Novartis announces positive results from final Phase III omalizumab registration study in severe form of chronic skin disease CSU.


  • Omalizumab significantly reduced itch and hives caused by chronic spontaneous urticaria (CSU) as early as Week 1; benefit sustained over  24 weeks of active treatment[1]
  • Omalizumab 300 mg was nearly twice as effective in improving patients’ quality of life within 12 weeks of treatment versus placebo[1]
  • ASTERIA I is the final omalizumab CSU registration study to be presented; regulatory applications were filed with EU and US authorities in Q3 2013
  • CSU is a debilitating form of hives and chronic itch; more than 50% of patients do not respond to approved doses of antihistamines, the only licensed treatment

Novartis announced today new results from the Phase III ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU)[1], a chronic and debilitating form of hives. ASTERIA I is the final pivotal registration study for omalizumab in CSU to be announced, and results were presented today for the first time at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey. Omalizumab is currently not approved for the treatment of CSU.

The ASTERIA I data support the positive and consistent results from two previously reported pivotal Phase III registration studies of omalizumab in CSU (ASTERIA II and GLACIAL), which were presented at major medical congresses earlier this year[2],[3]. Regulatory applications for omalizumab in CSU were filed with US and EU health authorities in the third quarter of 2013, based on data from nearly 1,000 patients included in these Phase III studies.

“The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50% of patients don’t respond to approved doses of antihistamines, the only licensed treatment option,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “With submissions to EU and US regulatory authorities now completed, we are on track to bring omalizumab to people suffering from this chronic and debilitating disease.”

Specifically, the ASTERIA I study showed that patients treated with omalizumab responded as early as Week 1 (300 mg dose), compared to Week 4 in the placebo group (p=<0.0001)[1]. By Week 12 all three omalizumab doses (300 mg, 150 mg and 75 mg) were significantly superior to placebo in improving patients’ weekly Itch Severity Score (ISS), which was the primary endpoint of the study[1]. This benefit was maintained throughout active treatment (Week 24)[1].

The study also showed patients treated with omalizumab 300 mg experienced nearly twice the improvement in their quality of life compared to those taking placebo by Week 12 (p<0.0001)[1]. Quality of life measures are critical to assessing CSU treatments, because the disease can frequently lead to other negative consequences such as sleep deprivation, depression and anxiety[4].

In addition, by Week 12 more than half (52%) of omalizumab 300 mg patients in the study had their CSU symptoms (itch, hives) well controlled and 36% had no symptoms at all (p<0.0001)[1]. At the same time point, omalizumab 300 mg treated patients also experienced a significant increase in the proportion of days free of deep tissue swelling, also known as angioedema (p<0.0001)[1].

The study met all pre-specified secondary efficacy endpoints for omalizumab 300 mg and 150 mg compared to placebo, except the 150 mg group did not reach statistical significance versus placebo for the quality of life measurement at Week 12.

The incidence and severity of adverse events (AEs) was similar across all ASTERIA I treatment groups. Five omalizumab patients experienced serious AEs during the treatment period (75 mg group n=2, 150 mg group n=3, 300 mg group n=0), compared to four patients in the placebo group[1]. No deaths were reported during this study[1].

CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin[5],[6] that spontaneously present and re-occur for more than six weeks[2].At any given time, the prevalence of CSU is 0.5% to 1% worldwide[4].

Omalizumab is being jointly developed by Novartis and Genentech, Inc. for CSU.

About the ASTERIA I Study ASTERIA I was a 40-week, global, multi-center, randomized double-blind study that evaluated the efficacy and safety of omalizumab compared to placebo. It involved 318 patients between the ages of 12 and 75 with moderate-to-severe CSU who remained symptomatic despite prior treatment with H1 antihistamine treatment. Patients were randomized to omalizumab 300 mg, 150 mg, 75 mg or placebo (1:1:1:1), given subcutaneously every four weeks for a total period of 24 weeks, and subsequently monitored during a 16 week follow-up period when there was no active treatment[1].

The primary endpoint, ISS at Week 12, was assessed via a 21-point scale at Week 12[1]. Omalizumab significantly improved the mean weekly ISS from baseline by 9.4 in the 300 mg treatment arm (p<0.0001), 6.7 in the 150 mg treatment arm (p=0.0012) and 6.5 in the 75 mg treatment arm (p=0.0010), compared to a 3.6 improvement in patients on placebo[1].

Health-related quality of life was assessed using the Dermatology Life Quality Index (DLQI) questionnaire (range of 0-30, with a higher score representing greater impairment)[1]. Control of CSU symptoms was assessed by a measure of itch and hives called the weekly urticaria activity score (UAS7), where any score of 6 or less out of a 42 point score is considered to represent a well-controlled disease and a score of zero represents a complete resolution of symptoms[1]. In addition, time to response was measured by the median time to Minimally Important Difference (MID)[1].

About Omalizumab (Xolair®) Omalizumab is a targeted therapy unique in binding to immunoglobulin E (IgE). It is currently not approved for the treatment of CSU. Omalizumab suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms[7]. Research is ongoing to understand the mechanism of action of omalizumab in CSU, which could lead to deeper understanding of how the disease develops[8].

