Sunday, August 26, 2012

Critique American Academy of Pediatrics 2012 Circumcision Policy

As you are all aware the AAP has released its 2012 circumcision policy and it is very  pro-circumcision.

My response to the AAP is as follows:

  1. You have failed your patients which are American Children, and not Parents, not Doctors, not Hospitals, and not Religious groups. 
  2. You have failed to represent the interests of baby boys.
  3. You have failed to account for the human rights of baby boys.
  4. You have failed to account for medical ethics and how it applies to non-therapeutic amputative surgery of a non-consenting minor.
  5. You have failed to mention the male foreskin is a functional sex organ in its own right.
  6. You have failed to mention all of the scientific literature which contradicts the protective effects of circumcision for STI & HIV prevention.  A basic tenet of the scientific method is to use all available to data to disprove your theory, and not to selectively choose data which supports your theory.
  7. You have failed to mention the large body of evidence which documents the harms of circumcision from injury & infection to death in children, to sexual dysfunction in adults, and adult resentment of their infant circumcison.
  8. AAP your 2012 Circumcision Policy is a FAIL, and I hope it brings you both internal and international shame.
Is there a greater moral failing than to fail defenseless children?

Friday, July 27, 2012

German Dr's letter on circumcision translated


Undue Suffering Circumcision for Non-Medical Reasons Is Wrong


A Commentary By Dr. Maximilian Stehr

As the debate over the medical ethics of circumcision rages in Germany, some have argued that the practice provides health benefits. But many in the medical community disagree. Circumcision is not in the best interest of boys who undergo the procedure.

Info

In July 2011 a mother took her 2-year-old son to a pediatric clinic in Munich. Up to that point he had been the picture of health. There was absolutely nothing wrong with him. His parents simply wanted him to be circumcised at a medical facility on religious grounds.

But something went wrong when the boy was anesthetized, and the surgical team suddenly couldn't ventilate him anymore. The oxygen levels in his blood dropped, and his heart stopped beating. A dramatic scene unfolded in the minutes that followed, as the doctors tried to reanimate him, eventually calling in the emergency pediatric specialist. By the time the specialist arrived, the boy's body had been starved of oxygen for at least 10 minutes. The team finally managed to resuscitate the boy, and he was taken to our hospital by ambulance. But the child never regained consciousness. The lack of oxygen had caused too much damage to his brain.

I'm not telling this story to be sensationalist. I'm telling it because it moved me deeply. A healthy child that had probably happily crawled out of his bed that very morning had been anesthetized unnecessarily a few hours later, and by midday he lay in our intensive care unit, severely disabled for the rest of his life.

This shocking tale makes one thing absolutely clear: We doctors must never unnecessarily endanger the patients entrusted to our care. After all, had this boy not been circumcised, there would have been no emergency during his anesthetization. Every surgical intervention and every anesthesia is associated with a certain amount of risk. In this case the risk is not very great, but should nevertheless be taken only when justified. Under no circumstance should the dangers be overlooked because we think "It's only a minor operation." It's not.

'First, Do No Harm'

Munich's university hospital, the Klinikum Grosshadern, stopped circumcising boys without medical indication back in 2001. Many renowned pediatric hospitals had taken similar steps even before the Cologne Regional Court recently declared religious circumcision of children illegal. The medical community has been debating the issue for almost a decade. It's only thanks to the judges in Cologne that the matter has been brought to the attention of the public.

One of the fundamental principles of medical ethics is that no one should be harmed. The oath formulated by Hippocrates (approx. 460-370 BC) and sworn by all doctors includes the following statement: "I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone." Another key idea lies at the heart of all ethical behavior by medical personnel: "Primum nihil nocere," or "First, do no harm," a phrase coined by Scribonius Largus, a doctor at the court of the emperor Tiberius Claudius. The treatment of patients must be with their welfare in mind, and must therefore have priority over other interests, such as science, financial gain or profit.

Medically unnecessary circumcision causes damage because it results in an irreversible loss of healthy bodily tissue. Some people may consider it insignificant because the foreskin serves no discernible purpose. But the foreskin does indeed have a number of functions, although very few of the people engaging in the debate are aware of them.

No Medical Benefit

After birth, the foreskin protects the head of the penis (the glans) and prevents the external urethral orifice from abrasion and drying out. Following circumcision, the surface of the glans regularly thickens and calluses. This can lead to a constriction of the opening of the urethra, the most common complication associated with circumcision in infancy, occurring in up to 30 percent of cases. It's not unusual for several operations to be required before affected children can empty their bladder properly.

The foreskin also plays a role in arousal. In contrast to the glans, which has deep sensitivity, the foreskin has what are known as tactile corpuscles which can only be found in similar density in the tips of the fingers, the lips and the eyelids. It's therefore hardly surprising that the foreskin is considered a male erogenous zone. A significant majority of men who are circumcised in adulthood, and are therefore in a position to make comparisons, say they are less sensitive in this area after surgery. But that's not the only reason why circumcision affects sexuality: Couples in which the man is circumcised uniformly report a loss of male secretions during sex and therefore greater friction and resulting pain. It can therefore be assumed that circumcision can indeed have a negative impact on sexuality and the sex life of both circumcised men and their partners. These findings are not new. Major studies and surveys have been conducted and published as far back as the 1990s.

But the direct consequences of an operation must also be considered. Post-surgical complications occur in between 0.19 and 2 percent of circumcisions, but rise to 11 percent for patients circumcised in infancy. These complications primarily involve secondary bleeding or infection. In rare cases the urethra or the glans may be damaged or even need to be amputated. I see such complications time and again at our clinic, even though they occur in less than one percent of medical procedures. They mean painful surgery for the child.

Often enough, circumcision is deemed to be of medical benefit, for instance in preventing infectious diseases or cancer. But it's worth taking a closer look at the figures and the findings of related studies: Circumcised infants may have only a tenth as many urinary tract infections in their first year, but these infections generally occur so rarely that 100 circumcisions would be needed to prevent a single urinary tract infection. This doesn't make sense in otherwise healthy babies. There is no medical benefit to routine circumcision.

Wait For Consent

Nor does it reduce the likelihood of passing on or contracting sexually transmitted diseases. As early as 1855, a study suggested a possible link between circumcision and the transmission of venereal diseases. Since then, more than 30 studies have been published on the matter. However, the findings of these studies are extremely inhomogeneous. In effect, circumcision doesn't have any effect on the incidence of most sexually transmissible diseases (gonorrhea, syphilis, herpes and AIDS).

In 2007, the World Health Organization recommended circumcision as a prophylactic measure against HIV infection. This recommendation was based on studies from Kenya and Uganda that suggested that the risk of infection with HIV was 50 percent lower in circumcised heterosexual men than in non-circumcised ones. But demands for routine or blanket circumcision don't take into account the fact that the WHO considers circumcision only for adult males who can decide for themselves and are at a high risk of infection.

From an epidemiological perspective, the practice makes no sense for Germany. Furthermore, circumcision for this purpose could also be carried out at an age at which the person in question can make their own decisions. The same concern also applies to the supposed preventative nature of circumcision with regard to penis carcinoma or even cervical cancer: If circumcision had an unambiguously positive influence -- and not all scientists agree it does -- this operation would only make sense at an age when the man is sexually active, in other words at an age when the young man can consent himself.

A Chance For Dialogue

Medically, there is no evidence of advantages for boys. Therefore non-medically indicated circumcision is not in the child's best interests either. This is the key argument against the inadmissible comparison of circumcision with a recognized vaccine. The effectiveness and therefore the utility of the vaccine for the child have been scientifically proven.

Doctors have to weigh potential risks and benefits. There are no medical benefits to circumcision on religious grounds. For this reason it's all the more significant that it's a serious surgical procedure fraught with risks and complications. Whether it's carried out under local or general anesthetic, circumcision causes boys undue suffering. This procedure must therefore be rejected from both a medical and an ethical perspective.

As a devout Catholic, I have great respect for the concerns of religious communities. As a scientist, I feel discredited by Chancellor Angela Merkel's comments about how the circumcision ruling makes Germany "a laughing stock." The Cologne Regional Court presented us with an opportunity to work together with the various religious communities to consider the rights of physical inviolability and religious freedom. Some Muslims have already shown a willingness to accept that boys be circumcised only when they are old enough to give their consent. But in Berlin the debate is at risk of being stifled politically, robbing us of the chance for dialogue.

