This research article investigated the effect of the widespread administration of a homeoprophylactic preparation against a bacterial zoonotic disease in a developing country after a period of particularly heavy rainfall. The authors claim to have given this oral preparation to all members of the population over 1 year of age, in three provinces of the country where this disease is prevalent (over 2 million people). This was done in parallel to the country’s conventional vaccination and surveillance programme. The authors claim that this intervention significantly reduced the incidence of the disease in the treated provinces compared with the non-treated provinces.
We asked the authors to provide more information on how they had addressed the ethical aspects of this study and to provide supporting documentation. They stated they would include a paragraph on ethical considerations in the text, but argued that the principle aim of the study was to report the results of a healthcare intervention as a response to an emergency situation and was not classical clinical trial research. They further argued that the product used in the intervention is a registered product of common use on the public health system of the country in question and all the administration was approved and regulated by the “National Regulatory Agency” and “Competing Health Authorities”. They also claimed that they had obtained ethics committee approval from four different ethics committees.
Despite repeated requests from us, the authors failed to provide documentation from the ethics committees or the National Regulatory Agency or to explain how they had obtained consent. They eventually did supply a document in Spanish purporting to be “approval from the National Regulatory Agency for the intervention that was granted after the analysis of proposals by ethic committee and meeting National Regulations from the Minister of Public Health”. However, on translation by one of our Spanish speaking members of staff, it turned out to be a statement of their intention to obtain ethics approval and consent.
We contacted the CDC to enquire whether such an intervention was known to be in use in this country. We were told that they were not aware that this intervention is in use in any official capacity. We rejected the manuscript on ethical grounds explaining to the authors why we were not prepared to consider it. All authors are affiliated to a private institute. The last author is its founder.
We would welcome advice from the committee on whether and how we should take this further, given the scale of the study and the conflicting statements of the authors and the CDC.
The Forum was told that this study was funded privately. The Forum questioned whether it was in fact a study? From the description, it seemed to be a report of a public health intervention. If that is indeed the case, then consent is not needed. The advice from the Forum was to seek confirmation that these interventions actually took place (since the numbers involved are so large and because of the discrepancy with the information from the CDC). Did the government introduce it? The Ministry of Health could be contacted. If the editor discovers that the whole event was fraudulent, then he should bring the case back to COPE.
We attempted to contact the Ministry of Health without success. We have contacted the director of PAHO (the Pan American Health Organization) and are awaiting a response.