Just eight weeks remain before uninsured Americans can start shopping online for subsidized health insurance under the president's overhaul.
Health and Human Services Secretary Kathleen Sebelius said Monday consumers can now go online to healthcare.gov and create personal accounts by establishing a username and password.
Serious shopping will have to wait until sometime in September, when details on insurance plans and premiums offered in local areas become available.
The new online insurance marketplaces will be geared to people who don't have coverage through their jobs.
Open enrollment starts Oct. 1, and insurance benefits take effect Jan. 1.
Sebelius also said she doesn't mind if people call it "Obamacare" ? if that helps getting the uninsured signed up.
Embattled celebrity chef Paula Deen has fired her Georgia attorneys and called in the big guns?including famed Hollywood attorney-to-the-stars Patricia Glaser?to help salvage her reputation and media empire.
Deen is embroiled in a sexual and racial harassment lawsuit based on her ownership of a Savannah, Ga., restaurant.
After Deen admitted in a deposition to past use of racial slurs, the Food Network canceled her cable TV show, and she lost lucrative merchandise deals with Walmart and other retailers.
After a disastrous round of media appearances in which Deen tried to explain away her past statements, she apparently had second thoughts about the legal advice she was receiving.
Now she has brought in the high-stakes litigation heavy hitters: the Los Angeles law firm GlaserWeil.
Glaser will personally oversee Deen?s case. The attorney is known for representing stars such as Keith Olbermann and Conan O?Brien in civil litigation and television contract negotiations.
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BAGHDAD (AP) ? Iraqi authorities say bomb and mortar attacks across the country have killed eight people, including a judge.
Police officials say a roadside bomb struck an army patrol near the northern city of Mosul early Sunday, killing three soldiers.
In Tikrit, in central Iraq, a car bomb killed judge Sajid Abdul-Amir as he was driving to his work, police said.
In eastern Baghdad, two people were killed in a blast in a commercial street, police said. Meanwhile, mortar rounds landed on houses in the capital's western suburbs, killing two people.
Medical officials confirmed the death toll for all attacks. All officials spoke on condition of anonymity as they were not authorized to talk to the media.
Violence has increased recently in Iraq alongside escalating political and sectarian tensions.
A look at key moments this past week in the wrongful death trial in Los Angeles between Michael Jackson's mother, Katherine Jackson, and concert giant AEG Live LLC, and what is expected at court in the week ahead:
THE CASE
Jackson's mother wants a jury to determine that the promoter of Jackson's planned comeback concerts didn't properly investigate Dr. Conrad Murray, who was convicted of involuntary manslaughter by a criminal jury for Jackson's June 2009 death. AEG's attorney says the case is about personal choice, namely Jackson's decision to have Murray serve as his doctor and give him doses of a powerful anesthetic as a sleep aid. Millions, possibly billions, of dollars are at stake.
WHAT HAPPENED THIS PAST WEEK
? Consultant Eric Briggs told jurors that projections Jackson would have earned $1 billion or more if he had lived are speculative and not supported by the singer's history of earnings for his previous tours.
? Briggs underwent grueling cross-examination with an attorney for Jackson's mother pointing out that he had billed AEG Live for more than $600,000 worth of work and had compiled only about an inch of research and a couple pages of notes.
? Michael La Perruque, Jackson's former head of security, testified that he was concerned the singer would overdose on prescription medications and he occasionally went into the entertainer's bedroom to make sure he was still breathing. He said he didn't have similar concerns when he worked for Jackson in late 2007 and early 2008.
? La Perruque recounted an incident in a Florida hotel room in 2001 or 2002 in which Jackson's children called 911 after finding their father unconscious in a hallway of their hotel suite. He said he was able to rouse Jackson before paramedics arrived and saw no signs of drugs or alcohol the singer had taken to cause the episode.
WHAT THE JURY SAW
? Briggs struggle to answer questions about his work estimating the value of Jackson's signature asset, a stake in the Sony-ATV music catalog that includes songs by The Beatles and other top-name acts. Briggs only answered the questions after being ordered to by a judge; he cited confidentiality agreements with other clients as the reason he didn't want to answer the questions.
