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Gene Therapy, New Drug Battle a Rare But Deadly Disease in Kids

WEDNESDAY, Nov. 1, 2017 (HealthDay News) — Babies born with a previously untreatable degenerative nerve disease now have two fresh sources of hope for their future. Two innovative new therapies for spinal muscular atrophy (SMA) type 1 have proven highly effective in clinical trials, researchers report. Babies with SMA are born without the gene that promotes production of survival motor neuron (SMN) protein. Without this protein, nerve cells in the spinal cord and brain stem stop working and start to die off. These babies slowly lose the ability to move their arms and legs. Those with the most severe form, SMA type 1, eventually lose the ability to breathe on their own and rarely survive beyond 2 years of age. Two research groups say they've produced breakthrough therapies for these children. First, a new genetic treatment employed a DNA-loaded virus to replace the missing SMN1 gene with a fresh, healthy copy of the gene. Second, an already-approved drug called nusinersen (Spinraza) was used to promote production of the crucial nerve protein by a backup gene called SMN2. Both approaches increased survival in babies with SMA and preserved or improved their motor function, the researchers said. "These are the first realistic treatment options for SMA," said Dr. Ans van der Ploeg. She is chair of the Center for Lysosomal and Metabolic Diseases at Erasmus MC University in Rotterdam, the Netherlands. Both therapies aim to increase production of SMN protein in the motor neurons and thereby improve the survival and function of motor neurons, she said. This leads to better muscle and respiratory function and survival, added van der Ploeg, who wrote an editorial accompanying the two clinical trial reports. About one in every 11,000 babies is born with SMA, and six in 10 of them have type 1, said Dr. Richard Finkel. He is chief of neurology at Nemours Children's Hospital in Orlando, Fla., and lead researcher of the nusinersen clinical trial. The gene therapy treatment was tested in 15 babies with SMA type 1. All received one intravenous dose of a genetically engineered virus containing the new copy of the SMN gene. The virus is named AVXS-101. This was a phase 1 trial to test safety. "We are trying to replace SMN1 with enough gene that works in enough nerve cells to change function," said lead researcher Dr. Jerry Mendell, director of neuromuscular disorders and neurosciences at Nationwide Children's Hospital in Columbus, Ohio. All 15 patients treated with AVXS-101 are still alive, Mendell said, and some are thriving. Higher doses produced better responses. "All the patients in the trial have improved with the exception of one," Mendell said. "We have patients living out past three years now. And we had patients who actually could walk and run and play." Nusinersen was tested in 80 babies at 31 hospitals as part of a phase III trial prior to its 2016 approval. "The drug is kind of novel," Finkel said. "It's not your standard off-the-shelf pharmacy kind of drug. It's similar to a little piece of DNA." The drug targets the SMN2 gene, a backup gene to the SMN1 gene missing in these babies. It is injected into the spinal fluid. Patients undergo four "loading doses" via lumbar punctures within the first two months, and receive maintenance doses every four months, Finkel said. Nusinersen amps up protein production by the SMN2 gene, potentially halting progression of nerve damage. In the trial, 41 percent of infants who received the earliest treatment with nusinersen and 51 percent of infants in the final analysis experienced stable or improved motor function, the researchers reported. Babies treated with nusinersen also were more likely to survive. The risk of death was 63 percent lower in the nusinersen group compared with the control group, the findings showed. Results were so promising that the clinical trial was halted early so the control group could receive nusinersen, the study authors said. "This study shows the drug has a clinically meaningful response with a higher likelihood of improved survival and motor function," Finkel said. Nusinersen, made by Biogen, is available for treatment now. AVXS-101 will proceed to broader clinical trials involving more children at multiple hospitals, Mendell said. Neither treatment had any clinically significant side effects, according to the researchers. The treatments do not constitute a full cure for children who have already developed symptoms of SMA. However, both research teams hope that kids treated before symptoms arise won't suffer any degenerative nerve loss. Finkel said, "If we can get these babies before they show these signs of weakness, I think that's going to give the best chance for the most robust response, possibly even a cure." Van der Ploeg added that younger, less severely affected patients had a better chance of a good response in the trials. Also, while the gene therapy pilot trial results are promising, more data are required, she noted. The nusinersen trial was paid for by Biogen and the drug's developer, Ionis Pharmaceuticals. The AVXS-101 trial received funding from AveXis, developer of the designer virus. Results of the studies were published in the Nov. 2 issue of the New England Journal of Medicine. More information For more on spinal muscular atrophy, visit the Nemours Foundation. Let's block ads! (Why?) Original Article

