Harford County Lyme Disease Support Group, Inc.

Contact: Jean F. Galbreath

JGLyme@aol.com

This challenge is to the ‘One Pill for Prevention of Lyme’ theory

The IDSA guidelines state: A single dose of doxycycline may be offered to adult patients (200 mg dose) and to children 8 years of age (4 mg/kg up to a maximum dose of 200 mg) (B- I) when all of the following circumstances exist:

The first requirement

(a) the attached tick can be reliably identified as an adult or nymphal I. scapularis tick that is estimated to have been attached for 36 h on the basis of the degree of engorgement of the tick with blood or of certainty about the time of exposure to the tick;

An adult female Ixodes scapularis tick, actual size.

. A nymph tick, species unknown, actual size.

. A larval tick, species unknown, actual size.

Several tick species, actual size- can you identify them?

CDC: “Most cases of human illness occur in the late spring and summer when the tiny nymphs are most active and human outdoor activity is greatest.” CDC website

1. The majority of practicing physicians cannot distinguish one tick species from another if they were to have access to a tick that bit someone.

2. Most bites are from nymphs that can barely be seen.

3. Many physicians have traveled to the United States from foreign countries and many have never seen a tick. They often have difficulty distinguishing them from spiders.

4. Expecting physicians to only treat bites from a certain species of tick, when it is impossible for most people to tell the difference, is not a reasonable requirement.

5. When grade school children were asked if they could tell how long a tick was on them before it was removed the typical answer was, “If I knew it was ON me, I would have taken it off!” Adults responded to the question with a similar answer, “Of course I don’t know how long it was on me! If I knew it was going to bite me I wouldn’t have let it.”

6. Since many people spend days outdoors in the warmer weather when ticks are most active and many work outdoors, it would not be feasible to expect them to pinpoint the time of day or even which day the tick attached itself.

7. Households with pets running in and out may not know their pet carried in a tick that later bit them and would not necessarily know how long the tick was attached.

8. The requirement to pinpoint a specific time for the original tick attachment is not practical and may exclude people from treatment who don’t know the correct answer.

**This recommendation should be excluded due to the fact it is impractical to comply with these conditions in the clinical setting. The IDSA’s plan is not treating patients at all if a tick cannot be identified, which is totally unacceptable.

The second requirement:

(b) prophylaxis can be started within 72 h of the time that the

tick was removed;

1. Many people venture outdoors on the weekend. If an attached tick is spotted on a Friday night, for example, people do not have instant access to a physician’s office. Emergency rooms, already overcrowded, should not be burdened with people trying to race in to get medication within a short time period for fear of not getting any treatment.

2. People living in endemic areas would have to pay approximately $100.00 - $200.00 for a doctor’s appointment in order to be prescribed one dose of Doxycycline (200 mg.), which they pay 32 cents for at the local pharmacy. Many will ignore the need for treatment, not because of the price of the one dose of antibiotics, but the inconvenience of taking off work to go to the doctor (lost wages) and the additional cost of the doctor’s visit.

3. In endemic areas most people know the serious consequences involved with having untreated Lyme disease. If they go to a doctor, pay for the visit, miss work and would like preventative treatment (their right to have), they will not be satisfied with the recommendation of one dose. Most people know that one dose of an antibiotic will not prevent Lyme disease.

4. Children, the ones most at risk, are not provided any preventative treatment if they are under 8 years old. This is not acceptable considering the consequences.

**This recommendation should be excluded because it is not at all practical. If this requirement is not met, people are provided no treatment and no alternatives. That is not acceptable.

The third requirement:

(c) ecologic information indicates that the local rate of infection of these ticks with B. burgdorferi is 20%;

1. Very few localities have the luxury of having regular and expensive scientific study results on hand to be able to confirm the rate of infected ticks in their area.

2. Locations not currently considered endemic would be more at a disadvantage for the simple reason that, until a problem is documented extensively, funding normally isn’t provided for research.

3. A person regularly bitten by ticks in an area where the rate of infection is 10% is just as likely of contracting Lyme and other tick borne diseases as someone in an area with a higher infection rate that is only bitten once. Refusing to treat a person because they have less chance of contracting Lyme, makes as much sense as withholding treatment in a case where a person is suffering from an expanding necrotic wound after a spider bite because more hobo spiders are thought to be in the area than brown recluses.

4. If a physician encountered a tick bite patient and refused to treat because no data was available to inform them of the infection rate, it does not diminish the risk to the patient of contracting Lyme and developing the later stages. The old adage, “a ounce of prevention is worth a pound of cure” certainly applies in this situation.

**Until each state and county has documented studies determining the current rate of infection, this requirement is not practical. Without studies, infection rates are impossible to determine. This requirement should be excluded from the guidelines.

The IDSA’s fourth requirement:

and (d) doxycycline treatment is not contraindicated.

