New Diet Drug Approved By FDA

Story first reported from USA TODAY


The U.S. Food and Drug Administration has approved the diet drug Qsymia, the agency's latest move to give doctors and their patients more tools to fight excessive weight gain as obesity rates continue to bulge in the U.S. and around the world.  A Salt Lake City Defective Drug Lawyer is leery of the effects this new drug will have.

An advisory panel voted 20 to two to approve the drug in February, the first time the FDA voted to approve a weight-loss drug in more than a decade. Originally known as Qnexa, the FDA required Vivus, the manufacturer of the drug, to change its name in order to prevent its confusion with other drugs with similar-sounding names. Data presented by the company showed that it helped patients lose about 10 percent of their body weight.

The committee's recommendation and Tuesday's approval by the FDA drew both praise and criticism, reflecting concern over the drug's side effects as well as the need to give patients more choices beyond diet, exercise and bariatric surgery.

About one-third of Americans are obese, and many have chronic, expensive medical conditions as a result, such as heart disease, diabetes and arthritis. Until recently, the array of available options has been frustratingly sparse for many doctors and their patients: diet, exercise and, for those overweight enough to qualify, bariatric surgery.

Weight loss was a struggle for Meg Evans, a 63-year-old mother of four in San Diego, until she took Qsymia. She said she was the quintessential jock in high school and college: physically active, involved in sports and always staying fit and trim. After she had her children, she started to put on weight.

Evans said she tried several diets over the years and continued to stay active, playing goalie for her soccer team. But she couldn't seem to get the scale to tick downward.When her doctor told her for the first time that her blood pressure was high, Evans realized it was time to try something different. Her doctor recommended that she enroll in the clinical trials for Qsymia, and she readily agreed.

She started taking the drug in February 2008 and also worked with a counselor once a week to develop a diet and exercise plan. By March 2009, she had lost 48 pounds. She said the only noticeable effect of the drug was that it decreased her hunger pangs.

Qsymia is a combination of two FDA-approved drugs: phentermine, a stimulant related to the amphetamines that suppresses the appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight-loss side effects. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise.

In June, the FDA approved another diet drug, lorcaserin or Belviq. The drug is also an appetite suppressant and intended for patients who are obese and have one additional weight-related health problem, such as high blood pressure, type 2 diabetes or high cholesterol. However, studies of Belviq found that patients lost about 4 percent of their body weight, compared with the 10 or 12 percent lost by Qsymia patients.

But Qsymia is not without drawbacks. When Qsymia's manufacturer, Vivus, initially submitted the drug for approval in 2010, the FDA voted it down, citing concerns over the potential for dangerous heart problems, birth defects and cognitive effects such as mental fogginess or lack of concentration in patients taking the drug. . The 2012 panel voted to approve the drug only with Vivus' assurances that the company would provide detailed information to physicians about the risks of the drug and how to manage them. A Minneapolis Defective Drug Lawyer has seen such side effects with other once-approved drugs, and is ready to help those who experience illness or injury from defective pharmacueticals

Still, doctors are mixed in their concern over the potential for side effects, particularly in light of the history of diet drugs, such as fen-phen, approved by the FDA, then withdrawn from the market over concerns about heart risks and other dangerous side effects. If in need of legal representation due to illness related to defective pharmacueticals, a Savannah Defective Drug Lawyer may be able to help.

Evans said she's gained about 20 pounds since she stopped taking Qsymia in 2009. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was. But she said she would definitely consider taking it again to help her bring her weight down.

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Whitney Houston Death Investigation to Take Weeks

First appeared in LA Times

Toxicology tests that could help show how Whitney Houston died Saturday in Beverly Hills are expected to take weeks to complete.

The Los Angeles County coroner's office performed an autopsy Sunday, but no official cause of death has been determined. Houston was found in the bathtub of her suite at the Beverly Hilton hotel, and officials are trying to determine whether she drowned.

A member of Houston's entourage found her unresponsive Saturday afternoon in her suite at the hotel and called authorities. Beverly Hills Fire Department paramedics performed CPR for about 20 minutes before declaring her dead.

Sources who were briefed on the probe Sunday said drowning is one of several scenarios investigators are exploring. The sources stressed that investigators still have many unanswered questions, particularly about what Houston was doing in the hours before her death. Investigators are also interviewing family members and friends to determine whether Houston had any underlying medical conditions, said the sources, who spoke to The Times on the condition of anonymity because the case was ongoing.

