Disclosures. Ticked-off... Myths, Truths, and Realities of Tick-borne Infections including Lyme, Babesia, and Ehrlichia

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1 Disclosures Ticked-off... Myths, Truths, and Realities of Tick-borne Infections including Lyme, Babesia, and Ehrlichia Vanessa Pomarico-Denino, MS, APRN, FNP-BC, FAANP Interim Director/Lead Faculty SCSU FNP track Senior Consultant Fitzgerald Health Education Associates, LLC (FHEA) No real or potential conflict of interest to disclose. No off-label, experimental or investigational use of drugs or devices will be presented. Fitzgerald Health Education Associates 2 Objectives At the end of the presentation, the participant will be able to: Differentiate between types of tick-borne diseases. Recognize clinical presentation of specific infections. Objectives At the end of the presentation, the participant will be able to: (cont.) Understand current therapies to treat specific tick-borne and vector borne diseases. Interpret findings of laboratory testing. Fitzgerald Health Education Associates 3 Fitzgerald Health Education Associates 4 References All references are listed in your program as well as at the end of this presentation Tick-borne Pathogens Transmitted through bite of infected ticks Bacteria, virus, protozoal High risk Those who work outdoors, high grass, forestry, construction, landscaping, RR, wildlife or park management Peak season April to October; highest in June to August Fitzgerald Health Education Associates 5 Fitzgerald Health Education Associates 6

Tick-borne Pathogens Transmitted through bite of infected ticks (cont.

Mountain spotted fever Powassan Types Vector borne West Nile Virus Chikungunya Zika Personal photo Fitzgerald Health Education Associates 7 Fitzgerald Health Education Associates 8

Lifecycle approximately 2 years 4 life-stages Egg Six-legged larva Eight-legged nymph Adult When eggs hatch, ticks must feed on a blood meal at every stage in order to survive How

Public Health Image Library ID #10871 Fitzgerald Health Education Associates 9 Fitzgerald Health Education Associates 10 How Transmitted Lyme Disease (Borrelia Burgdorferi) Front

2 Tick-borne Pathogens Transmitted through bite of infected ticks (cont.) Are considered reportable diseases to DPH Consider widespread testing due to concomitant infection risk Tick borne Lyme Babesia Anaplasmosis (also known as Ehrlichia) Rocky Mountain spotted fever Powassan Types Vector borne West Nile Virus Chikungunya Zika Personal photo Fitzgerald Health Education Associates 7 Fitzgerald Health Education Associates 8 The lifecycle of a tick. Lifecycle approximately 2 years 4 life-stages Egg Six-legged larva Eight-legged nymph Adult When eggs hatch, ticks must feed on a blood meal at every stage in order to survive How Transmitted Questing Ticks wait on ends of blades of grass, leaves on hind legs Attach to suitable host after making contact Source: CDC.gov. Public Health Image Library ID #10871 Fitzgerald Health Education Associates 9 Fitzgerald Health Education Associates 10 How Transmitted Lyme Disease (Borrelia Burgdorferi) Front legs attach onto host to begin feed Infection is transmitted through tick saliva. Tick will feed then fall off host until time to feed again in next lifecycle. Source: CDC.gov. Public Health Image Library ID # Photo by James Gathany Spirochete Transmitted by infected ticks, usually deer ticks Originated in Lyme, CT Most common tick-borne disease in the country. Also found in Australia, Asia, Europe Fitzgerald Health Education Associates 11 Fitzgerald Health Education Associates 12

