A physician in private practice wrote to our journal asking if we were interested in a paper discussing his experience of offering a novel intravenous therapy to his patients. He hoped we wouldn’t discriminate against him for being an author in private practice. He had given this therapy to nine patients with a variety of acute and chronic illnesses, including himself. The physician says that all patients went into remission. He did not compare this new therapy against any standard therapy. It is unclear from the physician’s letter to us whether the patients knew that this was an untested experimental treatment, or that they were essentially in a trial. The physician made no mention of whether he obtained informed consent from his patients. He made no mention of ethics committee approval. We therefore wrote to him to ask about informed consent and ethics committee approval. He then faxed to us 7 signed consent statements from his patients, which were clearly collected in response to our request—after receiving the treatment. The statement which the 7 patients signed said, “I have been informed by Dr X that the treatment I received for my disease Y was not an established treatment for the disorder and that I may or may not benefit from the treatment.” Five of the seven patients signed a statement that had the additional sentence: “As I have benefited from this treatment, I wish that Dr X give me this treatment on an needed basis in the future.” We still have no indication of ethics committee approval. The author has a patent on this treatment.
Case number:
04-21