Thanks to a new ad campaign from Procter & Gamble, Mason's artistic, family-driven side will soon be on full display to the entire nation. He and his family will be featured in the company's upcoming ad campaign, "The Everyday Effect."
"We embrace the notion that the biggest impact in our lives comes not in the grand gestures, but in the everyday acts," according to P&G's website.
For Mason, giving his wife, Andrea, a kiss in front of their fireplace or seeing his kids happily jump on a bed are the simple things that make a big impact.
"This ad campaign is really talking about the direction of life," said Mason, who starred at OSU before moving on to the NBA, including time with the Thunder during its first season in Oklahoma City. "Little things make such a difference, and there are a lot of things that happen daily that we almost take for granted."
Mason's family was suggested to P&G for the campaign after a friend shot videos and photos with the family on Mother's Day.
Mason played games in 11 different NBA seasons. He averaged a career-best 17.2 points per game while making 71 starts with Milwaukee in 2004-05. He averaged 16.1 points per game in three years at OSU.
"We were surprised and happy we were selected," Mason said. "We didn't know about the direction P&G was going with their ad campaign. When we learned about it, we really felt like it would be a great fit for us."
The ad campaign is just part of a busy post-basketball life for Mason and his family. While Andrea is working on expanding the barre3 exercise studios beyond Oklahoma City, Desmond was one of six artists recently selected for a five-country art tour of Asia. His works of art will be featured in Hong Kong, Shanghai and other locations.
"This is really a huge step for me," Mason said. "I'm a very emotional painter, and my life experiences, including my family, are what spearhead the art for me. Tulsa is on my list for an art show once I get back from Asia. I hear Tulsa is a great art market and I'm looking forward to having a show there."
Mason was asked recently if he was a basketball player turned into an artist. He believes it's the opposite.
"I was drawing and painting long before I ever played basketball," Mason said. "Basketball will never go away, and I will never deny the impact it had on me. It changed my life and my family's life, but art has always been first and foremost in my mind."
Jan. 29, 2013 ? In a first-of-its-kind feat of science and engineering, a National Science Foundation (NSF)-funded research team has successfully drilled through 800 meters (2,600 feet) of Antarctic ice to reach a subglacial lake and retrieve water and sediment samples that have been isolated from direct contact with the atmosphere for many thousands of years.
Scientists and drillers with the interdisciplinary Whillans Ice Stream Subglacial Access Research Drilling project (WISSARD) announced Jan. 28 local time (U.S. stations in Antarctica keep New Zealand time) that they had used a customized clean hot-water drill to directly obtain samples from the waters and sediments of subglacial Lake Whillans.
The samples may contain microscopic life that has evolved uniquely to survive in conditions of extreme cold and lack of light and nutrients. Studying the samples may help scientists understand not only how life can survive in other extreme ecosystems on Earth, but also on other icy worlds in our solar system.
The WISSARD teams' accomplishment, the researchers said, "hails a new era in polar science, opening a window for future interdisciplinary science in one of Earth's last unexplored frontiers."
A massive ice sheet, almost two miles thick in places, covers more than 95 percent of the Antarctic continent. Only in recent decades have airborne and satellite radar and other mapping technologies revealed that a vast, subglacial system of rivers and lakes exists under the ice sheet. Lakes vary in size, with the largest being Vostok Subglacial Lake in the Antarctic interior that is comparable in size to Lake Ontario.
WISSARD targeted a smaller lake (1.2 square miles in area), where several lakes appear linked to each other and may drain to the ocean, as the first project to obtain clean, intact samples of water and sediments from a subglacial lake.
The achievement is the culmination of more than a decade of international and national planning and 3 1/2 years of project preparation by the WISSARD consortium of U.S. universities and two international contributors. There are 13 WISSARD principal investigators representing eight different U.S. institutions.
NSF, which manages the United States Antarctic Program, provided over $10 million in grants as part of NSF's International Polar Year portfolio to support the WISSARD science and development of related technologies.
The National Aeronautics and Space Administration's (NASA) Cryospheric Sciences Program, the National Oceanic and Atmospheric Administration (NOAA), and the private Gordon and Betty Moore Foundation also provided support for the project.
The interdisciplinary research team includes groups of experts in the following areas of science: life in icy environments, led by John Priscu, of Montana State University; glacial geology, led by Ross Powell, of Northern Illinois University; and glacial hydrology, led by Slawek Tulaczyk, of the University of California, Santa Cruz.
Sharing of expertise by the groups of disciplinary experts will allow the data collected to be cast in a systemic, global context.
The WISSARD team will now process the water and sediment samples they have collected in hopes of answering seminal questions related to the structure and function of subglacial microbial life, climate history and contemporary ice-sheet dynamics.
Video surveys of the lake floor and measurements of selected physical and chemical properties of the waters and sediments will allow the team to further characterize the lake and its environs.
The approach to drilling was guided by recommendations in the 2007 National Research Council-sponsored report, "Exploration of Antarctic Subglacial Aquatic Environments: Environmental and Scientific Stewardship," aimed to protect these unique environments from contamination.
A team of engineers and technicians directed by Frank Rack, of the University of Nebraska-Lincoln, designed, developed and fabricated the specialized hot-water drill that was fitted with a filtration and germicidal UV system to prevent contamination of the subglacial environment and to recover clean samples for microbial analyses. In addition, the numerous customized scientific samplers and instruments used for this project were also carefully cleaned before being lowered into the borehole through the ice and into the lake.
Following their successful retrieval, the samples are now being carefully prepared for their shipment off the ice and back to laboratories for numerous chemical and biological analyses over the coming weeks and months.
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Jan. 28, 2013 ? Stanford Engineering's Center for Turbulence Research (CTR) has set a new record in computational science by successfully using a supercomputer with more than one million computing cores to solve a complex fluid dynamics problem -- the prediction of noise generated by a supersonic jet engine.
Joseph Nichols, a research associate in the center, worked on the newly installed Sequoia IBM Bluegene/Q system at Lawrence Livermore National Laboratories (LLNL) funded by the Advanced Simulation and Computing (ASC) Program of the National Nuclear Security Administration (NNSA). Sequoia once topped list of the world's most powerful supercomputers, boasting 1,572,864 compute cores (processors) and 1.6 petabytes of memory connected by a high-speed five-dimensional torus interconnect.
