Intuitive Surgical OKd by FDA on urological surgery system

Intuitive Surgical, Inc. (Nasdaq: ISRG), today announced a new U.S. Food and Drug Administration (FDA) clearance for the da Vinci SP surgical system for urologic surgical procedures that are appropriate for a single port approach.

The da Vinci SP system provides surgeons with robotic-assisted technology designed for deep and narrow access to tissue in the body. The ability to enter the body through a single, small incision helps surgeons perform more complex procedures. Intuitive anticipates pursuing further regulatory clearances for da Vinci SP, including transoral, transanal, and extraperitoneal applications, broadening the applicability of the SP platform over time.

“The da Vinci SP is the latest in our integrated product family that shows our commitment to improving minimally invasive surgery with technology that can positively impact patient outcomes,” said Gary Guthart, chief executive officer for Intuitive. “Our da Vinci SP compliments da Vinci X^® and Xi^® systems by enabling surgeons to access narrow workspaces while maintaining high quality vision, precision, and control that surgeons have come to trust from da Vinci^® systems.”

The da Vinci SP system includes three, multi-jointed, wristed instruments and the first da Vinci fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy to avoid external instrument collisions that can occur in narrow surgical workspaces. The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses the same surgeon console as the da Vinci X and Xi systems.

“Intuitive continues to bring tomorrow’s surgery today by addressing surgeon and patient needs, as well as working closely with hospitals to systematically improve the overall experience in the operating room,” said Salvatore J. Brogna, Intuitive executive vice president and chief operating officer.

Since the initial U.S. FDA clearance in April 2014 for the da Vinci SP surgical system, Intuitive invested in important platform refinements. Intuitive plans to launch the da Vinci SP surgical system in the United States in a measured fashion, with customer shipments beginning in the third quarter of 2018.

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3 Possible Outcomes Of Clinical Hold On Crispr Therapeutics Sickle Cell Candidate

Shares of Crispr Therapeutics AG CRSP 6.36% fell more than 7 percent Thursday morning after the U.S. Food and Drug Administration said it placed a clinical hold on the company’s therapy.

What Happened

The FDA placed a clinical hold on the Investigational New Drug application for Crispr’s CTX001 for the treatment of sickle cell disease, Crispr and its partner Vertex Pharmaceuticals Incorporated VRTX 1.69% said in a press release. The hold is subject to the companies answering certain questions from the FDA as part of its review of the IND.

Why It’s Important

The details of the FDA’s hold are not revealed to the market, so the overall implications for Crispr aren’t fully known, Chardan’s Gbola Amusa said in a research report. Three outcomes are possible, the analyst said:

• A hold can be based on concerns over Crispr’s specificity or editing efficiency (overall sector risk).
• A hold can be based on an element of the CTX001 production or an aspect of the trial design (company-specific risk).
• A “rapid resolution” would help mitigate a negative impact on the CTX001 program and the gene editing space.

Chardan has a Buy rating on Crispr with a $72.50 price target.

What’s Next

Crispr and Vertex expect to receive additional information on the FDA’s list of questions in the “near future” and will “work rapidly” with the FDA toward a solution, the press release said.

https://bit.ly/2Hcy9GE

More Drivers Killed Under the Influence of Drugs Than Alcohol

SOME 22.3 PERCENT OF fatally injured motorists who were tested for drugs tested positive for marijuana in 2016, a figure that researchers say has “increased substantially” in recent years as states have legalized the drug for recreational or medicinal use, according to a new report.

The finding, in a study released Thursday by the Governors Highway Safety Association, was one of several regarding the growing prevalence of drugs in vehicle fatalities. The report also found that 44 percent of drivers killed in automobile accidents in 2016 who were tested for drugs tested positive for one or more substances – a number that was up 28 percent from 10 years prior. That figure eclipsed the 37.9 percent who were known to have been tested for alcohol and tested positive – a figure that actually fell in the last decade, from 41 percent in 2006.

The report was intended to draw attention to the need to incorporate a drug message into programs that encourage motorists not to drive while impaired. It noted that marijuana was the most commonly found drug. Jim Hedlund, author of the study, says “marijuana use has become more normalized” as states across the country decriminalize the drug.

“If use is up, use by drivers is up,” Hedlund says.

