Massachusetts firm linked to US meningitis outbreak searched

Investigators in the United States have raided the premises of a Massachusetts pharmaceutical company linked to a meningitis outbreak.

The Food and Drug Administration (FDA) raised concerns about sterility and cleanliness at the New England Compounding Center (NECC).

So far 16 people have died from a rare fungal form of meningitis, apparently after using contaminated drugs.
More than 200 people in 15 US states have been affected.

Steroids and heart drugs produced by the Boston-based NECC are under investigation and the FDA has warned doctors not to prescribe any of the company's products.

Meningitis is an inflammation of the membranes covering the brain and spinal cord. Symptoms include severe headache, nausea and fever as well as slurred speech and difficulty walking.

Fungal meningitis is not contagious, according to US health officials.

Compounding concerns

 
Criminal investigators from the FDA searched the NECC premises on Tuesday as part of a broad state and federal investigation into the deadly outbreak.

Paul Cirel, a lawyer for the pharmaceutical company, told Associated Press that it was "difficult to understand the purpose" of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.

They have been several calls by US congressmen for a full-scale criminal investigation into the NECC's practices.

The outbreak has raised questions about the practice of drug compounding, where pharmacies prepare specialised doses of medication. Compounding is not regulated by the FDA, which generally oversees drug makers.

NECC has suspended operations and recalled the steroid injection initially linked with the outbreak, methylprednisolone.

The Food and Drug Administration says it is looking into reports of a patient with possible meningitis who received an injection of triamcinolone, a different steroid, from NECC.

Two transplant patients also developed a fungal infection after receiving an unnamed heart drug made by the firm.

The FDA has not confirmed that these three infections were caused by NECC products, and has said that it is very possible that the heart patients were infected by another source.

On Monday, the drug regulator expanded its recommendation for doctors to warn anyone who received any injection made by the company, including drugs used in eye surgery.

Last week, health officials said 12,000 of the roughly 14,000 people in 23 states who received the steroid shots had been contacted.

Drug compounding

• Drug compounding is used to make unique drugs for individual patients when there are no existing licensed treatments
• It is common practice around the world to make medicines for rarer conditions and children, for example
• Individual pharmacists or specialist drug companies combine, mix, or alter ingredients to create medications to meet these specific needs
• In the US, compounded drugs are not approved by the regulator the FDA, which means their safety and efficacy are unverified
• In the UK, compounded drugs come under the same scrutiny as other drugs regulated by the MHRA
• Poor practices on the part of drug compounders can result in contamination or in products that don't possess the strength, quality and purity required

Too little sleep plays havoc with fat cells

Here's another reason to get a good night's sleep: Too little shut-eye plays havoc with your fat cells, which could lead to weight gain and type 2 diabetes, researchers reported Monday.

Scientists have known for years that sleep deprivation makes you tired and cranky and less able to think clearly. It also can make you fat because it increases levels of a hunger hormone and decreases levels of a fullness hormone, which could lead to overeating and weight gain.

The latest study indicates that not getting enough sleep reduces your fat cells' ability to respond properly to the hormone insulin, which is crucial for regulating energy storage and use. Over time the disruption could lead to weight gain, type 2 diabetes and other health problems, the researchers say.

"Our fat cells need sleep to function properly," says Matthew Brady, one of the study's authors and vice chair of the committee on Molecular Metabolism and Nutrition at the University of Chicago. "If you're sleep deprived, your brain may feel groggy, and it turns out that your fat cells also need sleep or they are metabolically groggy."

The study is the first to examine the effects of sleep deprivation on fat cells in humans, he says.

Brady and colleagues had seven healthy, lean young adults live in a sleep laboratory for four days on two separate occasions, spaced four weeks apart. Participants were fed identical meals for the eight days, and they had no access to snacks.

For one part of the study, the participants spent 8½ hours in bed on four consecutive nights. They slept an average of 7.87 hours a night. For the other part, they spent 4½ hours in bed for four consecutive nights, sleeping an average of 4.35 hours. At the end of the four days, they were sleep-deprived by an average of 14 hours.

