Food stamp program may reduce food insecurity for children

(Reuters Health) – A program that provides nutrition assistance to millions of low-income families may be linked to improved well-being among children, according to a new study.

Researchers found that children in households who participated in the Supplemental Nutrition Assistance Program (SNAP) for six months had substantial improvements in their consistent access to food – or “food security.”

Food insecurity has been linked to a number of health and developmental problems among children, the authors write.

“Stated simply, SNAP works,” James Mabli told Reuters Health.

Mabli, the study’s lead author, is a senior researcher with Mathematica Policy Research in Cambridge, Massachusetts, a data collection and analysis company.

“SNAP is achieving its objective of reducing hunger, and it’s achieving that objective for one of the most vulnerable populations which are households with children,” he said.

The findings are especially important now because the program in general and the amount of benefits households receive have been under fire for the past few years, he said.

SNAP is run by the U.S. Department of Agriculture (USDA). It’s the largest U.S. food assistance program and reached approximately 47 million people in 2013. Families enrolled in SNAP can use benefits to buy most food, but not alcohol, supplements or prepared meals.

About half of SNAP enrollees are children, according to Mabli and his colleague Julie Worthington.

Previous studies have looked into whether SNAP improves people’s food security, but the results have been mixed.

One recent report found people who received assistance through SNAP fared no better than people in similar conditions who were not eligible or didn’t enroll in the program (see Reuters Health story of November 25, 2013 here:

The new study, Mabli said, includes the largest number of households and most recent information and takes into account other factors that could affect food security, such as changes in income.

The data came from the SNAP Food Security survey, which was conducted by Mathematica for the USDA Food and Nutrition Service from 2011 to 2012. It included about 3,000 families who were enrolled in SNAP.

First, the researchers compared survey information from households that had enrolled within the previous five days to families who’d been in SNAP for six to seven months.

Next, they followed up with the new-entrant families about six months later to see if there had been any changes in their access to food.

In the first part of the study, the proportion of households in which children were food insecure was 37 percent for new-entrant households compared to 27 percent for families that had been enrolled for six months.

When the researchers followed up with the new-entrant families six months later, they found the rate of food insecurity among children had dropped to just under 25 percent.

SNAP was also linked to a decrease in the odds of children experiencing severe food insecurity, the researchers reported in Pediatrics.

“We examined whether there is a larger improvement in food security for people who have received more benefits because we expect there to be a larger improvement,” Mabli said. “In one of the two samples, we found that SNAP decreased the chance of being food insecure by 50 percent, so it cut it in half.”

“There is a greater improvement (in) food security for people who receive greater benefit amounts. And so when in the news you see people advocating reduction of benefits you really have to consider the effect it’s going to have on children’s food security,” Mabli said.

Funding has been cut to SNAP recently. A temporary increase that was part of the American Recovery and Reinvestment Act of 2009 ended in November of last year. The 2014 Farm Bill that was signed in February cuts about $8 billion of SNAP funding over the next 10 years.

In 2013, the average SNAP recipient received about $133 per month, but that number will drop below $130 per month this year, according to the Center on Budget and Policy Priorities.

“For households that continue to be eligible in participating, decreasing the benefit can have a severe impact on the lives of children,” Mabli said. “Any reduction of benefits needs to be carefully targeted to avoid eroding food security.”

There are a number of people on SNAP who are still food insecure, he added, which means they have trouble finding enough food or being able to purchase enough food.

SOURCE: Pediatrics, online March 3, 2014.

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First patient fitted with Carmat artificial heart dies -hospital

(Reuters) – The first patient fitted with an artificial heart made by the French company Carmat has died, the hospital that had performed the transplant in December said on Monday.

The 76-year-old man died on Sunday, 75 days after the operation, the Georges Pompidou European Hospital in Paris said in a statement, adding that the cause of his death could not be known for sure at this stage.

When he was fitted with the device, the man was suffering from terminal heart failure – when the sick heart can no longer pump enough blood to sustain the body – and probably had only a few weeks, or even days, to live.

Representatives of Carmat could not immediately be reached for comment.

The bioprosthetic organ product is designed to replace the real heart for up to five years, mimicking nature’s work using biological materials and sensors. It is aimed at helping the thousands of patients who die each year while awaiting a donor, and reducing the side-effects associated with transplants.

Three more patients in France with acute heart failure are due to be fitted with the device.

The clinical trial will be considered a success if patients survive with the implant for at least a month.

