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FDA Extends Authority to e-Cigarettes: Implications for Smoking Cessation?

On August 8, a final rule from the US Food and Drug Administration (FDA) goes into effect that tobacco control experts say could dramatically change the status of e-cigarettes in this country. The rule extends the agency’s regulatory authority to all tobacco products, including e-cigarettes, and requires manufacturers to report product ingredients and undergo the agency’s premarket review to receive marketing authorization.

The move is intended to “improve public health and protect future generations from the risks of tobacco use,” the FDA said in a statement. Tobacco-control experts lauded the FDA for restricting e-cigarette use in adolescents: the rule makes it illegal for the products to be sold in person or online to people younger than 18 years. Use of e-cigarettes has skyrocketed among adolescents, and there’s some early evidence that it may lead to cigarette smoking in this demographic. 

Yet some experts have expressed misgivings about unintended consequences of tight regulations that could potentially block cigarette smoking cessation efforts by adult e-cigarette users.

The concerns bring to light the health conundrum presented by e-cigarettes: do these devices deliver a recreational drug or a medicine? If they can do both, which some experts argue is likely the reality, how do health agencies and health care professionals balance the risks with the benefits?

POPULARITY GROWS
According to the first estimates from a nationally representative household interview survey, more than 12% of US adults have tried an e-cigarette, while less than 4% are current users. Since they entered the US market in 2007, e-cigarettes, which typically contain nicotine in varying dosages, have become increasingly popular among cigarette smokers trying to quit or reduce their harm.

“Survey after survey shows [that] when you ask people who have tried e-cigarettes what [they tried] for, one big chunk says to quit smoking and another big chunk says to reduce smoking,” said Jonathan Foulds, PhD, professor of public health sciences and psychiatry at Penn State College of Medicine’s Cancer Institute.

There aren’t robust data yet on how many people in the United States are switching from cigarettes to e-cigarettes to help them quit. However, in the United Kingdom, where e-cigarettes are already a widely accepted quit-smoking tool, there’s a clear preference for the devices over traditional nicotine replacement therapy (NRT).

The trend...

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Coal Dust Kills 23,000 Per Year in EU: Report

The report blamed coal plant pollution for nearly 12,000 new cases of chronic bronchitis and more than half-a-million asthma attacks in children in the EU in 2013

HIGHLIGHTS

  1. There are a total of 280 coal-fired plants in the European Union
  2. Coal accounted for 18% of EU's greenhouse gas emissions in 2014
  3. Poland, Germany, Romania, Bulgaria and UK among the worst offenders

Paris, France: Lung-penetrating dust from coal-fired power plants in the European Union claims some 23,000 lives a year and racks up tens of billions of euros in health costs, an NGO report said Tuesday.

Even as the bloc shifts towards renewable sources like wind and Sun energy, coal still accounted for 18 per cent of the EU's greenhouse gas emissions in 2014 and a quarter of its electricity mix in 2015, said the analysis.

Emissions from 257 power plants for which data was available "were associated with 22,900 premature deaths in 2013," said the report entitled "Europe's dark cloud: How coal-burning countries make their neighbors sick".

There are a total of 280 coal-fired plants.

The study was compiled by researchers from four green energy lobby groups: the Health and Environment Alliance, the WWF, Climate Action Network Europe and Sandbag.

In addition to deaths, the report blamed coal plant pollution for nearly 12,000 new cases of chronic bronchitis and more than half-a-million asthma attacks in children in the EU in 2013.

The medical treatment required, as well as reduced productivity caused by absence from work, amassed "substantial costs" of 32.4 billion to 62.3 billion euros ($36 billion to $70 billion), said the report.

About 83 percent of deaths, some 19,000 in total, were blamed on inhalation of fine particulate matter, air-borne particles so small -- under 2.5 micrometers in diameter -- that they can enter deep into the lungs and bloodstream.