Hedlund attributes the decline in alcohol-related deaths to the “broad societal consensus” that drunk driving is wrong. There’s a “strong societal consensus. It’s [drunk driving] is bad,” he says. “Everyone knows it’s bad.” However, this way of thinking hasn’t caught up to drug-impaired driving yet. That’s where education comes in.

“That’s the next step. Precisely to provide that education,” Hedlund says.

The report suggests that some of the strategies used to decrease drunk driving can be applied to prevent people from driving while on drugs. However, several challenges come with that. A driver can consume a vast number of drugs that would be difficult to test for. Additionally, no nationally accepted method exists for testing drug-impaired drivers, and different drugs have different effects on different people.

Among recommendations to reduce drug-impaired driving, the study points to the need to develop impairment-assessment tools, such as oral-fluid devices and marijuana breath-test instruments, to support the drug-impaired-driving prosecution process by increasing law enforcement training, authorizing electronic search warrants for drug tests, and to educate prosecutors and judges on drug-impaired driving.

Hedlund outlined additional recommendations, including raising public awareness about the impairments certain drugs have on the body, and working with pharmacists to improve communication between drugmakers and consumers.

https://bit.ly/2Jn9PqI

Health-care workers are committing suicide in unprecedented numbers

As America focuses on one epidemic — the opioid crisis — another goes entirely ignored. American health-care workers are dying by suicide in unprecedented numbers. Earlier this month, a medical student and a resident at NYU medical school completed suicide less than a week apart.

My junior colleague took her life just 11 days before her 35th birthday. I had supervised her as she transitioned into practice from fellowship. She said that the way I said her name foretold if the conversation pointed to a weakness or a strength in her patient assessment. My last sight of her was as she drove off to her new job. Less than six months later, she made a life-ending choice.

A scan of her suicide note, asking that I be notified, was emailed to me. I did not show it to anyone. The news of her suicide was announced by an email in the department. We all went about our business, as if suicide by a young colleague is usual. And perhaps, in a way it is.

After all, physician suicide — and more broadly health-care worker suicide — is a huge issue in the U.S. In my own experience, I have lost six colleagues to suicide — five physicians and one physician assistant. That does not include the suicides that I have heard about through the whisper network at work.

My junior colleague was among an estimated 400 physicians who took their lives in 2016. Many physicians know more doctors than patients who have taken their lives. Physicians and nurses complete suicide more often than do average Americans; rates are even higher for women in bothprofessions. Respect, fear and love for our colleagues often leads us to list the cause of death differently on death certificates. We frequently self-medicate, so suicides may instead be listed as accidental. Phrases to describe the scope like “an entire medical school class a year” or “a doctor a day” have particularly ominous meanings for physicians.

All of the physicians that I knew who took their lives were American medical graduates, a worrisome statistic if it reflects the general trend. A full 24 percent of physicians in the U.S. are international medical graduates; my specialty, pathology, is about 40 percent international graduates.

Although a recent report of suicides among residents does not suggest differential suicide rates among international and American medical graduates, the data may be limited by the nature of the study. The number for nurse or other health-care worker suicide is unknown, since we do not even track these numbers. Earlier this year, the National Academy of Medicine released a paper to raise awareness of nurse suicide, calling for a closer look at another facet of this epidemic. The high suicide rates correlate with the high rates of depression among physicians and nurses.

Why physicians and health-care workers are more likely to complete suicide is unknown. It perhaps has to do with a work-related mental health syndrome called disengagement and burnout, which has reached epidemic proportions in health-care providers and nurses. Excessive pressures and expectations at work, paired with seemingly unattainable goals for quality and productivity as well as societal loss of trust in physicians, has led to a loss of meaning of work and of self for physicians. This is not the norm that physicians or nurses expected when we answered the call to be care-providers.

Regardless of why medical workers tend to die by suicide, there needs to be a call to arms to do something about it. Health-care organizations need to more proactively report suicide in their workforce, so we can begin to understand the drivers for suicide in health-care workers. The information needs to be granular enough to identify risks by specialty and work-type.

More immediately, institutions need to develop procedures and processes for grief recovery support for colleagues of the deceased. Many institutions shy away from even mentioning suicide at the workplace. There is concern for suicide contagion, an increased tendency toward suicide in the already predisposed upon hearing of a suicide. There is stigma to talking about suicide among leaders, and fear that it will cast a shadow on them or their organization.

