Ireland opens new probe into death of woman denied abortion












DUBLIN (Reuters) – Ireland has opened a new investigation into the death of a woman denied an abortion of her dying fetus, as the government scrambled to stem criticism of its handling of an incident that polarized the overwhelmingly Catholic country.


Savita Halappanavar, a 31-year old dentist, was admitted to hospital in severe pain on October 21 and asked for a termination after doctors said her baby would not survive, according to husband Praveen, but in a country with some of the world’s most restrictive abortion laws, surgeons would not remove the fetus until its heartbeat stopped days later.












Husband Praveen Halappanavar, who believes the delay contributed to the blood poisoning that killed his wife on October 28, has said he would not cooperate with an investigation already launched by the country’s health service because he did not believe it would be neutral.


On Friday, the Health Information and Quality Authority (HIQA) watchdog, which is government-funded but independent of the state health service, said it had also launched an investigation after receiving information from the health service and University Hospital Galway, where Halappanavar died.


A solicitor acting on behalf of the husband said the new inquiry was unlikely to be enough to satisfy his client.


“My client has always made his position very clear … He wants a public inquiry. He has made it clear he wants to get to the truth of the matter, so I don’t think that the framework of HIQA will suffice,” Gerard O’Donnell, told RTE radio.


He added that the next step would be to consider an application to the European Court of Human Rights, which criticized Ireland’s abortion ban in 2010.


Halappanavar’s death has reopened a decades-long debate over whether the government should legislate to explicitly allow abortion when the life of the mother is at risk.


Irish law does not specify exactly when the threat to the life of the mother is high enough to justify a termination, leaving doctors to decide. Critics say this means doctors’ personal beliefs can play a role.


Though the influence of the Catholic Church over Irish politics has waned since the 1980s, successive governments have been loath to legislate on an issue they fear could alienate conservative voters.


CALL TO CLARIFY


Ireland’s abortion stance is enshrined in a 1983 constitutional amendment that intended to ban abortion in all circumstances. In 1992, when challenged in the “X-case” involving a 14-year-old rape victim, the Supreme Court ruled that abortion was permitted when the woman’s life was at risk, including from suicide.


But successive governments refused to make clear the circumstances under which a threat would make an abortion legal. After several challenges, the European Court of Human Rights ruled in 2010 that Ireland must clarify its position.


Prime Minister Enda Kenny, whose ruling Fine Gael party made an election pledge not to introduce new laws allowing abortion, said last week he would not be rushed into a decision on the issue.


The government was forced into an embarrassing u-turn this week when it removed three Galway-based consultants from the health service inquiry following criticism from Praveen Halappanavar.


The issue has raised tensions between Fine Gael and the more socially liberal Labour Party, its junior coalition partner, which has campaigned for a clarification of the country’s abortion rules.


The country’s president, Michael D. Higgins, a former member of the Labour Party, weighed into the debate this week when he said an investigation was needed that satisfied the dead woman’s family.


Opposition party Sinn Fein introduced a motion to parliament on Wednesday calling for parliament to legislate on abortion, but it was rejected.


“Successive governments over the past 20 years have failed in respect of legislation. That failure is in large measure due to fear or cowardice,” said Mary Lou McDonald, vice president of Sinn Fein.


(Editing by Will Waterman)


Health News Headlines – Yahoo! News


Read More..

The politics of shopping: Does that store lean left or right?

Black Friday: It’s a day in which most American citizens put aside politics in pursuit of shopping bargains. But in Washington we can sort almost anything in the US in terms of partisan proclivity, and temples of commerce are no exception. Want to know whether the big box store where you’re waiting in line leans Democratic or Republican? The folks at the invaluable Center for Responsive Politics have compiled a handy guide based on campaign contributions.


Toys R Us, for instance, seems a solidly blue store. Self-identified employees of the store gave $39,000 to political candidates in the 2012 election cycle, and $36,000 of that went to Democrats.