Hearth Disease, Cancer

"Most common causes of death connected to particulate matter exposure are strokes, heart disease, chronic lung disease or lung cancer," said the report.

It warned the particles "are transported hundreds of kilometers and across national borders, impacting the health of people both within the country of production and further afield."

The report listed the EU's worst offenders, attributing 4,690 premature deaths to coal power stations in Poland, 2,490 to Germany, 1,660 to Romania, 1,390 to Bulgaria and 1,350 to Britain.

The five countries most affected by pollution...

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Frail COPD Patients Benefit from Pulmonary Rehabilitation, Study Reveals

Researchers at King’s College London, in collaboration with several other U.K. institutions, found that pulmonary rehabilitation is helpful for frail patients with chronic obstructive pulmonary disease (COPD).

Findings from the study “Physical frailty and pulmonary rehabilitation in COPD: a prospective cohort study,” were published in the journal Thorax.

COPD, an umbrella term for several progressive pulmonary diseases characterized by inflamed and obstructed airways that eventually make breathing extremely difficult, is often accompanied by physical frailty. About 10% of people age 65 and older with frailty associated with COPD experience eventual disability, injurious falls and hospitalization. In some cases, frailty has been blamed for deadly accidents.

Because pulmonary rehabilitation aims to improve several health issues such as breathlessness, fatigue, muscle weakness, and physical inactivity, researchers maintained that the same rehabilitation might also be helpful to manage or even reverse and frailty.

In the study, researchers investigated the influence of pulmonary rehabilitation on frailty among COPD patients.
Dr. Matthew Maddocks, first author of the study based out of the Cicely Saunders Institute at King’s College, said frailty effects one in 10 people over age 65 and and one in four people over age 80 – but the combined therapy of exercise training and education could help.

“Although pulmonary rehabilitation is aimed at people with respiratory problems, it involves working the arms and legs to strengthen the muscles, and uses walking and cycling to improve fitness and balance. This model could be adapted to benefit older adults in other healthcare settings,” Maddocks said in a press release.

The study consisted of 816 COPD patients who averaged age 70 from November 2011 through January 2015. Researchers used weight loss, exhaustion, low physical activity, slowness, and weakness as criteria to measure frailty before and after pulmonary rehabilitation. The team then compared data between those who were not able to complete the rehabilitation program and those who completed it. Further analysis was completed by age and sex.

The results revealed that among all participants, 209 patients were found to suffer from sustained frailty. Largely, the inability to improve came with older patients who also struggled with other illnesses, caused them to drop from the program.

On the other hand, patients who were...

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White House Pulled FDA Restrictions on E-Cigarette Flavors

A White House office deleted language in a recently introduced tobacco regulation that would have removed flavored e-cigarettes from the market until they had been authorized by the Food and Drug Administration, an edited version of the document shows.

On May 5, the FDA released a final rule extending its tobacco authority to include e-cigarettes, pipe tobacco, cigars and hookah. The rule becomes effective in early August. Under the rule, companies must seek marketing authorization for any tobacco product introduced after Feb. 15, 2007.

The rule gives manufacturers a grace period of up to two years to submit marketing applications, during which they can continue to sell their products. They can sell them for an additional year while the FDA completes its review.
As submitted by the FDA to the White House Office of Management and Budget (OMB), the rule gave a grace period for flavored products of only 90 days after the rule became effective.

Public health advocates have long called for flavored tobacco products to be banned, saying flavors such as bazooka Joe Bubble Gum and Cotton Candy are designed to appeal to children.

The FDA provided pages of data and scientific studies in support of its plan, noting "a dramatic rise in youth and young adult use of typically flavored tobacco products, like e-cigarettes and waterpipe tobacco, and continued youth and young adult use of cigars."

The OMB deleted both the FDA's planned policy and the rationale for the policy.

