Happy New Year to Our Loyal Readers, Friends and Colleagues

 

We wish all of our friends and colleagues a HAPPY NEW YEAR and welcome back after a brief holiday!

 

Besides a major thrust to expand our paperless solutions for clinical trials, part of Target Health Inc.’s strategy this year, is to link up with more academic institutions in the NY region who want to do translational medicine. We are already partnering with technology out of SUNY Stony Brook, with funding from the Department of Defense (DOD); and technology out of Rutgers, with funding from the NIH. In addition, we are currently negotiating with several academic research centers in NYC and Long Island. Target Health is also very active with NY Medical College (NYMC), where Dr. Mitchel gave a keynote presentation a few weeks ago when NYMC launched their new incubator BioInc@NYMC. The topic of the presentation was “How Creative One Can Be When Working with the FDA to Optimize the Drug and Device Development Process.“ The presentation was recorded and can be found on the homepage of our website. Academia is beginning to come around.

 

First 2015 View From the 24th Floor

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Red Sky in Morning, Sailors Take Warning – ©Target Health 2015

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

QUIZ

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How Dangerous is Artificial Intelligence?

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H A L 9 0 0 0 – Space Odyssey

 

When it comes to advances in artificial intelligence (AI), we’ve come a long way: self-driving cars are no longer limited to science-fiction novels, robots may soon replace a huge chunk of the labor force and a robot named 1) ___ is a “Jeopardy!“ champion, who graduated to Sloan Kettering in Manhattan training to be a PA (physician’s assistant) and then graduated to The Cleveland Clinic for more advanced training as a PA. All that sounds impressive, but to Stephen 2) ___, it also sounds ominous. In a recent interview with BBC, Hawking said that the “development of full artificial intelligence could spell the end of the human race.“ “It would take off on its own, and re-design itself at an ever increasing rate,“ Hawking said. “Humans, who are limited by slow 3) ___ evolution, couldn’t compete, and would be superseded.“ The possibility that AI will eventually outstrip humans’ ability to keep pace with it is known as the “technological singularity,“ and it’s a concern Hawking has mentioned before. As he wrote in a May 2014 op-ed for The Independent: “Success in creating AI would be the biggest event in human history. Unfortunately, it might also be the last.“

 

Hawking, who is best-known for his blockbuster best-seller “A Brief History of Time,“ wonders if we’re innovating faster than we’re considering the possible repercussions. Hawking lays out the incredible technological advancements that are currently taking place in AI, from self-driving cars to digital personal assistants like SIRI and Google Now. He believes we’re on the cusp of the kinds of artificial intelligence that were previously exclusive to science 4) ___ films. AI is no longer science fiction, now, it’s reality.

 

He’s not wrong. A.I. start-ups are fast emerging in the tech sphere and quickly garnering the financial support necessary to innovate. Google recently paid $650 million for DeepMind Technologies, an AI company. Late last year, Google picked up Robotics maker Boston Dynamics for an undisclosed sum. “The amount of money that Google and other commercial companies will pour into robotics and artificial intelligence could at last take it truly into the commercial world where we actually do have smart 5) ___roaming our streets.“ Robotics Professor Noel Sharkey told The Guardian.

 

What’s the problem with all that innovation? Hawking lays out concerns that seem straight out of a sci-fi horror film — essentially worrying that eventually the machines will outsmart us all. “Whereas the short-term impact of AI depends on who controls it, the long-term impact depends on whether it can be controlled at all.“ Regardless of whether artificial Intelligence outpaces human intelligence as Hawking fears, we’re already seeing 6) ___ replaced by machines. According to a research report from Oxford University’s Programme on the Impacts of Future Technology, 45% of Americans could lose their jobs to computers in the next two decades. Hawking’s suggestion? Thinking before we create. Hawking advocates for more research into where robotics and artificial intelligence could lead. And whether you’re a theoretical physicist or an entrepreneur, Hawking believes that when it comes to artificial intelligence, “All of us should ask ourselves what we can do now to improve the chances of reaping the benefits and avoiding the 7) ___.“ Hawking isn’t alone in his concern. Elon Musk, CEO of SpaceX and Tesla Motors, said last month that “we should be very careful about artificial intelligence. With artificial 8) ___ we are summoning the demon. Noted AI expert Oren Etzioni, CEO of the Allen Institute for Artificial Intelligence in Seattle, told participants in a recent Reddit AMA that he wasn’t afraid of AI and that “I don’t think you should be either.“ It’s possible that the singularity would arrive in a million years or so, Etzioni said, but apocalyptic visions of clever computers taking over the world are simply “silly.“ “The plausible scenario based on my working actively in this field for more than 25 years is that we will continue to make progress but that there’s no runaway intelligence. We are building increasingly sophisticated programs to read and understand text, but they are in no danger of running anywhere,“ he wrote.

