Roche probed for not reporting side effects

FILE - In this June 6, 2011 file picture, the logo of Swiss drugmaker Roche is photographed in Rotkreuz, Switzerland. The European Medicines Agency has started an infringement procedure against pharmaceutical giant Roche for allegedly failing to properly report side effects in patients in the U.S. (AP Photo/Keystone/Urs Flueeler, File)

FILE - In this June 6, 2011 file picture, the logo of Swiss drugmaker Roche is photographed in Rotkreuz, Switzerland. The European Medicines Agency has started an infringement procedure against pharmaceutical giant Roche for allegedly failing to properly report side effects in patients in the U.S. (AP Photo/Keystone/Urs Flueeler, File)

LONDON (AP) ? Europe's top drug regulator announced Tuesday it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by U.S. patients.

It is the first time the European Medicines Agency has begun a so-called 'infringement proceeding' against a drug maker. European regulations lay out numerous requirements for pharmaceuticals, including reporting suspected side effects and submitting such cases to officials.

Eight of the drugs involved are used for the treatment of cancer, including breast cancer. They include Avastin, Herceptin, Tarceba, and Xeloda. The flu drug Tamiflu was also included in the list.

British authorities brought the problem to the attention of the European authorities in May after noticing "serious shortcomings" in how Roche AG reported potential side effects.

Regulators said about 80,000 reports by consumers of possible adverse effects to drugs sold in the U.S. had not been properly analyzed. Among those reports were over 15,000 deaths, though it was unclear if those deaths were caused by Roche medicines.

The regulator said there was no evidence that users of Roche's drugs were at risk.

The European Medicines Agency did not state what the side effects were but said it was more concerned that these potential reactions were not properly reported.

"It could have been anything like a rash on your hand to something more serious," including death, said Monika Benstetter, an agency spokeswoman. "There was a failure in the system," she said, noting officials didn't have information on how many of the side effects may have been reported.

If Roche is found to have violated its reporting requirements, it could be fined up to five percent of its sales revenue in the European Union from the preceding year. Shares in the company fell 2 percent on Tuesday.

The European Commission, the executive body for the 27-country EU, asked the European Medicines Agency to begin the infringement process. In a statement, the European Medicines Agency said it will further investigate the allegations against Roche.

The agency sent Roche a detailed letter listing the allegations against them and is now awaiting the company's response. Officials have 18 months to finish their investigation. After that, it will be up to the European Commission to decide whether Roche should be penalized.

Daniel Grotzky, a Roche spokesman, said the company was working with the EMA to provide more information and it did not want to speculate on the outcome of the investigation. Roche said patient safety was "of paramount importance" and that it was possible some of the potential side effects may have been reported to European officials in other ways, such as reports from doctors.

"Both the EMA and other health authorities have consistently said there is no change to the safety profile of our drugs," Grotzky said.

He said Roche recognized that some adverse events had not properly been reported in the past.

"We are taking measures within the company...to make sure this does not happen again," he said.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/f70471f764144b2fab526d39972d37b3/Article_2012-10-23-Roche-Side%20Effects/id-e8a942cfc2a14aba9a26f8def204dcb9

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Microsoft reveals new Skype app for Windows 8

Microsoft has now announced that the company will be releasing a new Skype app for both Windows 8 as well as Windows RT. Microsoft has also mentioned that the app will come pre-installed with the top twelve Windows 8 OEM made machines, however it will not come installed with the Windows RT based surface tablet and users will have to download it via the Windows Store.

Most importantly, the new Skype app will no longer be using the peer-to-peer infrastructure but instead it will utilize a hybrid model using the Windows Messenger Infrastructure. Also, Microsoft has revealed that for storing pictures and videos the app will use the Windows Azure backend. As it is made for Windows 8 and Windows RT, the app has its entire design based on the Metro user interface, which also is the new face of Windows. While Facebook integration will exist with the new Skype it won?t be very Facebook-centric as it has been since its integration.

Microsoft has also announced that later this fall, Skype for Windows 8 will have a new video messaging feature which will allow users to send short video messages to their Skype friends. There is no doubt that Microsoft is highly focused on introducing this huge change throughout their vast products.

