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Scott Hixson

My heroes are predominately literary figures. Some are authors. All are dead. I like to collect antiquated things. My prized possessions in this world are two typewriters and neither one of them has ink. You could say I like useless things, and you’d be right. Between my typewriters, vinyl, library of yellowing pages and English major I am, in essence, utterly useless. In a past life, I was a drop of ink on page 57 of Agatha Christie’s “And Then There Were None.” I then became a sandy rock and I have not moved since. I often like chain-smoking because I find I would rather worry about killing time than killing myself slowly. I pretend my freckles are constellations. I’ve yet to find any discernible shapes. My teeth are too big for my head. I’m just like everybody else, but stretched out. This has led many to feel like they can criticize, as if skinny people are less conscious about their weight than obese people. I’ve had nicknames ranging from the relatively tame “Tree” to the more absurd, and frankly offensive, “Ethiopian dynamite." I got a brain tattooed on my chest to remind me to think more. It didn’t work. I’ve noticed since I reached manhood that elderly men hit on me more than any other demographic. I can’t quite figure out why. I like ghost stories though I don’t believe in the existence of ghosts. I stole yard gnomes from a neighbor’s garden when I was much younger. I thought I was part of something coined the National Gnome Liberation Front. I’m pretty sure the statute is up for that so I have no qualms. Also, they were mean neighbors. I consider the smell of old books an aphrodisiac, I think it’s the sign of a serious mental condition. I think MDMA is a cup of hot chocolate with whipped cream, cinnamon sugar and an Oreo on top on a rainy day. Whisox!

Former Lucchese Crime Family Member Died

The former informant’s story became immortalized in the film “GoodFellas”

Henry Hill, the former member of the Lucchese crime family and whose story has been immortalized in the classic film GoodFellas, passed away Tuesday as the result of complications from smoking, according to Nate Caserta, the son of Lisa Caserta, Hill’s girlfriend.

Henry Hill served with the Lucchese crime family throughout the 60s and 70s before becoming an informant against the syndicate under the umbrella of the witness protection program in the 80s. Hill has admitted that he did “a lot of bad things back then.”

“I shot at people. I busted a lot of heads and I buried a lot of bodies,” Henry Hill said during a 2010 interview with the London-based Daily Telegraph. “You can try to justify it by saying they deserved it, that they had it coming, but some just got whacked for absolutely no reason at all.”

Henry Hill, 69, passed away Tuesday at West Hills Hospital in West Hills, Calif. Hill had undergone open-heart surgery in 2011 and died resulting from complications of heart problems related to smoking, according to Caserta.

Henry Hill’s criminal career with the Lucchese crime syndicate was documented by journalist Nicholas Pileggi in his 1987 bestselling biography Wiseguy: Life in a Mafia Family. Pileggi’s biography would become the basis for Martin Scorcese’s 1990 classic film GoodFellas, which starred Ray Liotta as Henry Hill.

Hill’s criminal acts were well documented. In 1978, Henry Hill took part in the single largest cash robbery in U.S. history, stealing $5.8 million from the Lufthansa air cargo terminal at JFK International Airport. Hill was also implicated in the fixing of Boston College basketball games during the 1978-79 season, as well as the 1967 robbery of $420,000 from the Air France terminal at Kennedy Airport.

Henry Hill became an informant for prosecutors following his 1980 arrest for running a cocaine smuggling operation. At the time, Henry Hill had become paranoid that his associate and reputed mastermind of the Lufthansa heist, Jimmy “The Gent” Burke, would attempt to silence him from testifying against him. According to Hill, Burke began killing anyone who had been associated with the robbery to both keep from sharing the profits and to ensure there were no rats.

“I knew I was going to get whacked, and it came pretty close,” Hill said in 2010. “So it was either me or them. I knew it, and they knew it.”

Hill’s testimony regarding the 1978 airport heist, murders and other crimes resulted in about 50 convictions, including Burke (who later died in prison) and a Lucchese crime family captain, Paul Vario.