3 Lyme Disease (Borrelia Burgdorferi) Tick must generally be in place >24 hours in order to transmit infection to host. Different ticks not all carry Lyme Tick bite frequently unnoticed Tick may be in area that is not noticeable. Can engorge itself and fall off without ever being detected Fitzgerald Health Education Associates 13 Tick vector Ixodes scapularis Ixodes pacificus Ixodes ricinus Geographic location Northeastern, north central and mid-atlantic regions of U.S. West coast Percentage of infection (dependent upon region) Carrier 15 65% Mammals, birds, reptiles, amphibians (snakes, frogs) 2% adult ticks 2 15% nymph ticks Lizards, birds, mammals Europe 4 16% Wood mice, cattle, deer, small rodents Ixodes Asia 27% Sheep, cattle, persulcatus horse, dog Transmission Spread through the bite of an infected tick Most common areas Groin Axillae Scalp Most common time of year Spring and summer Source: CDC.gov Public Health Image Library ID #2417 Transmission Ticks not known to transmit Lyme disease include Lone star ticks (Amblyomma americanum) American dog tick (Dermacentor variabilis) Rocky Mountain wood tick (Dermacentor andersoni) Brown dog tick Fitzgerald Health Education Associates 15 Fitzgerald Health Education Associates 16 Incidence of Recently Confirmed Lyme Cases CT: 1873 CA: 83 MA: 2922 NJ: 3932 NY: 3252 PA: 7351 TN: 6 AK, CO, HI, WY: 0 Source: /tables.html Source: Fitzgerald Health Education Associates 17 Fitzgerald Health Education Associates 18

Clinical Presentation Flu-like symptoms ( summer flu ) and possibly a rash Stage 1: Early localized infection Approximately 3 30 days after initial tick bite Erythema migrans Localized erythema at

Public Health Image Library ID # 14476 Source: CDC.gov.

after initial infection 50 60% of patients with EM become bacteremia Malaise, fatigue*, fever, HA (sometimes severe), neck pain, generalized myalgia/arthralgia *Fatigue can persist for months

4 Clinical Presentation Flu-like symptoms ( summer flu ) and possibly a rash Stage 1: Early localized infection Approximately 3 30 days after initial tick bite Erythema migrans Localized erythema at site of insertion Target lesion with central area of clearing 10 20% of patients do not develop rash or lesion Source: CDC.gov. Public Health Image Library ID # Source: CDC.gov. Public Health Image Library ID # Fitzgerald Health Education Associates 19 Fitzgerald Health Education Associates 20 Clinical Presentation Stage 2: Early disseminated infection Weeks to months after initial infection 50 60% of patients with EM become bacteremia Malaise, fatigue*, fever, HA (sometimes severe), neck pain, generalized myalgia/arthralgia *Fatigue can persist for months Clinical Presentation Stage 2: Early disseminated infection (cont.) Cranial nerve VII palsy or meningitis (10 15%) Rare complication: AV block (~4 10%) or myopericarditis, panophthalmitis Fitzgerald Health Education Associates 21 Fitzgerald Health Education Associates 22 Clinical Presentation Stage 3: Late, persistent infection Can occur months to years after initial infection Moderate to severe generalized arthralgias (60%) Monarticular or oligoarticular arthritis involving the knee or hip usually self-limiting Joint aspiration yields a mean WBC 25,000/mcL with predominance of neutrophils Clinical Presentation Rare neurologic manifestations Subacute encephalopathy, sleep disturbance, memory loss, mood changes, intermittent paresthesias, ataxia, spastic paraparesis, bladder dysfunction Fitzgerald Health Education Associates 23 Fitzgerald Health Education Associates 24

Fibromyalgia Arthritis Fitzgerald Health Education Associates 26 Diagnosis and Treatment National surveillance case definition 30-day window of exposure prior to onset of symptoms Erythema migrans as

5 Clinical Presentation If patient presents with symptoms of Bell s palsy, heart block or myopericarditis, test for Lyme! Source: CDC.gov. Public Health Image Library ID # 6633 ECG courtesy of Nick Tullo, MD Fitzgerald Health Education Associates 25 Differential Diagnosis Bell s palsy Contact dermatitis Tinea corporis Herpes zoster Fibromyalgia Arthritis Fitzgerald Health Education Associates 26 Diagnosis and Treatment National surveillance case definition 30-day window of exposure prior to onset of symptoms Erythema migrans as diagnosed by HCP At least one late manifestation of disease Confirmatory lab testing Incidence of Lyme True incidence unknown due to several factors. Serologic testing is not standardized. Clinical manifestations are not specific and can mimic other illness or infection. Serology is not sensitive enough in early stage of disease leading to false negative readings. Source: Papadakis, M., & McPhee, S. (2017). Current medical diagnosis & treatment. (56th ed). New York, NY: McGraw-Hill Fitzgerald Health Education Associates 27 Fitzgerald Health Education Associates 28 Lab Testing ELISA two step testing (EIA) If ELISA is +, Western blot assay to detect both IgM and IgG antibodies IgM + within 2 4 weeks (~70%); can seroconvert to IgG after 6 weeks IgM Western blot (IFA) must have two of the following three bands present: 23, 39, and 41kDa for diagnosis IgG must have 5/10 bands + for diagnosis ESR may be elevated. LFT abnormalities, shift in WBC Fitzgerald Health Education Associates 29 Treatment: Prevention Caveats Known tick bite <72 h Tick is identified as an adult or nymph scapularis tick estimated to have been attached for 36 h. Prophylaxis can be started within 72 h of the time that the tick was removed. Source: Wormser, et al. (2006) Fitzgerald Health Education Associates 30

