Sorry Thurman, but I would like to contribute one last gasp on this thread. And Rubin, I thought you were doing better at trying to avoid that stroke, but I fear you are falling off the wagon! As I recall, you are a pharmacist, so it is understandable that you are knowledgeable and passionate about this subject.
It is a popular theme promoted by the drug companies to blame the FDA for delays in approval and for costs, but, in my opinion, it is overblown. My late husband worked at the FDA for 10 years and would have confirmed the astounding sums spent on marketing and at least some of the stories of delays that were not the FDA's doing, but because of the requirement that proprietary information be kept confidential, they were largely prohibited from exposing the truth. He and his colleagues did manage to publish an article or letter to the editor, I don't recall which, that exposed one nefarious practice. Research submitted to the FDA as part of the information needed to win approval for a drug was being published later in medical journals with another, more favorable, endpoint. This is a statistical taboo unless it is disclosed and accounted for. The creation of a database of all drug research would likely help to curb such practices, which is one of the reasons such a database would be desireable. I do not believe any drug companies are paying for trips for doctors any longer as the ability to spend money like this has been severely curbed, thank goodness. As for pill splitting pills, if you really want to get that cost down, split the generic, lovastatin. The efficacy might be slightly less, however. Thanks to the VA for publishing the research showing such pill splitting is safe and efficacious. Now back to the FDA regulating drugs and software. CDER is drugs, CDRH is for devices. I certainly could have used my husband's help at sorting through this device regulation business. On Friday 12 August 2005 03:34 pm, James Gray wrote: > ----- Original Message ----- > From: "Ruben Safir" <[EMAIL PROTECTED]> > To: <hardhats-members@lists.sourceforge.net> > Sent: Friday, August 12, 2005 10:44 AM > Subject: [Hardhats-members] RE: VistA Imaging FDA and NonCommercial Use Re: > [Hardhats-members] Re: TIU Interface for Document Scanning > > >> Still, > >> our FDA approval process has far more influence on costs than any > >> imagined > >> profitability. > > > > That's just a flat out lie. The companies spend more in their bribery > > than they do on regulatory affairs or research. In fact, its not even > > close. > > > > > > Ruben > > Ruben, I wonder why you are the only member of this list that uses such > inflamatory negative words. I think that a careful logical analysis would > even indicate that the meaning of the word "lie" is not accurate to > describe the assertion of another member of this list. > > Jim Gray > > > > ------------------------------------------------------- > 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 -- Nancy Anthracite ------------------------------------------------------- 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
