[Note: For more information, see Jim Thornton’s 11 October blog on “Boston/Botswana circ. trial update,” available at: http://ripe-tomato.org/2013/10/11/bostonbotswana-circ-trial-update/]
As part of medical research to find the best technique to circumcise new-born boys in Africa, a doctor in Botswana circumcised 300 babies 2-11 days old during 2009-10. The US government paid for the research, and a doctor from Brigham and Women’s Hospital in Boston managed the research [reference 1, below].
Three of the 300 babies died within 4 months after being circumcised [reference 2]. There is no controversy about two of the deaths: one baby died after “prolonged coughing and diarrhea” more than 10 weeks after being circumcised; a second died of gastroenteritis 25 days after circumcision .
However, one baby’s death raises questions. The day after being circumcised, the baby was brought to the local health center with fever and difficulty breathing, and was then transferred to the district hospital. He died that day – only 3 days old and 1 day after being circumcised. The research staff did not learn of his hospital admission or death until the next day .
Did the circumcision contribute to his death? Without reporting any information from blood or other tests or any observation of the infant’s circumcision wound, the study team in April 2013 reported the baby “died of neonatal sepsis on his second [3rd?] day of life, with the death reviewed by the study Data Safety and Monitoring Committee, Botswana Health Research and Development Committee, and Brigham and Women’s Hospital Institutional Review Board and not thought to be procedure related” [emphasis added; from pp e133-134 of reference 1].
So, with stout denials but minimal information, the question is still there: Did the circumcision contribute to the baby’s death?
Here’s an expert opinion by Dr Jim Thornton, former editor of the British Journal of Obstetrics and Gynecology (quoted from: http://ripe-tomato.org/2013/10/11/bostonbotswana-circ-trial-update/): “A healthy term baby dies 24 hours after a research operation and no tests nor autopsy are done. However the researchers, their own DSMC [Data Safety Monitoring Committee], and the two IRB’s [Institutional Review Boards] who had approved the research all conclude ‘that it was extremely unlikely that the baby’s death was related to the circumcision procedure’! Am I going mad? ‘Extremely unlikely’! How can any sane doctor possibly conclude that?”
Medical researchers are ethically and legally responsible to protect research participants. Because the study was funded by the US government, US laws apply. The research team did not report adequate information to support their claim the death was unrelated to the circumcision. Without convincing evidence the death was not related, it should have been reported as possibly related, as required by US regulations (see section b in this link: http://www.hhs.gov/ohrp/policy/advevntguid.html#Q2; see also regulation 45 CFR 46.103(b)(5) in this link: http://www.gpo.gov/fdsys/pkg/CFR-2011-title45-vol1/pdf/CFR-2011-title45-vol1-sec46-103.pdf ). Accepting the possibility the circumcision was at least partially responsible for the baby’s death, the researchers should have reported the death as an adverse event and compensated the parents for the death of their child.
Because the death was not adequately explained, because researchers’ denied responsibility with insufficient evidence, and because the Institutional Review Board at Brigham and Women’s Hospital’s did not insist that researchers adequately explain the death and/or acknowledge the possibility the death may have been related to the research, the US government’s Office for Human Research Protections should investigate the death, the management of the research project, and the conduct of the Institutional Review Board.
On 18 July 2013, eight doctors disturbed by the baby’s death wrote to the US Office of Human Research Protections asking for an investigation and complaining that the Institutional Review Board’s “monitoring of adverse events [ie, the 3rd baby’s death] was inadequate.” The doctors stated: “In our opinion the conclusion that ‘it was extremely unlikely that the baby’s death was related to the circumcision procedures’ is irrational. This was a healthy newborn baby. The death occurred 24 hours post procedure. No investigations were done… We believe that the IRB [Institutional Review Board] had ceased to protect the research participants, and was protecting the researchers from criticism” (quoted from their letter, available at: http://ripetomato2uk.files.wordpress.com/2013/10/allegation-to-ohrpe.pdf (accessed 24 October 2013).
Overlooking the unexplained death, the research team concluded: circumcising babies “can be performed safely in Botswana”[quoted from p e136, reference 2]. That conclusion is doubtful. Here’s an unintended conclusion from the research: If you agree to be a participant in medical research funded by the US government in Africa, you might not be protected by US regulations. Here’s another unintended conclusion: You probably shouldn’t believe everything you read about the safety of circumcision in health care settings in Africa.
1. Plank RM. Infant male circumcision in Gaborone, Botswana, and surrounding areas: feasibility, safety, and acceptability. Study record, trial NCT00971958. Available at: http://clinicaltrials.gov/show/NCT00971958 (accessed 26 October 2013).
2. Plank RM, Ndubuka NO, Wirth KE, et al. A randomized trial of Mogen Clamp versus Plastibell for neonatal male circumcision in Botswana. J Acquir Immune Defic Syndr. 2013: 62: e131-e137. Available for free download at: http://journals.lww.com/jaids/Fulltext/2013/04150/A_Randomized_Trial_of_Mogen_Clamp_Versus.14.aspx (accessed 24 October 2013).
3. Plank RM. Author’s Reply: A Randomized Trial of Mogen Clamp Versus Plastibell for Neonatal Male Circumcision in Botswana. J Acquir Immune Defic Syndr. 2013; 64: e13-e14. Available for free download at: http://journals.lww.com/jaids/Fulltext/2013/10010/Author_s_Reply___A_Randomized_Trial_of_Mogen_Clamp.20.aspx (accessed 24 October 2013).