Tina J. Garcia

Post Office Box 2654

Mesa, Arizona  85214-2654

480-219-6869  Phone

480-830-2788  Fax

                                                                                    October 19, 2006

Lyle R. Petersen, M.D., MPH

Centers for Disease Control (NCID)

Division of Vector-Borne Infectious Disease

P.O. Box 2087 (Foothills Campus)

Fort Collins, CO  80522

            Re:  The Clock is Still Ticking -- Days, Weeks, Months and Years Go By

Dear Dr. Petersen:

            Although I was glad to finally receive your June 29, 2006 response to my March 1, 2006 letter to CDC Director, Dr. Julie Gerberding, it is disappointing that the response came only as a result of Senator John McCain having to forward to the CDC a second copy of my March letter.  To me, this is just another example of the lack of concern for Lyme disease patients exhibited by the CDC over the past twelve to thirteen years since implementation of the Dearborn criteria began to take place.

            I am concerned about what is perceived by many patients to be the continued feigned interest and compassion from the CDC with regard to the causes of the ongoing lack of diagnosis and treatment for Lyme disease patients throughout the United States and Europe.  Many patients and patient advocates have contacted your agency over the years only to receive weak lip service to pacify the frustration that is boiling over in the Lyme patient community.

Second National Conference on Serologic Diagnosis of Lyme Disease

(Dearborn Criteria)

            Representatives from Smith Kline Beecham (SKB) met with the CDC and the FDA in June of 1994 to review the requirements for a case definition of Lyme disease.  It was necessary for SKB to obtain the requirements during their developmental clinical trials of the Lymerix vaccine so that the vaccine could ultimately be approved.  SKB, CDC and FDA were all aware of the unusual method in which the proposed Lymerix vaccine would prevent infection from a tick bite, that is, by utilizing the OspA (31 kDa) band in the midgut of the tick.

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Two

            Four months later, in October of 1994, the Second National Conference on Serologic Diagnosis of Lyme Disease was held in Dearborn, Michigan.  At this conference, armed with the knowledge that OspA (31kDa) was being utilized in the development of the Lymerix vaccine and with the anticipation that large numbers of people would be vaccinated after approval was obtained, the OspA (31kDa) band was REMOVED from the serologic testing criteria to prevent patients who had received the Lymerix OspA vaccine from testing positive on standardized, patented tests.  The OspB (34kDa) band was also REMOVED at that time.  This criteria became known as the Dearborn Criteria and is still being utilized today by standardized, patented Lyme disease laboratory test kits.  Although “poor sales” was the reason given by SKB for taking the vaccine off the market, a more accurate reason was that the SKB/Yale Lymerix vaccine failed miserably after approval, resulting in lawsuits filed by attorneys representing Lyme vaccine recipients who suffered Lyme disease symptoms after receiving the vaccine.

            Prior to the Lymerix vaccine clinical trials, the OspA (31kDa) and OspB (34kDa) were accepted as necessary bands for testing.  It is the CDC’s position that these two bands were not removed because of the Lymerix vaccine.  You stated in your letter that the CDC is a “science-based organization.”  If so, please provide science-based answers to the following:

●If not to accommodate the SKB/Yale vaccine clinical trials, why then were these two bands suddenly determined to be unnecessary to include in the serologic testing criteria to coincide with SKB/Yale conducting vaccine clinical trials?  Please provide the SPECIFIC reason and scientific published research that was used to support the REMOVAL of these two PREVIOUSLY-ACCEPTED BANDS from the serologic testing criteria at the Dearborn Conference in October of 1994.

●What “misclassification” are you referring to in this statement in your letter?  “This work, however, did not look at a control population of healthy people or people with other illnesses to assess the extent of misclassification that could potentially result if these bands were added to the scoring criteria.”

I am not suggesting, and neither are the many other Lyme disease patient advocates, that OspA and OspB be utilized “in isolation.” 

●Please provide the scientific published research that demonstrates scoring OspA or OspB by themselves should be considered inconclusive or a false positive.

●Please provide the scientific published research that shows that OspA and OspB scoring with the other bands of the Dearborn criteria would interfere with or cause the serologic test results to be inconclusive or a false positive.

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Three

●Please provide the scientific published research that proves that the OspA band is NOT important, essential or specific to Borrelia burgdorferi.

●Please provide scientific statistics that demonstrate patients who have developed Lyme arthritis are seropositive by the Dearborn scoring criteria.  PLEASE NOTE:  Relying upon this is flawed “science” due to the fact that it excludes a large number of patients who have developed other manifestations of the Bb infection, not only Lyme arthritis.