One source with knowledge of the case said that although Houston was found in the bathtub, officials are still unsure if she died of natural causes or was in some other way stricken.

[Updated at 5 p.m.: At a press conference, a coroner's spokesman said the autopsy was complete but a cause of death was still pending. The Beverly Hills police put a security hold on the case, so no more details were revealed.]

Houston struggled with drug and alcohol problems for years, and last May her spokeswoman said the singer was going back into rehab.

She was in Beverly Hills for music industry titan Clive Davis’ annual pre-Grammys party Saturday night at the Beverly Hilton. Over the previous few days, she had made several public appearances. At times, she was said to have been acting strangely, skipping around a ballroom and reportedly doing handstands near the hotel pool. Houston greeted people with a warm smile but at times appeared disheveled in mismatched clothes and with her hair dripping wet.

On Thursday, she dropped by the rehearsals for the event, where the news media -- including a Times reporter -- were in attendance. A Grammy staffer said that as reporters interviewed Davis and singers Brandy and Monica, Houston was dancing just off camera to make them laugh. Grammy personnel expressed concern that she'd be caught on camera and that reporters would write about her behavior.

Beverly Hills police, who are investigating the case in conjunction with the coroner's office, said Saturday night it was far too early to determine whether drugs or alcohol played any role in Houston's death.

Beverly Hills police Lt. Mark Rosen said Houston was at the hotel with a large entourage of family, friends and co-workers, some of whom helped identify her body after she was declared dead.

On Sunday morning, a bleary-eyed music star Ray J was briefly inside the lobby of the Beverly Hilton with three companions.

Ray J, who reportedly had been dating Houston off and on, had his hood up and was being consoled.

“Whitney dead,” he repeated multiple times, as one friend grabbed him by the shoulders. “Whitney dead. We all gotta live with that.”

A little later, he left the hotel in the passenger seat of a red Ferrari.

The hotel has been besieged by fans who assembled a makeshift memorial of flowers, candles and notes for Houston.

“Bittersweet memories that is all we will take with us,” read one note. “We will always LOVE you.”

One woman drove by, turning onto Santa Monica Boulevard from Wilshire Boulevard, asking a reporter on the street corner to add a bouquet to the mix. Another woman snapped a photo with her iPhone on the way to the bus stop.

“Oh, there's my bus, I'm always late,” she said, running to the stop. “Just hope I'm not late to heaven.”

Worshipers at the First A.M.E. Church of Los Angeles held a special moment of silence in honor of Houston at their 10 a.m. service. Their pastor, John J. Hunter, described Houston as “one of the most dynamic voices of our time,” according to an announcement on the church website. “We are all deeply saddened by her passing, and our hearts go out to her family,” he said.

Meanwhile, Whitney Houston’s teenage daughter was taken by paramedics from the Beverly Hilton to a nearby hospital Sunday morning. She was reportedly released in the afternoon.

Cocaine vs Steroids in MLB

First appeared in Bleacher Report

Dennis "Oil Can" Boyd has a book coming out in which he admits to using cocaine throughout his baseball career. Boyd admitted in an interview with WBZ-Radio that he played under the influence of cocaine two-thirds of the time he was on the mound. According to Boyd, it wasn't just him (via Boston.com).

“I feel like my career was cut short for a lot of reasons, but I wasn’t doing anything that hundreds of ballplayers weren’t doing at the time; because that’s how I learned it," he said.

Boyd's career spanned the decade of the 1980s when cocaine was the worst-kept secret in baseball. Today's culture is so caught up with steroids that many of us forget—or weren't around yet—when the drug of choice for Major League Baseball players was cocaine, not steroids, human growth hormone or the new wave of performance enhancers.

Is there really a difference?

That's the question I can't wrap my head around when former athletes come out and admit they used cocaine or other "recreational drugs" during their careers: Why is that different than taking performance-enhancing drugs?

It's not different. Taking amphetamines or cocaine before a game would enhance performance just as much, if not more, than taking steroids. In fact, taking steroids is the long-form way of breaking the rules while cocaine and amphetamines should be looked at as the "get hits quick" method of cheating the game.

Most anabolic steroids, as we have learned through baseball's very public history with the drugs, are used to help athletes heal faster and give muscles the ability to recover quicker after exertion.

With steroids, the player still has to put in the work. You can't just shoot yourself in the ass and magically become faster or stronger. Yes, surely it has been well-documented that steroids help that process, but you can't compare the immediate benefits of anabolic steroids or human growth hormone to the instant reaction your body has by taking cocaine.