? Survey figures that showed Jackson's popularity in the United States dropped significantly after he was accused of child molestation in the mid-2000s. Briggs said the survey stopped asking questions about Jackson's likeability after 2006 due to his low scores, making it unlikely he would have gotten an endorsement deal for his "This Is It" shows.
QUOTABLE MOMENTS
? "He fought very hard not to be dependent on these prescription medications," La Perruque said of Jackson.
? "We live in a world unfortunately where headlines impact perceptions," Briggs said, explaining why he believes that Jackson would not have been able to secure endorsement deals even though he was acquitted of child molestation charges.
WHAT'S NEXT
Jurors will continue to hear from La Perruque, who will likely recount his recollections of Jackson's relationship with his children. Jurors may also see the videotaped testimony of Jackson's younger brother, Randy.
Source: www.thelantern.com --- Sunday, August 04, 2013 Although a project has been proposed to create a new office in Page Hall for former Ohio State President E. Gordon Gee, Board of Trustees Chairman Robert Schottenstein said Wednesday no... ...
A vehicle plowed through a group of people near Venice Beach, Calif., killing a woman, in an incident caught on security video cameras. NBC's Miguel Almaguer reports.
By Miguel Almaguer and M. Alex Johnson, NBC News
A California man was held on suspicion of murder after a car plowed through Los Angeles' popular Venice Beach boardwalk Saturday night, killing a young Italian woman in the U.S. for her honeymoon and injuring 11 other people, authorities said Sunday.
Police said Nathan Louis Campbell, 38, of Los Angeles, was being held on $1 million bail after he fled the scene in a dark sedan in an incident that was captured on security camera video.
The video shows a man parking a black car along the boardwalk, watching for several minutes and then speeding into the crowd about 6 p.m. (9 p.m. ET).?It shows the car careening around barriers intended to block automobiles from reaching the boardwalk's pedestrian area.
Alice Gruppioni, 32, of Italy was killed, the Los Angeles County coroner's office told NBC News. Eleven other people, all of them believed to have been pedestrians on the boardwalk, were injured, one of them critically.
The Italian news agency ANSA reported that Gruppioni, of Bologna in northern Italy, was married July 20 to Christian Casadei, an architect from Cesena.
Casadei suffered minor injuries and was at his wife's side when she died, it said, quoting Giuseppe Perrone, the Italian consul general in Los Angeles, who accompanied Casadei to the hospital.
Perrone told ANSA in a telephone interview that Casadei and his new wife were strolling along the boardwalk when the car came barreling through.
"We were walking, we were happy, we were on our honeymoon and everything, and suddenly everything changed," Casadei said, according to Perrone.
"I still can't believe it, and I don't even remember exactly what happened. It's all very confusing."
Perrone described Casadei as "destroyed and in disbelief."
Witnesses said it appeared that the driver took aim at people on the boardwalk.
"All I saw was a car emerging from the crowd driving southbound on the boardwalk just plowing through whomever was in its way," said Scott Levinsky, a vendor at the packed tourist attraction.
"We're never going to forget that moment," he said. "I'm still thankful to God that we are still alive and surviving."
Chelsea Alvarez, who was visiting the boardwalk Saturday night, said the scene was "really bad."
"There was tables, there was people everywhere, blood everywhere," she said. "There was scattered stuff. It was horrible. It was the ugliest scene I've ever seen."
Alvarez told NBC Los Angeles that her grandmother Linda Alvarez, 75, was among those hit, suffering broken ribs.
"She's good. She's just resting. She's sleeping right now," Alvarez said.
Los Angeles City Council member Mike Bonin told the station that the barriers in place at the Venice boardwalk are insufficient. He said he would ask the council to move quickly to install new barriers before the end of the year.
Gruppioni was the daughter of Valerio Gruppioni, president of Sira Group, based in Bologna, one of the world's largest producers of radiators for heating. Bologna FC, a club in the top flight of Italian soccer, confirmed her death in a statement offering condolences to Valerio Gruppioni, a former president of the club.