●How can the CDC implement such a restricted testing criteria when, as a “science-based organization,” it is aware of the following scientific published research by Alan G. Barbour who, according to the  Lyme Disease Association’s Conflicts of Interest in Lyme Disease: Laboratory Testing, Vaccination, and Treatment Guidelines 2001, “owns rights to multiple patents related to Lyme vaccines and tests and is the inventor of the vaccine technology used by Aventis Pasteur to manufacture its second (and third and beyond) generation vaccines?”

Dr. Barbour’s published research confirms ANTIGENIC VARIATION in Lyme borreliosis, which renders the Dearborn criteria ineffective in screening for and establishing Borrelia burgdorferi infection.

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 MEDLIN

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Four

            The CDC is directly responsible for REDEFINING Lyme disease in 1994, and consequently, excluding a large number of extremely ill patients.  Although this important issue is continually brought to your attention, the CDC refuses to make any changes to the Dearborn serologic testing criteria, despite the fact that the OspA vaccine is “no longer available.” 

            In addition, it is a fact that continued development of Lyme disease vaccines are currently being conducted based upon the OspA band.  Due to the CDC’s continued acceptance and adherence to the vaccine-friendly Dearborn criteria, in other words accommodation of the pharmaceutical companies currently developing these vaccines, thousands of late-stage Lyme disease sufferers in the United States and Europe are still being precluded from proper diagnosis and treatment. 

●The CDC is aware of this ongoing problem.  Please provide your basis for refusing to make any changes in the criteria that would be favorable of better diagnosis and treatment.

IDSA Treatment Guidelines

(Short-Term Antibiotic Therapy is Sufficient to Cure Lyme Disease)

“As a science-based organization, we believe that the weight of the current scientific literature better supports the treatment guidelines developed under the auspices of IDSA.”

What type of science does the CDC base its decisions upon?  If the CDC is “science-based” as you purport to be, how do you explain the acceptance of the IDSA Treatment Guidelines as science-based, which have been authored by researchers who have published scientific research that contradicts the IDSA Treatment Guidelines that they are responsible for?  Referenced below is scientific research published by Allen C. Steere and Raymond J. Dattwyler, two of the authors of both the 2000 and most recently the 2006 updated IDSA Treatment Guidelines.  Let me also remind you of the fact that Dr. Steere, Dr. Dattwyler and Dr. Barbour were involved with the development and the approval of the Lymerix vaccine years ago

            This is an abstract from a published article co-written by Allen 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.”

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Five

The following is from another published article by Allen C. Steere:

.  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.”

From Raymond J. Dattwyler, another author of the 2000 and 2006 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.”

●This scientific published research does not support the IDSA hypothesis that chronic Lyme disease is caused from autoimmune response.  It does demonstrate that chronic Lyme disease is caused from PERSISTENT BACTERIAL INFECTION!

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Six

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●Although long-term antibiotics do not always cure the infection, it allows a person to continue LIVING and it improves their QUALITY OF LIFE!  If the CDC is truly interested in better health for people in America and the rest of the world, why does it continue to promote the IDSA Treatment Guidelines that only cause extended suffering and disability for Lyme disease patients?

●The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis:  Clinical Practice Guidelines by the Infectious Diseases Society of America recently updated in 2006 place restrictive requirements upon physicians and patients for administering antibiotic treatment immediately following a tick bite.  The four requirements are out-of-touch with reality for the following reasons:

“For prevention of Lyme disease after a recognized tick bite”

            ●          Many patients present to their GP’s with an EM and neither the patient

                        nor the GP recognize the EM as the “most common clinical

                        manifestation of Lyme disease.” (See Background in the IDSA

                        Guidelines).  “Recognized tick bites” are not commonly recognized by

                        physicians as demonstrated by the high number of patients who have

                        been examined immediately following a tick bite, with or without the EM

                        clinical manifestation, and the GP fails to diagnose the EM or fails to

                        entertain the possibility of Borrrelia infection.

            ●          Most patients will remove the tick immediately, IF IT IS EVEN

                        DISCOVERED ATTACHED TO THEIR BODIES.  In addition, most people

                        will not use a stop watch to begin timing how long the tick is attached.

                        If it is discovered, it will most likely be removed immediately.  Most

                        patients will not know the actual start time of tick attachment, and

                        therefore, to arbitrarily set a >36 hour attachment criteria to routine use

                        of antimicrobial prophylaxis or serologic testing, is ludicrous!