“Initially, I had a lot of remorse, and it took me a long time to forgive myself for what I did, for being a rat. But I knew I saved a lot of lives by putting a lot of horrible people away. You live by the sword, you die by the sword,” Hill told London’s Daily Telegraph.

According to a 2001 Associated Press story, Henry Hill was released from the witness protection program in 1987 after being convicted of burglary, assault and three DWIs.

Henry Hill spoke with the British newspaper the Sun in 2010, stating of his attraction to the mob: “I was intoxicated by their lifestyle when I was young. Those guys were the role models of my neighborhood; they were the guys with Cadillacs and diamond rings and a girl on each arm.”

Hill has maintained that he never murdered anyone, acting only as the “money man.”

“I never killed anyone personally, but I buried a lot of bodies. They would whack somebody, and I had to go and dig the hole,” he said. “I witnessed a lot of executions, maybe 10. I’ve seen guys killed for nothing. I had many sleepless nights, and I still do today.”

 

Joe Biden makes controversial remark on campaign trail

Vice President Joe Biden ignited controversy by invoking the word “chains” at a rally in Virginia

 

Joe Biden ignited a war of words with his unfortunate phrasing at a campaign event in Virginia Tuesday. The vice president is no stranger to gaffes and may even be the political embodiment of “foot in mouth.”

Joe Biden appeared at a campaign event in Virginia Tuesday and spoke of the Republican budget conceived in part by vice presidential candidate Paul Ryan. His ill-phrased comment has since sparked heated debate on both sides of the political aisle.

“We got a clear picture of what they all value,” said Vice President Joe Biden. “Every Republican’s voted for it. Look at what they value and look at their budget and what they’re proposing. Romney wants to let the – he said in the first hundred days he’s going to let the big banks once again write their own rules, ‘unchain Wall Street.’ They’re going to put y’all back in chains.”

GOP opponents immediately seized on this comment, focusing on the unintended racial undertone and reference to African-American’s shared misery at the hands of the institution of slavery. The Mitt Romney campaign has since said that the Obama re-election campaign had “reached a new low.”

“His campaign has resorted to diversions and distractions, to demagoguing and defaming others,” said Romney on the final stop of his Ohio bus tour. “It’s an old game in politics; what’s different this year is that the president is taking things to a new low.”

ABC’s Arlette Saenz reported that the vice president has said that he misspoke, intending to use the work “unshackle” instead of “unchain.” The GOP has used the word “unshackle” in the past, the veep stated.

“I’m told that when I made that comment earlier today in Danville, Virginia, the Romney campaign put out a tweet. You know, tweets these days? Put out a tweet, went on the airwaves saying, ‘Biden, he’s outrageous in saying that,’ I think I said instead of ‘unshackled,’ ‘unchained.’ ‘Outrageous to say that.’ That’s what we had. I’m using their own words. I got a message for them. If you want to know what’s outrageous, it’s their policies and the effects of their policies on middle class America. That’s what’s outrageous,” said Vice President Joe Biden in response to the criticism.

White House Deputy Communications Director Jen Psaki defended Biden in a press briefing Wednesday. “He often talks about the middle class and the importance of unshackling the middle class. He was using a metaphor yesterday and talking about Wall Street reform and the fact that we can’t allow Republicans to defund Wall Street reform.”

Regardless of what Joe Biden intended, his comment rubbed a number of the electorate the wrong way. Some have even remarked it could spell his end as President Obama’s running mate. Former Alaska Gov. Sarah Palin told Greta Van Susteren of Fox News that Biden’s comment should be considered “the nail in the coffin” for his spot on the Democratic ticket. Of course, only time will tell.

Kids vitamins deemed not as healthy as advertised, according to FTC

Disney and Marvel Complete Tablets marketed by NBTY Inc.

 

Kids vitamins are not as healthy as advertised, according to the Federal Trade Commission, resulting in the marketer of Disney and Marvel hero-themed vitamins for children refunding more than $2 million to consumers who purchased the kids vitamins in recent years.

The kids vitamins in question contained only a fraction of the nutritional value advertised on the package, admitted the marketer NBTY. The vitamins were advertised as containing enough DHA to satisfy a child’s daily requirement. However, according to the FTC, in some cases the vitamins contained only a miniscule amount of DHA, an omega-3 fatty acid found in fish.