"President (Albano) Guaraldi and all of Bologna FC are with the Gruppioni family in this time of unspeakable pain," the club said.
In a statement Sunday, rival club AC Milan, one of the world's premier teams, expressed its "condolences to former Bologna president Valerio Gruppioni and his family following the passing of his daughter Alice."
Watch US News videos on NBCNews.com
Gil Aegerter and Hasani Gittens of NBC News contributed to this report.
This story was originally published on Sun Aug 4, 2013 2:48 PM EDT
Iranian President Hasan Rouhani, sits in a meeting at the presidency office, in Tehran, Iran, Saturday, Aug. 3, 2013. Iran's supreme leader formally endorsed Hasan Rouhani as president Saturday, allowing the moderate cleric to take charge of a country weakened by economic sanctions over its nuclear program. (AP Photo/Ebrahim Noroozi)
Iranian President Hasan Rouhani, sits in a meeting at the presidency office, in Tehran, Iran, Saturday, Aug. 3, 2013. Iran's supreme leader formally endorsed Hasan Rouhani as president Saturday, allowing the moderate cleric to take charge of a country weakened by economic sanctions over its nuclear program. (AP Photo/Ebrahim Noroozi)
WASHINGTON (AP) ? The White House says it hopes Iran's new president will "heed the will" of the voters and make choices that will "lead to a better life" for Iranians.
Hasan Rouhani (hah-SAHN' roh-HAH'-nee) took the oath of office on Sunday.
White House press secretary Jay Carney says in a statement that Rouhani's inauguration gives Iran a chance "to act quickly" to address international concerns about the country's disputed nuclear program.
The U.S. and its allies contend that Iran is pursuing nuclear weapons, but Tehran denies that.
The White House says Rouhani will find "a willing partner" in the U.S. if his government decides "to engage substantively and seriously" in honoring its international obligations and works toward a peaceful solution to the nuclear issue.
Both employees and companies benefit from flexible wage systemsPublic release date: 3-Aug-2013 [ | E-mail | Share ]
Contact: Jakob Roland Munch Jakob.Roland.Munch@econ.ku.dk 45-23-28-22-42 University of Copenhagen
Research from the University of Copenhagen has revealed the effects of a decade of decentralised wage negotiations in the private sector. In an article in the Journal of Labor Economics, researchers conclude that wages have risen for all employees and that companies are now better able to retain key personnel.
"Average wages rise when employees and managers negotiate on an individual basis, without a collective-bargaining agreement dictating fixed rates for all," explains Jakob Roland Munch, professor of economics at the University of Copenhagen.
For the first time, this trend has been followed over a ten-year period and results indicate that the effect on wages has been positive. The research shows that the average increase for Danes employed in the private sector and subject to decentralised wage bargaining is 5% higher than for employees whose wages are calculated on the basis of parameters such as seniority.
"The examples we have unearthed in the private sector show clearly that the average wage rises under decentralised bargaining," says Professor Munch. "We didn't expect such a large difference. Even those at the bottom of the hierarchy win under a flexible system. Many other countries in Europe organise wage negotiations in a similar manner, so they may be interested in and inspired by our results." The other two researchers involved in the project are Professor Christian Mller Dahl of the University of Southern Denmark, and Assistant Professor Daniel le Maire, also from the University of Copenhagen.
Flexible wage systems reward abilities
Among those who benefit the most are those with a long-term higher education and long-term work experience. For this group, wages have risen by 7%, while those with shorter education and little work experience have seen their wages rise by 3%.
A flexible wage system affords better opportunities to reward employees according to their abilities, which means that companies can adapt more easily to market demand.
"Globalisation and technological progress affect companies differently and create a need for restructuring. For example, flexible wage systems make it easier for companies facing growing demand to retain key employees, while employees under threat of outsourcing can end up keeping their jobs at a lower wage," Munch continues.
"One fairly obvious interpretation of the positive effect revealed by our study is that a decentralised system means companies are better placed to cope with changes to market conditions and are therefore more productive.
Our research concerns the private sector, but the principles are transferrable to other sectors," he stresses.
