Xbox SmartGlass updated with second-screen ESPN and NBA Game Time app experiences

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“Fiscal cliff” deal closer, but gaps remain

WASHINGTON (Reuters) – After making major concessions on long-held “fiscal cliff” positions, President Barack Obama and House of Representatives Speaker John Boehner will test the reaction Tuesday of their respective parties in the U.S. Congress and continue talks aimed at further narrowing their differences.

The effort is designed to avert the steep tax hikes and across the board spending cuts set to take effect unless a deal is enacted into law before December 31. Enactment would require a buy-in by the full U.S. Senate and House on whatever Obama and Boehner present to them. Neither Obama or Boehner can be certain yet on how much resistance they might meet.

Though much work remains, the progress contrasted dramatically with previous movement so slow that as recently as Sunday, some Washington insiders saw a 50-50 chance of going over the cliff – which the Congressional Budget Office says would bring on a new recession.

In rapid developments Monday, the two sides came significantly closer to bridging gaps on critical issues such as tax hikes for the wealthy and cuts in Social Security cost-of-living benefits. Those issues have the potential to cause problems politically for both leaders, as Republicans and Democrats start to study them.

Obama and Boehner made the most headway on extending the reduced tax rates originally enacted in the administration of President George W. Bush. Both have agreed to keep the low rates for everyone but the wealthy, but they still differ on who qualifies as wealthy for tax purposes.

Obama, whose definition has for months been taxpayers above the $ 250,000 threshold, traveled to $ 400,000 in his latest offer. Boehner was at $ 1 million, but could move down to $ 500,000.

Obama also offered a “fast track” process for major tax and spending reforms in the year ahead. A Republican aide who asked not to be identified said that “conceptually,” there was agreement to make permanent changes in the tax code, with some of those changes taking effect at the start of 2013 and others at the beginning of 2014.

A comprehensive cliff-avoiding agreement would immediately substitute new and more targeted spending cuts for the indiscriminate slashing of defense and non-defense programs known as “sequestration.”

Possible plans to produce cuts in spending for Medicare and Medicaid, the government health insurance programs for seniors and low income Americans respectively, remain to be discussed.

Boehner and Obama have made headway on the politically explosive question of the president’s ability to avoid constant battles over raising the debt ceiling, which controls the level of borrowing by the government. Boehner is ready to give Obama a year of relative immunity from conservative strife over the debt ceiling, while Obama is pushing for two years.

Boehner is set to meet with Republicans in the House Tuesday morning and then speak to reporters. Also likely Tuesday is a White House briefing which could shed more light on the work ahead.

The reaction Tuesday from their party allies in Congress may help determine how much further each can go to finish off a deal and how much long it would require to do so.

(Reporting by Richard Cowan, Mark Felsenthal, David Lawder and Fred Barbash. Editing by Fred Barbash)

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Newtown Fallout: Cerberus Retreats From Guns

While President Barack Obama and other Democratic politicians clear their throats about proposing new gun control laws sometime next year, the marketplace is responding swiftly to the Newtown, Conn., elementary school massacre.

Dick’s Sporting Goods, one of the largest retailers in its industry, said Tuesday it is suspending the sale of certain military-style semiautomatic rifles similar to the one used by the Newtown killer. Fox News reported that Discovery Channel has decided to cancel its popular reality show “American Guns.”

Less visible to consumers, but no less important, Cerberus, a $ 20 billion private-equity firm based in New York, announced overnight that, under pressure from the California teachers’ pension fund, it will sell its controlling stake in the country’s largest guns-and-ammo manufacturer, a conglomerate called Freedom Group. The semiautomatic rifle used to slaughter 26 people at Sandy Hook Elementary School, 20 of them children, was made by Bushmaster Firearms, one of the companies that operates under the Freedom Group umbrella.

The California State Teachers’ Retirement System, which has $ 751 million invested with Cerberus, said it would review its relationship with the private-equity firm “given the tragic events last Friday in Newtown, Conn.” Cerberus then followed with its announcement, saying that unloading Freedom Group “allows us to meet our obligations to the investors whose interests we are entrusted to protect without being drawn into the national debate” on gun control.

Bloomberg TV’s Tom Keene asked me this morning on his “Surveillance” program whether this the beginning of something akin to the divestment campaign aimed at breaking South Africa’s apartheid system. That’s a provocative question. The answer is probably no, and the reasons shed light on the nature of the American gun market.