Because of Sequoia's impressive numbers of cores, Nichols was able to show for the first time that million-core fluid dynamics simulations are possible -- and also to contribute to research aimed at designing quieter aircraft engines.
The physics of noise
The exhausts of high-performance aircraft at takeoff and landing are among the most powerful human-made sources of noise. For ground crews, even for those wearing the most advanced hearing protection available, this creates an acoustically hazardous environment. To the communities surrounding airports, such noise is a major annoyance and a drag on property values.
Understandably, engineers are keen to design new and better aircraft engines that are quieter than their predecessors. New nozzle shapes, for instance, can reduce jet noise at its source, resulting in quieter aircraft.
Predictive simulations -- advanced computer models -- aid in such designs. These complex simulations allow scientists to peer inside and measure processes occurring within the harsh exhaust environment that is otherwise inaccessible to experimental equipment. The data gleaned from these simulations are driving computation-based scientific discovery as researchers uncover the physics of noise.
More cores, more challenges
"Computational fluid dynamics (CFD) simulations, like the one Nichols solved, are incredibly complex. Only recently, with the advent of massive supercomputers boasting hundreds of thousands of computing cores, have engineers been able to model jet engines and the noise they produce with accuracy and speed," said Parviz Moin, the Franklin M. and Caroline P. Johnson Professor in the School of Engineering and Director of CTR.
CFD simulations test all aspects of a supercomputer. The waves propagating throughout the simulation require a carefully orchestrated balance between computation, memory and communication. Supercomputers like Sequoia divvy up the complex math into smaller parts so they can be computed simultaneously. The more cores you have, the faster and more complex the calculations can be.
And yet, despite the additional computing horsepower, the difficulty of the calculations only becomes more challenging with more cores. At the one-million-core level, previously innocuous parts of the computer code can suddenly become bottlenecks.
Ironing out the wrinkles
Over the past few weeks, Stanford researchers and LLNL computing staff have been working closely to iron out these last few wrinkles. This week, they were glued to their terminals during the first "full-system scaling" to see whether initial runs would achieve stable run-time performance. They watched eagerly as the first CFD simulation passed through initialization then thrilled as the code performance continued to scale up to and beyond the all-important one-million-core threshold, and as the time-to-solution declined dramatically.
"These runs represent at least an order-of-magnitude increase in computational power over the largest simulations performed at the Center for Turbulence Research previously," said Nichols "The implications for predictive science are mind-boggling."
A homecoming
The current simulations were a homecoming of sorts for Nichols. He was inspired to pursue a career in supercomputing as a high-school student when he attended a two-week summer program at Lawrence Livermore computing facility in 1994 sponsored by the Department of Energy. Back then he worked on the Cray Y-MP, one of the fastest supercomputers of its time.
"Sequoia is approximately 10 million times more powerful than that machine," Nichols noted.
The Stanford ties go deeper still. The computer code used in this study is named CharLES and was developed by former Stanford senior research associate, Frank Ham. This code utilizes unstructured meshes to simulate turbulent flow in the presence of complicated geometry.
In addition to jet noise simulations, Stanford researchers in the Predictive Science Academic Alliance Program (PSAAP), sponsored by the Department of Energy, are using the CharLES code to investigate advanced-concept scramjet propulsion systems used in hypersonic flight (with video) -- flight at many times the speed of sound -- and to simulate the turbulent flow over an entire airplane wing.
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MOSCOW (Reuters) - A Moscow court postponed a preliminary hearing on Monday in the posthumous trial of whistleblower Sergei Magnitsky, whose death in custody has damaged Russia's image and strained ties with the United States.
The court appointed a legal team to defend Magnitsky during the trial after his family and lawyers refused to attend Monday's hearing because they say the case is politically motivated.
Magnitsky was 37 when he died after 358 days in jail on suspicion of tax evasion and fraud, during which he said he was denied treatment as his health declined.
"Today's preliminary court hearing was moved to February 18 ... because Magnitsky's defence team did not show up. And the judge, in order to observe the principle of equality (before the law), appointed a defense," said court spokeswoman Alexandra Berezina.
Russian authorities said Magnitsky died of a heart attack. But his former employer, investment fund Hermitage Capital, says he was killed because he was investigating a $230 million theft by law enforcement and tax officials.
(Reporting by Thomas Grove, Editing by Timothy Heiortage)
NEW YORK (AP) ? Stocks opened mixed on Wall Street, with the Standard & Poor's 500 holding at 1,500.
The Dow Jones industrial average rose 3 points to 13,855. The Nasdaq composite fell 7 points to 3,146.
Markets are absorbing data from several fronts Tuesday.
Ford blew by Wall Street expectations for the fourth quarter, but its losses in Europe continue to mount. Its stock declined 3.4 percent to $13.31.
U.S. home prices accelerated in November compared with a year ago, pushed higher by rising sales and a tighter supply of available homes, according to the Standard & Poor's/Case-Shiller index.
Investors will be looking for a report on January consumer confidence and hints from the U.S. Federal Reserve, which opens a two-day policy meeting.
The National Center for Education Statistics released this week a report on public-school graduation and dropout rates, and the news overall isn?t bad. About 78 percent of high school students have graduated within four years, the highest average since 1974.
(RELATED: Recession Pushes States to Make Deep Cuts to Higher-Ed Budgets)
Graduation rates by race and ethnicity are up across the board, with Hispanic students seeing a 10-point increase over five years to 71.4 percent, and black students showing a 7-point increase to 66.1 percent.
But it?s hard to ignore comparative gaps. Asian-American students graduate at a rate of 93 percent--nearly 27 points higher than black students--while white students are at 83 percent.
Also, students of color drop out at a higher rate. While the national average stands at 3.4 percent, the rate for Hispanics is 5.5 percent, and that for black students is 5 percent. In comparison, just 1.9 percent of Asian and Pacific Islanders and 2.3 percent of white students are not finishing high school.
The maps below show graduation and dropout rates.?The darker areas represent higher percentages of students either graduating within four years or dropping out of school.
On average, students on the East and West coasts complete school at rates better than students in parts of the South. Dropout rates appear to almost mirror that effect: More students drop out in the South than anywhere else.
Try switching back and forth between students by race and ethnicity.?
