This is a response to the document "Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation" [regulations.gov Docket ID: CDC-2011-0011] ( http://www.regulations.gov/#!documentDetail;D=CDC-2011-0011-0001 ).
The deadline for submissions is 23 December 2011.
This submission can be made by anybody from any country around the world.
Download and save the document from the following link (Click 'Download Now', then click 'Slow download', Wait for the counter to reach zero and click 'Download file now'):
Go to the following regulations.gov submission page:
Enter your name in the appropriate fields (Optional). Click browse under '3. UPLOAD FILE(S)' to upload the saved document from your harddisk. Click 'Submit'.
In case anyone encounters problems with the above 4shared link, the full text of the submission is below, which you can copy and paste into the word processor or text editor of your choice, save to your harddisk and upload to regulations.gov:
Response to "Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation" [regulations.gov Docket ID: CDC-2011-0011]
Thank you for the opportunity to provide feedback to "Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation" [regulations.gov Docket ID: CDC-2011-0011]. This document shall briefly address the special danger posed to newly circumcised baby boys from acquiring transfusion-transmitted hepatitis B virus [HBV] infection, and consequences for both the future supply and demand for donated organs.
Transfusion-transmitted HBV infection and consequences for the future supply of healthy donated organs
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 2011b). Indviduals infected with transmission-transmitted HBV can latter become carriers of the virus in the general community (HHS 2011).
Controversy exists about the suitability of those who have been infected with HBV, to later become organ donors and the circumstances under which an organ donation from such individuals should be considered (ECRI 2010). The present recommendation from the Centers for Disease Control and Prevention [CDC] is that individuals who have ever tested positive for HBV not donate blood or organs (CDC 2009).
Circumcision and haemophilia A as special risk factors for acquiring transfusion-transmitted HBV infections and subsequent increased demand for donated organs
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). 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 4,000 male births (CDC 2011a). 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.
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, necessitating a liver transplant procedure at the end-stage of these respective diseases (Weisberg et al 2007).
Genital integrity [non-circumcision] is most likely to produce the highest state of health and well-being and is the preferred medical option for newborn boys (KNMG 2010, Van Howe 2004).
Public health officials should act to suspend the performance of medically-unnecessary non-therapeutic circumcision of boys.
Hospital administrators must respond to this threat to all children and especially circumcised boys by limiting circumcisions to those for which there is a clear and present immediate medical indication.
The CDC and Department of Health and Human Services can reduce the danger of transfusion-transmitted HBV to boys and subsequent reduced supply of, and increased demand for, donated organs by advising against circumcision of male minors in the absence of a clear and present immediate medical indication.
AHRQ (2011) Hospital Stays for Children, 2009. HCUP Statistical Brief #118 prepared by Yu, H. (RAND Corporation), Wier, L.M. (Thomson Reuters), and Elixhauser, A. (AHRQ) August 2011. Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb118.jsp
Bell, SJ & Nguyen, T (2009) The management of hepatitis B Aust Prescr 23 (4): 99–104 Full-text available at http://www.australianprescriber.com/magazine/32/4/99/104/
Candotti & Allain (2009) Transfusion-transmitted hepatitis B virus infection J Hepatol. 2009 Oct;51(4):798-809. Epub 2009 Jun 10 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19615780
CDC (2009) Hepatitis B FAQs for the Public Centers for Disease Control and Prevention Full-text available at http://www.cdc.gov/hepatitis/B/bFAQ.htm#overview
CDC (2011a) Hemophilia Facts Centers for Disease Control and Prevention Full-text available at http://www.cdc.gov/ncbddd/hemophilia/facts.html
CDC (2011b) National Vital Statistics System Birth Data Centers for Disease Control and Prevention Full-text available at http://www.cdc.gov/nchs/births.htm
ECRI (2010) Solid Organ Transplantation and the Probability of Transmitting HIV, HBV, or HCV: A Systematic Review to Support an Evidence-based Guideline ECRI Institute Full-text available at http://www.regulations.gov/#!documentDetail;D=CDC-2011-0011-0003
HHS (2011) COMBATING THE SILENT EPIDEMIC of VIRAL HEPATITIS Action Plan for the Prevention, Care & Treatment of Viral Hepatitis United States Department of Health & Human Services Full-text available at http://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf
KNMG (2010) Non-theraputic circumcision of male minors Royal Dutch Medical Association Full-text available at http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976
Mahomed A, Zaparackaite I, Adam S (2009) Improving outcome from Plastibell circumcisions in infants Int Braz J Urol. 2009 May-Jun;35(3):310-3; discussion 313-4 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19538766
Qazi A, Haider N, Crabbe D (2010) A simple technique to control bleeding after Plastibell circumcision Ann R Coll Surg Engl. 2010 Apr;92(3):261-2 Full-text available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080088/
Ragni MV, Fogarty PJ, Josephson NC, Neff AT, Raffini LJ, Kessler CM (2011) Survey of current prophylaxis practices and bleeding characteristics of children with severe haemophilia A in US haemophilia treatment centres Haemophilia. 2011 May 4. doi: 10.1111/j.1365-2516.2011.02554.x. [Epub ahead of print] Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21539695
Smith JF (2011) The professional imperative for obstetrician-gynecologists to discontinue newborn male circumcision Am J Perinatol. 2011 Feb;28(2):125-8. Epub 2010 Aug 10 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=20700861
Steele M, Cochrane A, Wakefield C, Stain AM, Ling S, Blanchette V, Gold R, Ford-Jones L (2009) Hepatitis A and B immunization for individuals with inherited bleeding disorders Haemophilia. 2009 Mar;15(2):437-47 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19335752
Van Howe RS (2004) A cost-utility analysis of neonatal circumcision Med Decis Making. 2004 Nov-Dec;24(6):584-601 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15534340
Weisberg IS, Brown RS Jr & Sigal SH (2007) Hepatitis B and end-stage liver disease Clin Liver Dis. 2007 Nov;11(4):893-916, ix Abstract availabe at http://www.ncbi.nlm.nih.gov/pubmed/17981234
It would be greatly appreciated if those who know the workings of Facebook and other social networking sites better than I do could re-post this "Call to Action", accompanied by whatever text you feel will achieve the highest uptake.
You can either copy and paste the original post, or link to this thread here at MDC:
The latter is also a good way of promoting MDC
Thank you, Ma Cactus.
The comment period has been extended by the CDC until 21 December 2011.
I'm not sure yet if I want to use the time to improve the response to CDC-2011-0011, or move onto other opportunities.
For the time being, the above 4shared link will remain active.
If anyone else would like to improve on this response and post a new call to action for CDC-2011-0011, they are welcome to it.