cdc-2014-0012-2446-libre
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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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