The hazardous drug used in an unlicensed way
The author (a clinician) sent in a case series, involving two patients. Both patients presented with severe pain, which was resistant to strong analgesics. The author then gave them a drug with potentially very serious sideeffects, including a small risk of disability or death. This drug is only licensed for a small number of indications. Neither of these two patients met the clinical criteria for its use, yet the author gave it to them in a quasi-experimental way. It is unclear whether the doctor told them that the drug was being used in this way. There is no mention of informed consent or ethics committee approval. In the UK, when using this drug for its licensed indications, it is a standard procedure to warn patients about the serious side effects and ask for their consent before giving it. Does COPE feel that this constitutes clinical and/or research misconduct?
_ Where there has been no hypothesis, but yet the treatment has worked, what should then transpire? _ The authors were not suggesting that this was research, and it is not possible to assess how hazardous the treatment was from the information given. _ The treatment should have been carried out with patient consent, and the editors must be satisfied that this has indeed been obtained. _ This prerequisite should be met before submission and should be made clear to all authors intending to submit manuscripts. _ Ethics committee approval was not required in this case, but patient consent was necessary.
The author was contacted. The reply merely says “Thank you for the letter. ” The editor will write again. The author was contacted, but the reply was an automatic receipt. The editor did not write again.