We look at the history of cocaine use (and abuse) in baseball as a recreational problem because it exists in recreational circles. In the 1980s, anyone in the stadium—players, coaches, fans, media—could leave the game and find a place to do cocaine. Players could go into the stadium bathrooms during games to find some blow just like the guy in the nosebleed seats (cheap pun, I know).

Cocaine exists in the real world. In the 1990s and into the 2000s, steroid use added a layer of disconnect the more recreational drugs never had. Reporters and fans would never go hang out with friends after a game and stick steroid needles in each other. Unless you are a workout freak, there is no "recreational" reason to use steroids like there is with cocaine.

That doesn't mean cocaine isn't also a performance enhancer.

Let's WebMD this for a minute:

What's so great about being high on coke? Cocaine users often describe the euphoric feeling as:

·         an increasing sense of energy and alertness

·         an extremely elevated mood

·         a feeling of supremacy

Those sure sound like performance enhancers to me.

In September of 1985, MLB made national news when players on the Pittsburgh Pirates and several other teams in the league were brought before a grand jury in connection to the buying and selling of cocaine. There was talk at the time that Dave Parker's potential Hall of Fame bid was hurt by his involvement in the scandal. Tim Raines, now a hot topic with baseball purists for Hall of Fame induction, was right at the center of that scandal as well.

Jerry Crasnick of ESPN wrote a story back in 2007 that laid out the case for Raines making the Hall of Fame. After highlighting his numbers—certainly Hall of Fame statistics when properly dissected—Crasnick explained Raines' (literal) baggage:

Raines has some personal baggage to overcome. During the Pittsburgh drug trials in the early 1980s, Raines testified that he kept a gram of coke in his uniform pocket, snorted during games, and made a point of sliding head-first so as not to break the vial. Not exactly a wholesome image there.

It would be a cheap joke to wonder why Raines really he had the nickname "Rock," but Raines' involvement with cocaine was certainly no joke. He had it in his pocket during games? Cocaine was so important to Raines the drug actually impacted the way he played on the field. Twenty-seven years after Raines was embroiled in an enormous scandal for the sport, it seems there is not a baseball writer alive who doesn't stump for Raines to get into the Hall of Fame. Well, except whatever voters are still keeping him out.

Because cocaine is seen as a recreational stimulant, people looked at players hooked on the drug as addicts. Cocaine has ruined the lives of many people in the world and certainly had negative effects on the careers of several prominent baseball players in the 1980s. Bring up cocaine to Mets fans and they can run down a list of players whose careers were impacted by the drug.

I'm not downplaying the addictive nature of cocaine. I'm merely trying to point out that because normal people get addicted to it all the time, fans and media covering baseball seem to make excuses for players who use cocaine when it comes to the history of the game.

Players who abused cocaine had a problem. Players who abused steroids are cheaters.

In 2005, Bud Selig got the MLB Players Association to officially ban the use of amphetamines (greenies), a drug experts suggest had a far bigger impact on the drop of offense between 2005 and 2010 than steroid enforcement.

Hall of Famer Mike Schmidt wrote a book in 2006 that openly discussed the use of greenies during games, saying amphetamines were "widely available in major-league clubhouses."

Schmidt explained that amphetamines helped players get up for games during the long, daunting baseball season. Blogger Murray Chass, writing back then for The New York Times, mentioned that players couldn't take the pills too early in case the game was rained out and they "spent the rest of the night climbing walls."

Willie Mays—one of the four or five greatest players in the history of the sport—reportedly had a liquid form of amphetamines in his locker when he played with the Mets.

Mays reportedly had a bottle in his locker containing a liquefied drug, classified as a controlled substance, and how is this different from Mark McGwire having a bottle of Androstenedione or Barry Bonds having "the cream" and "the clear" in his locker? How?

Yes, thankfully baseball has better testing now than it did when Mays or Boyd or even Bonds played. From what we know, the game is remarkably cleaner than it has been at any time in history. It just feels like the gatekeepers of baseball's history are making an example out of this generation of player without using proper context into how drugs—both recreational and performance-enhancing—have helped the careers of previous generations.

Ferguson Jenkins was once briefly suspended from baseball when a customs agent found drugs in his luggage, including three grams of cocaine. Some suggest "that cocaine incident" delayed his induction into the Hall of Fame. Others have suggested the same for Raines, that his involvement with cocaine could be a reason why he hasn't gotten into Cooperstown yet.