Gun ownership in the United States is not apartheid. Millions of Americans relish firearms and use them for lawful hunting, shooting sports, and self-defense. To many people, guns represent individualism and self-reliance. The Supreme Court has interpreted the Second Amendment as protecting an individual right to keep a handgun in the home. Forty-nine states allow their citizens to carry guns concealed in public. A federal appeals court recently said that the sole holdout, Illinois, violated the Second Amendment by prohibiting concealed carry.

The $ 2 billion American gun industry is not the South African economy. The gun market historically has been fragmented and made up of relatively small companies. It consolidated in recent years, driven largely by Cerberus buying companies such as Bushmaster (and Remington, Marlin, and Para USA) in hopes of squeezing redundancies from their operations and selling off the roll-up in an IPO. To Cerberus’ frustration, the initial private offering had stalled for reasons having nothing to do with Newtown. (Finding efficiencies and cross-marketing opportunities turned out to be more difficult than the private-equity gurus anticipated.) Now, Cerberus will use the cover of renewed controversy over gun control–and the suddenly shocked sensibilities of the California teachers pension-fund managers (from whom Freedom Group presumably had not been kept secret)–to dump a guns-and-ammo play that wasn’t working out smoothly.

There are personal elements to the move, as well. Stephen Feinberg, who founded Cerberus in 1992, and is an avid hunter and gun enthusiast. His father, Martin Feinberg, lives in Newtown and told Bloomberg News the shooting was “devastating.”

Cerberus’ move and the prospect that the companies within Freedom Group will get sold off individually or in small clumps will return the fractious gun industry to something closer to what it looked like a half-dozen years ago. Smith & Wesson (SWHC) and Sturm Ruger (RGR), the two publicly traded gun makers in the U.S., will stand a little larger in relative terms. Glock, Beretta, and Taurus will continue to import guns from, respectively, Austria, Italy, and Brazil (as well as assemble weapons in their U.S. plants). And overall, gun makers will likely enjoy increased sales over the next six to 12 months, as consumers buy additional pistols and rifles out of fear that their favorites might be more difficult to obtain if Democrats succeed in pushing through new restrictions.

There will be additional post-Newtown reaction from retailers and from Hollywood. Wal-Mart (WMT) is a major gun seller. It accounts for about 13 percent of Freedom Group’s sales, for example. The world’s biggest retail chain will doubtless come under pressure from anti-gun activists to curb its firearms sales, and the image-conscious company may follow its more specialized rival Dick’s.

In the entertainment world, the cable channel TLC has already delayed airing a show called “Best Funeral Ever.” Violent movie trailers might get postponed or edited. The massacre during a showing of The Dark Knight Rises in Aurora (Colo.) in July prompted Warner Bros. to pull the trailer for the forthcoming Gangster Squad, which showed a theater shooting. Later the studio cut the scene entirely.

Whether marketplace behavior will change over the long haul is a different question. Gangster Squad‘s opening was delayed but not cancelled. The film, pitting organized crime killers against police in Depression-era Los Angeles, is now slated to begin in theaters next month, and it will still include plenty of gunplay.

Businessweek.com — Top News

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Syrian rebels take control of Damascus Palestinian camp

BEIRUT (Reuters) – Syrian rebels took full control of the Yarmouk Palestinian refugee camp on Monday after fighting raged for days in the district on the southern edge of President Bashar al-Assad‘s Damascus powerbase, rebel and Palestinian sources said.

The battle had pitted rebels, backed by some Palestinians, against Palestinian fighters of the pro-Assad Popular Front for the Liberation of Palestine-General Command (PFLP-GC). Many PFLP-GC fighters defected to the rebel side and their leader Ahmed Jibril left the camp two days ago, rebel sources said.

“All of the camp is under the control of the (rebel) Free Syrian Army,” said a Palestinian activist in Yarmouk. He said clashes had stopped and the remaining PFLP fighters retreated to join Assad‘s forces massed on the northern edge of the camp.

The battle in Yarmouk is one of a series of conflicts on the southern fringes of Assad’s capital, as rebels try to choke the power of the 47-year-old leader after a 21-month-old uprising in which 40,000 people have been killed.

Government forces have used jets and artillery to try to dislodge the fighters but the violence has crept into the heart of the city and activists say rebels overran three army stations in a new offensive in the central province of Hama on Monday.

On the border with Lebanon, hundreds of Palestinian families fled across the frontier following the weekend violence in Yarmouk, a Reuters witness said.

Syria hosts half a million Palestinian refugees, most living in Yarmouk, descendants of those admitted after the creation of Israel in 1948, and has always cast itself as a champion of the Palestinian struggle, sponsoring several guerrilla factions.

