FDA examining antibacterial soaps, body washes

Manufacturers of antibacterial hand soap and body wash will be required to prove their products are more effective than plain soap and water in preventing illness and the spread of infection, under a proposed rule announced Monday by the Food and Drug Administration.

Those manufacturers also will be required to prove their products are safe for long-term use, the agency said.
“Millions of Americans use antibacterial hand soap and body wash products,” the agency said in a statement. “Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water.

“Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.”
About 2,000 individual products contain these products, health officials said.

“Our goal is, if a company is making a claim that something is antibacterial and in this case promoting the concept that consumers who use these products can prevent the spread of germs, then there ought to be data behind that,” said Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research.

“We think that companies ought to have data before they make these claims.” Studies in rats have shown a decrease in thyroid hormones with long-term exposure, she said. Collecting data from humans is “very difficult” because the studies look at a long time period.

Get dangerous germs out of your home

Before the proposed rule is finalized, companies will need to provide data to support their claims, or — if they do not — the products will need to be reformulated or relabeled to remain on the market.

“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney for the Natural Resources Defense Council. “FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.

The FDA first proposed removing triclosan from certain products in 1978, the council said, “but because the agency took no final action, triclosan has been found in more and more soaps.”

In 2010, the council said it sued FDA to force it to issue a final rule. The new proposed rule stems from a settlement in that suit, according to the NRDC.

The rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information, followed by a 60-day period for rebuttal comments, according to the FDA.

The target deadline is June 2014 for the public comment period, then companies will have until December 2014 to submit data and studies. The FDA wants to finalize the rule and determine whether these products are “generally recognized as safe and effective” by September 2016.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school and public settings, where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The action is part of FDA’s ongoing review of antibacterial active ingredients, the agency said. Hand sanitizers, wipes and antibacterial products used in health care settings are not affected.

Most hand sanitizers have 60% alcohol or ethanol and are generally recognized as safe when water isn’t available, Kweder said. However, health officials still believe washing hands with soap and water is the best method.

Source: CNN


Flu vaccine prevented 6.6 million illnesses last year, says CDC

According to the Centre for Disease Control and Prevention (CDC), flu vaccines prevented 6.6 million illnesses and 79,000 hospitalizations last year. Health officials urge people to get flu shots to prepare for upcoming “peak” months of this flu season.

Federal health officials are urging all Americans six months and older to get the flu vaccine in preparation for this year’s flu season, after evidence showed that the vaccine protected more people against the disease last year.

Last year’s flu season was more severe than recent seasons, according to findings by the Center for Disease Control and Prevention. The season started earlier than expected, causing 381,000 people to become hospitalized and 169 children to die from the flu last year.

There is good news, however. Although the virus impacted many lives, the flu vaccine also prevented millions more from becoming ill.
“We estimate that during last year’s flu season, flu vaccination prevented 6.6 million people from getting sick with flu, 3.2 million from going to see a doctor and at least 79,000 hospitalizations,” Center for Disease Control and Prevention Director Dr. Tom Frieden said in a CNN article Thursday, calling the findings on the flu vaccine and protection “eye-opening”

Although Friden explained the importance of getting vaccinated, less than half of Americans — 40 percent—have gotten the flu shot this year. To put the findings by health officials into perspective, if 70 percent of Americans had gotten the flu vaccine last year, another 4.4 million cases of flu and 30,000 hospitalizations would have been prevented. As the flu season begins to pick up across the country, especially in some Southeastern states, Frieden and other health officials now use the data to urge people to get vaccinated.

“We know that it will increase in the coming weeks and months, but we cannot predict where and when and how severe this year’s flu season will be,” Frieden stated in an article for WebMD. “What we can predict is that the best way you can protect yourself against flu is to get a flu vaccine. “It’s not too late to get vaccinated.

CDC’s Center for Global Health Director Dr. Anne Schuchat also spoke of the importance of getting vaccinated as soon as possible, noting that flu season typically peaks between January and March. She also explained that it was particularly important for children to get the flu shot.

“Already, three children have died this year from the flu,” Shuchat said in an article for CNN. “We hate to see anyone die from the flu, but particularly children. I really urge parents to make sure their children are vaccinated.”

