Word: fda
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Dates: during 2000-2009
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...gain approval from the Food and Drug Administration. That's why in May 2005 Dr. Philip Rosenfeld, a macular-degeneration specialist in Miami, offered an offbeat solution: he proposed administering a drug with a similar molecular structure,?also made by Genentech, which was already approved by the FDA - for treating colorectal cancer. Since then an estimated 10,000 people worldwide have given the drug, Avastin, a shot - literally - by taking an injection of it in the eye. And most of them have had very good results with the Lucentis cousin...
...good news, then, that Lucentis will likely get its FDA stamp of approval this week. Until now no approved treatment has improved sight in patients with AMD so well. Although Lucentis can't repair the irreversible retina damage that occurs when AMD has gone untreated, it prevents the blood-vessel leakage in the back of the eye that causes damage in the first place, leaving patients with distorted, wavy vision, and eventually a gap in the center of their vision. Up to 40% (depending on the dosage) of those in Lucentis trials improved their eyesight by at least three lines...
...only problem? Lucentis will likely cost more than 100 times as much as the temporary fix.??A dose of Avastin for the eye costs as little as $13, says Rosenfeld, who is also a lead author on Lucentis trial reports. (Using FDA-approved drugs for "off-label" uses is??common practice, especially in ophthalmology.) Lucentis is almost certain to be pricier when Genentech announces the U.S. sales tag: competing treatments cost up to $3000 per dose...
...When Lucentis is approved, it is doubtful Americans will continue to use Avastin for AMD - even though the cheaper drug has worked so well that some 30 states now cover it for macular-degeneration treatment, says Rosenfeld. Doctors predict patients will go for the drug that has the FDA imprimatur, as long as insurance companies pick up the higher cost. Doctors too will most likely turn to the more expensive drug. "Let's just say there's a bad outcome," says Dr. John Sorenson, an AMD expert in New York City. "You can already hear the lawyers say, 'Doctor...
...would lead to promiscuity is inexcusable." At a time when government data shows 70% of girls having had intercourse by the time they're 18, the need for a vaccine seemed self-evident. "It was our belief that (conservatives) were trying to make their opposition clear to the FDA, which has been politically responsive during the Bush Administration to these conservative groups," says Gandy, "and that gave us tremendous concern that their influence would translate into non-approval of this vaccine...