Translated from the German by Jan Liebelt



Tuesday, July 3, 2012

Women at greater risk with circumcised men

 There are now 2 Research studies that show women who have sex with a circumcised man are at greater risk for contracting HIV!!!!!! Why no Awareness campaigns no Publicity, WHY?  My additions are in Bold type.

Randomized Trial of Male Circumcision in HIV-infected Men: Effects on HIV Transmission to Female Partners, Rakai, Uganda

Abstract

Background

A randomized trial of male circumcision (MC) was conducted among HIV-infected males to test the hypothesis that MC would reduce HIV transmission to female sexual partners.

Methods

This randomized, unblinded trial, conducted in Rakai District, Uganda, enrolled 922 uncircumcised, HIV-infected asymptomatic men aged 15–49 with CD4 counts ≥350. Men were randomly assigned to immediate circumcision (intervention) or circumcision delayed for 24 months (control). Concurrently enrolled HIV-negative female partners were followed up at 6, 12 and 24 months, to assess HIV acquisition by male MC assignment (primary outcome). An intention-to-treat analysis assessed women’s HIV acquisition using survival analysis and Cox proportional hazards modeling. The trial was registered in the Clinical Trials.gov Protocol Registration System (NCT00124878).

Findings

The trial was terminated for futility (Why for futility? It was an important finding male circumcision may be a risk factor for women?). Ninety three concurrently enrolled female partners of intervention arm (Circumcised Men) men and 70 partners of control arm men (Intact) provided follow up data. Cumulative probabilities of female HIV infection at 24 months were 21.7% (95% CI 12.7–33.4) in the intervention arm (Circumcised Men) and 13.4% (95% CI 6.7–25.8) in the control arm (Intact men) (adjusted hazard ratio= 1.49, 95% CI 0.62–3.57, p = 0.368). At 6 months, intervention arm male-to-female transmission in couples who resumed intercourse ≥5 days prior to certified surgical wound healing was 27.8% (5/18), compared to 9.5% in couples who abstained longer post-surgically (6/63, p = 0.06) and 7.9% in control arm couples (5/63, p = 0.04)  (Wht not state here that there is a 50% to 60% increase in hiv infections with a circumcised man, and beginning intercourse early creates a 400% increase in HIV infection risk)

Interpretation

Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months, and transmission risk may be increased with early post-surgical resumption of intercourse. (Why not state the truth and say that evidence exists that male circumcision increases the risk of HIV for females) Longer-term effects could not be assessed. (They could'nt be assessed because you ended the trial early, male circumcison might be an important risk factor for females, dont women of the world need to know this?)  Post surgical sexual abstinence and subsequent consistent condom are essential for HIV prevention.
Keywords: Male circumcision, randomized trial, HIV-infected men, female HIV acquisition, Uganda

 

1994 Apr;23(2):371-80.

Risk factors associated with prevalent HIV-1 infection among pregnant women in Rwanda. National University of Rwanda-Johns Hopkins University AIDS Research Team.

Source

Department of Epidemiology, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, MD 21205.

Abstract

This study evaluated risk factors associated with prevalent HIV-1 infection among pregnant women in a semi-rural but densely populated area surrounding the town of Butare in Rwanda. Overall seroprevalence was 9.3% in 5690 pregnant women who sought antenatal care at one of five health centres. Factors associated with higher seroprevalence of HIV-1 included history of multiple sexual partners, history of at least one sexually transmitted disease (STD), relatively high socioeconomic status (SES), being unmarried, young age at first pregnancy, and low gravidity. Women who had used oral contraceptives, smoked more than one cigarette per day, whose partners were circumcised, and had had sex to support themselves were also at higher risk of being infected. A history of blood transfusion in the past 5 years was not associated with HIV-1 infection. History of multiple sexual partners, history of STD, high household income, partner circumcision, and past oral contraceptive use remained strongly associated with HIV-1 infection even when simultaneously controlling for other covariates. Among legally married women who lacked sexual behaviour risk factors, history of STD, high SES, young age at first pregnancy, and low gravidity were significantly associated with HIV-1 seroprevalence.

PMID:
8082965
[PubMed - indexed for MEDLINE]

 

 

 

 

 

 

 

 

Introduction

Three trials of male circumcision (MC) in HIV-negative men, including one conducted in Rakai, Uganda, showed that circumcision reduced male HIV acquisition by 50–60 () and MC is now recommended for HIV prevention in men.() As programs scale up, it is inevitable that HIV-positive men will also request MC, partly to avoid stigmatization. We previously reported that MC was safe and reduced rates of genital ulcer disease (GUD) in asymptomatic HIV-infected men with CD4 cell counts ≥350.(,). Given the social considerations and clinical findings, WHO/UNAIDS has recommended that surgery be provided on request to HIV-infected men unless there are medical contraindications.()
A prior observational study in HIV-discordant couples in Rakai suggested a lower rate of male-to-female HIV transmission from circumcised HIV-infected men, particularly if their HIV viral load below 50,000 copies/mL.() Two other observational studies also reported an association between MC and reduced female HIV risk.(,)
In parallel to the trial of MC in HIV-negative men referenced above, we conducted a randomized trial of MC in HIV-infected men and enrolled their female partners. Trial objectives were to assess MC safety and efficacy for STI prevention in HIV-infected men, (,) and to test the hypothesis that MC would reduce HIV and STI transmission from HIV-infected men to their HIV-uninfected female sexual partners. This paper reports trial results in the women partners of HIV-infected men, , including HIV incidence and rates of STI symptoms and vaginal infections.

Methods

The trial was conducted in Rakai District, Uganda, between 2003 and 2006.

Male participation

Trial procedures for HIV-infected men, including consent, randomization, and data and sample collection, were the same as those previously reported in the MC trial of HIV-negative men;() and are briefly summarized here. Men received an explanation of study goals and provided written informed consent for screening and HIV testing. Prior to screening and throughout the trial, men were offered HIV results, counseling and information on HIV prevention. They were informed that the effects of MC on HIV/STI transmission to women partners were unknown and that adherence to safe sexual practices was imperative.
In all, 1,151 HIV-positive eligible uncircumcised men were identified, of whom 922 consented and were enrolled. Eligibility criteria included being HIV-infected, uncircumcised, aged 15 to 49 years, having no medical indications or contraindications for circumcision and, because the safety of MC in HIV-infected men was unknown, no evidence of immunosuppression (WHO clinical stages III or IV, or a CD4 count below 350 cells/ml3). Men with genital infections or a hemoglobin ≤ 8 gm/dL were treated and rescreened prior to enrollment.
Participants were randomly assigned to be circumcised within approximately two weeks (intervention arm) or after 24 months (control arm). Random assignment was in blocks of 20, with replacement.() Prior to circumcision men were provided with detailed instructions on postoperative wound care, hygiene, abstention from intercourse until complete wound healing had been certified and safe sexual practices thereafter. They were given an information sheet with these instructions to share with their sexual partners. Circumcisions were performed using the “sleeve” procedure.(,) Postoperative follow up visits were scheduled at 24–48 hours, 5–9 days and 4–6 weeks, and predefined adverse events (AEs) were recorded.(,) Men whose wound was not fully healed at the 4–6 week visit were followed weekly until healing was certified.
At each postoperative follow up, participants were interviewed and the wound was inspected. Participants were asked about resumption of sexual intercourse; those who resumed sex were asked when intercourse first occurred following surgery and whether condoms were used. The sexual risk reduction information, including post-surgical sexual abstinence until completed wound healing, was reiterated at each postoperative visit. Male participants in both arms were then followed at 6, 12 and 24 months post-enrollment; interviewed regarding sexual behaviors, health and related issues; and examined. Venous blood samples and penile swabs were collected.

