text:
We offer discount to nonprofits, government agencies, and federal contractors
In just the last two weeks, congressional calls to #EndFamilyDetention have turned the tide of momentum significantly.
AILA Doc No. 11062232 | Dated June 22, 2011 | File Size: 103 KDownload the Document
ICE press release announcing that more than 2,400 undocumented individuals with prior criminal convictions were arrested in May 2011 as a result of a targeted Cross Check operation which was carried out across all 50 states over a seven-day period.
[[To print the PDF on this page please use the print function in the PDF reader.]]
Cite as AILA Doc. No. 11062232.Open the Document
American Immigration Lawyers Association
1331 G Street NW, Suite 300
Washington, DC 20005
Copyright © 1993-2015
American Immigration Lawyers Association.


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Stream House of Cards
The Latest
Final Shots: Pluto.TV Enters Into Content Agreement with Hulu
The streaming service's free content will be available through Pilot.TV's website.
10 TV Deaths We Never Got Over (GALLERY)
We all get attached to TV character and, as such, have very emotional reactions when they die.
10 TV Deaths We Never Got Over
We all get attached to TV characters and, as such, have very emotional reactions when they die.
'House of Cards' Star Kevin Spacey And 'Daredevil' Star Charlie Cox Interview Each Other
The actors team up for the first episode of Netflix: The Originals, an new interview web series.
Why Netflix's Lowest Rated Original Series Is Actually A Win for Viewers
Pompidou is the first Netflix Original that has been labelled bad by its viewers. Here's why that's not necessarily a bad thing.
Six Things Hillary Clinton Should Stream On Her 2016 Campaign Trail
We have a few suggestions as to what the candidate should watch during those long hours on the road.
The Creepiest Creeps Who Ever Creeped: Actors Who Are Great At Making Our Skin Crawl
Disclaimer, the following may be perfectly warm and welcoming IRL, but on-screen? Yikes! We get goosebumps.
This Season, 'Scandal' And 'House Of Cards' Dismantled The Myth Of A Post-Racial America
Both Olivia Pope and Remy Danton learn that having the President on speed dial doesn't make them immune to the American black experience.
Final Shots: 'Seinfeld' Is Soon To Be The Master Of The Streaming Domain (But Not On Netflix)
The movie would be the director's first boxing film since Raging Bull.
Final Shots: Prepare For The End Of 'Mad Men' With An Oral History Worth Reading
Yes, January Jones went out for the role of Peggy Olson.


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The 2013 Susan Sontag Prize for Translation was just announced, with Nathaniel Rudavsky-Brody receiving this year's honors for his translation of Benjamin Fondane's Ulysse.
Not much info up on the Sontag site yet, although I think this literally just went online. (I've been refreshing that page like a crack addict in hopes the U of R student and Volodine translator J.T. Mahany would win . . . )
Anyway, the Center for the Art of Translation/Two Lines has a bit of Ulysse available on their website:
The world opens within us at the view of ships
departing—they depart with their hair in the wind
returning—they return old and decrepit
in the dance of lights,
in the farewell revels of ports
like invalids
seated while everyone dances.
And here's a bit of info about the author and translator:
Benjamin Fondane (1893-1944) published poems, translations and criticism in his native Romania before moving to Paris in 1923. After devoting seven years to perfecting his French, he resumed his literary activity in that language. His works include the long poems Ulysses (1933), Titanic (1937), and Exodus, and The Sorrows of Ghosts (both posthumous), as well as works of criticism on Baudelaire, Rimbaud and his mentor, the philosopher Lev Chestov.
Nathaniel Rudavsky-Brody lives in Brussels, where he works as a programmer in digital publishing. He studied math in Chicago and medieval literature in Poitiers and Paris. He has published translations of Benjamin Fondane and an article on the philosophy of sailing.
Congrats to Nathaniel and everyone who entered.
Founded in 1960 by such creative pioneers as George Perec, Raymond Queneau and Italo Calvino, the Oulipo, shorthand for Ouvroir de littérature potentielle, came about in when a group of writers and mathematicians sought constraints to find new structures and. . .
There's little to say about a series of prose poems that willfully refuse to identify pronoun antecedents. Or perhaps there are a million things. The poems in Morse, My Deaf Friend— the chapbook by Miloš Djurdjević published by Ugly Duckling. . .
The Crimson Thread of Abandon is the first collection of short fiction available in English by the prolific Japanese writer and all-around avant-garde trickster Terayama Shūji, who died in 1983 at the age of 47. This collection would be important. . .
Last year, NYRB Classics introduced English-language readers to Catalan writer Josep Pla with Peter Bush's translation of The Gray Notebook. In that book, Pla wrote about life in Spain during an influenza outbreak soon after World War I, when. . .
"Your bile is stagnant, you see sorrow in everything, you are drenched in melancholy," my friend the doctor said.
bq. "Isn't melancholy something from previous centuries? Isn't some vaccine against it yet, hasn't medicine taken care of it yet?" I. . .
What to make of Vano and Niko, the English translation of Erlom Akhvlediani's work of the same name, as well as the two other short books that comprise a sort of trilogy? Quick searches will inform the curious reader that. . .
The opening of Jón Gnarr's novel/memoir The Indian is a playful bit of extravagant ego, telling the traditional story of creation, where the "Let there be light!" moment is also the moment of his birth on January 2nd, 1967. Then. . .
Mahasweta Devi is not only one of the most prolific Bengali authors, but she's also an important activist. In fact, for Devi, the two seem to go together. As you can probably tell from the titles, she writes about women. . .
The prolific Spanish author Benito Pérez Galdós wrote his short novel, Tristana, during the closing years of the nineteenth century, a time when very few options were available to women of limited financial means who did not want a husband.. . .
Pedro Zarraluki's The History of Silence (trans. Nick Caistor and Lorenza García) begins with the narrator and his wife, Irene, setting out to write a book about silence, itself called The History of Silence: "This is the story of how. . .


text:
Photo by Seth Beck
YIELD: Makes 6 cupcakes
To make the pudding, place the cashews in the Personal Blender with the grinder lid and 2-cup container or a food processor and grind into a powder. Add the bananas, lemon juice, and agave syrup and process until smooth. Place in the fridge to chill.
To make the cupcakes, combine the pecans, coconut, and salt in the food processor and process into evenly sized small pieces, taking care not to overprocess into a butter. Scoop the mixture into another bowl. Combine the dates and vanilla in the food processor and process into small pieces. Return the pecan mixture to the food processor and pulse to mix. The cake mix should have a crumbly but sticky texture.
Place 6 cupcake liners in a muffin pan. Use a 1/2-cup measuring cup to scoop 1/2 cup loosely packed pecan mixture into each. Using your fingertips, gently press to firm up the cupcakes and create cavities in the centers to hold the pudding. Make sure the edges reach the tops of the cupcake liners.
To assemble, scoop about 3 tablespoons pudding into each cupcake and top with coconut. Place the muffin pan in the refrigerator to chill for several hours to firm up the cupcakes before serving.
The pudding will keep for a few days in fridge when stored separately. The cupcakes, stored separately, will keep for several weeks in the fridge. The assembled cupcakes will keep in the fridge for a few days.
From Ani's Raw Food Desserts: 85 Easy, Delectable Sweets and Treats by Ani Phyo. Copyright © 2009 by Ani Phyo. Food photographs Copyright © 2009 by Seth Beck. Used by permission of Da Capo Press.


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Front Wheel Drive Vehicles in GTA San Andreas
10,824pages on
this wiki
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Remember to check what links here and the page history before deleting.
The following is a list of the front wheel drive vehicles in GTA San Andreas:


