Tuesday, March 19, 2013

GSK promises to publish detailed drug trial data

* UK drugmaker paid $3 bln last year to settle fraud case

* Company criticised for keeping medicine data secret

* Will publish detailed clinical study reports

* Historical data back to 2000 will also be revealed

LONDON, Feb 5 (Reuters) - British drugmaker GlaxoSmithKline , which paid $3 billion last year to settle charges that it gave misleading information on its medicines, said on Tuesday it would publish more of its clinical research data.

When the company agreed to the fines last July, government officials called it the largest healthcare fraud case in U.S. history, involving Glaxo drugs such as the antidepressant Paxil and diabetes pill Avandia.

Other firms have also reached settlement deals and the industry has come under growing pressure from campaign groups to release all their clinical trial data.

GSK said it would publish the results of clinical study reports (CSRs) and clinical trials, showing its commitment to transparency.

The company already promised in October 2012 to make data from its clinical trials available to other researchers. This would include patient-level results that sit behind trials of approved and failed drugs.

"Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register," the company said in a statement.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the United States Food and Drug Administration and European Medicines Agency.

The drugmaker said that it would now publish CSRs for all its medicines once they are approved or discontinued from development. This would allow for the data to be first reviewed by regulators and the scientific community, it said. Patient data will be removed to ensure confidentiality.

Patrick Vallance, GSK's president of pharmaceuticals research and development, said the promises were aimed at helping "advance scientific understanding and inform medical judgment".

"Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research," he said in the statement.

In an apparent effort to put its past record straight, GSK also said it intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.

It said this would take time and resources as it would require retrieval and examination of each historic CSR to remove confidential patient information.

"Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years," it said.


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NRA Endorsement Actually A Curse For Candidates, Poll Finds

Endorsements from the National Rifle Association might be doing political candidates more harm than good, according to a new poll from Public Policy Polling.

In a national survey, 39 percent of voters said that they are less likely to vote for a politician whose candidacy has garnered NRA backing. Only 26 percent believe they’re more likely to support such a candidate.

But more importantly, the number of independent voters — those who are really up for grabs in any election — are far less likely to see the NRA nod as a good thing: 41 percent say they’re inclined not to support a candidate who’s backed by the NRA.

This information serves to bust the myth that the NRA is an all-powerful lobbying group that dictates political outcomes. While the organization may enjoy wide support among those politicians whose campaigns it bankrolls, soon there may be few of such politicians left; in 2012, only .81 percent of the group’s spending went to politicians who won. And if the NRA is having a negative influence on swing voters as well, then it really has no sway on political elections overall.


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Netflix’s ‘House of Cards’ Thinks It’s Tough, But It Goes Easy On Washington

This post discusses, in its entirety, the first season of Netflix’s House of Cards.

Over the past two days, I watched all of Netflix’s most ambitious original series yet, a remake of the British miniseries House of Cards. While the show raises interesting questions about both television business models and narrative structures, and while it’s deeply entertaining to watch Kevin Spacey, as Democratic Majority Whip Frank Underwood, chomp scenery and occasionally on Kate Mara’s ambitious young reporter Zoe Barnes, I couldn’t help but feel that House of Cards has a fatal flaw. For all that the show looks attractive, and even half-authentic to the District sometimes, and for all House of Cards is trying its darndest to replicate the repellant chilliness of the British original, it’s actually far too nice to the people and institutions the show would like to skewer. And that’s because House of Cards itself falls prey to some of the kinds of thinking that are most pernicious in the nation’s capital.

Part of the problem is House of Cards‘ insistence that there’s a grandness, rather than a grandiosity, to Frank—while the show believes he’s malign, it’s still convinced that he’s Milton’s Satan rather than Dostoyevsky’s, who Arturo Perez-Reverte once described as “petty. A civil servant with dirty nails.” He declares in the first episode that “My job is to clear the pipes and keep the sludge moving,” and House of Cards seems largely to agree with his assessment. Frank may hold up an education bill to get a version that suits his ends, or derail the nomination of the man who was chosen to be Secretary of State over him, but he does get a bill to the President’s desk roughly on deadline, and once the other man is out of the way, speeds the confirmation of his hand-picked replacement. What really distinguishes him from his colleagues, however, and what the show portrays as the source of Frank’s efficacy, however unattractive it may be, is his treatment of power as a higher good than policy. “Leave ideology to the armchair generals,” he says in one of his many editorial asides to the camera. “It does me no good.”

