Sesame Street introduces muppet with autism to teach children about disorder

Sesame Street is adding a new character to its ranks – a muppet called Julia, who has autism.

Julia, a four-year-old with bright orange hair, a pink dress and a favorite toy rabbit called Fluffster, will make her debut on 10 April in an episode called “Meet Julia”. She has already appeared in Sesame Street cartoons and books, but this will be her first appearance on the famous children’s show.

“We wanted to address autism in general because of the growing number of children who are diagnosed with autism spectrum disorder,” Sherrie Westin, EVP of global social impact and philanthropy at Sesame Workshop, the non-profit behind Sesame Street, told the Guardian.

“We felt that creating a character who was autistic would allow children to identify her but equally important, it would allow us to model for all children the differences and commonalities of a child with autism.

“It was an opportunity to help explain autism and to help increase awareness and understanding.”

On Monday, Sesame Street released a number of video clips featuring Julia. One shows her sitting at a table, painting with some of the other characters. Big Bird arrives and says hello to Julia, who carries on with her work rather than saying hello back.

Big Bird and Sesame Street stalwart Elmo appeared on CBS’s 60 minutes on 17 March, to talk with host Lesley Stahl. Big Bird told Stahl he had initially been perturbed by Julia’s lack of response.

“I thought that maybe she didn’t like me,” Big Bird said.

“We had to explain to Big Bird that Julia likes Big Bird,” Elmo said. “It’s just that Julia has autism. So sometimes it takes her a little longer to do things.”

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Sesame Street introduces Julia to the Associated Press.

Later in the episode – according to a clip seen by the Associated Press – Julia becomes distressed when a siren goes off.

“She needs to take a break,” the muppets’ human friend Alan calmly explains. Julia soon relaxes and the friends carry on playing.

Another video shows Elmo approaching Julia, who is playing with Fluffster on her own. Elmo sees that Julia is focused on her own activity and says: “We can play side by side, like we do sometimes.”

“There’s lots of ways to play,” Elmo tells the camera.

Julia’s introduction is part of an initiative: “Sesame Street and Autism: See Amazing in all Children”. Sesame Workshop said it consulted with more than 250 organizations and experts over a five-year period, ahead of unveiling the character.

Julia is played by puppeteer Stacey Gordon, who told the Associated Press her 13-year-old son also has autism.

“The ‘Meet Julia’ episode is something that I wish my son’s friends had been able to see when they were small,” Gordon said. “I remember him having meltdowns and his classmates not understanding how to react.”

Sesame Street introduces muppet with autism to teach children about disorder

Ginger’s life on the street: a battle with people’s disgust, illness … and the cold

For three days he hadn’t slept, at least not properly. The last time he remembered drifting off was before dawn on Tuesday. It was now 1:40pm on Friday, and Ginger was hunched in his sleeping bag on the freezing slab of north London pavement he called home. His resting place was outside a branch of HSBC, metres from Camden Town tube station. There might be more crowded locales in London but few are more frantic. Around him surged crowds of tourists and revellers starting the weekend early. A bunch of Italians took it in turns to take pictures of Ginger, red-eyed and weary, a very modern face of the capital. Others struggled to hide their pity; some looked plainly disgusted.

But it wasn’t the incessant tumult of Camden that had induced Ginger’s most recent bout of insomnia. “It’s the cold. You can’t sleep. You just lie there, freezing. Even when you turn numb, it’s still painful. And someone stole my gloves,” he shook his hands forcefully to mimic his shivers as the temperature fell to -3C last week.

Ginger said the best thing to kill the cold was heroin. “It’s the only thing that makes you feel warm, from the inside. But it’s been so cold, even that hasn’t worked.”

An articulate and incisive character, Ginger is one of Britain’s growing cohort of rough sleepers, among the 960 identified in London last year. Last week government figures showed that the number of rough sleepers in England had risen for the sixth year in a row, up 16% on the previous year, nearly double the number since 2010. Across the country 4,134 people were forced to sleep outside. Ginger describes it as a life of extremes, an existence that brings out the best and the worst of people. “Some people try to bully you, try to pick a fight, some spit at you or shout at you to get a job or get some benefits. Mostly they tend to stick their nose up at you.

“And then a lady will walk by and give you a helping of homemade stew that she’s made especially – that happened yesterday,” he smiles. Considering his profound fatigue, Ginger looks well, although he admits he feels “much older” than his 41 years. The average age of death for rough sleepers is 47. The lowest average life expectancy in the world is in west Africa’s Sierra Leone: 44.4 years.

Ginger, born in upper Clapton, east London, in March 1975, describes his life’s journey as a string of squandered opportunities, bad luck, bad decisions, substance abuse and ultimately the shocking murder of a loved one. His first setback occurred at the age of six and a half. Ginger’s mother walked out on him and his father. He has not spoken to her since. “She didn’t want anything to do with me.” His father, now 67, brought him up single handedly and, according to Ginger, remains supportive.

After leaving school aged 16, Ginger went to live with his uncle in the Irish city of Limerick. There, he fell in love with the outdoors. In the River Shannon he caught his first salmon. He went rabbit hunting in the fields below the Slieve Felim mountains. “I became a keen fisherman, I really took to the life.” But the lure of London drew him back and, aged 19, Ginger found work as a painter and decorator in Camden, making £50 a day cash in hand, a grand a month. “That was big money in those days,” he said. But his disposable income was invested disastrously. Ginger began drinking heavily in Camden pubs like the World’s End – opposite where he now sleeps – or the Camden Head. “The problem was that I was drinking with the wrong crowd.”