text:
Definition of cankles
- a fat ankle - one that is as thick as the person's calf, such that there's no visible anatomical difference in the two. From "calf" + "ankle." Usually used in the plural.
Look at the cankles on her!
Last edited on Dec 15 2010. Submitted by April W from Fairfax, VA, USA on Dec 11 2001.
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|Definitions include: an American who is driven by money.
|Definitions include: a minor legal infraction such as jaywalking, carrying an open container of alcohol, driving on a suspended license, etc.
|Definitions include: an alcoholic beverage.
|Definitions include: a disorderly, chaotic combination of things.
|Definitions include: "blowjob".
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text:
|Jul 2015
|Wed 1st
|Gina J
|Jun 2015
|Tue 30th
|Blanca & Luna
|Mon 29th
|Kirsa Solo
|Sun 28th
|Sat 27th
|Maylin & Willa
|Fri 26th
|Thu 25th
|Marleen S & Bjorn
|Maylin & Willa
|Wed 24th
|Tue 23rd
|Marleen S & Bjorn
|Hania & Maely
|Mon 22nd
|Backstage 471
|Sun 21st
|Sat 20th
|Billie T & Bobbie
|Fri 19th
|Thu 18th
|Billie T & Bobbie
|Wed 17th
|Is it cheating if I kiss another girl?
Got something on your mind? Tell us how we can improve our site.Feedback
|Bobbing for Bobbie
|Hii, I'm Nina! Nic ...
|Oh Ophie can we se ...
|Abby Winters model ...
|"Introducing me" b ...
|Lotte :D
|A Spectacular Year ...
|Let's improve AW s ...
|Nude girl Yara (co ...
|More sketches and ...
|Lesbian Sex: Billi ...
|Let's improve AW s ...
|A Spectacular Year ...
|Lesbian Sex: Jada ...
|Nude girl Gina J ( ...
|Lesbian Sex: Billi ...
|Want to see more o ...
|Video masturbation ...
|Nude girl Antonell ...
|New Model: Ivana
|Poll: Photoshop so ...
"When I'm in bed, I call it my pussy." Billie's bare foot eases open the glass door, the sunlight highlighting the tops of her small breasts in her delicate lace bra. Lifting up her skirt, Billie shows us her knickers, her dark pubic hair visible below the feminine blue flowers as her fingers softly tug at a stray public hair. Smiling, she heads outside.
"I've always liked the feeling of my stomach. It's always super soft and really smooth and a little bit podgy!" Billie's panties and irresistible bottom are visible upskirt as she bends forwards to soak her cloth, the sound of the water mixing with the natural sounds flooding in from the garden. Raising up to tip toes, Billie washes the windows, the muscles of her legs twitch in the light. Stray water droplets trickle off Billie's warm thigh, making tracks down her shapely legs. Squeezing the cloth onto her bare chest, Billie opens the buttons of her blouse so we can follow the droplets of water down to her bra.
After a long day of shooting back home in the car.
Billie slowly unbuttons her blue blouse, revealing her lace bra as she smiles suggestively.
Showing off her pert round bum with glimpses up her short skirt, Billie teases at the rest of her slender, petite body. Washing the window, she drips the soapy water onto her bare chest, the droplets of water glistening on her skin and drawing you closer wanting to see more. Holding eye contact, she removes the rest of her clothing, exposing her full bush and pale skin. Pushing her fingers between her labia, she opens up her vulva, showing her pink wetness.
Can you guess who the owner is of this bum?
Maely leans back so she is nestled against Salma's bare breasts, watching as the long fingers tease open the hair of her full bush, seeking out her quivering clit. Placing her hand on top of Salma's, Maely guides her fingers as they stimulate her until she can take the tease no longer, "will you fuck me from behind please?!"
'That already turns me on, you just saying that!' Even as they sit chatting in their before video, Maley and Salma are stroking each other's thighs, the heat between them is visible and intense, this was always going to go with a bang! Play fighting on the sofa, the ladies tumble together in a twist of limbs, Maely momentarily seems to overpower the much taller Salma, sitting with Salma's bare thigh between her legs. As Maley is turned onto her back with her arms pinned, her excited breathing and the wild look behind her glasses give away her lust as she anticipates what is about to happen. "Oh god, kiss me!" Peeling away clothing, they suck and lick their ways around one another's bodies with an insatiable appetite. "Let me taste myself."
Happy and tired after lot's of sex!
Say 'haii' to our new model with her great bum!!
"I usually masturbate over my panties." Claudia's long hair cascades down her shoulders framing her small breasts as she rubs into her smooth labia lips.
Moistening her young lips with the tip of her finger, Claudia puts away her lip balm and smiles up into the camera. Pulling at her pink jumper, Claudia tells us how she likes to pleasure herself, "I like to grab my breasts!" Claudia's transparent knickers stick to her crotch as her fingers rub into the fabric revealing the outline of her most intimate parts.
With her toy stuffed inside her vagina, Noa lays back on her bed, reaching for her sensitive clit with her fingers. Her vulva flushes a deep pink as pleasure rushes between her legs, eyes closed, lips quivering, Noa begins to gasp as her orgasm comes. "It sort of stretches me from the inside, I love that feeling!"
Sun streams in from Noa's open balcony door as she guides us around her home. Inspired by the sun, Noa has opted for a thin shirt tied at her waist, exposing her pale tummy with her pink bra peeping below the light fabric as she moves around. "I really like to masturbate a lot, sometimes several times a day." Noa's lies on her sofa in the afternoon sun, her fingers rubbing into her knickers, the lace clinging to her crotch in a moist camel toe. Peeling back the fabric, Noa rubs into her sensitive crotch before running back to her bedroom. Opening her bra, Noa's fingers slide over her beautiful breasts then lying down, naked, she teases us with her peachy bottom, wiggling it up and down, a seductive smile springing to her face as her bed starts to creek. "I hope you enjoyed that because I did!"
As long-legged Salma naps on the couch, Maley approaches with devilish intention and starts to undress. Startling Salma awake, she caresses and kisses her face and neck before sliding her hands underneath Salma's t-shirt to feel her pert nipples.
Wrapped in each other's arms, Maley moves her gaze downward to get a better look at Salma's bush and guides her fingers into her pussy. The touch is not enough as Maley licks and sucks on Salma's clit before being turned on all fours as Salma begins to pleasure her from behind. In a lovely mess of tangled limbs, they begin to rub their clit's into each other and start tribbing on the couch. Wanting to taste one another again, they raise themselves to orgasm in the sixty-nine position.
A happy Blanca mid way through her photos this afternoon, smiling and working her lovely ass off!
AW Ed is a series of videos where we ask 15 to 20 models questions on what it's like to be a young woman in today's society, and edit their responses together, providing an interesting look into how some ladies think.
In this edition of AW Ed we ask: would a visit to a massage parlour be considered cheating?
If you have a burning question to be answered, post on the AW Ed question suggestions thread, to be considered for the next round of AW Ed
Unbuttoning her shirt, Noa exposes her pink lace bra, the outline of her nipples visible through the thin fabric.
Showing us around her new apartment, Noa removes her clothes as she shows us some of the favorite things from inside her home. Lying back on the bed, she exposes her slender frame, pale skin and beautiful pert breasts! Gripping her pink dildo in one hand, she reaches down with the other, her fingers touching her wetness before penetrating herself!
Today we got a HUGE box of goodies - thank you very much to our lovely sender, we have lots of lovely clothes ready to gift to some of our lovely models and everyone in the office shared the sweets and chocolates very nicely.
"Some music is so good that I get aroused!" Yara smiles over her shoulder as behind her, Anjali begins to touch herself. Yara's skilled fingers float across the piano keys, her improvised tune rising and falling taking Anjali with it, Anjali's moans building up to crescendo with the piano as she orgasms.
"Sometimes I hold myself and I pretend someone else is doing it." Yara's hands trace over her curves as she describes to Anjali how she likes to turn herself on, pausing every now and then to tuck her auburn hair behind her glasses. As the ladies open up, so do Yara's legs, offering flashes of her knickers between her thighs and then a release of sexual tension as Yara pushes her legs open to rubs her thigh against Anjali's naked foot. As Yara's leg rubs onto her, Anjali peels back her knickers exposing her pubic hair before sliding her hand inside, she touches herself. Side by side they masturbate, legs locked together in the middle, tanned and pale. Anjali inserts two fingers deep inside herself while Yara rubs her clitoris making her long labia dance below her fingers.
We are excited because soon we will be shooing lot's of model outdoors again
Monica lies back on her bed, her hands wandering over her slender and natural body. Gripping her ripe breasts and feeling her smooth shaved labia, she tells stories of her first kiss and sexual experiences!
In her bedroom, Aussie Monica smiles and exposes her braces as she slowly undresses herself. Lifting her top up, she flicks back her strawberry blonde hair before moving to unbutton her jeans. Running outside for a pee on her parent's lawn, she runs back inside relieved and starts to masturbate!
Not bad for a Monday, amazing breasts, legs that lead you downwards - lets see where this week takes us!
Strawberry blonde Aussie Monica, shows us around her pink and cosy bedroom as she teases glimpses of her slender body.
Smiling she exposes her cute braces before lifting off her top and playing with her cotton bra. Feeling more and more horny she lets her hands glide over her body, underneath her bra and down her little panties. Feeling her smooth shaved vulva she pushes a finger inside her wetness - her whole body tensing with the pleasure!
Noa is wishing you a lovely Sunday