The amount of DHA in Disney and Marvel Complete Tablets equaled only one-thousandth of what NBTY claimed per serving for children age 4 and older, the FTC found.

For children ages 2 to 4, court documents filed by the FTC alleged, the discrepancy was much greater, only five-10-thousandths of what was advertised.

The kids vitamins, Disney and Marvel Complete Tablets, were sold at CVS Pharmacy, Wal-Mart, Target, Walgreens, Kroger, Kmart, Meijer and Rite Aid, as well as online. The boxes were priced between $4 and $8 each.

The refunds announced Tuesday stem from a case filed in 2010 alleging NBTY make false and deceptive advertising claims about their nutritional supplements. The refund amount totals $2.1 million.

The FTC urges consumers who believe they may have bought Disney and Marvel Complete Tablets between May 1, 2008 and September 30, 2010, to file a claim online, or call 866-224-4336 to request a paper claim form in the mail. Consumers eligible for the refund have until October 12, 2012 to file their claims.

More information on the refund can be found via the FTC’s announcement.

Online claims can be made at the FTC website.

Dave Mustaine calls Colorado and Wisconsin mass shootings Obama conspiracy

The frontman for the heavy metal band Megadeth is an outspoken “birther”

 

Dave Mustaine, the lead singer of heavy-metal band Megadeth, has stated he believes President Barack Obama is responsible for the recent mass shootings in Aurora, Colorado and Oak Creek, Wisconsin.

Dave Mustaine appeared at a concert last week in Singapore and made the following statement:

“Back in my country, my president is trying to pass a gun ban. So he’s staging all of these murders, like the Fast and Furious thing down at the border and Aurora, Colorado, all the people that were killed there. And now the beautiful people at the Sikh temple.”

Mustaine’s statement drew a confused response from audience members as Mustaine continued, “I don’t know where I’m gonna live if America keeps going the way it’s going because it looks like it’s turning into Nazi America.”

Dave Mustaine has voiced his dislike for President Obama numerous times in recent months. As an outspoken “birther,” someone who questions the validity of President Obama’s birth certificate, Mustaine said in a March interview with radio host Alex Jones, “With all of the proof about his birth certificate being fake. And you see the signs in Kenya that say ‘the birthplace of Barack Obama.’ Hello?! C’mon, guys. How stupid are we right now?”

The Megadeth frontman voiced his support for then-GOP candidate Rick Santorum, while criticizing the eventual Republican nominee Mitt Romney.

“I was floored the other day to see that Mitt Romney’s five boys have a $100 million trust fund,” Mustaine told MusicRadar.com. “Where does a guy make that much money?”

The latest album from Megadeth, Th1rt3en, topped the Hard Rock albums chart on its release in late 2011. The band’s past albums include the 1986 Peace Sells… But Who’s Buying?, the 1990 Rust in Peace and the 1992 Countdown to Extinction, which fostered the band’s only Hot 100 entry, Symphony of Destruction.

George Zimmerman: Defense fund nearing empty

The 28-year-old and his wife are living in hiding and are jobless, according to defense lawyer

 

George Zimmerman is living “as a hermit” with his wife and nearly broke, according to his lawyer, Mark O’Mara. Zimmerman is accused of the infamous murder of 17-year-old Trayvon Martin in late February.

George Zimmerman is living “in hiding” somewhere in Seminole County, Florida as he and his wife fear for their lives, according to a statement made by O’Mara to the Orlando Sentinel.

Both Zimmerman and his wife are currently jobless and, according to O’Mara, are “not doing well.” Based on what O’Mara told the Orlando Sentinel, George Zimmerman is nearing broke, as his legal-defense fund has decreased to around $50,000, with approximately $20,000 in payments due, far below the total he raised through donations earlier this year, $250,000.

O’Mara has said that a declaration of indigency would likely be needed for Zimmerman, which would mean the state of Florida would pay for his legal defense. “The money is not coming in all that strongly right now,” O’Mara said.

