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Denied, withheld, and uncollected evidence and unethical research cloud what really happened during three key trials of circumcision to protect men


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Mass circumcision based on assumption, not evidence

Programs to circumcise millions of men in Africa’s are based on selected evidence from three trials in South Africa, Kenya, and Uganda.[1-4] Many people think these trials showed circumcision reduced men’s risk to get HIV from sex by more than 50%.

The trials don’t say that; specifically, the trials don’t say men’s infections came from sex. None of the studies collected all information needed to measure the impact of circumcision on men’s risk to get HIV from sex — asking about all blood and sexual risks and trading and testing sexual partners.[5]

Trials in South Africa and Uganda report new infections in men according to whether the men reported any possible sexual exposure to HIV (any sex without a condom). The evidence from these two trials suggests less than a third of men’s infections came from sex (see details below). It is, of course, possible that men misreported their sexual behavior. In other words, programs to circumcise men in Africa are not based on evidence, but rather on assuming away evidence.

Were men’s sexual partners HIV-positive? We don’t know. The Ugandan trial tested most of the men’s spouses and live-in partners for HIV (including women who did not want to know their HIV status [see “eligibility criteria” in reference 6]). The trial observed most new infections in men who reported no non-marital partner. But the trial has not reported the HIV status of the long-term partner of any circumcised or intact man who got HIV during the trial.

The South African trial found most new infections in men who reported only 0-1 sexual partner after the last HIV-negative test. The Kenyan study collected but has not reported information on men’s sexual behavior during the trial; at baseline a majority reported 0-1 partners in the previous 6 months. There is no indication either trial made any effort to trace and test the sexual partners of men who got HIV during the trial. This would have been not only good research, but was also ethical — protecting women who were not the source of men’s new infections.

Evidence from these trials supports other recommendations

Beware skin-piercing risks: As noted above (and detailed below), evidence from two trials says less than a third of men’s infections came from sex. Moreover, two studies report new infections in men with specific healthcare encounters. In the South African trial: men who “attended a clinic for a health problem related to the genitals” vs. men who did not were 5.7 times more likely to get HIV; and men who reported an injection, transfusion, and/or hospitalization vs. men with none of these risks were 1.7 times more likely to get HIV.  The Kenyan trial found four men new infections one month after they were circumcised. (See details below.)

Trust your body’s natural defenses: In Uganda, not washing one’s penis after sex cut men’s risk (whether circumcised or intact) for HIV. Thus, one message from the Ugandan trial is that natural defenses against HIV in sexual fluids may be as effective as circumcision (see details below and two other pages).

Beware unethical research: The circumcision trial in Uganda (together with research in a linked trial) tested many of the men’s wives and stable partners for HIV, but did not insist that women learn their HIV status or warn their husbands if women were HIV-positive. The trial followed men to see them get HIV, without warning them. The trial in South Africa followed men, at least some of whom did not know their HIV status. None of the trials required testing and warning wives and other partners when men got new HIV infections (see details below).

More details from the three trials

South Africa: The first study of the three studies to report was carried out in South Africa during 2002-05.[2] The study team solicited men willing to be circumcised, then on a random basis assigned half the men to an intervention group to be circumcised first and the other half to a control group to remain intact until the end of the study. The study team then followed and retested the men – circumcised and intact – at scheduled visits over as long as two years.

During follow-up, 20 men in the intervention (circumcision) group got HIV at the rate of 0.85% per year, while 49 men in the control (intact) group got HIV at the rate of 2.11% per year. If all the men’s infections came from sex, this says that circumcision cuts men’s risk to get HIV from sexual partners from 2.11% to 0.85% per year.

But did all or even most infections come from sex? Not according to evidence the study collected and reported. Twenty-three of the 69 men with new infections said they had no sexual partner or always used condoms from their last HIV-negative test to their first HIV-positive test. Men reporting no sexual risks got HIV at the rate of 1.11% per year. If these men are telling the truth, they apparently got HIV from blood during injections, dental care, tattooing, and other skin-piercing events. If men with no sexual risks got HIV from blood, we can estimate that men with sexual risks also got HIV from blood contact at the same rate. The rate of getting new HIV infections in men who reported at least one unprotected (without a condom) sex event was 1.86% per year. The modestly faster rate to get HIV in men reporting vs not reporting sexual risks explains less than 1/3 of the men’s infections (using standard epidemiological terms, the crude population attributable fraction of incident HIV associated with reporting any vs. no unprotected sex is 27%).

