Saturday, Sep 25, 2021

NYC Set To Regualate Metzitzah B'peh

The New York City Department of Health and Mental Hygiene (“DOH”) has proposed an amendment to the NYC. Health code to require written parental consent prior to circumcision with oral suction (metzitzah b'peh, or “mbp”). This would be first time in US history that government legislated against any aspect of bris milah. Although legally requiring parental consent might seem an innocuous protocol to ensure informed choice, the DOH's stated justification is to “protect” infants from “out-of-hospital” circumcisions. Ironically, a DOH report of recent cases of infectious disease, purporting to show the risk of doing mbp, actually documents its safety. This is dangerous for both public health and bris milah, for the DOH's continued targeting of mbp in these cases overlooks their real causes and allows them to continue -- and sets the stage for future cases which public health officials might then cite as “evidence” for further action.

“NEVER BE PERFORMED”
 
At the least, the DOH wants mbp eliminated. This is clear from its Notice of Public Hearing for the amendment, as well as from the Commissioner’s public comments last month. By requiring mohelim to tell parents about mbp’s “potentially serious consequences, such as brain damage and death” due to “a risk” that mbp “will transmit herpes simplex virus or other infectious disease to the infant being circumcised,” the DOH commissioner hopes to achieve the goal that mbp “never be performed.”

 

And if informed consent fails to stop mbp, the DOH is laying the groundwork for more aggressive action. Since the consent requirement would infringe upon a religious practice, the DOH must show a “compelling state interest”: in this case, to protect public health. As Dr. Jay K. Varma, the DOH’s deputy commissioner for disease control, acknowledges: “Since we are regulating how part of a religious procedure is done, this will be heavily scrutinized by legal experts, and it may be challenged at some point. But we feel we are on very firm legal ground, because there is a compelling interest on behalf of the city in protecting the health of infants.”

 

One would think that protecting public health requires stopping a dangerous practice, not consenting to it. While the DOH hopes that informing parents of the supposed risks of mbp will get them to stop it on their own, basing the consent on public health concerns will give it a precedent to take more direct action if that fails (for example, with an outright ban).

 

“CIRCUMCISION SHOULD BE PERFORMED UNDER STERILE CONDITIONS”

 

The DOH may be anticipating even more. In its Statement of Basis and Purpose for the consent requirement, it discusses bris milah itself, saying “circumcision should be performed under sterile conditions.” In a report submitted this month to the Centers for Disease Control (CDC), the DOH went further, describing bris milah as “a surgical procedure” which “should be performed under sterile conditions,” citing risks it sees in “out-of-hospital Jewish ritual circumcision.” The CDC picked up these tacks, writing in its editorial comments to the DOH report that “circumcision is a surgical procedure,” and bemoaning the difficulty in “preventing” mbp “because ritual circumcision is a religious practice that usually occurs outside of health-care facilities.” Not surprisingly, the CDC is headed today by the former NYC DOH commissioner who initiated the attack on mbp over 6 years ago, citing risks in “out-of-hospital” circumcisions.

 

All in, with this proposed amendment to the health code the DOH may be preparing, with the complicity if not encouragement of the CDC, not simply to eliminate mbp but to further regulate bris milah, perhaps relegating it exclusively to in-hospital surgery. If the present move is left unchallenged, and if the source of neonatal HSV-1 incidence is NOT mbp, then focusing on mbp to the exclusion of other sources means such incidence will continue to occur and will continue to be ascribed to mbp.

 

A RECENT DEATH

 

The DOH is facing pressure to act in response to an infant death last fall. The media only recently picked up and sensationalized this tragic case, after the medical examiner waited 4 months to state the cause of death as “Complicating Ritual, Circumcision with Oral Suction.” Was the mohel the source, through mbp?

 

DNA molecular typing of the virus in the infant would have to be matched with the DNA of virus found in the mohel for a direct link to be shown. But how could the medical examiner have made such a match, as the DOH report says the mohel is unknown? (The DOH data lists this case as only a “probable” case of mbp, by the way, as opposed to other cases it lists as “confirmed.”)

 

In fact, the DOH concedes that no attempt made in any other cases to obtain virus through cheek-swabs has ever been successful. As of today, there is not a single case anywhere in the medical literature or otherwise showing a viral DNA match between any mohel and a newborn.

 

Worse, the investigation surrounding this tragedy points to serious problems with the city’s predisposition to blame mbp: missing a much more obvious source. This baby was known to have been in close contact with a symptomatic brother who had recurring outbreaks of active herpes cold sores. HSV-1 is most easily transmitted by contact with individuals with cold sores, as they are highly infectious.