This book cover image released by Soho Press shows "Little Elvises," by Timothy Hallinan. (AP Photo/Soho Press)
This book cover image released by Soho Press shows "Little Elvises," by Timothy Hallinan. (AP Photo/Soho Press)
"Little Elvises" (Soho Press), by Timothy Hallinan
Ever since Dashiell Hammett introduced us to Sam Spade in "The Maltese Falcon" 83 years ago, hundreds of writers have adopted his formula, flooding the bookshelves with wisecracking private eyes who work both sides of the law, disrespect authority, icily stare down gun barrels and conceal an immutable code of honor beneath a cynical outer shell.
This can get awfully tiresome, but every now and then a writer comes along with the imagination and skill to make the whole thing feel fresh and new again. That's what veteran crime novelist Timothy Hallinan has accomplished with his latest series of novels featuring Junior Bender, full-time Los Angeles burglar and part-time private eye-style fixer for the city's criminal element.
The first book in the series, "Crashed" (2012), was great fun. The new one, "Little Elvises," is even better, with an intricate high-stakes plot, a compelling subplot and heart-pounding suspense.
As the story opens, Junior is in a fix, or rather, a bunch of them. The ex-wife he still yearns for has a new man in her life. His precocious daughter, who just turned 13, has acquired her first boyfriend, and Junior doesn't approve. The daughter of Junior's eccentric landlady has run off with a cad, and she needs Junior's help to bring her home. And an L.A.P.D. detective is going to frame Junior for invading a judge's house, pistol-whipping his honor's wife and stealing their jade collection unless Junior finds a way to get the cop's elderly uncle out of a murder rap.
The uncle, a record producer in Philadelphia back in the 1950s, got rich by recruiting a bunch of no-talent pretty boys, fixing their hair and teaching them to curl their lips to make them look like Elvis Presley, and foisting their abysmal howls on teenage record buyers. (Those with the misfortune of remembering the likes of Len Barry, Johnny Caswell and Johnny Madara know this really happened.) Hence, the book's title.
Along the way, Hallinan introduces us to a drugged-out, pain-impervious hit man, a nonagenarian puppet master who rules the L.A. underworld, a tabloid reporter who uses his job as a cover to blackmail the rich and the famous, and a host of other characters as dangerously outrageous as the murderous crew obsessed with obtaining the black bird in Hammett's 1930 masterpiece.
___
Bruce DeSilva, winner of the Mystery Writers of America's Edgar Award, is the author of "Cliff Walk" and "Rogue Island."
AUSTIN, Texas (Reuters) - Kimberly McCarthy is scheduled to be executed by lethal injection in Texas on Tuesday, the first woman to be put to death in the United States in more than two years, for the stabbing murder of her neighbor in 1997.
Women are rarely executed in the United States. Only 12 female inmates were put to death since capital punishment was reinstated by the Supreme Court in 1976, according to the Death Penalty Information Center.
The last woman executed was Teresa Lewis in Virginia on September 23, 2010, the information center said.
"Although women commit about 10 percent of murders, capital cases also require some aggravating factor like rape, robbery, or physical abuse," said Richard Dieter, executive director of the information center, adding that women usually have not committed a long list of prior felonies.
"It's unclear whether jurors or prosecutors may be more lenient in potential prosecutions of women, since there are relatively few," said Dieter.
McCarthy, 51, was convicted of entering the Lancaster, Texas home of her 71-year-old neighbor, Dorothy Booth, on July 21, 1997, under the pretense of borrowing some sugar. She then stabbed Booth five times, according to the Texas attorney general's summary of the case.
She also cut off Booth's left ring finger in order to take her diamond ring, which she later pawned.
McCarthy also was believed to be responsible for the murders of two other elderly women, one using a meat tenderizer as a weapon and another using a claw hammer, according to the Attorney General's summary.
McCarthy was found guilty in 1998 by a Dallas County jury of murdering Booth and sentenced to death. Her conviction was overturned by the Texas Court of Criminal Appeals in 2001 because no attorney was present when she was questioned after the crime even though she had requested a lawyer, court documents show. She was tried a second time in 2002, was again found guilty by a Dallas County jury, and again sentenced to death.
The Texas Court of Criminal Appeals in 2004 agreed with the second conviction.
McCarthy would be the second person executed in the United States so far this year. Forty-three inmates were put to death in 2012.
(Reporting by Corrie MacLaggan; Writing by Greg McCune; Editing by Bernard Orr)
A coalition of racial, labor, and religious groups announced today they are encouraged by the Senate bipartisan plan on immigration reform, but at the same time made a call for ?action,? announcing a massive rally in Washington on April 10th in support of reform.
?We need to have the same compass, and the compass is a path to citizenship,? said labor leader Hector Figueroa, of the Service Employees International Union (SEIU) Local 32BJ, who then said ?a vessel cannot move without the wind driving it ? we want to create that wind,? urging communties to get involved in supporting reform through upcoming ?Day of Actions? and the big rally in April.
Eighteen-year-old Veronica Sarav?a, from the organization CASA de Maryland, is a DREAMER who helped organize the effort in Maryland which led to voter approval of a ?Dream Act? in the state. ?She was at the press conference accompanied by her 10-year-old sister Diana. ??I come from a typical family,? explained Sarav?a, one in which her little sister is a citizen, while she is a Dreamer who has applied for Deferred Action. ?Her mother is an undocumented nanny, her father is on temporary status and her grandmother is a citizen.
?I hope to study psychology and nursing without the fear of being deported, and I want to see my mother retired happily without a struggle,? said Sarav?a.
Another group which came out in support was the nation?s largest and oldest civil rights organization, the NAACP. ? ?Four out of five African-Americans support pushing for comprehensive immigration reform,? said the NAACP?s president, Ben Jealous.??This is an issue that black voters see as a basic humanitarian need; it does not improve for any workers for us to exploit any workers,? said Jealous, adding ? we in the black community understand what it?s like to be mistreated, and we understand the pain of migration.?
Chung-Wha Hong, Executive Director of the New York Immigration Coalition, says her group has been fighting for reform for 20 years, and they have one main concern: ?I?m here to talk about families ? the fear of being separated from their loved ones is the number one concern,? said Hong. ??Why must we see any more children whose parents are taken away in the middle of the night in shackles??
Sister Simone Campbell, Executive Director of NETWORK, said the faith community understands this is not about a special interest group; ?we all know immigrants who are suffering because of our broken system,? said Campbell, who is a Catholic nun. She said she was at a Safeway supermarket when she started talking to the young woman behind her, who said she was a Dreamer and was worried about what was going to happen.
