British medical journal slams Roche on Tamiflu

LONDON (AP) — A leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the flu.

The drug has been stockpiled by dozens of governments worldwide in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.

On Monday, one of the researchers linked to the BMJ journal called for European governments to sue Roche.

"I suggest we boycott Roche's products until they publish missing Tamiflu data," wrote Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen. He said governments should take legal action against Roche to get the money back that was "needlessly" spent on stockpiling Tamiflu.

Last year, Tamiflu was included in a list of "essential medicines" by the World Health Organization, a list that often prompts governments or donor agencies to buy the drug.

Tamiflu is used to treat both seasonal flu and new flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the agency had enough proof to warrant its use for unusual influenza viruses, like bird flu.

"We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.

In the U.S., the Centers for Disease Control and Prevention recommends Tamiflu as one of two medications for treating regular flu. The other is GlaxoSmithKline's Relenza. The CDC says such antivirals can shorten the duration of symptoms and reduce the risk of complications and hospitalization.

In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.

"Despite a public promise to release (internal company reports) for each (Tamiflu) trial...Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.

In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.

"Roche has made full clinical study data ... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.

Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.

Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the U.S.

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Online:

www.bmj.com.tamiflu/

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Moderates could enhance image of state Legislature

SACRAMENTO — The next class of the Legislature will be stocked with a new variety of lawmaker, the product of a new political order intended to foster moderation, compromise and foresight in an institution not known for such things.

Able to serve longer in one house under revamped term limits, the newly elected will have time to develop expertise. They may well be more accountable to voters because their seats will no longer be safe as they were when districts were gerrymandered to maintain the status quo.

And their moderation, born of more balanced districts and nonpartisan primaries, can serve as a check on Democrats' emerging supermajorities in both houses. That historic development would allow Democrats to sidestep Republicans on tax votes and in placing proposals on the statewide ballot.

Taken together, the changes have the potential to rehabilitate the image of the Legislature, which has taken a beating during years of partisan gridlock, protracted budget wars and short-term solutions that kicked problems down the road.

Ambitious legislators will no longer seek to simply "get a couple of bills passed and create the impression they did something," said Bob Hertzberg, a former Assembly speaker who pushed for the changes. The new rules, he said, force lawmakers to "think longer term, and not just engage in the optics of politics."

The effect of the changes will be felt most in the Assembly. Nearly half of the lower house will be freshmen — the largest number since 1934. The state Senate will welcome 10 new members, all but one of whom hails from the Assembly.

The newcomers will be the first to operate under new rules that allow lawmakers to serve their entire tenure — up to 12 years — in one house. Under California's old term limits, enacted 22 years ago, legislators could have three terms in the Assembly and two in the Senate, for a total of 14 years.

In that system, political analysts said, lawmakers had lost sight of how to govern. Short tenures left them reliant on lobbyists for guidance on complex issues and prompted a perpetual scramble for higher office and cash to fund the next campaign. Lobbyists exercised extraordinary power as both campaign donors and policy advisors, earning a nickname as the "Third House."

Focus will be critical for the new lawmakers as they tackle Gov. Jerry Brown's ambitious agenda. It includes implementing President Obama's healthcare law, overhauling the state's water system, amending environmental regulations to encourage economic growth and promoting California's high-speed rail project.

Many of those legislators will have some freedom to operate independently of their caucuses. The nonpartisan primary system, which allows the top-two finishers to face off in the general election, is expected to ease caucus leaders' grip.

The bosses prize party discipline to deliver critical votes. In recent years, deals on the state budget have been hammered out by the "Big Five," a group composed of those leaders and the governor.

Now, "if it plays out the way people are expecting, you will have a little bit less of a notion that … top leaders make all the decisions," said Raphael Sonenshein, who heads the Pat Brown Institute of Public Affairs at Cal State L.A.

In Tuesday's election, 20 races pitted two candidates of the same party against each other. Contenders in those districts had to please voters beyond their own parties.