 

The attending physicians were aware of the infectious brother: his mother told them. Thus, the DOH researchers and the medical examiner should have known as well. By focusing on the “probability” that mbp was performed, the doctors, researchers and even the medical examiner overlooked the sibling as a potential source.

 

An infectious disease expert reviewed the file and was told of the suspicion that mbp was performed. Although the baby had a few herpes blisters, none appeared in a location consistent with transmission by mbp, so mbp was deemed not a likely source. On the other hand, he noted the infectious nature of a close family member. In his opinion, after taking into account all of the facts and circumstances, he concluded that “the most likely route of acquisition of this infection was through a family member . . .[namely] a sibling.” As he noted, “transmission from a family member is well described in the medical literature in the setting. This has been proved with DNA fingerprinting in the literature. The family history, examination, and clinical course is perfectly consistent with this as the route of transmission.”

 

Inexplicably, the DOH is again publicly warning parents about the dangers of mbp, as it did over 6 years ago, but it has not made any similar attempt — to this day to advise parents to keep newborns away from anyone with cold sores.

 

The DOH claims that over 6 years ago, another baby died and a third suffered brain damage from HSV-1 associated with mbp. No direct link to mbp was found there either, and if the story of the recent baby’s death is any indication, those investigations may have been compromised as well, overlooking much more likely sources of the virus.

 

 In sum, in the case of the baby who died last year, the medical examiner’s conclusions were arrived at with zero evidence from the mohel. More importantly, it ignored critical information pointing to a very different source for the baby’s virus — a sibling known to have infectious symptoms.

 

Continuing to overlook this not uncommon source — and failing to advise the public regarding preventive measures — means, chas v’shalom, it is likely to continue.

 

UNDERREPORTING?

 

The DOH report undermines a fundamental assumption it long held — that cases of HSV-1 associated with mbp are underreported. Seven years ago, subsequent to its efforts against a renowned mohel, the DOH sought to take broader action against mbp but was unable to in part because there were simply not enough cases. Yet they reasoned there must be many more out there (the existing cases were but the “tip of the iceberg,” as one journal article put it) since mbp involved direct contact with an open wound on an infant with a weak immune system. Suspecting such underreporting was to protect the practice and its practitioners, it mandated HSV-1 reporting in April of 2006. Henceforward, hospitals, healthcare providers and clinical laboratories were to exercise “heightened suspicion” whenever an infant had as much as a fever after mbp, and were required to report all such cases to the DOH.

 

Yet no higher incidence of cases of HSV-1 after mbp was found. In the 6 years after HSV-1 became reportable in April 2006, 5 cases were reported to the DOH that it deemed mbp-related.  The rate of about 1 case per year (in the years prior to mandatory reporting) stayed the same after HSV became reportable. In fact, the heightened level of suspicion led to an overreporting of potential mbp-related HSV-1 cases after April 2006, as many suspected cases later turned out not to be HSV at all. This is without correcting for data and methodological biases in the DOH report, which would make the rate after mandatory reporting significantly lower than before (and which might raise similar bias questions about the pre-2006 cases).

 

THE DOH REPORT

 

The DOH report states that those that have mbp are 3.4 times more likely to get HSV-1. This provides the cover, the “compelling interest,” for the DOH’s informed consent: as the CDC advises in its editorial comments to the report, “mohelim should inform both parents” if they perform mbp “and explain the risk of herpes transmission, so that parents can choose not to have their newborn exposed.”

 

However, the report’s few cases and arguable methodology make its conclusion almost unquestionably wrong. Using its data and assumptions actually indicates that mbp may pose no additional risk at all. How so? The medical literature estimates the national rate of all HSV cases (both HSV-1 and HSV-2, the latter having no connection to mbp) between 1 in 1500 to 1 in 3200 live births. To determine how many of these would be HSV-1 cases, let’s use the DOH’s approach for factoring out HSV-2 cases in NYC. They found a total of 45 cases, broken down as 22 confirmed HSV-1 cases, 15 HSV-2 cases and 8 cases of HSV that they couldn’t subtype into HSV-1 or HSV-2, but which they classed together with confirmed HSV-1 for reasons they didn’t disclose. This leaves 15 confirmed HSV-2 cases; the remaining 30 are the core data for the DOH’s computation of “relative risk.”  The ratio of these 30 cases to the total of 45 HSV cases is about 67%.

 

Applying this to the national range of 1 in 1500 to 1 in 3200, the rate of HSV-1 in NYC would be in the range of 1 in 2,239 (1500/.67) to 1 in 4,776 (3200/.67). One more step: to find a national population that did not have mbp, to compare to those in our population that did, we still have to factor out girls. Boys constituted 54% of the total HSV cases during the study period (45/84). Applying this to our HSV-1 range, the general rate of HSV-1 in NYC boys(without mbp) would be between 1 in 4,146 (2,239/.54) and 1 in 8,844 (4,776/.54). (By contrast, the DOH’s “found” rate of 1 in over 14,000 could have been influenced by factors such as missed diagnoses in non-mbp populations due to lower awareness.)

