FDA warns doctors of counterfeit Botox

WASHINGTON (AP) — Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.

The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.

The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.

The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.

In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.

A request for comment from the drug distributor was not immediately returned.

Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.

In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.

Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG’s Genentech unit.

___

Online:

The FDA’s warning letter, plus a list of doctors who received it: http://1.usa.gov/R7jKiR

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Markets steady amid Xmas exodus, US budget doubts

LONDON (AP) — Financial markets were largely steady in holiday-thinned trading Monday though concerns remain over the progress of U.S. budget discussions and the future of the economic reform program in Italy.

For weeks, the discussions between the White House and Congress over a budget deal have been the main driver in markets. If a deal isn’t agreed to by the start of 2013, automatic spending cuts and tax increases worth hundreds of billions of dollars will be imposed — which many economists think could push the U.S. economy back into recession.

The prevailing view has been that a deal would be agreed to in time but as the deadline nears there are growing doubts over whether the U.S. will be able to avoid the so-called “fiscal cliff.”

“The reality is given that the U.S. government is now closed for the holiday break the likelihood of anything other than soothing procrastination is highly unlikely much before the Jan. 1 deadline,” said Michael Hewson, senior market analyst at CMC Markets.

Most markets across Europe were only open for half a day and will only re-open again on Thursday. German markets, and others, were closed for Christmas Eve.

Among those that were open, Britain’s FTSE 100 index of leading British shares closed up 0.2 percent at 5,954.18 while the CAC-40 in France was down an equivalent rate at 3,652.61.

Wall Street was poised for falls at the open in what will also be a holiday-shortened trading day — both Dow futures and the broader S&P 500 futures were down 0.3 percent.

Doubts over the progress of discussions prompted a fairly sizeable sell-off last Friday though many analysts still think there will be agreement on some sort of short-term measures.

“Even if this stopgap measure is implemented it may not be enough to prevent unwanted volatility in equity markets going into 2013 as investors try and assess the adverse impact on the U.S. economy,” said Neil MacKinnon, global macro strategist at VTB Capital.

As well as monitoring developments in the U.S. over the coming days, investors will be keeping a close watch on what’s going on in Italy ahead of a general election in February.

Over the weekend, outgoing Prime Minister Mario Monti indicated that he would be willing to return to the role if pro-reform parties back him.

Over the past year or so, Monti and his technocratic government have won plaudits in the markets for their economic reforms and efforts to get a grip on the country’s borrowing. Italy has the second-highest debt burden among the 17 EU countries that use the euro. Only Greece’s is higher.

Earlier in Asia, Hong Kong’s Hang Seng, closed up 0.1 percent at 22,531.51 while South Korea’s Kospi rose less than 0.1 percent to 1,981.82. Japanese markets were closed for the Emperor’s birthday holiday.

Other financial markets were subdued too. In the currency markets, the euro was up 0.2 percent at $ 1.3224 while the benchmark New York oil price was down 16 cents at $ 88.50 a barrel.

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New Zealand level series thanks to Guptill century

EAST LONDON, South Africa (Reuters) – A brilliant, unbeaten century from opener Martin Guptill led New Zealand to an eight-wicket victory off the final ball against South Africa in the second T20 international on Sunday.

Chasing 169 for victory in 19 overs at Buffalo Park, Guptill helped erase the memory of Friday’s embarrassing capitulation to 86 all out in Durban with a stunning batting display as the tourists reached their target for the loss of just two wickets to level the series 1-1.

Requiring 39 from the final four overs and 11 off the last, Guptill was on 97 and needing four for victory when Rory Kleinveldt bowled the final delivery – a low full toss which was eased away through extra cover.

Guptill’s unbeaten 101 was just the third T20 international century by a New Zealander, the first two belonging to captain Brendon McCullum who was almost anonymous with 17 from 15 balls during a second-wicket partnership of 73 with Guptill.

The right-handed opener was similarly dominant during an opening stand of 76 with Rob Nicol (25) as he drove the Proteas attack impeccably straight and displayed the skills – and patience – so obviously missing from the New Zealand batsman in Durban.

Captain Faf du Plessis led from the front once again as South Africa posted a competitive 165-5 in 19 overs after losing the toss and being asked to bat first.

Du Plessis paced his innings to perfection on a tricky pitch to reach 63 from 43 balls with eight fours and a six in a match reduced to 19 overs per side following a 52-minute floodlight failure.

The deciding match takes place in Port Elizabeth on Wednesday.

