cdc-2014-0012-2446-libre

Upload: lhedaven

Post on 01-Jun-2018

215 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/9/2019 CDC-2014-0012-2446-libre

    1/12

    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

  • 8/9/2019 CDC-2014-0012-2446-libre

    2/12

  • 8/9/2019 CDC-2014-0012-2446-libre

    3/12

    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.

  • 8/9/2019 CDC-2014-0012-2446-libre

    4/12

  • 8/9/2019 CDC-2014-0012-2446-libre

    5/12

    Aluru L (2013) Siaya County seeks forced male cut law 2 October 2013 Standard Digital News

    http://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-

    male-cut-lawAccessed: 2013-12-15. Archived by WebCite athttp://www.webcitation.org/6LtnVPjiW

    Amnesty International (2013) Kenyas ICC trials Amnesty International website 16 September 2013Amnesty International website http://www.amnesty.org/en/news/kenya-s-icc-trials-2013-09-16

    Accessed: 2013-12-15. Archived by WebCite athttp://www.webcitation.org/6LtoCK3gQ

    Bell K (2014) HIV prevention: Making male circumcision the 'right' tool for the job Glob Public

    Health. 2014 Apr 10. [Epub ahead of print] Abstract available at

    http://www.ncbi.nlm.nih.gov/pubmed/24720343

    Boyle GJ, Hill G (2011) Sub-Saharan African randomised clinical trials into male circumcision and

    HIV transmission: methodological, ethical and legal concerns J Law Med. 2011 Dec;19(2):316-34

    Abstract available athttp://www.ncbi.nlm.nih.gov/pubmed/22320006

    Bronselaer GA, Schober JM, Meyer-Bahlburg HF, T'Sjoen G, Vlietinck R, Hoebeke PB (2013) Male

    circumcision decreases penile sensitivity as measured in a large cohort BJU Int. 2013 May;111(5):820-

    7. doi: 10.1111/j.1464-410X.2012.11761.x. Epub 2013 Feb 4 Abstract available at

    https://www.ncbi.nlm.nih.gov/pubmed/23374102

    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 (2011) Trends in In-Hospital Newborn Male Circumcision - United States 1999-2010 Prepared by

    Xinjian Zhang, PhD, Sanjyot Shinde, PhD, Peter H Kilmarx, MD, Robert T Chen, MD, Div of

    HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention;

    Shanna Cox, MSPH, Lee Warner, PhD, Div of Reproductive Health, National Center for Chronic

    Disease Prevention and Health Promotion; Maria Owings, PhD, Div of Healthcare Statistics, National

    Center for Health Statistics; Charbel El Bcheraoui, PhD, EIS Officer, CDC. Morbidity and Mortality

    Weekly Report (MMWR) Full-text available at

    http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_w

    http://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-lawhttp://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-lawhttp://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-lawhttp://www.webcitation.org/6LtnVPjiWhttp://www.webcitation.org/6LtnVPjiWhttp://www.webcitation.org/6LtnVPjiWhttp://www.amnesty.org/en/news/kenya-s-icc-trials-2013-09-16http://www.amnesty.org/en/news/kenya-s-icc-trials-2013-09-16http://www.webcitation.org/6LtoCK3gQhttp://www.webcitation.org/6LtoCK3gQhttp://www.webcitation.org/6LtoCK3gQhttp://www.ncbi.nlm.nih.gov/pubmed/24720343http://www.ncbi.nlm.nih.gov/pubmed/24720343http://www.ncbi.nlm.nih.gov/pubmed/22320006http://www.ncbi.nlm.nih.gov/pubmed/22320006http://www.ncbi.nlm.nih.gov/pubmed/22320006https://www.ncbi.nlm.nih.gov/pubmed/23374102https://www.ncbi.nlm.nih.gov/pubmed/23374102http://www.ncbi.nlm.nih.gov/pubmed/19615780http://www.ncbi.nlm.nih.gov/pubmed/19615780http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_whttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_whttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_whttp://www.ncbi.nlm.nih.gov/pubmed/19615780https://www.ncbi.nlm.nih.gov/pubmed/23374102http://www.ncbi.nlm.nih.gov/pubmed/22320006http://www.ncbi.nlm.nih.gov/pubmed/24720343http://www.webcitation.org/6LtoCK3gQhttp://www.amnesty.org/en/news/kenya-s-icc-trials-2013-09-16http://www.webcitation.org/6LtnVPjiWhttp://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-lawhttp://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-law
  • 8/9/2019 CDC-2014-0012-2446-libre

