Myanmar says Obama to visit later this month

YANGON, Myanmar (AP) — President Barack Obama will make a groundbreaking visit later this month to Myanmar, an official said Thursday, following through with his policy of rapprochement to encourage democracy in the Southeast Asian nation.

The Myanmar official speaking from the capital, Naypyitaw, said Thursday that security for a visit on Nov. 18 or 19 had been prepared, but the schedule was not final. He asked not to be named because he was not authorized to give information to the media.

The official said Obama would meet with opposition leader Aung San Suu Kyi as well as government officials including reformist President Thein Sein.

It would be the first-ever visit to Myanmar by an American president. U.S. officials have not yet announced any plans for a visit, which would come less than two weeks after Obama’s election to a second term.

Obama’s administration has sought to encourage the recent democratic progress under Thein Sein by easing sanctions applied against Myanmar’s previous military regime.

Officials in nearby Thailand and Cambodia have already informally announced plans for visits by Obama that same week. Cambodia is hosting a summit meeting of the Association of Southeast Asian Nations, and Thailand is a longtime close U.S. ally.

The visit to Myanmar, also known as Burma, would be the culmination of a dramatic turnaround in relations with Washington as the country has shifted from five decades of ruinous military rule and shaken off the pariah status it had earned through its bloody suppression of democracy.

Obama’s ending of the long-standing U.S. isolation of Myanmar’s generals has played a part in coaxing them into political reforms that have unfolded with surprising speed in the past year. The U.S. has appointed a full ambassador and suspended sanctions to reward Myanmar for political prisoner releases and the election of Nobel laureate Suu Kyi to parliament.

From Myanmar’s point of view, the lifting of sanctions is essential for boosting a lagging economy that was hurt not only by sanctions that curbed exports and foreign investment, but also by what had been a protectionist, centralized approach. Thein Sein’s government has initiated major economic reforms in addition to political ones.

A procession of senior diplomats and world leaders have traveled to Myanmar, stopping both in the remote, opulent capital city, which was built by the former ruling junta, and at Suu Kyi’s dilapidated lakeside villa in the main city of Yangon, where she spent 15 years under house arrest. New Zealand announced Thursday that Prime Minister John Key would visit Myanmar after attending the regional meetings in Cambodia.

The most senior U.S. official to visit was Hillary Rodham Clinton, who last December became the first U.S. secretary of state to travel to Myanmar in 56 years.

The Obama administration regards the political changes in Myanmar as a marquee achievement in its foreign policy, and one that could dilute the influence of China in a country that has a strategic location between South and Southeast Asia, regions of growing economic importance.

But exiled Myanmar activists and human rights groups are likely to criticize an Obama visit as premature, rewarding Thein Sein before his political and economic reforms have truly taken root. The military — still dominant and implicated in rights abuses — has failed to prevent vicious outbreaks of communal violence in the west of the country that have left scores dead.

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China’s leadership challenge in new era: douse “inequality volcano”

YANGCHANG, China (Reuters) – In the mountain village of Yangchang in the backwater province of Guizhou in southwestern China, the roof of the Yang family home is cracked and about to cave in, held upright only by a few rickety tree trunks.

Nearly penniless after quitting their jobs in a coastal city, Yang Hechun and her husband recently returned to the village to care for a sickly 71-year-old grandmother and two young children.

“We can hardly afford to eat, never mind mend our house,” said Yang, over a meal of rice, chilli bean sprouts, peanuts and tofu. “We earn one yuan, then we spend one yuan.”

As China prepares for its once in a decade leadership transition at the 18th Communist Party Congress, which begins on Thursday in Beijing, the outside world sees an inexorably rising economic power: Beijing is now the world’s largest exporter, the second-biggest economy overall, and it controls over $ 3.2 trillion in foreign exchange reserves.

Yet the disconnect between those numbers and the lives of families like the Yangs lies at the core of the most vexing issues the country’s incoming leadership will confront: sustaining economic growth, rooting out corruption, narrowing the wealth gap, and preserving the party’s legitimacy in the face of mounting public grievances over decades of iron-fisted rule.

President Hu Jintao, in a speech at the opening of the party congress on Thursday, is expected to tout the country’s economic advances over the past decade, while acknowledging that China still faces many difficulties.

