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Microsoft word - response to nys circumcision protocol.doc

DEPARTMENT OF HEALTH AND MENTAL HYGIENE _______________________________________________________________ Antonia C. Novello, MD, MPH, DrPH Commissioner NYS Department of Health ESP, Tower Building, Rm 1483 Albany, NY 12237 Dear Dr. Novello: We have reviewed your protocol entitled “Circumcision protocol regarding the prevention of neonatal herpes transmission”. We have four fundamental, and a number of other concerns. The fundamental concerns are outlined in this letter, and the others in the Attachment. First, in order to reduce risk, post-metzitzah b’peh wound care should be strengthened (Section II B2). After careful consideration, we believe that the most feasible and useful such measure would be universal use of betadine/povidone after each such procedure which includes metzitzah b’peh. This is likely to reduce risk of infection following metzitzah b’peh, would not interfere in any way with religious practice, and would be easily accomplished prior to dressing of the circumcision site. Second, section III A indicates that NYSDOH will be the entity conducting the investigation, and does not mention any role for local health officers. The NYC DOHMH does not intend to cede its authority to investigate disease incidence occurring in New York City and to intervene when appropriate. The protocol should be very clear that NYSDOH or the local health officer having jurisdiction will conduct the investigation. Related to this issue, the protocol states that “community rabbis are expected to lend their support and cooperation in the event of any such public health investigation” – “so long as each local health department in whose jurisdiction such public health investigation is proceeding agrees to be bound by, without addition to or modification of, any and all provisions of [the proposed] Circumcision Protocol” (Section III B). It is important to involve the community and its leaders. However, your language implies that a community can stipulate how to conduct an investigation and may be justified in not cooperating. There is absolutely no justification for not cooperating in an investigation surrounding a potentially life-threatening illness in an infant or other vulnerable member of the population. Such a provision in this protocol will only foster debate about the nature of a particular investigation and create an easy excuse for non-cooperation. Any “Circumcision Protocol” cannot be conditioned upon this Department ceding its statutory obligations or upon having to negotiate how an investigation is undertaken in order to obtain cooperation. Third, the protocol’s approach to culture and molecular analysis has many fundamental problems. One fundamental issue is that your protocol would allow an individual who has been epidemiologically linked to one or more cases of neonatal herpes to continue to perform metzitzah b’peh if they take unproven steps to eliminate risk, including mouthwash and valacyclovir (Section IV, D3, para B and C). The best available information on risk of herpes virus transmission and the role of oral antivirals in reducing that risk comes from the scientific literature on genital herpes infection due to HSV-2. These data show that oral antivirals, in conjunction with usual measures, reduce, but do not eliminate, genital shedding of herpes virus and reduce (by about half), but do not eliminate transmission (1). There are few data to show that oral antivirals reduce oral shedding of HSV-1 and no data to show that oral antivirals eliminate transmission of HSV-1 from the mouth (2). Related to this concern is the implicit assumption in your protocol that lack of a positive culture from the mohel may be associated with a lower risk of infectiousness. HSV-1 antibody positivity demonstrates infection with HSV-1, and most oral shedding of HSV-1 virus occurs when a person has no signs or symptoms of infection. Shedding is essentially universal in HSV-1-positive individuals; a negative culture result would merely indicate that shedding was not occurring at the time of sampling. Knaup et al (3) showed that all but one of 13 PCR+ individuals had periods of more than 30 days in which selected samples were negative. Given the infrequency with which virus may be isolated in culture, or even detected by PCR, it should be expected that for many case investigations it will not be possible to obtain virus from both baby and mohel for RFLP comparison. Your protocol also assumes that virus will always be available from the infant. This may not be the case, for several reasons. PCR is increasingly used for herpes testing, so that an infant may have laboratory-confirmed herpes infection without culture-documentation. Furthermore, even if an isolate is obtained from the infant, there are occasions where isolates are lost or do not remain viable in storage. Furthermore, identifying a caretaker with a viral isolate which is an RFLP match with the infant’s isolate cannot be used to rule out the mohel as the source of infection (Section IV D3). As you know, any laboratory result must be interpreted as part of an epidemiologic investigation; it is possible, for example, that a family member’s HSV infection resulted from contact with the infected infant. There is a need to interpret any data, including RFLP data, in the context of an epidemiologic investigation. All of this goes to show how easy it will be to get embroiled in endless debate if “cooperation” were to be conditional as explained in our second concern above. Our fourth fundamental concern is that the children of parents for whom metzitzah b’peh is not considered religiously necessary may undergo this procedure without the knowledge and/or request of both parents, and this is not addressed by your protocol. Every effort should be made, in conjunction with practicing mohelim, to ensure that metzitzah b’peh is only performed when parents clearly are aware that it will be performed and wish it to be performed. Other less fundamental concerns