Generic Drugs Are Actually Not the Same as Name-Brands, Thanks to FDA Malfeasance
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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.
Richards’ suit involved a drug that was not tested by Cetero. But his case spotlights the possible dangers of a generic medication that isn’t actually equivalent to the name-brand original.
The drug Richards took is Teva Pharmaceutical USA’s 300 milligram version of extended-release buproprion — an antidepressant better known by its brand name, Wellbutrin XL. Shortly after Teva’s generic Wellbutrin was approved by the FDA in 2006, patients began to complain that the drug wasn’t working as well as the name-brand version. Some contended that it was causing more severe side effects.
Richards says he suffered his seizure in March 2008 after his pharmacy switched him to the Teva generic. Within a few days of starting the new pills, he says, he started to experience jolts and jerks. “Sometimes when you’re falling asleep, you get what’s called a sleep start,” Richards says. “Well, I would get that but I was awake.” Then the seizure hit.
Despite having stopped taking Teva’s drug, Richards says he continues to have spasms several times a day. Richards, who was a lead plaintiff in a lawsuit against Teva, contends that it was a direct result of his taking Teva’s generic Wellbutrin. The suit ended in a settlement in which Teva did not admit fault. Teva and Richards won’t discuss the financial terms, but a judge’s ruling approving the settlement suggests that it was for $4.5 million, the vast majority of which went to legal fees and costs.
Neither Teva, nor Impax Laboratories, which manufactures the pill, have admitted that there was anything wrong with the pills. “The product was approved on the basis of the bioequivalency testing that we were required to perform at the time,” said Marc Donohue, Impax’s Senior Director for Corporate Communications. “There had never been a safety issue with the product.” Teva did not answer questions about the Wellbutrin case.