House of Cards is full of acid portraits of people whose conviction has made them weak or duplicitous without being excellent at it. Even if the show has some sympathy for their dedication to and principal on the issues, it never gives them triumphs over Frank, and frequently suggests that passion makes them obvious, slow, or otherwise unfit to play the game that Frank has mastered so well, his competence overriding our moral calculus. During a subplot that involves the passage of a major education reform bill, Frank’s partner on the legislation, a life-long liberal reformer who’s a stand-in for the late Sen. Ted Kennedy turns out to be a naive patsy without the stomach for compromise or maneuver. “I could put my mind to policy, but I’m no good at this brand of politics,” the man tells Frank in agreeing to take the fall for a leak of his proposed bill that garners negative press coverage, and to let Frank take over writing the next draft. His actual ideas about the issues are never mentioned, simply summed up by Zoe as “very far left wing” for a headline. Somewhere in Massachusetts, Kennedy is rotating in his grave fast enough to dislodge the dirt above him so he can haunt House of Cards writer Beau Willimon for this perfidy.

Elsewhere in the education fight, the only discussion of policy are facile mentions of charter schools, collective bargaining, and performance standards. A union official appears in one scene to declare that “Charters jeapordize our ability to organize, which is reason enough” to object to Frank’s draft of the bill. Otherwise, the movement is represented only by picketers who melt when Frank and his wife serve them barbeque, and by a paid lobbyist who is manipulated into decking Frank in his office, giving him the advantage he needs to force a settlement to a teacher’s strike and a legislative deadlock. When Frank manipulates Congressman Russo (Corey Stoll) into running for Governor of Pennsylvania, his opposition is largely personified by the head of a shipbuilder’s union decimated by the BRAC process that shutters a local shipyard. The man is ultimately undone by his unwillingness to get personal in his fight with Russo, who he has known since childhood, and then subsumed into the political power structure when he is given an opportunity to run for Russo’s seat in congress. During a battle to pass a wetlands bill, House of Cards gives us bleeding-heart liberals who Frank describes as quailed by the sight of their own heart’s blood—in a twist, they’re manipulated by Frank’s wife Claire (Robin Wright), who has a grievance to fulfill. Even Gillian Cole (Sandrine Holt), a brilliant young activist Claire hires to help expand the international operations of the clean water non-profit she runs (in one of House of Cards‘ most perceptive subplots, Claire stops work in the District of Columbia to focus her efforts on the trendier third world) isn’t allowed to be both principled and effective for long. When Claire sells the organization’s credibility to an oil and gas company in exchange for help getting machinery out of South Sudan, Gillian baits Claire into firing her. But instead of exposing Claire as the pathetic shill that she is, Gillian’s chosen method of revenge is a pregnancy discrimination suit. “Organizations like yours get 90 percent of the grant money and cozy up to corporate sponsors who destroy the environment,” she spits at her former boss. But it’s hard for me to believe, given all we’ve seen over the course of the show, that she’ll be able to triumph over the Underwoods. And her chosen method of retaliation makes her look like a cheap liar, rather than a principaled hero worth rooting for against Claire.

In a stronger anti-hero show, we’d see the costs of Frank’s actions, or have credible alternatives to his behavior that challenge our romance with the sheer force of hisa bility. But House of Cards is fundamentally flawed on that score. When Zoe tells her editor that an article she’s working on isn’t good enough because it’s all political horserace speculation, it’s laughable, not perceptive: House of Cards is rooted in the idea that precisely that kind of horserace gossip is the true substance in Washington. “I don’t give a hoot about natural gas, but I have 67 deputy whips and they all need campaign cash,” Frank tells us at one point, and his entire relationship with a lobbyist for precisely that issue is based on what will gain him a relative advantage. The show’s race to the finish line is entirely concerned with who’s up and who’s down in a vice presidential vetting process. And Frank is only outflanked when he meets Raymond Tusk (Gerald McRaney), a billionaire whose influence is international where Frank’s is global, and who proves not to be stronger or more interested in the merits of any given issue than Frank is, but better at political arbitrage.

