Significant drop in measles cases








By James Gallagher
Health and science reporter, BBC News


Measles jab


There was a sharp fall in the number of cases of measles in England at the end of 2013, figures from Public Health England show.

Twenty four people were infected between October and December, in sharp contrast to the hundreds of cases each month at the beginning of the year.

The fall has been put down to efforts to get more children vaccinated with the MMR jab.

However, the number of cases of mumps has increased slightly.

A drop in the number of children being vaccinated, due to the MMR-scare a decade ago, led to a resurgence in measles infections in 2012 and 2013.

Back in 2010 there were just 380 cases all year in England.

Outbreaks in the north-west and north-east of England led to 2,030 cases in 2012 and 1,413 last year.

There was also a large outbreak of measles in Wales with more than 1,200 reported cases.

However, after the summer of 2013 the cases fell significantly and to very low levels in last three months of 2013.

There were 24 cases in England and previous figures showed 25 cases in Wales and two in Northern Ireland.


Child with mumpsA child with mumps

Public Health England said there were 3,524 cases of mumps in 2013 – a marked increase on the 2,476 case the previous year.

The head of immunisation at Public Health England, Dr Mary Ramsay, said: “Measles is a potentially fatal, but entirely preventable, disease so we are delighted that measles cases have recently decreased.

“The best way to prevent measles outbreaks is to ensure good uptake of the MMR vaccine across all age groups, so it’s heartening to see the success the catch-up programme had in ensuring 95% of 10 to 16 year olds in England received at least one dose of the vaccine.

“Although mumps has increased a little from the same quarter of last year, the numbers remain much lower than the levels seen in 2004/5, when outbreaks were reported in several universities.”

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Nighttime finger splints can ease arthritis pain


(Reuters Health) – Inexpensive splints worn nightly can reduce the pain of hand osteoarthritis, a chronic ailment that affects a majority of older adults, a new study shows.

“It’s a well-tolerated, safe and cheap intervention,” rheumatologist Dr. Fiona Watt told Reuters Health.

Watt, from the Arthritis Research UK Centre for Osteoarthritis Pathogenesis at the University of Oxford, led the new study. She and her colleagues tested custom-made splints on London clinic patients who suffered painful and deforming hand osteoarthritis.

Up to 70 percent of adults 55 years and older have hand osteoarthritis, the authors write in the journal Rheumatology. The condition can include episodes of persistent and debilitating pain, limit hand use and erode quality of life.

Previous research has shown splints cut hand arthritis pain (see Reuters Health story of January 27, 2011 here: reut.rs/1hz5IAe). One study found that hand pain was halved for patients who wore a long and rigid splint every night for a year.

In the current study, hand therapists fashioned rigid splints out of $5 to $6 worth of thermoplastic for one arthritic finger joint per patient, and patients wore the splints nightly while sleeping for three months, Watt said.

Twenty-six patients, mostly women, were included in the study. Of the 23 who completed the study, 17, or 74 percent, reported reduced pain after wearing the splints for three months, the study found.

Three months after patients stopped wearing the splints, their average pain was significantly lower in splinted joints than in their other arthritic finger joints that had not been splinted.

Watt said she was surprised to see continued benefits three months after patients stopped using the splints.

“It might suggest that this is a modification of the disease that extends beyond the use of the splint,” she said.

The majority of the patients, 61 percent, chose to continue to use the splints when the study was completed, “which is a good sign, probably better than any statistics,” Watt said.

Dr. Prosper Benhaim, hand surgery chief at UCLA Medical Center in Los Angeles, told Reuters Health he had successfully used similar splints on his patients’ thumbs.

Benhaim was not involved in the new research and has not splinted his patients’ farthest finger joints, as was done in the current study. But he said the study convinced him to try.

“Wearing a splint when you’re sleeping actually seems to work,” he said. “It’s so simple. When you’re asleep, it’s free time. There’s no inconvenience.”

Why splinting relieves arthritic pain is not well understood, the study authors write.

Benhaim believes nighttime splints work because they reduce inflammation. Arthritis stems from a combination of inflammation and a loss of cartilage.

“It just repositions the fingers into a more relaxed position,” Benhaim said.