In Northern California wine country, Democrat Marc Levine bested incumbent Assemblyman Michael Allen (D-Santa Rosa) in a tight contest, though some ballots remain uncounted. Allen had attacked Levine for campaigning before Republican groups. Levine championed an overhaul of the state's public pension system strongly opposed by labor groups that backed Allen.

"Voters are looking for leaders with solutions to the challenges facing California," Levine said in an interview.

Some Republicans also shifted toward the political middle.

In 2010, Kristin Olsen of Modesto won an Assembly seat after she joined her GOP colleagues in signing a no-tax pledge. This year, running against a Democrat in a newly drawn district, she declined to renew the vow, saying it encumbers lawmakers from showing leadership.

Backers of the new political system are optimistic about the fruits it may bear.

"With more time," said Kathay Feng, executive director of California Common Cause, "we hope these new legislators will develop a greater personal knowledge of issues, deepen relations with legislators on both sides of the aisle and be able to resolve some of the long-term challenges that California faces."

michael.mishak@latimes.com

patrick.mcgreevy@latimes.com

For the latest California election results, go to latimes.com/electionresults and latimes.com/socalresults.

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F.B.I. Said to Have Stumbled Into News of Petraeus Affair

WASHINGTON — The F.B.I. investigation that led to the sudden resignation of David H. Petraeus as C.I.A. director on Friday began with a complaint several months ago about “harassing” e-mails sent by Paula Broadwell, Mr. Petraeus’s biographer, to another woman who knows both of them, two government officials briefed on the case said Saturday.

When F.B.I. agents following up on the complaint began to examine Ms. Broadwell’s e-mails, they discovered exchanges between her and Mr. Petraeus that revealed that they were having an affair, said several officials who spoke of the investigation on the condition of anonymity. They also discovered that Ms. Broadwell possessed certain classified information, one official said, but apparently concluded that it was probably not Mr. Petraeus who had given it to her and that there had been no major breach of security. No leak charges are expected to be filed as a result of the investigation.

The identity of the woman who complained about the harassing messages from Ms. Broadwell has not been disclosed. She was not a family member or in the government, the officials said, and the nature of her relationship with Mr. Petraeus was not immediately known. But they said the two women seemed to be competing for Mr. Petraeus’s loyalty, if not his affection.

One Congressional official who was briefed on the matter said senior intelligence officials explained that the F.B.I. investigation “started with two women” — evidently Ms. Broadwell and the woman who complained about her e-mails. “It didn’t start with Petraeus, but in the course of the investigation they stumbled across him,” said the Congressional official. “We were stunned.”

Ms. Broadwell has made no statement since the affair became public on Friday, and attempts to reach her for comment have been unsuccessful.

The circumstances surrounding the collapse of Mr. Petraeus’s career remain murky. It is not clear when Attorney General Eric H. Holder Jr. or Robert S. Mueller III, the director of the F.B.I., became aware that the F.B.I.’s investigation into Ms. Broadwell’s e-mails had brought to light compromising information about Mr. Petraeus. Tracy Schmaler, a spokeswoman for Mr. Holder, declined to comment Saturday.

Neither the Congressional Intelligence Committees nor the White House learned of the investigation or the link to Mr. Petraeus until last week, officials said. Neither did Mr. Petraeus’s boss, James R. Clapper Jr., the director of national intelligence.

A senior intelligence official said Saturday that Mr. Clapper had learned of Mr. Petraeus’s situation only when the F.B.I. notified him, about 5 p.m. on Tuesday, election night. That evening and the next day, the official said, the two men discussed the situation, and Mr. Clapper told Mr. Petraeus “that he thought the right thing to do would be to resign,” the intelligence official said.

Mr. Clapper notified the president’s senior national security staff late Wednesday that Mr. Petraeus was considering resigning because of an extramarital affair, the official said.