Reforms, most economists agree, will be vital to avoid stagnation and bigger socio-economic disruptions. What’s unclear is just how aggressively the incoming leadership will push new policies.

Though Yang Hechun acknowledges her family’s life has improved over the past decade, their continuing daily struggles resonate in villages, cities, campuses and factory floors throughout China.

$ 1.25 A DAY

At a roundabout in Bijie, the region of Guizhou where the Yangs live, a towering billboard bedecked with flowers and adorned with an image of Hu Jintao proclaims: “Explore, develop and pioneer … work hard to lift, reform and construct Bijie to a higher level.”

The Yangs’ village was designated an experimental zone for poverty alleviation policies and economic development in 1988, during president Hu Jintao’s stint as party chief of Guizhou.

Development over the past few years has brought a two-lane highway and bridges to the once remote region, along with electricity.

But the Yangs still have no running water, and food, education and medical expenses swiftly erode their meager earnings from harvesting chilli peppers and corn on a tiny farm.

Thirteen percent of China’s 1.3 billion people still live on less than $ 1.25 per day according to the United Nations Development Program and Guizhou has the poorest per capita income of any of the country’s provinces.

Beijing set aside 415 billion yuan ($ 66.5 billion) over the past five years to fund minimum livelihood allowances for China’s most needy, while welfare coverage — including basic health insurance — has broadened to include almost 95 percent of households, as have primary school fee waivers in more areas.

Yet, goodwill earned from those measures has been corroded by deeply held suspicions of corruption. Nationwide, over half a million grassroots officials were punished for graft and other so called “discipline violations” over the last five years.

The Yangs believe the failure to pave broken roads and build water pipes in their village is because of local corruption. Public works projects have been talked about for years but never built, even with state funding and contributions from residents.

WOLF FANGS

Across China, the perception of widespread corruption is intensifying grassroots demands for official accountability —demands that the party all too often ignores.

Shen Zhiyun is a crippled former farmer who lives in the nearby village of Guole. He and other villagers were told by village officials recently that hundreds of hectares of farmland would be flooded to form a reservoir serving a new industrial estate in a nearby town.

Despite the threat to local livelihoods, district cadres never consulted the villagers, and will soon build a dam.

“We oppose it, but we also can’t oppose it. That’s how things are in China,” said Shen. “They eat the people and don’t even spit out the bones … those officials with wolf’s fangs.”

The sense of powerlessness Shen expresses is widespread, and poses, in the minds of some analysts, a broad threat to the party’s cherished stability.

As vast as the income disparity is between the rich and poor — Beijing hasn’t published official inequality statistics for over a decade, but the United Nations estimates the gap has grown steadily wider over the last decade — the maltreatment of ordinary Chinese citizens by officials may be the more dangerous flashpoint.

“The main challenge is not income inequality, it’s power inequality, and it’s much less easy to deal with,” said Martin Whyte, a Harvard University sociologist and author of a book on China and its disparities.

“Keeping this power inequality volcano dormant may be much more difficult than keeping the income inequality volcano under control, since to do so would require not simply new programs and financial resources, but fundamental political reforms.”

RISING EXPECTATIONS

Even in the more prosperous parts of China, the pressures on the government from the bottom up are no less relentless. Two years ago, in the factory town of Xiaolan in the Pearl River Delta — China’s factory for the world — workers at a Honda Lock auto parts manufacturer went on strike, weary of their low-paid, grinding work.

Word of their action — a rare, early instance of a strike that crippled production at a multinational corporation in China — spread rapidly on social media. It inspired other factory workers across the country and forced many firms and local authorities to respond by raising minimum wages and benefits.

At Honda Lock, pay has increased 30 per cent since 2010, including increases in housing and transport subsidies.

Lin Wenwu is one of the workers who benefited from the strike. He makes about $ 560 a month now. A new desktop computer sits in the small one-room flat he and his wife rent, and he zips around Xiaolan on a newly purchased black motorcycle.

Still, Lin’s not satisfied. He is one of China’s army of migrant workers — 150 million strong — who largely remain second class citizens, denied welfare benefits that accrue to local city dwellers through a household registration (or “hukou”) system, an outdated policy from the Mao era originally intended to control rural-urban drift.

The system means Lin’s two children can’t get free schooling in Xiaolan, so he leaves them behind in his home province of Guangxi, where they’re cared for by relatives. He sees them roughly three times a year for several weeks.