Both Assad’s government and the mainly Sunni Muslim Syrian rebels have enlisted and armed divided Palestinian factions as the uprising has developed into a civil war.

“NEITHER SIDE CAN WIN”

Syrian Vice President Farouq al-Sharaa said in a newspaper interview published on Monday that neither Assad’s forces nor rebels seeking to overthrow him can win the war.

Sharaa, a Sunni Muslim in a power structure dominated by Assad’s Alawite minority, has rarely been seen since the revolt erupted in March 2011 and is not part of the president’s inner circle directing the fight against Sunni rebels. But he is the most prominent figure to say in public that Assad will not win.

Sharaa said the situation in Syria was deteriorating and a “historic settlement” was needed to end the conflict, involving regional powers and the U.N. Security Council and the formation of a national unity government “with broad powers”.

“With every passing day the political and military solutions are becoming more distant. We should be in a position defending the existence of Syria. We are not in a battle for an individual or a regime,” Sharaa was quoted as telling Al-Akhbar newspaper.

“The opposition cannot decisively settle the battle and what the security forces and army units are doing will not achieve a decisive settlement,” he said, adding that insurgents fighting to topple Syria’s leadership could plunge it into “anarchy and an unending spiral of violence”.

Sources close to the Syrian government say Sharaa had pushed for dialogue with the opposition and objected to the military response to an uprising that began peacefully.

In a veiled criticism of the crackdown, he said there was a difference between the state’s duty to provide security to its citizens, and “pursuing a security solution to the crisis”.

He said even Assad could not be certain where events in Syria were leading, but that anyone who met him would hear that “this is a long struggle…and he does not hide his desire to settle matters militarily to reach a final solution.”

In Hama province, rebels and the army clashed in a new campaign launched on Sunday by rebels to block off the country’s north, activists said.

The Syrian Observatory for Human Rights, an opposition-linked violence monitor, said fighting raged through the provincial towns of Karnaz, Kafar Weeta, Halfayeh and Mahardeh.

It said there were no clashes reported in Hama city, which lies on the main north-south highway connecting the capital with Aleppo, Syria’s second city.

Qassem Saadeddine, a member of the newly established rebel military command, said on Sunday fighters had been ordered to surround and attack army positions across the province. He said Assad’s forces were given 48 hours to surrender or be killed.

In 1982 Hafez al-Assad, father of the current ruler, crushed an uprising in Hama city, killing up to 30,000 civilians.

Qatiba al-Naasan, a rebel from Hama, said the offensive would bring retaliatory air strikes from the government but that the situation is “already getting miserable”.

(Additional reporting by Oliver Holmes, Erika Solomon and Dominic Evans in Beirut, Afif Diab at Masnaa, Lebanon; editing by Philippa Fletcher)

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Syrian rebels take control of Damascus Palestinian camp

BEIRUT (Reuters) – Syrian rebels took full control of the Yarmouk Palestinian refugee camp on Monday after fighting raged for days in the district on the southern edge of President Bashar al-Assad‘s Damascus powerbase, rebel and Palestinian sources said.

The battle had pitted rebels, backed by some Palestinians, against Palestinian fighters of the pro-Assad Popular Front for the Liberation of Palestine-General Command (PFLP-GC). Many PFLP-GC fighters defected to the rebel side and their leader Ahmed Jibril left the camp two days ago, rebel sources said.

“All of the camp is under the control of the (rebel) Free Syrian Army,” said a Palestinian activist in Yarmouk. He said clashes had stopped and the remaining PFLP fighters retreated to join Assad‘s forces massed on the northern edge of the camp.

The battle in Yarmouk is one of a series of conflicts on the southern fringes of Assad’s capital, as rebels try to choke the power of the 47-year-old leader after a 21-month-old uprising in which 40,000 people have been killed.

Government forces have used jets and artillery to try to dislodge the fighters but the violence has crept into the heart of the city and activists say rebels overran three army stations in a new offensive in the central province of Hama on Monday.

On the border with Lebanon, hundreds of Palestinian families fled across the frontier following the weekend violence in Yarmouk, a Reuters witness said.

Syria hosts half a million Palestinian refugees, most living in Yarmouk, descendants of those admitted after the creation of Israel in 1948, and has always cast itself as a champion of the Palestinian struggle, sponsoring several guerrilla factions.

Both Assad’s government and the mainly Sunni Muslim Syrian rebels have enlisted and armed divided Palestinian factions as the uprising has developed into a civil war.