The decisions on when to notify various administration officials, including Mr. Clapper on Tuesday, were “a judgment call consistent with policies and procedures,” according to one of the government officials who had been briefed.

If the investigation had uncovered serious security breaches or other grave problems, he said, the notifications would have been immediate. As it was, however, the matter seemed to involve private relationships with little implication for national security.

Some Congressional staff members said they believed that the bureau should have informed at least the Republican and Democratic leaders of the House and Senate Intelligence Committees about the unfolding inquiry. A spokesman for Representative Mike Rogers, a Michigan Republican who heads the House Intelligence Committee, said the lawmaker had summoned Sean Joyce, the F.B.I.’s deputy director, and Michael J. Morrell, the deputy C.I.A. director, for closed briefings on Wednesday about the investigation.

Michael D. Shear, Charlie Savage and Michael S. Schmidt contributed reporting.

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How Apple’s iPad Mini compares with rivals

The iPad Mini is just one of several tablets of its size. Here’s a look at how the Mini compares with other tablets with comparable screens.

Apple Inc.’s iPad Mini

— Price: $ 329 for base model with Wi-Fi only and 16 gigabytes of storage, $ 429 with 32 GB, $ 529 with 64 GB. Add $ 130 for versions with cellular capability.

— Screen size: 7.9 inches diagonally

— Screen resolution: 1024 by 768 pixels

— Weight: 0.68 pound (0.69 pound for cellular versions)

— Cameras: 5-megapixel camera on back and a low-resolution camera on front, for videoconferencing

— Battery life: 10 hours

— Operating system: Apple‘s iOS

Pros: Unmatched access to third-party applications, high-quality Apple software and the iTunes store. High-resolution screen. Available with access to fast 4G wireless broadband networks, starting at $ 459. Larger-screen version available.

Cons: Data storage cannot be expanded with memory cards.

Barnes & Noble Inc.‘s Nook HD

— Price: $ 199 with 8 gigabytes of storage, $ 229 with 16 GB

— Screen size: 7 inches diagonally

— Screen resolution: 1440 by 900 pixels

— Weight: 0.69 pound

— Cameras: None

— Battery life: Up to 10.5 hours of reading and up to 9 hours of video

— Operating system: Modified version of Google‘s Android

Pros: Expandable with microSD card. High-definition screen. Larger-screen version available.

Cons: Selection of third-party applications is small. Lacks cameras and option for cellular broadband.

Amazon.com Inc.‘s Kindle Fire HD.

— Price: $ 199 with 16 gigabytes of storage, $ 249 with 32 GB

— Screen size: 7 inches diagonally

— Screen resolution: 1280 by 800 pixels

— Weight: 0.87 pound.

— Cameras: Front-facing camera.

— Battery life: 11 hours.

— Operating system: Modified version of Google’s Android

Pros: Cheap and portable. Convenient access to Amazon store. High-definition screen. Dolby audio. Larger-screen version coming Nov. 20, including option for cellular broadband.

Cons: Small selection of third-party applications available from Amazon. No rear camera for taking video and photos. Data storage cannot be expanded with memory cards.

Amazon.com Inc.’s regular Kindle Fire:

— Price: $ 159 with 8 gigabytes of storage

— Screen size: 7 inches diagonally

— Screen resolution: 1024 by 600 pixels

— Weight: 0.88 pounds

— Cameras: none

— Battery life: 8.5 hours.

— Operating system: Modified version of Google’s Android

Pros: Cheap and portable. Convenient access to Amazon store.

Cons: No-frills tablet lacks camera and microphone. Small selection of third-party applications available from Amazon. Data storage cannot be expanded with memory cards. No option for cellular wireless broadband.

Google Inc.’s Nexus 7

— Price: $ 199 with 16 gigabytes of storage, $ 249 with 32 GB. Add $ 50 for 32 GB model with cellular capability (available Nov. 13).

