Early sales of Vivus’s diet pill disappoint, shares slide

(Reuters) – Vivus Inc reported lackluster initial sales of its weight-loss pill Qsymia as a lack of reimbursement coverage prompted concerns about the drug’s adoption and dragged down shares of diet-drug makers.

Shares of Vivus were down 24 percent at $ 11.38 on Tuesday afternoon on the Nasdaq after recovering from an earlier low of $ 11.00.

Arena Pharmaceuticals Inc‘s shares were down 6 percent at $ 7.51, while those of Orexigen Therapeutics Inc were off 5 percent at $ 4.99.

Arena’s diet pill Belviq is set to launch early next year and Orexigen is planning a re-submission of the marketing application for its competing product, Contrave.

Earlier this year, Belviq and Qsymia became the first new diet pills to receive marketing in 13 years as pressure mounts on the U.S. Food and Drug Administration to approve obesity treatments for some two-thirds of Americans who are considered overweight or obese.

Vivus recorded $ 41,000 in Qsymia sales since its launch on September 17 through the end of the month. Analysts on average had expected about $ 310,000, according to Thomson Reuters I/B/E/S.

The company’s chief commercial officer Mike Miller flagged concerns over the drug’s lack of insurance coverage and said “about 30 percent of patients chose not to fill after receiving a (Qsymia) prescription due to cash outlay.”

“The average retail price for the patient for 30 days or the recommended dose is approximately $ 160,” Miller said on a post-earnings call.

“Currently, we are seeing one out of five (patients) being covered by third-party insurance with an average co-pay of $ 62.”

Robert Hazlett of Roth Capital Partners, who maintained his “neutral” rating on the stock, said reimbursement was an obstacle, but given that the company is in the very early stages of selling the drug, it can overcome these hurdles over time.

A total of 656 Qsymia prescriptions were shipped from certified network pharmacies in September. That number rose to 5,560 through the week of October 26.

Cowen & Co analyst Simos Simeonidis also said insurers will slowly start reimbursing obesity drugs over the next few months, following the example set by the Centers for Medicare & Medicaid Services, which has started reimbursing weight-loss counseling.

“We continue to believe that in order for Qsymia to become a blockbuster, Vivus needs the help of a big pharma partner,” Simeonidis said in a note to clients, highlighting the importance of a large sales force.

Vivus’s shares saw much investor love during the period leading up to Qsymia approval in July, but have slid 30 percent since European health regulators rejected the drug in October, citing the potential for heart risks and birth defects related to its long-term use.

The company plans to appeal the decision and expects a fresh verdict in the first half of 2013.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Maju Samuel)

Seniors/Aging News Headlines – Yahoo! News

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If Obama wins, will he finally tell us his second-term agenda?

By Walter Shapiro

LIMA, Ohio—Speaking at a rally here last Friday afternoon, Barack Obama stressed his old-shoe familiarity: “After four years as president, you know me.” That’s a standard stump speech line, but the more than 3,000 Democrats in local high-school gym burst into cheers, brimming with confidence that they knew the Real Obama.

But does anyone outside his family and the inner sanctum of the White House staff really know Obama—or have a clear handle on what he would do with a second term? This question is not designed to feed any off-the-wall conspiracy theories about a secret second-term agenda. Rather, it’s designed to underscore the perception that Obama remains more opaque than most presidents.

During his speech in this blue-collar pocket of Ohio, the shirt-sleeved Obama waxed populist as he decried the way that the voices of the American people have “been shut out of our democracy for way too long by the lobbyists and the special interests.”

Referring to this us-versus-them rhetoric after the speech, a reporter friend, traveling with the president’s press corps, said, “That’s the real Obama.” But was it? Or was this just a president in a tight race harking back to the citizens-versus-lobbyists language that propelled him into the White House?

In his speeches, including the one in Lima, Obama talks about his second-term vision as he says, “I want to recruit 100,000 math and science teachers. I want to train two-million Americans at our community colleges.” Obama echoes this theme in a 60-second closing argument commercial heavily broadcast on Ohio television. In the ad, Obama implies that the money could come “from ending the war in Afghanistan so we can do some nation-building here at home.”