Female partner participation

Male participants in the trials of MC in HIV-infected and HIV-uninfected men were asked to invite their wives or permanent consensual partners (subsequently referred to as female partners) to enroll in a study to assess the efficacy of MC for prevention of male-to-female HIV and STI transmission. Enrolment and follow up procedures were the same for female partners regardless of the male’s HIV status. Results reported in this paper are for the partners of HIV-positive men.
Female partners were informed of study goals and procedures, were told that the effects of MC on transmission of HIV or STIs were unknown, and were counseled on HIV and STI prevention (including consistent condom use) and on the need to refrain from sexual intercourse following MC until completed wound healing was certified. All women participants provided written informed consent for enrolment and follow up.
Female partners were followed at 6, 12 and 24 months post-enrolment. At baseline and each follow up visit, women were administered a detailed sociodemographic, behavioral, and health interview and provided venous blood samples and self-collected vaginal swabs. Interviews were conducted in private, by trained same-sex interviewers fluent in Luganda.
At each study visit, participating men and their female partners were provided with intensive HIV/STI prevention education including abstinence, faithfulness and consistent condom use; were offered free condoms, and voluntary HIV counseling and testing (VCT) and couples counseling and testing (cVCT). Participants could enroll even if they declined to receive their HIV results or accept cVCT. Intensive efforts were made throughout the trial to facilitate individual and couples counseling and disclosure of HIV results, including the creation of couples’ support clubs. Participants were informed of the advantages of receiving HIV results including, as of 2004, access to free antiretroviral therapy offered by the RHSP through the President’s Emergency Program for AIDS Relief (PEPFAR).
In addition to the information provided to all participants, community meetings were conducted to inform the population of the trial and of the need for safe sexual practices regardless of the male partner’s circumcision status.
The protocol was reviewed and approved by the Uganda National Council for Science and Technology, and by three Institutional Review Boards (IRBs): the Science and Ethics Committee of the Uganda Virus Research Institute; the Committee for Human Research at Johns Hopkins University, Bloomberg School of Public Health; and the Western Institutional Review Board, Olympia, Washington. Trial oversight was provided by an independent Data Safety and Monitoring Board (DSMB). A Community Advisory Board (CAB) provided guidance on study design, conduct and the dissemination of results to the community. The trial was conducted in accordance with Good Clinical Practices and International Clinical Harmonization (GCP-ICH). Women were compensated for their time and travel costs, equivalent to $3.00 per visit, for a total of $12.00 for completion of all study visits. The CAB, DSMB and IRBs approved this compensation as appropriate.
The parallel MC trial in HIV-negative men was closed on December 12, 2006, following an interim analysis which demonstrated the efficacy of MC for HIV prevention in men.() Participants in both trials, as well as Rakai communities, were informed of this finding. Because continuation of the trial in HIV-infected men could result in stigmatization of participants, enrolment of HIV-positive men was paused and the investigators requested an unscheduled interim review and guidance from the DSMB. The DSMB determined that the conditional power to detect 60% efficacy, as specified in the study protocol, was only 4.9% and recommended that enrollment be closed. The investigators were unblinded, and study participants (men and women) were informed of the finding. However, the DSMB recommended continued follow up of enrolled participants. The DSMB reviewed the follow up data on Dec 17, 2007 and recommended that follow up of HIV-positive men and their partners be closed. The current analysis is based on results to that date.

Laboratory methods

HIV status was assessed by two enzyme immunoassays (EIAs): Vironostika HIV-1 (Organon Teknika, Charlotte, North Carolina, USA] and Murex Biotech [Central Road Temple Hill, Darford, UK). Discordant EIA results and seroconversions were confirmed by Western blot (Calypte Biomedical Corporation, Rockville, MD, USA). Male HIV viral load was measured by reverse transcriptase polymerase chain reaction (RT_PCR) assay (AMPLICOR HIV-1 MONITOR version 1.5, Roche Molecular Systems, Branchburg, N.J.). Women’s self-collected vaginal swabs were assessed for Trichomonas vaginalis by InPouch TV culture (BioMed Diagnostics, San Jose CA). Vaginal flora was quantified by the Nugent method;() a score of 7–10 was classified as BV.
To ascertain whether females had acquired HIV from their linked partner, viral sequence data were generated from both individuals for portions of the gag and gp41 fragments(). The genetic distance of the viral sequences between the two partners was compared to the variation between epidemiologically unrelated individuals in the Rakai population.(, ).

Statistical analyses

The primary endpoint was male-to-female HIV transmission. Based on our prior observational data,() the study was powered to detect an incidence rate ratio of 0. 41 for HIV transmission from intervention compared to control arm HIV-positive men. We estimated that 220 couples would provide 80% power to detect this reduction over two years, adjusting for losses to follow up and crossovers. We also hypothesized reduced transmission in couples in which the circumcised HIV-infected man had a viral load <50,000 cps/mL and estimated that the study had >90% power to detect >95% efficacy in this subgroup. No interim analyses were planned.
Enrolment characteristics of males and females in concurrently enrolled couples were assessed using Chi-square tests for differences in distributions between study arms. The effect of MC on male-to-female HIV transmission was assessed in an intention-to-treat analysis using Kaplan-Meier estimation, based on the time to the follow up visit at which the female partner was first HIV-positive. An overall risk difference and risk ratios were calculated at the end of follow-up, with 95% confidence intervals (95%CI) based on Greenwood variance estimates. Cox proportional hazards models were used to estimate the adjusted hazards ratio (adj HR) of HIV detection in female partners, after adjustment for covariates which differed between study arms at enrollment at p < 0.15. We evaluated male-to-female HIV transmission by female reported characteristics and behaviors at enrollment and follow up. Female risk behaviors were also compared between arms at each follow up visit. We determined the prevalence of vaginal infections and symptoms during follow up, and estimated the prevalence risk ratios using modified Poisson regression with robust variance estimation to account for repeat observations.
After unblinding the study, the DSMB requested further analyses, including male-to-female HIV transmission in intervention arm couples by timing of resumption of intercourse relative to certification of wound healing. Given the schedule of postoperative visits, timing of healing could not be precisely determined, since healing preceded certification (i.e., there was an unknown interval between actual and observed healing). We assumed that men who resumed sex within the 5 days prior to or after certified healing had initiated intercourse when the surgical wound was likely to be intact; and were classified as “delayed resumption of sex.” Couples who resumed sex more than 5 days prior to observed healing, when scar formation were less likely to have been complete, were classified as having “early resumption of sex”. We then assessed male-to-female HIV transmission in intervention arm couples reporting early and delayed resumption of sex.
After the study was unblinded, we examined HIV viral load (VL) prior to and after MC among consenting control arm men who received circumcision as a service, in order to assess whether the stress of surgery might upregulate HIV VL. Eighty nine men not on ART and 25 men on ART provided blood immediately prior to surgery and at the one month post surgical visit. (During the trial, bloods were not collected between the time of surgery and the 6 month follow up visit.) We estimated within-individual change in log10 HIV VL copies/mL after MC, relative to the preoperative levels, using a paired t test.

Trial registration, funding, role of the funding source and study collaborators

The trial was registered in the Clinical Trials.gov Protocol Registration System (NCT00124878) and was funded by The Bill and Melinda Gates Foundation as an investigator-initiated grant (Grant # 22006). Additional support for laboratory analyses and training were provided, respectively, by the Division of Intramural Research, National Institutes of Allergy and Infectious Diseases, National Institutes of Health and the Fogarty International Center (grants 5D43TW001508 and D43TW00015) The study was conducted by the Rakai Health Sciences Program, a research collaboration between the Uganda Virus Research Institute, and researchers at Makerere and Johns Hopkins Universities. FM and LHM had full access to all data until trial closure. All other investigators were blinded until trial closure and had access to data thereafter. RR from the Gates Foundation maintained oversight of progress, participated in open DSMB sessions and in the interpretation of data. The research team conducted data analyses at Johns Hopkins University and at the Rakai Health Sciences Center. The corresponding author had final responsibility for preparing results for publication.