Dig into the numbers though, and you’ll see that Toys R Us is not so much Democratic as Klobucharian. All that $36,000 went to one candidate, Sen. Amy Klobuchar (D) of Minnesota. (That’s kind of odd, isn’t it? The retailer’s corporate headquarters are in New Jersey.) Other than that, Mitt Romney got $1,750 from Toys R Us workers. President Obama got zilch, according to CRP’s Open Secrets blog.


Are you a smart shopper? Take our quiz to find out.


Macy’s employees, on the other hand, were big Obama fans. They donated $28,870 to the president’s reelection campaign, as opposed to $16,390 to GOP nominee Mr. Romney. This Democratic lean was counterbalanced to a certain extent by the store’s corporate political action committee, however. (Toys R Us doesn’t appear to have a central PAC.) Macy’s PAC gave $12,000 to Republicans, and $4,000 to Democrats.


Best Buy seems more of a red retailer. Both it s employees and the company’s PAC had a slight preference for Republicans, according to CRP. Store employees gave $17,662 to Democrats and $22,419 to the GOP, for instance.


But there’s Senator Klobuchar again – she’s the individual candidate to whom Best Buy-related entities donated the most. Yes, she’s chairperson of a Senate Commerce subcommittee on competitiveness, so that might have something to do with it. Maybe the money comes due to her political affiliation with Minnesota’s Gov. Mark Dayton? Governor Dayton is the scion of the Dayton retail empire, which among other things founded Target.


Hmm, we see that Target leaned GOP as well, so maybe that theory isn’t right. Of the store’s $483,777 in individual and PAC contributions, the majority went to the right side of the aisle, according to Open Secrets. And the top recipient is not Sen. Klobuchar, but Rep. Eric Paulsen – a Twin Cities Republican.


Then there’s Wal-Mart. Sam Walton’s empire has a major presence in politics compared with its big box brethren. Its employees and PAC gave $2.7 million to candidates in the 2012 cycle.


Employee donations skewed Republican – which might not be surprising, since Wal-Mart is a big employer in the exurban/rural areas where Romney ran strongly. The firm’s PAC gave roughly equal amounts to candidates of both parties, however. That might be because Wal-Mart lobbies hard in Washington and needs relationships on both sides of the aisle.


In fact, Wal-Mart has spent more than $12 million on lobbyists in the past two years. It has its own Washington office, with 15 employees, and pays hundreds of thousands of dollars in retainers to such top outside lobby firms as Patton Boggs and the Podesta Group.


The firm’s No. 1 issue is sales taxes – specifically, getting states to slap sales taxes on web retail. Rep. Steven Womack (R) of Arkansas, whose district includes Wal-Mart’s Bentonville headquarters, has long pushed national legislation that would force out-of-state online retailers to collect sales tax. He’s one of the top recipients of Wal-Mart campaign contributions.


“The traditional brick and mortar retailer is not asking for special treatment. They know they have to compete against a number of consumer criterion. What they don’t want – and should not compete against – is a disadvantage based on a tax loophole,” said Congressman Womack earlier this year during a Judiciary Committee hearing on the issue.


Are you a smart shopper? Take our quiz to find out.



Related stories


Read this story at csmonitor.com


Become a part of the Monitor community


Also Read
Read More..

Fights and lines: Shoppers descend on Black Friday deals




Black Friday got off to its earliest start ever as many shoppers cleared the table of Thanksgiving dinner and headed straight to the malls and big-box retailers across the nation to snag goods at bargain prices.



More than 10,000 people were wrapped around Macy's flagship store in New York City before the doors opened at midnight this morning. Across the country, up to 147 million people are expected to shop at some point this weekend.



Thousands lined up outside a Target in Chicago ahead of a 9 p.m. start time.



"I'm here because my mom is making me, because she said I couldn't eat any of the Thanksgiving food if I didn't hold her place in line," Alex Horton told ABC News station WLS-TV in Chicago Thursday.



Many critics panned the early start this year, saying it cuts into quality time that should be spent with family and friends.




PHOTOS: Black Friday Shoppers Hit Stores



Chicago resident Claudia Fonseca got creative and took Thanksgiving to go.



"We brought a plate, but that's about it, we've been here since 11 a.m. And that's it," Fonseca told WLS Thursday.