But there’s a major roadblock: The odds are very high that the Republicans will retain control of the House, even if Obama is reelected.

If that occurs, the Tea Party naysayers of 2010 almost certainly would feel emboldened by their personal electoral successes—and become even more obstinate in their resistance to new domestic spending. With the “fiscal cliff” end-of-the-year budget negotiations looming, a reelected President Obama will be hard-pressed to maintain even the current levels of educational spending let alone create new programs.

It’s politically telling that the president never mentions health care in his final TV ad and only flicked at the topic in his stump speech in Lima. But with the Democrats likely to hold the Senate, the reelection of Obama would all but guarantee that his signature domestic achievement will be fully implemented. As a result, tens of millions of Americans would never have to agonize about health insurance coverage again.

Reelected presidents, stymied by Congress, often turn their full attention to foreign affairs. While this single-mindedness can lead to unexpected breakthroughs (Richard Nixon and China), often it ends in the kind of frustration that Bill Clinton experienced over his failure to negotiate an Israeli-Palestinian peace settlement at Camp David in the waning days of his presidency.

The most likely flashpoint for the next president (whether Obama or Mitt Romney) is, of course, Iran. All occupants of the Oval Office and all who aspire to that job have unequivocally declared that a nuclear-armed Iran is unacceptable.

But what would that mean, in practice, in an Obama second term? Any temptation to categorize the president as a peacenik has to be squared against Obama’s enormous expansion of drone attacks against suspected terrorists. Even without a hawkish, even by Israeli standards, government in Jerusalem, the precise American response to a nuclear Iran would be hard for foreign-policy experts to game out in advance. For ordinary voters to do so at the frenzied end of a presidential campaign is well nigh impossible.

Maybe it’s unrealistic to expect a president running for reelection to be overly specific about his plans for a second term. Bill Clinton campaigned in 1996 on little more than the vague promise to build “a bridge to the 21st century.” And George W. Bush gave voters—and his fellow Republicans in Congress—little warning in 2004 that he intended to attempt to privatize Social Security in 2005.

Still, if Obama prevails on Tuesday (or survives a long count that stretches into Wednesday and beyond), I would be eager to read what he says in his post-election interviews. After a stealth reelection campaign, that might be the moment when we finally learn if Obama has fresh ideas for curbing the reign of special interest in Washington. Or how the soon-to-be two-term president intends to bridge the inevitably bitter stalemate in Congress.

In the end, it comes down to the elusive qualities of trust and character. Americans have had four years to make their own judgment about President Barack Obama. So, in fact, maybe we do know him as well as we ever will. Not as a friend or (in that awful cliché) a guy to have a beer with. But as a leader, who has sometimes stumbled but has mostly prevailed during four of the most arduous economic years in American history.

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Methane warnings ignored before NZ mine disaster

WELLINGTON, New Zealand (AP) — A New Zealand coal mining company ignored 21 warnings that methane gas had accumulated to explosive levels before an underground explosion killed 29 workers two years ago, an investigation concluded.

The official report released Monday after 11 weeks of hearings on the disaster found broad safety problems in New Zealand workplaces and said the Pike River Coal company was exposing miners to unacceptable risks as it strove to meet financial targets.

“The company completely and utterly failed to protect its workers,” New Zealand Prime Minister John Key said Monday.

The country’s labor minister, Kate Wilkinson, resigned from her labor portfolio after the report’s release, saying she felt it was the honorable thing to do after the tragedy occurred on her watch. She plans to retain her remaining government responsibilities.

The Royal Commission report said New Zealand has a poor workplace safety record and its regulators failed to provide adequate oversight before the explosion.

At the time of the disaster, New Zealand had just two mine inspectors who were unable to keep up with their workload, the report said. Pike River was able to obtain a permit with no scrutiny of its initial health and safety plans and little ongoing scrutiny.

Key said he agrees with the report’s conclusion that there needs to be a philosophical shift in New Zealand from believing that companies are acting in the best interests of workers to a more proscriptive set of regulations that forces companies to do the right thing.

The commission’s report recommended a new agency be formed to focus solely on workplace health and safety problems. It also recommended a raft of measures to strengthen mine oversight.