?We the people know this is not working ?- let?s make a change,? Campbell said.
BINGER, Okla. (AP) ? In the gently rolling hills of Oklahoma ranch country is a place that has seen more than its share of destructive weather ? tornadoes, ice storms and floods, year after year, for half of the last decade.
In fact, Caddo County has been declared a federal disaster area nine times since 2007, making it one of the nation's most ill-fated locations. But even here, farmers and ranchers say, no one has endured anything as crippling as the ongoing drought, which has dried out ponds, withered crops in the field and decimated the water table.
"It makes you become humble," said Charlie Opitz, who began his farming career selling peanut seeds in 1959 and grew his operation to more than 2,500 acres near the small town of Binger, about 60 miles west of Oklahoma City. "You realize there's something out there much greater than you are."
Oklahomans know better than most Americans about the perils of bad weather. Their state practically blew away during the Dust Bowl of the 1930s, and they live in the heart of tornado alley ? a wide corridor in the central United States where twisters are common.
Caddo County has endured all that and more. Its recent history reads like a storm chaser's logbook or some punishment inflicted by a vengeful god.
The area was hit by no fewer than five federal disasters in 2007 alone, including ice storms, violent winds, tornadoes and flooding. Then the county suffered a disaster each year for the next four, including more tornadoes and flooding in 2008, a blizzard in 2009, another ice storm in 2010 and tornadoes and flooding again in 2011.
By comparison, the county suffered only five federal disasters during the entire decade of the 1990s.
Now comes the drought, a ceaseless dry spell that began last summer and could persist through much of 2013.
Rainfall totals for 2012 were more than 10 inches below normal, and the two-year total of 51 inches is the fourth-lowest since record keeping began in 1895, according to the Oklahoma Climatological Survey.
A few scattered showers have brought much-needed rain to the region in recent weeks, but the entire county remains locked in extreme drought conditions, according to the U.S. Drought Monitor, a government service.
Karen Krehbiel, who raises sheep and grows wheat and milo near Hinton, said her farm's utility expenses more than doubled from about $15,000 in 2010 to $33,000 in 2012, mostly because of increased costs to irrigate parched fields. Sheep that traditionally would graze on pasture land must be fed hay, making the operation still more expensive.
"Because it was so hot and dry, even running irrigation all day, you couldn't produce enough water," said Krehbiel, who had to let 30 acres of alfalfa die in the field because she couldn't afford to irrigate it.
A pond on Krehbiel's property still hasn't returned to normal since the 2007 flood burst a dam and sent the pond gushing downstream. And an apple, pear and peach orchard near her in-law's home still bears the scars of an ice storm that took out dozens of trees.
Cattle rancher Scott Brower said the drought is easily the worst natural disaster he's experienced.
Even during the ice storm, his ranch was calving 100 heifers. But the drought "gets old in a hurry," he said, citing the challenge of hauling a thousand gallons of water at a time out to pasture.
Opitz said much of the land that he and his sons work is still recovering from the 2007 flood that sent the nearby Sugar Creek out of its banks.
"This whole valley was underwater, from hill to hill," said Opitz, whose grandfather started a grain elevator in Binger in 1903.
The family had to buy a bulldozer to repair all the ponds that were washed away, and the fields where they grow wheat and other crops still have deep gulleys carved into them as a result of the flooding.
If the drought doesn't break soon, valuable grazing grass could die.
"It will put several producers out of business," Opitz said. "That's not just speculation. That's a fact."
Across Oklahoma, the costs for various types of insurance ? homeowners, automobile and crop ? are going up because of the state's proclivity for disasters.
The higher rates are "the result of the exposures that exist here," said John Wiscaver, a spokesman for Oklahoma Farm Bureau Insurance.
As for Brower, he tries to stay upbeat and wait for relief that's bound to come, eventually.
"You just do the best you can do every day and hope it gets better," he said. "We'll get some moisture sooner or later. It will be our turn."
___
Sean Murphy can be reached at www.twitter.com/apseanmurphy ,
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PARK CITY ? In the deliciously seasoned genre treat, We Are What We Are, director Jim Mickle and his screenwriting partner Nick Damici take the bones of the 2010 Mexican film of the same name, about a family of ritualistic cannibals, and reassemble them into an entirely different creature. Exchanging impoverished urban anxiety for rural creepiness in upstate New York, this reimagining serves up chilling contemporary American Gothic that slowly crescendos into an unexpected burst of gloriously pulpy Grand Guignol. You may never look at a bowl of beef stew the same way again.
Picked up for U.S. release soon after its Sundance premiere by eOne Distribution, the film is that rare modern horror movie that doesn?t simply fabricate its scares with the standard bag of post-production tricks. Instead it builds them via a bracing command of traditional suspense tools ? foreboding atmosphere, methodical plotting, finely etched characters and a luscious orchestral score that effectively plays against the ominous tone of some scenes while dramatically heightening the tension of others. This is polished film craft.
One of Mickle and Damici?s smartest moves is to flip the gender of the surviving family figurehead from Jorge Michel Grau?s original. Instead of losing their father at the start of the movie, it?s the Parker kids? mother (Kassie Depaiva) who dies in an accident while picking up groceries in the backwoods Catskills town during the beginning of a torrential rainstorm.
That shifts the film?s dynamics to center on teenage sisters Iris (Ambyr Childers) and Rose (Julia Garner), who are expected to continue the woman?s sacred role of preparing the family meal. Staging the most macabre element of the story in scenes that evoke classic American family tradition ? the pioneer look of the Parkers? supper clothes, the solemnity of grace before meals, the folk songs heard playing softly ? makes it all the more disturbing. It also helps convey that the arcane ways of this unwholesome brood go back a long time.
But while grieving patriarch Frank Parker (Bill Sage) refuses to change plans for their mysterious ritual, which begins with three days of fasting, Iris and Rose have increasing qualms. Their young brother Rory (Jack Gore) is just hungry. In a scene that?s both shockingly funny and horrifying, he confesses as much when he bites the thumb of their kind neighbor, Marge (Kelly McGillis), who babysits him during his mother?s funeral.
