Extended Use of Breast Cancer Drug Suggested

The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long as is now customary, a finding that could upend the standard that has been in place for about 15 years.

In the study, patients who continued taking tamoxifen for 10 years were less likely to have the cancer come back or to die from the disease than women who took the drug for only five years, the current standard of care.

“Certainly, the advice to stop in five years should not stand,” said Prof. Richard Peto, a medical statistician at Oxford University and senior author of the study, which was published in The Lancet on Wednesday and presented at the San Antonio Breast Cancer Symposium.

Breast cancer specialists not involved in the study said the results could have the biggest impact on premenopausal women, who account for a fifth to a quarter of new breast cancer cases. Postmenopausal women tend to take different drugs, but some experts said the results suggest that those drugs as well might be taken for a longer duration.

“We’ve been waiting for this result,” said Dr. Robert W. Carlson, a professor of medicine at Stanford University. “I think it is especially practice-changing in premenopausal women because the results do favor a 10-year regimen.”

Dr. Eric P. Winer, chief of women’s cancers at the Dana-Farber Cancer Institute in Boston, said that even women who completed their five years of tamoxifen months or years ago might consider starting on the drug again.

Tamoxifen blocks the effect of the hormone estrogen, which fuels tumor growth in estrogen receptor-positive cancers that account for about 65 percent of cases in premenopausal women. Some small studies in the 1990s suggested that there was no benefit to using tamoxifen longer than five years, so that has been the standard.

About 227,000 cases of breast cancer are diagnosed each year in the United States, and an estimated 30,000 of them would be in premenopausal women with ER-positive cancer and prime candidates for tamoxifen. But postmenopausal women also take tamoxifen if they cannot tolerate the alternative drugs, known as aromatase inhibitors.

The new study, known as Atlas, included nearly 7,000 women with ER-positive disease who had completed five years of tamoxifen. They came from about three dozen countries. Half were chosen at random to take the drug another five years, while the others were told to stop.

In the group assigned to take tamoxifen for 10 years, 21.4 percent had a recurrence of breast cancer in the ensuing ten years, meaning the period 5 to 14 years after their diagnoses. The recurrence rate for those who took only five years of tamoxifen was 25.1 percent.

About 12.2 percent of those in the 10-year treatment group died from breast cancer, compared with 15 percent for those in the control group.

There was virtually no difference in death and recurrence between the two groups during the five years of extra tamoxifen. The difference came in later years, suggesting that tamoxifen has a carry-over effect that lasts long after women stop taking it.

Whether these differences are big enough to cause women to take the drug for twice as long remains to be seen.

“The treatment effect is real, but it’s modest,” said Dr. Paul E. Goss, director of breast cancer research at the Massachusetts General Hospital.

Tamoxifen has side effects, including endometrial cancer, blood clots and hot flashes, which cause many women to stop taking the drug. In the Atlas trial, it appears that roughly 40 percent of the patients assigned to take tamoxifen for the additional five years stopped prematurely.

Some 3.1 percent of those taking the extra five years of tamoxifen got endometrial cancer versus 1.6 percent in the control group. However, only 0.6 percent of those in the longer treatment group died from endometrial cancer or pulmonary blood clots, compared with 0.4 percent in the control group.

“Over all, the benefits of extended tamoxifen seemed to outweigh the risks substantially,” Trevor J. Powles of the Cancer Center London, said in a commentary published by The Lancet.

Dr. Judy E. Garber, director of the Center for Cancer Genetics and Prevention at Dana-Farber, said many women have a love-hate relationship with hormone therapies.

Read More..

DealBook: Freeport to Buy Plains Exploration and McMoRan

Freeport-McMoRan Copper and Gold said on Wednesday that it would buy two oil and natural gas companies, Plains Exploration and Production and the McMoRan Exploration Company, in a return to the energy business.

The two transactions will create a natural resources titan worth about $60 billion, including debt, and will formally reunite Freeport with McMoRan, the oil exploration company it spun off in 1994.

Under the terms of the deals, Freeport will pay about $6.9 billion in cash and stock for Plains. That offer consists of $25 a share in cash and 0.6531 of a Freeport share, worth about $50 a share based on Tuesday’s closing prices.

And Freeport will pay $14.75 a share in cash and 1.15 units of a trust that will hold a 5 percent interest in future production of McMoRan’s deepwater exploration operations. Freeport and Plains together already own about 36 percent of the smaller exploration company.

