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 might be taken for a longer duration as well.

“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 are in premenopausal women with estrogen receptor-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 10 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.

“They don’t feel well on them, but it’s their safety net,” said Dr. Garber, who added that the news would be welcomed by many patients who would like to stay on the drug. “I have patients who agonize about this, people who are coming to the end of their tamoxifen.”

Emily Behrend, who is a few months from finishing her five years on tamoxifen, said she would definitely consider another five years. “If it can keep the cancer away, I’m all for it,” said Ms. Behrend, 39, a single mother in Tomball, Tex. She is taking the antidepressant Effexor to help control the night sweats and hot flashes caused by tamoxifen.

Cost is not considered a huge barrier to taking tamoxifen longer because the drug can be obtained for less than $200 a year.

The results, while answering one question, raise many new ones, including whether even more than 10 years of treatment would be better still.

Perhaps the most important question is what the results mean for postmenopausal women. Even many women who are premenopausal at the time of diagnosis will pass through menopause by the time they finish their first five years of tamoxifen, or will have been pushed into menopause by chemotherapy.

Postmenopausal patients tend to take aromatase inhibitors like anastrozole or letrozole, which are more effective than tamoxifen at preventing breast cancer recurrence, though they do not work for premenopausal women.

Mr. Peto said he thought the results of the Atlas study would “apply to endocrine therapy in general,” meaning that 10 years of an aromatase inhibitor would be better than five years. Other doctors were not so sure.

The Atlas study was paid for by various organizations including the United States Army, the British government and AstraZeneca, which makes the brand-name version of tamoxifen.

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ICC lets ComEd delay smart meters until 2015

The Illinois Commerce Commission on Wednesday approved ComEd's request to delay the installation of smart meters until 2015 but said it will revisit the issue in April when the utility is scheduled to file a progress report on the program.

Under massive grid modernization legislation, ComEd was supposed to begin installing smart meters this year, but the ICC cut the funds ComEd was expecting to receive under the program and the utility said it could no longer afford to install the meters that quickly. The two sides are battling in court in a process that could take years.

An administrative law judge, as well as several consumer advocacy groups, had recommended the commission not accept the delay.

Jim Chilsen, spokesman for Citizens Utility Board, said a delay is not in the best interest of consumers. According to a ComEd commissioned analysis, the delay means consumers will miss out on approximately $187 million in savings that could come from the program over 20 years and will pay $5 million more for the smart meters. Chilsen said that CUB, which had urged the commission not to delay the program, will review the order once it becomes available and that it could seek to appeal the decision before the Illinois Appeals Court.

Other aspects of smart grid installation are under way, including "smart switches" used to automatically isolate outages and reroute power to customers. However, smart meters are the most consumer facing aspect smart grid and let the utility track on a computer what customers lack power and those who have had power restored.

Without the smart meters, customers must alert ComEd to an outage. Other parts of smart grid allow ComEd to see where the power is out in general.

The smart meters were a major component in ComEd's pitch to the state legislature for massive regulatory overhaul legislation that streamlines the rate-making processto give ComEd faster and more frequent rate hikes as it undertakes the multibillion-dollar grid modernization.

jwernau@tribune.com | Twitter @littlewern

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Hamstring strain could sideline Urlacher for season

The Bears have to brace themselves for the possibility of Brian Urlacher missing at least the rest of the regular season.

Multiple sources told the Tribune that Urlacher won't play for the next three games at a minimum after suffering a Grade 2 right hamstring strain during Sunday's 23-17 overtime loss to the Seahawks. An MRI confirmed the severity of Urlacher's injury.

What will the Bears be without him? Nick Roach is expected to make his fourth-career start at middle linebacker in place of Urlacher, with Geno Hayes expected to take Roach's usual strong-side linebacker spot.

The Bears (8-4) have four more regular-season games, starting with Sunday's division matchup against the Vikings in Minnesota. Urlacher hopes to recover in time for the playoffs, which start with wild-card weekend games Jan. 5-6.

If the playoffs started today, the Bears would be the fifth seed against the fourth-seeded and NFC East-leading Giants (7-5). To remain in playoff contention, the Bears need to win at least two of their final four games against the Vikings (6-6), Packers (8-4), Cardinals (4-8), and Lions (4-8).