    6/12

  • 8/9/2019 CDC-2014-0012-2446-libre

    7/12

    FDA (2012) FDA's HSP/BIMO Initiative Accomplishments: Update May 2012 Food and Drug

    Administration Full-text available at

    http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm Accessed:

    2012-06-10. Archived by WebCite athttp://www.webcitation.org/68JLjWhEP

    Frisch M, Lindholm M, Grnbk M (2011) Male circumcision and sexual function in men and women:

    a survey-based, cross-sectional study in Denmark Int J Epidemiol. 2011 Oct;40(5):1367-81. Epub 2011

    Jun 14 Abstract available athttp://www.ncbi.nlm.nih.gov/pubmed/21672947

    Gonzalez L L (2012) Africa: Less Global Funds, More Problems allAfrica 10 May 2012 Full-text

    available athttp://allafrica.com/stories/201205110671.html

    Green LW, Travis JW, McAllister RG, Peterson KW, Vardanyan AN, Craig A (2010) Male circumcision

    and HIV prevention insufficient evidence and neglected external validity Am J Prev Med. 2010

    Nov;39(5):479-82 Abstract available athttp://www.ncbi.nlm.nih.gov/pubmed/20965388

    Haberland NA, Kelly CA, Mulenga DM, Hewett PC, Mensch BS (2014) Women's (Mis) Understanding

    of Male Circumcision: A Mixed Methods Study in Zambia AIDS Res Hum Retroviruses. 2014 Oct;30

    Suppl 1:A198-9. doi: 10.1089/aid.2014.5426c.abstract. Abstract available at

    http://online.liebertpub.com/doi/full/10.1089/aid.2014.5426c.abstract

    Handable, N (2013) Zambia: Women Should Encourage Their Partners allAfrica.com

    http://allafrica.com/stories/201211201412.html Accessed: 2013-12-16. Archived by WebCite at

    http://www.webcitation.org/6LvIDW2pt

    Hatyoka, B (2013) Sensitise subjects on male circumcision Times of Zambia 22 May 2013 Accessed:

    2013-12-15. Archived by WebCite athttp://www.webcitation.org/6LtlPFBWm

    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

    http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htmhttp://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htmhttp://www.webcitation.org/68JLjWhEPhttp://www.webcitation.org/68JLjWhEPhttp://www.webcitation.org/68JLjWhEPhttp://www.ncbi.nlm.nih.gov/pubmed/21672947http://www.ncbi.nlm.nih.gov/pubmed/21672947http://www.ncbi.nlm.nih.gov/pubmed/21672947http://allafrica.com/stories/201205110671.htmlhttp://allafrica.com/stories/201205110671.htmlhttp://allafrica.com/stories/201205110671.htmlhttp://www.ncbi.nlm.nih.gov/pubmed/20965388http://www.ncbi.nlm.nih.gov/pubmed/20965388http://www.ncbi.nlm.nih.gov/pubmed/20965388http://online.liebertpub.com/doi/full/10.1089/aid.2014.5426c.abstracthttp://online.liebertpub.com/doi/full/10.1089/aid.2014.5426c.abstracthttp://allafrica.com/stories/201211201412.htmlhttp://allafrica.com/stories/201211201412.htmlhttp://www.webcitation.org/6LvIDW2pthttp://www.webcitation.org/6LvIDW2pthttp://www.webcitation.org/6LtlPFBWmhttp://www.webcitation.org/6LtlPFBWmhttp://www.webcitation.org/6LtlPFBWmhttp://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdfhttp://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdfhttp://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdfhttp://www.webcitation.org/6LtlPFBWmhttp://www.webcitation.org/6LvIDW2pthttp://allafrica.com/stories/201211201412.htmlhttp://online.liebertpub.com/doi/full/10.1089/aid.2014.5426c.abstracthttp://www.ncbi.nlm.nih.gov/pubmed/20965388http://allafrica.com/stories/201205110671.htmlhttp://www.ncbi.nlm.nih.gov/pubmed/21672947http://www.webcitation.org/68JLjWhEPhttp://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm
  • 8/9/2019 CDC-2014-0012-2446-libre

    8/12

    Kearney S, Sharathkumar A, Rodriguez V, Chitlur M, Valentino L, Boggio L, Gill J (2014) Neonatal

    circumcision in severe haemophilia: a survey of paediatric haematologists at United States Hemophilia

    Treatment Centers Haemophilia. 2014 Dec 4. doi: 10.1111/hae.12528. [Epub ahead of print] Abstract

    available athttp://www.ncbi.nlm.nih.gov/pubmed/25472876

    Kenyon CR, Osbak K, Buyze J (2014) The Prevalence of HIV by Ethnic Group Is Correlated with

    HSV-2 and Syphilis Prevalence in Kenya, South Africa, the United Kingdom, and the United States

    Interdiscip Perspect Infect Dis. 2014;2014:284317. doi: 10.1155/2014/284317. Epub 2014 Sep 24.