He said a Popsicle stick and a Band-Aid could work just as well as the thermoplastic splints used in the new study.

But a doctor or a physical therapist will know best how to size and fit a splint, he said.

SOURCE: bit.ly/1ciuO2P Rheumatology, online February 8, 2014.

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Tick test for persistent Lyme disease tried in humans


(Reuters Health) – A small experiment to see whether uninfected ticks could “diagnose” a lingering Lyme infection in people produced modest results, researchers say.

DNA from the Lyme parasite, but not live parasites themselves, were transmitted to the ticks from just two people out of two dozen who had persistent Lyme symptoms despite treatment.

In animal studies, researchers have successfully used “xenodiagnosis,” or diagnosis with another animal, to detect the signs of a persistent Lyme infection in the blood. The technique has also worked in people to detect another parasitic infection, Chagas disease.

But the new report, published in Clinical Infectious Diseases, describes the first attempt to use xenodiagnosis for Lyme disease.

“This is a very initial study, our main objective was to develop the technique in humans,” lead author Dr. Adriana Marques of the National Institutes of Health in Bethesda, Maryland, told Reuters Health.

“It is very hard to find evidence of the bacteria itself, not just antibodies, in infected people once the skin rash is gone,” she said. This tick method may make that process a bit easier, but only with further research, she said.

For most people who contract Lyme disease, a couple of weeks of antibiotics clear up the infection easily. About four weeks later, patients with no signs of the infecting bacteria in their blood get a clean bill of health.

But 10 to 20 percent of people who get Lyme disease, which is transmitted through a bite from an infected tick, continue to report having pain, fatigue or aches even when it appears the infection is gone.

The symptoms can last for more than six months and are called Post-Treatment Lyme Disease Syndrome(PTLDS).

In animal tests, mice and monkeys have been infected with Lyme disease then treated until no Lyme bacteria were detectable in their blood. If at that point an uninfected tick bit the animal and Lyme bacteria turned up in the tick, it meant the animal was actually still carrying the infection.

For the new study, researchers tried out the second-bite system on people with PTLDS. Of the 36 participants, 26 had either persistent symptoms after Lyme disease treatment, or still had an itchy, red lesion at the site of the original bite, or had unusually high levels of antibodies against the infection even though treatment seemed to have been successful.

The other ten volunteers were healthy and had never had Lyme disease.

Researchers placed 25 to 30 uninfected ticks on the arm of each person to feed, under a special dressing, and collected the ticks a few days later.

The ticks were then incubated for up to two weeks to allow any potentially transmitted Lyme bacteria to develop, and afterwards researchers did a variety of molecular tests looking for any sings of the bacteria.

None of the ticks from healthy volunteers had evidence of the Lyme bacteria. Researchers successfully harvested usable ticks from 23 participants with a history of Lyme, and 21 had no ticks test positive for signs of bacteria.

For another two people the results were unclear. For one person with persistent symptoms after antibiotic treatment and one person with a persistent rash who had just started antibiotics, the ticks did test positive for fragments of DNA from the bacterium.

“The next step will be to see if the results correlate with persistent symptoms. We can’t answer that question right now,” Marques said. Right now it doesn’t mean anything for the patients’ health one way or the other that bacterial DNA was present.

The main objective of the study was to see if this type of xenodiagnosis is safe and appropriate for humans, and the answer seems to be yes since the major complaint from subjects was mild itching, said Justin D. Radolf of the University of Connecticut Health Center in Farmington.

“But the results don’t change our understanding of PTLDS,” said Radolf, who wrote an editorial accompanying the study.

“There is consensus that post-Lyme disease syndrome as defined in the paper does exist and that it occurs in a minority of people,” said Linda K. Bockenstedt of Yale University School of Medicine in New Haven, Connecticut, who coauthored the editorial. “We do not know why this occurs, and the reasons may not be the same for everyone.”

The subject is controversial because “chronic Lyme disease” can describe a number of conditions and a constellation of symptoms in people who may never actually have been infected with the bacteria.

“Many chronic Lyme disease patients have been assigned the diagnosis based on symptoms only (not objective signs), and through either misinterpretation of appropriately conducted Lyme (blood tests) or the use of nonvalidated tests,” Bockenstedt told Reuters Health in an email.

