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Wednesday, November 16, 2005

The independent and nonpartisan US congressional watchdog, the Government Accountability Office (GAO) called the Food and Drug Administration’s decision not to allow over-the-counter (OTC) sales of an Emergency Contraceptive pill, “unusual”.

Emergency Contraceptive Pills or ECPs (“morning-after” or “next-day” pills ) are used to prevent an unintended pregnancy, following unprotected sexual intercourse. They are objectionable for abortion opponents who consider their use to be a form of abortion, though scientific studies (including those by the FDA) classify them as contraceptives. The pill, called Plan B is manufactured by Barr Laboratories and had been approved earlier by the FDA as a prescription drug.

Barr Laboratories requested that the drug be approved for OTC sale for adults and prescription-only sale for minors. The decision to not approve went against the advice given by the FDA’s Joint Advisory Committee and its Review staff and led to a GAO investigation into the decision making process. The investigation was requested by 30 House members and 17 Senators.

The GAO found several anomalies in the decision making process. The rationale used by Dr. Steven Galson, the acting director of the Centre for Drug Evaluation and Research for rejecting the application was novel and did not follow usual FDA practices. The decision was not signed off by the director of the office responsible for the application and the director of the Office of New Drugs, as they disagreed with the “reject” decision. The GAO also found that the FDA’s high-level management more involved in reviewing this decision than in other change-to-OTC applications.

The Plan B decision was the only one of 67 proposed prescription to OTC changes to be disapproved, even after advisory committees approved the changes. FDA review staff told the investigators that they were told early in the review process that the decision would be made by high-level management. E-mail and other documents involving the then-FDA Commissioner Mark McClellan were found to have been destroyed “routinely”.

The FDA has disagreed with the GAO’s finding that the high-level management was more involved in processing this application and that the rationale offered was novel, despite acknowledging that the adolescent cognitive ability rationale was unprecedented in FDA practice. The accounts as to whether the decision to reject was taken prior to the reviews being completed offered to the investigators were conflicting.

The acting director cited concerns about the potential behavioral implications for younger adolescents from OTC marketing of Plan-B, given their supposed lower cognitive ability, and that it was not valid to extrapolate data from older to younger audiences. However, the FDA had not considered similar “potential behavioral implications” for younger users for other OTC-switches and had previously considered it appropriate to extrapolate data from older to younger audiences.

Sunday, February 13, 2005

New York –”Buy cheap Viagra through us – no prescription required!” Anyone with an active email account will recognize lines like this one. According to some reports, unsolicited advertisements (spam) for Viagra and similar drugs account for one in four spam messages.

Ever since pharmaceutical giant Pfizer promised to cure erectile dysfunction once and for all with its blue pills containing the drug sildenafil citrate, spammers have tried to tap into male anxiety by offering prescription-free sales of unapproved “generic” Viagra and clones such as Cialis soft tabs. Legislation like the U.S. CAN-SPAM act has done little to stem the tide of email advertising the products.

Now Pfizer has entered a pledge with Microsoft Corporation, the world’s largest software company, to address the problem. The joint effort will focus on lawsuits against spammers as well as the companies they advertise. “Pfizer is joining with Microsoft on these actions as part of our shared pledge to reduce the sale of these products and to fight the senders of unsolicited e-mail that overwhelms people’s inboxes,” said Jeff Kindler, executive vice president at Pfizer.

Microsoft has filed civil actions against spammers advertising the websites CanadianPharmacy and E-Pharmacy Direct. Pfizer has filed lawsuits against the two companies, and has taken actions against websites which use the word “Viagra” in their domain names. Sales of controlled drugs from Canadian pharmacies to the United States are illegal, but most drugs sold in Canada have nevertheless undergone testing by the U.S. Food and Drug Administration. This is not the case for many of the Viagra clones sold by Internet companies and manufactured in countries like China and India. While it was not clear that CanadianPharmacy was actually shipping drugs from Canada, Pfizer’s general counsel, Beth Levine, claimed that the company filled orders using a call center in Montreal, reported the Toronto Star.

For Microsoft’s part, they allege that the joint effort with Pfizer is part of their “multi-pronged attack on the barrage of spam.” As the creator of the popular email program Outlook, Microsoft has been criticized in the past for the product’s spam filtering process. Recently, Microsoft added anti-spam measures to its popular Exchange server. Exchange 2003 now includes support for accessing so-called real-time block lists, or RTBLs. An RTBL is a list of the IP addresses maintained by a third party; the addresses on the list are those of mailservers thought to have sent spam recently. Exchange 2003 can query the list for each message it receives.

Monday, June 21, 2010

Sweden’s first royal wedding since 1976 took place Saturday when Crown Princess Victoria, 32, married her long-time boyfriend and former personal trainer, Daniel Westling, 36. The ceremony took place at Stockholm Cathedral.

