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.

Alcohol is more harmful than Heroin or Crack: Study

NY Daily News

It's sobering news for drinkers.

Alcohol is even worse than heroin and crack on the list of "most harmful" drugs, according to a new study published in the British medical journal, The Lancet.

A variety of social, physical and psychological problems that are caused by drugs were examined by a panel of experts, who concluded that alcohol, heroin and crack were the most harmful to others while heroin, crack cocaine and methamphetamine were the most harmful to individual users, CNN reported.

Dr. Petros Livados, director of the Addiction Institute of New York at St. Luke's-Roosevelt Hospital, agreed with the study findings.

"Both in terms of the medical consequences as well as societal consequences, I agree that alcohol ranks very high in overall harmfulness,"he told the News. "Alcohol has tremendous repercussions in our society in terms of drunk driving and societal consequences.”

Twenty drugs were scored on 16 criteria – nine related to the harms that a particular drug does to an individual and seven to the harms a drug does to others. All the drugs were scored out of 100 points, and overall, alcohol came in the highest, at 72 points, according to The Lancet. Heroin came in second with 55 points and crack cocaine took third place with 54 points.

While cocaine and tobacco were found to be equally harmful, LSD and ecstasy were found to be the least harmful, according to BBC.com.

Funding for the study came from the Centre for Crime and Justice Studies in London.

The report in the Lancet was co-authored by Professor David Nutt, Britain's former chief drug policy advisor, who stirred up controversy last year when he wrote an article that said riding a horse was more dangerous than taking ecstasy, CNN reported.

Almost 17.6 million adults in the United States either are alcoholics or have alcohol problems, according to the National Institutes of Health.

But because alcohol is legal and easy to access, many people don't think it is a problem for them, says addiction expert Dr. Jeffrey Parsons, chair of the psychology department at Hunter College.

"It is legal and socially sanctioned, so it does not carry the same stigma and issues that illegal drugs do,"he says. "But the negative health consequences of alcohol are even greater than with many illegal drugs.”

Drinkers tend to equate "legal"with "safe,"but that's not necessarily the case, says Lebanon Valley College psychology professor Lou Manza. "In the general public's mind, because you can go and buy alcohol in the store, it is okay,"he said.

One major difference between alcohol and other drugs, such as nicotine, is that there is a "safe"level of it for many people, Livados says. It's generally recognized that two drinks a day for men and one for women can be considered safe, with exceptions such as people with depression or anxiety, those with alcohol dependence and pregnant women.

"It's not the same with nicotine,"Livados says. "We have not been able to find a low threshold under which smoking cigarettes is safe. There's no such thing."

Alcohol dependence tends to be masked more often than dependence upon other drugs, Parsons says. "With alcohol, someone can feel like a law abiding citizen despite the fact that they're abusing a drug," he told The News.

Warning over Parent Alcohol Abuse 'Child Effect'

BBC News

Millions of children are at risk of neglect because of a parent's drinking, and yet the problem is being ignored, say charities.

Alcohol Concern and the Children's Society want social workers to have more compulsory training on how to deal with alcohol abuse within families.

Their report estimates 2.6m children live with a parent whose drinking could lead to neglect.

A body representing social workers said alcohol posed more problems than drugs.

Unsurprisingly, a poll carried out by Alcohol Concern in July found an overwhelming majority thought that heavy drinking by parents had a negative impact on children - many thought it was as harmful as drug abuse. However, the two charities say that the scale of the problem is not fully recognised.

The parents of the 2.6 million children are defined as "hazardous" drinkers - either because of the sheer amount or frequency of their drinking, or because their drinking, even at a lesser level, leads to other problems, such as not being able to get up in the morning, or fulfil "expected duties".

Of those 2.6m children, 700,000 are being raised by a parent defined as an alcoholic.

No training

Despite alcohol or substance misuse being suggested as a factor in more than half of social worker cases which progress to the "serious review" stage, there is relatively little emphasis placed on the problem within social worker training.

Recent research suggested that one third of social workers had received no training on alcohol or drugs, and, of the remainder, half had been given three hours or less.

Bob Reitemeier, the chief executive of The Children's Society, said: "I cannot stress strongly enough the harmful impact that substance abuse can have on both children and whole families - it is imperative that everyone understands these risks and we believe that education is the key.

"We are calling on the government to make sure that everyone who needs either training or education to deal with parental substance abuse is given the appropriate assistance."

Mandatory substance abuse training for social workers was recommended in a 2003 report from the government's own drug advisory group.

Alcohol Concern suggested that the system currently "sweeps the problem under the carpet".

Chief executive Don Shenker said: "Millions of children are left to do their best in incredibly difficult circumstances.

"A government inquiry must look into all aspects of parental alcohol misuse so that we can improve outcomes for these children."

Groups representing social workers agreed with the report's recommendations.

Dr Sarah Galvani, who chairs the British Association of Social Workers Special Interest Group in Alcohol and Other Drugs, said training for both newly-qualified and existing social workers was "lacking".

"Problematic alcohol abuse by parents is highlighted by social workers as far more prevalent than drug use.

"Alongside the overlapping experiences of domestic violence and mental ill health, parental alcohol and other drug use are the three factors that repeatedly put children at risk of serious harm.

"We must support social workers to work as best as they can in what are often very complex and challenging situations."

Public health minister Anne Milton said health service reforms would help local communities put in place services tailored to tackle problems such as this.

She said: "This report highlights the harm that millions of children face because their parents drink too much alcohol.

"It paints a shocking picture, which is why we must make sure that we identify early on, children and families that need support."

Michigan's new 'Super-Drunk' Law goes into Effect on Sunday

Lansing State Journal

 

Those who drink excessively and get behind the wheel may be in a sobering reality beginning Sunday.

New laws go into effect that double the jail sentences and license suspensions for first-time offenders who are convicted of having higher blood-alcohol levels while driving and expand the use of substance abuse treatment programs.

State officials say the “super-drunk” legislation is designed to target those first-time offenders who apparently have a serious drinking problem.

“When you get super-drunk, it becomes exceptionally dangerous,” said state Sen. Alan Cropsey, R-DeWitt, a sponsor of the legislation.

The new law essentially creates a new class of blood-alcohol content of 0.17 percent or higher for more serious first-time offenders; that’s slightly more than twice the minimum of 0.08 percent now required for a drunken-driving conviction.

Those convicted of the higher blood-alcohol level will get an automatic one-year driver’s license suspension -- twice the current penalty -- and would face 180 days in jail, which is roughly twice the current maximum.

They also face bigger fines and mandatory treatment for substance abuse.

Judge Harvey Hoffman of District 56A Court in Charlotte said substance abuse treatment Michigan for serious first-time offenders is critical to reducing the alcohol dependence and further offenses. Substance abuse treatment now is used more commonly for repeat offenders.

“The average person, if they a blow a 0.20, and you’re up and functioning enough to operate a motor vehicle, it shows you have an elevated tolerance to alcohol,” said Hoffman, who has dealt with drunken drivers for 14 years as a judge. “That’s pretty good proof you are dealing with someone who has a significant alcohol problem.”