 

If the robots take over, at least Elon Musk will be able to say “I told you so.“ The billionaire inventor loves to make the impossible possible, but he is deeply afraid of AI. On Twitter recently, Musk said that “we need to be super careful with AI,“ adding that they are “potentially more dangerous than 9) ___.“ If that weren’t concerning enough, Musk followed up his statement with another tweet that read: “Hope we’re not just the biological boot loader for digital superintelligence. Unfortunately, that is increasingly probable.“ Both are scary enough – one compares sentient networked robots with the most dangerous weapon on earth, and the other suggests we’re merely the fleshy precursors to robot dominance. This isn’t the first time that Musk has let known his feelings on AI. In an interview with CNBC earlier this year, Musk said that we should be incredibly careful when developing such systems, and he jokingly cited Terminator as an example of what could happen if we mess up. It isn’t hard to imagine what a doomsday scenario could look like – especially with Google snatching up Boston Dynamics, makers of the creepiest robots on earth, and an artificial intelligence company called DeepMind. Futurist and AI expert Ray Kurzweil (who happens to be employed by Google), offers a different argument than Musk. “In my view, biological humans will not be outpaced by the AIs because they (we) will enhance themselves (ourselves) with AI,“ Kurzweil said earlier this year. “It will not be us versus the machines, but rather, we will enhance our own capacity by merging with our intelligent creations.“ Musk, for his part, doesn’t seem to be writing off AIs completely – he just wants us to be careful. After all, he thinks Teslas will largely be driving themselves in just a couple of years. How’s that for 10) ___ intelligence taking over human behavior and human jobs.

 

ANSWERS: 1) Watson; 2) Hawking; 3) biological; 4) fiction; 5) robots; 6) humans; 7) risks; 8) intelligence; 9) nukes; 10) artificial

 

Stephen W. Hawking

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Stephen William Hawking, age 72

 

“My goal is simple. It is a complete understanding of the universe, why it is as it is and why it exists at all.“ – Stephen Hawking.

 

Stephen Hawking is known for his work regarding black holes and for authoring several popular science books. He suffers from amyotrophic lateral sclerosis (AML; or Lou Gehrig’s disease). Hawking’s chief theory is that black holes should emit radiation, which is known as Hawking radiation. His popular science book, “A Brief History of Time,“ has made science accessible to everyone.

 

Stephen Hawking was born on January 8, 1942, in Oxford, England. At an early age, Hawking showed a passion for science and the sky. At age 21, while studying cosmology at the University of Cambridge, he was diagnosed with ALS. Despite his debilitating illness, he has done ground-breaking work in physics and cosmology, and his several books have helped to make science accessible to everyone. The oldest of Frank and Isobel Hawking’s four children, Stephen William Hawking was born in Oxford, England, into a family of thinkers, on the 300th anniversary of the death of Galileo – long a source of pride for the noted physicist – on January 8, 1942. His Scottish mother, Isobel Hawking, had earned her way into Oxford University in the 1930s – a time when few women thought of going to college – making her one of the college’s first female students. His father, Frank Hawking, another Oxford graduate, was a respected medical researcher with a specialty in tropical diseases. Stephen Hawking’s birth came at an inopportune time for his parents, who didn’t have much money. The political climate was also tense, as England was dealing with World War II and the onslaught of German bombs. In an effort to seek a safer place to have their first child, Frank moved his pregnant wife from their London home to Oxford. The Hawkings would go on to have two other children, Mary (1943) and Philippa (1947). A second son, Edward, was adopted in 1956.