Omalizumab is approved for the treatment of moderate to severe persistent allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the EU it is approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents, and adults. Following approval in the EU, a liquid formulation of Xolair in pre-filled syringes has been launched in most European countries. In the US, Xolair (omalizumab) for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech, Inc.

Rise and shine.


Daily rituals
The daily routines of history’s most creative minds Benjamin Franklin spent his mornings naked. Patricia Highsmith ate only bacon and eggs. Marcel Proust breakfasted on opium and croissants. The path to greatness is paved with a thousand tiny rituals (and a fair bit of substance abuse) – but six key rules emerge.
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One morning this summer, I got up at first light – I’d left the blinds open the night before – then drank a strong cup of coffee, sat near-naked by an open window for an hour, worked all morning, then had a martini with lunch. I took a long afternoon walk, and for the rest of the week experimented with never working for more than three hours at a stretch.

This was all in an effort to adopt the rituals of some great artists and thinkers: the rising-at-dawn bit came from Ernest Hemingway, who was up at around 5.30am, even if he’d been drinking the night before; the strong coffee was borrowed fromBeethoven, who personally counted out the 60 beans his morning cup required. Benjamin Franklinswore by “air baths”, which was his term for sitting around naked in the morning, whatever the weather. And the midday cocktail was a favourite of VS Pritchett (among many others). I couldn’t try every trick I discovered in a new book, Daily Rituals: How Great Minds Make Time, Find Inspiration And Get To Work; oddly, my girlfriend was unwilling to play the role of Freud‘s wife, who put toothpaste on his toothbrush each day to save him time. Still, I learned a lot. For example: did you know that lunchtime martinis aren’t conducive to productivity?

As a writer working from home, of course, I have an unusual degree of control over my schedule – not everyone could run such an experiment. But for anyone who thinks of their work as creative, or who pursues creative projects in their spare time, reading about the habits of the successful, can be addictive. Partly, that’s because it’s comforting to learn that even Franz Kafka struggled with the demands of his day job, or that Franklin was chronically disorganised. But it’s also because of a covert thought that sounds delusionally arrogant if expressed out loud: just maybe, if I took very hot baths like Flaubert, or amphetamines like Auden, I might inch closer to their genius.

Several weeks later, I’m no longer taking “air baths”, while the lunchtime martini didn’t last more than a day (I mean, come on). But I’m still rising early and, when time allows, taking long walks. Two big insights have emerged. One is how ill-suited the nine-to-five routine is to most desk-based jobs involving mental focus; it turns out I get far more done when I start earlier, end a little later, and don’t even pretend to do brain work for several hours in the middle. The other is the importance of momentum. When I get straight down to something really important early in the morning, before checking email, before interruptions from others, it beneficially alters the feel of the whole day: once interruptions do arise, they’re never quite so problematic. Another technique I couldn’t manage without comes from the writer and consultant Tony Schwartz: use a timer to work in 90-minute “sprints”, interspersed with signficant breaks. (Thanks to this, I’m far better than I used to be at separating work from faffing around, rather than spending half the day flailing around in a mixture of the two.)

The one true lesson of the book, says its author, Mason Currey, is that “there’s no one way to get things done”. For every Joyce Carol Oates, industriously plugging away from 8am to 1pm and again from 4pm to 7pm, or Anthony Trollope, timing himself typing 250 words per quarter-hour, there’s a Sylvia Plath, unable to stick to a schedule. (Or a Friedrich Schiller, who could only write in the presence of the smell of rotting apples.) Still, some patterns do emerge. Here, then, are six lessons from history’s most creative minds.

1. Be a morning person

Georgia O'KeeffeGeorgia O’Keeffe: one of a majority of very early morning risers. Photograph: AP

It’s not that there aren’t successful night owls: Marcel Proust, for one, rose sometime between 3pm and 6pm, immediately smoked opium powders to relieve his asthma, then rang for his coffee and croissant. But very early risers form a clear majority, including everyone fromMozart to Georgia O’Keeffe to Frank Lloyd Wright. (The 18th-century theologian Jonathan Edwards, Currey tells us, went so far as to argue that Jesus had endorsed early rising “by his rising from the grave very early”.) For some, waking at 5am or 6am is a necessity, the only way to combine their writing or painting with the demands of a job, raising children, or both. For others, it’s a way to avoid interruption: at that hour, as Hemingway wrote, “There is no one to disturb you and it is cool or cold and you come to your work and warm as you write.” There’s another, surprising argument in favour of rising early, which might persuade sceptics: that early-morning drowsiness might actually be helpful. At one point in his career, the novelist Nicholson Baker took to getting up at 4.30am, and he liked what it did to his brain: “The mind is newly cleansed, but it’s also befuddled… I found that I wrote differently then.”

Psychologists categorise people by what they call, rather charmingly, “morningness” and “eveningness”, but it’s not clear that either is objectively superior. There is evidence that morning people are happier and more conscientious, but also that night owls might be more intelligent. If you’re determined to join the ranks of the early risers, the crucial trick is to start getting up at the same time daily, but to go to bed only when you’re truly tired. You might sacrifice a day or two to exhaustion, but you’ll adjust to your new schedule more rapidly.