That could mean that “chronic Lyme disease” is being used as a catchall when in fact another medical condition might underlie the symptoms.

It’s hard to say how useful this technique actually is in humans for Lyme disease, Bockenstedt and Radolf write in the journal. The only way to diagnose a persistent infection is by finding live bacteria, which this test did not.

SOURCE: bit.ly/1cPZLio Clinical Infectious Diseases, online February 11, 2014.

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Indoor tanning tied to risky behaviors among teens


(Reuters Health) – U.S. teenagers who use indoor tanning devices are more likely to take part in other risky behaviors, according to a new government study.

Researchers from the Centers for Disease Control and Prevention (CDC) found that using indoor tanning devices was linked to binge drinking, having sex and using unsafe methods to control weight among high school students.

“I think it’s important to understand the prevalence of indoor tanning and its relation to other risky behaviors,” Gery Guy, Jr., the study’s lead author from the CDC, told Reuters Health.

Understanding the relationship between other behaviors and indoor tanning can help public health advocates to understand the tanners’ motivations and better target campaigns to dissuade the practice.

The World Health Organization (WHO), the American Medical Association and the American Academy of Dermatology have come out against indoor tanning in recent years.

In 2009, WHO labeled tanning devices as high-level carcinogens, which puts tanning on par with tobacco use as a public health threat.

In 2007, a working group affiliated with WHO found that people who used tanning beds before their 30th birthday were 75 percent more likely to develop melanoma – the deadliest form of skin cancer.

That added risk translates, for example, to about seven more women out of every 10,000 developing melanoma. One past study showed that 24 out of 10,000 women who regularly used tanning beds developed melanoma compared to 17 out 10,000 women who rarely or never used them.

For the new study, the researchers analyzed data from two national CDC surveys of high school students in grades nine through 12 that asked about various behaviors related to their health. The surveys were conducted in 2009 and 2011.

About 16 percent of students said they had used indoor tanning devices in the 2009 survey and about 13 percent reported indoor tanning in the 2011 survey. The difference, however, could have been due to chance.

Also, in both years, the researchers write in JAMA Dermatology that female students were more likely to report using indoor tanning devices compared to males. That applied especially to older and non-Hispanic white students.

As for other risky behaviors, both male and female students who reported indoor tanning were more likely to report binge drinking, having sex and using unhealthy methods to control their weight.

Among girls, illegal drug use and having had sex with four or more partners were also more likely among those who used indoor tanning.

Using steroids that weren’t prescribed by a doctor, smoking daily and attempting suicide were more common among male students who used indoor tanning, Guy and his colleagues found.

Students who tanned were also more likely to play on sports teams and to eat vegetables.

Together these results, coupled with previous research, indicate that indoor tanners may be motivated by a desire to improve their appearance, the researchers suggest.

“Thus, efforts to reduce indoor tanning may be more successful if they address appearance-based motives and emphasize the detrimental appearance aspects of indoor tanning rather than solely focusing on the negative health effects,” they write.

For example, Guy said using videos to show the effects of UV radiation on a person’s skin may be more effective than pushing out a general health message.

“Early intervention is key among this population to avoid having the behavior continue into the adulthood,” he said.

SOURCE: bit.ly/MyJFiP JAMA Dermatology, online February 26, 2014.

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Supplement users are seeking wellness: study


(Reuters Health) – People who use multivitamins and other nutritional supplements tend to lead healthier lives overall, so taking supplements can be seen as a positive sign, suggests a new review of past research.

More than half of American adults use supplements such as multivitamins, calcium, omega-3 fatty acids, antioxidants and fiber, the researchers say. But the other things users are more likely to do – like exercise and maintaining a normal weight – are often downplayed in discussions of the value of dietary supplements.

“This evidence is based on the fact that dietary supplement users tend to be health seekers in a broader sense, that is they tend to use supplements as part of several things they do to try to improve their health,” said Annette Dickinson, the study’s lead author.

Dickinson is a consultant for the Council for Responsible Nutrition, a supplement industry trade group, and an adjunct professor in food science and nutrition at the University of Minnesota.