 

The Hawkings, as one close family friend described them, were an “eccentric“ bunch. Dinner was often eaten in silence, each of the Hawkings intently reading a book. The family car was an old London taxi, and their home in St. Albans was a three-story fixer-upper that never quite got fixed. The Hawkings also kept bees in the basement and made fireworks in the greenhouse. In 1950, Hawking’s father took work as the head of the Division of Parasitology at the National Institute of Medical Research, and spent the winter months in Africa doing research. He wanted his eldest child to go into medicine, but at an early age, Hawking showed a passion for science and the sky. That was evident to his mother, who, along with her children, often stretched out in the backyard on summer evenings to stare up at the stars. “Stephen always had a strong sense of wonder,“ she remembered. “And I could see that the stars would draw him.“ Early in his academic life, Hawking, while recognized as bright, was not an exceptional student. At one point during his high school years, he was third from the bottom of his class. But Hawking focused on pursuits outside of school; he loved board games, and he and a few close friends created new games of their own. At the age of 16, Hawking, along with several friends, constructed a computer out of recycled parts for solving rudimentary mathematical equations.

 

Hawking was also frequently on the go. “[He was] hardly ever still,“ a family friend once said of him. With his sister, Mary, Hawking, who loved to climb, devised different entry routes into the family home. He remained active even after he entered Oxford Universityat the age of 17. He loved to dance, and also took an interest in rowing, becoming one of the Oxford rowing team’s coxswain. To his father’s chagrin, Hawking turned down a career in medicine, instead expressing a desire to study mathematics. But since Oxford didn’t offer a mathematics degree, Hawking gravitated toward physics and, more specifically, cosmology. By his own account, Hawking didn’t put much time into his studies. He would later calculate that he averaged about an hour a day focusing on school. And yet he didn’t really have to do much more than that. In 1962, he graduated with honors, and went on to attend theUniversity of Cambridge for a Ph.D. in cosmology.

 

Hawking first began to notice problems with his physical health while he was at Oxford – on occasion he would trip and fall, or slur his speech – he didn’t look into the problem until 1963, during his first year at Cambridge. For the most part, Hawking had kept these minor symptoms to himself. But when his father took notice of the condition, he sent Hawking to see a doctor. For the next two weeks, the 21-year-old college student made his home at a medical clinic, where he underwent a series of tests. “They took a muscle sample from my arm, stuck electrodes into me, and injected some radio opaque fluid into my spine, and watched it going up and down with X-rays, as they tilted the bed,“ he once said. “After all that, they didn’t tell me what I had, except that it was not multiple sclerosis, and that I was an a-typical case.“ Eventually, however, doctors did inform the Hawkings about what was ailing their son: He was in the early stages of ALS. In a very simple sense, the nerves that controlled his muscles were shutting down. Doctors gave him two and a half years to live. It was devastating news for Hawking and his family. A few events, however, prevented him from becoming completely despondent. The first of these came while Hawking was still in the hospital. There, he shared a room with a boy suffering from leukemia. Relative to what his roommate was going through, Hawking later reflected, his situation seemed more tolerable. Not long after he was released from the hospital, Hawking had a dream that he was going to be executed. He said this dream made him realize that there were still things to do with his life. But the most significant change in his life was the fact that he was in love. At a New Year’s party in 1963, shortly before he had been diagnosed with ALS, Hawking met a young languages undergraduate named Jane Wilde. They were married in 1965.

 