Black Friday makes headlines every year, but not always for the right reason as violence has become linked to the day after Thanksgiving tradition.



In Los Angeles, police aren't taking any chances with the LAPD deploying dozens of extra officers around the city to make sure things don't get out of hand.



Ontario Mills shopping mall in Los Angeles opened at midnight last year, but decided to give excited shoppers a two-hour head start to get their hands on the cut-rate deals, especially for electronics.



"This is my first year," Gabriela Mendoza told ABC News station KABC-TV Thursday. "I tried to stay away from this but I've heard it's really exciting so, I'm looking forward to it."



Things have been relatively calmer compared to the incident last year when a woman was accused of unleashing pepper spray on other shoppers in a dash for electronics at Walmart in Los Angeles.



The Black Friday madness kicked off Thursday when a south Sacramento, Calif., Kmart opened its doors at 6 a.m. Thursday. A shopper in a line of people that had formed nearly two hours earlier reportedly threatened to stab the people around him.



At two Kmarts in Indianapolis, police officers were called in after fights broke out among shoppers trying to score vouchers for a 32-inch plasma TV going for less than $200, police told ABC News affiliate RTV6. No injuries or arrest were made.



Stores have taken preventive measures in hopes of shoppers and tempers at ease, where safety is the main concern for everyone involved.



Mall of America has tightened its Black Friday policies and will bar unaccompanied minors from the megamall all day today. After a chair-throwing melee last year after Christmas, which was captured on smartphones and posted online, the mall is taking steps to prevent any repeat.



At the Arden Fair Mall in Sacramento, Calif., security planned to place barricades at the mall entrance to control the crowds and officials planned to double the number of security officers.



ABC News' John Schriffen and Sarah Netter contributed to this report.

Also Read
Read More..

Former Ivory Coast leader’s wife wanted by ICC
















THE HAGUE, Netherlands (AP) — The International Criminal Court unsealed an indictment Thursday against former Ivory Coast President Laurent Gbagbo‘s wife on charges including murder, rape and persecution. It was the first time in the court’s 10-year history it has charged a woman.


The world’s first permanent war crimes tribunal said the arrest warrant was issued on Feb. 29 for former first lady Simone Gbagbo for crimes against humanity.













Her husband, Laurent Gbagbo, is already in custody at the court’s detention unit in The Hague facing similar charges stemming from his fight to retain power after losing a 2010 presidential election. If his wife is extradited, they could face justice together in an unprecedented husband-wife trial.


But a senior member of Ivory Coast President Alassane Ouattara‘s government, who requested anonymity because he wasn’t authorized to speak to the media, said Ivory Coast has already informed the ICC that the nation will not let her go.


“We informed them of this a long time ago,” he said.


The court’s chief prosecutor, Fatou Bensouda, urged Ivory Coast to extradite Gbagbo.


“The type of crimes committed in the aftermath of the 2010 elections did not happen by chance — they were planned and coordinated at the highest political and military levels and all those bearing the greatest responsibility must be held to account,” Bensouda said in a statement.


She said prosecutors continue to investigate crimes committed by both sides in Ivory Coast’s bloody power struggle and expect to issue further arrest warrants in the future.


“The investigations are objective, impartial and independent, and are conducted in strict accordance with the law,” she said.


Ivory Coast officials are holding the 63 year old under house arrest in the northwest town of Odienne. Last week, Ivorian prosecutor Noel Dje Enrike Yahau said lawyers had questioned Simone Gbagbo there for two days and that the domestic charges against her remained the same: genocide, blood crimes and economic crimes.


Unsealing the ICC arrest warrant issued nearly nine months ago appears to be a tactic by the court to put pressure on Ouattara’s administration to hand over Ms. Gbagbo.


If authorities in Ivory Coast want to prosecute her, they have to convince judges at The Hague tribunal that their case involves the same crimes she is charged with at the ICC. It is a court of last resort, meaning it only takes cases from countries unwilling or unable to prosecute them.


The international court said in the warrant that there is evidence pro-Gbagbo forces deliberately attacked perceived supporters of Ouattara in the aftermath of the election.


