FDA staff says Zogenix painkiller has abuse risks












(Reuters) – Drug reviewers said a painkiller developed by Zogenix Inc could possibly be abused more than currently available hydrocodone combination products.


Zogenix’s painkiller Zohydro is a single-entity product containing hydrocodone — a narcotic painkiller. Hydrocodone and oxycodone are often-abused drugs.












Combination hydrocodone drugs usually also contain acetaminophen, the active ingredient in common pain products such as Tylenol.


However, since an overdose of acetaminophen can cause liver damage, especially in patients on other acetaminophen medications, there is a requirement for painkillers without acetaminophen.


The reviewers said the expected higher levels of abuse with Zohydro were based on what has been observed for oxycodone products, according to briefing documents released by the U.S. Food and Drug Administration on Wednesday. (http://link.reuters.com/hux44t)


“The abuse ratio for oxycodone combination products was 24 emergency department visits per million tablets dispensed, compared with 85 visits for oxycodone single-entity ER products,” the FDA reviewers said in the documents.


An independent panel of experts will advise the FDA and vote on the drug’s safety, efficacy and approval on Friday.


Zogenix shares were down 6 percent at $ 2.39 in early trade on Wednesday on the Nasdaq.


(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)


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Exclusive: HSBC might pay $1.8 billion money laundering fine – sources












NEW YORK/WASHINGTON (Reuters) – HSBC Holdings Plc might pay a fine of $ 1.8 billion as part of a settlement with U.S. law-enforcement agencies over money-laundering lapses, according to several people familiar with the matter.


The settlement with Europe’s biggest bank – which could be announced as soon as next week – will likely involve HSBC entering into a deferred prosecution agreement with federal prosecutors, said the sources, who spoke on condition of anonymity.












The potential settlement, which has been in the works for months, is emerging as a test case for just how big a signal U.S. prosecutors want to send to try to halt illicit flows of money moving through U.S. banks.


An HSBC spokesman said: “We are cooperating with authorities in ongoing investigations. The nature of discussions is confidential.”


HSBC said on November 5 that it set aside $ 1.5 billion to cover a potential fine for breaching anti-money laundering controls in Mexico and other violations, although Chief Executive Stuart Gulliver said the cost could be “significantly higher.


In regulatory filings, HSBC has said it could face criminal charges. But similar U.S. investigations have culminated in deferred prosecution deals, where law-enforcement agencies delay or forgo prosecuting a company if it admits wrongdoing, pays a fine and agrees to clean up its compliance systems. If the company missteps again, the Justice Department could prosecute.


A deferred prosecution agreement could raise questions over whether HSBC is simply paying a big fine and nothing more, said Jimmy Gurule, a former enforcement official at the U.S. Treasury.


It would make a “mockery of the criminal justice system,” said Gurule, who is now a University of Notre Dame law-school professor.


In his view, the only way to really catch the attention of banks is to indict individuals.


“That would send a shockwave through the international finance services community,” Gurule said. “It would put the fear of God in bank officials that knowingly disregard the law.”


An HSBC settlement, long rumored, has been slow in coming. Inside the Justice Department, prosecutors in Washington, D.C. and West Virginia argued over how to best investigate HSBC. According to documents reviewed by Reuters, the U.S. Attorney’s office in Wheeling, West Virginia, was prepared as far back as 2010 to indict HSBC and include more than 170 money laundering counts.


Prosecutors in Washington ultimately took charge.


In July, the U.S. Senate Permanent Subcommittee on Investigations released a report saying HSBC allowed clients to move shadowy funds from Mexico, Iran, the Cayman Islands, Saudi Arabia and Syria.


The use of deferred prosecution agreements has surged in recent years because Justice Department officials believe they give prosecutors an option aside from indicting a company or dropping a case.


According to a report in May by the Manhattan Institute for Policy Research, a conservative-leaning think tank, there have been 207 deferred or non-prosecution agreements since 2004.


The agreements “have become a mainstay of white collar criminal law enforcement,” U.S. Assistant Attorney General Lanny Breuer said in September during an appearance at the New York City Bar Association.


“I’ve heard people criticize them and I’ve heard people praise them. DPAs have had a truly transformative effect on particular companies and, more generally, on corporate culture across the globe.”


