Keith, Keith Addison wrote: > The IRS has mercy? If so it seems to get left out in the telling, the way > Americans tend to tell it. >
That's the joke, yes. The FDA is like the IRS without mercy; like the Spanish Inquisition without the light hearted humor and clever reparteé. >> [...] For example, NSAIDs, drugs that help prevent heart problems, >> > > NSAIDs stands for Non-Steroidal Anti-Inflammatory Drugs. I'm aware that, as > well as for the anti-inflammatory effect, they're used to lower fever and for > pain relief, but (apart from aspirin) this is the first time I see them > described as drugs that help prevent heart problems. > My mistake. >> 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. >> > Science does, yes, within its limitations, when it's allowed to. Too often it > depends who's paying the piper. > > Equating science with the FDA is stretching it more than a little... Having been on the wrong end of the FDA's gun, I still think that the majority of what the Agency does is soundly based. And when I speak of the wrong end of the gun, I mean (for example) that our company suffered from the abuse of science at FDA's hands. They once quoted a peer-reviewed paper at us in the attempt to demonstrate that our device could potentially damage nerves. We happened to know the guy that wrote the paper, and he was kind enough to write them a letter saying "This is a misuse of my work." We further demonstrated that the parameter they said was dangerous in our device was 100 to 500 times worse in already-approved devices, or to turn that around, our device was 100 to 500 times safer than approved devices. FDA had to back off. Science won that round, and often does. In other words, I don't necessarily raise a salute when FDA marches past, and in saying the system is basically sound, I am not saying that I agree with everything the Agency does. I most certainly don't. What it does mean, however, is that we need a system that uses good science and valid statistics (perhaps an irreconcilable oxymoron) to demonstrate that the treatments and drugs that are used are safe and effective. The European system, in my view, is far superior, because it is not as much of an adversarial system. In Europe, there are three parties involved: the company, the government, and the Notified Bodies. These last are like consulting organizations, hired by the companies, and they are charged with insuring the law is followed. If the NBs fail to do that, they can lose their certification, which means they lose their place on the gravy train. So the NBs have to find the sharp edge of the blade in balancing between the government and the companies. Of course, there are abuses, mistakes and problems in that system as well. In the US, it's just the companies and the FDA, and there can be a bit of the revolving door. Even so, the situation with the FDA is far superior to what it would be without the FDA. In the end, however, the finest rules and regulations will fail precisely to the degree the people are corrupt, greedy, ignorant, or asleep. 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/20090505/3aab0ae6/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/
