[tasty_freeze]

How is this ethical? The ethics section of the summary simply asserts it was OK, but I don't see how this being done in a private practice excuses them from normal strictures. They say this wasn't an experimental protocol, nor research, so I guess they dosed grandma for shits and giggles?

Ethics statement

Ethical approval was not required for this single case report conducted in routine private clinical practice, in accordance with local legislation and institutional requirements. No experimental protocol or prospective research procedures were conducted. Written informed consent was obtained from the patient’s legal guardian for the publication of this case report.

[12_throw_away]

Not to comment on the overall ethical situation (dunno what constitutes informed consent for an alzheimer's patient in Brazil, presumably it involves some legal guardian), but this is a doctor reporting on an individual treatment of their patient. It is not a research study. Doctors have wide latitude in treating their own patients, they do not require board approval to do so.

[malfist]

> Written informed consent was obtained from the patient’s legal guardian

They didn't even get consent from the person being drugged. That is absolutely insane.

[embedding-shape]

They did, legal guardians, for all intents and purposes, "are the person", otherwise the concept in itself wouldn't really work.

[mschuster91]

> They say this wasn't an experimental protocol, nor research, so I guess they dosed grandma for shits and giggles?

Medical doctors have a veeeeery wide leeway when it comes to the question of what they are allowed to do to patients. If nothing goes wrong or no one complains, pretty much everything goes - ethics reviews are only a thing for large-scale studies.

The exception tends to come from drug laws - in countries like Germany, for example, psilocybin is completely banned from manufacture, possession or prescription outside of highly regulated and specially permitted academic studies, but in countries with more relaxed attitudes, as a doctor you can do individual therapies as long as you find someone willing to pay for it.

In fact, that is a common issue with cancer and rare diseases. A bunch of therapies popular in that space run either with approved medication that gets used for another purpose or in higher/lower dosages (=off label treatment) or with completely new, untested and unapproved substances - that one was an issue here in Germany with a doctor inventing his own COVID vaccine, it ended up being dragged through the courts, with a recent acquittal [1] as the court considered this as an individual therapy.

[1] https://www.lto.de/recht/nachrichten/n/lg-luebeck-corona-imp...