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News summary: Nintendo’s TVii replaces the remote

TVii LAUNCH: Nintendo if flipping on its TVii service Thursday, a month after sales started for its Wii U game console. The service turns the GamePad controller into a TV remote control, channel guide and Web video surfer.

SALES HOPES: Nintendo hopes the free service boosts sales of the console after recording 425,000 sales in the first week since its Nov. 18 launch.

HEAD START: It’s the first time a game console maker has put live TV controls into a device, but analyst Michael Pachter says competitors will copy the function soon.

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Nick Cassavetes Sued For Allegedly Stiffing Twin Canadian Pop Duo on $300K Movie Loan

LOS ANGELES (TheWrap.com) – Nick Cassavetes, Canadian twins and incest – besides three phrases that you probably didn’t expect to read in the same sentence today, they’re also elements of a bizarre new lawsuit that hit the California court system this week.

In a lawsuit filed Tuesday in Los Angeles Superior Court, TwinSpin music – home to twin Canadian pop duo Carmen & Camille – claim that “The Notebook” director failed to pay back a $ 300,000 loan to help make the upcoming drama “Yellow.”

The complaint alleges that the writer-director backed out of an agreement to give the duo parts in the movie and to feature a song of theirs in the Sienna Miller-Ray Liotta film.

The film chronicles a woman who’s addicted to pain pills and is fired from her teaching job for engaging in sexual shenanigans on school grounds. Oh, and she also had a love affair with her brother at one point. According to the suit – which also includes TwinSpin manager John Thomas as a plaintiff – TwinSpin and Cassavetes entered into an agreement in September 2010, in which TwinSpin would loan Cassavetes $ 300,000 to start production on the film.

In return, the suit says, Cassavetes agreed to pay the loan back with interest – for a total of $ 345,000 – the next month. Cassavetes also agreed to cast the duo in speaking roles in the film, use a song of theirs on the soundtrack, and to give Thomas a producer’s credit, the complaint claims.

But the money never came, the suit says – and neither did the roles, the song and the credit, without which the loan never would have been given.

“But for these representations, Plaintiffs never would have entered into the Loan Agreement or otherwise granted the Loan,” the lawsuit reads. “Plaintiffs are informed and believe that Cassavetes never had any intention of casting ‘Carmen & Camille’ in the Picture, or featuring a song by ‘Carmen & Camille’ in the Picture, of providing the producer credit to plaintiff Thomas, or of repaying the loan on a timely basis.”

Cassavetes’ agent has not yet responded to misrepresentation request for comment.

Alleging breach of contract, breach of covenant of good faith and fair dealing, fraudulent misrepresentation and negligent misrepresentation, the suit is asking for damages of $ 500,000, the amount that the plaintiffs believe is currently owed to them by Cassavetes, with accruing interest.

(Pamela Chelin contributed to this report)

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Meanwhile, Deep Inside Your Belly Button …

Dec 23, 2012 7:00am

Getty Images

Reported by Dr. Amish Patel:

Researchers have found that more than 2,000 different species of bacteria live in our umbilicus – the medical word for belly button.  That means you have more kinds of bacteria in your belly button than there are different kinds of ants or birds in North America, according to the study.

The majority of these bacteria were rare and occurred in just one individual.  No single type was common to all 60 belly buttons sampled.

“I don’t find it alarming,” said Dr. William Schaffner, an expert in infectious diseases at Vanderbilt University Medical Center in Nashville, Tenn.  “We knew belly buttons weren’t sterile.”

However, Schaffner believes that this does not minimize the study’s findings.

“This is in the context of a much larger study, which is trying to … get greater insight into the source of pathogens and how the [bacteria on our body] changes with antimicrobial therapy and age.”

Perhaps, he said, we can “use this to develop new antimicrobials.”

The benefits may extend beyond antibiotics.

“Understanding the biodiversity of our bodies and how it differs among people may play an important role in understanding why some … people are susceptible to the same pathogen or respond to the same drug or diet,” said Dr. Rob Knight, associate professor of molecular biophysics at the University of Colorado – Boulder.

Although the findings of the study do not have any immediate implications, this is good timing for a public service announcement from Dr. Gregory Poland, infectious disease expert at the Mayo Clinic in Rochester, Minn.

“The current fad of women piercing their umbilicus has led to many case reports of infections,” Poland said. “And with today’s multiple drug-resistant bacteria, it can lead to disasters.”

SHOWS: Good Morning America

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China and India: The $10 Trillion Engine of Future U.S. Growth

My friend and colleague Michael J. Silverstein, writing in this space in late October, mentioned that the most dangerous thing about China is America’s misguided attitude toward the country. In short, we appear to be afraid of China’s success.