Doxycycline is relatively contraindicated in pregnant women and children <8 years old. The panel does not believe that amoxicillin should be substituted for doxycycline in persons for whom doxycycline prophylaxis is contraindicated because of the absence of data on an effective short-course regimen for prophylaxis, the likely need for a multiday regimen (and its associated adverse effects), the excellent efficacy of antibiotic treatment of Lyme disease if infection were to develop, and the extremely low risk that a person with a recognized bite will develop a serious complication of Lyme disease (D-III).

Not treating pregnant women and young children is not acceptable. Period.

Gestational Lyme borreliosis. Implications for the fetus. MacDonald AB. Rheum Dis Clin North Am, 15(4):657-77. 1989. Autopsy and clinical studies have associated gestational Lyme borreliosis with various medical problems including fetal death, hydrocephalus, cardiovascular anomalies, neonatal respiratory distress, hyperbilirubinemia, intrauterine growth retardation, cortical blindness, sudden infant death syndrome, and maternal toxemia of pregnancy.

Borrelia burgdorferi in a newborn despite oral penicillin for Lyme borreliosis during pregnancy. Weber K, Bratzke HJ, Neubert U, Wilske B, Duray PH. Pediatric Infectious Disease Journal, 7:286-9. 1988. We have found B. burgdorferi in human neonatal brain and liver although the mother had been treated with an orally administered penicillin for LB during early pregnancy.

Congenital infections and the nervous system. Bale JF Jr, Murph JR. Pediatr Clin North Am Aug;39(4):669-90 1992 Despite vaccines, new antimicrobials, and improved hygienic practices, congenital infections remain an important cause of death and long-term neurologic morbidity among infants world-wide. In addition, several other agents, such as the varicella zoster virus, human parvovirus B19, and Borrelia burgdorferi, can potentially infect the fetus and cause adverse fetal outcomes.

Maternal-fetal transmission of the Lyme disease spirochete, Borrelia burgdorferi. Schlesinger PA, Duray PH, Burke BA, Steere AC, Stillman MT. Ann Intern Med. 1985 Jul;103(1):67-8. PMID: 4003991 We report the case of a woman who developed Lyme disease during the first trimester of pregnancy. She did not receive antibiotic therapy. Her infant, born at 35 weeks gestational age, died of congenital heart disease during the first week of life. Histologic examination of autopsy material showed the Lyme disease spirochete in the spleen, kidneys, and bone marrow.

Culture positive seronegative transplacental Lyme borreliosis infant mortality. Lavoie PE, Lattner BP, Duray PH, Barbour AG, Johnson HC. Arthritis Rheum, Vol 30 No 4, 3(Suppl):S50. 1987. We report a culture positive neonatal death occurring in California, a low endemic region. The boy was born by C-section because of fetal distress. He initially appeared normal. He was readmitted at age 8 days with profound lethargy leading to unresponsiveness. Marked peripheral cyanosis, systemic hypertension, metabolic acidosis, myocardial dysfunction, & abdominal aortic thrombosis were found. Death ensued. Bb was grown from a frontal cerebral cortex inoculation. The spirochete appeared similar to the original Long Island tick isolate. Silver stain of brain & heart was confirmatory of tissue infection.

Stillbirth following maternal Lyme disease. MacDonald AB, Benach JL, Burgdorfer W. N Y State J Med, Nov;87(11):615-6 1987 This report describes a clinicopathologic investigation of a stillborn fetus that led to a retrospective diagnosis of Lyme disease contracted during the first trimester of pregnancy.

The infectious origins of stillbirth. Goldenberg RL, Thompson C. Am J Obstet Gynecol. 2003 Sep; 189(3):861-73. 2003. PMID: 14526331 Toxoplasma gondii, leptospirosis, Listeria monocytogenes, and the organisms that cause leptospirosis, Q fever, and Lyme disease have all been implicated as etiologic for stillbirth.

Lyme disease during pregnancy. Markowitz LE, Steere AC, Benach JL, Slade JD, Broome CV. JAMA Jun 27;255(24):3394-6. 1986. Of the 19 pregnancies, five had adverse outcomes, including syndactyly, cortical blindness, intrauterine fetal death, prematurity, and rash in the newborn. Adverse outcomes occurred in cases with infection during each of the trimesters. Although B burgdorferi could not be implicated directly in any of the adverse outcomes, the frequency of such outcomes warrants further surveillance and studies of pregnant women with Lyme disease.

Infections in Obstetrics: Lyme disease during Pregnancy Helayne M. Silver, MD Infectious Disease Clinics of North America Vol 11 Number 1 1 March, 1997 The infant had severe congenital cardiac defects resulting in neonatal death at 39 hours of life. The neonatal autopsy revealed hypoplastic left side of heart and other cardiac anomalies. Spirochetes compatible with B. burgdorferi were found in the spleen, kidneys, and bone marrow; however, no inflammatory response to the organisms was seen.