If it passes the test, the device will then be fitted into about 20 patients with less severe heart failure.

“The doctors directly involved in the post-surgical care wish to highlight the value of the lessons learned from this first clinical trial, with regard to the selection of the patient, his surveillance, the prevention and treatment of difficulties encountered,” the hospital said in its statement.

(Reporting by Natalie Huet; Editing by Michel Rose and Kevin Liffey)

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Doctors aim to grow ears from fat

By James Gallagher
Health and science reporter, BBC News

Back of child's headNew ears could be the first application of the technique

Doctors at Great Ormond Street Hospital in London are aiming to reconstruct people’s faces with stem cells taken from their fat.

The team has grown cartilage in the laboratory and believe it could be used to rebuild ears and noses.

They say the technique, published in the journal Nanomedicine, could revolutionise care.

Experts said there was some way to go, but it had the potential to be “transformative”.

The doctors want to treat conditions like microtia, that results in the ear failing to develop properly and can be missing or malformed.

At the moment, children have cartilage taken from their ribs, which is then delicately sculpted by surgeons to resemble an ear and implanted into the child.

It requires multiple operations, leaves permanent scarring on the chest and the rib cartilage never recovers.

From fat

The team envisage an alternative – a tiny sample of fat would be taken from the child and stem cells would be extracted and grown from it.

An ear-shaped “scaffold” would be placed in the stem cell broth so the cells would take on the desired shape and structure. And chemicals would be used to persuade the stem cells to transform into cartilage cells.

This could then be implanted beneath the skin to give the child an ear shape.

The researchers have been able to create the cartilage in the scaffold, but safety testing is needed before they could be used in patients.

One of the researchers, Dr Patrizia Ferretti, told the BBC: “It is really exciting to have the sort of cells that are not tumourogenic, that can go back into the same patient so we don’t have the problem of immunosuppression and can do the job you want them to do.

“It would be the Holy Grail to do this procedure through a single surgery, so decreasing enormously the stress for the children and having a structure that hopefully will be growing as the child grows.”

New ear

Samuel ClompusSamuel Clompus before the operation to rebuild his ear

The technique could help patients like 15-year old Samuel Clompus, who has had the reconstructive ear surgery.

His mother, Sue, said the family welcomed the research.

She told the BBC: “They wouldn’t have needed to take the cartilage.

“He has a scar there now and Sam said it was the most uncomfortable bit.”

The technique could be used to create cartilage for other tissues such as the nose, which can be damaged in adults after cancer surgery.

Doctors say they could also make bone using the same starting material.

“Obviously we are at the beginning of this, the next step will be to perfect just the choice of materials and to develop this further,” said Dr Ferretti.

Commenting on the study, Prof Martin Birchall, a surgeon at University College London, said: “If you had something that was truly regenerative, that would be transformative.”

He was involved in the first operations to give people lab-grown windpipes.

He said the fat-based technique needed more safety testing to reach that stage.

“We used [bone marrow] stem cells as they’ve been used in 10,000s of people for bone marrow transplants, fat stem cells are likely to be fine, but they haven’t got that safety record yet.”

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Nightmares may be 'health warning'

By James Gallagher
Health and science reporter, BBC News

Nightmare of a clownDisturbed sleep may be a sign of mental health problems

Regular nightmares in childhood may be an early warning sign of psychotic disorders, researchers in the UK warn.

The study, in the journal Sleep, said most children had nightmares, but persistent ones may be a sign of something more serious.

Having night terrors – screaming and thrashing limbs while asleep – also heightened the risk.

The charity YoungMinds said it was an important study which may help people detect early signs of mental illness.

Nearly 6,800 people were followed up to the age of 12.

Parents were regularly asked about any sleep problems in their children and at the end of the study the children were assessed for psychotic experiences such as hallucinations, delusions and thinking their thoughts were being controlled.

The study showed that the majority of children had nightmares at some point, but in 37% of cases, parents reported problems with nightmares for several years in succession.

One in 10 of the children had night terrors, generally between the ages of three and seven.

Warning light

The team at the University of Warwick said a long-term problem with nightmares and terrors was linked to a higher risk of mental health problems later.

Around 47 in every 1,000 children has some form of psychotic experience.

However, those having nightmares aged 12 were three-and-a-half times more likely to have problems and the risk was nearly doubled by regular night terrors.