Judges who reviewed evidence supporting the charges against Ms. Gbagbo said they found “there are reasonable grounds to believe that Ms. Gbagbo bears individual criminal responsibility for the crimes … as ‘an indirect co-perpetrator.’”


The warrant called Gbagbo an “alter ego for her husband” with the power to make state decisions. It said there is evidence to suggest she “instructed the pro-Gbagbo forces to commit crimes against individuals who posed a threat to her husband’s power.”


Her husband was the first former head of state to be taken into custody by the court when he was extradited to The Hague by the Ivory Coast government last year.


Prosecutors say about 3,000 people died in violence by both sides after Gbagbo refused to concede defeat following the election. Ouattara finally took power in April 2011 with the help of French and U.N. forces.


Ivory Coast is not a member state of the court, but has voluntarily accepted its jurisdiction.


It is very rare for a woman to be charged by an international war crimes court. In the past, the Yugoslav war crimes tribunal convicted former Bosnian Serb President Biljana Plavsic of persecution and sentenced her to 11 years imprisonment.


The announcement of the arrest warrant and Ivory Coast’s refusal to hand over Gbagbo appeared likely to raise tensions between supporters of her husband and those who back Ouattara.


Moussa Toure Zeguen, a leader of the Gbagbo allies in exile in Ghana, said by phone from Accra that the former president’s supporters had no faith in the Ivorian authorities to give Simone Gbagbo a fair trial.


“We don’t trust them. The only thing that Ouattara is doing is revenge,” Zeguen said. “He wants to try us without trying any of the fighters from his side who also committed crimes. It is not fair, and this cannot bring reconciliation.”


____


Associated Press writers Rukmini Callimachi in Dakar, Senegal, and Robbie Corey-Boulet in Abidjan, Ivory Coast, contributed to this report.


Europe News Headlines – Yahoo! News



Read More..

Ex-’Price is Right’ model gets $8.5M in damages
















LOS ANGELES (AP) — The producers of “The Price is Right” owe a former model on the show more than $ 7.7 million in punitive damages for discriminating against her after a pregnancy, a jury determined Wednesday.


The judgment came one day after the panel determined the game show’s producers discriminated against Brandi Cochran. They awarded her nearly $ 777,000 in actual damages.













Cochran, 41, said she was rejected when she tried to return to work in early 2010 after taking maternity leave. The jury agreed and determined that FremantleMedia North America and The Price is Right Productions owed her more than $ 8.5 million in all.


“I’m humbled. I’m shocked,” Cochran said after the jury announced its verdict. “I’m happy that justice was served today not only for women in the entertainment industry, but women in the workplace.”


FremantleMedia said it was standing by its previous statement, which said it expected to be “fully vindicated” after an appeal.


“We believe the verdict in this case was the result of a flawed process in which the court, among other things, refused to allow the jury to hear and consider that 40 percent of our models have been pregnant,” and further “important” evidence, FremantleMedia said.


In their defense, producers said they were satisfied with the five models working on the show at the time Cochran sought to return.


Several other former models have sued the series and its longtime host, Bob Barker, who retired in 2007.


Most of the cases involving “Barker’s Beauties” — the nickname given the gown-wearing women who presented prizes to contestants — ended with out-of-court settlements.


Comedian-actor Drew Carey followed Barker as the show’s host.


___


Anthony McCartney can be reached at http://twitter.com/mccartneyAP .


Entertainment News Headlines – Yahoo! News



Read More..

Do drunks have to go to the ER?
















NEW YORK (Reuters Health) – With the help of a checklist, ambulance workers may be able to safely reroute drunk patients to detoxification centers instead of emergency rooms, according to a new study.


Researchers in Colorado found no serious medical problems were reported after 138 people were sent to a detox center to sleep it off, instead of to an ER.













In 2004, according to the researchers, it’s estimated that 0.6 percent of all U.S. ER visits were made by people without any problems other than being drunk. Those visits ended up costing about $ 900 million.