While the townspeople are busy dealing with post-storm flood damage, a distraught couple reports that their daughter has gone missing. At the same time, Doc Barrow (Michael Parks) performs an autopsy on Mrs. Parker that yields surprising findings about her condition. More inexplicably, his dog sniffs out what appears to be a human bone washed up in the creek. When the sheriff (Damici) shows little interest in his discovery, the doctor gets Deputy Anders (Wyatt Russell) on board. Back in town after training and eager to advance his high school crush on Iris, Anders is more than willing to go poking around the Parkers? property.
Making the family a part of the community and not the usual isolated weirdos adds an interesting layer. This is particularly so with the two girls, whose blond hair and alabaster skin give them an angelic appearance. They can be abrupt and suspicious when cornered, but their extreme distress the first time we see them doing their grisly duty reveals how deeply troubled they are by the warped scriptures laid down by their father.
Both actresses are terrific. A sweet-faced beauty, Childers? Iris shows the internal struggle of a girl who can picture a normal life, even if she somehow knows that prospect has been bred out of her nature. Garner ? memorable in Martha Marcy May Marlene, which this film at times recalls in its stretches of glowering stillness ? has a watchful intensity that foreshadows her resourceful behavior when the situation grows more dangerous.
Also serving as editor, Mickle modulates the tension with only one or two pardonable detours into ghoulish excess en route to the climactic carnage. He intercuts effectively among the family?s frictions, the doc?s investigation, and flashes of late 18th century action prompted by Rose?s reading of the family journal.
The showdown between Doc Barrow and Frank is right out of a Western. In a role that easily could have toppled over into fire-breathing quasi-religious fanaticism, Sage drags Frank?s menace from the depths of a somber man, all but broken by the death of his wife. Yet his eruptions of monstrous rage are scary indeed. And Parks? timeworn intelligence makes it seem less of a stretch that this small-town medic could be such an ace in the research department, his persistence fueled by lingering pain from the unexplained disappearance of his own daughter.
Among the smaller roles, Russell brings a nice relaxed manner to Anders? touching scenes with Iris; Gore strikes the right balance in a child who?s both innocent and haunted, his young face transformed at times into a ravaged death mask; and McGillis brings salt-of-the-earth warmth to her brief appearances.
Russell Barnes? production design and Elisabeth Vastola?s costumes cleverly support the evidence of the Parkers as descendants of another time and way of life.
The film was shot in locations still recovering in the wake of widespread flooding following Hurricane Irene in 2011, a reality echoed in the power outages that hit the town in this story after the storm. Cinematographer Ryan Samul casts a subtle graveyard gloom over the exteriors, bringing muted tones and a malevolent eye even to some gorgeous scenic shots.
We Are What We Are sustains not only suspense, but also internal logic. The Walking Dead showed that a comic book about a zombie apocalypse could yield muscular American survival drama with non-stereotypical characters. In a comparable way, Mickle and his collaborators have taken one of the more lurid horror subgenres, the predatory cannibal movie, and treated it with stylistic restraint, narrative integrity and even moments of gentle lyricism.
The film grips from start to finish, offering a slyly subversive reflection on clans ? cultists, fundamentalists, or just plain crazies ? who impose their diseased thinking from one generation to the next.
Venue: Sundance Film Festival (Park City at Midnight; eOne Distribution)
Cast: Bill Sage, Ambyr Childers, Julia Garner, Jack Gore, Kelly McGillis, Wyatt Russell, Michael Parks, Nick Damici, Kassie Depaiva, Odeya Rush
Production companies: Memento Films International, in association with Uncorked Productions, The Zoo
Director: Jim Mickle
Screenwriters: Nick Damici, Jim Mickle, based on the screenplay ?Somos lo Que Hay,? by Jorge Michel Grau
Producers: Rodrigo Bellott, Andrew D. Corkin, Linda Moran, Nicholas Shumaker, Jack Turner
Executive producers: Emilie Georges, Tanja Meissner, Brett Fitzgerald, Mo Noorali, Rene Bastian, Jacob Pechenick
What is Kickstarter? The answer you'll hear, as long-winded as it may be, will likely touch on Pebble. If it doesn't, you'll probably want to ask someone else -- with more than $10 million pledged, the people's smartwatch catapulted past the crowdfunding site's records and the startup's own expectations. It achieved a $100,000 funding goal in two hours, and it was clearly a favorite among our readers. Of course, there were doubts that Eric Migicovsky, the company's founder, would deliver such an appealing and seemingly powerful product for $125, but following our first look during the company's CES press conference, that dream became real.
So, what is Pebble? It's not a smartphone for your wrist, as we've seen attempted before. In fact, it's far less sophisticated than you might expect -- the lightweight device reads out basic text, lets you skip through music tracks and, of course, displays the time. It's hardly the greatest achievement of our generation, or even the device of the year. It's become incredibly popular, sure, but despite the hype, you certainly don't need to own one. Yet, somehow, even the most technologically inept people in our lives have heard it mentioned on morning talk shows, FM radio stations or from pre-teens anxious to impress their friends. Having a smartphone alone isn't enough anymore. Or is it?
We tested a black Pebble, which is the first color to ship. The face is slightly glossier than renders implied, but otherwise the production device looks nearly identical to early prototypes. There's a 22mm rubber strap for mounting the device to your wrist -- you'll likely be able to swap in your own band with matching dimensions. It's a fairly attractive combination, though regardless of the strap you choose, you'll probably want to leave Pebble behind during formal events, or walks down the runway.
Pebble feels very comfortable when fastened on the wrist -- it's relatively lightweight, and the smooth edges maintain their distance from sensitive skin. Still, it feels solid enough for regular use, and thanks to waterproofing down to 50 meters (164 feet), it can stay on your wrist during laps in the pool (or in the ocean), and it'll work just fine in the shower as well. There are two exposed metal connectors, used to pair up with the proprietary magnetic USB charging cable (the only accessory that ships in the box), but the housing appears to be properly sealed.
The secret to Pebble's weeklong battery life and daylight readability is a technology that's penetrated the lives of bookworms young and old: an e-paper display. The 114 x 168 black-and-white screen sports nearly 20,000 pixels, letting you view emails and a time readout in several fonts, along with watch faces and other indicators. The display looks great both indoors and out, though we did notice some odd black spotting while viewing the panel in direct sunlight -- adjusting the angle eradicates the issue.
