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Tech Blogger Vs. FDA

Posted Dec 06 2010 7:05am
Technology blogger James Kendrick describes how the FDA interfered with a medically necessary treatment for his blocked carotid artery:
It became apparent to me on the table that things weren’t going as the specialists anticipated. It turns out the imaging clearly demonstrated that the blockage was only 70-75 percent, and not the 80-90 percent previous imaging had indicated. That turned out to be very significant, as the FDA only allows the stents to be used in patients like me when the blockage is 80 percent or greater.

Even though the specialists felt I needed the stent to correct my problem, they were not allowed to put it in. [Emphasis mine. -- PSH] So after three hours of intense work by a great medical team, and even though I was already on the operating table ready for the full treatment, the doctors had to pull out without doing anything other than the angiogram. They faced serious sanctions by the FDA had they continued as planned with the actual correction of my medical problem.
(Read the full text of " FDA Takes Over in the OR ".)

The FDA claims to be protecting patients against unscrupulous doctors and medical device makers. However, it appears that what patients really need is protection against the FDA.

(Via R.K.)
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