Cannabis use rapidly evolved into crack and heroin addiction. His job suffered, his income evaporated. In 2000 Ginger received his first custodial sentence for robbery. For the following eight years life became a blur of prison and heroin use. He served time in Pentonville, Wandsworth and Portland, among others. Amid the chaos, Ginger managed to maintain a seven-year-relationship. He and his partner had two daughters and a son between 2002 and 2006. The family lived in a two-bedroom flat in a yellow tower block behind Euston station. “I had everything I ever wanted. I thought I’d made it.”

But in 2008 the relationship broken down. Ginger went clean but he has not heard from his partner or children since. His loss prompted a period where he tried to build a new life, and Ginger is adamant he would have never ended up on Camden’s streets had it not been for the brutal murder of his Irish uncle in 2015. An intruder attacked and viciously beat the 74-year-old in his Limerick home. “I was asked to go to the funeral but had to say no. I couldn’t bear to see him in the open coffin. I wanted to remember him as he was,” said Ginger, still visibly grief-stricken. Heroin anaesthetised the pain. By the summer of 2016 Ginger had lost everything and was a rough sleeper. “Once you’re back on the heroin, it’s hard to get straight,” he said, describing his current heroin intake as “dabbling”.

Spice – synthetic cannabis – is the narcotic of choice among Camden’s rough sleepers now. “Everyone’s on it. It just knocks you out,” said Ginger. Last May the government made spice illegal, and the only people to benefit have been the dealers. Before then, Ginger could procure five grams for £25 from a local shop. Now dealers cut the substance and charge £10 for half a gram.

Camden could be a violent place for a rough sleeper, he said. He is wary of the surrounding streets, recounting a drunken night in 2003 when he got into a mindless squabble with a stranger in a nearby alley. They began fighting. Initially Ginger thought his assailant had punched him in the leg. “Then I realised I’d been stabbed. You live in fear that that can happen at any time.”

Ginger also admitted that he was a danger to himself. In 2008 he was taken to St Pancras hospital in handcuffs after a psychotic episode. Once there, he sliced himself open with a craft knife he had hidden in his pants. Yanking up his jacket, he reveals two parallel lines of knotted scar tissue 30cm long, running across his lower stomach. “It was the voices that told me to do it.” He was diagnosed as a paranoid schizophrenic and currently receives a fortnightly injection to control his condition. Research by charity St Mungo’s shows that four in 10 people who sleep rough have a mental health problem.

But street life is not unswervingly bleak. Ginger’s survival relies on daily acts of unsolicited generosity. “Some people sit down for a chinwag and ask how I am. Others give me money, even 20p, for which I’m always grateful. People bring sandwiches or visit a local shop to buy me lunch, and local restaurants often bring leftover meals.”

Staff from the McDonald’s on Camden High Street bring over a quarterpounder with cheese, Ginger’s favourite. If not, there is the nearby soup kitchen which, in a sign of the times, can “become very crowded”.

Ginger talks fondly of his fellow rough sleepers, how they will defend each other if attacked or from new faces they don’t trust. In the past Ginger has befriended strangers and woken up without his shoelaces. Even so, rough sleeping is fundamentally wearying. Days begin around 5am, when the city starts waking up, and Ginger says he can only fully relax after 3am when Camden’s nightlife fades. His alternative “homes” – a doorway close to the American Apparel store across the high street and an alley behind the World’s End – are hardly more peaceful.

Ginger often thinks of the day he’ll be able to leave Camden’s streets. Like all rough sleepers his primary ambition is a permanent home. Without an address, securing a job and saving money is almost impossible.

But Ginger is also scared that he’ll never fully conquer the internal voices that he said prevented him from moving forward. “The medication is working in the sense that I can only hear mumbling. I can’t quite make out the voices but they are there, coming from behind my back. If they stop, I’ll be able to think more clearly.”

HOMELESSNESS FACTFILE

• Using a different methodology to the government figures, the Combined Homelessness and Information Network, found that 8,096 people slept rough at some point in London during 2015/16, an increase of 7% one the previous year.

• Of these, 5,276 people were new rough sleepers.

• 85% were male, with the proportion of women rising slightly over the last two years by 1%

• Many rough sleepers have pressing support needs: 43% have alcohol problems; 31% have drug addictions and 46% mental health issues. The proportion of rough sleepers with no support needs is around a quarter.

• A third of people seen rough sleeping in 2015/16 had served time in prison, while one in 10 had experience of the care system. Eight per cent had been in the armed forces.

• Where nationality was recorded, 3,271 people rough-sleeping were UK nationals – 41% of the total.

Ginger’s life on the street: a battle with people’s disgust, illness … and the cold

A moment that changed me: being abused on the street about my weight | Sofie Hagen

Any centre of any city on any Friday or Saturday night always has the same vibe. It is as if there has been a fire at the prick factory and everyone has escaped. I always try to stay away. If I have a standup gig in central London, I leave immediately after the show and get back to my safe bed as soon as I possibly can. Alcohol brings out the worst in some people – and no one has ever drunkenly told me something I really needed to hear.

This happened on a Saturday. I had rushed out of a gig and got the tube to Kennington, where I was waiting for my bus. I’d forgotten my headphones – I never forget my headphones – so I was hyper-aware of all the drunk people walking the streets, getting on the tube, going into London to seek shelter in nightclubs where the music, fortunately, is so loud that no one can hear them speak, which means they never have to develop personalities.

