Thursday, January 3, 2013

Attorney Website Development and Internet Marketing | Link Popularity

If your potential clients can?t find you online, they will discover your competititon. That?s why your website should be more than just a pretty face ? it should be a effective business tool that allows you to get in touch with your potential clients. Why drive a rusty-old second-hand car when you can drive a Ferrari? At Chameleon Graphix Web Design, we?re here to help turn your web presence and online marketing into a well oiled machine. View our web design portfolio at www.ClevelandWebsiteDesigner.com

Intense Lawyer Web Marketing

In today?s competitive online world, it is no longer just an option to have a professional website; your website could be the difference between closing up shop and having a thriving business enterprise. To be successful, you need a proactive, professional website that focuses on your specific practice areas of law.

You need Chameleon Graphics Website Design.

We aren?t interested in putting out cookie cutter internet sites. We are leaders in our industry and are constantly pushing the envelope. By working with our professionals, you can be assured knowing that you have a business associate who is as invested in your success as you are. View examples of our Law Firm Website Designs.

There are tons of options when searching for a web design and marketing firm, but only one clear choice: Chameleon Graphix. We consistently distinguish from the competitors through our award-winning design, our cutting edge technology and the implementation of aggressive, innovative internet marketing strategies. Better yet, we don?t provide just empty promises ? we deliver real results.

Once you become a Chameleon advertising and marketing customer, we will be there to support and guide you through the complex launch and SEO process. You will work with a skilled expert who knows you, and is ready to assist whenever? you need it.

Source: http://linkpopularity.au.ms/2012/12/31/attorney-website-development-and-internet-marketing/

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Source: http://reesegail.typepad.com/blog/2013/01/attorney-website-development-and-internet-marketing-link-popularity.html

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Wednesday, January 2, 2013

Mr. Tom's Tips for Emergency Preparedness: Plastic Containers

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There are many items made from plastic these days, several of which are items used for storing food. But not all plastics are good to use for storing food items, and some may actually contain toxic ingredients. So the question has come up as to what the difference is between a ?regular? container, and a ?food grade? container. Well, let?s discuss some things you should know.




What Is Food Grade Plastic?

????????? You should be mindful of two aspects of plastic production when choosing your containers. First: What type of plastic resin was used in the manufacturing? Second: What type of release agent was used? (A release agent is a chemical used to allow the plastic to break freely from the mold without sticking. You can think of it like using PAM? on your cookware.) While some products are technically made from ?food grade? plastic, the release agent used may contain toxic chemicals. True food grade plastic items have been made with a more expensive release agent that contains no toxins.



Food grade plastic films and containers may be made from polycarbonate, polyester, or polyethylene. They do not contain dyes or recycled plastics that have been deemed to be harmful to humans. However, this does not mean that food grade plastic cannot contain dyes or some recycled plastic. The U.S. Food & Drug Administration (FDA) requires that plastics used in food packaging be of greater purity than plastics used for non-food packaging. The FDA has detailed regulations concerning plastic purity. Plastic requirements.

The characteristics of plastic in terms of density, permeability and strength vary considerably. To limit permeability of moisture and oxygen, films of these plastics are sometimes laminated together, frequently with a metallic layer. Meals Ready to Eat (MRE) packaged in such a metalized polyester-polyethylene wrap have a shelf life Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 of 5+ years if kept cool.


Another aspect of using plastic for food storage is matching the appropriate type of plastic to a particular food product. Foods that are highly acidic (like tomatoes), contain alcohol, or fats, can leach chemicals from the plastic container into the food. Therefore you should only use plastic containers that are FDA approved for the particular type of food with which it will come in contact.



A plastic container that has been used to store non-food items like paint, chemicals, or detergent, can no longer be considered food grade. Because of the tiny pores in plastic, non-food chemicals will contaminate the container which in turn would contaminate any food items. (In other words, don?t re-use your empty detergent buckets for food storage purposes.) You can purchase food grade buckets at various locations on line such as Emergency Essentials; or Be Ready Inc.. You might be able to get used buckets for free or for a very low price from your neighborhood bakery or donut shop.?