 

Now let’s compare this national range of 1 in 4,146 to 1 in 8,844 to the rate determined in the DOH report for HSV-1 after mbp. The DOH found 5 cases of HSV-1 out of what it estimated to be 20,493 mbp brissen, for a rate of 1 in 4,098, just below the low end of the range. But one of the DOH’s 5 cases cannot be related to mbp at all, since the report says it had symptom onset 20 days after mbp was performed, and the universally accepted incubation period for HSV-1 is 2-12 days. Removing that single case yields a rate of HSV-1 after mbp of 1 in 5,123 (4/20,493), squarely within the range of the general male population rate without mbp. Couldn’t it be that whatever causes HSV-1 in the non-mbp general population is exactly what causes it post-mbp, nothing more?

 

Moreover, because active lesions are highly infectious, investigation into a case of neonatal HSV-1 should include determining whether caregivers, family members or others in close contact with the newborn had cold sores. Yet the DOH report concerning the 4 or 5 cases since 2006 states explicitly that it based its finding on only two factors — date of symptom onset and whether mbp was performed. This skewed the investigation toward mbp, notwithstanding the fact that one of those cases involved the baby discussed above that had close contact with a symptomatic sibling. (Taking out that case would lower the “mbp rate” to 1 in 6,831.)

 

Why is this significant? About 70% of adults have antibodies for HSV-1, meaning that they contracted it at some time in their life and could potentially transmit it to others. Since a mohel with open cold sores wouldn’t do mbp, those who believe mbp transmits HSV-1 are presuming that mohelim who are asymptomatic can “shed” virus without their knowledge and thereby infect a newborn via mbp. Still,asymptomatic “shedders” are much less contagious than those with symptoms. Conducting an unbiased investigation, and taking into account those found with actual symptoms, could easily have made the mbp rate even lower.

 

A recent “Position Paper” issued in Israel by the Interministerial Oversight Committee of Mohalim of the Israeli Chief Rabbinate and the Ministry of Health goes further. Correcting for weaknesses in the researchers’ assumptions, it estimated the real number of mbp brissen closer to 30,000 instead of around 20,000. It noted the reported 5 HSV-1 cases showed that only 2 were “confirmed” mbp, and one of those had no laboratory evidence that the infant had HSV-1, leaving only one of the 5 cases as confirmed HSV-1 after mbp. This rate of 1 in 30,000 means that “the incidence of contracting HSV after MBP is 0.46 times as great, rather than 3.4 — a 50% decrease in the risk of contracting HSV compared to those that did not undergo MBP.” (Emphasis added.)

 

Notwithstanding questionable methodology and investigative bias, the relative rate is, at worst, statistically the same.

 

OTHER RISKS?

 

The foregoing deals with the DOH’s concern about the “risk” of HSV-1. And yet the DOH’s consent form would require more: that parents be notified of the risk that mbp could transmit ”other infectious diseases” besides HSV-1. Here, the DOH is on even shakier ground, for it hasnever presented a single case where any “other infectious disease” was even thought to have been implicated by mbp. This is probably due to a simple reason: they haven’t found any.

 

The obvious question is why not. Why not, with a vast majority of adults being able to transmit HSV-1; why not, since a mouth is filled with all types of germs; why not, when direct contact is made on an open wound; why not, when a baby’s immune system is so weak. Why, from a medical standpoint — b’derech hateva – haven’t there been dozens and dozens of cases of all sorts of infectious diseases communicated to infants during mbp?

 

The answer, ironically, is embedded in comments to the DOH report made by editors from the CDC: “sterile technique should be used to minimize infection risk.” (Emphasis added.) All mohelim use precisely such sterile technique, even outside the sterile conditions of a hospital, by being careful to thoroughly wash and disinfect their hands and mouth before mbp. One study confirms the efficacy of antiseptic mouthwash in eliminating HSV-1 from saliva of symptomatic individuals for a period of time much longer than necessary for a bris with mbp; even moreso for mohelim, who at most are asymptomatic.

 

And yet the DOH is moving headstrong against mbp, opening the door for even tougher action in the future. There may well be such opportunities, having nothing to do with mbp, if likely routes of transmission are not addressed. Here lies the irony and the real public health menace: the DOH’s bias against mbp is leading them to regulate a practice whose safety has now been documented, and to blindly ignore real risks concerning neonatal HSV-1 that remain a danger.

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