A White House spokeswoman, Emily Cain, said the OMB "does not comment on changes made during the interagency review process." The FDA also does not comment, FDA spokesman Michael Felberbaum said.
In its originally submitted rule, the FDA said it recognized that numerous flavored products would come off the market within 180 days of the rule's publication "and that this will significantly impact the availability of flavored tobacco products at least in the short term."

But it said the move was important because tobacco products with characterizing flavors, including menthol but excluding tobacco flavor, were attractive to young people.

"FDA made an overwhelming scientific case to OMB," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in an interview. "For reasons that are not articulated, those people substituted their own judgment."

"We are deeply troubled that these important safeguards were stripped in this way when FDA repeatedly demonstrated that...

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Many Smokers Have COPD Symptoms, Without Diagnosis

Many smokers have symptoms of chronic obstructive pulmonary disease (COPD) even before they've been diagnosed with the lung condition, according to a new study.

Symptoms of COPD include shortness of breath, coughing, difficulty exercising and history of asthma. COPD is the third leading cause of death in the United States, researchers said. Smoking is a major cause of the disease.

"We found that a significant number of current and former smokers who don't meet the typical criteria for COPD [based on a breathing test] otherwise look and behave like patients who do carry a diagnosis of COPD," said study co-lead author Dr. Meilan Han, medical director of the University of Michigan Women's Respiratory Health Program.

The study included more than 2,700 people. It included current or former smokers and people who never smoked.

"We found significant respiratory symptoms in half of the current or former smokers with technically 'normal' breathing tests. We also found that these individuals needed to seek medical attention for breathing flare-ups with similar frequency as some patients who actually meet criteria for a diagnosis of COPD," Han said in a university news release.

But Han noted that it isn't clear if all of these people will eventually be diagnosed with COPD. More study is needed, she said.

"Given how common smoking is, everyone likely knows someone who suffers the condition we describe here. As these patients may require medical treatment and in some cases even hospitalization, the impact of this condition is very real. This study is just the first step in trying to better identify these patients so we can develop targeted treatments," Han said.

References:
www.mdspiro.com
http://www.upi.com/Health_News/2016/05/18/Many-smokers-have-COPD-symptoms-without-diagnosis/3761463599073/ 
http://www.nejm.org/doi/full/10.1056/NEJMe1515508 

The study was published recently in the New England Journal of Medicine.
Copyright © 2016 HealthDay. All rights reserved.

 

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Vitamin D could prevent asthma, allergies in children

A new study by a New Zealand doctor is the first to show that vitamin D supplements may prevent allergies and asthma development in babies and young children.

The study, composed by Associate Professor Cameron Grant, notes that there is a vitamin D deficiency in 57 per cent of New Zealand newborns - a statistic which may spawn from "a sun-avoidance public health policy".

Dr. Grant says the high level of prevalence of both asthma and allergies in children could also be sourced to our diets which feature low amounts of the vitamin and supplements containing it aren't often used.

"It's the first study to show that correcting poor vitamin D status during pregnancy and infancy might prevent childhood asthma," he said.

"In our clinical trial of vitamin D supplementation during pregnancy and infancy, we showed that when these supplements were started in the mum at 27 weeks’ gestation and then continued in her child until the child was six months old, they prevented sensitization of the child to house dust mites."

The Associate Professor from the University of Auckland says the implications of the findings could be life-changing.

"Early life events, including those before birth, can influence a baby's later sensitivity to allergens."

"In theory maintaining normal vitamin D status when that sensitivity is developing late in pregnancy and early in infancy, could prevent later allergy sensitivity in the child."

References:
www.mdspiro.com
https://www.tvnz.co.nz/one-news/new-zealand/vitamin-d-could-prevent-asthma-allergies-in-children

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Feds announce much tougher e-cigarette, cigar rule

Big news unfolded yesterday, May 05, 2016!  Electronic cigarettes will now be regulated much like tobacco cigarettes and their sale to children banned, according to a new federal rule issued.

