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Drug Trials

7/03/12 11:13am

OxyContin Study Recruits Children

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Could chewable Oxy be next? Photo via

Purdue Pharma is recruiting more than 150 children, ages six to 16, to participate in a study to see what happens when kids are given its highly addictive painkiller OxyContin. Nevertheless, Purdue spokesman James Heins tells The Fix, "We are not seeking FDA approval for the use of OxyContin to treat children nor are we making a children’s version of the medication. Purdue does not promote OxyContin for use in children or adolescents." Rather, the spokesman said, "The studies are evaluating the safety of OxyContin tablets in these young patients and the way the drug is absorbed, broken down and eliminated to see if there are any significant differences from the way the drug is handled by adults." He added, "Secondarily, we will be studying if the drug works as well for pain relief as it does in adults."

What is the opinion of the medical community regarding this study? Andrew Kolodny, MD, chair of psychiatry at New York City's Maimonides Medical Center and president of Physicians for Responsible Opioid Prescribing, offers his view to The Fix: "If they are testing Oxy on children with a diagnosis of cancer and they are at the end of their life, I don't really have a problem with their study. If on the other hand they are testing Oxy on children with chronic pain, I think that's unethical. We don't have good evidence that putting people with chronic pain on opioids is effective. And with a higher-risk populace like children—if you get addicted to opioids, that could affect the rest of your life."

The driving factor behind Purdue’s pursuit of this Oxy-for-kids test is a potential six-month patent extension on the drug from the FDA, which in recent years has begun offering such extensions as incentive for drug manufacturers to conduct clinical trials on children, a previously neglected area of study. (At present, Purdue’s patent on Oxy is set to expire in April 2013, after which generic versions of the drug would proliferate, undercutting profits on what is the drug company’s top seller, raking in $2.8 billion in revenue last year.) But Dr. Kolodny isn't wholly inclined to believe that Purdue is not also interested in getting permission to market Oxy to children. "They are not the most trustworthy of companies," he says.

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By Hunter R. Slaton

Headlines

7/03/12 5:00am

Morning Roundup: July 3, 2012

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President Nieto has vowed to help Mexico.
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By Gabrielle Wuhl

Celebrity Rehab

7/02/12 5:20pm

Happy Sober Birthday to LiLo!

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A sober birthday for LiLo. Photo via

At last, some good news about Lindsay Lohan: the actress, who turns 26 today, reportedly celebrated in West Hollywood this weekend without touching any booze. “There was a ton of alcohol at Lindsay’s table, however she didn’t appear to be drinking,” says a source. Instead, she indulged in traditional birthday fare like cake and cupcakes; witnesses say she “looked happy and carefree as she danced all around with her friends.” The birthday girl made news for the wrong reasons last month for lying to cops after a car accident and driving with an open container of alcohol in her car, and she also collapsed from exhaustion in her hotel room. While Lohan may be avoiding the booze right now, she's still frequently spotted smoking (some call it a “two-pack-a-day habit”), and apparently lights up as soon as she completes filming a scene of her upcoming biopic Liz & Dick. "You can hear the crew saying, 'That's cut—get a cigarette for Lindsay," a source claims. Still given all her recent trouble, the fact that she avoided any this weekend is a real cause for celebration.

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By Chrisanne Grise

Awards Benefit

7/02/12 4:26pm

Recovery Activists Honored at Stellar Event

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A night to remember. Photo via

Four activists and one grassroots community organization have been deservedly honored for advocating for the rights of people who are in recovery—or seeking recovery—from addiction. The America Honors Recovery ceremony was co-hosted by Hazelden's Center for Public Advocacy and Faces & Voices of Recovery last week—and The Fix was an event sponsor. A night full of inspiration and discussion also featured plenty of laughter. "It was a rededication and a recommitment for those of us who are in the community to continue to spread the message of hope," Laurie Dhue tells The Fix—she's a broadcaster, recovery advocate, Host Committee member, and Hazelden spokesperson, and she's been in recovery herself for over five years. "I think these kinds of events are a call to action for all of us to redouble our efforts."