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Liposuction May Ease Limb Swelling in Cancer Patients

WEDNESDAY, Nov. 1, 2017 (HealthDay News) — Liposuction may help people with lymphedema — a painful, disfiguring swelling of the arms, hands, legs or feet. Harvard researchers used the surgical technique to remove fat from just underneath the skin in three people with the condition. Two of the patients had lymphedema as a side effect of cancer treatment. The other one had a naturally developing form of lymphedema. In all three cases, there was improvement in the lymphedema after liposuction, the researchers said. And the improvement appears to be more effective and lasting than expected. One patient has had more than five years of follow-up. "Liposuction is extremely effective at removing fat from underneath the skin, which makes the arm or leg smaller," explained study author Dr. Arin Greene, director of the lymphedema program at Boston Children's Hospital. "And the new data show that the surgery improves lymphatic flow and increases quality of life. It actually allows the underlying lymphatic system to move the fluid," he said. But Greene did have a word of caution. "This is not a cure. It improves lymphatic flow, but people still need to take conservative measures, such as wearing compression garments," he noted. Greene said cancer probably causes about 99 percent of lymphedema cases. Another 1 percent have it due to a developmental problem. The reason people get lymphedema after cancer treatment is because when cancer spreads to lymph nodes, those nodes need to be removed. In this process, part of the lymph vessels attached to the node are also removed. Lymph nodes and vessels are part of the body's immune system. When removed, the body's natural drainage system for lymph fluid is disrupted and fluid builds up, sometimes to extreme levels, according to the American Cancer Society. Radiation therapy also can damage nodes and vessels or cause scarring that blocks drainage. Lymphedema can be very uncomfortable and cause a feeling of heaviness. Skin can feel tight. Wounds may heal more slowly, and lymphedema can cause reduced flexibility, the cancer society says. About 200 million people have lymphedema worldwide, according to the study authors. Treatment typically includes wearing compression garments and getting a special type of massage that helps promote fluid drainage. The study patients who had liposuction only had the procedure on an affected limb. They didn't have liposuction on their hands or feet. However, the two patients who had liposuction on their arm also saw improvement in their hand, and the one who had liposuction on her leg had improvement in the lymphedema affecting her foot. Greene said this was unexpected. He has several theories as to why liposuction was more effective than expected, though he emphasized that none are yet proven. One theory is that by removing the fat, pressure is taken off of the remaining lymph nodes and vessels, allowing them to function better. Another theory is that the fat may make fluid, too, so removing it might mean less overall fluid. Dr. Douglas Roth, chief of plastic and reconstructive surgery at Northern Westchester Hospital in Mount Kisco, N.Y., was impressed with the study's results. "As a plastic surgeon, I was taught to stay away from areas with lymphedema. The tissue is already compromised, making concerns about complications more significant. These areas need to be treated very, very carefully," said Roth, who was not involved with the study. "But this is definitely a breakthrough in thinking about the treatment of this problem, and it's a brand new procedure that could be very helpful," Roth said. He added that while the procedure hasn't been used for lymphedema in the United States, it has been used in Europe and Australia for about 10 years. Still, Roth said he'd want to see a larger trial on a U.S. population before he would consider it. Greene said insurance covered all three procedures. Roth said insurance companies would likely pay for liposuction done for a medical reason, such as lymphedema. When done on a purely cosmetic basis, liposuction is about $7,000 to $9,000 for the surgeon's fee and the operating room time, Roth estimated. The study was published Nov. 1 in the New England Journal of Medicine. More information To learn more about lymphedema, visit the American Cancer Society. Let's block ads! (Why?) Original Article