Source: digital journal


Cancer deaths rise to 8.2 million, breast cancer sharply up

The global death toll from cancer rose to 8.2 million in 2012 with sharp rises in breast cancer as the disease tightened its grip in developing nations struggling to treat an illness driven by Western lifestyles.

Cancer deaths were up 8 percent from 7.6 million in a previous survey in 2008 and breast cancer killed 522,000 women last year, up 14 percent in the same period, according to the World Health Organisation’s International Agency for Research on Cancer (IARC).

“Breast cancer is also a leading cause of cancer death in the less developed countries of the world,” said David Forman, head of IARC’s Section of Cancer Information, the group that compiles the global cancer data.

He said this was “partly because a shift in lifestyles is causing an increase in incidence, and partly because clinical advances to combat the disease are not reaching women living in these regions.”

An estimated 14.1 million people developed cancer in 2012, up from 12.7 million in 2008. And 1.7 million women were newly diagnosed with breast cancer last year, up by more than 20 percent from 2008.

IARC’s report, called GLOBOCAN 2012, gives the most up-to-date estimates for 28 different types of cancer in 184 countries and offers an overview of the global cancer burden.

It found that the most commonly diagnosed cancers worldwide in men and women combined were lung, breast and colorectal cancers. The most common causes of cancer death were lung, liver and stomach cancers.

SUBSTANTIVE INCREASE

Projecting forward, IARC experts said they expected “a substantive increase” in cancer cases worldwide, with annual new cases predicted to rise to 19.3 million by 2025 as the global population both grows and ages.

Worldwide trends show that in developing countries going through rapid societal and economic change, the shift towards lifestyles more typical of richer industrialized countries leads to a rising burden of cancers linked to reproduction, diet and hormones.

The IARC report said cancer incidence – the number of new cases each year – has been increasing in most regions of the world, but noted what it said were “huge inequalities” between rich and poor countries.

While rates of new cancer cases are still highest in more developed regions, death rates are relatively much higher in less developed countries because people’s tumors are often not detected and diagnosed early enough due to a lack of screening and access to treatment.

“An urgent need in cancer control today is to develop effective and affordable approaches to the early detection, diagnosis, and treatment of breast cancer among women living in less developed countries,” said Christopher Wild, IARC’s director.

He said it was critical to bring rates of disease and death in poorer countries in line with progress made in recent years in treating and curing some cancers on wealthier countries.

One stark example of the inequality is in cervical cancer – which kills hundreds of thousands of women in Africa each year but can be largely avoided with a vaccine or successfully treated if it is picked up early enough with screening.

In sub-Saharan Africa, 34.8 new cases of cervical cancer are diagnosed per 100,000 women each year, and 22.5 per 100,000 women die from the disease. That compares with 6.6 and 2.5 per 100,000 women respectively in North America.

“These findings bring into sharp focus the need to implement the tools already available for cervical cancer, notably HPV vaccination combined with well organized national programs for screening and treatment,” Wild said.

Source: reuters


E-cigarettes: a burning question for U.S. regulators

At the Henley Vaporium, one of a growing number of e-cigarette lounges sprouting up in New York and other United States cities, patrons can indulge in their choice of more than 90 flavours of nicotine-infused vapour, ranging from bacon to bubble gum.

The lounge, located in Manhattan’s trendy Lower East Side, features plush seating, blaring rock music, and fresh juice and coffee. A sprawling sign on one wall lists all the carcinogens that e-cigarette users avoid by kicking their smoking habits and using the devices instead.

But the growing popularity of e-cigarettes has not escaped the notice of the industry’s critics, who have stepped up calls for new regulations, including bans on their use in public places, even though the scientific evidence about exposure to their vapours remains inconclusive.

Selling for about US$30 to US$50 (S$37.60 to S$62.66) each, e-cigarettes are slim, reusable, metal tubes containing nicotine-laced liquids that come in exotic flavours. When users puff on the device, the nicotine is heated and releases a vapour that, unlike cigarette smoke, contains no tar, which causes cancer and other diseases.

The product, introduced in China in 2006, has become a worldwide trend at least in part because it may help smokers of regular cigarettes break the habit.

