OK, I told myself that i wasn't going to get into this...but just one comment and then I quit...albeit, a long comment...
My job is as a Regulatory & Compliance Consultant. I am currently working for one of the biggest pharma companys in the world. I am dealing with the writing of electronic submissions (which is the only way to submit applications, as of June 09, unless you get an exception from the FDA, and that's only a temporary one) for new drug applications, new devices and one combo product. Within the submission process, I deal extensively with clinical trials that are part of the applications, life cycle management, etc...all of which have new Codes of Feneral Regulations and Guidances written to try to help you understand the CFRs...I even teach classes on deciphering the CFRs and Guidances...boring classes that even I can't make entertaining...but anyway...
If you guys want to have an intelligent conversation about them...go to FDA.gov and search on Code of Federal Regulations and the Guidances that go with them...make sure you have the most updated ones...that's the little 'c' in cGMP, it stands for 'current' Good Manufacturing Practices...lots of infomation...there will be more than a few that could possibly apply. That is always a good debate in one of my classes...but even then it would be narrowed down to arguing about ONE specic Reg. So, determining what does and does apply is, in itself, a tedious process, such as, the stents are devices...the procedure to implant them is something else...now if they decide to put a drug in the stent, such as J&J has done with heart stents, in the past...that's covered under 'combo' products...there's a lot to read and most quite convuluded and boring...and they are just 'guidances' the FDA does not tell a company what it needs to do to get a drug, device, etc. approved, they just give you (what they call) guidance. However, before all this gets set in motion, the company's R&D scientists will meet numerous times with the FDA before they get too far into a trial and then realize it isn't what the FDA will approve anyhoo...
To summarize and stop my pontification...if you want to continue with this arguement, you should really at least have half a clue about which you so stringently argue...none of you understand how this works and as amusing as you were for a while...I'm pretty sure, you've covered this very complicated matter in a very juvenile manner...sorry to break the bad news to ya, but yep...y'all sound ridiculous...it will take years and studies of all types...mostly stuff that is understood, honestly, by a very few smart scientists, statisticians, risk mitigators, etc...oh, and if you do decide to go look all this up, then dont leave out all the Guidances and Codes on "Risk".
So, if the point is that there will be clinical trials in the future? Many. Will they prove out one side or the other? Depends. Are clinical trials useful? You betcha...is this conversation? Not at all...
Sorry
...But if you do pursue this...you'll probably need what would amount to a whole new forum...
See how (not) interesting my diatribe was? And I do know of what I speak...if that gives you a clue as to why I had to put my two cents worth in, after I promised myself that I wouldn't...OK, ok, I'm really done now...
Lisa aka CNClear
