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Monday, December 17, 2007

Birth Control Pill That Stops Periods Wins FDA Approval

The Food and Drug Administration yesterday approved the first birth control pill that eliminates a woman's monthly period.
Taken daily, the contraceptive, called Lybrel, continuously administers slightly lower doses of the same hormones in many standard birth control pills to suppress menstruation. It is designed for women who find their periods too painful, unpleasant or inconvenient and want to be free of them.

"This will be the first and only oral contraceptive designed to be taken 365 days a year, allowing women to put their periods on hold," said Amy Marren of Wyeth Pharmaceuticals, which expects Lybrel to be available with a prescription by July. "There are a lot of women who think that's a great option to have."
Company studies involving more than 2,400 women showed that Lybrel is as effective at preventing pregnancy as standard birth control pills and that it completely suppresses menstruation for many women within the first year, although some experience sporadic bleeding, the FDA said.
Advocates of birth control welcomed Lybrel, saying it provides women with another option.
"Every woman's birth control needs are different, and the best methods are those that fit a woman's lifestyle and meet her needs," said Vanessa Cullins, vice president for medical affairs at the Planned Parenthood Federation of America.
But others questioned whether enough research had been done to be sure that Lybrel is safe to suppress menstruation in the long term.
"There may be important health consequences that we don't know about," said Christine L. Hitchcock, an endocrinology researcher at the University of British Columbia. "I don't think we understand everything that the menstrual cycle does well enough to say with confidence that you can abolish it and not have any consequences."
Some criticized Lybrel for fueling biases and misconceptions about menstruation.
"I think it sends the wrong message about menstruation in women's lives, especially for young women," said Ingrid Johnston-Robledo, an associate professor of psychology and women's studies at the State University of New York at Fredonia. "It perpetuates a lot of negative attitudes and taboos about menstruation -- that it's something that's bothersome and dirty and debilitating and shameful."
Wyeth and the FDA said that there is no evidence of any long-term risks and that suppressing the menstrual cycle can have many benefits, especially for women who experience cramps, bloating and mood swings. There is no reason to think it would pose any additional health hazards, they said.
"The risks of using Lybrel are similar to other conventional oral contraceptives," said Daniel Shames, deputy director of the FDA's Center for Drug Evaluation and Research. "We don't suspect there are going to be any surprises in terms of long-term use of this product."

New Pills for Migration Headaches

Migration survivors tell their tales of long hours and lots of uncertainty while everyone's at home fluffing their pillows


Although large data migration jobs often mean long hours and lots of uncertainty for storage administrators, a few who feared the worst had an easier time than expected with new tools.
Traditionally, data migration projects are long processes that can be unpredictable, especially when large SANs are involved. The process can take days, and that’s if everything goes right. Migration tools usually don’t do a good job of shortening the process, or providing a good idea of how long it will take.
“Pick your poison,” one analyst who asked not to be named says when discussing migration tools. “There are a ton of data migration products -- Softek, StoreAge, Kashya, EMC’s SRDF, EMC SANcopy, NetApp SNAPmirror. Like I said, ‘Pick your poison.’”

But ask around, and it appears there are some solutions popping up that may be easier to swallow than others -- depending on your circumstances. New forms of help could be on the way. Last week Brocade launched its Tapestry Data Migration Manager (DMM) product, and today Xosoft announced InMotion software and Softek and EMC rolled out a collaboration on mainframe migration software called Logical Data Migration Facility (LDMF).
For example, Randy Simons, director of data center operations at Rancho Santiago Community College in California, found predictability an advantage in using Brocade’s DMM. (See Brocade Rolls Out Gear .)
DMM uses Brocade software running over a SilkWorm Fabric AP7420 switch to perform migrations. Brocade claims DMM can keep users informed about how long a migration is expected to take -- thereby helping to save some guesswork.
Simons found it took a lot less time than expected. He planned a migration from an HP EVA 5000 to a larger EVA 8000 over Labor Day weekend because it had to be a time when the college was shut down. He was prepared for the worst until an HP rep pointed out Brocade’s new DMM.
“When everybody’s home fluffing their pillows, we’re working away,” Simons says. “We were thinking it would be long hours, and a normal forklift upgrade. Instead it took a day and a half.”
That said, Simons said the migration project did require extensive training from Brocade and HP support people to get the job done properly.
RBC Product Development had a smaller but more urgent migration project to carry out. The Kansas City firm tests and develops applications for the medical industry. That’s highly collaborative work, and RBC CEO Carl Mayer says most of his company’s business is conducted over email.
“Exchange Server is the backbone of the way we work,” Mayer says.
So it was a big problem when one of RBC’s two Exchange Servers locked up in September and the IT staff couldn’t get it back. “We tried Service Packs, hot fixes, nothing worked,” Mayer says. “We had to migrate Exchange from the existing box to a new server, rebuild the server, and then swing Exchange back.”
Mayer says he looked at migration applications from NSI Software and XOSoft. He chose XOSoft’s new InMotion application, which was announced this week, mainly because of cost -- NSI’s application cost $3,000 per server compared to InMotion at $9 per user (or roughly $450 for Mayer's application). With two servers and about 50 users involved, Mayer found the savings significant enough to give the new package a shot.
But there was something else he liked about InMotion. “It’s not a move, it’s a copy, which is comforting,” he says. “You don’t want to crash halfway through a move, or you’re in a world of hurt. With InMotion, if you're halfway through and it crashes, you pick up from where you left off.”
Mayer didn’t have any crashes and was able to complete each copy in about an hour. On the downside, InMotion only supports Exchange, so it wouldn't have worked for a more general or comprehensive data center migration.