Spiritual Musings on a Chemical World

Monday, August 20, 2018

Freak of Nature: The FDA Approval Process

So, first of all, let's talk about the FDA drug approval process. According to fda.gov, Phase 1 of the clinical research process is the only stage of the FDA drug approval process that tests a new drug on healthy patients. All other phases are tested on patients with the condition a drug is intended to treat.

In Phase 1 of clinical research, their are only 20-100 subjects the drug is tested on. That's not very many!

Well, of course, safety is studied more in depth later on, on subjects with the condition. So, obviously, if you are being forced to take this drug, you indeed have the condition. There's no such thing as being misdiagnosed.

So if bipolar patient's brains differ in structure from other people's, it doesn't matter because we know for a 100% proven fact you do indeed have bipolar disorder.

Anyway, these are also subjects who are participating voluntarily. So if there is an intelligence gap between people who voluntarily agree to take unsafe medication and people who refuse, and thus a difference in brain structure, we wouldn't know about it.

So anyway, Rachel is being forced to take a new medication and is experiencing rapidly cycling mood up and down and up and down. When she is up, she sits by the bath tub and laughs her head off. When she is down, she contemplates suicide.

All this started the day her morning dose of Geodon was discontinued due to excessive morning sleepiness. Previously, we were giving her one after one (a basic grade of behavior, ones are bad, two's passing, three's excelling) due to falling asleep in group. As soon as the morning dose was discontinued, around about 3 pm she starts cycling rapidly up and down with her moods. Due to the fact that she is diagnosed bipolar, and mood swings are not a known side effect of Geodon, we can conclude that her condition worsened the same day we discontinued the morning dose of Geodon.

And we will continue to ignore Rachel's desperate pleas for us to take her off this medication.

No comments:

Post a Comment