This is a response to the document "Proposals, Submissions, and Approvals: PEPFAR Program Expenditures" [Form Number: DS-4213, OMB Control Number: 1405-0208].

Due to a past lack of oversight by the CDC, the State Department is proposing to require recipients of PEPFAR funds to account for expenditures by program area. This response is in agreement with this requirement, also highlighting the lack of oversight and free-spending culture of the NIH at the time of sponsoring the circumcision trials in Africa, the adverse affects of funding circumcision in Africa (coercion of men and boys to be circumcised, misdirection of scarce medical resources from higher priority health areas), and continuing problems within the CDC raising questions about the capability of the organisation to oversee the activities of grantees inrecipients of federal funds.

The deadline for submissions is 23 December 2013.

This submission can be made by anybody from any country around the world.

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Response to “PEPFAR Program Expenditures” [Form Number: DS-4213, OMB Control Number: 1405-0208]

Thank you for the opportunity to provide feedback to “PEPFAR Program Expenditures” [Form Number: DS-4213, OMB Control Number: 1405-0208]. This response document will briefly address concerns about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; concerns about adverse consequences of PEPFAR program areas; and concerns about the absence of oversight of the activities of PEPFAR funding recipients.

Ethical, Legal and Methodological Flaws with Past Research informing present PEPFAR Program Areas

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 Infections 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 and legality of which have been questioned in the professional medical literature (Boyle & Hill 2011; Green et al 2010). 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).

Adverse Consequences of PEPFAR Program Funding Areas

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 PEPFAR funding for mass circumcision programs in Africa, human rights organisations and local media in the 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; 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; ZimEye 2013).

Absence of Oversight

On the 15 June 2011, the OIG published a report critical of the Centers for Disease Control and Prevention's [CDC's] failure to oversee recipientss use of PEPFAR funds, concluding that the “lack of required documentation demonstrates that CDC has not exercised proper stewardship over Federal PEPFAR funds because it did not consistently follow departmental and other Federal requirements in monitoring PEPFAR recipients” (OIG 2011e). Further investigations by the OIG have also revealed specific failures of the CDC to monitor recipients use of PEPFAR funds in Namibia (OIG 2013c; OIG 2013d) and South Africa (OIG 2013b; OIG 2013e; OIG 2013f; OIG 2013g). In 2013, the OIG also published a report critical of the CDC's failure to oversee use of PEPFAR funds by the Vietnam Administration for HIV/AIDS Control (OIG 2013h), suggesting the possibility that more systemic problems may exist within the CDC, impacting the agency's ability to effectively oversee the activities of grantees in receipt of federal funds, and that this is not specific to difficulty with oversight of grantees in the African region.

Conclusion

Valid concerns exist about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; adverse consequences of PEPFAR program areas; and the absence of oversight of the activities of PEPFAR funding recipients. It is therefore imperative that full and complete disclosure and oversight in the proposed information collection activity take precedence over the CDC's and PEPFAR funding recipients' professed concerns for increased regulatory and administrative 'burden'.

References

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Ahlberg BM, Njoroge KM (2013) 'Not men enough to rule!': politicization of ethnicities and forcible circumcision of Luo men during the postelection violence in Kenya Ethn Health. 2013 Oct;18(5):454-68. doi: 10.1080/13557858.2013.772326. Epub 2013 Jun 11 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23758644

AHN (2012) HIV services in western refugee camps overwhelmed Gant Daily 29 March 2012 http://gantdaily.com/2012/03/29/hiv-services-in-western-refugee-camps-overwhelmed/

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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

Chibaya, M (2013a) Resistance hinders circumcision programme The Standard Full-text available at http://www.thestandard.co.zw/2013/05/19/resistance-hinders-circumcision-programme/ Archived by WebCite at http://www.webcitation.org/6Ltky3cRF

Chibaya, M (2013b) Winky D tackles circumcision controversy New Zimbabwe 21 October 2013 Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6LtoaHGyi

Chirombo, S (2013) Malawi: Kasungu Registers Low Turnout for Male Circumcision allAfrica.com 5 July 2013 Accessed: 2013-07-08. Archived by WebCite at http://www.webcitation.org/6HxNQ2VYn

Dube, C (2012) F/town adult males spurn circumcision The Monitor 21 May 2012 http://www.mmegi.bw/index.php?sid=1&aid=370&dir=2012/May/Monday21 Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68TqWHbxL

Echwala, E (2013) Zimbabwe's circumcision drive fails to take off IRIN News 9 July 2013 http://www.irinnews.org/report/98379/zimbabwe-s-circumcision-drive-fails-to-take-off Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6Ltn5kJBC