“This transaction will enable us to add assets with exceptional exploration and development potential to a world-class mining company to create a premier minerals and oil and gas business focused on value creation for shareholders,” James R. Moffett, Freeport’s chairman, said in a statement.

JPMorgan Chase is providing $9.5 billion to help pay for the cash portion of the deal and to repay some of Plains’s existing debt.

Freeport was advised by Credit Suisse and the law firm Wachtell, Lipton, Rosen & Katz. Plains was advised by Barclays and the law firm Latham & Watkins. McMoRan was advised by Evercore Partners and the law firm Weil, Gotshal & Manges.

Read More..

A Utah craftsman races illness to finish a vintage carousel

PETERSBORO, Utah — By any measure, Vean Woodbrey looms large.

Dressed in denim bib overalls, he stands 6 feet 4, weighs 275 pounds and wears size 16 shoes. His children — all 16 of them — jokingly call him Sasquatch because of the cartoonish spread of his footprint. So do many of his 70 grandchildren and great-grandkids.

And then there is the 7-foot-tall wooden giraffe he's carving inside his home workshop in this farming town near the Idaho border. He runs a gnarled hand along the figure's neck, wiping off the sawdust that covers everything like an early season snow.

"It's simple, but there's a certain beauty to it," Woodbrey, 69, said. "The best part is that it came straight out of my imagination."

Woodbrey is an aging craftsman on a mission to finish an amusement-park-sized carousel for his grandchildren and other other youth in this Mormon community before his declining health finally fails him.

As he painstakingly crafts a menagerie of 22 animals — horses, a panda, a zebra, a lion, a tiger, a camel, an elephant and the giraffe — Woodbrey knows time is running out. He has already battled prostate and bone cancer, both of which have slowed his once-loping gait. He also suffers from a neuropathy that numbs the toes in both feet, making him teeter like a child's top in its final throes of movement. To keep his balance in his shop, he holds onto his animals and various saws and sanders.

Every morning, he slowly scales the ramp onto his second-floor workshop to create his imaginary world out of scavenged lumber. Each day is one more sunrise wrung out of a life as a father, community leader, coach and scoutmaster.

"I've got to get this carousel done," he said. "There's this sense of urgency, but I'm inching my way there."

There have been delays: Once he stapled three fingers together with a nail gun. Then he took a fall and broke five toes on one foot. He's already burned through two drills.

He shakes his head. The illness has made him see things so clearly. The doctors say the bone cancer is 85% licked, but that either could return at any time. "When you have cancer, you take an inventory of what you've done, but there's so many things you still want to do," Woodbrey said. "Every day, my wife knows exactly where I am — up in the wood shop with my animals. I'm a man on a time clock."

****

Woodbrey's fondness for carousels dates to his boyhood in San Diego, where his father took the family's four children to a local amusement park. "My dad would buy one ticket he said would go to the eldest — and that was him," he said. "But he'd grab so many brass rings he'd win free tickets so we could all ride."

When the family moved to Salt Lake City, Woodbrey collected soda bottles to redeem for the money to ride the carousel at a local park. If he was lucky, he'd make enough to buy a drink or an ice cream cone.

Years later, after Woodbrey married his wife, Tonya, and they started raising their 16 kids, he took a job at nearby Hill Air Force Base where, for 40 years, he repaired F-4 fighter jets and, later, Minuteman missile systems. At home, he began making wooden dollhouses for his eight daughters and toys for his eight sons.

At age 58, he was struck with prostate cancer. As he lay in the hospital, one of his kids bought him a copy of a magazine dedicated to carousels. Once again, he was hooked — checking each new issue for trends, seeing which old carousels were up for sale.

Eight years later, Woodbrey was treated for a golf-ball-sized tumor in his skull. After weeks of radiation treatments, weary and depressed, he asked his wife, "What am I going to do?"

"She responded: 'Go do whatever you want. Just don't give up.'"

Woodbrey retired from his job at the base and began scouting a carousel to refurbish. He finally found the 7-ton shell of a 1930s Allan Herschell ride — its animals long ago sold off as antiques by the previous owner — for sale in Montana for $5,000

Woodbrey got the contraption home and set to work. One day, he called his eight sons and eight sons-in-law over to the house for a meal. But first the men were instructed to hoist the carousel's 16-foot center pole aloft into the sky and set it into place. They worked together, grunting and sweating, like Amish barn builders. "I told them nobody could eat until we were done," Woodbrey recalled.

