PEPFAR

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PEPFAR

The President's Emergency Plan For AIDS Relief (PEPFAR) is a United States governmental initiative to address the global HIV epidemic and help save the lives of those suffering from the disease. Launched by U.S. President George W. Bush in 2003 on the advice of Anthony Fauci, PEPFAR has provided more than $85 billion in cumulative funding for HIV/AIDS treatment, prevention, and research since its inception, making it the largest global health program focused on a single disease in history.

PEPFAR has begun providing money (United States tax dollars) for male circumcision programs.[1] Focus countries have been invited to request program funding to increase access to the procedure.

PEPFAR ignominiously ended the provision of non-therapeutic circumcision of boys under age 15 in November 2019 due to significant, complications, injuries, and other abuses.

Reimagining PEPFAR's Strategic Direction

This document, Reimagining PEPFAR's Strategic Direction, published in September 2022, provides new directions for PEPFAR's fight against the HIV pandemic. The document is entirely silent on male and female circumcision, although male circumcision was the cornerstone of the previous effort to prevent HIV infection and PEPFAR formerly proudly trumpeted the 27,700,000+ circumcisions (AKA genital mutilations) in Africa that it had sponsored. It is unclear if PEPFAR will continue to promote circumcision, which has been demonstrated to be ineffective.[2]

Swaziland

PEPFAR is helping fund the "Accelerated Saturation Initiative", a program to circumcise 80% of the men ages 18 to 49 within the year 2011.[3] Additionally, it is working with the Swaziland Ministry of Health to introduce and scale up neonatal circumcision.[4]

Point of Interest: In recent studies, HIV transmission was found to be more prevalent in circumcised males in Swaziland. The drive to circumcise the majority of Swazi men continues none the less.[5]

From the PEPFAR Swaziland Operational Plan Report FY 2011 (emphasis added):[6]

“ 4. Women and girl-centered Approach: ...Neonatal circumcision counseling for women who give birth to baby boys will be included in the nationwide campaign.

From the PEPFAR Blueprint: Creating an AIDS-free Generation (emphasis added):[7]

“ Action Step: Increase the number of males who are circumcised for the prevention of HIV.... 10. Build the capacity of partner governments to begin planning for and financing an integrated, long-term early infant male circumcision (EIMC) program as the adult V[oluntary ]M[edical ]M[ale ]C[ircumcision] program is being scaled-up. PEPFAR’s financial support is prioritized to the adult VMMC program. However, once the adult program has progressed sufficiently, PEPFAR funds may be used to support EIMC activities.

PEPFAR announced in November 2019 that it would no longer support circumcision of boys who have not reached their 15th birthday.[8]

PEPFAR's African Safaris

From a blog.AIDS.gov entry by Jeffrey S. Crowley, M.P.H.[a 1], Director, Office of National AIDS Policy dated 26 May 2011:[9]

“ Last week, I wrote about my attendance at the PEPFAR annual meeting in South Africa, the country that has more people living with HIV (over 5 million) than any other country in the world. After this meeting, I visited the neighboring country of Swaziland, which has the unwelcome distinction of having the highest HIV and TB prevalence rates in the world.

...

The United States Ambassador to Swaziland, the Honorable Earl Irving, was an incredible host. I attended a large reception at the Ambassador’s residence with the Honorable Minister of Health, Benedict Xaba and other Swazi leaders working on HIV, as well as representatives from PEPFAR, Peace Corps, CDC, USAID, DoD, and private American institutions, including Columbia University’s International Center for AIDS Care and Treatment Programs (ICAP) project. Another evening, the Ambassador hosted a dinner with leaders from the Swazi Cabinet, the Ministry of Health and the national AIDS commission. I participated in a handover ceremony where the Ambassador ceremoniously transferred nine vehicles from PEPFAR to the government of Swaziland that will support their HIV work in the field. Through this event I also had the opportunity to meet His Excellency the Right Honorable Prime Minister of Swaziland.

A major focus of PEPFAR’s work is to assist the Swazi government’s plan to scale up adult male circumcision. This lowers the risk that men will acquire HIV infection and research models indicate that if the country can get up to 80% of its adult men circumcised, they could observe a substantial decline in HIV transmission. I visited one of several mobile sites that enabled Swaziland and PEPFAR to quickly expand access to circumcision.

RCTs shown to be erroneous

Boyle & Hill (2011) established conclusively that the randomized controlled trials had disabling methodological and statistical flaws that invalidated their findings,[10] therefore the PEPFAR VMMC program is based on false information. Van Howe & Storms (2011) correctly forecast that institution of a circumcision program would increase the number of HIV infections.[11] Van Howe & Boyle (2018) added further critical comment and suggested the possibility of fraud.[12]

PEPFAR, however, paid no attention to these warnings and continued to promote the harmful VMMC program.