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Long Spaceflights Could Put Pressure on the Brain

WEDNESDAY, Nov. 1, 2017 (HealthDay News) — The brains of astronauts who spend months in space appear to shift upward inside their skulls by the time they return to Earth, a new study finds. The repercussions, if any, are uncertain for now, researchers said. It's not clear how quickly the brain might settle back into its rightful place once Earth's gravity has taken hold, said lead researcher Dr. Donna Roberts. But one concern is this: If the brain moves upward, it could compress a major vein that drains blood from the head — possibly increasing pressure within the skull. And in fact, it's already known that some astronauts have returned from the International Space Station with vision problems. NASA has dubbed the phenomenon "visual impairment and intracranial pressure" syndrome, or VIIP. Roberts said her team suspects the brain's upward shift can help explain VIIP — though it's too early to say for sure. The findings raise other questions, according to Roberts, an associate professor at the Medical University of South Carolina in Charleston. Specifically, what might happen to the human brain during deeper space travel? That's a possibility in the not-too-distant future, as NASA has laid out plans for getting humans to Mars by the 2030s. "If we see these brain changes after a few months on [the space station]," Roberts said, "what might happen on a mission to Mars?" A journey to Mars can take three to six months. Then, to reduce travel time between the Earth and Mars, the two planets need to be aligned favorably, which occurs approximately every two years, Roberts explained. The study findings, published Nov. 2 in the New England Journal of Medicine, are based on MRI brain scans of 34 astronauts. Eighteen had been on space station missions, averaging 165 days; the rest had been on shuttle missions, averaging 14 days. All the astronauts had brain scans taken before the mission, then again about a week after they'd returned. The researchers were able to look for certain structural changes in a subgroup of 18 astronauts. It turned out that all 12 space station astronauts showed an upward shift in the brain, versus none of the six who'd returned from a short-term mission. Similarly, the space station astronauts were much more likely to show a narrowing in the cerebrospinal fluid spaces at the top of the brain. Rachael Seidler, a professor at the University of Florida in Gainesville, is leading a NASA-sponsored study looking into the effects of prolonged spaceflight on movement, thinking and behavior. She described the dynamics of what the latest study showed in basic terms: The Earth's gravitational pull normally draws fluids downward in the body. But in the microgravity of space, more cerebrospinal fluid can build up around the brain — which pushes it up. "In a sense, the brain is getting a little squished," Seidler said. More work is needed to know what it all could mean. "How long do the [brain] changes last?" Seidler said. "Are there effects on behavior or physical performance?" Astronauts have, of course, been traveling to and from space for decades. And scientists have long studied the effects on the heart, bones and other body systems, Roberts said. The brain, however, has gotten little attention. That started changing in recent years, Roberts said, with the emergence of VIIP — which has cropped up almost exclusively after long-term missions. But the questions go beyond VIIP, according to Seidler. For example, she said, what happens when the brain is no longer getting normal sensory information from the legs for months? What are the effects of having the vestibular (balance) system thrown off by being in microgravity 24/7? Studying those questions, Seidler said, could help in better understanding earthly conditions, too — such as cases where people are on prolonged bed rest. This postflight MRI video shows an upward shift of the brain and narrowing of cerebrospinal spaces at the top of the brain of a NASA astronaut aboard the International Space Station. Video courtesy Dr. Donna Roberts. More information For more on the effects of spaceflight on the human body, visit NASA. Let's block ads! (Why?) Original Article

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U.S. Preemie Birth Rates Rise 2 Years in a Row