"Our research sends a signal that decentralisation actually makes it possible to identify areas in which more flexible wage bargaining makes units function more efficiently. It is easy to envisage the same effects in parts of the public sector, where wage bargaining is currently relatively centralised," the professor concludes.
###
Read the article here: http://www.press.uchicago.edu/ucp/journals/journal/jole.html
About the research:
The researchers studied wage bargaining in the private sector in Denmark from 1992 to 2001, using data from Statistics Denmark. The data is from 36 areas covered by collective-bargaining agreements.
Contact
Professor of Economics at the University of Copenhagen
Jakob Roland Munch
Email: Jakob.Roland.Munch@econ.ku.dk
Tel.: +45 35 32 30 19
Mobile: +45 23 28 22 42
[ | E-mail | Share ]
?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Both employees and companies benefit from flexible wage systemsPublic release date: 3-Aug-2013 [ | E-mail | Share ]
Contact: Jakob Roland Munch Jakob.Roland.Munch@econ.ku.dk 45-23-28-22-42 University of Copenhagen
Research from the University of Copenhagen has revealed the effects of a decade of decentralised wage negotiations in the private sector. In an article in the Journal of Labor Economics, researchers conclude that wages have risen for all employees and that companies are now better able to retain key personnel.
"Average wages rise when employees and managers negotiate on an individual basis, without a collective-bargaining agreement dictating fixed rates for all," explains Jakob Roland Munch, professor of economics at the University of Copenhagen.
For the first time, this trend has been followed over a ten-year period and results indicate that the effect on wages has been positive. The research shows that the average increase for Danes employed in the private sector and subject to decentralised wage bargaining is 5% higher than for employees whose wages are calculated on the basis of parameters such as seniority.
"The examples we have unearthed in the private sector show clearly that the average wage rises under decentralised bargaining," says Professor Munch. "We didn't expect such a large difference. Even those at the bottom of the hierarchy win under a flexible system. Many other countries in Europe organise wage negotiations in a similar manner, so they may be interested in and inspired by our results." The other two researchers involved in the project are Professor Christian Mller Dahl of the University of Southern Denmark, and Assistant Professor Daniel le Maire, also from the University of Copenhagen.
Flexible wage systems reward abilities
Among those who benefit the most are those with a long-term higher education and long-term work experience. For this group, wages have risen by 7%, while those with shorter education and little work experience have seen their wages rise by 3%.
A flexible wage system affords better opportunities to reward employees according to their abilities, which means that companies can adapt more easily to market demand.
"Globalisation and technological progress affect companies differently and create a need for restructuring. For example, flexible wage systems make it easier for companies facing growing demand to retain key employees, while employees under threat of outsourcing can end up keeping their jobs at a lower wage," Munch continues.
"One fairly obvious interpretation of the positive effect revealed by our study is that a decentralised system means companies are better placed to cope with changes to market conditions and are therefore more productive.
Our research concerns the private sector, but the principles are transferrable to other sectors," he stresses.
"Our research sends a signal that decentralisation actually makes it possible to identify areas in which more flexible wage bargaining makes units function more efficiently. It is easy to envisage the same effects in parts of the public sector, where wage bargaining is currently relatively centralised," the professor concludes.
###
Read the article here: http://www.press.uchicago.edu/ucp/journals/journal/jole.html
About the research:
The researchers studied wage bargaining in the private sector in Denmark from 1992 to 2001, using data from Statistics Denmark. The data is from 36 areas covered by collective-bargaining agreements.
Contact
Professor of Economics at the University of Copenhagen
Jakob Roland Munch
Email: Jakob.Roland.Munch@econ.ku.dk
Tel.: +45 35 32 30 19
Mobile: +45 23 28 22 42
[ | E-mail | Share ]
?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Arena Reports SHOW RESULTS - 8/3 ROH in Toronto, Canada: New Tag Champions, Whitmer injured, Title Tourney results
Aug 4, 2013 - 12:07:01 AM
PLEASE TAKE A MOMENT TO BOOKMARK US & VISIT US DAILY
Ring of Honor "All-Star Extravaganza" show results August 3, 2013 Toronto, Canada Est. Attendance: 2,000 Results submitted by Chris of PWPonderings.com
(1) KUSHIDA beat Adam Page with a corkscrew moonsault. This was KUSHIDA's ROH debut.