text:
Researchers suggest short transition period between RRMS therapies(18/06/15)
A team led by researchers at the University Hospital Basel in Switzerland say they have found a short period of eight to 12 weeks is the optimal timing to be considered when patients with relapsing-remitting multiple sclerosis (RRMS) are switched from Tysabri (natalizumab) to Gilenya (fingolimod) therapy.
The study was recently published in the journal Neurology.
In this study, researchers conducted a randomised, multicentre, double-blind, placebo-controlled trial (TOFINGO) to determine the optimal timing for initiating Tysabri after discontinuing Gilenya in 142 RRMS patients. The goal was to maintain disease control and avoid potentially harmful additive effects on immune surveillance. The team tested the intervals of eight, 12 and 16 weeks between the last Tysabri infusion and the first Gilenya treatment over 32 weeks. Brain MRI recurrence and clinical disease activity were evaluated.
Researchers found in total, 78.9% (112) of the patients completed the study. The number of active MRI lesions was found to increase according with the duration of the interval between the two therapies. More patients were found to be relapse-free in the eight-week (88%) and 12-week (91%) periods in comparison to the 16-week period (84%). Of the cohort, 68% of the patients experienced mild or moderate adverse events with no major differences between the groups. No unusually severe relapses or opportunistic infections were reported.
The team concluded that patients with RRMS switching from Tysabri to Gilenya therapy should undergo a short period of eight to 12 weeks between therapies, as this time interval is associated with less MRI disease activity than longer periods. The authors suggest that additional studies should be performed to determine whether an interval shorter than eight weeks would further improve disease control with reasonable risks.
Source: Multiple Sclerosis News Today © BioNews Services 2015 (18/06/15)
New insights into MS treatment(18/05/15)
Data from two Novartis phase III clinical trials show that adding brain shrinkage (brain volume loss) to an existing tool to assess multiple sclerosis activity (m-Rio) will give a more precise prediction of the likelihood of future disability progression.
A pooled analysis from the two-year Freedoms and Freedoms II trials also further confirm the high efficacy of Fingolimod in previously treated patients with highly-active relapsing MS. In the trials, patients on Fingolimod achieved no evidence of disease activity (Neda) across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving Neda is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.
The Fingolimod clinical trial data was presented at the 67th American Academy of Neurology annual meeting in Washington, DC. Developed by Novartis, Fingolimod is the only oral disease-modifying therapy to impact the course of relapsing MS with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression.
"Accurate assessment of disease activity is key to guide treatment decisions in relapsing MS. These data on Fingolimod and new methods of assessing the impact of MS have the potential to give physicians a more comprehensive picture of an individual's disease and allow patients to better understand their MS," said Dr Ludwig F. Damian, consultant neurologist.
"Novartis is committed to innovation beyond the research and development of new treatments to help physicians and patients improve how MS is managed," said Dr Nikolaos Tripodis, Novartis Healthcare Philippines president and managing director.
Source: INQUIRER.net © Copyright 1997-2015 INQUIRER.net (18/05/15)
Peripheral blood T cell dynamics predict relapse in MS patients on Fingolimod(29/04/15)
Fingolimod efficiently reduces multiple sclerosis (MS) relapse by inhibiting lymphocyte egress from lymph nodes through down-modulation of sphingosine 1-phosphate (S1P) receptors. We aimed to clarify the alterations in peripheral blood T cell subsets associated with MS relapse on fingolimod.
Methods/Principal Findings
Blood samples successively collected from 23 relapsing-remitting MS patients before and during fingolimod therapy (0.5 mg/day) for 12 months and 18 healthy controls (HCs) were analysed for T cell subsets by flow cytometry. In MS patients, the percentages of central memory T (CCR7+CD45RO+) cells (TCM) and naïve T (CCR7+CD45RO-) cells decreased significantly, while those of effector memory T (CCR7-CD45RA-) and suppressor precursor T (CD28-) cells increased in both CD4+T and CD8+T cells from 2 weeks to 12 months during fingolimod therapy. The percentages of regulatory T (CD4+CD25highCD127low) cells in CD4+T cells and CCR7-CD45RA+T cells in CD8+T cells also increased significantly. Eight relapsed patients demonstrated greater percentages of CD4+TCM than 15 non-relapsed patients at 3 and 6 months (p=0.0051 and p=0.0088, respectively). The IL17-, IL9-, and IL4-producing CD4+T cell percentages were significantly higher at pre-treatment in MS patients compared with HCs (p<0.01 for all), while the IL17-producing CD4+T cell percentages tended to show a transient increase at 2 weeks of fingolimod therapy (pcorr=0.0834).
The CD4+TCM percentages at 2 weeks to 12 months during fingolimod therapy are related to relapse.
Full Article
Source: PLOS One (29/04/15)
Patient taking Gilenya contracts PML(10/03/15)
A woman in a Gilenya after-market study says the company didn't notify all participants about a new case of progressive multifocal leukoencephalopathy (PML).
Novartis executives have confirmed a multiple sclerosis patient has developed the brain infection after taking their drug Gilenya for more than four years.
PML is a reactivation of the John Cunningham virus (JCV). JCV lives in the bodies of more than 75 percent of people in the United States. Most people's immune systems are strong enough to keep the virus at bay.
The Switzerland-based pharmaceutical company posted a notice on their website announcing the development. The website notice said the patient is doing well. It said the patient had been taking Gilenya for an extended period when he or she contracted PML.
A company spokesman said Novartis officials were not available to comment on the case.
In late October, a patient in Europe died from PML after taking Tecfidera for more than four years. Biogen Idec Inc. manufactures that MS drug.
In 2013, the Food and Drug Administration (FDA) sent out an alert after a patient in Europe developed PML after taking Gilenya for eight months.
In their web posting, Novartis officials noted Gilenya has a "positive benefit-risk profile" in relapsing-remitting MS patients based on experience with 114,000 people who have taken the drug.
One woman who is part of a current Gilenya after-market extension study said she learned about the most recent PML case after Novartis contacted another person in the study. The woman then found the announcement on the company's website.
The woman in the extension study, who has MS, said she was well aware of the remote possibility of contracting PML while taking Gilenya, so she wasn't surprised by the announcement. She claimed Novartis did not contact everyone in her study group or update their informed consent documentation.
"I'm not upset, but I am disappointed," the woman said.
People with weakened immune systems are at greater risk. That group includes people with AIDS, cancer patients taking chemotherapy drugs, transplant patients on anti-rejection drugs, and people taking immune-suppressing drugs for autoimmune conditions.
Source: Healthline Copyright © 2005 - 2015 Healthline Networks, Inc (10/03/15)
Gilenya may be best in MS patients failing initial treatment(11/02/15)
Switching multiple sclerosis patients with disease activity despite treatment with a first-line injectable to oral fingolimod (Gilenya) was associated with fewer relapses than switching them to another standard injectable, researchers have found.
In a study, patients on either interferons or glatiramer acetate (Copaxone) who were switched to fingolimod had a significantly lower mean annualized relapse rate than those who changed to another injectable immunomodulator, according to Tomas Kalincik, MD, PhD, of Royal Melbourne Hospital in Australia, and colleagues.
Patients in the study, reported online in JAMA Neurology, were switching medications following clinical relapse or disability progression while on the initial treatment.
In an accompanying editorial, Olaf Stuve, MD, PhD, of the University of Texas, and Diego Centonze, MD, PhD, of To Vergata University and Hospital in Rome, said the study adds to growing evidence that switching to newer agents like natalizumab (Tysabri) or fingolimod may be more effective.
Although it was an observational study, it assessed high-quality data and used appropriate propensity score matching to control for potential confounding factors, they wrote.
They noted, however, that the study's median follow-up of 13.1 months may be "too short to draw definite conclusions on the relapse rate."
Kalincik and colleagues conducted their matched retrospective analysis of data that was collected prospectively from MSBase, which collects data on MS patients in routine clinical care, from July 1996 to April 2014.
Patients with relapsing-remitting MS had been on a beta-interferon drug or glatiramer acetate for at least 6 months before making the change to another injectable (beta-interferon or glatiramer acetate) or to fingolimod because of clinical disease activity. They were then observed on the new medication for at least 3 months. Some of the patients initially taking a beta-interferon drug were switched to a different beta-interferon.
Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. Median follow-up was 13.1 months.
Kalincik and colleagues found that those switched to fingolimod not only had a lower mean annualized relapse rate but also a lower risk of first on-treatment relapse than those switched to another injectable immunomodulator.
Those changed to the oral drug also had a lower risk of disability progression and a higher rate of disability regression (HR 2.0, 95% CI 1.2-3.3, P=0.005), they reported.
They also had a lower rate of treatment discontinuation at 2 years.
The researchers noted that sensitivity analyses replicated in full the relapse and disability outcomes seen in the primary analysis. They did not, however, replicate the finding that switching to fingolimod improved treatment persistence, suggesting that this finding be interpreted with caution.
Kalincik and colleagues concluded that in the absence of randomized clinical trials, use of high-quality observational data provides an important tool for comparisons of drug effectiveness in a real-world setting.
In their editorial, Stuve and Centonze agreed that the quality of observational data in their study can provide "crucial information to support decision making relevant for MS management in real-world practice."
They said the results provide the first evidence that "switching to fingolimod is superior to switching to a second injectable immunomodulator with respect to disability outcomes, likely owing to the more efficient prevention of relapses associated with an incomplete recovery."
The results are in line with studies such as TRANSFORMS, one of the clinical trials leading up to fingolimod's approval, which found patients with active disease activity despite immunomodulatory therapy "may still have optimal disease control after switching to fingolimod."
In addition to the limitation of a short follow-up time, the study was also limited by lack of data on interferon-neutralizing antibodies, and because patients who were switched from one interferon preparation to another may not have served as true controls: "Most MS experts would not likely recommend this strategy because the agents are biochemically almost identical, and their mechanisms of action identical," they noted. The study, which was funded by fingolimod's manufacturer, also did not examine switches to natalizumab or newer oral agents.
Still, they concluded that evidence has accumulated that "escalating to the more effective medications natalizumab or fingolimod should be an early consideration for most patients with breakthrough disease. Switching to another injectable immunomodulator may still be considered in certain cases only."
The study was supported by Novartis, MSBase Foundation, Multiple Sclerosis Research Australia, National Health and Medical Research Council, and the Center for Research Excellence.
MSBase Foundation receives support from Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Sanofi.
The researchers disclosed financial relationships with Biogen Idec, Novartis, Genzyme, Merck Serono, Teva, Bayer Schering, Sanofi, Lundbeck, Bayer, Biologix, GSK, Roche, and bioCSL.
The editorialists disclosed financial relationships with Teva, Opexa, Merck Serono, Genzyme, Bayer Schering, Biogen Idec, Novartis, Almirall, GW Pharmaceuticals, Roche, and Mitsubishi.
Source: MedPage Today © 2015 MedPage Today, LLC (11/02/15)
MS drug Gilenya may increase risk of lymphopenia(05/01/15)
Studies in Sweden and Germany indicate that underweight women with multiple sclerosis who take the MS drug Gilenya (fingolimod) seem to be at increased risk for lymphopenia. The drug also poses a risk for patients who have low lymphocyte levels before they start drug treatment.
Lymphopenia (also known as lymphocytopenia) is a condition in which a person has a deficiency (penia) of lymphocytes, which are a subset of white blood cells (leukocytes). Lymphocytes, which can be T cells, B cells, or natural killer cells, play a crucial role in supporting immune system function.
It's been known that fingolimod can lower the level of circulating lymphocytes. In fact, among the serious side effects reported by the Food and Drug Administration (FDA) and the drug's manufacturer, Novartis Pharma Stein AG, is infections.
Risk of infections is increased because the drug lowers lymphocyte levels. The two newly reported studies cast new light on some of the factors associated with this risk.
In the German study, 418 individuals with relapsing-remitting multiple sclerosis were enrolled in an open label study in which they took 0.5 mg of fingolimod daily. Blood samples were collected on four separate occasions: immediately before treatment and at months 1, 4, and 6. In the Swedish study, data from 438 patients were used to validate the findings.
Here are some of the findings:
- Women who had a body mass index (BMI) less than 18.5 kg/m2 had a 26 percent increased risk for developing lymphopenia (counts at or lower than 0.2 x 109/L associated with drug use. This effect was not seen in men with this BMI.
- Individuals whose starting lymphocyte levels were less than 1.6 x 109/L had a 46 percent increased risk of lymphopenia while using the drug.
- Use of glatiramer acetate (Copaxone) before use of Gilenya seemed to help protect against the development of lymphopenia, although the researchers were uncertain about the immunologic effect of this drug.
Prior research (phase III trials) has indicated that the decline in lymphocyte counts among MS patients who take fingolimod is not associated with meal timing or the use of other medications, such as corticosteroids.
The findings of the two new studies provide doctors with additional information to consider when Gilenya is on the treatment table, such as monitoring of female patients who are underweight and/or individuals who have low baseline lymphocyte counts. Other serious side effects that may develop with use of Gilenya include slow heart rate (bradycardia), which can occur when starting treatment; macular edema, which typically appears after three to four months of treatment; liver problems; and shortness of breath.
Food and Drug Administration
Warnke C et al. Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia. Neurology 2014. DOI:10.1212/WNL.0000000000001049
Source: Emaxhealth (05/01/15)
Novartis provides update on fingolimod Phase 3 trial in primary progressive MS (01/12/14)
Novartis announced today that the Phase III INFORMS study in primary progressive multiple sclerosis (PPMS) did not show a significant difference between fingolimod and placebo on a combination of disability measures. The safety results were consistent with the well-characterized safety profile of fingolimod in relapsing MS (RMS).
PPMS is a disorder of the central nervous system (CNS) which affects approximately 10% of the 2.3 million patients diagnosed with MS worldwide. PPMS is a distinct disease form, different from relapsing MS in terms of its basic disease process, near-absence of acute relapses and fewer active MRI lesions. The severe irreversible damage to the CNS in PPMS is thought to be caused by different pathways leading to loss of nerve cells and a more rapid, continuous loss of function over time which profoundly impacts patients' lives. Additionally, the disease is typically diagnosed later than other types of MS, when significant damage to the CNS has already occurred. Despite considerable research and academic focus, there are currently no approved treatments that have been shown to change the course of this debilitating disease and management focuses mainly on the treatment of symptoms.
"We understand this news is very disappointing for those affected by PPMS and involved in its management. While PPMS is a focus of the MS community, relatively little is known about the disease so finding effective treatments remains a challenge. We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "Gilenya (fingolimod) revolutionized the treatment of relapsing MS as the first oral disease-modifying therapy. We remain strongly committed to continuing to research new treatment options for patients with MS and other neurological conditions."
The INFORMS study was based on the knowledge that fingolimod enters the central nervous system (CNS) and can interact with damage-causing cells residing in the CNS. It was hypothesized that this central effect, which is well understood in relapsing forms of MS, would also be relevant in PPMS. As opposed to the consistently strong efficacy seen in relapsing MS, the results of the INFORMS study seem to suggest that PPMS and relapsing forms of MS have different underlying mechanisms.
Fingolimod, marketed as Gilenya®, is approved in the US for first-line treatment of relapsing forms of MS in adults. In the EU, Gilenya is indicated for adult patients with highly active relapsing-remitting MS (RRMS) defined as either high disease activity despite treatment with at least one disease-modifying therapy (DMT), or rapidly evolving severe RRMS. Gilenya is the only DMT to impact the course of relapsing MS with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression. The likelihood of achieving 'no evidence of disease activity' (NEDA) across four key measures is more than four-times greater in relapsing MS patients treated with Gilenya compared to placebo. The safety profile of Gilenya in RMS is well understood and based on substantial evidence from three major clinical trials and extensive real-world experience in more than 100,000 patients, with the total patient exposure now at approximately 172,500 patient years.
About INFORMS
The INFORMS study is a double-blind, randomized, multi-center, placebo-controlled parallel group study, comparing the efficacy and safety of fingolimod (0.5 mg) versus placebo in people with primary progressive multiple sclerosis (PPMS)[16]. The INFORMS study is the largest clinical trial ever conducted in PPMS. Nine-hundred and seventy (970) people aged 25-69 years with PPMS were enrolled in INFORMS from 148 sites, across 18 countries, including Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey, UK and the US. Patients were treated for at least three years.
The primary endpoint was to evaluate the effect of fingolimod versus placebo on reducing the risk of three-month sustained disability progression based on a composite measure of Expanded Disability Status Scale (EDSS), assessment of upper limb function (9-Hole Peg Test, HPT), and walking speed (25-foot Timed Walk Test, TWT).
About Gilenya (fingolimod)
In relapsing MS, the loss of physical and cognitive function is driven by two types of damage that result in the loss of neurons and brain tissue - distinct inflammatory lesions (referred to as focal damage), and more widespread inflammatory neurodegenerative processes (referred to as diffuse damage). Focal damage results in the loss of brain tissue and can clinically present as relapses. Diffuse damage starts early in the disease, often goes unnoticed and is also associated with loss of brain tissue and accumulated loss of function.
Gilenya (fingolimod) targets both focal and diffuse central nervous system (CNS) damage that drive loss of function in relapsing MS. It prevents cells that cause focal inflammation from reaching the brain (referred to as 'peripheral' action), but also enters the CNS and reduces the diffuse damage by preventing the activation of harmful cells residing in the CNS (referred to as 'central action'). It is important to address both focal and diffuse damage in relapsing MS to effectively impact disease activity and help preserve an individual's physical (e.g. walking) and cognitive (e.g. memory) function.
Phase III studies with fingolimod are currently being conducted in two rare diseases, pediatric MS and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), where there is a high unmet need.
About Novartis in Multiple Sclerosis
Novartis is committed to the research and development of innovative and targeted treatment options for people suffering from different types of MS.
The Novartis MS portfolio includes Gilenya (fingolimod, oral DMT) and Extavia® (interferon beta-1b for subcutaneous injection) for the treatment of relapsing MS. In addition to the current clinical development program with Gilenya, Novartis is investigating BAF312 (siponimod), a second generation, selective S1P1 and 5 receptor modulator, in the largest Phase III trial in secondary progressive MS (SPMS). The IL-17 pathway is also being explored as a novel therapeutic target in MS.
Source: Novaratis 01/12/14
SMC first to introduce oral Gilenya® as a first line treatment option for people with a severe form of MS(14/10/14)
SMC first to introduce oral Gilenya® as a first line treatment option for people with a severe form of MS
• Scottish people with a severe form of relapsing remitting multiple sclerosis are first in UK to get access to once daily pill fingolimod as a first line treatment option1
• Once daily pill fingolimod reduces the risk of relapses by 67% compared to placebo2
Today, the Scottish Medicines Consortium (SMC) has accepted once daily pill fingolimod (Gilenya®) as a first line option for people with a severe form of relapsing remitting MS, which has been shown to reduce the risk of relapses by 67% compared to placebo.1,2 This is the first time that an oral treatment has been made available as a first line treatment option for people with this severe form of MS - known as rapidly evolving severe relapsing remitting MS (RES RRMS).1
The SMC heard from patient groups that MS is an incurable progressive disease with devastating effects on those with the condition and their families.1 Symptoms can include intense pain, mobility problems, severe depression, fatigue, incontinence and loss of vision.1 MS affects over 100,000 people in the UK, with rates highest in Scotland.3,4
85% of people with MS are diagnosed with the relapsing remitting form - when symptoms flare up aggressively - known as relapses.5 There are different types of RRMS, including highly active and RES RRMS.6 In September 2012, the SMC agreed to reimburse fingolimod for people with highly active RRMS who are failing on first line interferon injections.7 Today's decision means that fingolimod is now also reimbursed for RES RRMS – when a person has two or more disabling relapses in one year with associated MRI changes.1 The SMC's decision to broaden access to fingolimod means this is the first time that people with this more severe form of RRMS will have the choice of a once daily pill as a first line treatment option.1
Prior to today's decision, only one SMC approved treatment was available for people with RES RRMS – a hospital-based infusion called natalizumab required every 28 days.1 Fingolimod is a once daily pill that can be taken at home after the first dose, avoiding the need to travel to hospital every month. It has been shown to reduce relapses by 67% compared to placebo in those with RES RRMS (ARR 0.24 for fingolimod and 0.74 for placebo).2 The analysis was conducted in a subgroup of patients from the original phase III FREEDOMS trial.
Scottish patients with RES RRMS will have access to once daily pill fingolimod as a first line treatment option before those in the rest of the country. This is because the SMC process allows manufacturers to submit new data at any time. NICE is set to review fingolimod alongside a range of other MS treatments in 2015. This means that people with this severe form of RRMS north of the border will have an increased choice of first line treatments before their southern counterparts.
Today's announcement follows a series of recent decisions by the European Commission and NHS England to extend the use of fingolimod to a wider group of people, just three years after its original licence was granted in March 2011.
To date, more than 100,000 people worldwide have been treated with fingolimod in clinical trials and in the post-marketing setting.8 Fingolimod has been approved in 80 countries.8
References 1. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®). October 2014
2. Devonshire V, Havrdová E, Radue EW et al. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012; 11:420-28
3. The Scottish Parliament. Briefing for the Public Petitions Committee. http://www.scottish.parliament.uk/ResearchBriefingsAndFactsheets/Petitions%20briefings%20S3/PB10-1353.pdf Last accessed 10 October 2014.
4. MS Society. What is MS? http://www.mssociety.org.uk/about_ms/what_is_ms/index.html Last accessed 10 Oct 2014
5. MS Society. http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms Last accessed 10 October 2014
6. MS Trust. http://www.mstrust.org.uk/atoz/types.jsp Last accessed 10 October 2014
7. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®). SMC No. (763/12). 12 March 2012
8. Gilenya World Watch. http://www.gilenya-world-watch.com/English.html Last accessed 10 October 2014
9. European Commission. Community register of medicinal products for human use. Gilenya. http://ec.europa.eu/health/documents/community-register/html/h677.html Last accessed 10 October 2014.
10. NHS England commissioning guideline for Gilenya. June 2014
Source: Novartis (14/10/14)
MS drug Gilenya in new therapeutic indication: Added benefit not proven(13//10/14)
The immunosuppressive drug fingolimod (trade name: Gilenya) was approved for an expanded therapeutic indication in May 2014: It is now also available for adults with highly active relapsing remitting multiple sclerosis (RRMS) who had received other pretreatment than interferon beta (IFN-β). In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug offers an added benefit over the appropriate comparator therapy in this patient group.
According to the findings, such an added benefit is not proven: For some of the patients, the drug manufacturer presented no data. For other patients, the available study data either showed no differences between the treatment groups, or the data were not evaluable.
G-BA specifies appropriate comparator therapy
The Federal Joint Committee (G-BA) distinguishes between two patient groups for the assessment: In patients with highly active RRMS despite full previous treatment (no interferon beta), fingolimod was to be compared with glatiramer acetate or interferon beta. In patients with incomplete previous treatment, the G-BA distinguishes between two cases for the appropriate comparator therapy: In patients who had received glatiramer acetate, this medication was to be optimized and continued. In patients who had received a different drug, treatment was to be changed to interferon beta or glatiramer acetate.
Only data of few study participants relevant for the assessment
One relevant study was available for the early benefit assessment, an approval study on fingolimod (TRANSFORMS), which compared treatment with fingolimod versus treatment with IFN-β1a in adults with RRMS. However, the disease was rated as "highly active" in only nearly half of the 866 participants. Only 263 of these 402 patients had received full previous treatment. Only 42 participants, i. e. a little less than five percent of the total study population, had not been treated with interferon beta (17 patients in the fingolimod arm, 25 in the interferon beta arm). However, only these patients correspond to the subpopulation relevant for this benefit assessment, because it is only this subpopulation that fingolimod had received expanded approval for. The informative value of the results was considerably limited because only data of few participants were evaluable.
Differences between treatment arms not statistically significant
No deaths occurred during the total study duration of 12 weeks. There were differences between the fingolimod and the interferon beta group with regard to relapses and disability progression, but these were not statistically significant.
No evaluable data were available for the patient group for which fingolimod was newly approved regarding other aspects of the outcome "morbidity", e.g. fatigue or activities of daily living, and for the outcome "health-related quality of life". One of the reasons for this is that different proportions of patients were not considered in the analysis.
There were group differences in side effects (serious adverse events and treatment discontinuation due to adverse events), which again were not statistically significant.
Dossier without relevant study on patients with incomplete treatment
In its dossier, the manufacturer presented no relevant study for patients who had not received full previous treatment.
In summary, an added benefit of fingolimod is therefore not proven for patients with highly active relapsing remitting multiple sclerosis (RRMS) who had received a different pretreatment than interferon beta.
Discrepancy between approval and study population
In 2011, fingolimod had been approved for two therapeutic indications: for rapidly progressive severe RRMS and for highly active RRMS that had been pretreated with interferon beta. For these two patient groups, IQWiG had published a dossier assessment according to AMNOG in January 2012.
In this first assessment the problem had already occurred that participants with different types of RRMS had been included in the relevant study, and that the authorities had then limited the approval to specific, relatively small patient groups. Since the first approval and assessment, the manufacturer apparently conducted no further studies for the expansion of approval.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
Source: Medical Xpress © Medical Xpress 2011-2014, Science X network (13//10/14)
Wider use of MS drug Gilenya approved in Europe(12/06/14)
The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Swiss drug major Novartis' drug Gilenya (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis (RRMS).
The indication expansion will now give clinicians the flexibility to use fingolimod in the highly active RRMS group, for patients needing to switch from interferons as well as glatiramer acetate (Teva's Copaxone) and other DMTs.
Prior to the indication expansion, fingolimod, which generated sales of nearly $2 billion last year, was limited for use in those patients with highly active RRMS not responding to an interferon.
The European Commission approval was based on a favourable review of the long-term efficacy and safety data for fingolimod and comes three years after the initial licence was granted in March 2011. Fingolimod is now approved in 80 countries and it is estimated that more than 91,500 patients have been treated with fingolimod in clinical trials and in the post-marketing setting.
.Fingolimod is the only established oral therapy approved by the UK's drugs watchdog the National Institute for Health and Care Excellence (NICE) for the treatment of highly active RRMS that is effective across four key measures of MS disease activity – relapses, MRI lesions, brain volume loss and disability progression, the drugmaker noted. Novartis says it will work with the relevant European funding bodies to ensure that patients who meet these new criteria are able to access fingolimod in the near future.
Source: thepharmaletter(12/06/14)
MS drug Gilenya appears to slow brain volume loss in relapsing patients(01/05/14)
Novartis International AG announced new data showing that more patients with relapsing multiple sclerosis treated with Gilenya (fingolimod) achieved an average annual rate of brain volume loss within the range of those expected for healthy adults of a similar age vs. those patients taking placebo. People with multiple sclerosis experience shrinkage of the brain up to three to five times faster. This acceleration starts early in people with relapsing MS, even before symptoms are apparent.
"These data are impressive as they show that Gilenya slows brain volume loss in relapsing MS patients, an important indicator of disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals.
Gilenya is an oral disease modifying therapy that works on four key measures of multiple sclerosis disease activity - relapses, MRI lesions, brain volume loss and disability progression.
Source: NASDAQ. (01/05/14)
CHMP issues positive opinion to expand EU label for Gilenya in RRMS(29/04/14)
Swiss drug giant Novartis said that the Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion to expand the EU label for Gilenya (fingolimod) in relapsing remitting multiple sclerosis or RRMS.
The recommendation is to expand the label to include adult patients who have not responded to at least one disease-modifying therapy or DMT, including newly-approved oral DMTs. Gilenya is currently licensed in the EU for adult patients with RRMS who have not responded to treatment with interferons, or have rapidly evolving severe MS.
Novartis also announced new pooled analyses presented at the 66(th) American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania from the pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis or MS, confirming the consistent efficacy of Gilenya across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression). Addressing these four measures through effective treatment and disease management is important for improving the course of MS for patients.
The pooled analyses from the FREEDOMS and FREEDOMS II trials show that in patients with high disease activity previously treated in the past year, Gilenya demonstrated significant efficacy across the certain measures.
Gilenya reduced relapses (as measured by the annualized relapse rate) by almost half (48%) compared to placebo; new T2 lesion formation was reduced by 69% compared to placebo; Gilenya reduced the rate of brain volume loss by 46% compared to placebo; using a stringent six-month disability measure, Gilenya reduced disability progression by 45% compared to placebo.
Source: RTT News Copyright © 2014 RTTNews (29/04/14)