I saw four young men approach the bus stop. I was not surprised when they spoke – I expected it. “Oi you fat cunt!” one of them said. “Oink oink,” said another. The rest is a blur because I focused on whatever was on my phone. It hurt, of course. As it would have hurt anyone.

I cannot say it clearly enough: this happens on a daily basis to hundreds of thousands of fat people everywhere

Not having any idea what to do, I put it on Facebook. I shared it with my friends and followers. I just needed to do with that experience what I usually do when I do standup – take ownership of it and express myself. It felt a bit better.

I woke up the next day to my post having been shared thousands of times. It was even in newspapers and on blogs. “Danish Comedian Sofie Hagen says: They Shouted Abuse At Me” and “Men Shout At Danish Comedian – What Happens Next Will Shock You” and other such clickbaity headlines. People had commented underneath the post, things such as, “I am really sorry that happened to you,” and “Those guys were massive pricks.”

It stopped hurting. The hurt immediately disappeared. And all I was left with was anger.

Sofie Hagen performing at the Edinburgh Fringe, 2016. Photograph: Murdo Macleod for the Guardian

I cannot say it clearly enough: this is not a once-in-a-lifetime thing. This happens on a daily basis to hundreds of thousands of fat people everywhere. This will happen today, at this very moment, to a 14-year-old girl who is yet to realise that her body’s worth is not dependent on what the media tells her about it. It is happening to children. It will happen again. Maybe tonight when I am walking home from a gig, even though it is Monday and I’m nowhere near the centre of a city.

This will happen online – some people will even be inclined to write it under this very article. People will tell me to stop promoting obesity. People will tell me to just lose weight. People on Twitter will tweet at me without having read the article and pretend that they are merely worried about my health. Some will even tell me I am making it up. Some fat people will say they have never experienced anything like that.

This will happen on TV, in movies and in radio. As I am writing this, my fat friend told me that last week she was hit in the head with a kebab – and yes, that is a really funny sentence – I am but human, and “kebab” is a funny word and that is a funny image. It is, however, also normal and unforgivable.

It has always happened and it will continue to happen. But now it’s different. I no longer feel good when people pity or comfort me afterwards. I do not need people’s kind words. I need their fury. I need them to be angry with me. I need them to act.

I need everyone to realise the repercussions of making “fat” mean lazy, stupid, unattractive and unhealthy. Fat is not necessarily unhealthy and skinny is not necessarily healthy. I need people to stop saying “You are not fat, you are beautiful,” as though they are mutually exclusive. I need people to feel angry – not at these four idiots at Kennington station – but at the society that created them. I need people to demand change. Tweet companies who use fatphobia to promote their products, email TV shows portraying fat women as sexless and evil or motherly and goofy. Call out your friends, family and teachers.

If not, that is OK. But then keep your pity to yourself. I am a healthy, beautiful, intelligent, active and creative fat woman. I am doing what I love for a living. I have friends and family who love me. I am good. I am no longer sad. Now I am just angry, and I wish you were too.

• Sofie Hagel is on tour and will be performing Shimmer Shammer at the Soho Theatre in London, 5-17 December

A moment that changed me: being abused on the street about my weight | Sofie Hagen

Who Are The Folks In Your Neighborhood, Sesame Street?

Sesame Street has joined up with Autism Speaks as element of an initiative to “See Remarkable in All Children.” They kicked off this effort by receiving with each other with Bob and Suzanne Wright of Autism Speaks to light the Empire Empire State Building blue for World Autism Day on April two.

It’s admirable that Sesame Workshop needs to, as they say, “develop a new community engagement initiative to help minimize the stigma surrounding youngsters with autism.”

Except that they’re functioning with a person, Suzanne Wright, who wrote this about autism only five months ago.

An excerpt:

These families are not residing.

They are existing. Breathing – yes.  Eating – yes. Sleeping- possibly.  Functioning- most certainly – 24/7.

This is autism.

Existence is lived moment-to-second.  In anticipation of the child’s subsequent move.  In despair.  In dread of the future.

This is autism.

That doesn’t sound like somebody intent on “reducing stigma” about autism.

A information release from the individuals at Sesame Workshop estimates a representative speaking about the initiative:

“We have identified that there’s a lack of understanding amongst the basic public about kids with autism,” explained Dr. Jeanette Betancourt, Sesame Workshop’s Senior Vice President for Local community and Family members Engagement. “Sesame Workshop has a extended background of addressing diversity, acceptance, and inclusion, and we felt we could play a critical position in decreasing misconceptions by highlighting the commonalities children with autism share with all youngsters. With each other with our partners, we will leverage the energy of our engaging Muppets to help to carry this message to children, families, and communities.”

Except that acceptance does not look to be substantial on the list of the organization with whom they’ve partnered. You won’t locate that word in their mission statement. What you will locate is this:

We are devoted to funding global biomedical research into the triggers, prevention, treatments and a possible cure for autism.

How does this jibe with Sesame Workshop’s stated aim of “reducing misconceptions” and “highlighting commonalities” among kids with and without autism or emphasize “diversity, acceptance, and inclusion”? It does not appear to.

I know that in component thanks to organizations like Autism Speaks, the perception of autism is largely a adverse one, charged emotionally with the anguish of parents who have heard only negatives from the moment they heard that word linked to their youngsters. But autism is not cancer. It isn’t a disease–it’s not progressive, it’s not degenerative, it does not destroy.

It’s a situation that is not universally regarded as a adverse. It’s a issue that a lot of who have it take into account to reflect their identity in methods that are great as well as ways that raise obstacles. It’s one that I firmly feel we will come to understand far better and far better for positives as well as negatives if we shift our concentrate to Sesame Workshop’s very own phrases of “diversity, acceptance, and inclusion,” if we emphasis on really listening to autistic folks and their insights about themselves and what they need to have. Choosing an organization, Autism Speaks, that has no autistic people in its leadership, looks counter to that.