(2) Tommaso Ciampa beat Silas Young in an ROH Title tournament First Round match.
(3) Michael Bennett vs. B.J. Whitmer was thrown out in an ROH Title tournament First Round match. Whitmer was injured taking a piledriver on the ring apron. The match was stopped and Whitmer was taken to a local hospital. ROH said later in the show that Whitmer had feeling and movement in his arms and legs.
(4) Roderick Strong beat ROH TV champion Matt Taven in an ROH Title tournament First Round match.
(5) "Unbreakable" Michael Elgin beat Paul London in an ROH Title tournament First Round match. Elgin was the hometown star in this match.
(6) Adrenaline Rush (A.C.H. & Tadarius Thomas) beat C&C Wrestle Factory (Caprice Coleman & Cedric Alexander) and The Young Bucks (Nick & Matt Jackson) in a three-team tag match.
(7) Kevin Steen beat Brian Kendrick in an ROH Title tournament First Round match.
(8) Adam Cole beat Jay Lethal in an ROH Title tournament Second Round match. Cole advances to the semi-finals.
(9) American Wolves (Davey Richards & Eddie Edwards) beat new ROH tag champions Forever Hooligans (Rocky Romero & Alex Koslov) to capture the ROH Tag Titles. For the finish, Eddie had Rocky in powerbomb position and Davey came off the top rope for a backbreaker on the knees.
As a result of Saturday's tournament matches, the next tournament matches include:
Bracket 2 - Karl Anderson vs. Michael Elgin and Roderick Strong vs. Kevin Steen in second round matches.
Bracket 1 is TBD. Adam Cole is in the semi-finals. Tommaso Ciampa is in the second round, but the lack of an outcome for Bennett-Whitmer will have to be addressed to determine who faces Ciampa. Or, if Ciampa gets a bye to the semi-finals to face Cole.
[Torch photo credit Wade Keller (c) PWTorch.com]
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Location: Satish Dhawan Space Center, Sriharikota IN
Launch Time: TBA
India will launch the GSAT-14 telecommunications satellite on the Geosynchronous Satellite Launch Vehicle (GSLV). This is an important launch for India as it marks the second flight of the Indian-built cryogenic upper stage. The first launch of India's cryogenic upper stage failed in a 2010 flight.
Web Site Address: http://isrohq.vssc.gov.in/isr0dem0v5a/index.php/gsat-14
[unable to retrieve full-text content]Scientists have described findings that could enable the development of more effective drugs for addiction with fewer side effects. The study showed in a combination of cell and animal studies that one active compound maintains a strong bias towards a single biological pathway, providing insight into what future drugs could look like.
The best iPhone and iPad apps every home buyer needs to better prepare for financing, communicate with realtors, and get to the closing table!
Whether you're a first time home buyer or you're flipping houses fast and furiously, making the process as efficient and stress-free as possible is a huge win for everyone involved. From getting approved for financing to finding the perfect home(s), to negotiating price, there's a lot of work to be done for both you and your realtor. Luckily, the iOS App Store has a bunch of great apps to help you get the best deal possible done. Here are my favorites!
Credit Karma
Before searching for a home, it's important to be sure you can get financing (unless you're paying cash). A lot of realtors will even ask for a pre-approval letter from a bank before they will begin showing you homes. Credit Karma is a great tool that's available for free and can give you an estimated score that's provided by TransUnion, as well as an overview of how your score was calculated. What a bank sees may be a little different but the general consensus has been that Credit Karma is fairly accurate and generally within a few points. I pulled my own credit and then checked with my bank and both were within 10 points of each other.
Trulia's mortgage calculator is a quick and easy way to figure out what you can afford for your next house. By inputting your income, expenses, down payment amount, and more, Trulia will give you an idea of what price range you should be looking in, as well as what the monthly payment would be. This can help narrow your search and save you time and effort. Trulia can also give you rates in your area based on your credit score range and what price range you're looking in.
