Keith, Keith Addison wrote: >> For example, only the makers of FDA approved drugs can use the word cure... >> [and] the FDA only approves drugs that go through its specific approval >> process --- one that costs hundreds of billions of dollars. >> > > Could that be right? It really costs hundreds of billions of dollars to get a > drug approved? Does it cost even hundreds of millions? >
As someone who once ran a medical device company, and spent many a long hour dealing with FDA, I can affirm that the FDA is like the IRS, except they have no mercy, and the audits go on for years unending. It does not cost hundreds of billions, however. Such price tags are reserved for the morass of war. Not even the conquest of AIDS in Africa would be that expensive. That said, drug approval is often more expensive than device approval. Devices can often be approved after fairly small trials consisting of 100-200 people. When trying to gain approval for a drug, by contrast (after demonstrating sufficient safety in smaller trials), sometimes one must try to tease out fairly subtle health improvements or rare complications, and either requires many, many warm bodies. For example, NSAIDs, drugs that help prevent heart problems, must be given to enough people over a long enough time to demonstrate that there is sufficient positive reason to use them and a lack of a negative reason to avoid them. A 25% improvement in a problem or reduction in a complication that may afflict only a few tenths or hundredths of a percent of a certain population may require thousands of participants in a long-term drug trial before statistical certitude is sufficient. As implied, I often found dealing with the FDA to be like living in one of the circles of hell. In spite of all of it, however, I think the system is basically sound and that the ideas underlying it are reasonable. Of course we need to test drugs. Of course we need to have solid evidence of safety and efficacy. Science actually works. d. -- David William House "The Complete Biogas Handbook" |www.completebiogas.com| "Make no search for water. But find thirst, And water from the very ground will burst." (Rumi, a Persian mystic poet, quoted in /Delight of Hearts/, p. 77) http://bahai.us/ -------------- next part -------------- An HTML attachment was scrubbed... URL: /pipermail/attachments/20090505/3ad22bc3/attachment.html _______________________________________________ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/sustainablelorgbiofuel Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (70,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