But he will. Raines will be a Hall of Famer, maybe as early as next year, the same year that Bonds and Roger Clemens are eligible. Do voters have a that short of a memory? Do they not recall the drug use that impacted Raines' career and helped him perform on the field, or do they simply not care because there are other more topical drug issues to expose?

If Raines or any player—Schmidt, Mays and other Hall of Famers included—who used and abused "recreational" drugs is ostensibly forgiven for their drug-related sins over time, then Bonds, McGwire, Clemens, Alex Rodriguez and, heck, even guys like Ryan Braun should eventually be judged with the same wide scope. Throughout the history of the game, players have always been using something to get them through the rigors of the season. Using drugs to cheat the game is wrong, but to pretend this generation of cheating is somehow worse feels just as wrong.

In 25 years when players are injecting their muscles with liquefied oxygen because a scientist found it can regenerate muscles tears faster than steroids, will we look back at Bonds, McGwire and this generation of cheaters any differently? Will steroid users be remembered as addicts like history remembers the cocaine users in baseball and we will eventually feel sympathy for those who ruined their lives (or lost their lives) by taking steroids?

Oil Can Boyd is not a Hall of Famer. He's not even close. If he didn't take so many drugs, would things have been different for him? He thinks he might have won twice as many games in his career if it weren't for all those drug-addled sleepless nights.

The game is full of stories like Boyd's, the drug of choice changing with each passing generation. Some players had their careers destroyed by drugs. Others had Hall of Fame numbers because of them. History—specifically those who guard the entrance to history's front door—is ill-equipped to determine the difference between addiction and cheating, recreation and performance-enhancing.

Massachusetts Tax Repeal taps Drug, Alcohol Abuse Funds

Boston Herald

When Massachusetts voters decided to eliminate the sales tax on alcohol, they also eliminated a main source of funding for the state’s drug and alcohol abuse programs.

Now lawmakers and advocates are scrambling to shore up money for the programs in the face of an ongoing budget crunch.

Lawmakers last year voted to apply the state’s 6.25 percent sales tax rate to liquor sold in stores to bring in an extra $110 million annually to help pay for substance abuse treatment Massachusetts.

Liquor store owners and other opponents of the tax dumped more than $3.7 million into an advertising campaign to persuade voters to repeal the levy.

Supporters of the tax say that it was designed to help shield critically needed detox beds and other detox programs from the ups and downs of the budget cycle.

Programs to fight Drug Abuse in Jeopardy

Tennessean

Parental involvement and education programs dealing with student alcohol and drug use are keys to prevention, school officials say.

But at a time when binge drinking and prescription drug use is on the rise among Sumner County teens, programs aimed at fighting the problem could fall by the wayside, unless the Board of Education comes up with additional dollars in next year’s budget.

Safe Schools, Healthy Students, the school system’s anti-drug and violence prevention program, is completely funded by federal grants, and this year those dollars are funding more programs to combat obesity and bullying.

In jeopardy are programs like Students Taking A Right Stand, which has six full-time counselors working with parents to resolve issues at home and help students combat issues that might interfere with their academic achievements, such as family problems or drug and alcohol addictions.

Money will also run out this year for the school system’s three prevention coordinators – about $120,000 – who work with middle- and high-school students teaching alcohol education and making responsible decisions.

So far, at least one school board member says he is receptive to continue funding for alcohol and drug education, but that could change at budget time in June.

“My feeling is that if we can include athletic trainers in our budget, we can certainly include money for (prevention coordinators) whose work, in my opinion, is just as important as athletic trainers are,” said White House member Ted Wise.

Safe Schools, Healthy Students works year-round to reduce risk factors for young people by teaching drug and alcohol education beginning in kindergarten.

A survey recently completed by the Sumner County Anti Drug Coalition showed six percent of Sumner 12th-graders and 12 percent of 10th-graders reported having used prescription drugs without a doctor’s orders within 30 days in order to get high.

According to the survey, 17 percent of high school seniors surveyed reported binge drinking at least one or two times in the two-week period surveyed; another 7 percent of seniors reported binge drinking three to nine times; and 3 percent reported 10 or more occasions of binge drinking in the same two-week period

“If you can keep your kids from not using to the age of 21, it allows their brain to develop,” said Pat Conner, Sumner County Schools’ Safe Schools, Healthy Students coordinator. “If you can keep them from using until the age of 25, it greatly reduces their chances of becoming dependent.”

Conner says alcohol and drug use is not just a school problem – it's a community problem that’s brought into the schools.

“We do have a lot of students in our school system who are struggling emotionally,” she said. “Times are very difficult – families are stressed economically and some students have been displaced.”