“It’s an addiction — not everyone can quit cold turkey,” Mr Nick Edwards, 34, a Henley employee who says he kicked a 15-year cigarette habit the day he tried his first e-cigarette, said yesterday (Nov 11). “E-cigarettes give you a harm-reduction option.”

That’s one reason why the market for e-cigarettes is expected to surge, reaching US$2 billion by the end of this year and US$10 billion by 2017, according to Ms Bonnie Herzog, an analyst at Wells Fargo Bank in New York.

Ms Herzog said the US market alone could top US$1 billion this year. She predicts that by 2017 e-cigarettes sales will overtake sales of regular cigarettes. That estimate does not take into account the impact of potential government regulations on sales.

E-cigarettes may help smokers save money too. Mr Edwards, for one, says he cut his US$60 monthly cigarette bill in half when he switched. On top of the cost of the device, the smoking liquids cost around US$10 per refill.

Despite the perceived benefits, critics worry that the addictive nicotine found in e-cigarettes could lure more people into smoking and discourage others from quitting all together.

SOurce: today online


Malaria control efforts saved 3.3 million since 2000, WHO says

Global efforts to curb malaria have saved the lives of 3.3 million people since 2000, cutting global death rates from the mosquito-borne disease by 45 percent and by half in children under 5, the World Health Organization said on Wednesday.

WHO said in its World Malaria Report 2013 that expanded prevention and control measures helped produce declines in malaria deaths and illness. Of the 3.3 million lives saved, most were in the 10 countries with the highest malaria burden and among children under age 5, the group most afflicted by the disease.

“Investments in malaria control, mostly since 2007, have paid off tremendously,” said Ray Chambers, the United Nations secretary-general’s special envoy for malaria.

According to the WHO report, child deaths fell to fewer than 500,000 in 2012.

Overall, there were an estimated 207 million cases of malaria in 2012, which caused some 627,000 deaths, according to the report, which includes information from 102 countries with malaria transmission.

The estimated number of malaria cases per 1,000 at-risk individuals – a figure that takes population growth into account – shows a 29 percent drop globally between 2000 and 2012, and a 31 percent drop in Africa.

During the same period, death rates per 1,000 at-risk individuals fell by 45 percent globally and 51 percent in children under age 5.

“This remarkable progress is no cause for complacency: absolute numbers of malaria cases and deaths are not going down as fast as they could,” WHO Director-General Dr Margaret Chan said in a statement accompanying the release of the report.

“The fact that so many people are infected and dying from mosquito bites is one of the greatest tragedies of the 21st century.”

FUNDING CUTS

Malaria is endemic in more than 100 countries worldwide but can be prevented by the use of bed nets and indoor spraying to keep the mosquitoes that carry the disease at bay. The mosquito-borne parasitic disease kills hundreds of thousands of people a year, mainly babies in the poorest parts of sub-Saharan Africa.

An estimated 3.4 billion people continue to be at risk for malaria, mostly in Southeast Asia and in Africa where around 80 percent of cases occur.

Chambers said progress against malaria has been threatened by funding cuts in 2011-2012, which translated into a flattening in the curve of the decline. The WHO noted significant drops in delivery of insecticide-treated bed nets in its 2013 report.

But that could begin to ease. Last month, the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, the UK’s Department for International Development and the U.S. President’s Malaria Initiative agreed to provide over 200 million nets in the next 12 to 18 months, which will replace 120 million existing bed nets and provide 80 million new ones.

WHO also continues to track emerging parasite resistance to artemisinin, the core component of malaria drugs known as artemisinin-based combination therapies, or ACTs, and mosquito resistance to insecticides.

Four countries in Southeast Asia reported artemisinin resistance in 2013, and 64 countries found evidence of insecticide resistance, suggesting recent gains against malaria are still “fragile,” Dr Robert Newman, director of the WHO Global Malaria Programme, said in a telephone interview.

“The greatest threat to the future isn’t biological, but financial. It’s not having enough money to stay a step ahead,” Newman said.

Source: reuters


Driving with a hangover could be as dangerous as drunk driving, studies showv

Two new studies indicate that driving with a hangover could be just as dangerous as driving drunk, Medical Daily reported.

In one study, researchers from Utrecht University in the Netherlands and the University of the West of England in the U.K. put study participants through a series of driving tests that mimicked highway driving. All of the individuals had consumed an average of 10 drinks the night before.