The study reported two health care exposure in men with and without new HIV infections: (a) men who “attended a clinic for a health problem related to the genitals” were 6.8 times more likely to get HIV than men without this risk;[2] and (b) men who reported injections and/or transfusion and/or hospitalization were 1.7 times more likely to get HIV than men who reported none of those events (see Authors’ reply in this link).[7]

The study team has not said what procedures men got at clinics treating genital health problems; it has also not reported HIV incidence separately for injections, transfusions, or hospitalizations. The study has not reported other healthcare procedures, such as infusions and dental care. The study has also not reported any data on skin-piercing cosmetic procedures; did they ask?

The study team could have done a better job identifying the sources of men’s infections if they had asked more questions and reported more data. But where is the failure? Did they not ask, or are they not telling? Like most studies on HIV in Africa, this study does  not give other researchers’ free access to collected data (with safeguards to protect participants’ confidentiality). Also, like most studies on HIV risk in Africa, this study has not disclosed its questionnaire and data collection forms – so there is no public record of what information they collected and chose not to report (chose to withhold).

Table: What information on sex and blood risks did the three studies collect and report for men with and without new HIV infections?

Risks for HIV South Africa, 2002-05 Kenya, 2002-06 Uganda, 2003-06
Blood-borne risks
Circumcisions No report of infections after circumcision 4 infections in the month after circumcision No report of infections after circumcision
Injections Collected but not reported Unknown Unknown
Transfusion Collected but not reported Unknown Unknown
Hospitalization Collected but not reported Unknown Unknown
Injections, transfusions and/or hospitalization Increases risk by 1.7 times Unknown Unknown
Visiting a clinic for a genital health problem Increases risk by 6.8 times Unknown Unknown
Other blood risks Unknown Unknown Unknown
Sexual risks
Any vs. no partners Collected but not reported Collected but not reported Increases risk by 2.4 times
<100% condom use Collected but not reported Collected but not reported Increases risk by 1.1 times
Any vs no partners or <100% condom use Increases risk by 1.7 times Collected but not reported Increases risk by 1.6 times
Any vs no non-spouse partner Collected but not reported Collected but not reported Collected but not reported
HIV status of spouse Not collected Not collected Collected but not reported
HIV status of non-spouse partners Not collected Not collected Not collected
Intact men waiting >10 minutes to wash penis sex Not collected Not collected Decreases risk by 87%
Circumcision Decreases risk by 60% Decreases risk by 53% Decreases risk by  55%

Sources: see references in the text.

Kenya: The Kenya study,[3] 2002-06, was similar in design to the South Africa study. The study circumcised some men, then followed and retested circumcised and intact men for as long as two years to see who got HIV. Nineteen men in the intervention (circumcised) group got HIV at the rate of 1.9% over two years, while 46 men in the control (intact) group got HIV at the rate of 4.1% over two years.

How many of the 65 men got HIV from sex? The study asked men about sexual partners and condom use, but reports this information for only seven men infected during the first three months of follow-up. Five of the seven reported no sexual partners from the time they entered the trial (using sensitive tests, the study could not find HIV in blood collected then) until their first HIV-positive test after 1-3 months. The study team has said nothing about tracing and testing men’s sexual partners – did they do it and not report it, or just not do it?

As for blood-borne risks, the study reports four men circumcised in the trial had new HIV infections one month later. Contaminated local anaesthetic or instruments could have infected the men during circumcision, but the study team says nothing about what might have gone wrong. Aside from circumcisions, the study says nothing about blood-borne risks. This is a glaring oversight, because the study team had in hand evidence linking HIV in the community to blood-borne risks: While recruiting men for the trial, men who reported one or more injections in the previous six months were 2.5 time more likely to be HIV-positive vs other men; men with tattoos were 2.2 times more likely to be infected; men who had ever received saro (traditional blood-letting) were 2.1 times more likely to be infected,[8] and men who reported “blood exchange” were 18.6 times more likely to be HIV-positive.[9]

Uganda: The study in Uganda, 2003-06, followed the same design as studies in South Africa and Kenya: assigning men randomly to be circumcised or to remain intact, then following them for as long as long as two years to see who got HIV. Twenty-two men in the intervention (circumcised) group got HIV at the rate of 0.66% per year, and 45 men in the control (intact) group got HIV at the rate of 1.33% per year.[4]

During follow-up, researchers asked men whether and how they cleaned their penis after sex, expecting that washing or wiping might be protective. Intact men who cleaned their genitals after sex, but waited at least 10 minutes to do so, got HIV at the rate of 0.39% per year. Also, men who wiped only without using water got less HIV than men who used water. The authors proposed that acid in vaginal fluids “may impair HIV survival,” so that washing these away with water may “facilitate viral survival and possible infectivity.”[10]