She said published articles that are critical of supplement use often add statements saying that people shouldn’t use supplements as a substitute for a better diet and shouldn’t think they can compensate for bad habits by using supplements.

“Those are true statements, but it implies that those are the kind of people supplement users are,” Dickinson said. “We just wanted to highlight the fact that the evidence shows that that’s not primarily the way they use supplements – they use them as part of an overall approach to wellness.”

Several recent studies have shown no benefit from dietary supplements in preventing major illnesses like cancer and heart disease. This week, the U.S. Preventive Services Task Force, a government-backed advisory panel, said that barring known deficiencies, there’s no evidence to support taking supplements and there is evidence against taking certain vitamins (see Reuters Health article of February 24, 2014, here: reut.rs/1fCKqCP).

In their review, Dickinson and her co-author Douglas McKay, a vice president with the Council for Responsible Nutrition, rounded up past surveys of supplement users and analyzed their traits and behaviors compared to non-users.

Women are a bit more likely than men to take supplements, the researchers report in Nutrition Journal, and supplement use increases with age for both sexes.

Supplement use has also grown over time, from 23 percent of U.S. adults using supplements in the early 1970s to 49 percent in 2007 – 2010.

In general, the researchers found that supplement users tend to be better educated: 61 percent of people with more than a high school education used them in 2006, for example, compared to 37 percent of people with less than a high school education.

Supplement users were more likely to get regular exercise, and to try to eat healthier diets, while obese people and smokers were less likely to use supplements.

Dickinson said that virtually all supplement users start with a multivitamin.

“When they get interested in supplements as a general issue, the first thing they do is take a multivitamin and then they go on taking it sometimes for a very long time – for years, decades,” she said.

“But then as they learn more, they may decide to add additional things like omega-3s or calcium or vitamin D depending on their own personal risk factors and what they do or don’t do in terms of their diet, and where they think improvement might be beneficial,” Dickinson added.

“As has been reported previously, supplement users are more likely to report very good or excellent health, have health insurance, use alcohol moderately, not smoke cigarettes, and exercise more frequently,” Paul Coates told Reuters Health in an email.

“They tend to be more health conscious and take better care of themselves,” he said.

Coates is director of the Office of Dietary Supplements, which is part of the National Institutes of Health. He was not involved in the new review.

Coates said that multivitamin supplements are by far the most commonly consumed dietary supplements.

“Industry sales figures reported in the Nutrition Business Journal in 2012, showed that multivitamin/mineral supplements accounted for $5.4 billion of the total $32.5 billion in sales for all dietary supplements, or almost 17 percent of the total,” he said.

Coates also said the use of a multivitamin-mineral supplement helps many people to achieve recommended intakes of a variety of nutrients they don’t get from foods alone.

“But overall there are no unequivocal health benefits from taking a multivitamin-mineral supplement, either in improving health or decreasing the risk of chronic disease,” he added.

Coates cautions that larger doses are often not valuable for nutritional purposes, and are not always safe.

“Except on the advice of a healthcare provider, consumers generally should not take more than recommended levels of ingredients in dietary supplements,” he said.

“Remember, ‘natural’ doesn’t always mean safe,” Coates said.

Coates said people should talk to their healthcare providers about any dietary supplements they take and discuss the use of these products with them.

“Some supplements, for example, might interact adversely with medications you take or could affect a medical condition,” he said.

SOURCE: bit.ly/1lEPuvg Nutrition Journal, online February 6, 2014.

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Dirty stethoscopes 'bacteria threat'








GP using a stethoscopeStethoscopes can pick up bacteria directly from a patient’s skin


Doctors should disinfect their stethoscopes after every examination because the instruments are heavily contaminated by bacteria, a study says.

Stethoscopes were found to carry as many bacteria as the palms of doctors’ hands, and only doctors’ fingertips were ‘dirtier’.

University of Geneva researchers said stethoscopes may contain thousands of bacteria, including MRSA.

Doctors should clean stethoscopes regularly to cut down on transmission.

The study, published in an issue of Mayo Clinic Proceedings, said the hands of healthcare workers were still the main source of bacterial transmission in hospitals, but stethoscopes also appeared to have a major impact.

Lead researcher Dr Didier Pittet, director of the infection control programme at the University of Geneva Hospitals, said the instruments were transmitters of bacteria.