One of the researchers, Prof Dieter Wolke, told the BBC: “Nightmares are relatively common, as are night terrors, it is quite normal, but if they persist then there may be something more serious about it.”

The relationship between sleep problems and psychosis is not clear.

One theory is that bullying or other traumatic events early in life can cause both symptoms.

Or the way some children’s brains are wired means the boundaries between what is real and unreal, or sleeping and wakefulness, are less distinct.

It means treating the sleep issues may not prevent psychotic events.

However, nightmares may act as an early warning sign of future, more serious, problems.

Prof Wolke said a regular routine and quality sleep were key to tackling nightmares: “Sleep hygiene is very important, they should have more regular sleep, avoid anxiety-promoting films before bed and not have a computer at night.”

Night terrors occur at specific points during sleep and can be managed by briefly waking the child.

Lucie Russell, the director of campaigns at YoungMinds, said: “This is a very important study because anything that we can do to promote early identification of signs of mental illness is vital to help the thousands of children that suffer.

“Early intervention is crucial to help avoid children suffering entrenched mental illness when they reach adulthood.”

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Man's leg kept alive on his arm

By Sharon Barbour
BBC Look North health reporter

Ian McGregor

Ian McGregor said it was like an episode of Star Trek

Surgeons removed a man’s tumour and rebuilt his body using leg muscles and tissue they had removed and attached to his arm to keep alive.

The operation on Sunderland man Ian McGregor lasted 18 hours and is thought to be the first of its kind in the UK.

Surgeons in Newcastle took his calf, attached it to his arm and then used it to repair the site of the operation.

The 59-year old, who is making a good recovery, said: “You just can’t put into words what they did.”

The large aggressive tumour had spread from Mr McGregor’s pelvis into his thigh. Previous attempts had been made to treat the cancer over the past 10 years but had been unsuccessful.

‘Star Trekky’

For the latest attempt, surgeons feared the hole left would be too big to repair.

Then the team at Newcastle’s Freeman Hospital came up with the idea to remove his lower leg, except for the bones, and attach it to his forearm – thereby maintaining the blood flow.

Graphic showing how the surgeons attached the calf to the armMr McGregor’s calf was attached to his arm to keep the blood flowing

After removing his leg and the tumour they then disconnected the calf from his forearm and used it to repair the area from where the tumour had been removed.

The surgery last August started at about 09:00 and lasted until after 03:00 the following morning.

When they first told Mr McGregor what was going to be done, he thought it was “Star Trekky”.

He said: “I couldn’t imagine what they were telling me, how they would do it and if I would wake up from the operation.”

‘Wonderful feeling’

He said he had been given the choice about whether to have the operation but believed if he had not he would no longer be here. He said at the time he was in pain 24 hours a day.

He described what the surgeons had achieved as “amazing” and said he could not thank them enough.

Mr McGregor's upper leg and hip repaired with his calfSurgeons took the calf from Mr McGregor’s arm and then attached it to his hip and upper leg

“You can’t describe the feeling, you think you’re at death’s door and then you wake up and think wow, I’m here. It’s a wonderful feeling,” he said.

The experts at the Newcastle hospital believe it may be the first operation of its kind in the world – they understand it may have been attempted in the US but over the course of two operations.

Three consultant specialists worked together on the plan.

Consultant Plastic and Reconstructive Surgeon Mani Ragbir said it was very unusual.

“We are not aware of anyone having done this particular procedure before,” he said.

“It’s not easy for a surgeon to tell a patient that they haven’t done this particular procedure before.”

They now plan to publish their work and believe it may open up a new approach to surgery.

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Generic drugmakers ramp up campaign against FDA label proposal

(Reuters) – Generic drugmakers are furiously campaigning against a proposed U.S. rule that would require them to change the prescribing information on their products if they receive new safety information, which they say would open them to product liability lawsuits.

The rule would overturn regulations that have been in place for three decades that prohibit generic drugmakers from updating safety data on their labels without such changes first being made by the company that developed the drug.

The Food and Drug Administration, which issued its proposal in November, said the change is designed to “create parity” between branded and generic drug makers with respect to labeling changes, and remove an unnecessary impediment to the prompt communication of safety data.

Generic drugmakers say the proposed rule would raise the cost of drugs and lead to confusion among consumers.

“Disregarding decades of regulatory stability in this way will create unwarranted confusion, raises patient safety concerns and threatens the system that created thousands of affordable options for consumers,” said Gordon Johnston, a former deputy director of the FDA’s generic drugs division and current an industry consultant in a statement.