Findings

The trial profile is shown in figure 1. A total of 7,274 men were screened of whom 1,151 (15.8%) were HIV-infected and eligible; of these, 922 (80.1%) consented and enrolled. Among 474 HIV-infected men randomized to the intervention arm, 374 (78.9%) were currently married or in a consensual union: 291 (77.8%) of their female partners consented and enrolled, of whom 122 (42.0%) were HIV-negative at the time of enrolment. Of these HIV-negative women, 93 (32.0%) enrolled concurrently with their husbands and 92 had at least one follow up visit over 24 months. Among 448 HIV-positive men randomized to the control arm, 348 (77.6%) were in a current marriage/consensual union; 239 (68.7%) of these female partners consented and enrolled, of whom 100 (42.0%) were HIV-negative at the time of enrolment. Of these women, 70 (29.3%) enrolled concurrently with their husband and 67 had at least one follow up visit over 24 months. The 92 intervention arm couples and 67 control arm couples with concurrent female and male enrolment and at least one female follow up visit constitute the primary population for determining male-to-female HIV transmission.
Figure 1

Figure 1

Trial Profile.
An additional 29 HIV-negative female partners of intervention arm men and 30 HIV-negative partners of control arm men entered the study six or more months after their husband's enrollment. These women were excluded from the primary male-to-female HIV transmission analysis since, unless women enrolled at the same time as their partner, we did not know their HIV status at the time of their husband’s enrolment. Thus, we could not determine which HIV-infected late-enrolling women had seroconverted since their husband’s enrolment, and this could thus result in bias if HIV transmission in the first six months differed by study arm. The couples with delayed female enrollment were assessed in secondary analyses.
Table 1 shows the enrollment characteristics of HIV infected men and concurrently enrolled HIV-uninfected partners. There were no significant differences between arms in male characteristics or behaviors at enrollment. Female partners of men in both arms were comparable with respect to numbers of sexual partners in the past year, alcohol use and STI symptoms. However, intervention arm female partners were somewhat younger (p = 0.067) and less likely to report condom use in the past year (p = 0.017). At enrollment, 97.7% of intervention arm and 94.1% of control arm men had received their HIV results and post-test counseling. Among female partners, 68.8% in the intervention arm and 74.3% in the control arm accepted HIV results and post-test counseling at time of enrolment, and an additional 16.4% of intervention arm and 16.2% of control arm women reported they had previously received their results (i.e., 85.2% intervention and 90.5% control females had received HIV results). All participants received intensive HIV prevention education. Female retention rates were comparable in both arms at the 6, 12 and 24 month follow up visits. (Table 2)
Table 1

Table 1

Enrollment characteristics of HIV-infected men and HIV-negative women in couples enrolled concurrently.
Table 2

Table 2

Female Partner Retention Rates
Figure 2 shows the Kaplan-Meier cumulative probabilities of female HIV acquisition in couples with concurrent male and female enrolment. Over the 24 month follow up, the cumulative probability of female HIV acquisition was 21.7% (95%CI 12.7–33.4%) in the intervention arm and 13.4% (95%CI 6.7–25.8%) in the control arm (unadjusted HR=1.58, 95%CI: 0.68–3.66, p=0.287). After adjustment for differences in enrollment characteristics by Cox proportional hazards regression, the adjusted HR was 1.49, 95% CI 0.62–3.57, p = 0.368). When female partners who enrolled six months or more after their husband are included, the cumulative probability of infection was 17.4% in the intervention arm and 15.8% in the control arm (HR = 1.22, 95%CI 0.59–2.54, p = 0.65). There were no male crossovers among couples in the primary analysis. There were three crossovers among men whose female partner had delayed enrolment, but none of these crossover men transmitted to their partners.
Figure 2

Figure 2

Cumulative probability of Female HIV acquisition.
In a subanalysis (not specified in the protocol), we assessed whether HIV transmission in intervention arm couples was associated with the timing of resumption of intercourse relative to wound healing (Table 3). HIV acquisition, observed at six months, occurred in 27.8% (5/18) of women in intervention arm couples who resumed sex early, compared to 9.5% (6/63) of women in couples with delayed resumption of sex (RR = 2.92, 95%CI 1.01–8.46, p = 0.06). The proportion of women acquiring HIV by 6 months in intervention arm couples who delayed sex (9.5%) was comparable to the proportion of newly HIV-infected control arm women ( 7.9%[(5/63]; p = 1.0). However, the rate of female HIV acquisition at 6 months in intervention arm couples with early post-surgical resumption of sex (27.8%) was significantly higher than in control arm women (RR = 3.50. 1.14–10.76, p = 0.038).
Table 3

Table 3

Proportions of women with observed HIV acquisition at the 6 month follow-up visit in the control arm, and in the intervention arm by timing of resumption of intercourse in relation to post surgical wound healing.
There were no significant differences in HIV transmission between study arms by enrollment covariates, nor by female-reported sexual risk behaviors during follow up (data not shown). Among women whose partner’s enrollment viral load was <50,000 cps/mL, the cumulative probability of HIV acquisition was 15.7% (11/70) in the intervention arm and 10.6% (5/47) in the control arm (HR = 1.48, 95%CI 0.55–3.98, p = 0.43). Among couples with a male enrollment viral load > 50,000 cps/mL, female cumulative HIV acquisition was 27.3% (6/22) in the intervention arm and 15.0% (3/20) in the control arm (HR = 1.82, 95%CI 0.52–6.32, p = 0.34)
There were no statistically significant differences in female-reported number of sexual partners, condom use, or use of alcohol with sex during follow up (Table 4). In the intervention arm, 75.3% (70/93) of HIV-infected men disclosed their serostatus to their female partner; and in the control arm, 77.1% (54/70) of men disclosed their serostatus (p = 0.38).
Table 4

Table 4

Women’s sexual behaviors during follow up, by study arm
The proportions of follow up visits at which female partners reported STI symptoms or had laboratory diagnosed BV in the intervention and control arms, respectively, were: GUD, 16.4% (37/225) versus 16.1% (26/161), p=0.95; vaginal discharge, 36.4% (82/225) versus 32.3% (52/161), p=0.50; dysuria, 15.5% (35/225) versus 14.9% (24/161), p=0.89; and BV, 55.8% (121/217) versus 51.9% (83/160), p=0.54. Trichomonas was detected in 6.5% (9/138) of follow up visits in intervention arm women and 15.2% (17/112) of visits in control arm women (PRR = 0.43, 95%CI 0.18–1.02), which was of borderline statistical significance (p = 0.056).
Among 25 couples in which the female partner seroconverted during the trial, sequence data for both partners were available for 13 pairs. In all 13 couples, the genetic distance of the viral sequences between partners was < 0.5% , which was less than two standard deviations below the median distance of sequences between unrelated individuals in Rakai, indicating probable HIV acquisition within the partnership.()
We assessed pre- and postoperative HIV VL in 89 ART naïve control arm participants receiving MC as a service. Among 80 men with detectable VL prior to surgery, the mean VL log10 cps/mL was 4.30 (SD 0.83) preoperatively, and 4.50 (SD 0.74) at the fourth postoperative week, a mean increase in intra-individual VL of 0.20 log10 cps/mL (p = 0.002). All 9 men with undetectable VL load prior to surgery remained undetectable at week four. In 25 control arm men who had initiated ART prior to circumcision, we observed no increase in VL in the 21 (84.0%) who had an undetectable VL prior to surgery, nor in the 4 men who had detectable preoperative VL.