“I miss them,” he said. “We hope that after the (party congress) the leaders will do more to improve the livelihoods of people like us.”

LOSING FAITH

Back in Guizhou, huddled around a stove, the Yangs have little faith in their political leaders. The family is wondering how to raise the 40,000 yuan needed to rebuild the roof, now propped up by bricks and sawed-off tree-trunks.

So far, local village officials have rebuffed requests for a construction subsidy of 5,000 yuan normally eligible to most villagers, unless the family first coughs up 1,000 yuan to facilitate the application.

“Several neighbors paid up last year, but they’ve haven’t gotten any money back at all,” said Yang.

“Sometimes I feel the poorest people get nothing, and the richest get everything. We can only rely on ourselves.”

(Additional reporting by David Stanway in Beijing; Editing by Raju Gopalakrishnan)

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A Minute With: Taylor Lautner finding new dawn after “Twilight”

LOS ANGELES (Reuters) – As dusk sets on the “Twilight” saga with the final film, actor Taylor Lautner is looking at a new dawn for the next stage in his career.

Lautner, 20, shot to fame after being cast as werewolf Jacob Black in the “Twilight” films, entangled in a torrid love triangle with Kristen Stewart‘s Bella Swan and Robert Pattinson‘s vampire Edward Cullen. He became a household name and pin-up for his clean-cut good looks and shirtless scenes.

In “Breaking Dawn – Part 2,” out in U.S. theaters on November 16, Lautner’s character finds new love, albeit unusual, and indulges his comedic side as the story comes to an end.

Lautner spoke to Reuters about leaving Jacob and his cast mates behind, and why the final film may leave fans in tears.

Q: What’s different about Jacob in “Breaking Dawn – Part 2″?

A: “He’s always been so stressed and emotional and things aren’t going his way and there was a huge weight lifted off his shoulders in this one, huge. It was nice to play that side of Jacob where he could sit back and relax and have a smile on his face and crack a few funny jokes every now and then.”

Q: Jacob finds his soul mate in Bella and Edward’s daughter Renesmee from the moment she is born. Was it challenging to balance his affection for her without coming across creepy?

A: “It was a challenge, and it is so complicated, but really nobody understands it more than Stephenie Meyer who created it. I was picking her brain all day long about it. She basically told me over and over again, ‘Taylor, stop trying to overthink it, stop trying to take it different places … It’s a life-long bond between two people, that’s it.’ In the movie, (Renesmee) is 10 years old, it’s much more of a protector relationship right now, and of course the relationship will grow but we don’t explore that, but it was important for me to keep it simple.”

Q: What are you going to miss most about your character and the franchise?

A: “These characters have never stopped changing throughout the entire franchise, and that’s what I love about Jacob. Jacob himself has grown up so much and gone through so many hurdles and it was a fantastic character to play. For me, it’ll be tough to say goodbye to spending time with people that I love. We’ve grown so close over the past few years. Our relationships will go on past this but to not have that excuse to spend day after day together while filming or promoting will be different.”

Q: “Twilight” fans are not just interested in your characters, they’re also interested in your personal lives. The past summer has seen a lot of attention on Robert and Kristen’s relationship. How do you handle that level of scrutiny?

A: “It’s unlike anything else because when we do talk about the movies, 90 percent of the time people want to know more about ourselves than the characters and what’s going on. I guess that just comes with a fan base like this, it comes with the job and you try and not let it affect you too much, but I have no complaints … The scrutiny, is it unfortunate? Yeah, but you just got to make your way around it and think about things more.”

Q: Do you feel protective of your cast members?

A: “Yes, I definitely do, we’re so close by this point, I think that it’s hard not to.”

Q: What do you hope “Twilight” fans take away from “Breaking Dawn – Part 2″?

A: “I just hope they’re happy and they’re proud because we really do make these movies for them. They’re the reason we are able to make them, their support is unreal and we’re so proud of this last one. This last one specifically wraps it up so nicely, it’s an amazing movie. During the movie, it’ll keep you on the edge of your seat but by the end, I think more than a few of the fans will be in tears.”

Q: Post-Twilight, where do you want to take your career to, what roles would you like to explore? I hear you have a cameo in the comedy “Grown Ups 2″?