Just as importantly, if not more so from a company point of view, the move would make generic drugmakers more vulnerable than they are now to product liability lawsuits.

“The Generic Pharmaceutical Association cannot support a proposed rule that undermines public health merely to facilitate litigation against generic drug companies by the plaintiffs’ bar,” the association said in a position paper last month.

The House of Representatives Energy and Commerce Committee’s health panel will consider the proposed changes to generic drug labeling during a hearing on Monday.


Congress adopted the Hatch-Waxman Act in 1984 to speed generic drug approvals, and over the past 30 years the industry has mushroomed. Today generic drugs account for some 80 percent of all prescriptions filled in the United States.

Since generics are designed to be more or less the same as brand name drugs, from the active ingredients to the way they dissolve in the body to the prescribing information, the FDA historically forbade generic drug makers from making independent changes to their labeling.

In 2011, after years of legal wrangling, the Supreme Court ruled that the FDA’s prohibition on label changes meant generic drugmakers should not be held accountable for a failure to warn against risk. As a result, consumers taking a brand name drug can have legal recourse if they are injured by a drug, but those taking a generic effectively do not.

The FDA’s proposal would remove that protection and place equal responsibility for monitoring drug safety on the brand company and the generic manufacturers.

Supporters of the proposal say this is particularly important because there are some 2,000 generic drugs on the market, or about 45 percent of all generics sold, for which there is no longer a branded counterpart.

“If generic manufacturers are not actively monitoring and proposing safety updates, no manufacturer is doing so at all,” Allison Zieve, general counsel at consumer watchdog Public Citizen, said in testimony to be delivered to the House panel on Monday. “As generic market share increases, the brand-name manufacturer loses incentive to devote resources to post-approval safety monitoring.”

Public Citizen filed a petition in 2011 asking the FDA to authorize generic drug makers to revise product labeling through the procedures available to brand name manufacturers.

Both generic and branded drug companies are required to file reports about adverse events to the FDA, meaning the agency in theory could analyze the data, look for trends and make label recommendations itself. It has historically ceded part of the task to branded drug companies, due in part to limited resources.

“Given that the FDA cannot monitor all post-approval data by itself, drug safety is threatened when the regulatory and common-law incentives designed to motivate manufacturer diligence weaken with shifting control of market share,” Zieve said.

In a twist, the branded drug industry now wants the FDA to take over that responsibility for any drug for which there are generic equivalents. That would in theory protect the branded company from lawsuits by placing the burden of responsibility on the FDA.

“Requiring FDA approval for all safety-related labeling changes for a multisource drug will ensure uniform labeling across all versions of a drug,” the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a briefing note circulated earlier this week to congressional staff.

PhRMA has not suggested the FDA take over responsibility for monitoring the safety of its big-selling branded products.

(Reporting by Toni Clarke; Editing by Ros Krasny and Lisa Shumaker)

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Federal program aims to make pet food, livestock feed safer

(Reuters) – A new federal program aims to standardize inspection procedures for pet food and farm animal feed produced in the United States, making them safer, the U.S. Food and Drug Administration said on Friday.

The Animal Feed Regulatory Program Standards comprise a series of new voluntary standards for inspections by state and other regulatory programs that oversee the production of pet food and feed for farm animals such as cattle, chickens and pigs.

Concern over the safety of pet food and farm animal feed has mounted in recent years, as discoveries of salmonella-contaminated dog food and livestock feed contaminated with a corn-based toxin led to waves of product recalls and worries about the safety of the U.S. food production system.

Pet food is a more than a billion-dollar grain-based business in the United States, while livestock feed accounts for the primary use of the two biggest row crops in the country.

But routine inspection and enforcement practices can differ among the various state agencies responsible for conducting inspections of the companies that make these products, and problems can often fall through the gaps, critics say.

The new standards aim to help unify this process, with guidelines that range from on-site inspection protocols at feed plants to how to respond to feed-related illnesses or deaths.

While the program is not mandatory, “the FDA is encouraging state programs to implement the feed standards because this will build uniformity and consistency among state feed regulatory programs,” the agency said in an email.

The new program follows the 2011 federal Food Safety Modernization Act, which shifted the focus of federal regulators away from responding to food contamination to preventing it.

(Reporting By P.J. Huffstutter; Editing by Jonathan Oatis)

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