Generic Drugs Are Actually Not the Same as Name-Brands, Thanks to FDA Malfeasance
ProPublica / by Charles Seife, Bob Garver
The FDA failed to address compromised lab tests suggesting generic drugs are more similar to name-brands than they really are.
April 24, 2013 |
Andrew Richards remembers that he had just sat down in front of the TV when the lightning bolt struck. “It was almost like it went through my ear because I could hear it. It was kind of like, ‘fwomp,’ right through my head,” he says.
Stunned and disoriented, Richards tried to get up, he says, but spasms rumbled through his torso and his back; his muscles kept clenching and relaxing. He doesn’t recall falling. “It was almost like a little piece of time was missing, almost like a record skipped ahead a little bit,” he says, “like I was sitting on my couch and time had moved forward and I was on the floor.”
The next thing Richards remembers was calling out to his wife, who scooped him up and drove him to the emergency room. He would soon discover that the lightning bolt that struck him down was an electrical storm taking place entirely in his brain: a seizure. Less than a year later he was in court, contending that his seizure — and the spasms that he says still plague him — were caused by a faulty generic medication.
Generic medications are generally safe and effective, because the Food and Drug Administration mandates tests to show that they are equivalent to the name-brand originals. But in 2011, the Food and Drug Administration determined that a major laboratory had committed such “egregious” research violations that years’ worth of its tests — many comparing generics to name-brand drugs — were potentially worthless. The FDA has required drug manufacturers to redo many of the tests from that lab, owned by the now-defunct Cetero Research. But a
ProPublica investigation shows that the agency took little action to prevent consumers from taking medicines the FDA no longer knew for sure were safe or effective.
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