I mentioned health woos in a departmental training session yesterday

[TZ]

We had our annual training course on FDA regs (GMP and GLP) on how biopharmaceutical companies conduct their research...A three hour session on how the regs work how the researchers need to conduct themselves and the role of company QA.
When the QA guy talked about how much time the FDA looks through ALL the data (good and bad--not just "good data" as some woo claimed Pharmas do the other day) and takes a lot of time analyzing it. I mentioned that I heard of people who think the FDA just rubber stamp everything submitted by Pharmas and his response was classic...Eye rolls, big sigh and a "I can tell you that is NOT AT ALL the case....":rofl:

The other thing woos don't understand is how much WORSE things were before the FDA put these regulations in place in 1978. The QA guy was telling us a bunch of horror stories with animal/toxicology testing before these regs..Including my personal favorite an animal that died early on in a study and yet...later on reappeared again!! Zombie toxicology.....:rofl:

For those who think the FDA does nothing..No.Not at all true..and for those who think Pharmas don't respect the FDA...I've been in the building of a company when an unannounced FDA inspection occured. Can anyone say Chinese Fire Drill? The air of fear is palpable....

[lizerdbits]

1. We got an FDA visit but it was before I started so I didn't get to see it

although we just do animal work but some of our data might be used in the 'animal rule' which states if it's not ethical or possible to do the same trial on humans the data can be used to approve limited use of things like alternative smallpox vaccines. So we're still subject to FDA.

I did get to see the scramble for a CDC inspection of our facilities and now that we've got some H5 viruses we're also subject to the USDA since it's a poultry disease. We all got our usual email to keep the noise down and had to rearrange our work schedule due to a facility inspection and our big conference room full of 3829 notebooks and 3 people.

[Warpy]

2. I know the kind of paperwork I had to keep as a nurse

in any area where a double blind study was taking place on sick people, the new drug versus an old line drug. We had to keep reminding them to report anything that felt different to them while they were on the study and had to report every belch and fart. Then there were the metabolic studies with the blood sugar tests every 5 minutes...yeah, we put a line in for those so we didn't have to keep stabbing their fingers.

Trust me, all that stuff didn't just go into some circular file in some flunky's office. It was all tabulated. Some of the belches and farts were random. Some were later listed as side effects of a particular drug if enough patients getting the drug reported them.

The truth is that everybody at every step of the process keeps an eye on people getting any medication both before and after it's approved. Sometimes the extent of adverse effects aren't known until enough patients are taking a drug for it to show up; such was the case with Vioxx and an earlier pain drug, Zomax. Sometimes the drug companies try to cover it up like they did with Vioxx. The consequences usually outweigh the profits, so most of them acquiesce to black box warning labels as soon as a problem becomes known.

People outside the system just have no idea. I guess from a response to one of philb's latest idiocies in "Health," we just have to keep setting the record straight. People out there will listen.

[lizerdbits]

3. I feel sorry for those of you who had to record all that

I got a couple vaccines for stuff I work with that are considered Investigational New Drugs. (Stuff that someone not working with it would not likely get exposed to so they probably won't ever try to get them approved.) Every appointment it's 500 questions since even though a lot of these have been given for decades it's still GCP. I would never have the patience to enter all that information into some giant database.

[Deep13]

4. Speaking as a nonprofessional...

...I enjoy not having died of or crippled by numerous diseases: infections, killer childhood diseases, polio, dysentery, cholera etc. etc.