Read More..

NASA's Giant New Rocket Goes Supersonic (In a Wind Tunnel)

NASA has a big new rocket in the works, one designed to carry astronauts beyond earth orbit for the first time since the Saturn V took us to the moon. The Space Launch System will, among other things, make a trip to an asteroid, but before it can do that it must make a few trips to the wind tunnel.

The rocket’s first mission beyond earth orbit isn’t expected until 2017, assuming the program doesn’t fall off a fiscal cliff. Right now, NASA engineers are busy finalizing the design of the launch vehicle, testing a 10-foot model in the agency’s transonic tunnel in Langley, Virginia.

“The test includes the largest integrated vehicle model to be tested in a wind tunnel for SLS,” says John Blevins, SLS Lead Engineer for Aerodynamics and Acoustics. “It will simulate the environment of transonic flight that the SLS rocket will navigate during its flight.”

The model will be exposed to speeds up to Mach 1.2. There are 360 pressure transducers spread across the surface of the model, and data is acquired at a rate of thirteen thousand scans per second, according to NASA. The information gleaned from the wind tunnel tests will provide insight into the structural forces the SLS will endure during launch and acceleration from subsonic to supersonic flight.

The first mission will see the SLS launch the Orion spacecraft into lunar orbit as an initial check of the system. It will be an unmanned flight, but NASA hopes to fly astronauts around the moon by 2021 and expand the flight envelope of its new generation of space vehicles.

The Orion capsule has endured numerous kinds of testing in recent years, but it hit a bit of a speed bump recently when small cracks were found in the capsule slated for flight in 2017. The three hairline cracks, each less then two inches long, are located on the bottom of the vehicle. This capsule is expected to be used for a test flight to earth orbit atop a Delta IV rocket in 2014, three years before the SLS will launch an Orion into lunar orbit.

The cracks did not penetrate the aluminum skin of the Orion spacecraft. NASA says a simple fix will distribute the stress across the location where the cracks occurred according to the Denver Post.

“For this flight, since its unmanned, we can fix it and fly it” Orion program manager Mark Geyer told the newspaper. “When we build the one we’re actually going to put people on, we’ll make sure to fix this design.”

With NASA handing off the job of delivering astronauts and cargo to low earth orbit over to commercial companies like SpaceX and Orbital Sciences, the manned space program at the agency is focusing on exploration a bit deeper into space. Orion will be able to carry a four person crew on mission lasting up to 210 days. In addition to possible missions to an asteroid, Orion is also being designed for trips to the moon and Mars. For all trips the capsule would just be part of the space vehicle needed as was the case with the Apollo capsules which used a command module and lunar module for the missions.

Read More..

Howard Stern signs on for more “America’s Got Talent”

LOS ANGELES (Reuters) – Shock jock Howard Stern will return as a judge for his second season on NBC‘s summer talent show “America’s Got Talent,” the broadcaster said on Monday, although the high-priced radio host appears to have done little to improve the show’s ratings.

NBC hoped Stern, 58, known for this sexually explicit radio interviews, would attract bigger audiences, but the finale in September was watched by a record low of under 11 million viewers, according to ratings data.

“Howard Stern’s towering presence and opinions on last season’s show as a new judge made a dramatic impact and added a sharper edge to the fascinating developments on stage,” Paul Telegdy, president of alternative programming at NBC, said in a statement.

The show, which also features celebrity judges Sharon Osbourne and Howie Mandel, remained the top-rated summer series among adults aged 18-49, the demographic most coveted by advertisers.

NBC attributed the overall 2012 audience decline partly to an earlier start that pitted “Got Talent” against end-of-season original programming in May.

The network is still searching for a replacement for Osbourne, who has quit in a dispute with NBC over their decision to drop her son Jack from another reality show.

Unlike popular singing competitions “The Voice,” “The X Factor” and “American Idol,” “America’s Got Talent” is open to dancers, comics, dancers and other performers. It is produced by “The X Factor” creator and judge Simon Cowell.

Stern is noted for his say-anything and do-anything radio program but he toned down his act when he started appearing as a judge on the show.