2. Don’t give up the day job

TS EliotTS Eliot’s day job at Lloyds bank gave him crucial financial security. Photograph: Hulton Archive/Getty Images

“Time is short, my strength is limited, the office is a horror, the apartment is noisy,” Franz Kafka complained to his fiancee, “and if a pleasant, straightforward life is not possible, then one must try to wriggle through by subtle manoeuvres.” He crammed in his writing between 10.30pm and the small hours of the morning. But in truth, a “pleasant, straightforward life” might not have been preferable, artistically speaking: Kafka, who worked in an insurance office, was one of many artists who have thrived on fitting creative activities around the edges of a busy life. William Faulkner wrote As I Lay Dying in the afternoons, before commencing his night shift at a power plant; TS Eliot‘s day job at Lloyds bank gave him crucial financial security; William Carlos Williams, a paediatrician, scribbled poetry on the backs of his prescription pads. Limited time focuses the mind, and the self-discipline required to show up for a job seeps back into the processes of art. “I find that having a job is one of the best things in the world that could happen to me,” wrote Wallace Stevens, an insurance executive and poet. “It introduces discipline and regularity into one’s life.” Indeed, one obvious explanation for the alcoholism that pervades the lives of full-time authors is that it’s impossible to focus on writing for more than a few hours a day, and, well, you’ve got to make those other hours pass somehow.

3. Take lots of walks

TchaikovskyTchaikovsky ‘believed he had to take a walk of exactly two hours a day and that if he returned even a few minutes early, great misfortunes would befall him.’ Photograph: Hulton Archive/Getty Images

There’s no shortage of evidence to suggest that walking – especially walking in natural settings, or just lingering amid greenery, even if you don’t actually walk much – is associated with increased productivity and proficiency at creative tasks. But Currey was surprised, in researching his book, by the sheer ubiquity of walking, especially in the daily routines of composers, including Beethoven,Mahler, Erik Satie and Tchaikovksy, “who believed he had to take a walk of exactly two hours a day and that if he returned even a few minutes early, great misfortunes would befall him”. It’s long been observed that doing almost anything other than sitting at a desk can be the best route to novel insights. These days, there’s surely an additional factor at play: when you’re on a walk, you’re physically removed from many of the sources of distraction – televisions, computer screens – that might otherwise interfere with deep thought.

4. Stick to a schedule

Patricia HighsmithPatricia Highsmith, among others, ate virtually the same thing for every meal, in her case bacon and fried eggs. Photograph: Corbis Sygma

There’s not much in common, ritual-wise, between Gustave Flaubert – who woke at 10am daily and then hammered on his ceiling to summon his mother to come and sit on his bed for a chat – and Le Corbusier, up at 6am for his 45 minutes of daily calisthenics. But they each did what they did with iron regularity. “Decide what you want or ought to do with the day,” Auden advised, “then always do it at exactly the same moment every day, and passion will give you no trouble.” (According to legend,Immanuel Kant‘s neighbours in Königsberg could set their clocks by his 3.30pm walk.) This kind of existence sounds as if it might require intimidating levels of self-discipline, but on closer inspection it often seems to be a kind of safety net: the alternative to a rigid structure is either no artistic creations, for those with day jobs, or the existential terror of no structure at all.

It was William James, the progenitor of modern psychology, who best articulated the mechanism by which a strict routine might help unleash the imagination. Only by rendering many aspects of daily life automatic and habitual, he argued, could we “free our minds to advance to really interesting fields of action”. (James fought a lifelong struggle to inculcate such habits in himself.) Subsequent findings about “cognitive bandwidth” and the limitations of willpower have largely substantiated James’s hunch: if you waste resources trying to decide when or where to work, you’ll impede your capacity to do the work. Don’t consider afresh each morning whether to work on your novel for 45 minutes before the day begins; once you’ve resolved that that’s just what you do, it’ll be far more likely to happen. It might have been a similar desire to pare down unnecessary decisions that led Patricia Highsmith, among others, to eat virtually the same thing for every meal, in her case bacon and fried eggs. Although Highsmith also collected live snails and, in later life, promulgated anti-Semitic conspiracy theories, so who knows?

5. Practise strategic substance abuse

Ayn RandAyn Rand took Benzedrine. Photograph: New York Times Co/Getty Images

Almost every potential chemical aid to creativity has been tried at some time or another: Auden, Ayn Randand Graham Greene had their Benzedrine, the mathematician Paul Erdös had his Ritalin (and his Benzedrine); countless others tried vodka, whisky or gin. But there’s only one that has been championed near-universally down the centuries: coffee. Beethoven measured out his beans, Kierkegaard poured black coffee over a cup full of sugar, then gulped down the resulting concoction, which had the consistency of mud; Balzac drank 50 cups a day. It’s been suggested that the benefits of caffeine, in terms of heightened focus, might be offset by a decrease in proficiency at more imaginative tasks. But if that’s true, it’s a lesson creative types have been ignoring for ever. Consume in moderation, though: Balzac died of heart failure at 51.