The U.S. has never before run from a challenge. This is the wrong time to start.

As Silverstein and his co-authors—Carol Liao, David Michael, and Abheek Singhi—point out in their new book, The $ 10 Trillion Prize, one of the reasons many Americans feel threatened by China is they don’t know a lot about the country. What they do “know,” by and large, is what they’ve been told by politicians and others who accuse China of stealing U.S. jobs.

Yes, many low-skill, low-wage U.S. jobs have moved elsewhere, in many cases to China. Yes, many low-cost, mass-produced products that used to be made here are now being made there, and in other low-cost countries, such as India, Indonesia, Malaysia, Mexico, Thailand, and Vietnam. And, yes, many of those jobs will never come back.

But as China and the other developing countries grow, they also become potential customers for U.S. goods and services, from corn and soybeans to automobiles, commercial jetliners, heavy machinery, construction and farm equipment, and banking, investment, and insurance services, to name just a few.

It wasn’t that long ago that the prevailing American vision of the Middle Kingdom was that of millions of mindless peasants marching in automaton-like lockstep to the orders of the party bosses. They led lives of drudgery, on collective farms, toiling for mere survival. Everybody dressed like Chairman Mao. Dissent was met with tanks. And it wasn’t that long ago that that may have been accurate in some respects.

But China today, as Silverstein and his co-authors make clear, is a booming multiclass society with hundreds of millions of people who want nothing more than their own version of the American Dream: a nice home, a quality car, a good education for their children, appliances and conveniences, better health care, stylish clothes, more time for travel and leisure. In short: a better life for the next generation than the current generation enjoyed. The same is true in India.

The authors visited with and tell the stories of dozens of Chinese and Indian families and entrepreneurs who are striving for the same things Americans want—and for the first time in their lives, they have the money to get them.

My colleagues have calculated that between 2010 and 2020, Chinese and Indian consumers will spend some $ 64 trillion on goods and services. Chinese consumers will spend approximately $ 41.5 trillion, with annual expenditures reaching more than $ 6 trillion in 2020. Indians will spend $ 22.5 trillion, with annual spending hitting an estimated $ 3.6 trillion by 2020. Combined, they will be spending some $ 10 trillion per year by 2020—more than three times what they spent in 2010.

That’s what U.S. politicians and business leaders should be talking about: the promise of China and India as engines of future U.S. growth. That’s the prize the book is about.

China and India today show the kind of unbridled optimism that used to be the hallmark of America. Many Chinese and Indian entrepreneurs expect their companies to grow by factors of 10 over the next decade.

Rather than fear such growth, Americans should embrace it, wish them well, and make sure our businesses, farms, and factories are prepared to meet their needs.

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3-day trip becomes 3-week ordeal for 2 Jamaicans

SAN JUAN, Puerto Rico (AP) — It was supposed to be a three-day fishing trip at most. It turned into a three-week ordeal, drifting under an intense sun for hundreds of miles in the Caribbean in a small boat with a broken motor.

The two Jamaican fishermen survived by eating raw fish they caught and drinking water from melted ice they had brought to preserve their catch. The Colombian navy finally plucked them from the sea a week ago and delivered them home Saturday after treating them for severe dehydration, malnutrition and hypothermia.

Everton Gregory, 54, and John Sobah, 58, recounted their story in a telephone interview from Jamaica, while the boat owner and the men’s employer also provided details.

The men set off from Jamaica’s southeastern coast on Nov. 20. The water was glassy, the wind was calm and their boat was laden with 14 buckets of ice, 16 gallons of water and several bags of cereal, bread and fruit.

They headed to Finger Bank, a nearby sand spit 8-miles-long (13-kilometers) that is known for its abundance of fish like wahoo, tuna and mahi mahi. The owner of the 28-foot (8-meter) boat said she usually joins them on fishing trips, but she couldn’t go that afternoon.

After spending a couple of days around Finger Bank, the two men set off for home with their catch. But the boat’s engine soon died. The water was too deep to use the anchor and the current too strong to use the oars, so the boat slowly drifted away from Jamaica.

At first, the men got by on sipping the water and eating the food they brought with them. But days turned into weeks, and they began to eat the fish they had caught and drink the melted ice that had kept it fresh.

Gregory and Sobah kept eating raw fish and used a tarp to try to collect water, but the rain clouds remained at a distance.