After the fourth night under each experimental condition, researchers measured participants' overall response to insulin, and they collected abdominal fat tissue from the participants to measure how the fat cells reacted to insulin after sleep deprivation. "We looked at insulin on the cellular level," Brady says.

The findings reported in Tuesday's issue of the Annals of Internal Medicine showed that after four nights of sleep deprivation, the body's overall ability to respond to insulin properly decreased by an average of 16%, which is the first step toward developing type 2 diabetes, Brady says.

Also, after too little sleep, the fat cells' ability to use insulin properly, called insulin sensitivity, dropped by 30%. When fat cells don't respond to insulin properly, lipids (fats) circulate in the blood, which can lead to other health problems, including type 2 diabetes, Brady says.

People think of fat as a bad guy, but some fat "is your friend," Brady says. "When fat cells are functioning properly, they safely store fat away for future use such as when you are sleeping or exercising. Fat cells remove fatty acids and lipids from circulating in the body and damaging other tissues. But when your fat cells stop responding to insulin properly, then lipids leave the fat cells and leach out into your blood."

That allows lipids to accumulate in other tissues, such as the liver, he says.

Insulin also plays an important role in the release of the hormone leptin, which is involved in making people feel full.

"Insulin promotes release of leptin, so if your fat cells are less insulin-sensitive, you will make less leptin, which is associated with an increase in food consumption and weight gain," Brady says.

Leptin is released by the fat cells and tells the brain about the energy balance of the body, says Eve Van Cauter, another author of the study and co-director of the Sleep, Metabolism and Health Center at the University of Chicago. Low leptin levels tell your body it's starving and increase your appetite, she says.
Van Cauter says these new findings "are fascinating because they tell us that sleep is important not only for brain cells as we have known for a long time but for all cells of the body, including fat cells and probably muscle cells, liver cells and others."

David Neubauer, associate director of the Johns Hopkins Sleep Disorders Center, who wasn't involved in this study, says the research "is an important step in our understanding of the relationship of sleep and physiological functioning, particularly regarding the increased risk for type 2 diabetes and obesity in people who have inadequate sleep — whether due to chronic sleep deprivation or perhaps from sleep disorders, such as sleep apnea.

"This study reinforces the importance of good sleep generally in promoting health," he says.

The kind of sleep deprivation experienced by the participants in the study happens in the "real world" when people are cramming for finals, have a newborn in the house or have a lot of extra work for their job, Brady says. "A lot of people have had stretches where they have only been able to get three or four hours of sleep a night."

"Even for these healthy students, going just four nights without enough sleep impacted their fat cells' response to insulin," he says.

Brady recommends aiming for eight hours of sleep a night. "It's very important for not only your brain but likely the rest of your body."

How much sleep is enough?

Sleep needs vary, but in general most young adults need seven to nine hours a night, says Van Cauter. There are some people who can do with less, and others who need more. With aging, sleep need decreases to about seven to eight hours a night, she says.

Yet, many people don't know exactly how much sleep they need.

Van Cauter recommends trying to get a handle on your sleep needs by doing this: The next time you're on vacation, go to bed at your usual time, but do not use an alarm clock to wake up. The first couple of days, you may sleep more than usual. That way you will pay your sleep debt, she says.

Then, when your sleep has stabilized, record how much you sleep, plus or minus 15 minutes, she says. That is your sleep need or capacity.

GETTING ENOUGH SHUT-EYE?

Sleep needs vary among individuals, but here are some nightly guidelines.

Newborns (0-2 months): 12-18 hours

Infants (3-11 months): 14-15 hours

Toddlers (1-3 years): 12-14 hours

Pre-schoolers (3-5 years): 11-13 hours

School-age kids (5-10 years): 10-11 hours

Adolescents (10-17 years): 8.5-9.25 hours

Adults: 7-9 hours

Source: National Sleep Foundation

Second-hand smoke and your child

 

What you need to know

Quit Victoria defines second-hand smoke as being made up of ‘mainstream’ smoke, which the smoker breathes out, and ‘sidestream’ smoke, which drifts from the end of a burning cigarette.