How did the men get HIV? Six men with new HIV infections reported having no sex partners during the period between their last HIV-negative and first HIV-positive test; 10 others with new infections reported always using condoms. Taken together, the 16 men who reported no possible sexual exposure to HIV got HIV at the rate of 0.72% per year, presumably from skin-piercing events that exposed them to HIV in blood. Men who reported any unprotected sex got HIV at the rate of 1.17% per year. As in South Africa, the marginally faster rate at which men who reported sexual risks got HIV explains less than a third of the new infections observed during the trial (using standard epidemiological analyses and terms, the crude population attributable fraction of incident HIV associated with having any vs no unprotected sex is 29%).

Unlike the other two studies, the Uganda study team traced and tested most of the men’s wives (and other long-term partners) for HIV.[6] However, the study has not reported the wives’ HIV status for men who got HIV. Did they get HIV from their wives? The study team is sitting on that information.

The Uganda study team provides no data on injections and other skin-piercing events for men with and without new HIV infections, and does not say if they collected any such data.

Ethical short-comings

The three studies treated research participants in ways that would not be allowed in the US, Canada, and France, non-African countries that funded the studies:

  • The South Africa study recruited men and the Uganda study recruited wives without insisting they hear their HIV test results. Neither study has said how many participants did not hear their results.
  • The Uganda study followed men who did not know the study had found some of their wives to be HIV-positive (some of the wives also did not know) to watch the men get HIV.
  • None of the studies insisted that men who acquired HIV bring their wives for couple counseling. This ethical lapse – leaving wives with unknown risks – undermined the objective of the research, which was to see how much circumcision reduced sexual transmission.

Study teams for two of the three trials did not register the trials (ie, document what they were planning to do in their human subjects research) before the trial began. Both were registered only after follow-up was completed and less than one month before publication.[11, para 35 in reference 12]

References

1. WHO, UNAIDS. New data on male circumcision and HIV prevention: policy and programme implications. Geneva: WHO, 2007. Available at: http://apps.who.int/iris/bitstream/handle/10665/43751/9789241595988_eng.pdf?sequence=1 (accessed 2 May 2018).

2. Auvert B, Taljaard D, Lagarde E, et al. Randomized controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS t1265 trial. PLoS Med 2005; 2: 1112-1122. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1262556/pdf/pmed.0020298.pdf (accessed 2 May 2018).

3. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007; 369: 643-656. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321310 (accessed 2 May 2018).

4. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomized controlled trial. Lancet 2007; 369: 657-666. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321311 (accessed 3 May 2018).

5. Brewer, D. D., Rothenberg, R. B., Potterat, J. J., Brody, S., & Gisselquist, D. (2004). HIV epidemiology in sub-Saharan Africa: rich in conjecture, poor in data (reply to letter by Boily et al.). International Journal of STD & AIDS15, 63-65. Available at: http://www.interscientific.net/ijsa2004.html (accessed 2 May 2018).

6. Wawer M. Trial of male circumcision: HIV, sexually transmitted disease (STD) and behavioral effects men, women and the community. ClinicalTrials.gov, 2007. Available at: https://clinicaltrials.gov/ct2/show/NCT00124878 (accessed 2 May 2018).

7. Auvert B, Sobngwi-Tambekou J, Taljaard, et al. Author’s reply. PLoS Med 2006; 3: 0141-0143. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360639/pdf/pmed.0030065.pdf (accessed 2 May 2018).

8. Mattson CL, Bailey RC, Agot K, et al. A nested case-control study of sexual practices and risk factors for prevalent HIV-1 infection among young men in Kisumu, Kenya. Sex Transm Dis 2007; 34: 731-736. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321310 (accessed 2 May 2018).

9. Mattson et al. Sexual practices and risk factors for HIV among young men in Kisumu, Kenya. Available at: http://www.abstract-archive.org/ (accessed 2 May 2018).

10. Makumbi et al. Male post-coital penile cleansing and the risk of HIV-acquisition in uncircumcised men, Rakai District, Uganda. Abstract WEAC1LB, 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Australia, 25 July 2007. Available at: http://www.abstract-archive.org/ (accessed 3 May 2018).

11. Thornton J. Circumcision and HIV. Blog post 18 September 2012. Available at: https://ripe-tomato.org/2012/09/18/circumcision-and-hiv/ (accessed 2 May 2018).

12. World Medical Association. Declaration of Helsinki 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 3 May 2018).