6. Learn to work anywhere

Agatha ChristieAgatha Christie didn’t have a desk. Any stable tabletop for her typewriter would do. Photograph: AFP/Getty Images

One of the most dangerous procrastination-enabling beliefs is the idea that you must find exactly the right environment before you can get down to work. “For years, I said if only I could find a comfortable chair, I would rival Mozart,” the American composer Morton Feldman recalled.Somerset Maugham had to face a blank wall before the words would come (any other view, he felt, was too distracting). But the stern message that emerges from many other artists’ and authors’ experiences is: get over yourself. During Jane Austen‘s most productive years, at Chawton in Hampshire in the 1810s, she wrote mainly in the family sitting-room, often with her mother sewing nearby. Continually interrupted by visitors, she wrote on scraps of paper that could easily be hidden away. Agatha Christie, Currey writes, had “endless trouble with journalists, who inevitably wanted to photograph the author at her desk”: a problematic request, because she didn’t have one. Any stable tabletop for her typewriter would do.

In any case, absolute freedom from distraction may not be as advantageous as it sounds. One study recently suggested that some noise, such as the background buzz of a coffee shop, may be preferable to silence, in terms of creativity; moreover, physical mess may be as beneficial for some people as an impeccably tidy workspace is for others. The journalist Ron Rosenbaumcherishes a personal theory of “competing concentration”: working with the television on, he says, gives him a background distraction to focus against, keeping his attentional muscles flexed and strong.

But there is a broader lesson here. The perfect workspace isn’t what leads to brilliant work, just as no other “perfect” routine or ritual will turn you into an artistic genius. Flaubert didn’t achieve what he did because of hot baths, but through immeasurable talent and extremely hard work. Which is unfortunate, because I’m really good at running baths.

Benzedrine, naps, an early night: an extract from Daily Rituals

Gertrude Stein

In Everybody’s Autobiography, Stein confirmed that she had never been able to write for much more than half an hour a day, but added, “If you write a half-hour a day, it makes a lot of writing year by year.” Stein and her lifelong partner, Alice B Toklas, had lunch at about noon and ate an early, light supper. Toklas went to bed early, but Stein liked to stay up arguing and gossiping with visiting friends. After her guests finally left, Stein would wake Toklas, and they would talk over the day before both going to sleep.

Ludwig van Beethoven

Beethoven rose at dawn and wasted little time getting down to work. His breakfast was coffee, which he prepared himself with great care: 60 beans per cup. After his midday meal, he embarked on a long walk, which would occupy much of the rest of the afternoon. As the day wound down, he might stop at a tavern to read the newspapers. Evenings were often spent with company or at the theatre, although in winter he preferred to stay at home and read. He retired early, going to bed at 10pm at the latest.

WH Auden

“Routine, in an intelligent man, is a sign of ambition,” Auden wrote in 1958. If that’s true, the poet was one of the most ambitious men of his generation. He rose shortly after 6am, made coffee and settled down to work quickly, perhaps after taking a first pass at the crossword. He usually resumed after lunch and continued into the late afternoon. Cocktail hour began at 6.30pm sharp, featuring several strong vodka martinis. Then dinner was served, with copious amounts of wine. To maintain his energy and concentration, he relied on amphetamines, taking Benzedrine each morning. At night, he used Seconal or another sedative to get to sleep.

Sylvia Plath

Plath’s journal, which she kept from age 11 until her suicide at 30, records a near-constant struggle to find and stick to a productive writing schedule. Only near the end of her life, separated from her husband, Ted Hughes, and taking care of their two small children alone, did she find a routine that worked for her. She was using sedatives to get to sleep, and when they wore off at about 5am, she would get up and write until the children awoke. Working like this for two months in 1962, she produced nearly all the poems of Ariel.

Alice Munro

In the 1950s, as a young mother taking care of two small children, Munro wrote in the slivers of time between housekeeping and child-rearing. When neighbours dropped in, Munro didn’t feel comfortable telling them she was trying to work. She tried renting an office, but the garrulous landlord interrupted her and she hardly got any writing done. It ultimately took her almost two decades to put together the material for her first collection, Dance Of The Happy Shades.

David Foster Wallace

“I usually go in shifts of three or four hours with either naps or fairly diverting do-something-with-other-people things in the middle,” Wallace said in 1996, shortly after the publication of Infinite Jest. “So I’ll get up at 11 or noon, work till two or three.” Later, however, he said he followed a regular writing routine only when the work was going badly. “Once it starts to go, it requires no effort. And then actually the discipline’s required in terms of being willing to be away from it and to remember, ‘Oh, I have a relationship that I have to nurture, or I have to grocery-shop or pay these bills.’  ”

Ingmar Bergman

“Do you know what moviemaking is?” Bergman asked in a 1964 interview. “Eight hours of hard work each day to get three minutes of film.” But it was also writing scripts, which he did on the remote island of Fårö, Sweden. He followed the same schedule for decades: up at 8am, writing from 9am until noon, then an austere meal. “He eats the same lunch,” actor Bibi Anderssonremembered. “It’s some kind of whipped sour milk and strawberry jam – a strange kind of baby food he eats with corn flakes.” After lunch, Bergman worked from 1pm to 3pm, then slept for an hour. In the late afternoon he went for a walk or took the ferry to a neighbouring island to pick up the newspapers and the mail. In the evening he read, saw friends, screened a movie, or watched TV (he was particularly fond of Dallas). “I never use drugs or alcohol,” Bergman said. “The most I drink is a glass of wine and that makes me incredibly happy.”