            ●          Many times the tick has already removed itself from its host prior to the

                        EM appearing.  It is not possible to time tick attachment accurately and

                        to include a >36 hour attachment as a criteria for administering

                        antimicrobial prophylaxis or serologic testing is BEYOND ABSURD. 

                        The alleged esteemed members of the IDSA expert panel who authored

                        these guidelines should be required to take Borrelia burgdorferi 101 to

                        ground them and bring them back into touch with reality.

“on the basis of the degree of engorgement of the tick with blood”

            ●          Most patients and GP’s will not be inclined to use a caliper to measure

                        the degree of tick engorgement.   Has the IDSA instructed GP’s to

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Seven

                        measure the degree of tick engorgement?  I think not.  Therefore, this

                        requirement is also ridiculous on the basis that most physicians know

                        little to nothing about tick-borne infections in the first place. 

                        Additionally, if physicians don’t even entertain the POSSIBILITY of a

                        tick-borne infection, does the esteemed IDSA expert panel actually

                        believe that, during an insurance regulated 10-15 minute examination,

                        the physician will be inclined to go to the extreme of measuring the

                        engorgement of a tick?

            ●          The Merck Manual, Sixteenth Edition, states regarding Lyme disease:

                        “After an incubation period of 3 to 32 days, the organism migrates

                        outward in the skin (ECM) and may spread to lymph (regional

                        adenopathy) or disseminate in blood to organs or other skin sites.”

                        If the tick must be attached for at least 36 hours and prophylaxis may

                        be started within 72 hours of the 36 hours of attachment, that totals 108

                        hours or 4.5 days.  According to Merck, it takes 3 and up to 32 days for

                        the EM to even appear.  In order for a patient to receive initial routine

                        treatment for a tick bite, these updated Guidelines provide a 72-hour

                        window of time ONLY and IMMEDIATELY following removal of the tick.

                        The authors have not considered any of the actual scenarios outlined

                        above such as, tick removal prior to appointment, unknown time of

                        attachment, length of time from tick attachment to manifestation of EM

                        and length of time between tick attachment or removal and time of

                        appointment with physician.

            ●          Setting an infection rate at >20% for an adult to qualify for a single 200

                        mg dose and up to a 200 mg maximum dose for children precludes ALL

            `           geographic locations and states in which the INNACURATE

                        epidemiological studies of the spread of Bb show <20% and those

                        areas and states in which epidemiological studies are not performed AT

                        ALL!  This requirement precludes all patients who become infected in

                        an area that has a <20% infection rate! 

            ●          DID IT EVER OCCUR TO THE CDC AND THE IDSA GUIDELINE

                        AUTHORS THAT ONE PERSON MAY BECOME INFECTED BY ONE TICK

                        IN AN AREA WITH A 1% INFECTION RATE??

            ●          And for states that don’t test for Borrelia burgdorferi at all, the IDSA

                        Guidelines preclude ALL patients from receiving treatment!!  For                                         example, the last testing of Ixodes pacificus ticks in Arizona was

                        performed FOURTEEN YEARS AGO in 1992.  No further studies have

                        been performed, and therefore, the current infection rate is UNKNOWN.

                        Therefore, it is below the 20% infection rate arbitrarily imposed by the

                        authors of the IDSA Guidelines.  Patients who were infected or who

                        reside in these states will receive NO diagnosis or treatment and will

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Eight

                        remain untreated for years.  These people will develop chronic late-

                        stage Lyme disease with its devastating CNS, musculoskeletal and

                        possible cardiac involvement!

            ●          The 2006 IDSA Guidelines mention specifically certain antibiotics that

                        IDSA does not recommended for use in treating Lyme disease patients. 

                        These are antibiotics that are being utilized by experienced Lyme

                        physicians and patients to IMPROVE THE PATENTS’ QUALITY OF LIFE! 

                        The IDSA has provided an extremely narrow choice of antibiotic

                        prophylaxis, which does not assist the Lyme disease physician working

                        in the trenches on a daily basis; the result is injurious to patients. 

                        Narrowing the choices of antibiotic treatment ensures

                        that the most helpful antibiotic treatment for Lyme

                        disease will NOT be covered by most insurance, because

                        insurance companies utilize the IDSA Guidelines.