Discussion and interpretation

Circumcision of HIV-infected men did not reduce HIV transmission to their uninfected female partners (Figure 2), and we cannot exclude the possibility of higher transmission in couples who resumed intercourse before complete healing of the surgical wound (Table 3). Since study duration was limited and not all women completed 24 months of follow, we could not assess long term benefits or risks to women. The findings indicate that strict adherence to sexual abstinence during wound healing and consistent condom use thereafter must be strongly promoted when HIV-infected men receive MC. .
These findings have important implications for MC programs. The WHO and UNAIDS recommend that HIV-positive men who request MC be provided with the service unless there are medical contraindications.() Despite the lack of MC efficacy for HIV prevention in women, we agree with these recommendations for the following reasons. If programs excluded HIV-infected men it could result in stigmatization, and it is likely that HIV-positive men would seek surgery from potentially unsafe sources to mask their serostatus. Conversely, circumcised HIV-negative men could use their MC status to negotiate unsafe sex. Additionally, circumcision reduces genital ulcer disease() and human papillomavirus infection in HIV-infected men, (pc RG) which constitute direct health benefits.
Our finding that resumption of intercourse prior to complete healing may increase the risk of HIV transmission to women makes it imperative that circumcised men and their female partners be clearly instructed to abstain from intercourse until wound is healed. We previously reported that wound healing was complete in 73.0% of HIV-positive men at 4 weeks and 92.7% at 6 weeks after MC() Thus, it would be prudent to recommend abstinence for a minimum of six weeks following surgery and to reexamine men to assess healing prior to advising that sexual intercourse may resume. It should be noted that the possible short-term increase in transmission to partners of circumcised HIV-positive men if sex is resumed early is unlikely to have a substantial effect on the HIV epidemic: the exposure period of possible increased risk is short and the number of HIV-positive men with uninfected female partners who resume sex early will generally represent a small proportion of MC program clients. Nonetheless, comprehensive MC programs should, wherever feasible, promote and offer condoms, VCT and cVCT, and MC-related health messages for women. Offering MC to infants and to boys prior to sexual debut would mitigate the challenges of MC in HIV-infected men, but would require careful attention to consent and assent by parents and minors.
We observed an increase in HIV viral load among ART naïve men following surgery, which could result in higher infectivity.( ), Our post-surgical assessment was conducted at 4 weeks, and additional research is needed to determine whether MC affects VL beyond this period.
We were disappointed that the trial did not show protection from HIV infection in women, as was expected from observational studies.(). One possible explanation is that most men in the observational studies had been circumcised in childhood and did not initiate intercourse until long after completed wound healing. However, it should be noted that this trial did not show any trend towards protection at 12 and 24 months after surgery.
We previously reported that female partners of HIV-negative men randomized to MC had lower rates of GUD, trichomonas and BV.() In partners of HIV-positive men, MC was associated with lower rates of trichomonas (PRR = 0.42, 95% CI 0.18–1.02, p = 0.056),similar to the PRR in partners of HIV-negative men.() However, MC in HIV-positive men was not associated with lower rates of female partners’ STI symptoms or BV.
There are limitations to this study. The trial was underpowered, in part because the number of enrolled male HIV-positive/female HIV-negative discordant couples were lower than anticipated from prior Rakai cohort studies. Although the proportions of married men were comparable in both study arms (Figure 1), a higher proportion of intervention arm female partners enrolled (77.8%) compared to control arm partners (68.7%, p = 0.007). This suggests differential motivation to participate between arms, which may have introduced bias. However, with the exception of somewhat lower condom use reported by intervention arm women, there were no statistically significant differences in female baseline characteristics (Table 1) and adjustment did not materially affect the estimates of efficacy. The study was closed early and this limited our ability to assess longer-term effects. In addition, 29 wives in the intervention arm and 30 in the control arm were enrolled six or more months after their husbands, and were excluded from the primary analysis, however, inclusion of these late enrollees did not alter the results. Finally, for reasons of safety, we excluded HIV-positive men with CD4 cell counts less than 350 or WHO Stage III or IV disease. Thus, we cannot determine possible effects on female partners of MC in men with more advanced HIV infection.
It is important to note that this was not a classical discordant couples trial, in which participants enroll as a couple. HIV-positive males enrolled and were randomized as individuals, and were asked to invite their partners, who also enrolled as individuals. Participants were strongly encouraged to accept couples VCT at enrollment and throughout the trial, but about a quarter in each arm did not disclose their serostatus. In our prior experience, acceptance of cVCT is relatively low in this rural population and is more frequent in persons who know they are HIV-uninfected. HIV transmission rates in this study, particularly in the first six months, were high compared to studies of HIV-discordant couples enrolled after receiving cVCT. Such couples may represent a self-selected and motivated subpopulation and may be more likely to adopt preventive behaviors() than the individuals in this trial. For example, consistent condom use was uncommon at enrollment (Table 1), increased over time, but was still relatively low at 24 months (50.0% in the intervention arm and 36.4% in the control arm), despite repeated health education and the provision of free supplies.
It would be difficult to conduct another trial of MC effects on male-to-female HIV transmission. Given our results, such a trial would have to be powered to detect a low efficacy, requiring a very large population of male-infected HIV-discordant couples and protracted follow up. Given the potentially higher transmission rates in the post-surgical period, additional follow up visits and interim safety analyses would be needed. Thus costs, logistics and limited expectation of efficacy probably render such a trial unfeasible.
In conclusion, circumcision of HIV-infected men did not reduce HIV transmission to female partners, and the possibility of higher risk of transmission in couples who resumed intercourse before completed wound healing cannot be excluded. Wherever possible, MC should be offered in conjunction with HIV counseling services, condoms, and HIV prevention education for men and women, to optimize the health and safety of MC patients and their partners. However, the efficacy of MC for prevention of HIV in uninfected men is clear,() and reductions in male HIV acquisition attributable to circumcision are likely to reduce women’s exposure to HIV-infected men.(,) MC programs are thus likely to confer an overall benefit to women.

Acknowledgements

We thank the members of the Data and Safety Monitoring Board, as well as the institutional review boards that provided oversight (the Science and Ethics Committee of the Uganda Virus Research Institute; and the Western Institutional Review Board). We are also grateful for the advice provided by the Rakai Community Advisory Board. We wish to thank Dr. Edward Mbidde, Director, Uganda Virus Research Institute for his support. Finally, we wish to express our gratitude to the study participants whose commitment and cooperation made the study possible.
Funding: The trial was funded by The Bill and Melinda Gates Foundation (Grant 22006). Additional support for laboratory analyses and training were provided, respectively, by the Division of Intramural Research, National Institutes of Allergy and Infectious Diseases, National Institutes of Health and the Fogarty International Center (grants 5D43TW001508 and D43TW00015)

Friday, June 29, 2012

Some Honesty Please Religious Freedom vs Human Rights

Ok lets have some honesty here, and stop insulting everyone with half a brain.  When you object to a German Court Ruling that found "non-therapuetic circumcision of children is a violation of children's individual human rights", by calling it a ridiculous ruling, you insult me and everyone that believes and fights for individual human rights. 

The ruling is correct, it is intellectualy correct, it is correct in law, and because it is in accordance with the philosophy of individual human rights, it is therefore therefore morally correct from a human rights point of view.  You have a right not to like it because it interferes with your Religious freedom, but that does not make the ruling ridiculous.  Be honest, and show some guts and argue openly & publicly why you think religious freedom should take precedence over individual human rights.

Here's some clues for you = If you want to argue for religious freedom, then be intellectually honest about it.  Tell the truth!!  Say that you believe religious freedom is more important to you and your community than are individual human rights.  Be totally honest and admit that circumcision of children male or female is a violation of their bodily integrity and their individual human rights, but that you belive that religious freedom should take precendence over these individual human rights.  Be courageous, and ask for an exemption from law and human rights legislation, because your  practices of circumcision of children are more important within your religion, than are individual human rights.

Just dont insult me and the rest of the world, and argue that calling the circumcision of children a violation of individual human rights is ridiculous.  It is ridiculous that you expect to call such a ruling ridiculous and feel that it is somehow a valid statement and one that will go without challenge???

Friday, June 22, 2012

Imagine if it was a girl?

Imagine you have a new baby, she's a beautiful baby girl & she's your dream come true, she's healthy & fully formed, she's just 2 days old, but then the nurse comes and takes her away from you, she's led into a surgical room, she's strapped to a table, she beigins to cry from the restrainsts on her, her nappy is removed, she's dabbed in the genital area, then a doctor with a very sharp knife, starts to cut away at parts of her genitals, she bleeds, she screams in agony as loud as a 2 day old can scream, but her cries are ignored, She writhes but cant move, she struggles to breathe because of the pain, her heart pounds so hard it causes a severe stress reaction, & the screams go on and on and on .... until the cutting stops, then the surgery is over, she's quiet and in shock, she becomes catatonic, she's bought back to you, and the nurse tells you she slept thru the whole event, but she refuses to breastfeed, and she averts her gaze from you........ An unimaginable HORROR & What barbaric civilisation would allow this to happen?..... I'm sure at this point you;ve had enuff, and are saying this would never happen to a daughter of mine, and thank God it just doesnt happen (except in places like Malaysia), and we dont do that to our baby girls, .......Phew.......... what a horrible read........

But Somehow I imagine even if you are an intactivist, If I'd replaced the word girl with the word boy, you wouldnt have had such a vile reaction or thought it was an unimaginable horror......... Even I, an avid intactivist felt horrible writing it, trying to comfort myself that it doesnt happen in the real world.  Thats what cultural/tribal conditioning does to humans, it allows u to accept an Unimaginable horror committed to a 2 day old infant male child....its why its so hard to convince those who are in favor of infant male circumcision to see that it is WRONG.....  Its why babies dying from circumcision are tolerated, its why sucking the penis of a baby is tolerated, its why doctors make money from the procedure and dont want to give it up, its why the medical community looks for ways to justify the procedure, and conduct research on adults to justify cutting babies.......

So whats the message in all this?

WE need to work very hard and very long, & maybe for generations and we must never ever give up, & yes there'll be times of exhaustion, frustration and doubt, then you have a rest, you rest as long as you need, & then you come back because baby boys  need you to help change a culture!  And Never Forget = This also applies to ending FGM, because what I described above UNIMAGINABLE HORROR happens to little girls in Africa Asia & the Middle east and to baby girls in Malaysia!!!!!