The donation fund paid $100,000 for Zimmerman’s bond, approximately $50,000 for security guards for Zimmerman and his wife, Shelly, and about $30,000 for rent, utilities and other living expenses, according to O’Mara.

O’Mara has said that George Zimmerman, 28, and his wife cannot land work because of the attention paid to them based on the high profile and controversial case. The couple relies on family or friends to bring them groceries, according to O’Mara.

According to O’Mara’s statement, his office received a threat or two every week. “It is scary to be George Zimmerman,” O’Mara said. “You can’t be out in public, so how do you work?”

West Nile virus prompts Dallas Mayor to declare state of emergency

The CDC has confirmed nearly 700 cases of the virus nationwide

 

West Nile virus is blamed for 10 deaths and 200 illnesses in the city of Dallas, prompting the mayor to declare a state of emergency in America’s ninth largest city.

West Nile virus has resulted in almost 400 infections and 16 deaths state-wide, according to Texas officials. According to the Centers for Disease Control and Prevention, West Nile virus can be blamed for 693 cases and 26 deaths nationwide in 2012, as of August 14.

Dallas Mayor Mike Rawlings declared a state of emergency in Dallas on Wednesday and said the city has agreed to undergo its first aerial spraying of insecticide since 1996, when West Nile virus resulted in the deaths of more than a dozen due to encephalitis, or irritation or swelling of the brain.

The aerial spraying could take place as early as Thursday evening, depending on weather conditions. The aerial assault is a controversial move, carrying both risks and rewards. Mayor Rawlings has said the rewards outweigh the risks.

“I want to take the politics out of it,” the Mayor said. “I want to say this is my responsibility. I will take the heat for it.”

Texas officials have made assurances that the aerial insecticides used are safe for humans, although some continue to worry about the effects of such poisons on at-risk patients.

Dr. Beth Steven, an obstetrician-gynecologist, told CBS News, “We are going under the assumption that this isn’t going to be harmful for mother or unborn child.”

Mike Raupp, at the University of Maryland College of Agriculture, was asked during an interview with CBS This Morning about the risks of the aerial insecticide to be used in Dallas and across northern Texas.

“This is a matter of concern,” Raupp said. “I know that the elected officials down in Texas labored over this one quite a great deal. But it’s a risk benefit analysis here. … Basically, in this case, I think the benefits of these sprays far, far outweigh the risk. We’ve got people dying in Texas. We’ve got 16 people in the state now, we have more than 700 cases nationwide. The risks of being harmed by these pesticides are not at all unreasonable. The materials they are using are the same pesticides you would use to spray the vegetables in the garden or some of the pests that invade your home. These are relatively safe materials.”

Raupp added that the combination of birds carrying the West Nile virus, the high population of mosquitoes, high temperatures, wet conditions and a population susceptible to the disease make the situation possible, particularly within the center of the U.S. He continued to call the current outbreak in Texas and elsewhere across the nation “quite disturbing.”

The aerial assault to be used in Dallas will be conducted by the national spraying company Clarke, which has a contract with the state’s health department. The state will pay for the $500,000 operation using emergency funds. Clarke officials have said they will use two to five planes across Dallas County in the operation.

Dr. Lon Kightlinger, a South Dakota disease specialist, has said that the actual number of West Nile cases reported nationwide might be much higher, because most people do not recognize that they have been infected.

According to the Centers for Disease Control and Prevention, one in 150 patients becomes sick with symptoms of the virus that include body aches, chills, low-grade fever, paralysis and coma.

Jordan Conner, 15, is just one of the hundreds of victims in Texas to be infected with West Nile virus. A rare strand of the virus affects her brain and at any moment could cause her to lose consciousness or control of her limbs. The teen’s mother, Ebonie Conner, told CBS News, “Jordan went from lethargic when I woke her up to go to the doctor, to being narcoleptic.”

“It’s kind of like the flu, only I kept getting headaches… couldn’t feel body parts,” Jordan explained to ABC affiliate WFAA. “Like when I waked, I didn’t have balance; it felt weird.” Jordan did not realize the dire state she was in, “I thought they’d give me a shot and I’d get better.”