In a sense, Hawking’s disease helped him become the noted scientist he is today. Before the diagnosis, Hawking hadn’t always focused on his studies. “I was bored with life before my illness,“ he said. “There had not seemed to be anything worth doing.“ With the sudden realization that he might not even live long enough to earn his Ph.D., Hawking poured himself into his work and research. Groundbreaking findings from another young cosmologist, Roger Penrose, about the fate of stars and the creation of black holes tapped into Hawking’s own fascination with how the universe began. This set him on a career course that reshaped the way the world thinks about black holes and the universe. While physical control over his body diminished (he’d be forced to use a wheelchair by 1969), the effects of his disease started to slow down. In 1968, a year after the birth of his son Robert, Hawking became a member of the Institute of Astronomy in Cambridge. The next few years were a fruitful time for Hawking. A daughter, Lucy, was born to Stephen and Jane in 1969, while Hawking continued with his research (a third child, Timothy, arrived 10 years later). He then published his first book, the highly technical The Large Scale Structure of Space-Time (1975). He also teamed up with Penrose to expand upon his friend’s earlier work. In 1974, Hawking’s research turned him into a celebrity within the scientific world when he showed that black holes aren’t the information vacuums that scientists had thought they were. In simple terms, Hawking demonstrated that matter, in the form of radiation, can escape the gravitational force of a collapsed star. Hawking Radiation was born. The announcement sent shock waves of excitement through the scientific world, and put Hawking on a path that’s been marked by honors, notoriety and distinguished titles. He was named a fellow of the Royal Society at the age of 32, and later earned the prestigious Albert Einstein Award. In 1975 he journeyed to Rome, where he was honored with the Pius XI Gold Medal for Science from Pope Paul VI.

 

Teaching stints followed, too. One was at Caltech at Pasadena, California, where Hawking served as visiting professor for a year. Another was at Gonville & Caius College in Cambridge, England. In 1979, Hawking found himself back at Cambridge University, where he was named to one of teaching’s most renowned posts: the Lucasian Professor of Mathematics. Dating back to 1663, the position has been held by just 14 other people, including Sir Isaac Newton. Hawking’s ever-expanding career was accompanied, however, by his ever-worsening physical state. By the mid-1970s, the Hawking family had taken in one of Hawking’s graduate students to help manage his care and work. He could still feed himself and get out of bed, but virtually everything else required assistance. In addition, his speech had become increasingly slurred, so that only those who knew him well could understand him. In 1985 he lost his voice for good following a tracheotomy. The resulting situation required 24-hour nursing care for the acclaimed physicist. It also put in peril Hawking’s ability to do his work. The predicament caught the attention of a California computer programmer, who had developed a speaking program that could be directed by head or eye movement. The invention allowed Hawking to select words on a computer screen that were then passed through a speech synthesizer. At the time of its introduction, Hawking, who still had use of his fingers, selected his words with a handheld clicker. Today, with virtually all control of his body gone, Hawking directs the program through a cheek muscle attached to a sensor. Through the program, and the help of assistants, Stephen Hawking has continued to write at a prolific rate. His work has included numerous scientific papers, of course, but also information for the non-scientific community.

 

In 1988 Hawking, a recipient of the Commander of the Order of the British Empire, catapulted to international prominence with the publication of A Brief History of Time. The short, informative book became an account of cosmology for the masses. The work was an instant success, spending more than four years atop the London Sunday Times‘ best-seller list. Since its publication, it has sold more than 25 million copies worldwide and been translated into more than 40 languages. But it also wasn’t as easy to understand as some had hoped. So in 2001, Hawking followed up his book with The Universe in a Nutshell, which offered a more illustrated guide to cosmology’s big theories. Four years later, he authored the even more accessible A Briefer History of Time. Together the books, along with Hawking’s own research and papers, articulate the physicist’s personal search for science’s Holy Grail: a single unifying theory that can combine cosmology (the study of the big) with quantum mechanics (the study of the small) to explain how the universe began. It’s this kind of ambitious thinking that has allowed Hawking, who claims he can think in 11 dimensions, to lay out some big possibilities for humankind. He’s convinced that time travel is possible, and that humans may indeed colonize other planets in the future. Hawking’s quest for big answers to big questions includes his own personal desire to travel into space. In 2007, at the age of 65, Hawking made an important step toward space travel. While visiting the Kennedy SpaceCenter in Florida, he was given the opportunity to experience an environment without gravity. Over the course of two hours over the Atlantic, Hawking, a passenger on a modified Boeing 727, was freed from his wheelchair to experience bursts of weightlessness. Pictures of the freely floating physicist splashed across newspapers around the globe. “The zero-G part was wonderful and the higher-G part was no problem. I could have gone on and on. Space, here I come!“ he said.