Sesame Workshop has an chance right here to do for autistic people what they did for me when I was a kid and avid fan, only a small older than Sesame Street itself: Consist of them in and demonstrate viewers a globe exactly where absolutely everyone has differences. Every person has struggles. Yet no one is excluded, marginalized, informed they require to be prevented or cured or various from who they are. You can be a massive, weird, sensitive yellow talking bird chatting with his imaginary elephantine friend or a green guy who lives in a garbage can and gripes at every person as a defense mechanism, and the world is Ok with that and understands it. Joining with Autism Speaks, a group with a mission of prevention and a message of concern and despair, is a jarring, off-message move to me and one particular that belies the four-and-a-half decades of neighborhood that Sesame Street has worked to construct.

Who Are The Folks In Your Neighborhood, Sesame Street?

Volunteer paramedics face street visitors prosecution despite "seeking to do good"

Lady Justice Rafferty, sitting with Mr Justice Jay in London, mentioned she was saddened that medically skilled volunteers “seeking only to do good” had been efficiently constrained.

On Oct 14, 2012, the two men attended an accident at 8.17pm involving a car and motorcycle on the outskirts of Bury.

They recognized themselves to police as Hatzola Quickly Response personnel and have been allowed to give health care care just before an NHS ambulance arrived eight minutes later on.

The two men have been then told they would be reported for utilizing “blues and twos”.

At their original trial, District Judge Richardson was told that the Hatzola crew originated in America about 40 many years ago with the objective of saving lives. It has since spread to Britain.

It aims to give emergency very first help cover in defined locations, such as Salford and components of Bury, mainly but not exclusively for the Jewish neighborhood. In Salford there are 20 Hatzola members, ten of whom are skilled paramedics, such as Mr Issler and Mr Bamberger.

Their typical response time is “under two minutes”, compared with 7 to 10 minutes for NHS ambulances, the court was informed.

Their massive vehicles can carry health-related products, including defibrillators, oxygen and neck braces, as effectively as dressings and some medication.

Judge Richardson stated Hatzola’s 24-hour-a-day care was funded by voluntary contributions from the Jewish neighborhood.

“I discovered Hatzola to be a responsible, devoted and public-spirited organisation with properly-qualified and motivated operatives, of whom the defendants were two,” he stated.

He acquitted each men of the traffic charge, saying their cars had been getting “used for ambulance purposes”.

But the High Court judges ruled on Wednesday that his choice was incorrect. They agreed “with regret” that the appeal must be allowed.

Mr Justice Jay stated road traffic legislation did not supply an exemption for “first responder” voluntary organisations such as Hatzola to escape the restrictions on the use of “blues and twos”.

Edited by Andrew Marszal

Volunteer paramedics face street visitors prosecution despite "seeking to do good"

Lifestyle mapping will set you on the street to contentment

In accordance to constructive psychologist Miriam Akhtar, the writer of Constructive Psychology for Overcoming Depression (Watkins), setting life goals that improve your well-getting is likely to motivate you to succeed and set you on the upward spiral to flourishing – which means feeling very good and working nicely.

Constructive psychology pioneer Prof Martin Seligman has recognized five components important to human properly-becoming using the acronym PERMA. P is for positive emotions such as enjoy, joy, gratitude, awe and inspiration. E is for engagement – in activities that are absolutely absorbing and use your signature strengths. R is for relationships – getting authentically linked to other people. M is for meaning – residing a meaningful lifestyle and serving or belonging to something larger than you. A is for accomplishment – the pursuit of achievement as nicely as mastery for its personal sake.

“Using the PERMA model when compiling a existence map will increase your effectively-getting, and your goals are much more most likely to lead to success, which in turn will enhance properly-being — it is a virtuous circle,” adds Akhtar.

While mindfulness helps you accept what is, “savouring” is another thought that can enhance your feel-good factor. Akhtar says savouring “is about becoming mindful in order to create constructive feelings – to genuinely observe and appreciate what’s excellent about the present moment.”

Retaining a gratitude journal is also important, as is calming a hectic mind.

Sandy C Newbigging, meditation teacher and ideal-marketing author of 5 books, such as the new Mind Calm (Hay House), says that residing in the present minute when functioning towards your goals is paramount.

“From the here and now, and with a clear thoughts, you will be astonished at what can be completed,” he says. “With calm and clarity you get whatever action is necessary now, and move on to the next point and then the next. Before you know it, you have written a guide, constructed a organization or attained anything spectacular – with really tiny pressure and a wonderful deal of serenity. You get to appreciate the journey correctly and knowledge the destination as a bonus, not a necessity.”

When producing your lifestyle map, focus on projects that actually inspire you. Nick Williams, writer of eight inspirational books such as The Work We Have been Born to Do (Element), believes in the power of taking little one methods. “Each stage taken, every obstacle overcome and every single dread faced leads to you expanding in self confidence, capability and awareness,” he says. “Then new vistas open up, new tasks emerge and the cycle continues.”

So your life map is not set in stone – it will evolve as you open by yourself up to the joy in the existing moment. Have exciting with it and let existence unfold in a route that helps you flourish.

How to produce a life map

To function out your prepare, first take by yourself out of your standard program and find a quiet location exactly where you will not be disturbed. Then prepare to solution some massive queries.

