Novartis heart failure drug cuts death by 37 percent: study

LOS ANGELES (Reuters) – An experimental Novartis AG drug to treat hospitalized acute heart failure patients reduced deaths by 37 percent compared with a placebo and appeared to be safe, according to data from a late stage clinical trial presented on Tuesday.

The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is considered one of the most important medicines in the Swiss drugmaker’s developmental pipeline.

“With a meaningful mortality benefit, we believe Serelaxin could represent a $ 2.5 billion (annual) sales opportunity,” Deutsche Bank analysts said in a research note prior to release of the final data at the American Heart Association scientific meeting in Los Angeles.

Novartis said it now planned to seek approval for serelaxin. In the study of 1,161 patients, the drug cut deaths from any cause at six months by 37 percent and led to a marked reduction in worsening of heart failure during hospitalization, researchers said.

Patients who received 48 hours of continuously infused serelaxin experienced more than 45 percent fewer episodes of worsening heart failure symptoms than those who got a placebo.

Novartis had previously disclosed that serelaxin met one of the study’s two primary goals measuring relief of dyspnea, or extreme shortness of breath – a common symptom of acute heart failure – and that it reduced deaths. But the company did not say by how much. By one measure, serelaxin led to a 19 percent improvement in dyspnea, researchers said.

The drug failed to hit a secondary goal of the study that combined cardiovascular death with need for reshospitalizations, but researchers felt the life saving benefit was more important.

“We did have a startling death benefit. One of the reasons there may have been an inability to show a decrease in hospitalizations is more patients were alive to be rehospitalized,” said Dr John Teerlink, one of the trial’s co-lead researchers.

The data showed that only 29 acute heart failure patients would have to be treated with serelaxin to prevent one cardiovascular death, said Teerlink, a cardiologist and heart failure specialist at the San Francisco VA Medical Center.

Doctors say there is an enormous need for a treatment for acute heart failure, with few available options for the condition in which the heart is unable to pump enough blood.

“If it was approved we would not only use it, there would be a mandate to use it because we don’t have anything for acute decompensated heart failure,” said Dr. Milton Packer, a prominent cardiologist from the University of Texas Southwest Medical Center in Dallas, who was not involved in the study.

“If that mortality finding is real, boy are we going to get excited,” said Packer, who has been a member of FDA advisory panels for heart drugs.

There are more than one million hospitalizations in the United States each year for acute heart failure and another million in Europe. About half of all patients die within five years of diagnosis, often as a result of acute episodes that require urgent hospital care.

TREATMENT BENEFITS

The study showed the Novartis drug also reduced the duration of time spent in intensive care units by almost half a day and cut the length of hospital stay by almost a full day.

There was no difference in serious side effects between the two groups, but there was a significant increase in kidney impairment in the placebo group, as the Novartis drug appears to prevent worsening of kidney function, researchers said.

Despite missing some of the pre-set end points, or goals, of the study, Novartis said it is likely to seek approval of the drug based on the trial results.

“We believe this is a strong set of data and have started discussions with the main regulatory agencies. Our filing strategy will be determined by the outcome of these discussions,” said Ameet Nathwani, Novartis’ global business franchise head for critical care.

Dr John McMurry of the University of Glasgow, who was on a panel to critique the study, said that if there were a second serelaxin trial that also showed a mortality benefit it would be hard for health regulators to ignore.

“I think the agent was beneficial. This drug is doing something good in terms of relief,” he said.

(Reporting by Bill Berkrot and Deena Beasley. Editing by Andre Grenon and Richard Pullin)

Medications/Drugs News Headlines – Yahoo! News

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Race for the White House: Join us live

By Lylah M. Alphonse An unexpected glitch almost caused one central Pennsylvania voter to cast his ballot for the wrong candidate, highlighting concerns about voter fraud in a number of states on an already tense Election Day. [Related: Election Results from Yahoo! News] Among the issues are ballot-scanning problems, which have been reported in Ohio [...]Read More

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Methane warnings ignored before NZ mine disaster

WELLINGTON, New Zealand (AP) — A New Zealand coal mining company ignored 21 warnings that methane gas had accumulated to explosive levels before an underground explosion killed 29 workers two years ago, an investigation concluded.