There's a simple backlight that illuminates the panel briefly at night, automatically when you receive a notification or manually when you activate any of the four side-mounted buttons. It's fairly dim, enabling you to avoid disturbing fellow moviegoers or that patient significant other sharing your bed, but still bright enough for you to catch every detail. Pebble will reflect even a small amount of ambient light, however, so your backlight usage is likely to be fairly minimal.
Pebble doesn't offer much functionality without a smartphone. You'll need one (and an accompanying app) to get started, and although you'll be able to display the time while disconnected (in Airplane Mode, for example), software updates, feature additions and notifications all require a Bluetooth connection. Fortunately, there's Bluetooth 4.0 support, which offers speedy performance with reduced energy consumption. This also contributes to Pebble's weeklong battery life, and a reported five to 10 percent hit to your smartphone's longevity.
We'll detail the user interface more in the section below, but since there's no touch functionality here, you'll need to navigate using the four side-mounted buttons. There's a home (or back) button on the top left side, which brings you back to Pebble's main configuration page. Positioned to the right of the e-paper panel: a top button scrolls up, a smaller center button makes selections and the control on the bottom scrolls down -- through messages, menus or tracks while controlling music playback. All of these buttons require a firm press, rather than a tap, and while you won't accidentally activate the controls, registering input can take a bit of effort.
Software
Pebble's two apps -- one for Android 2.3 or later and the second for Apple devices running iOS 5 or later -- enable everything from initial setup to push notifications. There's no user manual in the box, so you'll need to download your respective app to get started. Pairing takes a few seconds, and then you're good to go. The smartwatch will automatically adopt the local time on your smartphone, and you can select from a few default watch faces, ranging from Text Watch, which you're probably already familiar with, to Classic Analog.
To take full advantage of the device's functionality, you'll need to head back over to the smartphone app, where you can push additional watch faces (there are currently just five to download, including TicTockToe). Eventually, this custom app store will include third-party apps, such as the bike computer and golf rangefinder that the company pitched on its Kickstarter page, though they're not available now.
The app's Settings page is where you'll select notifications to push. Based on the apps installed on our Galaxy Note II, we were able to choose from incoming call alerts, text messages, calendar reminders, email previews, Google Talk messages, Google Voice messages and Facebook messages. Each option has a checkbox, so if you want to use your Pebble for caller ID but don't want to be bothered with Facebook messages, that's perfectly OK. With each notification, the watch will vibrate once, the backlight will flip on (for a few seconds) and the message will pop up.
Theoretically, you can simply shake your wrist to dismiss the notification, though we were only able to accomplish this by pressing one of the buttons. You can choose from large and small fonts for notifications, but regardless of the size, you can scroll to see more using the up and down buttons. You'll need to hop over to your smartphone to read the full message or send a response. Similarly, when you receive a call, your only option on the watch is to dismiss the notification, but doing so won't send your caller to voicemail.
Unless you're looking at your watch every few seconds, there will likely come a time when your inbox contains multiple messages. Unfortunately, Pebble will only display the very last notification received, so it won't completely eliminate a need to check your smartphone. Also, it's not currently able to display certain languages -- a message we received with Chinese characters rendered as several lines of rectangles on the display.
At this point, all of the interactions between Pebble and a connected smartphone go in one direction -- from your handset to the watch -- with one exception. The wristwatch's music player controls playback on your Android or iOS device, including play / pause and track skipping. There's no volume control, which seems reasonable given the limited number of buttons. With our Android phone, the watch was able to identify and control music from the native app, but not third-party services, such as Spotify.
The competition
Although it may seem to be the case given the excitement surrounding this launch, Pebble is not the only smartwatch on the market. Sony and now Toshiba are two of the giants behind similar tech, and the former company's SmartWatch is even reasonably priced, at $149. Allerta, the company behind Pebble, released its own wearable several years ago, called inPulse, but smartphone compatibility was limited to BlackBerry models and certain Android-powered handsets, and the device uses an OLED display. Similarly, WIMM Labs' WIMM One was made available to developers, but is no longer in production.
Pebble's success stems from the promise of third-party apps and the practical e-paper display, along with the marketing power of Kickstarter. Functionality remains somewhat limited, but this is a first-generation device from a small manufacturer that's currently only in the hands of a very limited number of lucky backers. If consumer interest is any indication, developers will likely soon be hard at work on a variety of unique applications, if they aren't already. The platform is incredibly young, and the best is yet to come.
Wrap-up
We've really enjoyed our time with Pebble so far -- it's not a fashion statement, necessarily, but we wouldn't be surprised to see it pop up on many wrists in the weeks and months to come. Functionality is still quite limited at this point, and considering how fresh the device is, that's to be expected. The features that are already available work well, and the smartwatch has been a pleasure to use.
Taking price into account, Pebble is an excellent value, especially for lucky Kickstarter backers who were able to take advantage of $99, $115 and $125 pre-orders. We're very optimistic for the device's future -- our chief concern relates not to the hardware, but how it will affect behavior: If you thought that friend who glances at his smartphone every few minutes was rude, just wait until he owns a Pebble.
Don't ask, don't get. That's why we rang up Canonical and requested an early build of Ubuntu for the Galaxy Nexus. (Politely declined.) Next, we asked if maybe the company could speed up development of its dual OS solution for Android, since we're really looking forward to it. (Funny looks.) Finally, we wondered if there was any possibility of dropping by the London HQ and interviewing someone in charge. ("Come on over!") We promptly found ourselves sitting across a desk from Richard Collins, who left the Symbian Foundation 18 months ago to work at Canonical, and who has a very firm grasp of how Ubuntu is going to be hauled into the mobile era. He explains everything after the break, so if you have a big OS-shaped gap in your belly, or if you're just intrigued to hear the proposition of a new player, read on.
Ubuntu for Smartphones
How is Ubuntu on a smartphone really the same Ubuntu we know from desktop PCs?
It's the same code base, with our Unity UI, adapted to provide a very particular experience according to the device it's running on. That makes it straightforward for developers to say, "here's an Ubuntu application that I know works brilliantly on the desktop, I only have to adapt it using the tools that Ubuntu provides in order to make it work on a smartphone."
But legacy desktop apps will still have to be ported?
Legacy apps will have to be adapted. They'll need to compile on ARM processors, but that's not a significant amount of work. When we start launching products, we'll include an SDK which will allow developers to build apps which work on both the smartphone and the desktop interface.