But the thing is, actions like Frank’s have consequences beyond what they mean for his position on Capitol Hill. The decision to go out and stay on strike is an extraordinarily difficult one, which the show presents as essentially a gambit by lobbyists rather than a wrenching choice by teachers. When military bases close, the impact on the people who lose their jobs is more profound than the pain a Congressman experiences while being yelled at by a constituent in a town hall meeting. It really does matter that non-profits get coopted by their relationships with corporate donors. Accidents at nuclear power plants really do destroy people’s lives. But House of Cards is fundamentally less interested in those consequences than in the manipulations that lead them to come to pass. And in the world of the show, none of those negotiations are ever based on substance. Maybe it’s trying to say that this is a deplorable state of affairs. But the way House of Cards allocates its attention means the show ends up largely buying into Frank’s worldview: substance doesn’t matter, because it’s not the basis on which decisions are made, or on which people rise to significant power.

It’s difficult for me to take seriously any critique of Washington that is so enamored, whether that was Willimon’s intention or not, with one of the ugliest parts of our political culture, and one of the most substance-free elements of our political journalism. And part of what’s odd about watching House of Cards‘ journalism subplots is the extent to which the show believes it’s being awfully tough on Washington political reporters, when actually it’s letting them off relatively easy. It’s meant to be shocking when Zoe, who we meet as a young reporter at the Washington Herald, offers herself up to Frank as a mouthpiece, promising to print anything he feeds her, no questions asked. But the show, which generates friction between Zoe and her editor Tom, by suggesting that he’d be resistant either to blogging or to Zoe’s cable news-facilitated rise, is years out of date when it comes to either Zoe’s mode of reporting or Washington journalism’s approach to the internet. In 2013, when House of Cards is set, the Washington Post, which the Washington Herald is a clear stand-in for, has built a publication-within-a-publication around first-generation blogger Ezra Klein, given Alexandra Petri, a woman about Zoe’s age, a humor blog, and hired Max Fisher to blog about foreign affairs. In one of the most risible moments in the show, Frank tells Zoe that she shouldn’t go to television because she’s “more than a talking head.” “If I were to say Politico wanted to hire me, what would you say?” she asks him. “That would pique my interest,” Frank tells her, suggesting it would be more substantial than working as a correspondent for CBS. The show seems entirely unaware that in real life, Politico has regularly been accused of practicing precisely the kind of speedy, quid-pro-quo journalism that Zoe is meant to be exceptionally guilty of practicing.

House of Cards is so eager to make Zoe an outre figure by linking her compromised journalism to her affair with Frank that it misses a larger story of more profound and widespread professional degradation. The show, in a bit of truly revolting gender politics, argues that all female political correspondents are sleeping with their sources. “I used to suck, screw, and jerk anything that moved just to get a story,” Zoe’s rival Janine (Constance Zimmer, giving much better than she gets) eventually admits to her. “As career strategies go, it’s not worth fucking your way to the middle.” But House of Cards ignores that it doesn’t take the entanglement of an affair to get lots and lots of political journalists to practice the kinds of quid pros that Zoe adapts to so easily. It might have been shocking five or ten years ago that a publisher would protect and promote a reporter with Zoe’s standards because she liked the young woman’s hustle. But today, Washington journalism has adapted. Reporters like Klein have demonstrated that working online—and that succeeding on cable television—is no barrier to doing quality policy journalism of the kind the bores Zoe. And concurrently, the barriers to the shoddy kind of work Zoe is doing fell long ago.

The scandal of Washington journalism is hardly that one reporter would print a single-sourced story, or fail to interrogate information and spin handed to them by a source with whom they’re eager to preserve a relationship. It’s that so many of them do it, and have been doing it for so long. And, in keeping with House of Cards‘ myopia, the consequences of this kind of journalism Zoe practices are salacious and personal—in the show she unwittingly contributes to the relapse and death of Congressman Russo—than the reality, which is that they are systemic and unglamorous. The real villain of a show like House of Cards should be someone like Betsy McCaughey, whose pre-blogging collaboration with a Phillip Morris lobbyist resulted in “No Exit,” the error-ridden article in The New Republic that helped kill President Clinton’s health care reform bill. But that would require a show that’s interested in policy, and in its outcomes for ordinary people.

There are a few instances where House of Cards gets it right not by reaching for repulsion, but simply by documenting the way Washington actually works. As Frank’s fight with teacher’s unions over an education bill heats up, he looks for a way to discredit them, make the organizations seem at war with each other and distanced from the actual interests of their members. Claire suggests the phrase “disorganized labor” as a useful bit of rhetoric, and the show watches it spread through cable news like wildfire. House of Cards goes further than it needs to in having Frank use agents provocateur to make it seem like some union members are starting brawls and tossing bricks, giving the chairman of the Congressional Black Caucus a chance to opine on television that a prominent union lobbyist “might want to tone down the rhetoric before disorganized labor turns into organized crime.” But seeing that simple, clever, empty phrase leach into the discourse, and the power it gives Frank, is ugly enough.