The official report released Monday after 11 weeks of hearings on the disaster found broad safety problems in New Zealand workplaces and said the Pike River Coal company was exposing miners to unacceptable risks as it strove to meet financial targets.

“The company completely and utterly failed to protect its workers,” New Zealand Prime Minister John Key said Monday.

The country’s labor minister, Kate Wilkinson, resigned from her labor portfolio after the report’s release, saying she felt it was the honorable thing to do after the tragedy occurred on her watch. She plans to retain her remaining government responsibilities.

The Royal Commission report said New Zealand has a poor workplace safety record and its regulators failed to provide adequate oversight before the explosion.

At the time of the disaster, New Zealand had just two mine inspectors who were unable to keep up with their workload, the report said. Pike River was able to obtain a permit with no scrutiny of its initial health and safety plans and little ongoing scrutiny.

Key said he agrees with the report’s conclusion that there needs to be a philosophical shift in New Zealand from believing that companies are acting in the best interests of workers to a more proscriptive set of regulations that forces companies to do the right thing.

The commission’s report recommended a new agency be formed to focus solely on workplace health and safety problems. It also recommended a raft of measures to strengthen mine oversight.

Key said his government would consider the recommendations and hoped to implement most of them. He would not commit on forming a new agency. Workplace safety issues are currently one of the responsibilities of the Ministry of Business, Innovation and Employment.

In the seven weeks before the explosion, the Pike River company received 21 warnings from mine workers that methane gas had built up to explosive levels below ground and another 27 warnings of dangerous levels, the report said. The warnings continued right up until the morning of the deadly explosion.

The company used unconventional methods to get rid of methane, the report said. Some workers even rigged their machines to bypass the methane sensors after the machines kept automatically shutting down — something they were designed to do when methane levels got too high.

The company made a “major error” by placing a ventilation fan underground instead of on the surface, the report found. The fan failed after the first of several explosions, effectively shutting down the entire ventilation system. The company was also using water jets to cut the coal face, a highly specialized technique than can release large amounts of methane.

The report did not definitively conclude what sparked the explosion itself, although it noted that a pump was switched on immediately before the explosion, raising the possibility it was triggered by an electrical arc.

The now-bankrupt Pike River Coal company is not defending itself against charges it committed nine labor violations related to the disaster. Former chief executive Peter Whittall has pleaded not guilty to 12 violations and his lawyers say he is being scapegoated.

An Australian contractor was fined last month for three safety violations after its methane detector was found to be faulty at the time of the explosion.

Australia / Antarctica News Headlines – Yahoo! News

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Apple sells three million iPads over first weekend

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Rare John Lennon letter to Eric Clapton up for auction

LOS ANGELES (Reuters) – John Lennon held out the promise he could bring out more musical greatness in legendary guitarist Eric Clapton in a letter that could fetch as much as $ 30,000 when it is sold at auction next month, the organizers of the sale said on Monday.

The signed, hand-written letter by the Beatle, who died in 1980 at the age of 40, is one of a selection from some of the world’s great musicians that will go under the hammer in Los Angeles at the Profiles in History auction on December 18.

In a draft letter dated September 29, 1971, Lennon expressed his respect and admiration for British guitarist Clapton and suggested that they form a band together.

“Eric, I know I can bring out something great, in fact greater in you that had been so far evident in your music. I hope to bring out the same kind of greatness in all of us, which I know will happen if/when we get together,” Lennon wrote in the letter.

The letter will hold special significance for Beatles fans as auctioneer Joe Maddalena said it was widely known that there were problems in the Fab Four’s relationships with each other, and that Clapton had almost become a Beatle.

Clapton played in the Plastic Ono Band, formed by Lennon and Yoko Ono in 1969 before the breakup of the Beatles in 1970. He also played on the George Harrison song “While My Guitar Gently Weeps”, which was on the Beatles’ White Album.

“There was a point in time when George Harrison thought about leaving the band and his replacement was Clapton, so this letter is a link of what could have been,” Maddalena said.

The letter is one of 300 manuscripts and letters from literary, musical and political greats, that will be auctioned from the holdings of an American collector.

“What we know of history is from the written word, without these letters, it would all be verbal. It’s a really unique area of collecting as you’re getting a glimpse into people’s minds,” Maddalena said.