“Part of the issue has been – as it is in many busy ER departments – there’s a lot of chronic alcoholics that are brought in by ambulance, police or just come in. Often they are brought in because they have not committed a crime or there is limited space in our detoxification center. So the majority were brought to the ER department,” said Dr. David Ross, the study’s lead author from Penrose-St. Francis Health Services in Colorado Springs.


Ross said the ambulance company where he serves as medical director created the checklist with the help of the local detox center, which provided limited medical care by a nurse, and the local hospitals to reduce the number of drunks without medical needs being sent to the local ERs.


They created a checklist with 29 yes-or-no questions, such as whether the patient is cooperating with the ambulance worker’s examination and if the patient is willing to go to the detox center.


The patient was sent to the ER if the ambulance worker checked “no” on any question.


The researchers then went back to look at the patients they transported between December 2003 and December 2005 to see whether or not any of them ended up having serious medical problems at the detox center.


During that two year period, the ambulance workers transported 718 drunks. The detox center received 138 and the local ERs got 580.


Overall, 11 of the patients who were taken to detox were turned away because there was no room, their blood alcohol level exceeded the limit, their family came to pick them up or they were combative.


Another four patients at the detox center were taken to the ER because of minor complications, including chest and knee pain. However, there were no serious complications reported.


“We really believe that we did not miss anybody with a serious illness and injury that didn’t go to the ER as they should have,” said Ross.


But the researchers write in the Annals of Emergency Medicine that their study did have some limitations.


Specifically, the researchers did not plan in advance to do a study when they were creating the checklist, which means their findings are limited to whatever information was collected at the detox center and ERs.


Also, the number of people who were sent to the detox center in their study is relatively small, so it’s hard to tell how many serious complications they’d see among a larger group of people.


“We tried to estimate how likely we would have been to encounter a serious event… We estimated at most we’d encounter three serious adverse events (in 748 patients),” Ross told Reuters Health.


SOURCE: http://bit.ly/QgPCT5 Annals of Emergency Medicine, online November 9, 2012.


Health News Headlines – Yahoo! News



Read More..

Black Friday starts on Thursday right after Thanksgiving dinner


Black Friday is the Super Bowl of retail, but some of the nation's largest big-box stores can't wait until the day after Thanksgiving to open their doors to shoppers eager to grab great deals the same day as their turkey dinner.



Traditional Black Friday door-busting deals now start tonight, on what's been dubbed Gray Thursday. Major retail stores such as Kmart, Toys R Us, Walmart and Sears will open their doors beginning at 8 p.m. Target will join the party an hour later.



"It's traditionally been the day after Thanksgiving when the stores go into the black, where they make all their money. But that's not true anymore," retail expert Michelle Madhock said.





With Black Friday sales starting Thursday, that means lines started forming Wednesday, or in some extreme cases a week before as bargain hunters tried to get a turkey leg up on their competition.



Luciana Pendleton pitched a tent outside a Deptford Township, N.J., Best Buy Monday fully equipped with all she needed to spend the next few days away from home so she could be first in line when the doors open.



"I am just happy I beat my competition. They pulled up here around 3 p.m., and we were already here so I was happy," she said Monday.



Last year, some sale seekers became a little too excited and turned holiday shopping into a contact sport. In one ugly incident, a woman was accused of unleashing pepper spray on other shoppers in a dash for electronics at Walmart in Los Angeles.



This year, stores are beefing up security, and Best Buy even participated in training drills to handle the large crowds. More than 147 million people plan to shop this weekend, according to the National Retail Federation.



The hottest deals that are up for grabs this year include a 46-inch Samsung LED flat screen TV at Walmart with $200 off the original price. If that's not good enough, Sears has knocked $500 off the price of a 50-inch Toshiba flat screen. Target is offering the Nook Simple Touch at half price.



Black Friday officially kicks off at midnight for Best Buy, Sports Authority and Macy's.

Also Read
Read More..

U.S. troops in Afghanistan celebrate Thanksgiving

KABUL, Afghanistan (AP) — It was Army Sgt. Keith Wells' first Thanksgiving Day away from his family and despite a cornucopia of food provided for the troops, his taste buds were craving his wife's macaroni and cheese back home.

