9 ms·
"Unfortunately, we can't just order a batch and inject Bertrand. We need to get FDA approval, and we'll need Genzyme's cooperation. Even though his disease is
by orbenn 14y ago
"Unfortunately, we can't just order a batch and inject Bertrand.
We need to get FDA approval, and we'll need Genzyme's cooperation.
Even though his disease is life-threatening, his seizures are worsening and he continues to lose white matter, we'll need to prove that it's safe."
It's shit like this that makes me hate the FDA.
- meepmorp 14y ago> It's shit like this that makes me hate the FDA. So, what? You'd prefer no enforcement of basic drug safety testing? There are reasons why we have the controls we do in medical trials, other than just to provide busy work to career bureaucrats and generally make trouble for sick people. There is a process for getting patients access to investigational drugs, but you still typically need to do some paperwork in order to provide the drug to the patient. Given this is a new use of an existing, approved drug, this should go fairly quickly.
- CamperBob2 14y agoYou'd prefer no enforcement of basic drug safety testing? If only there was a middle ground of some kind.
- ef4 14y agoI don't think this is an approved drug. It's sold as a reagent to laboratories, but not used for anything medical.
- meepmorp 14y agoI think you're right. I just checked a manufacturer product page, and it looks like its just used in labs currently.
- deleted 14y ago[deleted]