No Substitute: When a Generic Drug Isn’t What it Seems

From ProPublica:

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.

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.

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.

Posted: 4/17/2013 10:49:00 AM

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Turning to Drugs to Stop Addiction

From Drug Discovery & Development:

Could a once-a-month alcoholism shot keep some of the highest-risk heroin addicts from relapse? A drug that wakes up narcoleptics treat cocaine addiction? An old antidepressant fight methamphetamine?

This is the next frontier in substance abuse: Better understanding of how addiction overlaps with other brain diseases is sparking a hunt to see if a treatment for one might also help another.

We're not talking about attempts just to temporarily block an addict's high. Today's goal is to change the underlying brain circuitry that leaves substance abusers prone to relapse.

It's "a different way of looking at mental illnesses, including substance abuse disorders," says National Institute on Drug Abuse Director Dr. Nora Volkow, who on Monday urged researchers at the American Psychiatric Association's annual meeting to get more creative in the quest for brain-changing therapies for addiction.

Rather than a problem in a single brain region, scientists increasingly believe that psychiatric diseases are a result of dysfunctioning circuits spread over multiple regions, leaving them unable to properly communicate and work together. That disrupts, for example, the balance between impulsivity and self-control that plays a crucial role in addiction.

These networks of circuits overlap, explaining why so many mental disorders share common symptoms, such as mood problems. It's also a reason that addictions - to nicotine, alcohol or various types of legal or illegal drugs - often go hand-in-hand with post-traumatic stress disorder, depression, schizophrenia and other mental illnesses.

So NIDA, part of the National Institutes of Health, is calling for more research into treatments that could target circuits involved with cognitive control, better decision-making and resistance to impulses. Under way:

-Manufacturer Alkermes Inc. recently asked the Food and Drug Administration to approve its once-a-month naltrexone shot - already sold to treat alcoholism - to help people kick addiction to heroin and related drugs known as opioids.

-Studies at several hospitals around the country suggest modafinil, used to fend off the sudden sleep attacks of narcolepsy, also can help cocaine users abstain.

-An old antidepressant, bupropion, that's already used for smoking cessation now is being tested for methamphetamine addiction, based on early-stage research suggesting it somehow blunts the high.

Medication isn't the only option. Biofeedback teaches people with high blood pressure to control their heart rate. O'Brien's colleagues at Penn are preparing to test if putting addicts into MRI machines for real-time brain scans could do something similar, teaching them how to control their impulses to take drugs.