Jordan spent eight days in the hospital and will have to endure many more in rehabilitation. “It’s just been unimaginable,” the girl’s mother said.

More information on the 2012 outbreak of the West Nile virus can be found at the CDC’s website. 

Soledad O'Brien debates Barbara Comstock and John Sununu

The CNN anchor was seen reading a liberal website during an interview with Romney campaign adviser

 

Soledad O’Brien was recently spotted looking at an article on a liberal website while debating Barbara Comstock, senior adviser for the Romney campaign.

Soledad O’Brien, who was filling in for Anderson Cooper, was seen reading a piece titled The Myth of Paul Ryan the Bipartisan Leader on the liberal website Talking Points Memo. Screen shots posted to Newsbusters.org show Soledad O’Brien… reading.

According to an article from FoxNews.com, titled Cameras catch CNN anchor Soledad O’Brien reading liberal blog during debate with Romney adviser, “While she does not directly cite the blog, she does read a quote from Sen. Ron Wyden (D-Or.) to Comstock that appears verbatim in the piece during the program.”

Soledad O’Brien also engaged in a heated debate with Romney supporter John Sununu on Tuesday’s Starting Point regarding Medicare and Paul Ryan.

Sununu, the former New Hampshire governor, appeared on the program to discuss the differences between vice presidential candidate Paul Ryan’s controversial budget plan and Romney’s own plan. To O’Brien, the plans seem very similar.

“Isn’t the Ryan plan the Romney plan?” O’Brien asked. “No, it isn’t,” Sununu responded.

Soledad O’Brien then quoted Romney as saying it would be “marvelous” if the Senate approved Ryan’s plan. “That sounds like a lot of support. Am I wrong?” O’Brien asked, to which Sununu responded that Romney has his own plan.

Sununu said that Romney’s plan would not “gut” Medicare by $717 billion as Obama’s and Ryan’s had. O’Brien stated that this claim was a “Republican talking point” whose figures have already been “debunked.”

“No, they haven’t,” Sununu replied.

“Yes they have!” O’Brien responded, adding that the President’s plan cuts “the expected rate of growth” in Medicare, not the program itself.

“Soledad, stop this!” Sununu said. “All you’re doing is mimicking the stuff that comes out of the White House and gets repeated on the Democratic blog boards out there. If you’re going to mouth what comes out of the White House…”

“I’m telling you what FactCheck.com tells you,” O’Brien interrupted. “I’m telling you what the CBO and CNN’s independent analysis does.”

“Put [an] Obama bumper sticker on your forehead when you do this,” Sununu shouted.

Soledad O’Brien eventually quieted Sununu, “There’s independent analysis, [FactCheck.com,] the CBO and CNN has already done its own independent analysis, and name calling to me and somehow acting as if by repeating a number of $716 billion that you can make that stick when that figure is being stolen from Medicare, that’s not true. You can’t just repeat it and make it true, sir.”

Lindsay Lohan to earn $2 million in 2012 says TMZ

The embattled celebrity reportedly earned $1 million for posing nude in Playboy

 

Lindsay Lohan is set to make $2 million in 2012, TMZ reports, between her appearance in Playboy and her roles in the Lifetime movie Liz & Dick and the upcoming Scary Movie 5.

Lindsay Lohan received $1 million for her appearance in Playboy. Though she posed for the publication in 2011, she was not paid until 2012. According to TMZ, Lindsay Lohan earned $300,000 for her role as Elizabeth Taylor in Liz & Dick, as well as $200,000 for appearing in the latest installment of the Scary Movie franchise.

TMZ reports that Lindsay Lohan is raking in just $6,480 for her current film, The Canyons, but she is also earning for her appearance on Glee, as well as from endorsements for brands such as Jag Jeans and designer Philipp Plein.

In total, TMZ reports, Lindsay Lohan is set to earn “north of $2 million” in 2012, not bad considering Lohan only finished probation earlier this year.

In only-somewhat-related-news, Lindsay Lohan’s earnings don’t seem to have affected her attitude, as she reportedly caused a disturbance at a Hollywood club Tuesday night.