Other highlights include a handwritten letter from George Washington, with a pre-sale estimate of up to $ 300,000, and a Charles Dickens manuscript with an obituary of novelist William Thackeray, expected to fetch between $ 40,000 and $ 60,000.

Also on the auction block is a signed, handwritten letter from German composer Ludwig van Beethoven to Tobias Haslinger, a friend of his publisher, in which the musician discussed the second performance of his Ninth Symphony and the Missa Solemnis, two of his most revered works.

The letter, written in German, is undated, but both the Ninth Symphony and Missa Solemnis debuted in performances in 1824. Because of the rarity of the letter, it is estimated it will sell for between $ 40,000 and $ 60,000.

Other items going under the hammer include a signed letter in Russian by composer Peter Ilyich Tchaikovsky, which has a pre-sale estimate of $ 10,000 to $ 15,000, and a letter by composer George Gershwin dated March 24, 1932, in which he compares his compositions “Rhapsody in Blue” and “An American in Paris”.

The Gershwin letter is expected to sell for as much as $ 3,000, according to the auction house.

(Reporting By Piya Sinha-Roy; editing by Patricia Reaney; and Peter Galloway)

Music News Headlines – Yahoo! News

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Appeals court questions Arizona’s late-term abortion ban

SAN FRANCISCO (Reuters) – A federal appeals court panel on Monday sharply questioned lawyers defending an Arizona law that bans late-term abortions starting at 20 weeks of pregnancy except in medical emergencies, which opponents say is the toughest in the United States.

In San Francisco, a three-judge panel of the 9th U.S. Circuit Court of Appeals heard the case after it blocked the Republican-backed Arizona law from going into effect earlier this year. Three abortion providers challenged the law in court.

The Arizona law bars doctors from performing abortions starting at 20 weeks of pregnancy, except in medical emergencies, and could send doctors who perform them to jail.

The American Civil Liberties Union, which is suing to stop the law, said it was more extreme than similar laws elsewhere, because the way Arizona measures gestation means it would bar abortions two weeks earlier than in other states.

Those states also set the limit at 20 weeks but have different ways to calculate gestation time. Arizona already bans abortions at the point of viability, when a fetus might survive outside the womb, generally at 23 to 24 weeks.

Judge Andrew Kleinfeld, a panel member appointed by former President George H.W. Bush, repeatedly expressed concern that the law might not afford women the opportunity to abort a fetus with birth defects in cases where the defects are not apparent until just before 20 weeks.

He also questioned the need to prohibit abortions at that stage of the pregnancy, especially for fetuses bound to develop “horrible birth defects.”

“They’re basically born into hell and then die,” Kleinfeld said. “I don’t see how the courts could act before viability” of the fetus.

“With due respect, that’s the woman’s problem,” responded David Cole, Arizona’s solicitor general. “She should have made that decision earlier.”

William Montgomery, the attorney for Maricopa County in Arizona who also defended the law before the appeals panel, said new medical evidence showed a fetus has the capacity to feel pain during an abortion at 20 weeks of development.

But Judge Marsha Siegel Berzon called that a “red herring” in terms of the constitutional questions the law raises.

The three-judge panel did not say when it could make a final ruling in the case. The U.S. Supreme Court legalized abortion nationwide in 1973, but has allowed states to place restrictions on the procedure from the time of viability unless the woman’s health was at risk.

In July, days before the 9th Circuit panel blocked the law until it could fully consider the case, U.S. District Judge James Teilborg ruled that the Arizona measure was consistent with limits federal courts have allowed.

Talcott Camp, deputy director of the ACLU reproductive freedom project, said the Arizona law’s exception to allow late-term abortion applies only in immediate emergencies if delay can jeopardize a woman’s life or seriously harm her health.

“The medical emergency exception is truly, horrifically narrow,” she said in a phone interview. “This is a law that allows her to get an abortion only when she is in emergency crisis.”

Aside from Arizona, seven U.S. states have put laws into effect in the past two years banning late-term abortions, based on hotly debated medical research suggesting a fetus feels pain starting at 20 weeks of gestation, according to the ACLU.

