I read this on IHUB I read it, but don’t participate I’m bored, so will address this very obnoxious twit
You’re aware that this little letter writing campaign was tried previously, and failed. (Thanks for the reminder, I didn’t participate in that one)
The product is cleared in 50 countries (or whatever) because efficacy is not a criteria (sp) for clearance.
(In my world, efficacious means the p value is less than 0.05. This is also the world the FDA should be in. Which planet do you hail from?)
In the US, it is. And that’s why it’s not cleared. (The Actipatch is efficacious based on the data given. Try debating the study set-up, and I would take this more seriously, but BIEL has the numbers.)
Writing letters attempting to sway politicians to clear a product because folks are abusing another is simply not going to work. (Google that-try REGEN among many others)
It has never worked in the history of the FDA. (Google that-try REGEN among many others)
BIEL attempted this once, and it failed. (we are lucky you were not a Wright Brother)
And I know, I know…there is a new sheriff in town at the FDA..but the regulations don’t change. (They do, though, don’t they, except for Flat Earth morons with a Soviet mindset.)
Show efficacy and the product will be approved. Don’t, and it won’t. (you seriously never heard of Google)
No amount of letter writing can make the clinical trial data magically significant. (AIDS protesters managed it by marching in front of the FDA—political pressure. Are you saying letters don’t work from commoners and we have to take it to the streets? Or are you just ignorant in general?
But if it makes you feel better, continue on. (Thanks you for validating my existence, TENS Troll.)