Consider a piece of A4 paper and divide it into 3 columns. In the proper-hand column, write down how you want to be remembered soon after you’ve gone.

In the central column, write down a listing of the extended-phrase goals that will aid you achieve your desired legacy.

In the left-hand column, make a note of objectives you can obtain during the following twelve months that will aid you accomplish your prolonged-term objectives.

You could also develop a thoughts map, placing by yourself at the centre and with lines radiating outwards that level to diverse places of your lifestyle: residence, occupation, relationships, finance, well being and whatever other topics you really feel are proper. Then free-associate to produce a diagram that represents how you want your daily life to appear.

As soon as you’ve determined on a format, reflect on the following:

one. Use only Wise – distinct, measurable, achievable, realistic and timed – ambitions.

two. When you are figuring out your targets, make positive they pass the PERMA check so that your properly-being will boost.

3. Recognize your values – characteristics that, for you, have intrinsic really worth and define what matters to you at the deepest degree – so you can set ambitions that are in alignment with what you stand for.

4. Identify your signature strengths – the factors you like doing and are good at.

5. Picture that you have as considerably income as you need to have and are living a relaxed lifestyle.

What would this most fulfilling lifestyle search like?

6. What would you most like to research, master or research? How can you issue it into your map?

7. What do you need in your daily life – past meals and shelter – for you to encounter satisfaction?

8. What causes are you inclined to dedicate your existence to?

9. Identify a peak moment in which you were completely at peace with the world – how can you go about encountering a lot more of individuals?

ten. What needs to take place, and who will you have to turn out to be, in order to transform your existence map into reality?

Excellent luck, and recognise what is excellent about your existence correct now to make far more joy in the long term.

* Beverley Glick has a Diploma in Human Potential Coaching from the Academy of Human Potential (academyofhumanpotential.org)

Lifestyle mapping will set you on the street to contentment

Wall Street Journal Op-Ed On Sham Surgical treatment Will get It Incorrect

In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should cease requiring healthcare device companies to use sham procedures when they test particular new goods. To assistance his argument he utilizes the illustration of renal denervation, a once highly promising new engineering for reducing blood stress. Unfortunately, Gottlieb extracts exactly the wrong lesson from this story, because the renal denervation story is a perfect example of why sham procedures can be each required and far more ethical than any option.

At very first glance it is tough to disagree with Gottlieb. The idea that patients would acquire an invasive surgical process that could do no great appears abhorrent. “Research that introduces harm or danger with no chance for advantage would seem to be to conflict with the ideas governing investigation on humans,” writes Gottlieb.

But the exact same actual phrases could and must be utilized to describe medical gadgets with no established advantage. In such instances, even so, instead of the reasonably modest quantity of patients possibly exposed to harm in clinical scientific studies, the variety of patients exposed to harm in the real world could be larger by many orders of magnitude.

Let’s examine this issue utilizing the exact same instance utilised by Gottlieb: renal denervation. In situation you haven’t been following this story, for the final handful of years renal denervation– the zapping of the renal artery with electric power to reduced blood pressure– has been widely deemed to be a single of the most thrilling and promising new healthcare technologies around. Based mostly on preliminary– and uncontrolled– scientific studies renal denervation was believed to constantly lower blood pressure by an astounding 25-thirty mm Hg and was hailed by several hypertension experts as a potential breakthrough remedy for people who had persistently and dangerously higher blood strain even right after taking a number of blood strain drugs.

Then actuality intruded. Medtronic announced last month that its pivotal trial of renal denervation had not met its main endpoint. It grew to become clear that renal denervation was neither a remedy nor a breakthrough. Although the particulars of the trial have not been revealed, the underlying trigger of the trial’s failure is reasonably nicely understood. Final summer a few skeptical British researchers very carefully examined the underlying science and concluded– contrary to what market and the professionals had been saying– that the correct blood strain decreasing result of renal denervation wold be a lot smaller sized than predicted. And the cause was straightforward: since all the early research had been either uncontrolled or poorly controlled, the firms and the researchers had tremendously overestimated the real result of renal denervation. The Medtronic trial, by contrast, was a lot more rigorous, in element because it integrated the notorious sham procedures decried by Gottlieb.

As Gottlieb notes, renal denervation “is already obtainable in Europe, where regulators authorized it primarily based on classic research.” Gottlieb fails to recognize how this undercuts his stage. Following all, several 1000′s of men and women in Europe have acquired a gadget from which they may possibly have obtained no or minor advantage and may have seasoned harm. But this does not appear to concern Gottlieb. Right here, creating about the impact of effectively-managed trials, is what does concern Gottlieb:

All of this raises development costs—and it encourages firms to skip the U.S. industry and commercialize new items overseas. This can suppress innovation. When a sham trial doesn’t produce positive final results, the organization may possibly have exhausted its assets and have no capital left to refine a excellent idea into a beneficial product.

But, as the renal denervation story demonstrates, the trial did not “suppress innovation.” As an alternative it showed that the so-referred to as “innovation” was, effectively, a sham.

Even though he waves the flag for ethics, it is clear that what truly motivates Gottlieb to stand up and salute is organization revenue. He’s far far more interested in the overall health of businesses than he is in the well being of individuals. If he were in fact interested in the welfare of sufferers he would spend consideration to the medical particulars of his examples. But rather his genuine concern appears to be the overall health the’ bottom line.

This isn’t the first time Gottlieb has baffled ethics and economics. In 2012 he wrote about another new health-related technology, transcatheter aortic valve substitute (TAVR), and argued that the FDA and CMS had prevented the American public from benefiting from the process. As I wrote then, Gottlieb fully ignored the complicated issues of the story, spinning an untrue but compelling tale in which the forces of government were preventing desperately sick folks from getting a new daily life-conserving therapy.