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Guardian Life Insurance seeks overpayment of disability benefits for child social security disability benefits awarded to disabled claimant's daughter
A recent lawsuit filed against Guardian Life Insurance Company highlight an issue that comes up regularly for disability insurance claimants that have minor children and are approved for Social Security Disability Benefits. Monica Johnson has been receiving long-term disability benefit payments from Guardian Life (Guardian) since August, 2003 as result of her becoming completely and totally disabled in April, 2003. Under the terms of the group long-term disability benefit plan Monica purchased while working for EBE Office Source, Inc., Guardian is allowed to offset her monthly benefit payment according to the amount of Social Security disability income she receives.
Ms. Johnson applied for Social Security Disability Income (SSDI) in 2005, and was approved by the Social Security Administration on or about August 18, 2009 to receive disability income payments retroactive to July 1, 2005. Ms. Johnson's monthly SSDI payments amounted to $1,545.80. Guardian was already paying Ms. Johnson $2,505 per month up until the time she was approved for SSDI in 2009. That means Guardian can offset Ms. Johnson's payment by $1,545.80.
Guardian did some calculating upon being notified of Ms. Johnson's SSDI approval, and concluded that they overpaid Ms. Johnson to the tune of $70,232 between July 1, 2005 and January of 2010. At that time, Guardian withheld payment from Ms. Johnson until a time such that Guardian felt that they had been properly reimbursed for overpayment of benefits. With the combination of a lump sum payment made by Ms. Johnson and Guardian withholding disability benefit payments from her, Guardian informed Ms. Johnson it in a letter dated December 8, 2010 stating that terms for reimbursement to Guardian have been satisfied.
But now, Ms. Johnson's daughter, Jenna, is thrown into the mix.
As an unmarried minor living with her mother who is completely and totally disabled, Jenna Johnson is entitled to apply for child benefits under the Social Security Act. Having been approved to receive Social Security benefits, Jenna received a monthly benefit of $772 per month as of July 1, 2005.
Monica Johnson, the aforementioned claimant and Jenna's mother, received a letter from Guardian on February 17, 2011 stating that per terms of the group long-term disability plan she purchased prior to becoming completely and totally disabled Guardian could use the amount of the monthly Social Security benefit Jenna receives to offset the payment Guardian makes to Monica every month. With that said, Guardian claims they overpaid Monica and additional $49,168.54 since Jenna's monthly Social Security benefit was not factored in to Monica's monthly payments from Guardian. Guardian said they would withhold monthly payments to Monica and also demanded Monica to pay a lump sum of $41,448.54 to Guardian until reimbursement had been made.
Not so, says Monica. That's why she filed a civil complaint on behalf of her daughter in United States District Court for the Eastern District of Pennsylvania against Guardian with the help of her disability attorney to prevent Guardian from, in essence, taking away Jenna's monthly Social Security benefit.
Ms. Johnson alleges that her daughter relies on her Social Security benefit so she may have a place to live, food to eat, clothes to wear, and other necessities of life. Furthermore, Monica alleges that neither she nor her daughter assigned Jenna's Social Security benefits to Guardian. Ms. Johnson further alleges that pursuant to section 207 of the Social Security Act, "Jenna's future SSD child benefits may not be assigned or transferred."
Therefore, Monica Johnson is suing on her daughter's behalf to keep Guardian from essentially taking away Jenna's child benefits from Social Security. Ms. Johnson is asking the court to compel Guardian to pay her long-term disability benefits without deducting the amount her daughter, Jenna, receives from Social Security. Additionally, Ms. Johnson is asking for any lost income benefits that were withheld as result of Guardian deducting Jenna's monthly Social Security benefit. Finally, Ms. Johnson asks the court for reasonable attorney's fees and costs related to this litigation.
It will be interesting to track the outcome of this case. If the disability policy specifically allows for an offset for child disability benefits, then this will be a difficult case for the claimant to win. However, if the policy has language which violates state or federal law, then the court can rule in favor of the claimant.
There is one opinion so far. Add your comment now.
What is the outcome in this case? Did Gaurdian pay a benefit regarding Jenna? If not how can they justify withholding Monica's and/or Jenna's benefit based on Jenna's receiving a benefit from SSA based on her mother's disability?
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Original recipe yields 16 servings
Amount per serving ({{servings}} total)
Based on a 2,000 calorie diet
Ready In
I had a small trimmed brisket (2 lb) and made the smaller version of this recipe, excluding the beer-we just don't care for that flavor anywhere, and substituted 2 T of Bourbon instead. I spread...
Tried this like it was suggested cooking with the beer and spices first for 6 hours then poured that off sliced it then added the sauce did add 2 tsp of bourbon to the sauce returning for the re...
In addition to the recipe, I let the marinade sit overnight in the refrigerator. This beef is soooooo good. It's tasty, tender and great for leftover sandwiches. MMMMMMMMM