The company will reveal more details on the same on its October 26 event for Windows 8 and we can expect to see much more of Skype on their October 29 event for Windows Phone 8.

Source: http://www.technoholik.com/news-apps/microsoft-reveals-new-skype-app-for-windows-8/4214

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Google cameras map popular Grand Canyon trails

GRAND CANYON NATIONAL PARK, Ariz. (AP) ? Google and its street-view cameras already have taken users to narrow cobblestone alleys in Spain using a tricycle, inside the Smithsonian with a push cart and to British Columbia's snow-covered slopes by snowmobile.

The search giant now has brought its all-seeing eyes ? mounted for the first time on a backpack ? down into the Grand Canyon, showcasing the attraction's most popular hiking trails on the South Rim and other walkways.

It's the latest evolution in mapping technology for the Mountain View, Calif., company, which has used a rosette of cameras to photograph thousands of cities and towns in dozens of countries for its Street View feature. With a click of the mouse, Internet users are transported virtually for a 360-degree view of locales they may have read about only in tourist books and seen in flat, 2-D images.

"Any of these sort of iconic, cultural, historical locations that are not accessible by road is where we want to go," said Ryan Falor, product manager at Google.

Google announced the trekker earlier this year but made its first official collection of data this week at the Grand Canyon.

The backpacks aren't ready for volunteer use, but Google has said it wants to deploy them at national forests, to the narrow streets of Venice, Mount Everest and to ancient ruins and castles.

The move to capture the Grand Canyon comes after Apple chose to drop Google Maps from its mobile operating systems and opted to use its own mapping program that was derided for, among other things, poor directions and missing towns.

Steve Silverman, operations manager for Google didn't directly address the competition in saying: "Just trying to document a trail, it's going to be hard to beat this."

Google launched its Street View feature in 2007 and has expanded from 5 U.S. cities to more than 3,000 in 43 countries. Google teams and volunteers have covered more than 5 million miles with the Street View vehicles on a scale that other companies haven't approached, said Mike Dobson, president of Telemapics, a company that monitors mapping efforts.

"You could safely say that it's a standout, well-used application and they don't really have any competition," he said.

As the sun rose Monday, Luc Vincent, Google engineering director, strapped on one of the 40-pound backpacks and set down the Bright Angel Trail to the Colorado River ? a nearly 10-mile hike that goes from 6,900 feet in elevation to 2,400 feet. He hiked back up from Phantom Ranch, which can be 30 degrees warmer than at the rim, through the South Kaibab Trail and also gathered data on other trails.

The so-called trekker captures images every 2.5 seconds with 15 cameras that are 5 megapixels each, from the rest areas, the steep switchbacks, the change from juniper trees to scrub brush and the traffic that moves aside as a courtesy to mule riders.

The GPS data is limited, so Google must compensate with sensors that record temperature, vibrations and the orientation of the device as it changes, before it stiches the images together and makes them available to users in a few months, Falor said.

Hikers that were on the trail when the data was gathered will have their faces blurred ? an attempt by Google to ensure privacy. Street View has run into problems in places like Europe and Australia for scooping up information transmitted over unsecured wireless networks.

A removable hard drive on the trekker stores the data gathered at the Grand Canyon. Tourists looked at the trekker strangely this week, as if it was something from outer space.

Sharon Kerfoot, a first-time visitor from Alberta said being able to view the terrain ahead of time, gauge the difficulty of the hike and know just how wide the path is would benefit those considering a trip to the Grand Canyon. She and a group of friends headed down the same path as Vincent but on mules, not foot.

"I think it's an excellent idea to give people a broader perspective on what they're getting into," she said.

What the images won't tell visitors is how much water they should carry down the trails, how to prepare for temperature changes, what type of food to bring and how much, and how best to protect the natural resources, park spokeswoman Maureen Oltrogge said.

"Stitched together with other information out there, the technology could be valuable," she said.

___

Follow Felicia Fonseca on Twitter: http://www.twitter.com/FonsecaAP

Source: http://www.seattlepi.com/news/article/Google-cameras-map-popular-Grand-Canyon-trails-3976905.php

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Postscript Regarding Employers Trying To Use Health Insurance To ...

Back in March, I argued that employers don?t have any moral right to prevent workers from using employer-provided insurance to buy birth control, any more than employers have the right to prevent workers from using employer-provided paychecks to buy birth control.