Since Android is also Linux-based, is there any plan for Ubuntu to run Android apps?
Many Android developers already use Ubuntu as their desktop OS and we have a very close affinity with them. We intend to encourage them to make their Android applications run on Ubuntu, but we won't engineer any middleware for running Android apps. Developers are intelligent and capable enough to make their apps run on our devices. We have an active initiative right now to directly help them achieve this. [See More Coverage below.]
Will you have a full app store ready for the launch of your smartphone?
In terms of our first go-to-market product strategy, the intention is not to have an application store full of ready-made applications that are there to download. We have a very definite approach in terms of addressing an important part of the market where users are primarily interested in being able to use a core set of applications.
"The intention is not to have an application store [at launch]"
You're saying people interested in low-cost phones don't need lots of apps?
At launch, we'll have the capability for a mobile app store, but at this stage we don't believe it is essential for the entry-level smartphone market we're targeting. However, we won't just be saying "there's your basic applications, that's all you're going to need." Our strategy includes giving carriers and manufacturers ways of delivering services in conjunction with us -- we plan to give them more influence.
Do you want people buying your entry-level phone, in China for example, to know the Ubuntu brand?
Yes, of course. I want them to associate Ubuntu with a very interesting, relevant and enjoyable experience. The challenge for us is to take the success we have with developers, with enterprises, and take that into the consumer market.
Budget rivals
Are you going after the same market as Mozilla's Firefox OS?
[Mozilla] has a very particular type of technology. We believe that a rich user experience requires a native capability -- it can't be entirely addressed by a phone that only runs web applications. Web apps sit on servers in different parts of the internet, so it's hard for them to interact and share information.
Nokia's S40 is only defined as being a low-end smartphone platform. Ubuntu is engineered to run across different devices, and it's engineered to scale up to higher-end devices.
High-end rivals
What advantages do you have over Android as a smartphone OS?
With Android, it's implicit that if you want to run Google services then there's a levy associated with that. Our model is entirely different. We're working with industry partners who want to have more influence over the way services are provided to end users. We won't try to lock people into licensing our services.
Windows already straddles the divide between x86 and ARM. Has Microsoft stolen a march on you?
"Microsoft generates uncertainty and conflict..."
We compete with them, in that sense. There are ways in which Windows is a very costly OS to build hardware on. We have an alternative approach that is more software-based, more collaborative, more open, and offers more promise for developers who want their apps to run on desktops, phones, TVs and so on.
Microsoft generates uncertainty and conflict in the way it's trying to gain market share. They're in conflict with their own hardware partners. There's a very different stance in the way we propose to work with people.
Ubuntu for Android
Many people are waiting on mobile Ubuntu because they want to see boundaries pushed and the market disrupted. Won't your first phone jar with those types of users?
Not if we're clear about where we want to take Ubuntu. We're planning to very quickly follow our initial launch with a high-end converged device, which will have high-performing system components that will allow Ubuntu to run as a desktop OS when docked. It'll also have full access to the Ubuntu Software Center. So we need to be clear about our roadmap -- we don't have tunnel vision around low-end products.
Speaking of which, are you okay with how long it's taking Ubuntu for Android to come to market?
It takes a long time to release a software-based product and turn it into a hardware-based product. But I can tell you that you might not have much longer to wait before you see something on that side.
Makin' money
You're not going to be like Microsoft or Google, but how will you make money?
The simplest model would be per-unit licensing. Then there's also the fact that hardware manufacturers and carriers don't want to focus on software. They want people like us to manage that on their behalf and it might be possible to commercialize that.
So you'd directly look after the software -- including updates, for example?
Yes, absolutely. There's no fragmentation in terms of the way we will progress our OS. Each update will come on a six-monthly basis and manufacturers will be able to rely on that. They'll be able to deliver their services without worrying about OS versions.
How would those services run regardless of OS version?
Because often those types of services will be web-based. With Ubuntu, web applications can feel more like part of the main operating system. We can make them feel very native.
Will you try to advertize on mobile Ubuntu?
That has to be done in conjunction with carriers and manufacturers. But part of what we're doing with the OS is providing direct access to services that the user has subscribed to, and putting them in the main UI -- like with Amazon.
The Future
Where do you want to be in two years' time?
I want to be shipping in mass volume, in the millions of units, and for Ubuntu to be recognized globally as one of the major platforms. Our analysis says there's the opportunity to gain a 7-8 percent market share by 2016. There's a window of opportunity for a new player to capture that kind of share.
PARIS (Reuters) - France's health regulator has opened an inquiry into acne drug Diane-35, which is also used as a contraceptive, after four deaths linked to the drug in the past 25 years.
Health regulator ANSM said on Sunday that Diane-35, produced by German drugmaker Bayer, is authorized in 135 countries and sold in more than 116. Last year about 325,000 women in France used the drug, ANSM said, adding it would publish its report next week.
ANSM said the four deaths were due to thrombosis linked to the use of Diane-35. Three other deaths possibly connected to the drug, reported by the media, were linked to other health issues, the agency said.
Diane-35, also sold as Dianette in some countries, reduces acne for women by regulating hormones, according to several medical websites. The drug is also used as a contraceptive.
Earlier this month, ANSM said it was studying the possibility of limiting the use of third- and fourth-generation contraceptive pills after a woman sued Bayer over alleged side-effects such as embolism, or blood clots.
(Reporting by Geert De Clercq; editing by Jane Baird)
NEW ORLEANS (AP) ? Stevie Wonder is the latest in a parade of entertainers that will perform in New Orleans Super Bowl weekend.
The Rock and Roll Hall of Fame singer is headlining an outdoor concert near the Wyndham Riverfront Hotel on Feb. 2, the evening before the big game.
A spokeswoman for the event said Friday that Bud Light is sponsoring the concert. It will include performances by Texas blues guitarist Gary Clark Jr. and others.
Also that night, Justin Timberlake is appearing in his first concert in more than four years during "DIRECTV Super Saturday Night," an invitation-only concert being held after DIRECTV's "Celebrity Beach Bowl" that will include a performance by Miami rapper Pitbull.
"Celebrity Beach Bowl" is a star-studded flag football match that will include rapper Snoop Dogg and actor Neil Patrick Harris.