Key said his government would consider the recommendations and hoped to implement most of them. He would not commit on forming a new agency. Workplace safety issues are currently one of the responsibilities of the Ministry of Business, Innovation and Employment.

In the seven weeks before the explosion, the Pike River company received 21 warnings from mine workers that methane gas had built up to explosive levels below ground and another 27 warnings of dangerous levels, the report said. The warnings continued right up until the morning of the deadly explosion.

The company used unconventional methods to get rid of methane, the report said. Some workers even rigged their machines to bypass the methane sensors after the machines kept automatically shutting down — something they were designed to do when methane levels got too high.

The company made a “major error” by placing a ventilation fan underground instead of on the surface, the report found. The fan failed after the first of several explosions, effectively shutting down the entire ventilation system. The company was also using water jets to cut the coal face, a highly specialized technique than can release large amounts of methane.

The report did not definitively conclude what sparked the explosion itself, although it noted that a pump was switched on immediately before the explosion, raising the possibility it was triggered by an electrical arc.

The now-bankrupt Pike River Coal company is not defending itself against charges it committed nine labor violations related to the disaster. Former chief executive Peter Whittall has pleaded not guilty to 12 violations and his lawyers say he is being scapegoated.

An Australian contractor was fined last month for three safety violations after its methane detector was found to be faulty at the time of the explosion.

Australia / Antarctica News Headlines – Yahoo! News

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Apple sells 3 million iPads over first weekend

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No Doubt apologize to Native Americans for Wild West video

LOS ANGELES (Reuters) – The Pop band No Doubt was forced to remove a new Wild West-themed music video and issue an apology after getting complaints from the Native American community, saying its intention was “never to offend, hurt or trivialize” their culture or history.

The Southern California band – made up of lead singer Gwen Stefani, guitarist Tom Dumont, bassist Tony Kanal and drummer Adrian Young – posted an apology on their official website on Saturday following the release of their latest video for the single “Looking Hot.”

“As a multi-racial band our foundation is built upon both diversity and consideration for other cultures. Our intention with our new video was never to offend, hurt or trivialize Native American people, their culture or their history,” the band said.

The video, which debuted on Friday, featured Stefani dressed in tribal garments as a Native Indian princess captured by Young and Dumont dressed as cowboys, while Kanal played a tribe chief who rescues Stefani.

Some users took to social media platforms to criticize the band’s use of tribal imagery, leading No Doubt to remove the video online, adding that “being hurtful to anyone is simply not who we are.”

“Although we consulted with Native American friends and Native American studies experts at the University of California, we realize now that we have offended people … We sincerely apologize to the Native American community and anyone else offended by this video,” they said.

“Looking Hot” is the second single from No Doubt’s latest album “Push and Shove,” their first studio release in a decade. The band initially rose to fame in the early 1990s in the new wave ska-punk scene and crossed over into pop with hits such as “Don’t Speak” and “Just A Girl.”

(Reporting By Piya Sinha-Roy; Editing by Paul Simao)

Music News Headlines – Yahoo! News

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Multivitamins don’t cut heart disease risk in men – study

LOS ANGELES (Reuters) – Taking a daily multivitamin does not reduce the risk of heart disease for older men, according to data from a large study presented on Monday.

About half of U.S. adults take at least one daily dietary supplement, the most popular being a multivitamin, according to the U.S. Centers for Disease Control and Prevention.

The U.S. Physicians Health Study II monitored nearly 15,000 male doctors aged 50 and older for more than 10 years. Participants were randomly assigned to take a multivitamin or a placebo.

“We found that after more than a decade, there is neither benefit nor risk,” in terms of cardiovascular disease, said Dr. Howard Sesso, study author and associate epidemiologist at Brigham and Women’s Hospital in Boston.

Researchers reported last month that the same trial showed that a daily multivitamin reduced the men’s overall risk of cancer by 8 percent.

“We still feel very comfortable with the conclusions for the cancer findings,” Dr. Sesso said. “The lack of effect for cardiovascular disease versus cancer benefit isn’t necessarily inconsistent. There could be a difference in mechanism of effect.”

The findings were presented in Los Angeles at the American Heart Association scientific meeting and published in the Journal of the American Medical Association.

