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 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]. 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

grown in the years since (Bronselaer et al 2013; Frisch et al 2011; Sorrells et al 2007). In the years
following publication of the African circumcision trials, regulatory agencies under the aegis of the
Department of Health and Human Services have moved to strengthen protections afforded human
research subjects and to increase the rigor with which trials conducted abroad are assessed as a basis
for seeking approval of new drugs and medical devices in the U.S. market (FDA 2012; OHRP 2011),
although concerns continue to be raised about the capability of National Institutes of Health [NIH] Data
and Safety Monitoring Boards to ensure the safety of study subjects and validity and integrity of the
data for clinical trials (OIG 2013a).

Despite the concerns identified above, the results of the African circumcision trials continue to be used
to justify the en masse circumcision of men in Africa using PEPFAR funds and to justify the
circumcision of boys and male infants - both in the United States and abroad - in the absence of clear
and present immediate medical indications, and in the latter instance, with the tacit endorsement of
U.S. government agencies in receipt of PEPFAR program funding (CDC 2011; Llewellyn 2012). In the
wake of publication of the African circumcision trials, human rights organisations and local media in
the African region have reported coercion of men and boys to be circumcised (AFP 2012; Ahlberg &
Njoroge 2013; Aluru 2013; Amnesty International 2013; Chibaya 2013a; Chibaya 2013b; Chirombo
2013; Dube 2012; Echwala 2013; Handable 2013; Hatyoka 2013; Langa 2012; Layoo 2013; MaughanBrown 2014; Mbanje 2013; Mhlanga 2012; News24 2013; Ngwega 2012; Okwii 2013; Onyango 2012;
Otieno 2013; Towindo 2012) and misdirection of limited medical resources from other priority areas to
male circumcision (AHN 2012; Gonzalez 2012; Laiton 2014). In the U.S., the results of the African
circumcision trials have been cited in calls for the private insurance and state Medicaid programs to
subsidise the circumcision of male minors in the absence of a clear and present immediate indication
(Svoboda et al 2013).

Special danger posed to newly circumcised baby boys by excessive bleeding, undiagnosed
haemophilia and transfusion-transmitted hepatitis B virus [HBV] infection

HBV remains a major risk of transfusion-transmitted infection due to the pre-seroconversion window
period, infection with immunovariant viruses, and with occult carriage of HBV infection (Candotti &
Allain 2009). Recipients of blood transfusions in the U.S continue to be at risk for HBV infection as a
result of breakdowns in basic infection control and limitations in the laboratory screening of donated
blood (HHS 2011). Blood transfusions were the fifth most common procedure received by children and

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 the
HBV 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.

Conclusion

These draft recommendations are informed disproportionately by research conducted abroad that would
be unlikely to receive ethical approval to be conducted in the United States, the methodology,
conclusions, ethics, legality and real-world applicability of which have been questioned in the
professional medical literature. 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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