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pharmaceuticals

12/04/12 2:45pm

Court Rules to Protect Off-Label Rx Drug Promotion

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Is the ruling a win for Big Pharma? Photo via

A recent court overruling may make it harder for the government to monitor how drugs are marketed and sold. Alfred Caronia, a sales representative for Orphan Medical Inc, now part of Jazz Pharmaecuticals Plc., was convicted in 2008 of conspiracy of introducing a misbranded drug into interstate commerce. He promoted "off-label" use of the drug Xyrem (an FDA-approved drug to treat patients with narcolepsy) by recommending it to consumers for muscle disorders, chronic pain and fatigue. The misdemeanor conviction led to 100 hours of community service and a year of probation, but the 2nd U.S. Circuit Court of Appeals in New York found that the sales representative's First Amendment rights had been violated and the ruling was overturned. "In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed," Circuit Judge Denny Chin wrote for a 2-1 majority; however, off-label promotion that is false or misleading does not get First Amendment protection. Caronia argued that it should not be illegal for drug companies and sales reps to promote FDA-approved drugs for legal, off-label uses, since doctors may do so without penalty. The 2nd Circuit sided with him, citing that the U.S. Supreme Court ruled last year that speech-aided drug marketing is a form of constitutionally protected expression. Circuit Judge Debra Ann Livingston was the lone dissenter, citing a similar 2004 case in which the court found no First Amendment protection. "The majority calls into question the very foundations of our century-old system of drug regulation," Livingston wrote. "I do not believe that the Supreme Court's precedents compel such a result."

 

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By McCarton Ackerman

Anti-Energy Drinks

12/04/12 2:01pm

"Anti-Energy" Drink Sickens Kids

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Too much mellow for the kids. Photo via

An “anti-energy” drink named after iconic reggae star Bob Marley caused nausea, vomiting and dizziness among students who purchased the beverage in their school cafeteria. Billed as a “premium relaxation drink,” Marley’s Mellow Mood claims to contain 100% natural botanical ingredients. But the label does include a warning: “The all natural botanical ingredients in this product have been specially blended to mellow your mood, and may cause drowsiness. Best enjoyed when you are ready to relax. Do not mix with alcohol. Not intended for children." Last week, a number of students at a New Jersey middle school were sent to the nurse's office after consuming the beverage and becoming ill. "It was like a zombie-fest," said one student. A spokesperson for Chartwells School Dining Services, who distributed the beverage to cafeterias, issued a statement saying: "We were informed that Marley's was a new product that did not go through the approval process required for all new products...We sincerely regret that this product was sold and that students had an adverse reaction to it." The drinks have since been removed from schools and Chartwells says the on-site manager responsible for the mishap has been removed pending an investigation. In recent years, highly-caffeinated energy drinks like Monster and 5-Hour Energy have been linked to illness and a number of deaths in children and teens; this is the first time an official "anti-energy" drink has come under investigation.

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By Chrisanne Grise

alcohol in prison

12/04/12 1:08pm

How to Make Hooch in Prison

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$125 per leg Photo via

When drugs aren't available in prison, or when prisoners just prefer to get drunk, they'll turn to making wine, or "hooch," as it's called inside. There are a few options on the table: "There's different types of wine—fruit wine, potato wine and tomato wine. That's basically the three you can make in prison," a prisoner tells The Fix. The other ingredients are simple enough: "You need sugar and water; two pounds of sugar per gallon of water. Unless it's fruit wine—then only one pound of sugar per gallon." Next, you have to decide where to cook it and how to store it. "Take a pair of prison-issued khaki pants and cut off the legs as high as possible," says our man. "Sew the bottoms up and line them with two trash bags. Pour two and a half gallons of water into each leg. Then add five pounds of sugar, five cups of diced tomatoes and one cup of tomato paste per pant leg. This is to help kick if off and make it turn faster." The hooch cooks because when the tomatoes rot, they ferment, causing the sugar to turn into alcohol.