“It is hard for us to recommend, at this point in time, taking a multivitamin to avoid cardiovascular disease,” Dr. Sesso said, noting that patients need to discuss all over-the-counter medicines with their doctors.

He said patients often view multivitamins as a “quick fix,” which can lead them to let up on other efforts to improve their health.

“The danger of taking multivitamins is that it will lead you to think you can forgo other lifestyle changes,” such as not smoking and maintaining a healthy diet, said Dr. Dariush Mozaffarian, associate professor in the department of epidemiology at Harvard School of Public Health.

The research was funded by the National Institutes of Health and with a grant from BASF Corp. The multivitamins and packaging were provided by BASF, Pfizer Inc and DSM Nutrition Products.

“Many patients think that because they are getting an OTC (over-the-counter) medication it is safe and the risk of complications is low,” said Dr. Elliott Antman, chairman of the AHA Scientific Sessions Committee and professor of medicine at Harvard Medical School. “That appears to be right, but we still need to remind them of the need for lifestyle changes.”

Two other studies involving Omega-3 fatty acids derived from fish oil that were presented at the meeting on Monday also failed to help specific heart conditions.

In one, taking fish oil for a year failed to limit recurrent symptomatic atrial fibrillation, a type of irregular heartbeat that significantly raises the risk of stroke.

In the other trial, short term use of fish oil failed to decrease incidence of atrial fibrillation that commonly occurs after patients undergo heart surgery.

Dr. Peter Wilson, from the Emory University School of Medicine in Atlanta who was not involved in the studies, was disappointed by the results.

Every time we’ve looked at Omega-3, he said, “we’ve come up short. It’s very discouraging.”

(Reporting By Deena Beasley and Bill Berkrot; Editing by Stacey Joyce, Bernard Orr)

Diseases/Conditions News Headlines – Yahoo! News

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Everything you wanted to know about voting machines

Ever since punch-card voting machines produced the "hanging chads" that led to the Florida recount in the 2000 election, Americans have been looking for new and more reliable technology to use on Election Day.

One result: The Help America Vote Act of 2002, which authorized $3.9 billion in federal funds for trading in punch-card and lever systems with either e-voting or optical scan systems. The act also stipulates that all polling places should make available a handicap-accessible voting device.

But while the country, for the most part, has moved on from the older, more unreliable machines, the new models present their own set of challenges. From shadowy conspiracy theories to genuine concerns about glitches, here's what you need to know about the machines that are supposed to make democracy work.

What kind of machines are used, and where?

Sixty percent of the country now supplies voters with optical scanners. To use them, voters shade in their choices on paper ballots (similar to how they would take an SAT test) before feeding it to the machines. These optical scanners, while not exactly a brand-new technology, are the state-of-the-art for both their accuracy in processing votes and their security against tampering.

But the same cannot always be said for the alternative, e-voting equipment (direct-recording electronic machines, or DREs), which is used in about 25 percent of the country. These are lined up in places like Georgia, Maryland, Utah, Nevada, New Jersey, Pennsylvania, Indiana and Texas.

E-voting machines come in three variants: push-button machines sporting a keypad; LCD touch-screens; and machines that use a rolling wheel to select and confirm a vote onscreen. All of these register votes on an electronic ballot. The absence of a paper trail, which is preserved by the optical scanners, has caused concerns since the inception of the machines.

VerifiedVoting.org provides more specifics on the history and different forms of voting technology, including a map showing the brand of election equipment for different states.

Does anyone still use punch-card or lever systems?

Four counties in Idaho still use punch-card ballots, while none in the country has used lever machines since 2010.

What are some of the examples of problems with e-voting machines?

In 2004, electronic votes were wiped from machines in New Jersey and North Carolina. But the much more ominous worries over the limits and liabilities of e-voting became clear in 2008, when a study by Princeton University revealed how easy it would be to hack into the Sequoia brand of e-voting machines (used chiefly in New Jersey, Pennsylvania and Louisiana) to steal votes.