    Full-text available athttp://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25328516/

    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

    Laiton, C (2014) 4 nurses steal drugs, operate private clinic NewsDay 11 October 2014

    https://www.newsday.co.zw/2014/10/11/4-nurses-steal-drugs-operate-private-clinic/ Accessed 13

    January 2015

    Langa, V (2012) 175 MPs to be circumcised NewsDay 18 May 2012

    http://www.newsday.co.zw/article/2012-05-18-175-mps-to-be-circumcised/ Accessed: 2012-06-17.

    Archived by WebCite at http://www.webcitation.org/68Tqz9L2u

    Layoo, R (2013) Former inmates decry forced circumcision Daily Monitor

    http://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-

    /688334/2110502/-/1wm3ydz/-/index.html Accessed: 2013-12-16. Archived by WebCite at

    http://www.webcitation.org/6Ltvm2Hi9

    Llewellyn, E (2012) Infant Circumcision: A Tipping Point for HIV Prevention USAID Frontlines

    May/June 2012 Full-text available at

    http://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.html Accessed:

    2012-06-17. Archived by WebCite athttp://www.webcitation.org/68U9lv9vt

    http://www.ncbi.nlm.nih.gov/pubmed/25472876http://www.ncbi.nlm.nih.gov/pubmed/25472876http://www.ncbi.nlm.nih.gov/pubmed/25472876http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25328516/http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25328516/http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25328516/http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976https://www.newsday.co.zw/2014/10/11/4-nurses-steal-drugs-operate-private-clinic/https://www.newsday.co.zw/2014/10/11/4-nurses-steal-drugs-operate-private-clinic/http://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.htmlhttp://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.htmlhttp://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.htmlhttp://www.webcitation.org/6Ltvm2Hi9http://www.webcitation.org/6Ltvm2Hi9http://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.htmlhttp://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.htmlhttp://www.webcitation.org/68U9lv9vthttp://www.webcitation.org/68U9lv9vthttp://www.webcitation.org/68U9lv9vthttp://www.webcitation.org/68U9lv9vthttp://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.htmlhttp://www.webcitation.org/6Ltvm2Hi9http://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.htmlhttp://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.htmlhttps://www.newsday.co.zw/2014/10/11/4-nurses-steal-drugs-operate-private-clinic/http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25328516/http://www.ncbi.nlm.nih.gov/pubmed/25472876
  • 8/9/2019 CDC-2014-0012-2446-libre

    9/12

  • 8/9/2019 CDC-2014-0012-2446-libre

    10/12

    OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the

    Changes Being Considered Office of Human Research Protections website Full-text available at

    http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Accessed: 2012-01-16. Archived by

    WebCite athttp://www.webcitation.org/64jh4cWek

    OIG (2011a) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    HHSN266-2006-00015C With NexBio, Inc. (A-03-10-03119) Health and Human Services Office of

    Inspector General website 21 September 2011 Full-text available at

    http://oig.hhs.gov/oas/reports/region3/31003119.pdf

    OIG (2011b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    HHSN272-2008-00013C with the EMMES Corporation (A-03-10-03115) Health and Human Services

    Office of Inspector General website 31 October 2011 Full-text available at

    http://oig.hhs.gov/oas/reports/region3/31003115.pdf

    OIG (2011c) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    N01-AI-15416 With the University of California at San Francisco Audit (A-03-10-03120) on the

    Health and Human Services Office of Inspector General website 10 July 2011 Available at

    http://oig.hhs.gov/oas/reports/region3/31003120.pdf

    OIG (2011d) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    N01-AI-3-0052 With Avecia Biologics Limited (A-03-10-03117) Health and Human Services Office of

    Inspector General website 21 September 2011 Full-text available at

    http://oig.hhs.gov/oas/reports/region3/31003117.pdf

    OIG (2012a) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    HHSN266-2005-00022C With PPD Development, LP (Audit A-03-10-03118) Health and Human