— Screen size: 7 inches diagonally

— Screen resolution: 1280 x 800 pixels

— Weight: 0.75 pounds

— Cameras: Front-facing, 1.2 megapixel camera

— Battery life: 8 hours

— Operating system: Google’s Android

Pros: Access to a variety of games, utilities and other software for Android devices, though not as extensive as apps available for iPad. Option for cellular wireless broadband.

Cons: Integrates with Google Play store, which is still new and isn’t as robust as Apple or Amazon’s stores. Data storage cannot be expanded with memory cards.

Gadgets News Headlines – Yahoo! News

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James Blake Weds Emily Snider

People Exclusive

By Jennifer Garcia

11/11/2012 at 09:00 AM EST

Emily Snider and James Blake

STUDIO duva

Game, set, match!

James Blake is a married man. The tennis player, 32, tied the knot with publicist Emily Snider Friday night in Del Mar, Calif., the couple confirms to PEOPLE exclusively.

The sunset ceremony took place at the beach front L' Auberge Del Mar hotel with the bride, 37, donning an Ines DiSanto gown and the groom in a Hugo Boss suit.

The couple of four years had their 5-month-old daughter Riley Elizabeth (Riley is also Blake's middle name) head down the aisle with the bride's mother, Kathy Snider.

For their wedding party, the duo kept it all family: The groom's brother Thomas Blake beside James and the bride's brother Jason Snider beside Emily. The ring bearer was Snider's nephew Frank, 3.

Among the 150 guests were Blake's longtime tennis pal Andy Roddick, New York Yankee Nick Swisher and his wife, actress JoAnna Garcia Swisher, tennis players Mardy Fish, Robby Ginepri and John Isner and singer Tyrone Wells. ESPN analyst and former NFL player Marcellus Wiley deejayed the nuptials.

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Malaria vaccine a letdown for infants

LONDON (AP) — An experimental malaria vaccine once thought promising is turning out to be a disappointment, with a new study showing it is only about 30 percent effective at protecting infants from the killer disease.

That is a significant drop from a study last year done in slightly older children, which suggested the vaccine cut the malaria risk by about half — though that is still far below the protection provided from most vaccines. According to details released on Friday, the three-shot regimen reduced malaria cases by about 30 percent in infants aged 6 to 12 weeks, the target age for immunization.

Dr. Jennifer Cohn, a medical coordinator at Doctors Without Borders, described the vaccine's protection levels as "unacceptably low." She was not linked to the study.

Scientists have been working for decades to develop a malaria vaccine, a complicated endeavor since the disease is caused by five different species of parasites. There has never been an effective vaccine against a parasite. Worldwide, there are several dozen malaria vaccine candidates being researched.

In 2006, a group of experts led by the World Health Organization said a malaria vaccine should cut the risk of severe disease and death by at least half and should last longer than one year. Malaria is spread by mosquitoes and kills more than 650,000 people every year, mostly young children and pregnant women in Africa. Without a vaccine, officials have focused on distributing insecticide-treated bed nets, spraying homes with pesticides and ensuring access to good medicines.

In the new study, scientists found babies who got three doses of the vaccine had about 30 percent fewer cases of malaria than those who didn't get immunized. The research included more than 6,500 infants in Africa. Experts also found the vaccine reduced the amount of severe malaria by about 26 percent, up to 14 months after the babies were immunized.

Scientists said they needed to analyze the data further to understand why the vaccine may be working differently in different regions. For example, babies born in areas with high levels of malaria might inherit some antibodies from their mothers which could interfere with any vaccination.

"Maybe we should be thinking of a first-generation vaccine that is targeted only for certain children," said Dr. Salim Abdulla of the Ifakara Health Institute in Tanzania, one of the study investigators.

Results were presented at a conference in South Africa on Friday and released online by the New England Journal of Medicine. The study is scheduled to continue until 2014 and is being paid for by GlaxoSmithKline and the PATH Malaria Vaccine Initiative.