5 Tips to Keep a Conversation Going When You Meet New People.


“I love meeting new people; I think everyone has a story to tell. We should all listen sometimes.” ~ Kim Smith

When you meet a person that seems interesting or fun, and that could potentially be a friend, what do you do to keep the conversation going, and stay in touch?

If you struggle for words, hesitate, or get too anxious to make a good impression, then I want to share with you 5 of my best tips on keeping a conversation going, connecting quickly, so you can stay in touch and even become friends. Read on…

“I love meeting new people; I think everyone has a story to tell. We should all listen sometimes.”

1. You Don’t Have To Be Super Interesting

What I notice is that people are too worried about making a good first impression. From my experience, if it’s not a job interview or celebrity red carpet thingy, then relax, it’s time to have fun.

If you’re in a social event and you want to connect with interesting people, all you have to say about yourself is that you’re interested in something you’re doing (your job, your future job, a hobby, or anything that makes your eyes shine…), and that you’re able to have fun.

People just need to know that you’re interested in something, which literally means that you’re interesting as a person. They may not be interested in the same thing, but they definitely won’t see you as a boring person with no passion.

For the fun part, all you have to do is talk about what you like to do for fun, or mention one or two stories about places (bars, movie theaters, vacations…) you’ve been to and what you liked about them.

That’s it. You don’t “have to” be more interesting than that.

2. No need to Filter Yourself

If you don’t want to kill your conversations, then you better not put too much pressure on yourself. Again, you don’t have to filter your thoughts and only talk about what’s super cool, super interesting, or super funny.

You can talk about anything that comes on your mind, as long as it’s not too weird for normal people to wrap their heads around.

This labels you as a genuine person who’s not trying to put out a show on how awesome and perfect they are. You’re not perfect, they’re not perfect, so just be and say whatever the hell you want.

Too many people think they have to be “very clever” in conversations… so they filter out what goes on in their minds, and you know what’s left? Nothing! On the other hand, if you start to give yourself more freedom to speak your mind, you’ll see how people open up and engage with you.

3.  Get people to talk to you more

The way to get people to keep talking to you is to keep listening to them! Of course you have to show you’re interested in what they’re saying.

One way to do this is to use the universal 5-word phrase: “Interesting! Tell me more…” This phrase works almost every time. This signals to the other person that they’re valuable and interesting, so they keep talking.

Another way to do it is to ask “Why”. I rarely see people using this in conversation with new people, but those who use it know how great it is for spicing up a chat. When someone says “I moved to Indiana 3 years ago and launched my company”… ask “why Indiana?” this will make the conversation more intimate and interesting, instead of it being just a cold exchange of information.

4. Become a “this reminds me of…” person

If you start to notice, everything in life is connected to everything else. Any topic you can think of can be linked to many other topics and stories. This means that any subject someone mentions is also a start for other projects.

You could talk until your jaws hurt if you use the technique of “this reminds me of…”. But don’t only talk about the stuff that happens in your life, that’s too limiting. You can talk about other people’s stories, stuff you heard or read on the news, things you’ve read in books or seen in movies, or tv shows.

People will see you as a very valuable person, because you’re always ready to bring new perspectives, information, and funny stories to any subject of conversation.

5.  Stay in touch with new friends using the “double commonality” technique

Now that you got yourself relaxed and free to talk about anything you want, you expressed what you’re interested in, and shared stories from all around you, let’s get you to stay in touch with the people you meet.

This technique will help you do just that: one of the main reasons why people want to see you again is if they feel that they can relate to you. This is why it’s a great idea to find something you have in common with them.

But, if you pay attention, and find a second commonality, then you get to a whole new level. If you can relate to a person in two domains, you make it very natural for both of you to want to stay in touch, and maybe even become friends.

This layering of commonalities naturally creates a sense of closeness, and is the foundation for making new friends.

Do you think it’s easier for extroverts to make friends than it is for introverts?

Exercise is Statistically as Good as Pharmaceuticals to Treat Diseases.



A recent study 
published in BMJ found that physical activity is as effective as drug interventions for patients with existing cardiovascular diseases and other chronic conditions such as diabetes.

In the few conditions where the life-saving benefits of exercise have been studied, physical activity was often found to be as effective as drugs at reducing the risk of death, according to the first study to aggregate and assess the comparative benefits of drugs and exercise for reducing mortality in a wide range of illnesses.

 

“We were surprised to find that exercise seems to have such powerful life-saving effects for people with serious chronic conditions,” said Huseyin Naci, an HMS visiting fellow in population medicine at the Harvard Pilgrim Health Care Institute, and a graduate student at the London School of Economics. “It was also surprising to find that so little is known about the potential benefits of physical activity for health in so many other illnesses.”