Although no alcohol was present in the blood of any participants at the time of testing, the subjects demonstrated increased weaving in traffic and a decreased ability to pay attention on the road. Their results were comparable to those of a person who had a blood alcohol concentration (BAC) of .05.

The second study, conducted by the same researchers, asked participants to undergo a driving test that simulated stop-and-go traffic after a night of drinking, according to Medical Daily. According to researchers, the drivers experienced delayed reaction times and drove at inconsistent speeds.

The researchers said that people experiencing a hangover are undergoing short-term withdrawal from alcohol, combined with other factors like dehydration and sleep deprivation, which can ultimately make driving dangerous. They hope their studies will create awareness about the risks of driving after a night of drinking.

“We have a law that’s based on blood alcohol concentration. There’s no real way of measuring how hungover someone is. So we’re a bit limited in what we can do,” said Dr. Mark King, senior researcher at the Center for Accident Research and Road Safety at the Queensland University of Technology. “…All we can really do is provide advice to people and say your driving could be affected just as badly as if you were under the influence of alcohol as when you’re hungover.”

Source: news.nom


U.S. issues rules for removing antibiotics from farms

In response to concerns about the rise in drug-resistant super bugs worldwide, US regulators issued voluntary guidelines to help cut back on antibiotics routinely fed to farm animals.

The plan described by the Food and Drug Administration is not mandatory, and applies only to certain pharmaceuticals that are given to healthy livestock in a bid to grow bigger animals and boost food production.

“We need to be selective about the drugs we use in animals and when we use them,” said William, deputy director Flynn yesterday for science policy at the FDA’s Centre for Veterinary Medicine.

“Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”

The FDA guidelines set out a three-year timeframe for phasing out the use of antibiotics that are important in human medicine for growth uses in farm animals.

Companies that make animal feed containing antibiotics would be restricted to marketing them only for sick animals.

The medicines would also have to be administered or prescribed by a veterinarian with a view to preventing or controlling disease.

The World Health Organisation says inappropriate use of antimicrobial medicines in farm animals is one the factors underlying the spread of drug-resistant infections in people, including tuberculosis, malaria and gonorrhea.

Other factors include people’s failure to complete the full doses of antibiotics when sick and the lack of a coordinated global response to dangerous illnesses.

Consumer advocates say 80 percent of antibiotics sold in the United States are destined for use in livestock, so leaving the responsibility in the hands of business is a mistake.

Louise Slaughter, the only microbiologist in Congress, described the FDA’s voluntary guidance as “an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.”

This guidance “falls woefully short of what is needed to address a public health crisis,” she added in a statement.

Source: the Japan Times


Tummy `clock` tells us how much to eat

Scientists have found the first evidence that the nerves in the stomach act as a circadian clock, limiting food intake to specific times of the day. The discovery, by University of Adelaide researchers , could lead to new information about how the gut signals to our brains about when we’re full, and when to keep eating.

In the University’s Nerve-Gut Research Laboratory, Dr Stephen Kentish investigated how the nerves in the stomach respond to stretch, which occurs as a consequence of food intake, at three-hourly intervals across one day. “These nerves are responsible for letting the brain know how much food we have eaten and when to stop eating,” said Kentish, who is the lead author of the paper.

“What we’ve found is that the nerves in the gut are at their least sensitive at time periods associated with being awake. This means more food can be consumed before we feel full at times of high activity, when more energy is required,” Kentish added.

“However, with a change in the day-night cycle to a period associated with sleeping , the nerves in the stomach become more sensitive to stretch, signalling fullness to the brain quicker and thus limiting food intake.

“This variation repeats every 24 hours in a circadian manner, with the nerves acting as a clock to coordinate food intake with energy requirements ,” he said. So far this discovery has been made in lab studies, not in humans. “Our theory is that the same variations in nerve responses exist in human stomachs , with the gut nerves being less sensitive to fullness during the day and more sensitive at night,” he said.

Source: Deccan Chronicle


Mild brain injuries from bomb blasts have lasting effects on vets

Even mild brain injuries from bomb blasts may put soldiers at risk for long-term health effects, HealthDay News reported.