Upon arriving at Bootsy Bellows, Lindsay Lohan reportedly saw Francesca Eastwood seated at a private table with friends. This caused Lohan to go into hysterics, demanding to have Eastwood removed.

“I’m a star, she’s a nobody, get her out of here!” Lohan reportedly yelled.

Neither Eastwood nor Lohan’s representatives would go into detail about the confrontation, only acknowledging that there was a disturbance that left everyone confused.

“We were celebrating my girlfriend Francesca’s birthday at Bootsy Bellows, and it was a blast,” said Tyler Shields, Eastwood’s boyfriend. “Suddenly, there was a burst of chaos, and as quickly as it started, it was over. After the fact, we were all a bit confused about what just happened.”

“I’m not sure what exactly sparked Lindsay’s outburst,” Eastwood said. “Regardless, I still had an amazing birthday and Parent Trap is still my favorite movie.”

Helen Gurley Brown, influential editor of Cosmo, passed away Monday at 90

The longtime editor of Cosmopolitan magazine revolutionized American culture with her work

 

Helen Gurley Brown, the longtime editor of Cosmopolitan magazine, author and driving force for women’s sexual independence, passed away Monday at the age of 90.

Helen Gurley Brown served as editor at Cosmopolitan magazine from 1965 to 1997, but before her pioneering work with Cosmo, she authored the controversial but highly influential 1962 advice book, Sex and the Single Girl.

Sex and the Single Girl emphasized sexual and financial independence for women and laid the ground work for a generation of women who flaunted their sexuality as much as their independence. Brown drew criticism from feminists and conservatives alike. Feminists alleged that her beliefs hindered the feminist cause, whereas conservatives responded with disgust for her liberal view of women’s sexuality.

“What she did was combine feminism with this sexy package and kittenish style,” said editor in chief of Allure magazine, Linda Wells. “It seemed anti-feminist but it was ahead of its time. Her influence was felt in the frankness with which she approached sexuality, in the way she thought women should own it. And there was no one flirtier. She would flirt with men, she would flirt with me!”

Helen Gurley Brown, along with photographer Francesco Scavullo and stylist Sean Byrnes, developed Cosmo’s famous lusty, highly sexualized covers using models and celebrities with as little covering as possible.

In a 2004 interview with Booth Moore of the Los Angeles Times, Helen Gurley Brown spoke of the impetus for her work at Cosmopolitan. “We discussed what we wanted, which was the most gorgeous girl in the world, ravishing, sensual and sexy, but in good taste and friendly, because at the time girls were looking very snippy and haute.

“I wanted to show bosom,” Brown added. “I knew women wanted to look at bosom as much as men did, to see how they compared. This was before the times of breast augmentation, and Francesco and Sean always showed bosom. They used bobby socks, breast tape, baseballs, whatever they had to.”

“She was the first woman to say you could have it all – and by that she meant a career AND a man AND a hot sex life,” said Bonnie Fuller, the celebrity editor who succeeded Helen Gurley Brown at Cosmopolitan in 1997. “She was a visionary. She created the modern woman.”

New York City Mayor Michael Bloomberg called Brown “a pioneer who reshaped not only the entire media industry, but the nation’s culture. She was a role model for the millions of women whose private thoughts, wonders and dreams she addressed so brilliantly in print.”

Hugh Hefner, the Playboy founder and publisher and good friend of Brown, called her “a very important and independent voice who related to the changing of women’s roles.”

Cosmopolitan’s busty models, sex quizzes and tips for landing a man had profound influences on American culture, resulting in everything from Miracle bras, the popularity of plastic surgery and HBO’s Sex and the City. The sexy-girl-next-door archetype Cosmo developed during Brown’s time as editor lives on with modern celebrities gracing the cover and influencing young women all over the world.

“The Cosmo cover is so recognized throughout [the] world,” said Wells. “The people change, the language changes, but the mission at heart, the identity is still recognizable. [Brown] made sexy women something that could appeal to women, and that wasn’t the case before her. Sexy women were for men and housewives or clean-cut college types like Ali MacGraw were for women. That was subversive and powerful.”