Regular physical activity has been shown to reduce the morbidity and mortality from many chronic diseases. Millions suffer from chronic illnesses that can be prevented or improved through regular physical activity. This include heart disease, heart attack, type 2 diabetes, obesity, colon cancer, hip fractures, stroke and high blood pressure. On average, people who are physically active outlive those who are inactive.

Despite the well-known benefits of physical activity, most adults and many children lead a relatively sedentary lifestyle and are not active enough to achieve these health benefits. A sedentary lifestyle is defined as engaging in no leisure-time physical activity (exercises, sports, physically active hobbies) in a two-week period.

Study Details

In addition to providing guidance for patients and clinicians about the importance of discussing the potential benefits of exercise, the researchers highlighted the importance of continuing to research the value of exercise for health.

The researchers argue that more trials comparing the effectiveness of exercise and drugs are urgently needed to help doctors and patients make the best treatment decisions. In the meantime, they say exercise “should be considered as a viable alternative to, or alongside, drug therapy.”

“We’re not saying people who have had a stroke should go off their medication and head to the gym,” Naci said, “but having a conversation with their physician about incorporating exercise into their treatment might be beneficial in many cases.”

Preventable illness makes up approximately 80% percent of the burden of illness and 90% of all healthcare costs. Preventable illness accounts for eight of the nine leading categories of death.

In the United States, 80 percent of people 18 and older failed to meet the recommended levels of aerobic and muscle-strengthening physical activity in 2011, according to the CDC. What’s more, the average number of retail prescriptions per capita for calendar year 2011 was 12.1, according to the Kaiser Family Foundation.

For people with chronic ailments, exercise used to be viewed as asking for trouble. However, current evidence suggests that in both health and disease, the overall prognosis is better for the exerciser than for the sedentary. For example, a recent study showed that intensive workouts can not only slow the progress of coronary disease, but actually restore lost coronary function when the disease is still stable.

“We’ve yet to find a disease state where exercise isn’t helpful.” said Miriam Nelson, Ph.D, from Tufts University.

For the current study, the researchers analyzed the results of 305 randomized controlled trials involving 339,274 individuals and found no statistically detectable differences between exercise and drug interventions for secondary prevention of heart disease and prevention of diabetes.

Exercise Often More Effective Than Drugs

Among stroke patients, exercise was more effective than drug treatment.

The authors point out that the amount of trial evidence on the mortality benefits of exercise is considerably smaller than that on the benefits of drugs, and this may have had an impact on their results. Of the nearly 340,000 cases analyzed, only 15,000 patients had had exercise-based interventions.

For chronically ill individuals, the psychological as well as physical benefits of exercise can be profound. Even ten minutes of light exercise a day, can help most chronically ill patients feel more vibrant, energetic and alert.

“Exercise is empowering and energizing, and it increases your sense of control over the situation. You’re never too sick or too old to get started exercising,” stated Bess Marcus, Ph.D, of Brown’s University.

The researchers argue in the paper that this “blind spot” in available scientific evidence “prevents prescribers and their patients from understanding the clinical circumstances where drugs might provide only modest improvement but exercise could yield more profound or sustainable gains in health.”

Participation in regular physical activity– at least 30 minutes of moderate activity on at least five days per week, or 20 minutes of vigorous physical activity at least three times per week–is critical to sustaining good health. Youth should strive for at least one hour of exercise a day. Regular physical activity has beneficial effects on most (if not all) organ systems, and consequently it helps to prevent a broad range of health problems and diseases. People of all ages, both male and female, derive substantial health benefits from physical activity.

Regular physical activity reduces the risk of developing or dying from some of the leading causes of illness in the United States. Regular physical activity improves health in the following ways:

·         Reduces the risk of dying prematurely from heart disease and other conditions;

·         Reduces the risk of developing diabetes;

·         Reduces the risk of developing high blood pressure;

·         Reduces blood pressure in people who already have high blood pressure;

·         Reduces the risk of developing colon and breast cancer5;

·         Helps to maintain a healthy weight;

·         Helps build and maintain healthy bones, muscles, and joints;

·         Helps older adults to become stronger and better able to move about without falling;

·         Reduces feelings of depression and anxiety; and

·         Promotes psychological well-being. 


Exercise v.s. Diet v.s. Drugs

Exercise v.s. diet v.s. drugs is often the debate that many health professionals evaluate. By examining each disease through clinical trials, we can better determine the efficacy of both exercise and diet in the treatment of many common ailments. Diet, for example, is the cornerstone of diabetes care, but if diet is combined with exercise, diabetics dramatically improve their condition by more than 45% than with diet alone.