Investigations by the Office of Inspector General (OIG)

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 recipients’ use of PEPFAR funds.[13] The report read in part:

“ Our review found that CDC did not always monitor recipients’ use of President’s Emergency Plan for AIDS Relief (PEPFAR) funds in accordance with departmental and other Federal requirements. CDC implements PEPFAR, working with ministries of health and other public health partners to combat HIV/AIDS by strengthening health systems and building sustainable HIV/AIDS programs in more than 75 countries in Africa, Asia, Central and South America, and the Caribbean. HHS receives PEPFAR funds from the Department of State through a memorandum of agreement. There was evidence that CDC performed some monitoring of recipients’ use of PEPFAR funds. However, most of the award files did not include all required documents or evidence to demonstrate that CDC performed required monitoring on all cooperative agreements. Of the 30 cooperative agreements in our sample, the award file for only 1 agreement contained all required documents. The remaining 29 award files were incomplete. In addition, 14 of 21 files were missing audit reports. (A report was not yet due for 9 of the 30 cooperative agreements.) 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.

On the 19 November 2012, the OIG published a report critical of the CDC Namibia Office's failure to properly monitor recipients' use of PEPFAR funds [14]. The report read in part:

“ CDC's office in Windhoek, Namibia (CDC Namibia), is responsible for PEPFAR funds awarded to government agencies and for-profit and nonprofit organizations (recipients) in Namibia. Our audit found that CDC Namibia did not always monitor recipients' use of PEPFAR funds in accordance with HHS and other Federal requirements. There was evidence that CDC Namibia performed some monitoring of recipients' use of PEPFAR funds. However, most of the recipient cooperative agreement files did not include required documents or evidence that CDC Namibia had monitored all cooperative agreements. CDC Namibia did not consistently monitor the cooperative agreements in accordance with HHS and other Federal requirements because it did not have written policies and procedures for the monitoring process. As a result, CDC Namibia did not have assurance that PEPFAR funds were used as intended by law.

On the 4 February 2013, the OIG published a report critical of Namibia's Ministry of Health and Social Services failure to manage PEPFAR funds and meet program goals in accordance with award requirements [15]. The report read in part:

“ Through its Global HIV/AIDS Program, CDC implemented the President's Emergency Plan for AIDS Relief (PEPFAR), working with ministries of health and other in-country partners to combat HIV/AIDS by strengthening health systems and building sustainable HIV/AIDS programs in more than 75 countries. Through a 5-year cooperative agreement, CDC awarded PEPFAR funds totaling $20.6 million to the Republic of Namibia, Ministry of Health and Social Services (the Ministry) for the budget period September 30, 2009, through September 29, 2010.

Our audit found that the Ministry did not always manage PEPFAR funds or meet program goals in accordance with award requirements. With respect to financial management, specifically financial transaction testing, we found that $3.7 million of the $4 million reviewed was allowable, but $243,000 was not. Additionally, the Ministry used PEPFAR funds to pay $565,000 of potentially unallowable value-added taxes (VAT) on purchases, did not accurately report PEPFAR expenditures for this cooperative agreement on its financial status report (FSR) submitted to CDC, and did not obtain an annual financial audit as required by Federal regulations.

Our program management review showed that 12 of the 30 accomplishments sampled from the annual progress report were not related to the goals and objectives of the cooperative agreement. Seven accomplishments were not supported by documentation and six were only partially supported. Also, the Ministry did not submit its annual progress report to CDC within the allotted time frame in accordance with Federal regulations.

The Ministry’s policies and procedures did not ensure that it:

(1) Maintained adequate supporting documentation for allowable expenditures under the cooperative agreement and accurately reported costs on its FSR,

(2) Submitted its progress report timely and included only items related to the agreement that it could fully support, and

(3) Obtained an annual financial audit and submitted the report as required by Federal regulations.

On the 12 February 2013, the OIG published a report critical of the CDC South Africa Office's failure to properly monitor recipients' use of PEPFAR funds [16]. The report read in part:

“ Our audit found that CDC South Africa did not always monitor recipients' use of PEPFAR funds in accordance with HHS and other Federal requirements. There was evidence that CDC South Africa performed some monitoring of recipients' use of PEPFAR funds. However, most of the recipient cooperative agreement files did not include required documents or evidence that CDC South Africa had monitored all cooperative agreements. CDC South Africa did not have written policies and procedures to help ensure that it consistently monitored the cooperative agreements for recipients in accordance with HHS and other Federal requirements. As a result, CDC South Africa did not have assurance that PEPFAR funds were used as intended by law.

