Powerful New Painkiller Has Addiction Experts Worried

"Drug companies are working to develop a pure, more powerful version of the nation’s second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse.
The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin. Four companies have begun patient testing, and one of them — Zogenix of San Diego — plans to apply early next year to begin marketing its product, Zohydro.
If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.
Critics say they are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it to release an intense, immediate high.
“I have a big concern that this could be the next OxyContin,” said April Rovero, president of the National Coalition Against Prescription Drug Abuse. “We just don’t need this on the market.”
OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to manage pain with a formula that dribbled one dose of oxycodone over many hours.
Abusers quickly discovered they could defeat the timed-release feature by crushing the pills. Purdue Pharma changed the formula to make OxyContin more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs that do not have a timed-release feature.
Oxycodone is now the most-abused medicine in the United States, with hydrocodone second, according to the Drug Enforcement Administration’s annual count of drug seizures sent to police drug labs for analysis.
The latest drug tests come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful — and addictive — opiate narcotics.
“It’s like the wild west,” said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. “The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”
The pharmaceutical firms say the new hydrocodone drugs give doctors another tool to try on patients in legitimate pain, part of a constant search for better painkillers to treat the aging U.S. population.
“Sometimes you circulate a patient between various opioids, and some may have a better effect than others,” said Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product.
The companies say a pure hydrocodone pill would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin. They also say patients will be more closely supervised because, by law, they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products now on the market can be refilled up to five times.
Zogenix has completed three rounds of patient testing, and last week it announced it had held a final meeting with Food and Drug Administration officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013. (...) "
in Time
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Brain Scans Help Predict Alzheimer’s Disease Early

"Alzheimer’s disease has always been difficult to diagnose — the only way to identify it definitively is by autopsying the brain after death — but scientists may now have an easier way to spot the degenerative brain disease long before that, even before symptoms appear, using brain scans.
People who go on to develop symptoms of memory loss and cognitive deficits are more likely to show shrinkage in certain areas of the brain early on, compared with those who don’t develop Alzheimer’s, and such changes can be seen in MRI scans of the brain, report Dr. Bradford Dickerson at the Harvard Medical School and Massachusetts General Hospital and colleagues in the journal Neurology. The team worked with hundreds of brain scans of patients at various stages of Alzheimer’s disease, collected by the Alzheimer’s Disease Neuroimaging Initiative database.
Dickerson’s team had previously identified nine regions of the cortex of the brain that seem to be most affected by the amyloid plaque deposits and disintegration of nerve networks that are the hallmark of Alzheimer’s disease. By studying people’s brain scans over time, they were able to see that these nine brain regions appear to be thinner in people who eventually go on to develop Alzheimer’s — but that it takes many years for this structural difference to show up as symptoms of memory loss or cognitive problems.

Using this brain-size signature as a yardstick, the researchers decided to confirm the correlation by testing the patients’ cognitive abilities three years after a baseline brain scan. Indeed, they found that 21% of participants, who had the thinnest Alzheimer’s-related brain regions but showed no signs of memory problems or other cognitive deficits at the start of the study did show signs of cognitive decline three years later, compared with none of the subjects who did not have the same brain thinning and 7% who showed moderately thinner brain areas.
The brain regions in question are responsible for functions such as higher-level cognition, memory and language, which are all affected by Alzheimer’s, so it makes sense that they would shrink in those developing the disease.
“We’ve known for years that there are certain areas that are affected by the amyloid plaques and tangles that damage the brain,” says Dickerson. “It’s not as if the whole brain is damaged at first; much of the brain is fine at the early stages. But if you just looked at the whole forest, you might miss the signature brain areas affected by the disease. So you have to zoom in and specifically focus on the areas that are affected in people with known dementia.”
The results are critical for helping doctors identify patients earlier in the course of the disease, and that’s important since many experts now believe that intervening at the beginning stages may offer patients the best chance for controlling the brain degeneration that causes symptoms. Many of the drugs that have failed to help patients in the advanced stages of Alzheimer’s, for example, may benefit those who are in the first weeks or months of the condition. (...) "
in Time
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Sun 'stops chickenpox spreading'