CONDITION

TYPE OF EXERCISE

MAXIMUM IMPROVEMENT WITH EXERCISE

MAXIMUM IMPROVEMENT WITH DRUGS

MAXIMUM IMPROVEMENT WITH DIET

High Blood Pressure

Aerobic

15%

9%

11%

Diabetes

Strength training, flexibility, low-impact aerobic

52%

5%

38%

Stroke

Strength training, flexibility, low-impact aerobic

28%

7%

Heart Disease

Aerobic

33%

11%

26%

High LDL cholesterol

13%

20%

Low HDL cholesterol

Aerobic

15%

High Blood Sugar

Aerobic

15%

11%

30%

Arthritis Pain

Strength training, flexibility, low-impact aerobic

40%

12%

Low Bone Density

Weight bearing

3%

2%


Regular physical activity is associated with lower mortality rates for both older and younger adults. Even those who are moderately active on a regular basis have lower mortality rates than those who are least active. Regular physical activity leads to cardiovascular fitness, which decreases the risk of cardiovascular disease mortality in general and coronary artery disease mortality in particular. High blood pressure is a major underlying cause of cardiovascular complications and mortality. Regular physical activity can prevent or delay the development of high blood pressure, and reduces blood pressure in persons with hypertension.

Despite this uncertainty, the authors claim that based on the available data physical activity is potentially as effective as many drug interventions and more trials to address the disparity between exercise and drug-based treatment evidence are needed.

 

“What we don’t know about the benefits of exercise may be hurting us,” Naci said.

Sources:
bmj.com
nlm.nih.gov
preventdisease.com
medicalnewstoday.com

Russia is Considering a Total Ban on GMOs.


As one of the few nations in the world with a GMO-free platform, Russia does not allow any cultivation of GMOs for commercial purposes. Their regulatory agencies recently suspended the import and use of an American GM corn following a study suggesting a link to breast cancer and organ damage. The Russian Prime Minister has now ordered the same agencies to consider a possible ban on all GMO imports into Russia.

The Russian Federal Environmental Assessment Commission has not adopted any commercialized GM varieties for agricultural use.

The recent decision by the Russians to suspend authorisation for American GM corn threatens to trigger a transatlantic commercial and diplomatic row.

growing body of scientific research – done mostly in Europe, Russia, and other countries – showing that diets containing engineered corn or soya cause serious health problems in laboratory mice and rats.

Experts at the University of Caen , conducted an experiment running for the full lives of rats – two years.

(RELATED: Join the March Against Monsanto happening10/12/13http://www.march-against-monsanto.com/p/blog-page.html)

The findings, which were peer reviewed by independent experts before being published in a respected scientific journal, found raised levels of breast cancer, liver and kidney damage.

Russian Prime Minister Announces Possible Ban On All Imports

Russia’s consumer rights watchdog and Health Ministry, Rospotrebnadzor, announced one year ago that it had suspended the import and use of the Monsanto GM corn.

Now, the Russian Prime Minister Dmitry Medvedev has ordered the relevant agencies to consider a possible ban of all imports into Russia of products containing genetically modified organisms (GMOs) by October 15.

The order is addressed to Rospotrebnadzor, the Agriculture Ministry, and the Trade and Economic Development Ministry. They have been ordered to “submit proposals on amendments to the Russian legislation aimed at tightening control over the turnover of products containing components obtained from GMOs together with the relevant federal executive bodies.”

The aforementioned agencies are also ordered to submit proposals “on the possibility of banning the import of such products into the Russian Federation.”

A list of the prime minister’s orders was drawn up to fulfill the presidential orders issued after the meeting on the socio-economic development of the Rostov region held on September 18. Medvedev’s orders have been posted on the government website, Interfax news agency reported last September 25.

Russia is currently taking a hard line on GMOs — in August the first independent project for identifying whether Russian farmers are growing illegal GM crops started in the Belgorod region.

NAGS (The National Association for Genetic Safety) conducted the first checks of agricultural crops for the presence of GMOs. No GMO plants were found in any Belgorod fields.

According to the current law, 19 GM lines are allowed in foodstuffs, but the cultivation of GMOs is not allowed.

After joining the World Trade Organisation (WTO), Russia is being pressured simplify the procedure for registration of genetically modified products, seed and feed, to stop their safety checks, and to stop controls over their distribution.

Nations Banning Monsanto’s Glyphosate Herbicide 

Glyphosate is the world’s top selling herbicide, and Monsanto’s formulations Roundup is used with more than 80 percent of all genetically modified (GM) crops grown globally. But evidence of its extreme toxicity has been emerging within the past decade. Glyphosate was found to kill human placental cells at concentrations below that recommended for agricultural use and approved by our regulators, while Roundup was lethal at even lower concentrations.

The toxic effects of Roundup (R400) begin at 5 ppm, and the first endocrine disrupting action is already evident at 0.5 ppm, 800 times lower than the level of 400 ppm authorized by the US Environment Protection Agency in food or feed.

According to one analysis, GMO corn tested by Profit Pro contains a number of elements absent from traditional cord, including chlorides, formaldehyde and glyphosate. While those elements don’t appear naturally in corn, they were present in GMO samples to the tune of 60 ppm, 200pm and 13 ppm, respectively.

“Glyphosate is a strong organic phosphate chelator that immobilizes positively charged minerals such as manganese, cobalt, iron, zinc [and] copper,” Dr. Don Huber attested during a separate GMO study recently released, adding that those elements “are essential for normal physiological functions in soils, plants and animals.”