If U.S. prosecutors agree to a deferred agreement, they still could wield a powerful legal tool by accusing the bank of laundering money.


That would be a much more serious charge than if prosecutors, in a deferred agreement, charged HSBC with criminal violations of the Bank Secrecy Act, a law that requires banks to maintain programs that root out suspicious transactions.


In March 2010, for example, Wells Fargo & Co’s Wachovia entered into a deferred prosecution agreement to pay $ 160 million as part of a Justice Department probe that examined how drug traffickers moved money through the bank. Wachovia was accused of violating the Bank Secrecy Act, a decision that prompted criticism from some observers who thought a money laundering charge should have been employed and individual bankers prosecuted.


A charge of money laundering would be a rare move by the Justice Department and would send a signal to other big banks that the agency is intent on cracking down on dirty money moving through the U.S. financial system.


(This story corrects month the Senate report was published to July in paragraph 13)


(Reporting by Carrick Mollenkamp and Brett Wolf; Additional reporting by Emily Flitter and Aruna Viswanatha)


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Sri Lanka see backlash from Aussie ‘wounded soldiers’












(Reuters) – Sri Lanka captain Mahela Jayawardene has warned his team to be wary of a backlash from Australia in their three-test series after the hosts were stung by their series defeat to South Africa earlier this week.


Australia’s hopes of snatching the Proteas’ top test ranking ended in a crushing 309-run defeat in the third and final test in Perth on Monday, but Jayawardene took little comfort from the home side’s disappointment.












“I see them as wounded soldiers – they could come back stronger against us,” Jayawardene told reporters in Canberra on Wednesday, on the eve of a three-day tour match against a Chairman’s XI side.


“So we just need to make sure we are ready for that and start well.


“We can’t be complacent – we need to make sure we know from ball one we give them a good go at it.”


Sri Lanka have their own problems coming into the first test at Hobart next week, losing their last test at home to New Zealand by 167 runs to level a two-match series 1-1, with key batsmen out of form.


Kumar Sangakkara scored five, nought and 16 in his three innings against New Zealand, but Jayawardene backed the veteran to bounce back in Sri Lanka’s bid to win their first test Down Under.


“I am happy that he went through a lean phase because he’ll be really hungry for runs – that’s Kumar for you,” Jayawardene said of the 35-year-old stalwart.


Jayawardene also said he would weigh up his future as captain after the series, which includes tests in Melbourne and Sydney, after taking on the role for a second time in the wake of Tillakaratne Dilshan’s sudden resignation in January.


“After this, we get a well-deserved four weeks off, after about three years, so it gives me a bit of time to think (about) what I need to do,” said Jayawardene, who captained the team for more than three years in his first stint from 2006.


“We need to groom another leader as well. It’s very important to have that changeover done smoothly while the senior players are still in the side.”


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Hugh Hefner heads to altar again, with “runaway bride”












LOS ANGELES (Reuters) – Playboy founder Hugh Hefner is headed to the altar again – with the blonde Playmate who ditched him five days before their planned wedding in 2011.


Hefner, 86, and his former “runaway brideCrystal Harris, 26, obtained a marriage license in Beverly Hills on Tuesday, Los Angeles County Recorder spokeswoman Elizabeth Knox said.












Celebrity website TMZ.com said the couple, who reunited earlier this year, are planning a New Year’s Eve wedding.


Harris was Playboy magazine‘s Miss December 2009 and appeared on the July 2011 cover of the adult magazine with a “runaway bride” sticker covering her bottom half.


In what was described at the time only as a “change of heart,” Harris dumped the magazine mogul and left his Playboy Mansion five days before a lavish June 2011 wedding before 300 guests.


This time around, the couple are playing it low-key, staying mum on their busy Twitter accounts with Hefner’s spokeswoman declining to confirm or deny their plans.


Hefner, founder of the Playboy adult entertainment empire, has been married twice before. He and his second wife Kimberley Conrad, also a former Playmate, divorced in 2010 after a lengthy separation. His first marriage to Mildred Williams ended in divorce in 1959. He has two children from each marriage.


(Reporting By Jill Serjeant)


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Casting Light on Astronaut Insomnia: ISS to Get Sleep-Promoting Lightbulbs












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The U.S.-China Cold War Over Accounting












U.S. regulators are cracking down on Chinese companies for issuing misleading financial reports. But the feds have been stymied so far by a wall of resistance to U.S. accounting rules—and not just from the companies.