Looking back on her time at the magazine, Brown reflected, “I would want my legacy to be, ‘She created something that helped people.’ My reader, I always felt, was someone who needed to come into her own.”

Diabetic macular edema drug Lucentis approved by FDA

Diabetic macular edema affects as many as half a million Americans

 

Diabetic macular edema is a degenerative eye disease affecting the macula, the center of the retina, causing damage to this part of the eye and eventually severe loss of vision and blindness. Now, the FDA has announced its approval of the drug, the first of its kind, Lucentis for treatment of diabetic macular edema.

Diabetic macular edema can cause damage to blood vessels in the eye. The swelling of the macula affects the retina in what is called diabetic retinopathy, the most common diabetic eye disease. Damaged blood vessels can leak fluid and blood, which causes swelling and blurred vision, possibly resulting in severe loss of vision and blindness. The macula is the area of the eye associated with sharp central vision. People with damage to this part of the eye lose central vision, but not peripheral vision. They can’t see faces, for example.

The FDA announced to the press Friday its approval of Genentech’s drug Lucentis (ranibizumab injection) for the treatment of diabetic macular edema. The FDA noted that the drug is for use with “good diabetic sugar control” and is designed to be given once a month as an injection into the eye by a qualified health care professional.

The drug is already approved in the U.S. for the treatment of neovascular age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO).

Two studies were conducted that tested the safety and effectiveness of the drug as a treatment for diabetic macular edema. Together, the studies RIDE and RISE treated and followed 759 patients for three years. The patients were randomly divided into three groups: one group of 250 patients received a 0.3 mg dose, another group of 252 were given a 0.5 mg dose, and the control group of 257 received a fake drug for the first 24 months.

The patients underwent an eye test at month 24 where they had to read letters arranged on a vision test-chart line by line.

The results showed that the group who received the 0.3 mg dose of Lucentis demonstrated significant improvements in vision compared to the control group. The group given 0.5 mg doses of the drug did not show such improvement.

The most significant improvements from the trials, according to Catharine Paddock PhD in her article for Medical News Today titled Diabetic Macular Edema Drug Wins FDA Approval, include:

·      Patients who received the drug at 0.3 mg per dose were able to read three extra lines (15 letters) on the eye chart more than the control group – in the RIDE study, 34% of the drug group compared to 12% in the control group, and in the RISE study, 45% of the drug group versus 18% of the control group.

·      Patients that received Lucentis at the 0.3 mg dose demonstrated an average vision improvement of more than two lines (10 letters). In the RIDE study, 10.9 letters for the drug group versus 2.3 letters for the control group. In the RISE study, 12.5 letters compared to 2.6 letters, respectively.

·      After the first treatment, significant gain in average vision was noted after just seven days.

·      Patients receiving the 0.3 mg dose were significantly more likely to maintain their vision. Within the studies, this was defined as losing fewer than 15 letters on the vision chart. In the RIDE study, this was 98% of the drug group versus 92% of the control group. The RISE study showed similar improvement, 98% versus 90% respectively.

·      Improvements in vision measured at 24 months in the drug group were maintained through to 36 months with continued treatment.

Common side effects reported in patients treated with Lucentis included bleeding of the conjunctiva, increased pressure inside the eye, eye pain and “floaters.”

According to the U.S. Centers for Disease Control and Prevention, 26 million Americans live with diabetes type 1 or type 2. Diabetes is seen as the main cause for blindness among those 24 to 74.

According to the National Health and Nutrition Examination Survey (NHANES) from 2005-2008, more than 4.2 million Americans 40 or older have diabetic retinopathy. A subsequent study revealed that over half a million Americans suffer from diabetic macular edema.

According to Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, “Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema. Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

In a statement to the press, clinical trial investigator and Retinal Specialist at The Methodist Hospital in Houston, Texas, David M. Brown said of the FDA’s decision, “This approval is an important advancement in the fight against blindness for people with diabetes.”

Brown added, “Now that it will be available, Lucentis therapy can begin to make a difference in the lives of our patients with DME.”