El Salvador has recently voted to ban glyphosate, the pesticide that most GM crops are designed to be grown with, along with 52 other chemicals.

Predictably, protests have been raised by the GM lobby group CropLife, which is scaremongering about losses of up to 60% in crop production if the chemicals are banned.

 

The news of the historic El Salvadorean vote comes on the anniversary of the publication of the groundbreaking study led by Prof GE Seralini, which found that the glyphosate-based pesticide Roundup – and a GM maize engineered to tolerate it – caused severe organ damage and increased rates of tumours and premature death in rats. Roundup was found to be toxic at half the level permitted in EU drinking water.
Denmark has also imposed widespread bans on the spraying of glyphosate in response to research showing that the sprays have been contaminating the countrys groundwater.

The chemical has, against all expectations sieving down through the soil and polluting the ground water at a rate of five times more than the allowed level for drinking water, according to tests done by the Denmark and Greenland Geological Research Institution (DGGRI).

A decade ago, the Danish environment minister Hans Christian Schmidt announced unprecedented restrictions on glyphosate, the country’s and Europe’s most widely used herbicide.

Source: 
gmwatch.org

Tooth implant restores vision in blind man in UK.


A 43-year-old blind man in the UK has had his sight miraculously restored after a pioneering surgery that involved implanting one of his teeth into his eye.

Ian Tibbet, a factory worker, lost his vision after a piece of scrap metal from an oven struck him in the right eye during a workplace accident.

Ian’s sight remained fine for the first few years but then he began to suffer recurrent problems. Eventually, in 1998, he lost the sight in his right eye and had to stop working. A year later he lost the vision in his left eye too.

Ian has now been able to see his kids for the first time, thanks to a revolutionary procedure,the ‘Mirror’ reported.

During the technique osteo-odonto-keratoprosthsesis, one of Ian’s front teeth and a part of jaw was removed and used as a lens holder in his right eye.

“It was an incredible moment – I never thought I would ever be able to see my own children,” said Ian.

The revolutionary tooth transplant, carried out by Professor Christopher Liu at the Sussex Eye Hospital in Brighton, began when one of Ian’s teeth was removed and it acted as a cradle for a false lens.

The tooth was then inserted into his cheek for three months to enable it to grow new tissue and blood vessels.

The doctors then inserted the tooth, complete with the fitted lens into Ian’s right eyeball.

Within weeks of the final operation, his sight returned.

Lost Leonardo da Vinci painting of a noblewoman with same smile as the Mona Lisa discovered in Swiss vault after 500 years.


·         The oil portrait of Isabella d’Este had been missing for five centuries

·         It was discovered in a family’s bank vault in Switzerland

·         It is a rendering of a well-known pencil sketch, which hangs in the Louvre

·         ‘There is no doubt the portrait is the work of Leonardo,’ says world expert.

Isabella d’Este

For five centuries, it has been one of the art world’s greatest mysteries, with even its very existence in doubt.

But now, almost 500 years after he painted it, a priceless Leonardo da Vinci masterpiece has been unearthed in a Swiss bank vault. 

In a story that seemed to come directly from the pages of a Dan Brown novel, the portrait of Italian noblewoman, Isabella d’Este, was discovered as part of a private collection in a Swiss bank.

The Italian owners have decided to keep their identity a secret. 

The painting is a canvas and oil, finished rendering of a well-known pencil sketch of the same woman, the wife of the Marquess of Mantua and one of Renaissance Italy’s most influential women

The sketch, which was drawn in 1499, hangs in the Louvre, and is considered a forerunner to his most famous painting, the Mona Lisa. 

Isabella, who appears to share the world-famous subject’s mysterious smile and rounded chin, wanted to be painted by the all the greatest artists of the day, which naturally included da Vinci.

The preliminary sketch was greatly admired by the aristocratic lady’s friends so she asked him to finish the commission.

But art historians had long been divided over whether the finished version of the commission existed. 

Da Vinci soon after begun one of his most compelling and large scale projects, The Battle of Anghiari, in Florence town hall. Then in 1503, he began the Mona Lisa. 

Leonardo da Vinci
Original sketch

The painting is a canvas and oil, finished rendering of a well-known pencil sketch of d’Este (right). The sketch, which was drawn in 1499 and hangs in the Louvre, is considered a forerunner to da Vinci’s (left) most famous painting, the Mona Lisa

Now experts believe that the striking portrait is indeed the work of the Italian genius.

Professor Carlo Pedretti of the University of California, Los Angeles, the world’s leading expert in da Vinci told Italy’s Corriere della sera newspaper. ‘There are no doubts that the portrait is the work of Leonardo.

‘I can immediately recognise Da Vinci’s handiwork, particularly in the woman’s face.’

Carbon dating has shown that there is a 95 per cent probability that the portrait was painted during the Renaissance period. 

And scientific tests have revealed that the primer used to treat the canvas is the same as that used by da Vinci

Further tests will make clear whether some of the lady’s accessories, including the gold crown, could have been painted by one of da Vinci’s assistants.