Emmy-award winning reporter and anchor Pat O’Brien made a self-deprecating speech about his public breakdown that had the crowd laughing hard, while making a serious point. He focused on the idea that addiction doesn't discriminate—and that recovery shouldn't, either. "I have fallen in love with recovery," he told the audience, encouraging them to share their stories.

Those honored included: Rev. Dr. Robert Gilmore, Sr., founder of Real Urban Ministry and author of A True Story: Hope After Dope, From A Drug Addict To A Doctor; Walter Ginter, project director of the Medication-Assisted Recovery Services (MARS) Project and leading face and voice of medication-assisted treatment and recovery; Rosemary Tisch, for her work with Celebrating Families!, an evidence-based, multi-family skill-building recovery curriculum from the National Association for Children of Alcoholics; Jeff Blodgett, Project Coordinator of the Alliance Project, who helped launch Faces & Voices of Recovery; and Massachusetts Organization for Addiction Recovery (MOAR), which organizes people in recovery and educates policy-makers and the general public in Massachusetts. The awards are named for three trailblazers who dedicated their lives to addiction recovery: Johnson Institute founder Dr. Vernon E. Johnson, and advocates Joel Hernandez and Lisa Mojer-Torres.

Congressman Patrick Kennedy, director of the National Institute on Drug Abuse Dr. Nora Volkow, and White House Office of National Drug Control Policy deputy director of state, local and tribal affairs Benjamin Tucker were among some high-powered attendees. “In recovery, we say 'We can do together what we cannot do apart,'" Laurie Dhue tells us. "At an event like this, we all come together to demonstrate what we’ve already accomplished and to set goals for what we can accomplish in the future. It takes time, it takes energy, it takes money, it takes awareness—and I think this event was the perfect way to address those things.”

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By Chrisanne Grise

celebrity rehab

7/02/12 3:31pm

Melanie Griffith's Daughters Got Her Sober

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Griffith's commitment to family runs deep.
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Melanie Griffith, 54, says she was finally able to kick her addiction to prescription pain pills after her daughters intervened. "It takes what it takes and you'll know when you know," she said when asked about her sobriety—and for her, this "tipping point" occurred three years ago during a conversation with her daughters Dakota, 22, and Stella, 16. "They were the ones who said, 'You really need to get help,' and I heard them and knew what they meant," says the actress, who went to rehab for three months and has been sober ever since. "I couldn't have done it without them." Griffith's husband, Antonio Banderas, recently said his wife was "an unbelievable lion fighting" her addiction, which began with a knee injury. The actor even credited her addiction with helping them maintain their marriage, saying he and the couple's three kids participated in her recovery, including attending group therapy sessions together. As far as her multiple relapses in the past, she says, "it doesn't mean that I'm stupid. It's just that that's what the disease is."

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By May Wilkerson

Drunk Driving

7/02/12 2:32pm

France Forces Drivers to Carry Breathalyzers

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Photo via Is self-testing realistic?

France has recently been developing some alarming drunk driving rates to add to its reputation for fine food and, ahem, wines. Now, in an attempt to protect both drunk and innocent drivers, the country is requiring all drivers to carry two breathalyzer kits in their vehicle. The law—which came into effect Sunday, but will allow people a four-month grace period to purchase the kits—aims to get drivers to check their own alcohol levels before they start their engines. France suffered about 4,000 road deaths in 2011—around 30% of which were alcohol-related. The law allows for a fine of €11 (about $14) for those who don't comply—and surveys find that most drivers have yet to do so. The new rule is inevitably causing controversy. Critics say that it's nothing but a way for breathalyzer manufacturers to make a quick buck—and that there's already a breathalyzer kit shortage in the country. Others argue that breathalyzers are no guarantee that an inebriated driver will act responsibly. "The whole idea of self-testing sounds like nonsense," scoffs Keith Peat of the Association of British Drivers. But safety advocates in the US would happily back a similar law here. "If they were mandatory in every vehicle," says Capt. Ted Richardson of the Laurens County Sheriff's Office in South Carolina, "the roads would be safer. There's no doubt about that." 

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By Gabrielle Wuhl

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