AN ESTIMATE OF U.S. CIRCUMCISION-RELATED INFANT DEATHS

AS we seem to lose access to a lot of journal articles, I thought I'd copy this to make sure we always have a copy of this impt one!

 

LOST BOYS: AN ESTIMATE OF U.S. CIRCUMCISION-RELATED INFANT DEATHS

Baby boys can and do succumb as a result of having their foreskin removed. Circumcision-related mortality rates are not known with certainty; this study estimates the scale of this problem. This study finds that approximately 117 neonatal circumcision-related deaths (9.01/100,000) occur annually in the United States, about 1.3% of male neonatal deaths from all causes. Because infant circumcision is elective, all of these deaths are avoidable. This study also identifies reasons why accurate data on these deaths are not available, some of the obstacles to preventing these deaths, and some solutions to overcome them. Keywords: male, infant, death, mortality, neonatal, circumcision, penis, foreskin, United States.


Publication: Thymos
Author: Bollinger, Dan
Date published: April 1, 2010
"The life of man is., nasty, brutish, and short."
-Thomas Hobbes
Circumcision is a surgical procedure performed upon newborn baby boys in the United States once every seven seconds,1 three thousand times a day, over a million times a year. The practice is so deeply rooted in American childbirth and medical culture that the public is largely unaware of two facts: first, that infant circumcision is not medically necessary in almost all instances, and second, that it carries serious medical risks, including the risk of death. For some parents, circumcising their son will mean losing their baby boy to what they have been told is a harmless procedure.
Medical associations fail to warn parents of the very real risk of death from circumcision. Neither the American Academy of Pediatrics (AAP, 1999), nor the American College of Obstetricians and Gynecologists (ACOG, 2001), nor the American Medical Association (AMA, 1999) mentions death as a possible outcome of the surgery in their policy statements on circumcision. The American Academy of Family Physicians (AAFP, 2002) statement says death is possible, but (according to this study's findings) significantly underreports the risk as 1/500,000.
Parenting and baby books are equally culpable in failing to mention death as a possible, if rare, outcome of circumcision. A survey of ten popular infant-care books found that none warn that circumcision could result in a baby's death.2 Most websites and literature on circumcision also minimize or ignore the risk of death, and no contemporary study has attempted to learn the magnitude of this problem. Perhaps this is due to the peculiar place occupied by circumcision in American medicine- an elective, almost incidental, procedure carried out on babies, behind closed doors, and mostly by residents and obstetricians rather than by the baby's own doctor (Stang & Snellman, 1998).
This study reviews the few sources that have reported on deaths occurring as a result of circumcision and attempts to provide a rough estimate for neonatal (first 28 days after birth) circumcision-related mortality in the United States. Since infant circumcision is elective, this study will consider all circumcision sequelae, not just the procedure itself. Its goal is to promote discussion, encourage solutions, and- most importantly- save children's lives.
Background
About 1 .3 million boys are circumcised each year in the United States (HCUP, 2007); however, the number of boys who died from those surgeries has not been reported or estimated in any credible way. Some reasons include record-keeping practices, indifference, and- no doubt- concerns about liability.
Death certificates typically do not list circumcision as the immediate or leading cause of death and rarely list circumcision as an underlying cause. Incomplete and inaccurate death certificates for children are a common phenomenon (Cunniff , Carmack, Kirby, & Fiser, 1995). Thus, many circumcision-related deaths are more often reported as surgical mishap, infection, hemorrhage, cardiac arrest, stroke, reaction to anesthesia, or even parental neglect.
In recent years, U.S. infant deaths have been infrequently reported in the media (Rachter, 1982; The State, 1992; Miami Herald, 1993; Lum & Sorelle, 1995; NewsNet5, 1998; Proctor, 2002; Cohen, 2005; Verges, 2009). Reports of circumcision-related deaths have sporadically appeared in the medical literature beginning in the early 1900s (Holt, 1913; Reuben, 1916; Sauer, 1943; Scurlock & Pemberton, 1977; GeIUs, 1978; Baker, 1979; Hiss, Horowitz, & Kahana, 2000). In Africa, dozens of deaths from circumcision initiation rites are reported every year, but, as in America, are often treated with indifference (Ncayiyana, 2003).
Lost Boys
Boys have been lost to circumcision in the United States from the time it was first practiced to the present day, for a variety of reasons, as the following examples illustrate. The first known reported circumcision-related deaths were in New York City, where circumcision was introduced. The first was Julius Katzenstein in 1856 (New York Times) and the second was one -week-old Myer Jacob Levy in 1858 (New York Times). Both boys were circumcised by a Dr. Abrahams, and the same coroner reviewed both deaths. The coroner found that Abrahams had performed the surgeries properly, and that the boys died from blood loss as a result of parental neglect. Neither boy had received a follow-up examination.
Allen Ervin, born 1985, was in a coma for more than six years before he died. He had been on life support after his brain was damaged from oxygen deprivation during his circumcision (The State, 1992).
Demetrius Manker was born in 1993 and died soon thereafter from blood loss. The coroner's examination found a large, gaping wound on the underside of the boy's penis extending almost to the scrotum. The coroner listed cause of death as blood loss due to penile circumcision (Welti, 1993); however, there is no mention of further action being taken.
A West Virginia child, whose name was withheld, was born in 1996 without incidence and circumcised prior to hospital release. A few days later, the parents rushed him to the emergency room because he was having seizures and his penis had turned green in color. He died the next day from septicemia (Ballad, 1997).
Death sometimes occurs following repair of a circumcision complication. Dustin Evans, Jr., was circumcised soon after being born in 1998. The surgeon took so much shaft skin that the scar healed as a tight "collar" around his penis, preventing him from urinating. When he was later given an anesthetic in order to repair the damage, he immediately died of cardiopulmonary arrest (Giannetti, 2000). His father lamented, "You think, 'What could go wrong with a circumcision?' The next thing I know, he's dead."
In a 2004 Vancouver, Canada, incident, one-month-old Ryleigh McWillis was sent home from the hospital immediately following his circumcision. He later bled to death, his disposable diapers absorbing the small amount of blood from his circumcision wound necessary to send him into hypovolemic shock (Newell, 2004).
Because the penis is highly vascularized, blood-loss is a risk even for boys circumcised past the neonatal period. In 2008, 6- week-old Native American Eric Keefe died from massive blood loss. Hospital officials claimed his circumcision was not to blame, but instead faulted the parents because they had administered over-the-counter pain medication that, they also claimed, thinned his blood. The parents were not told about this possible complication (Verges, 2009). Since then the hospital has stopped performing infant circumcisions.3
Nor are ritual circumcisions without risk, either. In 2004, an infant twin born to Jewish parents was circumcised by a mohel, a ritual circumciser who was infected with Herpes simplex virus 1 . He practiced the orthodox version of circumcision called metzitzah b'peh (in which the circumciser sucks blood from the wound with his mouth), thereby transmitting herpes to the boy via his saliva. The baby boy died a few days later (Cohen, 2005).
Previous Death Estimates
The widely varying results from the handful of researchers that have attempted to estimate circumcision-related deaths can be explained by their choice of survey criteria. A study by Dr. Douglas Gairdner in 1949 included deaths due both to surgery and to ensuing complications. He reviewed case histories of 90,000 circumcisions for boys under five years old from 1942 to 1947 in England and Wales, identifying 95 deaths attributable to circumcision. Of these, he found 16 deaths per 100,000 annually for boys less than one year old, including postoperative, postrelease deaths. Some of these were due to reactions to anesthesia; Gairdner nevertheless classified these as circumcisionrelated since the boy would not have been administered anesthesia except for circumcision. This was considered a definitive study in the United Kingdom, and led the British government to deem infant circumcision an unnecessary and nonreimbursable medical procedure. When extrapolated to the present-day United States, Gairdner's findings represent an estimated 230 deaths annually. Children's-rights activists in the United States often claim this death toll (Baker, 1979), rather than underreport the risk using lower estimates, in an attempt to portray the gravity of the problem. However, this rate is misleading because it does not allow for improvements in healthcare from postwar, pre-penicillin Britain to the present day United States. Thus, this figure is likely overstated. The question is, How much is it overstated?
In a 1953 letter to the editor of Obstetrics and Gynecology, Dr. H. Speert states that of 566,483 circumcisions performed between 1939 and 1951 , there was one operative death. Applied to the present U.S. incidence that would equal 2.4 operative deaths per year. Circumcisionists cite this ratio in order to minimize the death risk. But this estimate reports only those who died on the operating table- it ignores the much larger number of postoperative deaths both inside and outside the hospital.