A: “It was great to do (comedy), just hop in and show a different side, do something fun and work with somebody like Adam (Sandler). But now I’m looking forward to doing something different from that. There are a few projects that I’m very excited about that are extremely challenging and dramatic and would be tough.”

(Reporting By Piya Sinha-Roy, editing by Jill Serjeant and Patricia Reaney)

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Pediatric clinical trials not going overseas – study

NEW YORK (Reuters Health) – Despite some concerns that medical studies involving children could make an ethically dubious shift to developing nations, a new study suggests that’s not happening.

It’s really only in the last decade that clinical trials – even in the U.S. and Europe – have started to focus on children, said Dr. Dianne Murphy, director of the U.S. Food and Drug Administration (FDA) Office of Pediatric Therapeutics.

Since children cannot give informed consent to enter a study (their parents have to do it), kids have historically been left out of clinical trials testing vaccines, drugs and other therapies.

But that’s a problem, Murphy explained, because children are not small adults, and study results from adults cannot simply be extended to them.

“We don’t know if we’re giving them the right dose, or if it’s even going to be effective,” Murphy explained.

So pediatric clinical trials are necessary. But since most children are, fortunately, healthy, researchers have to cast a wider net for study participants.

“You do have to reach out to more countries and more locations,” Murphy said.

And that has led some to question whether there could be an inappropriate shift to countries where ethical guidelines – like making sure parents give truly informed consent – might not be closely monitored.

In the new study, however, Murphy and her colleagues found that the number of pediatric clinical trials in developing countries has actually declined in recent years. And the U.S. remains, by far, the most common trial location.

Of 346 pediatric trials the FDA reviewed, the U.S. participated in 86 percent, providing three-quarters of the patients. Less developed and transitional countries, like Mexico, Brazil and India, took part in 22 percent and accounted for 10 percent of all kids involved.

The figures come from trials submitted to the FDA in support of therapies approved between 2007 and 2010.

Developing nations, the agency found, played a smaller role in those trials than they had just a few years earlier.

In an earlier study of trials submitted between 2002 and 2007, the FDA found that developing countries took part in 38 percent of trials, and accounted for almost one-quarter of patients.

Those numbers will naturally shift depending on the diseases and treatments being studied in a given time period, Murphy noted.

If there are more trials testing vaccines or treatments for infectious disease, developing nations will tend to be more involved. And that’s appropriate, Murphy said, because those diseases are a far bigger problem in developing countries.

“Children shouldn’t be in a trial unless there’s an opportunity for them to benefit,” Murphy said.

The researchers didn’t find evidence that kids in developing countries were being recruited into trials for diseases that are irrelevant to them. Of children enrolled in Mexico, for example, 97 percent were involved in vaccine trials.

In addition, most trials being done in developing countries (75 percent) were also running in wealthy ones.

Murphy said the FDA is taking steps to ensure that pediatric trials are being done appropriately. “For one,” she noted, “everyone should be aware that we’re reviewing this. That alone is important.”

But she said the agency also offers training to regulators in other countries, and has regular conference calls with officials in developing nations to help them with “in-the-weeds kinds of questions.”

“These conversations, particularly for (trials with) children, are very important,” Murphy said.

Continuing to do trials involving kids is also vital, according to Murphy.

“If we don’t, then your child becomes an experiment of one,” she said, noting that research suggests that products that work for adults’ ills do not work for children about one-fifth of the time.

SOURCE: http://bit.ly/UwOXbC Pediatrics, online November 5, 2012.

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Wall Street left to rebuild Obama ties after backing Romney

(Reuters) – Wall Street firms gambled on Mitt Romney and lost.

Now, faced with the prospect of even tougher regulations in President Barack Obama‘s second term, their stocks paid the price. Shares of Goldman Sachs Group, JPMorgan Chase & Co and Citigroup dropped 5 percent, Bank of America lost 6 percent and Morgan Stanley fell 7 percent in midday trading on Wednesday.

“This is the triumph of the regulators,” said Terry Haines, senior analyst at Potomac Research Group in Washington and a former staff director of the U.S. House of Representative’s Financial Services Committee.

Obama’s win is bad news for financial firms, particularly big bank holding companies, which face regulations still being written to implement the 2010 Dodd-Frank reform law, Haines said. “The Administration’s regulatory approach has triumphed and is going to continue for some years,” said Haines.