More disturbing is this quote from Roger Johnston, a computer science expert leading a subsequent test on Diebold AccuVote e-voting machines just last year: "I've seen high-school science fair projects that are more sophisticated than what is needed to hijack a voting machine." His crash course in vote-jacking went as follows: The equipment was hacked by inserting a very inexpensive homemade device into the voting machine, which could be remotely controlled from afar. In practice, when the voter attempted to mark her e-ballot, the hacker could intercept and alter the vote from one party to the other.

Despite these widely reported studies, as well as HBO's 2006 documentary "Hacking Democracy," there has not yet been any effort to address these sorts of problems with either the Diebold machines or the smaller malfunctions of e-voting machines more broadly. (It is, of course, also true that there have been problems with fraud and machine error with more traditional forms of voting technology.)

The software for the e-voting machines is proprietary, which means that only the companies that manufacture them have access to their design, which they have kept from examination through extended legal battles.

What's with stories about Tagg Romney owning voting machines?

In a tight election, even the most tenuous connections can be spun quickly into a web of conspiracy. That's not to say that there aren't genuine links between very enthusiastic Mitt Romney donors and Hart InterCivic, a large supplier of voting machines in Ohio—but the theories attempting to prove that Tagg Romney, the Republican nominee's eldest son, owns Ohio voting machines overstep the boundaries of available evidence.

As Rick Ungar reported in Forbes, two Hart InterCivic board members made direct donations to the Romney campaign; furthermore, several directors of H.I.G. capital, which owns Hart, are major money-raisers for the campaign. (Some of them were in the room during Romney's infamous "47 percent" remarks.)

But there is no evidence that Tagg Romney's private equity firm, Solamere Capital, invests, owns or controls voting machines made by InterCivic. The closest one gets by following the money is to find Solamere investing in H.I.G.'s medical fund, BioVentures, a wholly separate fund, as reported by Eugene Kiely and Lucas Isakowitz at Factcheck.org.

What will superstorm Sandy's impact be on voting in the Northeast?

In the back of people's minds, Sandy's effect on voting in the Northeast has been a quiet but pressing concern. As Thad Hall, a University of Utah political scientist and researcher for the Voting Technology Project, told the Associated Foreign Press, "Some voters will literally not be able to vote because they will have been evacuated from their local polling place and there is no provision for remote voting."

The voting machines themselves will be left operating on batteries, not an encouraging prospect as Election Day drags on longer in areas where debris and destruction have complicated the process and organization.

In New Jersey, the state is allowing residents to combat the aftermath of the storm by voting through absentee ballots by email or fax. And state officials in New York have said that residents may be granted an extra day to vote if Tuesday's turnout is below 25 percent.

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Newspaper discloses new Cameron text messages

LONDON (AP) — A British lawmaker says he’s asked the country’s media ethics inquiry to consider newly disclosed text messages sent between Prime Minister David Cameron and Rebekah Brooks, the ex-chief executive of Rupert Murdoch‘s British newspaper division.

The Mail on Sunday newspaper on Sunday published two previously undisclosed messages exchanged between the pair, who are friends and neighbors.

Brooks is facing trial on conspiracy charges linked to Britain’s phone hacking scandal, which saw Murdoch close down The News of The World tabloid.

In one newly disclosed message, Cameron thanked Brooks in 2009 for allowing him to borrow a horse, joking it was “fast, unpredictable and hard to control but fun.”

Opposition lawmaker Chris Bryant has asked a judge-led inquiry scrutinizing ties between the press and the powerful to examine the messages.

Europe News Headlines – Yahoo! News

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Google's Android software in 3 out of 4 smartphones

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Robbie Williams returns to top spot on UK pop charts

LONDON (Reuters) – Robbie Williams‘ new single “Candy” shot straight to number one in Britain’s pop charts on Sunday, the Official Charts Company said, dislodging Labrinth and Emeli Sande‘s “Beneath Your Beautiful” from the top spot.

Scottish producer and singer Calvin Harris entered the album charts at number one with “18 Months”, his second top-selling effort, and Kylie Minogue‘s “The Abbey Road Sessions” came in at number two on the long player list.

“Candy”, written with Take That band mate Gary Barlow, is Williams’ 14th career number one.

(Reporting by Matt Falloon)

Music News Headlines – Yahoo! News

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