Children most commonly come into contact with second-hand smoke when their parents, family and friends smoke.

But the problem isn’t just smoking around children – second-hand smoke hangs around for up to five hours. It gets left on furniture, carpets and clothing. This means babies and children are still exposed to it even after adults have finished their cigarettes.

Infants and children are particularly at risk from second-hand smoke because they have smaller airways and less mature immune systems. Their smaller airways mean they breathe faster, so they breathe in relatively more second-hand smoke – and its harmful chemicals – than an adult would in the same amount of time. 

Health risks linked with passive smoking

Passive smoking dramatically increases health risks for babies, children and teenagers. Studies show that children exposed to second-hand smoke are at an increased risk of premature death and disease and are more likely to have thickening, irritation and inflammation of their airways.

Second-hand smoke can impair a baby’s breathing and heart rate, which can put them at a higher risk of Sudden Infant Death Syndrome (SIDS). If parents smoke during pregnancy and after their baby is born, their baby’s SIDS risk increases. If one parent smokes, the risk of SIDS doubles. If both parents smoke, the risk doubles again.

If children are exposed to second-hand smoke, they’re more likely to develop a range of lung and other health problems, including:

• asthma
• bronchiolitis
• bronchitis
• childhood cancers, including leukaemia
• croup
• ear infections
• impaired sense of smell
• meningitis
• meningococcal disease
• pneumonia
• tonsillitis.

There’s also evidence that exposure to second-hand smoke can increase the likelihood of behaviour problems and learning difficulties.

If children live in a household where one or more adults smoke, they’re exposed to greater health risks. They need to go to the doctor more often. The chance that they will take up smoking in adolescence doubles.

Protecting your child from second-hand smoke

The most important way to protect your child from second-hand smoke is to quit smoking. This greatly reduces your child’s exposure to second-hand smoke. It also gives your child a positive non-smoking role model.

If you’re not quite ready to quit, or someone else in your home is the one smoking, there are still things you can do to reduce your child’s exposure to the smoke. One of the most important things you can do is to make sure no-one smokes in front of your child. This means you’ll have to do it away from your child, and that you’ll need to ask other family members, friends and visitors to do the same. Explain to them that simply blowing smoke away from your child doesn’t protect him from the harmful effects of smoke. Also make sure you never smoke in an enclosed area near your child.

When visiting friends, or leaving children in the care of someone else, try to make sure the environment is smoke-free.

Never smoke in a car that carries children. Opening the car window isn’t enough to stop smoke affecting children. In most Australian states, it’s illegal to smoke in a car that carries a child under the age of 18. This legislation is backed by the evidence that second-hand smoke is particularly harmful to children. Hefty on-the-spot fines are enforced if you’re caught smoking in a car that carries children.

Make a commitment that your home and car will be smoke-free at all times. Insist that no-one smokes around your child. Every child has the right to grow up in a smoke-free environment.

Safe sleep: SIDS precautions

Strong evidence shows that exposure to smoke harms babies, and that smoking during pregnancy and after birth increases the risk of SIDS. The link between SIDS and smoking is strong even when parents smoke away from their baby.

one important precaution you can take against SIDS is keeping the smokes outside and away from your baby all the time, not just when baby’s sleeping. 

Smoking in cars 'affects kids' health'

Smoking in cars is likely to affect the health of any children present, even if the windows are open, a new study has shown.

According to UK scientists, the habit results in high levels of toxic fine particulate matter - a type of air pollution - from tobacco smoke being pumped into the car. These levels far exceed the safe levels recommended by the World Health Organisation (WHO) and occur even with open windows.

The team carried out a study involving 17 drivers and over 100 car journeys. Fourteen of the drivers were smokers. The average journey lasted just under a half-an-hour.

The levels of fine particulate matter were measured in the back seats of the cars every minute during any journeys taken. This took place over a three-day period.

The study found that levels of particulate matter were 10 times higher in ‘smoking ‘ cars and this appeared directly linked to the number of cigarettes that were smoked.