The Securities Exchange Commission on Dec. 3 formally accused the Chinese affiliates of the Big Four accounting firms of violating U.S. law. The issue at hand: failure to provide documents in ongoing accounting fraud investigations of nine U.S.-listed, China-based companies.












Ernst & Young Hua Ming, Deloitte Touche Tohmatsu Certified Public Accountants, KPMG Huazhen, and PricewaterhouseCoopers Zhong Tian CPAs have been charged “with violating the Securities Exchange Act and the Sarbanes-Oxley Act, which requires foreign public accounting firms to provide the SEC upon request with audit work papers involving any company trading on U.S. markets,” said a statement on the SEC website. The SEC also named a fifth U.S. firm, BDO China Dahua.


“Only with access to work papers of foreign public accounting firms can the SEC test the quality of the underlying audits and protect investors from the dangers of accounting fraud,” SEC Enforcement Director Robert Khuzami said in a prepared statement. “Firms that conduct audits knowing they cannot comply with laws requiring access to these work papers face serious sanctions.”


Over the past two years, the SEC has audited scores of Chinese firms amid concerns that many are issuing financial statements that don’t reflect their real operations. The alleged violations include overstating revenue and profit. Many of them have listed on U.S. exchanges through so-called reverse mergers—when a company buys a largely inactive shell company that already has a listing and so can avoid strict disclosure requirements. To date, the SEC has deregistered almost 50 companies, including China MediaExpress Holdings, and launched fraud investigations against more than 40 issuers and company executives.


The investigations, however, have faced serious obstacles to gathering evidence within China. Beijing’s attitude has been that its own accounting system is fully adequate and that there is no need for the U.S. to conduct its own probe. And China’s security regulators and finance officials have been loathe to participate in any joint investigation.


The international accounting firms, for their part, say compliance with SEC demands would mean breaking Chinese law. “The fact that the action is being taken collectively against all of the four largest audit firms and one other firm demonstrates that this is a profession-wide issue,” Caroline Nolan, a PricewaterhouseCoopers spokeswoman, said in an e-mail statement. “For its part, PwC China has cooperated with the SEC at every opportunity. However, PwC China will, and must, comply with its legal obligations under China law.”


“Ernst & Young Hua Ming supports close working relationships between regulators to enable them to cooperate and share information with one another,” Will White, director of global and EMEIA media relations for Ernst & Young, said in an e-mail statement. “We hope that an agreement can be reached between U.S. and Chinese regulators that will enable our compliance with all applicable laws and regulations.”


The issue is also tied up with China’s historic resistance to perceived foreign meddling in its internal affairs, says Paul Gillis, a professor at Peking University’s Guanghua School of Management and an expert on China’s accounting standards. National security has also been raised as a possible concern by Beijing. This makes any resolution even less likely, and the impasse could eventually lead to the delisting of all Chinese companies in the U.S., predicts Gillis.


“The U.S. is looking at this in terms of its own laws and regulations,” says Gillis, who maintains a blog on China accounting. “China is approaching this issue more ideologically, from a national sovereignty issue. This involves Chinese views of foreign oppression going all the way back to the Opium Wars and Japanese occupation. The idea of foreigners pushing around Chinese is deeply offensive.”


Businessweek.com — Top News


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Officials: NATO to decide on missiles for Turkey












BRUSSELS (AP) — NATO foreign ministers are expected to approve Turkey‘s request for Patriot anti-missile systems to bolster its defense against possible strikes from neighboring Syria.


NATO foreign ministers are meeting on Tuesday and Wednesday in Brussels. Parliaments in both nations must approve the deployment, which would also involve several hundred soldiers.












Ankara, which has been highly supportive of the Syrian opposition, wants the Patriots to defend against possible retaliatory attacks by Syrian missiles carrying chemical warheads. NATO leaders have repeatedly said they would provide any assistance Turkey needs.


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Judge gives initial OK to revised Facebook privacy settlement












(Reuters) – A U.S. judge on Monday gave his preliminary approval to a second attempt by Facebook Inc to settle a class action lawsuit which charges the social networking company with violating privacy rights.


