מציצה בפה נישט קיין פראבלעם!!!...

DEPARTMENT OF HEALTH AND MENTAL HYGIENE

_______________________________________________________________

nyc.gov/health

June 9, 2006

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.

(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

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 noncooperation.

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

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.

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

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.

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

Please do not hesitate to contact my office for discussion of your protocol.

Sincerely,

Thomas R. Frieden, M.D., M.P.H.

Commissioner

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.

Additional comments on "Circumcision protocol regarding the prevention of neonatal herpes

transmission"

1. The protocol is based on investigation of infants who acquire herpes 'within a compatible

infants who acquire HSV-1 (or untyped herpes) infection within a 'compatible incubation period

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