Ventilation is important. "Wind the top of the trash bags together around a pen case—leaving an opening—as close to the liquid as possible, to let it breathe," the prisoner says. "You rubber band around the tubing tight. Then take the pant leg and roll it up to right above the opening and tie it off. Then you have to find a place to hang the bag at." The warmer it is, the quicker the wine will cook. "Behind the toilet, in the vent, in your locker—anyplace where it can sit unmolested for 12 days. If you got a kicker, it will come back in six to nine days." Prisoners make kickers out of old potatoes, as well as tomato paste. Yeast is the best kicker option of all—but is very difficult to get inside. "You can make a kicker in a small vitamin bottle," the prisoner says. "You get some old fruit, like orange wedges, and put it in the bottle with some sugar and water and let it rot."

In most prisons winemaking is a lucrative business to be in; good money can be made from fellow inmates' love of getting out of their heads. "You can sell half a gallon of wine for $25," the prisoner says. "Each pant leg makes two and a half gallons, so you do the math. It's a good hustle. If you want to get away with it, a lot of factors go into it. Like if you're a troublemaker; if you stay out of the guards' way; who you sell to. I got away with it for almost three years at the last spot I was at. A lot of dumb dudes get busted because they don't know how to hide the smell, or where to stash it while it cooks, or how to break it down. When you're making wine it's about when you're doing it and how. It's illegal, so you got to be smart."

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By Seth Ferranti

bon jovi

12/04/12 12:01pm

Bon Jovi Speaks About Daughter's OD

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Bon Jovi was "shocked" over his daughter's
heroin use. Photo via

Rocker Jon Bon Jovi is speaking out about his daughter's recent heroin overdose, revealing he had been in the dark about her struggles with drugs. Nineteen-year-old Stephanie Bongiovi was hospitalized and charged with drug possession after being found unresponsive in her dorm room at Hamilton College in upstate New York in November. "I'm shocked as much as the next parent with this situation and had no idea," says Bon Jovi, who expresses gratitude to his friends and fans for their support. "But then you surround them with best help and love and move on, and that's where we're at with it," he says. "Steph is a great kid...she was doing great. Then a sudden and steep decline. Hopefully, we caught it when we did and that's the end of it. But who knew? I've got three more (children) to come." This is not the first time that addiction has hit close to home for the singer/songwriter. His band mate Richie Sambora bounced in and out of rehab for alcoholism before his teenage daughter inspired him to finally get sober last year. And while Bon Jovi has dabbled with substances in the past, he says the druggy life wasn't for him. "I did the drug thing very young and wised up very young too, because I was into drugs a little too much," he says. "I've never been a drug guy. I've always felt I didn't have the mental stability to handle drugs."

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By McCarton Ackerman

Binge Drinking

12/04/12 10:59am

Are Your Genes Making You Binge Drink?

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Your brain could be to blame. Photo via

Scientists have discovered a gene that could explain why some teens are more prone to binge drinking. A new study—published in the journal Proceedings of National Academy of Sciences (PNAS)—pinpoints a gene called "RASGRF-2" that plays a role in controlling the release of dopamine. "If people have a genetic variation of the RASGRF-2 gene, alcohol gives them a stronger sense of reward, making them more likely to be heavy drinkers," says lead author Gunter Schumann, from the King's College London's Institute of Psychiatry. Researchers analyzed brain scans of 663 14-year-old boys; they found those with genetic variations to RASGRF-2 showed more brain activity linked to dopamine release when anticipating a reward. This suggests that individuals with this genetic variation may experience an increase in pleasure when anticipating the positive feelings associated with heavy drinking. "People seek out situations which fulfill their sense of reward and make them happy, so if your brain is wired to find alcohol rewarding, you will seek it out," says Schumann. "We now understand the chain of action: how our genes shape this function in our brains and how that, in turn, leads to human behavior."

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By Valerie Tejeda

headlines

12/04/12 5:00am

Morning Roundup: December 4, 2012

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Tyson admits he was under the influence
on screen in the hit film. Photo via

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