Dr. Baker: Thank you Dr. Fallon, we’ll go on to Dr. Sood.

Dr. Sood: Good afternoon my name is Sunil Sood I’m from Schneider Children’s Hospital, Long Island and professor of pediatrics at Albert Einstein College of Medicine. I just want to apologize I have only one slide and it becomes relevant only later on in the talks so you don’t need to look at it right now. So I became interested in lyme disease almost two decades ago upon moving to Long Island from New Orleans from Louisiana a non pandemic area primarily because of the number of calls that would come to our division office asking for advice on treating tick bites and also request of diagnostic testing which at the time was not commercially available. I set up a lyme disease diagnostic research laboratory I was a participant in the 2nd National Conference on serologic standardization in 1994 and as far as our pediatric infectious disease clinical practice is concerned the diagnostic criteria had been validated and valuable and useful since 1994. What changed from publication of the IDSA guidelines made it even easier to interpret serology on children before doing a pediatric lyme disease center for second opinions because now we could cite a unified reference and this helps us to stay advised by private pediatricians on the appropriate use and interpretation of commercially available assets. So my perspective on the IDSA 2006 guidelines is general and not going to be critiquing or quoting any specific studies based upon what my role as a consultant to a hundred of pediatricians in our endemic area and as author of review articles of pediatric lyme disease and secondly my editorship of a clinical text book on lyme borreliosis so firstly in my role as an ID consultant to pediatricians I just want to state that I find the guidelines to be up to space rigorous and comprehensive some chapters in text books and many online resources tend not to have detailed or sometimes not even reliable information for diagnosis and treatment of lyme disease but the IDSA guidelines do so it’s a good teaching tool for residents and students as well and for pediatricians the treatment tables and the pediatric closing are particularly valuable as you know the American Academy of Pediatrics guidelines are adapted from the IDSA guidelines which is useful to pediatricians. Secondly as editor of the first text book on clinical aspects of lyme borreliosis both adult and pediatric the first one to be published in about 11 years I have collaborated with 23 experts contributors from America and Europe. I’ve had the privilege of editing their earlier reviews of the following aspects of lyme borreliosis which are on the slide which include epidemiology biology of the spiral ticks early lyme borreliosis nervous system lyme disease arthritis lympocaetoma and dermatitis in Europe, co-infections with other tick-bone and diagnosed by culture and diagnosis with serology prognosis and prevention. In this endeavor this long endeavor, I cross checked almost all of the approximately 1200 references I don’t think I read every article myself but I cross checked them which were utilized by the contributors as evidence space and their chapters and I found no evidence that conflicted with the evidence used by the guidelines panel note that most of the contributors to my book were not panelists or consultants for the 06’ guidelines and about one half of them were European physicians or scientists. Their review of the evidence was based upon their independent examination of the literature. This exercise to me provided an unbiased assessment of the entire lyme borreliosis literature and a parallel fashion to that carried out by the IDSA panel and to reiterate this recent comprehensive review of all aspects of lyme borreliosis that was based upon the worldwide body of literature had no conflict

again with the evidence-based review of the IDSA guidelines. I’ve submitted to the panel a few items from the guidelines that could merit an update in the event that a revision is decided upon, these suggestions really reflect a change in emphasis rather than changes in the existing guidelines. The first items concerns differential diagnosis of the EM Erythro Migraines and again being in pediatric practice I see that a common occurrence in pediatric practice is the over treatment of small ring shaped rashes as EM it would be adequate to emphasize that most of these are probably mosquito bites and not even tick bites. These might help decrease the unnecessary use of antibodies that precede during the summer season in pediatrics. The second relates to prophylaxis antibiotic tick bites would suggest a minor change the current recommendation is to administer prophylaxis with Doxycycline for unidentified tick bite for children eight years and older that has been attached for 36 or more hours which is practically only a day so this has the effect of perpetuating the common practice of trading tick bites without trying even to verify the duration of attachment that’s assuming that it’s been identified as a tick. Again this results in discriminative use of antibiotics for tick bites. The guideline could be revised to change the attachment duration to 60 or 72 hours based upon some correlation of duration of attachment with risk of lyme borreliosis and to human studies for which are provided. The reference one is from our group and the other is from the Westchester [Inaudible] [00:05:55] group. Thirdly an important complication that’s observed frequently in early neurologic lyme borreliosis and more often in children is Papilledema this has been reported to result in permanent blindness occasionally physicians and emergency room physicians are typically unaware of this I find. A sentence could be added emphasizing the importance of endoscope examination in every child with asceptic or suspected lyme meningitis in an endemic area which is a daily occurrence for us at this time of the year. On co-infections, an emerging area of confusion I think among patients and some of their physicians is the prevalence of tick bone co-infections with lyme borreliosis although this is addressed briefly the guidelines could be updated with statistics on co-infections and although I find the geographic epidemiology [indiscernible] is detailed in the guidelines the epidemiology of the geography of human [Inaudible] [00:06:55] with lyme disease in the endemic areas is not and this would be helpful. I would like to point out a practical impediment to more widespread usage of the guidelines, this is as we’ve said again comprehensive medical research and immensely useful piece of work but it does not lend itself to easy reference by physicians in primary care for the following reasons they are voluminous as you’ve seen them and busy practitioners just do not read them, they are published in clinical in infectious disease journal, a journal read by these specialists even though freely available on the IDSA websites many physicians especially pediatricians are actually not aware of the existence of IDSA guidelines of any kind so the onus is on IDSA specialists like us to communicate them to other physicians but many of my colleagues are intimidated by the size of the document IDSA could possibly increase its efforts to propagate summaries of guidelines through the mass medical media, maybe a short section entitled advise and explanations could be added importantly because educating the public is now a recognized tool in improving health care standards IDSA should consider developing patient-friendly materials lay handouts that are based upon the guidelines. In closing I would like to recount in brief an illustrated case a patient that I saw recently. A young lady whose promising career in my opinion is being stymied by an inaccurate diagnosis of chronic

