Ashton Kutcher files for divorce from Demi Moore






LOS ANGELES (AP) — Ashton Kutcher filed court papers Friday to end his seven-year marriage to actress Demi Moore.


The actor’s divorce petition cites irreconcilable differences and does not list a date that the couple separated. Moore announced last year that she was ending her marriage to the actor 15 years her junior, but she never filed a petition.






Kutcher’s filing does not indicate that the couple has a prenuptial agreement. The filing states Kutcher signed the document Friday, hours before it was filed in Los Angeles Superior Court.


Kutcher and Moore married in September 2005 and until recently kept their relationship very public, communicating with each other and fans on the social networking site Twitter. After their breakup, Moore changed her name on the site from (at)mrskutcher to (at)justdemi.


Kutcher currently stars on CBS’ “Two and a Half Men.”


Messages sent to Kutcher’s and Moore’s publicists were not immediately returned Friday.


Moore, 50, and Kutcher, 34, created the DNA Foundation, also known as the Demi and Ashton Foundation, in 2010 to combat the organized sexual exploitation of girls around the globe. They later lent their support to the United Nations’ efforts to fight human trafficking, a scourge the international organization estimates affects about 2.5 million people worldwide.


Moore was previously married to actor Bruce Willis for 13 years. They had three daughters together — Rumer, Scout and Tallulah Belle — before divorcing in 2000. Willis later married model-actress Emma Heming in an intimate 2009 ceremony at his home in Parrot Cay in the Turks and Caicos Islands that attended by their children, as well as Moore and Kutcher.


Kutcher has been dating former “That ’70s Show” co-star Mila Kunis.


The divorce filing was first reported Friday by People magazine.


___


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


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The New Old Age Blog: The Ex-Wives Club

Weather permitting, Kappy Lundy and Barbara Thompson are heading out to Vancouver, Wash., on Saturday night to have a holiday dinner with the parents of their daughter’s husband.

Yes, these women both mothered the same children — now grown and with children of their own. Ms. Lundy is their biological parent; Ms. Thompson is the stepmother who married their father after he and Ms. Lundy divorced.

But that doesn’t really begin to describe their relationship. Over more than 40 years, these two have been friends and what they call “wife-in-laws,” in addition to moms-in-tandem. Now, they’re so close they feel like sisters, they say.

There’s yet another dimension to this relationship that makes it so unusual: Ms. Lundy, who is 71, has become a caregiver for Ms. Thompson, who’s 67 and was given a diagnosis of mild cognitive impairment in 2009.

One wife caring for another, through thick and through thin – think about that. It’s another example of how the new old age is spawning unusual — and creative — alliances.

Ms. Lundy went with Ms. Thompson to eight months of classes on memory loss offered by the Alzheimer’s Association chapter in Portland, Ore., where the two women live. And now they go together to monthly meetings of the Wild Bunch, a group of people with dementia and their caregivers who’ve come together to provide each other emotional support. (More on that group to come in a future post.)

Ms. Lundy talks to Ms. Thompson every day and tries to get together with her once a week.

“We’re just really good friends, and we want to know what’s going on, what are you doing, like everybody else,” said Ms. Thompson, who moved into an independent living facility in Portland nearly a year ago, after Ms. Lundy helped pack up her previous apartment.

Ms. Lundy, who lives across town, about 20 minutes away, said: “We’ll go to happy hour together and have a little toddy and maybe a nice meal. And crack up – she makes me laugh.”

Both women grew up in Eugene, Ore., but became friends later, after they moved to Portland in their 20s. Their favorite haunt was the Goose Hollow Inn, a tavern where artists, architects and writers would congregate. Ms. Lundy and her husband began to socialize regularly with Ms. Thompson and her first husband.

“She’s full of life and fun – a gypsy at heart,” is how Ms. Thompson describes Ms. Lundy.

“She’s funny and smart and a really good listener,” is how Ms. Lundy describes Ms. Thompson.

