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Response to Recommendations for Providers Counseling Male Patients and Parents Regarding

Male Circumcision and the Prevention of HIV Infection, STIs, and other Health Outcomes

[Regulations.gov ID: CDC-2014-0012-0001]

Thank you for the opportunity to provide feedback to Recommendations for Providers CounselingMale Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection, STIs,

and other Health Outcomes [Regulations.gov ID: CDC-2014-0012-0001]. This response document

will briefly address concerns about the ethical, legal and methodological flaws with past research

informing these CDC recommendations; and the special danger posed to newly circumcised baby boys

by excessive bleeding, undiagnosed haemophilia and transfusion-transmitted hepatitis B virus [HBV]

infection.

Ethical, legal and methodological flaws with past research informing these CDC

recommendations

In 2011 and 2012, the Department of Health and Human Services Office of Inspector General [OIG]

published a series of audit reports revealing that throughout fiscal years 2000-2010, the National

Institute of Allergy and Infectious Diseases [NIAID], did not comply with the time and amount

requirements specified in appropriations statutes, in awarding several federal contracts to commercial

partners, committing the federal government to tens of millions of dollars of expenditure ahead of

appropriation of funds from Congress (OIG 2011a; OIG 2011b; OIG 2011c; OIG 2011d; OIG 2012a;

OIG 2012b). During this time, NIAID also funded and sponsored research conducted abroad, that

would be unlikely to receive ethical approval to be conducted in the United States, incorporating the

excision of healthy tissue from subjects in the absence of a clear and present immediate medical

indication, specifically ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 ['the

African circumcision trials'] (NIH 2008; NIH 2007), the methodology, conclusions, ethics, legality and

real-world applicability of which have been questioned in the professional medical literature (Bell

2014; Boyle & Hill 2011; Darby 2014; Green et al 2010; Haberland 2014; Kenyon 2014; Nkosi et al

2014; Richardson 2014).

Consent forms for the African circumcision trials failed to include then known information, from the

professional medical literature, about the importance to mens' sexual health of the prepuce, frenulum,

ridged-band and other tissues removed by circumcision (Taylor et al 1996), evidence for which has

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infants in U.S hospitals for the year 2009, with approximately 109,400 transfusions being administered

(AHRQ 2011). Prophylactic HBV vaccine was received by less than 1.33 million infants in the year

2009 (AHRQ 2011), out of approximately 4.13 million births for that year (CDC 2011a). Indviduals

infected with transfusion-transmitted HBV can latter become carriers of the virus in the general

community (HHS 2011). While over 95% of people infected as adults will spontaneously clear theHBV virus, this reduces to 30% in children, and 5% in infants (Bell & Nguyen 2009). Untreated,

chronic hepatitis B acquired early in life results in cirrhosis, liver failure, or hepatocellular carcinoma

in up to 40% of individuals (Weisberg et al 2007).

Circumcision of male minors, in the absence of a clear and present immediate medical indication, is a

controversial practice within the medical profession (KNMG 2010; Smith 2011), with doubts having

been raised in the professional literature about whether it is even lawful to circumcise, and to allow the

circumcision, of healthy boys at the expense of Medicaid (Adler 2011). Despite this, more than 1.14

million circumcision procedures were performed on male infants in U.S. hospitals in the year 2009

(AHRQ 2011). One of the commonest complications of circumcision is excessive bleeding and rates as

high as 35% have been quoted in the literature (Mahomed et al 2009). Babies often present after several

hours of continued bleeding and blood transfusion may be necessary (Qazi et al 2010).

A survey conducted by Ragni et al (2011) of current prophylaxis practices and bleeding characteristics

of children with severe haemophilia A in U.S. haemophilia treatment centres [HTCs], found that among

226 newborns with severe haemophilia A in 62 HTCs, the median age at first bleed, excluding

circumcision, was 7 months and that of the 113 [53.5%] newborns who underwent circumcision, 62

[54.9%] bled. Haemophilia A occurs among approximately 1 out of every 6,250 male births (CDC

2011b). Most U.S. HTCs do not have an established protocol for management of circumcision in the

newborn haemophilia patient (Kearney et al 2014). Although lower than in the past, HBV infection

remains a risk among those with haemophilia A who rely on blood products to counteract the disease

(Steele et al 2009).

Thus, a higher proportion of boys are already at greater risk of acquiring transfusion-transmitted HBV

infection relative to girls, and circumcision worsens that disadvantage.

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