 

If there is such a thing as a rock-star scientist, Stephen Hawking embodies it. His forays into popular culture have included guest appearances on The SimpsonsStar Trek: The Next Generation a comedy spoof with comedian Jim Carrey on Late Night with Conan O’Brien, and even a recorded voice-over on the Pink Floyd song “Keep Talking.“ In 1992, Oscar-winning filmmaker Errol Morris released a documentary about Hawking’s life, aptly titled A Brief History of Time. Of course, as it is with any celebrity, fame has brought with it an interest in Hawking’s personal life. And there have been some news-making events. In 1990, Hawking left his wife, Jane, for one of his nurses, Elaine Mason. The two were married in 1995, and the marriage put a strain on Hawking’s relationship with his own children, who claimed Elaine closed off their father from them. In 2004, nurses looking after Hawking reported their suspicions to police that Elaine was physically abusing her husband. Hawking denied the allegations, and the police investigation was called off. In 2006, however, Hawking and Elaine filed for divorce. In the years since, the physicist has apparently grown closer with his family. He’s reconciled with Jane, who has remarried, and published a science book for children with his daughter, Lucy. Hawking’s health, of course, remains a constant concern – a worry that was heightened in early 2009 when he failed to appear at a conference in Arizona because of a chest infection. In April 2009, Hawking, who had already announced he was retiring after 30 years from the post of Lucasian Professor of Mathematics at Cambridge University, was rushed to the hospital for being what university officials described as “gravely ill.“ It was later announced that he was expected to make a full recovery.

 

Hawking is scheduled to fly to the edge of space as one of Sir Richard Branson’s pioneer space tourists. He said when asked about the subject in 2007, “Many people have asked me why I am taking this flight. I am doing it for many reasons. First of all, I believe that life on Earth is at an ever increasing risk of being wiped out by a disaster such as sudden global warming, nuclear war, a genetically engineered virus, or other dangers. I think the human race has no future if it doesn’t go into space. I therefore want to encourage public interest in space.“ In September 2010, Hawking spoke against the idea that God could have created the universe in his book The Grand Design. Hawking previously argued that belief in a creator could be compatible with modern scientific theories. His new work, however, concludes that the Big Bang was the inevitable consequence of the laws of physics and nothing more. “Because there is a law such as gravity, the universe can and will create itself from nothing,“ Hawking says. “Spontaneous creation is the reason there is something rather than nothing, why the universe exists, why we exist.“

The Grand Design is Hawking’s first major publication in almost a decade. Within his new work, Hawking sets out to challenge Sir Isaac Newton’s belief that the universe had to have been designed by God, simply because it could not have been born from chaos. “It is not necessary to invoke God to light the blue touch paper and set the universe going,“ Hawking said.

 

Hawking made news in 2012 for two very different projects. It was revealed in early April that he had participated in a 2011 trial of a new headband-styled device called the iBrain. The device is designed to “read“ the wearer’s thoughts by picking up “waves of electrical brain signals,“ which are then interpreted by a special algorithm, according to an article in The New York Times. This device could be a revolutionary aid to Hawking and others with ALS. Also around this time, Hawking showed off his humorous side on American television. He made a guest appearance on The Big Bang Theory, a popular comedy about a group of young, geeky scientists. Playing himself, Hawking brings the theoretical physicist Sheldon Cooper (Jim Parsons) back to Earth after finding an error in his work. Hawking earned kudos for this lighthearted effort. In 2014, Hawking spoke out about the possible dangers of artificial intelligence, or AI. His comments were inspired by the Johnny Depp film, Transcendence, which features clash between humanity and technology. In the Independent newspaper, Hawking wrote that “success in creating AI could be the biggest event in human history,“ but cautioned that “it might also be the last, unless we learn how to avoid the risks.“ He warned of a time when this technology would be “outsmarting financial markets, out-inventing human researchers, out-manipulating human leaders, and developing weapons we cannot even understand“ and called for more research to be done on all possible ramifications of AI. In November of the same year, a film about the life of Stephen Hawking was released. The Theory of Everything stars Eddie Redmayne as Hawking and encompasses his early life and school days, his courtship and marriage to Jane Wilde, the progression of his crippling disease, and his scientific triumphs.