lyme disease, this bright and articulate fresh college graduate reports that her knee gave out suddenly during her sophomore year she had to be on crutches and a knee immobilizer there was no knee swelling, a year later she passed out when driving and received emergency supportive treatment. She became more anxious in her words and states that her medical history has been poured downhill from there. She presented to me a long list of symptoms including vision changes, tiredness pulsation and palpitation and ringing ears flashing images hallucinations bugs crawling on her muscle twitches, nerves on fire and anxiety. Clearly she is ill, she had no known tick bites, she received [indiscernible] [0:09:15] multiple sclerosis saw several specialists did a spinal head lumbar puncture, received steroids for that was administered a multiple skin testing panel for [Inaudible] [00:09:27] and other organisms which are said to have shown positive reactions to some of these agents. She had been seen interestingly in our adult infectious disease division towards the beginning of her illness but she did not return for follow up, based upon a positive IGM blot and her lyme IDG block was negative she went to see another physician in her words "LLMD" and has since been on one antibiotic or another continuously four weeks of [Inaudible] [00:10:01] followed by several oral antibiotics and now on azithromycin for about six months, her physical examination was completely normal, she was a bright vivacious young lady with a normal affect who stated she had a great degree of anxiety about her illness. Four months prior C6 Elisa was negative, I’m not a psychiatrist but we do see children of all ages and my diagnosis was anxiety disorder, I discussed a very serious matter spurious diagnose of lyme disease and the harm of being on long term antibiotics for no infection. She admitted there was no improvement in her symptoms after being on azithromycin but she became very anxious when I suggested she should stop the antibiotics. I discussed this at length with the patient and her parents with no immediate persuasive effect. All I can take from this is the fault is not hers, is not of her parents the problem is the refusal on the part of her physicians to use evidence-based guidelines. I think I’ve tried my best to break the self-enforcing circle that Barbara Johnson so elegantly proposed that was initiated in her case by false positive IGM block but unless her current physicians are willing to do the same she will not receive the urgent treatment she needs for her anxiety disorder and those are all the comments I have, thank you.

Dr. Baker: Thank you Dr. Sood. I believe you are the only pediatrician to testify this morning so I will make a comment.

Dr. Sood: And Jean Shapiro.

Dr. Baker: Oh and Jean Shapiro, Jean had to catch a plane, I’m glad he’s not here to hear the slide I just gave him but I have a question on something that you didn’t mention in your presentation. Both the documentary film under your skin and some of the materials we’ve received from the public talk about a disorder, two aspects; one is fetal loss from lyme disease during pregnancy and the second is congenital lyme infection in infants.

Dr. Sood: So again as part of the reviewing of in one of the chapters in my book we did look at the evidence very closely and we have reviewed all the studies on subject and there were some initial reports of what was thought to be spirochete like structures in the

autopsy of children with SIDS or Sudden Infant Death Syndrome that has not been reported since and basically there is no evidence that I’m aware of that there is vertical transmission.

Dr. Baker: And fetal loss?

Dr. Sood: As far as I know there is no evidence

Dr. Baker: Yes Dr. Duray sorry

Dr: Duray: Thank you for that rather superior presentation I’ll be curious to know what your experience has been and how you define managing these patients prevention for .

Dr. Sood: you mean tick bite. Yes so we have an active tick bite identification program people bring in ticks adults and children alike we actually went to a workshop with Dr. Fish we learned to identify ticks we identify as you know we have [Inaudible] [00:13:36] dog ticks as well as where we are and we base it on identification of a tick and measurement of duration of attachment by the fetal index which is again developed at the Medical College and because we had the local expertise we are able to do that so we specifically advised the pediatrician based on the ID of the tick and the duration of attachment whether or not we would suggest a prophylactic dose of antibiotics. So we think we provide useful advice and it’s a very small sub-set of people bitten by tick who qualify for a prophylactic antibiotic treatment. So we are very active in tick bite and lyme prevention.

Dr. Baker: And you managed this by how to slide TIA for children under eight with prophylaxis.

Dr. Sood: Yeah we extrapolated from the study of [Inaudible] [00:14:36] think the pediatrician is inclined to do that again based on an identified tick with the duration of attachment in our lab more than 72 hours.

Dr. Baker: Thank you very much, are there any other questions from the panel? If not, thank you very much Dr. Sood.