"My wife's a foodie — you know the Food Network, cooking shows. Everything she makes is golden," Wells of Charlotte, N.C., said Thursday at a large international military base in the Afghan capital, Kabul.

The dining hall served up mac-and-cheese along with traditional Thanksgiving Day fixings. Wells was thankful for the good food, but he still missed his wife's home-cooking.

Huge hunks of beef greeted the estimated 2,500 diners as soldiers lined up in the dining hall. Red-white-and-blue decorations filled the room. Brochures titled "Learn about combat stress" served as table centerpieces.

There was roast turkey, sliced turkey, ham and rib-eye steaks. The troops were served steaming side dishes of dressing, corn, collard greens, yams and mashed potatoes and gravy that some lapped up with spoons. For dessert, there was a massive cake with a turkey etched in icing, pumpkin spice cookies and scores of pies.

A short walk from the dining hall, service members were playing a modified version of American football.

Parts of the scene could have come from a snapshot of any U.S. city: American guys in sweats tossing the pigskin, a scoreboard, a coin toss to start the game.

But on this military base, concrete barriers surrounded the field. The referees wore camouflaged shirts and the spectators carried rifles. The artificial turf was frayed and so dusty that when one player spiked the football, a puff of dirt rose from the field.

The players used a regulation football, but the game was a mix of football, soccer and rugby to fit the short field.

Some soldiers commented about the 11-year-old war that has claimed the lives of 2,029 American service members.

Army Chief Warrant Officer 4 Chuck Minton of Monroe, Ga., who has traveled extensively across Afghanistan, was optimistic. "It's been progressing here, getting better. The Afghans have taken over more missions," Minton said.

President Barack Obama pulled 10,000 troops out of Afghanistan in 2011 and 23,000 more this year, leaving about 66,000 American service members still deployed in the country. Nearly all international combat troops are to withdraw by the end of 2014 when Afghan forces will be fully in charge of securing the nation.

Army Maj. Rodney Gehrett of Colorado Springs, Colo., said he was surprised that the war was barely mentioned during the last U.S. presidential election — evidence that some Americans had tuned out the news from the front line a half a world away.

"The war in Afghanistan wasn't even brought up as a topic of conversation" during the election, Gehrett said. "It was a little surprising to me. Hopefully, that will change and people will realize that we still have troops here and they are fighting every day."

Army Sgt. Adam Draughn of Denver, Colo., said some people back home have the impression that the Afghan people don't want American troops in their country.

"Honestly, I think the biggest misconception in my opinion is that, you know, we actually are loved here," Draughn said. "The nationals do care about us. They do want us here to help them. We're not here uninvited."

Most of the holiday chatter, however, was focused on family.

Taking a break from the game, Army Capt. Robert Mikyska of North Aurora, Ill., pulled out a photocopied photo that was taken of he and his wife just before he deployed to Afghanistan nine months ago.

"Hi, honey!" Mikyska said, looking at the picture. "In a couple weeks, I'll be home. I can't wait to be back."

"My family's here," Army Spc. Ricky Clay, also of Monroe, Ga., said as he smiled and embraced his teammates on the sidelines of the football field.

Read More..

TSX hits one-week high as RIM surges
















TORONTO (Reuters) – Canada‘s main stock index hit a one-week high on Thursday as higher commodity prices boosted mining stocks and as Research In Motion Ltd shares jumped 11 percent on growing hopes for its new devices.


The market was also supported by data that showed China’s manufacturing sector was picking up steam, a signal of increased demand for Canadian resources.













Research In Motion was up 11.1 percent at C$ 11.36 after National Bank Financial raised its price target on the stock to $ 15, citing “positive sentiment building in the industry” ahead of the launch of its BlackBerry 10 devices.


The stock played the second-biggest role of any single company in leading the market higher.


“The dominant news today is the performance of RIM,” said John Ing, president of Maison Placements Canada.


“The company has had nothing but bad news over the past year, and the stock has been oversold,” he said.


At midmorning, the Toronto Stock Exchange‘s S&P/TSX composite index <.GSPTSE> was up 63.94 points, or 0.53 percent, at 12,164. Earlier in the session, the index hit 12,171.20, its highest level since November 13.