"The University of London team found chickenpox less common in regions with high UV levels, reports the journal Virology.  Sunlight may inactivate viruses on the skin, making it harder to pass on. However, other experts say that other factors, including temperature, humidity, and even living conditions are equally likely to play a role.  
The varicella-zoster virus is highly contagious, while it can be spread through the coughs and sneezes in the early stages of the infection, the main source is contact with the trademark rash of blisters and spots.
UV light has long been known to inactivate viruses, and Dr Phil Rice, from St George's, University of London, who led the research, believes that this holds the key why chickenpox is less common and less easily passed from person to person in tropical countries.
It could also help explain why chickenpox is more common in the colder seasons in temperate countries such as the UK - as people have less exposure to sunlight, he said.
He examined data from 25 earlier studies on varicella-zoster virus in a variety of countries around the world, and plotted these data against a range of climatic factors.
This showed an obvious link between UV levels and chickenpox virus prevalence.
Even initially confusing results could be explained - the peak incidence of chickenpox in India and Sri Lanka is during the hottest, driest and sunniest season.
However, Dr Rice found that, due to atmospheric pollution, UV rays were actually much lower during this season compared with the rainier seasons.
He said: "No-one had considered UV as a factor before, but when I looked at the epidemiological studies they showed a good correlation between global latitude and the presence of the virus."
Professor Judy Breuer from University College London said that while UV could well be contributing to the differences in the prevalence of chickenpox between tropical and temperate regions, there were other factors which needed to be considered.
She said: "Lots of things aside from UV could affect it - heat, humidity and social factors such as overcrowding.
"It's quite possible that UV is having an effect, but we don't have any firm evidence showing the extent this is happening." (...)"
in BBC
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States to weigh in on basic health coverage

"U.S. health officials will allow states to select the basic set of medical benefits that must be offered by insurance plans participating in new exchanges mandated by the federal healthcare overhaul, the U.S. government said on Friday.
The Department of Health and Human Services announcement relates to the so-called essential health benefits for millions of Americans expected to qualify for coverage sold through state-based insurance exchanges beginning in 2014.
The proposed approach reflects the federal government's commitment to give states flexibility as they set up the exchanges, HHS Secretary Kathleen Sebelius said on Friday.
"The coverage that works in Florida may not work in Nebraska," Sebelius told reporters on a conference call.
Under the approach announced on Friday, states can select an existing health plan to set the benchmark for services included in the essential health benefits package.
As benchmarks, states would be able to choose either: One of the three largest small employer plans in the state; one of the three largest state employee health plans; one of the three largest federal employee health plan options; or the largest health maintenance organization plan offered in the state's commercial market.
As set out in the law, states must ensure the essential benefits package covers services in at least ten categories of care, among them preventive care, emergency services, maternity care and prescription drugs.
Ron Pollack, executive director of healthcare advocacy group Families USA, said that HHS needed to provide "strong oversight and enforcement" of the benefit standards as they are implemented in the states.
"It will be important to ensure that adequate coverage across all ten required benefit categories is provided - marking an improvement over many plans offered today," Pollack said.
HHS said it would take comments on the proposal until January 31. The announcement on Friday addressed only the services and items covered by a health plan, not cost sharing, such as deductibles, co-payments, and co-insurance. HHS plans to address cost in a future announcement.
The essential benefits are perhaps the most anticipated piece of information still awaited by states, employers, health providers and especially insurers under President Barack Obama's landmark healthcare overhaul.
The exchanges are designed to create easy access to an open marketplace of insurance plans and to allow uninsured people and small businesses to band together to negotiate cheaper rates for healthcare coverage, as well as automatically be considered for government subsidies.
HHS has been subject to intense lobbying over the rule as virtually the entire U.S. healthcare system, including insurers such as Aetna Inc and WellPoint Inc, could be affected by it.
The Institute of Medicine, an advisory group to U.S. policymakers, recommended in October that essential benefits stay in line with the cost of insurance in a typical small employer plan, in step with inflation and medical advances.
The healthcare overhaul is designed to extend coverage to an estimated 32 million Americans who are now uninsured."
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Haemophilia gene therapy shows early success

