Sounds like desperate people trying something highly experimental, it's a gamble.
So mike, by your logic, no drug developed in the last 80 years or so is safe.
Nothing should ever go to clinical trials if it doesn't work the first time you pump it into some one. After all, if it doesn't work the first time it's administered at a random dose by some Doc who's only read about it in a magazine, it can never work at all.