The New York Times reports that the feds, who think you could die if you take, say, antibiotics imported from Canada, sometimes have a slightly less rigorous approval standard:
The Food and Drug Administration may soon approve a medical device that would be the first new treatment option for severely depressed patients in a generation, despite the misgivings of many experts who say there is little evidence that it works.
The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain....
But in the only rigorously controlled trial so far in depressed patients, the stimulator was no more effective than surgery in which it was implanted but not turned on.
While some patients show significantly improved moods after having the $15,000 device implanted, most do not, the study found. And once the device is implanted, it is hard to remove entirely; surgeons say the wire leads are usually left inside the neck.
Costs 15 grand, never completely comes out, and doesn't work? Wow! Where do I sign up?
The Times story goes on for 42 paragraphs and 1,640 words. The writer, Benedict Carey, struggles manfully to figure out why the device was approved:
The drug agency has given mixed signals about the stimulator. In August 2004, it told Cyberonics in a letter that the treatment was not approvable, saying more information was needed. But in February, after the company provided more data, the agency changed that position, informing the company that the stimulator could now be approved....
Hmmm -- Cyberonics? Gosh, could there be something special about Cyberonics? Hmmm, let me check this Reuters story....
Cyberonics Chief Executive Robert "Skip" Cummins ... acknowledged the company appealed to a number of Republican and Democratic Senators and Congressmen, as well as the Senate Finance Committee for help after the negative decision from the FDA.
He declined to say whether House Majority Leader Tom DeLay, a Republican who represents the congressional district in which Cyberonics is located, was among them.
Oh. How interesting.
Ah, but DeLay's name never once comes up in the Times story, so that couldn't possibly be the explanation, right?