When Ms. Lundy’s marriage to Phil Thompson — a handsome bear of a man, with a charismatic personality and an artistic sensibility — began falling apart, both members of the couple turned to their friend Barbara for support. “She listened to me and my anger, and she listened to him about how he was hurting,” says Ms. Lundy, who was separated from her husband for a year before the divorce was official.

There were no hard feelings when Phil’s feelings toward Barbara turned romantic, Ms. Lundy says. But she didn’t see the couple much during subsequent years of work and travel abroad. During those years, her children, Jessica and David, stayed with their father in Portland.

Eventually, Ms. Lundy came home and was invited to holidays at the Thompson house. She grew close to Barbara again and let go of negative feelings toward her former husband, she said. Over time, they became bound together as family.

“It’s incredible,” their daughter said. “They’re just really caring for each other and not threatened by each other.

“My dad got a big kick out of it and would always introduce them as ‘my wives.’”

When Phil Thompson died in August 2008, both women were at his bedside. And when Ms. Thompson started having memory problems months later, Ms. Lundy was one of the first to notice. “We could see she wasn’t remembering things, but she said, ‘This is my grief,’” Ms. Lundy recalled. It became clear something else might be going on as problems persisted and a doctor’s evaluation yielded the mild cognitive impairment diagnosis.

Ms. Thompson described her reaction to that information: “It was scary. Very scary. I didn’t know if it meant the end of my freedom, of my ability to just live my own life.”

For her part, Ms. Lundy said: “The hardest thing for me from the very beginning was to see my party pal and my dear, dear friend changing. It was very frustrating to me. And very hurtful. I wanted to support her. But sometimes I didn’t have the patience. Because, you know, she wasn’t acting like Barbara. It’s taken a while, but slowly, slowly, slowly and surely, I’ve accepted that this is who Barbara is.”

Ms. Lundy isn’t the only caregiver for Ms. Thompson: Jessica and David, her stepchildren, and two close friends also help out, as needed.

For Ms. Lundy, the uncertainty associated with her friend’s mild cognitive impairment diagnosis is hard to live with. Will it progress to dementia? Will it stay stable, or even get better? The doctor can’t say, and “all that not-knowing business is unsettling,” she said.

Becoming a caregiver has “made our friendship even stronger, I think,” Ms. Lundy says. “We’re closer now. Even though we’ve been friends for years and years, I never felt responsible for her before.”

For Ms. Thompson, what’s hardest is living alone after nearly 30 years of being married to Phil and worrying about losing her independence — notably, her ability to continue driving.

“I feel isolated with the disease,” she said. “And being alone in a new apartment with lots of strangers here has been a little difficult.”

“I’m very grateful to Kappy,” Ms. Thompson said. “I didn’t used to feel that she would be this way. She was always doing her own thing. But she has definitely reached out, beyond what most people would do.”

On Christmas the two women will be at Jessica’s house, arriving at around noon, after the grandchildren have opened their presents, and staying through the late afternoon. After the holidays, Ms. Lundy says she plans to take Ms. Thompson out more often and “have a couple of beers and a laugh and be happy and just be Barbie and Kappy,” two old friends, enjoying each other’s company.

This is the one of the most unusual caregiving relationships I know of. It reaffirms what I’ve been told several times: You never know who will end up being there for you when you need help. Sometimes the people we expect will care for us don’t, and others step forward. Has that been your experience?

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Boehner rejects Democrats' push for immediate vote on gun bill









WASHINGTON -- House Speaker John A. Boehner rejected calls from Democrats to schedule a vote on new gun restrictions before the end of the year, saying he wants to wait for recommendations from a newly formed White House task force before committing to a legislative response to the mass shooting at a Connecticut school.

“When the vice president's recommendations come forward, we'll certainly take them into consideration,’’ Boehner (R-Ohio) said Thursday in his first public comments on calls for new gun legislation since the slaying of 20 students and six adults at Sandy Hook Elementary School. “But at this point I think our hearts and souls ought to be to think about those victims in this horrible tragedy.”


President Obama on Wednesday said he had asked Vice President Joe Biden to lead a task force to come up with initiatives to stem gun violence by the end of next month. House Democratic Leader Nancy Pelosi of San Francisco and fellow Democrats have pressed for an immediate vote on a long-stalled bill that would ban ammunition magazines containing more than 10 rounds.