WEDNESDAY, Nov. 1, 2017 (HealthDay News) — After nearly a decade of decline, the preterm birth rate in the United States has risen for the second year in a row, the March of Dimes reports. And racial and ethnic disparities are driving the increase, the group added. The premature birth rate rose from 9.63 percent in 2015 to 9.8 percent in 2016, and the number of preterm births increased by 8,000, according to the group's new report. The premature birth rate was 9.57 percent in 2014, according to the March of Dimes. "The U.S. preterm birth rate is among the worst of highly developed nations," said Stacey Stewart, president of the March of Dimes. "This report card is a public wake-up call, an urgent call to action on the health of our nation's moms and babies." Compared to white women, black women are 49 percent more likely to deliver preterm. For American Indian/Alaska Native women, the number is 18 percent. "Moms and babies face a higher risk of preterm birth based on race and zip code," Stewart said in a March of Dimes news release. A baby born before 37 weeks of pregnancy is considered premature. A full-term birth is around 40 weeks. Each year, more than 380,000 babies are born preterm in the United States, putting them at increased risk of death before their first birthday, lifelong disabilities and chronic health conditions. Preterm birth is the leading cause of infant death in the United States, the organization says. And preterm birth is associated with more than $26 billion annually in avoidable medical and societal costs, according to the National Academy of Medicine. "We must address the social and environmental factors that impact health," said Dr. Paul Jarris, chief medical officer of the March of Dimes. "Only by improving the broader social context for health will we be able to level the playing field for mothers and babies in every community." More information The U.S. National Institute of Child Health and Human Development has more on preterm labor and birth. Let's block ads! (Why?) Original Article

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Americans Stressed About Nation’s Future, Poll Finds

WEDNESDAY, Nov. 1, 2017 (HealthDay News) — It's a high-anxiety time: Nearly two-thirds of Americans are stressed out by thinking about the future of the United States, a new survey finds. Stress rates tied to worries about where the nation is headed were slightly higher than rates for "regular" sources of stress, such as money and work. "We're seeing significant stress transcending party lines," Arthur Evans Jr., chief executive officer of the American Psychological Association, said in a news release from the group, which sponsored the poll. About 63 percent of survey respondents cited the country's future as a very or somewhat significant source of stress, versus 62 percent who acknowledged financial stress and 61 percent who cited job-related stress. The survey of more than 3,400 adults, conducted in August, found that 59 percent of respondents said they consider this the lowest point in American history that they can remember. Poll participants included people who had lived through World War II, the Vietnam War, the Cuban Missile Crisis and the Sept. 11 terrorist attacks. Roughly six in 10 people cited current social divisions in the nation as the cause of stress. "The uncertainty and unpredictability tied to the future of our nation is affecting the health and well-being of many Americans in a way that feels unique to this period in recent history," Evans said. Among respondents, proportionately more Democrats saw the country's future as stressful: 73 percent, versus 56 percent of Republicans and 59 percent of independents. When thinking about the future of the United States, the issues most often identified as stress-inducing were: health care (cited by 43 percent of respondents); the economy (35 percent); trust in government (32 percent); hate crimes (31 percent); crime (31 percent); wars/conflicts with other countries (30 percent); terrorist attacks in the United States (30 percent); unemployment and low wages (22 percent); and climate change and environmental issues (21 percent). The state of the nation has led 51 percent of poll respondents to volunteer for or support causes important to them. The findings showed that 59 percent have taken some form of action in the past year, including 28 percent who signed a petition, and 15 percent who boycotted a company or product because of its social or political views or actions. The survey also found that while 95 percent of respondents follow the news regularly, 56 percent said that doing so causes them stress, and 72 percent believe the media exaggerates issues. "With 24-hour news networks and conversations with friends, family and other connections on social media, it's hard to avoid the constant stream of stress around issues of national concern," Evans said. "These can range from mild, thought-provoking discussions to outright, intense bickering, and over the long term, conflict like this may have an impact on health," he said. "Understanding that we all still need to be informed about the news, it's time to make it a priority to be thoughtful about how often and what type of media we consume." Results of the poll, "Stress in America: The State of Our Nation," were released Nov. 1. More information The U.S. National Institute of Mental Health has more on stress. Let's block ads! (Why?) Original Article