are outlined in the attachment. These include, however, the essential requirement that chain of custody of samples be maintained and outlining of more realistic timeframes for completing the investigation than are included in your proposal. Overall, we think it might be most practical to simply propose that every metzitzah b’peh is preceded by mouthwash with Listerine or similar product, is followed by application of povidone/iodine, that it not occur if there is an active oral lesion, and that it only occur for children for whom the parents feel it is religiously necessary. Such an approach would merely reflect the taking of minimal precautions, which should be taken as an ethical matter regardless of the existence or not of a protocol relating to investigations, and none of which encroach in any way on any religious freedoms. We would all hope that these measures might be universally adopted, and might result in the disappearance, or virtually disappearance, of HSV-1 infections following metzitzah b’peh in the future. Please do not hesitate to contact my office for discussion of your protocol. References (1) Corey L, Wald A, Patel R, et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. New England Journal of Medicine. 2004. 350:11-20. (2) Miller CS, Avdiushko SA, Kryscio RJ, Danaher RJ, Jacob RJ. Effect of Prophylactic Valacyclovir on the Presence of Human Herpesvirus DNA in Saliva of Healthy Individuals after Dental Treatment. Journal of Clinical Microbiology. 2005. (43)5:2173-2180. (3) Knaup B, Schunemann S, Wolff MH. Subclinical reactivation of herpes simplex virus type 1 in the oral cavity. Oral Microbiol Immunol. 2000 Oct;15(5):281-3. Attachment
Additional comments on “Circumcision protocol regarding the prevention of neonatal herpes 1. The protocol is based on investigation of infants who acquire herpes ‘within a compatible incubation period following metzitzah b’peh’ (Section III A). Because it may not be possible to determine whether metzitzah b’peh was performed, the protocol should outline investigation of infants who acquire HSV-1 (or untyped herpes) infection within a ‘compatible incubation period following circumcision’. The protocol should clearly define the incubation period considered compatible with possible acquisition at circumcision (e.g. 1-14 days after circumcision). 2. The protocol should specify that any laboratory testing done during the course of the investigation (e.g. culture, antibody testing, PCR, RFLP) will be conducted by a laboratory of the public health authority’s choosing, as test sensitivity and specificity of various serologic tests vary substantially. The public health authority should assume responsibility for specimen collection and maintain chain of custody of all specimens collected both during the initial investigation, and, in the event that no culture can be obtained from the mohel, during any future culturing undertaken. 3. Given our experience with conducting such investigations, the requirement to complete an investigation within 45 days is completely unrealistic (Section III). Even the ability to complete an investigation in a 120-day time frame is contingent on a high degree of cooperation from all parties. 4. The audience for the protocol appears limited to public health practitioners, rabbis and mohelim. Pediatricians and obstetricians should also be expected to play a role in preventing cases of neonatal herpes through education and appropriate medical management when maternal infection is known, recognizing and treating cases that do occur, and reporting cases to public health authorities. Any protocol to address reducing the risk of herpes transmission to newborn infants should spell out the role that medical providers will play, and should reference guidelines for the appropriate diagnostic evaluation of an infant suspected of having herpes infection. 5. In addition, any protocols should make clear that epidemiologic investigations are the mandate of public health authorities, and are conducted in a confidential manner. Unless a community rabbi is also a mohel associated with a case of neonatal herpes, public health authorities will not share information with parties not directly involved in the investigation. 6. The protocol should avoid specifying HSV type when it is not relevant. There is reference to the importance of physical findings for recognizing HSV-1 infection (Section I-G). Those physical findings are just as valuable for recognizing HSV-2 infection. A related issue is that skin lesions are absent in up to 30% of cases of neonatal herpes, so parents and physicians cannot count on the presence of skin lesions to suggest herpes infection. 7. The first page of the protocol (Section I A-G) fails to mention that herpes is a sexually transmitted disease, that most men and women are unaware of their genital herpes infections, that neonatal herpes is one of the most serious outcomes of that sexually transmitted disease, and inappropriately places the burden of responsibility on the mother to recognize and report her genital infection to her health care providers. The greatest risk for neonatal herpes occurs among infants born to women who acquire genital herpes in the third trimester (1). Most cases of herpes in infants are the result of transmission from mothers who are unaware of their genital infection. While caesarean section is advised for women with lesions present at delivery, most women with genital herpes will not have lesions present at delivery. 8. It is not clear why the responsibility for communicating risks accompanying metzitzah b’peh rests only on the rabbis, and how, when, and to which parent(s) the rabbis will communicate about this risk. There is a similar lack of specificity regarding distribution of educational materials to parents (Section I G). References (1) Brown ZA, Wald A, Morrow RA, Selke S, Zeh J, Corey L. Effect of serologic status and cesarean delivery on transmission rates of herpes simplex virus from mother to infant. JAMA. 2003 Jan 8;289(2):203-9


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