Inexplicably, no deaths at all were reported from any cause in a population of 100,157 circumcised, neonatal boys in a survey of U.S. Army hospital records (Wiswell & Geschke, 1989). However, the national male neonatal death rate from just two causes- hemorrhage and sepsis- is 30.2 per 100,000 (NCHS, 2004), leaving us unsure what to make of this discrepancy.
Hospital discharge records reveal that, during the 1991-2000 decade, on average 35.9 boys died from all causes each year during their stay (average 2.4 days) in the hospital in which both their birth and circumcision occurred (Thompson Reuters, 2004). These were among the average of 1,243,392 boys circumcised annually during the same period, but this number is limited to deaths inside the hospital, some of which are undoubtedly due to circumcision.
Complications from circumcision are as high as 55%, according to Patel's (1966) circumcised-infant cohort study, which reviewed case histories, examined infants in the home, and questioned parents on outcomes, making it the most thorough circumcision-complication study performed to date. Eight percent of boys in the cohort became infected after being circumcised, and they were 700% more likely to have become infected after hospital release than before. Bacterial sepsis and hemorrhage are both frequent fatal complications of circumcision, and circumcised boys are at a higher risk for streptococcus infection (Cleary & Kohl, 1979). Gairdner reported that one in fifty circumcised boys returned to the hospital for treatment of excessive bleeding, some requiring transfusions.
Infection has become even more of a factor recently with the epidemic of methicillin-resistant Staphylococcus aureus (MRSA) now under way in the United States. The medical literature is replete with reports of MRSA infections occurring first in hospitals and now in the community (Rabin, 2003; Klevens et al., 2007). Circumcised boys are at a higher risk for this "superbug" than intact (not circumcised) boys (Enzenauer et al., 1985), most likely because of the open circumcision wound. A 2003 outbreak of MRSA in a Long Island, New York, hospital maternity ward resulted in three newborns' being infected: all were boys; all had been circumcised (Rabin). Circumcision is a double whammy when it comes to MRSA: the American Medical Association identified both surgery and young age as risk factors (Zeller, 2007). The mortality rate for neonates once subcutaneous tissue becomes infected is more than 70% (Sawin, Schaller, Tapper, Morgan, & Canili, 1994). The risk from MRSA alone would seem to dictate ceasing the practice of unnecessary surgery such as infant circumcision.
Mortality Estimation
Though the data previously cited are insufficient to establish a definitive death rate on their own, there is enough available information to calculate an estimate. Not all of the reported 35.9 deaths out of 1,243,392 circumcisions can be attributed to related causes. What portion, then, is circumcision- related and how may we extrapolate to the number of deaths after hospital release? What we can safely assume is that it is unlikely that any of these infants would have been subjected to the unnecessary trauma of circumcision if they had been in critical condition, or that they would have been circumcised after their death.
Gender-ratio data can help extrapolate a figure. Males have a 40.4% higher death rate than females from causes that are associated with male circumcision complications, such as infection and hemorrhage,4 during the period of one hour after birth to hospital release (day 2.4), the time frame in which circumcisions are typically performed (CDC, 2004). Assuming that the 59.6% portion is unrelated to gender, we can estimate that 40.4% of the 35.9 deaths were circumcision-related. This calculates to 14.5 deaths prior to hospital release.
But as is often the case with hemorrhage and infection, some circumcision-related deaths occur days, even weeks, after hospital release. The CDCs online searchable database, Mortality: Underlying cause of death, 2004 (CDC), lists causes by various age ranges and reveals that the percentage of deaths after release, compared with deaths before, is 772% greater. This ratio is comparable to Patel's (1966) 700% postrelease infection rate.
Multiplying the 772% adjustment factor for age-at-time-of-death by the 14.5 hospital-stay deaths calculated above, the result is approximately 112 circumcision-related deaths annually for the 1991-2000 decade, a 9.01/100,000 death-incidence ratio. Applying this ratio to the 1,299,000 circumcisions performed in 2007, the most recent year for which data are available (HCUP, 2007), the number of deaths is about 117. This is equivalent to one death for every 1 1 ,105 cases, which is not in substantial conflict with Patel's observation of zero deaths in 6,753 procedures. It is more than some other estimates (Speert, 1953; Wiswell, 1989), but less than the overstated 230 figure derived from Gairdner (1949). Breaking this statistic down further, about 40% of these deaths (47) would have been from hemorrhage, and the remainder (70) from sepsis, using a hemorrhage-to-sepsis ratio for infant mortality (NCHS, 2004).
In summary: through a thorough review of the literature and the application of common-sense calculations, this study has arrived at a reasoned estimate of circumcision-related neonatal deaths in the United States: approximately 117 per year.
Ulterior Motives
Many factors combine to explain the lack of reliable mortality data or why this problem has not received more attention. To ignore or hide the likely cause of so many infant deaths for so many years requires a significant amount of denial or obfuscation- by: parents, physicians, hospital staff, insurers, medical associations, and legislators. The silence of human-rights, men's-rights, women's-rights, and children's-rights groups concerning these deaths is shocking. It might indicate that they are unaware of the problem, or that they wish to appear politically correct in regard to religious circumcisions, even though more than 96.5% of those performed are not for religious reasons (US Census Bureau, 2008) .5 The explanation for such lack of concern and discussion is unknown, but one fundamental reason has to be a lack of information disseminated among people who can correct the situation.
Not only will parents of a dead boy be in shock, but also potentially embarrassed, by what seems now to have been a whimsical choice for their infant. Their understandable reaction is to withdraw into protective silence or to defend their choice despite their loss. They might insist, as parents of one deceased child did recently, that they would "make the same choice with their next boy" (Fournier, 2004). Parents are sometimes irrational concerning circumcision. Many quickly sign the consent form without first learning more about the physical, psychological, and sexual consequences of circumcision. Some sign because they take their physician's mention of the topic as a recommendation, or because they feel coerced by repeated inquires. Others sign because they fear being regarded bad parents, rather than considering what is in the best interests of their son. For instance, nine out of ten parents who chose circumcision did so knowing full well that the procedure was excruciatingly painful for their newborn boy (Ahaghotu, Okafor, Igiehon, & Gray, 2009).
To hospital residents, the birth of a boy is celebrated as an opportunity to practice surgery. A resident's first surgery upon a live human being does not always go as planned- especially when the patient is not a sedated, consenting adult, but a screaming, thrashing baby. The resident's mentor is likely to provide cover for any errors, lest they reflect poorly on him or her and their institution. Busy residents often have a quota of interventions to meet in order to qualify in their specialty, which means that they have a conflict of interest, potentially an unethical stake, in performing the procedure. Thus, most adult American males can be seen as having been child medical-training draftees, now sporting a "scalpel practice" penis, carved on by a twenty-something-year-old undertaking his or her first surgery.
The relative simplicity of circumcision means that a charge that it was done poorly is a glaring indictment of the clinician. The notion that a child died as a result is, of course, even more embarrassing to them and would call forth some sort of preemptive defense. This often takes the form of blaming the parents for inadequate postoperative care, or insisting that it was the child's fault for being too feeble to withstand the procedure, turning the medical phrase "failure to thrive" into a euphemism for these iatrogenic deaths.
Because of the inadequacies of the death-certificate system and the apparent lack of investigation, it is easy to see how the medical system could either unwittingly or intentionally obscure the true cause of these deaths. American courts aid the medical institution by sometimes ruling that the parents signed the circumcision consent form, and that the parents took their chances even if they were not informed of such a possible outcome. Thus, medical practitioners have a tactical choice. They can list on a lengthy consent form every conceivable risk of circumcision, including death, which might undersell the procedure, or, calculating that the danger of failure and detection is low, soft-pedal the risks in hopes that parents will sign anyway.
Few death cases are ever litigated in court because hospitals recognize that their defenses are few and expensive to plead, and that the publicity would prove harmful. Such cases usually result in an offer to the parents of a private, sealed settlement. Sadly, the death of a child is considered less of a liability than an injury case, and therefore compensation for a dead infant is rarely substantial. On the other hand, severe injury cases- loss of all or part of the glans, or, even worse, the entire penis- are intensely litigated and may produce substantial monetary damages in the millions of dollars. The crass logic of the law is that the injured male will have to bear his injury for a lifetime, whereas the dead infant barely sensed his own existence, and so would not even sense the loss of himself. Invariably such settlements include a confidentiality clause, intended, of course, to protect the reputation of both the individual medical practitioner and the institution.