“NEITHER SIDE CAN WIN”

Syrian Vice President Farouq al-Sharaa said in a newspaper interview published on Monday that neither Assad’s forces nor rebels seeking to overthrow him can win the war.

Sharaa, a Sunni Muslim in a power structure dominated by Assad’s Alawite minority, has rarely been seen since the revolt erupted in March 2011 and is not part of the president’s inner circle directing the fight against Sunni rebels. But he is the most prominent figure to say in public that Assad will not win.

Sharaa said the situation in Syria was deteriorating and a “historic settlement” was needed to end the conflict, involving regional powers and the U.N. Security Council and the formation of a national unity government “with broad powers”.

“With every passing day the political and military solutions are becoming more distant. We should be in a position defending the existence of Syria. We are not in a battle for an individual or a regime,” Sharaa was quoted as telling Al-Akhbar newspaper.

“The opposition cannot decisively settle the battle and what the security forces and army units are doing will not achieve a decisive settlement,” he said, adding that insurgents fighting to topple Syria’s leadership could plunge it into “anarchy and an unending spiral of violence”.

Sources close to the Syrian government say Sharaa had pushed for dialogue with the opposition and objected to the military response to an uprising that began peacefully.

In a veiled criticism of the crackdown, he said there was a difference between the state’s duty to provide security to its citizens, and “pursuing a security solution to the crisis”.

He said even Assad could not be certain where events in Syria were leading, but that anyone who met him would hear that “this is a long struggle…and he does not hide his desire to settle matters militarily to reach a final solution.”

In Hama province, rebels and the army clashed in a new campaign launched on Sunday by rebels to block off the country’s north, activists said.

The Syrian Observatory for Human Rights, an opposition-linked violence monitor, said fighting raged through the provincial towns of Karnaz, Kafar Weeta, Halfayeh and Mahardeh.

It said there were no clashes reported in Hama city, which lies on the main north-south highway connecting the capital with Aleppo, Syria’s second city.

Qassem Saadeddine, a member of the newly established rebel military command, said on Sunday fighters had been ordered to surround and attack army positions across the province. He said Assad’s forces were given 48 hours to surrender or be killed.

In 1982 Hafez al-Assad, father of the current ruler, crushed an uprising in Hama city, killing up to 30,000 civilians.

Qatiba al-Naasan, a rebel from Hama, said the offensive would bring retaliatory air strikes from the government but that the situation is “already getting miserable”.

(Additional reporting by Oliver Holmes, Erika Solomon and Dominic Evans in Beirut, Afif Diab at Masnaa, Lebanon; editing by Philippa Fletcher)

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Clearwire accepts slightly sweeter bid from Sprint

(Reuters) – Clearwire Corp agreed to sell roughly half of the company for $ 2.2 billion to majority shareholder Sprint Nextel Corp, which would then have full ownership of spectrum that will help it offer high-speed wireless services.

The $ 2.97-per-share deal is only 7 cents per share higher than a bid many minority shareholders said was too low days before. Clearwire shares tumbled 12.2 percent to $ 2.96 in morning trading on Monday.

Sprint already owns slightly more than half of Clearwire. The company said owners of 13 percent of Clearwire shares – Comcast Corp, Intel Corp and Bright House Networks LLC – had agreed to vote for the deal.

But it was not immediately clear whether Sprint, the No. 3 U.S. wireless carrier, could win the backing of a majority of Clearwire’s minority shareholders, which it needs to take control.

“This is not going to be popular with the minority shareholders,” said Davidson & Co analyst Donna Jaegers.

But Clearwire’s top executive told analysts on a Monday call that the company had little alternative.

“Despite our efforts we have been unable to secure new partnerships,” said Clearwire Chief Executive Officer Erik Prusch. “Our existing governance agreements prevented us from offering third parties the governance rights they desired in a partnership.”

Shareholders with more than 13 percent of Clearwire shares said last week that they were not happy with the $ 2.90-per-share offer, and some have said Sprint should offer as much as $ 5 per share.

Crest Financial, which owns more than 3 percent of Clearwire, recently filed a lawsuit to stop the company from selling itself to Sprint.

After the deal was announced on Monday, Crest said it had amended the lawsuit to make it a class action.

Another shareholder, Mount Kellett, said last week that the $ 2.90-a-share deal “grossly” undervalued Clearwire.

Clearwire, which also counts Sprint as its biggest customer, has been seeking financing for a high-speed wireless network upgrade and to keep itself afloat.

While some analysts and shareholders said Clearwire did not need to rush into a sale to Sprint, others have said that move would be its best hope for survival.