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“Fifty Shades of Grey” Sex Toys Strike a Nerve

Yes, the slap-and-tickle fest that is Fifty Shades of Grey just keeps rolling right along: Sexy themed merchandise, inspired by the flick, has hit the shelves at Target stores nationwide. Yes, the slap-and-tickle fest that is Fifty Shades of Grey just keeps rolling right along: Sexy themed merchandise, inspired by the flick, is hitting the shelves at Target stores nationwide. "The Official Pleasure Collection," as it's called, features such items as a Fifty Shades Yours and Mine Vibrating Silicone Love Ring (guaranteed to stretch "to accommodate his girth," $15, target.com), a No Peeking Soft Twin Blindfold Set ("take it in turns to sink into submission"), and "Silky Caress Silk Lubricant." Employees have been told to place the provocative items in the back of the "adult health section," sandwiched, one would assume, somewhere between the condoms and yeast infection creams. But a cheeky salesperson at one Target decided to display the Fifty Shades goodies in a far more interesting location next to the children's toothbrushes ("Clean up on Aisle 7!"). Personally, I would have gone with the Cadbury Créme Eggs or cast-iron skillets, but whatever… Those looking for something slightly more tame might want to peruse the offerings online. Among them: a metallic silver FSOG iPhone case; OPI nail polish (with names like "My Silk Tie" and "Dark Side of the Mood"); even a Christian Grey Bear from the Vermont Teddy Bear Company (for those who "want to dominate Valentine's day"), his paws clutching a satin eye mask and teeny pair of handcuffs. Time editor Belinda Luscombe (let's just call her Belinda "Killjoy" Luscombe), who's been covering the FSOG phenomenon for the magazine, isn't convinced that this kind of sex will sell, opining, "I'm actually dubious about the connection between sales of the items that, you know, for the bedroom and the book and the movie. I think that you see a little spike as people's curiosity goes up, but I don't think that it's lasting." But Luscombe may be underestimating the spunk, up-for-anything spirit of the American public: Studies show that after the novel's release, sales of sex-themed products like toys, videos, and more increased by 7.5%, according to a report from the research firm IBISWorld. That's a whole lot of soccer moms. Somewhere, deep inside in a dungeon in New York's West Village, a dominatrix is weeping. Let's block ads! (Why?) Original Article

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Kidney Failure Can Isolate Young Patients

FRIDAY, Oct. 20, 2017 (HealthDay News) — Kidney failure takes an especially tough toll on young adults, affecting their employment and relationships, researchers report. Young people with kidney failure are less likely to have jobs or be in long-term relationships than others their age, according to a new British research review. "It is vital to understand how kidney failure affects social goals, because by defining these we can seek interventions to improve areas of deficit," said Dr. Alexander Hamilton, of the University of Bristol in England. His team analyzed 60 published studies that included nearly 16,000 kidney failure patients aged 16 to 30. They were either on dialysis or had received a kidney transplant. Compared to their healthy peers, these young people had a worse quality of life and were more likely to be unemployed and to live in their parents' home, the study found. They also were less likely to be married or have a romantic partner. These social, employment and lifestyle issues were worse among those on dialysis than among those who'd had a kidney transplant, the researchers said. There were no differences between kidney failure patients and their healthy peers in terms of education levels or rates of smoking and drinking. The study was published in the Oct. 19 issue of the Clinical Journal of the American Society of Nephrology. "We know that most young people with end-stage kidney disease have a kidney transplant, but they are high-risk for the transplanted kidney to fail," Hamilton said in a journal news release. While much attention has been paid to the transition between pediatric and adult care for kidney patients, he said it's also essential to look at the social ramifications among this younger adult age group. "These areas really matter to patients," Hamilton said. More information The American Kidney Fund has more on kidney failure. Let's block ads! (Why?) Original Article

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How Many Mutant Genes Drive Cancer?

