A patient was given an experimental course of complementary medicine when a standard treatment was available
A case report was submitted to a journal, describing a patient with a very serious, curable infectious disease who had been given complementary medicine (plant extract) rather than the standard treatment. A search of the literature indicated that the authors were known to support complementary therapies. The alternative treatment was not evidence based. The case took place in a country were the standard treatment was easily available. The authors reported that the patient had given informed consent, but did not provide any detail. No mention was made of ethics committee approval for the experimental treatment. The editors in particular questioned the acceptability of: 1. prescribing a new therapy, without evidence of its efficacy, for an infectious treatable condition; 2. prescribing experimental treatment without ethics committee approval; 3. how well the patient was informed. A full review of the manuscript echoed these concerns. The authors were asked to confirm/explain if they had received informed consent from the patient and ethics committee approval. They were also asked to clarify the treatment plan. In a brief email, the authors stated that they had received both consent from the patient and ethics committee approval, but after several chases, have failed to send the corresponding documents. The authors also stated that the patient was started on the standard treatment course “3 weeks later. ”The manuscript was rejected. Should the editors take further action? Does the fact that the authors advise that the patient was given standard therapy make any difference?
_ Was this a doctor’s choice rather than the patient’s decision? Had the patient specifically requested the alternative treatment? There was no evidence to prove either. _ This is a grave issue and the editors should definitely pursue the authors for documentation of the patient’s consent and ethics committee approval. _ To have undertaken such a course of action without either of these calls the authors’ medical practice and judgement into question. _ The editor should write to the authors again with a short deadline, informing them that the matter would be referred to both the authors’ employers and the appropriate regulatory body. _ Even if the patient had pleaded for the alternative therapy, the fact that the disease is infectious and potential fatal means that public interest would outweigh the patient’s preference. _ The editors should write to the regulatory authorities as the course of action taken had endangered both the patient and other people. _ The police might also have the jurisdiction to investigate. _ The burden of investigation does not lie with editors; it is their duty to inform the relevant authorities.
The editors have written to all the authors explaining their editorial decision and intention to submit the case to the relevant authorities. Lawyers wrote back on behalf of the corresponding author. One author was unreachable because the email address was invalid; another expressed surprise at receiving the editors’ message, explaining that he could not remember having approved any manuscript for submission. The editors are now planning to write to the authors’ institutions and regulatory bodies.