“By considering that stethoscopes are used repeatedly over the course of a day, come directly into contact with patients’ skin and may harbour several thousand bacteria (including MRSA) collected during a previous physical examination, we consider them as potentially significant vectors of transmission.”

Dr Pittet added: “From infection control and patient safety perspectives, the stethoscope should be regarded as an extension of the physician’s hands and be disinfected after every patient contact.”

Dr Clare Taylor, a council member from the Royal College of General Practitioners and a GP in Birmingham, said doctors were “more aware than ever” of the importance of maintaining hygiene standards to protect patients.

She said: “I regularly clean my own stethoscope with alcohol wipes and ensure I wash or sanitise my hands after every patient. It’s part of our role to ensure we do everything we can to prevent the spread of infection.”


Contaminated

The University of Geneva research team carried out tests for bacteria on the diaphragm or metal circular end of a stethoscope, which is put against the skin to listen to the body’s internal sounds, and the tube connecting it to the ear-pieces.

They also measured bacteria levels on four areas of a doctor’s dominant hand – the back of the hand, fingertips and two regions of the palm.

They did this after each of 71 patients had been examined.

Three doctors carried out the examinations using a sterile stethoscope and sterile gloves.

While the doctors’ gloved fingertips were found to be most heavily contaminated by bacteria, the stethoscope diaphragm was more contaminated than all other areas of the doctors’ hands and the tube of the stethoscope carried more bacteria than the back of the doctors’ hands.

When researchers looked for levels of MRSA contamination (meticillin-resistant staphylococcus aureus) in particular, they found similar high levels of bacteria on stethoscopes and doctors’ hands.

They did not isolate any other bacteria.

The study said further research was needed to understand how stethoscopes could best be disinfected.

More work is also required on how long bacteria survive on stethoscopes and how they are transmitted on to a person’s skin, the Geneva team added.

The British Medical Association said there was no evidence of infections coming from stethoscopes.

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Three-person baby details announced








By James Gallagher
Health and science reporter, BBC News


Baby


How the creation of babies using sperm and eggs from three people will be regulated in the UK has been announced.

The draft rules will be reviewed as part of a public consultation and could come into force by the end of 2014.

Doctors say three-person IVF could eliminate debilitating and potentially fatal diseases that are passed from mother to child.

Opponents say it is unethical and could set the UK on a “slippery slope” to designer babies.

Using the parents’ sperm and eggs plus an additional egg from a donor woman should prevent mitochondrial disease.

Mitochondria are the tiny, biological “power stations” that provide energy to nearly every cell of the body.

One in every 6,500 babies has severe mitochondrial disease leaving them lacking energy, resulting in muscle weakness, blindness, heart failure and even death.

As mitochondria are passed down from mother to child, using an extra egg from a donor woman could give the child healthy mitochondria.

However, it would also result in babies having DNA from two parents and a tiny amount from the donor as mitochondria have their own DNA.

Scientists have devised two techniques that allow them to take the genetic information from the mother and place it into the egg of a donor with healthy mitochondria.



Method one: Embryo repair1) Two eggs are fertilised with sperm, creating an embryo from the intended parents and another from the donors 2) The pronuclei, which contain genetic information, are removed from both embryos but only the parents’ is kept 3) A healthy embryo is created by adding the parents’ pronuclei to the donor embryo, which is finally implanted into the womb


Method two: Egg repair1) Eggs from a mother with damaged mitochondria and a donor with healthy mitochondria are collected 2) The nucleus, containing the majority of the genetic material, is removed from both eggs 3) The mother’s nucleus is inserted into the donor egg, which can then be fertilised by sperm.


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The Department of Health has already backed the technique and says this consultation is not about whether it should be allowed, but how it is implemented.

The regulatory body, the Human Fertilisation and Embryology Authority, will have to decide in each cases that there is a “significant risk” of disability or serious illness.

It is anticipated that only the most severely affected women – perhaps 10 cases per year – would go ahead.

The regulations suggest treating the donor woman in the same manner as an organ donor.

Any resulting children will not be able to discover the identity of the donor, which is the case with other sperm and egg donors.