FRIDAY, Oct. 20, 2017 (HealthDay News) — Depending on the cancer, between one and 10 genetic mutations are needed to trigger the development of tumors, a new study reports. "We have addressed a longstanding question in cancer research that has been debated since the 1950s: How many mutations are needed for a normal cell to turn into a cancer cell?" said study author Peter Campbell, with the Wellcome Trust Sanger Institute in Cambridge, England. "The answer is — a small handful," he added. "For example, about four mutations per patient, on average, drive liver cancers, whereas colorectal cancers typically require 10 or so driver mutations." The findings, culled from analyses of more than 7,600 tumors from 29 types of cancer, could help lead to more targeted therapies for treatment, the researchers said. The researchers explained that they developed a way to determine which genes are involved in cancer evolution and how many mutations in those genes drive cancer. It may someday be possible to use such approaches to identify which mutations are responsible for an individual patient's cancer, the researchers said. Study co-author Inigo Martincorena is also a research scientist at Wellcome Trust. "In the study, we revealed that around half of these key mutations driving cancer occur in genes that are not yet identified as cancer genes," he said in an institute news release. "There is already much insight into the most important genes involved in cancer; but there are many more genes yet to be discovered," Martincorena said. "We will need to bring together even larger numbers of cancers studied by DNA sequencing, into the tens of thousands, to find these elusive genes." The researchers also found that the mutations responsible for cancer are usually well-tolerated by cells in the body. This was surprising because mutations that people inherit from their parents are often poorly tolerated and are generally eliminated over generations, the researchers said. "This research shows that across cancer types a relatively consistent small number of such mutated genes is required to convert a single normal cell into a cancer cell, but that the specific genes chosen differ according to cancer type," said study co-author Mike Stratton, director of the institute. "The study also shows that we have not yet identified many of these driver genes, and they will be the target for further searching in the future. This increasingly precise understanding of the underlying changes that result in cancer provides the foundation for the discovery and use of targeted therapies that treat the disease," Stratton said. The study was published Oct. 19 in the journal Cell. More information The American Cancer Society has more on cancer. Let's block ads! (Why?) Original Article

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Yoga + Aerobics Doubles Heart Benefits

FRIDAY, Oct. 20, 2017 (HealthDay News) — A combination of yoga and aerobic exercise may benefit people with heart disease, according to a new study. "Combined Indian yoga and aerobic exercise reduce mental, physical and vascular stress and can lead to decreased cardiovascular mortality and morbidity," said study authors Sonal Tanwar and Dr. Naresh Sen, from Hridaya Ganesha Sunil Memorial Superspeciality Hospital in Jaipur, India. The study included 750 obese Indian heart disease patients with type 2 diabetes. They were divided into three groups. A group of 225 patients did aerobic exercise, a group of 240 did yoga, and the remaining 285 did both. All three groups saw improvements in their heart disease risk factors after participating in three sessions of the activities lasting six months each. Blood pressure went down similarly for the aerobic exercise-only and yoga-only groups. These groups also had similar improvements in total cholesterol, triglycerides and bad LDL cholesterol. Weight and waist circumference also went down similarly for both of these groups, the study said. But patients who did both yoga and aerobic exercise had two times greater reductions for those measures than the other groups. They also had significant improvements in heart function and exercise capacity, the researchers said. The study was to be presented Thursday at the Emirates Cardiac Society Congress. This meeting is in collaboration with the American College of Cardiology Middle East Conference, in Dubai. "Heart disease patients could benefit from learning Indian yoga and making it a routine part of daily life," Tanwar and Sen said in a meeting news release. Findings presented at meetings are typically viewed as preliminary until published in a peer-reviewed journal. More information The U.S. Centers for Disease Control and Prevention has more on heart disease. Let's block ads! (Why?) Original Article

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