????????? There is a caveat that you should consider with plastics and the claims regarding food safety. The plastic used for food items, like frozen dinner trays or water bottles, have been tested ONLY for their ?intended use.? This means that when you re-use those trays, or use them for other purposes, all bets are off. Some plastics are allowed to be in contact with food in the microwave while others are not. Keep in mind that bacteria can grow on virtually any packaging material if stored in conditions suitable for bacterial growth. Therefore, it?s best to clean plastic containers with hot soapy water and dry thoroughly before reuse.

Types of Plastic

In the Plastic industry, the following codes represent the seven categories of plastic resin used in nearly all plastic containers and product packaging:



PET or PETE (polyethylene terephthalate) is a clear, tough polymer with exceptional gas and moisture barrier properties. PET's ability to contain carbon dioxide (carbonation) makes it ideal for use in soft drink bottles.

Examples: Water bottles, soft drink bottles, detergent bottles.
?

HDPE (high density polyethylene) is used in milk, juice and water containers in order to take advantage of its excellent protective barrier properties. Its chemical resistance properties also make it well suited for items such as containers for household chemicals and detergents. Most five gallon buckets are made from HDPE.

Examples: Milk bottles, some shopping bags, toys.
?

Vinyl (Polyvinyl chloride or PVC) provides excellent clarity, puncture resistance and cling. As a film, vinyl can breathe just the right amount, making it ideal for packaging fresh meats that require oxygen to ensure a bright red surface while maintaining an acceptable shelf life.

Examples: Plastic food wrap, shrink wrap, garden hoses, vegetable oil bottles. (Saran Wrap? has been reformulated and no longer contains PVC.)
?

LDPE (low density polyethylene) offers clarity and flexibility. It is used to make bottles that require flexibility. To take advantage of its strength and toughness in film form, it is used to produce garbage bags, shrink and stretch film, and coating for milk cartons.

Examples: Squeeze bottles, dry cleaning bags, some grocery bags.
?

PP (polypropylene) has high tensile strength, making it ideal for use in caps and lids that have to hold on tightly to threaded openings. Because of its high melting point, polypropylene can be hot-filled with products designed to cool in bottles, including ketchup and syrup. It is also used for products that need to be incubated, such as yogurt. Many Cambo?, Tupperware?, and Rubbermaid? food storage containers are made from polypropylene.

Examples: Bottle caps, take-out food containers, drinking straws.
?

PS (polystyrene), in its crystalline form, is a colorless plastic that can be clear and hard. It can also be foamed to provide exceptional insulation properties. Foamed or expanded polystyrene (EPS) is used for products such as meat trays, egg cartons and coffee cups. It is also used for packaging and protecting appliances, electronics and other sensitive products.

Examples: Plastic foam, disposable utensils, coat hangers.

Other: Denotes plastics made from other types of resin or from several resins mixed together. These usually cannot be recycled.

Examples: Three and five-gallon water bottles, DVDs, iPod and computer cases, signs and displays, certain food containers.

Common plastics polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) do not have recycling numbers.

Polycarbonate is a clear shatter-resistant material used in restaurant food storage containers and recently in the Rubbermaid Stain Shield? line of products for home use. (Polycarbonate is the same plastic used to make light weight lenses for eye glasses.)


Plastics that have been approved for food storage are:? polyethylene terephthalate, and high density polyethylene (#1 & #2 above). Polycarbonate has also been approved, but I would like to point out the following information regarding this plastic:


BPA:


Bisphenol A (BPA), is a synthetic estrogen used to make plastics hard: It has been the subject of many news reports questioning its safety. The U.S. Food and Drug Administration says it?s safe to use BPA in food-contact applications, but that claim is still being hotly debated. Apparently there was an expos? in the December 2010 issue of Consumer Reports, with actual test data from canned foods. (Plastic types #1, 2, 4, 5, and 6 are free of BPA.) For information supporting BPA, click here. For more information against BPA, click here.

????????? Major factors to BPA leaching into your water or other food products seems to be time and heat. The longer something is stored in a container made with BPA, the more leaching will take place. Also, as the temperature of the container rises, more of the chemical can be released. For example, boiling water stored in a Nalgene? bottle will leach BPA 55 times faster than cold water.