After backing Romney nearly across the board, the financial services industry must quickly reverse course and seek to mend ties, Haines and other public policy experts said.

But there were mixed signs of accommodation in the wake of Obama’s re-election, with some bankers maintaining their critique of the Democratic President’s regulatory policies.

“He will continue to increase regulation, demonize and vilify businesses, and spend a lot of money, and tax people, and so forth,” said Dick Kovacevich, former CEO of Wells Fargo & Co and supporter of Republican challenger Romney.

On the other side, Scott Sperling, co-president of private equity firm Thomas H Lee Partners, reached out towards Obama, who he abandoned for Romney in 2012. “It is incumbent on us to work with the administration in a productive way to deal with these issues,” he said.

Wall Street firms are also worried about Elizabeth Warren, whose victory in the Massachusetts Senate race may galvanize her to push for more regulations on bank lending to protect consumers. Warren was instrumental in creating the Consumer Financial Protection Bureau, which critics say could weigh down the economy with new regulations.

“I think the Obama win, along with Elizabeth Warren, will lead to more accountability and tighter regulation on Wall Street,” said Chris Tobe, who advises pension plans as a principal at Stable Value Consultants and is a trustee of the Kentucky state pension fund. “Especially after a big shift to Romney from Wall Street, Obama I believe will be less likely to hold back on regulation this term.”

Republican former regulators sought to downplay Warren’s impact. “Wall Street has a decided enemy on its hands,” said Harvey Pitt, who ran the Securities and Exchange Commission under President George W. Bush. Still, Warren’s election by itself “isn’t going to have a very dramatic impact on anything,” he said. “She’s just one of 100 senators.”

People working in the U.S. securities and investment industry gave $ 20 million to Romney’s campaign, versus $ 6 million to Obama, according to the Center for Responsive Politics. Four years ago, Obama received $ 16 million and Republican nominee John McCain only attracted $ 9 million.

Obama’s administration has still not finished writing many of the most important rules called for in the Dodd Frank law, passed after the U.S. financial system nearly collapsed in 2008, forcing taxpayers to pour hundreds of billions of dollars into banks’ coffers.

Many Americans believe the financial crisis was caused by banks’ terrible judgment in areas like mortgage lending and securitization. Public support is strong for laws designed to make the financial system safer, even if bank profits suffer.

A 2010 Gallup poll showed that Dodd-Frank was Obama’s most popular law, exceeding healthcare reform, for example. Few Washington lobbyists thought that Romney could fully repeal Dodd-Frank, because public support for the law is too high.

RELATIONS WITH REGULATORS

Banks must now focus on softening regulations to the extent they can. Among the financial industry’s top complaints are the Volcker rule, which prevents banks from making big bets in financial markets with their own money, and the Durbin Amendment, which limits the fees they can charge merchants for processing debit-card transactions.

Banks also want to scale back capital requirements, which cut into the returns banks can earn on their equity capital.

The industry had hoped to weaken the Consumer Financial Protection Bureau through steps like changing its structure to be headed by Democrat and Republican commissioners, but these steps are unlikely to gain much traction, analysts said.

“What I was told last night by Obama’s win is, there will be no change to the CFPB in 2013,” said Isaac Boltansky, a policy analyst at Compass Point Research & Trading in Washington.

SECOND-TERM APPOINTMENTS

Some banking industry lobbyists say their focus will be on the key regulators Obama is expected to name in his second term.

Major power players under Obama, including Treasury Secretary Timothy Geithner, are expected to step down, offering Wall Street a chance to reset relations.

Chairmen determine agendas at agencies such as the SEC and Commodity Futures Trading Commission (CFTC), so Obama’s choices to fill any open spots could affect how quickly new rules are implemented.

“If there was a different chair who had a different agenda, you could slow things down,” said Bart Chilton, a Democratic commissioner at the Commodity Futures Trading Commission.

One possible replacement for Geithner, who has said he will not stay for a second Obama term, is White House Chief of Staff Jack Lew, a former Citigroup banker.

“I hope Obama puts someone in who understands fiscal issues and who will have stature to work on the Hill to negotiate some type of package on fiscal reform,” said Sheila Bair, former Federal Deposit Insurance Corp chairman.