LONDON (AP) ? Lionel Messi and Barcelona have fallen from the top of the Associated Press Global Football Rankings this week, replaced by rivals Cristiano Ronaldo and Real Madrid.
Messi dropped to fifth place Tuesday and Barcelona out of the list altogether after a 3-2 loss to Real Sociedad, the team's first league defeat of the season.
Ronaldo was masterful in Madrid's 5-0 rout of a powerful Valencia team that is still in the Champions League. He scored twice and was influential in the other goals.
Ronaldo earned 115 points in the vote by the 15-member panel, which awards 10 points for its top player and team in the separate polls. Real Madrid teammate Angel di Maria made his first appearance in the top 10, in sixth position.
A call to prevent unsafe high-risk medical devices from reaching the marketplacePublic release date: 22-Jan-2013 [ | E-mail | Share ]
Contact: Leland Kim leland.kim@ucsf.edu 415-502-6397 University of California - San Francisco
Commentary sheds light on approval process for implantable body parts
Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.
"This could be potentially very dangerous. Many Americans patients and even physicians - are not aware of how many devices in this country are on the market without having clinical data of safety and effectiveness," said Rita F Redberg, MD, MSc, professor of medicine and director of the UCSF Women's Cardiovascular Services.
UCSF and the Australian Joint Registry published this month a perspective in the New England Journal of Medicine that reveals the complex history of how metal-on-metal hip implants reached the marketplace. The implants are categorized by the FDA as high-risk devices, yet have been allowed into the marketplace without first testing them. They failed at a dangerously high rate, often requiring reparative surgery at least four times as often as traditional hip replacement surgery.
The perspective's authors are calling for changes in how the FDA approves metal-on-metal hip replacement devices and other high-risk devices for the marketplace.
"If those hip implants are recalled, besides the problem of having to remove them because they're very painful, they can release chromium ions into the blood stream which pose an unknown risk," Redberg said. "Patients would also undergo significant disability having a second, third or fourth hip operation."
U.S. hospitals perform 48 million medical procedures each year, according to the U.S. Centers for Disease Control and Prevention. Of that number, roughly 676,000 patients undergo total knee replacement surgeries and 327,000 undergo total hip replacement surgeries.
"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that's just for the metal-on-metal implants."
An Obscure Loophole
These high-risk metal-on-metal devices avoid going through clinical trials because of FDA loopholes in the 510(k) clearance, which allow them into the marketplace by claiming "substantial equivalence," which means they are similar to already approved devices or "predicate devices."
"All you have to do is show that your device is substantially similar to a number of other devices," Redberg said. "And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those 'predicate devices' that claimed 'substantial equivalence.'"
Even voluntarily recalled devices can serve as predicates under the 510(k) clearance as long as the FDA did not require their removal from the market or a court did not find they were misbranded or misrepresented in any way.
"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval (PMA) process doesn't always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."
Questions to Ask
For patients who are in the process of undergoing a medical procedure, Redberg suggests they stay informed and ask many questions.
"Just like for any kind of procedure, I would ask, 'Are there scientific data that show this procedure or device is going to help me?'" Redberg said. "'Has it been studied in clinical trials? Has it been studied in patients like me? What are the risks? What are the alternatives?' Those are the questions patients should be asking before every procedure."
###
Redberg is the senior author of the paper; co-authors include Brent M. Ardaugh, MPH, MS, of the Framingham Heart Study; and Stephen E. Graves, MBBS, D.Phil, of the Australian Orthopaedic Association National Joint Replacement Registry in Adelaide, Australia.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
A call to prevent unsafe high-risk medical devices from reaching the marketplacePublic release date: 22-Jan-2013 [ | E-mail | Share ]
Contact: Leland Kim leland.kim@ucsf.edu 415-502-6397 University of California - San Francisco
Commentary sheds light on approval process for implantable body parts
Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.
"This could be potentially very dangerous. Many Americans patients and even physicians - are not aware of how many devices in this country are on the market without having clinical data of safety and effectiveness," said Rita F Redberg, MD, MSc, professor of medicine and director of the UCSF Women's Cardiovascular Services.
UCSF and the Australian Joint Registry published this month a perspective in the New England Journal of Medicine that reveals the complex history of how metal-on-metal hip implants reached the marketplace. The implants are categorized by the FDA as high-risk devices, yet have been allowed into the marketplace without first testing them. They failed at a dangerously high rate, often requiring reparative surgery at least four times as often as traditional hip replacement surgery.
The perspective's authors are calling for changes in how the FDA approves metal-on-metal hip replacement devices and other high-risk devices for the marketplace.
"If those hip implants are recalled, besides the problem of having to remove them because they're very painful, they can release chromium ions into the blood stream which pose an unknown risk," Redberg said. "Patients would also undergo significant disability having a second, third or fourth hip operation."
U.S. hospitals perform 48 million medical procedures each year, according to the U.S. Centers for Disease Control and Prevention. Of that number, roughly 676,000 patients undergo total knee replacement surgeries and 327,000 undergo total hip replacement surgeries.
"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that's just for the metal-on-metal implants."
An Obscure Loophole
These high-risk metal-on-metal devices avoid going through clinical trials because of FDA loopholes in the 510(k) clearance, which allow them into the marketplace by claiming "substantial equivalence," which means they are similar to already approved devices or "predicate devices."
"All you have to do is show that your device is substantially similar to a number of other devices," Redberg said. "And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those 'predicate devices' that claimed 'substantial equivalence.'"
Even voluntarily recalled devices can serve as predicates under the 510(k) clearance as long as the FDA did not require their removal from the market or a court did not find they were misbranded or misrepresented in any way.
"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval (PMA) process doesn't always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."
Questions to Ask
For patients who are in the process of undergoing a medical procedure, Redberg suggests they stay informed and ask many questions.
"Just like for any kind of procedure, I would ask, 'Are there scientific data that show this procedure or device is going to help me?'" Redberg said. "'Has it been studied in clinical trials? Has it been studied in patients like me? What are the risks? What are the alternatives?' Those are the questions patients should be asking before every procedure."
###
Redberg is the senior author of the paper; co-authors include Brent M. Ardaugh, MPH, MS, of the Framingham Heart Study; and Stephen E. Graves, MBBS, D.Phil, of the Australian Orthopaedic Association National Joint Replacement Registry in Adelaide, Australia.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
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Public release date: 22-Jan-2013
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