Human fetal borreliosis, toxemia of pregnancy, and fetal death. MacDonald AB. Zentralbl Bakteriol Mikrobiol Hyg [A]. Dec; 263(1-2):189-200. 1986. PMID: 3554838

Congenital relapsing fever (Borrelia hermsii). William A. Dittman Sr, Sacred Heart Medical Center, Spokane, WA. Blood, 15 November 2000, Vol. 96, No. 10, pp. 3333-3333 The child was treated with fluids for the septic shock. Ampicillin and cefotaxime were given initially, and erythromycin was added when the spirochetes were found. Dexamethasone was administered for the septic shock and thrombocytopenia. Improvement was progressive until day 9 when hypotension, pallor, and abdominal distension occurred. Autopsy revealed bleeding into a liver abscess with subsequent rupture of a subcapsular hematoma. No organisms were found in the abscesses at autopsy.

Tick-borne relapsing fever and pregnancy outcome in rural Tanzania. Jongen VH, van Roosmalen J, Tiems J, Van Holten J, Wetsteyn JC. Acta Obstet Gynecol Scand. Oct; 76(9):834-8. 1997. PMID: 9351408 The impact of tick-borne relapsing fever (TBRF) on pregnancy outcome was investigated in a case-control study of 137 pregnant women and 120 non-pregnant women infected with this condition and treated at a rural hospital in Tanzania's Tabora region during 1985-95. The risk of premature delivery during TBRF was 58%, with a perinatal mortality of 436 per 1000 births. Total pregnancy loss, including abortions, was 475 per 1000. The case-fatality rate was 1.5% in pregnant women compared with 1.7% in non-pregnant controls. The relapse rate was 3.6% in pregnant women and 1.7% in controls. Pregnant women with TBRF had higher densities of spirochetes than controls, and the risk of delivery during an attack was significantly correlated with increasing spirochete density and gestational age.

Complications of pregnancy and transplacental transmission of relapsing-fever borreliosis. Larsson C, Anderson M, Guo BP, Nordstrand A, Hagerstrand I, Carlsson S, Bergstrom S. J Infect Dis. 2006 Nov 15;194(10):1367-74. Epub 2006 Oct 3. PMID: 17054065. Relapsing-fever borreliosis caused by Borrelia duttonii is a common cause of complications of pregnancy, miscarriage, and neonatal death in sub-Saharan Africa.

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Conclusion

The guidelines state the following goals for their one dose of Doxycycline prevention protocol:

The principal desired outcome is prevention of Lyme

disease. Another desired outcome is the prevention of other

Ixodes-transmitted illnesses, including HGA (caused by A. phag-

ocytophilum) and babesiosis. Either of the latter 2 infections

may occur alone or in conjunction with Lyme disease, and

occasionally all 3 infections may occur together [24–28].

The IDSA guidelines recommend one dose of an antibiotic be provided to patients meeting specific requirements and only if they are bitten by a tick in an endemic area that may harbor one or more diseases.

1. Referenced were 81 articles to base this one pill decision on (compared to the chronic late stages, such as ACA, which only had three articles referenced).

2. IDSA panel members, the same ones found guilty of having multiple conflicts of interest, etc, wrote approximately 50% of these articles. Of these articles (one was written in this century), only three were concerning treatment following a tick bite.

3. All three articles were contested by professionals working with the patients who were failed by the IDSA treatment guidelines.

4. This practice is so out-of-touch with reality it is rarely used in endemic areas by physicians with experience treating Lyme disease.

5. Pharmacists recommended patients go to a different doctor when customers are prescribed the one dose of Doxycycline for a tick bite.

6. The general public understands the risks of contracting Lyme disease and also understands one dose of an antibiotic will not prevent Lyme disease.

7. Patients concerned about Lyme disease who are given one dose of an antibiotic have walked out one doctor’s door and gone to another to be properly treated, invalidating the clinical trials.

8. This recommendation ignores the risks to pregnant women and young children, some of our most precious and valuable resources and ones often most at risk.

9. One dose of Doxycycline will not prevent the development of tick borne coinfections as the authors had hoped.

10. Antibiotics can alter future test results for Lyme disease, making this recommendation even more dangerous.

The IDSA author’s recommendations for prevention methods have failed miserably. The one dose Doxycycline therapy has failed patients. The 3-week protocol is at the center of a war that will not end until reasonable recommendations are forthcoming due to the numerous failures it has produced. The Lyme tests are a failure. The vaccine failed. The authors have been investigated by officials for their blatant biased guidelines. The research funding has been wasted by using tests that are not accurate, which in turn were used to base study results on over the years.

The IDSA guidelines should be totally revised

to be appropriate in clinical practice.

That is the only way lives will be saved.