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Posted by RudyMARYBallet on Dec 14, 2012
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Bible Prophecy and World Events
The future is in the Bible; Everyone wants to know about the future!
The bible tells us about the beginning and about history, but a large part of the bible is prophetic, this means it is foretelling the future, like in the Old Testament the birth and crucifixion of Jesus was foretold, also the end times (and the end of the world as we know it) is foretold in both the Old and the New Testament, the book of Daniel (O.T.) and book of Revelation (N.T.) specifically foretell these times in which we now live. Also in the Gospel of Matthew, specifically chapter 24, Jesus foretells these end times and events ahead.
God created the universe, the earth and everything and everybody in and on it, none of us share the same fingerprint, have you ever stood still at these wonders. The same God loves us so much that he atoned our sin by sacrificing his only son, Jesus Christ, and resurrected Him, that we may have everlasting life.
There are two futures ahead. Which one will be yours?
But did you know that in a very real way, there are two different futures? One is the fate that lies ahead of a world that continues to reject (or deny) Jesus Christ as Lord and Saviour. The other is a marvelous destiny that belongs to all who have come to Jesus Christ in faith by believing.
You and you alone will determine which future will be yours!
Many have complained that Bible Prophecy is a message of "Doom and Gloom," but that is not necessarily the case. Bible Prophecy is simply future history written in advance! Because of that, we recognize it to be the compassionate message of a loving God. It is designed to produce faith in your heart, prompting you to make decisions in your life that will secure a wonderful future for you - both in this life and in the eternities to come.
The fate of the world will be to move into an era of globalism, culminating in a one world government (New World Order), a one world religion (where they will leave Jesus, the son of God out of it), and a one world economic system - the cashless society with the Mark of the beast ,which is probably a very small chip in your forehead or right hand used for buying and selling; NOTE Revelation 13: 16-17 "And he [the antichrist] causeth all, both small and great, rich and poor, free and bond, to receive a mark in their right hand, or in their foreheads. And that no man might buy or sell, save he that had the mark, or the name of the beast, or the number of his name."
And all who do receive his mark are eternally doomed: Rev 14:11 "And the smoke of their torment ascendeth up for ever and ever: and they have no rest day nor night, who worship the beast and his image, and whosoever receiveth the mark of his name."
But the triumphal return of Jesus Christ - The Second Coming is at hand
By believing in Jesus Christ as your personal Saviour, and by being born again in the spirit you become a member of a marvelous entity that is called "the body of Christ, which is His body." When you make that decision, you are instantly and eternally saved.
If you haven't yet believed on Jesus Christ as your personal Lord and Saviour, why not do it now?
Today would be a wonderful day to begin the rest of eternity as a victorious Child of God. Read how on page http://www.bornagainministry.org/howdoiacceptjesus.php


