SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Politics : PRESIDENT GEORGE W. BUSH -- Ignore unavailable to you. Want to Upgrade?


To: Mark Harjes who wrote (124294)1/29/2001 6:21:48 PM
From: Patricia Trinchero  Read Replies (1) | Respond to of 769667
 
The FDA doesn't stop any innovator from anything. Unfortunately, rare diseases don't bring forth the financial return that common diseases generate so many potential drugs for rare diseases get "deep six'd" early in the game. You can blame the FDA if you like but it's also the fault of the businessmen who simply can't make enough money with certain projects so they are sidelined for economic reasons.

Scientific method does require repetition and consistency in an intensely documented data record. It's not the liberal politicians that conjured up that method, it' the scientists and MD.'s that generated the methodology. These methods, over time, have proven to give the most reliable results. No one is trying to do anything but stifle fraud in an industry that could cause much harm if left uncontrolled. I would not want any of my family to be the "guinea pig" for some unscrupulous scientist who passed a drug on phony data. The FDA rules are structured so that this doesn't happen. Even with these laws and regulations in place many drugs get to a phase III clinical trial and bomb out............whoops.......wonder how they got that far? As they say in the old country, " Something was rotten in Denmark."

The FDA has a format the rules out phony documentation and this is an important part of their process.

I work in the field and have heard many stories of corruption.

I don't make the rules, I simply agree with them based on my own experiences in the pharmaceutical industry over a career that has lasted many years and covered many miles.