Prof Doug Turnbull, who has pioneered research in mitochondrial donation at Newcastle University, said: “I am delighted that the government has published the draft regulations.

“This is very good news for patients with mitochondrial DNA disease and an important step in the prevention of transmission of serious mitochondrial disease.”

The chief medical officer for England, Prof Dame Sally Davies, said: “Allowing mitochondrial donation would give women who carry severe mitochondrial disease the opportunity to have children without passing on devastating genetic disorders.

“It would also keep the UK at the forefront of scientific development in this area.

“I want to encourage contributions to this consultation so that we have as many views as possible before introducing our final regulations.”

Dr David King, the director of Human Genetics Alert, said this was a decision of “major historical significance” which had not been debated adequately.

“If passed, this will be the first time any government has legalised inheritable human genome modification, something that is banned in all other European countries.

“The techniques have not passed the necessary safety tests so it is unnecessary and premature to rush ahead with legalisation.

“The techniques are unethical according to basic medical ethics, since their only advantage over standard and safe egg donation is that the mother is genetically related to her child.

“This cannot justify the unknown risks to the child or the social consequences of allowing human genome modification.”

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Obese kids may face higher risk of bad elbow breaks


(Reuters Health) – Complicated elbow fractures could be added to a growing list of heightened health risks for obese children, according to a recent analysis.

Obese kids were nine times more likely to suffer an elbow fracture with multiple fracture lines in the same arm, or with the bone exposed through the skin, compared to normal-weight children, researchers found. Obese kids were also more likely to have fallen on their outstretched hand.

“As a public health message, this study validates the efforts of medical organizations to raise awareness about childhood obesity,” Dr. Michelle Caird told Reuters Health.

“And I think it opens up a conversation about building and maintaining skeletal health,” she said. “The skeleton structurally and metabolically supports the human body,” she added.

Caird, an orthopedic surgeon, led the study from the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor.

She and her team analyzed the health records of 354 children who underwent surgery at that hospital for elbow fractures between 1999 and 2011.

Ninety-two injuries happened on monkey bars or trampolines and 88 fractures occurred from a fall at a standing height.

Additionally, obese kids were more likely to experience nerve palsy post-surgery.

Boys made up a little over half of the sample and patients averaged 6 years old. Most kids in the study were normal weight, but the group included underweight, overweight and obese children.

About 17 percent of American kids could be classified as obese, according to the U.S. Centers for Disease Control and Prevention. The CDC categorizes a child’s body mass index (BMI), a measure of weight relative to height, by comparing it to other children in the same age group.

For example, a 6-year-old boy who stands three feet, six inches and weighs 60 pounds would fall in the 99th percentile for his age. This means that 99 percent of kids in the U.S. have a lower BMI. In the current study, kids with a BMI higher than the 95th percentile were considered obese.

The researchers point out in the Journal of Bone & Joint Surgery that their study doesn’t delve into the “why” behind complicated elbow fractures in heavy kids.

But past research offers some possible explanations, Caird said. For example, some evidence links high-fat diets with hampering the body’s ability to absorb calcium and Vitamin D in the bones. Other studies have suggested that since obese children tend to be more inactive in general, their balance and movement may not be as sharp as normal-weight kids, Caird said.

“There isn’t enough data available in the literature to assess whether or not the findings of the current study are representative of the broader national experience,” Dr. Marc Michalsky told Reuters Health.

Michalsky, who was not involved in the study, is surgical director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital in Columbus, Ohio.

Research on pediatric fractures among obese kids is such a new field that it’s difficult to know if the high risk is an expected, low or high statistic, he said.

Besides serving as a reminder of the ongoing U.S. obesity epidemic, the study highlights “significant health differences between obese and non-obese populations,” Michalsky said.

Caird pointed out that the best time for growing strong, healthy bone mass is during childhood.

“We can grow bone mass only until we are about 30 years old,” she said.

Kids of all sizes who exercise should all follow proper safety precautions when playing sports or being active, like wearing helmets or joint guards, Michalsky said.

“The last thing we want to do is avoid physical activity,” he said.

SOURCE: bit.ly/1aYJOYj The Journal of Bone & Joint Surgery, online February 5, 2014.