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There is a typo in the the lesson "To Grab Space or to Not Grab Space?". Before your first move, under the dotted line in the commentary section on the right (don't know what it's called), it says "and being board...", which should be changed to "bored".
The pun, also called paronomasia, is a form of word play which suggests two or more meanings, by exploiting multiple meanings of words, or of similar-sounding words, for an intended humorous or rhetorical effect.[1][2] These ambiguities can arise from the intentional use and abuse of homophonic, homographic, metonymic, or metaphorical language. A pun differs from a malapropism in that a malapropism uses an incorrect expression that alludes to another (usually correct) expression, but a pun uses a correct expression that alludes to another (sometimes correct but more often absurdly humorous) expression. Henri Bergson defined a pun as a sentence or utterance in which "two different sets of ideas are expressed, and we are confronted with only one series of words".[3] Puns may be regarded as in-jokes or idiomatic constructions, given that their usage and meaning are entirely local to a particular language and its culture. For example, camping is intense (in tents).
What is that for?
He's implying it's a pun.
Implication negated.
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License & Identifications
A medical license is required for a doctor to practice medicine in a particular state. Requirements vary by state but most require, at a minimum, post-graduate training in the doctor's specific specialty. An NPI number is a national identifier unique to an individual health care provider and is managed by the Center for Medicare & Medicaid Services (CMS).
Learn more about Dr. Leslie Klevay:
View the full profile to get information on:
- Qualifications
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The overall average patient rating of Dr. Leslie Klevay is Good.
Education & Awards
Dr. Klevay graduated from University of Wisconsin at Madison.
Home > Find an Internist > ND > Grand Forks Internists > Dr. Leslie Klevay, MD
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- Dr. Leslie Michael Klevay MD is a male Internist and practices in Internal Medicine.
- Where does Dr. Leslie M. Klevay practice?
- Dr. Leslie Klevay has 1 office location.
Dr. Leslie Klevay practices Internal Medicine near Grand Forks, ND.
See Grand Forks Internists.