Obama has outlined a slightly slower pace for action, urging Congress to hold a vote “in a timely manner” in the new year.


Both Obama and Democrats on Capitol Hill say they are trying to seize on what appears to be a burst of momentum behind gun legislation in the wake of the Newtown, Conn., tragedy. Similar efforts initiated after other high-profile shootings faltered after national attention veered elsewhere.


Biden held the first meeting of the task force Thursday, gathering several cabinet members and White House officials with a group of local law enforcement leaders. In remarks before the meeting, the vice president noted his work on the 1994 crime bill, which banned the sale of some assault weapons, and said he would again be working closely with police groups to craft proposals.


“What I think the public has learned about you is you have a much more holistic view of how to deal with violence on our streets and in our country that you’re ever given credit for,” Biden told the law enforcement officials. “I want to hear your views because, for anything to get done, we’re going to need your advocacy.”


richard.simon@latimes.com


Twitter: @richardsimon11


kathleen.hennessey@latimes.com


Twitter: @khennessey





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Net Neutrality, Data-Cap Legislation Lands in Senate



A proposal forbidding internet service providers from turning the data-cap meter off to grant a so-called internet fast lane to preferential online services was introduced Thursday in the Senate.


The bill by Sen. Ron Wyden (D-Oregon) comes a week after a report found that the institutionalization of data caps by ISPs is geared toward profiteering rather than the stated goal of managing traffic congestion.


“A covered internet service provider may not, for purposes of measuring data usage or otherwise, provide preferential treatment of data that is based on the source or the content of the data,” (.pdf) Wyden’s bill reads.


Ars Technica noted that Comcast had not counted its Xbox video-streaming app against its data caps. Comcast, however, no longer enforces its data caps.


“Data caps create challenges for consumers and run the risk of undermining innovation in the digital economy if they are imposed bluntly and not designed to truly manage network congestion,” Wyden said in a statement.


Among other things, the proposal demands a standardized method for measuring data and also questions data caps altogether. That’s because it grants the Federal Communications Commission with regulatory power over data-cap pricing.


“The commission shall evaluate a data cap proposed by an internet service provider to determine whether the data cap functions to reasonably limit network congestion in a manner that does not unnecessarily discourage use of the internet,” according to the proposal.


That means internet companies might have to explain why the caps are imposed at low-traffic times, such as in the middle of the night.


The proposal was immediately applauded by the digital rights group Public Knowledge.


“Data caps create an artificial scarcity in the broadband market that limits consumer choice and hinders the creation of new competitive content online,” Christopher Lewis, the group’s vice president, said in a statement.


For the moment, the proposal is going nowhere as lawmakers are expected to adjourn for the year in the coming days.



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World Music Awards postponed due to visa issues, Newtown tragedy






LOS ANGELES (Reuters) – The World Music Awards was postponed on Thursday due to “logistical and multiple visa issue,” organizers said, two days before the event was scheduled to be held in Miami.


Event producers John Martinotti and Marcol International said in a statement that the December 22 awards ceremony also was being delayed in the wake of the elementary school shooting in Newtown, Connecticut, last week.






“We are sorry for any inconvenience but this decision had to be made due to logistical and multiple visa issues and in view of this week’s national mourning. Fans have been a great support to the artists and have voted online in huge numbers,” the producers said in a statement.


The winners in categories ranging from world’s best song, world’s best artists and entertainer of the year, are picked by fans who vote online. The statement said that votes will continue to be collected until a new date is set for the show.


This year’s nominees include Usher, Justin Bieber, Nicki Minaj, Rihanna and Chris Brown. Past winners include Whitney Houston, Mariah Carey and Michael Jackson.


The awards ceremony, founded in 1989 and hosted by Monaco’s Prince Albert II, has primarily taken place in Monte Carlo and proceeds from the show go to charity. This year, show producers decided to move it to Marlins Park Stadium in Miami.