Sprint, whose shares rose 1 percent to $ 5.61 on Monday, needs Clearwire’s substantial spectrum to better arm itself against larger rivals Verizon Wireless and AT&T Inc.

Reuters reported last week that Japan’s Softbank Corp, which recently struck a deal to buy 70 percent of Sprint, would not consent to a bid of more than $ 2.97 per share.

Softbank said on Monday that it supported the deal.

(Reporting by Sinead Carew in New York and Sayantani Ghosh in Bangalore; Editing by Rodney Joyce, Sriraj Kalluvila and Lisa Von Ahn)

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Jason Mraz tops Myanmar anti-trafficking concert

YANGON, Myanmar (AP) — American singer-songwriter Jason Mraz mixed entertainment with education to become the first world-class entertainer in decades to perform in Myanmar, with a concert to raise awareness of human trafficking.

Mraz’s 2008 hit “I’m Yours” was the finale for Sunday night’s concert before a crowd of about 50,000 people at the base of the famous hilltop Shwedagon Pagoda in Yangon, the country’s biggest city.

Local artists, including a hip-hop singer, also played at the event organized by the anti-trafficking media group MTV EXIT — for “End Exploitation and Trafficking” —in cooperation with U.S. and Australian government aid agencies and the anti-slavery organization Walk Free.

Myanmar is emerging from decades of isolation under a reformist elected government that took office last year after almost five decades of military rule. It has been one of the region’s poorest countries, and its bad human rights record made it the target of political and economic sanctions by Western nations.

But democratic reforms initiated by President Thein Sein have led to the lifting of most sanctions, and the country is hopeful of a political and economic revival. Nobel Peace Prize laureate Aung San Suu Kyi, the pro-democracy opposition leader, was released from house arrest in late 2010 and won a seat in parliament last April.

Mraz called his top-billed appearance at the concert a “tremendous honor.”

“I think the country is, at this time, downloading lots of new information from all around the world,” he said. “I’ve always wanted my music to be here, (for) hope and celebration, peace, love and happiness. And so I’m delighted that my music can be a part of this big download that Myanmar is experiencing right now.”

Organizers said Mraz was the first international artist to perform at an open-air, mass public concert in Myanmar. Jazz artists Count Basie, Duke Ellington and Charlie Byrd visited the country under U.S. government sponsorship in the 1970s, when it was still called Burma, but played at much smaller venues.

Many in the crowd queued for two hours before being admitted to the concert site. Yangon native Sann Oo, 31, wearing a white T-shirt with a sketch of Mraz, said he was pleased that Mraz had come and that there would be a broadcast of the event.

“His visit can promote the image of Myanmar, because people outside have been seeing the country as an insecure place, and poor,” he said. “Now they can see how we look like from the concert. It also opens the potential for more concerts by foreign artists.”

Mraz has a history of involvement with human rights and other social causes.

But there was some criticism of his visit by campaigners for Myanmar‘s Muslim Rohingya community, which has been the target of ethnic-based violence this year that has forced tens of thousands of people from their homes into makeshift refugee camps. They feel Myanmar’s government has been complicit in the discrimination, and that Mraz’s visit provides it cover with the image of being a defender of human rights.

Mraz said he was aware of the issue, but that if he didn’t come to do the concert because someone else had asked him to protest another problem, then that would not help tackle the exploitation and human trafficking issue.

“I understand that there is a lot of wrongdoing in this world,” he said. “Today I’m here for this.”

Walk Free used the occasion of Sunday’s concert to launch a campaign calling on the world’s major corporations “to work together to end modern slavery by identifying, eradicating and preventing forced labor in their operations and supply chains.” They are seeking to have the companies make a “zero tolerance for slavery pledge” by the end of March next year.

“While many think of slavery as a relic of history, experts estimate that there are currently 20.9 million people living under threat of violence, abuse and harsh penalties,” the Australia-based group said in a statement. “Within this massive number, the majority of people – more than 14.2 million – are in a forced labor situation, used to source raw materials, and create products in sectors such as agriculture, construction, manufacturing and domestic work.”

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In The Flesh: The Embedded Dangers of Untested Stem Cell Cosmetics

When cosmetic surgeon Allan Wu first heard the woman’s complaint, he wondered if she was imagining things or making it up. A resident of Los Angeles in her late sixties, she explained that she could not open her right eye without considerable pain and that every time she forced it open, she heard a strange click—a sharp sound, like a tiny castanet snapping shut. After examining her in person at The Morrow Institute in Rancho Mirage, Calif., Wu could see that something was wrong: Her eyelid drooped stubbornly, and the area around her eye was somewhat swollen. Six and a half hours of surgery later, he and his colleagues had dug out small chunks of bone from the woman’s eyelid and tissue surrounding her eye, which was scratched but largely intact. The clicks she heard were the bone fragments grinding against one another.