It seems clear that Gottlieb has really small interest in a critical discussion of clinical trials or the best way to check and introduce new medical technological innovation. What he really desires is to offer a basis for campaign slogans that undermine the FDA and government involvement in medicine. It does not matter that sham surgical treatment is a complex issue or that TAVR had as considerably possible danger as advantage. It’s simple to score polemical factors by scaring people, telling them that they will be subject to damaging procedures or that their government is preventing them from acquiring existence-conserving remedies. It’s a lot harder, and less politically advantageous, to take into account the full complexity of these problems.

Update:

Sanjay Kaul sent the following comment:

“Those who can’t don’t forget the past are condemned to repeat it”.

There are several examples the place the “scam” of some gadget-primarily based therapies has been exposed by the “sham” process. How can any person forget the traditional examples of laser TMR (TransMyocardial Revascularization) or Pacemaker for hypertrophic cardiomyopathy, both touted as breakthrough interventions. It would not surprise me a single bit if RF ablation for atrial fibrillation ends up with a similar fate!

Wall Street Journal Op-Ed On Sham Surgical treatment Will get It Incorrect

Clinical Trial Data At Heart Of Landmark Wall Street Insider Trading Scandal

Yesterday, Manhattan U.S. Lawyer Preet Bharara issued this statement shortly after the jury conviction of Mathew Martoma, a former portfolio manager at SAC Capital Advisors.

“As the jury unanimously identified, Mathew Martoma cultivated and bought the self confidence of medical professionals with secret information of an experimental Alzheimer’s drug, and utilized it to engage in unlawful insider trading. Martoma bought the response sheet prior to the examination – more than after – netting a quarter billion bucks in revenue and losses avoided for SAC, as properly as a $ 9 million bonus for him. In the brief run, cheating may possibly have been profitable for Martoma, but in the end, it made him a convicted felon, and probably will consequence in the forfeiture of his unlawful windfall and the reduction of his liberty. Mathew Martoma gets to be the 79th man or woman convicted of insider trading following trial or by guilty plea in this District in the last 4 years.” Statement of Manhattan U.S. Lawyer Preet Bharara (here)

A synopsis of the case was also supplied late yesterday by Over the Law (right here):

* The income produced and losses avoided by SAC Capital as a result of Martoma’s insider trading: $ 275 million.
* The win/loss record of U.S. Attorney Preet Bharara and the S.D.N.Y. in insider-trading circumstances: 79-.
* How prolonged the Mathew Martoma trial lasted: 4+ weeks.
* How extended the jury deliberated: 15 hrs.
* Gender breakdown of the jury: 7 women, five males.
* Counts of conviction: two counts of securities fraud, 1 count of conspiracy.
* Penalties paid by SAC Capital back in November 2013: $ 1.two billion.
* Recent or former workers of SAC Capital (such as Martoma) who have been convicted of criminal insider-trading fees (no matter whether by guilty plea or trial): eight.
* Number of “A” grades on Mathew Martoma’s fake Harvard Law School transcript: four (out of 7 grades).
* Number of D.C. Circuit judges that Martoma acquired clerkship interviews with: three.
* Age of Mathew Martoma: 39.
* How numerous youthful children Martoma has: three.
* The length of Martoma’s most likely prison sentence (pursuant to the non-binding federal sentencing recommendations): seven-ten many years.

Forbes has extensive coverage (here and here) on the Wall Street insider trading aspect – but the implications for the healthcare industry are equally crucial. Why? Because numerous believe the income to SAC Capital Adivsors – a substantial flying hedge fund with an equally substantial flying track record of achievement – were the result of the “most profitable within tip of all time” (PBS Frontline right here). That tip was within information offered by Dr. Sidney Gilman – a best Alzheimer investigation scientist who was earning $ 258,000 a 12 months as a professor at the University of Michigan (in which he was for decades).

The Frontline episode (“To Catch A Trader” right here) just aired last month. Central to Frontline’s claim of the “largest insider trading situation in history” was comprehensive clinical trial data provided by Dr. Gilman in a sequence that allowed SAC Capital to very first revenue from constructive trial data – and then keep away from large losses when subsequent trial data was adverse. The profit on each the excellent and undesirable clinical trial news was about $ 275 million.

In December of 2012, the New York Times profiled Dr. Gilman and his background of providing inside info to a selection of financial companies with the headline: Quiet Medical doctor, Lavish Insider: A Parallel Existence (right here).

What struck me wasn’t the normal Wall Street insider plot since there had been lots of publicly traded firms referenced in the Frontline section. A lot of were bellwether silicon valley chip producers with easily recognizable brand names. What struck me was how a single doctor – with within clinical trial details – could be at the very heart of one of the greatest – if not the largest – insider trading scandal in U.S. historical past. By assisting the Feds with their case towards Mathew Martoma it’s conceivable if not very likely that he will steer clear of criminal prosecution himself. It also highlights the enormous value of clinical trial information for one drug and 1 issue. The relative ease by which the details was provided (the inference was an early release of a presentation – likely by email) was noteworthy.

Mr. Martoma’s fate is now in the hands of sentencing – and then (really potentially) subsequent negotiations. He’s not the biggest fish the Feds are right after in their ongoing investigation. That would be Steven A. Cohen – the billionaire founder of SAC Capital Advisors. According to the Frontline section, Mr. Cohen’s fate might well escape any criminal prosecution. Even even though his insider trading record is an astonishing 79-, Mr. Preet Bharara ended the Frontline section with this sober legal assessment.