(Reporting By Piya Sinha-Roy, editing by Eric Kelsey)


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German Health Care Attracts Foreign Patients





BERLIN — When Jalal Talabani, the president of Iraq, needed advanced medical care for a stroke suffered this week, he flew not to the United States or Britain but to Germany, for treatment here in the capital.




For many Americans, Germany is known as a way station where soldiers wounded in Iraq and Afghanistan received immediate medical care on United States military bases. But it is also a popular destination for wealthy and prominent patients from the Middle East, Russia and beyond, experts say.


Before the Arab Spring uprisings, the Egyptian president Hosni Mubarak traveled to Munich in 2004 for back treatment and to Heidelberg in 2010 to have his gallbladder removed. Last year, President Nursultan Nazarbayev of Kazakhstan reportedly had a surgical procedure on his prostate at the University Medical Center Hamburg-Eppendorf.


According to German government statistics, the number of hospital patients from the United Arab Emirates rose to 1,754 from 339 between 2000 and 2010, the most recent year available. From Saudi Arabia, the figure climbed to 712 from 143. The numbers from Iraq were smaller but still rose to 176 from 95. Over the same period, the number of Russians jumped to 4,873 from 842.


“We have one of the worldwide best health care systems and people from abroad know that,” said Isabella Beyer, research associate in medical tourism at the Bonn-Rhein-Sieg University of Applied Sciences. Mr. Talabani, 79, is among them; he was treated in Germany before for back trouble.


Mr. Talabani is now being cared for at Berlin’s Charité hospital, which is more than 300 years old and is one of Europe’s largest university hospitals. The storied institution was home to several Nobel Prize winners, including Robert Koch and Paul Ehrlich. A spokeswoman for Charité, Manuela Zingl, confirmed that Mr. Talabani was being treated there but said that she could not disclose any information on his condition because of rules on medical privacy.


Mr. Talabani was said to be in “stable” condition after suffering a stroke this week, though there were unconfirmed reports that he was in a coma. He was rushed to the Baghdad Medical City on Monday.


He was treated there by medical experts from Iran, Germany and Britain, according to Iraqi staff members. Barazan Sheik Othman, the head of the presidential media office, said in a telephone interview that Mr. Talabani left for Germany accompanied by doctors after they established that he was well enough to be transferred.


Hospitals and clinics here have increasingly sought to market themselves as a destination for international patients. Ms. Beyer said that Germany benefited from a combination of lower prices than the United States but still provided high-quality care. Shorter waiting times and the proximity to the Middle East also helped.


“Before, a lot flew to Geneva,” said Salah Atamna, 44, whose business, Europe Health, seeks to link up patients from abroad with German hospitals and clinics.


Many wealthy Arabs would fly to Germany in the summer to escape the blistering heat at home, Mr. Atamna said, scheduling their vacation to coincide with an operation or other treatment. They often traveled with family members and large entourages. After the attacks of Sept. 11, 2001, it became harder to acquire visas to the United States, and medical travelers began searching for alternatives.


Duraid Adnan contributed reporting from Baghdad, and Victor Homola from Berlin.



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Russia bill to ban U.S. adoptions of Russian children advances









MOSCOW — Russia's parliament took a first step Wednesday toward banning the adoption of Russian children by American parents, a move intended as retaliation for an anti-corruption law recently passed by Congress.


The State Duma, the lower house of parliament, voted 399 to 17 in favor of a bill that included the ban and also would annul an adoption agreement between the two countries that Russia ratified in July. The measure still has to be approved by the upper house and signed by President Vladimir Putin, who has sent mixed signals about his support.


The Dima Yakovlev law is named after a Russian boy who died of heatstroke in 2008 after being left in a parked car by his adoptive American father. If approved, the legislation would cut off adoptions as of Jan. 1.





American parents have adopted more than 60,000 Russian children over the last two decades. Americans adopt 1,000 to 3,000 Russian children a year, said Boris Altshuler, who heads Right of the Child, a Moscow-based advocacy group. Russian families adopt about 7,000 children a year, far from enough to meet the country's needs.