The index’s materials sector, which includes mining stocks, rose 0.7 percent, extending gains made in the previous session on higher prices for gold and other commodities.


Miner Barrick Gold Corp was up 1.2 percent at C$ 35.04. Fertilizer producer Potash Corp gained 1.4 percent to C$ 38.77, while Silver Wheaton Corp was up 1.18 percent at C$ 36.74.


The financial sector rallied for the fifth day, with investors optimistic about quarterly results from Canadian banks, which start reporting next week. The group was up 0.4 percent. Royal Bank of Canada , the country’s biggest bank, was up 0.5 percent at C$ 59.90.


In China, data showed expansion in the manufacturing sector accelerated in November for the first time in 13 months, a sign that the pace of economic growth has revived after seven consecutive quarters of slowdown.


(Reporting by John Tilak; Editing by Peter Galloway)


Wireless News Headlines – Yahoo! News



Read More..

Roche, under fire, offers compromise in flu drug row
















LONDON (Reuters) – Roche has offered an olive branch to scientific critics in a bid to end a bitter row over blockbuster flu drug Tamiflu that has led to calls for a boycott of the Swiss drugmaker’s products.


Tamiflu has been approved by regulators worldwide and stockpiled by many governments in case of a global outbreak – but some researchers claim there is little evidence it works and have lobbied since 2009 for Roche to hand over all its data from clinical trials.













Sales of the drug hit close to $ 3 billion in 2009, due to the H1N1 swine flu pandemic, although they have since declined.


Roche’s pharmaceuticals head said on Thursday he had written to the Cochrane Collaboration, a non-profit group that reviews trial data to assess the value of drugs, offering to set up a multi-party advisory board to review all the Tamiflu data.


The board of experts from academia and private institutions, including Cochrane critics, would then agree on what analyses were useful in assessing Tamiflu’s public health role.


“We think that would be an appropriate, fair and transparent way of handling this debate,” Daniel O’Day said in an interview.


O’Day said complete transparency had to be balanced against the need to protect patient privacy, respect commercial sensitivity and ensure the scientific merit of any statistical analysis.


He stopped short of matching a promise from rival GlaxoSmithKline to make patient-level data from all company-sponsored clinical trials available on a routine basis.


Roche said it had not handed over the full collection of data requested by Cochrane because the group refused to sign a confidentiality agreement.


Cochrane, meanwhile, has accused Roche of stonewalling and urged a boycott of the company’s products until it publishes the missing data. Its campaign to force Roche’s hand has been backed by the respected British Medical Journal.


EU AGENCY PROMISES OPENNESS


The new attempt by Roche to break the deadlock comes as regulators and healthcare experts meet in London to discuss ways to increase transparency over clinical trials.


As Reuters reported in July, the European Medicines Agency (EMA) aims to open its data vaults to systematic scrutiny, after a ruling by the European Ombudsman that keeping data secret is not compatible with the public interest.


Guido Rasi, executive director of the EMA, told the London meeting on Thursday that the question now was “how” to publish clinical trials data not “if” it should be released.


The move puts the EMA ahead of the U.S. Food and Drug Administration (FDA) in terms of data transparency.


The EMA stance is also forcing drug companies to review how far they can keep information they hold on medicines under wraps.


Most companies have committed in recent years to publishing results of clinical trials, either in journals or online, but that openness has not so far extended to the raw data that lies behind those trials.


Britain’s GlaxoSmithKline, however, broke ranks last month when it announced that patient-level data from its clinical trials of approved and failed drugs would be made available to other researchers.


Roche’s O’Day said his company responded to requests for such data on a case-by-case basis, provided scientists were prepared to sign confidentiality agreements if needed, but this did not mean all data should be released as a matter of course.


“To what level data will be shared proactively and constantly is something we need to discuss,” he said.


A Roche spokesman said Cochrane had acknowledged receipt of its proposal for a Tamiflu advisory board but had not given any immediate response.


(Reporting by Ben Hirschler; Editing by Erica Billingham)


Medications/Drugs News Headlines – Yahoo! News



Read More..