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National Institutes of Health

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NICHD funded studies: Wikify
[[Image:NIH.jpg|right|thumb]]
The U.S. National Institutes of Health (NIAID, FIC, NIHCD, NCI) funded the three major RCTs being used by the [[WHO]] to endorse circumcision as [[HIV ]] prevention<ref name='DOC%252525252525252525252525252525202008'>{{REFweb | quote=...funding from the United States National Institutes of Health to conduct randomized controlled trials (RCTs) in Africa. | last= | first= | publisher=[[Doctors Opposing Circumcision(D.O.C.)]] | yeardate=2008 | title=The Use of Male Circumcision to Prevent HIV Infection | url=http://www.doctorsopposingcircumcision.org/info/HIVStatement.html | accessdate=2011-03-05}}</ref>. They continue to fund further "research" and promotion of circumcision as [[HIV ]] prevention in Africa.
== Three RCTs in Africa ==
The NIH funded the three major RCTs being used by the [[WHO ]] to endorse [[circumcision ]] as [[HIV ]] prevention: One in Orange Farm, South Africa under the supervision of French circumcision proponent [[Bertran Auvert]]<ref>{{RCT Auvert et al 2005}}</ref>, one in Kenya under the supervision of North American circumcision proponent [[Robert C. Bailey]] and [[Stephen Moses]]<ref>{{RCT Bailey et al 2007}}</ref>, and one in Uganda under the supervision of North American circumcision proponent [[Ronald H. Gray]]<ref>{{RCT Gray et al 2007}}</ref>. Green et al. (2008), in a preliminary report, published a long list of methodological issues with the RCTs.<ref name="green2008">{{REFjournal |last=AuvertGreen |first=BLawrence W. |init=LW |author-link= |last2=TaljaardMcAllister |first2=DRyan S. |init2=RS |author2-link=Ryan McAllister |last3=LagardePeterson |first3=EKent W. |init3=KW |author3-link= |last4=Sobngwi-TambekouTravis |first4=JJohn W. |last5init4=SittaJW |first5author4-link=RJohn W.Travis |etal=yesno |datetitle=2005Male circumcision is not the HIV ‘vaccine’ we have been waiting for! |trans-title=Randomized, controlled intervention trial of male circumcision for reduction of |language= |journal=Future HIV infection risk: The ANRS 1265 trialTherapy |location= |journaldate=PLoS Med2008
|volume=2
|issue=e2983 |article= |page= |pages=193-9 |url=http://www.plosmedicinefuturemedicine.orgcom/articledoi/info:doifull/10.13712217/journal17469600.2.pmed3.0020298193 |archived= |quote= |pubmedID= |pubmedCID= |DOI=10.13712217/journal17469600.2.pmed3.0020298193 |accessdate=2022-11-04}}</ref> [[Gregory J. Boyle|Boyle]] & [[George Hill|Hill]] (2011) studied their reports and found disabling methodological and statistical errors that invalidated their purported findings.<ref name="boyle-hill2011">{{BoyleGJ HillG 2011}}</ref>, one in Kenya under the supervision of North American circumcision proponent  [[Robert CS. BaileyVan Howe|Van Howe]] and & [[Stephen MosesGregory J. Boyle|Boyle]](2018) further elaborated on these findings and suggested possible coordination between the RCTs and hinted at the possibility of fraud.<refname= "vanhowe2018">{{REFjournal |last=BaileyVan Howe |first=RRobert S.C |init=RS |author-link=Robert S.Van Howe |last2=MosesBoyle |first2=SGregory J. |last3init2=ParkerGJ |first3author2-link=C.BGregory J.Boyle |etal=yesno |title=Male circumcision for Meta-analysis of HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial-acquisition studies incomplete and unstable |journal=LancetBJU Int |location= |date=20072018-10-31 |volume=369 |issue= |pages=643-656 |url=httphttps://www.thelancetbjuinternational.com/journalsletters/lancet/article/PIIS0140meta-analysis-circumcision-6736(07)60312incomplete-2unstable/abstract}}</ref>, and one in Uganda under the supervision of North American circumcision proponent [[Ronald H. Gray]]<ref>{{REFjournal |lastarchived=Gray |firstquote=R.H. |last2=Kigozi |first2=G. |last3=Serwadda |first3=D. |etal=yes |title=Male 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 for as an intervention to prevent HIV prevention in men in Rakai, Uganda: a randomised trialinfection should be treated with greater scepticism. |journalpubmedID=Lancet |datepubmedCID=2007 |volumeDOI=369 |pagesaccessdate=5572022-56611-04}}</ref>.
== Other Projects ==
The NIH fund other projects for the "research" and promotion of circumcision, such as the Center for Infectious Disease Research in Zambia, who in turn are collaborating with the {{UNI|University of Alabama, at Birmingham |UAB}} to conduct a "study" an the "Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia."