About three months earlier the woman had opted for a relatively new kind of cosmetic procedure at a different clinic in Beverly Hills—a face-lift that made use of her own adult stem cells. First, cosmetic surgeons had removed some the woman’s abdominal fat with liposuction and isolated the adult stem cells within—a family of cells that can make many copies of themselves in an immature state and can develop into several different kinds of mature tissue. In this case the doctors extracted mesenchymal stem cells—which can turn into bone, cartilage or fat, among other tissues—and injected those cells back into her face, especially around her eyes. The procedure cost her more than $ 20,000, Wu recollects. Such face-lifts supposedly rejuvenate the skin because stem cells turn into brand-new tissue and release chemicals that help heal aging cells and stimulate nearby cells to proliferate.

During the face-lift her clinicians had also injected some dermal filler, which plastic surgeons have safely used for more than 20 years to reduce the appearance of wrinkles. The principal component of such fillers is calcium hydroxylapatite, a mineral with which cell biologists encourage mesenchymal stem cells to turn into bone—a fact that escaped the woman’s clinicians. Wu thinks this unanticipated interaction explains her predicament. He successfully removed the pieces of bone from her eyelid in 2009 and says she is doing well today, but some living stem cells may linger in her face. These cells could turn into bone or other out-of-place tissues once again.

Dozens, perhaps hundreds, of clinics across the country offer a variety of similar, untested stem cell treatments for both cosmetic and medical purposes. Costing between $ 3,000 and $ 30,000, the treatments promise to alleviate everything from wrinkles to joint pain to autism. The U.S. Food and Drug Administration (FDA) has not approved any of these treatments and, with a limited budget, is struggling to keep track of all the unapproved therapies on the market. At the same time, pills, oils, creams and moisturizers that allegedly contain the right combination of ingredients to mobilize the body’s resident stem cells, or contain chemicals extracted from the stem cells in plants and animals, are popping up in pharmacies and online. There’s Stem Cell 100, for example, MEGA STEM and Apple Stem Cell Cloud Cream. Few of these cosmetics have been properly tested in published experiments, yet the companies that manufacture them say they may heal damaged organs, slow or reverse natural aging, restore youthful energy and revitalize the skin. Whether such cosmetics may also produce unintended and potentially harmful effects remains largely unexamined. The increasing number of untested and unauthorized stem cell treatments threaten both people who buy them and researchers hoping to conduct clinical trials for promising stem cell medicine.

When is a skin cream a drug?
So far, the FDA has only approved one stem cell treatment: a transplant of bone marrow stem cells for people with the blood cancer leukemia. Among the increasing number of unapproved stem cell treatments, some clearly violate the FDA’s regulations whereas others may technically be legal without its approval. In July 2012, for example, the U.S. District Court upheld an injunction brought by the FDA against Colorado-based Regenerative Sciences to regulate just one of the company’s several stem cell treatments for various joint injuries as an “unapproved biological drug product.” The decision hinged on what constitutes “minimal manipulation” of cells in the lab before they are injected into patients. In the treatment that the FDA won the right to regulate, stem cells are grown and modified in the lab for several weeks before they are returned to patients; in Regenerative Science’s other treatments, patients’ stem cells are extracted and injected within a day or two. Regenerative Sciences now offers the legally problematic treatment at a Cayman Island facility.

Many stem cell cosmetics reside in a legal gray area. Unlike drugs and “biologics” made from living cells and tissues, cosmetics do not require premarket approval from the FDA. But stem cell cosmetics often satisfy the FDA’s definitions for both cosmetics and drugs. In September 2012 the FDA posted a letter on its Web site warning Lancôme, a division of L’Oréal, that the way it describes its Genifique skin care products qualify the creams and serums as unapproved drugs: they are supposed to “boost the activity of genes,” for example, and “improve the condition of stem cells.” Other times the difference between needing or not needing FDA approval comes down to linguistic nuance—the difference between claiming that a product does something or appears to do something.