More revelations to come

From "Spotlight on... Grants Management and Oversight" published by the OIG on 4 February 2013:[17]

“ President's Emergency Plan for AIDS Relief Funds
The President's Emergency Plan for AIDS Relief (PEPFAR) program authorized $78 billion from 2003 through 2014 in support of international programs for prevention, treatment, and care to combat HIV/AIDS, tuberculosis, and malaria. OIG examined the funds spent through this program in a 2011 report focusing on whether the Centers for Disease Control and Prevention's (CDC) oversight met departmental and Federal regulations. OIG found that while CDC performed some oversight of recipients' fund use, most of the award files did not include all required documents or evidence to demonstrate that CDC performed required monitoring. Because of these concerns, OIG expanded its audits internationally to include CDC's monitoring of PEPFAR funds by offices in other countries as well as audits of recipient organizations abroad. OIG issued two audits on Namibia, one in 2012 and another in 2013, and has an additional eight audits conducted there and in South Africa and Vietnam that are near completion." OIG is also planning seven more audits of PEPFAR grantees in Ethiopia and Zambia for FY 2013.

Recent developments

Garenne & Matthews (2019) reported that there is little difference in the incidence of HIV infection between circumcised men and intact men in Zambia. The authors stated that the "effectiveness of VMMC could therefore be seriously questioned."[18]

The VMMC Experience Project published a massive, illustrated 153-page report on VMMC in Africa for the United Nations on 4 May 2019.[19]

As reported above, PEPFAR announced in November 2019 that the program to circumcise children would be discontinued due to abuses and an extremely high incidence of botched circumcision resulting in permanent injuries and mutilations.[8]

Brendon Marotta discussed the child circumcision scandal at PEPFAR in a video in December 2019.


George C. Denniston, M.D.[a 2], M.P.H.[a 1], the president of Doctors Opposing Circumcision (D.O.C.), in a letter to Ambassador Deborah L. Birx, M.D.[a 2], M.P.H.[a 1], dated 29 June 2020, the head of the President’s Emergency Plan for AIDS Relief (PEPFAR), has called on PEPFAR to suspend the provision of male circumcision because it is ineffective and may increase the reception of HIV infection due to the loss of immunological protections of the foreskin, and to focus on the provision of anti-retroviral therapy and condoms.[20]

The VMMC Experience Project published an 18-page article on 9 September 2020, that is highly critical of PEPFAR's male circumcision program. In brief, it charges:

Campaigns to circumcise millions of boys and men to reduce HIV transmission are being conducted throughout eastern and southern Africa, recommended by the World Health Organization and implemented by the United States government and Western NGOs. In the United States, proposals to mass-circumcise African and African American men are longstanding, and have historically relied on racist beliefs and stereotypes. The present campaigns were started in haste, without adequate contextual research, and the manner in which they have been carried out implies troubling assumptions about culture, health, and sexuality in Africa, as well as a failure to properly consider the economic determinants of HIV prevalence. This critical appraisal examines the history and politics of these circumcision campaigns while highlighting the relevance of race and colonialism. It argues that the “circumcision solution” to African HIV epidemics has more to do with cultural imperialism than with sound health policy, and concludes that African communities need a means of robust representation within the regime.[21]

David Gisselquist (2021) reported that "circumcising men to reduce their risk to get HIV from sex" was an error.

In 2007, WHO and UNAIDS recommended “male circumcision should be recognized as an additional, important strategy for the prevention of heterosexually acquired HIV infection in men.” Subsequently, WHO and UNAIDS endorsed programs to circumcise 20 million men in 14 countries in sub-Saharan Africa during 2008-15.[34] After 11.7 million circumcisions were reported through 2015, UNAIDS set a new target to circumcise another 25 million men in 15 countries during 2016-20. Through 2017, the US government supported more than 80% of these circumcisions.

WHO’s and UNAIDS’ recommendation was based on three studies in Africa that reported circumcised men were less likely to get HIV than intact men. But what happened in those studies? In two of the studies, men who reported no sexual risks (no partners or 100% condom use) got HIV at rates more than half as fast as the rates for men who reported any unprotected sex. The third study did not report men’s sexual risks. One study tested most wives, but has not said if the wives of men getting new infections during the study were known to be HIV-positive or HIV-negative.