Urlacher's return in a month, however, might be a long shot considering the severity of the injury.

Gus Gialamas, an orthopedic surgeon from Sea View Orthopedic Medical Group in San Clemente, Calif., said a Grade 2 hamstring typically takes four to six weeks of recovery.

"Grade 2 means it's not a complete rupture, but it's a partial rupture,'' Gialamas said. "It takes a while -- maybe a week to 10 days -- for the inflammation to stop. That muscle then has to heal, and then you have a lot of physical therapy for strengthening and stretching. The goal is to avoid as much scar tissue in the hamstring as possible.

"I'm thinking he would be lucky to come back in four weeks, and I wouldn't be surprised if it was longer than that. It's just a tough injury.''

When reached by the Tribune, Urlacher declined to discuss the injury or his playing status. He initially felt a "pop'' while chasing Seahawks quarterback Russell Wilson near the sideline during overtime. Urlacher pulled himself from the game before the final play.

The eight-time Pro Bowler entered the 2012 season still recovering from a serious knee injury. He sprained the medial collateral ligament and partially sprained the posterior cruciate ligament in his left knee during last year's season finale against the Vikings.

Despite sitting out some practices to rest his knee, Urlacher started the first 12 games.

The Bears are 7-15 without Urlacher since he entered the league in 2000.

"He's the leader of our defense,'' defensive tackle Henry Melton said Tuesday. "He's a huge locker room guy. We love having him around. He's what Chicago Bears football is all about.''

Nevertheless, Melton expressed confidence in Roach.

"Nick has been rotating (at middle linebacker in practice) just in case measures called for it,'' Melton said. "It's not going to be the same without Brian, of course. But Nick can get the job done.''

The 34-year-old Urlacher has base salary of $7.5 million in this, the final year of his contract. He expressed a desire to play at least two more seasons, depending on his health. His says his knee feels better than ever after multiple procedures. Now, it's a matter of how long the hamstring strain lingers.

General manager Phil Emery wouldn't commit to re-signing the future Hall of Famer and said any contract offers would be based on performance. Urlacher has made a statement with a team-leading 88 tackles, one interception return for a touchdown, three forced fumbles and two fumble recoveries. He was named the NFC's Defensive Player of the Week following his Week 9 performance against the Titans.

vxmcclure@tribune.com

Twitter @vxmcclure23

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Huston’s “Infrared” wins Bad Sex fiction prize

LONDON (AP) — It’s the prize no author wants to win.

Award-winning novelist Nancy Huston won Britain’s Bad Sex in Fiction award Tuesday for her novel “Infrared,” whose tale of a photographer who takes pictures of her lovers during sex proved too revealing for the judges.

The choice was announced by “Downton Abbey” actress Samantha Bond during a ceremony at the Naval & Military Club in London.

Judges of the tongue-in-cheek prize — which is run by the Literary Review magazine — said they were struck by a description of “flesh, that archaic kingdom that brings forth tears and terrors, nightmares, babies and bedazzlements,” and by a long passage that builds to a climax of “undulating space.”

Huston, who lives in Paris, was not on hand to collect her prize. In a statement read by her publicist, the 59-year-old author said she hoped her victory would “incite thousands of British women to take close-up photos of their lovers’ bodies in all states of array and disarray.”

The Canada-born Huston, who writes in both French and English, is the author of more than a dozen novels, including “Plainsong” and “Fault Lines.” She has previously won France’s Prix Goncourt prize and was a finalist for Britain’s Orange Prize for fiction by women.

She is only the third woman to win the annual Bad Sex prize, founded in 1993 to name and shame authors of “crude, tasteless and … redundant passages of sexual description in contemporary novels.”

Some critics, however, have praised the sexual passages in “Infrared.” Shirley Whiteside in the Independent on Sunday newspaper said there were “none of the lazy cliches of pornography or the purple prose of modern romantic fiction” — though she conceded the book’s sex scenes were “more perfunctory than erotic.”

Huston beat finalists including previous winner Tom Wolfe — for his passage in “Back to Blood” describing “his big generative jockey” — and Booker Prize-nominated Nicola Barker, whose novel “The Yips” compares a woman to “a plump Bakewell pudding.”