Heat affects the other plastics as well, so you shouldn?t store water bottles in your car where the temperatures can reach well over 100 degrees on a sunny day. If you want to carry water in your car, it might be a better idea to keep it in the trunk where the temps will remain cooler. I encourage you to do your own research and draw your own conclusions.?


Plastic Bags

????????? If you?re not sure whether your storage bucket is made from food grade plastic, or for added protection, you can line your bucket with a plastic bag. Once again, keep in mind not all plastics are created equal. You should not use plastic bags that were made for a non-food use, such as trash bags or dry cleaning bags!


????????? There are several types of bags you could consider for lining buckets of food, and they include: Ziploc brand bags; turkey roasting bags; and Mylar laminate bags. Keep in mind that the bags should not be considered ?air-tight? unless they are heat sealed. In order for oxygen absorbing packets to be effective with long-term storage, you will need to make sure your liner is heat sealed!

(The Ziploc bags are handy, but they don?t provide an airtight seal.) Some kitchen supply stores sell other plastic bags for food use, but they?re fairly expensive.


Lids



????????? Storing food or other items in plastic buckets is a great way to organize your storage supplies. Some people put an entire meal of pre-packaged items into one bucket and then label the container accordingly. (For example a bucket labeled ?Dinner? could contain: canned chicken; stove top stuffing; canned gravy; canned vegetables; drink mix; and Jell-O or pudding mix.) You might be able to fit an entire days worth of food into one bucket. You could also use buckets for non-food items such as tools; cooking supplies; First Aid supplies; pet food; clothing, etc.


????????? In addition to Gamma Seal Lids, you can purchase a replacement lid for your buckets that is a toilet seat. With these lids, you simply line your bucket with a plastic bag and take care of business. (Of course, you don?t need food grade buckets or bags for this purpose.)


Summary

????????? Not all plastics are suitable for food storage! Be sure to use only food grade plastic to store food items. Non food grade containers may be used for food items if they?re lined with a food grade bag. Never use a container for food items that has been used previously for non-food chemicals or paint. You can buy replacement lids that will allow you easy access to your supplies while providing an airtight and watertight seal. While plastic gives a good seal for your food items, it is still permeable (over time, air and chemicals may still leach through the container). Avoid high temperatures (over 85? F) when using plastics for storage of food or water. ?


Mr. Tom

Source: http://www.mrtomstips.com/2013/01/plastic-containers.html

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Source: http://godalkycc.posterous.com/mr-tom39s-tips-for-emergency-preparedness-pla

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Sofia Vergara, Nick Loeb Brawled in Miami on NYE

Sofia Vergara and her fiance Nick Loeb definitely did not start 2013 off on the right foot. The couple was partying in Miami on New Year's Eve, but the festivities soon turned sour when Loeb started a fight with those around him and Vergara got involved.

Source: http://www.ivillage.com/sofia-vergara-nick-loeb-brawled-miami-nye/1-a-512201?dst=iv%3AiVillage%3Asofia-vergara-nick-loeb-brawled-miami-nye-512201

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Tips Handicapping The Biggest Horse Races ? Recreation and Sports

Thoroughbred and harness horse racing tips are predicted by jockeys, trainers, owners, grooms, professional gamblers and even horse racing bettors .

Tips that payout generally will come from an insider usually if the horse is the odds on favorite or if you are a close friend or relative to an owner, trainer or jockey. No person is going to give you a real tip because they like you, because the more people who know about it the less the horse will pay . So if you are not close to an insider then the only very good tips are probably the ones coming from a capper on a free picks sheet who wants to impress you with his expertise so you will continue to buy his picks.

Owners always believe their horses are going to win, so free horse racing tips from an owner may not be so good. Trainers and groomers are with the horses 24/7, so their predictions will be correct more often.

The best horse racing tips do come from the jockeys, lets face it the owner and a trainer can only tell a jockey how to ride but it?s the jockey who is out there on the track deciding if he will go to the front or lay back and close at the end . Sometimes some jockeys in a race will together by one of them preventing any other riders from the front or going to the lead and get into a speed duel to burn out other horses to alow the horse they want to win .