"Just one injection could be enough to mean people with haemophilia B no longer need medication, according to an early study in the UK and the US.
Six patients were given a virus that infects the body with the blueprints needed to produce blood-clotting proteins. Four of them could then stop taking their drugs.
Doctors said the gene therapy was "potentially life-changing".
Other researchers have described it as a "truly a landmark study."
People with haemophilia B have an error in their genetic code, which means they cannot produce a protein called factor IX, which is critical for blood-clotting.
Patients are currently treated with factor IX injections, sometimes multiple times per week, but the manufacturing process is expensive.
Researchers at University College London and St Jude Children's Research Hospital in the US were looking for a more permanent solution.
Virus modification
They took a virus which infects people without symptoms - adeno-associated virus eight. It was then modified to infect liver cells with the genetic material for factor IX. The gene should then persist in the liver cells, telling the cells to manufacture the protein.
Six people were injected with the modified virus at the Royal Free Hospital in London. Two were given a low dose, two a middle dose and two a high level.
Results published in the New England Journal of Medicine showed levels of factor IX could be increased.
Normally, patients will have factor IX levels less than 1% of those found in people without haemophilia.
After injection, levels of factor IX ranged from 2% to 12%. The first patient treated has maintained levels of 2% for more than 16 months. One of the patients receiving the highest dose maintained levels which fluctuated between 8% and 12% for 20 weeks.
Carl Walker, aged 26 and from Berkshire, showed the greatest improvement. He said: "I have not needed any of my normal treatment, either preventative or on-demand as a result of an injury. Previously, I used to infuse at home three times a week. (...)"

in BBC
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Nintendo's creative leader working on 'Something really new'

"Shigeru Miyamoto, the creator of beloved Nintendo game franchises including "Super Mario," "Donkey Kong" and the "Legend of Zelda," wants to make something new.
"I am really keen to work on something really new, which eventually is going to be important for the future of Nintendo," he said, through a translator, in an interview here at Nintendo's offices on Thursday. "I would like to try to do something which might be able to expand the boundary or the definition of video games."
Miyamoto spoke with CNN the day after Wired reported that the game visionary would step down as a top Nintendo director and producer overseeing the development of games and products. CNN has a syndication agreement with Wired.
A Nintendo spokeswoman disputed the Wired report, which quotes Miyamoto telling colleagues that he is ready to retire. Miyamoto was being sarcastic, but that nuance was lost in translation, she said.
"Miyamoto's role at Nintendo is not changing," the company said in a statement. "He will continue to be a driving force in Nintendo's development efforts."
The 59-year-old video-game pioneer may spend less time working directly on blockbuster games in Nintendo's biggest franchises, he said. But he will have a senior role, which involves helping to determine the future direction of Nintendo's hardware and software.
"We've got to incorporate something new all the time," Miyamoto said. "Everything starts from something small whenever we are trying to find out something new."
Miyamoto suggested in the interview that he may be tiring of shepherding each new entry into the franchises he dreamed up decades ago. The three biggest games Nintendo launched in the last month are sequels.
As its name implies, "Mario Kart 7" for the 3DS hand-held system is the seventh in the go-cart racing series. There were more than a dozen "Zelda" games before the "Legend of Zelda: Skyward Sword" for the Wii. And who can keep count of how many adventures Mario was in before "Super Mario 3D Land?"
Here's a telling number: Miyamoto said the word "new" more than a dozen times in the course of an interview that lasted just under an hour.
He suggested that with execs like Eiji Aonuma, who runs the "Zelda" series, Nintendo's most prized franchises are in good hands. Miyamoto said he's instilled in the teams a desire to make big changes often and constantly perfect their products.
Miyamoto declined to describe his new project in depth. He mentioned gyroscopes and wireless proximity communication, both of which are built into the Nintendo 3DS, as technologies he'd like to tap in the future. To demonstrate his wacky thinking, he said he had considered working on a digital globe with a map of the world that people could carry around with them.
Ideas for games often come from encounters in Miyamoto's own life, he said. As legend has it, the idea for Pikmin, a decade-old game in which an alien leads a race of plantlike creatures, sprang from Miyamoto's garden.
"I'm the person who thinks very differently," Miyamoto said. "I'm the guy who believes in the numerous possibilities of video games. Even by looking around and taking advantage of the existing video-game technologies, we can certainly make something brand new." "
in CNN
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Scientists Find a Black Hole the Size of 21 Billion Suns

"They're huge. They're voracious. They're blacker than a panther on a moonless night. They're black holes, the mind-bending, space-warping cosmic objects with gravity so insanely powerful that even a beam of light that wanders too close will be sucked in, never to emerge. Einstein's theory of general relativity predicted they might exist, but the great physicist himself doubted it would really happen.

