We received a pre-submission enquiry about whether we were interested in publishing a case report of a novel therapy that provided “a complete cure for heart disease.” The therapy involved a “membranotrophic drug” combined with diet and exercise.
The therapy had been given to a patient who had experienced a myocardial infarction. Eighteen months later, the patient was apparently free of heart disease.
The presubmission enquiry stated: “This experimental treatment was at all times under the supervision and with the consent and approval of several cardiologists, a cardiac surgeon and a neurologist.” But there was no mention of whether the patient had consented to receive this “experimental treatment” or whether an ethics committee had approved the n of 1 experiment.
We wrote to the lead author to clarify these two points, and the lead author wrote back to say that he himself was the patient, and that he wanted to spread the word about this dramatic treatment and the “membranotrophic drug.” The article had previously been rejected by four biomedical journals.
It remains unclear whether the patient knew this was an n of 1 trial. He is delighted with the outcome, and is writing up the case, but can we assume that his delight constitutes sufficient consent?
This paper was written in a very oblique form. It is also very unusual, because the author is the patient! The paper is from the US from a private practice and the editor was not able to find out more about the co-authors. The author of the paper was a surgeon. The author of the paper was not able to provide a consent form (signed by himself). The committee thought that was a rather unusual situation, but was concerned if the treatment had not worked. Then the doctors providing the treatment would have been at fault. Other editors shared their experiences of where authors had applied the procedures to themselves and then tried to publish the papers.
The committee thought it was doubtful that the editor could take this any further.
There was no follow-up. The paper was rejected.