    Services Office of Inspector General website 14 September 2012 Full-text available at

    https://oig.hhs.gov/oas/reports/region3/31003118.pdf

    http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.htmlhttp://www.hhs.gov/ohrp/humansubjects/anprmchangetable.htmlhttp://www.webcitation.org/64jh4cWekhttp://www.webcitation.org/64jh4cWekhttp://www.webcitation.org/64jh4cWekhttp://oig.hhs.gov/oas/reports/region3/31003119.pdfhttp://oig.hhs.gov/oas/reports/region3/31003119.pdfhttp://oig.hhs.gov/oas/reports/region3/31003115.pdfhttp://oig.hhs.gov/oas/reports/region3/31003115.pdfhttp://oig.hhs.gov/oas/reports/region3/31003120.pdfhttp://oig.hhs.gov/oas/reports/region3/31003120.pdfhttp://oig.hhs.gov/oas/reports/region3/31003117.pdfhttp://oig.hhs.gov/oas/reports/region3/31003117.pdfhttps://oig.hhs.gov/oas/reports/region3/31003118.pdfhttps://oig.hhs.gov/oas/reports/region3/31003118.pdfhttps://oig.hhs.gov/oas/reports/region3/31003118.pdfhttp://oig.hhs.gov/oas/reports/region3/31003117.pdfhttp://oig.hhs.gov/oas/reports/region3/31003120.pdfhttp://oig.hhs.gov/oas/reports/region3/31003115.pdfhttp://oig.hhs.gov/oas/reports/region3/31003119.pdfhttp://www.webcitation.org/64jh4cWekhttp://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html
  • 8/9/2019 CDC-2014-0012-2446-libre

    11/12

    OIG (2012b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract

    N01-AI-30068 With PPD Development, LP (Audit A-03-10-03116) Health and Human Services Office

    of Inspector General website 14 September 2012 Full-text available at

    https://oig.hhs.gov/oas/reports/region3/31003116.pdf

    OIG (2013a) Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing

    Some Issues (Report OEI-12-11-00070) Health and Human Services Office of Inspector General

    website 28 June 2013 Full-text available athttps://oig.hhs.gov/oei/reports/oei-12-11-00070.pdf

    Okwii, E (2013) Mbale Residents Flee Forceful Circumcision Uganda Picks 24 June 2013

    http://www.ugandapicks.com/2013/06/mbale-residents-flee-forceful-circumcision-16457.html

    Accessed: 2013-06-26. Archived by WebCite athttp://www.webcitation.org/6HgAOPB1e

    Onyango, H (2012) Kenya: The Cut for Boys to Tame HIV allAfrica

    http://allafrica.com/stories/201205111262.html 10 May 2012 Accessed: 2012-06-17. Archived by

    WebCite athttp://www.webcitation.org/68TrTJpmb

    Otieno, S (2013) Met to get cash, food prizes for circumcision The Star 22 July 2013http://www.the-

    star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcision Accessed: 2013-07-25. Archived

    by WebCite athttp://www.webcitation.org/6IMrKH0CD

    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 athttp://www.ncbi.nlm.nih.gov/pubmed/21539695

    https://oig.hhs.gov/oas/reports/region3/31003116.pdfhttps://oig.hhs.gov/oas/reports/region3/31003116.pdfhttps://oig.hhs.gov/oei/reports/oei-12-11-00070.pdfhttps://oig.hhs.gov/oei/reports/oei-12-11-00070.pdfhttps://oig.hhs.gov/oei/reports/oei-12-11-00070.pdfhttp://www.ugandapicks.com/2013/06/mbale-residents-flee-forceful-circumcision-16457.htmlhttp://www.ugandapicks.com/2013/06/mbale-residents-flee-forceful-circumcision-16457.htmlhttp://www.webcitation.org/6HgAOPB1ehttp://www.webcitation.org/6HgAOPB1ehttp://www.webcitation.org/6HgAOPB1ehttp://allafrica.com/stories/201205111262.htmlhttp://allafrica.com/stories/201205111262.htmlhttp://www.webcitation.org/68TrTJpmbhttp://www.webcitation.org/68TrTJpmbhttp://www.webcitation.org/68TrTJpmbhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.webcitation.org/6IMrKH0CDhttp://www.webcitation.org/6IMrKH0CDhttp://www.webcitation.org/6IMrKH0CDhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080088/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080088/http://www.ncbi.nlm.nih.gov/pubmed/21539695http://www.ncbi.nlm.nih.gov/pubmed/21539695http://www.ncbi.nlm.nih.gov/pubmed/21539695http://www.ncbi.nlm.nih.gov/pubmed/21539695http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080088/http://www.webcitation.org/6IMrKH0CDhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcisionhttp://www.webcitation.org/68TrTJpmbhttp://allafrica.com/stories/201205111262.htmlhttp://www.webcitation.org/6HgAOPB1ehttp://www.ugandapicks.com/2013/06/mbale-residents-flee-forceful-circumcision-16457.htmlhttps://oig.hhs.gov/oei/reports/oei-12-11-00070.pdfhttps://oig.hhs.gov/oas/reports/region3/31003116.pdf
  • 8/9/2019 CDC-2014-0012-2446-libre