6 Treatment: Prevention Caveats (cont.) Local rate of infection of these ticks with B. burgdorferi is 20%. Doxycycline treatment is not contraindicated. Doxycycline 200 mg PO single dose Source: Wormser, et al. (2006) Outpatient Treatment of Lyme Disease: One of the following regimens Doxycycline 100 mg PO BID 21 d Do not use in pregnancy,? lactation OR Amoxicillin 500 mg PO TID 21 d Safe for pregnancy/lactating women OR Cefuroxime axetil 500 mg PO BID 21 d OR Erythromycin 500 mg PO QID d Use of probiotic to prevent C-diff. colitis Fitzgerald Health Education Associates 31 Fitzgerald Health Education Associates 32 Inpatient treatment of Lyme disease with cardiac complications Ceftriaxone: drug of choice: days of therapy Pedi: mg/kg/day IV once daily Adults: 2 g IV once daily PCN G potassium: days of therapy Pedi: 200, ,000 million units/kg/day in divided doses every 4 hours Adult: million units/kg/day IV every 4 hours Outpatient Treatment: Pedi One of these regimes Pedi Amoxicillin 50 mg/kg PO QD in 3 divided doses Maximum of 500 mg per dose Cefuroxime axetil 30 mg/kg PO QD in 2 divided doses Maximum of 500 mg per dose Age >8 years: Age 8 years, doxycycline PO (4 mg/kg per day in 2 divided doses [maximum of 100 mg per dose]) Fitzgerald Health Education Associates 33 Fitzgerald Health Education Associates 34 Treatment Alternatives To be used if PCN allergic or intolerant of other recommended medications Azithromycin 500 mg PO daily 7 10 days Clarithromycin 500 mg PO BID days Post-Treatment Lyme Disease Syndrome Formerly referred to as chronic Lyme Controversial No documentation or studies to prove/disprove its existence Refer to infectious disease specialist if symptoms persist beyond treatment Fitzgerald Health Education Associates 35 Fitzgerald Health Education Associates 36

Babesiosis Source: CDC.gov. Public Health Image Library Protozoan parasitic infection transmitted by ticks, usually on cattle, wild animals Generally found in the coastal northeastern U.S. 95% of the cases were reported by 7 states: CT (205), MA (537), NJ (159), NY(471), RI (172) Total for U.

7 Babesiosis Source: CDC.gov. Public Health Image Library Protozoan parasitic infection transmitted by ticks, usually on cattle, wild animals Generally found in the coastal northeastern U.S. 95% of the cases were reported by 7 states: CT (205), MA (537), NJ (159), NY(471), RI (172) Total for U.S. in 2014= 1744 Fitzgerald Health Education Associates 37 Fitzgerald Health Education Associates 38 Babesiosis Causes B. microti or B. divergens Infected by same ticks carrying B. burgdoferi Nymph ticks the size of a poppy seed People rarely know they were bitten by a tick. + vertical transmission from mother to fetus Clinical Presentation of Babesia Flu-type symptoms gradually worsening Fever, HSM Arthralgias, myalgias May not have any rash Hemolytic anemia and thrombocytopenia Fitzgerald Health Education Associates 39 Fitzgerald Health Education Associates 40 Clinical Presentation of Babesia Symptomatic within a week but may be asymptomatic for many months Can be fatal in elderly or people without spleen Diagnosing Babesia Detailed history of high risk exposure and high index of suspicion Labs CBC with anemia due to RBC destruction and low platelets Proteinuria Hemoglobinuria Elevated LFTs, BUN/creatinine Fitzgerald Health Education Associates 41 Fitzgerald Health Education Associates 42