The ban is intended to punish the United States for the so-called Magnitsky law, passed by Congress this month and named for Sergei Magnitsky, a Russian lawyer and whistle-blower who died in pretrial custody in Moscow in 2009. The Magnitsky law imposed visa restrictions on a group of Russian officials connected to the lawyer's prosecution and death.


Calling the Magnitsky law unfriendly and provocative, Russian legislators initially retaliated with a bill that included visa bans on an unspecified number of U.S. officials as well as on American parents who mistreat adopted Russian children and judges who are deemed lenient with such parents. The State Duma later added the adoption restrictions, accusing U.S. parents of mistreating and killing adopted Russian children and blaming unspecified middlemen of turning adoption into a corrupt and lucrative business.


"More than 80% of Russian children [adopted abroad] are adopted by the United States, and it is no secret for anyone in Russia today that this is a dirty business," Svetlana Goryacheva, a lawmaker with the Just Russia party, told reporters after the vote. "So today we in Russia are notorious for selling our children, and it is high time to stop it."


Ilya Ponomaryov, the only Duma member to speak out against the adoption ban, said there are 1,500 Russian children, including 49 with serious disabilities, whose adoptions by U.S. parents are awaiting approval in Russian courts.


"Today the State Duma for all practical purposes issued a grave verdict for these seriously sick children, who, I am sure, will languish in Russian orphanages for the rest of their lives without proper love and care," Ponomaryov said in an interview after the vote. "Their last chance is Putin's veto."


Putin warned lawmakers last week against "an excessive response" to the Magnitsky law, but gave his blessing to Wednesday's vote, according to his press secretary, Dmitry Peskov.


In an interview with the Russia-24 television network, Peskov called the U.S. law "an unfriendly act" and said the president understands the Russian lawmakers' tough stance.


The measure faces opposition from human rights groups and some Russian officials, including Foreign Minister Sergei Lavrov and the Kremlin's human rights envoy, Vladimir Lukin.


Besides adding the adoption ban, the measure was amended to suspend the activities of Russian nongovernmental organizations funded by the United States.


Rachel Denber, deputy director of the Europe and Central Asia division of Human Rights Watch, denounced both amendments. The U.S. law is designed to protect Russian citizens from corrupt officials, she said, so a symmetrical Russian response would be a measure aimed at corrupt American officials.


"Instead the Russian lawmakers decided to hit where it hurts more," she said in an interview. "They hit U.S. people who want to adopt Russian children and they hit U.S. organizations and activists who want to promote democracy in Russia."


"I am having a hard time believing that the prohibition of the adoption of Russian children by U.S. families can be in the best interests of Russian orphans," she added.


In the last 15 years, 19 adopted Russian children have died in accidents in the United States, while more than 1,200 adopted children have died in Russian families during the same period, according to Altshuler of Right of the Child.


"Our lawmakers thus sacrifice thousands of Russian orphans by locking them up in institutions instead of letting them have a chance to be adopted in the United States and have a real future," he added.


Altshuler said nearly 300,000 Russian children are in orphanages, about two-thirds of whom have parents who can't or won't support them. He called the situation critical and said that adoptions by Russian families aren't sufficient to resolve it.


Earlier Wednesday, Prime Minister Dmitry Medvedev urged Russians to adopt more children.


"Foreign adoption stems from the weak attention of the state and the society toward orphans," Medvedev said at a gathering of the ruling United Russia party.


sergei.loiko@latimes.com





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Cosmo Strikes Again, Taking Over Another Westboro Twitter Account











It feels a little bit like hacker Groundhog Day. After hijacking a Westboro Baptist Church leader’s Twitter account on Monday, Wired has confirmed that the 15-year-old hacker known as Cosmo the God took over another account belonging to one of the of the same church members on Wednesday, using much the same method.


A source with direct knowledge of the attack who spoke on condition of anonymity confirmed to Wired that Cosmo had in fact taken possession of Fred Phelps Jr.’s Twitter account. Phelps Jr. is the son of church leader Fred Phelps Sr. Cosmo took over the @WBCFredJR Twitter account via Phelps’ Hotmail account, which he gained entry to by forwarding the password-reset phone number on the Hotmail account to the phone number he controlled, according to Wired’s source.