According to a new study presented at the annual meeting of the Radiological Society of North America, researchers used diffusion tensor imaging – a special type of magnetic resonance imaging (MRI) – to analyze the brains of 10 American veterans of the Iraq and Afghanistan wars. All of the vets had been diagnosed with mild traumatic brain injuries.

The researchers found that the veterans demonstrated significant differences in their brains’ white matter, when compared to a group of 10 people without any brain injuries. The differences were linked with a variety of health problems – including attention deficits, delayed memory and poorer movement and motor skills.

According to the researchers, these findings suggest that even mild brain injuries from blasts can result in long-term brain changes.

“This long-term impact on the brain may account for ongoing [mental] and behavioral symptoms in some veterans with a history of blast-related [mild traumatic brain injuries],” study co-author P. Tyler Roskos, a neuropsychologist and assistant research professor at the Saint Louis University School of Medicine, said in a society news release.


Norma Spear: a tragic case of neglect and dehydration

71-year-old from Birmingham died after becoming dehydrated, losing 35lb in five weeks despite being under the supervision of care workers.

When Carol Clay dropped her mother off at the Druids Meadow residential home on the outskirts of Birmingham it was only meant to be a six-week stay.

Norma Spear, a lifelong Brummie approaching her 71st birthday, was increasingly falling while alone at home due to worsening arthritis. After one particularly nasty fall put her in hospital, it was agreed that Norma should move temporarily into a home in September 2010 while her house underwent refurbishment.

Norma, a fiercely independent woman, was against the idea. “She liked her own way and she liked routine,” says Carol, 53, who was Norma’s only child. “She got very frightened of medical people.”

Before arthritis set in Norma would often help out elderly friends who lived close by, pruning flowers in the garden and keeping them company over mugs of tea. Even when her joints began to stiffen she preferred not to be seen in public in a wheelchair, opting for a Zimmer frame instead.

“That’s me done then, isn’t it?” Norma joked with her daughter when told of the plan to move into care. Three years on, the words have lost their humor.

At first Norma settled in well. Carol would visit every day and take her mother out for trips. Aside from some early quibbles over how tough it was to get the staff’s attention, Druids Meadow seemed a safer place to be than home alone.

But things soon turned for the worse. As a coroner would later find, Norma was repeatedly failing to eat enough. She developed a urinary tract infection and begun drinking less and less water, despite being under the supervision of staff.

The situation came to a head in October while Carol was away for the week in London visiting the National History Museum with her daughter Jessica, now 9.

“As the week went on, mum got more and more incoherent, to the point where the phone stopped being answered,” Carol recalls. Despite reassurances from the care home staff, she cut short her trip after sensing something was wrong and rushed to the home.

“From the moment I got there it was apparent that some major change had taken place,” says Carol. “She was dehydrated; there was no doubt about it. … She was very quiet, very sleepy. She would mutter a word and drop off mid-sentence.”

Carol was insistent that her mother was dangerously dehydrated: her inner lips were dry and flaky; she became delirious, envisioning snakes coiled by the light fittings. Yet despite repeated requests for a doctor to treat her mother it was not until November 1 – Norma’s 71st birthday – that she was examined, according to the coroner.

Throughout her birthday Norma sat slumped and motionless in a wheelchair, head down. Three days later she was in hospital. Five days later she was dead.

When Norma passed away on November 6 2010 she weighed just five stone. During five weeks in the home she had lost 35lb. At an inquest earlier this year, neglect was found to have played a part in her death, as did dehydration.

“The failures I found are gross because they were so terribly simple,” concluded Birmingham’s deputy coroner Sarah Ormond-Walshe. “Without one or more of these gross failures, Norma Spear would have survived.”

Speaking almost three years to the day since Norma’s passing, Carol says she still feels guilt. “If I hadn’t gone to London, she would probably have lived … I have got to carry that guilt for the rest of my days,” she says.

But there is also anger at the Britain’s care system. “I don’t actually blame the staff at the care home,” she says. “I blame the total lack of protocol and training which we have in all our assisted care homes.”

When told that more than 1,000 people died dehydrated in care homes over the past decade, Carol says she is saddened but doubts 10 years from now nothing will have changed. “I honestly don’t believe it will stop.”

Source: Healcon