Narrator: As it stands, the criminal negligence laws that apply to some industries do not apply to finance. To alter that, Congress would require to pass a new statute. 

Preet Bharara: We have conspiracy statutes and we have aiding and abetting statutes and we have the criminal capability to carry a situation against an institution … but we really don’t carry criminal cases towards people for negligence.

Correspondent Martin Smith: Do you feel you’ll ever see a case in which negligence rises to the level of criminal liability? …. in the hedge fund planet?

Preet Bharara: I would doubt that.

Clinical Trial Data At Heart Of Landmark Wall Street Insider Trading Scandal

Coronation Street: Hayley"s funeral, ITV, overview

See, funny. And fitting of every single and every single character. Hayley had also selected a cardboard coffin, so that she could be recycled by nature. “I’m not shuffling off like a piece of flatpack furniture,” chimed Norris, with his typical caustic tone.

Roy silently and reluctantly attended the service at the crematorium. Additional moments of humour were peppered during. Hayley’s coffin, carried by her fellow factory staff, was brought in to Queen’s Don’t Quit Me Now. Back at the Rovers, where the wake was to be held, Steve was juggling with the Scotch eggs from the buffet table.

But, as expected, it was Neilson’s delicate performance that stopped us in our tracks, especially when he interrupted Fiz’s eulogy simply because he believed that every person need to know the truth. We believed that he may well speak the unspeakable, speak about these drugs and her “choice”.

“She wasn’t ideal, she was flawed,” he began. But as his eyes gravitated in the direction of her floral-patterned coffin, and with heart-breaking poignancy, he changed his thoughts.

“She was… a beautiful coruscating light. She was my constant, my compass. Hayley was my truth.”

IN Images: The twenty greatest Tv couples

Neilson conveyed the anguish and emotion so effortlessly that it was challenging not to physically feel the sadness aching via his bones. The meticulous detail of these episodes and the careful managing of this kind of an important topic has been outstanding. As Roy disappeard into the evening clutching his infamous purchasing bag as if it have been the only factor left that he could hold shut, it was clear that the cobbles will by no means fairly be the very same yet again.

Picture Special: CORONATION STREET Best STORYLINES

Coronation Street: Hayley"s funeral, ITV, overview

NHS faces £24m bill following glue injected into girl"s brain at Great Ormond Street

A simple mix-up in an working theatre that left a “pleased, active” ten-year-previous lady with catastrophic brain damage has led to the NHS facing a £24m payout – the biggest in a case of healthcare negligence.

Maisha Najeeb was keen on dancing and hoped to turn into a medical professional when glue was accidentally injected into her brain throughout surgical treatment at Fantastic Ormond Street children’s hospital in London in June 2010.

The accident occurred when a syringe containing glue was mistaken for one containing dye. Maisha, who is now 13, suffered what her attorneys describe as “catastrophic and permanent brain damage”. She is in a wheelchair, can barely move, is blind in one particular eye, requirements round the clock care and suffers from unpleasant spasms in her legs.

In a settlement agreed at the high court in London, she will obtain an original £2.8m plus annual payments of £383,000 till she is 19. That will then rise to £423,000 a 12 months right up until she dies.

If she lives right up until she is 64, as an skilled hired by her family members stated they anticipated, then the NHS would have to ultimately shell out total damages of practically £24.2m.

“We are sad and devastated by what took place to our daughter. Her lifestyle is ruined. All her dreams have been broken,” explained Maisha’s father, Sadir Hussain. He mentioned he hoped that the family’s legal action meant that “lessons will have been learned to stay away from this occurring to other households”.

The hospital, which admitted liability, supplied “unreserved apologies for the shortcomings in her care, the consequences of which have been tragic and devastating for Maisha and her household.” It could not say if any member of personnel had been disciplined over the incident. Following an internal inquiry, the hospital has established an action strategy of improvements, which includes the introduction of total colour-coding for all fluids and prescription drugs used in radiology procedures and, crucially, a new program of labelling syringes. Maisha’s family had “engaged open-heartedly” with them and assisted with that overhaul, stated a hospital spokesperson.

The NHS Litigation Authority, which insures hospitals against lawsuits for health care negligence and acts on their behalf, will pay out the agreed damages rather than Great Ormond Street itself.

Edwina Rawson, the family’s solicitor at Area Fisher Waterhouse, mentioned: “What is so heartbreaking about this situation is that the injury was so avoidable.If the syringes had been marked up so the hospital could see which contained glue and which contained dye, then Maisha would not have suffered what is an utterly devastating brain damage. Such simply avoidable mistakes should not come about.”

Prior to the blunder Maisha was a healthful ten-12 months-outdated, however she suffered from a unusual issue known as arterio-venous malformation (AVM), in which arteries and veins become tangled, which can lead to bleeding. Each time she suffered a bleed she went into Wonderful Ormond Street for embolisation, in which glue is employed to seal off the blood vessels that are bleeding and dye to highlight the blood flow.

The two sides could not agree on what influence the brain harm and AVM would have on Maisha’s existence expectancy. Her family members explained she could live till she was 64, but the hospital estimated that she could die of a bleed on her brain by 23.

Deborah Evans, chief executive of the Association of Personal Injury Laweyers, mentioned the funds would shell out for the 24/seven care that Maisha will need forever. “Even though this is probably the greatest agreed payment we have observed, the quantity is dependent on life expectancy and will by no means change the life she would have led,” Evans stated.