Einstein was wrong. Over the past decade or two, black holes have been discovered all over the place — small ones peppered around the Milky Way and huge ones, impressively called "supermassive" black holes, lurking the centers of galaxies. The one at the core of Milky Way weighs as much as a couple of million stars, and it could swallow the sun without even noticing, the way you'd swallow a pistachio.

But that's positively puny compared with the two new black holes, each about 330 million light-years away or so, just announced in the journal Nature. The smaller one, located inside a galaxy known as NGC 3842, is as massive as 9.7 billion suns, and the other, in a galaxy called NGC 4889, is more than twice as large: if you put it on a very large balance, it would take at least 21 billion stars to even things out. Another way to think about things: even the smaller of the two is nearly 30% bigger than the previous record holder, announced last winter, and it would make for a great storyline if astronomers were surprised, amazed, flabbergasted, blown away by the awesome giganticness of these monsters. Truthfully, though, they kind of expected it. "If we infer the existence of quasar black holes of ten billion solar masses at early cosmic times," Harvard theorist Avi Loeb told Nature's Ron Cowen for the journal's online news blog, "we'd better find their counterparts in the present-day Universe."

Loeb is referring to quasars — beacons of light so intensely bright they can be seen halfway across the universe. When astronomers first spotted them in the late 1950s, nobody knew what they were. Nowadays, everyone pretty much agrees that quasars are supermassive black holes at the cores of young galaxies. The holes themselves aren't visible, of course, but when they suck in surrounding matter, the stuff heats up to millions of degrees, sending bursts of energy shooting across the cosmos.

Back when the universe was young, there was plenty of gas floating around to feed these monsters. Nowadays, much of it the gas is gone, and so are the quasars — but the black holes that powered them should, as Loeb says, still be around (where would they go, after all?). Now, thanks to some of the world's most powerful telescopes, astronomers know that indeed they are. While scientists can't see the black holes directly, they can see stars whipping around at high speeds in the two galaxies' cores — and by clocking those speeds carefully, the astronomers can calculate how big and how dense the object they're orbiting must be. In each of these cases, nothing but a supermassive black hole fits the bill.

Such observations are technically difficult, so in one sense the latest black-hole discoveries are extraordinary. Still, astronomers expected to find such things all along, so it might not seem like such a big deal to space experts. Indeed, Martin Rees, the British astronomer royal, dubbed the new results "an incremental step" in the New York Times, with nary a word about shock or awe. If you've got a professional interest in how black holes were born and how they evolved, this is more grist for the mill.

For the rest of us — well, they're just kind of awesome."

in Time
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Why American Presidents (and Some Oscar Winners) Live Longer

"American presidents seem to age before our eyes. But the common belief that high-office stress grays our leaders faster than usual — possibly even hastening death — may be a myth, new research finds. In fact, the majority of American presidents have lived longer than typical men of their times.

That's not to say that chronic stress has no effect on a person's lifespan, but so does high social standing. The findings add to a body of research linking high status to better health: for instance, Oscar winners live longer than those who were only nominated; British civil servants at the top of the greasy pole outlive those at the bottom; and the longevity effect is also seen in Nobel laureates and even baboons.

The new study, which was published in the Journal of the American Medical Association, analyzed the dates of birth, inauguration and death of all 34 past presidents who died of natural causes. The average lifespan for these men should have been 68 years, if they'd aged twice as fast during their years in office as the popular wisdom suggests they do.
Instead, the study found, these presidents lived an average 73 years. And indeed, 23 of the 34 presidents who died of natural causes lived longer than expected, compared with other men their age during their lifetimes.

For our earliest presidents, the longevity effect was especially pronounced. The first eight leaders of the U.S. lived on average 79.8 years, yet life expectancy at birth for men in the 18th and early 19th centuries was under 40. Some presidents survived an exceptionally long time: Gerald Ford died at 93.5 years, Ronald Reagan at 93.3, John Adams at 90.7, and Herbert Hoover at 90.2. All currently living presidents have already exceeded their life expectancy, or are likely to do so.

"Just because they experience what would appear to be accelerated aging outwardly, doesn't mean they will die any sooner," the study's author, S. Jay Olshansky of the University of Illinois-Chicago, told Reuters.

So why do people at the top of the hierarchy fare better than those below? Access to wealth, education and the best health care of their times would seem to be obvious factors (although medical attention seems to have actually killed President Garfield, who succumbed to a fatal infection introduced by his doctors' unsterile treatment techniques after he was shot by an assassin). But research suggests that far more than that is at play.