Betting on Horse Racing is an fascinating experience during the 2 minutes the race is on. From your local horse racing track to the prestigious Triple Crown Races you have a chance to win alot of money.

One of the betting options you can do is to box the horses you like on the same bet. This strategy ensures your chances of winning are enhanced . It ogives you more opportunities to place several bets on the horses you think will win the race and come into fist, second or third, on and exacta or triple bet. Ofcourse with these bets there will be a larger overall risk amount needed .

Another tip in winning your bets is having in-depth knowledge of the most succesful horse trainers in every race and what their win %?s are overall and what they are for the current meet. Some of the worlds best horse trainers that have remarkable win percentages in horse racing across the world are:

1).Aidan O?Brien: He is a one of the world celebrated horse trainers. The Irish has an outstanding records having trained the best horses that have won some of the world?s top horse races. He runs the the Coolmore racing team. Going by current results from George Washington and Dylan Thomas racing tournament this is one of the trainers you can place your bets confidently expect to cashpout .

2). Bob Baffet: Bob a top US trainer is an exceptional horse trainer that currently controls most of the races in California including the Triple Crown. You can always rely on cashing in when betting on horses trained by him.

3). Mark Johnson: The proprietor of the prestigious Kingsley House is a top trainer from the U.K. . Currently, Mark Johnson trains roughly 140 horses. If you have to place your bet in the top UK horse racing events then you can count on this Englishman as your bet on your favorite horse .

Apart from these helpful ideas, there are many online racebooks that will give you helpful instruction so that you can bet smarter. Some of the sites are remarkably willing to refund part of your bet so you do not always lose as much.


Tags: free horse racing tips, free picks

Source: http://recreationandsports.russiacourse.com/uncategorized/tips-handicapping-the-biggest-horse-races/

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Information & Questions

This is where I'll be putting any additional story-based information, as well as answering and story-based questions that anyone may have. Please keep in mind that this is still a developing universe, so things may change slightly or even drastically as we go on.

Terminology

Emperor Tarrow: Soria's current Emporer. All though his time on the throne has been short, he is a just ruler, and well liked. There have been many attempts to take his life by assassins.

The High Preist: The spiritual leader of Soria, he acts as a spiritual link between the Sorians and the Gods.

The Shari: Ancient demons who served the Ovu in their attempt to conquer Soria. Recently there have been multiple reports of sightings in both Wargleam and Peacemark, though most dismiss this as rumor.

The Ovu: A group of powerful humanoid Shari, the Ovu are powerful sorcerers who tried to conquer the world in the time of the warrior's but were defeated and sealed away by the Shujaa. Secretly, they have broken free of their seal, and have gone into hiding, planning their attack.

Shujaa: An ancient order of knights, and the wielders of the ten sacred swords. They gave their lives to seal the Ovu away, and now lie deep inside the tower of Istrikahn, forever guarding the demons with their lingering will.

The Interfectors: An elite secret service group, dedicated to protecting the Emporer, and all political aspects of Soria. Only the current Emporer, along with a handful of lords know of their existence, and anyone who discovers them is sworn to secrecy or death.

The God's gaurd: An elite guard sworn to protect the high priest. They also serve as the city guard in Peacemark.

The tower of Istrikahn: A tower erected on top of the seal of the Ovu, it stands as a memorial to the brave Shujaa, and their sacrifice to keep Soria safe. It is guarded by a mysterious tower guardian.

The tower guardian: The mysterious watcher of the tower, he is said to be an immortal from the times of the warriors, and guards the tower from any who wish to disrupt the warrior's seal. The prophecy states that he must train a new group of Shujaa to defeat the awakened Ovu.

Peacemark: An eastern desert city, famous for it's role in the infamous battle of the grey sands. ?The city is home to the high priest, as well as the God's guard, and is governed by the Crosswell family, namely lord Henrick Crosswell.

Wargleam: A central city, surrounded by lush jungle and regal mountains, Wargleam is home the Senos company, who are a group of highly-trained blacksmiths responsible for arming most of Soria's military, as well as taking private contracts. The city is governed by the Staxus family, and their head Lord Venator Staxus, who is also the head of the Senos company.