PROVIDING INFORMED CONSENT WITH TREATMENT GUIDELINES FROM BOTH THE International Lyme and Associated Diseases Society (ILADS) and the Infectious Diseases Society of America (IDSA)

●As I informed you in my previous correspondence, INFORMED CONSENT requires physicians to provide ALL treatment options to patients.  Long-term antibiotic treatment is utilized consistently by physicians who specialize in treating Lyme disease patients.  Long-term antibiotic treatment  has become a STANDARD OF CARE for Lyme disease.

●THE CDC IS FAILING TO PROVIDE ADEQUATE INFORMATION ON ITS WEBSITE TO PHYSICIANS SO THAT THE PHYSICIANS CAN PROVIDE INFORMED CONSENT TO THEIR PATIENTS.  IT IS THE RESPONSIBILITY OF THE CDC TO PROVIDE ALL INFORMATION REGARDING TREATMENT, NOT ONLY THE OPTION THAT THEY ENDORSE.

●IT IS NOT THE CDC’S DECISION AS TO WHAT TREATMENT PATIENTS SHOULD HAVE.  ACCORDING TO THE AMA’s INFORMED CONSENT GUIDELINES, THE CDC SHOULD NOT BE FORCING ONLY ONE TREATMENT OPTION UPON THE PUBLIC, BUT PROVIDE ALL THE TREATMENT OPTIONS

AVAILABLE, SO THAT THE TREATMENT DECISION CAN BE MADE BY THE PATIENT AND THEIR PHYSICIAN.

●AGAIN, ON BEHALF OF SUFFERING CHRONIC LYME DISEASE PATIENTS AND LYME PHYSICIANS, I AM INSISTING THAT BOTH THE ILADS AND IDSA TREATMENT GUIDELINES BE POSTED ON THE CDC WEBSITE TO COMPLY WITH THE AMA’s GUIDELINES FOR INFORMED CONSENT.

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Nine

IMPORTANT - See:   http://www.lymediseaseassociation.org/Conflicts.doc

Information disseminated on CDC Lyme Disease Website

            “CDC takes quite a different view of material and information posted on our website, and will only make available materials that we feel reflect the best currently available scientific knowledge.”

            There are many contradictory, false and misleading statements on the CDC Lyme Disease Website.  In fact, there are so many false and contradictory statements (not based upon scientific research), along with a deliberate use of misleading words like “some patients” and “a few patients”, that the entire website deserves a complete dissection to address all of the inconsistencies being disseminated to physicians and patients worldwide.  References made to “some patients” and “a few patients” is a deliberate use of words that paints an inaccurate picture in the mind of the reader for the purpose of minimizing the seriousness and frequency of this tick-borne infection.

            It is difficult to swallow and digest the CDC’s feigned statements regarding concern for the plight of Lyme disease patients when there are so many flagrant falsehoods on its website.  Rebutting all of these false and misleading statements would be a monumental task that I cannot undertake presently..

●This is my second request for you to provide me with copies of all Borrelia burgdorferi tick and vector test results conducted in Arizona from 1980 to the present.  In a July 10, 2006 letter, I was informed by the Arizona Department of Health Services (ADHS) that Dr. Joe Peisman and Gary Maupin from the CDC provided field and laboratory support in collecting and testing the ticks and that notification of the test results would have been provided to the ADHS by them.  I have yet to receive copies of these test results from either the ADHS or the CDC.  What is the problem?

            Taking into account all of the above information, I am confident in asserting that the Infectious Diseases Society of America (IDSA) and the Centers for Disease Control and Prevention (CDC) are CONTROLLING Lyme disease and PREVENTING Lyme disease patients from obtaining treatment.  This would not be the first time the CDC has done this to American citizens.

The CDC by its own admission committed health-related crimes against citizens without any reservation or moral accountability while conducting the Tuskegee Study, which lasted close to 40 years.  The similarity between the syphilis bacteria and the Lyme disease bacteria and the similarity between the orchestrated prevention of treatment in the Tuskegee Study and the current IDSA Treatment Guidelines is FRIGHTENING and SUSPECT!

Lyle R. Petersen, M.D., MPH

October 19, 2006

Page Ten

            Please address all the questions and issues in this letter and refrain from any more pacifying statements about your feigned care, interest and concern.  The Lyme disease patient community is fed up with the lack of action from the CDC and the carefully-designed Treatment Guidelines from IDSA with regard to our situation.

                                                                                    With Mounting Frustration,

                                                                                    Tina J. Garcia

                                                                                    Lyme Disease Patient Advocate