15 responses to “Denied, withheld, and uncollected evidence and unethical research cloud what really happened during three key trials of circumcision to protect men

  1. hughcirc@gmail.com February 12, 2012 at 12:50 am

    This is scandalous! Ethical comparison with Tuskegee or the Guatemala syphilis
    experiments is appropriate. The scandal continues with mass circumcision of men and
    boys with ill-informed consent (often by coercion or even force) using this seriously flawed data as an excuse.

  2. Petite Poulet February 12, 2012 at 4:20 pm

    There are several things from these trials that do not make much sense. Coming into the South African trial with the number of men who were found to be HIV-infected at enrollment, the average age of these men and the average age of the onset of sexual activity the baseline risk of HIV infection was 1.02 per 100 person-years. So it is not clear why, over the next two years, the risk doubled to 2.1 per 100 person-years in the control group. Using this historical control, the risk was only slightly reduced in the intervention group by 0.17 per 100 person-years (1.02 minus 0.85). Over two years, the number needed to treat would be 294 to “prevent” one infection.

    So what happened in the control group that their HIV-risk suddenly doubled? No one seems to be answering this question.

    In the Ugandan study, men who consistently used condoms had higher infection rates than those who reported never using condoms. In the control group the rate of infection was 1.08 per 100 person-years for those who never used condoms and 1.49 per 100 person-years in those who consistently used condoms. So, would the take-home lesson from this study be to recommend that condoms never be used?

    The Uganda study was less forthcoming in providing data on the risk of infection in those who were not having sex or always using condoms. The only data provided are for the six men who should not have become infected, which accounts for an infection rate of 0.48 per 100 person-years.

    In the Kenyan study, given the number of men who were found to be HIV-infected at enrollment, the average age of these men and the average age of the onset of sexual activity the baseline risk of HIV infection was 1.94 per 100 person-years. During the trial, the risk of infection was 1.00 per 100 person-years in the intervention group and 2.12 per 100 person-years in the control group.

    The Kenyan study also was less forthcoming in providing data on the risk of infection in those who were not having sex or always using condoms. There were 5 men who should not have become infected and account for a rate of 0.73 per 100 person-years.

    Interesting that with the little data that they disclosed that the validity of the their studies crumbles. It would be interesting to see what full disclosure of their data would reveal. Two of these studies were paid for with my tax dollars through the NIH, so the data should be available to the public.

  3. Lillian Cannon February 17, 2012 at 1:22 pm

    Thank you for this great post. It is truly disgusting that my tax dollars are being used for this unethical research, but it is not surprising. Cultural conditioning and psychological denial die hard.

  4. anonymous February 17, 2012 at 4:08 pm

    In about 2001 Robert Bailey, the main author of the Kenya study, predicted in advance that his study would show efficacy, according to one article. “Dr. Bailey and his colleagues now intend to conduct a randomized, controlled trial of circumcision in Kenya. The study will compare HIV acquisition rates in 1000 control subjects who will remain uncircumcised with those of 1000 subjects who will be circumcised as part of the study. Bailey’s group estimates that a study of this size will demonstrate the benefits of the approach within 2 years.” Myron S Cohen, MD, “Circumcision as an HIV Prevention Intervention,” http://medscape.com/viewarticle/418368, accessed 4/8/2010 and 02/17/12. Perhaps these studies were “self-fulfilling prophecies.” Are the researchers intentionally concealing the real facts? The public certainly has a right to full disclosure.

  5. Troy February 18, 2012 at 6:26 am

    Circumcision for boys is obviously not medically necessary. If it were, it would be common in most countries throughout the world, whereas it is actually in the minority. If boys needed to be circumcised, it would be common in the UK, France, Italy, Spain, Greece, Sweden, Norway, Denmark and many other countries. The question is, why are Americans so attracted to circumcision compared to the rest of the Western countries? Why does circumcising boys have such a strong cultural hold in America? I’ve been surprised at how many non-Jewish Americans I’ve met who consider circumcising their boys essential.

    • Anonymous February 29, 2012 at 8:09 pm

      I think it’s a combination of reasons, Troy. First is the US’s unique fascistic medical/state relationship. There’s a lot of profit to be made in circumcising non-consenting children. Second is the US’s political ties to the Middle East – Zionism has a strong grip in the upper echelons of US foreign policy and government, and one way to symbolize control over a tribe is to have them mark their children in this way. Third reason is the most powerful of all – American men are in denial that their sexual organs have been needlessly mutilated. So they must invent new reasons for it as often as possible, and downplay their loss in sexual enjoyment and function.