U.S. District Judge Richard Seeborg in California rejected a settlement in August over Facebook‘s ‘Sponsored Stories’ advertising feature, questioning why it did not award money to Facebook members for using their personal information.












But in a ruling handed down Monday, Seeborg said a revised settlement “falls within the range of possible approval as fair, reasonable and adequate.”


In a revised proposal, Facebook and plaintiff lawyers said users now could claim a cash payment of up to $ 10 each to be paid from a $ 20 million total settlement fund. Any money remaining would then go to charity.


The company also said it would engineer a new tool to enable users to view content that might have been displayed in Sponsored Stories and opt out if they desire, a court document said.


If it receives final approval, the proposed settlement would resolve a 2011 lawsuit originally filed by five Facebook Inc members.


The lawsuit alleged the Sponsored Stories feature violated California law by publicizing users’ “likes” of certain advertisers without paying them or giving them a way to opt out. The case involved over 100 million potential class members.


A spokesman for Facebook said the company was “pleased that the court has granted preliminary approval of the proposed settlement.” Lawyers for the plaintiffs weren’t immediately available for comment Monday evening.


Outside groups and class members will have a chance to object to the latest settlement before Seeborg decides whether to grant final approval. A hearing on the fairness of the deal has been set for June 28, 2013. The case in U.S. District Court, Northern District of California is Angel Fraley et al., individually and on behalf of all others similarly situated vs. Facebook Inc, 11-cv-1726.


(Reporting by Jessica Dye; Editing by Michael Perry)


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Matt Damon, Alec Baldwin, Don Cheadle Sign on for James Cameron’s Climate-Change Doc












LOS ANGELES (TheWrap.com) – James Cameron‘s climate-change documentary “Years of Living Dangerously” has lined up some high-level talent to get its message across. Matt Damon, Alec Baldwin and Don Cheadle have signed on to narrate the documentary, Showtime – which will air the project over multiple episodes next year – said Monday.


Actor Edward Norton is also expected to come aboard, Showtime said, with additional talent to be announced.












As previously reported exclusively by TheWrap, Cameron is teaming with producer and noted philanthropist Jerry Weintraub on the project, which will report on first-person accounts of people who’ve been affected by global warming. Cameron and Weintraub will executive “Years of Living Dangerously,” along with Arnold Schwarzenegger.la


“60 Minutes” producers Joel Bach and David Gelber are also executive-producing, along with climate expert Daniel Abbasi.


“The recent devastation on the East Coast is a tragic reminder of the direct link between our daily lives and climate change,” Showtime Networks’ president of entertainment David Nevins said. “This series presents a unique opportunity to combine the large-scale filmmaking styles of James Cameron, Jerry Weintraub and Arnold Schwarzenegger – arguably some of Hollywood’s biggest movie makers – with the hard-hitting, intimate journalism of ’60 Minutes’ veterans Joel Bach and David Gelber. I believe this combination will make for a thought-provoking television event.”


“We’ll make it exciting,” added Cameron. “We’ll make it investigative. We’ll bring people the truth. And people are always hungry for the truth.”


In addition to the narrators, “Years of Living Dangerously” will use reporting from the field, with New York Times journalists Thomas Friedman and Nicholas Kristof, columnist Mark Bittman and MSNBC host Chris Hayes.


“Years of Living Dangerously” will air over six to eight one-hour episodes, Showtime said.


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NFL-Kansas City Chiefs murder/suicide key may never be unlocked












* Player’s death adds to recent NFL suicides


* Player head injuries seen as ongoing problem












* Experts wonder if drugs such as steroids involved


Dec 3 (Reuters) – The murder/suicide committed on Saturday by Kansas City Chiefs football player Jovan Belcher left the National Football League, its fans and health professionals struggling to understand what drove him to do it.


Belcher, 25, shot and killed his 22-year-old girlfriend Kasandra Perkins, the mother of his three-month-old daughter, in front of his own mother at home before driving to Arrowhead Stadium where he shot himself dead in the parking lot after thanking team officials for all they had done for him.


For the NFL, arguably the most popular U.S. professional sport, the tragic shootings cast the league in a frightfully brutal light as Belcher became the fourth player this year to die of a self-inflicted gunshot.


Former players Junior Seau in May, Ray Easterling in April and Michael Current in January all committed suicide.


