All or none.

[trotsky]

Classic hallmark of woo thinking.

If the FDA doesn't prevent ALL cases of bad drugs or treatments, then they are good for NOTHING.

How can you argue with this mindset? Exactly what perfect utopia does its holder think we live in? The FDA is set up to fail. If they delay something to assure safety, they're withholding life-saving treatment. If they let something go into the market and someone is harmed, well they obviously should have held on to it longer!

Is the FDA perfect? Hell no. They've never had the budget they need. There are too many cozy relationships with the industry they're supposed to regulate. But it's all we've got, and I shudder at the alternative libertopia that the woos evidently would prefer: individuals figuring out for themselves what's safe and what's not, and gambling with their health based on the contents of a YouTube video.

Just a rant, I guess, from reading the Health Scare Lounge too much lately. Thank you for your time.

[TZ]

1. See this shit REALLY irritates me.

These same woos scream about the EPA, USDA and other regulatory agencies NOT doing their job. Or if they try to regulate unregulated crap like supplements its THEY ARE TAKING OUR HERBS AWAY!
And it FUCKING PISSES ME OFF BECAUSE I HAVE THE FDA LOOKING OVER MY SHOULDER EVERY FUCKING DAY!!!!
I wish these morons could sit through an FDA inspection. I can't tell you how many hours of training I have had on how to deal with an inspection especially a SURPRISE inspections.
Sorry Trotsky, thought I would take a chance to rant as well, since I am one of the few people here that does deal with the FDA/regs on a daily basis really.

[trotsky]

3. I interviewed once at a small pharmaceutical company.

I work in I.T. The guy who would have been my supervisor showed me the friggin STACK of papers that HE had to certify from an upgrade they were doing on their CRM system! The freaking I.T. department! My goodness, that outfit was regulated to within an inch of its life and it wasn't even close to being one of the major players. I can only imagine what it's like for researchers like you.

[lizerdbits]

5. We have one IT guy who does virtually nothing more than

focus on the validation of programs for GLP studies. When you put data into Excel, Prism, or any program for a GLP study it has to be validated (a nightmare I would never want to experience) and you can only do it on certain computers that aren't hooked up to your network. If it's hooked up to the network then other people could access and alter your data. We also had to hire a temp specialist to validate our document control system once we went to an online format and that took a year. It had to be proven that there was no way around 'read only' so you couldn't change SOPs outside of the normal procedure. We don't do human studies either, but some of our animal data could be used to design human trials or for the "Animal Rule" where human trials are not possible or ethical.

[varkam]

2. Health Scare Lounge. I like it!

I think a lot of people just don't know about what the FDA actually does, or the process that drugs have to go through. Like you say, it ain't perfect but it works (at least most of the time). I, too, tire of calls to dismantle the FDA whenever they screw something up - as if that will make us safer somehow.

[trotsky]

4. Can't take credit for term.

I think it's cosmik's. But it's perfect, isn't it?

[Orrex]

6. Infuriating, indeed

The other maddening half of it is that Woos are forgiven any number of bad decisions, bogus treatments, expensive magical waters, and ineffectual touchie-feelie new ageisms, as long as just one of their magical therapies just happens to work, even by accident, somewhere along the way.

Double standard? Nah...