Food and Drug Administration

Federal Judge Blocks Graphic Ads on Cigarette Packages

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The ads don’t bother me, but I suppose the law is clear about advocacy and the role of government.

A judge on Monday blocked a federal requirement that would have begun forcing tobacco companies next year to put graphic images including dead and diseased smokers on their cigarette packages.

U.S. District Judge Richard Leon ruled that it’s likely the cigarette makers will succeed in a lawsuit to block the requirement. He stopped the requirement until the lawsuit is resolved, which could take years.

Leon found the nine graphic images approved by the Food and Drug Administration in June go beyond conveying the facts about the health risks of smoking or go beyond that into advocacy – a critical distinction in a case over free speech.

More than likely there will be an appeal, but the images will not be placed on cigarette packages for the foreseeable future.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, urged the Obama administration to appeal the ruling that he said “is wrong on the science and wrong on the law.” He said a delay would only serve the financial interests of tobacco companies that spend billions to downplay the health risks of smoking and glamorize tobacco use.

“Studies around the world and evidence presented to the FDA have repeatedly shown that large, graphic warnings, like those adopted by the FDA, are most effective at informing consumers about the health risks of smoking, discouraging children and other nonsmokers from starting to smoke, and motivating smokers to quit,” Myers said in a statement. “Because of that evidence, at least 43 other countries now require large, graphic cigarette warnings.”

Congress instructed the FDA to require the labels, following the lead of the Canadian regulations that require similarly graphic images on cigarette packs. The cigarette makers say their products have had Surgeon General warnings for more than 45 years, but that they never filed a legal challenge against them until these images were approved.

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Smoking

Chantix IS Unsuitable for First-Line Smoking Cessation

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According to a new study.

The poor safety profile of the smoking-cessation drug varenicline (Chantix™) makes it unsuitable for first-line use, according to a study published in the Nov. 2 edition of the journal PLoS ONE, an online publication of the Public Library of Science.

Varenicline, which already carries a “black box warning” from the U.S. Food and Drug Administration (FDA), showed a substantially increased risk of reported depression or suicidal behavior compared to other smoking-cessation treatments, according to researchers at Wake Forest Baptist Medical Center, the Institute for Safe Medication Practices, Harvard Medical School and Johns Hopkins University School of Medicine.

The researchers found that 90 percent of all reported suicides related to smoking- cessation drugs since 1998 implicated varenicline, even though it was on the market only four years in the nearly 13-year study period. They also found that varenicline was eight times more likely to result in a reported case of suicidal behavior or depression than nicotine replacement products.

The drug looked promising, I suppose. I had some friends who were heavy smokers and they reported the weird feelings and dreams as a result of taking Chantix.

They soon abandoned the program and returned to smoking.

Nicotine is a nasty, highly addictive drug and the best course of treatment is probably not to start in the first place.

“While suicidal behavior or depression appear to be prominent side effects of varenicline, they are by no means the only safety issues,” said Thomas J. Moore, senior scientist at the Institute for Safe Medication Practices and lead author of the study. “Varenicline has been associated with aggression and violence in three studies and carries a warning about this behavior. Its effects on vision, cognition and motor control and other risks have led to its being banned for airline pilots, air traffic controllers, military pilots and missile crews, and restricted for truck drivers.”

Varenicline also is associated with an increase in the risk of serious cardiovascular events, as reported in the July 4, 2011, issue of the Canadian Medical Association Journal by Furberg and scientists at Wake Forest Baptist, Johns Hopkins University School of Medicine and the University of East Anglia in the United Kingdom.

“We strongly recommend that the FDA should revise the ‘black box warning’ to say what this study and the FDA’s own data show — that varenicline has higher risks for suicidal behavior and depression than other smoking-cessation treatments,” Furberg said.

“We agree with the recommendations of the U.S. Veterans Administration (VA) that varenicline should be prescribed only after failure of nicotine replacement, bupropion or a combination,” he added. “The VA also recommends a mental status examination to assess risk of suicidal or violent behavior prior to prescribing varenicline.”

Tobacco use is responsible for one in five deaths in the United States each year and adds $193 billion to health care costs. It is among the most treatment-resistant forms of drug dependency, with 36 percent of the nation’s smokers attempting to quit each year but only 3 percent succeeding for six months or more, according to the Department of Health and Human Services.

Here is a video of some of the problems with Chantix:

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Smoking

2.5 Million Children Exposed to Secondhand Smoke in California?

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The answer is yes, according to a new policy brief from the UCLA Center for Health Policy Research.

Despite having the second-lowest smoking rate in the nation, California is still home to nearly 2.5 million children under the age of 12 who are exposed to secondhand smoke, according to a new policy brief from the UCLA Center for Health Policy Research.

