FDA approved nonexistant product set up by Congressional sting operation

[a completely inoffensive name]

http://coto2.wordpress.com/2011/01/1...human-testing/

In another thread, I showed both my contempt and ignorance at the Pharma Industry to which Rory kindly pointed out to me what the real situation from his perspective is. However, these kind of stories hit my feed a lot and they kind of continually whittle down my tolerance of Big Pharma in general and the notion that Big Pharma hasn't got its corrupt hands within government.

EDIT: Found an article back when the sting actually happened. http://www.nytimes.com/2009/03/13/business/13sting.html

[Crazed Rabbit]

The title is misleading. An FDA subcontractor approved testing plans for a drug. They didn't approve the drug or any real test results.

Also, this site seems to have a lot of stupid, namely they support the hysterical, thoroughly disproved anti-vaccine scare: http://coto2.wordpress.com/2009-vax-scam/

Approval of poor drug testing plans is somewhat worrying. But I'd worry about the FDA denying experimental drugs to cancer patients first.

CR

[Xiahou]

Also, this site seems to have a lot of stupid, namely they support the hysterical, thoroughly disproved anti-vaccine scare: http://coto2.wordpress.com/2009-vax-scam/

Yeah, they lost me as soon as they mentioned their raw milk quackery.

[a completely inoffensive name]

Yeah, it's why I found the second article, I wanted to make sure this story had a credible website talking about it. Otherwise I would have just edited all this out.

[Crazed Rabbit]

Yeah, the NYT is waaaaaaaaaaay more legit (I'm not being sarcastic).

But it's possible part of the reason Congress went after was indeed grandstanding. That's part of their daily bread and butter.

And given what I've read about the arduous process new drugs being tested must take, even these sort of slip ups by subcontractors won't allow unsafe drugs to sneak onto the market. If the subcontractors controlled the whole process and operated like this, I'd be worried.

CR

[rory_20_uk]

Thoughts:

It's a review board. Not licensed. MASSIVE difference. I mean, truly vast. From the articles I am not exactly sure what they were asking for. Was this seeking approval for a phase 1 trial?
Not so many years ago, for Phase 1 trials, companies didn't need approval. They just paid some people and gave them the drugs and saw what happened.

The system seems incredibly lax, as most of the time the companies need such good evidence for the drug approval (which is a different thing, requiring about 50,000+ pages of data and explanations and three rounds of questions from experts, plus a Q&A in person if required) that they were relying on the company only needing a rubber stamp - as no one can afford to blow tens of millions on a duff trial (plus the indirect cost to be seen to be taking risks).

These... non ethical ethics committees should be scrapped, but this isn't evidence that bad drugs are getting to market - as the author happily makes the herculean jump between this and post-registration drug withdrawal (and let's not forget - who finds out these drugs are dangerous? The companies themselves - as they undertake PSUR - Periodic Safety Update Reports!!!)