Then, there’s Frank’s efforts to discredit the nominee for Secretary of State who displaced him, by drawing attention to an editorial published when the man was editing his college newspaper, though it does not bear his name, that suggests that Israel has a moral imperative to pull back from the West Bank. The only reason Frank can get it into circulation at all his is no questions asked deal with Zoe, and then even she is skeptical, asking “Did he write the editorial? Did he personally write it? Then there’s no story.” But Frank is clever enough to give her the frame she needs to sell the story to her editor, and by the time she’s making the pitch—”I’m not saying there’s a story. All I’m saying is there’s a question that needs to be answered.”—Zoe half-believes it herself. Any attempt to beat back the ridiculousness of the charge only draws the nominee in deeper. When he insists “This is ludicrous” on a cable news appearance, Frank summons Anti-Defamation League Dennis Mendel to his office, Mendel declares that “We do not consider Israel and Palestine a laughing matter,” and Frank informs us that “It’s too easy.”

In between these two anecdotes, a gaffe Frank commits and that’s immediately Auto-Tuned, and the way Zoe’s appearances on television enable her own rapid rise through the Washington journalism stratosphere, House of Cards could mount the critique of cable news that Aaron Sorkin only dreamed of writing in The Newsroom. But it doesn’t really have the time to spend on this weird engine of Washington capital, nor the interest in parsing out the brilliant malevolence of Fox News, the attempts by MSNBC to punch back, and the increasing irrelevance of CNN. And maybe more to the point, House of Cards relies too heavily on appearances by real-life talking heads to lend the show a timely frisson to risk alienating the people who help ground it in the real world, a Washington entanglement of the show’s very own.

Towards the end of the show, when Zoe begins to realize the extent to which Frank has used their relationship, and how complicated their machinations are, Janine, by then working alongside her at a web-based publication, bucks up the younger woman by telling her “The only articles I have written that truly mattered scared the shit out of me.” House of Cards wants to be the same kind of terrifying expose of what happens in Washington. Instead, it feels more like one of Frank Underwood’s targets, spun in circles, and too clueless to realize its own dizziness.


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Statement by Assistant to the President for Homeland Security and Counterterrorism John Brennan on Bulgaria’s Announcement of Hizballah’s Role in the 2012 Burgas Terrorist Attack

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For Immediate Release February 05, 2013 Statement by Assistant to the President for Homeland Security and Counterterrorism John Brennan on Bulgaria’s Announcement of Hizballah’s Role in the 2012 Burgas Terrorist Attack

The United States commends the Government of Bulgaria for its professional and comprehensive investigation into the barbaric July 18, 2012 terrorist attack in Burgas.  Today, following a thorough review of the evidence collected to date, Bulgarian authorities announced their judgment that Lebanese Hizballah was responsible for carrying out this act of terrorism, which killed six innocent civilians and injured many others. 
 
Bulgaria’s investigation exposes Hizballah for what it is – a terrorist group that is willing to recklessly attack innocent men, women, and children, and that poses a real and growing threat not only to Europe, but to the rest of the world.  We commend Bulgarian authorities for their determination and commitment to ensuring that Hizballah is held to account for this act of terror on European soil.  The United States will continue to provide the Bulgarian Government assistance in bringing the perpetrators of this heinous attack to justice. 

Hizballah’s dangerous and destabilizing activities – from attacking tourists in foreign countries to leader Hassan Nasrallah’s active support of Bashar al-Assad’s violent campaign against the Syrian people – threaten the safety and security of nations and citizens around the world.  Bulgaria’s implication of Hizballah underscores the importance of international cooperation in disrupting terrorist threats.  We call on our European partners as well as other members of the international community to take proactive action to uncover Hizballah’s infrastructure and disrupt the group’s financing schemes and operational networks in order to prevent future attacks.

The United States is proud to stand with its friend and NATO ally Bulgaria.  We deeply value our strong partnership on a wide range of issues including advancing global and regional security in Afghanistan and the Balkans, expanding economic and commercial ties, and promoting cultural and education programs.