== Response from NIH ==
{{Citation
|Title=When inquired about their involvement, an intactivist received this response
|Text=This is in response to your email dated June 30, 2010, to Dr. Francis S. Collins, M.D.{{MD}}, Ph.D.{{PhD}}, Director of the National Institutes of Health (NIH), concerning clinical trial #NCT01115335l, “Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia,” and the premise upon which it was designed. That is, that circumcision prevents the transmission of [[HIV ]] infection. Your email has been forwarded to the National Institute of Allergy and Infectious Diseases (NIAID), the NIH component with primary responsibility for research on [[HIV]]/[[AIDS]].
The World Health Organization/Joint United Nations Program on [[HIV]]/[[AIDS ]] has concluded that the research evidence that male circumcision is efficacious in reducing sexual transmission of [[HIV ]] from women to men is compelling, and that it has been proven beyond reasonable doubt. (http://data.unaids.org/pub/Report/2007/mc_recommendations_en.pdf) Their report and additional information is available on male circumcision for [[HIV ]] prevention at www.malecircumcision.org. This Web site/clearinghouse is a service of the World Health Organization (WHO), the Joint United Nations Programme on [[HIV]]/[[AIDS ]] (UNAIDS), the AIDS Vaccine Advocacy Coalition (AVAC), and Family Health International (FHI).
You may also be interested to know that NIAID-supported research has found that medical circumcision can help heterosexual men significantly reduce their risk of acquiring two other sexually transmitted infections—herpes infections—[[herpes]] simplex virus type 2 (HSV2), the cause of genital [[herpes]], and human papillomavirus (HPV), which can cause penile and cervical cancer and genital warts. (see http://www.niaid.nih.gov/about/whoWeAre/Documents/scienceadvances2009.pdf).
You are correct that in 1999, the American Academy of Pediatrics (AAP) changed from a neutral stance on circumcision to a position that the data then available were insufficient to recommend routine neonatal male circumcision. However, AAP has convened a panel to reconsider its circumcision policy in light of additional data now available. You may wish to review the most recent data that support revision of the AAP policy in the following review article, which is available from your nearest medical library: Tobian, AA et. al. “Male circumcision for the prevention of acquisition and transmission of sexually transmitted infections: the case for neonatal circumcision.” Arch Pediatr Adolesc Med. 2010 Jan;164(1):78-84.
This article also evaluates the evidence that circumcision decreases bacterial vaginosis, T vaginalis infection, and genital ulcer disease in heterosexual men’s female partners. Additionally, it discusses the plausibility of a biological basis for why male circumcision would reduce viral sexually transmitted diseases.
As to the ethics of the Zambian study, we do not believe that it violates the basic [[human rights ]] of its participants. Parents must make choices for their children when they are unable to consent for themselves. Although there may be controversy over the question of whether parents can give proxy consent to non-therapeutic interventions, especially if they carry risks, there is no controversy over whether parents can give proxy consent to therapeutic interventions such as vaccines or appendectomies. The randomized clinical trial data provides assurance that male circumcision is therapeutic, unlike female circumcision. You may be interested in the position of the WHO which states that female circumcision can be very harmful and that there are not any health benefits derived from the procedure (http://www.who.int/mediacentre/factsheets/fs241/en/).
We can assure you that safeguards are in place for all NIH-supported research involving people. For instance, local committees--called Institutional Review Boards (IRBs) and Research Ethics Committees (RECs)--are required to review research to assure that the rights and welfare of study participants are protected. This review includes the equitable selection of participants, maintenance of privacy and confidentiality, minimizing coercion or undue influence, and ensuring appropriate safeguards in vulnerable participants. Committee members have knowledge of the local research context and cultural considerations. In addition, research is often conducted in adult populations to obtain safety data prior to acquiring data in vulnerable population such as children. In the case of Zambia, the Zambian Ministry of Health (MOH) oversees research. It is the MOH’‘s role to consider the ethical and public health implications of research studies within their purview. As such, the Zambian MOH is responsible for approving and implementing the WHO recommendations regarding male circumcision for [[HIV ]] prevention in that country and have made the decision to do so. Since the Zambian Ministry of Health and the local IRB/REC have reviewed and approved the research study in question, the local ethical and public health issues, in their opinion, have been addressed.
We appreciate your concerns and hope that this information helps clarify the rationale for circumcision as an important component of [[HIV ]] prevention.