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 at http://www.webcitation.org/68JLjWhEP

Gonzalez L L (2012) Africa: Less Global Funds, More Problems allAfrica 10 May 2012 Full-text available at http://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 at http://www.ncbi.nlm.nih.gov/pubmed/20965388

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 at http://www.webcitation.org/6LtlPFBWm

Langa, V (2012) 175 MPs to be circumcised News Day 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 at http://www.webcitation.org/68U9lv9vt

Mbanje, P (2013) Zimbabwe government takes circumcision into the classroom The Standard http://www.thestandard.co.zw/2013/12/08/zimbabwe-government-takes-circumcision-classroom/ Accessed: 2013-12-16. Archived by WebCite at http://www.webcitation.org/6LtvSfy7N

Mhlanga, P (2012) Govt sharpens knives for forced circumcision NewsDay 1 December 2012 Full-text available at http://www.newsday.co.zw/2012/12/01/govt-sharpens-knives-for-forced-circumcision/

News24 (2013) Minister urges MPs to get circumcised News24 website http://www.news24.com/SouthAfrica/Politics/Minister-urges-MPs-to-get-circumcised-20131022 Archived by WebCite at http://www.webcitation.org/6Ltunawpb

NIH (2008) Male Circumcision and HIV Rates in Kenya ClinicalTrials.gov website 28 May 2008 Full-text available at http://www.clinicaltrials.gov/ct2/show/NCT00059371

NIH (2007) Male Circumcision for HIV Prevention in Rakai, Uganda ClinicalTrials.gov website 23 August 2007 Full-text available at http://www.clinicaltrials.gov/ct2/show/NCT00425984

Ngwega, N (2012) Tanzania: Handeni Promotes Male Circumcision to Curb HIV Spread allAfrica.com 11 February 2012 Full-text available at http://allafrica.com/stories/201302110873.html

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 at http://www.webcitation.org/64jh4cWek

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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 (2011e) Review of the Centers for Disease Control and Prevention’s Oversight of the President’s Emergency Plan for AIDS Relief Funds for Fiscal Years 2007 Through 2009 (A-04-10-04006) Health and Human Services Office of Inspector General website 15 June 2011 Full-text available at http://oig.hhs.gov/oas/reports/region4/41004006.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

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 at https://oig.hhs.gov/oei/reports/oei-12-11-00070.pdf

OIG (2013c) The Centers for Disease Control and Prevention's Namibia Office Did Not Always Properly Monitor Recipients' Use of the President's Emergency Plan for AIDS Relief Funds Audit (A-04-12-04020) Health and Human Services Office of Inspector General website 19 November 2012 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204020.pdf

OIG (2013d) The Republic of Namibia, Ministry of Health and Social Services, Did Not Always Manage the President’s Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-04-12-04019) Health and Human Services Office of Inspector General website 19 November 2012 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204019.pdf

OIG (2013b) The Centers for Disease Control and Prevention's South Africa Office Did Not Always Properly Monitor Recipients' Use of the President's Emergency Plan for AIDS Relief Funds (Audit A-04-12-04022) Health and Human Services Office of Inspector General website 12 February 2013 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204022.pdf

OIG (2013e) National Health Laboratory Service Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00024) Health and Human Services Office of Inspector General website 15 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200024.pdf

OIG (2013f) The South African National Department of Health Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00022) Health and Human Services Office of Inspector General website 23 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200022.pdf

OIG (2013g) Aurum Institute for Health Research Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00021) Health and Human Services Office of Inspector General website 23 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200021.pdf

OIG (2013h) The Vietnam Administration for HIV/AIDS Control Did Not Always Manage the President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-06-11-00057) Health and Human Services Office of Inspector General website 10 June 2013 Full-text available at http://oig.hhs.gov/oas/reports/region6/61100057.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 at http://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 at http://www.webcitation.org/68TrTJpmb

Otieno, S (2013) Met to get cash, food prizes for circumcision The Star 22 July 2013 http://www.the-star.co.ke/news/article-129000/met-get-cash-food-prizes-circumcision Accessed: 2013-07-25. Archived by WebCite at http://www.webcitation.org/6IMrKH0CD

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 at http://www.webcitation.org/6LtwhZhpQ

ZimEye (2013) Zimbabwe Buys Into Controversial Israeli Style Circumcision ZimEye website http://www.zimeye.org/zimbabwe-buys-into-controversial-israeli-style-of-circumcision/ Accessed: 2013-12-16. Archived by WebCite at http://www.webcitation.org/6LvHdFdC2