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Getting natural gas right a priority

By Sen. Ron Wyden (D-Ore.) - 02/05/13 05:29 PM ET

As the seventh chairman of the Senate Committee on Energy and Natural Resources, I could not be more excited to step up to the challenge of strengthening U.S. energy policy. 

It’s been five years since Congress last passed a major energy bill. Over that time, natural-gas prices have dropped nearly in half, the amount of wind power installed here has more than doubled to 50 gigawatts and U.S. greenhouse gas emissions have actually fallen. Most significantly, the goal of U.S. energy independence has gone from being a pipe dream to something that experts are predicting will become reality in just a few years. 

But despite these positive developments, the U.S. has critical decisions to make in the next few years. How will it address the newly accessible reserves of shale gas? How can government encourage the continued growth of cleaner sources of power? What is the best way to fund research into innovative energy sources of the future while safeguarding taxpayer dollars? 

Looming over all of those decisions is the threat of climate change, which is unquestionably the most pressing environmental challenge of our time. 

Let’s start with the proposition that there are practical steps the government can take right now to accelerate the transition to a low-carbon economy. Done right, this transition will strengthen the U.S. economy and make it more competitive with other countries that are looking to win the fight for the globe’s clean-energy future. 

I plan to work with my colleagues on the committee to start finding answers to each of those questions. I fully expect to find common ground with members on both sides of the aisle and write bills that can pass through the Senate. One colleague told me recently, “No one expects to pass bills this year, but I expect Energy and Natural Resources to pass some bills.” 

I agree. I want this committee to get things done. 

The committee’s first order of business will be natural gas: how it’s produced, how it’s used and how much of it the U.S. should use it here or send abroad. Whether you are for more renewables or for traditional fuels, there’s no escaping the fact that the shale gas revolution is dominating today’s energy discussion. 

First, it’s important that companies extract this resource safely. Common-sense rules can safeguard communities that could be affected by gas development, without harming natural-gas producers.

Next, decisions about exporting natural gas could have enormous consequences for how shale gas affects the economy. I want to ensure misguided government policy doesn’t shut down the manufacturing resurgence this country has seen as a result of reliable, low-cost natural-gas supplies. But I don’t oppose all exports. My aim is to find a sweet spot that allows some exports and keeps wells in production, while ensuring U.S. manufacturing and national security are not harmed by allowing unfettered liquefied natural-gas exports. 

Getting natural gas right is the first step, but it’s not enough. The low-carbon economy also needs more renewable energy and more efficient use of the energy the U.S. already has. 

Clean-energy developers have told me they’ve been hurt by inconsistent federal policies, which make it hard to plan and find financing for projects. I hope to work with Senate Finance Committee Chairman Max Baucus (D-Mont.) to replace the roller coaster of short-term incentives with more stable, technology-neutral policies that reward renewable and domestic energy sources. 

At the same time, the Energy Department should continue to support research into innovative energy technologies, to make sure the U.S. is home to the next game-changing energy breakthrough. 

That’s just a start. There’s also nuclear waste, revenue sharing and a host of natural-resources issues that need action in this Congress. 

To accomplish anything, though, the committee will have to get back to doing business the way it did not too long ago. I say that with great respect for former Sen. Jeff Bingaman (D-N.M.), whose accomplishments rival that of any Energy Committee chairman and who had to cope with events outside his control. 

The numbers tell the story: In the 106th Congress, the committee passed 226 bills, most of them public lands bills with no opposition. In the 112th Congress, Energy and Natural Resources passed just 75 bills.

I’ve spent my career finding bipartisan solutions to tough issues. And I’ve learned that pragmatism and principles don’t have to conflict. My colleagues and I are aiming to get things done over the next two years, because the challenges the U.S. faces on energy are too pressing to pass on to the next Congress.

Wyden is chairman of the Senate Energy and Natural Resources Committee.

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UPDATE 1-GSK promises to publish detailed drug trial data

* Drugmakers under fire for keeping medicine data secret

* New move builds on previous GSK pledge to be more open

* GSK will now publish detailed clinical study reports

* Industry critic Ben Goldacre says GSK move "excellent"

LONDON, Feb 5 (Reuters) - Britain's largest drugmaker GlaxoSmithKline is extending a promise to make more of its pharmaceutical research data public by publishing detailed clinical study reports as well as the results of all drug trials.