 

Stem Cell Transplants May Halt Progression of Multiple Sclerosis

 

MS affects more than 2.3 million people worldwide and symptoms can vary widely and may include disturbances in speech, vision and movement. Most people with MS are diagnosed with relapsing-remitting multiple sclerosis (RRMS). RRMS is the most common form of MS, a progressive autoimmune disease in which the immune system attacks the brain and spinal cord. RRMS is characterized by periods of relapse or flare up of symptoms followed by periods of recovery or remission. Over years, the disease can worsen and shift to a more progressive form.

 

According to an article published online in JAMA Neurology (29 December 2014), three-year outcomes from an ongoing clinical trial suggest that high-dose immunosuppressive therapy followed by transplantation of a person’s own blood-forming stem cells may induce sustained remission in some people with RRMS. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded Immune Tolerance Network (ITN).

 

Results showed that three years after the treatment, called high-dose immunosuppressive therapy and autologous hematopoietic cell transplant or HDIT/HCT, nearly 80% of trial participants had survived without experiencing an increase in disability, a relapse of MS symptoms or new brain lesions. Few serious early complications or unexpected side effects were observed, although many participants experienced expected side effects of high-dose immunosuppression, including infections and gastrointestinal problems. The study tested the effectiveness of HDIT/HCT in 25 volunteers with RRMS who had relapsed and experienced worsened neurological disability while taking standard medications. For the study, blood-forming stem cells were collected from participants who then received high-dose chemotherapy to destroy their immune systems. After the chemotherapy regimen, the stem cells were returned to the participants to rebuild and reset their immune systems. Notably, participants did not receive any MS drugs after transplant, yet most remained in remission after three years. In contrast, other studies have shown that the best alternative MS treatments induce much shorter remissions and require long-term use of immunosuppressive drugs that can cause serious side effects. The authors plan to follow participants for a total of five years, recording all side effects associated with the treatment. Final results from this and similar studies promise to help inform the design of larger trials to further evaluate HDIT/HCT in people with MS.

 

Chronic High Blood Sugar May Be Detrimental to the Developing Brain of Young Children

 

NIH study shows young children with type 1 diabetes have significant difference in brain development

 

According to an article published online in the journal Diabetes (17 December 2014), young children who have long-term high blood sugar levels are more likely to have slower brain growth. While the authors did not find significant cognitive differences between the healthy children and those with type-1 diabetes, they believe a continuing study with the same groups of children may show changes there as well. According to the NIH, the findings could lead to a major shift in the way children with type 1diabetes are treated.

 

The study tracked 144 children ages 4 to 9 who had been living with type 1diabetes for an average of 2 and one-half years. The authors used MRI scans to examine brain structure and function in the children with type 1 diabetes compared with 72 healthy children, including siblings. The children were well-matched for age, body mass index and socioeconomic status. Results found significantly slower brain growth overall, as well as in specific brain regions. In addition to high blood sugar levels, researchers found that blood sugar levels often varied, spiking too high and dropping too low. These sharp swings raised concerns about the impact to brain function.

 

Traditionally, pediatricians have allowed young children with type 1 diabetes to maintain above-normal blood sugar levels. The theory was that it was safer to run high than low, since consistently low blood sugar levels could risk a child having a seizure. In contrast, the present study shows that chronic high blood sugar levels may slow growth in the brain’s gray matter, which affects cells and signals, as well as in the brain’s white matter, which affects the brain’s wiring.

 

FDA Approves Weight-Management Drug

 

Body mass Index (BMI), which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

 

The FDA has approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management, in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a BMI of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).

 

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively). However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.

 

The safety and effectiveness of Saxenda were evaluated in three clinical trials that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. All patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity. Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.5% from baseline compared to treatment with a placebo at one year. In this trial, 62% of patients treated with Saxenda lost at least 5% of their body weight compared with 34% of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7% from baseline compared to treatment with placebo at one year. In this trial, 49% of patients treated with Saxenda lost at least 5% of their body weight compared with 16% of patients treated with placebo.