Personal Cell Sciences, in Eatontown, N.J., sells some of the more sophisticated stem cell–based cosmetics: an eye cream, moisturizer and serum infused with chemicals derived from a consumer’s own stem cells. According to its website and marketing materials, these products help “make skin more supple and radiant,” “reduce the appearance of fine lines and wrinkles around the eyes and lips,” “improve cellular renewal” and “stimulate cell turnover for renewed texture and tone.” In exchange for $ 3,000, Personal Cell Sciences will arrange for a participating physician to vacuum about 60 cubic centimeters (one quarter cup) of a customer’s fat from beneath his or her skin and ship it on ice to American CryoStem Corp. in Red Bank, N.J., where laboratory technicians isolate and grow the customer’s mesenchymal stem cells to around 30 million strong. Half these cells are frozen for storage; from the other half, technicians harvest hundreds of different kinds of exuded growth factors and cytokines—molecules that help heal damaged cells and encourage cells to divide, among other functions. These molecules are mixed with many other ingredients—including green tea extract, caffeine and vitamins—to create the company’s various “U Autologous” skin care products, which are then sold back to the consumer for between $ 400 and $ 800. When the customer wants a refill, technicians thaw some of the frozen cells, collect more cytokines and produce new bottles of cream.

In an unpublished safety trial sponsored by Personal Cell Sciences, Frederic Stern of the Stern Center for Aesthetic Surgery in Bellevue, Wash., and his colleagues monitored 19 patients for eight weeks as they used the U Autologous products on the left sides of their faces. A computer program meant to objectively analyze photos of the volunteers’ faces measured an average of 25.6 percent reduction in the volume of wrinkles on the treated side of the face. Analysis of tissue biopsies revealed increased levels of the protein elastin, which helps keep skin taut, and no signs of unusual or cancerous cell growth.

Only skin deep?
Supposedly, the primary active ingredients in the U Autologous skin care products are the hundreds of different kinds of cytokines they contain. Cytokines are a large and diverse family of proteins that cells release to communicate with and influence one another. Cytokines can stimulate cell division or halt it; they can suppress the immune system or provoke it; they can also change a cell’s shape, modulate its metabolism and force it to migrate from one location to another like a cowboy corralling cattle. Researchers have only named and characterized some of the many cytokines that stem cells secrete. Some of these molecules certainly help repair damaged cells and promote cell survival. Others seem to be involved in the development of tumors. In fact, some recent evidence suggests that the cytokines released by mesenchymal stem cells can trigger tumors by accelerating the growth of dormant cancer cells. Personal Cell Sciences does not pick and choose among the cytokines exuded by its customers’ stem cells—instead, it dumps them all into its skin care products.

Based on the available evidence so far, topical creams containing cytokines from stem cells pose far less risk of cancer than living stem cells injected beneath the skin. But scientists do not yet know enough about stem cell cytokines to reliably predict everything they will do when rubbed into the skin; they could interact with healthy skin cells in a completely unexpected way, just as the unintended interplay between calcium hydroxylapatite and stem cells produced bones in the Los Angeles woman’s eye. Stern acknowledges that unusual tissue growth is a concern for any treatment based on stem cells and the chemicals they release. “Down the line, we want to continue watching that,” he says. Unlike many other clinics, he and his colleagues have been keeping tabs on their patients through regular follow-ups. John Arnone, CEO of American CryoStem and founder of Personal Cell Sciences, says the fact that U Autologous skin care products contain such a diversity of cytokines does not bother him: “I’ve seen worse things out there. I’ve been putting this formulation for almost a year on myself prior to the study. I’m the best guinea pig here.”

Beyond the considerable risks to consumers, unapproved stem cell treatments also threaten the progress of basic research and clinical trials needed to establish safe stem cell therapies for serious illnesses. By harvesting stem cells, subsequently nourishing them in the lab and transplanting them back inside the human body, scientists hope to improve treatment for a variety of medical conditions, including heart failure, neurodegenerative disorders like Parkinson’s, and spinal cord injuries—essentially any condition in which the body needs new cells and tissues. Researchers are investigating many stem cell therapies in ongoing, carefully controlled clinical trials. Some of the principal questions entail which of the many kinds of stem cells to use; how to safely deliver stem cells to patients without stimulating tumors or the growth of unwanted tissues; and how to prevent the immune system from attacking stem cells provided by a donor. Securing funding for such research becomes all the more difficult if shortcuts taken by private clinics and cosmetic manufacturers—and the subsequent botched procedures and unanticipated consequences—imprint a stigma on stem cells.