Pathbane: A western seaside trading city, famous for it's enormous port. The largest city in Soria, and also the most populous, it's also known as "The city that never rests" due to the fact that the ports are constantly being used, and almost any type of entertainment can be found within. Governed by the corrupt Kodaht family, any their money-loving lord John Kodaht.

Whitehawk: The Northern capital city, Whitehawk is home to the Emperor and the senate. It is surrounded by tall mountains, and the only direct entry route to the city is directly in front. Also known as "The Shielded city" Whitehawk is supposedly impossible to invade. It is governed by the Emperor himself, Callum Tarrow.

The Gods:

Samaria: The Mother Goddess. Rules over Life, Birth, Marriage and Free will. She takes the form of a kind, motherly woman with flowing brown hair and a white dressto symbolize purity. The eternal rival of Kucheka.

Jenga: The God of constructs. Rules over building and structures. He takes the form of a spry, glasses-wearing young man, with hands that glow a dim grey.

Amotokali: The Goddess of Summer. Rules over fire, heat, the arts and summer. She sometimes takes the form of a Magnificent Phoenix, and other times, a fiery-eyed, crimson-haired young woman, with tanned skin and dancer's clothing. The eternal Rival of Baridi.

Baridi: The God of Winter. Rules over Ice, snow, winter and knowledge. He tends to take the form of an Snowy Owl, and other times that of a wise young man, with frosted icy hair and frosted robes. The eternal rival of Amotokali.

Zuri: Goddess of Spring. Rules over Love, growth, plants and beauty. She takes the form of a Fox, and other times, a breath-takingly beautiful young blonde woman, with a dress made of leaves, and a black panther at her side. The eternal rival of Jani.

Jani: God of autumn. Rules over wind, change, travel and autumn.Takes the form of a crow, and other times, the form of a masked figure, covered in a dark orange cloak. The eternal rival of Zuri.

Usin: God of sleep. Rules over sleep, dreams and visions. Takes the form of a Black bear.

Hatari: God of combat. Rules over Combat, war, strategy and pain. Takes the form of an armored lion, or a divine-looking knight.

Namune: God of Mankind and Magic. Watches over human affairs. Takes the form of a Wise old man, with a white cloak and a long white beard.

Zwei: God of the Moon. Rules over the Moon, and the ocean. Takes the form of a grey wolf, and other times, a shirtless black-haired man, with pale skin and gleaming yellow eyes, wielding a greatsword. The eternal rival of Sol.

Sol: Goddess of the son. Rules over the sun, and the land. Takes the form on a large bald eagle, and other times, a bright blonde-haired woman, with olive branches behind her ears, in white robes, wielding a spear. The eternal rival of Zwei.

Kucheka: The laughing one. Rules over madness, death, creativity, free will and the sick. Takes the form of a grey haired man, in kingly attire, with a well-kept grey head of hair and a stylish beard. The eternal rival of Samaria.

Source: http://feedproxy.google.com/~r/RolePlayGateway/~3/bchmOALRT-k/viewtopic.php

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Tuesday, January 1, 2013

'The Hobbit' holds on to first place with $32M

FILE - This publicity file photo released by Warner Bros., shows the character Gollum voiced by Andy Serkis in a scene from the fantasy adventure "The Hobbit: An Unexpected Journey." (AP Photo/Warner Bros., File)

FILE - This publicity file photo released by Warner Bros., shows the character Gollum voiced by Andy Serkis in a scene from the fantasy adventure "The Hobbit: An Unexpected Journey." (AP Photo/Warner Bros., File)

(AP) ? A tiny hobbit has a mighty hold on the box office, staying on top for a third-straight week and wrapping up a year that saw a record-breaking $10.8 billion in total annual grosses.

The Warner Bros. fantasy "The Hobbit: An Unexpected Journey" remained at No. 1 with $32 million for a total of $221.7 million, according to final studio figures Monday. That's slightly down from the Sunday estimate of just under $33 million but enough to retain first place in a holiday weekend that featured the much-anticipated debuts of awards contenders "Django Unchained" and "Les Miserables."