Over 1,200 guests, including many rulers, politicians, royals and other dignitaries from across the world, attended the wedding, which cost an estimated 20 million Swedish kronor. Victoria wore a wedding dress with five-metre long train designed by Pär Engsheden. She wore the same crown that her mother, Queen Silvia, wore on her wedding day 34 years previously, also on June 19. Victoria’s father, King Carl XVI Gustaf, walked Victoria down the aisle, which was deemed untraditional by many. In Sweden, the bride and groom usually walk down the aisle together, emphasising the country’s views on equality. Victoria met with Daniel half-way to the altar, where they exchanged brief kisses, and, to the sounds of the wedding march, made their way to the the silver altar. She was followed by ten bridesmaids. The couple both had tears in their eyes as they said their vows, and apart from fumbling when they exchanged rings, the ceremony went smoothly.

Following the ceremony, the couple headed a fast-paced procession through central Stockholm on a horse-drawn carriage, flanked by police and security. Up to 500,000 people are thought to have lined the streets. They then boarded the Vasaorden, the same royal barge Victoria’s parents used in their wedding, and traveled through Stockholm’s waters, accompanied by flyover of 18 fighter jets near the end of the procession. A wedding banquet followed in the in the Hall of State of the Royal Palace.

Controversy has surrounded the engagement and wedding between the Crown Princess and Westling, a “commoner”. Victoria met Westling as she was recovering from bulemia in 2002. He owned a chain of gymnasiums and was brought in to help bring Victoria back to full health. Westling was raised in a middle-class family in Ockelbo, in central Sweden. His father managed a social services centre, and his mother worked in a post office. When the relationship was made public, Westling was mocked as an outsider and the king was reportedly horrified at the thought of his daughter marrying a “commoner”, even though he did so when he married Silvia. Last year, Westling underwent transplant surgery for a congenital kidney disorder. The Swedish public have been assured that he will be able to have children and that his illness will not be passed on to his offspring.

Westling underwent years of training to prepare for his new role in the royal family, including lessons in etiquette, elocution, and multi-lingual small talk; and a makeover that saw his hair being cropped short, and his plain-looking glasses and clothes being replaced by designer-wear.

Upon marrying the Crown Princess, Westling took his wife’s ducal title and is granted the style “His Royal Highness”. He is now known as HRH Prince Daniel, Duke of Västergötland. He also has his own coat-of-arms and monogram. When Victoria assumes the throne and becomes Queen, Daniel will not become King, but assume a supportive role, similar to that of Prince Phillip, the husband of the United Kingdom’s Queen Elizabeth II.

Saturday, October 20, 2007

Dell Inc. announced on Tuesday that it will partner up with the Microsoft-Nortel Innovative communications alliance (ICA) team to sell Unified Communications and VoIP products.

The announcement on Tuesday the 16th of October 2007 includes Dell selling VoIP, data and wireless networking products from Nortel and the Microsoft Office Communications Server 2007 and other unified communications products.

The partnership with both manufacturers should allow Dell to provide a pre-integrated solution.

In March 2007, competitors IBM and Cisco announced they would join in the competition for developing unified communications applications and the development of open technologies around the unified communications and collaboration (UC2) client platform an application programming interfaces (APIs) offered by IBM as a subset of Lotus Sametime.

“We want to make it simple for our customers to deploy unified communications so their end users can get access to all their messages in one place – whether its e-mail, phone or mobile device. This will pave the way for more business-ready productivity tools,” said vice president of solutions, Dell Product Group, Rick Becker.

• Customers have four options:
  • Core Office Communication Server 2007 – provides instant messaging and on-premise Microsoft Live Meeting.
  • Office Communication Server: Telephony – enables call routing tracking and management, VoIP gateway and public branch exchange (PBX) integration.
  • Audio and Video Conferencing – allows point-to-point conference, video conference and VoIP audio conference.
  • Exchange Unified Messaging – provides voicemail, e-mail and fax in Microsoft Outlook, and anywhere access of Microsoft Outlook Inbox and Calendar.

Tuesday, January 19, 2010

A Scottish woman who set out before Christmas to purchase a turkey finally made it home on Monday, after being cut off by snow for a month. Kay Ure left the Lighthouse Keeper’s cottage on Cape Wrath, at the very northwest tip of Great Britain, in December. She was heading to Inverness on a shopping trip.

However on her return journey heavy snow and ice prevented her husband, John, from travelling the last 11 miles to pick her up. She was forced to wait a month in a friend’s caravan, before the weather improved and the couple could finally be reunited.

They were separated not just for Christmas and New Year, but also for Mr Ure’s 58th birthday. With no fresh supplies, he was reduced to celebrating with a tin of baked beans. He also ran out of coal, and had to feed the couple’s six springer spaniels on emergency army rations.