But, that is the wrong response. Colleagues suffer when one of their own is lost to suicide. One spends a third of one’s life at work. Sustained relationships at work are particularly important in an environment that is so stressful. The responsibility for another’s well-being and the ever-present risk for potential harm to another from a misjudgment extracts a heavy emotional toll on health-care providers.

We perhaps even blame ourselves more when we lose a colleague to suicide. Why did I not see it? Could I have done something to prevent it? One wonders about one’s self worth and one’s ability to care for patients when one fails a colleague and friend. One institution at least, UCSD, has heard this call to action and created the Healer Education and Assessment Referral program, which promotes self-assessment for depression and provides support for all health-care workers in the setting of a coworker’s suicide. But more needs to be done — at a department level, at an institutional level and at a national level.

Postvention programs to provide support for survivors of a co-worker suicide need to be developed in the profession. Structured prevention strategies to reduce suicide need to be developed as has been done for the police and military — two other at-risk professions for suicide. Leaders need to be trained to give support to their providers, so providers can heal and continue in their job of caring for their patients, after one of theirs is lost to suicide.

Vinita Parkash M.D. is an associate professor of pathology at the Yale School of Medicine. She is a Public Voices fellow with the OpEd Project, which is an organization that focuses on increasing the number of women thought leaders contributing to key commentary forums and media outlets.

https://bit.ly/2sryUpP

Constant Interruptions From Smartphone Can Impact Brain Chemistry

Constant interruptions from alerts and messages on your smartphone can impact brain chemistry.

It can be hard to concentrate when you’re always being diverted by your phone. It’s a pattern that scientists say creates something they call the switch cost.

Research shows constant interruptions can create a different chemistry in the brain.

“There’s this phenomenon they call switch cost that when there’s an interruption we switch away from the task that we were at and then we have to come on back. We think it interrupts our efficiency with our brains, by about 40 percent. Our nose is always getting off the grindstone, then we have to reorient ourselves,” said Dr. Scott Bea, a psychologist at Cleveland Clinic.

The new reality for many is that technology has put the brain on high alert most of the time, waiting for the next notification. Doctors say when it happens, people can get little surges of the stress hormone cortisol, which can cause the heart rate to jump, some people to get sweaty hands and muscles can get a little tight.

Being unable to check phones immediately can cause those feelings of anxiety to last until people are able to check their device. Doctors say breaking that pattern involves creating a new habit, which can take time.

“Initially, when you start trying to stay away from the technology, or confine it, you’ll be a little uncomfortable, you’ll have that fear of missing out, or a little anxiety that something is getting past you, but with practice, your brain can get used to it,” said Bea.

Breaking the habit is also difficult because experts say there can be an addictive component to technology as the brain gets rewarded with constant updates and the behavior is repeated over and over.

https://cbsloc.al/2xr7E0i

Homeschooling surges as parents seek safer option for children

After a gunman opened fire on students in Parkland, Florida, the phones started ringing at the Texas Home School Coalition, and they haven’t stopped yet.

The Lubbock-based organization has been swamped with inquiries for months from parents seeking safer options for their kids in the aftermath of this year’s deadly school massacres, first in Parkland and then in Santa Fe, Texas.

“When the Parkland shooting happened, our phone calls and emails exploded,” said coalition president Tim Lambert. “In the last couple of months, our numbers have doubled. We’re dealing with probably between 1,200 and 1,400 calls and emails per month, and prior to that it was 600 to 700.”

Demands to restrict firearms and beef up school security have dominated the debate following the shootings, but flying under the radar is the surge of interest in homeschooling as parents lose faith in the ability of public schools to protect students from harm.

And it’s not just the threat of school shootings. Christopher Chin, president of Homeschool Louisiana, said parents are also increasingly concerned about “the violence, the bullying, the unsafe environments.”

“One of the things we’ve seen definitely an uptick in the last five years is the aspect of violence. It’s the bullying. That is off the charts,” Mr. Chin said.

In his experience, a mass shooting won’t change the minds of parents satisfied with their children’s public-school experiences, but it can tip the balance for those already leaning toward home education.

“I think what happens with these school shootings is they’re the straws that broke the camel’s back,” Mr. Chin said. “I don’t think it’s the major decision-maker, but it’s in the back of parents’ minds.”