NHS faces £24m bill following glue injected into girl"s brain at Great Ormond Street

Great Ormond Street patient receives payout after brain injected with glue

Fantastic Ormond Street hospital. Photograph: Peter Macdiarmid/Getty Images

A girl whose brain was accidentally injected with glue during treatment at Fantastic Ormond Street hospital is to obtain a multimillion-pound damages payout.

Despite getting a uncommon healthcare issue that involved arteries and veins receiving tangled, which could outcome in a bleed, ten-yr-old Maisha Najeeb was outwardly healthy ahead of she went into hospital in June 2010.

On other occasions she had obtained effective embolisation treatment, which entails injecting glue to block off bleeding blood vessels, and an injection of a harmless dye to check the movement of blood about the brain and head.

But on this occasion, mentioned the solicitor Edwina Rawson, of Discipline Fisher Waterhouse, there was no system in location for distinguishing amongst the syringes containing the glue and people containing the dye, and they got mixed up.

This resulted in glue currently being wrongly injected into the artery to Maisha’s brain, creating catastrophic and permanent brain harm.

On Monday a judge at the substantial court authorized a settlement against Great Ormond Street Hospital for Young children NHS trust of a £2.8m lump sum, plus £383,000 a year until finally Maisha is 19, rising to £423,000 per year for as long as she lives, which some professionals assume to be to the age of 64.

Great Ormond Street patient receives payout after brain injected with glue

The welfare culture: I see "Benefits Street" each day

A couple of weeks in the past, a person initial spat at me and then threw a chair at me, simply because I had the audacity to suggest that if he continued to inject himself with heroin every day, despite becoming in remedy for more than two many years, he should be discharged from the services and that this might have an effect on his advantages. ”They cannot stop my funds,’’ he shouted. ”I’ll just go thieving.’’

As regular readers will know, I have spent much of my profession as a doctor working with disadvantaged and disfranchised patient groups. I have worked with the mentally ill, in paediatric palliative care, geriatrics, outreach programmes, drug clinics and with the homeless. Several of these folks are desperately in want.

And this is why I become so enraged when I listen to those critics who persist in the belief that some of the individuals featured on Advantages Street are a fantasy.

Welfare paying in Britain has increased more rapidly than in practically any other nation in Europe given that 2000. It has risen from 18.6 per cent of GDP to 23.7 per cent – an improve of 27 per cent. By contrast, the regular increase in welfare paying in the OECD nations was 16 per cent.

I believe it is just and noble for a country to support its weakest members. I want pensions and welfare payments to enhance, as at the minute they barely lift individuals over the poverty line. But if we are going to do this, we have to acknowledge that there is a proportion of rewards claimants that do not deserve them a proportion for whom advantages have turn into a way of existence.

How have we got to the state whereby for some, the welfare state is no longer a safety net, but a feather-filled mattress on which to recline even though enjoying your Xbox? I am tired of seeing match and wholesome people who choose not to perform, even though there are poor, needy and desperate men and women operating tough but struggling to pay out simple payments. I’m tired of seeing young children who go to college hungry and pensioners dying of cold while there are able-bodied men and women who have by no means had a work in their daily life. I’m tired of seeing the chronically unwell consumed by poverty even though others use spurious medical complaints to play the system and continue to be on prolonged-term sickness benefit.

There is no effortless response to this issue. Jobcentres are powerless to force folks to work. Attempts to assess suitability for Disability Residing Allowance have been a disaster as the approach relies on crude and poorly validated exams.

But while there may possibly be a issue with the procedure, that doesn’t mean the sentiment is incorrect. Our opprobrium should be directed at the men and women featured on Advantages Street – not at a programme that proves that they exist.

The Very good Samaritan who made a decision not to stroll on by

Six many years ago, Jonny Benjamin, then a pupil, climbed over the railings of Waterloo Bridge and ready to leap into the swirling, icy Thames. He had not too long ago been diagnosed with schizoaffective disorder, a type of schizophrenia characterised by episodes of psychosis mixed with serious depression.

Life, he considered, was no longer really worth living. However a passer-by stopped and, somehow, persuaded him to climb back to security. The youthful man, a stranger, was on his way to operate but his determination not to stroll on by saved Jonny’s existence.

Jonny, who has gone on to have a effective career in television manufacturing and now campaigns for far better understanding of mental wellness issues, has launched a search for the man who aided him in purchase to thank him and raise awareness of mental illness. He knows practically nothing about the Very good Samaritan and so has nicknamed him ”Mike’’.

What an uplifting tale of the kindness of strangers. It reminds me of the lovely Hebrew saying: ”He who saves a lifestyle, saves the planet entire’’.

Even if Jonny in no way finds Mike, their quick encounter a single January morning is an instance of how every of us can make a distinction if we take the time to cease and speak to somebody.

Thank you, Prof Hawking

In a heartfelt tribute, Prof Stephen Hawking has, when once more, stood up for the beleagured NHS. The renowned physicist, who was diagnosed with motor neurone ailment at the age of 21, mentioned in a recording for a new documentary that he would not have survived without the care he has acquired from the well being service, which he described as ”Britain’s best public service’’.

His remarks come at a time when the NHS is below escalating strain to embrace the personal sector. Solutions are currently being cut or decreased and there is great uncertainty about the long term. It is straightforward to feel overwhelmed and undervalued, so Prof Hawking’s words are specifically welcome. Thank you!

Max Pemberton’s newest guide, ‘The Medical professional Will See You Now’, is published by Hodder. To order a copy, call Telegraph Books on 0844 871 1515

The welfare culture: I see "Benefits Street" each day