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Do medical researchers in Africa protect babies? Maybe not always


[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 [3].

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 [3].

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.

References

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).

One response to “Do medical researchers in Africa protect babies? Maybe not always

  1. Joseph4GI October 26, 2013 at 5:18 pm

    I think the history of circumcision and related deaths in the United States bears mentioning.

    Currently, approximately 80% of the American male population has been circumcised from birth. This is because the circumcision of healthy newborns was performed routinely in hospitals. The rates of newborn infant circumcision have dropped considerably, from about 90% in the 1980’s, to about 55% today. Infant circumcision was once common in most English speaking countries, but it has fallen out of style, except in the United States, where approximately 1.2 million boys a year continue to be circumcised.

    As infant circumcision in the United States is a falling trend, and its validity as legitimate medical practice is increasingly being questioned, circumcision advocates have been trying to reverse this trend by flooding medical literature with “research” that says infant circumcision is “medically beneficial.” In particular, a quest to link circumcision with a decrease in HIV transmission began in 1986, when circumcision advocate Aaron J. Fink began promoting the idea that infant circumcision could prevent HIV, without any demonstrable proof according to his very own admission. Since then there have been a number of “researchers,” mostly American, interested in writing “studies” that show circumcision prevents HIV, and that infant circumcision is “harmless,” always culminating in the suggestion that the majority of males must be circumcised.

    As circumcision is still a common procedure in the United States, and the American medical profession profits financially from it, there is a conflict of interest that brings the validity of the “circumcision studies” being churned out by American researchers. Reporting negative results puts American “researchers” in the awkward position of questioning a procedure that is still commonly performed in their native United States, and bringing the physicians that continue to offer and realizing it for parents into disrepute, not to mention the disrepute of “mass circumcision campaigns” that are already being carried out in Africa. Grants that researchers themselves may be receiving from parties that want to see circumcision flourish may also be at stake. There is therefore much incentive to only publish positive data regarding circumcision, while suppressing negative data.

    It is a known fact that deaths that occur as a result of circumcision are often intentionally misattributed to secondary factors to hide any connection of the death to the circumcision. For example, instead of reporting the death as happening as a direct result of circumcision, the death is attributed to “hemorrhage” or “septic shock.” In media sagas that follow circumcision death cases, one can witness circumcision advocates increasing the time buffer between the time of circumcision and the time of death; perhaps the best example of this can be seen in the death of Amitai Moshe in London, the UK.

    It should be no surprise if this is what is happening here concerning this death. Who is to hold these American researchers accountable in Africa, where American rules of conduct aren’t necessarily enforced? What is the reason this “research” is being conducted in Africa? Is it because American researchers know that they couldn’t get away with this conduct in their native land? Is it because it is assumed no one would ever conduct a serious investigation? Is it because they know they can treat Africans as guinea pigs and get away with it?

    Some facts to know about circumcision death in America; American medical institutions aren’t required to release data regarding death and infant circumcision. Deaths related to circumcision are often misattributed to secondary causes of death. As infant circumcision is an accepted cultural norm in the United States, parents are often complicit in keeping the details of the death of their child secret. There is financial, as well as cultural, perhaps even religious incentive to keep deaths related to circumcision low key. It is therefore very difficult to get accurate statistics regarding circumcision and related deaths in the United States. Perhaps the same should be expected from American researchers who are “studying” circumcision, particularly infant circumcision in Africa.

    I think an investigation should be in order, but the investigation should be carried out by investigators from countries where there is no financial, cultural, religious incentive to distort the truth. Will it ever happen? Or can American circumcision “researchers” rest on their laurels, assured that their reputation is in no serious danger? That’s what I’d like to know.

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