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Groups urge FDA to halt launch of Zohydro pain drug


(Reuters) – A coalition of addiction experts, physicians and others is urging U.S. health officials to reverse course and block the launch of a powerful painkiller called Zohydro, expected to hit the market next month.

The opioid drug, manufactured by Zogenix Inc, contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.

“Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.

In December, attorneys general from 28 states also urged the FDA to reconsider its approval of the drug.

Shares of San Diego-based Zogenix were down 2 percent to $4.59 in mid-day trading on the Nasdaq.

Zogenix, in a statement, said it was confident in the FDA’s approval of the drug, which will be “subject to stricter prescribing and dispensing rules.” The company has said it plans to start selling the drug in early March.

The latest petition came as the United States grapples with an epidemic of prescription drug abuse, especially involving powerful opioid pain medications. Opioids are a class of drugs that includes morphine, codeine and oxycodone as well as hydrocodone.

Nearly 5 million people in the United States ages 12 and older abuse pain drugs, outpacing sedatives, stimulants and other abused medications, according to a 2012 U.S. government survey.

The FDA, which has launched its own efforts aimed at curbing abuse of pain-killing medications, approved Zohydro last year despite earlier concerns from a panel of FDA outside advisers worried about addiction risks.

The FDA advisers echoed the concerns of public health experts, law enforcement and others, who pointed to the drug’s delivery system and say they are worried about the potential for Zohydro to be crushed or injected.

Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc’s Vicodin or UCB Inc’s Lortab, advocates said in their petition.

“Zohydro is not safer,” they wrote.

Both Vicodin and Lortab also contain the pain-killing ingredient acetaminophen. Zohydro does not.

FDA officials have said they are working to balance public health worries about opioid addiction with access to the drugs for patients seeking pain relief. The FDA has said Zohydro’s benefits outweigh its risks.

FDA spokeswoman Morgan Liscinsky said the agency would review the group’s letter.

The petition was signed by 42 supporters, including representatives of advocacy groups such as Public Citizen as well as physicians and community addiction treatment providers.

(Reporting by Susan Heavey; Editing by Jeffrey Benkoe)

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Cognitive decline in obese diabetic mice can be reversed with regular exercise, surgical removal of belly fat


Cognitive decline that often accompanies obesity and diabetes can be reversed with regular exercise or surgical removal of belly fat, scientists report.


A drug already used to treat rheumatoid arthritis also helps obese/diabetic adult mice regain their ability to learn and comprehend, while transplanting belly fat to a normal mouse reduces those abilities, said Dr. Alexis M. Stranahan, neuroscientist at the Medical College of Georgia at Georgia Regents University.


Studies in humans and animals indicate that obesity and diabetes – which often go hand in hand – essentially triple the risk of mild cognitive impairment as well as Alzheimer’s. Stranahan focused on the effect of fat- and diabetes-associated inflammation in the brain‘s hippocampus, the center of learning and memory.


“These obese diabetic mice have very high levels of inflammatory cytokines and I think it’s because their bodies are reacting to the invasion of fat into tissues where it does not belong,” said Stranahan, corresponding author of the study in The Journal of Neuroscience. “It’s almost as if the fat were an external pathogen.”


Cytokines are major components of an immune response that typically targets invaders such as viruses. “They kind of mobilize all the natural killer cells and macrophages to kill off whatever is causing the pathogenic environment,” Stranahan said. After clearing debris or danger, cytokine levels should subside. However in obesity, fat appears viewed as a chronic invader that keeps levels of interleukin-1 beta and inflammation high.


Like a perfect storm, obesity also weakens the protective blood-brain barrier, easing access of high interleukin-1 beta levels to the brain.


Inside the brain, interleukin-1 beta turns normally supportive microglial cells predatory. Microglia typically scarf up trash and infectious agents in the brain but when interleukin-1 beta binds to their receptors, microglia signal neurons to malfunction. Microglia then consume neuronal synapses, the major points of communication between brain cells. “This interleukin-1 beta signal makes them predatory. They eat them up,” Stranahan said.


Exercise and surgery lower levels of the troublemaker in the body, so it doesn’t affect the brain while the cytokine antagonist sequesters interleukin-1 beta so it can’t reach receptors on the neurons or microglia.

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