Brian D. Ray, president of the National Home Education Research Institute in Salem, Oregon, who has conducted homeschool research for 33 years, said school safety has increasingly become an issue for parents looking at teaching their kids at home.

He said the top three reasons that parents choose homeschooling are a desire to provide religious instruction or different values than those offered in public schools; dissatisfaction with the academic curriculum, and worries about the school environment.

“Most parents homeschool for more than one reason,” Mr. Ray said. “But when we ask families why do they homeschool, near the top nowadays is concern about the environment of schools, and that includes safety, pressure to get into drugs, pressure to get into sexual activity. It includes all of that.”

After the Feb. 14 shooting in Parkland, Florida, vows by parents to pull their kids out of school erupted on social media, and some of them apparently followed through by making contact with their local homeschool advocates.

“I talk with these people on a regular basis, and clearly after a shooting, more of them are saying, ‘Hey, we’re getting more phone calls, we’ve got more people at the beginner session asking about safety,’” Mr. Ray said.

Not everyone agrees with the homeschool response. Takisha Coats Durm, lead virtual school teacher for the Madison County Schools System in Huntsville, Alabama, said that fleeing the classroom teaches the wrong lesson.

“Even though it seems we may be protecting them, we may be sheltering them instead of teaching them to work and find a solution for the issues and not necessarily running away from them, because these things are going to happen,” Ms. Durm told WAAY-TV in Huntsville.

Her comments came shortly after the May 18 shooting at Santa Fe High School, which left 10 dead, just three months after 17 were killed in the massacre at Marjory Stoneman Douglas High School in Parkland.

Tracking the numbers

While homeschool advocates are confident their ranks are growing, pinning down the number of U.S. at-home students is a challenge, given most states don’t keep count.

A 2017 U.S. Department of Education report estimated 1.69 million homeschool students from ages 5-17 in spring 2016, using data from the National Household Education Surveys program, which mailed questionnaires to about 200,000 selected households.

Those findings would indicate that homeschooling has been flat since 2012, but Mr. Ray estimated there were 2.3 million homeschool students in spring 2016, using figures provided by the 15 states that track homeschoolers, as well as Maricopa County, Arizona.

His figure represented a 25 percent increase between 2012-16. During the same period, the U.S. school-age population grew by about 2 percent.

“My bottom-line summary is that it’s been growing at an estimated 2 to 8 percent per year, and that’s compounded,” Mr. Ray said.

In Louisiana, which does ask homeschoolers to report their kids, Mr. Chin said there were 30,134 homeschool students registered in January, up from an estimated 18,500 to 20,000 in 2011.

“Homeschooling has exploded in our state,” said Mr. Chin, who homeschools his five children with his wife in New Orleans. “If homeschoolers were their own school district in our state, we would be the sixth largest in the state.”

Texas doesn’t require registration, but Mr. Lambert, who homeschooled his four now-adult children, estimated that the state has about 150,000 families and more than 300,000 students being taught at home.

“In fact we have more students being homeschooled in Texas than we have in traditional private schools in Texas, and that’s quoted by a number of our state officials,” he said.

His organization sponsored a poll last year that found safety ranked fourth among reasons parents decide to educate their kids at home.

“I’m required by law to place my kids in a public school or private or homeschool, but the state is not accountable in terms of the safety of these children,” said Mr. Lambert. “So we get lots of calls from people saying, ‘Hey my kid’s being bullied, my kid’s being attacked, and the school either can’t or won’t do anything about it, so we’re going to take care of our child. We’re withdrawing him.’”

Like Mr. Chin, he said a highly publicized school shooting may come as the tipping point for parents already inclined to pull their kids out of the public system.

“When a shooting happens, I call it the straw that basically breaks their idea of the public schools,” Mr. Lambert said. “They’ve already been thinking about it, and now somebody gets stabbed, or another teacher beats up another kid, or another kid beats up another teacher, and they say, ‘You know what? We don’t want to be there.’”

https://bit.ly/2LM0QO9

How to stop or reduce a stutter

Stuttering is a common condition that causes difficulty speaking fluently. Working with a speech therapist can greatly improve stuttering in the long term, while several strategies can help with managing a stutter on a daily basis.

Everyone experiences periods in which speech is not fluent. For some, a stutter can get in the way of everyday life.