Following a death, the coroner or the medical examiner, who is usually a physician, will rule whether the death was from suspicious causes. In the United States, that coroner (who, if male, is probably circumcised) is not likely to face squarely and on the record the fact that his or her colleague performed an unnecessary and nontherapeutic surgery that resulted in the death of an infant. This malfeasance could itself be cause for an investigation, could have serious repercussions for the circumcising physician and institution, and therefore seems an unlikely move for coroners, especially if they are elected officials.
Primary and secondary causes of death are all too easy to conceal because of the lack of healthcare oversight. There is remarkably little regulation of medical practice by the Federal government, and little coordination among states to regulate medical procedures. Ironically, circumcision devices (e.g., restraints and clamps) are more closely scrutinized than their application.
The American Academy of Pediatrics (AAP) was found to be partially liable in the death of Dustin Evans, Jr., according to the Iowa Law Review (Giannetti, 2000). It reached the conclusion that his death was attributable to his circumcision, and that the AAP should either have labeled circumcision as experimental or proved its worth through exhaustive scientific testing. Yet the AAP has continued over the past four decades to issue a string of policy statements regarding circumcision, each one carefully worded so as to increasingly shift liability from its membership to parents, thereby protecting their members' lucrative income stream.
Physicians are less likely to circumcise their sons than the general populace (Topp, 1978), suggesting that they know it is an unnecessary surgery, but don't relay this valuable information to parents. Many physicians say that they prefer not to perform circumcisions, but do them anyway, rationalizing that the boy will be in better hands with them than with a physician they might refer the parents to. This may seem a noble position at first, but there can be no pretending to be a conscientious objector to circumcision while simultaneously performing one.
Circumcision is a $2 billion healthcare market, which includes costs for the procedure itself, dealing with complications, and payment for repairs (Fauntleroy, 2001). A study of Medicaid records found that a greater number of circumcisions are performed in states where Medicaid pays more for the procedure (Craig & Bollinger, 2006). A busy delivery-room obstetrician will do as many as five circumcisions a week. Physician reimbursement is at about $167 each6 (Van Howe, 2004), which means that they can potentially make an extra $3 ,340 per month, or $40 ,080 per year. That is moie than an entire year's income for 45% of Americans (US Census Bureau, 2005). One physician brazenly admitted, "I love doing circumcisions- they make my Mercedes payments!"7
At the very heart of this problem is a lack of honesty about an entrenched medicalized ritual. Circumcisers are quick to sidestep ethics and put their real patient- the baby boy- at risk. But they are not likely to speak out, simply because calling attention to their unethical actions would likely jeopardize them or their peers, reduce their income, and, possibly, have dangerous legal consequences.
Implications
Risk assessment for an unnecessary surgery must be held to a higher standard than that for a life-saving surgery. We accept that a heart transplant carries with it a substantial risk of death, but without it there is a certainty of death. On the other hand, the risk from circumcision, which has no therapeutic value, needs to be zero for the infant's sake, all the more so because he is never consulted about whether he wishes to take his chances.
We hear very little in the media about circumcision-related deaths compared with other causes. For instance, compare the 1 17 annual deaths from circumcision with those from other causes for male infants: suffocation (44), mother's use of addictive drugs (27), HTV/ATDS (19), homicide (17), automobile accidents (8), drowning (2), and falls (1) (CDC, 2004). Sudden infant-death syndrome (SIDS) killed 1 ,216 boys under the age of one year in 2004; of those, 115 were under the age of 1 month (CDC), which is the same risk as from circumcision. Approximately 36 teen-aged boys are killed in schoolyard shootings each year (Donohue, Schiraldi, & Ziedenberg, 1998). But there is more publicity for the SIDS deaths and shootings than for the circumcision-related deaths.
Is male circumcision so ingrained in American masculinity that we are hardened to its consequences? Have we inherited the recurring theme in religion and mythology of offering our sons to the gods? Or do we stoically value it as a painful male initiation rite, requiring sacrifice of blood and a body part (Zoske, 1990)- and therefore believed to be worth the occasional death-cost?
If a similar number of children were dying from another optional body modification-say, tattooing or piercing- would the public be outraged at the people and institutions benefiting financially? If not, is it then due to gender bias? Imagine the uproar if a hundred girls were dying from female circumcision each year. Why are so many adults silent about this atrocity? Adults would be furious and highly vocal, to say the least, if someone were to forcibly cut their genitals.
Solutions
The problem is this: circumcision is a killer of baby boys. No one, except for some human-rights activists, is trying to save them. It is unlikely that improving circumcision techniques would eliminate these deaths. No matter how skilled the physician is, some deaths will always occur.
Improving the process of securing informed consent from parents by listing death as a possible outcome would, at first, seem to be a logical solution, but it would fail to save lives for two reasons. First, even well-informed parents will sometimes insist on circumcision (Binner, Mastrobattista, Day, Swaim, & Monga, 2002). Second, healthcare providers cannot be trusted to provide truthful disclosure of the risks involved. The fact that physicians and nurses are already willing to perform well over a million of these unnecessary surgeries a year is proof they are generally untrustworthy.
The overwhelming majority of infant circumcisions are nontherapeutic and therefore unnecessary; the simple solution is eliminating them. To start with, physicians and nurses should be prohibited from initiating a discussion with, or soliciting circumcision from, expectant parents. Circumcision should also be defunded, following the examples set by the sixteen states that have already eliminated Medicaid coverage.
Physicians regularly give parents information favoring circumcision, but rarely provide instructions on how to care for the intact penis. Furnishing parents with this knowledge would alleviate their anxiety concerning a body part unfamiliar to them (Bollinger, 2008). All medical textbooks and parenting guides should include intact-care information and mention death as a possible outcome.
Physicians who perform unnecessary surgeries that result in death must be held accountable for their actions in criminal and civil court. Professional associations that protect their members rather than their patients should be forced to change their policies. Physicians must talk with their peers about ceasing circumcision, or at the very least become conscientious objectors. Legislation to protect boys must be passed, beginning with demanding that Congress rewrite the 1996 Federal law prohibiting female circumcision to make it gender-neutral. A nationwide system that reports all infant deaths with all contributing factors rigorously listed must be established.
Few human emotions compare with the profound grief that results from the loss of a newborn child. Adding guilt to that grief- from the realization that you requested the optional surgery that caused his death- is beyond imagination. Most parents would likely refrain from talking about it publicly. People affected by a circumcision-related death must speak up. Parents must be encouraged to talk about why they chose circumcision, what happened to their son, what they are feeling, what they would advise other parents to do, and whether they would choose circumcision again. Family members and friends must also be involved in the discussion.
Conclusion
It is reasonable to conclude that about 117 circumcision-related deaths occur each year in the United States- approximately 1 out of every 77 male neonatal deaths- and that thousands of boys have died since this practice was first medicalized 160 years ago. These boys died because physicians have been either complicit or duplicitous, and because parents ignorantly said "Yes," or lacked the courage to say "No." Every one of these boys would have had a chance at life had he not been circumcised. Circumcision can no longer be called either a beneficial surgery or a beneficent rite of passage, but by its true designation: an unrecognized sacrifice of innocents.
1 Based on a workweek of five, 8-hour days.
2 Survey by author of the ten highest ranked books listed on Amazon.com, November 10, 2008.
3 Personal communication with author at the 2009 AAP national conference, Washington, DC.
4 Selected from ICD- 10 codes P21.9-22.9, 29.0-29.1, 29.8-29.9, 36.0-36.9, 37.5, 39.8-38.9, 50.9, 52.3, 54.3, 54.8-54.9, 55.9, 96.8-96.9
5 If all Jews, Muslims, and Coptic Christians in the United States circumcise.
6 Adjusted for medical inflation to year 2010, does not include hospital's portion of $136, or what they obtain from foreskin sales to laboratories and cosmetic companies.
7 Personal communication at the 2003 AAP national conference, New Orleans, Louisiana.
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Author affiliation:
Dan Bollinger*
Author affiliation:
* Boy's Health Advisory.
Correspondence concerning this article should be addressed to Dan Bollinger, Boy's Health Advisory, 1970 North River Road, West Lafayette, IN 47906. Email: danbollinger@comcast.net


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