Previously, Cosmo had control of church spokesperson and attorney Shirley Lynn Phelps-Roper’s @DearShirley Twitter account for about 24 hours before the account was suspended. During that time, Wired’s source also claims that Cosmo remotely recorded gay porn to her DVR, before canceling her internet service.


Westboro Baptist Church is notorious for picketing funerals of American soldiers killed in action in Iraq and Afghanistan. Last week the organization apparently announced its intention to protest at the funerals of the children killed at Sandy Hook Elementary in Newtown, Connecticut. Following the church’s announcement, the hacker collective Anonymous and others have targeted WBC members online, especially in ways that affect their ability to communicate and operate.


Cosmo and his group UG Nazi took part in many of the highest-profile hacking incidents of 2012, including taking down websites for NASDAQ, CIA.gov, and UFC.com, redirecting 4Chan’s DNS to point to its own Twitter feed, and defeating CloudFlare CEO Matthew Prince’s Google two-step authentication. He was arrested in June, as part of a multi-state FBI sting and was recently sentenced to probation until his 21st birthday, during which time he is prohibited from using the internet without supervision and prior consent.


Clearly, the account takeovers in the past few days would violate those terms.






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Music, roses at singer Jenni Rivera’s memorial






UNIVERSAL CITY, Calif. (AP) — Jenni Rivera‘s “celestial graduation” was marked by festive music, heartfelt speeches in Spanish and English and passionate chants of “Jen-ni! Jen-ni!”


Rivera’s children and famed singers Olga Tanon and Joan Sebastian performed during the nearly 2 ½-hour memorial service Wednesday at the Gibson Amphitheatre, where thousands of fans gathered to salute the “Diva de la Banda” who died in a plane crash Dec. 9.






One fan, Veronika Flores, drove nearly eight hours from her home in Woodland, Calif., near Sacramento, to be united with other fans at the service.


“I just came to say goodbye to a Latina woman, La Gran Senora,” she said, invoking the name of one of Rivera’s most beloved songs.


Famed Mexican singers Marco Antonio Solis and Ana Gabriel and actors Lou Diamond Phillips and Kate del Castillo were also among the guests at Wednesday’s service.


A red casket sat onstage amid a sea of white roses as images of Rivera played on three big screens. Family members embraced and kissed the casket at the conclusion of the service, laying more white roses atop it.


While most of the speeches and songs were delivered in Spanish, Rivera’s children spoke in English, often directly to their late mother.


“We’re not here to mourn the death,” said son Michael, 21. “We’re here to celebrate the life and graduation of a singer, an entertainer, a diva, a fighter, an entrepreneur, a philanthropist, and more than anything, a mother — the best mother.”


He then called for 27 seconds of silence for the victims of the massacre in Newtown, Conn.


Rivera’s youngest child, 11-year-old Johnny, was heartbreakingly poised as he said, “The person that everyone’s talking about is my mom.”


“Mama, I’ve been crying so much these last few days. I miss you so much,” said the little boy, wearing a red bow tie like many of his family members. “I hope you’re taking care of my dad and I hope he’s taking care of you, too.”


Rivera’s second husband, Juan Lopez, died in 2009. The couple divorced in 2003.


Rivera’s brothers and sisters spoke lovingly of the singer, calling her “the queen of queens,” ”perfectly imperfect” and an “eternal diva.” Her father said Rivera’s “happiness, smile and care for the public will never be forgotten.” He then performed a song he wrote about his daughter, a woman who rose from humble roots to become “la Diva de la Banda.”


One of Rivera’s brothers said his sister “made it OK for women to be who they are. Jenni also made it OK to be from nothing with the hopes of being something.”


The family asked that Latin radio stations play Rivera’s song “La Gran Senora” at noon Thursday in her honor.


The service was closed to most media, although a broadcast of the proceedings was made available.


The burial will be private.


Rivera’s last album before her death, “La Misma Gran Senora,” topped the Latin albums chart this week, selling 27,000 copies — the best sales week for any Latin album this year. Rivera also holds three spots on the Billboard 200 albums chart.