(Editing by Alex Dobuzinskis and Cynthia Johnston. Desking by Christopher Wilson)

Health News Headlines – Yahoo! News

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Newspaper discloses new Cameron text messages

LONDON (AP) — A British lawmaker says he’s asked the country’s media ethics inquiry to consider newly disclosed text messages sent between Prime Minister David Cameron and Rebekah Brooks, the ex-chief executive of Rupert Murdoch‘s British newspaper division.

The Mail on Sunday newspaper on Sunday published two previously undisclosed messages exchanged between the pair, who are friends and neighbors.

Brooks is facing trial on conspiracy charges linked to Britain’s phone hacking scandal, which saw Murdoch close down The News of The World tabloid.

In one newly disclosed message, Cameron thanked Brooks in 2009 for allowing him to borrow a horse, joking it was “fast, unpredictable and hard to control but fun.”

Opposition lawmaker Chris Bryant has asked a judge-led inquiry scrutinizing ties between the press and the powerful to examine the messages.

Europe News Headlines – Yahoo! News

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Google's Android software in 3 out of 4 smartphones

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Dizzying array of media streams spotlight election

NEW YORK (AP) — The days of watching Election Night coverage on a single television set may soon be a quaint anachronism.

Americans have an array of alternatives for following returns on Tuesday night. Television news divisions are throwing everything they have into the story. People will be able to construct their own media experiences, seek out desired information instead of waiting for it, participate in conversations and hear analysis that reflects their own perspectives or none in particular.

Virtually all of the media organizations covering the election promise an abundance of information available online, from interactive maps that display state-by-state results to data from exit polls.

It’s expected to be a huge night for social media. And news organizations say they will monitor the conversations and have their own journalists actively participate.

Entertainment News Headlines – Yahoo! News

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Bypass tops stents in diabetics with diseased arteries

LOS ANGELES (Reuters) – Diabetics with more than one diseased artery fared significantly better if they underwent bypass surgery than those who received drug coated stents following artery clearing procedures to improve blood flow to the heart, according to data from a five-year study presented on Sunday.

After five years, the bypass group had a lower combined rate of heart attacks, strokes and deaths of 18.7 percent versus 26.6 percent for the stent group in the 1,900-patient study funded by the U.S. National Institutes of Health.

The result was deemed to be highly statistically significant, researchers said.

Previous studies had demonstrated the superiority of bypass surgery over the use of bare metal stents – tiny mesh tubes used to prop open cleared arteries. Researchers suspected that newer stents coated with drugs to prevent reclogging might negate some of the bypass advantage, but that turned out not to be the case.

“The advantages were striking in this trial and could change treatment recommendations for thousands of individuals with diabetes and heart disease,” said Dr. Valentin Fuster, from Mount Sinai School of Medicine in New York, who presented the findings at the American Heart Association scientific meeting in Los Angeles.

There was a higher incidence of stroke in bypass patients — 5.2 percent versus 2.4 percent. Stroke is a known risk of the surgical procedure in which a piece of a healthy blood vessel from another part of the body is grafted on to re-route blood flow around a blocked heart artery.

But deaths from any cause were significantly lower with bypass surgery than those who received artery clearing angioplasty and a drug eluting stent – 10.9 percent compared with 16.3 percent. There were also twice as many heart attacks among diabetics in the stent group within five years – 99 vs 48, which Fuster called “very significant.”

More than one million bypass surgeries or stenting procedures are performed in the United States each year and some 25 to 30 percent of those involve diabetics with multiple diseased arteries, researchers said.

If the results of this study alter clinical practice, it could eat into lucrative profits of the companies that sell drug coated stents, such as Abbott Laboratories, Boston Scientific Corp and Medtronic Inc. Boston Scientific and Johnson & Johnson supplied the stents used in the study, but J&J has since exited the stent business.

Dr. David Williams of Brigham and Women’s Hospital in Boston, who was not involved in the study, called the results “very convincing.”

“I think the (treatment) guidelines will recognize this and I do think it will be adopted,” he said.

However, Fuster cautioned that longer term follow-up of patients was necessary.

“We always want to know how long the effects last,” he said. “The gap could begin to close or the results could get better and better.”

(Reporting by Bill Berkrot and Deena Beasley; Editing by Marguerita Choy)

Medications/Drugs News Headlines – Yahoo! News

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