If you're getting a mortgage, get Trulia's mortgage calculator .
Zillow lets you drill down to the type of property you want, price range, and more. Zillow will also show you, under the price listing, what they estimate the mortgage payment to be. There's plenty of useful info in Zillow in regards to property taxes and pricing history as well, which is helpful when figuring out what could be added to your payment. Zillow also provides what they call Zestimates, which give what Zillow believes is fair market value for the home. It's not an appraisal nor should you treat it as one, but it can still give you a general idea of what the house is actually worth based on similar properties around it.
If you're still looking for a home, and need to narrow down your search, you need Zillow.
Trulia also offers a home search app but uses different sources and metrics to figure out valuations. Zillow seems to be more accurate (at least in my area) when it comes to giving estimates on market prices, but Trulia gives more information than Zillow when it comes to lot size, amenities, garages, and other, general information. Using both in conjunction with each other should give you a better overall picture of what a home is really worth and what it comes with.
If you're looking for a home, and want more detailed information about the property, you'll want Trulia.
Homesnap lets you snap a picture of a home in order to view information about it. Instead of searching in your area and then going to look at houses, if you see a house for sale that interests you, Homesnap can tell you all about it. You can see at a quick glance basic details such as bedrooms, bathrooms, and square footage. Homesnap also provides a range in which it thinks the property will most likely sell for to help you gauge whether you are underpaying or overpaying. Along with that data it gives a score of how well that property could produce cash flow for investors.
Homesnap is ideal for anyone looking to invest in multiple properties and wants to quickly rule out ones with low income potential. .
Everyone is a little different when it comes to buying a home since no one's situation is identical. Did you use any apps when buying a home that really helped you gain information or communicate with realtors, brokers, and banks better? Let us know in the comments!
Vandetanib in thyroid cancer: Added benefit not provenPublic release date: 2-Aug-2013 [ | E-mail | Share ]
Contact: Press Contact presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Uncertain data, no conclusion on harm possible, hint of positive effect in people aged under 65 years
Vandetanib (trade name: Caprelsa) has been approved in Germany since February 2012 for the treatment of adult patients who have a particular form of aggressive thyroid cancer. In a new benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).
There is a hint that pain occurs later or gets worse later in a part of the patients, the ones aged under 65 years.But because of the overall poor data on side effects, no conclusion could be drawn about harm. Therefore it was not possible to balance positive and negative effects. Overall, an added benefit of vandetanib is therefore not proven.
Contents of the first dossier on vandetanib were incomplete
Vandetanib underwent a first early benefit assessment procedure in 2012. In this procedure, the drug manufacturer did not present any data for the patients for whom the drug is approved. The added benefit was regarded as not proven because the contents of the dossier were incomplete. The pharmaceutical company could apply for a reassessment of vandetanib within a transition period and submit a new dossier to the Federal Joint Committee (G-BA).
"Best supportive care" as the appropriate comparator therapy
In the newly submitted dossier, the company now presented an analysis of data for patients who were treated according to the approval status. As specified by the G-BA, vandetanib was compared with "best supportive care". This means the best possible supportive therapy, optimized for the individual patient for alleviation of symptoms and improvement in the quality of life.
The only study relevant for the benefit assessment, the approval study, compared the administration of vandetanib in combination with "best supportive care" with a treatment consisting of "best supportive care" in combination with a placebo.
Study population differed from approval population
Vandetanib is approved for patients with an "aggressive and symptomatic" medullary thyroid cancer (MTC) in whom surgery is not possible (anymore), the cancer is already very large or secondaries (metastases) have formed in other regions of the body. The European regulatory authority, the European Medicines Agency (EMA), had restricted the therapeutic indication in such a way in order to produce an overall positive benefit-risk balance. This is because treatment with vandetanib also involves major risks and can, for example, lead to severe heart rhythm disturbances.