“Many of us are super excited about stem cells, but at same time we have to be really careful,” says Paul Knoepfler, a cell biologist at the University of California, Davis, who regularly blogs about the regulation of stem cell treatments. “These aren’t your typical drugs. You can stop taking a pill and the chemicals go away. But if you get stem cells, most likely you will have some of those cells or their effects for the rest of your life. And we simply don’t know everything they are going to do.”Follow Scientific American on Twitter @SciAm and @SciamBlogs.Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

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Japan’s Nikkei outperforms as opposition wins big

LONDON (AP) — Japanese shares outperformed all others Monday amid hopes that the new government will enact fresh stimulus measures to boost the world’s third-largest economy.

Signs that U.S. politicians are inching toward a budget deal helped Wall Street open stronger than earlier predicted and shored up European markets after a bad morning.

The standout index was Japan‘s Nikkei 225, which closed up 0.9 percent at 9,828.88, its highest level since April, after the country’s Liberal Democratic Party swept back into power at weekend elections with a landslide victory.

Party chief Shinzo Abe, who is in line to become prime minister, favors increased spending on public works and setting a 3 percent economic growth target. He’s also expected to lobby for stronger action by the central bank to get Japan out of its deflationary trap.

“Japanese equities rallied today on the back of a resounding victory by Shinzo Abe‘s LDP, giving them a mandate to boost economic growth through more aggressive fiscal and monetary easing,” said Rebecca O’Keeffe, head of investment at Interactive Investor.

Expectations of further stimulus in Japan, despite the country’s sky-high debt levels and doubts over the effectiveness of looser economic policy, further weighed on the yen. The dollar was 0.4 percent higher at $ 83.73 yen.

The yen’s recent weakness is a potential boon to the country’s powerhouse exporters. Automaker Nissan Motor Co. rose 1.8 percent, Sony Corp. climbed 1.4 percent and Panasonic Corp jumped 2.3 percent.

Elsewhere, markets remained largely beholden to developments over the U.S. budget. The concern is whether the White House and Congress will agree a budget deal in time to avoid the “fiscal cliff” of automatic tax increases and spending cuts at the start of next year.

In Europe, the FTSE 100 index of leading British shares was down 0.4 percent at 5,896 while Germany’s DAX fell 0.1 percent to 7,590. The CAC-40 in France was 0.3 percent lower at 3,631.

In the U.S., the Dow Jones industrial average was up 0.5 percent at 13,194 while the broader S&P 500 index rose the same rate to 1,421.

Though the budget measures associated with the “fiscal cliff” would not all be introduced at once and the Republicans have indicated a willingness to increase taxes on households earning over $ 1 million, investors won’t breathe easily until a deal is signed, sealed and delivered.

“Investors have so far remained hopeful that an agreement can be reached in a sufficiently timely manner,” said Nick Bennenbroek, an analyst at Wells Fargo Bank. “However, with a year-end deadline for a deal now looming closer, those budget developments should become increasingly important through the end of December.”

In recent weeks, the dollar had suffered, at least against the euro, due to the U.S. budget fears. On Monday, the currencies were steady, with the euro up 0.1 percent at $ 1.3165.

Oil markets were subdued too, with the price of benchmark New York crude up 27 cents at $ 87 a barrel.

Elsewhere in Asia, China’s shares fared fairly well as its new leaders promised more spending if needed to underpin a wobbly economic recovery. Those hopes helped the Shanghai Composite to rise 0.4 percent to 2,160.34 and the smaller Shenzhen Composite index to end 0.4 percent higher to 819.58.

On Sunday, China’s new Communist Party leaders under party General Secretary Xi Jinping pledged a “proactive fiscal policy” and “prudent monetary policy” in a statement carried by the official Xinhua News Agency. They were references to the willingness to boost spending if needed and keep credit easy so long as inflation stays low.

Elsewhere in Asia, South Korea’s Kospi lost 0.6 percent to 1,983.07 and Hong Kong’s Hang Seng was down 0.4 percent at 22,513.61.

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Iran media: Son of ex-president released on bail

TEHRAN, Iran (AP) — Iranian media say the son of influential former President Akbar Hashemi Rafsanjani has been released on bail.

Several papers, including the pro-reform Etemad daily, say Mahdi Hashemi was released late Sunday and immediately went to his father’s home.

Authorities arrested the younger Hashemi in late September, a day after he returned to Iran from Britain.

He is held on charges of fomenting unrest in the aftermath of Iran’s disputed 2009 presidential election that brought President Mahmoud Ahmadinejad a second term in office. Hashemi also faced corruption charges.

His arrest came days after his sister, Faezeh, was taken into custody to serve a six-month sentence on charges of making propaganda against Iran’s ruling system.

Since Rafsanjani backed Ahmadinejad’s reformist challenger in 2009, his family has come under pressure from hardliners.

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