But criticizing these studies – how they were badly managed and reported[10] – does not get to the heart of the problem with circumcising millions of men to prevent HIV. Insofar as sex is a risk, men already have multiple options to protect themselves. And because there is overwhelming evidence bloodborne risks – most likely in medical settings – drive Africa’s epidemics (Chapter 6), it is irresponsible to put millions of men at risk for HIV and other bad outcomes from unnecessary operations.[22]

George Hill, CFI, ATR, acting for Doctors Opposing Circumcision (D.O.C.), wrote to Deborah L. Birx on 28 January 2021 regarding her lack of action and to transmit a copy of the article by Fish et al. (2020).[23]

The United States Department of State on 10 February 2021, announced a "temporary pause" in the development of Country Operational Plans and Regional Operational Plans, which it said was caused by the COVID-19 pandemic. The Department of State affirmed that "HIV prevention and treatment services" would continue, but made no mention of male circumcision or VMMC.[24]

Population-based studies

September 2021 saw the publication of two huge population studies on the relationship of circumcision and HIV infection:

  1. Mayan et al. (2021) carried out a massive empirical study of the male population of the province of Ontario, Canada (569,950 males), of whom 203,588 (35.7%) were circumcised between 1991 and 2017. The study concluded that circumcision status is not related to risk of HIV infection.[25]
  2. Morten Frisch & Jacob Simonsen (2021) carried out a large scale empirical population study in Denmark of 855,654 males regarding the alleged value of male circumcision in preventing HIV and other sexually transmitted infections in men. They found that circumcised men have a higher rate of STI and HIV infection overall than intact men.[26]

No association between lack of circumcision and risk of HIV infection was found by either study. There now is credible evidence that the massive, expensive African circumcision programs have not been effective in preventing HIV infection.

Two African surveys

The previously reported studies were from developed Western nations. Now we have information from Sub_Saharan Africa.

French scientist Michel Garenne, Ph.D. has published two reports in 2022 comparing the incidence of HIV infection in circumcised and intact men.

In his first report, Garenne presented the findings from a study in Lesotho, the enclave in South Africa. He reported:

In couple studies, the effect of circumcision and VMMC on HIV was not significant, with similar transmission from female to male and male to female. The study questions the amount of effort and money spent on VMMC in Lesotho.[27]

In his second report, Garenne (2022) presented information from six Sub-Saharan African nations (Eswatini, Lesotho, Malawi, Namibia, Zambia, Zimbabwe). He reported:

"Results matched earlier observations made in South Africa that circumcised and intact men had similar levels of HIV infection."[28]

See also

External links

Abbreviations

  1. ↑ a b c REFweb Master of Public Health or Master of Philosophy in Public Health, Wikipedia. Retrieved 14 June 2021.
  2. ↑ a b REFweb Doctor of Medicine, Wikipedia. Retrieved 14 June 2021. In the United Kingdom, Ireland and some Commonwealth countries, the abbreviation MD is common.