A fifth suicide victim, former Chicago Bears player Dave Duerson killed himself by gunshot less than two years ago, leaving a note requesting that his brain be examined for a post-concussive disease that might have led to his severe depression.


An brain analysis showed that Duerson had a degenerative brain disease, as he had believed.


Details on Belcher’s health have been slow to emerge.


Dr. Alan Hilfer, Director of Psychology at Maimonides Medical Center in New York, said just why Belcher suddenly snapped could remain a mystery.


“We may never know the reasons,” Hilfer told Reuters in a telephone interview on Monday. “Something was terribly wrong.”


The league has come under fire from former players who have joined to sue the NFL, claiming league officials looked the other way while the players were absorbing concussions that have led to long-term disabilities.


LOOKING FOR AN EDGE


Others suspect that the high-speed, muscular contact game leads players to look for a doping edge despite drug testing, and that can lead to psychological instability.


Chiefs Chairman Clark Hunt said Sunday that doctors and coaches told him they knew of no physical or emotional issues bothering Belcher, who reached the NFL as a free agent after going to the University of Maine.


“What do you look for? It’s a very hard question to answer,” Hilfer said. “Certainly you look for mood changes. Certainly you look for increased levels of impulsively and anger.


“These things sometimes occur so suddenly. Sometimes there is just no way you could possibly know that someone is going to perpetrate an act of violence of this magnitude.”


Don Hooton, who founded the Taylor Hooton Foundation to promote steroids education in 2004, seven months after his son, Taylor, committed suicide following his use of anabolic steroids, suspects doping.


“Every time I hear a story like this, my mind runs immediately to anabolic steroids,” Hooton said. “Not necessarily to the exclusion of anything else, but because anabolic steroids can affect the mind in these crazy ways.


“I hope when they do the autopsy on this young man, that they look for these substances because it’s possible that what we saw was ‘Roid Rage’” – a label given to the exhibition of anger among steroid users.


Hooton said that despite efforts in professional leagues to stem the use of performance-enhancing drugs (PED), recent studies showed that steroids use was on the rise among U.S. school children.


“It’s not getting better – it’s getting worse,” said Hooton. “We better wake up, America.”


LARGER SOCIETAL PROBLEMS


Dan Lebowitz, executive director of Sport in Society at Northeastern University, said he saw the Belcher tragedy as something that speaks to societal problems transcending sports.


“This is an issue of men’s violence against women, not just football players being too violent,” Lebowitz said.


“When I look at it, I try to take it out of the realm of sport. I just think about the way we acculturate young boys in this country and our whole view of manhood.”


Lebowitz’s group has worked for the NFL on a 2010 training program aimed at gender equality and respect in the workplace, and ran a training project at the soccer World Cup in South Africa on preventing gender violence.


“If you look at how many NFL players commit gender violence in proportion to the overall population, the percentage falls in line with the general population, three to five percent.


“From what I hear she came home from a concert late and he reacted horrifically. We don’t have a healthy concept of what manhood is and how certain things that we see as an affront to manhood probably aren’t that at all.”


Lebowitz said the awful incident could spawn an opportunity to educate others.


“Nothing happens in a bubble. This is the fifth NFL player to commit suicide by a self-inflicted gunshot … this one was (preceded) by a murder. Right now there is an absolute heightened spotlight on all the issues around sports in general.


“How do we make a healthier sport, and how do we make a healthier man? How do we engage in a real conversation about respect for women’s rights and freedoms?”


Dr. Hilfer said athletes were often reluctant to seek help.


“They can benefit from additional help, especially considering the rash of suicides from concussive syndromes,” he said. “I would have loved to get this guy into some form of counseling therapy.


“It would have been wonderful if they could ask for help but athletes are often reluctant because their image is that of a tough guy who can handle things. They are as a rule some of the people who are least likely to access mental health services.”


Mike Paul, who runs a New York public relations business specializing in reputation management, said the incident would challenge NFL Commissioner Roger Goodell.


“This is a big one for him,” Paul told Reuters. “The helmet (safety) issue and the steroids and PED issue, continue. Now it is right back in his face again and he has two choices.


“He can confront it head on and say it is time for further examination as we go into 2013 … or he can try to slide it under the rug by saying it’s a one-off.


“I think it would be a big mistake to say it was a one-off.” (Editing by Philip Barbara)


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