However, in the study presented by the manufacturer, patients in whom the course of the disease was not "aggressive and symptomatic" were also enrolled. So the study population was much wider than the approval population. Only a subpopulation of the approval study was therefore relevant for the dossier assessment: the dossier provided analyses for patients with progressive and symptomatic course of disease, whose characteristics IQWiG considered to be an adequate approximation to the approval population (with aggressive and symptomatic course of disease).
Risk of bias in the approval study
The risk of bias of the approval study is very high, particularly because the study participants could change the treatment as soon as the course of disease got worse (progression). About two thirds of the participants changed from the placebo group to the open treatment with vandetanib. At the same time, the median treatment duration in the study arm with vandetanib was considerably longer (88.6 weeks) than the one in the study arm with "best supportive care" alone (37.1 weeks).
With the exception of survival time, the analyses in the manufacturer's dossier for most outcomes were limited to observations made during the treatment the patients were originally allocated to. This means that data on courses of disease after the change of treatment were not considered anymore.
Pain progression in people aged under 65 years occurred later
There were no statistically significant differences between treatment with or without vandetanib regarding mortality (overall survival).
Regarding symptoms and complaints, there was a hint of a minor added benefit of vandetanib in people aged under 65 years: In the younger patients, the time to pain progression was almost eight months longer on average under vandetanib plus "best supportive care" than under "best supportive care" alone. IQWiG therefore initially considers there to be a hint of a minor added benefit of vandetanib. There was no advantage in people aged over 65 years.
The manufacturer's dossier did not provide any usable data on health-related quality of life.
Greater harm cannot be excluded
The harm side remains completely unclear: The analysis did not consider the different treatment duration in both study arms adequately for most side effects (adverse events), so that no final conclusion on harm can be drawn. Greater harm from vandetanib can also not be excluded.
Since, due to the great uncertainty regarding harm, it can also not be excluded that negative effects outweigh the positive effects, an added benefit of vandetanib in comparison with "best supportive care" alone is not proven.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
###
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on vandetanib.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book (SGB) V and specific German-language information on the assessment of vandetanib.
[ | E-mail | Share ]
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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Vandetanib in thyroid cancer: Added benefit not provenPublic release date: 2-Aug-2013 [ | E-mail | Share ]
Contact: Press Contact presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
Uncertain data, no conclusion on harm possible, hint of positive effect in people aged under 65 years
Vandetanib (trade name: Caprelsa) has been approved in Germany since February 2012 for the treatment of adult patients who have a particular form of aggressive thyroid cancer. In a new benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).
There is a hint that pain occurs later or gets worse later in a part of the patients, the ones aged under 65 years.But because of the overall poor data on side effects, no conclusion could be drawn about harm. Therefore it was not possible to balance positive and negative effects. Overall, an added benefit of vandetanib is therefore not proven.
Contents of the first dossier on vandetanib were incomplete
Vandetanib underwent a first early benefit assessment procedure in 2012. In this procedure, the drug manufacturer did not present any data for the patients for whom the drug is approved. The added benefit was regarded as not proven because the contents of the dossier were incomplete. The pharmaceutical company could apply for a reassessment of vandetanib within a transition period and submit a new dossier to the Federal Joint Committee (G-BA).
"Best supportive care" as the appropriate comparator therapy
In the newly submitted dossier, the company now presented an analysis of data for patients who were treated according to the approval status. As specified by the G-BA, vandetanib was compared with "best supportive care". This means the best possible supportive therapy, optimized for the individual patient for alleviation of symptoms and improvement in the quality of life.
The only study relevant for the benefit assessment, the approval study, compared the administration of vandetanib in combination with "best supportive care" with a treatment consisting of "best supportive care" in combination with a placebo.
Study population differed from approval population
Vandetanib is approved for patients with an "aggressive and symptomatic" medullary thyroid cancer (MTC) in whom surgery is not possible (anymore), the cancer is already very large or secondaries (metastases) have formed in other regions of the body. The European regulatory authority, the European Medicines Agency (EMA), had restricted the therapeutic indication in such a way in order to produce an overall positive benefit-risk balance. This is because treatment with vandetanib also involves major risks and can, for example, lead to severe heart rhythm disturbances.