Using data from several cycles of the California Health Interview Survey, the study’s authors estimate that 561,000 children are directly exposed to secondhand smoke in the home. Another 1.9 million are at risk because they live in a home where another family member is a smoker, even though smoking may not be allowed in the home itself.

Secondhand smoke exposes children to a greater risk of developing asthma, respiratory infections and countless other ailments. Research shows that children raised by smokers have a greater risk of becoming smokers themselves.

“The next frontier in the campaign against smoking is to reduce smoking at home,” said Sue Holtby, the study’s lead author and a senior researcher at the Public Health Institute, which works with the UCLA Center for Health Policy Research in conducting the California Health Interview Survey. “California’s fight against tobacco has been a major public health success story, but we still need to spread awareness and ensure that every family knows the dire consequences of addiction.”

Other findings:

  • African American children three times more likely to live with smokers
  • Children living in households at or above 300 percent of the federal poverty level (FPL) are far less likely to be exposed to secondhand smoke
  • Rural children at greater risk than urban
  • Although Los Angeles doesn’t have the highest percentage of smoking households (10.8 percent) it has a surprisingly high percentage (4.1 percent) of households with children where smoking in the home is allowed, relative to other regions.

The entire policy brief is here.

Again, please for your health, quit smoking or better yet – never start.

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Health

Smokers Suffer Heart Attacks at a Younger Age

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According to a new study.

Smokers tend to suffer heart attacks years earlier than non-smokers, suggests a new study from Michigan.

“Individuals who smoke are much more likely to have a heart attack, and will present with a heart attack a decade or more earlier,” said Dr. Gregg Fonarow, a cardiologist at the David Geffen School of Medicine at the University of California, Los Angeles, who wasn’t involved in the new study.

The findings, he said, also show that people who smoke “could have a heart attack in the absence of other risk factors.”

Researchers led by Dr. Michael Howe from the University of Michigan Health System in Ann Arbor studied about 3,600 people who were hospitalized with a heart attack or unstable angina.

One-quarter of the patients were current smokers. And on average, they were younger with fewer health problems than non-smokers with heart trouble.

The mean ages at hospital admission were 64 for non-smoking men vs 55 for male smokers. For women, mean ages were 70 for non-smokers and 57 for smokers.

Smokers were less likely to have other health problems that are linked to cardiac risks, including high cholesterol, high blood pressure and diabetes.

That and their younger age explained why researchers also found that smokers were less likely to die in the six months following the index event than non-smokers.

That “smoker’s paradox” — the idea that smokers who have a heart attack have better outcomes, including a lower risk of death — didn’t last. The difference in death over the next six months was explained by age and other risk factors.

Dr. Fonarow said the findings are just one more example of the heart dangers posed by smoking, but emphasized that kicking the habit can erase those extra risks.

“Even within a few days of stopping smoking, there is a reduction in (heart) risk. As time goes by, within one to two years much of that risk is gone for heart attacks,” he told Reuters Health. “From a coronary risk standpoint, there is an immediate benefit and that continues to extend over time.”

Smoking is just a very bad risk factor for cardiac disease.

You know how I feel.

Please quit if you can and don’t start…..

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Health

Smokers Twice as Likely to Have Strokes and Younger Too

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According to a new study.

Not only are smokers twice as likely to have strokes, they are almost a decade younger than non-smokers when they have them, according to a study presented October 3 at the Canadian Stroke Congress.

Between January 2009 and March 2011, researchers studied 982 stroke patients (264 smokers and 718 non-smokers) at an Ottawa prevention clinic. They found the average age of stroke patients who smoked was 58, compared to age 67 for non-smokers.

“The information from this study provides yet another important piece of evidence about the significance of helping people stop smoking,” said Dr. Andrew Pipe of the University of Ottawa Heart Institute, one of the study’s authors. “It also alerts the neurology community to the importance of addressing smoking in stroke patients.”

Smoking causes a build-up of debris on the inside of blood vessels, a condition called atherosclerosis, and it contributes to a higher likelihood of clots forming, said Dr. Pipe.

The Ottawa Hospital study, led by principal investigators Dr. Mike Sharma and Dr. Robert Reid, found smokers have double the risk of a stroke caused by a dislodged blood clot (ischemic stroke) and four times the risk of a stroke caused by a ruptured blood vessel (hemorrhagic stroke) than the non-smoking population.

In addition, smokers have a greater chance of having more complications and recurrent strokes. Patients who have had a minor stroke are 10 times more likely to have a major stroke, especially if they continue to smoke, said Dr. Pipe.

Stroke is preventable.

So, quit smoking, follow a healthy diet and exercise regularly – for your health’s sake.

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