Previous recipients of the dubious honor, usually accepted with good grace, include Sebastian Faulks, the late Norman Mailer and the late John Updike, who was awarded a Bad Sex lifetime achievement award in 2008.

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Online: http://www.literaryreview.co.uk

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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 5, 2012

An article on Tuesday about business strategies of generic drug makers in the face of fewer drug patent expirations misidentified the country in which the pharmaceutical company Endo is based. It is in the United States, not Japan.

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South Loop residents oppose DePaul arena

The prospect of a DePaul University men's basketball arena being constructed on land just north of McCormick Place is drawing strong opposition from the Prairie District Neighborhood Alliance, a South Loop residents' organization, according to a letter released Tuesday.
 
A survey of 700 neighbors of the site, conducted by the community group, found more than 70 percent oppose construction of a Blue Demons arena there, Tina Feldstein, president of the organization, stated in the letter.
 
An arena would not fit within the residential and historic character of the area and could put two landmark structures, the Harriet F. Rees House and the American Book Co. building, at risk, the letter stated. It would also add to traffic congestion and potential rowdiness in an area already overburdened when conventions are in progress at McCormick Place or major events, including Chicago Bears games, are taking place at Soldier Field, Feldstein said in an interview.
 
"We're not against vibrant development, which hotel and retail would bring," Feldstein said. And the group would support an arena at an alternate site on the Near South Side, she said.
 
The letter was written in support of an alternate plan for the so-called "Olde Prairie" blocks, which is being put forward in bankruptcy court by developers Pam Gleichman, Karl Norberg and Gunnar Falk. Their plan calls for hotel and retail development on property directly north of the McCormick Place administrative offices and West Building on Cermak Road.
 
If they lose control of the property, it is expected to go up for auction, making it possible for the Metropolitan Pier and Exposition Authority, the state-city agency that owns McCormick Place, or other parties to make a run at it.
 
DePaul is weighing several sites, including property near McCormick Place and the United Center on the Near West Side. As well, the Allstate Arena in Rosemont is fighting to retain the team.
 
The neighborhood's opposition adds to resistance by Ald. Robert Fioretti, whose 2nd Ward includes McCormick Place.
 "That is not a place to put an arena -- far away from the school," he said. "I think there are traffic issues related, and it would be a bad deal for taxpayers in these economic times."

Fioretti noted such a project likely would require public subsidy.
 
The Olde Prairie blocks have not been officially designated as a potential site for a DePaul arena, but Fioretti said it is his understanding that they are being seriously considered.
 
Jim Reilly, chief executive officer of the exposition authority, known as McPier, has publicly acknowledged that there have been talks with DePaul. A spokeswoman on Tuesday said it would be premature to comment further at this point.

A DePaul spokesperson could not be reached for immediate comment.
 
Chicago Mayor Rahm Emanuel has said he would like DePaul to bring men's basketball back to the city. A spokesman declined comment beyond that.
 kbergen@tribune.com | Twitter @kathy_bergen

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5 shot near currency exchange in South Shore neighborhood

Five people were hospitalized after a shooting in the South Shore neighborhood this evening, officials said. (Posted Dec. 3rd, 2012)

By Carlos Sadovi




Tribune reporter

8:40 p.m. CST, December 3, 2012

Five people were hospitalized after a shooting near a currency exchange in the South Shore neighborhood this evening, officials said.

The shooting happened on the 7500 block of South Exchange Avenue at about 5:45 p.m., according to Chicago Fire Department and police officials.

Neighbors said that the shooting happened at or near a currency exchange at that location.

Of the shooting victims, four people were in serious-to-critical condition, according to Fire Department officials. Two of them were taken to John H. Stroger, Jr. Hospital of Cook County while the two others were taken to Northwestern Memorial Hospital, officials said.

A fifth victim was taken in good-to-fair condition to South Shore Hospital, officials said.

Police said that of the victims, four appeared to have sustained non-life threatening injuries while the fifth was critically wounded.

Fire department officials had called for an Emergency Medical Services Plan 1 which summoned six ambulances to the scene, officials said.

Sources tell WGN news that the shooting may have been retaliation for a gang fight which happened earlier Monday afternoon.

