviews the affiliations of the IDSA committee members who authored the IDSA Guidelines in 2000. 

IMPORTANT - 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 the lead researcher at the new Boston University Biowarfare Lab.

Julie Gerberding, M.D.

March 1, 2006

Page Seven

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.”

            How conflicting!!  The 2000 IDSA Treatment Guidelines, partially authored by Allen C. Steere and Raymond J. Dattwyler, promote an extremely short course of antibiotics.  Clearly, the published IDSA Treatment Guidelines that the CDC has posted on its website for physicians and patients are contradictory to published research, some of that research performed by the very individuals who authored the contradictory IDSA Guidelines!  To make matters worse, a review of several of the authors’ affiliations by reading the Lyme Disease Association’s 2001 Conflicts of Interest report referenced above will reveal some serious potential conflicts of interest.

            According to the Lyme Disease Association’s 2001 report entitled Conflicts of Interest in Lyme Disease:  Laboratory Testing, Vaccinations, and Treatment Guidelines, the IDSA 2000 Lyme disease Guideline Committee members, and thus the Infectious Diseases Society of America itself, have potential conflicts of interest and should not be the authors of treatment guidelines that have a deleterious impact upon Lyme disease patients nationwide by precluding them from receiving extended antibiotic treatment that can improve their quality of life. 

            If extended antibiotic therapy can get some patients up and working again, the cost of paying for disability benefits will decrease.  I have spoken to many Lyme disease patients who have the desire to function the way they did prior to contracting the infection, but are unable to do so for lack of treatment.

            I OBJECT TO TREATMENT GUIDELINES THAT ARE AUTHORED BY PATENT-HOLDING, FINANCIAL-INTEREST-BEARING INDIVIDUALS WITH POTENTIAL CONFLICTS OF INTEREST!!

            It is quite apparent that SERIOUS potential conflicts of interest exist in the web of individuals who have and are writing and promoting the IDSA Edicts.  These IDSA Edicts are in some cases proving to be a slow and lingering death sentence for Lyme disease patients like me.

Julie Gerberding, M.D.

March 1, 2006

Page Eight

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.

Julie Gerberding, M.D.

March 1, 2006

Page Nine

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 the CDC to abide by informed consent guidelines by providing BOTH PUBLISHED STANDARDS OF CARE IN PLAIN VIEW on its website without any biased commentary or studies for physicians to utilize in their practices and patients to obtain adequate information.  This will prevent exposure to LEGAL LIABILITY for not providing informed consent to Lyme disease patients and physicians.

            These are my thoughts with regard to your statement that, “We receive frequent calls from patients and family members who are confused and upset by false and misleading information they have read on the Internet.”  I believe that the CDC, through its Lyme disease website, is providing “false and misleading information” which is causing patients and

physicians to make “ill-informed decisions” that ARE affecting their health and well being.  I believe that I have an obligation to make YOU aware of this problem! 

            Ignorance enjoys bliss and complacency; knowledge requires ACCOUNTABILITY.  The CDC is NOT providing adequate information for physicians to abide by informed consent guidelines and for patients to be fully informed.  I expect the CDC to immediately provide BOTH PUBLISHED STANDARDS OF CARE IN PLAIN VIEW on its website and without any biased commentary or studies. 

            This will prevent exposure to LEGAL LIABILITY.

Julie Gerberding, M.D.

March 1, 2006

Page Ten

            I have been informed that the CDC assisted in conducting studies of Borrelia burgdorferi in vectors and ticks in the State of Arizona.  Please provide me with complete copies of the following:

-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

Cc:      Secretary Michael Leavitt, U.S. Department of Health and Human Services

            Anthony S. Fauci, M.D., National Institute on Allergy and Infectious Diseases

            Senator Jon Kyl, Arizona

            Senator John McCain, Arizona

            Senator Robert C. Byrd, West Virginia