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Tales From the Bargain Bin: Anarchy Reigns
140d ago - Tim Allen, GIZORAMA - "Platinum Games, the eccentric Japanese developer behind titles such as Bay... | Xbox 360
Sega Super Sale Hits Xbox 360 - Excellent $5 Deals Abound
373d ago - This week, there's an amazing sale on Sega-published stuff on the Xbox 360. | Xbox 360
Devil May Cry 4 Special Edition (XB1) Review
Now - Ken revisits the fourth entry in the saga of Dante (and Nero). | Promoted post
5 Video Game Soundtracks That Belong In Your Music Library [Capsule Computers]
463d ago - Frank Inglese Writes: Video games, over time, have grown and evolved to be much more than just... | Nintendo DS
Games We Missed Out On In 2013
511d ago - Twinfinite writes: "We're all human here at Twinfinite, regardless of what you may or may not hav... | PC
Ten Best Xbox 360 Games You Missed In 2013
538d ago - GR - The Xbox 360 is dead. Long live Xbox 360. With Xbox One under televisions and on store shelv... | Xbox 360
You had to be there: The Concertification of Video Games
623d ago - Simon, from DarkZero, writes - "I still remember, with perfect clarity, getting my Xbox Live star... | Culture
Up Up Down Down: Anarchy Reigns
631d ago - GameZone: "On this installment of Up Up Down Down, we're going to venture forth into the weird la... | Xbox 360
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799d ago - Hardcore Gamer; If you thought $30 was too much to spend for a game that seems ideal for an exten... | Xbox 360
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813d ago - Now, you can purchase Bayonetta as a DLC add-on for $0.99 on the PlayStation Store. With her wick... | Xbox 360
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Phoenix Suns
Suns center Alex Len: Better spacing in NBA will help offensive game
During his collegiate career at Maryland, Alex Len proved he was an athletic big who could protect the rim at a high level -- led the ACC with 2.1 blocks per game in 2012-13.
But when discussing the Phoenix Suns' selection of Len with the No. 5 overall pick in the 2013 NBA Draft, the focus often turns to the 7-foot-1 center's offensive production at College Park, or sometimes lack there of.
During his sophomore season, the 20-year-old's offense was often the foot note of his skill set, not the highlight. He averaged just 11.9 points per game -- the lowest total for any player taken in the top 10 not named Nerlens Noel.
On Draft Night, Suns head coach Jeff Hornacek said the organization wasn't overly concerned with Len's offensive stats, because they had less to do with a deficiency and more to do with the fact that "he didn't get the ball enough."
Friday, general manager Ryan McDonough echoed similar sentiments to Arizona Sports 620's Burns and Gambo.
"Alex is 7-1, he can't dribble the ball up the court and then throw an entry pass to himself," McDonough said. "So when I watched him play in person and when I studied the film, he got great position a lot of the time and he had his man sealed under the basket, had a good target ready to receive the ball, and I thought his guards did a very poor job of getting him the ball."
At his introductory press conference Friday afternoon, Len went a step further.
"In the NBA, there is better spacing [than there is in college]," Len said. "It makes it easier on the big guys, because we have more space to work on the block.
"I know I can contribute right away on the defensive end of the floor. I have size, I can alter shots, I can rebound and run the floor. On offense, we'll see what Coach [Hornacek] wants me to do. I'll just do my role."
While the Suns' No. 5 pick noted that he can't wait to play at a level where floor spacing doesn't "suck", he also reiterated to the media how thrilled he is to play in an offensive system that highlights his strengths: agility and athleticism.
"I know the Phoenix Suns like to play high tempo, run up-and-down, so I think it fits my game well," said Len.
"My agility came from a long time ago when I did gymnastics when I was young. It helped me with my coordination and my agility, it's a good thing. The high-tempo game fits me well."
His head coach seemed to agree that the fit will be a good one for both the Suns and Len offensively.
"Like Alex said, we're going to be pushing the ball," said Hornacek. "But if we get into some quick swing-actions, he's either going to be the first one down getting in that post-up area, or he's going to trail the play, swing it and go into quick pick-and-rolls.
"He has great pick-and-roll pop action, where he can make that 15 to 17-foot shot. So, there's a variety of ways we can use him."
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MTA Adding Spy Cams, Motion Detectors Related LinksMTA Email This StoryPrint This Story Aug 23, 2005 2:22 pm US/Eastern(1010 WINS) (NEW YORK) Over the next three years, the Metropolitan Transportation Authority will add 1,000 surveillance cameras and 3,000 motion sensors to its sprawling network of subways and commuter rail facilities as part of a $212 million security upgrade announced Tuesday with Lockheed Martin Corp.The agreement marks the MTA's largest financial commitment to its counterterrorism program. Although the agency approved a $591 million security plan in 2002, it had spent only a fraction of that until the deal with Lockheed Martin.
Defense contractor Lockheed Martin will lead a team of companies in a deal struck with North America's largest transportation network just one month after bombers attacked the London transit system on July 7, killing 52 people
Mace was not listed as a supplier, don't look for any spikes because of the Lockheed deal.
Found a link for you if you want to see who actually will be involved in the NY project. Sorry to say that MACE isn't among them.http://biz.yahoo.com/prnews/050823/dctu034.html?.v=20


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Hit Musical Comedy The 25th Annual Putnam County Spelling Bee
* Additional fees apply. No coupon or promo codes necessary to enjoy the displayed discount price.
The last date listed for The 25th Annual Putnam County Spelling Bee was Saturday August 16, 2014 / 8:00pm.
Currently at OnStage Atlanta
The Addams Family: Creepy, Kooky Musical Comedy
- Full Price:
- $23.00
- Our Price:
- $11.50
Na-na-na-na *snap* *snap* na-na-na-na *snap* *snap* -- You can't even say "Addams Family" without… More
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Reviews & Ratings
Featured review from Kathie CiottiRed Velvet
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Every year we do a "Broadway" show for my daughter's birthday. She had been hoping to see Putnam County for awhile. This show did NOT disappoint! We were thrilled to bring along a few friends as well. The cast was exceptionally talented and so gracious and they all posed for with my daughter and her friends at the end. I love this place!
star this review starred report as inappropriate
Is was a cute play with talented actors and actresses. Enjoyed it!!
star this review starred report as inappropriate
I've seen this play done elsewhere where it was much more hilarious, mostly because of the character/caricature development or lack thereof here. It is still a funny play with some great lines, especially the definitions and how the word is used...continued
star this review starred report as inappropriate
Beautiful fun experience with some underlying truths. This humorous audience participatory experience was creative, smart ,well delivered, wonderfully conceived musical was loaded with the effects of labeling on kids and adults. The pressures...continued