A neighbor said he noticed the police racing to the area and was told that several people were shot near the currency exchange. The man said the shooting happened at about 5:30 p.m.

"About four or five people got shot across the street...Oh man, it's hellish around here," said the man, who did not give his name. "It's pretty bad."

chicagobreaking@tribune.com

Twitter: @ChicagoBreaking

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News Corp shutting down iPad newspaper ‘The Daily’ on December 15th

News Corp’s iPad newspaper “The Daily” is officially dead. Launched in February 2011, The Daily was a “ bold experiment in digital publishing and an amazing vehicle for innovation,” but like so many pioneering ideas, it “could not find a large enough audience quickly enough” to keep the publication going, according to Rupert Murdoch, the Chairman of News Corporation and Chairman and CEO of Fox Group. The Daily will officially cease publishing on December 15th and will see Jesse Angelo, its Editor-in-Chief and Executive Editor of The New York Post move into the role of Publisher for the latter. The Daily was supposed to signal a new era of app-based interactive newspapers, but alas, in a world of Flipboard, Instapaper and social media, finding a new channel to distribute and aggregate news has proven to be challenging, even for corporations with plenty of resources.

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Additional copies of ‘Lincoln’ headed to theaters

LOS ANGELES (AP) — “Lincoln” is marching to more movie theaters.

Disney, which distributed the DreamWorks film, is making additional prints of director Steven Spielberg‘s historical saga starring Daniel Day-Lewis to meet an unexpected demand that has left some moviegoers in Alaska out in the cold.

“To say that we’re encouraged by the results to date or that they’ve exceeded our expectations is an understatement,” said Dave Hollis, head of distribution at the Walt Disney Co. “We’re in the midst of making additional prints to accommodate demand and will have them available to our partners in exhibition by mid-December for what we hope will be a great run through the holiday and awards corridor.”

The film, which opened in wide release Nov. 9 and has earned $ 83.6 million in North America so far, has been unavailable at some smaller venues, such as the Gross Alaska theaters in Juneau.

But the extra prints are coming a little too late to fit the movie into the five-screen Glacier Cinemas theater during the holiday season, said Kenny Solomon-Gross, general manager of the Gross Alaska, which runs two theaters in Juneau and one in Ketchikan, Alaska.

“When we had the room for ‘Lincoln,’ Disney didn’t have a copy for us,” Solomon-Gross said Monday.

His film lineup is pretty booked through the end of the year, and he probably can’t screen “Lincoln” until after the first of the new year. Yes, the excitement over the film will have dimmed, but then the Academy Awards season will be stirring up, he said. That should kick up the buzz.

In the meantime, Solomon-Gross plans to head to Las Vegas this week and catch the film there.

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Follow AP Entertainment Writer Derrik J. Lang on Twitter at http://www.twitter.com/derrikjlang . Associated Press writer Rachel D’Oro in Anchorage, Alaska, contributed to this report.

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Online:

http://www.thelincolnmovie.com

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Global Update: GlaxoSmithKline Tops Access to Medicines Index

Sang Tan/Associated Press

GlaxoSmithKline hung on to its perennial top spot in the new Access to Medicines Index released last week, but its competitors are closing in.

Every two years, the index ranks the world’s top 20 pharmaceutical companies based on how readily they get medicines they hold patents on to the world’s poor, how much research they do on tropical diseases, how ethically they conduct clinical trials in poor countries, and similar issues.

Johnson & Johnson shot up to second place, while AstraZeneca fell to 16th from 7th. AstraZeneca has had major management shake-ups. It did not do less, but the industry is improving so rapidly that others outscored it, the report said.

The index was greeted with skepticism by some drugmakers when it was introduced in 2008. But now 19 of the 20 companies have a board member or subcommittee tracking how well they do at what the index measures, said David Sampson, the chief author.

The one exception was a Japanese company. As before, Japanese drugmakers ranked at or near the index’s bottom, and European companies clustered near the top. Generic companies — most of them Indian — that export to poor countries are ranked separately.

Johnson & Johnson moved up because it created an access team, disclosed more and bought Crucell, a vaccine company.

The foundation that creates the index now has enough money to continue for five more years, said its founder, Wim Leereveld, a former pharmaceutical executive.

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