While the smokers did tend to open windows in the car if they were smoking during a journey, the levels of particulate matter found still exceeded the WHO's recommended limit of 25 µg/m3. In fact, they averaged 85 µg/m3 and during one journey, reached as high as 880 µg/m3.

The scientists noted that children who are exposed to second hand smoke have an increased risk of developing a number of health problems, including asthma and middle ear disease.

"Children are likely to be at greater risk from (second hand smoke) exposure due to their faster breathing rates, less developed immune system and their inability to move away from the source in many home and car settings," they explained.

The scientists said they support the introduction of bans on smoking in cars.

Earlier this year, the government confirmed that it is drafting new laws to ban smoking in cars when children are present. However, it is not yet known when this ban will come into operation or how it will be monitored.

Details of this study are published in the medical journal, Tobacco Control.

Kaylee Davidson-Olley marks 25 years with new heart

The UK's first baby heart transplant survivor has celebrated a quarter of a century since her historic operation. 

Kaylee Davidson-Olley, of Houghton-le-Spring, near Sunderland, was just five months old when she had the operation at Newcastle's Freeman Hospital.

To mark 25 years since the procedure, Ms Davidson-Olley met medical experts from around the world at Newcastle's Centre for Life.

She was joined by 30 other patients who got new hearts aged under a year.

Ms Davidson-Olley, a shop sales advisor, regularly takes part in the World Transplant Games and has spent her life campaigning to get more people on the organ donor list.

'Important decision'

She said: "I cannot believe that I am fit and healthy 25 years after my transplant.

"This was only made possible because of the generosity of a family who made that important decision about organ donation, a decision that saved my life.

"Without that family discussing organ donation, I simply would not be here."

In total, 112 babies aged under a year have received new hearts in the UK during the past 25 years.

Consultant paediatric consultant Dr Richard Kirk, based at the Freeman, said that despite awareness campaigns, there was a shortage of baby hearts - two UK babies have died this year waiting for a new organs.

He also said six babies were desperately ill waiting for new hearts.

Dr Kirk said: "We are very proud of Kaylee and urge parents to consider organ donation, despite incredibly difficult circumstances."

Anthony Clarkson, assistant director for Organ Donation with NHS Blood and Transplant, said three people died in the UK every day waiting for an organ transplant.

Baby boomer alcohol harm 'more likely than in young'

More NHS money is spent treating alcohol-related illness in baby boomers than young people, a study says.

The Alcohol Concern report found the cost of hospital admissions linked to heavy drinking among 55 to 74-year-olds in 2010-11 was more than £825m.

That was 10 times the figure for 16 to 24-year-olds.

In total, nearly £2bn was spent on alcohol-related in-patient admissions in England, the report found.
This comes as more than 10 million people in England are drinking above the recommended levels, according to the report.

The sum spent on treating the baby boomer generation went on 454,317 patients, compared with the 54,682 under-24s who were treated at a cost of £64m.

Problem drinking is a contributing factor for a host of diseases, including liver, kidney and heart disease, as well as increasing the risk of injury.

In many ways the findings are not surprising as the effects of drinking are more likely to catch up with people later in life.

'Expensive care'

 
But the charity said part of the reason for compiling the report, which was based on NHS figures, was to break down the data by individual local authority area.

It hopes the information, compiled with funding from drug company Lundbeck, will be used by councils next year when they take responsibility for problem drinking as part of their new remit covering public health under the shake-up of the NHS.

Alcohol Concern chief executive Eric Appleby said he hoped they would use the findings to help them focus their energy on schemes to tackle problem drinking.

"It is a common perception that young people are responsible for the increasing cost of alcohol misuse, but our findings show that in reality this is not the case.

"It is the middle-aged, and often middle-class drinker, regularly drinking above recommended limits, who are actually requiring this complex and expensive NHS care."

Liver disease expert Sir Ian Gilmore, a former president of the Royal College of Physicians, who has long campaigned about alcohol misuse, agreed. He said: "It is the unwitting chronic middle-aged drinkers who are taking serious risks with their health."