The top 20 movies at U.S. and Canadian theaters Friday through Sunday, followed by distribution studio, gross, number of theater locations, average receipts per location, total gross and number of weeks in release, as compiled Monday by Hollywood.com are:

1. "The Hobbit: An Unexpected Journey," Warner Bros., $31,960,000, 4100 locations, $7,795 average, $221,743,000, three weeks.

2. "Django Unchained," Weinstein Co., $30,122,888, 3010 locations, $10,008 average, $63,443,153, one week.

3. "Les Miserables," Universal, $27,281,735, 2814 locations, $9,695 average, $66,720,160, one week.

4. "Parental Guidance," Fox, $14,554,053, 3367 locations, $4,323 average, $29,342,745, one week.

5. "Jack Reacher," Paramount, $14,010,000, 3352 locations, $4,180 average, $44,661,000, two weeks.

6. "This Is 40," Universal, $12,501,060, 2914 locations, $4,290 average, $36,431,350, two weeks.

7. "Lincoln," Disney, $7,337,362, 1966 locations, $3,732 average, $131,867,159, eight weeks.

8. "The Guilt Trip," Paramount, $6,700,000, 2431 locations, $2,756 average, $21,102,000, two weeks.

9. "Monsters, Inc. 3-D," Disney, $6,447,437, 2618 locations, $2,463 average, $18,573,901, two weeks.

10. "Rise of the Guardians," Paramount, $4,900,000, 2055 locations, $2,384 average, $90,230,000, six weeks.

11. "Skyfall," Sony, $4,600,000, 1637 locations, $2,810 average, $289,600,000, eight weeks.

12. "Silver Linings Playbook," Weinstein Co., $4,079,314, 745 locations, $5,476 average, $27,330,036, seven weeks.

13. "Life of Pi," Fox, $3,780,269, 1178 locations, $3,209 average, $86,650,453, six weeks.

14. "Cirque du Soleil: Worlds Away," Paramount, $2,400,000, 840 locations, $2,857 average, $7,407,000, two weeks.

15. "The Twilight Saga: Breaking Dawn ? Part 2," Summit, $2,359,289, 1191 locations, $1,981 average, $286,039,065, seven weeks.

16. "Wreck-It Ralph," Disney, $1,855,213, 913 locations, $2,032 average, $175,505,332, nine weeks.

17. "Argo," Warner Bros., $1,015,000, 345 locations, $2,942 average, $108,474,000, 12 weeks.

18. "Anna Karenina," Focus, $525,790, 218 locations, $2,412 average, $10,705,866, seven weeks.

19. "Flight," Paramount, $460,000, 400 locations, $1,150 average, $91,922,000, nine weeks.

20. "Hyde Park on Hudson," Focus, $429,694, 84 locations, $5,115 average, $1,737,996, four weeks.

___

Online:

http://www.hollywood.com

___

Universal and Focus are owned by NBC Universal, a unit of Comcast Corp.; Sony, Columbia, Sony Screen Gems and Sony Pictures Classics are units of Sony Corp.; Paramount is owned by Viacom Inc.; Disney, Pixar and Marvel are owned by The Walt Disney Co.; Miramax is owned by Filmyard Holdings LLC; 20th Century Fox and Fox Searchlight are owned by News Corp.; Warner Bros. and New Line are units of Time Warner Inc.; MGM is owned by a group of former creditors including Highland Capital, Anchorage Advisors and Carl Icahn; Lionsgate is owned by Lions Gate Entertainment Corp.; IFC is owned by AMC Networks Inc.; Rogue is owned by Relativity Media LLC.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/4e67281c3f754d0696fbfdee0f3f1469/Article_2012-12-31-Box%20Office/id-00a78f5d6fbd4dd398a608df47a6a36a

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FDA approves 1st new tuberculosis drug in 40 years

(AP) ? The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.

The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.

Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.

Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.

The standard drugs used to fight the disease were developed in the 1950s and 1960s.

"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.

The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.

"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."

Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.

Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.

Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.

"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."

The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.

Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/bbd825583c8542898e6fa7d440b9febc/Article_2012-12-31-FDA%20Approval-Tuberculosis/id-90fbcbe7027a4e61a85dc5f8dc412397

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