8 Diagnosis Manual peripheral blood smear Can need more than one sample to detect parasites Must request manual reading! Diagnosis Indirect immunofluorescent antibody Anti-babesia IgG titers >1:64 Antibodies detected 2 4 weeks after infection Titers generally rise to 1:1024 during the first weeks of illness and decline gradually over 6 months Can remain detectable at low levels for a year or more Fitzgerald Health Education Associates 43 Fitzgerald Health Education Associates 44 Outpatient Treatment First-line Atovaquone 750 mg PO BID plus azithromycin mg PO on day 1 then mg PO for 7 10 days Alternative Clindamycin 600 mg PO TID + quinine 650 mg PO TID for 7 10 days Higher adverse effect profile Blood Donation Patients diagnosed with Babesia are indefinitely deferred from donating blood Currently, no routine screening for Babesia with blood donation exists Patients should be advised to refrain from blood donations unless their specimen is screened for Babesia Fitzgerald Health Education Associates 45 Fitzgerald Health Education Associates 46 Medication Risks Antimalarials Pregnancy category C Use with caution if breast feeding Pedi patients must weigh >11 lbs (5 kg) Azithromycin Safe for pregnancy, lactation and pedi patients Medication Risks Antimalarials (cont.) Clindamycin Pregnancy category B Is excreted in breast milk but is compatible with breast feeding Contains benzyl alcohol, which has been associated with a fatal "gasping syndrome" in premature infants Fitzgerald Health Education Associates 47 Fitzgerald Health Education Associates 48

9 Ehrlichiosis or Anaplasmosis Source: Used with permission from Graham Hickling, PhD, University of Tennessee. Human monocytic ehrlichiosis (HGE) caused by Ehrlichia chaffeensis from the Lone Star tick from white-tailed deer Became reportable in 1999 <1000 cases reported in 2008 Now known as human granulocytic anaplasmosis (HGA) Fitzgerald Health Education Associates 49 Fitzgerald Health Education Associates 50 Ehrlichiosis or Anaplasmosis More prevalent Northeastern and Midwestern U.S. Peaks June-December May-August: Highest transmission time Short incubation: 9 days 2 weeks Can be fatal in <1% of those who are untreated Ehrlichiosis or Anaplasmosis Prodrome Malaise, rigors, fever, HA, myalgia, N/V/D Rash is rare. Coinfection with Lyme, Babesia not uncommon Fitzgerald Health Education Associates 51 Fitzgerald Health Education Associates 52 Diagnosis and Treatment Indirect immunofluorescence assay (IFA)-gold standard PCR assay Enzyme immunoassay (EIA) Serologic only gives + or (-) result high false positive Peripheral blood smear Diagnosis and Treatment CBC/diff, LFTs Can have thrombocytopenia, leukopenia, transaminitis Infect monocytes and granulocytes Presence of morulae Source: American Academy of Pediatrics Committee on Infectious Diseases Fitzgerald Health Education Associates 53 Fitzgerald Health Education Associates 54

10 Diagnosis and Treatment Treatment Doxycycline 100 mg PO BID days Rifampin PO if pregnant/lactating or pediatric patient Use of antibiotics other than doxycycline increases the risk of patient death Source: American Academy of Pediatrics Committee on Infectious Diseases Rocky Mountain Spotted Fever Causative organism Rickettsia rickettsii Can be potentially fatal if not treated within the first few days Spread by dog tick or wood tick, fleas, lice and mice 5 14 day incubation period Fitzgerald Health Education Associates 55 Fitzgerald Health Education Associates 56 Clinical Presentation Fever Rash: Appears 2 5 days after infection in 90% of pts Nonpruritic, erythematous macular rash on wrists, forearms, ankles, trunk Petechial rash generally not seen until after day 6 of illness Pedi pts will develop rash more quickly than adults. Clinical Presentation HA N/V/abdominal pain Anorexia Conjunctival irritation Fitzgerald Health Education Associates 57 Fitzgerald Health Education Associates 58 Pediatric Clinical Presentation More likely to present with headache Earlier onset of rash than adults Abdominal pain Conjunctival injection Altered mental status Diagnosis Important to diagnose and treat early if high index of suspicion Skin biopsy of rash quickest way to diagnosis due to rapid turnaround + antibodies after 7 10 days Fitzgerald Health Education Associates 59 Fitzgerald Health Education Associates 60