Rivera and six other people died Dec. 9 in a northern Mexico plane crash that remains under investigation. Rivera, a mother of five children and grandmother of two, was 43.


Rivera sold more than 15 million copies of her 12 major-label albums. Her soulful singing style and honesty about her tumultuous personal life won her fans on both sides of the U.S.-Mexico border. She was also an actress and reality TV star.


Born in Los Angeles, Rivera launched her career by selling cassette tapes at flea markets. By the end of the 90s, she won a major-label contract and built a loyal following.


Many of her songs deal with themes of dignity in the face of heartbreak, which Rivera spoke of openly with her fans.


She had recently filed for divorce from her third husband, was once detained at a Mexico City airport with tens of thousands of dollars in cash, and publicly apologized after her brother assaulted a drunken fan who verbally attacked her in 2011.


“She was a fighter, a woman who can push boundaries,” said Flores. “That’s why I liked her, because I’m just like her.”


Entertainment News Headlines – Yahoo! News





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F.D.A. and States Meet About Regulation of Drug Compounders


Mary Calvert/Reuters


Margaret Hamburg, the F.D.A. commissioner, testified on the meningitis outbreak before Congress in November. She addressed the need for greater federal oversight of large compounding pharmacies, which mix batches of drugs on their own, often for much lower prices than major manufacturers charge.







SILVER SPRING, Md. – The Food and Drug Administration conferred with public health officials from 50 states on Wednesday about how best to strengthen rules governing compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted pain medication produced by a Massachusetts pharmacy.




It was the first public discussion of what should be done about the practice of compounding, or tailor-making medicine for individual patients, since the F.D.A. commissioner, Dr. Margaret Hamburg, testified in Congress last month about the need for greater federal oversight of large compounding pharmacies. So far, 620 people in 19 states have been sickened in the outbreak, and 39 of them have died.


Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.


“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”


Large-scale compounding has expanded drastically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.


“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws had not kept pace.


“We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems,” Dr. Hamburg said.


Under current law, compounders are not required to give the F.D.A. access to their books, and about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, although compounders are only a small part of the agency’s regulatory responsibilities.


The F.D.A.'s critics argue that the agency already has all the legal authority it needs to police compounders. They say that many compounders have been operating as major manufacturers, shipping to states across the country, and that the F.D.A. should be using its jurisdiction over manufacturers to regulate those companies’ activities.


“There should be one uniform federal standard that is enforced by one agency – the F.D.A.,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, a nonprofit consumer organization, who has been a critic of the agency’s approach. “They have been lax in enforcing that standard.”


But Dr. Hamburg contends that the distinction is not so simple. Lumping large compounders in with manufacturers would mean they would have to file new drug applications for every product they make, a costly and time-consuming process that is not always necessary for the products they make, like IV feeding tube bags, for example. Dr. Hamburg has proposed creating a new federal oversight category for large-scale compounders, separate from manufacturers.


“What concerns me is the idea that we could assert full authority over some of these facilities as though they were manufacturers, as though there were an on-off, black-white option,” Dr. Hamburg said. “That is a heavy-handed way to regulate a set of activities that can make a huge positive difference in providing necessary health care to people.”


The central problem, state representatives said, is how to define large-scale compounding. Should companies be measured by how much they produce, whether they ship across state lines, the types of products they produce, or some combination of those factors?


“It’s easy to stand at a distance and ask why can’t there be a bright line?” said Jay Campbell, executive director of the North Carolina Board of Pharmacy. “Let’s not let the perfect get in the way of the good. We won’t be able to make a distinction that is razor sharp.”


Large-scale compounders play an important role in the health care supply chain when they produce high-quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals.


Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.


Carmen Catizone, head of the National Association of Boards of Pharmacy, said that states were not equipped to regulate the large-scale compounders and that the F.D.A. needed to find a middle path for regulating them.


“Either hospitals are not going to like the solution, or the manufacturers aren’t going to like the fact that these guys get a shorter path,” he said. “But something’s got to give.”


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