SEC Chairman Mary Schapiro’s term does not expire until June 2014, but speculation about her departure has been swirling for well over a year. Last month, she attempted to shoot down the rumors, saying she had not thought about her post-SEC plans.

SEC watchers speculate the job could go to SEC Commissioner Elisse Walter, a close friend of Schapiro’s and a former executive at the Financial Industry Regulatory Authority, an industry-funded watchdog.

CFTC Chairman Gary Gensler’s term technically expired in April. He is allowed to stay on as chairman until the end of 2013 and his renomination is an open question.

Gensler has been assailed by Republicans over his implementation of Dodd-Frank and criticized by lawmakers on both sides of the aisle following the collapse of futures brokerages MF Global and Peregrine Financial Group.

FISCAL CLIFF

Much of Wall Street‘s regulatory agenda, however, is set to take a backseat in the short term due to the looming fiscal cliff — a package of tax increases and federal spending cuts that will begin in January unless lawmakers act.

Bankers fear an impasse in solving the issue could spark an economic downturn that would hurt the industry.

In the longer term, banking lobbyists and other opponents of Dodd-Frank acknowledge that much is in the hands of rulemakers, and the best they can do is to try to beat back some rules with technicalities.

Paul Atkins, a Republican and former SEC commissioner, said he expects Dodd-Frank reform critics may have some success making narrow legal challenges and seeking to throttle reforms through congressional oversight.

“Dodd-Frank assigned a lot of powers to the regulatory agencies, so there is not much that Congress can do,” he said.

“I expect that the Republican House would keep the pressure on through hearings, like they are doing now. People will also certainly take the fight to the courts.” (Reporting By Emily Stephenson and Sarah N. Lynch in Washington, D.C., Rick Rothacker in Charlotte, Lauren LaCapra, Dan Wilchins, Olivia Oran and Katya Wachtel in New York, and Aaron Pressman and Ross Kerber in Boston; Writing by Aaron Pressman and Greg Roumeliotis; Editing by Paritosh Bansal, Tiffany Wu, Richard Pullin, Maureen Bavdek and Tim Dobbyn)

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Merkel says Germany, Britain must work together on EU

LONDON (Reuters) – Germany and Britain must cooperate to work round their differences on the European Union‘s long-term spending plans, German Chancellor Angela Merkel said on Wednesday.

“Despite differences that we have it is very important for me that the UK and Germany work together,” Merkel said through a translator before a meeting in London with Prime Minister David Cameron to discuss the EU‘s 2014-2020 budget.

“We always have to do something that will stand up to public opinion back home. Not all of the expenditure that has been earmarked has been used with great efficiency … We need to address that,” she said.

EU leaders meet in Brussels on November 22-23 to try to secure a seven-year budget for the 27-nation bloc amid signs of differences of opinion over what action should be taken.

(Reporting by Peter Griffiths; Editing by Andrew Osborn)

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Amazon’s offers monthly option on Prime, challenging Netflix

SAN FRANCISCO (Reuters) – Amazon.com Inc is testing a new monthly option for its popular Prime video-streaming service as the world’s largest Internet retailer steps up competition with Netflix Inc.

Prime typically costs $ 79 a year in the United States for free two-day shipping, free video streaming and access to Amazon‘s Kindle e-book lending library. The company is now offering the service for $ 7.99 a month on its website, which works out to $ 95.88 a year, but at that rate it can be purchased strictly on a month-to-month basis.

The monthly option is more comparable to Netflix’s streaming video subscription, which also costs $ 7.99 a month but does not come with free shipping and an e-book library. Another streaming rival, Hulu, also charges $ 7.99 a month.

An Amazon spokesman said the monthly Prime option was a test and declined to comment further.

Netflix and Hulu offer greater video selection than Amazon, though Amazon is spending hundreds of millions of dollars buying more content from Hollywood and TV studios.

“As Amazon continues to add movie and TV content to Prime, we see it likely adding more competitive pressure to the legacy online video services,” Colin Sebastian, an analyst at R.W. Baird, wrote in a note to investors on Tuesday.

Netflix shares fell 2.5 percent to $ 76.27 in afternoon trading on Tuesday. Amazon shares climbed 1.1 percent to $ 237.01.