Back home, friends and family called police and used their own boats to search the area where the men were last seen. The two fishermen work for the Florida-based nonprofit group Food for the Poor, which chartered a plane to search along Jamaica’s coast.

Marva Espuet, the owner of the boat, said she knew she had packed it with more food and water than needed for a three-day trip, but the thought provided little relief.

“If I had gone, there would have been two boats going,” said the 52-year-old woman, a longtime friend of both fishermen.

With searches proving fruitless, Sobah’s niece grew frantic, recalled Nakhle Hado, a fishing manager for Food for the Poor who helped lead the search. She “begged me that she wanted John back for Christmas,” Hado said.

Hado said some people believed the two men would never be found, but he and others didn’t give up. “My gut was telling me that they were still alive,” he said.

Hado said he had trained Gregory and Sobah on how to survive at sea.

“In case something happens, they don’t have to think twice. They know how to react,” he said. “It’s very important, their mental state.”

Gregory and Sobah finally ran out of fresh water and went several days without drink. A healthy human being can die from dehydration anywhere from three to five days without water.

Then on Dec. 12, a Colombian navy helicopter patrolling off the coast of that South American country spotted the men near Lack of Sleep cay, more than 500 miles (800 kilometers) from where they started. It took two days for a navy vessel to reach them because of bad weather. The men were hospitalized for several days at the Colombian island of San Andres before boarding a plane back home to Jamaica.

“It feels good,” Sobah told the AP in a brief phone interview after arriving.

Gregory said he had lost hope, but Sobah tried to keep him positive that they would be rescued. “I just had that belief,” Sobah said. “I believe in the Creator.”

Yet it is Gregory who plans to keep fishing despite the ordeal because he needs the job.

Sobah said he’s done. “I’m not going to go fishing again. No way.”

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Facebook’s new easier-to-manage ‘Privacy Shortcuts’ rolling out globally

Managing Facebook (FB) privacy settings can be a daunting nightmare. Facebook’s new “Privacy Shortcuts” is designed to make sharing items as transparent as possible with always-visible privacy button on the top toolbar. The update also brings “an easier-to-use Activity Log, and a new Request and Removal tool for managing multiple photos you’re tagged in.” The new Facebook privacy controls are rolling out globally starting on Friday and will arrive for all users by the end of the year. For the full details on all of the new changes, be sure to visit Facebook’s Newsroom here.

[More from BGR: Fan-made tweak gives Apple a blueprint for better multitasking in iOS 7 [video]]

This article was originally published by BGR

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How the Holidays Hurt Your Sex Drive

Ladies, does all of the cooking, baking, shopping, entertaining, wrapping, and decorating associated with good holiday cheer leave you too jingle-jangled to be naughty OR nice? If so, here’s some good news: There’s probably nothing seriously wrong with you if you prefer catching some shut-eye to knocking boots this time of year. The main factors contributing to low sex drive in women — including younger woman — seem to intensify during the craziness of the holidays.

7 Ways The Holidays Hurt Your Looks

Sex Drive Killers

“There’s no doubt that some women experience low or no desire, and that this troubles them. That said, we need to be more critical about lumping women into low or no desire groups, particularly as some women are not distressed by their lack of desire,” explains sex expert Debby Herbenick, PhD, research scientist at Indiana University and author of Because It Feels Good (Rodale, 2009). “They may not have a particularly warm or kind partner, or they may be very stressed about work or family, or exhausted as they care for a newborn, and may well realize that there are times in life when sex takes a temporary backseat for a good reason.”

Contrary to what you may see on TV, a lull in sexual desire isn’t always a crisis. “We should challenge ideas that suggest that women or men should always want lots of sex, all the time,” Herbenick says.

In a 2010 study published in the Journal of Sexual Medicine, researchers looked at 400 premenopausal women age 18 or older with low sexual desire disorder. (The researchers estimate that seven to 12 percent of the female population lives with decreased sexual desire and associated distress.) In the study, it turned out that 85 percent of the low-sex-drive women cited multiple factors for their low drive. Here are the main culprits.

1. Stress or fatigue (60 percent of study participants said these factors contribute to low sex drive)

2. Dissatisfaction with personal appearance (41 percent)

3. Sexual difficulties, including problems reaching orgasm (34 percent)

The study authors conclude that boosting self-esteem, along with reducing fatigue and stress, could significantly fire up a woman’s sex life.

Holiday Relationship Rescue

***

More from Prevention:

31 Days Of Healthy, Happy Holiday

Your Stay-Slim Holiday Survival Plan

7 Reasons Sex Does Your Body Good

Did You Marry The Right Man

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