My view was met in comments with a degree of skepticism.

So forgive me if I?m pleased to note that Judge Carol Jackson, a H.W. Bush-appointee, said much the same thing in a ruling earlier this month (pdf link, emphasis added by me).

The health care plan will offend plaintiffs? religious beliefs only if an employee (or covered family member) makes an independent decision to use the plan to cover counseling related to or the purchase of contraceptives. Already, [plaintiffs] pay salaries to their employees ? money the employees may use to purchase contraceptives or to contribute to a religious organization. By comparison, the contribution to a health care plan has no more than a de minimus impact on the plaintiff?s religious beliefs than paying salaries and other benefits to employees.

The burden of which plaintiffs complain is that funds, which plaintiffs will contribute to a group health plan, might, after a series of independent decisions by health care providers and patients covered by OIH?s plan, subsidize someone else?s participation in an activity that is condemned by plaintiffs? religion. This Court rejects the proposition that requiring indirect financial support of a practice, from which plaintiff himself abstains according to his religious principles, constitutes a substantial burden on plaintiff?s religious exercise.

[The Religious Freedom Restoration Act] is a shield, not a sword. It protects individuals from substantial burdens on religious exercise that occur when the government coerces action one?s religion forbids, or forbids action one?s religion requires; it is not a means to force one?s religious practices upon others. RFRA does not protect against the slight burden on religious exercise that arises when one?s money circuitously flows to support the conduct of other free-exercise-wielding individuals who hold religious beliefs that differ from one?s own.

Amanda at Pandagon writes:

Because this is about female sexuality and there?s all these sex-phobic and misogynist arguments being thrown around, the basic issue has gotten somewhat obscured, which is that your boss is not actually your master. [...] If the door is opened to allowing employers to control how you use your compensation after you?ve earned it, god only knows what other kinds of restrictions on how you spend your money they?re going to start angling for.

I think this is one of the basic differences between conservatives (including, alas, most libertarians) and progressives. To paint in broad strokes: When conservatives talk about protecting liberty, they want to protect the bosses from the government; when progressives talk about protecting liberty, we want to protect the workers from the bosses.

Of course, this ruling is not the end of the matter; I?m sure eventually the Supreme Court will decide. Given the conservative majority?s dislike of rights for workers, I won?t be surprised if Judge Jackson is eventually overturned. One more reason to hope Obama wins reelection.

Related posts:

1. Health Insurance Reform Flowchart
2. A Frightening First: Health Insurance Costs For Family Exceed Minimum Wage
3. Employers Discriminate More Against Pregnant Women
4. Universal Health Care & Personal Health Concerns
5. Workers killed by willfully negligent employers; OSHA doesn't give a damn

Source: http://www.amptoons.com/blog/2012/10/23/postscript-regarding-employers-trying-to-use-health-insurance-to-force-their-beliefs-on-employees/

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Video: How Elections Impact Fed Policy

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Source: http://video.msnbc.msn.com/cnbc/49538240/

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Pacific Wild Monitors Whale Behavior with Barix IP Audio Solution ...

Non-profit conservation organization depends on reliable, high-quality audio streams from Barix devices to study humpback whales in their natural setting off the Canadian coast

ZURICH, SWITZERLAND, October 23, 2012 ? Audio over IP pioneer Barix AG is well-known for supplying one-way and two-way audio solutions for broadcast radio, entertainment, in-store media, security and transportation applications. Scientific audio is a lesser-known application from Barix ? but one that non-profit conservation organization Pacific Wild has found clear benefits from using.

Dedicated to protecting Canada?s Pacific coast, Pacific Wild has deployed audio monitoring stations at four points along the British Columbia shoreline to capture live sounds of humpback whales in their natural marine environment. The monitoring stations use rugged ?hydrophones? ? microphones designed for underwater listening and recording ? to capture whale audio and other sounds of the ocean in high quality.

Barix Instreamer IP audio devices encode the captured sounds live and stream the audio 24/7 over the internet to Pacific Wild offices, allowing Pacific Wild employees, scientists and wildlife enthusiasts to study and learn from the behavioral patterns of humpback whales ? and how surrounding activity such as shipping activity affects their behavior. The live stream is accessible for the public at http://pacificwild.org/site/great-bear-live/hydrophones/.