“It’s the first time we’ve been separated”, said Mr Ure in December. “We’ve been snowed in here for three weeks before, so we are well used to it and it’s quite nice to get a bit of peace and quiet.”

Monday, September 24, 2007

73,000 United Auto Workers (UAW) union members launched a nationwide strike today against General Motors (GM), the largest auto manufacturer in the United States.

UAW President Ron Gettelfinger said GM would need to meet pay, health care, and job security issues. Gettelfinge said, “This is nothing we wanted…No one benefits in a strike. But there comes a point where someone can push you off a cliff. That’s what happened here.”

The strike was officially launched at 11 a.m. EDT (UTC-4) today.

Negotiations were reportedly going to occur again this afternoon, but there have been no reports of any negotiating going on from either side.

80 facilities in 30 different states closed today because of the strike.

CNN reports that GM facilities in Mexico and Canada may close soon, too.

The vice president of global vehicle forecasts for CSM Worldwide, Michael Robinet, said today that dealerships in the US likely won’t feel the effects of the strike for several weeks.

A statement from GM today said, “We are disappointed in the UAW’s decision to call a national strike. The bargaining involved complex, difficult issues that affect the job security of our U.S. work force, and the long-term viability of the company. We are fully committed to working with the UAW to develop solutions together to address the competitive challenges facing General Motors. We will continue focusing our efforts on reaching an agreement as soon as possible.”

If the strike continues, UAW strike funds will supply each striker with US$200 a month and medical coverage.

Wednesday, March 21, 2012

The United States Air Force is replacing emergency oxygen handles on its 170 F-22 Raptor jet fighters. The move follows a report into a November 2010 crash that killed a pilot in Alaska.

The report finds Captain Jeffrey Haney’s death was partly due to aircraft design flaws. The experienced 31-year-old was on a night mission when his aircraft crashed nose-down among mountains. Planemaker Lockheed Martin now faces legal action from his widow Anna, which they vow to contest.

The report identified three separate problems with the ring handle to activate emergency oxygen. The first was that pulling the ring could require intense effort, the second that it was possible to drop the ring between seats, and the third that pilots in cold-weather gear could struggle to grasp it.

Now new handles have been designed in Arizona and the Air Force will place them on all of the $143 million aircraft. All 40 Raptors at Haney’s base, Joint Base Elmendorf-Richardson near Anchorage, have received the $47 upgrade. The Air Force bought 200 of them.

Haney’s death has been attributed by his employer as the result of his “channelized attention” on getting the main oxygen system to restart after it automatically cut out when it detected engine bay air leaks. This makes breathing through the jet’s mask difficult. The Air Force say he should have activated his emergency oxygen but the accident report and lawsuit question his ability to do so. The report notes he was conscious and fighting to keep his jet airbourne up until impact.

Documents filed with a court in Illinois claim the handle’s position is “in an area impossible for a pilot to reach while he or she maneuvered the sophisticated aircraft at speeds exceeding the speed of sound and while he or she experienced forces many times the force of gravity.”

The fatal accident is not the only such problem to beset the F-22, which despite being billed by the Air Force as their most advanced fighter has never been deployed to combat since coming into service seven years ago. Three other Joint Base Elmendorf-Richardson pilots activated emergency oxygen supplies during “physiological incidents” last month, said a spokesperson for the base. Raptors were grounded nationwide for five months last Summer over the oxygen systems.

Friday, June 27, 2008

Newspaper The Guardian reports today that the sale of the BBC subsidiary BBC Resources Ltd., has cost £3.4m in consultancy fees — over £1m more than the £2.3m trading profit the commercial division is estimated to have made for the last financial year. Details of the failed privatisation were released by the BBC following a freedom of information request, and prior to publication of its annual report on July 8.

Fourteen months after advisers were appointed to try to sell BBC Resources Ltd., only one of the three main business units has been sold — its Outside Broadcast division to Satellite Information Services Limited (SIS), for an estimated £20m. On March 7, 2008 it was also announced that the studios operation would remain in BBC ownership and in early June, the fate of the third business was put on hold with the BBC stating that “like Studios, Post Production will remain within BBC Resources, which will continue to operate as a wholly-owned commercial subsidiary of the BBC.”

BBC Resources Ltd. made an operating profit of £6.1m for 2005-06, down from £7.4m the year before, with the BBC accounting for 83.3% of its turnover, down from 87.4% for 2004-05. Last year’s published figure for 2006-07 was £5.2 million — with BBC business at 80% of turnover.

BECTU Assistant General Secretary Luke Crawley is quoted as saying: “It’s fairly outrageous that around half the profit of the company [announced last year] has been spent trying to sell it. It’s an inordinate amount of money. The BBC was promised big returns if it sold BBC Resources but it’s only managed to sell outside broadcasts and we do not know how much it made out of that. We think the £3.4m is a poor investment.”