11 Diagnosis Gold standard: Indirect immunofluorescence assay (IFA) with R. rickettsii antigen First sample within first week Second sample 2 4 weeks after Repeat 2 4 weeks Vasculitis due to infection of endothelial cells Limb amputation due to decreased circulation Internal organ damage Complications Neurological deficits Thrombocytopenia Hyponatremia Elevated LFTs Fitzgerald Health Education Associates 61 Fitzgerald Health Education Associates 62 Treatment Doxycycline 100 mg PO BID x 7 14 days is treatment of choice Fever generally subsides within hours after initiation of treatment Children <45 kg (<100 lbs): 2.2 mg/kg body weight given twice a day Chloramphenicol if pregnant or allergic to doxycycline Outpatient Treatment of RSMF: Additional information for Pedi Doxycycline binds less readily to calcium and has not been shown to cause the same tooth staining as TCN Blinded study in 2013 revealed that no differences in tooth color, staining, or weakness were found between children < 8 yo who had received doxycycline and those who had not Source: Fitzgerald Health Education Associates 63 Fitzgerald Health Education Associates 64 Powassan Found in Northwestern and Great Lakes region of the U.S. Peak transmission: Late spring, early summer, mid-fall Incubation: 1 week to 1 month # of reported cases in 2013= 12 Source: CDC.gov. Public Health Image Library ID #14489 Fitzgerald Health Education Associates 65 Fitzgerald Health Education Associates 66

Clinical Presentation HA Fever Vomiting Weakness Confusion Loss of coordination Seizures Indicative of meningitis or encephalitis Fitzgerald Health Education Associates 67 Diagnosing CSF <500 WBC/mm

12 Clinical Presentation HA Fever Vomiting Weakness Confusion Loss of coordination Seizures Indicative of meningitis or encephalitis Fitzgerald Health Education Associates 67 Diagnosing CSF <500 WBC/mm 3 ; granulocytosis early in disease EEG With slower brain wave activity Brain MRI Consistent with microvascular ischemia or demyelinating disease Viral testing during autopsy Fitzgerald Health Education Associates 68 Treatment ~50% will have permanent neuro deficits Supportive measures Ventilator Respiratory support IVF Medications to decrease brain swelling Fitzgerald Health Education Associates 69 Adequate covering of all exposed skin DEET or permethrin products Extensive skin checks if in exposed area Removal of tick in its entirety Prevention Source: CDC.gov Public Health image library Fitzgerald Health Education Associates 70 Case Study Gary, 56-year-old male patient PMH: Obesity, HLD, HTN, gout PSH: Splenectomy age 10 CC Fatigue Arthralgias Myalgias No energy Case Study Medications Valsartan-amlodipine-HCTZ 160 mg/5 mg/25 mg PO daily ASA 81 mg PO daily Glucosamine 500 mg PO TID Fitzgerald Health Education Associates 71 Fitzgerald Health Education Associates 72

13 Case Study SH Non-smoker, social ETOH use Avid golfer daily during the warmer months Walks the golf course with his dogs daily Married, real estate agent Fitzgerald Health Education Associates 73 Case Study CC Summer flu ROS Worsening fatigue Arthralgias and myalgias Constant headache Feels feverish but did not take his temp Denies N/V/D Fitzgerald Health Education Associates 74 Case Study Labs WBC /uL ( u/l) Neutrophils 70% (37 84%) 0.7 proportion ( proportion) Lymphs 16% (8 49%) 0.16 proportion ( proportion) Monos 14% (4 15%) 0.14 proportion ( proportion) RBC 3.9 M/uL ( M/uL) Hgb 11.6 g/dl ( g/l) 1160 g/l ( g/L) Hct 36.5% (37 52%) proportion ( proportion) Fitzgerald Health Education Associates 75 Platelets ( /uL) /uL BNP 479 pg/ml ( pg/ml) Lyme IgM: Positive 2/3 bands ANA/RA: Negative ALT: 58 U/L (0 34 U/L) AST: 63 U/L (0 34 U/L) Urine: Moderate protein Case Study BabesiaPCR + for BabesiaDNA: Detectable parasites with distinct morphology different from malaria Rings with basophilic stippling Ehrlichia: Negative Fitzgerald Health Education Associates 76 Case Study Treatment: Need both Azithromycin 500 mg PO daily 7 10 days Atovaquone 750 mg PO BID 7 10 days Alternative Quinine 650 mg TID x 7 10 days PO plus clindamycin 600 mg PO TID x 7 10 days Higher adverse effect profile Usually reserved for severe disease Fitzgerald Health Education Associates 77 Follow-up Serial CBC/diff, CMP and Babesia peripheral smear to determine eradication of parasites If outpatient, weekly labs until negative then one month after therapy has been completed Repeat labs if patient becomes symptomatic again Fitzgerald Health Education Associates 78