Since August, the school system has seen 122 cases of child abuse, Conner said.

“That’s a serious sign of dysfunction in the community,” she said.

Organized in 2006 by former Criminal Court Clerk Judge Jane Wheatcraft, the coalition's goal is to crack down on the problem by asking everyone in the community to become involved and address the problem.

The coalition regularly teams with local law enforcement to hold events such as prescription drug drop-off nights throughout the county and regular compliance checks with area businesses to make sure they don’t sell alcohol to anyone underage.

Because the rate of illegal prescription drug use is rapidly increasing, the coalition wants the community to get the message to lock up their prescription drugs, and if they’re expired, get rid of them.
Teen years crucial for brain development

Parents who strictly monitor their teens' behavior while also modeling good behaviors are the most influential forces in preventing children from using drugs and alcohol.

But education and health officials say it’s also important for parents to understand how alcohol and drug use affects brain development in adolescents.

For many years it was thought that by the time children reached their teen years, brain development was complete, said Dr. Mary Romano, a pediatrician specializing in adolescent medicine at Monroe Carrell Jr. Children's Hospital at Vanderbilt in Nashville.

“The old belief was that a teenager is a mini-adult, but studies have shown that the adolescent’s brain continues to grow and change dramatically into the early 20s,” Romano said, pointing to a recent studies published the National Institute of Mental Health showing the frontal lobes of the brain, responsible for reasoning and problem-solving, develop last.

Further brain research reveals alcohol, tobacco and drug use during adolescence can interrupt this process, stunting the development of the brain and leading to lifelong problems, inability to cope, learning and memory problems, impulsiveness, problem-solving and planning skills, impulsiveness, anger management problems and immaturity.

The earlier teens drink, smoke or use drugs, the more likely they are to become addicts, Romano said.

“It’s the same theory as why you shouldn’t expose a fetus to drugs or alcohol in the womb,” Romano said.

“The brain is actively changing and growing rapidly in the teen years, and research has shown [drugs and alcohol] definitely have very negative effects in that development phase and sets them up for lifelong addiction.”

Crackdown on Boozing Problem

The Star UK

A community assembly in Sheffield is cracking down on alcohol misuse in its area as part of a national awareness week about the dangers of drinking.

The council's South East Community Assembly is using this week's Alcohol Awareness Week to tackle the issue, a huge cause of anti-social behaviour and health problems in the city.

Members will be carrying out checks on pubs and off-licences to make sure they are not selling to underage drinkers, conducting patrols to tackle young people boozing and carrying out education work with parents and youngsters in schools.

They will also look into introducing a designated public place order to give police additional powers to tackle street drinking in Woodhouse.

Assembly chairman Coun David Barker said: "We have come a long way in getting local people involved with combating alcohol abuse in their community. But there is still work to do in this area, and we hope this week will raise more awareness of what people can do if they need support."

Canada: Many School Suspensions linked to Alcohol, Drug Use

Times Colonist

 

There have been 54 suspensions handed out to students in the Nanaimo-Ladysmith school district so far this year, with 24 due to drug and/or alcohol offences in the district's high schools. The other major offences causing suspensions so far this year also include fighting (12) and assaults (five).

Superintendent Mike Munro said that while it's "not uncommon" for students to experiment with drugs and alcohol, they can be suspended for three to 10 days for a first offence, along with the possibility that the students and their families be referred to local social agencies for assistance or drug addiction treatment.

He said after three drug/alcohol offences within an 18-month period, students can be suspended for up to 20 days and are automatically referred to the district's disciplinary committee that deals with more serious incidents and committee members determine the next steps. After four offences, Munro said the district then has to determine if the student has medical issues and requires some sort of intervention. Students in this category are often referred to appropriate social agencies and their academic programs usually continue outside of regular school instruction.

However, Munro said for students who take alcohol and/or drugs to school with the purpose of selling, the penalties are much more severe.

"These students are trying to make money off the weaknesses of others and we take a very dim view of this," Munro said.

"Students under 16 who participate in these activities can be suspended for a full calendar year, with the matter also referred to the discipline committee, while those over 16 can be expelled. The police are often involved in these cases and charges can be brought forward, as has been the case in many instances over the years."

Munro said statistics around which of the district's high schools have the most drug/alcohol suspensions are not available, but in his experience they are typically spread out equally between all of them.

"There are other options and programs available to us rather than kicking these kids out of school or suspending them for long periods of time," he said. "The current policy has been in place for 15 years and it's now under review."