According to Rob MacKenzie, a freelance IT engineer working with Pacific Wild, the Barix solution has significantly raised live audio quality from the hydrophones. MacKenzie was brought in to ?bring the technological level up a few notches? and improve the end-to-end system. The previous audio system recorded 8-bit audio at 8kHz, which made it challenging to capture clear sound. The Barix solution digitizes the hydrophone-captured audio into 16-bit MP3 for the best signal integrity and compatibility.

?I was tasked with rebuilding the entire system,? said MacKenzie. ?I put up a new Linux recording system, added new monitoring systems, improved network availability and rebuilt the power systems for all the enclosures. But the Barix Instreamer has been instrumental to our research. We?re capturing everything from loud identification calls to soft back-and-forth chatter. Just being able to record those very soft sounds proves the bit depth and audio quality we get from Barix.?

MacKenzie noted that while there are a number of research stations for whale behavior in British Columbia, there has been a gap in the central coast area that Pacific Wild is now covering. Pacific Wild expects to expand to 12 sites over the next five years, using Barix to encode and stream all live audio.

?There is a lot of research going on with humpback whales, including male song and how it changes across large geographical areas,? said MacKenzie. ?We can monitor how one whale will start singing a slightly different song, and how it is passed along to other whales. We?re also studying how ambient underwater noises and shipping traffic affect their behavior and ability to communicate. The Barix devices, in addition to providing audio, help us perform measurements, create graphs and understand trends related to all these sounds.?

MacKenzie adds that the Barix Instreamer has been extremely reliable, with relatively no setup process beyond assigning each device an IP address. The devices are bolted into protective, solar-powered enclosures installed off the shoreline and out in the wild, built to withstand the icy blasts of wind and year-round moisture associated with the harsh regional climate.

?The Barix encoders spit out data constantly and consistently as long as the radios are up,? he said. The complete, end-to-end network includes 802.11 microwave radios to deliver the live Barix stream from the remote locations to Pacific Wild headquarters.

?Barix devices serve scientific applications worldwide,? said Johannes Rietschel, CEO of Barix AG. ?The AWI (Alfred Wegener Institute)?s PALAOA station in Antarctica has been using our devices for many years to monitor underwater nature sounds. With the Pacific Wild project, whales are now monitored both in the northern and southern hemisphere by Barix devices! These are just two examples of Barix devices in action, with thousands of installations worldwide serving their purpose with Swiss precision and bespoke reliability.?

About Barix AG (www.barix.com)
Barix AG, headquartered in Zurich Switzerland, specializes in research and development of state of the art IP based communication and control technology. The company is a long-term and reliable supplier of IP audio and control devices, with more than 150,000 devices shipped in its first decade of business. Barix products are stand-alone and able to remotely connect worldwide over standard networks / Internet offering new and improved solutions to the commercial audio distribution, communication and automation industry. Barix products provide solutions in Audio over IP (audio distribution and monitoring, communication, security) and automation (remote controlling, monitoring and maintenance).
# # #

Barix AG, Seefeldstrasse 303, 8008 Zurich, Switzerland
Phone: +41 43 43322 11, Fax: +41 44 2742849
Barix Technology Inc, St. Paul, MN ? (866) 815-0866

http://www.barix.com

http://www.ip-audio.info

Source: http://blog.svconline.com/briefingroom/2012/10/23/pacific-wild-barix-whale-monitoring/

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Fess up: Who's buying an iPad mini?

So Apple's finally invented the small form factor tablet, and the iPad mini is upon us. We're sure some of you will have been tempted by Apple's latest bundle of aluminum, silicon and glass. Maybe you're having second thoughts about that Nexus 7 you've been eyeing up. Perhaps you're considering parting company with an Android tablet and taking the plunge with the Mini, or even its big brother, the fourth-gen iPad.

We're not here to judge anyone, of course, but if any of you filthy turncoats want to explain yourselves, we'll leave the comments wide open for you to do just that.

More: iPad mini coverage on iMore.com

Source: http://feedproxy.google.com/~r/androidcentral/~3/-kx4NHT6vVY/story01.htm

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