The decision marks a new level of openness in the drugs industry that other companies may be under pressure to follow. Drugmakers have long been criticised for keeping important information about their medicines under wraps.

Ben Goldacre, a British doctor and author of "Bad Science" and "Bad Pharma", who has led a campaign called AllTrials urging clinical study report (CSR) disclosure, said GSK's support for the initiative was "excellent and amazing".

GSK, which agreed a $3-billion U.S. settlement last year over misleading information about some of its drugs, already said in October it would make anonymised patient-level data from clinical trials available to other researchers.

"Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register," the firm said in a statement on Tuesday.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the U.S. Food and Drug Administration and European Medicines Agency.

Campaigners argue that CSRs are essential to assess the real value of medicines because brief summaries about trials, such as those published in academic journals, can be incomplete.

GSK said that from now on, it would publish CSRs for all of its medicines once they have been approved or discontinued from development. This would allow for the data to be first reviewed by regulators and the scientific community, it said. Patient information will be removed to ensure confidentiality.

Patrick Vallance, GSK's president of pharmaceuticals research and development, said the promise was aimed at helping "advance scientific understanding and inform medical judgment".

"Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research," he added.

Demands for greater transparency by the drug industry have come to a head in Britain with the AllTrials campaign, whose supporters include the group Sense About Science, the British Medical Journal and the Centre for Evidence-based Medicine.

In an apparent effort to put its past record straight, GSK also said it intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.

It said this would take time and resources as it would require retrieval and examination of each historic CSR to remove confidential patient information.

"Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years," it said.


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UPDATE 1-U.S. Senate to mull ban on 'pay for delay' pharmaceutical deals

* Branded, generic drug companies expected to oppose bill

* Similar measures failed in previous Congress

* Supreme Court has agreed to hear 'pay for delay' case

WASHINGTON, Feb 5 (Reuters) - Key Democratic and Republican senators reintroduced legislation on Tuesday that would make it illegal for brand-name pharmaceutical companies to pay generic drug makers to keep their cheaper medicines off the market.

Such deals, in which big drug companies resolve patent litigation with potentially infringing generic firms by reaching a settlement that delays a generic version of a drug in exchange for a payment, have angered U.S. and European antitrust enforcers for years.

The bill is sponsored by Senator Amy Klobuchar, a Democrat from Minnesota and the new chair of the Senate Judiciary Committee's antitrust panel, and by Senator Chuck Grassley, a Republican from Iowa.

"I have long supported efforts to crack down on this behavior and the recent rise in pay-for-delay agreements underscores the need for legislation to help make sure people have access to the drugs they need at a price they can afford," Klobuchar said in a statement.

Similar bills, including one in 2010, have failed in part because of opposition from the drug industry, both branded and generic. It was not immediately known if a companion bill would be introduced in the U.S. House of Representatives.

Opponents of the measure are already pressing for meetings with the two lawmakers and are confident that it will go nowhere, said Ralph Neas, chief executive of the Generic Pharmaceutical Association trade group.

"I do believe that a majority of Congress opposes the bill," said Neas, who said the settlements were good for consumers. "I know that (Federal Trade Commission Chairman) Jon (Leibowitz) has this catchy phrase 'pay for delay' but it's wrong. Patent settlements save."

The FTC said in January that brand name drug firms reached agreements with generic manufacturers 40 times in the latest fiscal year, delaying the arrival of cheaper drugs to pharmacists' shelves. That was up from 28 the previous year and the highest since the FTC started tracking them.

The commission has had mixed success in fighting the deals in court, but the issue could be coming to a head.

Most recently, the U.S. Supreme Court agreed to hear an appeal by the FTC, which had challenged annual payments of $31 million to $42 million by then-owner Solvay Pharmaceuticals Inc to stop generic versions of AndroGel, a treatment for the underproduction of testosterone, until 2015. AndroGel is now a product of AbbVie.

In Brussels in late January, EU antitrust regulators stepped up their fight against drug companies suspected of blocking cheap generic medicines, charging Johnson & Johnson and Novartis over the painkiller fentanyl.

The European antitrust watchdog said it believed the two had agreed on a "pay-for-delay" deal on generic versions of the drug, hurting Dutch consumers and healthcare providers.


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Medicines Co, Alnylam Pharma enter alliance

PARSIPPANY, N.J. -- Drugmaker Medicines Co. is entering an alliance with Alnylam Pharmaceuticals Inc. to help develop the biopharmaceutical company's RNA interference drugs that could potentially help lower cholesterol.