"The results look bad now, but they will probably be worse later," said Adrian Hill of Oxford University, who is developing a competing malaria vaccine. He noted the study showed the Glaxo vaccine lost its potency after several months. Hill said the vaccine might be a hard sell, compared to other vaccines like those for meningitis and pneumococcal disease — which are both effective and cheap.

"If it turns out to have a clear 30 percent efficacy, it is probably not worth it to implement this in Africa on a large scale," said Genton Blaise, a malaria expert at the Swiss Tropical and Public Health Institute in Basel, who also sits on a WHO advisory board.

Eleanor Riley of the London School of Hygiene and Tropical Medicine, said the vaccine might be useful if used together with other strategies, like bed nets. She was involved in an earlier study of the vaccine and had hoped for better results. "We're all a bit frustrated that it has proven so hard to make a malaria vaccine," she said. "The question is how much money are the funders willing to keep throwing at it."

Glaxo first developed the vaccine in 1987 and has invested $300 million in it so far.

WHO said it couldn't comment on the incomplete results and would wait until the trial was finished before drawing any conclusions.

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'Modern Family' teen star had 'unlawful sex' with boyfriend, mother charges

Authorities are investigating an allegation by the mother of "Modern Family" star Ariel Winter that her daughter's 18-year-old boyfriend had unlawful sex with the 14-year-old actress, according to sources familiar with the investigation.

The L.A. County Sheriff''s Department's Special Victims Unit also is separately examining whether Winter's mother, Chrisoula Workman, physically abused the teenage actress.

So far, detectives have not gathered any specific evidence to substantiate the allegations in either investigation involving Ariel, otherwise  known to millions as Alex Dunphy, the brainy member of "Modern Family's"  Dunphy family.

The investigations began last month after a judge awarded temporary guardianship of Ariel, whose real name is Ariel Workman, to her adult sister, Shanelle Gray, also an actress. Ariel, through her sister's attorney, alleged in a court filing that she was subject to ongoing physical and mental abuse by her mother. 

Three days after Ariel took legal action to split from her mother, Chrisoula Workman reported on Oct. 6 to the sheriff's Crescenta Valley station that her daughter's 18-year-old boyfriend had unlawful sex with the underage actress.

Chrisoula Workman contends she discovered her daughter in the guest bedroom of her Montrose home on Sept. 24 in bed with a young man, believed to be 18, according to sources not authorized to discuss the investigation.

The young man was described as the teenage actress' boyfriend of several months, according to the sources. According to sources, both the teenagers have denied doing anything unlawful.

Detectives also have been unable to substantiate Ariel's abuse allegations, but the investigation remains ongoing.

"It's all untrue, it's all untrue," Chrisoula Workman told People magazine. "I have
my doctor's letter that my daughter's never been abused. ... I have
stylists' letters that she's never been abused."

She added in an interview with E!: "I would never abuse her in any way, and I have always tried my best to
always protect her and do what is right for her. My daughter is in a
business that requires you to grow up fast. It's hard enough being a
teenage girl, but it's even harder when you are in the public eye. 
However, because you are in the public eye, it doesn't mean you are no
longer in need of good parenting."

A judge last month ordered the actress' mother to
stay away from Ariel and have no contact with the minor, pending a Nov.
20 hearing on the guardianship and control of at least $500,000 in
assets.

"Minor Ariel Workman has been a victim of on-going physical abuse
(slapping, hitting, pushing) and emotional abuse (vile name-calling,
personal insults about minor and minor's weight, attempts to sexualize
minor, deprivation of food etc.) for an extended period of time by the
minor’s mother, Chrisoula Workman. ...," her attorneys said in a petition for guardianship.

As is standard practice in such cases, an attorney is representing
the interests of the young actress. To protect her earnings and existing
assets, lawyers are seeking to move her money to accounts off-limits
to her mother.

-- Richard Winton and Andrew Blankstein

Photo: Actress Ariel Winter in September. Credit: Richard Shotwell / Invision / Associated Press

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