Sincerely,
== NICHD funded studies ==
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is presently funding a five-year (2009-2013), $465,108 'study' entitled "[[HIV ]] PREVALENCE, SEXUAL BEHAVIOR, AND ATTITUDES TOWARD CIRCUMCISION AMONG COLOMBIA" (sic) with the stated aim of investigating "individual, social, and structural influences on [[HIV ]] risk and serostatus among men who have sex with men (MSM) in Bogota, Colombia...Moreover, it will evaluate the protection against [[HIV ]] afforded by [[circumcision ]] among MSM in Colombia"<ref>{{REFweb
|url=http://projectreporter.nih.gov/project_info_description.cfm?icde=0&aid=7495232
|title=Project Information 1R01HD057785-01A1
== Office of Inspector General (OIG) investigations of NIAID commercial partnerships ==
On the 10 June 2011, the OIG published its results from an audit of a contract between the National Institute of Allergy and Infectious Diseases (NIAID) and the {{UNI|University of California |UCSF}} at San Francisco, which read in part:<ref>{{REFweb
|last=
|first=
|date=2011-06
|title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-15416 With the {{UNI|University of California |UCSF}} at San Francisco Audit (A-03-10-03120)
|url=http://oig.hhs.gov/oas/reports/region3/31003120.pdf
|accessdate=2011-06-25
{{Citation
|Title=
|Text=On November 1, 2002, NICHD awarded contract HHSN275-03-3345 (the Contract), totaling $164.7 million, to Westat, Inc. (Westat), in Rockville, Maryland. The Contract required Westat to establish an international pediatric and perinatal [[HIV ]] studies network-coordinating center to maintain, coordinate, and manage a network of clinical centers. These clinical centers, under subcontracts with Westat, conducted research on the treatment, prevention, diagnosis, epidemiology, and natural history of [[HIV ]] infection and disease in pediatric, adolescent, and maternal patient populations.
|Author=
|Source=
...
The video, available at http://nccam.nih.gov/video/yoga, highlights the work of two respected researchers in the field of yoga. George Salem, Ph.D.{{PhD}}, at the {{UNI|University of Southern California|USC}}, uses innovative technology to examine how older adults use their muscles and joints in certain yoga postures. Karen Sherman, Ph.D.{{PhD}}, M.P.H{{MPH}}, at Group Health Research Institute in Seattle, focuses on how yoga may be a beneficial complementary health practice for people with chronic low-back pain.
This is the second installment in NCCAM's The Science of Mind and Body Therapies video series. The first video, Tai Chi and Qi Gong for Health and Well-Being, was released in September 2010.
== Continuing advocating for more circumcision ==
From a National [[HIV ]] Vaccine Awareness Day statement dated 18 May 2011 by [[Anthony Fauci| Anthony S. Fauci]], M.D.{{MD}}, Director of NIAID (emphasis added):<ref>{{REFweb |last=Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health
|first=
|date=2011-05
{{Citation
|Title=
|Text=To speed the pace at which promising [[HIV ]] vaccine candidates become viable for evaluation in large clinical trials, NIAID is exploring the use of innovative or adaptive clinical trial designs that let scientists quickly modify ongoing trials in response to data acquired during the study. Such flexibility in trial design will allow the research community to maximize efficiencies in studying vaccine candidates.
[...]
No matter how effective a preventive [[HIV ]] vaccine is, however, we will need to evaluate and administer it in combination with other biomedical and behavioral [[HIV ]] prevention tools. No single [[HIV ]] prevention strategy will control and ultimately end the [[HIV]]/[[AIDS ]] pandemic. That is why it is important for NIAID to continue supporting promising research on vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded [[HIV ]] testing with linkage to care. That is also why public health workers will continue to advocate and implement scientifically proven [[HIV ]] prevention strategies such as condom use, medically supervised adult <strong>male circumcision</strong>, harm-reduction strategies for injection drug users and the prevention of mother-to-child transmission of [[HIV]].
|Author=
|Source=
}}
== Population-based studies ==
{{Population-based studies}}
==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:
<blockquote>
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.<ref name="garenne2022A">{{REFjournal
|last=Garenne
|first=Michel
|init=M
|author-link=Michel Garenne
|title=Changing relationships between HIV prevalence and circumcision in Lesotho
|url=https://pubmed.ncbi.nlm.nih.gov/35373731/
|date=2022-04-04
|journal=J Biosoc Sci
|volume=online ahead of print
|pages=1-16
|DOI=10.1017/S0021932022000153
|pubmedID=35373731
|accessdate=2022-11-04
}}</ref>
</blockquote>
 
In his second report, Garenne (2022) presented information from six Sub-Saharan African nations (Eswatini, Lesotho, Malawi, Namibia, Zambia, Zimbabwe). He reported:
<blockquote>
"Results matched earlier observations made in South Africa that [[circumcised]] and [[intact]] men had similar levels of HIV infection."<ref name="garenne2022B">{{REFjournal
|last=Garenne
|first=Michael
|init=M
|author-link=
|etal=no
|title=Age-incidence and prevalence of HIV among intact and circumcised men: an analysis of PHIA surveys in Southern Africa
|trans-title=
|language=
|journal=J Biosoc Sci
|location=
|date=2022-10-26
|season=
|volume=
|issue=
|article=
|page=
|pages=1-13
|url=https://www.cambridge.org/core/journals/journal-of-biosocial-science/article/abs/ageincidence-and-prevalence-of-hiv-among-intact-and-circumcised-men-an-analysis-of-phia-surveys-in-southern-africa/CAA7E7BD5A9844F41C6B7CC3573B9E50
|archived=
|quote=
|pubmedID=36286328
|pubmedCID=
|DOI=10.1017/S0021932022000414
|accessdate=2022-11-04
}}</ref></blockquote>
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[[Category:InstitutionsInstitution]] 
[[Category:Circumcision in Africa]]
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[[Category:From IntactWiki]]
 
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