Posted by doug cater on October 19, 2000, at 19:06:34
In reply to Re: ghb (Xyrem) is still not FDA approved » Ant-Rock, posted by ash on October 19, 2000, at 10:39:34
This state of affairs is a curious replay of what I went through with the FDA back in 1997. BioCraft Labs in NJ had been trying to get FDA approval for treatment of narcolepsy and in two years of reasearch, had gone from the requisite white rat testing stage to extensive trials with live narcoptics. But they were getting the cold shoulder from the FDA. Maurice Bordoni, the Head of Reasearch had explained to me that he was well aware of the many benefits of GHB for all sorts of ailments, but that getting approval as an"orphan drug" for a rare ailment was the best hope for getting a foot in the door, because the cost of passing FDA requirements for all the other uses was insurmountable. Phil Lee, an old family friend was the Undersecretary of Health (1997) and when I gave him a report on GHB, he was very interested. Three times he set up conference calls between Biocrat, himself and the FDA and three times the FDA mysteriously cancelled at the last moment. Then the word came down that the FDA, wiothout even looking at Biocrafts research, was demanding that they return to white rat testing.
Such is the level of resistence that the FDA has had against GHB, ranging from their "demonization" campaign to thwarting even the most benign application for those who suffer from narcolepsy. I have read testimonies from narcoleptics who swear by it and despair of it being made impossible to get now that it has been banned in America. So the FDA has loosened up a little, undoubtedly because these people with a genuine medical need hold a little political sway,
and it looks like theres a light at the end of the tunnel for them, maybe. The point is that the FDA will do any thing to prevent a natural, non-patented compound from coming into common use when their whole grip on this nation is based on the funding they get from the billion dollar Pharmaceutical Lobby. Why, does mention of the blatant FDA inconsistency in even considering what they have just succeeded in convincing everyone is a deadly poison might have medical uses bring forth the myopic response that "well, it's only tentative approval..." Can't you see the forest for the trees? Is it a deadly drug or a benign catalyst for deep natural rest and healing? Why the uproar over nitpicking detail?
poster:doug cater
thread:46036
URL: http://www.dr-bob.org/babble/20001012/msgs/46802.html