(Reporting by Eric Kelsey; Editing by Jill Serjeant)

TV News Headlines – Yahoo! News

Read More..

National Briefing | New England: New Hampshire: Not Guilty Plea in Hepatitis Case

A traveling hospital technologist accused of stealing drugs and infecting patients with hepatitis C through contaminated syringes pleaded not guilty in federal court on Monday. The technologist, David Kwiatkowski, whom prosecutors described as a “serial infector,” was indicted last week on charges of tampering with a consumer product and illegally obtaining drugs. Until May, Mr. Kwiatkowski worked as a cardiac technologist at Exeter Hospital, where 32 patients were given diagnoses of the same strain of hepatitis C he carries. Before that, he worked in 18 hospitals in seven states, moving from job to job despite having been fired twice over accusations of drug use and theft. In addition to the New Hampshire patients, a handful of patients in Kansas and one in Maryland have been found to carry the strain Mr. Kwiatkowski carries.

Read More..

Generic Drug Makers Facing Squeeze on Revenue

They call it the patent cliff.

Brand-name drug makers have feared it for years. And now the makers of generic drugs fear it, too.

This year, more than 40 brand-name drugs — valued at $35 billion in annual sales — lost their patent protection, meaning that generic companies were permitted to make their own lower-priced versions of well-known drugs like Plavix, Lexapro and Seroquel — and share in the profits that had exclusively belonged to the brands.

Next year, the value of drugs scheduled to lose their patents and be sold as generics is expected to decline by more than half, to about $17 billion, according to an analysis by Crédit Agricole Securities.“The patent cliff is over,” said Kim Vukhac, an analyst for Crédit Agricole. “That’s great for large pharma, but that also means the opportunities theoretically have dried up for generics.”

In response, many generic drug makers are scrambling to redefine themselves, whether by specializing in hard-to-make drugs, selling branded products or making large acquisitions. The large generics company Watson acquired a European competitor, Actavis, in October, vaulting it from the fifth- to the third-largest generic drug maker worldwide.

“They are certainly saying either I need to get bigger, or I need to get ‘specialer,’ ” said Michael Kleinrock, director of research development at the IMS Institute for Healthcare Informatics, a health industry research group. “They all want to be special.”

As one consequence of the approaching cliff, executives for generic drug companies say, they will no longer be able to rely as much on the lucrative six-month exclusivity periods that follow the patent expirations of many drugs. During those periods, companies that are the first to file an application with the Food and Drug Administration, successfully challenge a patent and show they can make the drug win the right to sell their version exclusively or with limited competition.

The exclusivity windows can give a quick jolt to companies. During the first nine months of 2012, sales of generic drugs increased by 19 percent over the same period in 2011, to $39.1 billion from $32.8 billion, according to Michael Faerm, an analyst for Credit Suisse. Sales of branded drugs, by contrast, fell 4 percent during the same period, to $174.2 billion from $181.3 billion.

But those exclusive periods also make generic drug makers vulnerable to the fickle cycle of patent expiration. “The only issue is it’s a bubble, too,” said Mr. Kleinrock. He said next year, the generic industry would enter a drought that was expected to last about two years.  Of the drugs that are becoming generic, fewer have exclusivity periods dedicated to a single drug maker.

In 2013, for example, the antidepressant Cymbalta, sold by Eli Lilly, is scheduled to be available in generic form. But more than five companies are expected to share in sales during the first six months, according to a report by Ms. Vukhac.

Heather Bresch, the chief executive of Mylan, the second-largest generics company in the United States, said Wall Street analysts were obsessed with the issue. “I can’t go anywhere without being asked about the patent cliff, the patent cliff, the patent cliff,” she said. “The patent cliff is one aspect of a complex, multilayered landscape, and I think each company is going to face it differently.”

Jeremy M. Levin, the chief executive of Teva Pharmaceuticals, the largest global maker of generic drugs, agreed. “The concept of exclusivity — where only one generic player could actually make money out of the unique moment — has diminished,” he said. “In the absence of that, many companies have had to really ask the question, ‘How do I really play in the generics world?’ ”

For Teva, Mr. Levin said, he believes the answer will be both its reach  — it sells 1,400 products, and one in six generic prescriptions in the United States is filled with a Teva product  — and what he says is a reputation for making quality products. That focus will be increasingly important, he said, given recent statements by the F.D.A. that it intends to take a closer look at the quality of generic drugs. Mr. Levin also said he planned to cut costs, announcing last week that he intended to trim from $1.5 to $2 billion in expenses over the next five years.