However, in the study presented by the manufacturer, patients in whom the course of the disease was not "aggressive and symptomatic" were also enrolled. So the study population was much wider than the approval population. Only a subpopulation of the approval study was therefore relevant for the dossier assessment: the dossier provided analyses for patients with progressive and symptomatic course of disease, whose characteristics IQWiG considered to be an adequate approximation to the approval population (with aggressive and symptomatic course of disease).
Risk of bias in the approval study
The risk of bias of the approval study is very high, particularly because the study participants could change the treatment as soon as the course of disease got worse (progression). About two thirds of the participants changed from the placebo group to the open treatment with vandetanib. At the same time, the median treatment duration in the study arm with vandetanib was considerably longer (88.6 weeks) than the one in the study arm with "best supportive care" alone (37.1 weeks).
With the exception of survival time, the analyses in the manufacturer's dossier for most outcomes were limited to observations made during the treatment the patients were originally allocated to. This means that data on courses of disease after the change of treatment were not considered anymore.
Pain progression in people aged under 65 years occurred later
There were no statistically significant differences between treatment with or without vandetanib regarding mortality (overall survival).
Regarding symptoms and complaints, there was a hint of a minor added benefit of vandetanib in people aged under 65 years: In the younger patients, the time to pain progression was almost eight months longer on average under vandetanib plus "best supportive care" than under "best supportive care" alone. IQWiG therefore initially considers there to be a hint of a minor added benefit of vandetanib. There was no advantage in people aged over 65 years.
The manufacturer's dossier did not provide any usable data on health-related quality of life.
Greater harm cannot be excluded
The harm side remains completely unclear: The analysis did not consider the different treatment duration in both study arms adequately for most side effects (adverse events), so that no final conclusion on harm can be drawn. Greater harm from vandetanib can also not be excluded.
Since, due to the great uncertainty regarding harm, it can also not be excluded that negative effects outweigh the positive effects, an added benefit of vandetanib in comparison with "best supportive care" alone is not proven.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
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An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on vandetanib.
The G-BA website contains both general English-language information on benefit assessment pursuant to 35a Social Code Book (SGB) V and specific German-language information on the assessment of vandetanib.
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We've all heard of the boringly named "staycation" where you just sit around your town and take some time off work, but Threadnote co-founder Bryan Clark shares his version of that, the MakeCation.
The basic idea here is really simple. If you can't (or just don't want to) spend the money on traveling, take some time off work and make something. Clark explains:
When you?re stuck on a project, there?s only one way out: push through it. I was finishing up a year-long project at work, so I put in for two weeks of time off. Normally I?d relax, but this wasn?t a vacation: I wanted to finish the tough bits and ship the app. As cheesy as the name is, I called it my ?MakeCation?.
I woke up at the usual time, headed to a cafe, and worked on our app as if it were a full-time job. I only needed three things: Wi-Fi, Xcode, and OmniFocus. Those ten days led to an app that was nearly done, and a few weeks later, Ryan and I launched our app.
We?re often told to ?just ship it?; there?s a notion that quality can be built in later. With an app, though, you only get one launch day.
Clark's example shows that when you take the time to make that last push you can make something great.
Don't Quit Your Day Job, Take a MakeCation | A Better Mess via 99U
In an effort to raise the bar on local reviews, Google has just announced the launch of the City Experts program, open to Google+ users with at least 50 reviews under their belts. To maintain membership, City Experts must write a minimum of five reviews per month that meet Google's standards for quality. Said standards aren't particularly strenuous; City Experts are expected to produce three or four sentences that give an accurate and substantial impression of the businesses they're reviewing. To encourage people to sign up, the company is offering a slew of goodies, like custom Google swag, invitations to local events and exclusive offers in the program's monthly newsletter. If nothing tickles your fancy more than slamming or praising businesses in your area, you can sign up at the source link below.
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Although a project has been proposed to create a new office in Page Hall for former Ohio State President E. Gordon Gee, Board of Trustees Chairman Robert Schottenstein said Wednesday no... ...![[ Back to EurekAlert! ]](http://www.eurekalert.org/images/back2e.gif){kind=small}
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