Alnylam's drugs use RNA interference, or RNAi, technology. RNAi therapies work by turning off or silencing disease-causing genes.

Under terms of the exclusive alliance, Medicines will make a $25 million upfront cash payment to Alnylam. There is also the potential for up to $180 million in development and commercial payments if certain milestones are met.

Medicines is based in Parsippany, N.J. Alnylam is based in Cambridge, Mass.

Medicines' stock fell 42 cents to $30.11 in afternoon trading, while shares of Alnylam declined 57 cents, or 2.4 percent, to $23.67.


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Rick Scott’s Secretary Of State Says Florida Should Restore Early Voting

Florida Secretary of State Rick Detzner Florida Secretary of State Rick Detzner

Because Gov. Rick Scott (R) and his legislative allies spent much of 2011-2012 filling up the November ballot with complicated and unnecessary ballot questions and pushing through measures aimed at suppressing voter turnout, Florida voters had to wait in lines for up to six hours. Now, Scott’s handpicked Secretary of State has released a report recommending that Florida expand early voting and limit the length of future ballot questions.

Secretary of State Rick Detzner, who in the days after the November elections said he had no regrets about the Scott administration’s handling of the election, acknowledged in the report that there was widespread frustration with “the length of lines at polling places, which were believed to have been caused by the record number of voters, a shortened early voting schedule, inadequate voting locations and a long ballot.” He makes no mention of the reasons for those factors — Scott’s unwillingness to extend early voting hours, a Scott-signed law shortening early voting, and an effort by the Republican legislature to load the ballot up with complicated ballot measures sure to slow down voters at the polls.

But, he encourages Scott and his fellow Republicans not to repeat the same mistakes in future elections, recommending Florida:

Extend the early voting schedule from a minimum of 8 days to a maximum of 14 days, while also allowing supervisors of elections the flexibility to offer early voting on the Sunday immediately prior to Election Day.Expand the allowable locations of early voting sites at government owned, managed or occupied facilities to include the main or branch office of a supervisor of elections, a city
hall, courthouse, county commission building, public library, civic center, convention center, fairgrounds or stadium.Set a word limit for proposed legislative amendments.Repeal statutes allowing the full text (stricken or underlined) of a constitutional amendment or revision to be placed on a ballot.Allow mail ballot elections for candidates in certain elections.

While the 14-day period would be an improvement over the eight days currently provided by Florida law, it would represent a return to where things were before Scott took office.

It remains to be seen whether Florida acts on these recommendations. In November, Gov. Scott defended his suppression tactics as having done “the right thing” and a month later blamed the legislature for the early voting limits he himself signed into law. But last month, he endorsed re-expanding the early voting he limited.


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Readout of the President's Call with Baltimore Ravens Coach Harbaugh and General Manager Newsome

Readout of the President's Call with Baltimore Ravens Coach Harbaugh and General Manager Newsome | The White House Skip to main content | Skip to footer site map The White House. President Barack Obama The White House Emblem Get Email UpdatesContact Us Go to homepage. The White House Blog Photos & Videos Photo Galleries Video Performances Live Streams Podcasts 2012: A Year in Photos

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For Immediate Release February 05, 2013 Readout of the President's Call with Baltimore Ravens Coach Harbaugh and General Manager Newsome

This afternoon, the President called Head Coach John Harbaugh and General Manager Ozzie Newsome to congratulate them and the Baltimore Ravens on winning Super Bowl XLVII.  He commended the Ravens on an unbelievable year and for the steadiness the team displayed through the end.  The President also expressed how moved he and the First Lady were by the story of O.J. Brigance.  The President said he looks forward to congratulating the team in person at the White House. 

Extending Middle Class Tax Cuts

Blog posts on this issue February 05, 2013 3:00 PM ESTPresident Obama Makes a Statement on the Sequester

President Obama explains that while our economy is headed in the right direction, looming automatic budget cuts will cost jobs and slow down our recovery.

February 05, 2013 12:48 PM ESTAnnouncing the State of the Union White House Social

Apply today for a chance to join the White House social media team for the State of the Union.

February 05, 2013 10:58 AM ESTAnnouncing We the People 2.0 and a White House Hackathon

We're working towards Petitions 2.0, releasing an API, and inviting a small group to join us on February 22, 2013 for the White House Open Data Day Hackathon.

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