 

Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working. If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

 

Saxenda has a boxed warning stating that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Saxenda but that it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Saxenda should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC).

 

Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate. In clinical trials, the most common side effects observed in patients treated with Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.

 

The FDA is requiring the following post-marketing studies for Saxenda:

 

1. clinical trials to evaluate dosing, safety, and efficacy in pediatric patients;

2. a study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rats;

3. an MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda; and

4. an evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials.

 

In addition, the cardiovascular safety of liraglutide is being investigated in an ongoing cardiovascular outcomes trial.

 

The FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda.

 

Saxenda is manufactured by Novo Nordisk A/S, Bagsvaerd, Denmark and is distributed by Novo Nordisk, Inc. Plainsboro, New Jersey.

 

Baked Apples with Candied Chestnut and Fresh Ginger

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While these stuffed apples are baking, breath in deeply; your kitchen will smell w o n d e r f u l! ©Joyce Hays, Target Health Inc.

 

Ingredients

 

4 sweet apples, like Golden Delicious or Red Delicious

1/2 cup candied chestnuts (in brandy, if you can find this)

2 Tablespoons finely grated ginger

2 Tablespoons unsalted butter

1/2 fresh lemon zest, then use the juice

Topping: Whipped Cream or No-Fat Cool Whip or Sour Cream

 

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Gather all ingredients in one place ©Joyce Hays, Target Health Inc.

 

Directions

 

  1. Preheat the oven to 350 degrees
  2. Cut each apple in half and remove the core and seeds. Keep the skin.
  3. Scoop out the apple flesh, but leave some attached to the apple skin, to support the skin. Brush the scooped out apple, with fresh lemon juice.
  4. 4. Place the scooped out the apple flesh on a cutting board and chop coarsely.
  5. Now, in a bowl, add to the chopped apple, the grated ginger, lemon zest, candied chestnuts and mix together

 

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6. Grease a baking dish with butter.

7. Fill the hollowed-out apples with the mixture of ginger, chopped apple, candied chestnuts and top each one off with a small lump of butter

 

 

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Going into the oven ©Joyce Hays, Target Health Inc.

 

8. Bake on the lowest oven rack for about 45 minutes (or less), until the apples are tender. Check on the apples every once in a while – if there are signs that anything is burning, turn down the heat. Dark brownish is fine.

9. Serve hot or warm, topping each apple with a teaspoon or more of the sour cream. (or yogurt, or whipped cream, or no-fat cool whip or even vanilla ice cream.)

 

 

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Just taken out of the oven and onto the table – nice and warm. ©Joyce Hays, Target Health Inc.

 

It was on a cold night during the holiday season and I was looking for comfort food that was also healthy with not too many calories. I made the baked apple in several ways and am showing you the version that worked the best for us. The version where I took the whole apple and just cut off the top and filled one whole apple, didn’t come out as well as I thought it would. Cutting an apple in half, is the best version. Instead of adding candied chestnuts, you could try adding grated cheese, but so far, I prefer the candied chestnuts which I found on Amazon – candied chestnuts in brandy.

 

Another ingredient that really adds a certain kick, is the freshly grated ginger

 

This baked apple recipe can be a dessert, but equally good, serve it as a side dish with chicken, turkey or fish. We don’t like pork, but probably the apple side dish would go well with pork.

 

Our meal started and ended with wine and cheese. When I lived in London, I had heard about a delicious English cheese called Cotswold, which is made with chives and onions blended in with the cheese, but only got around to sampling it this past week. Delicious with red or white wine!

 

On every list of winter comfort food should be a recipe for chili, which I served in earthen ware bowls, just to add to the cozy hominess. I also made my cauliflower dish made with truffle oil, which I will share in the newsletter soon. Because our son was staying with us for 17 days and is an LA kale person, I also served one of my versions of kale salad. (He ate a whole kale salad every single day). These comforting homey meals were so happy and cheerful. They made our holidays, joyful events that we will never forget.

 

Hope your holidays were filled with happiness and love.

 

 

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Wine and English Cotswold cheese – ©Joyce Hays, Target Health Inc.

 

Happy New Year

 

From Our Table to Yours!

 

Bon Appetit!