Amazon’s new monthly Prime option coincides with the holiday shopping season, giving shoppers a way to use the two-day shipping service for gifts without the annual obligation, Sebastian noted.

“While one risk for Amazon is that consumers use Prime for just one month to take advantage of free shipping on large purchases, the test could also reveal that a ready market for alternative pricing and serve as a new customer acquisition tool,” the analyst wrote.

(Reporting By Alistair Barr; Editing by Leslie Adler)

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Sharon Osbourne has double mastectomy: magazine

LONDON (Reuters) – British celebrity Sharon Osbourne has had a double mastectomy after discovering she was carrying a gene that increased the risk of her developing breast cancer, she told Hello! magazine in an interview published on Monday.

Osbourne, 60, told the publication that the decision was a “no-brainer” in the end.

“As soon as I found out I had the breast cancer gene, I thought: ‘The odds are not in my favor’,” she said in remarks that also ran in the Daily Mirror tabloid.

“I’ve had cancer before and I didn’t want to live under that cloud: I decided to just take everything off, and had a double mastectomy.”

Osbourne, who put the eccentric life of her family on view in the reality TV series “The Osbournes”, said she did not want to spend the rest of her life with “that shadow hanging over me.

“I want to be around for a long time and be a grandmother to Pearl,” she added, referring to her son Jack’s first child.

“I didn’t even think of my breasts in a nostalgic way, I just wanted to be able to live my life without that fear all the time. It’s not ‘pity me’, it’s a decision I made that’s got rid of this weight that I was carrying around.”

Osbourne raised her profile by appearing as a judge on successful talent shows “The X Factor” and “America’s Got Talent”. She is married to heavy metal singer Ozzy Osbourne.

Her London publicist referred Reuters to the interview which ran in Hello! and the Daily Mirror when asked to confirm the news.

(Reporting by Mike Collett-White, editing by Paul Casciato)

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Heart devices often approved without comparisons

NEW YORK (Reuters Health) – Many new heart devices, such as valves and stents, are approved for use by the U.S. Food and Drug Administration (FDA) without good studies showing that they offer any benefits beyond existing treatments, according to a new study.

“This really leaves open the question of, ‘are you better off with this new device or whatever conventional therapy is already?’” said Dr. Rita Redberg, one of the authors of the study and a professor at the University of California, San Francisco.

Given that devices often require surgery, “from a patient point of view, you’re taking a lot more risk with a device, so the harms are potentially much greater,” added Redberg, whose team published the work in the Journal of the American Medical Association. “So it’s really very important to know that the device is an improvement over what you could have had.”

High-risk heart devices, which include implanted defibrillators, mechanical pumps and tubes called stents, go through an approval process called “premarket approval,” which includes a more stringent review of the evidence than for less risky devices.

However, the requirements for the approval of devices in general are less strict than for drugs.

The FDA requires two studies comparing the drug to a “control” – typically, the current standard of care or a fake pill called a placebo – before it will approve a drug.

For first-of-a-kind devices, FDA does require controlled trials, FDA spokeswoman Michelle Bolek told Reuters Health by email. However, the agency does not have such demands for devices that aren’t first-of-a-kind, and approval can be given without direct comparisons to controls, depending on the use of the device and the extent of experience doctors have had with it.

The FDA said there are good reasons why comparing new devices to other treatments or older generations of a product might not be feasible or ethical.

“And, requiring them could significantly and unnecessarily delay patient access to critical new technology,” Bolek added.

COMPARATIVE EFFECTIVENESS RESEARCH

Recent studies have found that sometimes patients are given newer and more expensive products without a clear indication that they’re better off for it (see Reuters report of February 28, 2012 and Reuters Health report of July 9, 2012).

The 2010 Patient Protection and Affordable Care Act, commonly called Obamacare, established the Patient-Centered Outcomes Research Institute, which funds research on comparing the effectiveness of different approaches to medical care.

To see how often heart devices are compared to existing therapies as part of the approval process, Redberg and her colleagues collected information from the FDA on all high-risk device approvals from 2000 to 2011.

They found that 40 percent of approved devices had been in studies comparing them to other treatments.

The comparison treatment could be an older generation of the same implant, a medication or a surgical procedure.

The rest of the approved devices relied on either the results from other studies in which controls were used, but the new device was not compared head-to-head with other treatments; from expectations of how well the device should work; or from research with no comparisons.

