Monday, October 17, 2011

How bad is the African HIV Circumcision research?

  1. The research did not prove life-long protection only partial episodic protection (relative to the trial conditions for only 18months).
  2. The trials also did not reflect not real world settings, and therefore how can they be applicable to real world settings.
  3. Rarely reported or emphasised, A significant number of circumcised men in the study became infected with HIV. 
  4. The participants were not randomly selected, but selected themselves, creating a potential bias or distortion in the generalisability of the results to any general population.
  5. The participants were paid adult male volunteers who wanted to be circumcised and therefore had a bias in favour of it, and could possibly have been in favour of circumcision because they were high risk candidates who had unprotected sex (no condoms) with multiple sex partners, and were looking for a way to maintain high risk behaviours.
  6. Therefore as the participants were not randomly selected, and were a potentially biased self-selected sample of the population, the results cannot be extrapolated to general populations outside of this population sub-group. (Van Howe & Storms, 2011)
  7. Inadequate Controls: Participants in the trials were not treated equally with the circumcised group given more education about healing from surgery, advised to not resume sex for 6 to 8 weeks and therefore, abstained from sex longer, and participants were given greater time and emphasis about wearing condoms during the period of healing from surgery.
  8. No control was undertaken to examine possible non-sexual blood exposures by participants. No control was undertaken for dry sex as practised by some african cultures.
  9. No control for the sex (gender) of partners, and no control for anal intercourse. (Van Howe & Storms, 2011)
  10. Unexplained and disrtorting the statistics was the finding that in the first three months of the Kenyan trial, five men became HIV-positive who reported no sexual activity in the period before the seroconversion (0.73/100 person-years, 95%CI=0.30-1.76). (Van Howe & Storms, 2011)Data suggests a percentage of infections were from non-sexual exposures, with 23 infected men reporting no sexual contact without a condom. No explanations or investigations undertaken for non-sexual exposures to HIV infections. (Van Howe & Storms, 2011)
  11. The African HIV Trial researchers were all pro-circumcision and with a history of activism in the area.
  12. Nearly 10 times as many participants dropped out of the clinical studies as were infected, with HIV status unknown. 
  13. The studies were ended early exagerrating effects. 
  14. The vast majority of participants in the study were HIV free, therefore, why was no attempt made by researchers to identify the 100% condom users and compare these to the circumcised group, Was 100% condom use more effective than circumcision = Most probably yes!! but researchers did not want to find this and report it.  
  15. No long term follow-up possible with all subjects circumcised at end of trial.
  16. Researchers used speculative hypotheses to explain trial findings, such as Langeran present in the foreskin cells are targeted by HIV, whereas later research found Langeran cells actually kill HIV. (Van Howe & Storms, 2011)
  17. The studies had such high numbers of participants leading to an overpowering of the statistical analysis, inflating the results. (Van Howe & Storms, 2011)
  18. French demographer Garenne criticised the findings by demonstrating that interventions with a near 50% clinical trial efficacy had very little population effect.
  19. At best the research findings are only valid for adult circumcision volunteers, and populations with high prevalence of HIV, not babies or low prevalence nations. At worst the research is so floored the findings only have validity within similar research conditions and virtually zero validity for real world situations.
  20. Comparisons with vaccinations are invalid.  Most vaccinations are administered orally, dermally or via injection and not surgery removing healthy tissue.  Those that are vaccinated are virtually fully protected, and those that come within proximity, whereas circumcision only partially protects the male for a period of 18months, does not protect female or male partners, with evidence of increased infections in female partners od circumcised males, does not protect against blood exposures, or injecting users, does not protect against male to male sex.  A very poor vaccine indeed.
  21. The conclusions to circumcise baby boys does not follow from the experiment which was tested on male adult volunteers for a period of 18 months.
  22. The research does not explain how many circumcised populations have higher HIV infections than non-circmcised populations.