Watching this FDA thread triggers historical recollections shattering a few cog-webs. To understand FDA one must review the influence of Frances Kelsey, M.D. Until Dr. Kelsey's time FDA was a more or less "rubber stamp" for the drug companies. For some reason it is getting harder to find her connect FDA connection in the past two years. Even an extensive report on FDA fails to mention her name. http://www.cato.org/pubs/regulation/reg18n2c.html
However, she still gets some recognition. http://www.pnc.com.au/~cafmr/online/research/thalid2.html http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.ht ml Rhetoric abounds decrying cost of medicine in the U.S. to the point some advocate importing from Canada. Adding that to the recent fiasco regarding the COX inhibitors leaves plenty room to wonder about efficacy of FDA. I am somewhat concerned when I listen to physicians, who haven't bothered to check profitability, or PE ratio, lament drug costs. Sure, as an industry pharmaceuticals do well, though not the absolute highest performers. Still, our FDA approval process has far more influence on costs than any imagined profitability. And, while helpful, FDA is not the panacea of how well we practice medicine. I recognize this (thread) conveys a bit of philosophy. thurman > -----Original Message----- > From: [EMAIL PROTECTED] [mailto:hardhats- > [EMAIL PROTECTED] On Behalf Of Greg Woodhouse > Sent: Thursday, August 11, 2005 1:02 PM > To: hardhats-members@lists.sourceforge.net > Subject: RE: VistA Imaging FDA and NonCommercial Use Re: [Hardhats- > members] Re: TIU Interface for Document Scanning > > Fair enough. It is just disconcerting to see all this talk about how to > find "loopholes" in FDA regulations (e.g., the use vs. marketing > discussion). I realize not everyone lives in the U.S. and not everyone > is subject to the same laws, but I'd think VistA developers would want > to embrace regulations designed to promote quality and safety, not > attempt to skirt them. > > As far as scanned documents go: well, I think I've already said I think > trying to use medical imaging software and equipment to manage scanned > documents is a ridiculous case of overkill. But I'll just leave it at > that. > > --- Thurman Pedigo <[EMAIL PROTECTED]> wrote: > > > They may be still safer than some chemicals promoted in health food > > stores - > > or more important, consider the safety of paper records - where is > > FDA > > there? ...thx/t > > > > > > === > Gregory Woodhouse <[EMAIL PROTECTED]> > > "Design quality doesn't ensure success, but design failure can ensure > failure." > > --Kent Beck > > > > > > > > > ------------------------------------------------------- > SF.Net email is Sponsored by the Better Software Conference & EXPO > September 19-22, 2005 * San Francisco, CA * Development Lifecycle > Practices > Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA > Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf > _______________________________________________ > Hardhats-members mailing list > Hardhats-members@lists.sourceforge.net > https://lists.sourceforge.net/lists/listinfo/hardhats-members ------------------------------------------------------- SF.Net email is Sponsored by the Better Software Conference & EXPO September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf _______________________________________________ Hardhats-members mailing list Hardhats-members@lists.sourceforge.net https://lists.sourceforge.net/lists/listinfo/hardhats-members