“We were surprised and disappointed,” said Redberg, who is also editor of the Archives of Internal Medicine and a member of the FDA’s Drug Administration Circulatory System Devices Panel. “We had already seen (in a previous study) there wasn’t as many randomized controlled trials as one would hope for devices, but we didn’t appreciate it until we looked at the data.”

SOMETIMES JUSTIFIABLE?

Some devices were less likely to have been compared to a conventional therapy than others.

Ventricular assist devices, for instance, used in severe cases of heart failure, were approved without any comparison to another therapy, but this could be justified, said Dr. David Brown, a professor at Stony Brook University in New York, who was not involved in the study.

“People are near death when they need the device, and it may not be ethical or practical to design a trial that compares it to something else,” he said.

“However, if you look at most of the devices in the other categories, they’re not anywhere near being performed in people who don’t have other options,” Brown told Reuters Health.

For instance, there are alternatives to new cardiac stents, pacemakers and defibrillators, such as drugs or other versions of the same devices, he pointed out.

Yet only about four out of 10 approvals for these types of devices included studies that compared them to existing treatments.

The FDA’s Bolek said the information Redberg’s group used to evaluate the studies conducted to get a device approved “does not reflect all of the data reviewed by the FDA in a (premarket approval) submission.”

Bolek said FDA weighs the quality of studies and their results, tests performed outside of the clinic and data monitoring committees.

Congress, Bolek said, has authorized the FDA to take the “least burdensome provision” to approve devices, to ensure that patients are not denied early access to new medical technology.

Dr. Ron Waksman, the associate director of the division of cardiology at the MedStar Washington Hospital Center, said the study does not differentiate between new products and slight improvements on already-approved devices.

“You don’t need to…for every change and iteration, do a clinical randomized trial” said Waksman, who was not part of the study but has been a consultant to medical device companies.

Still, Dr. William Boden at the Albany VA Stratton Medical Center said the different requirements for drug and device approvals is “egregious.”

“I think (the study) really elucidates the fact that there is just an unfortunate double standard, where there is a lack of transparency and a critical need for more comparative effectiveness evaluation before these devices come to market,” said Boden, who did not participate in the current research but whose research has been funded by pharmaceutical companies.

Brown said consumers should express their concerns about a lack of comparative effectiveness studies to their representatives in Congress.

SOURCE: http://bit.ly/Uge4Fb Journal of the American Medical Association, online November 5, 2012.

Medications/Drugs News Headlines – Yahoo! News

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Suspect Voter Fraud? Romney’s Campaign Has an App for That

Tens of thousands of volunteer poll watchers—self-appointed election vigilantes from both parties and from independent groups—have planted themselves in voting precincts across the country today to look over the shoulders of harried election officials and ensure that votes for their candidates get counted. The Romney campaign’s effort, dubbed Project ORCA, features something unusual: a smartphone app with a “voter fraud” button that poll watchers can use to instantly alert a squad of campaign lawyers stationed at the Boston Convention Center.

Ryan Williams, a Romney spokesman, says many of the campaign’s 34,000 volunteers watching over polls in hotly contested states have the app. They’re instructed not to talk to voters, says Williams, but looking over a poll worker’s shoulder to see who’s been checked off the voter list is O.K. The poll watchers are also checking whether voting machines work. If they suspect trouble of any kind (such as someone trying to vote twice), they hit the “voter fraud” button. That dials Boston, where lawyers will decide whether to file a lawsuit.

Voter fraud is rare. According to Jane Mayer at the New Yorker, there have been only seven convictions for fraud by impersonation since 2000. Democrats see the GOP’s measures as an effort to suppress voting, not protect it. In a memo circulated last week, Robert Bauer, general counsel to the Obama campaign, used blunt language to describe the GOP strategy: “Either directly, through its vendors, or in close association with allied organizations, the Republicans are attempting to disrupt the electoral process and create obstacles to the fair and effective exercise of the right to vote. All of this is done in the name of investigating and combating ‘fraud.’”

The Romney campaign isn’t just using its ORCA app to alert Boston to funny business, though. They’re also using it to see if someone on their list hasn’t voted yet. Those who haven’t turned out might get a call at home. Or the campaign could dispatch a surrogate to a local radio station to ask for votes.

Businessweek.com — Top News

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