  6. Pingback: The problem with HIV as a justification for circumcision » Moralogous

  7. Patricia Date March 3, 2012 at 7:54 am

    Just stating the obvious here.

    The three trials found a marked reduction in HIV incidence among the men who were circumcised against the men who weren’t.

    If your hypothesis is that some of the infections were not sexually acquired, then the protective effect of circumcision for men in heterosexually acquired HIV is actually GREATER than what was observed – not less – unless you want to propose some mechanism by which circumcision might protect against HIV acquired through unsterile dental care, tattooing, injections, etc.

    I can’t think of one.

    • davidgisselquist March 4, 2012 at 7:05 pm

      Hi Patricia,
      Thanks for your comment.
      The point I tried to make above is that there is too much reliance on speculation, due in large part to study teams denying, avoiding, and withholding relevant evidence. African men and policy-makers need evidence to make good decisions.
      But If you wish, let’s play with hypotheses.
      If your hypothesis is true — that circumcising men reduces their risk to get HIV through their penis by more than 50%-60% — then why did the study teams not do a better job finding and reporting relevant evidence? They clearly want to promote circumcision — so why didn’t they trace and test sexual partners? If someone has evidence behind them, don’t you usually expect them to lay it all out? Why are they not doing so?
      But let’s suppose — for the sake of argument — that your hypothesis is true. Where does that get us? Consider: National surveys in 5 African countries (Cameroon, Ghana, Malawi, Rwanda, and Zimbabwe) find that circ’ed men are more likely to be HIV-positive vs intact men (see: https://dontgetstuck.wordpress.com/circumciseion-intact-living-with-hiv/). So if your hypothesis is true — that circ’ing cuts men’s risk to get HIV through the penis by more than 50%-60% — then most HIV-positive men in those countries got HIV some other way. It also means that circ’ing men could be expected to have little impact on their overall risk to get HIV as well as on HIV epidemics.
      You ask me to speculate about how intact men might be more likely than circ’ed men to get HIV from blood exposures. I prefer facts, but OK, here’s some speculation: The study teams might be telling men that circing protects them from sexually transmitted infections. Intact men might be scared that every (imaginary) itch is a sexual infection and go for injections. Clinic staff with the same idea might be giving intact men more injections.
      But why are we still speculating when data are or could be available? Instead of asking me to speculate, why not ask study teams to report all their data? Decades ago we could have moved beyond speculation to explain Africa’s HIV epidemics — If researchers had done their jobs. Simply done their jobs. Nothing stupendous or insightful. Just trace infections to find where they’re coming from.

    • Hugh7 March 7, 2012 at 12:16 am

      What if non-circumcised men are more likely to seek medical treatment – whether for foreskin-related ailments, or some other reason (such as less fear of doctors?) – and hence get infected through medical equipment?

  8. Gregory Boyle, PhD, DSc March 6, 2012 at 12:58 pm

    Flawed African Studies into Male Circumcision and HIV Sexual Transmission:

    Ref: Boyle GJ, Hill G. Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: Methodological, ethical and legal concerns. J Law Med 2011;19:316-334.

    The Journal of Law and Medicine, has published a new critique of those three randomized clinical trials from Africa that have purported to find that male circumcision reduces female-to-male sexual transmission of HIV by 60 percent.

    This critique finds numerous flaws in the execution of these studies and finds that the absolute reduction in HIV transmission is about 1.3 percent, not the claimed 60 percent. The 1.3 percent is not considered to be clinically significant.

    This is offset by a 61 percent relative increase in male-to-female HIV transmission when the male partner is circumcised.

    Given this, the three RCTs should not be used in the formulation of public health policy.

    See the attached Pdf.

    http://www.salem-news.com/articles/december112011/circumcision-hiv-rg.php

    http://www.newzimbabwe.com/NEWS-7273-Circumcision+HIV+impact+doubted/NEWS.aspx

    http://www.newsday.co.zw/article/2012-02-26-more-questions-on-male-circumcision–and-hiv-prevention/

    http://www.monitor.co.ug/News/National/-/688334/1360190/-/axfghjz/-/

    Gregory Boyle, PhD, DSc, FAPS
    Independent Research Consultant

  9. Simon Collery March 6, 2012 at 1:27 pm

    Thanks Gregory. I don’t see the attached PDF, could you supply it as a link or send it to me and I’ll put it on the site so it can be accessed by anyone who wishes to read it. Also, what was the absolute increase in male to female transmission as a result of male circumcision?

  10. Pingback: Wait and wipe, don’t cut « Don't Get Stuck With HIV

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