References

  1. ↑ REFweb The White House (1 October 2010). World AIDS Day at the White House. Retrieved 10 April 2011.
  2. ↑ REFdocument Reimagining PEPFAR's Strategic Directio PDF, U.S. Department of State. (September 2022). Retrieved 28 November 2022.
  3. ↑ REFnews Mazzotta, Meredith (4 March 2011)."Swaziland embarks on ambitious plan to circumcise 80 percent of men 18 to 49 this year", Science Speaks: HIV & TB News. Retrieved 6 May 2011.
    Quote: Much attention has been paid to the launch of an aggressive medical male circumcision (MC) campaign in Swaziland that starts this month, a program aiming to circumcise 80 percent of the small nation’s men aged 18-49 by the year’s end with significant support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program.
  4. ↑ REFnews Mazzotta, Meredith (4 March 2011)."Swaziland embarks on ambitious plan to circumcise 80 percent of men 18 to 49 this year", Science Speaks: HIV & TB News. Retrieved 6 May 2011.
    Quote: The Ministry of Health, supported principally by UNICEF and PEPFAR, is currently working to introduce and scale up neonatal circumcision.
  5. ↑ REFjournal Swaziland Demographic and Health Survey 2006-07. Mbabane, Swaziland: Central Statistical Office and Macro International Inc.. 2008; Retrieved 6 May 2011.
    Quote: As Table 14.10 shows, the relationship between HIV prevalence and circumcision status is not in the expected direction. Circumcised men have a slightly higher HIV infection rate than men who are not circumcised (22 percent compared with 20 percent
  6. ↑ REFweb (3 October 2012). PEPFAR Swaziland Operational Plan Report FY 2011. Retrieved 19 November 2012.
  7. ↑ REFweb (30 November 2012). PEPFAR Blueprint: Creating an AIDS-free Generation. Retrieved 30 December 2012.
  8. ↑ a b REFweb (2019). PEPFAR SCANDAL: Finally To End Botched Male Circumcision Campaign In Africa, Lipstick Alley. Retrieved 17 June 2020.
  9. ↑ REFweb (May 2011). My Visit to Swaziland: The Country with the World’s Highest HIV Prevalence Rate. Retrieved 17 October 2011.
  10. ↑ a b REFjournal Boyle GJ, Hill G. Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: Methodological, ethical and legal concerns PDF. Thompson Reuter. December 2011; 19(2): 316-34. PMID. Retrieved 30 December 2020.
  11. ↑ REFjournal Van Howe RS, Storms M. How the circumcision solution in Africa will increase HIV infections. Journal of Public Health in Africa. March 2011; 2(1): 11-5. DOI. Retrieved 16 February 2021.
  12. ↑ REFjournal Van Howe RS, Boyle GJ. Meta-analysis of HIV-acquisition studies incomplete and unstable. BJU Int. 31 October 2018; Retrieved 1 January 2022.
    Quote: Given the effectiveness of condoms, the lack of consistent findings on national levels, the methodologically flawed RCTs, the lack of translational research, and the impressive potential uptake and effectiveness of pre-exposure prophylaxis, circumcision as an intervention to prevent HIV infection should be treated with greater scepticism.
  13. ↑ REFweb (June 2011). 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). Retrieved 25 June 2011.
  14. ↑ REFweb (November 2012). 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 (A-04-12-04020). Retrieved 7 December 2012.
  15. ↑ REFweb (February 2013). 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. Retrieved 4 February 2013.
  16. ↑ REFweb (February 2013). 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). Retrieved 27 February 2013.
  17. ↑ REFweb (February 2013). Spotlight on... Grants Management and Oversight. Retrieved 4 February 2013.
  18. ↑ REFjournal Garenne M, Matthews A. Voluntary medical male circumcision and HIV in Zambia: expectations and observations. J Biosoc Sci. 2019; 52(4): 560-72. PMID. DOI. Retrieved 7 March 2021.
  19. ↑ REFdocument Fish, Max: Circumcision Campaigns: African experience and human rights: The U.N. Report PDF, VMMC Experience Project. (7 May 2019). Retrieved 15 May 2021.
  20. ↑ REFdocument Denniston, George C.: Letter to Deborah L. Birx, M.D., Doctors Opposing Circumcision (D.O.C.). (29 June 2020). Retrieved 4 September 2020.
  21. ↑ REFjournal Fish, Max, Shavisi, Arianne, Gwaambuka, Tatenda, Tangwa, Godfrey B., Ncayiyana, Daniel, Earp, Brian D. A new Tuskegee? Unethical human experimentation and Western neocolonialism in the mass circumcision of African men. Developing World Bioeth. 9 September 2020; 00: 1-16. PMID. Retrieved 7 March 2021.
  22. ↑ REFbook Gisselquist D (2021): Stopping Bloodborne HIV: investigating unexplained infections. ISBN 978-1-913976-01-9. Retrieved 16 February 2021.
  23. ↑ REFdocument Hill, George: Letter to Deborah L. Birx PDF, Doctors Opposing Circumcision (D.O.C.). (28 January 2021). Retrieved 13 February 2021.
  24. ↑ REFweb (10 February 2021). Temporary Pause on PEPFAR COP/ROP 2021 Development Due to COVID-19. Retrieved 13 February 2021.
  25. ↑ REFjournal Mayan M, Hamilton RJ, Juurlink DN, Austin PC, Jarvi KA. Circumcision and Risk of HIV Among Males From Ontario, Canada. J Urol. 23 September 2021; PMID. DOI. Retrieved 21 August 2022.
    Quote: We found that circumcision was not independently associated with the risk of acquiring HIV among men from Ontario, Canada.
  26. ↑ REFjournal Frisch M, Simonsen J. Non-therapeutic male circumcision in infancy or childhood and risk of human immunodeficiency virus and other sexually transmitted infections: national cohort study in Denmark. Eur J Epidemiol. 26 September 2021; 37: 251–9. PMID. DOI. Retrieved 16 January 2022.
  27. ↑ REFjournal Garenne M. Changing relationships between HIV prevalence and circumcision in Lesotho. J Biosoc Sci. 4 April 2022; online ahead of print: 1-16. PMID. DOI. Retrieved 4 November 2022.
  28. ↑ REFjournal Garenne M. Age-incidence and prevalence of HIV among intact and circumcised men: an analysis of PHIA surveys in Southern Africa. J Biosoc Sci. 26 October 2022; : 1-13. PMID. DOI. Retrieved 4 November 2022.
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