For example, on average, actors who win Oscars live four years longer than those who just get nominated. For directors, the survival boost is an extra four and a half years. (Sadly, writers who win Oscars actually "lose" 3.6 years of life expectancy, perhaps because the award doesn't carry as much prestige in the writing profession as do the acting and directing awards in their respective fields.) Nobel laureates also tend to outlive their scientific colleagues.

Similarly, the Whitehall studies of health in British civil servants found that the higher a man's rank in the British government bureaucracy, the longer his life expectancy (for women, it is more complicated, and if married, the status of their husbands also plays a role). The men at the top of the hierarchy had a threefold reduction in mortality risk at all ages, compared with those at the bottom. Only about a third of this difference could be attributed to lifestyle factors like smoking, exercise and diet. And since all of the employees were enrolled in the U.K.'s National Health Service, access to medical care wasn't what made the difference, either.

Even baboons — which, like humans, have social hierarchies — show health differences related to rank, with those at the top, or just shy of the top, faring better. Low-ranking males have worse cholesterol and stress hormone levels.

Stress almost certainly plays a role here, but it's more complicated than one would think. Clearly, people in positions of high responsibility — like presidents and CEOs — face as much stress, if not more, than many others; high-power positions are often exceedingly stressful, as is competing to get them. But stress alone — even in high doses — doesn't automatically damage health. It's lack of control over stress that really matters. (...)"

in Time
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Chinese court rejects Apple lawsuit over iPad name

"A court in southern China has rejected a lawsuit by Apple Inc, accusing a Chinese technology company of infringing its iPad trademark, a newspaper reported on Tuesday, the latest move in a protracted tug-of-war over the name.
The Intermediate People's Court in the southern boomtown of Shenzhen rejected Apple's lawsuit against Proview Technology (Shenzhen). Proview, it said, lawfully registered the iPad trademark as long ago as 2000 for products in a number of countries including China, the Southern Metropolis Daily newspaper reported, citing court documents.
Apple developed its iPad tablet computer some years after that.
Caixin Online reported in October that Proview was also taking legal action, seeking 10 billion yuan ($1.5 billion) in compensation from Apple for copyright infringement.
Apple, Proview Technology (Shenzhen), and the Shenzhen court were not immediately available for comment when contacted by Reuters."

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Stem cell therapy poised to come in from the cold

"A rogue surgeon injects stem cells from a fetus into a sick man's brain. The cells morph and form body parts. When the man dies, the pathologist finds cartilage, skin and bone clumped in his brain.
The scene is not from a horror movie; it happened to Max Truex, a former Olympic runner who suffered from Parkinson's disease. The case sent a chill through the scientific community when it came to light 15 years ago and typifies some of the hurdles researchers have faced while trying to bring stem cell therapies to the market.
Now, it appears, their efforts are closer than ever to paying off.
Dozens of adult stem cell treatments are moving through clinical trials and showing early success, raising hopes that some could reach the market within five years.
"It will only take a few successes to really change the field," said Gil Van Bokkelen, chief executive of Athersys Inc and chairman of the Alliance for Regenerative Medicine. "As you see things getting closer and closer to that tipping point, you're going to see a frenzy of activity take place."
Many of the trials focus on heart disease and inflammatory conditions, some of the biggest markets in medicine. The cells used are derived from adult tissue such as fat, or bone marrow, thereby circumventing the ethical concerns raised by the use of cells derived from embryos.
Data for the most part remains early, but as more results emerge, pharmaceutical companies are beginning to take note.
"A lot of big companies are looking to place bets on some Phase II products once that data has been confirmed," said Paul Schmitt, managing partner at venture capital firm Novitas Capital. "Even now they're attending all the medical meetings and talking to all the stem cell companies."
Venture funds like Novitas are taking different approaches to playing the emerging field. Novitas invested $4 million in Amorcyte Inc, a company recently acquired by NeoStem Inc that is developing a treatment for heart disease. It is sticking to that investment for now.
By contrast, Aspire Capital Partners LLC is investing more broadly in the hope that one success will offset the inevitable failures.
"My philosophy in the stem cell space is that it's very difficult at this point to pick the winners and losers," said Steven Martin, managing member at Aspire. "We believe that over time there will be some very significant clinical progress, and valuations will improve, but we're still a long way from an approved therapy."
In the meantime, he said, "we are willing to be patient because we think the upside is tremendous." (...)"

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