
Self-Experimentation and Its Role in Medical Research (2012) - wslh
http://pubmedcentralcanada.ca/pmcc/articles/PMC3298919/
======
gumby
Bit of experience here: in the USA the FDA gets very upset about unsanctioned
experimentation. There is a quasi-exception. The one drug I worked on that
made it into trials had previously been tried on one human -- me. I already
knew it wouldn't have tox implications -- we were more interested in the
injection procedure itself. Plus we did some diffusion tests on my tissue
which showed results consistent with the guinea pigs. The quasi-exception is
that I was the CEO -- even the chief scientist couldn't do it since it could
later be claimed I coerced her. But supposedly the CEO couldn't be coerced.

It's only a quasi-exception since you still have to report it in the back of
your NDA (New Drug Application) and you're reporting a violation of procedure.
But the NDA is enormous (used to be truckloads of documents, though now
electronic), and by that time you have hundreds of human experiences with the
drug. Obviously with an n of 1 it can't count as trial data, you're just
writing up that once you were naughty.

(the whole process is weird -- technically, when you apply to test a new drug
you're not actually asking _permission_ , you are actually asking the Agency
is not to prosecute you for using an unlicensed drug because you promise to be
careful and that your plans fit into one of the exceptions written up in
section 505(b) of the food and drug act.)

------
beefman
The team that discovered ibuprofen routinely tested candidates on
themselves.[1] It wasn't uncommon. My dad did it at Merck in the '70s. In one
case, he and his lab partner took a candidate appetite suppressant
(serotonergic) and then went out for Chinese. They ate like kings and
concluded it didn't work.

[1]
[http://www.bbc.com/news/health-34798438﻿](http://www.bbc.com/news/health-34798438﻿)

------
kirrent
I remember attending an interview where Barry Marshall jokingly claimed that
he was the only person who'd ever earned a Nobel prize with a study size of
n=1. At the time it seemed like a reasonable claim, not just a joke, and it's
now interesting to me to see how wrong he was with that joke.

~~~
gumby
Yeah, I was surprised not to see his case mentioned until I learned from the
article itself how common it is.