    12/12

    Richardson ET, Collins SE, Kung T, Jones JH, Hoan Tram K, Boggiano VL, Bekker LG, Zolopa AR

    (2014) Gender inequality and HIV transmission: a global analysis J Int AIDS Soc. 2014 Jun

    27;17(1):19035. doi: 10.7448/IAS.17.1.19035. eCollection 2014. Full-text available at

    http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24976436/

    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

    Sorrells ML, Snyder JL, Reiss MD, Eden C, Milos MF, Wilcox N, Van Howe RS (2007) Fine-touch

    pressure thresholds in the adult penis BJU Int. 2007 Apr;99(4):864-9 Abstract available at

    http://www.ncbi.nlm.nih.gov/pubmed/17378847

    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 athttp://www.ncbi.nlm.nih.gov/pubmed/19335752

    Svoboda JS, Van Howe RS (2013) Out of step: fatal flaws in the latest AAP policy report on neonatal

    circumcision J Med Ethics. 2013 Mar 18. [Epub ahead of print] Abstract available at

    http://www.ncbi.nlm.nih.gov/pubmed/23508208

    Taylor JR1, Lockwood AP, Taylor AJ (1996) The prepuce: Specialized mucosa of the penis and its loss

    to circumcision Journal of Urology (1996), 77, 291-295 Abstract available at

    http://www.ncbi.nlm.nih.gov/pubmed/8800902

    Towindo, L (2012) Were we fooled? The Sunday Mail 13 July 2012 Full-text available at

    http://www.sundaymail.co.zw/index.php?option=com_content&view=article&id=29913 Accessed:

    2013-12-16. Archived by WebCite athttp://www.webcitation.org/6LtwhZhpQ

    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 athttp://www.ncbi.nlm.nih.gov/pubmed/17981234

    http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24976436/http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24976436/http://www.ncbi.nlm.nih.gov/pubmed?term=20700861http://www.ncbi.nlm.nih.gov/pubmed?term=20700861http://www.ncbi.nlm.nih.gov/pubmed/17378847http://www.ncbi.nlm.nih.gov/pubmed/17378847http://www.ncbi.nlm.nih.gov/pubmed/19335752http://www.ncbi.nlm.nih.gov/pubmed/19335752http://www.ncbi.nlm.nih.gov/pubmed/19335752http://www.ncbi.nlm.nih.gov/pubmed/23508208http://www.ncbi.nlm.nih.gov/pubmed/23508208http://www.ncbi.nlm.nih.gov/pubmed/8800902http://www.ncbi.nlm.nih.gov/pubmed/8800902http://www.sundaymail.co.zw/index.php?option=com_content&view=article&id=29913http://www.sundaymail.co.zw/index.php?option=com_content&view=article&id=29913http://www.webcitation.org/6LtwhZhpQhttp://www.webcitation.org/6LtwhZhpQhttp://www.webcitation.org/6LtwhZhpQhttp://www.ncbi.nlm.nih.gov/pubmed/17981234http://www.ncbi.nlm.nih.gov/pubmed/17981234http://www.ncbi.nlm.nih.gov/pubmed/17981234http://www.ncbi.nlm.nih.gov/pubmed/17981234http://www.webcitation.org/6LtwhZhpQhttp://www.sundaymail.co.zw/index.php?option=com_content&view=article&id=29913http://www.ncbi.nlm.nih.gov/pubmed/8800902http://www.ncbi.nlm.nih.gov/pubmed/23508208http://www.ncbi.nlm.nih.gov/pubmed/19335752http://www.ncbi.nlm.nih.gov/pubmed/17378847http://www.ncbi.nlm.nih.gov/pubmed?term=20700861http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24976436/