Questions? End of Presentation. Thank you for your attention Vanessa Pomarico-Denino, MS, APRN, FNP-BC, FAANP www.fhea.com vanessa@fhea.

14 Questions? End of Presentation. Thank you for your attention Vanessa Pomarico-Denino, MS, APRN, FNP-BC, FAANP Fitzgerald Health Education Associates 79 Fitzgerald Health Education Associates 80 References Buttaro, T., Trybulski, J., Polgar Bailey, J. (2016). Primary Care: A collaborative practice. (5th ed). St. Louis, Missouri: Elsevier Center for Disease Control (CDC): Evans, D. & Meires, J. (2016). Chikungunya Virus: A rising health risk in the United States and how nurse practitioners can help address and reduce the risk. Journal for Nurse Practitioners. 12(5): References Mcneil, C., Shreve, M., Jarrett, A., & Perry, C. (2016). Zika: What providers need to know. The Journal for Nurse Practitioners. 12(6): Moore, K. (2015). Lyme Disease: Diagnosis, treatment, guidelines, and controversy. The Journal for Nurse Practitioners. 11(1): Fitzgerald Health Education Associates 81 Fitzgerald Health Education Associates 82 References Papadakis, M., & McPhee, S. (2017). Current medical diagnosis & treatment. (56th ed). New York, NY: McGraw-Hill Wooten, A. (2015). Zika Virus: An emerging threat to travelers. The Journal for Nurse Practitioners. 12(5): e References Wormser, G., Dattwyler, R., Shapiro, E., Halperin, J., Steere, A., Klempner, M., Krause, P., Bakken, J., Strle, F., Stanek, G., Bockenstedt, L., Fish, D., Dumler, J.S., & Nadelman, R. (2006). The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases. 43 (9): Fitzgerald Health Education Associates 83 Fitzgerald Health Education Associates 84

15 Photo Credits Graham Hickling, PhD, University of Tennessee. CDC public health image library. Pixnio. Images/Illustrations: Unless otherwise noted, all images/ illustrations are from open sources, such as the CDC or Wikipedia or property of FHEA or author. All websites listed active at the time of publication. Fitzgerald Health Education Associates 85 Fitzgerald Health Education Associates 86 Copyright Notice Copyright by Fitzgerald Health Education Associates All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording or any information storage and retrieval system, without permission from Fitzgerald Health Education Associates Requests for permission to make copies of any part of the work should be mailed to: Fitzgerald Health Education Associates 85 Flagship Drive North Andover, MA Statement of Liability The information in this program has been thoroughly researched and checked for accuracy. However, clinical practice and techniques are a dynamic process and new information becomes available daily. Prudent practice dictates that the clinician consult further sources prior to applying information obtained from this program, whether in printed, visual or verbal form. Fitzgerald Health Education Associates disclaims any liability, loss, injury or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents of this presentation. Fitzgerald Health Education Associates 87 Fitzgerald Health Education Associates 88 Fitzgerald Health Education Associates 85 Flagship Drive North Andover, MA Fax Website: fhea.com Learning & Testing Center: fhea.com/npexpert Fitzgerald Health Education Associates 89

Tick Talk: What s new in Lyme Disease. May 5 th, 2017 Cristina Baker, M.D., M.P.H.

Tick Talk: What s new in Lyme Disease May 5 th, 2017 Cristina Baker, M.D., M.P.H. Dr. Baker indicated no potential conflict of interest to this presentation. She does not intend to discuss any unapproved/investigative