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How to Create a JVM Instance in JNI
Experience how to shed some light on the way to utilizing Java code in C++.
Experience how to shed some light on the way to utilizing Java code in C++.
Now's the time to receive instruction to get a first taste of Android Programming in Java in a simple manner.
Dig deeper into some of the key concepts of exception handling in JNI.
Explore how to manipulate Java objects from a native code such as C/C++ using JNI.
Dig into function and data type mapping between Java and C/C++. You'll also find some appropriate examples to guide you.
Explore the world of JNI (Java Native Interface), a programming interface through which Java byte code can interact with any native code.
In my humble opinion, security is a farce. The most secure code is the code that you have never written and the most secure language is the language never invented. Learn more about reflection in Java.
Discover some of reflection's core areas of the API with a few examples to implement them in programming.
Reflection provides some value so that we can create our own recipe rather than eulogize a bullet-proof black box of language paradigm.
Explore the simplicity of integration between two very different types of languages, especially from the point of view of a JavaFX application.
Look into some nooks and corners and key aspects of scripting in Java in general.
If you've used the 2D APIs of JavaFX, working with the 3D APIs will be almost child's play.
Get a solid footing on key ideas and master the intricacies involved before one considers jumping into 3D programming.
Become proficient with specialization and generalization, which is the subclass and superclass hierarchy mechanism in a relational database.
Take advantage of dependency injection to eliminate hard dependencies and make your classes easier to test and maintain.
Master the power and versatility of JavaFX to achieve animations of several types.
Become adept with using best practices that should be followed while writing code to perform asynchronous operations in Java.
Discover the depth and intricacies of JavaFX, which is built primarily to create and deliver rich Internet applications (RIAs).
Learn to use Graphics2D, an extension of the legacy Graphics class of the AWT package and which supports more drawing capabilities than its predecessor.
Take advantage of serialization to persist an object's state.
Explore the Java GUI in general and work with a couple of practical graphics implementations.
Gain an understanding of the JVM and its components.
Explore the ten crucial points to begin with graphics programming.
Leverage the power of lambda expression, a functional programming construct that promotes faster, clearer coding with simplicity.
Master some of the important aspects of email monitoring and their implementation through code.


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Funny Or Die
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Kroll Videos, Kroll Pictures, Kroll Articles
The Ed Hardy Boyz 2 Trailer
The Ed Hardy Boyz are back to solve a new mystery.
Rich Dicks
These two guys are rich, on the prowl and ready to party at a moments notice. They're also dicks.
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Nick Kroll springs a surprise on Seth Meyers and talks about the end of Kroll Show.
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The cast of A Good Old Fashioned Orgy talks candidly about co-star, Nick Kroll. facebook.com/agofo
Nick Kroll, Seth Morris, Jon Daly - Knob Gobblers - @midnight with Chris Hardwick
It's Groundhog Day, and Nick Kroll, Seth Morris and Jon Daly celebrate by coming up with other predictions that Punxsutawney Phil might make. Watch full e...
Nine Lives w/ Christian Slater, Elijah Wood & Patricia Arquette
A man's spirit takes a bizarre journey.
Fabrice Fabrice Interviews People about the Writer's Strike
Fabrice Fabrice takes to the streets of Las Vegas to find out what people think about the current writer's strike in Hollywood.
The Oh, Hello Show: Gil and George visit Mona
Gil and George visit Mona.
Oh, Hello Show Introduction
Opening sequence from that TV Show, "Oh, Hello" -- Gil and George romp around The Upper West Side.
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Bobby Bottleservice has a message for all the mothers out there.
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Gil and George host a video club. Guest starring Dave Hill.
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Comedy Bang Bang brings you the ultimate teaser trailer for the summers biggest blockbuster. See it all unfold June 8th, 2012 on IFC.
Fabrice Fabrice at the MTV Movie Awards
Fabrice Fabrice hits the the Red Carpet of the MTV Movie Awards to talk to all of the stars about being stars in the land of a million stars.
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See what happens when a broke music-video director sells the creative rights to his latest project to anybody with an idea.
Dear Woman
Based on the "Manifesto for Conscious Men," balance your energies and allow for a new wave of evolution on our planet. See the original at http://www.funnyor...
Lincoln Navigator
I just got a brand new Lincoln Navigator.


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1996 Geo Prizm Q&A
1996 Geo Prizm Question: Driving Cycle
The e-check company is having trouble reading the codes on my vehicle. It has been about 5 weeks since I had the repair done on my vehicle, and they are still having trouble reading the codes. - Aneisha
Answer 1
Are they having a problem reading the trouble codes? Or is your vehicle unable to complete a driving cycle? This may be due to a weak battery. Here are some articles that explain driving cycles, take a look and pass them on to the guys e-check people. http://repairpal.com/drive-cycle-emissions-readiness http://repairpal.com/Drive-Cycle-Issues http://repairpal.com/drive-cycle-how-to-perform-a-basic-drive-cycle - Bret Bodas
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"Lakes and Palaces" Udaipur by bradbeaman
Udaipur Travel Guide: 52 reviews and 80 photos
Udaipur is set in The Aravalli Range literally meaning 'line of peaks' and locally called Mewat Hills. Udaipur is nicknamed the city of lakes and also known as the Venice of the East. There are beautiful palaces and the city if filled with luxury hotels mostly from restored acncient places of the Mewadi kingdom who are attracted tt the beauty of the lakes and places surrounded by the Avaralli hills.
I have been wanting to visit Updaipur for a while. One of the airlines had their jet over the Palace lake and the hotel is listed as the best in India. Put Udaipur on my to visit list.
Fatehsagar has two island parks with boat rides out to the parks.
Reviews (6)
There are many art schools in Udaipur that keep the silk painting craft from the Mewar empire alive. They will... more travel advice
Udaipur overlooks Lake Pichola and City Palace. more travel advice
The Oberoi Udaivilas is rated as the best hotel in Asia and the 5th best hotel in the world. But odly enough it may not... more travel advice
How could you come and go from Udaipur without taking some time to get the best possible photo of the floating Palace. I... more travel advice
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Aroma2Go is running some very nice specials! Several diffusers are Buy One/Get One, and many others are up to 30 percent off. If you're thinking of running a contest with your team, diffusers are a great prize, or simply stock up your own inventory. Here are some of the choices:
Maya – 7 Color Changing Aromatherapy Diffuser (Black or White) Great Essential Oil Diffuser
Leo – Silent Aromatherapy Ultrasonic Diffuser (White or Wood) – The perfect essential oil diffuser
Vesuvio Aromatherapy Lighted Diffuser – Ultrasonic & Silent essential oil diffuser
Perfect Purifier Essential Oil Diffuser
USB Home Charger Port or Car Charger Port – MANY COLORS
Corky – White Porcelain w/ real cork Aromatherapy Diffuser
Victoria – 7 Color Changing Aromatherapy Diffuser
Mina 2 Nebulizing Hand Crafted Aromatherapy Diffuser (Solid Wood Finish)
Louis – Ceramic, Ultrasonic Aromatherapy Diffuser – Silent & Elegant Essential Oil Diffuser
Pippa – Nebulizing, Negative Ion, Glass / Wood Aromatherapy Diffuser


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• Designed to be an upgrade for JTL Versalight, the Versalight E is JTL's newest professional studio series strobe light for portrait photography. Featuring a standard fan cooled, aluminum alloy housing, and a 360-degree photo slave, this light has a built-in stabilizer for providing an output precision of +/- 0.1F.
It features a detachable optidress flash tube with UV correction coating (protected by a glass-made safety cover) for accurate color temperature, which is crucial for portrait pictures. In addition, a variety of accessories are available for the Versalight E, including flash tubes, kits, standard metal reflectors, and stand fixtures.
Reviewed by 4 customers
Weddings Shoots Portraits Good for the buck
Woof woof! This is a great product!
Very nice built monolight with good mounting clamp. Stays in place with a 36 in. softbox. Good value for the price. I'm trying to find out if accessories from other manufactures would fit the mounting of the JTL since the JTL accessories are limited. [...]
Pleasantly surprised at the value of this light. It's actually better than I would have thought for the cost and seems to be a very good monolight.