This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of this article misstated the country in which the pharmaceutical company Endo is based. It is an American company, not Japanese.

Read More..

Supreme Court keeps California in suspense on gay marriage

By Jessica Garrison, Los Angeles Times

December 3, 2012, 7:27 a.m.

The U.S. Supreme Court did not address the California gay-marriage case on Monday morning. The next time they can consider it is on Friday.

The case against Proposition 8, the 2008 ballot initiative that banned gay marriage in California, had been discussed by justices last Friday, but was not on the list of cases the court said it would review.

Many speculated that the court might have decided not to take the case, which would let an appeals court ruling on the matter stand. The 9th Circuit Court of Appeals found earlier this year that Proposition 8 was unconstitutional, clearing the way for same-sex marriage in California unless the Supreme Court decides to get involved.

But the matter will remain in suspense for a while longer. The court could continue to discuss the case at conferences this year and early next year in advance of possibly hearing the case in June. They could also hold the matter over for the fall. 

Gay-marriage activists expressed disappointment that there was no news Monday.

"We understand that it is a complex case, and if they need another week to reach the right decision, we're fine with that," said Adam Umhoefer, executive director of the American Foundation for Equal Rights, which is fighting to overturn Proposition 8.

Read More..

Induction Charging Comes to Public Transit

Say goodbye to catenary wires. Utah State University has unveiled an electric bus that charges through induction, topping off its batteries whenever it stops to pick up passengers.

Designed by USU’s Wireless Power Transfer team and the Utah Science Technology and Research initiative’s Advanced Transportation Institute, the prototype Aggie Bus is already on the road. It uses the same wireless charging principle as an electric toothbrush or a wireless smartphone charger, except optimized for a massive public-transit vehicle.

As in all modern inductive-charging setups, a transformer is “split” between the bus and a charge plate under the bus stop. When the bus drives over the charging plate, current flows with no physical contact required. Engineers at USU designed their system so that the Aggie Bus can be misaligned up to 6 inches from the charge plate and still get 25kW of power and 90 percent efficiency from the power grid to the battery.

Because of the fixed routes they run and frequent stops they make, induction charging is ideal for buses. Instead of charging up a massive battery overnight before a route, the Aggie Bus features a smaller battery setup that recharges every time the bus reaches a predetermined stop. The smaller batteries free up interior space, reduce downtime and lower battery costs — although induction plates must be added to bus stops.

Though the Aggie Bus is a working prototype, USU is working with Wireless Advanced Vehicle Electrification (WAVE) — a company spun-out from USU — in order to bring a commercialized bus to market. In mid-2013, WAVE and the Utah Transit Authority are planning to unveil a 40-foot induction-charged transit bus on the USU campus that’s capable of taking a 50kW charge. The project was funded by USU, who will purchase the bus, and a $2.7 million grant from the Federal Transit Administration.

Charging a bus through induction may be a new idea in the U.S., but bus routes with similar wireless charging systems have been in place in Torino, Italy, since 2003 and Utrecht, the Netherlands, since 2010. Ideally, induction charging would be used in city centers to replace noisy, smoky diesel buses. It would also work on already electrified routes, allowing cities to take down unsightly hanging catenary wires.

Read More..

Led Zeppelin will Reunite – for “Letterman” interview

LOS ANGELES (TheWrap.com) – The surviving members of Led Zeppelin will make a rare appearance together on “Late Show With David Letterman” on December 3, CBS said Friday.

Jimmy Page, Robert Plant and John Paul Jones will drop in on the late-night show for an interview – which isn’t quite the reunion that Zep fans have been patiently waiting for, but it might have to do. With the exception of a one-off tribute concert for Atlantic Records founder Ahmet Ertegun at London’s O2 Arena in 2007 – which was released as the DVD “Celebration Day” in October – Jones has largely been estranged from Page and Plant since the group’s 1980 breakup following drummer John Bonham‘s death.

The “Late Show” appearance won’t be the only time that Letterman hangs out with the rock legends – the group, along with Letterman, will be lauded at the 35th Annual Kennedy Center Honors in Washington, D.C., which will take place December 2 and air December 26 on CBS.

Music News Headlines – Yahoo! News

Read More..