A person who stutters may only struggle with certain words or sounds. They may experience:

• blocks, in which there is a long pause before being able to say a word
• prolongations, in which certain sounds in a word are extended
• repetition of a word or part of a word

Stuttering can also have physical signs, such as movements in the face and body as a person attempts to pronounce a word.

According to the Stuttering Foundation, over 70 million people worldwide are affected. Of these, 3 million live in the United States. Males are four times more likely to stutter than females, and about 5 percent of children will go through a period of stuttering.

For people who regularly experience stuttering, and for those who experience it due to stress, several methods can help to reduce the frequency or eliminate it altogether.

Quick tips to stop stuttering

Slowing down, speaking with a rhythm, and focusing on breathing can help to reduce stuttering.

The following techniques can help a person to avoid or reduce stuttering in everyday situations, or, for example, when giving a presentation.

Focus on breathing

Before a social interaction or a period of prolonged speech, make a conscious effort to relax and breathe. Results of a study published in 2012 suggest that deep, mindful breathing helps to reduce blood pressure and increase the flow of oxygen-rich blood throughout the body. Deep breathing also reduces anxiety, which can have a powerful effect on stuttering.

Slow down

Focus on maintaining a slow rate of speech, and remember to pause between sentences and words. Continue to take deep breaths while speaking to keep anxiety under control.

Speaking too quickly can make a person feel more anxious and increase the rate of stuttering.

Avoid certain words

For many people who stutter, some words are more difficult to get out than others. Make a note of these trigger words and find alternatives to use. Also, practicing these trigger words can help to reduce the likelihood of stuttering while saying them socially. A speech therapist can advise about the best ways to practice.

Speak with a rhythm

Many people report that stuttering disappears when they sing. This is partly due to the smooth, controlled rhythm of sung language. Before speaking, imagine that you are about to sing. Also, practice putting a slight rhythm into your speech. This may help to improve speech fluency.

Visualize interactions

Many people use this technique ahead of presentations and public speaking, but it can also be useful in everyday conversations.

Anyone who is feeling nervous about speaking should try to visualize their words before they are pronounced. This can help a person to feel more prepared, in control, and confident in their communication.

Research published in 2015 suggests that imagining interactions and rehearsing speeches ahead of time can improve the fluency of speech and a person’s own evaluation of their performance.

It may also help to visualize positive outcomes of conversations. This can ease a person’s nerves and help them to avoid stuttering during interactions.

Use body movements to calm nerves

Channeling nervous energy into deliberate body movements may help to reduce stuttering. People often use this technique when speaking in public.

For a presenter, this may involve making slow movements across the stage or controlled gestures. During conversations, a person may benefit from walking or using hand gestures.

How to stop stuttering permanently

A speech therapist can help a person manage their stuttering.

For many, lots of time and effort are needed to reduce or eliminate a stutter. Over time, speech therapy and practice at home can result in drastic improvements.

Speech therapy

A speech therapist can help children and adults to manage stuttering. For some, speech therapy may be required at different times throughout life.

Initially, a therapist tests a person’s speech and assesses the severity of a stutter. Every person who stutters has a unique experience, and a therapist will ask about the impact that stuttering has on a person’s life. They will then tailor their sessions to suit the individual.

A speech therapist can also teach coping strategies to reduce anxiety around stuttering.

Practice

Practicing and rehearsing speech, especially trigger words or phrases, can help to improve a stutter. Practice should focus on:

• speaking slowly
• using compensatory strategies
• completing thoughts
• reducing tension
• taking deep breaths while speaking

It can help to practice in front of a mirror or with members of a support network.

Develop a strong support network

Often, the reactions of others can have a big impact on how a person who stutters sees themselves. It is important to be surrounded by positive, supportive people so that a person can speak without the fear of judgment.

Electronic devices

Some people who stutter benefit from a device called a speech monitor that is attached to the outer ear. This alters sound frequencies and uses delayed feedback to help a person regulate their speech.

While insurance sometimes covers the cost, these devices can be expensive. A doctor may be able to recommend more affordable options.

Many people find speech monitors helpful, but there is no guarantee that they provide permanent benefits.

Outlook

By practicing techniques and working on long-term strategies, many people can overcome stuttering.

Some children go through a phase of stuttering as part of their natural development. For others, stuttering never entirely goes away, though it may change as a person ages. For example, a person may only stutter when under pressure, such as during a presentation.

With patience and practice, most people can reduce the frequency of stuttering.

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