Under the rule, the U.S. Food and Drug Administration would have to approve all tobacco products not currently regulated that hit stores after February 2007. The e-cigarette industry was virtually non-existent before then.

Premium, hand-rolled cigars, as well as hookah and pipe tobacco, are also included in the new regulation, which federal officials call "historic." The rule prohibits selling "covered tobacco products" to people younger than 18, and buyers must show photo ID. It also requires health warnings be displayed on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements; and bans free samples and the sale of covered products in vending machines not located in adult-only facilities.

The Tobacco Control Act of 2009 sets Feb. 15, 2007, as the latest date by which all tobacco products would have to have to be grandfathered in. Mitch Zeller, head of the FDA's Center for Tobacco Products, has said publicly that he couldn't choose a later date, although industry officials disagree.

That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.

An amendment to appropriations legislation working its way through the House would change the date so more e-cigarettes would be grandfathered in. White House Press Secretary Josh Earnest said Thursday that President Obama "takes a very dim view of attaching ideological riders to appropriations bills," but stopped short of threatening a veto of any legislation.

The proposed rule was released more than two years ago, in April 2014, and the final rule gives the industry two additional years to comply. The industry will have had "plenty of time to submit their applications," says Robin Koval, CEO of the Truth Initiative, an anti-tobacco health group.

However, stores have to comply with the rule in about three months (90 days from its publication May 10), and Zeller says contractors tasked with enforcement will be ready to "hit the ground running" on Day 91.
Koval says "it's perfectly reasonable"...

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Prenatal exposure to BPA associated with pediatric wheeze

Diminished lung capacity and development of persistent wheeze in children were associated with prenatal but not postnatal exposure to bisphenol A, according to recent study data.

Adam Spanier, MD, PhD, MPH, FAAP, associate professor of pediatrics and behavioral pediatrics medical director, University of Maryland Midtown Campus, and colleagues studied 398 pregnant women between March 2003 and January 2006 in the Cincinnati area who were aged 18 years or older, were at 16 weeks’ gestation and lived in a home built before 1979. The women were tracked through pregnancy, and children were tracked through age 5 years. Gestational and child bisphenol A (BPA) exposure were assessed through maternal urine samples during pregnancy at 16 and 26 weeks and child urine samples annually.

Main outcomes included parent-reported wheeze every 6 months for 5 years, and child FEV1 measured at ages 4 and 5 years. Associations of BPA exposure with respiratory outcomes (FEV1, child wheeze and wheeze phenotype) were studied.

Data for maternal urinary BPA concentrations and FEV1, assessed for 208 children, showed a mean range of 0.53 to 293.55 mcg/g creatinine (geometric mean, 2.4; 95% CI, 2.1-2.7 mcg/g creatinine). Urinary BPA concentrations and parent-reported wheeze results, available for 360 children, ranged from 15.9% (at 30 months) to 24.1% (at 12 months).

“In multivariable analysis, every 10-fold increase in the mean maternal urinary BPA concentration was associated with a 14.2% (95% CI, –24.5% to –3.9%) decrease in the percentage of predicted FEV1 at 4 years, but no association was found at 5 years,” the researchers wrote. “Every 10-fold increase in the mean maternal urinary BPA concentration was marginally associated with a 54.8% increase in the odds of wheezing (adjusted OR=1.55; 95% CI, 0.91-2.63).”

There was a 10-fold increase in 16-week maternal urinary BPA concentration associated with an increase in persistent wheeze odds (aOR=4.27; 95% CI, 1.37-13.3). No association, however, existed between the mean maternal urinary BPA concentration and wheeze phenotype.

There were no associations between child urinary PBA concentrations and FEV1 or wheeze.

“If future studies confirm that prenatal PBA exposure may be a risk factor for impaired respiratory health, it may offer another avenue to prevent development of asthma,” the researchers concluded.

References: 
www.mdspiro.com 
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